CODE OF FEDERAL REGULATIONS
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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows:
Title 1 through Title 16
Title 17 through Title 27
Title 28 through Title 41
Title 42 through Title 50
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Title 42—
The OMB control numbers for the Centers for Medicare & Medicaid Services appear in § 400.310 of chapter IV. For the convenience of the user, subpart C consisting of §§ 400.300-400.310 is reprinted in the Finding Aids section of the third volume.
(This book contains parts 1 to 399)
Sec. 408 of Pub. L. 92-255, 86 Stat. 79, as amended by sec. 303 (a), (b) of Pub L. 93-282, 83 Stat. 137, 138; sec. 4(c)(5)(A) of Pub. L. 94-237, 90 Stat. 244; sec. 111(c)(3) of Pub. L. 94-581, 90 Stat. 2852; sec. 509 of Pub. L. 96-88, 93 Stat. 695; sec. 973(d) of Pub. L. 97-35, 95 Stat. 598; and transferred to sec. 527 of the Public Health Service Act by sec. 2(b)(16)(B) of Pub. L. 98-24, 97 Stat. 182 and as amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290ee-3) and sec. 333 of Pub. L. 91-616, 84 Stat. 1853, as amended by sec. 122(a) of Pub. L. 93-282, 88 Stat. 131; and sec. 111(c)(4) of Pub. L. 94-581, 90 Stat. 2852 and transferred to sec. 523 of the Public Health Service Act by sec. 2(b)(13) of Pub. L. 98-24, 97 Stat. 181 and as amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290dd-3), as amended by sec. 131 of Pub. L. 102-321, 106 Stat. 368, (42 U.S.C. 290dd-2).
The restrictions of these regulations upon the disclosure and use of drug abuse patient records were initially authorized by section 408 of the Drug Abuse Prevention, Treatment, and Rehabilitation Act (21 U.S.C. 1175). That section as amended was transferred by Pub. L. 98-24 to section 527 of the Public Health Service Act which is codified
(a)
Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.
(b)
(1) The content of any record referred to in subsection (a) of this section may be disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed under regulations prescribed pursuant to subsection (g) of this section.
(2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows:
(A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
(B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner.
(C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure.
(c)
Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record referred to in subsection (a) of this section may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient.
(d)
The prohibitions of this section continue to apply to records concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.
(e)
The prohibitions of this section do not apply to any interchange of records—
(1) within the Armed Forces or witrhin those components of the Veterans' Administration furnishing health care to veterans, or
(2) between such components and the Armed Forces.
The prohibitions of this section do not apply to the reporting under State law of incidents of suspected child abuse and neglect to the appropriate State or local authorities.
(f)
Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined not more than $500 in the case of a first offense, and not nore than $5,000 in the case of each subsequent offense.
(g)
Except as provided in subsection (h) of this section, the Secretary, after consultation with the Administrator of Veterans' Affairs and the heads of other Federal departments and agencies substantially affected thereby, shall prescribe regulations to carry out the purposes of this section. These regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection (b)(2)(C) of this section, as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.
The restrictions of these regulations upon the disclosure and use of alcohol
(a)
Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to alcoholism or alcohol abuse education, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.
(b)
(1) The content of any record referred to in subsection (a) of this section may be disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed under regulations prescribed pursuant to subsection (g) of this section.
(2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows:
(A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
(B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner.
(C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure.
(c)
Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record referred to in subsection (a) of this section may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient.
(d)
The prohibitions of this section continue to apply to records concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.
(e)
The prohibitions of this section do not apply to any interchange of records—
(1) within the Armed Forces or within those components of the Veterans' Administration furnishing health care to veterans, or
(2) between such components and the Armed Forces.
(f)
Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense.
(g)
Except as provided in subsection (h) of this section, the Secretary shall prescribe regulations to carry out the purposes of this section. These regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection(b)(2)(C) of this section, as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.
(a)
(1) Definitions, applicability, and general restrictions in subpart B (definitions applicable to § 2.34 only appear in that section);
(2) Disclosures which may be made with written patient consent and the form of the written consent in subpart C;
(3) Disclosures which may be made without written patient consent or an authorizing court order in subpart D; and
(4) Disclosures and uses of patient records which may be made with an authorizing court order and the procedures and criteria for the entry and scope of those orders in subpart E.
(b)
(2) These regulations are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. They are intended to insure that an alcohol or drug abuse patient in a federally assisted alcohol or drug abuse program is not made more vulnerable by reason of the availability of his or her patient record than an individual who has an alcohol or drug problem and who does not seek treatment.
(3) Because there is a criminal penalty (a fine—see 42 U.S.C. 290ee-3(f), 42 U.S.C. 290dd-3(f) and 42 CFR 2.4) for violating the regulations, they are to be construed strictly in favor of the potential violator in the same manner as a criminal statute (see
Under 42 U.S.C. 290ee-3(f) and 42 U.S.C. 290dd-3(f), any person who violates any provision of those statutes or these regulations shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense.
(a) The report of any violation of these regulations may be directed to the United States Attorney for the judicial district in which the violation occurs.
(b) The report of any violation of these regulations by a methadone program may be directed to the Regional Offices of the Food and Drug Administration.
For purposes of these regulations:
(a) Who is a patient or employee of a program or who becomes a patient or employee of a program at the request of a law enforcement agency or official: and
(b) Who at the request of a law enforcement agency or official observes one or more patients or employees of
(a) An individual or entity (other than a general medical care facility) who holds itself out as providing, and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment; or
(b) An identified unit within a general medical facility which holds itself out as providing, and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment; or
(c) Medical personnel or other staff in a general medical care facility whose primary function is the provision of alcohol or drug abuse diagnosis, treatment or referral for treatment and who are identified as such providers. (See § 2.12(e)(1) for examples.)
(a) In the case of a program which is an individual, that individual:
(b) In the case of a program which is an organization, the individual designated as director, managing director, or otherwise vested with authority to act as chief executive of the organization.
(a) Provides services to a program, such as data processing, bill collecting, dosage preparation, laboratory analyses, or legal, medical, accounting, or other professional services, or services to prevent or treat child abuse or neglect, including training on nutrition and child care and individual and group therapy, and
(b) Has entered into a written agreement with a program under which that person:
(1) Acknowledges that in receiving, storing, processing or otherwise dealing with any patient records from the progams, it is fully bound by these regulations; and
(2) If necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by these regulations.
(a)
(i) Would identify a patient as an alcohol or drug abuser either directly, by reference to other publicly available information, or through verification of such an identification by another person; and
(ii) Is drug abuse information obtained by a federally assisted drug abuse program after March 20, 1972, or is alcohol abuse information obtained by a federally assisted alcohol abuse program after May 13, 1974 (or if obtained before the pertinent date, is maintained by a federally assisted alcohol or drug abuse program after that date as part of an ongoing treatment episode which extends past that date) for the purpose of treating alcohol or drug abuse, making a diagnosis for that treatment, or making a referral for that treatment.
(2)
(b)
(1) It is conducted in whole or in part, whether directly or by contract or otherwise by any department or agency of the United States (but see paragraphs (c)(1) and (c)(2) of this section relating to the Veterans' Administration and the Armed Forces);
(2) It is being carried out under a license, certification, registration, or other authorization granted by any department or agency of the United States including but not limited to:
(i) Certification of provider status under the Medicare program;
(ii) Authorization to conduct methadone maintenance treatment (see 21 CFR 291.505); or
(iii) Registration to dispense a substance under the Controlled Substances Act to the extent the controlled substance is used in the treatment of alcohol or drug abuse;
(3) It is supported by funds provided by any department or agency of the United States by being:
(i) A recipient of Federal financial assistance in any form, including financial assistance which does not directly pay for the alcohol or drug abuse diagnosis, treatment, or referral activities; or
(ii) Conducted by a State or local government unit which, through general or special revenue sharing or other forms of assistance, receives Federal funds which could be (but are not necessarily) spent for the alcohol or drug abuse program; or
(4) It is assisted by the Internal Revenue Service of the Department of the Treasury through the allowance of income tax deductions for contributions to the program or through the granting of tax exempt status to the program.
(c)
(2)
(i) Any interchange of that information within the Armed Forces; and
(ii) Any interchange of that information between the Armed Forces and
(3)
(i) Within a program or
(ii) Between a program and an entity that has direct administrative control over the program.
(4)
(5)
(i) Are directly related to a patient's commission of a crime on the premises of the program or against program personnel or to a threat to commit such a crime; and
(ii) Are limited to the circumstances of the incident, including the patient status of the individual committing or threatening to commit the crime, that individual's name and address, and that individual's last known whereabouts.
(6)
(d)
(2)
(i) Third party payers with regard to records disclosed to them by federally assisted alcohol or drug abuse programs;
(ii) Entities having direct administrative control over programs with regard to information communicated to them by the program under § 2.12(c)(3); and
(iii) Persons who receive patient records directly from a federally assisted alcohol or drug abuse program and who are notified of the restrictions on redisclosure of the records in accordance with § 2.32 of these regulations.
(e)
(2)
(3)
(4)
(i) Diagnosis which is made solely for the purpose of providing evidence for use by law enforcement authorities; or
(ii) A diagnosis of drug overdose or alcohol intoxication which clearly shows that the individual involved is not an alcohol or drug abuser (e.g., involuntary ingestion of alcohol or drugs or reaction to a prescribed dosage of one or more drugs).
(a)
(b)
(c)
(2) Any answer to a request for a disclosure of patient records which is not permissible under these regulations must be made in a way that will not affirmatively reveal that an identified individual has been, or is being diagnosed or treated for alcohol or drug abuse. An inquiring party may be given a copy of these regulations and advised that they restrict the disclosure of alcohol or drug abuse patient records, but may not be told affirmatively that the regulations restrict the disclosure of the records of an identified patient. The regulations do not restrict a disclosure that an identified individual is not and never has been a patient.
(a)
(b)
(c)
(2) Where State law requires parental consent to treatment the fact of a minor's application for treatment may be communicated to the minor's parent, guardian, or other person authorized under State law to act in the minor's behalf only if:
(i) The minor has given written consent to the disclosure in accordance with subpart C of these regulations or
(ii) The minor lacks the capacity to make a rational choice regarding such consent as judged by the program director under paragraph (d) of this section.
(d)
(1) A minor applicant for services lacks capacity because of extreme youth or mental or physical condition to make a rational decision on whether to consent to a disclosure under subpart C of these regulations to his or her parent, guardian, or other person authorized under State law to act in the minor's behalf, and
(2) The applicant's situation poses a substantial threat to the life or physical well being of the applicant or any other individual which may be reduced by communicating relevant facts to the minor's parent, guardian, or other person authorized under State law to act in the minor's behalf.
(a)
(2)
(b)
(2)
(a) Written records which are subject to these regulations must be maintained in a secure room, locked file cabinet, safe or other similar container when not in use; and
(b) Each program shall adopt in writing procedures which regulate and control access to and use of written records which are subject to these regulations.
(a)
(b)
No person may require any patient to carry on his or her person while away from the program premises any card or other object which would identify the patient as an alcohol or drug abuser. This section does not prohibit a person from requiring patients to use or carry cards or other identification objects on the premises of a program.
(a)
(1) The patient who is the subject of the records gives written consent (meeting the requirements of § 2.31) to a transfer of the records to the acquiring program or to any other program designated in the consent (the manner of obtaining this consent must minimize the likelihood of a disclosure of patient identifying information to a third party); or
(2) There is a legal requirement that the records be kept for a period specified by law which does not expire until after the discontinuation or acquisition of the program.
(b)
(1) Sealed in envelopes or other containers labeled as follows: “Records of [insert name of program] required to be maintained under [insert citation to statute, regulation, court order or other legal authority requiring that records be kept] until a date not later than [insert appropriate date]”; and
(2) Held under the restrictions of these regulations by a responsible person who must, as soon as practicable
The statutes authorizing these regulations (42 U.S.C. 290ee-3 and 42 U.S.C. 290dd-3) do not preempt the field of law which they cover to the exclusion of all State laws in that field. If a disclosure permitted under these regulations is prohibited under State law, neither these regulations nor the authorizing statutes may be construed to authorize any violation of that State law. However, no State law may either authorize or compel any disclosure prohibited by these regulations.
(a)
(b)
(a)
(1) Communicate to the patient that Federal law and regulations protect the confidentiality of alcohol and drug abuse patient records; and
(2) Give to the patient a summary in writing of the Federal law and regulations.
(b)
(1) A general description of the limited circumstances under which a program may acknowledge that an individual is present at a facility or disclose outside the program information identifying a patient as an alcohol or drug abuser.
(2) A statement that violation of the Federal law and regulations by a program is a crime and that suspected violations may be reported to appropriate authorities in accordance with these regulations.
(3) A statement that information related to a patient's commission of a crime on the premises of the program or against personnel of the program is not protected.
(4) A statement that reports of suspected child abuse and neglect made under State law to appropriate State or local authorities are not protected.
(5) A citation to the Federal law and regulations.
(c)
(d)
The confidentiality of alcohol and drug abuse patient records maintained by this program is protected by Federal law and regulations. Generally, the program may not say to a person outside the program that a patient attends the program, or disclose any information identifying a patient as an alcohol or drug abuser
(1) The patient consents in writing:
(2) The disclosure is allowed by a court order; or
(3) The disclosure is made to medical personnel in a medical emergency or to qualified personnel for research, audit, or program evaluation.
Violation of the Federal law and regulations by a program is a crime. Suspected violations may be reported to appropriate authorities in accordance with Federal regulations.
Federal law and regulations do not protect any information about a crime committed by a patient either at the program or against any person who works for the program or about any threat to commit such a crime.
Federal laws and regulations do not protect any information about suspected child abuse or neglect from being reported under State law to appropriate State or local authorities.
(a)
(b)
(a)
(1) The specific name or general designation of the program or person permitted to make the disclosure.
(2) The name or title of the individual or the name of the organization to which disclosure is to be made.
(3) The name of the patient.
(4) The purpose of the disclosure.
(5) How much and what kind of information is to be disclosed.
(6) The signature of the patient and, when required for a patient who is a minor, the signature of a person authorized to give consent under § 2.14; or, when required for a patient who is incompetent or deceased, the signature of a person authorized to sign under § 2.15 in lieu of the patient.
(7) The date on which the consent is signed.
(8) A statement that the consent is subject to revocation at any time except to the extent that the program or person which is to make the disclosure has already acted in reliance on it. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third party payer.
(9) The date, event, or condition upon which the consent will expire if not revoked before. This date, event, or condition must insure that the consent will last no longer than reasonably necessary to serve the purpose for which it is given.
(b)
(c)
(1) Has expired;
(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through a reasonable effort could be known, by the person holding the records to be materially false.
This information has been disclosed to you from records protected by Federal confidentiality rules (42 CFR part 2). The Federal rules prohibit you from making any further disclosure of this information unless further disclosure is expressly permitted by the written consent of the person to whom it pertains or as otherwise permitted by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. The Federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.
If a patient consents to a disclosure of his or her records under § 2.31, a program may disclose those records in accordance with that consent to any individual or organization named in the consent, except that disclosures to central registries and in connection with criminal justice referrals must meet the requirements of §§ 2.34 and 2.35, respectively.
(a)
(b)
(1) The disclosure is made when:
(i) The patient is accepted for treatment;
(ii) The type or dosage of the drug is changed; or
(iii) The treatment is interrupted, resumed or terminated.
(2) The disclosure is limited to:
(i) Patient identifying information;
(ii) Type and dosage of the drug; and
(iii) Relevant dates.
(3) The disclosure is made with the patient's written consent meeting the requirements of § 2.31, except that:
(i) The consent must list the name and address of each central registry and each known detoxification or maintenance treatment program to which a disclosure will be made; and
(ii) The consent may authorize a disclosure to any detoxification or maintenance treatment program established within 200 miles of the program after the consent is given without naming any such program.
(c)
(d)
(1) The name, address, and telephone number of the member program(s) in which the patient is already enrolled to the inquiring member program; and
(2) The name, address, and telephone number of the inquiring member program to the member program(s) in which the patient is already enrolled. The member programs may communicate as necessary to verify that no error has been made and to prevent or eliminate any multiple enrollment.
(e)
(a) A program may disclose information about a patient to those persons within the criminal justice system which have made participation in the program a condition of the disposition of any criminal proceedings against the patient or of the patient's parole or other release from custody if:
(1) The disclosure is made only to those individuals within the criminal justice system who have a need for the information in connection with their duty to monitor the patient's progress (e.g., a prosecuting attorney who is withholding charges against the patient, a court granting pretrial or posttrial release, probation or parole officers responsible for supervision of the patient); and
(2) The patient has signed a written consent meeting the requirements of § 2.31 (except paragraph (a)(8) which is inconsistent with the revocation provisions of paragraph (c) of this section) and the requirements of paragraphs (b) and (c) of this section.
(b)
(1) The anticipated length of the treatment;
(2) The type of criminal proceeding involved, the need for the information in connection with the final disposition of that proceeding, and when the final disposition will occur; and
(3) Such other factors as the program, the patient, and the person(s) who will receive the disclosure consider pertinent.
(c)
(d)
(a)
(b)
(c)
(1) The name of the medical personnel to whom disclosure was made and their affiliation with any health care facility;
(2) The name of the individual making the disclosure;
(3) The date and time of the disclosure; and
(4) The nature of the emergency (or error, if the report was to FDA).
(a) Patient identifying information may be disclosed for the purpose of conducting scientific research if the program director makes a determination that the recipient of the patient identifying information:
(1) Is qualified to conduct the research;
(2) Has a research protocol under which the patient identifying information:
(i) Will be maintained in accordance with the security requirements of § 2.16 of these regulations (or more stringent requirements); and
(ii) Will not be redisclosed except as permitted under paragraph (b) of this section; and
(3) Has provided a satisfactory written statement that a group of three or more individuals who are independent of the research project has reviewed the protocol and determined that:
(i) The rights and welfare of patients will be adequately protected; and
(ii) The risks in disclosing patient identifying information are outweighed by the potential benefits of the research.
(b) A person conducting research may disclose patient identifying information obtained under paragraph (a) of this section only back to the program from which that information was obtained and may not identify any individual patient in any report of that research or otherwise disclose patient identities.
(a)
(1) Performs the audit or evaluation activity on behalf of:
(i) Any Federal, State, or local governmental agency which provides financial assistance to the program or is
(ii) Any private person which provides financial assistance to the program, which is a third party payer covering patients in the program, or which is a quality improvement organization performing a utilization or quality control review; or
(2) Is determined by the program director to be qualified to conduct the audit or evaluation activities.
(b)
(1) Agrees in writing to:
(i) Maintain the patient identifying information in accordance with the security requirements provided in § 2.16 of these regulations (or more stringent requirements);
(ii) Destroy all the patient identifying information upon completion of the audit or evaluation; and
(iii) Comply with the limitations on disclosure and use in paragraph (d) of this section; and
(2) Performs the audit or evaluation activity on behalf of:
(i) Any Federal, State, or local governmental agency which provides financial assistance to the program or is authorized by law to regulate its activities; or
(ii) Any private person which provides financial assistance to the program, which is a third part payer covering patients in the program, or which is a quality improvement organization performing a utilization or quality control review.
(c)
(2) Consistent with the definition of program in § 2.11, program includes an employee of, or provider of medical services under, the program when the employee or provider is the subject of a civil investigation or administrative remedy, as those terms are used in paragraph (c)(1) of this section.
(3) If a disclosure to a person is authorized under this section for a Medicare or Medicaid audit or evaluation, including a civil investigation or administrative remedy, as those terms are used in paragraph (c)(1) of this section, then a quality improvement organization which obtains the information under paragraph (a) or (b) may disclose the information to that person but only for purposes of Medicare or Medicaid audit or evaluation.
(4) The provisions of this paragraph do not authorize the agency, the program, or any other person to disclose or use patient identifying information obtained during the audit or evaluation for any purposes other than those necessary to complete the Medicare or Medicaid audit or evaluation activity as specified in this paragraph.
(d)
(a)
(b)
(2) An authorizing court order is entered under these regulations, but the person authorized does not want to make the disclosure. If there is no subpoena or other compulsory process or a subpoena for the records has expired or been quashed, that person may refuse to make the disclosure. Upon the entry of a valid subpoena or other compulsory process the person authorized to disclose must disclose, unless there is a valid legal defense to the process other than the confidentiality restrictions of these regulations.
A court order under these regulations may not authorize qualified personnel, who have received patient identifying information without consent for the purpose of conducting research, audit or evaluation, to disclose that information or use it to conduct any criminal investigation or prosecution of a patient. However, a court order under § 2.66 may authorize disclosure and use of records to investigate or prosecute qualified personnel holding the records.
(a) A court order under these regulations may authorize disclosure of confidential communications made by a patient to a program in the course of diagnosis, treatment, or referral for treatment only if:
(1) The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, including circumstances which constitute suspected child abuse and neglect and verbal threats against third parties;
(2) The disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one which directly threatens loss of life or serious bodily injury, including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or
(3) The disclosure is in connection with litigation or an administrative proceeding in which the patient offers testimony or other evidence pertaining to the content of the confidential communications.
(b) [Reserved]
(a)
(b)
(1) Adequate notice in a manner which will not disclose patient identifying information to other persons; and
(2) An opportunity to file a written response to the application, or to appear in person, for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order.
(c)
(d)
(1) Other ways of obtaining the information are not available or would not be effective; and
(2) The public interest and need for the disclosure outweigh the potential injury to the patient, the physician-patient relationship and the treatment services.
(e)
(1) Limit disclosure to those parts of the patient's record which are essential to fulfill the objective of the order;
(2) Limit disclosure to those persons whose need for information is the basis for the order; and
(3) Include such other measures as are necessary to limit disclosure for the protection of the patient, the physician-patient relationship and the treatment services; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient's record has been ordered.
(a)
(b)
(1) Adequate notice (in a manner which will not disclose patient identifying information to third parties) of an application by a person performing a law enforcement function;
(2) An opportunity to appear and be heard for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order; and
(3) An opportunity to be represented by counsel independent of counsel for an applicant who is a person performing a law enforcement function.
(c)
(d)
(1) The crime involved is extremely serious, such as one which causes or directly threatens loss of life or serious bodily injury including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, and child abuse and neglect.
(2) There is a reasonable likelihood that the records will disclose information of substantial value in the investigation or prosecution.
(3) Other ways of obtaining the information are not available or would not be effective.
(4) The potential injury to the patient, to the physician-patient relationship and to the ability of the program to provide services to other patients is outweighed by the public interest and the need for the disclosure.
(5) If the applicant is a person performing a law enforcement function that:
(i) The person holding the records has been afforded the opportunity to be
(ii) Any person holding the records which is an entity within Federal, State, or local government has in fact been represented by counsel independent of the applicant.
(e)
(1) Limit disclosure and use to those parts of the patient's record which are essential to fulfill the objective of the order;
(2) Limit disclosure to those law enforcement and prosecutorial officials who are responsible for, or are conducting, the investigation or prosecution, and limit their use of the records to investigation and prosecution of extremely serious crime or suspected crime specified in the application; and
(3) Include such other measures as are necessary to limit disclosure and use to the fulfillment of only that public interest and need found by the court.
(a)
(2) The application may be filed separately or as part of a pending civil or criminal action against a program or the person holding the records (or agents or employees of the program or person) in which it appears that the patient records are needed to provide material evidence. The application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny or the patient has given a written consent (meeting the requirements of § 2.31 of these regulations) to that disclosure.
(b)
(c)
(d)
(2) No information obtained under this section may be used to conduct any investigation or prosecution of a patient, or be used as the basis for an application for an order under § 2.65 of these regulations.
(a)
(b)
(1) The program director is involved in the criminal activities to be investigated by the undercover agent or informant; or
(2) The program director will intentionally or unintentionally disclose the proposed placement of an undercover agent or informant to the employees or agents who are suspected of criminal activities.
(c)
(1) There is reason to believe that an employee or agent of the program is engaged in criminal activity;
(2) Other ways of obtaining evidence of this criminal activity are not available or would not be effective; and
(3) The public interest and need for the placement of an undercover agent or informant in the program outweigh the potential injury to patients of the program, physician-patient relationships and the treatment services.
(d)
(1) Specifically authorize the placement of an undercover agent or an informant;
(2) Limit the total period of the placement to six months;
(3) Prohibit the undercover agent or informant from disclosing any patient identifying information obtained from the placement except as necessary to criminally investigate or prosecute employees or agents of the program; and
(4) Include any other measures which are appropriate to limit any potential disruption of the program by the placement and any potential for a real or apparent breach of patient confidentiality; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient's record has been ordered.
(e)
Sec. 3(a), Pub. L. 91-513 as amended by sec. 122(b), Pub. L. 93-282; 84 Stat. 1241 (42 U.S.C. 242a(a)), as amended by 88 Stat. 132.
(a) Section 303(a) of the Public Health Service Act (42 U.S.C. 242a(a)) provides that “[t]he Secretary [of Health and Human Services] may authorize persons engaged in research on mental health, including research on the use and effect of alcohol and other psychoactive drugs, to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.” The regulations in this part establish procedures under which any person engaged in research on mental health including research on the use and effect of alcohol and other psychoactive drugs (whether or not the research is federally funded) may, subject to the exceptions set forth in paragraph (b) of this section, apply for such an authorization of confidentiality.
(b) These regulations do not apply to:
(1) Authorizations of confidentiality for research requiring an Investigational New Drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new drugs, such as methadone, requiring continuation of long-
(2) Authorizations of confidentiality for research which are related to law enforcement activities or otherwise within the purview of the Attorney General's authority to issue authorizations of confidentiality pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c)) and 21 CFR 1316.21.
(c) The Secretary's regulations on confidentiality of alcohol and drug abuse patient records (42 CFR part 2) and the regulations of this part may, in some instances, concurrently cover the same transaction. As explained in 42 CFR 2.24 and 2.24-1, 42 CFR part 2 restricts voluntary disclosures of information from applicable patient records while a Confidentiality Certificate issued pursuant to the regulations of this part protects a person engaged in applicable research from being compelled to disclose identifying characteristics of individuals who are the subject of such research.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(a) Any person engaged in (or who intends to engage in) the research to which this part applies, who desires authorization to withhold the names and other identifying characteristics of individuals who are the subject of such research from any person or authority not connected with the conduct of such research may apply to the Office of the Director, National Institute on Drug Abuse, the Office of the Director, National Institute of Mental Health, or the Office of the Director, National Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville, Maryland 20857 for an authorization of confidentiality.
(b) If there is uncertainty with regard to which Institute is appropriate or if the research project falls within the purview of more than one Institute, an application need be submitted only to one Institute. Persons who are uncertain with regard to the applicability of these regulations to a particular type of research may apply for an authorization of confidentiality under the regulations of this part to one of the Institutes. Requests which are within the scope of the authorities described
(c) An application may accompany, precede, or follow the sumission of a request for DHHS grant or contract assistance, though it is not necessary to request DHHS grant or contract assistance in order to apply for a Confidentiality Certificate. If a person has previously submitted any information required in this part in connection with a DHHS grant or contract, he or she may substitute a copy of information thus submitted, if the information is current and accurate. If a person requests a Confidentiality Certificate at the same time he or she submits an application for DHHS grant or contract assistance, the application for a Confidentiality Certificate may refer to the pertinent section(s) of the DHHS grant or contract application which provide(s) the information required to be submitted under this part. (See §§ 2a.4 and 2a.5.)
(d) A separate application is required for each research project for which an authorization of confidentiality is requested.
In addition to any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project shall contain:
(a) The name and address of the individual primarily responsible for the conduct of the research and the sponsor or institution with which he or she is affiliated, if any. Any application from a person affiliated with an institution will be considered only if it contains or is accompanied by documentation of institutional approval. This documentation may consist of a written statement signed by a responsible official of the institution or of a copy of or reference to a valid certification submitted in accordance with 45 CFR part 46.
(b) The location of the research proj-ect and a description of the facilities available for conducting the research, including the name and address of any hospital, institution, or clinical laboratory facility to be utilized in connection with the research.
(c) The names, addresses, and summaries of the scientific or other appropriate training and experience of all personnel having major responsibilities in the research project and the training and experience requirements for major positions not yet filled.
(d) An outline of the research protocol for the project including a clear and concise statement of the purpose and rationale of the research project and the general research methods to be used.
(e) The date on which research will begin or has begun and the estimated date for completion of the project.
(f) A specific request, signed by the individual primarily responsible for the conduct of the research, for authority to withhold the names and other identifying characteristics of the research subjects and the reasons supporting such request.
(g) An assurance (1) From persons making application for a Confidentiality Certificate for a research project for which DHHS grant or contract support is received or sought that they will comply with all the requirements of 45 CFR part 46, “Protection of Human Subjects,” or
(2) From all other persons making application that they will comply with the informed consent requirements of 45 CFR 46.103(c) and document legally effective informed consent in a manner consistent with the principles stated in 45 CFR 46.110, if it is determined by the Secretary, on the basis of information submitted by the person making application, that subjects will be placed at risk. If a modification of paragraphs (a) or (b) of 45 CFR 46.110 is to be used, as permitted under paragraph (c) of that section, the applicant will describe the proposed modification and submit it for approval by the Secretary.
(h) An assurance that if an authorization of confidentiality is given it will not be represented as an endorsement of the research project by the Secretary or used to coerce individuals to participate in the research project.
(i) An assurance that any person who is authorized by the Secretary to protect the privacy of research subjects
(j) An assurance that all research subjects who participate in the project during the period the Confidentiality Certificate is in effect will be informed that:
(1) A Confidentiality Certificate has been issued;
(2) The persons authorized by the Confidentiality Certificate to protect the identity of research subjects may not be compelled to identify research subjects in any civil, criminal, administrative, legislative, or other proceedings whether Federal, State, or local;
(3) If any of the following conditions exist the Confidentiality Certificate does not authorize any person to which it applies to refuse to reveal identifying information concerning research subjects:
(i) The subject consents in writing to disclosure of identifying information,
(ii) Release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of Federal Regulations), or
(iii) Authorized personnel of DHHS request identifying information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See § 2a.7(b));
(4) The Confidentiality Certificate does not govern the voluntary disclosure of identifying characteristics of research subjects;
(5) The Confidentiality Certificate does not represent an endorsement of the research project by the Secretary.
(k) An assurance that all research subjects who enter the project after the termination of the Confidentiality Certificate will be informed that the authorization of confidentiality has ended and that the persons authorized to protect the identity of research subjects by the Confidentiality Certificate may not rely on the Certificate to refuse to disclose identifying characteristics of research subjects who were not participants in the project during the period the Certificate was in effect. (See § 2a.8(c)).
(a) In addition to the information required by § 2a.4 and any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project which involves the administering of a drug shall contain:
(1) Identification of the drugs to be administered in the research project and a description of the methods for such administration, which shall include a statement of the dosages to be administered to the research subjects;
(2) Evidence that individuals who administer drugs are authorized to do so under applicable Federal and State law; and
(3) In the case of a controlled drug, a copy of the Drug Enforcement Administration Certificate of Registration (BND Form 223) under which the research project will be conducted.
(b) An application for an authorization of confidentiality with respect to a research project which involves the administering of a controlled drug may include a request for exemption of persons engaged in the research from State or Federal prosecution for possession, distribution, and dispensing of controlled drugs as authorized under section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 21 CFR 1316.22. If the request is in such form, and is supported by such information, as is required by 21 CFR 1316.22, the Secretary will forward it, together with his or her recommendation that such request be approved or disapproved, for the consideration of the Administrator of the Drug Enforcement Administration.
(a) In reviewing the information provided in the application for a Confidentiality Certificate, the Secretary will take into account:
(1) The scientific or other appropriate training and experience of all personnel having major responsibilities in the research project;
(2) Whether the project constitutes bona fide “research” which is within the scope of the regulations of this part; and
(3) Such other factors as he or she may consider necessary and appropriate. All applications for Confidentiality Certificates shall be evaluated by the Secretary through such officers and employees of the Department and such experts or consultants engaged for this purpose as he or she determines to be appropriate.
(b) After consideration and evaluation of an application for an authorization of confidentiality, the Secretary will either issue a Confidentiality Certificate or a letter denying a Confidentiality Certificate, which will set forth the reasons for such denial, or will request additional information from the person making application. The Confidentiality Certificate will include:
(1) The name and address of the person making application;
(2) The name and address of the individual primarily responsible for conducting the research, if such individual is not the person making application;
(3) The location of the research proj-ect;
(4) A brief description of the research project;
(5) A statement that the Certificate does not represent an endorsement of the research project by the Secretary;
(6) The Drug Enforcement Administration registration number for the project, if any; and
(7) The date or event upon which the Confidentiality Certificate becomes effective, which shall not be before the later of either the commencement of the research project or the date of issuance of the Certificate, and the date or event upon which the Certificate will expire.
(c) A Confidentiality Certificate is not transferable and is effective only with respect to the names and other identifying characteristics of those individuals who are the subjects of the single research project specified in the Confidentiality Certificate. The recipient of a Confidentiality Certificate shall, within 15 days of any completion or discontinuance of the research project which occurs prior to the expiration date set forth in the Certificate, provide written notification to the Director of the Institute to which application was made. If the recipient determines that the research project will not be completed by the expiration date set forth in the Confidentiality Certificate he or she may submit a written request for an extension of the expiration date which shall include a justification for such extension and a revised estimate of the date for completion of the project. Upon approval of such a request, the Secretary will issue an amended Confidentiality Certificate.
(d) The protection afforded by a Confidentiality Certificate does not extend to significant changes in the research project as it is described in the application for such Certificate (e.g., changes in the personnel having major responsibilities in the research project, major changes in the scope or direction of the research protocol, or changes in the drugs to be administered and the persons who will administer them). The recipient of a Confidentiality Certificate shall notify the Director of the Institute to which application was made of any proposal for such a significant change by submitting an amended application for a Confidentiality Certificate in the same form and manner as an original application. On the basis of such application and other pertinent information the Secretary will either:
(1) Approve the amended application and issue an amended Confidentiality Certificate together with a Notice of Cancellation terminating original the Confidentiality Certificate in accordance with § 2a.8; or
(2) Disapprove the amended application and notify the applicant in writing that adoption of the proposed significant changes will result in the issuance of a Notice of Cancellation terminating the original Confidentiality Certificate in accordance with § 2a.8.
(a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of
(b) A Confidentiality Certificate granted under this part does not authorize any person to refuse to reveal the name or other identifying characteristics of any research subject in the following circumstances:
(1) The subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information,
(2) Authorized personnel of DHHS request such information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See 45 CFR 5.71 for confidentiality standards imposed on such DHHS personnel), or
(3) Release of such information is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated thereunder (title 21, Code of Federal Regulations).
(c) Neither a Confidentiality Certificate nor the regulations of this part govern the voluntary disclosure of identifying characteristics of research subjects.
(a) A Confidentiality Certificate is in effect from the date of its issuance until the effective date of its termination. The effective date of termination shall be the earlier of:
(1) The expiration date set forth in the Confidentiality Certificate; or
(2) Ten days from the date of mailing a Notice of Cancellation to the applicant, pursuant to a determination by the Secretary that the research project has been completed or discontinued or that retention of the Confidentiality Certificate is otherwise no longer necessary or desirable.
(b) A Notice of Cancellation shall include: an identification of the Confidentiality Certificate to which it applies; the effective date of its termination; and the grounds for cancellation. Upon receipt of a Notice of Cancellation the applicant shall return the Confidentiality Certificate to the Secretary.
(c) Any termination of a Confidentiality Certificate pursuant to this section is operative only with respect to the names and other identifying characteristics of individuals who begin their participation as research subjects after the effective date of such termination. (See § 2a.4(k) requiring researchers to notify subjects who enter the project after the termination of the Confidentiality Certificate of termination of the Certificate). The protection afforded by a Confidentiality Certificate is permanent with respect to subjects who participated in research during any time the authorization was in effect.
42 U.S.C. 216, 286.
(a) The regulations of this part govern access to the National Library of Medicine's facilities and library collections and the availability of its bibliographic, reproduction, reference, and
(b) The regulations of this part do not apply to:
(1) The Library's internal functions relating to the acquisition and preservation of materials and the organization of these materials as required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1) and (2)).
(2) The availability of “records” under the Freedom of Information Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are covered in 45 CFR parts 5 and 5b.
(3) Federal assistance for medical libraries and other purposes which are authorized by sections 469-477 of the Act (42 U.S.C. 286b to 286b-8). (See parts 59a, 61 and 64 of this chapter.)
(4) The availability of facilities, collections, and related services of Regional Medical Libraries established or maintained under the authority in section 475 of the Act (42 U.S.C. 286b-6). (See part 59a, subpart B of this chapter.)
As used in this part:
The purpose of the Library is to assist the advancement of medical and related sciences and aid the dissemination and exchange of scientific and other information important to the progress of medicine and the public health. The Library acquires and maintains library materials pertinent to medicine, including audiovisual materials; compiles, publishes, and disseminates catalogs, indices, and bibliographies of these materials, as appropriate; makes available materials, through loan or otherwise; provides reference and other assistance to research; and engages in other activities in furtherance of this purpose.
(a)
(b)
(c)
(1) Persons engaged in “special scientific projects” under section 473 of the Act (42 U.S.C. 286b-4),
(2) Health-sciences professionals, and
(3) The general public.
(a)
(b)
(2)
(c)
(2)
(3)
(4)
(a)
(b)
(c)
The Director may charge reasonable fees for any service provided by the Library under this part, in accordance with a schedule available at the Library upon request, which are designed to recover all or a portion of the cost to the Library of providing the service.
Lists of bibliographies, Library publications sold by the Government Printing Office, necessary application forms, and other information concerning the organization, operation, functions, and services of the Library, are available from the National Library of Medicine, Bethesda, Maryland 20894.
Sec. 215 of the Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216); sec. 332 of the Public Health Service Act, 90 Stat. 2270-2272 (42 U.S.C. 254e).
Nomenclature changes to part 5 appear at 57 FR 2480, Jan. 22, 1992.
These regulations establish criteria and procedures for the designation of geographic areas, population groups, medical facilities, and other public facilities, in the States, as health professional(s) shortage areas.
(a) Using data available to the Department from national, State, and local sources and based upon the criteria in the appendices to this part, the Department will annually prepare listings (by State and health service area) of currently designated health professional(s) shortage areas and potentially designatable areas, together with appropriate related data available to the Department. Relevant portions of this material will then be forwarded to each health systems agency, State health planning and development agency, and Governor, who will be asked to review the listings for their State, correct any errors of which they are aware, and offer their recommendations, if any, within 90 days, as to which geographic areas, population groups, and facilities in areas under their jurisdiction should be designated. An information copy of these listings will also be made available, upon request, to interested parties for their use in providing comments or recommendations to the Secretary and/or to the appropriate HSA, SHPDA, or Governor.
(b) In addition, any agency or individual may request the Secretary to designate (or withdraw the designation of) a particular geographic area, population group, or facility as a health professional(s) shortage area. Each request will be forwarded by the Secretary to the appropriate HSA, SHPDA, and Governor, who will be asked to review it and offer their recommendations, if any, within 30 days. An information copy will also be made available to other interested parties, upon request, for their use in providing comments or recommendations to the Secretary and/or to the appropriate HSA, SHPDA, or Governor.
(c) In each case where the designation of a public facility (including a Federal medical facility) is under consideration, the Secretary will give written notice of the proposed designation to the chief administrative officer of the facility, who will be asked to review it and offer their recommendations, if any, within 30 days.
(d) After review of the available information and consideration of the comments and recommendations submitted, the Secretary will designate health professional(s) shortage areas and withdraw the designation of any areas which have been determined no longer to have a shortage of health professional(s).
(a) The Secretary will give written notice of the designation (or withdrawal of designation) of a health professional(s) shortage area, not later
(1) The Governor of each State in which the area, population group, medical facility, or other public facility so designated is in whole or in part located;
(2) Each HSA for a health service area which includes all or any part of the area, population group, medical facility, or other public facility so designated;
(3) The SHPDA for each State in which the area, population group, medical facility, or other public facility so designated is in whole or in part located; and
(4) Appropriate public or nonprofit private entities which are located in or which have a demonstrated interest in the area so designated.
(b) The Secretary will periodically publish updated lists of designated health professional(s) shortage areas in the
(c) The effective date of the designation of an area shall be the date of the notification letter to the individual or agency which requested the designation, or the date of publication in the
(d) Once an area is listed in the
A.
1.
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of primary medical care professional(s) if both the following criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of FTE primary care physicians serving the institution is at least 1,000:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-stay are not specified, or if the information provided does not indicate that intake medical examinations are routinely performed upon entry, then—Number of internees=average number of inmates.
(ii) If the average length-of-stay is specified as one year or more, and intake medical examinations are routinely performed upon entry, then—Number of internees=average number of inmates+(0.3)×number of new inmates per year.
(iii) If the average length-of-stay is specified as less than one year, and intake examinations are routinely performed upon entry, then—Number of internees=average number of inmates+(0.2)×(1+ALOS/2)×number of new inmates per year where ALOS=average length-of-stay (in fraction of year). (The number of FTE primary care physicians is computed as in part I, section B, paragraph 3 above.)
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-shortage groups based on the number of inmates and/or the ratio (R) of internees to primary care physicians, as follows:
Group 1—Institutions with 500 or more inmates and no physicians.
Group 2—Other institutions with no physicians and institutions with R greater than (or equal to) 2,000:1.
Group 3—Institutions with R greater than (or equal to) 1,000:1 but less than 2,000:1.
B.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of primary medical care services:
(i) A county, or a group of contiguous counties whose population centers are within 30 minutes travel time of each other.
(ii) A portion of a county, or an area made up of portions of more than one county, whose population, because of topography, market or transportation patterns, distinctive population characteristics or other factors, has limited access to contiguous area resources, as measured generally by a travel time greater than 30 minutes to such resources.
(iii) Established neighborhoods and communities within metropolitan areas which display a strong self-identity (as indicated by a homogeneous socioeconomic or demographic structure and/or a tradition of interaction or interdependency), have limited interaction with contiguous areas, and which, in general, have a minimum population of 20,000.
(b) The following distances will be used as guidelines in determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available: 20 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 15 miles.
(iii) In flat terrain or in areas connected by interstate highways: 25 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 30 minutes travel time.
2.
The population count used will be the total permanent resident civilian population of the area, excluding inmates of institutions, with the following adjustments, where appropriate:
(a) Adjustments to the population for the differing health service requirements of various age-sex population groups will be computed using the table below of visit rates for 12 age-sex population cohorts. The total expected visit rate will first be obtained by multiplying each of the 12 visit rates in the table by the size of the area population within that particular age-sex cohort and adding the resultant 12 visit figures together. This total expected visit rate will then be divided by the U.S. average per capita visit rate of 5.1, to obtain the adjusted population for the area.
(b) The effect of transient populations on the need of an area for primary care professional(s) will be taken into account as follows:
(i) Seasonal residents, i.e., those who maintain a residence in the area but inhabit it for only 2 to 8 months per year, may be included but must be weighted in proportion to the fraction of the year they are present in the area.
(ii) Other tourists (non-resident) may be included in an area's population but only with a weight of 0.25, using the following formula: Effective tourist contribution to population=0.25×(fraction of year tourists are present in area)×(average daily number of tourists during portion of year that tourists are present).
(iii) Migratory workers and their families may be included in an area's population, using the following formula: Effective migrant contribution to population=(fraction of year migrants are present in area)×(average daily number of migrants during portion of year that migrants are present).
3.
(a) All non-Federal doctors of medicine (M.D.) and doctors of osteopathy (D.O.) providing direct patient care who practice principally in one of the four primary care specialities—general or family practice, general internal medicine, pediatrics, and obstetrics and gynecology—will be counted. Those physicians engaged solely in administration, research, and teaching will be excluded. Adjustments for the following factors will be made in computing the number of full-time-equivalent (FTE) primary care physicians:
(i) Interns and residents will be counted as 0.1 full-time equivalent (FTE) physicians.
(ii) Graduates of foreign medical schools who are not citizens or lawful permanent residents of the United States will be excluded from physician counts.
(iii) Those graduates of foreign medical schools who are citizens or lawful permanent residents of the United States, but do not have unrestricted licenses to practice medicine, will be counted as 0.5 FTE physicians.
(b) Practitioners who are semi-retired, who operate a reduced practice due to infirmity or other limiting conditions, or who provide patient care services to the residents of the area only on a part-time basis will be discounted through the use of full-time equivalency figures. A 40-hour work week will be used as the standard for determining full-time equivalents in these cases. For practitioners working less than a 40-hour week, every four (4) hours (or
(c) In some cases, physicians located within an area may not be accessible to the population of the area under consideration. Allowances for physicians with restricted practices can be made, on a case-by-case basis. However, where only a portion of the population of the area cannot access existing primary care resources in the area, a population group designation may be more appropriate (see part II of this appendix).
(d) Hospital staff physicians involved exclusively in inpatient care will be excluded. The number of full-time equivalent physicians practicing in organized outpatient departments and primary care clinics will be included, but those in emergency rooms will be excluded.
(e) Physicians who are suspended under provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act for a period of eighteen months or more will be excluded.
4.
An area will be considered as having unusually high needs for primary health care services if at least one of the following criteria is met:
(a) The area has more than 100 births per year per 1,000 women aged 15-44.
(b) The area has more than 20 infant deaths per 1,000 live births.
(c) More than 20% of the population (or of all households) have incomes below the poverty level.
5.
An area's existing primary care providers will be considered to have insufficient capacity if at least two of the following criteria are met:
(a) More than 8,000 office or outpatient visits per year per FTE primary care physician serving the area.
(b) Unusually long waits for appointments for routine medical services (i.e., more than 7 days for established patients and 14 days for new patients).
(c) Excessive average waiting time at primary care providers (longer than one hour where patients have appointments or two hours where patients are treated on a first-come, first-served basis).
(d) Evidence of excessive use of emergency room facilities for routine primary care.
(e) A substantial proportion (2/3 or more) of the area's physicians do not accept new patients.
(f) Abnormally low utilization of health services, as indicated by an average of 2.0 or less office visits per year on the part of the area's population.
6.
Primary care professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Primary care professional(s) in the contiguous area are more than 30 minutes travel time from the population center(s) of the area being considered for designation (measured in accordance with paragraph B.1(b) of this part).
(b) The contiguous area population-to-full-time-equivalent primary care physician ratio is in excess of 2000:1, indicating that practitioners in the contiguous area cannot be expected to help alleviate the shortage situation in the area being considered for designation.
(c) Primary care professional(s) in the contiguous area are inaccessible to the population of the area under consideration because of specified access barriers, such as:
(i) Significant differences between the demographic (or socio-economic) characteristics of the area under consideration and those of the contiguous area, indicating that the population of the area under consideration may be effectively isolated from nearby resources. This isolation could be indicated, for example, by an unusually high proportion of non-English-speaking persons.
(ii) A lack of economic access to contiguous area resources, as indicated particularly where a very high proportion of the population of the area under consideration is poor (i.e., where more than 20 percent of the population or the households have incomes below the poverty level), and Medicaid-covered or public primary care services are not available in the contiguous area.
C.
Designated areas will be assigned to degree-of-shortage groups, based on the ratio (R) of population to number of full-time equivalent primary care physicians and the presence or absence of unusually high needs for primary health care services, according to the following table:
D.
(1) For areas without unusually high need or insufficient capacity:
(2) For areas with unusually high need or insufficient capacity:
A.
1. In general, specific population groups within particular geographic areas will be designated as having a shortage of primary medical care professional(s) if the following three criteria are met:
(a) The area in which they reside is rational for the delivery of primary medical care services, as defined in paragraph B.1 of part I of this appendix.
(b) Access barriers prevent the population group from use of the area's primary medical care providers. Such barriers may be economic, linguistic, cultural, or architectural, or could involve refusal of some providers to accept certain types of patients or to accept Medicaid reimbursement.
(c) The ratio of the number of persons in the population group to the number of primary care physicians practicing in the area and serving the population group is at least 3,000 : 1.
2. Indians and Alaska Natives will be considered for designation as having shortages of primary care professional(s) as follows:
(a) Groups of members of Indian tribes (as defined in section 4(d) of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are automatically designated.
(b) Other groups of Indians or Alaska Natives (as defined in section 4(c) of Pub. L. 94-437) will be designated if the general criteria in paragraph A are met.
B.
Each designated population group will be assigned to a degree-of-shortage group, based on the ratio (R) of the group's population to the number of primary care physicians serving it, as follows:
Population groups which have received “automatic” designation will be assigned to degree-of-shortage group 4 if no information on the ratio of the number of persons in the group to the number of FTE primary care physicians serving them is provided.
C.
Primary care physician shortage=number of persons in population group/3,000−number of FTE primary care physicians
A.
1.
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of primary medical care professional(s) if both the following criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of FTE primary care physicians serving the institution is at least 1,000:1. (Here the number of internees is the number of inmates present at the beginning of the year plus the number of new inmates entering the institution during the year, including those who left before the end of the year; the number of FTE primary care physicians is computed as in part I, section B, paragraph 3 above.)
2.
Designated correctional institutions will be assigned to degree-of-shortage groups based on the number of inmates and/or the ratio (R) of internees to primary care physicians, as follows:
B.
1.
Public or non-profit private medical facilities will be designated as having a shortage of primary medical care professional(s) if:
(a) the facility is providing primary medical care services to an area or population group designated as having a primary care professional(s) shortage; and
(b) the facility has insufficient capacity to meet the primary care needs of that area or population group.
2.
In determining whether public or nonprofit private medical facilities meet the criteria established by paragraph B.1 of this Part, the following methodology will be used:
(a)
A facility will be considered to be providing services to a designated area or population group if either:
(i) A majority of the facility's primary care services are being provided to residents of designated primary care professional(s) shortage areas or to population groups designated as having a shortage of primary care professional(s); or
(ii) The population within a designated primary care shortage area or population group
Migrant health centers (as defined in section 319(a)(1) of the Act) which are located in areas with designated migrant population groups and Indian Health Service facilities are assumed to be meeting this requirement.
(b)
A facility will be considered to have insufficient capacity to meet the primary care needs of the area or population it serves if at least two of the following conditions exist at the facility:
(i) There are more than 8,000 outpatient visits per year per FTE primary care physician on the staff of the facility. (Here the number of FTE primary care physicians is computed as in Part I, Section B, paragraph 3 above.)
(ii) There is excessive usage of emergency room facilities for routine primary care.
(iii) Waiting time for appointments is more than 7 days for established patients or more than 14 days for new patients, for routine health services.
(iv) Waiting time at the facility is longer than 1 hour where patients have appointments or 2 hours where patients are treated on a first-come, first-served basis.
3.
Each designated medical facility will be assigned to the same degree-of-shortage group as the designated area or population group which it serves.
A.
1.
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of dental professional(s) if both the following criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of FTE dentists serving the institution is at least 1,500:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-stay are not specified, or if the information provided does not indicate that intake dental examinations are routinely performed by dentists upon entry, then—Number of internees=average number of inmates.
(ii) If the average length-of-stay is specified as one year or more, and intake dental examinations are routinely performed upon entry, then—Number of internees=average number of inmates+number of new inmates per year.
(iii) If the average length-of-stay is specified as less than one year, and intake dental examinations are routinely performed upon entry, then—Number of internees=average number of inmates+
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-shortage groups based on the number of inmates and/or the ratio (R) of internees to dentists, as follows:
Group 1—Institutions with 500 or more inmates and no dentists.
Group 2—Other institutions with no dentists and institutions with R greater than (or equal to) 3,000:1.
Group 3—Institutions with R greater than (or equal to) 1,500:1 but less than 3,000:1.
B.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of dental health services:
(i) A county, or a group of several contiguous counties whose population centers are within 40 minutes travel time of each other.
(ii) A portion of a county (or an area made up of portions of more than one county) whose population, because of topography, market or transportation patterns, distinctive population characteristics, or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to such resources.
(iii) Established neighborhoods and communities within metropolitan areas which display a strong self-identity (as indicated by a homogenous socioeconomic or demographic structure and/or a traditional of interaction or intradependency), have limited interaction with contiguous areas, and which, in general, have a minimum population of 20,000.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 40 minutes travel time.
2.
The population count use will be the total permanent resident civilian population of the area, excluding inmates of institutions, with the following adjustments:
(a) Seasonal residents, i.e., those who maintain a residence in the area but inhabit it for only 2 to 8 months per year, may be included but must be weighted in proportion to the fraction of the year they are present in the area.
(b) Migratory workers and their families may be included in an area's population using the following formula: Effective migrant contribution to population=(fraction of year migrants are present in area)×(average daily number of migrants during portion of year that migrants are present).
3.
(a) All non-Federal dentists providing patient care will be counted, except in those areas where it is shown that specialists (those dentists not in general practice or pedodontics) are serving a larger area and are not addressing the general dental care needs of the area under consideration.
(b) Full-time equivalent (FTE) figures will be used to reflect productivity differences among dental practices based on the age of the dentists, the number of auxiliaries employed, and the number of hours worked per week. In general, the number of FTE dentists will be computed using weights obtained from the matrix in Table 1, which is based on the productivity of dentists at various ages, with different numbers of auxiliaries, as compared with the average productivity of all dentists. For the purposes of these determinations, an auxiliary is defined as any non-dentist staff employed by the dentist to assist in operation of the practice.
If information on the number of auxiliaries employed by the dentist is not available, Table 2 will be used to compute the number of full-time equivalent dentists.
The number of FTE dentists within a particular age group (or age/auxiliary group) will be obtained by multiplying the number of dentists within that group by its corresponding equivalency weight. The total supply of FTE dentists within an area is then computed as the sum of those dentists within each age (or age/auxiliary) group.
(c) The equivalency weights specified in tables 1 and 2 assume that dentists within a particular group are working full-time (40 hours per week). Where appropriate data are available, adjusted equivalency figures for dentists who are semi-retired, who operate a reduced practice due to infirmity or other limiting conditions, or who are available to the population of an area only on a part-time basis will be used to reflect the reduced availability of these dentists. In computing these equivalency figures, every 4 hours (or
4.
An area will be considered as having unusually high needs for dental services if at least one of the following criteria is met:
(a) More than 20% of the population (or of all households) has incomes below the poverty level.
(b) The majority of the area's population does not have a fluoridated water supply.
5.
An area's existing dental care providers will be considered to have insufficient capacity if at least two of the following criteria are met:
(a) More than 5,000 visits per year per FTE dentist serving the area.
(b) Unusually long waits for appointments for routine dental services (i.e., more than 6 weeks).
(c) A substantial proportion (
6.
Dental professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Dental professional(s) in the contiguous area are more than 40 minutes travel time from the center of the area being considered for designation (measured in accordance with Paragraph B.1.(b) of this part).
(b) Contiguous area population-to-(FTE) dentist ratios are in excess of 3,000 : 1, indicating that resources in contiguous areas cannot be expected to help alleviate the shortage situation in the area being considered for designation.
(c) Dental professional(s) in the contiguous area are inaccessible to the population of the area under consideration because of specified access barriers, such as:
(i) Significant differences between the demographic (or socioeconomic) characteristics of the area under consideration and those of the contiguous area, indicating that the population of the area under consideration may be effectively isolated from nearby resources. Such isolation could be indicated, for example, by an unusually high proportion of non-English-speaking persons.
(ii) A lack of economic access to contiguous area resources, particularly where a very high proportion of the population of the area under consideration is poor (i.e., where more than 20 percent of the population or of the households have incomes below the poverty level) and Medicaid-covered or public dental services are not available in the contiguous area.
C.
The degree of shortage of a given geographic area, designated as having a shortage of dental professional(s), will be determined using the following procedure:
Designated areas will be assigned to degree-of-shortage groups, based on the ratio (R) of population to number of full-time-equivalent dentists and the presence or absence of unusually high needs for dental services, or insufficient capacity of existing dental care providers according to the following table:
D.
(1) For areas without unusually high need:
(2) For areas with unusually high need:
A.
1. In general, specified population groups within particular geographic areas will be designated as having a shortage of dental care professional(s) if the following three criteria are met:
a. The area in which they reside is rational for the delivery of dental care services, as defined in paragraph B.1 of part I of this appendix.
b. Access barriers prevent the population group from use of the area's dental providers.
c. The ratio (R) of the number of persons in the population group to the number of dentists practicing in the area and serving the population group is at least 4,000:1.
2. Indians and Alaska Natives will be considered for designation as having shortages of dental professional(s) as follows:
(a) Groups of members of Indian tribes (as defined in section 4(d) of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are automatically designated.
(b) Other groups of Indians or Alaska Natives (as defined in section 4(c) of Pub. L. 94-437) will be designated if the general criteria in paragraph 1 are met.
B.
Each designated population group will be assigned to a degree-of-shortage group as follows:
C.
A.
1.
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of dental professional(s) if both the following criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of FTE dentists serving the institution is at least 1,500:1. (Here the number of internees is the number of inmates present at the beginning of the year plus the number of new inmates entering the institution during the year, including those who left before the end of the year; the number of FTE dentists is computed as in part I, section B, paragraph 3 above.)
2.
Designated correctional institutions will be assigned to degree-of-shortage groups as follows, based on number of inmates and/or the ratio (R) of internees to dentists:
B.
1.
Public or nonprofit private facilties providing general dental care services will be designated as having a shortage of dental professional(s) if both of the following criteria are met:
(a) The facility is providing general dental care services to an area or population group designated as having a dental professional(s) shortage; and
(b) The facility has insufficent capacity to meet the dental care needs of that area or population group.
2.
In determining whether public or nonprofit private facilities meet the criteria established by paragraph B.1. of this part, the following methodology will be used:
(a)
A facility will be considered to be providing services to an area or population group if either:
(i) A majority of the facility's dental care services are being provided to residents of designated dental professional(s) shortage areas or to population groups designated as having a shortage of dental professional(s); or
(ii) The population within a designated dental shortage area or population group has reasonable access to dental services provided at the facility. Reasonable access will be assumed if the population lies within 40 minutes travel time of the facility and non-physical barriers (relating to demographic and socioeconomic characteristics of the population) do not prevent the population from receiving care at the facility.
Migrant health centers (as defined in section 319(a)(1) of the Act) which are located in areas with designated migrant population groups and Indian Health Service facilities are assumed to be meeting this requirement.
(b)
A facility will be considered to have insufficient capacity to meet the dental care needs of a designated area or population group if either of the following conditions exists at the facility.
(i) There are more than 5,000 outpatient visits per year per FTE dentist on the staff of the facility. (Here the number of FTE dentists is computed as in part I, section B, paragraph 3 above.)
(ii) Waiting time for appointments is more than 6 weeks for routine dental services.
3.
Each designated dental facility will be assigned to the same degree-of-shortage group as the designated area or population group which it serves.
A.
1. The area is a rational area for the delivery of mental health services.
2. One of the following conditions prevails within the area:
(a) The area has—
(i) A population-to-core-mental-health-professional ratio greater than or equal to 6,000:1 and a population-to-psychiatrist ratio greater than or equal to 20,000:1, or
(ii) A population-to-core-professional ratio greater than or equal to 9,000:1, or
(iii) A population-to-psychiatrist ratio greater than or equal to 30,000:1;
(b) The area has unusually high needs for mental health services, and has—
(i) A population-to-core-mental-health-professional ratio greater than or equal to 4,500:1 and
A population-to-psychiatrist ratio greater than or equal to 15,000:1, or
(ii) A population-to-core-professional ratio greater than or equal to 6,000:1, or
(iii) A population-to-psychiatrist ratio greater than or equal to 20,000:1;
3. Mental health professionals in contiguous areas are overutilized, excessively distant or inaccessible to residents of the area under consideration.
B.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of mental health services:
(i) An established mental health catchment area, as designated in the State Mental Health Plan under the general criteria set forth in section 238 of the Community Mental Health Centers Act.
(ii) A portion of an established mental health catchment area whose population, because of topography, market and/or transportation patterns or other factors, has limited access to mental health resources in the rest of the catchment area, as measured generally by a travel time of greater than 40 minutes to these resources.
(iii) A county or metropolitan area which contains more than one mental health catchment area, where data are unavailable by individual catchment area.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 40 minutes travel time.
2.
The population count used will be the total permanent resident civilian population of the area, excluding inmates of institutions.
3.
(b) Definitions:
(i)
(ii)
(A) Is certified as a psychiatrist or child psychiatrist by the American Medical Specialities Board of Psychiatry and Neurology or by the American Osteopathic Board of Neurology and Psychiatry, or, if not certified, is “broad-eligible” (i.e., has successfully completed an accredited program of graduate medical or osteopathic education in psychiatry or child psychiatry); and
(B) Practices patient care psychiatry or child psychiatry, and is licensed to do so, if required by the State of practice.
(iii)
(iv)
(A) Is certified as a clinical social worker by the American Board of Examiners in Clinical Social Work, or is listed on the National Association of Social Workers' Clinical Register, or has a master's degree in social work and two years of supervised clinical experience; and
(B) Is licensed to practice as a social worker, if required by the State of practice.
(v)
(A) Is certified by the American Nurses Association as a psychiatric and mental health clinical nurse specialist, or has a master's degree in nursing with a specialization in psychiatric/mental health and two years of supervised clinical experience; and
(B) Is licensed to practice as a psychiatric or mental health nurse specialist, if required by the State of practice.
(vi)
(c) Practitioners who provide patient care to the population of an area only on a part-time basis (whether because they maintain another office elsewhere, spend some of their time providing services in a facility, are semi-retired, or operate a reduced practice for other reasons), will be counted on a partial basis through the use of full-time-equivalency calculations based on a 40-hour
(d) In some cases, practitioners located within an area may not be accessible to the general population of the area under consideration. Practitioners working in restricted facilities will be included on an FTE basis based on time spent outside the facility. Examples of restricted facilities include correctional institutions, youth detention facilities, residential treatment centers for emotionally disturbed or mentally retarded children, school systems, and inpatient units of State or county mental hospitals.
(e) In cases where there are mental health facilities or institutions providing both inpatient and outpatient services, only those FTEs providing mental health services in outpatient units or other short-term care units will be counted.
(f) Adjustments for the following factors will also be made in computing the number of FTE providers:
(i) Practitioners in residency programs will be counted as 0.5 FTE.
(ii) Graduates of foreign schools who are not citizens or lawful permanent residents of the United States will be excluded from counts.
(iii) Those graduates of foreign schools who are citizens or lawful permanent residents of the United States, and practice in certain settings, but do not have unrestricted licenses to practice, will be counted on a full-time-equivalency basis up to a maximum of 0.5 FTE.
(g) Practitioners suspended for a period of 18 months or more under provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act will not be counted.
4.
(a) 20 percent of the population (or of all households) in the area have incomes below the poverty level.
(b) The youth ratio, defined as the ratio of the number of children under 18 to the number of adults of ages 18 to 64, exceeds 0.6.
(c) The elderly ratio, defined as the ratio of the number of persons aged 65 and over to the number of adults of ages 18 to 64, exceeds 0.25.
(d) A high prevalence of alcoholism in the population, as indicated by prevalence data showing the area's alcoholism rates to be in the worst quartile of the nation, region, or State.
(e) A high degree of substance abuse in the area, as indicated by prevalence data showing the area's substance abuse to be in the worst quartile of the nation, region, or State.
5.
(a) Core mental health professionals in the contiguous area are more than 40 minutes travel time from the closest population center of the area being considered for designation (measured in accordance with paragraph B.1(b) of this part).
(b) The population-to-core-mental-health-professional ratio in the contiguous area is in excess of 3,000:1 and the population-to-psychiatrist ratio there is in excess of 10,000:1, indicating that core mental health professionals in the contiguous areas are overutilized and cannot be expected to help alleviate the shortage situation in the area for which designation is being considered. (If data on core mental health professionals other than psychiatrists are not available for the contiguous area, a population-to-psychiatrist ratio there in excess of 20,000:1 may be used to demonstrate overutilization.)
(c) Mental health professionals in contiguous areas are inaccessible to the population of the requested area due to geographic, cultural, language or other barriers or because of residency restrictions of programs or facilities providing such professionals.
C.
* Note: “gte” means “greater than or equal to”.
D.
(1) For areas without unusually high need:
(2) For areas with unusually high need:
A.
1. Access barriers prevent the population group from using those core mental health professionals which are present in the area; and
2. One of the following conditions prevails:
(a) The ratio of the number of persons in the population group to the number of FTE core mental health professionals serving the population group is greater than or equal to 4,500:1 and the ratio of the number of persons in the population group to the number of FTE psychiatrists serving the population group is greater than or equal to 15,000:1; or,
(b) The ratio of the number of persons in the population group to the number of FTE core mental health professionals serving the population group is greater than or equal to 6,000:1; or,
(c) The ratio of the number of persons in the population group to the number of FTE psychiatrists serving the population group is greater than or equal to 20,000:1.
B.
C.
A.
1.
Medium to maximum security Federal and State correctional institutions for adults or youth, and youth detention facilities, will be designated as having a shortage of psychiatric professional(s) if both of the following criteria are met:
(a) The institution has more than 250 inmates, and
(b) The ratio of the number of internees per year to the number of FTE psychiatrists serving the institution is at least 2,000:1. (Here the number of internees is the number of inmates or residents present at the beginning of the year, plus the number of new inmates or residents entering the institution during the year, including those who left before the end of the year; the number of FTE psychiatrists is computed as in part I, section B, paragraph 3 above.)
2.
Correctional facilities and youth detention facilities will be assigned to degree-of-shortage groups, based on the number of inmates and/or the ratio (R) of internees to FTE psychiatrists, as follows:
Group 1—Facilities with 500 or more inmates or residents and no psychiatrist.
Group 2—Other facilities with no psychiatrists and facilities with 500 or more inmates or residents and R>3,000.
Group 3—All other facilities.
B.
1.
A State or county hospital will be designated as having a shortage of psychiatric professional(s) if both of the following criteria are met:
(a) The mental hospital has an average daily inpatient census of at least 100; and
(b) The number of workload units per FTE psychiatrists available at the hospital exceeds 300, where workload units are calculated using the following formula:
Total workload units = average daily inpatient census + 2 × (number of inpatient admissions per year) + 0.5 × (number of admissions to day care and outpatient services per year).
2.
State or county mental hospitals will be assigned to degree-of-shortage groups, based
Group 1—No psychiatrists, or R>1,800.
Group 2—1,800>R>1,200.
Group 3—1,200>R>600.
Group 4—600>R>300.
C.
1.
A community mental health center (CMHC), authorized by Pub. L. 94-63, or other public or nonprofit private facility providing mental health services to an area or population group, may be designated as having a shortage of psychiatric professional(s) if the facility is providing (or is responsible for providing) mental health services to an area or population group designated as having a mental health professional(s), and the facility has insufficient capacity to meet the psychiatric needs of the area or population group.
2.
In determining whether CMHCs or other public or nonprofit private facilities meet the criteria established in paragraph C.1 of this Part, the following methodology will be used.
(a)
The facility will be considered to be providing services to a designated area or population group if either:
(i) A majority of the facility's mental health services are being provided to residents of designated mental health professional(s) shortage areas or to population groups designated as having a shortage of mental health professional(s); or
(ii) The population within a designated psychiatric shortage area or population group has reasonable access to mental health services provided at the facility. Such reasonable access will be assumed if the population lies within 40 minutes travel time of the facility and nonphysical barriers (relating to demographic and socioeconomic characteristics of the population) do not prevent the population from receiving care at the facility.
(b)
This condition will be considered to be met if the facility, by Federal or State statute, administrative action, or contractual agreement, has been given responsibility for providing and/or coordinating mental health services for the area or population group, consistent with applicable State plans.
(c)
(i) There are more than 1,000 patient visits per year per FTE core mental health professional on staff of the facility, or
(ii) There are more than 3,000 patient visits per year per FTE psychiatrist on staff of the facility, or
(iii) No psychiatrists are on the staff and this facility is the only facility providing (or responsible for providing) mental health services to the designated area or population.
3.
Each designated facility will be assigned to the same degree-of-shortage group as the designated area or population group which it serves.
A.
A geographic area will be designated as having a shortage of vision care professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of vision care services.
2. The estimated number of optometric visits supplied by vision care professional(s) in the area is less than the estimated requirements of the area's population for these visits, and the computed shortage is at least 1,500 optometric visits.
3. Vision care professional(s) in contiguous areas are excessively distant, overutilized, or inaccessible to the population of the area under consideration.
B.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of vision care services:
(i) A county, or a group of contiguous counties whose population centers are within 40 minutes travel time of each other;
(ii) A portion of a county (or an area made up of portions of more than one county) whose population, because of topography, market or transportation patterns, or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 40 minutes travel time.
2.
The number of optometric visits required by an area's population will be estimated by multiplying each of the following visit rates by the size of the population within that particular age group and then adding the figures obtained together.
For geographic areas where the age distribution of the population is not known, it will be assumed that the percentage distribution, by age groups, for the area is the same as the distribution for the county of which it is a part.
(3)
The estimated supply of optometric services will be determined by use of the following formula:
(4)
Size of shortage (in number of optometric visits) will be computed as follows:
Optometric visit shortage = visits required − visits supplied
(5)
Vision care professional(s) in area contiguous to an area being considered for designation will be considered execessively distant, overutilized or inaccessible to the population of the area if one of the following conditions prevails in each contiguous area:
(a) Vision care professional(s) in the contiguous area are more than 40 minutes travel time from the center of the area being considered for designation (measured in accordance with paragraph B.1(b) of this part).
(b) The estimated requirement for vision care services in the contiguous area exceeds the estimated supply of such services there, based on the requirements and supply calculations previously described.
(c) Vision care professional(s) in the contiguous area are inaccessible to the population of the area because of specified access barriers (such as economic or cultural barriers).
C.
Designated areas (and population groups) will be assigned to degree-of-shortage groups, based on the ratio of optometric visits supplied to optometric visits required for the area (or group), as follows:
Group 1—Areas (or groups) with no optometric visits being supplied (i.e., with no optometrists or ophthalmologists).
Group 2—Areas (or groups) where the ratio of optometric visits supplied to optometric visits required is less than 0.5.
Group 3—Areas (or groups) where the ratio of optometric visits supplied to optometric visits required is between 0.5 and 1.0.
A.
Population groups within particular geographic areas will be designated if both the following criteria are met:
(1) Members of the population group do not have access to vision care resources within the area (or in contiguous areas) because of non-physical access barriers (such as economic or cultural barriers).
(2) The estimated number of optometric visits supplied to the population group (as determined under paragraph B.3 of part I of this Appendix) is less than the estimated number of visits required by that group (as determined under paragraph B.2 of part I of this Appendix), and the computed shortage is at least 1,500 optometric visits.
B.
The degree of shortage of a given population group will be determined in the same way as described for areas in paragraph C of part I of this appendix.
A.
A geographic area will be designated as having a shortage of podiatric professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of podiatric services.
2. The area's ratio of population to foot care practitioners is at least 28,000:1, and the computed podiatrist shortage to meet this ratio is at least 0.5.
3. Podiatric professional(s) in contiguous areas are overutilized, excessively distant, or inaccessible to the population of the area under consideration.
B.
In determining whether an area meets the criteria established by paragraph A of this Part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of podiatric services:
(i) A county or a group of contiguous counties whose population centers are within 40 minutes travel time of each other.
(ii) A portion of a county, or an area made up of portions of more than one county, whose population, because of topography, market and/or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes from its population center to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the area corresponding to 40 minutes travel time.
2.
The population count used will be the total permanent resident civilian population of the area, excluding inmates of institutions, adjusted by the following formula to take into account the differing utilization rates of podiatric services by different age groups within the population:
3.
(a) All podiatrists providing patient care will be counted. However, in order to take into account productivity differences in podiatric practices associated with the age of the podiatrists, the following formula will be utilized:
(b) In order to take into account the fact that orthopedic surgeons and general and family practitioners devote a percentage of their time to foot care, the total available foot care practitioners will be computed as follows:
4.
Size of shortage (in number of FTE podiatrists) will be computed as follows:
5.
Podiatric professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Podiatric professional(s) in the contiguous area are more than 40 minutes travel time from the center of the area being considered for designation.
(b) The population-to-foot care practitioner ratio in the contiguous areas is in excess of 20,000 : 1, indicating that contiguous area podiatric professional(s) cannot be expected to help alleviate the shortage situation in the area for which designation is requested.
(c) Podiatric professional(s) in the contiguous area are inaccessible to the population of the area under consideration because of specified access barriers (such as economic or cultural barriers).
C.
Designated areas will be assigned to groups, based on the ratio (R) of adjusted population to number of foot care practitioners, as follows:
A.
A geographic area will be designated as having a shortage of pharmacy professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of pharmacy services.
2. The number of pharmacists serving the area is less than the estimated requirement for pharmacists in the area, and the computed pharmacist shortage is at least 0.5.
3. Pharmacists in contiguous areas are overutilized or excessively distant from the population of the area under consideration.
B.
In determining whether an area meets the criteria established by paragraph A of this Part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of pharmacy services:
(i) A county, or a group of contiguous counties whose population centers are within 30 minutes travel time of each other; and
(ii) A portion of a county, or an area made up of portions of more than one county, whose population, because of topography, market or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 30 minutes to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available: 20 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 15 miles.
(iii) In flat terrain or in areas connected by interstate highways: 25 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the area corresponding to 30 minutes travel time.
2.
All active pharmacists within the area will be counted, except those engaged in teaching, administration, or pharmaceutical research.
3.
(a)
(b)
4.
The size of the shortage will be computed as follows:
5.
Pharmacists in areas contiguous to an area being considered for designation will be considered excessively distant or overutilized if either:
(a) Pharmacy professional(s) in contiguous areas are more than 30 minutes travel time from the center of the area under consideration, or
(b) The number of pharmacists in each contiguous area is less than or equal to the estimated requirement for pharmacists for that contiguous area (as computed above).
C.
Designated areas will be assigned to degree-of-shortage groups, based on the proportion of the estimated requirement for pharmacists which is currently available in the area, as follows:
Group 1—Areas with no pharmacists.
Group 2—Areas where the ratio of available pharmacists to pharmacists required is less than 0.5.
Group 3—Areas where the ratio of available pharmacists to pharmacists required is between 0.5 and 1.0.
A.
A geographic area will be designated as having a shortage of food animal veterinary professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of veterinary services.
2. The ratio of veterinary livestock units to food animal veterinarians in the area is at least 10,000 : 1, and the computed food animal veterinarian shortage to meet this ratio is at least 0.5.
3. Food animal veterinarians in contiguous areas are overutilized or excessively distant from the population of the area under consideration.
B.
A geographic area will be designated as having a shortage of companion animal veterinary professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of veterinary services.
2. The ratio of resident civilian population to number of companion animal veterinarians in the area is at least 30,000 : 1 and the computed companion animal veterinary shortage to meet this ratio is at least 0.5.
3. Companion animal veterinarians in contiguous areas are overutilized or excessively distant from the population of the area under consideration.
C.
In determining whether an area meets the criteria established by paragraphs A and B of this part, the following methodology will be used:
1.
(a) The following areas will be considered rational areas for the delivery of veterinary services:
(i) A county, or a group of contiguous counties whose population centers are within 40 minutes travel time of each other.
(ii) A portion of a county (or an area made up of portions of more than one county) which, because of topography, market and/or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
2.
Since various types of food animals require varying amounts of veterinary care, each type of animal has been assigned a weight indicating the amount of veterinary care it requires relative to that required by a milk cow. Those weights are used to compute the number of “Veterinary Livestock Units” (VLU) for which veterinary care is required.
The VLU is computed as follows:
3.
The number of food animal veterinarians is determined by weighting the number of veterinarians within each of several practice categories according to the average fraction of practice time in that category which is devoted to food animal veterinary care, as follows:
4.
The number of full-time equivalent companion animal veterinarians is determined by weighting the number of veterinarians within each of several practice categories by the average portion of their practice which is devoted to companion animal care by the practitioners within that category, as follows:
5.
The size of shortage will be computed as follows:
(a) Food animal veterinarian shortage=(VLU/10,000)−(number of food animal veterinarians).
(b) Companion animal veterinarian shortage=(resident civilian pop./30,000)−(number of companion animal veterinarians).
6.
Veterinary professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant from the population of the area or overutilized if one of the following conditions prevails in each contiguous area:
(a) Veterinary professional(s) in the contiguous area are more than 60 minutes travel time from the center of the area being considered for designation (measured in accordance with paragraph C.1.(b) of this part).
(b) In the case of food animal veterinary professional(s), the VLU-to-food animal veterinarian ratio in the contiguous area is in excess of 5,000 : 1.
(c) In the case of companion animal veterinary professional(s), the population-to-companion animal veterinarian ratio in the contiguous area is in excess of 15,000 : 1.
C.
Designated areas will be assigned to degree-of-shortage groups as follows:
Group 1—Areas with a food animal veterinarian shortage and no veterinarians.
Group 2—Areas (not included above) with a food animal veterinarian shortage and no food animal veterinarians.
Group 3—All other food animal veterinarian shortage areas.
Group 4—All companion animal shortage areas (not included above) having no veterinarians.
Group 5—All other companion animal shortage areas.
Sections 215 and 224 of the Public Health Service Act, 42 U.S.C. 216 and 233.
This part applies to entities and individuals whose acts and omissions related to the performance of medical, surgical, dental, or related functions are covered by the Federal Tort Claims Act (28 U.S.C. 1346(b) and 2671-2680) in accordance with the provisions of section 224(g) of the Public Health Service Act (42 U.S.C. 233(g)).
(a)
(1) Section 329 of the Act (relating to grants for migrant health centers);
(2) Section 330 of the Act (relating to grants for community health centers);
(3) Section 340 of the Act (relating to grants for health services for the homeless); and
(4) Section 340A of the Act (relating to grants for health services for residents of public housing).
(b)
(a) Officers and employees of a covered entity are eligible for coverage under this part.
(b) Contractors of a covered entity who are physicians or other licensed or certified health care practitioners are eligible for coverage under this part if they meet the requirements of section 224(g)(5) of the Act.
(c) An individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of a covered entity will not be covered for acts or omissions occurring after receipt by the entity employing such individual of notice of a final determination by the Attorney General that he or she is no longer covered by this part, in accordance with section 224(i) of the Act.
Eligible entities will be covered by this part only on and after the effective date of a determination by the Secretary that they meet the requirements of section 224(h) of the Act. In making such determination, the Secretary will receive such assurances and conduct such investigations as he or she deems necessary.
(a) Only acts and omissions occurring on and after the effective date of the Secretary's determination under § 6.5 and before the later date specified in section 224(g)(3) of the Act are covered by this part.
(b) Only claims for damage for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions are covered by thispart.
(c) With respect to covered individuals, only acts and omissions within the scope of their employment (or contract for services) are covered. If a covered individual is providing services which are not on behalf of the covered entity, such as on a volunteer basis or on behalf of a third-party (except as described in paragraph (d) of this section), whether for pay or otherwise, acts and omissions which are related to such services are not covered.
(d) Only acts and omissions related to the grant-supported activity of entities are covered. Acts and omissions related to services provided to individuals who are not patients of a covered entity will be covered only if the Secretary determines that:
(1) The provision of the services to such individuals benefits patients of the entity and general populations that could be served by the entity through community-wide intervention efforts within the communities served by such entity;
(2) The provision of the services to such individuals facilitates the provision of services to patients of the entity; or
(3) Such services are otherwise required to be provided to such individuals under an employment contract or similar arrangement between the entity and the covered individual.
(e)
(1) A community health center deemed to be a covered entity establishes a school-based or school-linked health program as part of its grant supported activity. Even though the students treated are not necessarily registered patients of the center, the center and its health care practitioners will be covered for services provided, if the Secretary makes the determination in paragraph (d)(1) of this section.
(2) A migrant health center requires its physicians to obtain staff privileges at a community hospital. As a condition of obtaining such privileges, and thus being able to admit the center's patients to the hospital, the physicians must agree to provide occasional coverage of the hospital's emergency room. The Secretary would be authorized to determine that this coverage is necessary to facilitate the provision of services to the grantee's patients, and that it would therefore be covered by paragraph (d)(2) of this section.
(3) A homeless health services grantee makes arrangements with local community providers for after-hours coverage of its patients. The grantee's physicians are required by their employment contracts to provide periodic cross-coverage for patients of these providers, in order to make this arrangement feasible. The Secretary may determine that the arrangement is within the scope of paragraph (d)(3) of this section.
Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title V of the Independent Offices Appropriation Act of 1952 (31 U.S.C. 9701); and sec. 352 of the Public Health Service Act, as amended (42 U.S.C. 263).
The provisions of this part are applicable to private entities requesting from the Centers for Disease Control (CDC) reference biological standards and biological preparations for use in their laboratories.
Except as otherwise provided in § 7.6, a user charge shall be imposed to cover the cost to CDC of producing and distributing reference biological standards and biological preparations.
The charges imposed in § 7.2 are based on the amount published in CDC's price list of available products. These charges will reflect direct costs (such as salaries and equipment), indirect costs (such as rent, telephone service, and a proportionate share of management and administrative costs), and the costs of particular ingredients. Charges may vary over time and between different biological standards or biological preparations, depending upon the cost of ingredients and the complexity of production. An up-to-date schedule of charges is available from the Biological Products Branch, Center for Infectious Diseases, Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333.
The requester may obtain information on terms of payment and a fee schedule by writing the “Centers for Disease Control,” Financial Management Office, Buckhead Facility, Room 200, Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333.
State and local health departments, governmental institutions (e.g., State hospitals and universities), the World Health Organization, and ministries of health of foreign governments may be exempted from paying user charges, when using biological standards or biological preparations for public health purposes.
21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.
The regulations in this part establish the procedures by which the Secretary of Health and Human Services (the Secretary) will determine whether a practitioner is qualified under section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) to dispense opioid drugs in the treatment of opioid addiction. These regulations also establish the Secretary's standards regarding the appropriate quantities of opioid drugs that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(g)(1)). Under these regulations, a practitioner who intends to dispense opioid drugs in the treatment of opioid addiction must first obtain from the Secretary or by delegation, from the Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA), a certification that the practitioner is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification will depend upon the practitioner obtaining accreditation from an accreditation body that has been approved by SAMHSA. These regulations establish the procedures whereby an entity can apply to become an approved accreditation body. This part also establishes requirements and general standards for accreditation bodies to ensure that practitioners are consistently evaluated for compliance with the Secretary's standards for opiate addiction treatment with an opioid agonist treatment medication.
The following definitions apply to this part:
(a)
(b)
(1) Name, address, and telephone number of the applicant and a responsible official for the accreditation body. The application shall be signed by the responsible official;
(2) Evidence of the nonprofit status of the applicant (
(3) A set of the accreditation elements or standards and a detailed discussion showing how the proposed accreditation elements or standards will ensure that each OTP surveyed by the applicant is qualified to meet or is meeting each of the Federal opioid treatment standards set forth in § 8.12;
(4) A detailed description of the applicant's decisionmaking process, including:
(i) Procedures for initiating and performing onsite accreditation surveys of OTPs;
(ii) Procedures for assessing OTP personnel qualifications;
(iii) Copies of an application for accreditation, guidelines, instructions, and other materials the applicant will send to OTPs during the accreditation process, including a request for a complete history of prior accreditation activities and a statement that all information and data submitted in the application for accreditation is true and accurate, and that no material fact has been omitted;
(iv) Policies and procedures for notifying OTPs and SAMHSA of deficiencies and for monitoring corrections of deficiencies by OTPs;
(v) Policies and procedures for suspending or revoking an OTP's accreditation;
(vi) Policies and procedures that will ensure processing of applications for accreditation and applications for renewal of accreditation within a timeframe approved by SAMHSA; and
(vii) A description of the applicant's appeals process to allow OTPs to contest adverse accreditation decisions.
(5) Policies and procedures established by the accreditation body to avoid conflicts of interest, or the appearance of conflicts of interest, by the applicant's board members, commissioners, professional personnel, consultants, administrative personnel, and other representatives;
(6) A description of the education, experience, and training requirements for the applicant's professional staff, accreditation survey team membership, and the identification of at least one licensed physician on the applicant's staff;
(7) A description of the applicant's training policies;
(8) Fee schedules, with supporting cost data;
(9) Satisfactory assurances that the body will comply with the requirements of § 8.4, including a contingency plan for investigating complaints under § 8.4(e);
(10) Policies and procedures established to protect confidential information the applicant will collect or receive in its role as an accreditation body; and
(11) Any other information SAMHSA may require.
(c)
(1) At least 9 months before the date of expiration of an accreditation body's term of approval, the body shall inform SAMHSA in writing of its intent to seek renewal.
(2) SAMHSA will notify the applicant of the relevant information, materials, and supporting documentation required under paragraph (b) of this section that the applicant shall submit as part of the renewal procedure.
(3) At least 3 months before the date of expiration of the accreditation body's term of approval, the applicant shall furnish to SAMHSA three copies of a renewal application containing the information, materials, and supporting documentation requested by SAMHSA under paragraph (c)(2) of this section.
(4) An accreditation body that does not intend to renew its approval shall so notify SAMHSA at least 9 months before the expiration of the body's term of approval.
(d)
(2) If SAMHSA determines that the applicant does not substantially meet the requirements set forth in this subpart. SAMHSA will notify the applicant of the deficiencies in the application and request that the applicant resolve such deficiencies within 90 days of receipt of the notice. If the deficiencies are resolved to the satisfaction of SAMHSA within the 90-day time period, the body will be approved as an accreditation body. If the deficiencies have not been resolved to the satisfaction of SAMHSA within the 90-day time period, the application for approval as an accreditation body will be denied.
(3) If SAMHSA does not reach a final decision on a renewal application before the expiration of an accreditation body's term of approval, the approval will be deemed extended until SAMHSA reaches a final decision, unless an accreditation body does not rectify deficiencies in the application within the specified time period, as required in paragraph (d)(2) of this section.
(e)
(f)
(1) Transfer copies of records and other related information as required by SAMHSA to a location, including another accreditation body, and according to a schedule approved by SAMHSA; and
(2) Notify, in a manner and time period approved by SAMHSA, all OTPs accredited or seeking accreditation by the body that the body will no longer have approval to provide accreditation services.
(g)
(h)
(a)
(2) Accreditation bodies must agree to conduct for-cause inspections upon the request of SAMHSA.
(3) Accreditation decisions shall be fully consistent with the policies and procedures submitted as part of the approved accreditation body application.
(b)
(i) Accreditation bodies shall either not accredit or shall revoke the accreditation of any OTP that substantially fails to meet the Federal opioid treatment standards.
(ii) Accreditation bodies shall notify SAMHSA as soon as possible but in no case longer than 48 hours after becoming aware of any practice or condition in an OTP that may pose a serious risk to public health or safety or patient care.
(iii) If an accreditation body determines that an OTP is substantially meeting the Federal opioid treatment standards, but is not meeting one or more accreditation elements, the accreditation body shall determine the necessary corrective measures to be taken by the OTP, establish a schedule for implementation of such measures, and notify the OTP in writing that it must implement such measures within the specified schedule in order to ensure continued accreditation. The accreditation body shall verify that the necessary steps are taken by the OTP within the schedule specified and that all accreditation elements are being substantially met or will be substantially met.
(2) Nothing in this part shall prevent accreditation bodies from granting accreditation, contingent on promised programmatic or performance changes, to OTPs with less substantial violations. Such accreditation shall not exceed 12 months. OTPs that have been granted such accreditation must have their accreditation revoked if they fail to make changes to receive unconditional accreditation upon resurvey or reinspection.
(c)
(2) Accreditation bodies shall establish procedures to protect confidential information collected or received in
(i) Information collected or received for the purpose of carrying out accreditation body responsibilities shall not be used for any other purpose or disclosed, other than to SAMHSA or its duly designated representatives, unless otherwise required by law or with the consent of the OTP.
(ii) Nonpublic information that SAMHSA shares with the accreditation body concerning an OTP shall not be further disclosed except with the written permission of SAMHSA.
(d)
(2) Accreditation bodies shall make a summary of the results of each accreditation survey available to SAMHSA upon request. Such summaries shall contain sufficient detail to justify the accreditation action taken.
(3) Accreditation bodies shall provide SAMHSA upon request a list of each OTP surveyed and the identity of all individuals involved in the conduct and reporting of survey results.
(4) Accreditation bodies shall submit to SAMHSA the name of each OTP for which the accreditation body accredits conditionally, denies, suspends, or revokes accreditation, and the basis for the action, within 48 hours of the action.
(5) Notwithstanding any reports made to SAMHSA under paragraphs (d)(1) through (d)(4) of this section, each accreditation body shall submit to SAMHSA semiannually, on January 15 and July 15 of each calendar year, a report consisting of a summary of the results of each accreditation survey conducted in the past year. The summary shall contain sufficient detail to justify each accreditation action taken.
(6) All reporting requirements listed in this section shall be provided to SAMHSA at the address specified in § 8.3(b).
(e)
(f)
(g)
(h)
(i) The dispensing and administration of drugs subject to control under the Controlled Substances Act (21 U.S.C. 801
(ii) Medical issues relating to the dosing and administration of opioid agonist treatment medications for the treatment of opioid addiction;
(iii) Psychosocial counseling of individuals undergoing opioid treatment; and
(iv) Organizational and administrative issues associated with opioid treatment programs.
(2) Members of the accreditation team must be able to recuse themselves at any time from any survey in which either they or the OTP believes there is an actual conflict of interest or the appearance of a conflict of interest.
(i)
(1) The accreditation body shall make public its fee structure, including those factors, if any, contributing to variations in fees for different OTPs.
(2) At SAMHSA's request, accreditation bodies shall provide to SAMHSA financial records or other materials, in a manner specified by SAMHSA, to assist in assessing the reasonableness of accreditation body fees.
SAMHSA will evaluate periodically the performance of accreditation bodies primarily by inspecting a selected sample of the OTPs accredited by the accrediting body and by evaluating the accreditation body's reports of surveys conducted, to determine whether the OTPs surveyed and accredited by the accreditation body are in compliance with the Federal opioid treatment standards. The evaluation will include a determination of whether there are major deficiencies in the accreditation body's performance that, if not corrected, would warrant withdrawal of the approval of the accreditation body under § 8.6.
If SAMHSA determines that an accreditation body is not in substantial compliance with this subpart, SAMHSA shall take appropriate action as follows:
(a)
(1) In the event of a major deficiency, SAMHSA shall notify the accreditation body of the agency's action and the grounds on which the approval was withdrawn.
(2) An accreditation body that has lost its approval shall notify each OTP that has been accredited or is seeking accreditation that the accreditation body's approval has been withdrawn. Such notification shall be made within a time period and in a manner approved by SAMHSA.
(b)
(1) If SAMHSA places an accreditation body on probationary status, the body shall notify all OTPs that have been accredited, or that are seeking accreditation, of the accreditation body's probationary status within a time period and in a manner approved by SAMHSA.
(2) Probationary status will remain in effect until such time as the body can demonstrate to the satisfaction of SAMHSA that it has successfully implemented or is implementing the corrective action plan within the established schedule, and the corrective actions taken have substantially eliminated all identified problems.
(3) If SAMHSA determines that an accreditation body that has been
(c)
(2) If SAMHSA determines that the new application demonstrates that the body satisfactorily has addressed the causes of its previous unacceptable performance, SAMHSA may reinstate approval of the accreditation body.
(3) SAMHSA may request additional information or establish additional conditions that must be met before SAMHSA approves the reapplication.
(4) SAMHSA may refuse to accept an application from a former accreditation body whose approval was withdrawn because of fraud, material false statement, or willful disregard of public health.
(d)
(a)
(2) To obtain certification from SAMHSA, an OTP must meet the Federal opioid treatment standards in § 8.12, must be the subject of a current, valid accreditation by an accreditation body or other entity designated by SAMHSA, and must comply with any other conditions for certification established by SAMHSA.
(3) Certification shall be granted for a term not to exceed 3 years, except that certification may be extended during the third year if an application for accreditation is pending.
(b)
(1) A description of the current accreditation status of the OTP;
(2) A description of the organizational structure of the OTP;
(3) The names of the persons responsible for the OTP;
(4) The addresses of the OTP and of each medication unit or other facility under the control of the OTP;
(5) The sources of funding for the OTP and the name and address of each governmental entity that provides such funding; and
(6) A statement that the OTP will comply with the conditions of certification set forth in paragraph (f) of this section.
(7) The application shall be signed by the program sponsor who shall certify that the information submitted in the application is truthful and accurate.
(c)
(2) SAMHSA may deny the application if SAMHSA determines that:
(i) The application for certification is deficient in any respect;
(ii) The OTP will not be operated in accordance with the Federal opioid treatment standards established under § 8.12;
(iii) The OTP will not permit an inspection or a survey to proceed, or will not permit in a timely manner access to relevant records or information; or
(iv) The OTP has made misrepresentations in obtaining accreditation or in applying for certification.
(3) Within 5 days after it reaches a final determination that an OTP meets the requirements for certification, SAMHSA will notify the Drug Enforcement Administration (DEA) that the OTP has been determined to be qualified to provide opioid treatment under section 303(g)(1) of the Controlled Substances Act.
(d)
(e)
(2) An extension of provisional certification may be granted in extraordinary circumstances or otherwise to protect public health. To apply for a 90-day extension of provisional certification, an OTP shall submit to SAMHSA a statement explaining its efforts to obtain accreditation and a schedule for obtaining accreditation as expeditiously as possible.
(f)
(2) OTPs shall allow, in accordance with Federal controlled substances laws and Federal confidentiality laws, inspections and surveys by duly authorized employees of SAMHSA, by accreditation bodies, by the DEA, and by authorized employees of any relevant State or Federal governmental authority.
(3) Disclosure of patient records maintained by an OTP is governed by the provisions of 42 CFR part 2, and every program must comply with that part. Records on the receipt, storage, and distribution of opioid agonist treatment medications are also subject to inspection under Federal controlled substances laws and under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). Federally-sponsored treatment programs are subject to applicable Federal confidentiality statutes.
(4) A treatment program or medication unit or any part thereof, including any facility or any individual, shall permit a duly authorized employee of SAMHSA to have access to and to copy all records on the use of opioid drugs in accordance with the provisions of 42 CFR part 2.
(5) OTPs shall notify SAMHSA within 3 weeks of any replacement or other change in the status of the program sponsor or medical director.
(6) OTPs shall comply with all regulations enforced by the DEA under 21 CFR chapter II, and must be registered by the DEA before administering or dispensing opioid agonist treatment medications.
(7) OTPs must operate in accordance with Federal opioid treatment standards and approved accreditation elements.
(g)
(2) Before SAMHSA may grant such approval, the OTP must provide SAMHSA with documentation from the chief public health officer of the State in which the OTP operates demonstrating that:
(i) Such officer does not object to the providing of interim maintenance treatment in the State;
(ii) The OTP seeking to provide such treatment is unable to place patients in a public or nonprofit private comprehensive treatment program within a reasonable geographic area within 14 days of the time patients seek admission to such programs;
(iii) The authorization of the OTP to provide interim maintenance treatment will not otherwise reduce the capacity of comprehensive maintenance treatment programs in the State to admit individuals (relative to the date on which such officer so certifies); and
(iv) The State certifies that each individual enrolled in interim maintenance treatment will be transferred to a comprehensive maintenance treatment program no later than 120 days from the date on which each individual first requested treatment, as provided in section 1923 of the Public Health Service Act (21 U.S.C. 300x-23).
(3) SAMHSA will provide notice to the OTP denying or approving the request to provide interim maintenance treatment. The OTP shall not provide such treatment until it has received such notice from SAMHSA.
(h)
(i)
(2) Certification as an OTP under this part will not be required for the maintenance or detoxification treatment of a patient who is admitted to a hospital or long-term care facility for the treatment of medical conditions other than opiate addiction and who requires maintenance or detoxification treatment during the period of his or her stay in that hospital or long-term care facility. The terms “hospital” and “long-term care facility” as used in this section are to have the meaning that is assigned under the law of the State in which the treatment is being provided. Nothing in this section is intended to relieve hospitals and long-term care facilities from the obligation to obtain registration from the Attorney General, as appropriate, under section 303(g) of the Controlled Substances Act.
(a)
(b)
(c)
(2) An OTP must maintain a current “Diversion Control Plan” or “DCP” as part of its quality assurance program that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use and that assigns specific responsibility to the medical and administrative staff of the OTP for carrying out the diversion control measures and functions described in the DCP.
(d)
(e)
(2) Maintenance treatment for persons under age 18. A person under 18 years of age is required to have had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period to be eligible for maintenance treatment. No person under 18 years of age may be admitted to maintenance treatment unless a parent, legal guardian, or responsible adult designated by the relevant State authority consents in writing to such treatment.
(3) Maintenance treatment admission exceptions. If clinically appropriate, the program physician may waive the requirement of a 1-year history of addiction under paragraph (e)(1) of this section, for patients released from penal institutions (within 6 months after release), for pregnant patients (program physician must certify pregnancy), and for previously treated patients (up to 2 years after discharge).
(4) Detoxification treatment. An OTP shall maintain current procedures that are designed to ensure that patients are admitted to short- or long-term detoxification treatment by qualified personnel, such as a program physician, who determines that such treatment is appropriate for the specific patient by applying established diagnostic criteria. Patients with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the OTP physician for other forms of treatment. A program shall not admit a patient for more than two detoxification treatment episodes in one year.
(f)
(2) Initial medical examination services. OTPs shall require each patient to undergo a complete, fully documented physical evaluation by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician, before admission to the OTP. The full medical examination, including the results of serology and other tests, must be completed within 14 days following admission.
(3) Special services for pregnant patients. OTPs must maintain current policies and procedures that reflect the special needs of patients who are pregnant. Prenatal care and other gender specific services or pregnant patients must be provided either by the OTP or by referral to appropriate healthcare providers.
(4) Initial and periodic assessment services. Each patient accepted for treatment at an OTP shall be assessed initially and periodically by qualified personnel to determine the most appropriate combination of services and treatment. The initial assessment must include preparation of a treatment plan that includes the patient's short-term goals and the tasks the patient must perform to complete the short-term goals; the patient's requirements for education, vocational rehabilitation, and employment; and the medical, psychosocial, economic, legal, or other supportive services that a patient needs. The treatment plan also must identify the frequency with which these services are to be provided. The plan must be reviewed and updated to reflect that patient's personal history, his or her current needs for medical, social, and psychological services, and his or her current needs for education, vocational rehabilitation, and employment services.
(5) Counseling services. (i) OTPs must provide adequate substance abuse counseling to each patient as clinically
(ii) OTPs must provide counseling on preventing exposure to, and the transmission of, human immunodeficiency virus (HIV) disease for each patient admitted or readmitted to maintenance or detoxification treatment.
(iii) OTPs must provide directly, or through referral to adequate and reasonably accessible community resources, vocational rehabilitation, education, and employment services for patients who either request such services or who have been determined by the program staff to be in need of such services.
(6) Drug abuse testing services. OTPs must provide adequate testing or analysis for drugs of abuse, including at least eight random drug abuse tests per year, per patient in maintenance treatment, in accordance with generally accepted clinical practice. For patients in short-term detoxification treatment, the OTP shall perform at least one initial drug abuse test. For patients receiving long-term detoxification treatment, the program shall perform initial and monthly random tests on each patient.
(g)
(2) OTPs shall include, as an essential part of the recordkeeping system, documentation in each patient's record that the OTP made a good faith effort to review whether or not the patient is enrolled any other OTP. A patient enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances. If the medical director or program physician of the OTP in which the patient is enrolled determines that such exceptional circumstances exist, the patient may be granted permission to seek treatment at another OTP, provided the justification for finding exceptional circumstances is noted in the patient's record both at the OTP in which the patient is enrolled and at the OTP that will provide the treatment.
(h)
(2) OTPs shall use only those opioid agonist treatment medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of opioid addiction. In addition, OTPs who are fully compliant with the protocol of an investigational use of a drug and other conditions set forth in the application may administer a drug that has been authorized by the Food and Drug Administration under an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act for investigational use in the treatment of opioid addiction. Currently the following opioid agonist treatment medications will be considered to be approved by the Food and Drug Administration for use in the treatment of opioid addiction:
(i) Methadone; and
(ii) Levomethadyl acetate (LAAM).
(3) OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial dosing requirements are met:
(i) Methadone shall be administered or dispensed only in oral form and shall
(ii) For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams and the total dose for the first day shall not exceed 40 milligrams, unless the program physician documents in the patient's record that 40 milligrams did not suppress opiate abstinence symptoms.
(4) OTPs shall maintain current procedures adequate to ensure that each opioid agonist treatment medication used by the program is administered and dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures must ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record.
(i) Unsupervised or “take-home” use. To limit the potential for diversion of opioid agonist treatment medications to the illicit market, opioid agonist treatment medications dispensed to patients for unsupervised use shall be subject to the following requirements.
(1) Any patient in comprehensive maintenance treatment may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and State and Federal holidays.
(2) Treatment program decisions on dispensing opioid treatment medications to patients for unsupervised use beyond that set forth in paragraph (i)(1) of this section, shall be determined by the medical director. In determining which patients may be permitted unsupervised use, the medical director shall consider the following take-home criteria in determining whether a patient is responsible in handling opioid drugs for unsupervised use.
(i) Absence of recent abuse of drugs (opioid or nonnarcotic), including alcohol;
(ii) Regularity of clinic attendance;
(iii) Absence of serious behavioral problems at the clinic;
(iv) Absence of known recent criminal activity,
(v) Stability of the patient's home environment and social relationships;
(vi) Length of time in comprehensive maintenance treatment;
(vii) Assurance that take-home medication can be safely stored within the patient's home; and
(viii) Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion.
(3) Such determinations and the basis for such determinations consistent with the criteria outlined in paragraph (i)(2) of this section shall be documented in the patient's medical record. If it is determined that a patient is responsible in handling opioid drugs, the following restrictions apply:
(i) During the first 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is limited to a single dose each week and the patient shall ingest all other doses under appropriate supervision as provided for under the regulations in this subpart.
(ii) In the second 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is two doses per week.
(iii) In the third 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is three doses per week.
(iv) In the remaining months of the first year, a patient may be given a maximum 6-day supply of take-home medication.
(v) After 1 year of continuous treatment, a patient may be given a maximum 2-week supply of take-home medication.
(vi) After 2 years of continuous treatment, a patient may be given a maximum one-month supply of take-home medication, but must make monthly visits.
(4) No medications shall be dispensed to patients in short-term detoxification treatment or interim maintenance treatment for unsupervised or take-home use.
(5) OTPs must maintain current procedures adequate to identify the theft or diversion of take-home medications,
(j)
(2) The program shall notify the State health officer when a patient begins interim maintenance treatment, when a patient leaves interim maintenance treatment, and before the date of mandatory transfer to a comprehensive program, and shall document such notifications.
(3) SAMHSA may revoke the interim maintenance authorization for programs that fail to comply with the provisions of this paragraph (j). Likewise, SAMHSA will consider revoking the interim maintenance authorization of a program if the State in which the program operates is not in compliance with the provisions of § 8.11(g).
(4) All requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions:
(i) The opioid agonist treatment medication is required to be administered daily under observation;
(ii) Unsupervised or “take-home” use is not allowed;
(iii) An initial treatment plan and periodic treatment plan evaluations are not required;
(iv) A primary counselor is not required to be assigned to the patient;
(v) Interim maintenance cannot be provided for longer than 120 days in any 12-month period; and
(vi) Rehabilitative, education, and other counseling services described in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this section are not required to be provided to the patient.
(a)
(b)
(2) Within 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by SAMHSA, OTPs currently accredited by the accreditation body must obtain accreditation from another accreditation body. SAMHSA may extend the time period for obtaining reaccreditation on a case-by-case basis.
(a)
(1) Has been found guilty of misrepresentation in obtaining the certification;
(2) Has failed to comply with the Federal opioid treatment standards in any respect;
(3) Has failed to comply with reasonable requests from SAMHSA or from an accreditation body for records, information, reports, or materials that are necessary to determine the continued eligibility of the OTP for certification or continued compliance with the Federal opioid treatment standards; or
(4) Has refused a reasonable request of a duly designated SAMHSA inspector, Drug Enforcement Administration (DEA) Inspector, State Inspector, or accreditation body representative for permission to inspect the program or the program's operations or its records.
(b)
(1) The failure to comply with the Federal opioid treatment standards presents an imminent danger to the public health or safety;
(2) The refusal to permit inspection makes immediate suspension necessary; or
(3) There is reason to believe that the failure to comply with the Federal opioid treatment standards was intentional or was associated with fraud.
(c)
(d)(1) If SAMHSA suspends certification in accordance with paragraph (b) of this section:
(i) SAMHSA will immediately notify DEA that the OTP's registration should be suspended under 21 U.S.C. 824(d); and
(ii) SAMHSA will provide an opportunity for a hearing under subpart C of this part.
(2) Suspension of certification under paragraph (b) of this section shall remain in effect until the agency determines that:
(i) The basis for the suspension cannot be substantiated;
(ii) Violations of required standards have been corrected to the agency's satisfaction; or
(iii) The OTP's certification shall be revoked.
(a) SMA-162—Application for Certification to Use Opioid AgonistTreatment Medications for Opioid Treatment.
(b) SMA-163—Application for Becoming an Accreditation Body under § 8.3.
The procedures in this subpart apply when:
(a) SAMHSA has notified an OTP in writing that its certification under the regulations in subpart B of this part has been suspended or that SAMHSA proposes to revoke the certification; and
(b) The OTP has, within 30 days of the date of the notification or within 3 days of the date of the notification when seeking an expedited review of a suspension, requested in writing an opportunity for a review of the suspension or proposed revocation.
(c) SAMHSA has notified an accreditation body of an adverse action taken regarding withdrawal of approval of the accreditation body under the regulations in subpart A of this part; and
(d) The accreditation body has, within 30 days of the date of the notification, requested in writing an opportunity for a review of the adverse action.
The following definitions apply to this subpart C.
(a)
(1) The treatment program which has been notified of its suspension or proposed revocation of its certification under the regulations of this part and has requested a review of the suspension or proposed revocation, or
(2) The accreditation body which has been notified of adverse action regarding withdrawal of approval under the regulations of this subpart and has requested a review of the adverse action.
(b)
(c)
The scope of review shall be limited to the facts relevant to any suspension, or proposed revocation, or adverse action, the necessary interpretations of the facts the regulations, in the subpart, and other relevant law.
The appellant's request for review shall specify the name, address, and phone number of the appellant's representative. In its first written submission to the reviewing official, the respondent shall specify the name, address, and phone number of the respondent's representative.
(a)
(b)
The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. The procedures for development of the review file and submission of written argument are:
(a)
(1) A review file containing the documents supporting appellant's argument, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages, explaining why respondent's decision to suspend or propose revocation of appellant's certification or to take adverse action regarding withdrawal of approval of the accreditation body is incorrect (appellant's brief).
(b)
(1) A review file containing documents supporting respondent's decision to suspend or revoke appellant's certification, or approval as an accreditation body, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in length, explaining the basis for suspension, proposed revocation, or adverse action (respondent's brief).
(c)
(d)
(e)
(f)
(a)
(b)
(c)
(d)
(e)
(2) Burden of proof/standard of proof. In all cases, the respondent bears the burden of proving by a preponderance of the evidence that its decision to suspend, propose revocation, or take adverse action is appropriate. The appellant, however, has a responsibility to respond to the respondent's allegations with evidence and argument to show that the respondent is incorrect.
(3) Admission of evidence. The rules of evidence do not apply and the presiding official will generally admit all testimonial evidence unless it is clearly irrelevant, immaterial, or unduly repetitious. Each party may make an opening and closing statement, may present witnesses as agreed upon in the pre-hearing conference or otherwise, and may question the opposing party's witnesses. Since the parties have ample opportunity to prepare the review file, a party may introduce additional documentation during the oral presentation only with the permission of the presiding official. The presiding official may question witnesses directly and take such other steps necessary to ensure an effective and efficient consideration of the evidence, including setting time limitations on direct and cross-examinations.
(4) Motions. The presiding official may rule on motions including, for example, motions to exclude or strike redundant or immaterial evidence, motions to dismiss the case for insufficient evidence, or motions for summary judgment. Except for those made during the hearing, all motions and opposition to motions, including argument, must be in writing and be no more than 10 double-spaced pages in length. The presiding official will set a reasonable time for the party opposing the motion to reply.
(5) Transcripts. The presiding official shall have the oral presentation transcribed and the transcript shall be made a part of the record. Either party may request a copy of the transcript and the requesting party shall be responsible for paying for its copy of the transcript.
(f)
(g)
(a)
(b)
(c)
(1) A review file containing essential documents relevant to the review, tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages, explaining the party's position concerning the suspension and any proposed revocation. No reply brief is permitted.
(d)
(e)
(f)
Except for routine administrative and procedural matters, a party shall not communicate with the reviewing or presiding official without notice to the other party.
(a)
(b)
In addition to any other authority specified in this subpart C, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of the procedures in this subpart.
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
(a)
(b)
(c)
(2) If the suspension and proposed revocation of OTP certification are denied, the revocation will not take effect and the suspension will be lifted immediately. Public notice will be given by publication in the
Before any legal action is filed in court challenging the suspension, proposed revocation, or adverse action, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal law. The reviewing official's decision, under § 8.28(e) or § 8.33(a), constitutes final agency action as of the date of the decision.
Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216.
As used in this part, the term:
(a)
(b)
(c)
(d)
(e)
(f)
Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216; sec. 208, 58 Stat. 685, as amended; 42 U.S.C. 209.
The terms
(a) A school, college, postgraduate school, or training course which has been accredited or approved by a professional body or bodies recognized by the Surgeon General for such purpose, or which, in the absence of such a body, meets generally accepted professional standards as determined by the Surgeon General, or
(b) In the case of a candidate who is applying for appointment as a medical officer, any non-approved medical school provided that the candidate has passed examinations given by a professional body or bodies recognized by the Surgeon General for such purpose.
(a)
(b)
Willfully false statements shall be cause for rejection of the application or, as provided in subpart N of this part, for dismissal.
Every candidate for appointment as an officer shall undergo such physical examination as the Surgeon General may direct, and no candidate who is not found to be physically qualified shall be appointed as an officer.
(a)
(1) Shall be a citizen of the United States;
(2) Shall be at least 18 years of age; and
(3) Shall have been granted an academic or professional degree from an approved school, college, or postgraduate school, and, unless the required professional training has been otherwise obtained from an approved school, college, or postgraduate school, shall have majored in the profession in which the examination is being held.
(b) [Reserved]
(c)
(a)
(1) Shall meet the requirements for eligibility for examination for appointment in the grade of junior assistant;
(2) Shall be at least 21 years of age; and
(3) Shall have had at least 7 years of educational and professional training or experience subsequent to high school, except that a candidate who applies for examination for appointment in the Reserve Corps to serve as a medical or dental intern may be examined for such appointment upon the completion of 6 years of such education, training, or experience.
(b)
Every candidate for examination for appointment in the grade of senior assistant shall meet the requirements for eligibility for examination for appointment in the grade of assistant and shall have completed at least 10 years of educational and professional training or experience subsequent to high school.
No candidate for appointment to the Regular Corps, except in the nurse category, shall be appointed (a) after age 31 to the permanent junior assistant grade, (b) after age 34 to the permanent assistant grade, or (c) after age 37 to the permanent senior assistant grade:
Every candidate for examination for appointment in grades above that of senior assistant shall meet the requirements for eligibility for examination for appointment in the grade of senior assistant. Candidates for examination for appointment in the full, senior, or director grade shall have completed at least 7, 14, or 15 additional years, respectively, of postgraduate professional training for experience. When officers of the Service are unavailable for the performance of duties requiring highly specialized training and experience in special fields related to public health, the Surgeon General may specify that a candidate for appointment to the Regular Corps with such highly specialized training and experience shall be examined for appointment in the full or senior grade upon completion of at least 5 or 12 additional years, respectively, of postgraduate professional training or experience, except that the total number of such appointments during a fiscal year shall not exceed three.
The level of academic attainment, the number of calendar years and the quality of educational and professional training and experience shall be considered in determining the number of years of such training and experience with which each candidate for appointment may be credited.
The Surgeon General is authorized, subject to the other provisions of this subpart to adopt additional standards by which the education, training, and experience required under this subpart, and evidence thereof, shall be of such specific kind and quality, pertinent to the particular profession concerned, as in his judgment are necessary to limit the examination to qualified candidates.
The Surgeon General shall from time to time appoint boards and subboards of officers to consider the qualifications of candidates for appointment as officers, and shall refer to such boards the applications of those candidates who are eligible for examination for appointment. Such boards and subboards shall consist of three or more officers, the majority of whom, so far as practicable, shall be of the same profession as the candidate. The Surgeon General shall prescribe the duties of boards and subboards in relation to the examination process not otherwise prescribed in this subpart.
Officers shall be appointed only to general service and shall be subject to change of station.
If a candidate for appointment in the Regular Corps or an officer of the Reserve Corps on inactive service has passed a physical examination within a period of one year from the date on which it is contemplated that he will be appointed or called to active duty, he shall, prior to being appointed or called to active duty, certify that to the best of his knowledge and belief he is free from all disease or injury not noted in his record at the time of his examination and that he is willing to serve in any climate. If a candidate for appointment in the Regular Corps, or an officer of the Reserve Corps on inactive service, has not passed a physical examination within a period of one year from the date on which it is contemplated that he will be appointed or called to active duty, he may, prior to being appointed or called to active duty, be required to undergo such physical examination as the Surgeon General may direct to determine his physical qualification for appointment or call to active duty in accordance with standards prescribed for original appointment, or he may be appointed or called to active duty after executing the certificate described in this section, but shall be physically examined to determine his physical qualification for continued active service in accordance with standards prescribed for original appointment within a period of 15 days after reporting for duty at his first station.
From time to time the Surgeon General may order examinations to be held in such professions or specialties within professions and for such grades as he deems necessary for the purpose of providing merit rolls of eligible candidates for appointment in the Regular Corps and shall, if a professional examination is to be required, prescribe the subjects relating to each profession or specialty within such profession in which candidates will be examined.
The examination for appointment to the junior assistant, assistant, or senior assistant grade in the Regular Corps shall consist of (a) a written professional examination relating to the fundamentals of the candidate's profession or specialty within his profession and their relationship to the activities of the Service, and (b) an examination as to the candidate's general fitness, which shall include an oral interview, and a review and evaluation of the candidate's academic and professional education and professional training and experience, and may include other written tests to determine the candidate's fitness for appointment as an officer. If an applicant for appointment to any of these grades is an officer of the Reserve Corps who has been on active duty for not less than one year immediately preceding his application, the Surgeon General may direct that the officer be examined as provided in § 21.43.
The examination for appointment to the full, senior, or director grade in the Regular Corps shall consist of a review and evaluation of the candidate's academic and professional education and professional training and experience. The Surgeon General may, however, direct that the examination of a candidate for appointment to any such grade shall also include an oral interview, a written or oral professional examination, or both.
In the discretion of the Surgeon General a candidate for appointment to any grade up to and including the senior assistant grade in the Regular
The examination of every candidate for appointment to any grade in the Regular Corps shall be rated by a board appointed pursuant to § 21.30 in accordance with such relative values for each part of the examination as are prescribed by the Surgeon General. No candidate who receives a final rating below 80 shall be appointed in the Regular Corps.
Each board appointed pursuant to § 21.30 to consider the qualifications of candidates for appointment as officers shall assign a numerical rating to each candidate for appointment in the Regular Corps who passes the examination, and shall submit a report to the Surgeon General of the ratings and the relative standing of all such candidates for each grade in each profession or specialty within a profession. The Surgeon General shall submit each such report with his recommendations to the Secretary, and, if approved by the Secretary, the report shall constitute a merit roll from which the Secretary shall, in accordance with relative standing, recommend available persons to the President for nomination as commissioned officers of the Regular Corps. A board may consider any newly discovered evidence relating to the physical, professional, or personal qualifications of any candidate examined for appointment. Upon recommendation of such board after review of such evidence, the Surgeon General, with the approval of the Secretary, may correct the rating of a candidate or may qualify or disqualify a candidate. The placing of a candidate's name on a merit roll shall give no assurance of an appointment. A merit roll shall expire when a new merit roll in the same profession or specialty within a profession and grade has been established, but no merit roll shall continue in effect longer than two years after its approval by the Secretary. Every candidate who has not been nominated by the President for appointment prior to the expiration of a merit roll on which his name appears, shall, unless he requests the opportunity to be reexamined, be rated with the next group of candidates of the same profession or specialty within a profession for appointment in the same grade and shall be given the same rating he had on the expired merit roll. If two candidates who were examined at the same time receive the same numerical rating the elder candidate shall assume relative standing on the merit roll over the younger candidate. If a candidate whose name is being transferred from an expired to a new merit roll has the same numerical rating as a candidate whose name is being placed on the new merit roll for the first time, the former shall assume relative standing on the merit roll over the latter. The name of a candidate may be removed from a merit roll in the event that he refuses an appointment when offered. No candidate's eligibility for appointment shall exceed two years unless he again becomes eligible as the result of another examination.
A potential candidate for appointment in any grade in the Regular Corps may be examined within a period of nine months prior to the date upon which it is anticipated that he will qualify for appointment under this subpart. Upon successful completion of the examination, his name will be entered on a merit roll. In the event that his name, in order of relative standing among all candidates, precedes that of fully qualified candidates, his name, for purpose of appointment, shall be passed over in favor of fully qualified candidates until such time as he becomes fully qualified, but in no event shall he otherwise lose his relative standing on the merit roll, except as provided in § 21.46. If the candidate fails to qualify for appointment at the time that it was anticipated that he would qualify, his name shall be removed from the merit roll.
The Surgeon General may recommend for original appointment in the Reserve Corps candidates who have specialized training or experience in administration and management relating to the functions of the Service. All such candidates shall be subject to the same eligibility requirements for original appointment as are applicable to other candidates, except that such a candidate may substitute experience in administration or management for the requirement of professional training or experience.
If, in time of war or national emergency proclaimed by the President, the Secretary determines that there is need for commissioned personnel to meet the needs of the Service, other than persons eligible for examination for original appointment under the eligibility requirements prescribed in this subpart, he may prescribe standards of eligibility for examination for the original appointment of officers in the Reserve Corps without regard to such eligibility requirements. Such standards shall, however, authorize the examination only of candidates with specialized experience in administration or management or candidates with training or experience in fields relating to public health. The permanent grade of an officer who becomes eligible for examination for appointment pursuant to such standards and who becomes eligible for appointment after passage of an examination shall be limited to the junior assistant or the assistant grade, except that, if upon examination a candidate is found to be exceptionally qualified for the performance of highly specialized duties with the Service pursuant to § 21.55, he may be recommended for appointment to any grade up to and including the director grade.
The examination of candidates for original appointment as officers to any grade in the Reserve Corps shall consist of a review and evaluation of their academic and other education and their training and experience. In the discretion of the Surgeon General the examination of any such candidate may include an oral interview, a written examination, or both.
A potential candidate for appointment in the Regular Corps who is pursuing a course of instruction which, upon completion, would qualify him under § 21.25 or § 21.26 for examination for appointment in the junior assistant or assistant grade may be examined for and appointed in the Reserve Corps in the junior assistant grade but shall not be called to extended active duty until the successful completion of such course of instruction, except that: (a) He may be called to active duty for purposes of training for periods not to exceed 120 days during any fiscal year, and (b) those students who have completed at least 3 years of collegiate or professional study leading to the qualifying degree for appointment may be called to active duty for the purpose of completing the requirements of § 21.25(a)(3). An appointment made under this subpart shall be terminated upon the officer's failure to continue a full-time course of study or failure to meet the requirements of § 21.25(a)(3) within 18 months after entering on active duty.
Any candidate eligible for examination for appointment in the grade of assistant pursuant to § 21.26 who, upon examination for such purpose, is found
An officer of the Reserve Corps, after being examined and found qualified for reappointment, may be recommended for reappointment to the same grade in the event that his commission expires before he becomes eligible for reappointment to a higher grade, or may be recommended for reappointment to a higher grade to be effective on or after the date on which he meets the qualifications prescribed in this subpart for original appointment to such higher grade.
The examination of an officer of the Reserve Corps on active duty who is being considered for reappointment in such corps shall consist of a review and evaluation of his record with the Service. The examination of an officer of the Reserve Corps on inactive duty who is being considered for reappointment in such corps shall consist of (a) a review and evaluation of his record with the Service while on active duty, if any, and (b) the record of his training or experience during the period of his inactive duty preceding such examination. In the discretion of the Surgeon General the examination for reappointment of an officer, whether on active or inactive duty, may include an oral interview.
Every officer of the Reserve Corps being considered for reappointment shall undergo such physical examination as the Surgeon General may direct. An officer on active duty may be recommended for reappointment unless he is found to have a physical disability which is determined to render him physically unfit to perform the duties of his office under section 402 of the Career Compensation Act of 1949, as amended. An officer may be recommended for promotion only if he meets the physical qualifications for original appointment. If an officer is not available to be physically examined because of circumstances which make it impracticable for the Service to require such examination, he may, in the discretion of the Surgeon General, be reappointed without such examination, but shall be examined as soon thereafter as practicable and his physical qualification or disqualification for continued or future active service shall be determined on the same basis as if the physical examination had been given prior to reappointment.
37 U.S.C. 101, 15 U.S.C. 1673, 42 U.S.C. 665.
Under references 37 U.S.C. 101, 15 U.S.C. 1673, and 42 U.S.C. 665, this subpart provides implementing policies governing involuntary child or child and spousal support allotments, assigns responsibilities, and prescribes procedures.
(a) This subpart applies to officers in the Public Health Service Commissioned Corps. The term “Public Health Service,” hereinafter shall be referred to as Service.
(b) Its provisions pertain to officers of the Service under a call or order to active duty for a period of six months or more.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a) It is the policy of the Department of Health and Human Services to withhold allotments from pay and allowances of commissioned officers on active duty in the Service to make involuntary allotments from pay and allowances as payment of child, or child and spousal, support payments when the officer has failed to make periodic payments under a support order in a total amount equal to the support payable for two months or longer. Failure to make such payments shall be established by notice from an authorized person to the designated official of the Department. Such notice shall specify the name and address of the payee to whom the allotment is payable. The amount of the allotment shall be the amount necessary to comply with the support order including amounts for arrearages as well as for current support. However the amount of the allotment, when added to any other amounts withheld from the officer'spay pursuant to a support order, shall not exceed the limits for involuntary allotments from pay as prescribed in section 303 (b) and (c) of the Consumer Credit Protection Act, 15 U.S.C. 1673. An allotment under this Subpart shall be adjusted or discontinued upon notice from any authorized person.
(b) Notwithstanding the above, no action shall be taken to withhold an allotment from the pay and allowances of any officer until such officer has had an opportunity to consult with a legal officer of the Department to discuss the legal and other factors involved with respect to the officer's support obligation and his or her failure to make payments. The Department shall exercise continuing good faith efforts to arrange such a consultation, but must begin to withhold allotments on the first end-of-month payday after 30 days have elapsed since notice of an opportunity to consult was sent to the officer.
(a) The General Counsel, Office of the Secretary, Department of Health and Human Services, shall be the Designated Official for the Department
(b) The Commissioned Personnel Operations Division, Office of Personnel Management, Office of Management, Office of the Assistant Secretary for Health, shall implement the provisions of these regulations.
(a)
(i) Full name of the officer;
(ii) Social security number of the officer;
(iii) Duty station location of the officer, if known;
(iv) A statement that support payments are delinquent by an amount at least equal to the amount of support payable for two months;
(v) A photocopy, along with any modifications, of the underlying support order;
(vi) A statement of the amount of arrearages provided for in the court order and the amount which is to be applied each month toward liquidation of the arrearages, if applicable;
(vii) The full name and address of the payee to whom the allotment will be payable;
(viii) Any limitations on the duration of the support allotment.
(2) The service of notice shall be accomplished by certified or registered mail, return receipt requested, or by personal service, upon the appropriate designated official of the Department. The designated official shall note the date and time of receipt on the notice.
(3) Valid service is not accomplished until the notice is received in the office of the designated official.
(4) If the order of a court or duly authorized administrative agency seeks collection of arrearages, the notice must state that the support allotment qualifies for the additional 5 percent in excess of the maximum percentage limitations found in 15 U.S.C. 1673. Supporting evidence must be submitted to the Department establishing that the support order is 12 or more weeks in arrears.
(5) When the information submitted is not sufficient to identify the officer the notice shall be returned directly to the authorized person with an explanation of the deficiency. However, before returning the notice, an attempt should be made to inform the authorized person who caused the notice to be served that it will not be honored unless adequate information is supplied.
(6) Upon proper service of notice of delinquent support payments and together with all required supplementary documents and information, the Service shall identify the officer from whom moneys are due and payable. The pay of the officer shall be reduced by the amount necessary to comply with the support order and liquidate arrearages if any, if provided by order of a court or duly authorized administrative agency. The maximum amount to be alloted under the provision together with any other moneys withheld from the officer for support pursuant to a court order may notexceed:
(i) 50 percent of the officer's disposable earnings for any month when the officer asserts by affidavit or other acceptable evidence that he or she is supporting a spouse or dependent child or both, other than a party in the support order. When the officer submits evidence, copies shall be sent to the authorized person, together with notification that the officer's support claim will be honored. If the support claim is contested by the authorized person, the authorized person may refer it to the appropriate court or other authority for resolution. Pending resolution of a contested support claim, the allotment shall be made but the amount of such allotment may not exceed 50 percent of the officer's disposable earnings;
(ii) 60 percent of the officer's disposable earnings for any month when the officer fails to assert by affidavit or other acceptable evidence, that he or she is supporting a spouse or dependent child or both;
(iii) Regardless of the limitations above, an additional five percent of the officer's disposable earnings shall be withheld when it is stated in the notice that the officer is in arrears in an amount equivalent to 12 or more weeks' support.
(b)
(i) Basic pay;
(ii) Basic allowances for quarters for officers with dependents and officers without dependents;
(iii) Basic allowance for subsistence;
(iv) Special pay for physicians, dentists, optometrists, and veterinarians;
(v) Hazardous duty pay;
(vi) Flying pay; and
(vii) Family separation allowances (only for officers assigned outside the contiguous United States).
(c)
(1) Owed by the officer to the United States.
(2) Required by law to be deducted from the remuneration or other payment involved including but not limited to:
(i) Amounts withheld from benefits payable under title II of the Social Security Act when the withholding is required by law;
(ii) FICA.
(3) Properly withheld for Federal and State income tax purposes if the withholding of the amounts is authorized or required by law and if amounts withheld are not greater than would be the case if the individual claimed all dependents to which he or she were entitled. The withholding of additional amounts pursuant to 26 U.S.C. 3402(i) may be permitted only when the officer presents evidence of a tax obligation which supports the additional withholding.
(4) Deducted for the Servicemen's Group Life Insurance coverage.
(5) Advances of pay that may be due and payable by the officer in the future.
(d)
(i) That notice has been served, including a copy of the documents submitted;
(ii) Of the maximum limitations set forth, with a request that the officer submit supporting affidavits or other documentation necessary for determining the applicable percentage limitation;
(iii) That by submitting supporting affidavits or other necessary documentation, the officer consents to the disclosure of such information to the party requesting the support allotment;
(iv) Of the amount of percentage that will be deducted if the officer fails to submit the documentation necessary to enable the designated official of the Service to respond to the legal process within the time limits set forth;
(v) That a consultation with a legal officer is authorized and will be provided by the Department. The name, address, and telephone number of the legal officer will be provided;
(vi) That the officer may waive the personal consultation with a legal officer; however if consultation is waived action will be taken to initiate the allotment by the first end-of-month payday after notification is received that the officer has waived his/her consultation;
(vii) That the allotment will be initiated without the officer having received a personal consultation with a legal officer if the legal officer provides documentation that consultation could not be arranged even though good faith attempts to do so had been made; and
(viii) Of the date that the allotment is scheduled to begin.
(2) The Commissioned Personnel Operations Division shall inform the appropriate legal officer of the need for consultation with the officer and shall provide the legal officer with a copy of the notice and other legal documentation served on the designated official.
(3) If possible, the Commissioned Personnel Operations Division shall provide the officer with the following:
(i) A consultation in person with the appropriate legal officer to discuss the legal and other factors involved with
(ii) Copies of any other documents submitted with the notice.
(4) The legal officer concerned will confirm in writing to the Commissioned Personnel Operations Division within 30 days of notice that the officer received a consultation concerning the officer's support obligation and the consequences of failure to make payments. The legal officer concerned must advise the Commissioned Personnel Operations Division of the inability to arrange such consultation and the status of continuing efforts to contact the officer.
(e)
(2) Where it appears that moneys are only temporarily exhausted or otherwise unavailable, the Commissioned Personnel Operations Division shall advise the authorized person in writing on a timely basis as to why, and for how long, the moneys will be unavailable.
(3) In instances where the officer separates from active duty, the authorized person shall be informed in writing on a timely basis that the allotment is discontinued.
(f)
(g)
Sec. 208(e) of the Public Health Service Act, 42 U.S.C. 210(e); E.O. 11140, 29 FR 1637.
(a) Non-commissioned officers and other employees of the Service shall not receive any additional compensation by reason of being assigned to any duty requiring intimate contact with persons with Hansen's disease. However, any such officer or employee who was entitled, on January 4, 1986, to receive additional pay by reason of being assigned to full-time duty, for a period of 30 days or more, at a station of the Service devoted to the care of Hansen's disease patients and who continues to be assigned to such duty, shall receive special pay as long as such assignment continues without a break.
(b) Such special pay shall, on any future date, be at an annual dollar level equal to the lower of the levels that would be paid under the following subparagraphs:
(1) 25% of the lowest level of basic pay that he or she has been receiving on any date from January 4, 1986, through that future date;
(2) The amount by which the level of an employee's basic pay plus special pay on January 4, 1986, exceeds the level of that employee's basic pay on that on that future date, except that
(c) An officer or employee may be paid special pay for any pay period, under paragraphs (a) and (b) of this section, only to the extent that it does not cause his or her aggregate pay for that pay period to exceed the biweekly rate of basic pay for Level V of the Executive Schedule. As used in this paragraph, “aggregate pay” comprises basic pay, this special pay, and premiums for overtime, nightwork, irregular duty, standby status, and Sunday or holiday work.
(a) When the Public Health Service requires the services of consultants who cannot be obtained when needed through regular Civil Service appointment or under the compensation provisions of the Classification Act of 1949, special consultants to assist and advise in the operations of the Service may be appointed, subject to the provisions of the following paragraphs and in accordance with such instructions as may be issued from time to time by the Secretary of Health and Human Services.
(b) Appointments, pursuant to the provisions of this section, may be made by those officials of the Service to whom authority has been delegated by the Secretary or his designee.
(c) The per diem or other rates of compensation shall be fixed by the appointing officer in accordance with criteria established by the Surgeon General.
The Secretary or his delegate may, pursuant to section 214(d) of the Public Health Service Act, 42 U.S.C. 215(d), and with the consent of the officer or employee concerned, arrange, through agreements or otherwise, for a civilian officer or employee of the Public Health Service to be placed on leave without pay for the period of a detail to a State, a subdivision thereof, or a private non-profit institution and be paid by the non-Federal organization. Such an arrangement may be for a period of not to exceed 2 years, but may be extended for additional periods of not to exceed 2 years each.
Secs. 333, 338E(c), and 338C(e)(1), Public Health Service Act. 90 Stat. 2272, as amended, 95 Stat. 905, 97 Stat. 1345 (42 U.S.C. 254f
This regulation applies to the assignment of National Health Service Corps personnel under section 333
As used in this subpart:
Any public or nonprofit private entity which is located in a health manpower shortage area, or has a demonstrated interest in the shortage area, may apply for the assignment of National Health Service Corps personnel.
(a) An application for the assignment of National Health Service Corps personnel must be submitted to the Secretary by an eligibe applicant in the form and at the time prescribed by the
(b) In addition to other pertinent information required by the Secretary, an application for the assignment of Corps personnel must include—
(1) A description of the applicant's overall organizational structure;
(2) A justification of the request for the assignment of personnel based upon the needs of the health manpower shortage area;
(3) A description of the applicant's financial plan for operating the National Health Service Corps site including a proposed budget, sources of non-Federal support obtained, and the proposed expenditures for obtaining adequate support staff, equipment and supplies;
(4) A list of the proposed fees and discounted fees to be charged for the provision of health services; and
(5) If an entity wishes to request an interest free loan (not to exceed $50,000) under section 335(c) of the Act to assist the applicant in establishing the practice of the assigned National Health Service Corps personnel, a detailed justification of the amount requested must be included.
(c) An application for assignment must include evidence that the applicant has provided a copy of the completed application for review to (1) each health systems agency designated under section 1515 of the Act for the health service area which includes all or part of the health manpower shortage area for which as assignment of National Health Service Corps personnel is sought or (2) if no health systems agency has been designated for such a health service area, to each State health planning and development agency designated under section 1521 of the Act for each State which includes all or part of the health manpower shortage area for which an assignment of National Health Service Corps personnel is sought.
(d) If an application for assignment is filed by an applicant which had previously been assigned National Health Service Corps personnel under an agreement entered into under section 329 of the Act as in effect before October 1, 1977, or under section 334 of the Act, the applicant must provide the information the Secretary considers necessary to make the determinations required by section 333(a)(1)(D) of the Act.
(a) In approving or disapproving an application for assignment of Corps personnel, the Secretary will consider, among other pertinent factors:
(1) The applicant's ability and plans to meet the operational requirements in § 23.8.
(2) The administrative and managerial capability of the applicant.
(3) The soundness of the applicant's financial plan for operating the National Health Service Corps site.
(4) The extent to which community resources will be used in operating the National Health Service Corps site.
(5) Comments received from any designated health systems agency or any designated State health planning and development agency to which an application was submitted for review under § 23.4(c).
(6) Comments received from health professional societies serving the health manpower shortage area.
(b) Special consideration for the assignment of Corps personnel will be given to the entity which is located in a health manpower shortage area over an entity which is not located in a health manpower shortage area but has a demonstrated interest in it.
(a) The Secretary may, upon approving an application for the assignment of personnel and after entering into an
(b) In assigning National Health Service Corps personnel to serve in a health manpower shortage area, the Secretary will seek to assign personnel who have those characteristics which will increase the probability of their remaining to serve in the health manpower shortage area upon completion of the period of assignment. In addition, the Secretary will apply a weighted-value system in which the first factor listed below is assigned the greatest weight and the second, and third factors are assigned lesser weights in descending order:
(1) The need of the health manpower shortage area as determined by criteria established under section 332(b) of the Act.
(2) The willingness of individuals, government agencies, or health entities within the health manpower shortage area to cooperate with the National Health Service Corps in providing effective health services.
(3) The comments of health professional societies serving the health manpower shortage area.
(a)
(1) Be responsible for charging for health services provided by assigned National Health Service Corps personnel;
(2) Take reasonable action for the collection of the charges for those health services;
(3) Reimburse the United States the sums required under section 334 of the Act; and
(4) Prepare and submit an annual report. The agreement will set forth the period of assignment (not to exceed 4 years), the number and type of Corps personnel to be assigned to the site, and other requirements which the Secretary determines necessary to carry out the purposes of the Act.
(b)
Each National Health Service Corps site must:
(a) Operate a health care delivery system within a planned or existing community structure to assure:
(1) The provision of high quality comprehensive health care;
(2) To the extent feasible, full professional health care coverage for the health manpower shortage area;
(3) Continuum of care; and
(4) The availability and accessibility of secondary and tertiary health care (the two more sophisticated levels of health care beyond primary care);
(b) Establish and maintain a patient record system;
(c) Implement a system for maintaining the confidentiality of patient records;
(d) Meet the requirements of applicable fire and safety codes;
(e) Develop, to the extent feasible, linkages with other health care facilities for the provision of services which supplement or complement the services furnished by the assigned Corps personnel;
(f) Operate a quality assurance system which meets the requirements of 42 CFR 51c.303(c) for the establishment and operation of a quality assurance system in a community health center; and
(g) Establish basic data, cost accounting, and management information and reporting systems as prescribed by the Secretary.
(a) Except as provided in paragraph (b) of this section, individuals receiving services from assigned National Health Service Corps personnel must be charged on a fee-for-service or other basis at a rate which is computed to permit recovery of the value of the services and is approved by the Secretary.
(b) In determining whether to approve fees to be charged for health services, the Secretary will consider: The costs to the National Health Service Corps of providing the health services; the costs to the health manpower shortage area for providing the services; and the charges for similar services by other practitioners or facilities in or nearby the health manpower shortage area. However, if assigned National Health Service Corps personnel are providing services within the framework of an established health services delivery system, the Secretary may approve the fees charged under that system without regard to the foregoing factors.
(c)(1) No charge or a nominal charge will be made for health services provided by assigned National Health Service Corps personnel to individuals within the health manpower shortage area with annual incomes at or below the “CSA Income Poverty Guidelines” (45 CFR 1060.2). However, no individual will be denied health services based upon inability to pay for the services. Any individual who has an annual income above the “CSA Income Poverty Guidelines,” but whose income does not exceed 200 percent of the CSA levels, will receive health services at a nominal charge. However, charges will be made for services to the extent that payment will be made by a third party which is authorized or under legal obligation to pay the charges.
(2) The provisions of this paragraph also apply with respect to services provided by an individual who is fulfilling an NHSC scholarship obligation under section 753 or who received a special grant under section 755.
(a) The Secretary may waive in whole or in part the reimbursement requirements of section 334(a)(3) of the Act if he determines that:
(1) The National Health Service Corps site is financially unable to meet the reimbursement requirements or that compliance with those requirements will unreasonably limit the ability of the site to adequately support the provision of services by assigned Corps personnel. In making these determinations, the Secretary will consider—
(i) The costs necessary to adequately support the health services provided by the assigned National Health Service Corps personnel and the income and financial resources available to meet the costs;
(ii) The ability of the applicant to obtain credit from suppliers, lending institutions, private organizations and individuals;
(iii) The need of the health manpower shortage area for health services; and
(iv) The extent to which the National Health Service Corps site utilizes health professions personnel.
(2) A significant percentage of the individuals who are located in the health manpower shortage area and are receiving the health services of the assigned National Health Service Corps personnel are elderly, living in poverty, or have other characteristics which indicate an inability to pay. For purposes of this section, “elderly” means persons 65 years or older and the “CSA Income Poverty Guidelines” will be used as the standard for determining whether individuals are living in poverty. Other characteristics indicating inability to pay include, but are not to be limited to, the ratio of unemployment in the health manpower shortage area and the area's cost-of-living index.
(b) The Secretary may waive in whole or in part the reimbursement requirements of section 334(f)(1) of the Act if he or she determines that the National Health Service Corps site is a small health center (as defined by section 334(f)(5) of the Act) that needs all
(1) Expand or improve its provision of health services;
(2) Increase the number of individuals served;
(3) Renovate or modernize facilities for its provision of health services;
(4) Improve the administration of its health service programs; or
(5) Establish a financial reserve to assure its ability to continue providing health services;
(c) Where the Secretary determines that a National Health Service Corps site is eligible for a waiver under paragraph (a) (1) or (2) of this section. the Secretary may waive the application of the reimbursement requirements of section 334(a)(3) of the Act and apply the reimbursement requirements of section 334(f)(1) of the Act. The Secretary may waive in whole or in part the reimbursement requirements of section 334(f)(1) for such a site if he or she determines that the National Health Service Corps site meets the requirements of paragraph (a)(1) of this section. Funds retained by a National Health Service Corps site as a result of such waiver must be used for the purposes set forth in paragraphs (b) (1) through (5) of this section.
(d) Requests for a prospective or retrospective waiver must be made at the time and in the manner and contain the documentation prescribed by the Secretary.
(a) Upon expiration of the assignment of all Corps personnel to a health manpower shortage area, the Secretary may sell equipment and other property of the United States used by the assigned personnel. The equipment may be sold at the fair market value or less than the fair market value to any entity providing health services in or to a health manpower shortage area if the Secretary determines that an entity is unable to pay the fair market value. In determining whether an entity is financially unable to purchase equipment or property at fair market value, the Secretary will consider (1) the present financial resources of the entity available to purchase the equipment or property based upon its current liabilities, and (2) the entity's ability to obtain the funds necessary to purchase the equipment or property. However, the Secretary will not sell the equipment or property for less than fair market value to a profitmaking organization unless the organization gives reasonable assurance that it will use the equipment or property to provide health services in or to the health manpower shortage area.
(b) The Secretary will give priority to sales to an entity providing reasonable assurance that it will use the equipment or property for the purpose of retaining within the health manpower shortage area National Health Service Corps personnel who have completed their assignments.
Assigned National Health Service Corps personnel will at all times remain under the direct supervision and control of the Secretary. Observance of institutional rules and regulations by the assigned personnel is a mere incident of the performance of their Federal functions and does not alter their direct professional and administrative responsibility to the Secretary.
National Health Service Corps sites are advised that in addition to complying with the terms and conditions of this regulation, the following laws and regulations are applicable—
(a) Title VI of the Civil Rights Act of 1964 (43 U.S.C. 2000d
(b) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) and its implementing regulations, 45 CFR part 84 (prohibiting discrimination in federally assisted programs on the basis of handicap).
(c) The Age Discrimination Act of 1975 (42 U.S.C. 6101
As used in this subpart, terms have the same meanings as those given to them in subpart A, § 23.2. In addition:
The purpose of the private practice loan is to assist NHSC scholarship recipients in establishing private full-time clinical practices in designated health manpower shortage areas.
(a) Eligibility for loans is limited to NHSC scholarship recipients who have completed at least 2 years of their service obligations at a NHSC site. NHSC scholarship recipients remain eligible for loans under this subpart for 1 year after they have completed their service obligations at a NHSC site.
(b) Scholarship recipients who are in arrears 31 days or more on a Health Professions Student Loan (42 U.S.C. 294m
(c) NHSC scholarship recipients who have received loans under either this subpart or subpart C of this part are ineligible for loans under this subpart.
The Secretary may make loans either in the amount of $12,500, if the recipient agrees to practice in accordance with the loan agreement for a period of at least 1 year but less than 2 years, or $25,000, if the recipient agrees to practice in accordance with the loan agreement for a period of at least 2 years.
Interest will be charged at the Treasury Current Value of Funds (CVF) rate in effect on April 1 immediately preceding the date on which the loan is approved and will accrue from the date the loan funds are disbursed to the borrower.
Payments shall be made at monthly intervals, beginning 1 month from the date of the loan disbursement, in accordance with the repayment schedule established by the Secretary and set forth in the loan agreement. Only interest payments are required during the first 2 years. The repayment schedule may be extended in accordance with § 23.31(a).
(a) Failure to make full payment of principal and/or interest when due will subject the borrower to the assessment of administrative costs and penalty
(b) Failure to make full payment of principal and/or interest when due may result in the Secretary placing the borrower in default of the loan. See § 23.28(a).
The following events will constitute defaults of the loan agreement:
(a) Failure to make full payment of principal and/or interest when due, andcontinuance of that failure for a period of sixty (60) days, or a lesser period of time if the Secretary determines that more immediate action is necessary in order to protect the interests of the Government.
(b) Failure to perform or observe any of the terms and conditions of the loan agreement and continuance of that failure for a period of sixty (60) days.
(c) The institution of bankruptcy proceedings, either voluntary or involuntary, under any State or Federal statute, which may adversely affect the borrower's ability to comply with the terms and conditions of the agreement or the promissory note.
(a) In the event of default, the Secretary may declare the entire amount owed (including principal, accrued interest and any applicable charges) immediately due and payable. Collection of the amount owed will be made in accordance with 45 CFR part 30.
(b) The borrower is not entitled to written notice of any default and the failure to deliver written notice of default in no way affects the Secretary's right to declare the loan in default and take any appropriate action under the loan agreement or the promissory note.
(c) The failure of the Secretary to exercise any remedy available under law or regulation shall in no event be construed as a waiver of his or her right to exercise that remedy if any subsequent or continued default or breach occurs.
The borrower shall have the option to prepay the balance of any part of the loan, together with accrued interest, at any time without prepayment penalty.
(a) Whenever health, economic, or other personal problems affect the borrower's ability to make scheduled payments on the loan, the Secretary may allow the borrower an extension of time or allow the borrower to make smaller payments than were previously scheduled; however, interest will continue to accrue at the rate specified in the promissory note until the loan is repaid in full. The loan must be fully repaid within 10 years after it was made.
(b) No waiver, full or partial, of repayment of the loan will be granted; except that the obligation of a borrower to repay a loan shall be cancelled upon the death or total and permanent disability of the borrower, as determined by the Secretary.
(c) In order to make a determination under paragraph (a) or (b) of this section, the Secretary may require supporting medical, financial, or other documentation.
(a) The borrower must use the total amount of the loan to purchase or lease, or both, equipment and supplies, to hire authorized personnel to assist in providing health services and/or to renovate facilities for use in providing health services in his or her private practice. Equipment and supplies purchased and/or leased, personnel hired and facilities renovated shall be limited to the items requested in the loan application and approved by the Secretary.
(b) The borrower must expend the loan funds within 6 months from the date of the loan or within such other time as the Secretary may approve. Documentation of the expenditure of funds must be furnished to the Secretary upon request.
The Secretary may require the borrower to pledge to the Secretary a security interest in specified collateral.
(a) The borrower must sign a loan agreement describing the loan and practice conditions, and a promissory note agreeing to repay the loan plus interest.
(b) The borrower must agree to enter into private full-time clinical practice in a HMSA for the time period specified in the loan agreement.
(c) The borrower must accept assignment, for the time period specified in the loan agreement, under section 1842(b)(3)(B)(ii) of theSocial Security Act as full payment for all services for which payment may be made under part B of title XVIII of that Act.
(d) The borrower must enter into an appropriate agreement, for the time period specified in the loan agreement, with the State agency which administers the State plan for medical assistance under title XIX of the Social Security Act to provide services to individuals entitled to medical assistance under the plan.
(e) During the time period specified in the loan agreement, the borrower must provide health services to individuals at the usual and customary rate prevailing in the HMSA in which services are provided; however, services must be provided at no charge or at a nominal charge to those persons unable to pay for these services.
(f) The borrower must keep and preserve all documents, including bills, receipts, checks, and correspondence which affect the operation of the private practice and the expenditure of loan funds for the period of the practice obligation specified in the loan agreement plus 3 years. Accounts will be maintained under one of the accounting principles identified by the Secretary in the loan agreement.
(g) The borrower must provide the Secretary and the Controller General of the United States, or their representatives, access during normal working hours to accounts, documents, and records for the purposes of audit or evaluation; and must permit the Secretary or his or her representative to inspect the private practice at reasonable times during the period of the practice obligation specified in the loan agreement plus 3 years. All information as to personal facts and circumstances about recipients of services shall be held confidential, and shall not be divulged without the individual's consent except as may be required by law or as may be necessary to provide medical service to the individual or to provide for medical or fiscal audits by the Secretary or his or her designee with appropriate safeguards for confidentiality of records.
(h) For the entire period of loan repayment, the borrower must acquire, maintain, and when requested, must provide the Secretary with copies of policies of insurance on equipment and supplies in amounts adequate to reasonably protect the borrower from risk, including public liability, fire, theft, and worker's compensation.
(i) If the Secretary retains a security interest pursuant to § 23.33, the borrower must keep and preserve all documents which affect that security interest for the period of the loan repayment and allow the Secretary or his or her designee access, during normal working hours, to those documents.
(j) The borrower must maintain the loan proceeds in a separate account from his or her other transactions and must agree to draw upon this account and expend the loan proceeds in accordance with § 23.32.
(k) The Secretary may impose other conditions which he or she deems appropriate under law or regulation to protect the Government's interests.
Approval of loan applications will be based on the criteria set forth below:
(a) The need in the HMSA for the applicant's health profession as determined under section 332 of the Act;
(b) The applicant's need for the loan funds; and
(c) The comments from State or local health professional societies on the appropriateness of the applicant's intended private practice; and
(d) The applicant's credit worthiness and projected financial ability to repay the loan.
The regulations set out in subpart B of this part are fully applicable to loans awarded under section 338C(e)(1) of the Public Health Service Act, except as noted below;
(a)
(i) Eligibility for loans is limited to NHSC scholarship recipients who plan to enter private practice and have not begun fulfilling their scholarship service obligation or are currently fulfilling their scholarship service obligation under section 338B of the Act and have completed less than 2 years of this obligation.
(2) In lieu of § 23.23(c), the following applies to loans made under this subpart:
(i) NHSC scholarship recipients who have received loans under either this subpart or subpart B of this part are ineligible for loans under this subpart.
(b)
(i) The Secretary may make loans in the amount of $12,500 if the recipient agrees to practice in accordance with the loan agreement for a period of at least 1 year but less than 2 years or the remaining period of the borrower's NHSC scholarship service obligation, whichever is shorter.
(ii) The Secretary may make loans in the amount of $25,000 if the recipient agrees to practice in accordance with the loan agreement for a period of at least 2 years or the remaining period of the borrower's NHSC scholarship service obligation, whichever is shorter.
(c)
(i) The borrower must use the total amount of the loan only to purchase or lease, or both, the equipment and supplies needed for providing health services in his or her private practice. Equipment and supplies purchased and/or leased shall be limited to the items requested in the loan application and approved by the Secretary.
Section 228(g) of the Public Health Service Act; 5 U.S.C. 301.
There is established in the Public Health Service (PHS) a Senior Biomedical Research Service (SBRS) consisting of members the maximum number of which is prescribed by law.
(a) The Secretary, within the number authorized in the PHS Act, shall determine the number of SBRS slots to be allocated to each participating Operating Division.
(b) The SBRS Policy Board may advise the Secretary to make adjustments to the allocation at any time.
(c) The majority of the SBRS allocation is to be reserved for recruitment. The remaining SBRS allocation may be used for the retention of current employees.
(d) SBRS slots will be used judiciously, resulting in SBRS appointments only where other senior-level appointing authorities are not sufficient to recruit or retain scientific talent.
(e) The Secretary will ensure that SBRS slots are used in support of high priority programs authorized by Congress and which directly support the research goals and priorities of the Department.
The Secretary or his/her designee shall establish an SBRS Policy Board to serve in an advisory capacity, recommending SBRS allocations among the participating Operating Divisions,
To be eligible for appointment to the Service an individual must have a doctoral-level degree in biomedicine or a related field and must meet the qualification standards prescribed by the U.S. Office of Personnel Management for appointment to a position at GS-15 of the General Schedule. In addition, the individual must be outstanding in the field of biomedical research or clinical research evaluation. Appointment to the Service will be made only to individuals actively engaged in either biomedical research or clinical research evaluation.
(a) Outstanding in the field of biomedical research means an individual who is actively engaged in peer-reviewed original biomedical research and whose work in this area is considered by his or her peers to be outstanding. In order to meet the eligibility criteria, an individual must have conducted original peer-reviewed biomedical research resulting in major accomplishments reflected by a steady and current record of highly cited publications in peer-reviewed journals of high stature. In addition, the individual should be the recipient of major prizes and awards (such as visiting professorships and named lectureships) in recognition of original contributions to research.
(b) Outstanding in the field of clinical research evaluation means that an individual is actively engaged in clinical research evaluation and is considered by his or her peers to be outstanding. In order to meet the eligibility criteria, an individual, by force of his or her own technical expertise, must be in a position to shape the course of drug or device evaluation or exert a similar influence on the PHS handling of other agents that may affect the public health. The individual would normally have dealt with complex, precedent-setting evaluation issues that involved significant scientific controversy, had far reaching implications for clinical research or resulted in a widespread economic effect in the health-care delivery system. In addition, the individual should have been involved in the development of scientific or regulatory guidelines for clinical research and been the recipient of invitations to speak at or to chair major national or international meetings and symposia.
An individual may not be considered for appointment into the SBRS unless his/her qualifications have been reviewed by a PHS peer review committee and the committee has recommended appointment to the Service.
The SBRS is an ungraded system, with a single, flexible pay range to include all members.
(a) Pay of the members of the Service shall be determined by the Secretary or his/her designee.
(b) The pay of a member of the Service shall be not less than the minimum rate payable for GS-15 of the General Schedule and shall not exceed:
(1) The rate payable for level I of the Executive Schedule unless a higher rate of pay is expressly approved on an individual basis by the President, pursuant to 5 U.S.C. 5377(d)(2), or
(2) The rate payable for level II of the Executive Schedule unless a higher rate of pay is expressly approved on an individual basis by the Secretary.
(c) While the full pay range will be used, individual pay at the higher end of the range will be used only as needed to recognize individual scientific value and as necessary to recruit or retain an exceptionally well-qualified scientist.
(d) The following factors will be used in establishing appropriate pay rates for individual members:
(1) Impact of the individual on the scientific field;
(2) Recognition of the individual by the scientific community;
(3) Originality of the individual's ideas/work products;
(4) Specific “clinical” or highly technical skills of the individual which are of benefit to the agency and which are in addition to requirements of the basic scientific assignment;
(5) The individual's earnings and monetary benefits;
(6) Salary surveys of similar skills in pertinent labor markets; and
(7) Other relevant factors.
(e) Annual adjustments to pay rates may be made effective on the first day of the first pay period on or after January 1 of each calendar year. The rate of such adjustments will be at the discretion of the Secretary or his/her designee, except that the minimum rate payable in the SBRS will be increased to the amount of the minimum rate of the GS-15 of the General Schedule.
(f) Other pay adjustments will be made on an individual basis by the Secretary or his/her designee.
(g) Except as provided in paragraph (h) of this section, new appointees to the Service, who are not covered by the Civil Service Retirement System, will be covered by the Federal Employees Retirement System.
(h) Upon the request of a member who performed service in the employ of an institution of higher education immediately prior to his appointment as a member of the Service, and retains the right to make contributions to the retirement system of such institution, the Department of Health and Human Services may contribute an amount not to exceed ten percent per annum of the member's basic pay to such institution's retirement system on behalf of such member. A member who participates in this program shall not be covered by any retirement system established for employees of the United States under title 5, United States Code.
The members of the Service shall be subject to a performance appraisal system which shall be designed to encourage excellence in performance and shall provide for a periodic and systematic appraisal of the performance of the members.
(a) Appointments to the Service shall be made without regard to the provisions of title 5, U.S. Code regarding appointments.
(b) Members of the Service shall not be covered by the following provisions of title 5, U.S. Code:
(1) Subchapter I of Chapter 35 (relating to retention preference in the event of reduction in force);
(2) Chapter 43, Performance Appraisal (and performance-basedactions);
(3) Chapter 51 (relating to classification);
(4) Subchapter III of Chapter 53, The General Schedule; and
(5) Chapter 75, Adverse Actions.
(c) Other provisions of Title 5 will be applied as administratively determined by the Secretary or his/her designee.
(a) A member of the Service may be subject to disciplinary action, including removal from the Service, for substandard performance of duty as a member of the service, for misconduct, for reasons of national security or for other reasons as determined by the Secretary.
(b) A member for whom disciplinary action is proposed is entitled to:
(1) Written notice of the proposed action and the basis therefor;
(2) A reasonable opportunity to answer the notice of proposed action both orally and in writing;
(3) The right to be represented by an attorney or other representative in making such answer; and
(4) A written decision on the proposal.
(c) The decision may be made by an official with delegated authority to take such action, but in no case may the official be at a level below the head of the Operating Division where the member is assigned.
(d) A member who is separated from the Service involuntarily and without cause and who, immediately prior to his appointment to the Service, was a career appointee in the civil service or the Senior Executive Service, may be
(e) A member who is separated from the Service involuntarily and without cause and who, immediately prior to appointment to the Service, was not a career appointee in the civil service or the Senior Executive Service may be appointed to a position in the excepted civil service at grade GS-15 of the General Schedule for a period not to exceed two years.
(f) There shall be no right to further review of the final decision on a disciplinary action. At his/her discretion, the Secretary may review an action taken under this section and may reduce, suspend, or overrule the action taken.
(g) A member of the Service may be removed from the Service for such other reasons as may be prescribed by the Secretary.
For each quarter of the first year of implementation and annually thereafter, participating Operating Divisions shall maintain reports on the operation of the SBRS. At a minimum, these reports should include the number of appointees, the source of those appointees, their earnings immediately prior to appointment, and their SBRS pay at appointment.
As used in this part, the term:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
To the extent and under the circumstances prescribed in §§ 31.2 to 31.10, the following persons shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service:
(a)
(2) Regular members of the Coast Guard Reserve when on active duty or when retired for disability;
(3) Temporary members of the Coast Guard Reserve when on active duty or in case of physical injury incurred or sickness or disease contracted while performing active Coast Guard duty;
(4) Members of the Women's Reserve of the Coast Guard when on active duty or when retired for disability;
(5) Members of the Coast Guard Auxiliary in case of physical injury incurred or sickness or disease contracted while performing active Coast Guard duty.
(b)
(c)
(2) Commissioned officers of the Reserve Corps of the Service when on active duty or when retired for disability.
Except as otherwise provided in §§ 31.3 to 31.10, the persons specified in § 31.2 shall be entitled to medical, surgical, and dental treatment and hospitalization only at medical relief stations and by designated physicians and designated dentists, and the cost of services procured elsewhere shall not be borne by the Service.
(a) When a person specified in § 31.2 who is on active duty requires immediate medical, surgical, or dental treatment or hospitalization and the urgency of the situation does not permit treatment at a medical relief station or by a designated physician or designated dentist, an officer of the same service as the patient may arrange for treatment or hospitalization at the expense of the Service.
(b) When the circumstances are such that an officer of the same service as the patient is not available to make the necessary arrangements, the treatment or hospitalization may be obtained by or on behalf of the patient at the expense of the Service.
(c) In every case of treatment or hospitalization as defined in paragraph (b) of this section, the responsible superior officer of the patient shall be notified as promptly as possible and a full report shall be submitted by such officer to the Surgeon General through appropriate official channels. As soon as practicable, unless the interests of the patient or the Government require otherwise, treatment or hospitalization shall be continued at a medical relief station or by a designated physician or designated dentist or at another appropriate Federal medical facility.
(d) When the necessary medical relief cannot be obtained from a medical relief station or a designated physician or designated dentist, preference shall be given to other Federal medical facilities when reasonably available and when conditions permit.
(e) Vouchers on proper forms covering expenses for treatment or hospitalization under the circumstances specified in paragraphs (a) and (b) of this section shall be forwarded to the Surgeon General through appropriate official channels. Each such voucher shall be accompanied by or contain a statement of the facts necessitating the treatment or hospitalization. Unreasonable charges for emergency
(f) Expenses for consultants or special services, or for dental treatment other than emergency measures to relieve pain, shall not be allowed except when authorized in advance by the headquarters of the Service or, in extraordinary cases, when subsequently approved by such headquarters upon receipt of report and satisfactory explanation as to the necessity and urgency therefor.
(a) An applicant for medical relief who is on active duty shall furnish a certificate identifying him. Such certificate, in the case of Coast Guard personnel, shall be signed by an officer of the Coast Guard, and in the case of National Ocean Survey personnel, shall be signed by an officer of the National Ocean Survey. Commissioned officers of any of the services mentioned in § 31.2 and officers in charge of units may sign their own certificates. In an emergency, the officer in charge of a medical relief station, or a designated physician or designated dentist, may accept other evidence of status satisfactory to him.
(b) A temporary member of the Coast Guard Reserve except when on active duty or a member of the Coast Guard Auxiliary shall, when applying for medical relief, furnish a statement signed by a responsible superior officer setting forth the facts and circumstances giving rise to the need for medical relief. In emergencies, such statement shall be furnished promptly after the member has received the immediately required care and treatment. Such statement shall be presumptive evidence of the facts stated, but if investigation indicates that the injury, sickness, or disease was not incurred or contracted in the manner stated, further treatment may be denied.
No member of any of the services enumerated in § 31.2 shall be entitled when absent without leave to medical relief except at a medical relief station or by a designated physician or designated dentist.
If a member is separated from any of the services enumerated in § 31.2, except persons specified in § 31.2(a) (3) and (5) who shall be entitled to treatment after separation under the conditions set forth in such paragraphs, while undergoing treatment by the Service, his treatment shall be discontinued immediately unless the physician in charge determines that the condition of the patient does not permit interruption of treatment, in which case the treatment shall be discontinued as soon as practicable and the condition of the patient permits. At that time he shall be discharged from treatment and shall not thereafter be afforded medical relief by the Service by reason of his previous service.
(a) A retired member of the Coast Guard, National Ocean Survey, or Public Health Service specified in § 31.2 shall be entitled to medical, surgical, and dental treatment and hospitalization at medical relief stations of the first-, second-, and third-class, upon presentation of satisfactory evidence of his status.
(b) Elective medical or surgical treatment requiring hospitalization shall be furnished only at hospitals operated by the Service.
(c) Dental treatment shall be furnished to the extent of available facilities only at medical relief stations where full-time dental officers are on duty; at other medical relief stations the dental treatment shall be limited
To the extent and under the circumstances prescribed in this part, the Service shall provide medical advice and outpatient treatment at first-, second-, and third-class medical relief stations and hospitalization at first-class stations to the dependent members of families of the following persons:
(a)
(b)
(c)
(a) A dependent member of the family of any person specified in § 31.9 shall, upon presentation of satisfactory evidence of such status, be entitled to medical advice and out-patient treatment at first-, second-, and third-class medical relief stations and hospitalization at first-class stations if suitable accommodations are available therein and if the condition of the dependent is such as to require hospitalization, both as determined by the medical officer in charge.
(b) Hospitalization at first-class stations shall be at a per diem cost to the officer, enlisted person, member of a crew or other person concerned. Such cost shall be at such uniform rate as may be prescribed from time to time by the President for the hospitalization of dependents of naval and Marine Corps personnel at any naval hospital.
(c) Hospitalization at first-class stations and out-patient treatment at first-, second-, and third-class stations may include such services and supplies as, in the judgment of the medical officer in charge, are necessary for reasonable and adequate treatment.
(d) Dental treatment shall be furnished to the extent of available facilities only at medical relief stations where full-time officers are on duty.
To the extent and under the circumstances prescribed in this part, the following persons shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service: Lightkeepers, assistant lightkeepers, and officers and crews of vessels of the former Lighthouse Service, including any such persons who subsequent to June 30, 1939, have involuntarily been assigned to other civilian duty in the Coast Guard, who were entitled to medical relief at hospitals and other stations of the Service prior to July 1, 1944, and who are now or hereafter on active duty or who have been or may hereafter be retired under the provisions of section 6 of the act of June 20, 1918, as amended (33 U.S.C. 763).
Except as otherwise provided herein, the persons specified in § 31.11 shall be entitled to medical, surgical, and dental treatment and hospitalization only at medical relief stations and by designated physicians and designated dentists, and the cost of services procured
(a) When a person specified in § 31.11 who is on active duty requires immediate medical, surgical, or dental treatment or hospitalization and the urgency of the situation does not permit treatment at a medical relief station or by a designated physician or designated dentist, an officer or other appropriate supervisory official of the Coast Guard may arrange for treatment or hospitalization.
(b) In every such case of treatment or hospitalization, a full report thereof shall be submitted to the Surgeon General through Coast Guard headquarters. As soon as practicable, unless the interests of the patient or the Government require otherwise, treatment or hospitalization shall be continued at a medical relief station or by a designated physician or designated dentist or at another appropriate Federal medical facility.
(c) When the necessary medical relief cannot be obtained from a medical relief station or a designated physician or designated dentist, preference shall be given to other Federal medical facilities when reasonably available and when conditions permit.
(d) Vouchers on proper forms covering expenses for treatment or hospitalization under the circumstances specified in paragraph (a) of this section shall be forwarded to the Surgeon General through Coast Guard headquarters. Each such voucher shall be accompanied by or contain a statement of the facts necessitating the treatment or hospitalization. Unreasonable charges for emergency treatment or hospitalization will not be allowed.
(e) Expenses for consultants or special services, or for dental treatment other than emergency measures to relieve pain, shall not be allowed except when authorized in advance by the headquarters of the Service or, in extraordinary cases, when subsequently approved by such headquarters upon receipt of report and satisfactory explanation as to the necessity and urgency therefor.
An applicant for medical relief who is on active duty shall furnish a certificate identifying him. Such certificate shall be signed by an officer or other appropriate supervisory official of the Coast Guard. In an emergency, the officer in charge of a medical relief station, or a designated physician or designated dentist, may accept other evidence of status satisfactory to him.
If a person is separated while undergoing treatment by the Service, his treatment shall be discontinued immediately unless the physician or dentist in charge determines that the condition of the patient does not permit interruption of treatment, in which case the treatment shall be discontinued as soon as practicable and the condition of the patient permits. At that time he shall be discharged from treatment and shall not thereafter be afforded medical relief by the Service by reason of his previous service.
(a) Any retired person specified in § 31.11 shall be entitled to medical, surgical, and dental treatment and hospitalization at medical relief stations of the first, second, and third class, upon presentation of satisfactory evidence of his status.
(b) Elective medical or surgical treatment requiring hospitalization shall be furnished only at hospitals operated by the Service.
(c) Dental treatment shall be furnished to the extent of available facilities only at medical relief stations where full-time dental officers are on duty; at other medical relief stations the dental treatment shall be limited
Secs. 320, 321 and 322(b), Public Health Service Act (42 U.S.C. 247e, 248 and 249(b)).
All terms not defined herein shall have the same meaning as given them in the Act.
(a)
(b)
(c)
(d)
(a) Under this part the following persons are entitled to care and treatment by the Service as hereinafter prescribed:
(1) Persons afflicted with Hansen's disease; and
(2) Non-beneficiaries for temporary treatment and care in cases of emergency.
(b) Separate regulations govern: (1) The medical care of certain personnel, and their dependents, of the Coast Guard, National Oceanic and Atmospheric Administration, and Public Health Service (see part 31 of this chapter);
(2) Physical and mental examination of aliens (see part 34 of this chapter); and
(3) Medical care for Native Americans (see part 36 of this chapter).
Any person with Hansen's disease who presents himself for care or treatment or who is referred to the Service by the proper health authority of any State, Territory, or the District of Columbia shall be received into the Service hospital at Carville, Louisiana, or into any other hospital of the Service which has been designated by the Secretary as being suitable for the accommodation of persons with Hansen's disease.
At the earliest practicable date, after the arrival of a patient at the Service hospital at Carville, Louisiana, or at another hospital of the Service the medical staff shall confirm or disprove the diagnosis of Hansen's disease. If the diagnosis of Hansen's disease is confirmed, the patient shall be provided appropriate inpatient or outpatient
Patients will be provided necessary clinical examinations which may be required for the diagnosis of primary or secondary conditions, and such treatment as may be prescribed.
Patients with Hansen's disease will be discharged when, in the opinion of the medical staff of the hospital, optimum hospital benefits have been received.
Upon the discharge of a patient the medical officer in charge shall give notification of such discharge to the appropriate health officer of the State, Territory, or other jurisdiction in which the discharged patient is to reside. The notification shall also set forth the clinical findings and other essential facts necessary to be known by the health officer relative to such discharged patient.
Hansen's disease patients being treated on either an inpatient or outpatient basis at a hospital or clinic facility of the Service, other than the National Center for Hansen's Disease (Carville, Louisiana), may, at the sole discretion of the Secretary and subject to available appropriations, be provided care for the treatment of Hansen's disease at the expense of the Service upon closure or transfer of such hospital or clinic pursuant to section 987 of the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35). Payment will only be made for care arranged for by an authorizing official of the Service as defined in § 32.1(f) of this part.
(a) Persons not entitled to treatment by the Service may be provided temporary care and treatment at medical care facilities of the Service in case of emergency as an act of humanity.
(b) Persons referred to in paragraph (a) of this section who, as determined by the officer in charge of the Service facility, are able to defray the cost of their care and treatment shall be charged for such care and treatment at the following rates (which shall be deemed to constitute the entire charge in each instance): In the case of hospitalization, at the current interdepartmental reciprocal per diem rate; and, in the case of outpatient treatment, at rates established by the Secretary.
42 U.S.C. 216, 249, 252; 8 U.S.C. 1182, 1224, 1226; sec. 601 of Pub. L. 101-649.
The provisions of this part shall apply to the medical examination of:
(a) Aliens applying for a visa at an embassy or consulate of the United States;
(b) Aliens arriving in the United States;
(c) Aliens required by the INS to have a medical examination in connection with determination of their admissibility into the United States; and
(d) Aliens applying for adjustment status.
As used in this part, terms shall have the following meanings:
(a)
(b)
(1) Chancroid.
(2) Gonorrhea.
(3) Granuloma inguinale.
(4) Human immunodeficiency virus (HIV) infection.
(5) Leprosy, infectious.
(6) Lymphogranuloma venereum.
(7) Syphilis, infectious stage.
(8) Tuberculosis, active.
(c)
(d)
(1) A communicable disease of public health significance;
(2)(i) A physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;
(ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; or
(3) Drug abuse or addiction.
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(1) A communicable disease of public health significance;
(2)(i) A physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;
(ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;
(3) Drug abuse or addiction; or
(4) Any other physical abnormality, disease, or disability serious in degree or permanent in nature amounting to a substantial departure from normal well-being.
(m)
(n)
(o)
(p)
(a)
(1) A communicable disease of public health significance;
(2)(i) A physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;
(ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;
(3) Drug abuse or addiction; and
(4) Any other physical abnormality, disease, or disability serious in degree or permanent in nature amounting to a substantial departure from normal well-being.
(b)
(i) Applicants for immigrant visas;
(ii) Students, exchange visitors, and other applicants for a nonimmigrant visa who are required by a consular authority to have a medical examination;
(iii) Aliens outside the United States who apply for refugee status;
(iv) Applicants in the United States who apply for adjustment of status under the immigration statute and regulations;
(v)
(2)
(ii) Aliens less than 2 years old shall be required to have a tuberculin skin test if there is evidence of contact with a person known to have tuberculosis or other reason to suspect tuberculosis. In the event of a positive tuberculin reaction, a chest X-ray examination shall be required. If the chest radiograph is consistent with tuberculosis, the alien shall be referred to the local health authority for evaluation. Evidence of this evaluation shall be provided to the
(3)
(4)
(5)
(c)
(d)
(1) Are not in possession of a valid medical notification, if required;
(2) Have a medical notification which is incomplete;
(3) Have a medical notification which is not written in English;
(4) Are suspected to have an excludable medical condition.
(e) The Attorney General, after consultation with the Secretary of State and the Secretary of Health and Human Services, may in emergency circumstances permit the medical examination of refugees to be completed in the United States.
(f) All medical examinations shall be carried out in accordance with such technical instructions for physicians conducting the medical examination of aliens as may be issued by the Director. Copies of such technical instructions are available upon request to the Director, Division of Quarantine, Mailstop E03, CDC, Atlanta GA 30333.
(a) Medical examiners shall issue medical notifications of their findings of the presence or absence of Class A or Class B medical conditions. The presence of such condition must have been clearly established.
(b)
(i) A communicable disease of public health significance;
(ii)(A) A physical or mental disorder, and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; or
(B) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;
(iii) Drug abuse or addition.
(2) The medical notification shall state the nature and extent of the abnormality; the degree to which the alien is incapable of normal physical activity; and the extent to which the condition is remediable. The medical examiner shall indicate the likelihood, that because of the condition, the applicant will require extensive medical care or institutionalization.
(c)
(2) The medical notification shall state the nature and extent of the abnormality, the degree to which the alien is incapable of normal physical activity, and the extent to which the condition is remediable. The medical examiner shall indicate the likelihood, that because of the condition, the applicant will require extensive medical care or institutionalization.
(d)
Whenever, upon an examination, the medical examiner is unable to determine the physical or mental condition of an alien, completion of the medical examination shall be postponed for such observation and further examination of the alien as may be reasonably necessary to determine his/her physical or mental condition. The examination shall be postponed for aliens who have an acute infectious disease until the condition is resolved. The alien shall be referred for medical care as necessary.
Aliens arriving at a port of the United States shall be subject to the applicable provisions of 42 CFR part 71, Foreign Quarantine, with respect to examination and quarantine measures.
(a) An alien detained by or in the custody of the INS may be provided medical, surgical, psychiatric, or dental care by the Public Health Service through interagency agreements under which the INS shall reimburse the Public Health Service. Aliens found to be in need of emergency care in the course of medical examination shall be treated to the extent deemed practical by the attending physician and if considered to be in need of further care, may be referred to the INS along with the physician's recommendations concerning such further care.
(b) In case of the death of an alien, the body shall be delivered to the consular or immigration authority concerned. If such death occurs in the United States, or in a territory or possession thereof, public burial shall be provided upon request of the INS and subject to its agreement to pay the
(a) The Director shall convene a board of medical officers to reexamine an alien:
(1) Upon the request of the INS for a reexamination by such a board; or
(2) Upon an appeal to the INS by an alien who, having received a medical examination in connection with the determination of admissiblity to the United States (including examination on arrival and adjustment of status as provided in the immigration laws and regulations) has been certified for a Class A condition.
(b) For boards convened to reexamine aliens certified as:
(1) Having a communicable disease of public health significance, the board shall consist of three medical officers, at least one of whom is experienced in the diagnosis and treatment of the communicable disease for which medical notification has been made, and the decision of the majority of the board shall prevail;
(2)(i) Having a physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; or
(ii) Having a history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; or
(iii) Being a drug abuser or addict;
(3) In circumstances covered by paragraph (b)(2) of this section, the board shall consist of three medical officers, at least one of whom shall be a board certified psychiatrist, and the decision of the majority of the board shall prevail.
(c) Reexamination shall include:
(1) Review of all records submitted by the alien, other witnesses, or the board;
(2) Use of any laboratory or additional studies which are deemed clinically necessary as a result of the physical examination or pertinent information elicited from the alien's medical history;
(3) Consideration of statements regarding the alien's physical or mental condition made by a physician after his/her examination of the alien; and
(4) An independent physical or psychiatric examination of the alien performed by the board, at the board's option.
(d) An alien who is to be reexamined shall be notified of the time and place of his/her reexamination not less than 5 days prior thereto.
(e) The alien, at his/her own cost and expense, may introduce as witnesses before the board such physicians or medical experts as the board may in its discretion permit; provided that the alien shall be permitted to introduce at least one expert medical witness. If any witnesses offered are not permitted by the board to testify, the record of the proceedings shall show the reason for the denial of permission.
(f) Witnesses before the board shall be given a reasonable opportunity to examine the medical notification and other records involved in the reexamination and to present all relevant and material evidence orally or in writing until such time as the proceedings are declared by the board to be closed. During the course of the hearing the alien's attorney or representative shall be permitted to examine the alien and he/she, or the alien, shall be permitted to examine any witnesses offered in the alien's behalf and to cross-examine any witnesses called by the board. If the alien does not have an attorney or representative, the board shall assist the alien in the presentation of his/her case to the end that all of the material and relevant facts may be considered.
(g) The findings and conclusions of the board shall be based on its medical examination of the alien, if any, and on the evidence presented and made a part of the record of its proceedings.
(h) The board shall report its findings and conclusions to the INS, and shall also give prompt notice thereof to the alien if his/her reexamination has been based on his/her appeal. The board's report to the INS shall specifically affirm, modify, or reject the findings and
(i) The board shall issue its medical notification in accordance with the applicable provisions of this part if it finds that an alien it has reexamined has a Class A or Class B condition.
(j) If the board finds that an alien it has reexamined does not have a Class A or Class B condition, it shall issue its medical notification in accordance with the applicable provisions of this part.
(k) After submission of its report, the board shall not be reconvened, nor shall a new board be convened, in connection with the same application for admission or for adjustment of status, except upon the express authorization of the Director.
Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216, sec. 321, 53 Stat. 695, as amended; 42 U.S.C. 248, unless otherwise noted.
The officer in charge of a station or hospital of the Service is authorized to adopt such rules and issue such instructions, not inconsistent with the regulations in this part and other provisions of law, as he deems necessary for the efficient operation of the station or hospital and for the proper and humane care and treatment of all patients therein. All general rules governing the conduct and privileges of patients, and of members of the public
All patients and visitors in stations and hospitals of the Service are expected to comply with the rules and instructions issued under the authority of the officer in charge.
Any patient who wilfully fails or refuses to comply with rules or instructions of a hospital or station or with regulations of the Service, may, by the direction of the officer in charge, be deprived of recreational or other privileges accorded patients. Any visitor who wilfully fails or refuses to comply with any such rules, instructions, or regulations may, by direction of the officer in charge, be denied visiting privileges.
(a) If the officer in charge finds, upon investigation, that a patient other than a leprosy patient, by willful and persistent failure or refusal to comply with such rules, instructions, or regulations is seriously impeding the course of his own care and treatment, or that of other patients, he may (1) discharge the patient, or (2) if the patient is not a voluntary patient, arrange for his transfer to the custody of the authority responsible for his admission to the station or hospital. No patient shall be discharged or transferred on account of noncompliance if to do so would seriously endanger his life or health, nor shall any patient be discharged if his failure to comply is due, in the opinion of the officer in charge, to a mental disease or disorder.
(b) If the discharge or transfer of a patient is likely to endanger the health of persons other than the patient or officers or employees of the station or hospital, the officer in charge shall give advance notice to appropriate State, county, or municipal authorities of the discharge or transfer.
No person otherwise entitled to care, treatment, or hospitalization at Service facilities, or in other facilities at the expense of the Service, shall be denied such care or treatment by reason of his prior discharge or transfer from any such facility under the provisions of § 35.4.
Except as may otherwise be provided for specific classes of patients by the regulations of this chapter, the officer in charge of the station or hospital to which application is made is authorized to determine the eligibility of applicants, as beneficiaries of the Service, for care and for treatment. Such determinations shall be subject to review by the chief of the division of the Service responsible for administration of the station or hospital concerned upon referral made by the officer in charge in doubtful cases or upon appeal made by an applicant who has been denied care or treatment.
Every in-patient, at the time of admission to the hospital or station or as soon thereafter as practicable, shall be requested to designate a person or persons to be notified in case of emergency.
(a) A place for the safekeeping of money and effects of patients shall be provided at each station or hospital, and an itemized receipt therefor shall be furnished to the patient and to any other person who places money or effects therein for the benefit of the patient.
(b) Money and effects may be withdrawn only by or on behalf of the patient, by his legally appointed representative authorized to receive or dispose of his property (including the money and effects in the custody of the station or hospital), or by a person who is authorized, under the law of the
Money and effects left on the premises by a patient shall be forwarded promptly to him. If because his whereabouts are unknown his money and effects cannot be delivered to him within 120 days after his departure, his money shall be deposited into the Treasury and credited to the account entitled “Money and Effects of Former Patients (PHS (T) name of patient),” and his effects shall be held for him for six months and then sold in accordance with § 35.49, and the proceeds deposited into the Treasury and credited to the above account.
The officer in charge shall cause to be destroyed effects brought into or received in the station or hospital area by patients which, in the judgement of such officer, are dangerous as a source of disease to the health or life of patients or personnel of the station or hospital or visitors therein and cannot otherwise be safely disposed of or rendered harmless by disinfection or other means. The destruction of effects shall be witnessed by at least one officer or employee designated for that purpose by the officer in charge, and appropriate records of the destruction shall be maintained.
A complete clinical record shall be maintained for each patient admitted to a station or hospital of the Service. Such records shall be confidential and shall not be disclosed except as may be provided elsewhere in regulations of the Service.
The solicitation, directly or indirectly, of legal business or of a retainer or agreement authorizing an attorney to render legal services, is prohibited in all stations and hospitals of the Service.
(a) No person shall be permitted to enter a station or hospital of the Service for the purpose of negotiating a settlement or obtaining a general or special release or statement from any patient with reference to any illness or personal injury for which the patient is receiving care or treatment, or for the purpose of conferring with him as an attorney or representative of an attorney with reference to such illness or injury, unless the patient has signified his willingness to have such person enter for such purpose and, in the judgment of the officer in charge, the physical or mental condition of the patient will not thereby be impaired.
(b) Any person entering a station or hospital for a purpose enumerated in paragraph (a) of this section shall register in the manner prescribed by the officer in charge, and shall furnish for the records of the station or hospital the name of each patient by whom he has been received for such a purpose.
All employees of the Service and all persons attached in any capacity to a station or hospital, including patients, are forbidden to communicate, directly or indirectly, with any person for the purpose of aiding in the solicitation of legal business or in the negotiation of a settlement or the obtaining of a general or special release or statement from any patient with reference to any
Except in emergencies when the patient is physically or mentally incapable of consenting and the delay required to obtain the consent of his natural or legal guardian would seriously endanger the patient's health, no operative procedure shall be undertaken unless the patient or, in the case of a minor or incompetent, his natural or legal guardian gives his consent, nor shall any major operative procedure or the administration of a general anaesthetic be undertaken unless such consent has been obtained in writing. The consent or refusal of consent shall be made a part of the clinical record.
Autopsies, or other post-mortem operations, including removal of tissue for transplanting, may be performed on the body of a deceased patient only by direction of the officer in charge and only if consented to in writing by a person authorized under the law of the State in which the station or hospital is located to permit an autopsy or such other post-mortem operation under the circumstances of the particular death involved. Restrictions or limitations imposed by the person consenting thereto on the extent of the autopsy or other post-mortem operation shall be observed. Documents embodying consent shall be made a part of the clinical record.
A prescribed fee, in accordance with the schedule in paragraph (c) of this section, shall be collected for each of the listed services.
(a)
(b)
(c)
(d)
(1) When the service or document is requested by another agency of the Federal Government for use in carrying out official Government business.
(2) When a clinical record is requested for the purpose of providing continued medical care to a Service beneficiary by a non-Service physician, clinic, or hospital, in which case the record will be forwarded only to the physician, clinic, or hospital concerned.
(3) When the service or document is requested by an attorney in the prosecution of a Service beneficiary's personal injury claim against a third person, involving the concurrent assertion of a government medical care claim under 42 U.S.C. 2651-2653. In such case, the service or document requested will be furnished only upon compliance with all additional requirements for the release of records in third party recovery cases, including the proper execution of form PHS-4686, Agreement to Assign Claim Upon Request.
(4) When the service or document is requested by, and furnished to, a Member of Congress for official use.
(5) When the service or document is requested by, and furnished to, a court in lieu of the personal court appearance of an employee of the Public Health Service.
(6) When the service or document is required to be furnished free in accordance with a Federal statute or an Executive order.
(7) When the furnishing of the service or document requested without charge would be an appropriate courtesy to a foreign country or international organization.
Except as otherwise provided by law or regulation with respect to certain classes of patients, the officer in charge of a station or hospital of the Service may provide, without any cost to the patient, for the transfer of the patient either from such station or hospital to another station or hospital of the Service or to any non-Service station or hospital at which the patient may be received, or from any non-Service hospital at which he is receiving care or treatment as a patient of the Service to a station or hospital of the Service.
Patients shall be transferred by such means and accompanied by such medical, nursing, or other attendants as may be necessary to protect the health and safety of the patient and other persons likely to come into contact with him, including in the case of a prisoner such guards as may be necessary to assure his safekeeping. A female patient requiring the services of attendants shall be accompanied by at least one female attendant. Medical or nursing attendants shall be qualified to care for persons suffering from the type of disease or disorder with which the patient is afflicted and shall be provided with equipment and medicines necessary for the care of the patient.
Subject to the rules of the station or hospital, patients may be accorded the privilege of retaining articles produced by them in the course of their curative treatment with the aid of materials furnished by the Service. Articles not retained by patients shall be disposed of as provided in this subpart. The provisions of this subpart do not apply to the products of industrial activities established for narcotic addicts.
The officer in charge shall appoint, from the personnel of the station or hospital, a board of three persons to serve at his pleasure. The board shall provide for the sale of articles having commercial value and shall keep appropriate records of such articles and their disposition.
The board shall determine and redetermine from time to time the prices at which articles are to be sold, and in doing so shall consider the cost of materials used, reasonable handling charges, and the fair market value of the articles. The sale price shall be indicated on each article by tag or other appropriate means, and a list of articles offered for sale and their respective sale prices shall be posted from time to time in the hospital or station area. In its discretion, the board may offer such articles for purchase by
No article purchased under the provisions of this subpart shall be resold in the hospital or station area at a price to exceed the sale price fixed by the board for such article.
Articles having no commercial value shall be stored, destroyed, or otherwise disposed of as the officer in charge may direct.
Promptly after the death of a patient in a station or hospital of the Service, an inventory of his money and effects left therein shall be made by two or more officers or employees of the Service designated for such purpose by the officer in charge.
The officer in charge shall notify in writing all persons known to him to whom delivery of the patient's money and effects might be made hereunder, and, in the case of an alien patient, a consul of the country of his apparent nationality. Each person so notified shall be requested to furnish information concerning (a) the existence or whereabouts of any persons to whom delivery of the deceased patient's money and effects may be made pursuant to these provisions, and (b) the permanent residence or home of the deceased.
(a) Delivery of the money and effects of a deceased patient shall be made only to a person who has filed a claim therefor on a form prescribed by the Surgeon General.
(b) A claimant shall furnish, in addition to the information on the prescribed form, such additional information as the officer in charge may consider necessary to establish the identity of the claimant and the truth of his statements.
(c) A person filing a claim as a legal representative shall be required to present letters of administration or a certificate of a court attesting his qualification or appointment.
(d) If a claim is made after the money, or proceeds from the sale of the effects, of a deceased patient have been deposited in the Treasury, the claim shall be referred to the General Accounting Office. If the claim is for checks or evidences of indebtedness of the United States which have been trasnsmitted to the issuing agency pursuant to §§ 35.47 and 35.48, the claimant shall be referred to such agency.
The money and effects of the deceased patient shall in all cases be delivered to the legal representative, if any, of his estate. If the value is $1,000 or less, and the officer in charge has neither notice nor other knowledge of the appointment or qualification of a legal representative, nor reason to believe that a legal representative will be appointed or qualified, he shall deliver all the money and effects, as soon as practicable after the expiration of 10 days from the sending of notices to one of the following in the indicated order of priority:
(a) A person, if any, designated in writing by the patient to receive the same.
(b) The patient's surviving spouse.
(c) The patient's child or children in equal parts.
(d) The patient's parent or parents in equal parts.
(e) Any other person who would be entitled to receive the money and effects under the law of the patient's domicile:
Irrespective of the provisions of this subpart, the officer in charge may (a) release from among the effects of the deceased patient so much of the patient's clothing as may be necessary for use in preparation of his body for burial and (b) cause to be destroyed, or otherwise disposed of, such used toilet articles of the patient as appear to have no commercial or other value.
In any case in which conflicting claims are filed or the officer in charge considers it to be in the interest of persons who may be ultimately entitled thereto, delivery may be withheld from all persons other than a duly qualified legal representative.
Notwithstanding any other provisions of this subpart, immediately upon completion of the inventory, checks drawn on the Treasurer of the United States shall be sent by safe means to the department, agency, or establishment of the Government of the United States issuing such checks. The transmittal shall be accompanied by a statement of the reasons therefor and of all available information which may aid the issuing unit in the disposition of the check transmitted. Notice of the disposition of any checks, with identifying information, shall be given to the person or persons, if any, to which money and effects are delivered in accordance with § 35.44.
If, within 120 days after sending of notices no claim has been filed pursuant to the provisions of § 35.43, the patient's money, consisting of all types of United States currency and coin, shall be deposited in the Treasury to the credit of the trust-fund account entitled “Money and Effects of Deceased Patients, Public Health Service.” If, within six months after the death of a patient, no claim has been filed pursuant to the provisions of § 35.43, his effects (including foreign currency and coin but excluding Postal Savings Certificates and other evidences of indebtedness of the United States) shall be sold at public auction or by sealed bids to the highest bidder and the proceeds deposited to the credit of the trust-fund account entitled “Money and Effects of Deceased Patients, Public Health Service.” Postal Savings Certificates and other evidences of indebtedness of the United States shall be transmitted to the issuing department or agency with a statement of the occasion therefor.
The following provisions shall govern the sale of effects:
(a)
(b)
(c)
(d)
(e)
The officer in charge shall dispose of effects offered for sale but remaining unsold in such manner as he considers to be proper, but, if practicable, such effects shall be used for the benefit of other patients of the Service.
(a) If a person entitled under this subpart to receive the money and effects of a patient is unable to take possession thereof at the station or hospital, they shall be sent to him at the expense of the United States in the most economical manner available. The records of the station or hospital shall show the names and addresses of persons to whom money or effects have been sent, the date of sending, the means used, an itemized list of the money or effects sent, and a statement by a witnessing officer or employee verifying the foregoing from his own observation.
(b) If not delivered personally by an authorized officer or employee of the Service, money, evidences of indebtedness, and other valuable papers and documents shall be sent by registered mail (or other safe means).
(c) Persons receiving the money and effects of a patient shall be required to execute an itemized receipt therefor.
Except for delivery of effects to purchasers at sales held in accordance with § 35.49, delivery or deposit under this subpart of the money or effects, or the proceeds of a sale of the effects, of a deceased patient constitutes only a transfer of possession and is not intended to affect in any manner the title to such money, effects, or proceeds.
Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 U.S.C. 216); sec. 321, 58 Stat. 695, as amended, 62 Stat. 1017 (42 U.S.C. 248).
This subpart sets forth the policies and procedures governing the acceptance and administration of contributions of money or property intended solely for the benefit of all patients in a ward or unit or a particular hospital or station of the Public Health Service, excluding outpatient clinics. Such contributions are distinguishable from (a) monies or other valuables belonging to specific patients which are accepted and held in custody for the convenience of the patient until such time as he or she wishes to withdraw them, and (b) gifts to the United States to support Public Health Service functions under section 501 of the Public Health Service Act or other statutory provisions, which may be accepted and administered only in accordance with such statutory provisions or other applicable laws.
(a) The officer in charge of a hospital or station or his delegate may accept contributions of money or personal property which are donated for the
(b) Contribution of money or property shall be accepted in writing.
(a) Contributions of money accepted pursuant to § 35.62 (hereinafter referred to as “patient fund”) will be treated consistently with Federal deposit rules and as supplemented with appropriate procedures of the facility. This regulation is not intended to exclude contributions for the benefit of patients from proper accountability and control of funds and property.
(b) Contributions of property accepted pursuant to § 35.62 shall be recorded and accounted for in the same manner as other property of a similar kind maintained in the hospital or station, but with suitable identification so that it can be distinguished from government-owned property.
Authorized contributions may be accepted from patients, employees and other individuals, and agencies and organizations.
Contributions of personal property which may be accepted pursuant to § 35.62 include, but are not limited to, recreational equipment, furniture, radios and television sets. After its useful life, any cash proceeds realized upon disposition of such property shall be deposited to the credit of the patient fund and shall be available for expenditure pursuant to § 35.66(c).
(a) Officials authorized to accept contributions shall not maintain control over the actual obligation or expenditure of such monies.
(b) Only those officers or employees specifically designated in writing by the officer in charge for such purpose may obligate and expend monies from the patient fund. The names of officials so designated shall be provided to the relevant fiscal control office.
(c) Subject to availability of sufficient funds, monies in the patient fund may be expended for materials, services or activities which contribute to the well-being or morale of patients, including but not limited to provision of reading and entertainment materials, recreation activities, and, in appropriate cases, necessary financial support (including travel expenses, meals, and lodging) of relatives, guardians, or friends of patients to enable such persons to be available for the patient's comfort and support.
(d) Officers in charge may issue such additional instructions, not inconsistent with this subpart, as may be necessary to implement its provisions.
Sec. 203, 83 Stat. 763; 30 U.S.C. 843, unless otherwise noted.
The provisions of this subpart set forth the specifications for giving, interpreting, classifying, and submitting chest roentgenograms required by section 203 of the act to be given to underground coal miners and new miners.
Any term defined in the Federal Mine Safety and Health Act of 1977 and not defined below shall have the meaning given it in the act. As used in this subpart:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(a)
(1) Following August 1, 1978 ALOSH will notify the operator of each underground coal mine of a period within which the operator may provide examinations to each miner employed at its coal mine. The period shall begin no sooner than the effective date of these regulations and end no later than a date specified by ALOSH separately for each coal mine. The termination date of the period will be approximately 5 years from the date of the first examination which was made on a miner employed by the operator in its coal mine under the former regulations of this subpart adopted July 27, 1973. Within the period specified by ALOSH for each mine, the operator may select a 6-month period within which to provide examinations in accordance with a plan approved under § 37.5.
ALOSH finds that between July 27, 1973, and March 31, 1975, the first roentgenogram for a miner who was employed at mine Y and who was employed in underground coal mining prior to December 30, 1969, was made on January 1, 1974. ALOSH will notify the operator of mine Y that the operator may select and designate on its plan a 6-month period within which to offer its examinations to its miners employed at mine Y. The 6-month period shall be scheduled between August 1, 1978 and January 1, 1979 (5 years after January 1, 1974).
(2) For all future voluntary examinations, ALOSH will notify the operator of each underground coal mine when sufficient time has elapsed since the end of the previous 6-month period of examinations. ALOSH will specify to the operator of each mine a period within which the operator may provide examinations to its miners employed at its coal mine. The period shall begin no sooner than 3
ALOSH finds that examinations were previously provided to miners employed at mine Y in a 6-month period from July 1, 1979, to December 31, 1979. ALOSH notifies the operator at least 3 months before July 1, 1983 (3
(3) Within either the next or future period(s) specified by ALOSH to the operator for each of its coal mines, the operator of the coal mine may select a different 6-month period for each of its mines within which to offer examinations. In the event the operator does not submit an approved plan, ALOSH will specify a 6-month period to the operator within which miners shall have the opportunity for examinations.
(b)
(1) An initial chest roentgenogram as soon as possible, but in no event later than 6 months after commencement of
(2) A second chest roentgenogram, in accordance with this subpart, 3 years following the initial examination if the miner is still engaged in underground coal mining. A second roentgenogram given to a miner according to former regulations under this subpart prior to August 1, 1978 will be considered as fulfilling this requirement.
(3) A third chest roentgenogram 2 years following the second chest roentgenogram if the miner is still engaged in underground coal mining and if the second roentgenogram shows evidence of category 1, category 2, category 3 simple pneumoconioses, or complicated pneumoconioses (ILO Classification).
(c) ALOSH will notify the miner when he or she is due to receive the second or third mandatory examination under (b) of this section. Similarly, ALOSH will notify the coal mine operator when the miner is to be given a second examination. The operator will be notified concerning a miner's third examination only with the miner's written consent, and the notice to the operator shall not state the medical reason for the examination nor that it is the third examination in the series. If the miner is notified by ALOSH that the third mandatory examination is due and the operator is not so notified, availability of the roentgenographic examination under the operator's plan shall constitute the operator's compliance with the requirement to provide a third mandatory examination even if the miner refuses to take the examination.
(d) The opportunity for chest roentgenograms to be available by an operator for purposes of this subpart shall be provided in accordance with a plan which has been submitted and approved in accordance with this subpart.
(e) Any examinations conducted by the Secretary in the National Study of Coal Workers' Pneumoconiosis after January 1, 1977, but before August 1, 1978 shall satisfy the requirements of this section with respect to the specific examination given (see § 37.6(d)).
(a) Every plan for chest roentgenographic examinations of miners shall be submitted on forms prescribed by the Secretary to ALOSH within 120 calendar days after August 1, 1978. In the case of a person who after August 1, 1978, becomes an operator of a mine for which no plan has been approved, that person shall submit a plan within 60 days after such event occurs. A separate plan shall be submitted by the operator and by each construction contractor for each underground coal mine which has a MSHA identification number. The plan shall include:
(1) The name, address, and telephone number of the operator(s) submitting the plan;
(2) The name, MSHA identification number for respirable dust measurements, and address of the mine included in the plan;
(3) The proposed beginning and ending date of the 6-month period for voluntary examinations (see § 37.3(a)) and the estimated number of miners to be given or offered examinations during the 6-month period under the plan;
(4) The name and location of the approved X-ray facility or facilities, and the approximate date(s) and time(s) of day during which the roentgenograms will be given to miners to enable a determination of whether the examinations will be conducted at a convenient time and place;
(5) If a mobile facility is proposed, the plan shall provide that each miner be given adequate notice of the opportunity to have the examination and that no miner shall have to wait for an examination more than 1 hour before or after his or her work shift. In addition, the plan shall include:
(i) The number of change houses at the mine.
(ii) One or more alternate nonmobile approved facilities for the reexamination of miners and for the mandatory examination of miners when necessary
(iii) The name and location of each change house at which examinations will be given. For mines with more than one change house, the examinations shall be given at each change house or at a change house located at a convenient place for each miner.
(6) The name and address of the “A” or “B” reader who will interpret and classify the chest roentgenograms.
(7) Assurances that: (i) The operator will not solicit a physician's roentgenographic or other findings concerning any miner employed by the operator,
(ii) Instructions have been given to the person(s) giving the examinations that duplicate roentgenograms or copies of roentgenograms will not be made and that (except as may be necessary for the purpose of this subpart) the physician's roentgenographic and other findings, as well as the occupational history information obtained from a miner unless obtained prior to employment in a preemployment examination, and disclosed prior to employment, will not be disclosed in a manner which will permit identification of the employee with the information about him, and
(iii) The roentgenographic examinations will be made at no charge to the miner.
(b) Operators may provide for alternate facilities and “A” or “B” readers in plans submitted for approval.
(c) The change of operators of any mine operating under a plan approved pursuant to § 37.5 shall not affect the plan of the operator which has transferred responsibility for the mine. Every plan shall be subject to revision in accordance with paragraph (d) of this section.
(d) The operator shall advise ALOSH of any change in its plan. Each change in an approved plan is subject to the same review and approval as the originally approved plan.
(e) The operator shall promptly display in a visible location on the bulletin board at the mine its proposed plan or proposed change in plan when it is submitted to ALOSH. The proposed plan or change in plan shall remain posted in a visible location on the bulletin board until ALOSH either grants or denies approval of it at which time the approved plan or denial of approval shall be permanently posted. In the case of an operator who is a construction contractor and who does not have a bulletin board, the construction contractor must otherwise notify its employees of the examination arrangements. Upon request, the contractor must show ALOSH written evidence that its employees have been notified.
(f) Upon notification from ALOSH that sufficient time has elapsed since the previous period of examinations, the operator will resubmit its plan for each of its coal mines to ALOSH for approval for the next period of examinations (see § 37.3(a)(2)). The plan shall include the proposed beginning and ending dates of the next period of examinations and all information required by paragraph (a) of this section.
(a) Approval of plans granted prior to August 1, 1978 is no longer effective.
(b) If, after review of any plan submitted pursuant to this subpart, the Secretary determines that the action to be taken under the plan by the operator meets the specifications of this subpart and will effectively achieve its purpose, the Secretary will approve the plan and notify the operator(s) submitting the plan of the approval. Approval may be conditioned upon such terms as the Secretary deems necessary to carry out the purpose of section 203 of the act.
(c) Where the Secretary has reason to believe that he will deny approval of a plan he will, prior to the denial, give reasonable notice in writing to the operator(s) of an opportunity to amend the plan. The notice shall specify the ground upon which approval is proposed to be denied.
(d) If a plan is denied approval, the Secretary shall advise the operator(s) in writing of the reasons for the denial.
(a) The Secretary will give chest roentgenograms or make arrangements with an appropriate person, agency, or institution to give the chest roentgenograms and with “A” or “B” readers to interpret the roentgenograms required under this subpart in the locality where the miner resides, at the mine, or at a medical facility easily accessible to a mining community or mining communities, under the following circumstances:
(1) Where, in the judgment of the Secretary, due to the lack of adequate medical or other necessary facilities or personnel at the mine or in the locality where the miner resides, the required roentgenographic examination cannot be given.
(2) Where the operator has not submitted an approvable plan.
(3) Where, after commencement of an operator's program pursuant to an approved plan and after notice to the operator of his failure to follow the approved plan and, after allowing 15 calendar days to bring the program into compliance, the Secretary determines and notifies the operator in writing that the operator's program still fails to comply with the approved plan.
(b) The operator of the mine shall reimburse the Secretary or other person, agency, or institution as the Secretary may direct, for the cost of conducting each examination made in accordance with this section.
(c) All examinations given or arranged by the Secretary will comply with the time requirements of § 37.3. Whenever the Secretary gives or arranges for the examinations of miners at a time, a written notice of the arrangements will be sent to the operator who shall post the notice on the mine bulletin board.
(d) Operators of mines selected by ALOSH to participate in the National Study of Coal Workers' Pneumoconiosis (an epidemiological study of respiratory diseases in coal miners) and who agree to cooperate will have all their miners afforded the opportunity to have a chest roentgenogram required hereunder at no cost to the operator. For future examinations and for mandatory examinations each participating operator shall submit an approvable plan.
(a) Any miner who, in the judgment of the Secretary based upon the interpretation of one or more of the miner's chest roentgenograms, shows category 1 (1/0, 1/1, 1/2), category 2 (2/1, 2/2, 2/3), or category 3 (3/2, 3/3, 3/4) simple pneumoconioses, or complicated pneumoconioses (ILO Classification) shall be afforded the option of transferring from his or her position to another position in an area of the mine where the concentration of respirable dust in the mine atmosphere is not more than 1.0 mg/m
(b) Any transfer under this section shall be in accordance with the procedures specified in part 90 of title 30, Code of Federal Regulations.
Any miner who wishes to obtain an examination at his or her own expense at an approved facility and to have submitted to NIOSH for him or her a complete examination may do so, provided that the examination is made no sooner than 6 months after the most recent examination of the miner submitted to ALOSH. ALOSH will provide an interpretation and report of the examinations made at the miner's expense in the same manner as if it were submitted under an operator's plan. Any change in the miner's transfer rights under the act which may result from this examination will be subject to the terms of § 37.7.
As part of the roentgenographic examination, a miner identification document which includes an occupational history questionnaire shall be completed for each miner at the facility where the roentgenogram is made at
(a) The chest roentgenographic examination shall be given at a convenient time and place.
(b) The chest roentgenographic examination consists of the chest roentgenogram, and a complete Roentgenographic Interpretation Form (Form CDC/NIOSH (M) 2.8), and miner identification document.
(c) A roentgenographic examination shall be made in a facility approved in accordance with § 37.42 by or under the supervision of a physician who regularly makes chest roentgenograms and who has demonstrated ability to make chest roentgenograms of a quality to best ascertain the presence of pneumoconiosis.
(a) Every chest roentgenogram shall be a single posteroanterior projection at full inspiration on a film being no less than 14 by 17 inches and no greater than 16 by 17 inches. The film and cassette shall be capable of being positioned both vertically and horizontally so that the chest roentgenogram will include both apices and costophrenic angles. If a miner is too large to permit the above requirements, then the projection shall include both apices with minimum loss of the costophrenic angle.
(b) Miners shall be disrobed from the waist up at the time the roentgenogram is given. The facility shall provide a dressing area and for those miners who wish to use one, the facility shall provide a clean gown. Facilities shall be heated to a comfortable temperature.
(c) Roentgenograms shall be made only with a diagnostic X-ray machine having a rotating anode tube with a maximum of a 2 mm. source (focal spot).
(d) Except as provided in paragraph (e) of this section, roentgenograms shall be made with units having generators which comply with the following: (1) The generators of existing roentgenographic units acquired by the examining facility prior to July 27, 1973, shall have a minimum rating of 200 mA at 100 kVp.; (2) generators of units acquired subsequent to that date shall have a minimum rating of 300 mA at 125 kVp.
A generator with a rating of 150 kVp. is recommended.
(e) Roentgenograms made with battery-powered mobile or portable equipment shall be made with units having a minimum rating of 100 mA at 110 kVp. at 500 Hz, or of 200 mA at 110 kVp. at 60 Hz.
(f) Capacitor discharge and field emission units may be used if the model of such units is approved by ALOSH for quality, performance, and safety. ALOSH will consider such units for approval when listed by a facility seeking approval under § 37.42 of this subpart.
(g) Roentgenograms shall be given only with equipment having a beam-limiting device which does not cause large unexposed boundaries. The beam limiting device shall provide rectangular collimation and shall be of the type described in part F of the suggested State regulations for the control of radiation or (for beam limiting devices manufactured after August 1, 1974) of the type specified in 21 CFR 1020.31. The use of such a device shall be discernible from an examination of the roentgenogram.
(h) To insure high quality chest roentgenograms:
(1) The maximum exposure time shall not exceed
(2) The source or focal spot to film distance shall be at least 6 feet;
(3) Medium speed film and medium speed intensifying screens are recommended. However, any film-screen combination, the rated “speed” of which is at least 100 and does not exceed 300, which produces roentgenograms with spatial resolution, contrast, latitude and quantum mottle
(4) Film-screen contact shall be maintained and verified at 6 month or shorter intervals;
(5) Intensifying screens shall be inspected at least once a month and cleaned when necessary by the method recommended by the manufacturer;
(6) All intensifying screens in a cassette shall be of the same type and made by the same manufacturer;
(7) When using over 90 kV., a suitable grid or other means of reducing scattered radiation shall be used;
(8) The geometry of the radiographic system shall insure that the central axis (ray) of the primary beam is perpendicular to the plane of the film surface and impinges on the center of the film;
(9) A formal quality assurance program shall be established at each facility.
(i) Radiographic processing:
(1) Either automatic or manual film processing is acceptable. A constant time-temperature technique shall be meticulously employed for manual processing.
(2) If mineral or other impurities in the processing water introduce difficulty in obtaining a high-quality roentgenogram, a suitable filter or purification system shall be used.
(j) Before the miner is advised that the examination is concluded, the roentgenogram shall be processed and inspected and accepted for quality by the physician, or if the physician is not available, acceptance may be made by the radiologic technologist. In a case of a substandard roentgenogram, another shall be immediately made. All substandard roentgenograms shall be clearly marked as rejected and promptly sent to ALOSH for disposal.
(k) An electric power supply shall be used which complies with the voltage, current, and regulation specified by the manufacturer of the machine.
(l) A densitometric test object may be required on each roentgenogram for an objective evaluation of film quality at the discretion of ALOSH.
(m) Each roentgenogram made hereunder shall be permanently and legibly marked with the name and address or ALOSH approval number of the facility at which it is made, the social security number of the miner, and the date of the roentgenogram. No other identifying markings shall be recorded on the roentgenogram.
(a) Approval of roentgenographic facilities given prior to January 1, 1976, shall terminate upon August 1, 1978 unless each of the following conditions have been met:
(1) The facility must verify that it still meets the requirements set forth in the regulations for the second round of roentgenographic examinations (38 FR 20076) and it has not changed equipment since it was approved by NIOSH.
(2) From July 27, 1973, to January 1, 1976, the facility submitted to ALOSH at least 50 roentgenograms which were interpreted by one or more “B” readers not employed by the facility who found no more than 5 percent of all the roentgenograms unreadable.
(b) Other facilities will be eligible to participate in this program when they demonstrate their ability to make high quality diagnostic chest roentgenograms by submitting to ALOSH six or more sample chest roentgenograms made and processed at the applicant facility and which are of acceptable quality to the Panel of “B” readers. Applicants shall also submit a roentgenogram of a plastic step-wedge object (available on loan from ALOSH) which was made and processed at the same time with the same technique as the roentgenograms submitted and processed at the facility for which approval is sought. At least one chest roentgenogram and one test object roentgenogram shall have been made with each unit to be used hereunder. All roentgenograms shall have been made within 15 calendar days prior to submission and shall be marked to identify the facility where each roentgenogram was made, the X-ray machine used, and the date each was made. The chest roentgenograms will be returned and may be the same roentgenograms submitted pursuant to § 37.51.
The plastic step-wedge object is described in an article by E. Dale Trout and
(c) Each roentgenographic facility submitting chest roentgenograms for approval under this section shall complete and include an X-ray facility document describing each X-ray unit to be used to make chest roentgenograms under the act. The form shall include: (1) The date of the last radiation safety inspection by an appropriate licensing agency or, if no such agency exists, by a qualified expert as defined in NCRP Report No. 33 (see § 37.43); (2) the deficiencies found; (3) a statement that all the deficiencies have been corrected; and (4) the date of acquisition of the X-ray unit. To be acceptable, the radiation safety inspection shall have been made within 1 year preceding the date of application.
(d) Roentgenograms submitted with applications for approval under this section will be evaluated by the panel of “B” Readers or by a qualified radiological physicist or consultant. Applicants will be advised of any reasons for denial of approval.
(e) ALOSH or its representatives may make a physical inspection of the applicant's facility and any approved roentgenographic facility at any reasonable time to determine if the requirements of this subpart are being met.
(f) ALOSH may require a facility periodically to resubmit roentgenograms of a plastic step-wedge object, sample roentgenograms, or a Roentgenographic Facility Document for quality control purposes. Approvals granted hereunder may be suspended or withdrawn by notice in writing when in the opinion of ALOSH the quality of roentgenograms or information submitted under this section warrants such action. A copy of a notice withdrawing approval will be sent to each operator who has listed the facility as its facility for giving chest roentgenograms and shall be displayed on the mine bulletin board adjacent to the operator's approved plan. The approved plan will be reevaluated by ALOSH in light of this change.
Except as otherwise specified in § 37.41, roentgenographic equipment, its use and the facilities (including mobile facilities) in which such equipment is used, shall conform to applicable State and Federal regulations (See 21 CFR part 1000). Where no applicable regulations exist, roentgenographic equipment, its use and the facilities (including mobile facilities) in which such equipment is used shall conform to the recommendations of the National Council on Radiation Protection and Measurements in NCRP Report No. 33 “Medical X-ray and Gamma-Ray Protection for Energies up to 10 MeV—Equipment Design and Use” (issued February 1, 1968), in NCRP Report No. 48, “Medical Radiation Protection for Medical and Allied Health Personnel” (issued August 1, 1976), and in NCRP Report No. 49, “Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of up to 10 MeV” (issued September 15, 1976). These documents are hereby incorporated by reference and made a part of this subpart. These documents are available for examination at ALOSH, 944 Chestnut Ridge Road, Morgantown, WV 26505, and at the National Institute for Occupational Safety and Health, 5600 Fishers Lane, Rockville, MD 20857. Copies of NCRP Reports Nos. 33, 48, and 49 may be purchased for $3, $4.50, and $3.50 each, respectively, from NCRP Publications, P.O. Box 30175, Washington, DC 20014.
(a) Chest roentgenograms shall be interpreted and classified in accordance with the ILO Classification system and recorded on a Roentgenographic Interpretation Form (Form CDC/NIOSH (M)2.8).
(b) Roentgenograms shall be interpreted and classified only by a physician who regularly reads chest roentgenograms and who has demonstrated proficiency in classifying the
(c) All interpreters, whenever interpreting chest roentgenograms made under the Act, shall have immediately available for reference a complete set of the ILO International Classification of Radiographs for Pneumoconioses, 1980.
This set is available from the International Labor Office, 1750 New York Avenue, NW., Washington, DC 20006 (Phone: 202/376-2315).
(d) In all view boxes used for making interpretations:
(1) Fluorescent lamps shall be simultaneously replaced with new lamps at 6-month intervals;
(2) All the fluorescent lamps in a panel of boxes shall have identical manufacturer's ratings as to intensity and color;
(3) The glass, internal reflective surfaces, and the lamps shall be kept clean;
(4) The unit shall be so situated as to minimize front surface glare.
(a) First or “A” readers:
(1) Approval as an “A” reader shall continue if established prior to (insert) effective date of these regulations).
(2) Physicians who desire to be “A” readers must demonstrate their proficiency in classifying the pneumoconioses by either:
(i) Submitting to ALOSH from the physician's files six sample chest roentgenograms which are considered properly classified by the Panel of “B” readers. The six roentgenograms shall consist of two without pneumoconiosis, two with simple pneumoconiosis, and two with complicated pneumoconiosis. The films will be returned to the physician. The interpretations shall be on the Roentgenographic Interpretation Form (Form CDC/NIOSH (M) 2.8) (These may be the same roentgenograms submitted pursuant to § 37.42), or;
(ii) Satisfactory completion, since June 11, 1970, of a course approved by ALOSH on the ILO or ILO-U/C Classification systems or the UICC/Cincinnati classification system. As used in this subparagraph, “UICC/Cincinnati classification” means the classification of the pneumoconioses devised in 1968 by a Working Committee of the International Union Against Cancer.
(b) Final or “B” readers:
(1) Approval as a “B” reader established prior to October 1, 1976, shall hereby be terminated.
(2) Proficiency in evaluating chest roentgenograms for roentgenographic quality and in the use of the ILO Classification for interpreting chest roentgenograms for pneumoconiosis and other diseases shall be demonstrated by those physicians who desire to be “B” readers by taking and passing a specially designed proficiency examination given on behalf of or by ALOSH at a time and place specified by ALOSH. Each physician must bring a complete set of the ILO standard reference radiographs when taking the examination. Physicians who qualify under this provision need not be qualified under paragraph (a) of this section.
(c) Physicians who wish to participate in the program shall make application on an Interpreting Physician Certification Document (Form CDC/NIOSH (M) 2.12).
(a) All chest roentgenograms which are first interpreted by an “A” or “B” reader will be submitted by ALOSH to a “B” reader qualified as described in § 37.51. If there is agreement between the two interpreters as defined in paragraph (b) of this section the result shall be considered final and reported to MSHA for transmittal to the miner. When in the opinion of ALOSH substantial agreement is lacking, ALOSH shall obtain additional interpretations from the Panel of “B” readers. If interpretations are obtained from two or more “B” readers, and if two or more are in agreement then the highest major category shall be reported.
(b) Two interpreters shall be considered to be in agreement when they
(a) Findings of, or findings suggesting, enlarged heart, tuberculosis, lung cancer, or any other significant abnormal findings other than pneumoconiosis shall be communicated by the first physician to interpret and classify the roentgenogram to the designated physician of the miner indicated on the miner's identifcation document. A copy of the communication shall be submitted to ALOSH. ALOSH will notify the miner to contact his or her physician when any physician who interprets and classifies the miner's roentgenogram reports significant abnormal findings other than pneumoconiosis.
(b) In addition, when ALOSH has more than one roentgenogram of a miner in its files and the most recent examination was interpreted to show enlarged heart, tuberculosis, cancer, complicated pneumoconiosis, and any other significant abnormal findings, ALOSH will submit all of the miner's roentgenograms in its files with their respective interprtations to a “B” reader. The “B” reader will report any significant changes or progression of disease or other comments to ALOSH and ALOSH shall submit a copy of the report to the miner's designated physician.
(c) All final findings regarding pneumoconiosis will be sent to the miner by MSHA in accordance with section 203 of the act (see 30 CFR part 90). Positive findings with regard to pneumoconiosis will be reported to the miner's designated physician by ALOSH.
(d) ALOSH will make every reasonable effort to process the findings described in paragraph (c) of this section within 60 days of receipt of the information described in § 37.60 in a complete and acceptable form. The information forwarded to MSHA will be in a form intended to facilitate prompt dispatch of the findings to the miner. The results of an examination made of a miner will not be processed by ALOSH if the examination was made within 6 months of the date of a previous acceptable examination.
(a) Each chest roentgenogram required to be made under this subpart, together with the completed roentgenographic interpretation form and the completed miner identification document, shall be sumitted together for each miner to ALOSH within 14 calendar days after the roentgenographic examination is given and become the property of ALOSH.
(b) If ALOSH deems any part submitted under paragraph (a) of this section inadequate, it will notify the operator of the deficiency. The operator shall promptly make appropriate arrangements for the necessary reexamination.
(c) Failure to comply with paragraph (a) or (b) of this section shall be cause to revoke approval of a plan or any other approval as may be appropriate. An approval which has been revoked may be reinstated at the discretion of ALOSH after it receives satisfactory assurances and evidence that all deficiencies have been corrected and that effective controls have been instituted to prevent a recurrence.
(d) Chest roentgenograms and other required documents shall be submitted only for miners. Results of preemployment physical examinations of persons who are not hired shall not be submitted.
(e) If a miner refuses to participate in all phases of the examination prescribed in this subpart, no report need
(a) Any miner who believes the interpretation for pneumoconiosis reported to him or her by MSHA is in error may file a written request with ALOSH that his or her roentgenogram be reevaluated. If the interpretation was based on agreement between an “A” reader and a “B” reader, ALOSH will obtain one or more additional interpretations by “B” readers as necessary to obtain agreement in accord with § 37.52(b), and MSHA shall report the results to the miner together with any rights which may accrue to the miner in accordance with § 37.7. If the reported interpretation was based on agreement between two (or more) “B” readers, the reading will be accepted as conclusive and the miner shall be so informed by MSHA.
(b) Any operator who is directed by MSHA to transfer a miner to a less dusty atmosphere based on the most recent examination made subsequent to August 1, 1978, may file a written request with ALOSH to review its findings. The standards set forth in paragraph (a) of this section apply and the operator and miner will be notified by MSHA whether the miner is entitled to the option to transfer.
(a) Medical information and roentgenograms on miners will be released by ALOSH only with the written consent from the miner, or if the miner is deceased, written consent from the miner's widow, next of kin, or legal representative.
(b) To the extent authorized, roentgenograms will be made available for examination only at ALOSH.
Sec. 508, 83 Stat. 803; 30 U.S.C. 957.
The provisions of this subpart set forth the conditions under which the Secretary will pay pathologists to obtain results of autopsies performed by them on miners.
As used in this subpart:
(a)
(b)
(c)
(1) A physician certified in anatomic pathology or pathology by the American Board of Pathology or the American Osteopathic Board of Pathology,
(2) A physician who possesses qualifications which are considered “Board of eligible” by the American Board of Pathology or American Osteopathic Board of Pathology, or
(3) An intern, resident, or other physician in a training program in pathology who performs the autopsy under the supervision of a pathologist as defined in paragraph (c) (1) or (2) of this section.
(d)
(a) The Secretary will pay up to $200 to any pathologist who, after the effective date of the regulations in this part and with legal consent:
(1) Performs an autopsy on a miner in accordance with this subpart; and
(2) Submits the findings and other materials to ALFORD in accordance with this subpart within 180 calendar
(3) Receives no other specific payment, fee, or reimbursement in connection with the autopsy from the miner's widow, his family, his estate, or any other Federal agency.
(b) The Secretary will pay to any pathologist entitled to payment under paragraph (a) of this section and additional $10 if the pathologist can obtain and submits a good quality copy or original of a chest roentgenogram (posteroanterior view) made of the subject of the autopsy within 5 years prior to his death together with a copy of any interpretation made.
(a) Every autopsy for which a claim for payment is submitted pursuant to this part:
(1) Shall be performed consistent with standard autopsy procedures such as those, for example, set forth in the “Autopsy Manual” prepared by the Armed Forces Institute of Pathology, July 1, 1960. (Technical Manual No. 8-300. NAVMED P-5065, Air Force Manual No. 160-19.) Copies of this document may be borrowed from ALFORD.
(2) Shall include:
(i) Gross and microscopic examination of the lungs, pulmonary pleura, and tracheobronchial lymph nodes;
(ii) Weights of the heart and each lung (these and all other measurements required under this subparagraph shall be in the metric system);
(iii) Circumference of each cardiac valve when opened;
(iv) Thickness of right and left ventricles; these measurements shall be made perpendicular to the ventricular surface and shall not include trabeculations or pericardial fat. The right ventricle shall be measured at a point midway between the tricuspid valve and the apex, and the left ventricle shall be measured directly above the insertion of the anterior papillary muscle;
(v) Size, number, consistency, location, description and other relevant details of all lesions of the lungs;
(vi) Level of the diaphragm;
(vii) From each type of suspected pneumoconiotic lesion, representative microscopic slides stained with hematoxylin eosin or other appropriate stain, and one formalin fixed, paraffin-impregnated block of tissue; a minimum of three stained slides and three blocks of tissue shall be submitted. When no such lesion is recognized, similar material shall be submitted from three separate areas of the lungs selected at random; a minimum of three stained slides and three formalin fixed, paraffin-impregnated blocks of tissue shall be submitted.
(b) Needle biopsy techniques shall not be used.
Every claim for payment under this subpart shall be submitted to ALFORD and shall include:
(a) An invoice (in duplicate) on the pathologist's letterhead or billhead indicating the date of autopsy, the amount of the claim and a signed statement that the pathologist is not receiving any other specific compensation for the autopsy from the miner's widow, his surviving next-of-kin, the estate of the miner, or any other source.
(b) Completed PHS Consent, Release and History Form (See Fig. 1). This form may be completed with the assistance of the pathologist, attending physician, family physician, or any other responsible person who can provide reliable information.
(c) Report of autopsy:
(1) The information, slides, and blocks of tissue required by this subpart.
(2) Clinical abstract of terminal illness and other data that the pathologist determines is relevant.
(3) Final summary, including final anatomical diagnoses, indicating presence or absence of simple and complicated pneumoconiosis, and correlation with clinical history if indicated.
I, _________, (Name) ______ (Relationship) of _________, (Name of deceased miner) do hereby authorize the performance of an autopsy (_________) (Limitation, if any, on autopsy) on said deceased. I understand that the report and certain tissues as necessary will be released to the United States Public Health Service and to _________ (Name of Physician securing autopsy)
1. Date of Birth of Deceased ______. (Month, Day, Year)
2. Social Security Number of Deceased _________.
3. Date and Place of Death ______, (Month, Day, Year) _________ (City, County, State).
4. Place of Last Mining Employment:
5. Last Job Title at Mine of Last Employment
6. Job Title of Principal Mining Occupation (that job to which miner devoted the most number of years)
7. Smoking History of Miner:
(a) Did he ever smoke cigarettes? Yes
(b) If yes, for how many years?______
(c) If yes, how many cigarettes per day did he smoke on the average?________
(d) Did he smoke cigarettes up until the time of his death? Yes ___ No ___
(e) If no to (d), for how long before he died had he not been smoking cigarettes?
8. Total Years in Surface and Underground Employment in Coal Mining, by State (If known) ___, (Years) ______ (State).
9. Total Years in
Sec. 413, Pub. L. 93-288. The Disaster Relief Act of 1974, 88 Stat. 157, 42 U.S.C. 5183, EO 11795, 39 FR 25939, as amended by EO 11910, 41 FR 15681.
(a)
(1) Professional counseling services to victims of a major disaster in order to relieve mental health problems caused or aggravated by such a major disaster or its aftermath; and
(2) Training of disaster workers to provide or assist in providing those professional counseling services.
(b)
All terms not defined herein shall have the same meaning as given them in the Act. As used in this part:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(a)
(1) An estimate of the number of disaster victims who may need professional mental health crisis counseling services and of the number of disaster workers who may need training in the provision of such services;
(2) Identification of the geographical areas in which the need exists;
(3) An estimate of the period during which assistance under this part will be required and of the total funds which will be required to provide such assistance;
(4) A description of the types of mental health problems caused or aggravated by the major disaster or its aftermath; and
(5) Identification of the State and local agencies and private mental health organizations capable of providing professional mental health crisis counseling to disaster victims or training of disaster workers.
(b)
(c)
(i) Have been located within the designated major disaster area or have been a resident of such area at the time of the major disaster or its aftermath; and
(ii) Have a mental health problem which was caused or aggravated by the major disaster or its aftermath.
(2) Disaster workers who are available on short notice to provide professional mental health crisis counseling services in a major disaster area are eligible for training under this part.
(d)
(a)
(b)
(c)
(d)
(e)
(1) Progress reports, to be submitted at the end of the first 30 days of the contract period and every 30 days therafter;
(2) A final report to be submitted within 60 days of the date upon which the contract terminates; and
(3) Such additional reports as the Secretary may prescribe including those which may be required to enable the Federal Coordinating Officer to carry out his functions.
(a)
(b)
(1) A proposed plan for the provision of the services for which grant assistance is requested;
(2) A proposed budget for the expenditure of the requested grant funds; and
(3) Such other pertinent information and assurances as the Secretary may require.
(c)
(2) Within the limits of the funds advanced by the Administrator, the amount of any grant award shall be determined on the basis of the Secretary's estimate of the sum necessary to carry out the grant purpose.
(3) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(d)
(e)
(f)
Attention is called to the requirements of 24 CFR 2205.13 relating to nondiscrimination on the grounds of race. religion, sex, color, age, economic status, or national origin in the provision of disaster assistance.
Attention is called to section 308 of the Act (42 U.S.C. 5148) which provides that the Federal Government shall not be liable for any claim based upon the exercise or performance of or the failure to exercise or perform a discretionary function or duty on the part of a Federal agency or an employee of the Federal Government in carrying out the provisions of the Act.
Attention is called to section 317 of the Act (42 U.S.C. 5157) which provides:
(a) Any individual who fraudulently or willfully misstates any fact in connection with a request for assistance under this Act shall be fined not more than $10,000 or imprisoned for not more than one year or both for each violation.
(b) Any individual who knowingly violates any order or regulation under this Act shall be subject to a civil penalty of not more than $5,000 for each violation.
(c) Whoever knowingly misapplies the proceeds of a loan or other cash benefit obtained under any section of this Act shall be subject to a fine in an amount equal to one and one half times the original principal amount of the loan or cash benefit.
The Secretary, the Administrator, and the Comptroller General of the United States, or their duly authorized representatives shall have access to any books, documents, papers, and records that pertain to Federal funds, equipment, and supplies received under this part for the purpose of audit and examination.
Sec. 215, Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42 U.S.C. 300a-4), unless otherwise noted.
Sec. 493, Public Health Service Act, as amended, 99 Stat. 874-875 (42 U.S.C. 289b); Sec. 501(f), Public Health Service Act, as amended, 102 Stat. 4213 (42 U.S.C. 290aa(f)).
This subpart applies to each entity which applies for a research, research-training, or research-related grant or cooperative agreement under the Public Health Service (PHS) Act. It requires each such entity to establish uniform policies and procedures for investigating and reporting instances of
As used in this subpart:
(a)
(1) Has established an administrative process, that meets the requirements of this Subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant; and
(2) Will comply with its own administrative process and the requirements of this Subpart.
(b)
(1) The institution's assurance shall be submitted to the OSI, on a form prescribed by the Secretary, as soon as possible after November 8, 1989, but no later than January 1, 1990, and updated annually therefter on a date specified by OSI. Copies of the form may be requested through the Director, OSI.
(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe.
(c)
(1) Establishes, keeps current, and upon request provides the OSIR, the OSI, and other authorized Departmental officials the policies and procedures required by this subpart.
(2) Informs its scientific and administrative staff of the policies and procedures and the importance of compliance with those policies and procedures.
(3) Takes immediate and appropriate action as soon as misconduct on the part of employees or persons within the organization's control is suspected or alleged.
(4) Informs, in accordance with this subpart, and cooperates with the OSI with regard to each investigation of possible misconduct.
(d)
(1) Inquiring immediately into an allegation or other evidence of possible misconduct. An inquiry must be completed within 60 calendar days of its initiation unless circumstances clearly warrant a longer period. A written report shall be prepared that states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions of the inquiry. The individual(s) against whom the allegation was made shall be given a copy of the report of inquiry. If they comment on that report, their comments may be made part of the record. If the inquiry takes longer than 60 days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period.
(2) Protecting, to the maximum extent possible, the privacy of those who in good faith report apparent misconduct.
(3) Affording the affected individual(s) confidential treatment to the maximum extent possible, a prompt and thorough investigation, and an opportunity to comment on allegations and findings of the inquiry and/or the investigation.
(4) Notifying the Director, OSI, in accordance with § 50.104(a) when, on the basis of the initial inquiry, the institution determines that an investigation is warranted, or prior to the decision to initiate an investigation if the conditions listed in § 50.104(b) exist.
(5) Notifying the OSI within 24 hours of obtaining any reasonable indication of possible criminal violations, so that the OSI may then immediately notify the Department's Office of Inspector General.
(6) Maintaining sufficiently detailed documentation of inquiries to permit a later assessment of the reasons for determining that an investigation was not warranted, if necessary. Such records shall be maintained in a secure manner for a period of at least three years after the termination of the inquiry, and shall, upon request, be provided to authorized HHS personnel.
(7) Undertaking an investigation within 30 days of the completion of the inquiry, if findings from that inquiry provide sufficient basis for conducting an investigation. The investigation normally will include examination of all documentation, including but not necessarily limited to relevant research data and proposals, publications, correspondence, and memoranda of telephone calls. Whenever possible, interviews should be conducted of all individuals involved either in making the allegation or against whom the allegation is made, as well as other individuals who might have information regarding key aspects of the allegations; complete summaries of these interviews should be prepared, provided to the interviewed party for comment
(8) Securing necessary and appropriate expertise to carry out a thorough and authoritative evaluation of the relevant evidence in any inquiry or investigation.
(9) Taking precautions against real or apparent conflicts of interest on the part of those involved in the inquiry or investigation.
(10) Preparing and maintaining the documentation to substantiate the investigation's findings. This documentation is to be made available to the Director, OSI, who will decide whether that Office will either proceed with its own investigation or will act on the institution's findings.
(11) Taking interim administrative actions, as appropriate, to protect Federal funds and insure that the purposes of the Federal financial assistance are carried out.
(12) Keeping the OSI apprised of any developments during the course of the investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.
(13) Undertaking diligent efforts, as appropriate, to restore the reputations of persons alleged to have engaged in misconduct when allegations are not confirmed, and also undertaking diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.
(14) Imposing appropriate sanctions on individuals when the allegation of misconduct has been substantiated.
(15) Notifying the OSI of the final outcome of the investigation.
(a)(1) An institution's decision to initiate an investigation must be reported in writing to the Director, OSI, on or before the date the investigation begins. At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation, and the PHS application or grant number(s) involved. Information provided through the notification will be held in confidence to the extent permitted by law, will not be disclosed as part of the peer review and Advisory Committee review processes, but may be used by the Secretary in making decisions about the award or continuation of funding.
(2) An investigation should ordinarily be completed within 120 days of its initiation. This includes conducting the investigation, preparing the report of findings, making that report available for comment by the subjects of the investigation, and submitting the report to the OSI. If they can be identified, the person(s) who raised the allegation should be provided with those portions of the report that address their role and opinions in the investigation.
(3) Institutions are expected to carry their investigations through to completion, and to pursue diligently all significant issues. If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements under § 50.103(d), a report of such planned termination, including a description of the reasons for such termination, shall be made to OSI, which will then decide whether further investigation should be undertaken.
(4) The final report submitted to the OSI must describe the policies and procedures under which the investigation was conducted, how and from whom information was obtained relevant to the investigation, the findings, and the basis for the findings, and include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct, as well as a description of any sanctions taken by the institution.
(5) If the institution determines that it will not be able to complete the investigation in 120 days, it must submit to the OSI a written request for an extension and an explanation for the delay that includes an interim report on the progress to date and an estimate for the date of completion of the report and other necessary steps. Any consideration for an extension must balance the need for a thorough and rigorous
(6) Upon receipt of the final report of investigation and supporting materials, the OSI will review the information in order to determine whether the investigation has been performed in a timely manner and with sufficient objectivity, thoroughness and competence. The OSI may then request clarification or additional information and, if necessary, perform its own investigation. While primary responsibility for the conduct of investigations and inquiries lies with the institution, the Department reserves the right to perform its own investigation at any time prior to, during, or following an institution's investigation.
(7) In addition to sanctions that the institution may decide to impose, the Department also may impose sanctions of its own upon investigators or institutions based upon authorities it possesses or may possess, if such action seems appropriate.
(b) The institution is responsible for notifying the OSI if it ascertains at any stage of the inquiry or investigation, that any of the following conditions exist:
(1) There is an immediate health hazard involved;
(2) There is an immediate need to protect Federal funds or equipment;
(3) There is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any;
(4) It is probable that the alleged incident is going to be reported publicly.
(5) There is a reasonable indication of possible criminal violation. In that instance, the institution must inform OSI within 24 hours of obtaining that information. OSI will immediately notify the Office of the Inspector General.
Institutions shall foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with research for which PHS funds have been provided or requested. An institution's failure to comply with its assurance and the requirements of this subpart may result in enforcement action against the institution, including loss of funding, and may lead to the OSI's conducting its own investigation.
The provisions of this subpart are applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, administered by the Public Health Service.
As used in this subpart:
The
Programs or projects to which this subpart applies shall perform or arrange for the performance of sterilization of an individual only if the following requirements have been met:
(a) The individual is at least 21 years old at the time consent is obtained.
(b) The individual is not a mentally incompetent individual.
(c) The individual has voluntarily given his or her informed consent in accordance with the procedures of § 50.204 of this subpart.
(d) At least 30 days but not more than 180 days have passed between the date of informed consent and the date of the sterilization, except in the case of premature delivery or emergency abdominal surgery. An individual may consent to be sterilized at the time of premature delivery or emergency abdominal surgery, if at least 72 hours have passed after he or she gave informed consent to sterilization. In the case of premature delivery, the informed consent must have been given at least 30 days before the expected date of delivery.
Informed consent does not exist unless a consent form is completed voluntarily and in accordance with all the requirements of this section and § 50.205 of this subpart.
(a) A person who obtains informed consent for a sterilization procedure must offer to answer any questions the individual to be sterilized may have concerning the procedure, provide a copy of the consent form, and provide orally all of the following information or advice to the individual who is to be sterilized:
(1) Advice that the individual is free to withhold or withdraw consent to the procedure any time before the sterilization without affecting his or her right to future care or treatment and without loss or withdrawal of any federally funded program benefits to which the individual might be otherwise entitled:
(2) A description of available alternative methods of family planning and birth control;
(3) Advice that the sterilization procedure is considered to be irreversible;
(4) A thorough explanation of the specific sterilization procedure to be performed;
(5) A full description of the discomforts and risks that may accompany or follow the performing of the procedure, including an explanation of the type and possible effects of any anesthetic to be used;
(6) A full description of the benefits or advantages that may be expected as a result of the sterilization; and
(7) Advice that the sterilization will not be performed for at least 30 days except under the circumstances specified in § 50.203(d) of this subpart.
(b) An interpreter must be provided to assist the individual to be sterilized if he or she does not understand the language used on the consent form or the language used by the person obtaining the consent.
(c) Suitable arrangements must be made to insure that the information specified in paragraph (a) of this section is effectively communicated to any individual to be sterilized who is blind, deaf or otherwise handicapped.
(d) A witness chosen by the individual to be sterilized may be present when consent is obtained.
(e) Informed consent may not be obtained while the individual to be sterilized is:
(1) In labor or childbirth;
(2) Seeking to obtain or obtaining an abortion; or
(3) Under the influence of alcohol or other substances that affect the individual's state of awareness.
(f) Any requirement of State and local law for obtaining consent, except one of spousal consent, must be followed.
(a)
(b)
(1) The individual to be sterilized; and
(2) The interpreter, if one is provided; and
(3) The person who obtains the consent; and
(4) The physician who will perform the sterilization procedure.
(c)
(i) Before the individual to be sterilized signed the consent form, he or she advised the individual to be sterilized that no Federal benefits may be withdrawn because of the decision not to be sterilized,
(ii) He or she explained orally the requirements for informed consent as set forth on the consent form, and
(iii) To the best of his or her knowledge and belief, the individual to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized.
(2) The physician performing the sterilization must certify by signing the consent form, that:
(i) Shortly before the performance of the sterilization, he or she advised the individual to be sterilized that no Federal benefits may be withdrawn because of the decision not to be sterilized,
(ii) He or she explained orally the requirements for informed consent as set forth on the consent form, and
(iii) To the best of his or her knowledge and belief, the individual to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized. Except in the case of premature delivery or emergency abdominal surgery, the physician must further certify that at least 30 days have passed between the date of the individual's signature on the consent form and the date upon which the sterilization was performed. If premature delivery occurs or emergency abdominal surgery is required within the 30-day period, the physician must certify that the sterilization was performed less than 30 days but not less than 72 hours after the date of the individual's signature on the consent form because of premature delivery or emergency abdominal surgery, as applicable. In the case of premature delivery, the physician must also state the expected date of delivery. In the case of emergency abdominal surgery, the physician must describe the emergency.
(3) If an interpreter is provided, the interpreter must certify that he or she translated the information and advice presented orally, read the consent form and explained its contents and to the best of the interpreter's knowledge and belief, the individual to be sterilized understood what the interpreter told him or her.
Programs or projects to which this subpart applies shall not perform or arrange for the performance of a sterilization of any mentally incompetent individual or institutionalized individual.
(a) Programs or projects to which this subpart applies shall not perform or arrange for the performance of any hysterectomy solely for the purpose of rendering an individual permanently incapable of reproducing or where, if there is more than one purpose to the procedure, the hysterectomy would not be performed but for the purpose of rendering the individual permanently incapable of reproducing.
(b) Except as provided in paragraph (c) of this section, programs or projects to which this subpart applies may perform or arrange for the performance of a hysterectomy not covered by paragraph (a) of this section only if:
(1) The person who secures the authorization to perform the hysterectomy has informed the individual and her representative, if any, orally and in writing, that the hysterectomy will make her permanently incapable of reproducing; and
(2) The individual or her representative, if any, has signed a written acknowledgment of receipt of that information.
(c)(1) A program or project is not required to follow the procedures of paragraph (b) of this section if either of the following circumstances exists:
(i) The individual is already sterile at the time of the hysterectomy.
(ii) The individual requires a hysterectomy because of a life-threatening emergency in which the physician determines that prior acknowledgment is not possible.
(2) If the procedures of paragraph (b) of this section are not followed because one or more of the circumstances of paragraph (c)(1) exist, the physician who performs the hysterectomy must certify in writing:
(i) That the woman was already sterile, stating the cause of that sterility; or
(ii) That the hysterectomy was performed under a life-threatening emergency situation in which he or she determined prior acknowledgment was not possible. He or she must also include a description of the nature of the emergency.
(a) A program or project must, with respect to any sterilization procedure or hysterectomy it performs or arranges, meet all requirements of this subpart.
(b) The program or project shall maintain sufficient records and documentation to assure compliance with these regulations, and must retain such data for at least 3 years.
(c) The program or project shall submit other reports as required and when requested by the Secretary.
(a) Federal financial assistance adminstered by the Public Health Service may not be used for expenditures for sterilization procedures unless the consent form appended to this section or another form approved by the Secretary is used.
(b) A program or project shall not use Federal financial assistance for any sterilization or hysterectomy without first receiving documentation showing that the requirements of this subpart have been met. Documentation includes consent forms, and as applicable, either acknowledgments of receipt of hysterectomy information or certification of an exception for hysterectomies.
The Secretary will request public comment on the operation of the provisions of this subpart not later than 3 years after their effective date.
I have asked for and received information about sterilization from _______ (doctor or clinic). When I first asked for the information, I was told that the decision to be sterilized is completely up to me. I was told that I could decide not to be sterilized. If I decide not to be sterilized, my decision will not affect my right to future care or treatment. I will not lose any help or benefits from programs receiving Federal funds, such as A.F.D.C. or medicaid that I am now getting or for which I may become eligible.
I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME PREGNANT, BEAR CHILDREN OR FATHER CHILDREN.
I was told about those temporary methods of birth control that are available and could be provided to me which will allow me to bear or father a child in the future. I have rejected these alternatives and chosen to be sterilized.
I understand that I will be sterilized by an operation known as a _______. The discomforts, risks and benefits associated with the operation have been explained to me. All my questions have been answered to my satisfaction.
I understand that the operation will not be done until at least 30 days after I sign this form. I understand that I can change my mind at any time and that my decision at any time not to be sterilized will not result in the withholding of any benefits or medical services provided by federally funded programs.
I am at least 21 years of age and was born on __ (day), __ (month), __ (year).
I, _______, hereby consent of my own free will to be sterilized by _______ by a method called _______. My consent expires 180 days from the date of my signature below.
I also consent to the release of this form and other medical records about the operation to:
Representatives of the Department of Health and Human Services or
Employees of programs or projects funded by that Department but only for determining if Federal laws were observed.
I have received a copy of this form.
You are requested to supply the following information, but it is not required:
If an interpreter is provided to assist the individual to be sterilized:
I have translated the information and advice presented orally to the individual to be sterilized by the person obtaining this consent. I have also read him/her the consent form in _______ language and explained its contents to him/her. To the best of my knowledge and belief he/she understood this explanation.
Before _______ (name of individual), signed the consent form, I explained to him/her the nature of the sterilization operation _______, the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.
I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or any benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appears to understand the nature and consequence of the procedure.
Shortly before I performed a sterilization operation upon _______ (name of individual to be sterilized), on _____ (date of sterilization), _______ (operation), I explained to him/her the nature of the sterilization operation _______ (specify type of operation), the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.
I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appeared to understand the nature and consequences of the procedure.
(
(1) At least 30 days have passed between the date of the individual's signature on this consent form and the date the sterilization was performed.
(2) This sterilization was performed less than 30 days but more than 72 hours after the date of the individual's signature on this consent form because of the following circumstances (check applicable box and fill in information requested):
Sec. 118, Pub. L. 96-86, Oct. 12, 1979, unless otherwise noted.
The provisions of this subpart are applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, appropriated to the Department of Health and Human Services and administered by the Public Health Service.
As used in this subpart: (a)
(b)
(c)
(d)
(2) A
Federal financial participation is not available for the performance of an abortion in programs or projects to which this subpart applies except under circumstances described in § 50.304 or § 50.306.
Federal financial participation is available in expenditures for an abortion when a physician has found, and so certified in writing to the program or project, that on the basis of his/her professional judgment, the life of the mother would be endangered if the fetus were carried to term. The certification must contain the name and address of the patient.
Federal financial participation is available in expenditures for medical procedures performed upon a victim of rape or incest if the program or proj-ect has received signed documentation from a law enforcement agency or public health service stating:
(a) That the person upon whom the medical procedure was performed was reported to have been the victim of an incident of rape or incest;
(b) The date on which the incident occurred;
(c) The date on which the report was made, which must have been within 60 days of the date on which the incident occurred;
(d) The name and address of the victim and the name and address of the person making the report (if different from the victim); and
(e) That the report included the signature of the person who reported the incident.
Federal financial participation is unavailable for the performance of abortions or other medical procedures otherwise provided for under §§ 50.304 and 50.306 if the program or project has paid without first having received the certifications and documentation specified in those sections.
Federal financial participation is available with respect to the cost of drugs or devices to prevent implantation of the fertilized ovum, and for medical procedures necessary for the termination of an ectopic pregnancy.
Programs or projects to which this subpart applies must maintain copies of the certifications and documentation specified in §§ 50.304 and 50.306 for three years pursuant to the retention and custodial requirements for rec-ords at 45 CFR 74.20
Information in the records or in the possession of programs or projects which is acquired in connection with the requirements of this subpart may not be disclosed in a form which permits the identification of an individual without the individual's consent except as may be necessary for the health of the individual or as may be necessary for the Secretary to monitor the activities of those programs or projects. In any event, any disclosure shall be subject to appropriate safeguards which will minimize the likelihood of disclosures of personal information in identifiable form.
Sec. 215, Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216); 45 CFR 16.3(c).
This subpart establishes an informal procedure for the resolution of certain postaward grant and cooperative agreement disputes within the agencies and offices identified in § 50.402.
This subpart applies to all grant and cooperative agreement programs, except block grants, which are administered by the National Institutes of Health; the Health Resources and Services Administration; the Centers for Disease Control and Prevention; the Agency for Toxic Substances and Disease Registry; the Food and Drug Administration; and the Office of the Assistant Secretary for Public Health and Science. For purposes of this regulation, the entities are hereinafter referred to as “agencies.”
The Secretary of Health and Human Services has established a Departmental Appeals Board for the purpose of providing a fair and flexible process for the appeal of written final decisions involving certain grant and cooperative agreement programs administered by constituent agencies of the Department. The regulatory provision which
(a) These procedures are applicable to the following adverse determinations under discretionary project grants and cooperative agreements (both referred to in this subpart as grants) issued by the agencies identified at § 50.402;
(1) Termination, in whole or in part, of a grant for failure of the grantee to carry out its approved project in accordance with the applicable law and the terms and conditions of such assistance or for failure of the grantee otherwise to comply with any law, regulation, assurance, term, or condition applicable to the grant.
(2) A determination that an expenditure not allowable under the grant has been charged to the grant or that the grantee has otherwise failed to discharge its obligation to account for grant funds.
(3) A determination that a grant is void.
(4) A denial of a noncompeting continuation award under the project period system of funding where the denial is for failure to comply with the terms of a previous award.
(b) A determination subject to this subpart may not be reviewed by the review committee described in § 50.405 unless an officer or employee of the agency has notified the grantee in writing of the adverse determination. The notification must set forth the reasons for the determination in sufficient detail to enable the grantee to respond and must inform the grantee of the opportunity for review under this subpart.
The head of the agency, or his or her designee, shall appoint review committees to review adverse determinations made by officials for programs under their jurisdiction. A minimum of three employees shall be appointed (one of whom shall be designated as chairperson) either on an ad hoc, case-by-case basis, or as regular members of review committees for such terms as may be designated. None of the members of the review committee reviewing any given appeal may be from the office of the responsible official whose adverse determination is being appealed (e.g., project officer, grants specialist, program manager, grants management officer).
(a) A grantee with respect to whom an adverse determination described in § 50.404(a) above has been made and who desires a review of that determination must submit a request for such review to the head of the appropriate agency or his or her designee no later than 30 days after the written notification of the determination is received, except that if the grantee shows good cause why an extension of time should be granted, the head of the appropriate agency or his or her designee may grant an extension of time.
(b) The request for review must include a copy of the adverse determination, must identify the issue(s) in dispute, and must contain a full statement of the grantee's position with respect to such issue(s) and the pertinent facts and reasons in support of the grantee's position. In addition to the required written statement, the grantee shall provide copies of any documents supporting its claim.
(c) When a request for review has been filed under this subpart with respect to an adverse determination, no action may be taken by the awarding
(d) Upon receipt of a request for review, the head of the agency or his or her designee will make a decision as to whether the dispute is reviewable under this subpart and will promptly notify the grantee and the office responsible for the adverse determination of this decision. If the head of the agency or his or her designee determines that the dispute is reviewable, he or she will forward the matter to the review committee appointed under § 50.405.
(e) The agency involved will provide the review committee appointed under § 50.405 with copies of all relevant background materials (including applications(s), award(s), summary statement(s), and correspondence) and any additional pertinent information available. These materials must be tabbed and organized chronologically and accompanied by an indexed list identifying each document.
(f) The grantee shall be given an opportunity to provide the review committee with additional statements and documentation not provided in the request for review described in paragraph (b) of this section. This additional submission, which must be organized and indexed as indicated under paragraph (e) of this section, should provide only material that is relevant to the review committee's deliberation of the issues in the case.
(g) The review committee may, at its discretion, invite the grantee and/or the agency staff to discuss the pertinent issues with the committee and to submit such additional information as the committee deems appropriate.
(h) Based on its review, the review committee will prepare a written decision to be signed by the chairperson and each of the other committee members. The review committee shall send the written decision with a transmittal letter to the grantee and shall send a copy of both to the official responsible for the adverse determination. If the decision is adverse to the grantee's position, the transmittal letter must state the grantee's right to appeal to the Departmental Appeals Board under 45 CFR part 16.
Sec. 215, Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216).
This subpart is applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, administered by the Public Health Service. It applies to Federal funds and to non-Federal funds which are required to be expended as a condition to receiving Federal funds under such programs or projects.
As used in this subpart:
(a)
(b)
(c)
(d)
(e)
It is the policy of the Secretary that program funds which are utilized for the acquisition of drugs be expended in the most economical manner feasible. In furtherance of this policy, the Secretary has established, in 45 CFR part 19, a procedure for determining the Maximum Allowable Cost for drugs which are purchased with program funds.
(a) The maximum amount which may be expended from program funds for the acquisition of any drug shall be the lowest of
(1) The maximum allowable cost (MAC) of the drug, if any, established in accordance with 45 CFR part 19, plus a dispensing fee determined by the Secretary in accordance with paragraph (b) of this section, to be reasonable;
(2) The acquisition cost of the drug plus a dispensing fee determined by the Secretary, in accordance with paragraph (b) of this section, to be reasonable; or
(3) The provider's usual and customary charge to the public for the drug;
(b) In determining whether a dispensing fee is reasonable, the Secretary will take into account:
(1) Cost components such as overhead, professional services, and profits,
(2) Payment practices of third-party payment organizations, including other Federal programs such as titles XVIII and XIX of the Social Security Act; and
(3) Any surveys by States, universities or others of costs of pharmacy operations and the fees charged in the particular area.
(c) A certification by a prescriber, pursuant to paragraph (a) of this section, that a brand of drug is medically necessary for a particular patient shall be in the prescriber's own handwriting, in such form and manner as the Secretary may prescribe. An example of an acceptable certification is the notation “brand necessary”. A procedure for checking a box on a form will not constitute an acceptable certification.
42 U.S.C. 216, 289b-1, 299c-3.
This subpart promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator.
This subpart is applicable to each Institution that applies for PHS grants or cooperative agreements for research and, through the implementation of
As used in this subpart:
(1) Salary, royalties, or other remuneration from the applicant institution;
(2) Any ownership interests in the institution, if the institution is an applicant under the SBIR Program;
(3) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
(4) Income from service on advisory committees or review panels for public or nonprofit entities;
(5) An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or
(6) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.
Each Institution must:
(a) Maintain an appropriate written, enforced policy on conflict of interest that complies with this subpart and inform each Investigator of that policy, the Investigator's reporting responsibilities, and of these regulations. If the Institution carries out the PHS-funded research through subgrantees, contractors, or collaborators, the Institution must take reasonable steps to ensure that Investigators working for such entities comply with this subpart, either by requiring those Investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with this subpart.
(b) Designate an institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in PHS-funded research.
(c)(1) Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children):
(i) That would reasonably appear to be affected by the research for which PHS funding is sought; and
(ii) In entities whose financial interests would reasonably appear to be affected by the research.
(2) All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.
(d) Provide guidelines consistent with this subpart for the designated official(s) to identify conflicting interests and take such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated.
(e) Maintain records of all financial disclosures and all actions taken by the Institution with respect to each conflicting interest for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 74.53(b) for different situations.
(f) Establish adequate enforcement mechanisms and provide for sanctions where appropriate.
(g) Certify, in each application for the funding to which this subpart applies, that:
(1) There is an effect at that Institution a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research projects for which funding is sought from the PHS,
(2) Prior to the Institution's expenditure of any funds under the award, the Institution will report to the PHS Awarding Component the existence of a conflicting interest (but not the nature of the interest or other details) found by the institution and assure that the interest has been managed, reduced or eliminated in accordance with this subpart; and, for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification;
(3) The Institution agrees to make information available, upon request, to the HHS regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias; and
(4) The Institution will otherwise comply with this subpart.
(a) The designated official(s) must: Review all financial disclosures; and determine whether a conflict of interest exists and, if so, determine what actions should be taken by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS-
(1) Public disclosure of significant financial interests;
(2) Monitoring of research by independent reviewers;
(3) Modification of the research plan;
(4) Disqualification from participation in all or a portion of the research funded by the PHS;
(5) Divestiture of significant financial interests; or
(6) Severance of relationships that create actual or potential conflicts.
(b) In addition to the types of conflicting financial interests described in this paragraph that must be managed, reduced, or eliminated, an Institution may require the management of other conflicting financial interests, as the Institution deems appropriate.
(a) If the failure of an Investigator to comply with the conflict of interest policy of the Institution has biased the design, conduct, or reporting of the PHS-funded research, the Institution must promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project.
(b) The HHS may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in PHS-funded research, including a requirement for submission of, or review on site, all records pertinent to compliance with this subpart. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records and/or other information that may be available, the PHS Awarding Component may decide that a particular conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict of interest in accordance with this subpart. The PHS Awarding Component may determine that suspension of funding under 45 CFR 74.62 is necessary until the matter is resolved.
(c) In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed as required by this subpart, the Institution must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research.
Several other regulations and policies apply to this subpart.
They include, but are not necessarily limited to:
42 U.S.C. 10801,
The provisions of this part apply to recipients of Federal assistance under the Protection and Advocacy for Mentally Ill Individuals Act of 1986, as amended.
In addition to the definitions in section 102 of the Act, as amended, the following definitions apply:
(1) Who is an inpatient or resident in a facility rendering care or treatment, even if the whereabouts of such impatient or resident is unknown;
(2) Who is in the process of being admitted to a facility rendering care or treatment, including persons being transported to such a facility, or
(3) Who is involuntarily confined in a detention facility, jail or prison.
The Secretary shall make allotments to eligible Systems from amounts apportioned each year under the Act on the basis of a formula prescribed by the Secretary in accordance with the requirements of sections 112 and 113 of the Act (42 U.S.C. 10822 and 10823).
The following parts of titles 42 and 45 CFR apply to grants funded under this part.
(a) Federal financial assistance for protection and advocacy activities for individuals with mental illness will be given only to a System that has been established under Part C of the Developmental Disabilities Assistance and Bill of Rights Act (42 U.S.C. 6041,
(b) The P&A system must meet the requirements of sections 105 and 111 of the Act (42 U.S.C. 10805 and 10821) and that P&A system must be operational. Each system shall submit an application at the beginning of each PAIMI authorization period. This application shall contain at a minimum the program priorities and budget for the first year of the authorization period and the required assurances and certifications. Thereafter, the system shall submit yearly updates of the budget and program priorities for the upcoming fiscal year through its annual report.
(c) Written assurances of compliance with sections 105 and 111 of the Act (42 U.S.C. 10805 and 10821) and other requirements of the Act and this part shall be submitted by the P&A system in the format designated by the Director. These assurances will remain in effect for the period specified in the application for funds unless changes occur within the State which affect the functioning of the P&A system, in which case an amendment will be required 30 days prior to the effective date of the change. The P&A system shall also provide the Department the name of the designated official.
(d) The Governor's written assurance that the allotments made available under the Act will be used to supplement and not to supplant the level of non-Federal funds available in the State to protect and advocate the rights of individuals with mental illness shall be submitted by the P&A system. The Governor may provide this assurance along with the assurances provided to ADD under 45 CFR part 1386, as long as it can reasonably be construed as applying to the PAIMI program. Any future “supplement and not supplant” assurance shall explicitly refer to the PAIMI program.
(a) Allotments must be used to supplement and not to supplant the level of non-Federal funds available in the State to protect and advocate the rights of individuals with mental illness.
(b) Allotments may not be used to support lobbying activities to influence proposed or pending Federal legislation or appropriations. This restriction does not affect the right of any P&A system, organization or individual to petition Congress or any other government body or official using other resources.
(c) Allotments may not be used to produce or distribute written, audio or visual materials or publicity intended or designed to support or defeat any candidate for public office.
(d) If an eligible P&A system is a public entity, that P&A system shall not be required by the State to obligate more than five percent of its annual allotment for State oversight administrative expenses under this grant such as costs of internal or external evaluations, monitoring or auditing. This restriction does not include:
(1) Salaries, wages and benefits of program staff;
(2) Costs associated with attending governing board or advisory council meetings; or
(3) Expenses associated with the provision of training or technical assistance for staff, contractors, members of the governing board or advisory council.
(e) No more than ten percent of each annual allotment may be used for providing technical assistance and training, including travel expenses for staff, contractors, or members of the governing board or advisory council as defined in § 51.27.
(f) Allotments may be used to pay the otherwise allowable costs incurred by a P&A system in bringing lawsuits in its own right to redress incidents of abuse or neglect, discrimination, and other rights violations impacting on individuals with mental illness and when it appears on behalf of named plaintiffs or a class of plaintiffs for such purposes.
In accordance with section 105(a)(1)(C) of the Act (42 U.S.C. 10805(a)(1)(C)) and the priorities established by the P&A system governing authority, together with the advisory council, pursuant to section 105(c)(2)(B) of the Act (42 U.S.C. 10805(c)(2)(B)), allotments may be used:
(a) To provide protection and advocacy services for:
(1) Individuals with mental illness as defined in 42 U.S.C. 10802(4) and 10805(a), including persons who report matters which occurred while they were individuals with mental illness;
(2) Persons who were individuals with mental illness who are residents of the State, but only with respect to matters which occur within 90 days after the date of the discharge of such individuals from a facility providing care or treatment; and
(3) Individuals with mental illness in Federal facilities rendering care or treatment who request representation by the eligible P&A system. Representation may be requested by an individual with mental illness, or by a legal guardian, conservator or legal representative.
(b) To provide representation of clients in civil commitment proceedings if the P&A system is acting on behalf of an eligible individual to obtain judicial review of his or her commitment in order to appeal or otherwise challenge acts or omissions which have subjected the individual to abuse or neglect or otherwise violated his or her rights. This restriction does not prevent a P&A system from representing clients in commitment or recommitment proceedings using other resources so long as this representation does not conflict with responsibilities under the Act.
By January 1 of each year, a report shall be submitted, pursuant to section 105(a)(7) of the Act (42 U.S.C. 10805(a)(7)), to the Secretary which is in the format designated by the Secretary.
At 62 FR 53564, Oct. 15, 1997, § 51.8 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
Failure to submit an annual report in the designated format on time or to submit requested information and documentation, corrective action plans and ongoing implementation status reports in response to Federal review and monitoring activities or to satisfy any other requirement of the Act, this part, or other requirements, may be considered a breach of the terms and conditions of the grant award and may required remedial action, such as the suspension or termination of an active grant, withholding of payments or converting to a reimbursement method of payment. Any remedial actions shall be taken consistent with 45 CFR Part 74 and 42 CFR Part 50, as appropriate.
At 62 FR 53564, Oct. 15, 1997, § 51.10 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
(a) An eligible P&A system should work cooperatively with existing advocacy agencies and groups and, where appropriate, consider entering into contracts for protection and advocacy services with organizations already working on behalf of individuals with metal illness. Special consideration should be given to contracting for the services of groups run by individuals who have received or are receiving mental health services or by family members of such individuals.
(b) An eligible P&A system may contract for the operation of all or part of its program with another public or private nonprofit organization with demonstrated experience in working with individuals with mental illness provided that:
(1) Any organization that will operate the full program meets the requirements of section 104(a)(1), 105 and 111 of the Act (42 U.S.C. 10804(a)(1), 10805 and 10821) and has the capacity to perform protection and advocacy activities throughout the State;
(2) The eligible P&A system institutes oversight and monitoring procedures which ensure that this system will be able to meet all applicable terms, conditions and obligations of the Federal grant;
(3) The eligible P&A system and the contractor organization enter into a written agreement that includes at least the following:
(i) A description of the protection and advocacy services to be provided;
(ii) The type of personnel, their qualifications and training;
(iii) The methods to be used;
(iv) A timetable for performance;
(v) A budget;
(vi) Assurances that the contractor will meet all applicable terms and conditions of the grant;
(vii) Assurances that the contractor has adequate management and fiscal systems in place, including insurance coverage, if appropriate:
(viii) Assurances that the contractor's staff is trained to provide advocacy services to and conduct full investigations on behalf of individuals with mental illness; and
(ix) Assurances that the contractor staff is trained to work with family members of clients served by the P&A system where the clients are:
(A) Minors;
(B) Legally competent and choose to involve the family member; or,
(C) Legally incompetent and the legal guardians, conservators or other legal representatives are family members.
(a) Each P&A system shall have a governing authority responsible for its planning, designing, implementing and functioning. It shall, jointly with the advisory council, annually establish program priorities and policies.
(b) If the P&A system is organized with a multi-member governing board:
(1) Each P&A system shall establish policies and procedures for the selection of its governing board members and for the board evaluation of the P&A system director. The terms of board members shall be staggered and
(2) The board shall be composed of members who broadly represent or are knowledgeable about the needs of the clients served by the P&A system and shall include a significant representation of individuals with mental illness who are, or have been eligible for services, or have received or are receiving mental health services, and family members, guardians, advocates, or authorized representatives of such individuals.
(3) If the governing authority is organized as a private nonprofit entity, the chairperson of the advisory council shall be a member of the governing board.
(c) Continuing efforts shall be made to include members of racial and ethnic minority groups as board members.
(d) Any member of the advisory council may also serve on the governing board.
(a) Each P&A system shall establish an advisory council to:
(1) Provide independent advice and recommendations to the system.
(2) Work jointly with the governing authority in the development of policies and priorities.
(3) Submit a section of the system's annual report as required under § 51.8.
(b) Members of the council shall include attorneys, mental health professionals, individuals from the public who are knowledgeable about mental illness, the advocacy needs of persons with mental illness and have demonstrated a substantial commitment to improving mental health services, a provider of mental health services, individuals who have received or are receiving mental health services and family members of such individuals. Continuing efforts shall be made to include members of racial and ethnic minority groups on the advisory council.
(1) At least 60 percent of the membership of the advisory council shall be comprised of individuals who have received or are receiving mental health services or who are family members of such individuals. At least one family member shall be a primary care giver for an individual who is currently a minor child or youth who is receiving or has received mental health services;
(2) The council shall be chaired by an individual who has received or is receiving mental health services or who is a family member of such an individual;
(3) The advisory council shall meet no less than three times annually. The terms of council members shall be staggered and for 4 years except that any member appointed to fill a vacancy for an unexpired term shall serve for the remainder of such term. A member who has been appointed for a term of 4 years may not be reappointed to the council during the 2-year period beginning on the date on which such 4-year term expired.
(c) Each P&A system shall provide its advisory council with reports, materials and fiscal data to enable review of existing program policies, priorities and performance outcomes. Such submissions shall be made at least annually and shall report expenditures for the past two fiscal years, as well as projected expenses for the next fiscal year, identified by budget category (e.g., salary and wages, contract for services, administrative expenses) including the amount allotted for training of each the advisory council, governing board and staff.
(d) Reimbursement of expenses. (1) Allotments may be used to pay for all or a part of the expenses incurred by members of the advisory council in order to participate in its activities. Expenses may include transportation costs, parking, meals, hotel costs, per diem expenses, stipends or subsistence allowances, and the cost of day care or child care (or its equivalent for the child's travel and subsistence expenses) for their dependents with mental illness or developmental disabilities.
(2) Each P&A system shall establish its own policies and procedures for reimbursement of expenses of council members, taking into account the
At 62 FR 53564, Oct. 15, 1997, § 51.23 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
(a) Program priorities and policies shall be established annually by the governing authority, jointly with the advisory council. Priorities shall specify short-term program goals and objectives, with measurable outcomes, to implement the established priorities. In developing priorities, consideration shall be given to, at a minimum, case selection criteria, the availability of staff and monetary resources, and special problems and cultural barriers faced by individuals with mental illness who are multiply handicapped or who are members of racial or ethnic minorities in obtaining protection of their rights. Systemic and legislative activities shall also be addressed in the development and implementation of program priorities.
(b) Members of the public shall be given an opportunity, on an annual basis, to comment on the priorities established by, and the activities of, the P&A system. Procedures for public comment must provide for notice in a format accessible to individuals with mental illness, including such individuals who are in residential facilities, to family members and representatives of such individuals and to other individuals with disabilities. Procedures for public comment must provide for receipt of comments in writing or in person.
(a) The P&A system shall establish procedures to address grievances from:
(1) Clients or prospective clients of the P&A system to assure that individuals with mental illness have full access to the services of the program; and
(2) Individuals who have received or are receiving mental health services in the State, family members of such individuals, or representatives of such individuals or family members to assure that the eligible P&A system is operating in compliance with the Act.
(b) At a minimum, the grievance procedures shall provide for:
(1) An appeal to the governing authority from any final staff review and/or determination; in cases where the governing authority is the director of the P&A system, the final review and/or determination shall be made by a superior of the governing authority, e.g., a supervisor, or by an independent entity, e.g., an appointed board or committee.
(2) Reports, at least annually, to the governing authority and the advisory council describing the grievances received and processed and their resolution;
(3) Identification of individuals responsible for review;
(4) A timetable to ensure prompt notification concerning the grievance procedure to clients, prospective clients or persons denied representation, and to ensure prompt resolution;
(5) A written response to the grievant; and
(6) Protection of client confidentiality.
At 62 FR 53564, Oct. 15, 1997, § 51.25 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
The P&A system must develop appropriate policies and procedures to avoid actual or apparent conflict of interest involving clients, employees, contractors and subcontractors, and members of the governing authority and advisory council, particularly with respect to matters affecting client services, particular contracts and subcontracts, grievance review procedures, reimbursements and expenses, and the employment or termination of staff.
A P&A system shall provide training for program staff, and may also provide training for contractors, governing board and advisory council members to
(a)(1) Training of program staff to work with family members of clients served by the program where the individual with mental illness is:
(i) A minor,
(ii) Legally competent and chooses to involve the family member; or
(iii) Legally incompetent and the legal guardian, conservator or other legal representative is a family member.
(2) This training may be provided by individuals who have received or are receiving mental health services and family members of such individuals.
(b) Training to enhance sensitivity to and understanding of individuals with mental illness who are members of racial or ethnic minorities and to develop strategies for outreach to those populations.
(c) Training to conduct full investigations of abuse or neglect.
(a) Consistent with State and Federal law and the canons of professional ethics, a P&A system may use any appropriate technique and pursue administrative, legal or other appropriate remedies to protect and advocate on behalf of individuals with mental illness to address abuse, neglect or other violations of rights.
(b) A P&A system shall establish policies and procedures to guide and coordinate advocacy activities. The P&A system shall not implement a policy or practice restricting the remedies which may be sought on behalf of individuals with mental illness or compromising the authority of the P&A system to pursue such remedies through litigation, legal action or other forms of advocacy. However, this requirement does not prevent the P&A system from placing limitations on case or client acceptance criteria developed as part of the annual priorities. Prospective clients must be informed of any such limitations at the time they request service.
(c) Wherever possible, the program should establish an ongoing presence in residential mental health care or treatment facilities, and relevant hospital units.
(d) Program activities should be carried out in a manner which allows program staff to:
(1) Interact regularly with those individuals who are current or potential recipients of protection and advocacy services;
(2) Interact regularly with staff providing care or treatment;
(3) Obtain information and review records; and
(4) Communicate with family members, social and community service workers and others involved in providing care or treatment.
(e) A P&A system may support or provide training, including related travel expenses, for individuals with mental illness, family members of such individuals, and other persons who are not program staff, contractors, or board or council members, to increase knowledge about protection and advocacy issues, to enhance leadership capabilities, or to promote Federal-State and intra-State cooperation on matter related to mental health system improvement. Decisions concerning the selection of individuals to receive such training shall be made in accordance with established policies, procedures and priorities of the P&A system.
(f) A P&A system may monitor, evaluate and comment on the development and implementation of Federal, State and local laws, regulations, plans, budgets, levies, projects, policies and hearings affecting individuals with mental illness as a part of federally funded advocacy activities. A P&A system shall carry out systemic advocacy—those efforts to implement changes in policies and practices of systems that impact persons with mental illness.
(g) Determination of “probable cause” may result from P&A system monitoring or other activities, including observation by P&A system personnel, and reviews of monitoring and
(h) A P&A which is a public P&A system shall be free from hiring freezes, reductions in force, prohibitions on staff travel, or other policies imposed by the State to the extend that such policies would impact program staff or activities funded with Federal dollars and would prevent the P&A system from carrying out its mandates under the Act.
(i) A P&A system may exercise its authority under State law where the authority exceeds the authority required by the Act. However, State law must not diminish the required authority of the Act.
(a) Each P&A system is encouraged to develop and employ techniques such as those involving negotiation, conciliation and mediation to resolve disputes early in the protection and advocacy process.
(b) Disputes should be resolved whenever possible through nonadversarial process involving negotiation, mediation and conciliation. Consistent with State and Federal laws and canons of professional responsibility, family members should be involved in this process, as appropriate, where the individual with mental illness is:
(1) A minor,
(2) Legally competent and chooses to involve the family member, or
(3) Legally incompetent and the legal guardian, conservator or other legal representative is a family member or the legal guardian, conservator or other legal representative chose to involve the family member.
(c) A P&A system must exhaust in a timely manner all administrative remedies, where appropriate, prior to initiating legal action in a Federal or State court.
(d) Paragraph (c) of this section does not apply to any legal action instituted to prevent or eliminate imminent serious harm to an individual with mental illness nor does it apply in circumstances where administrative procedures do not exist. If in pursing administrative remedies, the P&A system determines that any matter with respect to an individual with mental illness with mental illness with not be resolved within a reasonable time, the P&A system may pursue alternative remedies, including initiating legal action.
(e) A P&A system shall be held to the standard of exhaustion of remedies provided under State and Federal law. The Act imposes no additional burden respecting exhaustion of remedies.
(a) Access to records shall be extended promptly to all authorized agents of a P&A system.
(b) A P&A system shall have access to the records of any of the following individuals with mental illness:
(1) An individual who is a client of the P&A system if authorized by that individual or the legal guardian, conservator or other legal representative.
(2) An individual, including an individual who has died or whose whereabouts is unknown to whom all of the following conditions apply:
(i) The individual, due to his or her mental or physical condition, is unable to authorize the P&A system to have access.
(ii) The individual does not have a legal guardian, conservator or other legal representative, or the individual's guardian is the State or one of its political subdivisions; and
(iii) A complaint or report has been received and the P&A system has determined that there is probable cause to believe that the individual has been or may be subject to abuse or neglect.
(3) An individual who has a legal guardian, conservator, or other legal representative, with respect to whom a complaint or report has been received by the P&A system and with respect to whom the P&A system has determined that there is probable cause to believe that the health or safety of the individual is in serious and immediate jeopardy, whenever all of the following conditions exists:
(i) The P&A system has made a good faith effort to contact the representative upon prompt receipt of the representative's name and address;
(ii) The P&A system has made a good faith effort to offer assistance to the representative to resolve the situation; and
(iii) The representative has failed or refused to act on behalf of the individual.
(1) Information and individual records, obtained in the course of providing intake, assessment, evaluation, supportive and other services, including medical records, financial records, and reports prepared or received by a member of the staff of a facility or program rendering care or treatment. This includes records stored or maintained in locations other than the facility or program as long as the system has obtained appropriate consent consistent with section 105(a)(4) of the Act. The system shall request of facilities that in requesting records from service providers or other facilities on residents that they indicate in the release form the records may be subject to review by a system.
(2) Reports prepared by an agency charged with investigating abuse neglect, or injury occurring at a facility rendering care or treatment, or by or for the facility itself, that describe any or all of the following:
(i) Abuse, neglect, or injury occurring at the facility;
(ii) The steps taken to investigate the incidents;
(iii) Reports and records, including personnel records, prepared or maintained by the facility, in connection with such reports of incidents; or
(iv) Supporting information that was relied upon in creating a report, including all information and records used or reviewed in preparing reports of abuse, neglect or injury such as records which describe persons who were interviewed, physical and documentary evidence that was reviewed, and the related investigative findings.
(3) Discharge planning records.
(4) Reports prepared by individuals and entities performing certification or licensure reviews, or by professional accreditation organizations, as well as related assessments prepared for the facility by its staff, contractors or related entities, except that nothing in this section is intended to preempt State law protecting records produced by medical care evaluation or peer review committees.
(5) Professional, performance, building or other safety standards, demographic and statistical information relating to the facility.
(d) A P&A system shall have reasonable access and authority to interview and examine all relevant records of any facility service recipient (consistent with the provisions of section 105(a)(4) of the Act) or employee.
(e) A P&A system shall be permitted to inspect and copy records, subject to a reasonable charge to offset duplicating costs.
(a) Access to facilities and residents shall be extended to all authorized agents of a P&A system.
(b) A P&A system shall have reasonable unaccompanied access to public and private facilities and programs in the State which render care or treatment for individuals with mental illness, and to all areas of the facility which are used by residents or are accessible to residents. The P&A system shall have reasonable unaccompanied access to residents at all times necessary to conduct a full investigation of an incident of abuse or neglect. This authority shall include the opportunity to interview any facility service recipient, employee, or other persons, including the person thought to be the victim of such abuse, who might be reasonably believed by the system to have knowledge of the incident under investigation. Such access shall be afforded, upon request, by the P&A system when:
(1) An incident is reported or a complaint is made to the P&A system;
(2) The P&A system determines there is probable cause to believe that an incident has or may have occurred; or
(3) The P&A system determines that there is or may be imminent danger of serious abuse or neglect of an individual with mental illness.
(c) In addition to access as prescribed in paragraph (b) of this section, a P&A system shall have reasonable unaccompanied access to facilities including all area which are used by residents, are accessible to residents, and to programs and their residents at reasonable times, which at a minimum shall include normal working hours and visiting hours. Residents include adults or minors who have legal guardians or conservators. P&A activities shall be conducted so as to minimize interference with facility programs, respect residents' privacy interests, and honor a resident's request to terminate an interview. This access is for the purpose of:
(1) Providing information and training on, and referral to programs addressing the needs of individuals with mental illness, and information and training about individual rights and the protection and advocacy services available from the P&A system, including the name, address, and telephone number of the P&A system.
(2) Monitoring compliance with respect to the rights and safety of residents; and
(3) Inspecting, viewing and photographing all areas of the facility which are used by residents or are accessible to residents.
(d) Unaccompanied access to residents shall include the opportunity to meet and communicate privately with individuals regularly, both formally and informally, by telephone, mail and in person. Residents include minors or adults who have legal guardians or conservators.
(e) The right of access specified in paragraph (c) of this section shall apply despite the existence of any State or local laws or regulations which restrict informal access to minors and adults with legal guardians or conservators. The system shall make very effort to ensure that the parents of minors or guardians of individuals in the care of a facility are informed that the system will be monitoring activities at the facility and may in the course of such monitoring have access to the minor or adult with a legal guardian. The system shall take no formal action on behalf of individuals with legal guardians or conservators, or initiate a formal attorney/client or advocate/client relationship without appropriate consent, except in emergency situations as described in § 51.41(b)(3).
(f) A P&A system providing representation to individuals with mental illness in Federal facilities shall have all the rights and authority accorded other representatives of residents of such facilities pursuant to State and Federal laws.
If a P&A system's access to facilities, programs, residents or records covered by the Act or this part is delayed or denied, the P&A system shall be provided promptly with a written statement of reasons, including, in the case of a denial for alleged lack of authorization, the name, address and telephone number of the legal guardian, conservator, or other legal representative of an individual with mental illness. Access to facilities, records or residents shall not be delayed or denied without the prompt provision of written statements of the reasons for the denial.
(a) Records maintained by the P&A system are the property of the P&A system which must protect them from loss, damage, tampering or use by unauthorized individuals. The P&A system must:
(1) Except as provided elsewhere in this section, keep confidential all records and information, including information contained in any automated electronic database pertaining to:
(i) Clients to the same extent as is required under Federal or State laws for a provider of mental health services;
(ii) Individuals who have been provided general information or technical assistance on a particular matter;
(iii) Identity of individuals who report incidents of abuse or neglect or furnish information that forms the basis for a determination that probable cause exists; and
(iv) Names of individuals who are residents and provide information for the record.
(2) Have written policies governing access to, storage of, duplication and release of information from client records; and
(3) Obtain written consent from the client, if competent, or from his or her legal representative, from individuals who have been provided general information or technical assistance on a particular matter and from individuals who furnish reports or information that forms the basis for a determination of probable cause, before releasing information to individuals not otherwise authorized to receive it.
(b) Nothing in this subpart shall prevent the P&A system from. (1) Issuing a public report of the results of an investigation which maintains the confidentiality of the individuals listed in paragraph (a)(1) of this section or,
(2) Reporting the results of an investigation which maintains the confidentiality of individual service recipients to responsible investigative or enforcement agencies should an investigation reveal information concerning the facility, its staff, or employees warranting possible sanctions or corrective action. this information may be reported to agencies responsible for facility licensing or accreditation, employee discipline, employee licensing or certification, or criminal prosecution.
(c) For purposes of any periodic audit, report, or evaluation of the performance of the P&A system, the Secretary shall not require the P&A system to disclose the identity, or any other personally identifiable information, of any individual requesting assistance under a program. This requirement does not restrict access by the Department or other authorized Federal or State officials to client records or other records of the P&A system when deemed necessary for audit purposes and for monitoring P&A system compliance with applicable Federal or State laws and regulations. The purpose of obtaining such information is solely to determine that P&A systems are spending their grant funds awarded under the Act on serving individuals with mental illness. Officials that have access to such information must keep it confidential to the maximum extent permitted by law and regulations. If photostatic copies of materials are provided, then the destruction of such evidence is required once such reviews have been completed.
(d) Subject to the restrictions and procedures set out in this section, implementing section 106 (a) and (b) of the Act (42 U.S.C. 10806 (a) and (b)), this part does not limit access by a legal guardian, conservator, or other legal representative of an individual with mental illness, unless prohibited by State or Federal law, court order or the attorney-client privilege.
(a) Except as provided in paragraph (b) of this section, if a P&A system has access to records pursuant to section 105(a)(4) of the Act (42 U.S.C. 10805(a)(4)) which, under Federal or State law, are required to be maintained in a confidential manner by a provider of mental health services, it may not disclose information from such records to the individual who is the subject of the information if the mental health professional responsible for supervising the provision of mental health services to that individual has given the P&A system a written determination that disclosure of such information to the individual would be detrimental to the individual's health. The provider shall be responsible for giving any such written determination to the P&A system at the same time as access to the records containing the information is granted.
(b)(1) If the disclosure of information has been denied under paragraph (a) of this section to an individual, the following individuals or the P&A system may select another mental health professional to review the information and to determine if disclosure of the information would be detrimental to the individual's health:
(i) Such individual;
(ii) The legal guardian, conservator or other legal representative of the individual; or
(iii) An eligible P&A system, acting on behalf of an individual:
(A) Whose legal guardian is the State; or
(B) Whose legal guardian, conservator, or other legal representative has not, within a reasonable time after the denial of access to information under paragraph (a), selected a mental health professional to review the information.
(2) If such mental health professional determines, based on professional judgment, that disclosure of the information would not be detrimental to the health of the individual, the P&A system may disclose such information to the individual.
(c) The restriction in paragraph (b) of this section does not affect the P&A system's access to the records.
Sec. 1102 of the Social Security Act, 49 Stat. 647 (42 U.S.C. 1302); sec. 502(a), 502(b)(1)(A), and 506(a)(3) of the Social Security Act, 95 Stat. 819-20 (42 U.S.C. 702(a), 702(b)(1)(A) and 706(a)(3)).
The regulation in this part applies to grants, contracts, and other arrangements under section 502(a) and 502(b)(1)(A) of the Social Security Act, as amended (42 U.S.C. 702(a) and 702(b)(1)(A)), the Maternal and Child Health (MCH) Federal Set-Aside project grant programs. Section 502(a) authorizes funding for special projects of regional and national significance (SPRANS), research and training projects with respect to maternal and child health and children with special health care needs (including early intervention training and services development); genetic disease testing, counseling and information programs; comprehensive hemophilia diagnostic and treatment centers; projects for screening and follow-up of newborns for sickle cell anemia and other genetic disorders; and special maternal and child health improvement projects. Section 502(b)(1)(A) authorizes funding for projects termed community integrated service system (CISS) projects for the development and expansion of: maternal and infant health home visiting; projects to increase the participation of obstetricians and pediatricians in title V and title XIX programs; integrated maternal and child health service systems; maternal and child health centers operating under the direction of not-for-profit hospitals; rural maternal and child health programs; and outpatient and community-based services programs for children with special health care needs.
(a) With the exception of training and research, as described in paragraph (b) of this section, any public or private entity, including an Indian tribe or tribal organization (as those terms are defined at 25 U.S.C. 450b) is eligible to apply for federal funding under this Part.
(b) Only public or nonprofit private institutions of higher learning may apply for training grants. Only public or nonprofit institutions of higher learning and public or private nonprofit agencies engaged in research or in programs relating to maternal and child health and/or services for children with special health care needs may apply for grants contracts or cooperative agreements for research in maternal and child health services or in services for children with special health care needs.
An application for funding under the MCH Federal Set-Aside project grant programs must be submitted to the Secretary at such time and in such manner as the Secretary may prescribe. It must include a budget and narrative plan of the manner in which the project will meet each of the requirements prescribed by the Secretary. The plan must describe the project in sufficient detail to identify clearly the nature, need, and specific objectives of, and methodology for carrying out, the project.
(a) The Secretary will determine the allocation of funds available under sections 502(a) and 502(b)(1)(A) of the Act for each of the activities described in § 51a.1.
(b) Within the limit of funds determined by the Secretary to be available for each of the activities described in § 51a.1, the Secretary may award Federal funding for projects under this part to applicants which will, in his or her judgment, best promote the purpose of title V of the Social Security Act and address achievement of Healthy Children 2000 objectives,
(1) The extent to which the project will contribute to the advancement of maternal and child health and/or improvement of the health of children with special health care needs;
(2) The extent to which the project is responsive to policy concerns applicable to MCH grants and to program objectives, requirements, priorities and/or review criteria for specific project categories, as published in program announcements or guidance materials.
(3) The extent to which the estimated cost to the Government of the project is reasonable, considering the anticipated results;
(4) The extent to which the project personnel are well qualified by training and/or experience for their roles in the project and the applicant organization has adequate facilities and personnel; and
(5) The extent to which, insofar as practicable, the proposed activities, if well executed, are capable of attaining project objectives.
(c) For the following types of CISS projects, preference for funding will be given to qualified applicants in areas with a high infant mortality rate (relative to the latest average infant mortality rate in the United States or in the State in which the area is located):
(1) Projects for the development and expansion of maternal and infant health home visiting;
(2) Projects to increase the participation of obstetricians and pediatricians in title V and title XIX programs;
(3) Integrated maternal and child health service systems;
(4) Maternal and child health centers operating under the direction of not-for-profit hospitals;
(5) Rural maternal and child health programs; and
(6) Outpatient and community based services for children with special health care needs.
All information as to personal facts and circumstances obtained by the project's staff about recipients of services shall be held confidential, and shall not be disclosed without the individual's consent except as may be otherwise required by applicable law or as may be necessary to provide for medical audits by the Secretary with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.
(a) Several other DHHS regulations apply to awards under this part. These include, but are not limited to:
(b) In addition to the above regulations, the following apply to projects funded through grants:
(a) Recipients of project grants will be required to submit such additional information to the Secretary on an annual basis as the Secretary determines, including:
(1) the number of individuals served or trained, as appropriate under the project;
(2) a copy of any evaluation conducted by the recipient; and
(3) a list of Healthy Children 2000 objectives addressed by the project and data on how the project contributed toward meeting the objectives.
(b) The Secretary may at the time of award of project grants under this Part impose additional conditions, including conditions governing the use of information or consent forms, when, in the Secretary's judgment, they are necessary to advance the approved program, the interest of public health, or the conservation of grant funds.
Secs. 317 and 318, Public Health Service Act, 92 Stat. 3574 and 3582 (42 U.S.C. 247b, 247c); sec. 1743 Pub. L. 97-35, 95 Stat. 763 (31 U.S.C. 1243 note).
The regulations in this part apply to grants for preventive health service programs authorized under section 317 (42 U.S.C. 247b) and for venereal disease prevention and control programs authorized under section 318 (42 U.S.C. 247c) of the Act.
As used in these regulations:
(a) The project application shall contain a full description of the program objectives, plans, and activities. With respect to programs authorized by section 317 of the Act only, the application shall also provide, as the Secretary may require:
(1) The amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program.
(2) A description of the services provided by the applicant for this accounting period covered under paragraph (a)(1) of this section.
(3) The amount of Federal funds needed by the applicant to continue providing these services.
(4) A description of any proposed changes in the provision of the services, reasons and priorities, and the amount of Federal funds needed by the applicant to make the changes.
(b) The application shall contain evidence satisfactory to the Secretary that it has been submitted, as appropriate, for action to the planning agency designated by the Secretary under title XV of the Act (42 CFR parts 122 and 123). These grants are subject to the intergovernmental review of Federal programs of Executive Order 12372.
(c) The application shall contain assurances that no one will be denied services because of inability to pay, and that the services are provided in a manner which preserves human dignity and maximizes acceptance.
The Secretary may reduce a grant by the amount of the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished a grant recipient when furnished at the request of the recipient. The Secretary also may reduce a grant by the amount of the pay, allowances, travel expenses, and any other costs in connection with the detail of any officer or employee of the Government to the recipient when the detail is at the request of the recipient. The amount the grant is reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment or in detailing personnel and shall be deemed to have been paid to the recipient.
Several other HHS regulations apply to grants under this part. These include, but are not limited to:
(a) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 2 to 5 years.
(b) For budgetary and funding purposes, the project period is generally divided into 12-month intervals called budget periods. A grantee must submit a separate application to have the support continued for each subsequent budget period after the initial award. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(c) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(d) Any funds granted pursuant to this subpart shall be expended solely for the purposes for which the funds were granted in accordance with the
(e) The Secretary may, at the time of award, impose additional conditions, including conditions governing the use of information or consent forms, when, in the Secretary's judgment, they are necessary to advance the approved program, the interest of the public health, or the conservation of grant funds.
Nothing in these regulations shall be construed to require any State or political subdivision to have a preventive health service program which would require any person who objects to treatment to be treated under the program.
The regulations in this subpart apply to the award of grants under section 317 of the Act for programs to immunize children against vaccine preventable diseases.
As used in this subpart:
An applicant must be a State agency or an agency of a political subdivision of a State which has legal responsibility for disease control under the laws of a State.
(a) The initial application must cover the project period, and must include a description of the following:
(1) The need for grant support.
(2) The immediate (1 year budget period) and long-range (2-5 year project period) objectives of the project in specific and measurable terms.
(3) Current immunization programs and the additional or intensified activities to be carried out to meet the objectives and priorities.
(4) The following program elements should be included and described:
(i) A plan to assure that children begin and complete their immunizations on schedule, including the use of a standard immunization record card, a provider-based tickler system (public and private) for the recall of children, and a hospital-based immunization education program for new mothers.
(ii) Assessment of immunization status of school enterers, children attending licensed day-care centers, and children under 2 years of age and new enrollees under age 5 served in public clinics.
(iii) A plan for surveillance of vaccine-preventable diseases that includes morbidity and mortality reporting as well as field and laboratory investigations.
(iv) Procedures for prompt review of the data collected from the morbidity surveillance system to allow for immediate response to all occurrence of suspected diphtheria and polio cases upon notification and response to suspected measles cases within 48 hours.
(v) A system for monitoring vaccine-associated reactions including a mechanism for responding to persons with vaccine-related complaints.
(vi) A plan to systematically immunize susceptible children at school entry through vigorous enforcement of school immunization laws.
(5) The manner in which the applicant intends to evaluate the project.
(b) An application for a continuation grant must be submitted for each funding period. This continuation application must include the following:
(1) A budget and justification for the grant funds requested.
(2) A summary of the progress achieved during the previous budget period.
(3) A description of any changes in the information shown in the project application.
(a) Within the limits of funds available, the Secretary may award a grant to assist in meeting part of the cost of a childhood immunization program. Grants will be awarded to those applicants whose projects he determines will best promote the purposes of section 317 of the Act. Before awarding a grant to a local public entity of a State, the Secretary will consult with the State health authority.
(b) Priorities for funding will be based on the following factors:
(1) The relative extent of the problems which are caused by one or more of the vaccine preventable diseases in the area served by the applicant.
(2) The extent to which the proposed program is designed to eliminate or reduce the problems.
(3) The extent to which the proposed program will increase the immunization rates in population groups identified as having the lowest immunity levels.
(4) The extent to which the grantee will cooperate with and use public and nonprofit private entities and volunteers.
(5) The extent to which a strong commitment to the objectives of the program is reflected in the commitment of grantee resources to the program.
Grant funds awarded under this subpart may be used to purchase supplies, materials, and equipment for childhood immunization programs. Grant funds also may be used to pay for salaries or wages and related expenses for personnel directly involved in the planning, organization, promotion, epidemiology, surveillance, and other program activities.
The regulations in this subpart apply to the award of project grants under section 318(c) of the Act for venereal disease prevention and control programs, and under section 318(b) of the Act with respect to public information and education activities which are integral to a balanced, comprehensive venereal disease control program.
As used in this subpart:
An applicant must be a State agency or a political subdivision of a State which has legal responsibility for disease control under the laws of the State.
All information obtained by program personnel in connection with the examination, care, and treatment of an individual in this program shall be held confidential. It shall not be disclosed without the individual's consent except as may be required by the law of a
(a) The initial application must include a description of the following:
(1) The nature and extent of the venereal disease problem in the area.
(2) The need for project grant support.
(3) The immediate (1-year budget period) and long-range (2-5 year project period) objectives of the project in specific and measurable terms.
(4) The activities to be carried out to meet the objectives. The following program elements must be included and described:
(i) Venereal disease surveillance.
(ii) Casefinding and case followup.
(iii) Interstate epidemiologic referral and followup.
(iv) Public venereal disease information and education.
(v) Professional (including appropriate allied health personnel) venereal disease education, training, and clinical skills improvement activities, including efforts to assure high quality clinical services in public venereal disease clinics.
(5) At the option of the applicant, special studies or demonstrations to evaluate or test venereal disease prevention and control strategies and activities.
(6) The manner in which the applicant intends to conduct and evaluate the project, including a system for analysis of morbidity data so that control activities can be efficiently evaluated and targeted.
(7) The diagnostic and treatment services that will be provided.
(8) A budget and justification for the grant funds requested. Since public information and education activities are authorized separately from other control program activities, funds requested for this purpose must be itemized and justified separately in the narrative part of the application.
(b) An application for a continuation grant must be submitted for each funding period. This continuation application must include the following:
(1) A budget and justification for the grant funds requested.
(2) A summary of the progress achieved during the previous budget period.
(3) A description of any changes in the information shown in the project application.
(a) Within the limits of funds available, the Secretary may award a grant to assist in meeting the cost of a venereal disease control program. Before awarding a grant to a political subdivision of a State, the Secretary will consult with the State health authority.
(b) Priorities for funding will be based on the following factors:
(1) The relative extent of the venereal disease problem in the area served by the applicant.
(2) The design of the venereal disease prevention and control program.
(3) The general quality of the applicant's plan of operation and objectives in accordance with the requirements in these regulations. Emphasis will be placed on determining the extent to which services are coordinated among health care providers in the area served and integrated into a cohesive plan for delivery of service to groups having the highest incidence of venereal disease.
(4) The capacity of the applicant to make effective use of Federal funds.
(5) The commitment of the applicant to the control of venereal disease as reflected in the commitment of applicant resources to the program.
Grant funds awarded under this subpart may be used only for programs approved under section 318(c), and with respect to public information and education, those programs approved under section 318(b) of the Act. Unless specifically approved, grant funds shall not be used for performing diagnostic tests (other than gonorrhea screening tests),
(a) Special studies or demonstrations, (b) the support of developmental or start-up activity, or (c) the support of an essential service which will result in a savings to a detection or prevention activity supported by the grant. Unless otherwise approved, exceptions based on paragraphs (b) and (c) of this section are only allowed during one funding period. The grantee is expected to support these activities in subsequent funding periods.
The regulations in this subpart apply to the award of venereal disease control project grants for research, demonstrations, public information, and education activities which can be applied to achieve improvements in venereal disease prevention and control under section 318(b) of the Act.
An applicant must be a State, political subdivision of any State, or any other public or nonprofit private entity.
All information obtained by program personnel in connection with the examination, care, and treatment of an individual in this program shall be held confidential. It shall not be disclosed without the individual's consent except as may be required by the law of a State, or political subdivision of a State, or as may be necessary to provide services to the individual. Information may be disclosed in summary, statistical, or other form, or for clinical or research purposes, but only if the disclosure does not identify particular individuals.
(a) The initial application must include a description of the following:
(1) The setting and circumstances for which project grant support is being requested, including:
(i) The immediate and long-range objectives of the project in specific and measurable terms.
(ii) The activities which will be undertaken to accomplish the objectives, including the timing of these activities.
(iii) The anticipated application of findings to the national venereal disease control effort.
(iv) Any other information which will support the request for grant assistance.
(2) The relationship between the planned activities and the project objectives. The application must describe in detail how the applicant intends to proceed, particularly if the project is unusually complex and several activities are interdependent or unprecedented.
(3) A comprehensive and realistic plan which the applicant will use to evaluate the project. The plan must include periodic assessment of any possible impact, both positive and negative, that the proposed project might have upon the established venereal disease control program in the locality or localities in which the project will be undertaken.
(b) An application for a continuation grant must be submitted for each funding period. This continuation application must include the following:
(1) A budget and justification for the grant funds requested.
(2) A summary of the progress achieved during the previous budget period.
(3) A description of any changes in the information shown in the project application.
(a) Within the limits of funds available, the Secretary may award a grant to assist in meeting the costs of special activities authorized under section 318(b) of the Act.
(b) Grant applications will be reviewed and evaluated according to the following criteria:
(1) Is there adequate evidence that the proposed project is needed and that the outcome has potential to directly benefit the national venereal disease control effort?
(2) Are the project objectives specific, measurable, realistic, time phased, and related to promoting the purposes of section 318?
(3) Is the method of operation logical and clearly related to project objectives, and does it describe how the applicant intends to proceed particularly with activities which are complex, interrelated, or unprecedented?
(4) Does the method of operation include an assessment of any possible impact, both positive and negative, that the conduct of the proposed initiative might have upon the established venereal disease control program in the locality or localities in which the project will be undertaken?
(5) Does the proposal include a comprehensive and realistic plan for the evaluation of the project, and specify the measures and instruments of measurement to be used?
(6) Is the budget request reasonable and consistent with the intended use of grant funds?
(7) If the applicant intends only to evaluate an existing disease prevention and control approach, are the objectives substantially different from those which could be met by routine program evaluation?
(a) Grant funds may be used for the costs associated with planning, organizing, and conducting applied research, demonstrations, and public information and education programs.
(b) Grant funds may also be used to reimburse individuals who agree to be participants in the applied research projects. This reimbursement, however, must be justified as necessary and reasonable. A schedule of reimbursements must be submitted with the application and approved as part of the program plan.
(c) Grant funds may not be used to supplant funds supporting existing venereal disease control services provided by a State or locality.
Sec. 330, Public Health Service Act, 89 Stat. 342, (42 U.S.C. 254c); sec. 215, Public Health Service Act, 58 Stat. 690, (42 U.S.C. 216).
The regulations of this subpart are applicable to all project grants authorized by section 330 of the Public Health Service Act (42 U.S.C. 254c).
As used in this part:
(a)
(b)
(c)(1)
(i) Primary health services;
(ii) As determined by the Secretary to be appropriate for particular centers, supplemental health services necessary for the adequate support of primary health services;
(iii) Referral to providers of supplemental health services and payment, as determined by the Secretary to be appropriate and feasible, for their provision of such services;
(iv) Environmental health services, as determined by the Secretary to be appropriate for particular centers; and
(v) Information on the availability and proper use of health services.
(2) For purposes of paragraph (c)(1) of this section, the provision of a given service by a center will be determined by the Secretary to be appropriate where:
(i) There is a need, as determined by the Secretary, for the provision of such service in the catchment area; and
(ii) The provision of such service by the center is feasible, taking into consideration the center's projected revenues, other resources, and grant support under this part.
(d)
(e)
(1) Available health resources in relation to size of the area and its population, including appropriate ratios of primary care physicians in general or family practice, internal medicine, pediatrics, or obstetrics and gynecology to population;
(2) Health indices for the population of the area, such as infant mortality rate;
(3) Economic factors affecting the population's access to health services, such as percentage of the population
(4) Demographic factors affecting the population's need and demand for health services, such as percentage of the population age 65 and over.
(f)
(g)
(h)
(1) Diagnostic, treatment, consultative, referral, and other services rendered by physicians, and, where feasible, by physician's extenders, such as physicians' assistants, nurse clinicians, and nurse practitioners;
(2) Diagnostic laboratory services and diagnostic radiologic services;
(3) Preventive health services, including medical social services, nutritional assessment and referral, preventive health education, children's eye and ear examinations, prenatal and post-partum care, prenatal services, well child care (including periodic screening), immunizations, and voluntary family planning services;
(4) Emergency medical services, including provision, through clearly defined arrangements, for access of users of the center to health care for medical emergencies during and after the center's regularly scheduled hours;
(5) Transportation services as needed for adequate patient care, sufficient so that residents of the catchment area served by the center with special difficulties of access to services provided by the center receive such services; and
(6) Preventive dental services provided by a licensed dentist or other qualified personnel, including (i) oral hygiene instruction; (ii) oral prophylaxis, as necessary; and (iii) topical application of fluorides, and the prescription of fluorides for systemic use when not available in the community water supply.
(i)
(j)
(1) Inpatient and outpatient hospital services;
(2) Home health services;
(3) Extended care facility services;
(4) Rehabilitative services (including physical and occupational therapy) and long-term physical medicine;
(5) Mental health services, including services of psychiatrists, psychologists, and other appropriate mental health professionals;
(6) Dental services other than those provided as primary health services;
(7) Vision services, including routine eye and vision examinations and provision of eyeglasses, as appropriate and feasible;
(8) Allied health services;
(9) Pharmaceutical services, including the provision of prescription drugs;
(10) Therapeutic radiologic services;
(11) Public health services (including nutrition education and social services);
(12) Ambulatory surgical services;
(13) Health education services; and
(14) Services, including the services of outreach workers, which promote and facilitate optimal use of primary health services and services referred to in the preceding subparagraphs of this paragraph and, if a substantial number of individuals in the population served by the center are of limited English-speaking ability, the services of outreach workers and other personnel fluent in the language or languages spoken by such individuals.
Any public or nonprofit private entity is eligible to apply for a grant under this part.
(a) An application for a grant under this part shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe.
(b) The application shall contain a budget and narrative plan of the manner in which the applicant intends to conduct the project and carry out the requirements of this part. The application must describe how and the extent to which the project has met, or plans to meet, each of the requirements in subpart B (relating to grants for planning and developing community health centers), subpart C (relating to grants for the operation of community health centers), or subpart D (relating to grants for the operation of community health projects), as applicable. In addition, applications must include:
(1) A statement of specific, measurable objectives and the methods to be used to assess the achievement of the objectives in specified time periods and at least on an annual basis.
(2) The precise boundaries of the catchment area to be served by the applicant, including an identification of the medically underserved population or populations within the catchment area. In addition, the application shall include information sufficient to enable the Secretary to determine that the applicant's catchment area meets the following criteria:
(i) The size of such area is such that the services to be provided by the applicant are available and accessible to the residents of the area promptly and as appropriate;
(ii) The boundaries of such area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and areas served by Federal and State health and social service programs; and
(iii) The boundaries of such area eliminate, to the extent possible, barriers resulting from the area's physical characteristics, its residential patterns, its economic and social groupings, and available transportation.
(3) The results of an assessment of the need that the population served or proposed to be served has for the services to be provided by the project (or in the case of applications for planning and development projects, the methods to be used in assessing such need), utilizing, but not limited to, the factors set forth in § 51c.102(e)(1)-(4).
(4) Position descriptions for key personnel who will be utilized in carrying out the activities of the project and a statement indicating the need for the positions to be supported with grant funds to accomplish the objectives of the project.
(5) Letters and other forms of evidence showing that efforts have been made to secure financial and professional assistance and support for the project within the proposed catchment area and the continuing involvement of the community in the development and operation of the project.
(6) An assurance that an independent certified public accountant, or a public accountant licensed before December 31, 1970, will be engaged to certify that the system for the management and control of its financial assets will be in accord with sound financial management practices, including applicable Federal requirements.
(7) A list of all services proposed to be provided by the project.
(8) A list of services which are to be provided directly by the project through its own staff and resources and a description of any contractual or other arrangements (including copies of documents, where available) entered into, or planned for the provision of services.
(9) The schedule of fees and/or payments and schedule of discounts for services provided by the project.
(10) Evidence that all applicable requirements for review and/or approval of the application under title XV of the Act have been met.
(11) An assurance that the project will be conducted in accordance with the applicable requirements of this part.
(c) The application must be executed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the statute, the applicable regulations of this part, and any additional conditions of the grant.
A grant may be made under this part only if the applicable requirements of title XV of the Act relating to review and approval by the appropriate health planning agencies have been met.
(a) The amount of any award under this part will be determined by the Secretary on the basis of his estimate of the sum necessary for a designated portion of direct project costs plus an additional amount for indirect costs, if any, which will be calculated by the Secretary either:
(1) On the basis of the estimate of the actual indirect costs reasonably related to the project; or
(2) On the basis of a percentage of all, or a portion of, the estimated direct costs of the project when there are reasonable assurances that the use of such percentage will not exceed the approximate actual indirect costs. Such award may include an estimated provisional amount for indirect costs or for designated direct costs (such as fringe benefit rates) subject to upward (within the limits of available funds) as well as downward adjustments to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary:
(i) In determining the percentage of project costs to be borne by the grantee, factors which the Secretary will take into consideration will include the following:
(A) The ability of the grantee to finance its share of project costs from non-Federal sources;
(B) The need in the area served by the project for the services to be provided; and
(C) The extent to which the project will provide services in an innovative manner which the Secretary desires to stimulate in the interest of developing more effective health service delivery systems on a regional or national basis.
(ii) At any time after approval of an application under this part, the Secretary may retroactively agree to a percentage of project costs to be borne by the grantee lower than that determined pursuant to paragraph (a)(2)(i) of this section where he finds that changed circumstances justify a smaller contribution.
(iii) In determining the grantee's share of project costs, costs borne by Federal grant funds, or costs used to match other Federal grants, may not be included except as otherwise provided by law or regulations.
(b) All grant awards shall be in writing, and shall set forth the amount of funds granted and the period for which support is recommended.
(c) Neither the approval of any proj-ect nor any grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved project or portion thereof. For continuation support, grantees must make separate application.
(a) Any funds granted pursuant to this part, as well as other funds to be used in performance of the approved project, may be expended solely for carrying out the approved project in accordance with section 330 of the Act, the applicable regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.
(b) Project funds awarded under this part may be used for, but need not be limited to, the following:
(1) The costs of acquiring and modernizing existing buildings (including the costs of amortizing the principal of, and paying interest on, loans), but only in accordance with subpart E of this part and as approved in the grant award;
(2) The costs of obtaining technical assistance to develop and improve the management capability of the project, but only as approved by the Secretary;
(3) The reimbursement of members of the grantee's governing board, if any, for reasonable expenses actually incurred by reason of their participation in board activities;
(4) The reimbursement of governing board members for wages lost by reason of participation in the activities of such board if the member is from a family with an annual family income below $10,000 or if the member is a single person with an annual income below $7,000;
(5) The cost of delivering health services, including services rendered on a prepaid capitation basis, to residents of the project's catchment area within the following limitations: grant funds may be used to pay the full cost of project services to individuals and families with annual incomes at or below those set forth in the most recent “CSA Income Poverty Guidelines” (45 CFR 1060.2) issued by the Community Services Administration; and to pay the portion of the cost of services provided in accordance with the schedule of discounts which, under such schedule, is uncompensated;
(6) The cost of insurance for medical emergency and out-of-area coverage;
(7) The cost of providing to the staff of the project training related to the provision of health services provided or to be provided by the project, and, to the staff and governing board, if any, training related to the management of an ambulatory care facility, consistent with the applicable requirements of 45 CFR part 74; and
(8) The cost of developing and maintaining a reserve fund where required by State law for prepaid health care plans.
(c) Prior approval by the Secretary of revisions of the budget and project plan is required whenever there is to be a significant change in the scope or nature of project activities.
The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement for expenses incurred or to be incurred, to the extent he determines such payments necessary to promote prompt initiation and advancement of the approved project.
(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (78 Stat. 252, (42 U.S.C. 2000d et seq.)) and in particular section 601 of such Act which provides that no person in the United States shall on the grounds of race, color, or national origin be excluded from participation, in be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal Financial assistance. A regulation implementing such title VI, which applies to grants made under this part, has been issued by the Secretary of Health and Human Services with the approval of the President (45 CFR part 80). In addition, no person shall, on the grounds of age, sex, creed, or marital status (unless otherwise medically indicated), be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity so receiving Federal financial assistance.
(b) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.
All information as to personal facts and circumstances obtained by the project staff about recipients of services shall be held confidential, and shall not be divulged without the individual's consent except as may be required by law or as may be necessary to provide service to the individual or to provide for medical audits by the Secretary or his designee with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which
Except as may otherwise be provided under the terms and conditions of the award, the grantee may copyright without prior approval any publications, films, or similar materials developed or resulting from a project supported by a grant under this part, subject, however, to a royalty-free, nonexclusive, and irrevocable license or right in the Government to reproduce, translate, publish, use, disseminate, and dispose of such materials and to authorize others to do so.
(a)
(b)
(c)
(2)
(i) Any amount not accounted for pursuant to paragraph (a) of this section;
(ii) Any credits for earned interest pursuant to paragraph (b) of this section;
(iii) Any other amounts due pursuant to subparts F, M, and O of 45 CFR part 74.
The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this part to State and local governments as those terms are defined in subpart A of that part 74. The relevant provisions of the following subparts of part 74 shall also apply to grants to all other grantee organizations under this part:
The regulations of this subpart, in addition to the regulations of subpart
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the requirements of § 51c.104 of subpart A, contain information sufficient to enable the Secretary to determine that the project for which the grant is sought will meet the requirements of § 51c.203.
A project for the planning and developing of a community health center supported under this subpart must:
(a) Prepare an assessment of the need of the population proposed to be served by the community health center for the services set forth in § 51c.102(c)(1) of subpart A, with special attention to the need of the medically underserved population for such services. Such assessment of need shall, at a minimum, consider the factors listed in § 51c.102(e)(1)-(4).
(b) Design a community health center program for such population, based on such assessment, which indicates in detail how the proposed community health center will fulfill the needs identified in the assessment prepared pursuant to paragraph (a) of this section and how it will meet the requirements contained in subpart C of this part.
(c) Develop a plan for the implementation of the program designed pursuant to paragraph (b) of this section. Such implementation plan shall provide for the time-phased recruitment and training of the personnel essential for the operation of a community health center and the gradual assumption of operational status of the project so that the project will, in the judgment of the Secretary, meet the requirements contained in subpart C of this part as of the end of the project period.
(d) Implement the plan developed pursuant to paragraph (c) of this section in accordance with such paragraph.
(e) Make efforts to secure, within the proposed catchment area of such center to the extent possible, financial and professional assistance and support for the project.
(f) Initiate and encourage continuing community involvement in the development and operation of the project.
(g) Establish standards and qualifications for personnel (including the project director).
(h) Utilize, to the maximum extent feasible, other Federal, State, local, and private resources available for support of the project, prior to use of project funds under this subpart.
(a) Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which will, in his judgment, best promote the purposes of section 330(c) of the Act and the applicable regulations of this part, taking into account:
(1) The degree to which the proposed project satisfactorily provides for the elements set forth in § 51c.203;
(2) The relative need of the population to be served for the services to be provided;
(3) The administrative and management capability of the applicant;
(4) The potential of the project for development of new and effective methods for health services delivery and management;
(5) The soundness of the fiscal plan for assuring effective utilization of grant funds and maximizing non-grant revenue;
(6) The extent to which community resources will be utilized in the proj-ect;
(7) The extent to which grants approved under this part will provide for an appropriate distribution of resources throughout the country, taking into consideration the following factors;
(i) The urban-rural area to be served;
(ii) The nature of the organization applying; and
(iii) The organizational structure for delivery of services;
(8) Whether the project's catchment area is exclusive of the area served by a community health center;
(9) The degree to which the applicant intends to integrate services supported by a grant under this subpart with health services provided under other Federally assisted health services or reimbursement programs or projects.
(b) The Secretary may:
(1) Make no more than two grants under this subpart for the same project.
(2) Make a grant under this subpart to an entity which has been awarded one or more grants under section 330(d)(1)(A) and/or section 330(d)(1)(B) of the Act only if the grant under this subpart is for a new project.
The regulations of this subpart, in addition to the regulations of subpart A, are applicable to grants awarded pursuant to section 330(d)(1)(A) of the Act for the costs of operation of community health centers which serve medically underserved populations.
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the requirements of § 51c.104 of subpart A,
(a) Be submitted by an entity which may be a co-applicant which the Secretary determines is a community health center, and
(b) Contain information sufficient to enable the Secretary to determine that the center will meet the requirements of § 51c.103.
A community health center supported under this subpart must:
(a) Provide the health services of the center so that such services are available and accessible promptly, as appropriate, and in a manner which will assure continuity of service to the residents of the center's catchment area.
(b) Implement a system for maintaining the confidentiality of patient records in accordance with the requirements of § 51c.110 of subpart A.
(c) Have an ongoing quality assurance program which provides for the following:
(1) Organizational arrangements, including a focus of responsibility, to support the quality assurance program and the provision of high quality patient care;
(2) Periodic assessment of the appropriateness of the utilization of services and the quality of services provided or proposed to be provided to individuals served by the center. Such assessments shall:
(i) Be conducted by physicians or by other licensed health professionals under the supervision of physicians;
(ii) Be based on the systematic collection and evaluation of patient records; and
(iii) Identify and document the necessity for change in the provision of services by the center and result in the institution of such change, where indicated.
(d) Develop management and control systems which are in accordance with sound financial management procedures, including the provision for an audit on an annual basis (unless waived for cause by the Secretary) by an independent certified public accountant or a public accountant licensed prior to December 31, 1970, to determine, at a minimum, the fiscal integrity of grant financial transactions and reports, and compliance with the regulations of this part and the terms and conditions of the grant.
(e) Where the cost of care and services furnished by or through the proj-ect is to be reimbursed under title XIX or title XX of the Social Security Act, obtain or make every reasonable effort to obtain a written agreement with the title XIX or title XX State agency for such reimbursement.
(f) Have prepared a schedule of fees or payments for the provision of its services designed to cover its reasonable costs of operation and a corresponding schedule of discounts adjusted on the basis of the patient's ability to pay.
(g) Make every reasonable effort, including the establishment of systems for eligibility determination, billing, and collection, to:
(1) Collect reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act, to medical assistance under a State plan approved under title XIX of such Act, to social services and family planning under title XX of such Act, or to assistance for medical expenses under any other public assistance program, grant program, or private health insurance or benefit program on the basis of the schedule of fees prepared pursuant to paragraph (f) of this section without application of any discounts, and
(2) Secure from patients payments for services in accordance with the schedule of fees and discounts required by paragraph (f) of this section.
(h) Have a governing board which meets the requirements of § 51c.304.
(i) Have developed an overall plan and budget for the center that:
(1) Provides for an annual operating budget and a three-year financial management plan which include all anticipated income and expenses related to items which would, under generally accepted accounting principles, be considered income and expense items;
(2) Provides for a capital expenditures plan for at least a three-year period (including the year to which the operating budget described in paragraph (i)(1) of this section is applicable) which includes and identifies in detail the anticipated sources of financing for, and the objective of, each anticipated expenditure in excess of $100,000 related to the acquisition of land, the improvement of land, buildings, and equipment and the replacement, modernization and expansion of buildings and equipment which would, under generally accepted accounting principles, be considered capital items;
(3) Provides for plan review and updating at least annually; and
(4) Is prepared under the direction of the governing board, by a committee consisting of representatives of the governing board, and administrative staff, and the medical staff, if any, of the center.
(j) Establish basic statistical data, cost accounting, management information, and reporting or monitoring systems which shall enable the center to provide such statistics and other information as the Secretary may reasonably require relating to the center's costs of operation, patterns of utilization of services, and the availability, accessibility, and acceptability of its services and to make such reports to the Secretary in a timely manner with such frequency as the Secretary may reasonably require.
(k) Review its catchment area annually to insure that the criteria set out in § 51c.104(b)(2) of subpart A are met and, where such criteria are not met, revise its catchment area, with the approval of the Secretary, to conform to such criteria to the extent feasible.
(l) In the case of a center which serves a population including a substantial proportion of individuals of limited English-speaking ability, have developed a plan and made arrangements responsive to the needs of such populations for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and have identified an individual on its staff who is fluent in both that language and in English and whose responsibilities include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences. If more than one non-English language is spoken by such group or groups, an individual or individuals fluent in those languages and English shall be so identified.
(m) Be operated in a manner calculated to preserve human dignity and to maximize acceptability and effective utilization of services.
(n) To the extent possible, coordinate and integrate project activities with the activities of other Federally funded, as well as State and local, health services delivery projects and programs serving the same population.
(o) Establish means for evaluating progress toward the achievement of the specific objectives of the project.
(p) Provide sufficient staff, qualified by training and experience, to carry out the activities of the center.
(q) Assure that facilities utilized in the performance of the project meet applicable fire and life safety codes.
(r) Utilize, to the maximum extent feasible, other Federal, State, and local, and private resources available for support of the project, prior to use of project funds under this part.
(s) Provide for community participation through, for example, contributions of cash or services, loans of full-or part-time staff, equipment, space, materials, or facilities.
(t) Where the center will provide services through contract or other cooperative arrangements with other providers of services, establish rates and methods of payment for health care. Such payments must be made pursuant to agreements, with a schedule of rates and payment procedures maintained by the project. The proj-ect must be prepared to substantiate that such rates are reasonable and necessary.
(u) Operate in a manner such that no person shall be denied service by reason of his inability to pay therefor:
(v) In addition to the above, projects which are supported with grant funds for the operation of a prepaid health care plan also must provide:
(1) A marketing and enrollment plan, including market analysis, marketing strategy, and enrollment growth projections.
(2) A plan that provides for funding on a capitation basis of such portion of the residents of the catchment area of the center, as the Secretary shall determine.
(3) An assurance that services shall be available to all residents of the catchment area without regard to method of payment or health status.
A governing board for the center shall be established by an applicant as follows:
(a)
(b)
(2) No more than one-half of the remaining members of the board may be individuals who derive more than 10 percent of their annual income from the health care industry.
(3) The remaining members of the board shall be representative of the community in which the center's catchment area is located and shall be selected for their expertise in community affairs, local government, finance and banking, legal affairs, trade unions, and other commercial and industrial concerns, or social service agencies within the community.
(4) No member of the board shall be an employee of the center, or spouse or child, parent, brother or sister by blood or marriage of such an employee. The project director may be a non-voting, ex-officio member of the board.
(c)
(d)
(2) The governing board shall hold regularly scheduled meetings, at least once each month, for which minutes shall be kept.
(3) The governing board shall have specific responsibility for:
(i) Approval for the selection and dismissal of a project director or chief executive officer of the center;
(ii) Establishing personnel policies and procedures, including selection and dismissal procedures, salary and benefit scales, employee grievance procedures, and equal opportunity practices;
(iii) Adopting policy for financial management practices, including a system to assure accountability for center resources, approval of the annual project budget, center priorities, eligibility for services including criteria for partial payment schedules, and long-range financial planning;
(iv) Evaluating center activities including services utilization patterns, productivity of the center, patient satisfaction, achievement of project objectives, and development of a process for hearing and resolving patient grievances;
(v) Assuring that the center is operated in compliance with applicable Federal, State, and local laws and regulations; and
(vi) Adopting health care policies including scope and availability of services, location and hours of services, and quality-of-care audit procedures.
Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which will, in his judgment, best promote the purposes of section 330(d)(1)(A) of the Act and the applicable regulations of this part, taking into consideration;
(a) The extent to which the project would provide for the elements set forth in § 51c.303;
(b) The relative need of the population to be served for the services to be provided;
(c) The potential of the center for the development of new and effective methods for health services delivery and management;
(d) The soundness of the fiscal plan for assuring effective utilization of grant funds and maximizing non-grant revenue;
(e) The administrative and management capability of the applicant;
(f) The extent to which grants approved under this part will provide for an appropriate distribution of resources throughout the country, taking into consideration the following factors:
(1) The urban-rural area to be served;
(2) The nature of the organization applying;
(3) The organizational structure for delivery of services;
(g) The number of users of the center and the level of utilization of services in previous operational periods, if any;
(h) Whether the center's catchment area is exclusive of the area served by another center;
(i) The degree to which the applicant intends to integrate services supported by a grant under this subpart with health services provided under other Federally assisted health services or reimbursement programs or projects;
(j) The extent to which community resources will be utilized by the proj-ect;
(k) The extent to which the center will provide preventive health services so as to maintain and improve the health status of the population served; and
(l) The extent to which center operations will emphasize direct health services, efficiency of operations and sound financial management.
The regulations of this subpart, in addition to the regulations of subpart A are applicable to grants awarded pursuant to section 330(d)(1)(B) of the Act for the costs of operation of projects which provide health services to medically underserved populations.
To be approved by the Secretary under this subpart, an application for a
A project for the operation of a community health project supported under this subpart must:
(a) Meet all of the requirements of § 51c.303 of this part except for paragraph (h).
(b) Provide those services enumerated in § 51c.102(c)(1) of this part which the Secretary determines to be feasible and desirable and which are specified in the grant award.
(c) Establish a governing board meeting the requirements of § 51c.304 by the end of the period of support under section 330(d)(1)(B) of the Act and this subpart.
(a) Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which will, in his judgment, best promote the purposes of section 330(d)(1)(B) of the Act and the applicable regulations of this part,
(1) Where the project meets the requirements of § 51c.403(a); and
(2) Taking into consideration the following:
(i) The degree to which the project would provide the services enumerated in § 51c.102(c)(1) and the feasibility of its providing all of such enumerated services by the end of the period of support under section 330(d)(1)(B) of the Act and this subpart;
(ii) Whether the project will have a governing board meeting the requirements of § 51c.304 by the end of the period of support under section 330(d)(1)(B) of the Act and this subpart;
(iii) The degree to which the applicant intends to integrate services supported by a grant under this subpart with health services provided under other Federally assisted health service or reimbursement programs or projects;
(iv) The need of the population to be served for the services to be provided;
(v) The potential of the project for the development of new and effective methods for health services delivery and management;
(vi) The soundness of the fiscal plan for assuring effective utilization of grant funds and maximizing non-grant revenue;
(vii) The administrative and management capacity of the applicant; and
(viii) The extent to which community resources will be utilized in the proj-ect.
(b) The Secretary may:
(1) Make no more than two grants for the same entity under section 330(d)(1)(B) of the Act;
(2) Not make any grant under section 330(d)(1)(B) to an entity which, for the same project, has been awarded more than one grant under section 330(c) of the Act;
(3) Not make a grant under section 330(d)(1)(B) to an entity which has been awarded a grant under section 330(d)(1)(A) of the Act.
The regulations of this subpart, in addition to the regulations of the other applicable subparts of this part, are applicable to grants under section 330 of the Act for project costs which include the cost of acquisition and/or modernization of existing buildings (including the cost of amortizing the principal of, and paying the interest on, loans), except that, these regulations are not applicable to grants for project costs which include the costs of modernization of existing buildings if those costs can otherwise be supported under subparts B, C, or D of this part.
(a)
(b)
(c)
(a)
(1) A legal description of the site and a drawing showing the location of the building;
(2) A description of the architectural, structural, and other pertinent characteristics of the building sufficient to show that it is or that it will be, after alteration and renovation or after modernization, suitable for use by the project;
(3) A detailed estimate of the cost of the proposed acquisition and/or modernization;
(4) A description of, and copies of any relevant documents concerning, any existing or proposed financing arrangements for the acquisition and/or modernization;
(5) The proposed schedule for acquisition and/or modernization and occupancy;
(6) An assessment of the environmental impact of the proposed acquisition and/or modernization as called for by section 102(2)(c) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(c)) and such information as may be necessary to comply with the National Historic Preservation Act of 1966 (16 U.S.C. 470(f));
(7) Reasonable assurances that—
(i) The applicant has or will obtain a fee simple or such other estate or interest in the site, including necessary easements and rights-of-way, sufficient to assure for a period of not less than 20 years (in the case of interim facilities, for the period constituting the estimated useful life of such facilities) undisturbed use and possession for the purpose of the operation of the project;
(ii) The building will be used for the purposes for which the grant is made;
(iii) The building complies, or after alteration and renovation or after modernization will comply, with applicable State and local codes and with:
(A) “American National Standard Specifications for Making Buildings and Facilities Accessible to, and Usable by, the Physically Handicapped” Number ANSI A117.1-1961 (R 1971), as modified by other standards prescribed by the Secretary or the Administrator of the General Services Administration. The applicant shall be responsible for conducting inspections to insure compliance with the specifications;
(B) The applicable standards set forth in Life Safety Code 1973, NFPA No. 101, which is hereby incorporated by reference and made a part hereof. Copies of such document are available for examination at the Department's and Regional Offices' Information Centers listed in 45 CFR 5.31 and may also be obtained from the National Fire Protection Association, 470 Atlantic Avenue, Boston, MA 02210 for $3.00 per copy.
(iv) In the case of a public applicant with an approved project which involves the displacement of persons or businesses on or after January 2, 1971, whose real property has or will be taken, the applicant will comply with the provisions of the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 (Pub. L. 91-646) and the applicable regulations issued thereunder (45 CFR part 15);
(v) Sufficient funds will be available to meet any portion of the cost of acquiring and/or modernizing the building not borne by the grant under this part;
(vi) Sufficient funds will be available after acquisition and/or modernization of the building for effective use of the building for the purposes of the proj-ect;
(vii) The applicable requirements of the Flood Disaster Protection Act of 1973 have been met;
(8) Such other information as the Secretary may reasonably require.
(b)
(c)
(1) Plans and specifications for the proposed modernization which conform to the standards specified in § 51c.503(a)(7)(iii);
(2) Reasonable assurance that any laborer or mechanic employed by any contractor or subcontractor in the performance of work on the modernization project will be paid wages at rates not less than those prevailing on similar work in the locality as determined by the Secretary of Labor under the Davis-Bacon Act (40 U.S.C. 276a
(3) Copies of any construction and materials contracts already entered into for the proposed modernization.
(a)
(1)
(2)
(3)
(b)
(1)
(2)
(3)
(c)
(1)
(2)
(ii) Except as otherwise provided by State or local law, contract for construction (including the purchase and installation of built-in equipment) on a lump sum fixed-price basis, and award contracts on the basis of competitive bidding obtained by public advertising with award of the contracts to the lowest responsive and responsible bidders. The provision for exceptions based on State and local law shall not be invoked to give local contractors or suppliers a percentage preference over non-local contractors bidding for the same contract. Such practices are precluded by this paragraph.
(3)
(A) The provisions set forth in “DHHS Requirements for Federally Assisted Construction Contracts Regarding Labor Standards and Equal Employment Opportunities,” Form DHHS 514 (rev. 7/76) (issued by the Office of Grants Administration Policy, U.S. Department of Health and Human Services) pertaining to the Davis-Bacon Act, the Contract Work Hours Standards Act, and the Copeland Act (Anti-Kickback) Regulations, except in the case of contracts in the amount of $2,000 or less; and pertaining to Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, relating to nondiscrimination in construction contract employment, except in the case of contracts in the amount of $10,000 or less;
(B) That the contractor shall furnish performance and payment bonds each of which shall be in the full amount of the contract price, and shall maintain, during the life of the contract, adequate fire, workmen's compensation, public liability, and property damage insurance:
(C) That the Secretary shall have access at all reasonable times to work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
(ii)
(4)
(5)
(6)
(d) The Secretary may at any time approve exceptions to the provisions of this section where he finds that such exceptions are not inconsistent with section 330 of the Act, other requirements of law, or the purposes of the program.
The cost of acquisition and/or modernization of existing buildings for which funds may be granted under this part will be determined by the Secretary, utilizing such documentation submitted by the applicant as the Secretary may prescribe (including the reports of such real estate appraisers as the Secretary may approve) and other relevant factors, taking into consideration only that portion of the existing
Grant funds may be used to amortize the principal of or pay interest on a loan or mortgage on an existing building acquired under this part, including a building purchased by a grantee prior to the promulgation of this part, but only if the building is being used for the purposes of section 330 and complies with the applicable provisions of this subpart and only to the extent the Secretary finds such principal amounts and interest rates to be reasonable.
No grant for the acquisition of a facility which has previously received a Federal grant for construction, acquisition, or equipment shall serve either to reduce or restrict the liability of the applicant or any other transferor or transferee from any obligation of accountability imposed by the Federal Government by reason of such prior grant.
42 U.S.C. 290aa(m).
The regulations in this subpart apply to grants that enable public entities to respond to needs in local communities created by mental health or substance abuse emergencies, as authorized under section 501(m) of the Public Health Service Act (42 U.S.C. 290aa(m)).
As used in this part:
An applicant must be a public entity as defined by this subpart. Applicants are eligible for either or both Immediate and Intermediate awards.
(a)
(1) A certification by the State's chief executive officer, or, for the purposes of a Federally recognized Indian tribal government, the principal elected official, or such officer's or official's designee, that a mental health or substance abuse emergency exists, as well as a written statement setting out the basis for the certification;
(2) A brief program plan describing needs;
(3) An estimate of the number of people to be served and the geographical area to be served;
(4) A description of the types of services to be provided;
(5) A budget justifying the amount of the request;
(6) Required certifications; and
(7) Such other pertinent information as the Secretary may require.
(b)
(1) If the applicant has not applied previously for an Immediate award, a certification by the State's chief executive officer, or, for the purposes of a Federally recognized Indian tribal government, the principal elected official, or such officer's or official's designee, that a mental health or substance abuse emergency exists, as well as a written statement setting out the basis for the certification;
(2) An application submission date within three months of the date of the event that precipitated the mental health or substance abuse emergency, as certified in accordance with 51d.4(a)(1) or (b)(1), except that upon the request of a State, the Secretary may provide a waiver of this application submission deadline if the Secretary determines there is good cause to justify the waiver;
(3) A detailed and comprehensive assessment of need;
(4) Demographics specific to the estimated number of people to be served;
(5) A description of the services that were provided up to the date of the submission of the Intermediate award application;
(6) The geographical area to be served;
(7) A detailed implementation program plan and related time line, including a description of outreach to special population groups affected by the crisis;
(8) A budget justifying the amount of the request for personnel, equipment, supplies, travel, training, data collection and any technical assistance required; the budget shall include an identification of the resources the applicant is able to commit to the project, if any, including any in-kind contributions;
(9) Any information that has changed since an Immediate application was submitted, if one was submitted; and
(10) such other pertinent information as the Secretary may require.
(c)
(a) In making a decision as to whether a mental health or substance abuse emergency exists for purposes of section 501(m) of the PHS Act, the Secretary, using discretion, will consider
(1) Existing State, Tribal and local systems for mental health and/or substance abuse services are overwhelmed or unable to meet the existing mental health or substance abuse needs of the local community at issue; and
(2) This inability to meet the mental health and/or substance abuse service needs of a local community is the direct consequence of a clear precipitating event. This precipitating event must:
(i) Have a sudden, rapid onset and a definite conclusion, such as:
(A) A natural disaster (including, but not limited to, a hurricane, tornado, storm, flood, earthquake, fire, drought, or other natural catastrophe); or
(B) A technological disaster (including, but not limited to, a chemical spill, a major industrial accident, or a transportation accident); or
(C) A criminal act with significant casualties (including, but not limited to, a domestic act of terrorism, a hostage situation, or an incident of mass violence including school shootings and riots); and
(ii) Result in significant:
(A) Death,
(B) Injury,
(C) Exposure to life-threatening circumstances,
(D) Hardship,
(E) Suffering,
(F) Loss of property, or
(G) Loss of community infrastructure (
(3) No other local, State, Tribal or Federal funding is available to adequately address the specific level of need resulting from the precipitating event and resulting emergency mental health and/or substance abuse service needs of the impacted community.
(b) In making a determination that a mental health or substance abuse emergency exists, the Secretary will consider the certification and written statements provided in accordance with § 51d.4(a)(1) or (b)(1), and other information independently available to the Secretary.
(c) Once the Secretary determines that a mental health or substance abuse emergency exists, the Secretary may exercise discretion to make awards to enable public entities to respond to the emergency, within the limits of funds available.
(a) In assessing applications for funding, the Secretary will utilize the following criteria.
(1)
(2)
(a) The types of services to be provided (
(b) Strategies for targeting those identified as needing services, including high risk groups or populations with special concerns identified in the needs assessment;
(c) Appropriate training to be provided to staff to assure that services
(d) Quality control methods in place to assure appropriate services to the target population;
(e) Staff support mechanisms that are available;
(f) Plans for coordination of services with key local, State, Tribal and Federal partners involved in addressing the precipitating event (
(g) An estimate of the length of time for which said services requiring Federal funding will be needed, and the manner in which long-term cases will be referred for continued assistance after Federal funds have ended.
(3)
(b) In determining the appropriateness and necessity of funding, the Secretary may consult with other Federal agencies responsible for responding to crisis incidents, including the Readiness, Response and Recovery Directorate within the Federal Emergency Management Agency (FEMA), the Safe and Drug Free Schools Program within the U.S. Department of Education, the Office for Victims of Crime (OVC) within the U.S. Department of Justice, the National Transportation Safety Board (NTSB) within the U.S. Department of Transportation, the Emergency Response Program within the Environmental Protection Agency (EPA), the Bureau of Indian Affairs (BIA) within the U.S. Department of the Interior, the Animal and Plant Health Inspection Service within the U.S. Department of Agriculture, the Indian Health Service (IHS) within the U.S. Department of Health and Human Services, and other Federal agencies with jurisdiction over specific types of crisis response.
(1) Major construction costs;
(2) Childcare services, unless provided by the institution or entity providing mental health or substance abuse treatment and integral to the treatment program;
(3) Services outside of the geographic area specified in the application, except to the extent that the precipitating event requires physical relocation of either affected parties or facilities;
(4) Any mental health or substance abuse services not directly related to the mental health or substance abuse emergency;
(5) Any expenses that supplant ongoing local, State, Tribal or Federal expenditures; and
(6) Any other costs unallowable by Federal law or regulation.
Several other HHS regulations apply to grants under this part. These include, but are not limited to:
Award funding made under this authority is to be supplemental in nature. Consistent with the criteria in § 51d.5 and the certification in § 51d.4(a)(1), such funds will only be made available if no other local, State, Tribal or Federal source is available to adequately address the emergency mental health and/or substance abuse service needs of the impacted community.
(a) For immediate awards:
(1) A mid-program report only if an Intermediate award application is being prepared and submitted. This report shall be included as part of the Intermediate award application,
(2) Quarterly financial status reports of expenditures to date, due 30 days following the end of the reporting period, as permitted by 45 CFR 92.41(b),
(3) A final program report, a financial status report, and a final voucher 90 days after the last day of Immediate award services, in accordance with 45 CFR 92.50(b).
(b) For intermediate awards:
(1) Quarterly progress reports, due 30 days following the end of the reporting period, as permitted by 45 CFR 92.40(b),
(2) Quarterly financial status reports of expenditures to date, due 30 days following the end of the reporting period, as permitted by 45 CFR 92.41(b),
(3) A final program report, to be submitted within 90 days after the end of the program services period, in accordance with 45 CFR 92.50(b),
(4) A financial status report, to be submitted within 90 days after the end of the program services period, in accordance with 45 CFR 92.50(b),
(5) Such additional reports as the Secretary may require.
(c) The following shall be specifically addressed in final program reports:
(1) Description of services provided,
(2) Number of individuals assisted,
(3) Amount of funding expended and for what purposes,
(4) Personnel costs,
(5) Training costs,
(6) Technical consultation costs,
(7) Equipment costs,
(8) Travel and transportation costs, and
(9) A narrative describing lessons learned and exemplary practices, and a description of the transition plan, for how services will be funded or provided when Federal funds have been exhausted.
42 U.S.C. 216.
(a)
(b)
As used in this part:
(a)
(1) An individual or entity which is otherwise ineligible for an award under applicable law or regulation;
(2) Federal agencies or institutions, unless specifically authorized by law to receive the grant; or
(3) Individuals, corporations, institutions, agencies, and other entities during the period they are debarred or suspended from eligibility for Federal financial assistance (see 45 CFR part 76).
(b)
(c)
(1) Activities conducted by, or in cooperation with, the World Health Organization, and
(2) With respect to activities in the Western Hemisphere, activities conducted by, or in cooperation with, the Pan American Health Organization or the World Health Organization.
Each institution interested in applying for a grant under this part must submit an application at such time and in such form and manner as the Secretary may prescribe.
(a)
(b)
(a) Within the limits of funds available for that purpose, the Secretary will award a grant to those applicants whose approved projects will in the Secretary's judgment best promote the purposes of the statute authorizing the grant and the regulations of this part. The date specified by the Secretary as the beginning of the project period shall be no later than 9 months following the date of any initial or new award statement unless the Secretary finds that because of the nature of a project or the grantee's particular circumstances earlier assurance of grant support is required to initiate the project. Any funds granted under this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the award and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.
(b)
(c)
(2) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit an application at the time and in the form and manner as the Secretary may prescribe to have support continued for each subsequent year.
(3) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(d)
(e)
(f)
(a)
(b)
(c)
Several other HHS policies and regulations apply to grants under this part. These include, but are not necessarily limited to:
This policy is subject to changes, and interested persons should contact the Office of Research on Women's Health, NIH, Room 201, Building 1, MSC 0161, BETHESDA, MD 20892-0161 (301-402-1770; not a toll-free number) to obtain references to the current version and any amendments.]
This policy is subject to changes, and interested persons should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (301-496-9838; not a toll-free number) to obtain references to the current version and any amendments.]
This policy is subject to changes, and interested persons should contact the Grants Policy Branch, OASH, Room 17A45, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 (301-443-1874; not a toll-free number) to obtain references to the current version and any amendments.]
This policy is subject to changes, and interested persons should contact the Office for Protection from Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-496-7005; not a toll-free number) to obtain references to the current version and any amendments.]
The Secretary may with respect to any grant award or class of awards impose additional conditions prior to or at the time of any award when in the Secretary's judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of the public health, or the conservation of grant funds.
42 U.S.C. 216, 285a-3, 285a-6(c)(1)(E), 285a-7(c)(1)(G), 285b-4, 285c-5, 285d-6, 285e-2, 285e-3, 285f-1, 285g-5, 285g-7, 285m-3, 285n-2, 285o-2, 300cc-16.
(a) The regulations of this part apply to grants by the National Institutes of Health and its organizational components to support the planning, establishment, strengthening or expansion, and operation of research and demonstration and/or multipurpose centers in the health fields described in this paragraph. Specifically, these regulations apply to national cancer research and demonstration centers (including payments for construction, but not including the acquisition of land), as authorized by section 414 of the Act; national cancer research and demonstration centers with respect to breast cancer, as authorized by section 417 of the
(b) This part does not apply to:
(1) Grants for construction (see 42 CFR part 52b), except as noted in paragraph (a) of this section;
(2) Grants covered by 42 CFR part 52 (grants for research projects); or
(3) Grants for general research support under section 301(a)(3) of the Act (42 U.S.C. 241(a)(3)).
(c) This part also applies to cooperative agreements made to support the centers specified in paragraph (a) of this section. When a reference is made in this part to “grants,” the reference shall include “cooperative agreements.”
As used in this part:
(1) For purposes of grants authorized by section 414 of the Act, an agency or institution which provides for planning and conducting basic and clinical research into, training in, and demonstration of advanced diagnostic, control, prevention and treatment methods for cancer;
(2) For purposes of grants authorized by section 417 of the Act, an agency or institution which provides for planning and conducting basic, clinical, epidemiological, psychosocial, prevention and treatment research and related activities on breast cancer;
(3) For purposes of grants authorized by section 417A of the Act, an agency or institution which provides for planning and conducting basic, clinical, epidemiological, psychosocial, prevention and control, treatment, research, and related activities on prostate cancer;
(4) For purposes of grants authorized by section 422 of the Act, an agency or institution which provides for planning and basic and clinical research into, training in, and demonstration of, management of blood resources and advanced diagnostic, prevention, and treatment methods (including emergency services) for heart, blood vessel, lung, or blood diseases including sickle cell anemia;
(5) For purposes of grants authorized by section 431 of the Act, a single institution or a consortium of cooperating
(6) For purposes of grants authorized by section 441 of the Act, a single institution or a consortium of cooperating institutions which conducts basic and clinical research into arthritis and musculoskeletal diseases and orthopedic procedures, and provides training and information programs for health professionals and the general public;
(7) For purposes of grants authorized by section 445 of the Act, an entity (including a university medical center) which conducts basic and clinical research (including multidisciplinary research) into, training in, and demonstration of advanced diagnostic, prevention, and treatment methods for Alzheimer's disease;
(8) For purposes of grants authorized by section 445A of the Act, an entity which conducts research into the aging processes and into the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause, which includes research on the treatments, and on medical devices and other medical interventions regarding these diseases, disorders, and complications that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals;
(9) For purposes of grants authorized by section 447 of the Act, a single institution or consortium of cooperating institutions which conducts basic and clinical research on chronic fatigue syndrome;
(10) For purposes of grants authorized by section 452A of the Act, a single institution or consortium of cooperating institutions which conducts clinical and other applied research, training programs, continuing education programs, and information programs with respect to methods of contraception and infertility;
(11) For purposes of grants authorized by section 452C of the Act, an agency or institution which conducts research with respect to child health, and gives priority to the expeditious transfer of advances from basic science to clinical applications and improving the care of infants and children;
(12) For purposes of grants authorized by section 464C of the Act, a single institution or a consortium of cooperating institutions which conducts basic and clinical research into, training in, information and continuing education programs for health professionals and the general public about, and demonstration of, advanced diagnostic, prevention, and treatment methods for disorders of hearing and other communication processes and complications resulting from these disorders;
(13) For purposes of grants authorized by section 464J of the Act, an entity engaged in long-term interdisciplinary research relating to alcoholism and other alcohol problems;
(14) For purposes of grants authorized by section 464N of the Act, an entity for interdisciplinary research relating to drug abuse and other biomedical, behavioral, and social issues related to drug abuse; or
(15) For purposes of grants authorized by section 2316 of the Act, an entity for basic and clinical research into, and training in, advanced diagnostic, prevention, and treatment methods for acquired immunodeficiency syndrome.
(16) As provided in the section of the Act authorizing the particular program or on the determination of the Director, a center may include the facilities of a single institution or a consortium of cooperating institutions and, if practical, may be part of an equitable geographical distribution of centers with proven research capabilities.
(a) Any public or private nonprofit agency, institution, or consortium of agencies is eligible to apply for a grant under sections 414, 417, 417A, 422, 445, 445A, 447, 452A, and 2316 of the Act.
(b) Any public or private nonprofit or for-profit agency, institution, or consortium of agencies is eligible to apply for a grant under sections 431, 441, 452C, 464C, 464J, and 464N of the Act.
(c) Any applicant under this part must be located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).
Each application under this part must include detailed information as to the following:
(a) The personnel, facilities, and other resources available to the applicant with which to initiate and maintain the proposed center grants program;
(b) Any research, training, demonstration, or information dissemination activities in which the applicant is currently engaged; the sources of funding for these activities; and the relevance of these activities to the proposed center grants program;
(c) Proposed research, training, demonstration, and information dissemination activities;
(d) The proposed organizational structure of the center and the relationship of the proposed center to the applicant organization(s);
(e) The names and qualifications of the center director and key staff members who would be responsible for conducting the proposed activities;
(f) Proposed methods for monitoring and evaluating individual activities and the overall center program;
(g) Proposed methods for coordinating the center's activities, where appropriate, with similar efforts by other public and private organizations;
(h) The availability of any community resources necessary to carry out proposed activities; and
(i) Efforts to be made to generate and collect income from sources other than NIH to be used to further the purposes of the center program. NIH encourages these efforts. Income may include, but is not limited to, that generated from the sale or rental of products or services produced by grant-supported activities, such as laboratory tests, computer time, and payments received from patients or third parties, where appropriate (the disposition of grant-related income is governed by 45 CFR 74.40 through 74.47 and 45 CFR 92.25);
(j) The proposed budget for the center and a justification for the amount of the grant funds requested; and
(k) Any other information that the Director of the awarding institute may request.
(a) NIH considers the following in evaluating Center grant applications:
(1) The scientific and technical merit of the proposed program;
(2) The qualifications and experience of the center director and other key personnel;
(3) The statutory and program purposes to be accomplished;
(4) The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
(5) The extent to which the center's activities would be coordinated with similar efforts by other organizations;
(6) The administrative and managerial capability of the applicant;
(7) The reasonableness of the proposed budget in relation to the proposed program; and
(8) Other factors which the awarding institute, center, or division considers appropriate in light of its particular statutory mission.
(b) Where required by statute or NIH policy, applications are reviewed by appropriate national advisory councils or boards before awards are made. NIH grants may be awarded generally only after approval recommendations from both appropriate scientific peer review groups and national advisory councils or boards.
(a) The notice of grant award specifies how long NIH intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 1-5 years.
(b) Generally, the grant will initially be for one year, and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the NIH that continued funding is in the best interest of the Federal Government.
(c) Neither the approval of any application, nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
A grantee shall spend funds it receives under this part solely in accordance with the approved application and budget, the authorizing legislation, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed in 45 CFR 74.27.
Several other regulations and policies apply to this part. These include, but are not necessarily limited to:
This policy is subject to change, and interested persons should contact the Office of Research on Women's Health, NIH, Room 201, MSC 0161, BETHESDA, MD 20892-0601 (301-402-1770; not a toll-free number) to obtain references to the current version and any amendments.]
This policy is subject to change, and interested persons should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 6000 Executive Boulevard, MSA 7010, BETHESDA, MD 20892-7010 (301-496-9838; not a toll-free number) to obtain references to the current version and any amendments.]
This policy is subject to change, and interested persons should contact the Office for Protection from Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Bethesda, MD 20892-7507 (301-496- 7005; not a toll-free number) to obtain references to the current version and any amendments.]
The Director may, with respect to any grant award, impose additional conditions prior to or at the time of any award when in the Director's judgment the conditions are necessary to assure the carrying out of the purposes of the award, the interests of the public health, or the conservation of grant funds.
42 U.S.C. 216, 285a-2, 285a-3, 285b-3, 285b-4, 285d-6, 285i, 285m-3, 285o-4, 287a-2, 287a-3, 300cc-41.
(a)
(b)
(c)
As used in this part:
In order to be eligible for a construction grant under this part, the applicant must:
(a) Be a public or private nonprofit agency or institution;
(b) Be located in a state, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor states of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and
(c) Meet any additional eligibility criteria specified in the applicable provisions of the Act.
Applications for construction grants under this part shall be made at the times and in the form and manner as the Secretary may prescribe.
(a) In evaluating and approving applications for construction grants under this part, the Director shall take into account, among other pertinent factors, the following:
(1) The priority score assigned to the application by an NIH peer review group as described in paragraph (b) of this section;
(2) The relevance of the project for which construction is proposed to the objectives and priorities of the particular program authorized by the Act;
(3) The scientific merit of the research activities that will be carried out in the proposed facility;
(4) The scientific or professional standing or reputation of the applicant and of its existing or proposed officers and research staff;
(5) The availability, by affiliation or other association, of other scientific or health personnel and facilities to the extent necessary to carry out effectively the program proposed for the facility, including the adequacy of an acceptable biohazard control and containment program when warranted;
(6) The need for the facility and its total effects on similar or related facilities in the locale, and the need for appropriate geographic distribution of similar facilities; and
(7) The financial need of the applicant.
(b) The priority score of the application shall be based, among other pertinent factors, on the following criteria:
(1) The scientific merit of the total program and its component parts to be carried out in the facility;
(2) The administrative and leadership capabilities of the applicant's officers and staff;
(3) The organization of the applicant's research program and its relationship with the applicant's overall research programs;
(4) The anticipated effect of the project on other relevant research programs and facilities in the geographic area, and nationwide;
(5) The need for the project or additional space; and
(6) The project cost and design.
(a) Unless otherwise specified by statute, the rate of federal financial participation in a construction project supported by a grant under this part shall not be more than 50 percent of the necessary allowable costs of construction as determined by the Director, except that when the Director finds good cause for waiving this limitation, the amount of the construction grant may be more than 50 percent of the necessary allowable costs of construction.
(b) Subject to paragraph (a) of this section, the Director shall set the actual rate of federal financial participation in the necessary allowable costs of construction, taking into consideration the most effective use of available federal funds to further the purposes of the applicable provisions of the Act.
(a) The grantee shall use the facility (or that portion of the facility supported by a grant under this part) for its originally authorized purpose so long as needed for that purpose, or other period prescribed by statute, unless the grantee obtains advance approval from the Director, in the form and manner as the Director may prescribe, to use the facility for another purpose. Use for other purposes shall be limited as prescribed in § 52b.9(c)(2).
(b) The Director, in determining whether to approve an alternative use of the facility, shall take into consideration the extent to which:
(1) The facility will be used by the grantee or other owner for a purpose described in § 52b.9(c)(2); or
(2) There are reasonable assurances that alternative facilities not previously used for NIH supported research will be utilized to carry out the original purpose as prescribed in § 52b.9(c)(1).
(c)
NIH may monitor the use of each facility constructed with funds awarded under this part to ensure its continued use for the originally authorized research purpose, by means of reviewing periodic facility use certifications or reports, site visits, and other appropriate means.
(a) If the grantee plans to cease using the facility for the particular biomedical research or training purposes for which it was constructed as required by § 52b.7 (or alternate use authorized under § 52b.7(a) or paragraph
(1) The facility may be sold and the grantee or transferee shall pay to the United States an amount computed by multiplying the federal share of the facility times the proceeds from the sale (after deducting the actual and reasonable selling and fix-up expenses, if any, from the sales proceeds). The sales procedures must provide for competition to the extent practicable, and be designed to provide the highest possible return;
(2) The grantee may retain title and shall pay to the United States an amount computed by multiplying the current fair market value of the facility by the federal share of the facility; or
(3) The grantee shall transfer the title to either the United States or to an eligible non-federal party approved by the Director. The grantee shall be entitled to be paid an amount computed by multiplying the current fair market value of the facility by the nonfederal share of the facility.
(b) The grantee or transferor of a facility which is sold or transferred, or the owner of a facility the use of which has changed, as described in paragraph (a) of this section, shall report that action in writing to the Director not later than 10 days from the date on which the sale, transfer, or change occurs, in the form and manner as the Director may prescribe.
(c) In lieu of disposition of a facility pursuant to the provisions of paragraph (a) of this section, the Director may, for good cause, supported by assurances provided by the grantee or transferee, approve one of the following alternatives:
(1) Transfer of the remaining usage obligation to facilities of substantially comparable or greater value or utility, to carry out the biomedical research or training purpose for which the grant was awarded. In this event, the remaining usage obligation shall be released from the original facility constructed with grant funds and transferred to the new facility, and the grantee shall remain subject to all other requirements imposed under this part with respect to the new facility; or
(2) Use the facility for as long as needed, in order of priority, for one of the following purposes:
(i) For other health related activities consistent with the purposes of one or more of the activities of the awarding institute as authorized under title IV or other provisions of the Act;
(ii) To provide training and instruction in the health fields for health professionals or health related information programs for the public; or
(iii) Other health related purposes consistent with one or more of the purposes authorized under the Act.
(d) The right of recovery of the United States set forth in paragraph (a) of this section shall not, prior to judgment, constitute a lien on any facility supported in whole or in part by a federal grant, including a construction grant under this part.
(e) Any amount required to be paid to the United States under this section will be paid to the awarding institute for disposition as required by law.
In addition to any other requirement imposed by law or determined by the Director to be reasonably necessary to fulfill the purposes of the grant, each construction grant shall be subject to the terms and conditions and the grantee assurances required by this section, supported by such documentation as the Director may reasonably require. The Director may, by general policy or for good cause shown by an applicant, approve exceptions to these terms and conditions or assurances where the Director finds that the exceptions are consistent with the applicable provisions of the Act and the purposes of the particular program:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
Grant awards for the acquisition and modernization of existing facilities are permitted if authorized by the statutes authorizing the construction grant program and shall be subject to the requirements of this section.
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(1) “Guidelines for Design and Construction of Hospital and Health Care Facilities” (1996-97). American Institute of Architects Academy of Architecture for Health (AIA); available from AIA Rizzoli Catalogue Sales, 117 Post Street, San Francisco, CA 94108 (telephone 1-800-522-6657, fax 415-984-0024).
(2) 1995 ASHRAE Handbook: Heating, Ventilating, and Air Conditioning Applications (1995), Chapter 13, “Laboratory Systems.” American Society of Heating, Refrigerating and Air Conditioning Engineers, Inc., 1791 Tullie Circle, NE, Atlanta, GA 30329 (telephone 404-636-8400).
(3) ICBO “Uniform Building Code,” Volumes 1-3 (1997). International Conference of Building Officials (ICBO), 5360 South Workman Mill Road, Whittier, CA 90601-2298 (telephone 562-699-0541 or 800-284-4406).
(4) BOCA National Building Code (1996) 1998 Supplement, Building Officials and Code Administrators International, Inc. (BOCA), 4051 West Fossmoor Road, Country Club Hills, IL 60478-5795 (telephone 708-799-4981; fax 708-799-4981).
(5) “Recommended Lateral Force Requirements and Commentary” (1996). Structural Engineers Association of California; available from International Conference of Building Officials, 5360 South Workman Mill Road, Whittier, CA 90601-2298 (telephone 562-699-0541).
(6) “Prudent Practices in the Laboratory: Handling and Disposal of Chemicals” (1995). National Research Council; available from National Academy Press, 8700 Spectrum Drive, Landover, MD 20785 (telephone 1-800-624-6242).
(7) The following material is available for purchase from the National Fire Protection Association (NFPA), 11 Tracy Drive, Avon, MA 02322-9908 (telephone 617-770-3000 or 1-800-735-0100):
(i) NFPA 45, “Standard on Protection for Laboratories Using Chemicals” (1996).
(ii) NFPA 70, “National Electric Code” (1996).
(iii) NFPA 99, Chapter 4, “Gas and Vacuum Systems” (1996).
(iv) NFPA 101, “Life Safety Code” (1997).
(v) NFPA “Health Care Facilities Handbook” (1996).
(8) NSF Standard No. 49 for Class II (Laminar Flow) Biohazard Cabinetry (1992). National Sanitation Foundation (NSF), 3475 Plymouth Road, Box 1468, Ann Arbor, MI 48106 (telephone 734-769-9010).
(9) ACGIH “Industrial Ventilation: A Manual of Recommended Practice” (1998). American Conference of Governmental Industrial Hygienists (ACGIH), 1330 Kemper Meadow Drive, Cincinnati, OH 45240-1634 (telephone 513-742-2020).
(10) AIHA “Laboratory Ventilation Workbook” (1994). American Industrial Hygiene Association (AIHA), 2700 Prosperity Avenue, Suite 250, Fairfax, VA 22031 (telephone 703-849-8888).
(11) The following material is available for purchase from the Southern Building Code Congress (SBCC), 900 Montclair Road, Birmingham, AL 35213-1206 (telephone 205-591-1853; fax 202-591-0075:
(i) SBCC “International Standard Plumbing Code” (1997).
(ii) SBCC “Standard Building Code” (1997).
The Director may with respect to any grant award impose additional conditions consistent with the regulations of this part prior to or at the
Other federal laws, regulations, executive orders, and policies apply to grants under this part. These include, but are not necessarily limited to:
(a)
An Act to Provide for the Preservation of Historical and Archeological Data (and other purposes), as amended (16 U.S.C. 469
(b)
(c)
(d)
(1) Design Policy and Guidelines (1996). Division of Engineering Services, National Institutes of Health (
(2) NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (1994) (
(3) NIH Guidelines for Research Involving Recombinant DNA Molecules (1994) (
(4) “NIH Grants Policy Statement.” NIH Pub. No. 99-80 (Oct. 1998) (Note: To obtain copies of the policy, interested persons should contact the Extramural Outreach and Information Resources Office (EOIRO), Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20892-7910 (telephone 301-435-0714; not a toll-free number). Information may also be obtained by contacting the EOIRO via its e-mail address (asknih@odrockml.od.nih.gov) and by browsing the NIH Home Page site on the World Wide Web (http://www.nih.gov).).
(5) “Guide for the Care and Use of Laboratory Animals (1996). Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council (
(6) “Public Health Service Policy on Humane Care and Use of Laboratory Animals.” (Rev. Sept. 1986). Office for Protection from Research Risks, NIH (Note: To obtain copies of the policy, interested persons should contact the Office for Protection from Research Risks, NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD 20852-7507 (telephone 301-496-7005; not a toll-free number).).
(7) “Biosafety in Microbiological and Biomedical Laboratories.” DHHS Publication No. (CDC) 88-8395 (1993). Centers for Disease Control and Prevention (CDC) (
(8) “NIH Guidelines for the Laboratory Use of Chemical Carcinogens,” DHHS Publication No. (NIH) 81-2385 (May 1981) (
(9) “NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects (March 6, 1998).” NIH Guide for Grants and Contracts (
42 U.S.C. 216, 241(a)(3).
The regulations in this part apply to grants (under the Minority Biomedical Research Support Program) awarded in accordance with section 301(a)(3) of the Public Health Service (PHS) Act (42 U.S.C. 241(a)(3)) to increase the numbers of ethnic minority faculty, students, and investigators engaged in biomedical research, and to broaden the opportunities for participation in biomedical research of ethnic minority faculty, students, and investigators, by providing general support for biomedical research programs at eligible institutions.
As used in this part:
To be eligible for a grant under this Program, an applicant must be:
(a) One of the following:
(1) A public or private nonprofit university, four year college, or other institution offering undergraduate, graduate, or health professional degrees, with a traditionally high (more than 50 percent) minority student enrollment;
(2) A public or private nonprofit two year college with a traditionally high (more than 50 percent) minority student enrollment;
(3) A public or private nonprofit university, four year college, or other institution offering undergraduate, graduate, or health professional degrees, with a student enrollment a significant proportion (but not necessarily more than 50 percent) of which is derived from ethnic minorities, provided the Secretary determines that said institution has a demonstrated commitment to the special encouragement of and assistance to ethnic minority faculty, students, and investigators; or
(4) An Indian tribe which has a recognized governing body which performs substantial governmental functions, or an Alaska Regional Corporation as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601
(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).
An institution interested in applying for a grant under this part must submit an application at the time and in the form and manner that the Secretary may prescribe.
(a) Within the limits of funds available, and upon such recommendation as may be required by law, the Secretary shall award grants to those applications with proposed biomedical research programs which will, in the Secretary's judgment, best promote the purposes of this part, taking into consideration among other pertinent factors:
(1) The benefits that can be expected to accrue to the national effort in biomedical research and in increasing the pool of biomedical researchers;
(2) The institution's capability, from a scientific and technical standpoint, to engage in biomedical research;
(3) The benefits that can be expected to accrue to the institution and its students;
(4) The administrative and managerial capability and competence of the applicant;
(5) The availability of the facilities and resources (including where necessary collaborative arrangements with other institutions) to engage in biomedical research;
(6) The applicant's relative need for funding; and
(7) The overall significance of the proposal in terms of numbers of ethnic minority persons benefited thereby.
(b) The notice of grant award specifies how long HHS intends to support the project without requiring the proj-ect to recompete for funds. This period, called the project period, will usually be for 1-5 years.
(c) Generally the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(a) Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74.
(b) The Secretary may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the Secretary's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.
Several other regulations and policies apply to grants under this part. These include, but are not necessarily limited to:
The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in the Secretary's judgment those conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.
Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 U.S.C. 216); sec. 404(a)(4), 92 Stat. 3426 (42 U.S.C. 285).
The regulations in this part apply to grants under the Clinical Cancer Education Program authorized by section 404(a)(4) of the Public Health Service Act, to encourage planning and development of multidisciplinary educational programs aimed at achieving optimal care of cancer patients and to enable students in the health professions to acquire basic knowledge of neoplastic disease and the preventive measures and diagnostic and therapeutic skills necessary to the provision of such care.
(a)
(b)
(c) [Reserved]
(d)
(e)
(f)
To be eligible for a grant under this part, an applicant must be:
(a) A public or private school of medicine, osteopathy, dentistry, or public health, affiliated teaching hospital, or specialized cancer institute; and
(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust Territory of the Pacific Islands.
(a) Application for a grant under this subpart shall be made on an authorized form.
(b) [Reserved]
(c) In addition to any other pertinent information that the Director, NCI, may require, each application shall set forth in detail:
(1) A program plan defining the objectives of the proposed program and the means by which these objectives would be achieved, including descriptions of:
(i) The general educational level (e.g., pre-doctoral, post-doctoral) of the students to be involved in the program;
(ii) The proposed course of study and its relation to the diagnosis, prevention, control, and treatment of cancer;
(iii) The clinical experiences to be provided to the students;
(iv) Multidisciplinary aspects of the program;
(v) The particular schools or branches within the institution which would have responsibility for individual aspects of the program; and
(vi) The teaching mechanisms to be employed, including specific discussion of those techniques which would be innovative.
(2) The availability of personnel, facilities, and resources needed to carry out the program;
(3) The names, qualifications, and proposed duties of the program director and any staff members who would be responsible for the program, including a description of those duties which would actually be carried out by the program director and those which would be shared with or assigned to others;
(4) The names and qualifications of proposed members of a cancer education committee which would be established by the applicant to advise it on the planning, organization, operation and evaluation of the program and the specific duties which would be assigned to said committee;
(5) Insofar as necessary, cooperative arrangements with other schools, hospitals, and institutions which would participate in the program;
(6) The proposed project period, a detailed budget for the first budget period including a list of other anticipated sources of support and anticipated total needs for each of the succeeding budget periods of the requested project period, and a justification for the amount of grant funds requested;
(7) Proposed methods for monitoring and evaluating the program; and
(8) A description of how the education and training effort will be sustained upon expiration of the award.
(a) If the program is to be offered at the graduate level, it must be multidisciplinary in scope involving at least two or more clinical or preclinical sciences relating to cancer;
(b) The cancer education committee provided for in the approved application must meet at least four times per year, and must be chaired by the program director.
(a) Within the limits of funds available, after consultation with the Board, the Director, NCI, may award grants to applicants with proposed programs which in the NCI Director's judgment best promote the purposes of this part, taking into consideration among other pertinent factors:
(1) The relevance of the proposed program to the objectives of this part;
(2) The extent to which the program would involve innovative teaching techniques;
(3) The availability of adequate staff, facilities, and resources (including where necessary cooperative arrangements with other institutions or hospitals) to carry out the program;
(4) The qualifications and experience of the program director;
(5) The authority of the program director to ensure that the program is planned with multidisciplinary input and that multidisciplinary aspects of the program are carried out;
(6) The extent to which the cancer education committee is broadly representative of the disciplines concerned with cancer care and teaching and is allowed to participate in the planning, organization, operation, and evaluation of the program;
(7) If the program is to be offered at the pre-doctoral level, the extent to which its objectives are designed to aid students:
(i) To acquire a basic understanding of fundamental principles of cancer biology, epidemiology, detection, diagnosis, prevention, treatment and control;
(ii) To interest students in learning more about cancer; and
(iii) To develop an appreciation of the need for a comprehensive multidisciplinary approach to the care of cancer patients;
(8) The administrative and managerial capability of the applicant;
(9) The reasonableness of the proposed budget in relation to the proposed program;
(10) The adequacy of the methods for monitoring and evaluating the program on a continuing basis; and
(11) The degree to which the application adequately provides for the requirements set forth in § 52d.5.
(b) The notice of grant award specifies how long HHS intends to support the program without requiring the program to recompete for funds. This period, called the project period, will usually be for 1-5 years.
(c) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(a) Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the awards, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74, except that grant funds may not be used for costs incurred in connection with activities which, prior to the grant, were part of the grantee's standard curriculum.
(b) The Director, NCI, may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the NCI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.
Several other regulations apply to grants under this subpart. These include, but are not limited to:
The Director, NCI, may with respect to any grant award impose additional conditions prior to or at the time of any award when in the NCI Director's judgment those conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.
42 U.S.C. 216, 285b-1.
(a) This part applies to grants under section 419 of the Act (42 U.S.C. 285b-1) for projects to:
(1) Demonstrate and evaluate the effectiveness of new techniques or procedures for the prevention and control of heart, blood vessel, lung, and blood diseases, with special consideration given to the prevention and control of these diseases in children, and in populations that are at increased risk with respect to such diseases;
(2) Develop and evaluate methods of educating health practitioners concerning the prevention and control of these diseases; and
(3) Develop and evaluate methods of educating the public concerning the prevention and control of these diseases.
(b) For purposes of this part, prevention and control projects shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with public health agencies of State or local governments, with nonprofit private entities that are community-based health agencies, or with other appropriate public or nonprofit private entities.
As used in this part:
To be eligible for a grant under this part, an applicant must be a public or nonprofit private agency or institution.
(a) Application for a grant under this subpart shall be made on an authorized form.
(b) Each private institution which does not already have on file with the National Institutes of Health evidence of nonprofit status, must submit with its application acceptable proof of such status.
(c) In addition to any other pertinent information that the Director may require each application shall set forth in detail:
(1) The nature and purpose of the proposed project and the methods to be employed in carrying it out;
(2) The relevance of the proposed project to the National Program;
(3) The defined population to participate in the proposed project and the rationale for its selection;
(4) With respect to applications relating to projects covered by § 52e.1(a)(1), prior research findings on which the proposed project is based;
(5) The personnel, facilities, and other resources, including community resources, available to carry out the proposed project;
(6) Current activities of the applicant involving prevention or control of heart, blood vessel, lung, and blood diseases, the sources of funding for such activities, and the anticipated relationship of these activities to the proposed project;
(7) The names and qualifications of the project director and key staff members who would be responsible for conducting the proposed project;
(8) Proposed methods for monitoring and evaluating the project; and
(9) The proposed project period; a detailed budget for the first budget period, including a list of other anticipated sources of support and anticipated total needs for each of the succeeding budget periods of the requested project period; and a justification for the amount of grant funds requested.
(a) An approvable application must demonstrate to the satisfaction of the Director that:
(1) With respect to applications relating to projects covered by § 52e.1(a)(1), the techniques or procedures to be demonstrated and evaluated have been found safe and effective in the research setting and, based upon research findings, appear to have the potential for general applicability to the prevention, diagnosis, or treatment of heart, blood vessel, lung, or blood diseases;
(2) With respect to applications relating to projects covered by § 52e.1(a)(2) and § 52e.1(a)(3), the proj-ect will include development and evaluation of one or more methods for educating health practitioners or the public concerning advances in the prevention, diagnosis, or treatment of such diseases; and
(3) The nature of the project is such that its completion may be anticipated within the project period, or such other period as may be specified in the application.
(b) The project must, in the judgment of the Director, be necessary for cooperation by the National Heart, Lung, and Blood Institute with one or more other Federal Health agencies, State, local or regional public health agencies, or nonprofit private health agencies in the diagnosis, prevention, or treatment of heart, blood vessel, lung or blood diseases.
(a) Within the limits of funds available, after consultation with the Council, the Director may award grants to applicants with proposed projects which in the Director's judgment will best promote the purposes of section 419 of the Act, taking into consideration among other pertinent factors:
(1) The scientific and technical merit of the proposed project;
(2) The significance of the project in relation to the goals of the National Program;
(3) Whether the project appropriately emphasizes the prevention, diagnosis, or treatment of heart, blood vessel, lung, or blood diseases of children;
(4) The qualifications and experience of the project director and other key personnel;
(5) The administrative and managerial capability and fiscal responsibility of the applicant;
(6) The reasonableness of the proposed budget in relation to the proposed project;
(7) The adequacy of the methods proposed for monitoring and evaluating the proposed project; and
(8) The degree to which the application adequately provides for the requirements set forth in §§ 52e.5(a) and 52e.5(b).
(b) The notice of grant award specifies how long HHS intends to support the project without requiring the proj-ect to recompete for funds. This period,
(c) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(e) Any funds granted under this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms, and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.
(a) Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74.
(b) The Director may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the NHLBI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.
Several other regulations apply to grants under this part. These include but are not necessarily limited to:
The Director, may with respect to any grant award impose additional conditions prior to or at the time of any award when in the Director's judgment those conditions are necessary to assure or protect advancement of the approved project, the interests of the public health, or the conservation of grant funds.
Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 351 (42 U.S.C. 289
The regulations in this part apply to:
(a) Applications for grants for biomedical and behavioral research, under the Act to the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; or any of their components; or the Division of Nursing, Bureau of Health Professions, Health Resources and Services Administration. These regulations do not apply to applications for:
(1) Continuation funding for budget periods within an approved project period;
(2) Supplemental funding to meet increased administrative costs within a project period; or
(3) Construction grants.
(b) Biomedical and behavorial research and development contract projects administered by the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; or any of their components; or the Division of Nursing, Bureau of Health Professions, Health Resources and Services Administration.
(c) Applications for grants and contracts under section 2008 of the Act.
As used in this part:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(a) To the extent applicable, the Federal Advisory Committee Act (5 U.S.C. App. I), Department of Health and Human Services (45 CFR part 11), implementing regulations and chapter 9 of the Department of Health and Human Services General Administration Manual
(b) Subject to § 52h.5 and paragraph (a) of this section, the Director of the National Institutes of Health, the Administrator of the Alcohol, Drug Abuse and Mental Health Administration, and the Administrator of the Health Resources and Services Administration will adopt procedures for the conduct of reviews and the formulation of recommendations under §§ 52h.7, 52h.9 and 52h.10 within their respective agencies.
(a) To the extent applicable, the selection and appointment of members of peer review groups and their terms of service will be governed by Chapter 9 of the Department of Health and Human Services General Administration Manual.
(b) Subject to paragraph (a) of this section, members will be selected based upon their training and experience in
(1) The level of formal scientific or technical education completed or experience acquired by the individual;
(2) The extent to which the individual has engaged in relevant research, the capacities (e.g., principal investigator, assistant) in which the individual has done so, and the quality of such research;
(3) Recognition as reflected by awards and other honors received from scientific and professional organizations outside the Department of Health and Human Services; and
(4) The need for the group to have included within its membership experts from various areas of specialization within relevant scientific or technical fields.
(c) Not more than one-fourth of the members of any peer review group to which these regulations are applicable may be officers or employees of the United States. For purposes of the preceding sentence, membership on such groups does not make an individual an officer or employee of the United States.
(a) Members of peer review groups covered by this part are subject to relevant provisions in title 18 of the United States Code, relating to criminal activity, the Department of Health and Human Services Standards of Conduct (45 CFR part 73), and Executive Order 11222, as amended.
(b) In addition to any restrictions imposed under paragraph (a) of this section:
(1) No member of a peer review group may participate in or be present during any review by said group of a grant application, contract project, or contract proposal in which, to the member's knowledge, any of the following has a financial interest: (i) The member or his or her spouse, parent, child, or partner, (ii) any organization in which the member or his or her spouse, parent, child, or partner is serving as an officer, director, trustee, partner, or employee, or is otherwise similarly associated, or (iii) any organization with which the member or his or her spouse, parent, child, or partner is negotiating or has any arrangement concerning prospective employment or other similar association.
(2) In the event any member of a peer review group or his or her spouse, parent, child, or partner is currently or expected to be the principal investigator or member of the staff responsible for carrying out any research or development activities contemplated as part of a grant application, contract project, or contract proposal, that group is disqualified and the review will be conducted by another group with the expertise to do so. If there is no other group with the requisite expertise, the review will be conducted by an ad hoc group no more than 50 percent of whose members may be from the disqualified group. The composition of any such ad hoc group will be determined in accordance with § 52h.4(b) and § 52h.4(c) of this part and, to the extent feasible, § 52h.4(a) of this part.
(3) Where a member of a peer review group participates in or is present during:
(i) Development or review of a proj-ect approach or request for proposals by said group or
(ii) Review by said group under § 52h.10(b) or § 52h.10(c), i.e. after the issuance of a request for proposals, no contract may thereafter be awarded as the result of such development or review to said member, his or her spouse, parent, child, or partner or any organization in which the member, his or her spouse, parent, child, or partner was serving as officer, director, trustee, partner, or employee at the time of such development or review or with which the member, his or her spouse, parent, child, or partner was negotiating or had any arrangement concerning prospective employment at said time.
(4) No member of a peer review group may participate in any review under this part of a specific grant application or contract project for which the member has had or is expected to have any other responsibility or involvement (whether preaward or postaward) as an officer or employee of the United States.
(c) Where permissible under the statutes, standards, and order cited in paragraph (a) of this section, the Director of the National Institutes of Health, the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, the Administrator of the Health Resources and Services Administration, or their designees may waive the requirements in paragraph (b) of this section if he or she determines that there is no other practical means for securing appropriate expert advice on a particular grant application, contract project, or contract proposal.
Transcripts, minutes, and other documents made available to or prepared for or by a peer review group will be available for public inspection and copying to the extent provided in the Freedom of Information Act (5 U.S.C. 552), the Federal Advisory Committee Act (5 U.S.C. App. I), the Privacy Act (5 U.S.C. 552a), and implementing Department of Health and Human Services regulations (45 CFR parts 5, 5b).
(a) No awarding official will make a grant based upon an application covered by this part unless the application has been reviewed by a peer review group in accordance with the provisions of this part and said group has made recommendations concerning the scientific merit of such application. In addition, where under applicable law an awarding official is required to secure the approval or advice of a national advisory council or board concerning an application, said application will not be considered by the council or board unless it has been reviewed by a peer review group in accordance with the provisions of this part and said group has made recommendations concerning the scientific merit of the application except where the council or board is the peer review group.
(b) Except to the extent otherwise provided for by law, such recommendations are advisory only and not binding on the awarding official or national advisory council or board.
In carrying out its review under § 52h.7, the peer review group will take into account, among other factors:
(a) The significance and originality from a scientific or technical standpoint of the goals of the proposed research;
(b) The adequacy of the methodology proposed to carry out the research;
(c) The qualifications and experience of the principal investigator and proposed staff;
(d) The reasonable availability of resources necessary to the research;
(e) The reasonableness of the proposed budget and duration in relation to the proposed research; and
(f) Where an application involves activities which could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects.
(a) No awarding official will award a contract based upon an unsolicited contract proposal covered by this part unless the proposal has been reviewed by a peer review group in accordance with the provisions of this part (pursuant to procedures set forth in 41 CFR subpart 3-4.52) and said group has made recommendations concerning the scientific merit of such proposal.
(b) Except to the extent otherwise provided for by law, such recommendations are advisory only and not binding on the awarding official.
(a) Subject to paragraph (b) of this section, no awarding official will issue a request for contract proposals with respect to a contract project involving solicited contract proposals unless the project concept has been reviewed by a peer review group in accordance with the provisions of this part and said
(b) The awarding official may waive the requirements of paragraph (a) of this section for peer review before issuing a request for contract proposals if he determines that the accomplishments of essential program objectives would otherwise be placed in jeopardy and any further delay would clearly not be in the best interest of the Government. The awarding official shall specify in writing the grounds on which this determination is based. Under such circumstances, the awarding official will not award a contract based on the request for contract proposals unless the proposals received in response to the request have been reviewed by a peer review group and that group has made recommendations concerning the scientific merit of the project concept and of the approaches outlined in the proposals. The request for proposals will indicate that the project concept has not been reviewed by a peer review group and that no award will be made until such review is conducted and recommendations made based on such review.
(c) The Director of the National Institutes of Health, the Administrator of the Alcohol, Drug Abuse and Mental Health Administration, the Administrator of the Health Resources and Service Administration, or their designees may identify individual contracts or classes of contracts which may not be awarded unless all pertinent contract proposals have been reviewed by a peer review group in accordance with the provisions of this part and that group has made recommendations concerning the scientific merit of the proposals.
(d) Except to the extent otherwise provided for by law, such recommendations are advisory only and not binding on the awarding official.
(a) In carrying out its review of a project concept under § 52h.10(a) or § 52h.10(b), the peer review group will take into account, among other factors:
(1) The significance from a scientific or technical standpoint of the goals of the proposed research or development activity;
(2) The availability of the technology and other resources necessary to achieve these goals;
(3) The extent to which there are identified, practical uses for the anticipated results of the activity; and
(4) Where the review includes the project approach, the adequacy of the methodology to be utilized in carrying out the activity.
(b) In carrying out its review of unsolicited contract proposals under § 52h.9, the peer review group will take into account, among other factors, those criteria in § 52h.8 which are relevant to the particular proposals.
(c) In carrying out its review of solicited contract proposals under § 52h.10(c) the peer review group will evaluate each proposal in accordance with the criteria set forth in the request for proposals.
The regulations in this part are in addition to, and do not supersede other regulations concerning grant applications, contract projects, or contract proposals appearing elsewhere in this title, title 41, or title 45 of the Code of Federal Regulations.
Secs. 215, 603, 609, 621, 623, Public Health Service Act as amended, 58 Stat. 690, 78 Stat. 451 and 456, 84 Stat. 344 and 346 (42 U.S.C. 216, 291c, 291i, 291j-1 and 291j-3; 31 U.S.C. 9701).
(a)
(b)
(1) The term
(2) The term
(3)
(4) The term
(5) The term
(6) The term
(7)
(c)
(2) Prior to recommending that such requirement be waived, the State agency shall publish in a newspaper of general circulation in the area served by the applicant a notice of the request for such waiver and invite public comment thereon, allowing not less than 30 days therefor. All comments received shall be available for public inspection, and shall be considered by the State agency in arriving at its recommendation. Notice of the determination on the request for waiver shall be given to all interested persons and to the public before the approval of the Secretary is sought.
(d)
(e)
(2) With respect to each fiscal year for which a level of uncompensated services has been established in accordance with this section, the annual statement shall also set forth the amount of uncompensated services provided in such year.
(i) The provision of a level of uncompensated services in such year which equals or exceeds the level established pursuant to paragraph (h) of this section for such year shall constitute compliance with the assurance.
(ii) If the level of services provided was less than the level of uncompensated services established pursuant to paragraph (h) of this section, the applicant shall submit with such statement: A justification therefor, showing that the provision of such lower level of uncompensated services was reasonable under the circumstances; and a description of the steps it proposes to take to assure the availability and utilization of the level of uncompensated services to be established for the current fiscal year, which shall include an affirmative action plan, utilizing press releases or other appropriate means as the facility may desire to bring to the attention of the public the availability of such uncompensated services and the conditions of eligibility therefor.
(3) Each applicant shall file with its annual statement a copy of that portion of its adopted budget for the current fiscal year relating to the support of uncompensated services in such year. Such budget for uncompensated services shall be based on the operating costs of the applicant for the preceding
(i) A justification therefor, showing that such lower level of uncompensated services is reasonable under the circumstances, and
(ii) A plan to increase such uncompensated services to meet the presumptive compliance guideline or such other level of uncompensated services as may have been established or as it requests the State agency to establish in accordance with paragraph (h) of this section.
(4) The applicant shall also submit such additional reports related to compliance with its assurance as the State agency may reasonably require.
(5) Pending the establishment of a level of uncompensated services for any fiscal year pursuant to paragraph (h) of this section, the applicant shall, in such fiscal year, provide a level of services which is the higher of
(i) The level established for the preceding fiscal year (or if no such level has been established for such prior year, the level of services provided in such year) or
(ii) The level proposed in its adopted budget for the current fiscal year.
(f)
(i) Such determination may be made after the provision of such services in the case of services provided on an emergency basis:
(ii) Such determination may be made after the provision of such services in the case of a change in circumstances as a result of the illness or injury occasioning such services (e.g., the patient's financial condition has changed due to a loss of wages resulting from the illness) or in case of insurance coverage or other resources being less than anticipated or the costs of services being greater than anticipated.
(2) There shall be excluded from the computation of uncompensated services:
(i) Any amount which the applicant has received, or is entitled to receive, from a third party insurer or under a governmental program; and
(ii) The reasonable cost of any services for which payment in whole or in part would be available under a governmental program (e.g., Medicare and Medicaid) in which the applicant, although eligible to do so, does not participate, but only to the extent of such otherwise available payment.
(g)
(i) The health and medical care insurance coverage, personal or family income, the size of the patient's family, and other financial obligations and resources of the patient or the family in relation to the reasonable cost of the services;
(ii) Generally recognized standards of need such as:
(
(
(
(iii) Any other equivalent measures which are found by the Secretary to provide a reasonable basis for determining an individual's ability to pay for medical and hospital services.
(2) A copy of such criteria shall be provided by the applicant, upon request, to any patient or former patient of the applicant and to any person seeking services from the applicant.
(3) The State agency shall provide a copy of such criteria to any person requesting it.
(h)
(2) The State agency shall for the purpose of making such determination, review, and evaluate the annual statement, the budget and the related documents submitted by each applicant pursuant to paragraph (e) of this section, by applying the following criteria:
(i) The financial status of the applicant, taking account of income from all sources, and its financial ability to provide uncompensated services;
(ii) The nature and quantity of services provided by the applicant;
(iii) The need within the area served by the applicant for the provision, without charge or at charge which is less than reasonable cost, for services of the nature provided or to be provided by the applicant; and
(iv) The extent and nature of joint or cooperative programs with other facilities for the provision of uncompensated services, and the extent and nature of outreach services directed to the needs of underserved areas.
(3) In accordance with its findings made after such review and evaluation, the State agency shall, within 60 days after receipt of the annual statement and related documents required by paragraph (e) of this section, for each fiscal year of an applicant which begins following the expiration of 90 days after the effective date of this regulation:
(i) Establish a level of uncompensated services for each applicant which may be equal to or less than the presumptive compliance guideline:
(ii) Accept or modify a plan submitted pursuant to paragraph (e) of this section.
(4) The State agency shall notify the applicant in writing of the level of uncompensated services which it has established for the applicant for the fiscal year. At the time of notifying the applicant, the State agency shall also publish as a public notice in a newspaper of general circulation within the community served by the applicant the rate that has been established and a statement that the documents upon which the agency based its determination are available for public inspection at a location and time prescribed. In the case of the establishment by the State agency of a rate which is less than the presumptive compliance guideline, such notice shall also include a statement that persons wishing to object to the rate established may do so by writing to the State agency within 20 days after publication of the notice:
(5) In accordance with the provisions of paragraph (h)(4) of this section, the
(6) Within 20 days of receipt of written notice of the final determination of a State agency after ruling on objections to the rate established by the State agency, the applicant or any other interested person or organization may submit to the Secretary a written request for review of the State agency determination. Such review shall be made upon the record of the State agency determination which shall be sustained if supported by substantial evidence and is not otherwise arbitrary or capricious. If the Secretary or his designee determines that the rate established by the State agency is unsupported by the evidence in the record or is otherwise arbitrary or capricious, the Secretary or his designee shall, upon the basis of the record or upon other evidence or information which is before him or which he may obtain, establish a level of uncompensated services which he determines, in accordance with the criteria set out in paragraph (h)(2) of this section, is appropriate.
(7) The level of uncompensated services established for an applicant under this section for any fiscal year shall constitute a reasonable volume of services to persons unable to pay therefor with respect to such applicant for such fiscal year.
(i)
This hospital (or other facility) is required by law to give a a reasonable amount of service at no cost or less than full cost to people who cannot pay. If you think that you are eligible for these services, please contact our business office (give office location) and ask for assistance. If you are not satisfied with the results, you may contact (the State Hill-Burton agency with address).
(j)
(1) The State agency shall,
(i) At least annually, perform evaluations of the amount of the various services provided in each facility with respect to which Federal assistance has been provided under the Act, to determine whether such assurance is being complied with; and
(ii) Establish procedures for the investigation of complaints that such assurance is not being complied with.
(2) Evaluation pursuant to paragraph (j)(1) of this section shall be based on the annual budget of each facility for uncompensated services and on financial statements of such facilities filed pursuant to section 646 of the Act and § 53.128(q), and on such other information, including reports of investigations and hearing decisions, as the State agency deems relevant and material.
(3) The State plan shall provide for adequate methods of enforcement of the assurance, including effective sanctions to be applied against any facility which fails to comply with such assurance. Such sanctions may include, but need not be limited to, license revocation, termination of State assistance, and court action.
(k)
(2) In addition, the State agency shall promptly report to the Regional Attorney and Regional Health Director of the Department of Health and Human Services the institution of any legal action against a facility or the State agency involving compliance with the assurance.
(a) Before an application is recommended by a State agency to the Secretary for approval, the State agency shall obtain an assurance from the applicant that all portions and services of the entire facility for the construction or modernization of which, or in connection with which, aid under the Act is sought will be made available without discrimination on account of creed and no professionally qualified person will be discriminated against on account of creed with respect to the privilege of professional practice in the facility.
(b) Each construction contract is subject to the condition that the applicant shall comply with the requirements of Executive Order 11246, September 24, 1965 (30 FR 12319), relating to nondiscrimination in construction contract employment, and the applicable rules, regulations, and procedures prescribed pursuant thereto.
(c) Attention is called to the requirement of title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d; 78 Stat. 252) which provides that no person in the United States shall, on the ground of race, color, or national origin be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. A regulation implementing such title VI, applicable to assistance under this part for construction and modernization of hospitals and medical facilities, has been issued by the Secretary of Health and Human Services with the approval of the President (45 CFR part 80).
(a)
(b)
(1) The term
(2) The term
(3) The term
(4) The term
(c)
(d)
(1)(i) Make the services it furnishes available to the general public, or
(ii) Limit the availability of such services only on the basis of age, medical indigency, or type or kind of medical or mental disability, or
(iii) If the facility constitutes a medical or nursing care unit of a home or other institution, make such home or other institution available in accordance with paragraph (d)(1) (i) or (ii) of this section;
(2)(i) Make arrangements, if eligible to do so, for reimbursement for services with:
(A) Those principal State and local governmental third-party payors which provide reimbursement for services that is not less than the actual cost of such services as determined in accordance with accepted cost accounting principles; and
(B) Those Federal governmental third-party programs, such as Medicare and Medicaid, to the extent that the applicant is entitled to reimbursement at reasonable cost under a formula established in accordance with applicable Federal law.
(ii) Take such additional steps as may be necessary to ensure that admission to and services of the facility will be available to beneficiaries of the governmental programs specified in paragraph (d)(2)(i) of this section without discrimination (or preference) on account of their being such beneficiaries.
(e)
(f)
(1) The State agency shall,
(i) At least annually, evaluate the compliance of facilities with such assurance; and
(ii) Establish procedures for the investigation of complaints that such assurance is not being complied with.
(2) The State plan shall provide for adequate methods of enforcement of the assurance, including effective sanctions to be applied against any facility which fails to comply with such assurance. Such sanctions may include, but need not be limited to, license revocation, termination of State assistance and court action.
(g)
(2) In addition, the State agency shall promptly report to the Regional Attorney and Regional Health Director of the Department of Health and Human Services the institution of any legal action against a facility or the State agency involving compliance with the assurance.
In determining whether there is good cause for waiver of any right of recovery which he may have against a nonprofit private agency by reason of any payments made pursuant to a loan guarantee, or against a public agency by reason of the failure of such agency to make payments of principal and interest on a direct loan to such agency,
(a) The facility with respect to which the loan guarantee or direct loan was made will continue to be devoted by the applicant or other owner to use for the purpose for which it was constructed or another public or nonprofit purpose which will promote the purposes of the Act;
(b) There are reasonable assurances that for the remainder of the repayment period of the loan other public or non-profit facilities not previously utilized for the purpose for which the facility was constructed will be so utilized and are substantially equivalent in nature and extent for such purposes; and
(c) Such recovery would seriously curtail the provision of medical services to persons in need of such services in the area.
No official of the Department of Health and Human Services will approve any proposal to modify the terms of a loan guaranteed under title VI of the Public Health Service Act (42 U.S.C. 291
(a) Fees will be charged for the processing of requests for parity, and for major and minor modifications of the terms of documents evidencing and securing direct and guaranteed loans. In accordance with the requirements of the User Charge Statute, 31 U.S.C. 9701(b), the Secretary determines the amount of the application fee that must be submitted with each type of modification.
(1) As used in this section, a
(2) As used in this section, a
(3) As used in this section, a
(b) A request for modification is to be accompanied by a certified check or money order in the amount of the appropriate fee, payable to the U.S. Treasury. The fees for modification requests submitted on or after October 28, 1986 are as follows:
(1) $1,500 for a minor modification,
(2) $4,500 for a major modification, and
(3) $5,500 for a request for parity.
(c) A submitter may withdraw its request for modification within 10 business days following its receipt and receive a refund of the fee.
(d) If the Secretary determines that a change in the amount of a fee is appropriate, the Department will issue a notice of proposed rulemaking in the
Sec. 427(a), Federal Mine Safety and Health Act of 1977, 92 Stat. 100 (30 U.S.C. 937(a)).
Any State or public or private entity may apply for a grant under this part.
(a) The Secretary will give preference to a State, which meets the requirements of this part and applies for a grant under this part, over other applicants in that State.
(b) Within the limits of funds available for these purposes the Secretary may award grants to assist in the carrying out of those programs which will in the Secretary's judgment best promote the purposes of section 427(a) of the Act, taking into account;
(1) The number of miners to be served and their needs; and
(2) The quality and breadth of services to be provided.
All information as to personal facts and circumstances obtained by the grantee's staff about recipients of services shall be held confidential and shall not be disclosed without the individual's consent except as may be required by law or as may be necessary to provide service to the individual or to provide for audits with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.
Grantees must carry out their projects in accordance with their applications and the provisions of this part.
The Secretary may, for good cause shown, waive provisions of these regulations.
Other regulations which apply to the Black Lung Clinics Program include, but are not limited to, the following:
An approvable State application must contain assurances that the State will:
(a) Provide the following services for active and inactive miners in the State:
(1) Primary care;
(2) Patient and family education and counseling;
(3) Outreach;
(4) Patient care coordination, including individual patient care plans for all patients;
(5) Antismoking advice; and
(6) Other symptomatic treatments.
(b) Provide medical services in consultation with a physician with special training or experience in the diagnosis and treatment of respiratory diseases.
(c) Meet all criteria for approval and designation by the Department of Labor under 20 CFR part 725 to perform disability examination and provide treatment under the Act.
(d) Use grant funds under this part to supplement and not supplant existing services of the State.
(e) Provide the services described above for those miners previously served by a Black Lung Clinic in the State for which grant support expires during the funding period of the State's grant.
(f) Provide services described above regardless of a person's ability to pay.
(g) Audit its expenditures from amounts received under this part in accordance with the provisions of Attachment P, Audit Requirements, of Office of Management and Budget Circular A-102, Uniform Requirements for Assistance to State and Local Governments, as adopted for the Department of Health and Human Services by 45 CFR part 74.
An approvable application must contain the following:
(a) A plan for the provision of the services required by § 55a.201(a), consistent with the requirements of § 55a.201 (b) and (c). The plan must also contain at least the following elements:
(1) A description of the target population to whom services are to be provided, including a statement of the need for services;
(2) An assurance that charges shall be made for services rendered as follows:
(i) A schedule shall be maintained listing fees or payments for the provision of services, designed to cover reasonable costs of operations;
(ii) A schedule of discounts adjusted on the basis of a patient's ability to pay shall be maintained. The schedule of discounts must provide for a full discount to individuals and families with annual incomes at or below the poverty line established in accordance with section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)), (except that nominal fees for service may be requested, but not required, from individuals and families with annual incomes at or below the poverty line). No discounts shall be provided to individuals and families with annual incomes greater than twice the poverty line; and
(iii) Where third-party payors (including Government Agencies) are authorized or under a legal obligation to pay all or a portion of such charges, all services covered by that reimbursement plan will be billed and every reasonable effort will be made to obtain payment.
(b) An assurance that no person will be denied services because of inability to pay.
(c) An assurance that grant funds received under this part will be used to
Secs. 215, 319, Public Health Service Act (42 U.S.C. 216, 247d).
The regulations of this subpart are applicable to all grants authorized by section 319 of the Public Health Service Act (42 U.S.C. 247d).
As used in this part:
(a)
(b)(1)
(i) Cultivation and tillage of the soil;
(ii) The production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in, or on, the land; and
(iii) Any practice (including preparation and processing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in subsection (ii).
(c)
(d)
(e)
(f)
(g)(1)
(i) Primary health services;
(ii) As determined by the Secretary to be appropriate for particular centers, supplemental health services necessary for the adequate support of primary health services;
(iii) Referral to providers of supplemental health services and payment, as determined by the Secretary to be appropriate and feasible, for the provision of such services;
(iv) Environmental health services, as determined by the Secretary to be appropriate for particular centers;
(v) As determined by the Secretary to be appropriate for particular centers, infectious and parasitic disease screening and control services;
(vi) As determined by the Secretary to be appropriate for particular centers, accident prevention programs, including prevention of excessive exposure to pesticides through, but not limited to, notification of appropriate Federal, State or local authorities of hazardous conditions due to pesticide use; and
(vii) Information on the availability and proper use of health services.
(2) For purposes of paragraph (g)(1) of this section, the provision of a given service by a center will be determined by the Secretary to be appropriate where
(i) There is a need, as determined by the Secretary, for the provision of such service to individuals described in paragraph (g)(1) of this section in the catchment area; and
(ii) The provision of such service by the center is feasible, taking into consideration the center's projected revenues, other resources, and grant support under this part.
(h)
(i)
(j)
(k)
(l)
(1) Diagnostic, treatment, consultative referral, and other services rendered by physicians and, where feasible, by physicians' extenders, such as physicians' assistants, nurse clinicians, and nurse practitioners;
(2) Diagnostic laboratory services and diagnostic radiologic services;
(3) Preventive health services, including children's eye and ear examinations, prenatal and post-partum care, perinatal services, well child care (including periodic screening), immunizations, and voluntary family planning services;
(4) Emergency medical services, including provision, through clearly defined arrangements, for access of users of the center to health care for medical and dental emergencies during and after the center's regularly scheduled hours;
(5) Transportation services as needed for adequate patient care, sufficient so that residents of the catchment area served by the center with special difficulties of access to services provided by the center receive such services; and
(6) Preventive dental services provided by a licensed dentist or other qualified personnel, including—
(i) Oral hygiene instruction;
(ii) Oral prophylaxis, as necessary; and
(iii) Topical application of fluorides, and the prescription of fluorides for systemic use when not available in the community water supply.
(m)
(n)
(o)
(1) Inpatient and outpatient hospital services;
(2) Home health services;
(3) Extended care facility services;
(4) Rehabilitative services (including physical and occupational therapy) and long-term physical medicine;
(5) Mental health services, including services of psychiatrists, psychologists, and other appropriate mental health professionals;
(6) Dental services other than those provided as primary health services;
(7) Vision services, including routine eye and vision examinations and provision of eyeglasses, as appropriate and feasible;
(8) Allied health services;
(9) Pharmaceutical services, including the provision of prescription drugs;
(10) Therapeutic radiologic services;
(11) Ambulatory surgical services;
(12) Public health services (including nutrition education and social services);
(13) Health education services; and
(14) Services including the services of outreach workers, which promote and facilitate optimal use of primary health services and services referred to in the preceding subparagraphs of this paragraph and, if a substantial number of individuals in the population served by the center are of limited English-speaking ability, the services of outreach workers and other personnel fluent in the language or languages spoken by such individuals.
Any public or nonprofit private entity is eligible to apply for a grant under this part.
(a) An application for a grant under this part shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe.
(b) The application shall contain a budget and narrative plan of the manner in which the applicant intends to conduct the project and carry out the requirements of this part. The application must describe how and the extent to which the project has met, or plans to meet, each of the requirements in subpart B (relating to grants for planning and development of migrant health centers), subpart C (relating to grants for the operation of migrant health centers), subpart D (relating to grants for the operation of migrant health entities), subpart E (relating to grants for planning and developing migrant health programs), subpart F (relating to grants for the operation of migrant health programs), or subpart G (relating to grants for technical assistance), as applicable. In addition, applications must include:
(1) A statement of specific, measurable objectives and the methods to be used to assess the achievement of the objectives in specified time periods and at least on an annual basis.
(2) The precise boundaries of the catchment area to be served by the applicant. In addition, the application shall include information sufficient to enable the Secretary to determine that the applicant's catchment area meets the following criteria:
(i) The size of such area is such that the services to be provided by the applicant are available and accessible to the residents of the area promptly and as appropriate;
(ii) The boundaries of such area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and areas served by Federal and State health and social service programs; and
(iii) The boundaries of such area eliminate, to the extent possible, barriers resulting from the area's physical characteristics, its residential patterns, its economic and social groupings, and available transportation.
(3)(i) The number of migratory agricultural workers and members of their families, and seasonal agricultural workers and members of their families which resided in the project's catchment area in the most recent calendar year for which statistical data acceptable to the Secretary is available; and
(ii) The approximate period or periods of residence of all groups of migratory agricultural workers and their families counted under paragraph (b)(3)(i) of this section.
(4) The results of an assessment of the need that the population to be served has for the services to be provided by the project (or in the case of applications for planning and development projects, the methods to be used in assessing such need), taking into consideration the following factors:
(i) Available health resources in relation to size of the catchment area and population of migratory and seasonal agricultural workers and their families in such area, including appropriate ratios of primary care physicians in general or family practice, internal medicine, pediatrics, or obstetrics and gynecology, to such population;
(ii) Health indices for such population, such as infant mortality rate;
(iii) Economic factors affecting such population's use of health services, such as percentage of such population with incomes below the poverty level;
(iv) Demographic factors affecting such population's need and demand for health services, such as percentage of such population age 65 and over; and
(v) Special factors of access resulting from the conditions of employment of such workers (including working hours, housing, and sanitation).
(5) Position descriptions for personnel who will be utilized in carrying out the activities of the project and a statement indicating the need for the positions to be supported with grant funds to accomplish the objectives of the project.
(6) Letters and other forms of evidence showing that efforts have been made to secure financial and professional assistance and support for the project within the proposed catchment area and the continuing involvement of the community in the development and operation of the project.
(7) An assurance that an independent certified public accountant will be engaged to certify that the project's system for the management and control of its finances will be in accord with sound financial management practices, including applicable Federal requirements.
(8) A list of all services proposed to be provided by the project.
(9) A list of services which are to be provided directly by the project through its own staff and resources and a description of any contractual or other arrangements (including copies of documents, where available) entered into, or planned for the provision of services.
(10) The schedule of fees and/or payments and schedule of discounts for services provided by the project.
(11) If the applicant provides services to populations other than migratory and seasonal agricultural workers and their families, identification of such populations.
Funds granted under this part and non-Federal funds required to be expended by
(12) Evidence that all applicable requirements for review and/or approval of the application under title XV of the Act have been met.
(13) An assurance that the project will be conducted in accordance with the applicable requirements of this part.
(c) The application must be executed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the statute, the applicable regulations of this part, and any additional conditions of the grant.
A grant may be made under this part only if the applicable requirements of title XV of the Act relating to review and approval by the appropriate health planning agencies have been met.
(a) The amount of any award under this part will be determined by the Secretary on the basis of his estimate of the sum necessary for a designated portion of direct project costs plus an additional amount for indirect costs, if any, which will be calculated by the Secretary either:
(1) On the basis of the estimate of the actual indirect costs reasonably related to the project; or
(2) On the basis of a percentage of all, or a portion of, the estimated direct costs of the project when there are reasonable assurances that the use of such percentage will not exceed the approximate actual indirect costs. Such award may include an estimated provisional amount for indirect costs or for designated direct costs (such as fringe benefit rates) subject to upward (within the limits of available funds) as well as downward adjustments to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary:
(i) In determining the percentage of project costs to be borne by the grantee, factors which the Secretary will take into consideration will include the following:
(A) The ability of the grantee to finance its share of project costs from non-Federal sources;
(B) The need in the area served by the project for the services to be provided; and
(C) The extent to which the project will provide services in an innovative manner which the Secretary desires to stimulate in the interest of developing more effective health service delivery systems on a regional or national basis.
(ii) At any time after approval of an application under this part, the Secretary may retroactively agree to a percentage of project costs to be borne by the grantee lower than that determined pursuant to paragraph (a)(2)(i) of this section where he finds that changed circumstances justify a smaller contribution.
(iii) In determining the grantee's share of project costs, costs borne by Federal grant funds, or costs used to match other Federal grants, may not be included except as otherwise provided by law or regulations.
(b) All grant awards shall be in writing, and shall set forth the amount of funds granted and the period for which support is recommended.
(c) Neither the approval of any proj-ect nor any grant award, shall commit or obligate the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved project or portion thereof. For continuation support, grantees must make separate application.
(a) Grants under sections 319(c) (1)(A), 319(d)(1)(A), 319(d)(1)(B) of the Act and subparts B, C, and D of this
(1) Highest priority will be given to approvable applications which propose to serve catchment areas in which 6,000 or more migratory agricultural workers and members of their families reside for more than two months in the calendar year.
(2) Second priority will be given to approvable applications which propose to serve catchment areas in which fewer than 6,000 but more than 1,000 migratory agricultural workers and members of their families reside for more than two months in the applicable calendar year.
(3) Third priority will be given to approvable applications which propose to serve catchment areas in which migratory agricultural workers and members of their families reside but in which fewer than 1,000 such persons reside for more than two months in the applicable calendar year.
(4) Fourth priority will be given to approvable applications which propose to serve catchment areas in which migratory agricultural workers and members of their families reside in the applicable calendar year but in which no such persons reside for more than two months in such year.
(5) Fifth priority will be given to approvable applications which propose to serve catchment areas in which no migratory agricultural workers or members of their families reside for any period in the applicable calendar year but in which 6,000 or more seasonal agricultural workers and the members of their families reside.
(6) Lowest priority will be given to approvable applications which propose to serve catchment areas in which no migratory agricultural workers or members of their families reside for any period in the applicable calendar year and in which fewer than 6,000 seasonal agricultural workers and the members of their families reside.
(b) Grants under sections 319(c) (1)(B) and 319(d)(1)(C) of the Act and subparts E and F of this part will be made in accordance with priorities set forth in paragraphs (a)(2) through (a)(6) of this section, in the order set forth.
(c) For the purposes of this section, the applicable calendar year will be the calendar year for which data is provided in accordance with § 56.104(b)(3) of this subpart.
(a) Any funds granted pursuant to this part, as well as other funds to be used in performance of the approved project, may be expended solely for carrying out the approved project in accordance with section 319 of the Act, the applicable regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.
(b) Project funds awarded under this part may be used for, but need not be limited to, the following:
(1) The costs of acquiring and modernizing existing buildings (including the costs of amortizing the principal of, and paying interest on, loans), but only in accordance with subpart H of this part and as approved in the grant award;
(2) The costs of obtaining technical assistance to develop and improve the management or service capability of the project but only as approved by the Secretary;
(3) To reimburse members of the grantee's governing board established pursuant to § 56.304 of subpart C, or advisory council established pursuant to § 56.603(q) of subpart F, if any, for reasonable expenses actually incurred by reason of their participation in the activities of such board or council;
(4) To reimburse such governing board or advisory council members who are individuals eligible to be served by the project for wages lost by reason of participation in the activities of such board or council;
(5) The cost of delivering health services to migratory agricultural workers, seasonal agricultural workers and the members of their families within the project's catchment area, within the following limitations: grant funds may be used to pay the full cost of project services to such individuals and families with annual incomes at or below those set forth in the most recent “CSA Income Poverty Guidelines” (45 CFR 1060.2) issued by the Community Services Administration, and to pay the portion of the cost of services provided in accordance with the schedule
(i) Charges will be made to such individuals and families in accordance with § 56.303(f) of subpart C or § 56.603(e) of subpart F, as applicable;
(ii) Reasonable effort shall be made to collect such charges under a billing and collections system; and
(iii) The charge to grant funds shall exclude any amounts collected pursuant to paragraph (b)(5)(ii) of this section;
(6) The cost of insurance for medical emergency and out-of-area coverage; and
(7) The cost of providing to the staff and governing board, if any, of the project training related to the management of an ambulatory care facility, and to the staff of a project funded under subpart C, D, or F of this part, training related to the provision of primary, supplemental and environmental health services provided or to be provided by the project, consistent with the applicable requirements of 45 CFR part 74.
(c) Prior approval by the Secretary of revisions of the budget and project plan is required whenever there is to be a significant change in the scope or nature of project activities.
The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement for expenses incurred or to be incurred, to the extent he determines such payments necessary to promote prompt initiation and advancement of the approved project.
(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d
(b) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.
All information as to personal facts and circumstances obtained by the project staff about recipients of services shall be held confidential and shall not be divulged without the individual's consent except as may be required by law or as may be necessary to provide service to the individual or to provide for medical audits by the Secretary or his designee with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.
Except as may otherwise be provided under the terms and conditions of the award, the grantee may copyright without prior approval any publications, films, or similar materials developed or resulting from a project supported by a grant under this part, subject, however, to a royalty-free, non-exclusive, and irrevocable license or right in the Government to reproduce, translate, publish, use, disseminate, and dispose of such materials and to authorize others to do so.
(a)
(b)
(c)
(2)
(i) Any amount not accounted for pursuant to paragraph (a) of this section;
(ii) Any credits for earned interest pursuant to paragraph (b) of this section;
(iii) Any other amounts due pursuant to subparts F, M, and O of 45 CFR part 74.
The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this part to States and local governments as those terms are defined in subpart A of that part 74. The relevant provisions of the following subparts of part 74 shall also apply to grants to all other grantee organizations under this part:
The regulations of this subpart, in addition to the regulations of subpart A of this part, are applicable to grants awarded pursuant to section 319(c)(1)(A) of the Act for projects for planning and developing migrant health centers in high impact areas.
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the
A project for planning and developing a migrant health center supported under this subpart must:
(a) Determine (by survey or other appropriate means) the approximate number of (1) migratory agricultural workers and the members of their families, and (2) seasonal agricultural workers and the members of their families, within the proposed catchment area in the calendar year in which the grant is made and the period of time these workers and their families reside in the catchment area during such year.
(b) Prepare an assessment of the need of the population proposed to be served by the migrant health center for the services set forth in § 56.102(g)(1) of subpart A of this part. This assessment of need must, at a minimum, include the factors listed in § 56.104(b)(3) (i)-(iv).
(c) Design a migrant health center program for such population, based on the assessment prepared pursuant to paragraph (b) of this section which indicates in detail how the proposed center will fulfill the needs identified in that assessment and meet the requirements of subpart C of this part.
(d) Develop a plan for the implementation of the program designed pursuant to paragraph (c) of this section. This implementation plan must provide for the time-phased recruitment and training of the personnel essential for the operation of a migrant health center and the gradual assumption of operational status of the project so that the project will, in the judgment of the Secretary, meet the requirements contained in subpart C of this part by the end of the project period.
(e) Implement the plan developed pursuant to paragraph (d) of this section in accordance with such paragraph.
(f) Make efforts to secure within the proposed catchment area of such center, to the extent possible, financial and professional assistance and support for the project.
(g) Initiate and encourage continuing community involvement in the development and operation of the proj-ect through, for example, contributions or loans of cash, services, equipment, full-or part-time staff, space, materials, or facilities.
(h) Provide for sufficient staff, qualified by training and experience, to carry out the project and establish standards and qualifications for personnel (including the project director).
(i) Utilize, to the maximum extent feasible, other Federal, State, local, and private resources available for support of the project, prior to use of project funds under this subpart.
(j) Provide the means for evaluating the project's progress in achievement of its specific objectives, and submit such progress reports on the project as the Secretary may from time to time request.
(a) Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which, in his judgment, will provide needed health services in a catchment area which will not be served by another project funded under this part and meet the applicable requirements of section 319(c)(1)(A) of the Act and this part, in accordance with priorities established pursuant to section 319(b) of the Act and § 56.107 of subpart A of this part;
(1) Priority shall be given to applications submitted by community-based organizations which are representative of the population to be served by the project. For purposes of this paragraph, an applicant shall be deemed to be such an organization if it provides a formal mechanism (such as membership on the organization's governing body or membership on an advisory body) which gives migratory seasonal agricultural workers and their families significant
(2) Where all such applicants are community-based organizations representative of the population to be served by the project, the Secretary shall award the grant to the applicants which will, in his judgment, best promote the purposes of section 319(c)(1)(A) of the Act and the applicable regulations of this part, taking into account with respect to each application:
(i) The degree to which the proposed project satisfactorily provides for the elements set forth in § 56.203;
(ii) The administrative and management capability of the applicant;
(iii) The extent to which community resources will be utilized in the proj-ect; and
(iv) The degree to which the applicant intends to integrate services supported by a grant under this part with health services provided under other federally assisted health services or reimbursement programs or projects.
(b) The Secretary shall award no more than two grants under this subpart for the same project.
The regulations of this subpart, in addition to the regulations of subpart A of this part, are applicable to grants awarded pursuant to section 319(d)(1)(A) of the Act for the costs of operation of migrant health centers in high impact areas.
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the requirements of § 56.104 of subpart A of this part,
(a) Be submitted by an entity (which may be a co-applicant) which the Secretary determines is a migrant health center, and
(b) Contain information sufficient to enable the Secretary to determine that the center will meet the requirements of this part.
A migrant health center supported under this subpart must:
(a) Provide the health services of the center so that such services are available and accessible promptly, as appropriate, and in a manner which will assure continuity of service to the migratory and seasonal agricultural workers and their families within the center's catchment area.
(b) Implement a system for maintaining the confidentiality of patient records in accordance with the requirements of § 56.111 of subpart A of this part.
(c) Have an ongoing quality assurance program which provides for the following:
(1) Organizational arrangements, including a focus of responsibility, to support the quality assurance program and the provision of high quality patient care;
(2) Periodic assessment of the appropriateness of the utilization of services and the quality of services provided or proposed to be provided by the center, and by other providers through contract or other cooperative arrangement with the center. Such assessments must:
(i) Be conducted by physicians or by other appropriate health professionals under the supervision of physicians or, as appropriate, by health professionals who are peers of the health professionals who provided the services;
(ii) Be based on the systematic collection and evaluation of patient rec-ords; and
(iii) Identify and document the necessity for change in the provision of services by the center and result in the institution of such change, where indicated.
(d) Develop management and control systems which are in accordance with sound financial management procedures, including the provision for an audit (1) conducted in accordance with the “Guide for Audits of Migrant Health Grants” of the DHHS Audit Agency, and (2) conducted with reasonable frequency, usually annually but not less frequently than every two years (unless waived for cause by the
(e) Where the cost of care and services furnished by or through the center is to be reimbursed under title XIX or title XX of the Social Security Act, obtain or make every reasonable effort to obtain a written agreement with the title XIX or title XX State agency for such reimbursement.
(f) Have prepared a schedule of fees or payments for the provision of its services designed to cover its reasonable costs of operation and a corresponding schedule of discounts adjusted on the basis of the patient's ability to pay. The schedule of discounts must provide for a full discount to individuals and families with annual incomes at or below those set forth in the most recent CSA Poverty Income Guidelines (42 CFR 1060.2) (except that nominal fees for service may be collected from such individuals and families) and for no discount to individuals and families with annual incomes greater than twice those set forth in such Guidelines.
(g) Make every reasonable effort, including the establishment of systems for eligibility determination, billing, and collection, to
(1) Collect reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act, to medical assistance under a State plan approved under title XIX of such Act, to social services and family planning under title XX of such Act, or to assistance for medical expenses under any other public assistance program, grant program, or private health insurance or benefit program on the basis of the schedule of fees prepared pursuant to paragraph (f) of this section without application of any discounts, and
(2) Secure from patients payments for services in accordance with the schedule of fees and discounts required by paragraph (f) of this section.
(h) Have a governing board which meets the requirements of § 56.304.
(i) Have developed an overall plan and budget for the center that:
(1) Provides for an annual operating budget and a three-year financial management plan which includes all anticipated income and expenses related to items which would, under generally accepted accounting principles, be considered income and expense items;
(2) Provides for a capital expenditure plan for at least a three-year period (including the year to which the operating budget described in paragraph (h)(i)(1) is applicable) which includes and identifies in detail the anticipated sources of financing for, and the objective of, each anticipated expenditure in excess of $100,000 related to the acquisition of land, the improvement of land, buildings, and equipment and the replacement, modernization and expansion of buildings and equipment which would, under generally accepted accounting principles, be considered capital items;
(3) Provides for plan review and updating at least annually; and
(4) Is prepared under the direction of the governing board by a committee consisting of representatives of the governing board, the administrative staff, and the medical staff, if any, of the center.
(j) Establish basic statistical data, cost accounting, management information, and reporting or monitoring systems which will enable the center to provide such statistics and other information as the Secretary may reasonably require relating to the center's costs of operation, patterns of utilization of services, and the availability, accessibility, and acceptability of its services, and to make such reports to the Secretary in a timely manner with such frequency as the Secretary may reasonably require.
(k) Review its catchment area annually to insure that the criteria set out in § 56.104(b)(2) are met and, if criteria are not met, revise its catchment area, with the approval of the Secretary, to conform with such criteria to the extent feasible.
(l) In the case of a center which serves a population including a substantial proportion of individuals of limited English-speaking ability, have developed a plan and made arrangements responsive to the needs of such populations for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and have identified an individual on its staff who is fluent in both that language and in English and whose responsibilities include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences. If more than one non-English language is spoken by such group or groups, an individual or individuals fluent in those languages and English must be so identified.
(m) Be operated in a manner calculated to preserve human dignity and to maximize acceptability and effective utilization of services.
(n) To the extent possible, coordinate and integrate project activities with the activities of other federally funded, as well as State and local, health services delivery projects and programs serving the same population.
(o) Establish means for evaluating progress toward the achievement of the specific objectives of the project.
(p) Provide sufficient staff, qualified by training and experience, to carry out the activities of the center.
(q) Assure that facilities utilized in the performance of the project meet applicable fire and life safety codes.
(r) Utilize, to the maximum extent feasible, other Federal, State and local, and private resources available for support of the project, prior to use of project funds under this part.
(s) Provide for community participation through, for example, contributions of cash or services, loans of full- or part-time staff, equipment, space, materials, or facilities.
(t) Where the center will provide services through contract or other cooperative arrangements with other providers of services, the center must:
(1) Enter into the contract or arrangement only if the provider of services will provide the services in a timely manner and make the services accessible and acceptable to the population to be served;
(2) Make payment for services so provided only pursuant to agreements with the providers in accordance with a schedule of rates and payment procedures established and maintained by the center. The center must be prepared to substantiate that such rates are reasonable and necessary;
(3) Directly provide at least primary care unless the center has made arrangements for the provision of primary care which include transfer of all medical and financial information relating to such care to the center; and
(4) Enter into contracts or arrangements for the provision of primary health services only if alternative resources are reasonably available to provide these services in the event of termination of such arrangements.
(u) Operate in a manner such that no migratory or seasonal agricultural worker or member of their family will be denied service by reason of his or her inability to pay therefor.
The governing board of the center must meet the following requirements:
(a)
(b)
(2) No more than two-thirds of the remaining members of the board may be individuals who derive more than 10 percent of their annual income from the health care industry.
(3) The remaining members of the board must be representatives of the community in which the center's
(4) No member of the board shall be an employee of the center, or spouse or child, parent, brother or sister by blood of marriage of such an employee. The project director may be a nonvoting, ex-officio member of the board.
(c)
(d)
(2) The governing board shall hold regularly scheduled meetings, at least once each month, except for periods of the year, as specified in the bylaws, during which monthly meetings are not practical due to migration out of the catchment area.
(3) Minutes must be kept for all regularly scheduled meetings of the board.
(4) The governing board shall have specific responsibility for:
(i) Approval of the selection and dismissal of the project director or chief executive officer of the center;
(ii) Establishing personnel policies and procedures, including selection and dismissal procedures, salary and benefit scales;
(iii) The development of bylaws which specify the responsibility of the board and principal operating officials of the centers;
(iv) Adopting policy for financial management practices, including a system to assure accountability for center resources, approval of the annual project budget, center priorities, eligibility for services, including criteria for partial payment schedules, and long-range financial planning;
(v) Evaluating center activities, including services utilization patterns, productivity of the center, patient satisfaction, achievement of project objectives, and development of a process for hearing and resolving patient grievances;
(vi) Assuring that the center is operated in compliance with applicable Federal, State, and local laws and regulations; and
(vii) Adopting health care policies including scope and availability of services, location and hours of services, and quality assurance procedures.
(a) Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which, in his judgment, will provide needed health services in a catchment area which will not be served by another project funded under this part and meet the applicable requirements of section 319(d)(1)(A) of the Act and this part, in accordance with priorities established pursuant to section 319(b) of the Act and § 56.107 of subpart A of this part:
(1) The extent to which the project would provide for the elements set forth in § 56.303;
(2) The capability of the applicant to provide quality health care services;
(3) The soundness of the financial management plan for assuring effective utilization of grant funds and maximizing non-grant revenue;
(4) The administrative and management capability of the applicant;
(5) The capability of the applicant to provide primary health services directly. In evaluating the relative capability of the applicant to provide such services directly, the Secretary shall take into consideration whether the direct provision of such services is inappropriate because:
(i) Provision of such services through contract or other arrangement would be more cost-effective;
(ii) Provision of such services directly would unnecessarily duplicate existing resources; or
(iii) Provision of such services other than directly would enhance the accessibility or acceptability of such services to the population to be served.
(6) The degree to which the applicant intends to integrate services supported by a grant under this part with health services provided under other federally assisted health services or reimbursement programs or projects;
(7) The extent that community resources will be utilized by the project; and
(8) Consistent with the other requirements of this part, the degree to which and the manner in which the applicant provides specific health services which the Secretary has, through publication of a notice in the
The regulations of this subpart, in addition to the regulations of subpart A of this part, are applicable to grants awarded pursuant to section 319(d)(1)(B) of the Act for the costs of operation of entities which intend to become migrant health centers and which provide health services to migratory agricultural workers, seasonal agricultural workers, and the members of their families in high impact areas.
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the requirements of § 56.104 of subpart A of this part,
(a) Be submitted by an entity which the Secretary determines intends to become a migrant health center but which will not, at the time of the grant award, meet one or more of the requirements of paragraphs (a) through (l) of § 56.303 of subpart C of this part; and
(b) Contain information sufficient to enable the Secretary to determine that the project for which the grant is sought will meet the requirements of this part. Such information must include a plan which identifies which requirements of § 56.303 will not be met at the time of grant award and provides a timetable for and a detailed statement of the means to be employed in meeting those requirements.
A project for the operation of a migrant health entity supported under this subpart must:
(a) Meet all of the requirements of § 56.303 of this part,
(b) Provide those services enumerated in § 56.102(g)(1) of subpart A of this part which are specified in the grant award.
(c) Meet the requirements of § 56.303 of subpart C of this part by the end of the period of support under section 319(d)(1)(B) of the Act and this subpart, in accordance with the plan submitted under § 56.402(b) of this subpart.
(a) Within the limits of funds determined by the Secretary to be available for such purposes, the Secretary may award grants under this subpart to applicants therefor which, in his judgment, will provide needed health services in a catchment area not served by another project funded under this part and meet the applicable requirements of section 319(d)(1)(B) of the Act and this part, in accordance with the priorities established pursuant to section 319(b) of the Act and § 56.107 of subpart A of this part;
(1) The degree to which the project would provide the services enumerated in § 56.102(g)(1) and the feasibility of its providing all of such enumerated services by the end of the period of support under section 319(d)(1)(B) of the Act and this subpart;
(2) The degree to which the applicant intends to integrate services supported by a grant under this subpart with health services provided under other federally assisted health service or reimbursement programs or projects;
(3) The capability of the project to provide quality health care services;
(4) The administrative and management capability of the applicant; and
(5) The capability of the applicant to provide primary health services directly. In evaluating the relative capability of the applicant to provide such services directly, the Secretary shall take into consideration whether the direct provision of services is inappropriate because:
(i) Provision of such services through contract or other arrangement would be more cost-effective;
(ii) Provision of such services directly would unnecessarily duplicate existing resources; or
(iii) Provision of the services other than directly would enhance the accessibility or acceptability of the services to the population served.
(6) The extent to which community resources will be utilized by the proj-ect; and
(7) Consistent with the other requirements of this part, the degree to which and the manner in which the applicant provides specific health services which the Secretary has, through publication of a notice in the
(b) The Secretary shall:
(1) Make no more than two grants for the same entity under section 319(d)(1)(B) of the Act;
(2) Not make any grant under section 319(d)(1)(B) to an entity which, for the same project, has been awarded more than one grant under section 319(c) of the Act;
(3) Not make a grant under section 319(d)(1)(B) to an entity which has been awarded a grant under section 319(d)(1)(A) of the Act.
The regulations of this subpart, in addition to the regulations of subpart A of this part, are applicable to grants awarded pursuant to section 319(c)(1)(B) of the Act for projects to plan and develop migrant health programs to provide health services to migratory agricultural workers, seasonal agricultural workers and the members of their families in areas in which no migrant health center exists and in which not more than 6,000 migratory agricultural workers and their families reside for more than two months.
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the requirements of § 56.104 of subpart A of this part,
(a) Be submitted for a project within a catchment area which
(1) Is not served, in whole or in part, by a migrant health center, and
(2) Has not more than 6,000 migratory agricultural workers and members of their families residing therein for more than 2 months per year; and
(b) Contain information sufficient to enable the Secretary to determine that the project for which the grant is sought will meet the requirements of this part.
A project for the planning and development of a migrant health program supported under this subpart must:
(a) Determine (by survey or other appropriate means) the approximate number of
(1) Migratory agricultural workers and the members of their families, and
(2) Seasonal agricultural workers and the members of their families within the project's catchment area in the calendar year in which the grant is made and the period of time these workers and their families reside in the catchment area during such year.
(b) Prepare an assessment of need of the population proposed to be served by the migrant health program for the services set forth in § 56.603(a) of subpart F of this part. This assessment of need must, at a minimum, consider the factors listed in § 56.104(b)(3) (i)-(iv).
(c) Design a migrant health program for such population, based on such assessment, which indicates in detail how the proposed program will fulfill the needs identified in that assessment and meet the requirements of subpart F of this part.
(d) Develop a plan for the implementation of the program designed pursuant to paragraph (c) of this section. The implementation plan must provide for the time-phased recruitment and training of the personnel essential for the operation of a migrant health program and the gradual assumption of operational status of the project so that the project will, in the judgment of the Secretary, meet the requirements of subpart F of this part as of the end of the project period.
(e) Implement the plan developed pursuant to paragraph (d) of this section in accordance with such paragraph.
(f) Make efforts to secure within the proposed catchment area of such proj-ect, to the extent possible, financial and professional assistance and support for the project.
(g) Initiate and encourage continuing community involvement in the development and operation of the proj-ect through, for example, contributions or loans of cash, services, equipment, full- or part-time staff, space, materials, or facilities.
(h) Provide for sufficient staff, qualified by training and experience, to carry out the project and establish standards and qualifications for personnel (including the project director).
(i) Utilize, to the maximum extent feasible, other Federal, State, local, and private resources available for support of the project, prior to use of project funds under this subpart.
(j) Provide for the means of evaluating the project's progress in achievement of its specific objectives and submission of such progress reports on the project as the Secretary may from time to time request.
(a) Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which, in his judgment, will provide needed health services in a catchment area not served by another project funded under this part and meet the applicable requirements of section 319(c)(1)(B) of the Act and this part, in accordance with priorities established pursuant to section 319(b) of the Act and § 56.107 of subpart A of this part;
(1) Priority shall be given to applications submitted by community-based organizations which are representative of the population to be served by the project. For purposes of this paragraph, an applicant shall be deemed to be such an organization if it provides a formal mechanism (such as membership on the organization's governing body or membership on an advisory body) which gives migratory and seasonal agricultural workers and their families significant involvement in the formulation of the organization's policies; and
(2) Where all such applicants are community-based organizations representative of the population to be served by the project, the Secretary shall award the grant to the applicants which will, in his judgment, best promote the purposes of section 319(c)(1)(B) of the Act and the applicable regulations of this part, taking into
(i) The degree to which the proposed project satisfactorily provides for the elements set forth in § 56.203;
(ii) The administrative and management capability of the applicant;
(iii) The extent to which community resources will be utilized in the proj-ect; and
(iv) The degree to which the applicant intends to integrate services supported by a grant under this part with health services provided under other federally assisted health services or reimbursement programs or projects.
(b) The Secretary shall award no more than one grant under this subpart for the same project.
The regulations of this subpart, in addition to the regulations of subpart A of this part, are applicable to grants awarded pursuant to section 319(d)(1)(C) of the Act for projects for operating programs to provide health services to migratory agricultural workers, seasonal agricultural workers and the members of their families in areas in which no migrant health center exists and in which not more than 6,000 migratory agricultural workers and their families reside for more than two months.
To be approved by the Secretary under this subpart, an application for a grant must, in addition to meeting the requirements of § 56.104 of subpart A of this part,
(a) Be submitted for a project with a catchment area which
(1) Is not served, in whole or in part, by a migrant health center, and
(2) Has not more than 6,000 migratory agricultural workers and the members of their families residing therein for more than two months per year; and
(b) Contain information sufficient to enable the Secretary to determine that the project for which the grant is sought will meet the requirements of this part.
A project for operating a migrant health program supported under this subpart must:
(a) Provide to migratory and seasonal agricultural workers and the members of their families in its catchment area one or more of the following groups of services so that such services are available and accessible promptly as appropriate, and in a manner which will assure continuity of care, as approved by the Secretary and set forth (including specific services to be provided) in the grant award:
(1) Emergency health care, including diagnostic and treatment services in an ambulatory health care setting or hospital and dental services for the alleviation of acute pain and suffering for medical emergencies, when provision of such services is necessary to avoid jeopardizing the patient's condition until appropriate services from other providers can reasonably be obtained;
(2) Primary care;
(3) Arrangements with existing health care facilities to furnish primary health services (other than primary care);
(4) Other services set forth in § 56.102(g)(1) which are needed to improve the health of such individuals.
(b) Implement a system for maintaining the confidentiality of patient records in accordance with the requirement of § 56.111 of subpart A of this part.
(c) Develop management and control systems which are in accordance with sound financial management procedures, including the provision for an audit conducted in accordance with the DHHS Audit Agency Guide for Audits of Migrant Health Grants, as amended, on at least an annual basis (unless waived for cause by the Secretary), by an independent certified public accountant or public accountant licensed before December 31, 1970, to determine, at a minimum, the fiscal integrity of grant financial transactions and reports and compliance with the regulations of this part and the terms and conditions of the grant.
(d) When the cost of care and services furnished by or through the proj-ect is to be reimbursed under title XIX or
(e) Have prepared a schedule of fees or payments for the provision of its services designed to cover its reasonable costs of operation and a corresponding schedule of discounts adjusted on the basis of the patient's ability to pay. The schedule of discounts must provide for a full discount to individuals and families with annual incomes at or below those set forth in the most recent CSA Poverty Income Guidelines (42 CFR 1060.2) (except that nominal fees for service may be collected from individuals and families with annual incomes at or below such levels if imposition of such fees is consistent with project goals) and for no discount to individuals and families with annual incomes greater than twice those set forth in the Guidelines.
(f) Make every reasonable effort, including the establishment of systems for eligibility determination, billing, and collection, to
(1) Collect reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act, to medical assistance under a State plan approved under title XIX of such Act, to social services and family planning under title XX of such Act, or to assistance for medical expenses under any other public assistance program, grant program, or private health insurance or benefit program on the basis of the schedule of fees prepared pursuant to paragraph (e) of this section without application of any discounts, and
(2) Secure from patients payments for services in accordance with the schedule of fees and discounts required by paragraph (e) of this section.
(g) Develop an overall financial management plan and an operating budget for the project which include and identify, in accordance with generally accepted accounting principles, all anticipated current income and expense items and capital income and expense items, if any.
(h) Establish basic statistical data, cost accounting, management information, and reporting or monitoring systems which will meet the project's management needs and shall enable the project to provide such statistics and other information as the Secretary may reasonably require relating to the project's costs of operation, patterns of utilization of services, and the availability, accessibility, and acceptability of its services, and to make such reports to the Secretary in a timely manner with such frequency as the Secretary may reasonably require.
(i) Review its catchment area annually to insure that the criteria set out in § 56.104(b)(2) are met and, where such criteria are not met, revise its catchment area, with the approval of the Secretary, to conform with such criteria to the extent feasible.
(j) In the case of a project which serves a population including a substantial proportion of individuals of limited English-speaking ability, have a plan and made arrangements responsive to the needs of these populations for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and have identified an individual on its staff who is fluent in both that language and in English and whose responsibilities include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences. If more than one non-English language is spoken by such group or groups, an individual or individuals fluent in those languages and English must be so identified.
(k) Be operated in a manner calculated to preserve human dignity and to maximize acceptability and effective utilization of services.
(l) To the extent possible, coordinate and integrate project activities with the activities of other federally funded, as well as State and local, health services delivery projects and programs serving the same population.
(m) Establish means for evaluating progress toward the achievement of the specific objectives of the project.
(n) Provide sufficient staff, qualified by training and experience, to carry out the activities of the project.
(o) Assure that facilities utilized in the performance of the project meet applicable fire and life safety codes.
(p) Utilize, to the maximum extent feasible, other Federal, State and local, and private resources available for support of the project, prior to use of project funds under this part.
(q) Provide for community participation through, for example, contributions of cash or services, loans of full- or part-time staff, equipment, space, materials, or facilities, and, to the extent feasible, establishment of an advisory council to advise with respect to the overall management of the proj-ect including services to be provided, the manner of their provision, and appointment of personnel. The membership of such advisory council shall be representative of the population to be served in terms of appropriate demographic characteristics, such as race, sex, and ethnicity.
(r) Where the project will provide services through contract or other cooperative arrangements with other providers of services, the project must
(1) Enter into any such contract or arrangement only if the provider of services will provide the services in a timely manner and make the services accessible and acceptable to the population to be served; and
(2) Make payment for services so provided in accordance with a schedule of rates and payment procedures established and maintained by the project. The project must be prepared to substantiate that such rates are reasonable and necessary.
(s) Operate in a manner such that no migratory or seasonal agricultural worker or member of their families will be denied service by reason of his or her inability to pay therefor.
(t) Have an ongoing quality assurance program as described in § 56.303(c) except as the Secretary finds that such a program would not be feasible.
(a) Within the limit of funds determined by the Secretary to be available the Secretary may award grants under this subpart to applicants therefor which will, in his judgment, provide needed health services in a catchment area which will not be served by another project funded under this part and meet the applicable requirements of section 319(d)(1)(C) of the Act and this subpart, in accordance with priorities established pursuant to section 319(b) of the Act and § 56.107 of subpart A of this part;
(1) Priority shall be given to applications submitted by community-based organizations which are representative of the population to be served by the project. For purposes of this paragraph, an applicant shall be deemed to be such an organization if it provides a formal mechanism (such as membership on the organization's governing body or membership on an advisory body) which gives migratory seasonal agricultural workers and their families significant involvement in the formulation of the organization's policies; and
(2) Where all such applicants are community-based organizations representative of the population to be served by the project, the Secretary shall award the grant to the applicants which will, in his judgment, best promote the purposes of section 319(d)(1)(C) of the Act and the applicable regulations of this part, taking into account with respect to each application:
(i) The degree to which the proposed project satisfactorily provides for the elements set forth in § 56.203;
(ii) The administrative and management capability of the applicant;
(iii) The extent to which community resources will be utilized in the proj-ect; and
(iv) The degree to which the applicant intends to integrate services supported by a grant under this part with health services provided under other
The regulations of this subpart, in addition to the regulations of subpart A of this part except as otherwise set forth herein, are applicable to grants awarded pursuant to section 319(g) of the Act for the provision of technical and other non-financial assistance to grantees under sections 319(c)(1)(A), 319(d)(1)(A) and 319(d)(1)(B) of the Act.
To be approved by the Secretary under this subpart, an application for a grant must meet the requirements of §§ 56.104(a), 56.104(b) (1), (4), (7), (10), and (11), and 56.104(c) of subpart A of this part.
A project for the provision of technical assistance to migrant health centers and entities which intend to become migrant health centers which is supported under this subpart must:
(a) Provide to such centers and entities as are specified in the grant award, such technical and other nonfinancial assistance (such as fiscal and program management assistance or training of the staff of such center or entity in such management) as may be specified in the grant award. Such technical or other nonfinancial assistance shall be designed to assist such centers and entities in:
(1) Developing plans for becoming migrant centers; and/or
(2) Meeting the requirements of sections 319(f)(2) of the Act.
(b) Provide such assistance through its own staff or resources.
(c) Where the project will provide training to the staff of a center or entity in management or the provision of health services, provide such training consistent, as applicable, with § 56.108(b)(7).
(d) Maintain such records and make such reports on the expenditure of funds under this subpart and provision of such assistance as the Secretary may require.
Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants therefor which will, in his judgment, best promote the purposes of section 319(g) of the Act and applicable regulations of this part, taking into consideration:
(a) The cost-effectiveness of the application; and
(b) The number of centers and entities to be served by the applicant.
The provisions of 42 CFR part 51c, subpart E, establishing requirements for the acquisition and modernization of existing buildings, shall apply to all grants under section 319 of the Act for project costs which include the cost of acquisition and/or modernization of existing buildings (including the cost of amortizing the principal of, and paying the interest on, loans); except that, for purposes of this subpart, references within subpart E to part 51c, or to subparts of part 51c, shall be deemed to be references to part 56, or to the appropriate subparts of part 56, and references to section 330 of the Act shall be deemed to be references to section 319 of the Act.
Sec. 215 of the Public Health Service Act, 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); secs. 740-747 of the Public Health Service Act, 77 Stat. 170-173, as amended by 90 Stat. 2266-2268, 91 Stat. 390-391, 95 Stat. 920, 99 Stat. 532-536, and 102 Stat. 3125 (42 U.S.C. 294m-q); renumbered as secs. 721-735, as amended by Pub. L. 102-408, 106 Stat. 2011-2022 (42 U.S.C. 292q—292y).
The regulations of this subpart apply to the federal capital contributions made by the Secretary to public or other nonprofit health professions schools for the establishment of health professions student loan funds and to loans made to students by schools from these funds.
As used in this subpart:
(a) Each school seeking a Federal capital contribution must submit an application at the time and in the form and manner that the Secretary may require. The application must be signed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the statute, the regulations of this subpart, and the terms and conditions of the award.
(b) Each application will be reviewed to determine eligibility and the reasonableness of the amount of Federal support requested. The Secretary may require the applicant to submit additional data for this purpose.
(c) An application will not be approved unless an agreement between the Secretary and the applicant school for a Federal capital contribution under section 721 of the Act is reached.
(a)
(1) The amount requested in the application, or
(2) An amount which bears the same ratio to the total amount of Federal funds determined by the Secretary at the time of payment to be available for that fiscal year for the Health Professions Student Loan Program as the number of full-time students estimated by the Secretary to be enrolled in that school bears to the estimated total number of full-time students in all participating schools during that year. Amounts remaining after these payments are made will be distributed in accordance with this paragraph among schools whose applications requested more than the amount paid to them, but with whatever adjustments that may be necessary to prevent the total paid to any school from exceeding the total requested by it.
(b)
(c)
(1) The amount requested in the application, or
(2) An amount which bears the same ratio to the total amount of returned funds determined by the Secretary at
(a)
(1) The Federal capital contribution fund is to be used by the school only for:
(i) Health professions student loans to full-time students;
(ii) Capital distribution as provided in section 728 of the Act or as agreed to by the school and the Secretary; and
(iii) Costs of litigation, costs associated with membership in credit bureaus, and to the extent specifically approved by the Secretary, other collection costs that exceed the usual expenses incurred in the collection of health professions student loans.
(2) A school must review the balance in the fund on at least a semi-annual basis to determine whether the fund balance compared with projected levels of expenditures and collections exceeds its needs. A school in closing status must review the balance in the fund on a quarterly basis. Monies identified as in excess of the school's needs must be reported, and the Federal share returned to the Federal Government, by the due date of the required report which identifies the excess monies. The school's determination is subject to the review and approval of the Secretary.
(b)
(2) The Federal capital loans must be carried in a special account of the school, to be used by the school only for (i) repayments of principal and interest on Federal capital loans; and (ii) costs of litigation; costs associated with membership in credit bureaus; and, to the extent specifically approved by the Secretary, other collection costs that exceed the usual expenses incurred in the collection of health professions student loans.
(c) Failure to comply with the requirements of this section will subject a school to the noncompliance provisions of § 57.218 and the Department's Claims Collections regulations (45 CFR part 30), as appropriate.
(a)
(i) Residents of the United States and either a citizen or national of the
(ii) Enrolled, or accepted for enrollment in the school as full-time students;
(iii) In need of the amount of the loan to pursue a full-time course of study at the school;
(iv) Of exceptional financial need in the case of students of medicine or osteopathic medicine. A student will be considered to demonstrate exceptional financial need if the school determines that his or her resources, as described in paragraph (b)(1) of this section, do not exceed the lesser of $6,700 or one-half of the costs of attendance at the school. Summer earnings, educational loans, veterans (G.I.) benefits and earnings during the school year will not be considered as resources in determining whether an applicant meets the eligibility criteria for exceptional financial need, but will be considered in determining the amount of funds a student may receive; and
(v) In compliance with the requirement to register for the draft, if required to do so under section 3 of the Military Selective Service Act.
(2) An applicant who has previously attended an institution of higher education must submit a financial aid transcript which includes at least the following data:
(i) Applicant's name and social security number;
(ii) Amounts and sources of loans and grants previously received by the applicant for study at an institution of higher education;
(iii) Whether the applicant is in default on any of these loans, or owes a refund on any grants;
(iv) Certification from each institution previously attended by the applicant that the applicant has received no financial aid, if applicable; and
(v) From each institution previously attended, the signature of an official authorized by the institution to sign such transcripts on behalf of the institution.
(b)
(1) The financial resources available to the student by using one of the national need analysis systems or any other procedure approved by the Secretary of Education in combination with other information which the school has regarding the student's financial status. The school must take into account, regardless of the tax status of the student, the expected contribution from parents, spouse, self or other family members; and
(2) The costs reasonably necessary for the student's attendance at the school, including any special needs and obligations which directly affect the student's ability to attend the school on a full-time basis. The school must document the criteria used for determining these costs.
(c)
(d)
The total of the health professions student loans made from the fund to any student for a school year may not exceed $2,500 and the cost of tuition. The maximum amount loaned during a 12-month period to any student enrolled in a school which provides a course of study longer than the 9-month school year may be proportionately increased.
(a)
(1) Each promissory note must state that the loan will bear interest on the unpaid balance computed only for periods during which repayment of the loan is required, at the rate of 5 percent per year.
(2) Each promissory note must contain an acceleration clause provided by the Secretary, which will permit the acceleration of delinquent loans at the school's option.
(3) A copy of each executed note must be supplied by the school to the student borrower.
(b)
(c)
(i) The yearly and cumulative maximum amounts that may be borrowed by the student;
(ii) The terms under which repayment of the loan will begin;
(iii) The maximum number of years in which the loan must be repaid;
(iv) The interest rate that will be paid by the borrower and the minimum amount of the required monthly payment;
(v) The amount of any other fees charged to the borrower by the lender;
(vi) Any options the borrower may have for deferral, cancellation, prepayment, consolidation, or other refinancing of the loan;
(vii) A definition of default on the loan and a specification of the consequences which will result to the borrower if the borrower defaults, including a description of any arrangements which may be made with credit bureau organizations;
(viii) To the extent practicable, the effect of accepting the loan on the eligibility of the borrower for other forms of student assistance; and
(ix) A description of the actions that may be taken by the Federal Government to collect the loan, including a description of the type of information concerning the borrower that the Federal Government may disclose to:
(A) Officers, employees, or agents of the Department of Health and Human Services,
(B) Officers, employees, or agents of schools with which the Secretary has an agreement under this subpart, or
(C) Any other person involved in the collection of a loan under this subpart.
(2) For any loan made after June 30, 1986, the school shall, prior to the borrower's completion or termination of studies at the school, provide the following loan information to the student:
(i) Each amount borrowed by the student under this subpart;
(ii) The total amount borrowed by the student under this subpart; and
(iii) A schedule for the repayment of the amounts borrowed under this subpart, including the number, amount, and frequency of payments to be made.
(3) In addition to the requirements set forth in paragraphs (c)(1) and (c)(2) of this section, the school must comply with the applicable requirements of Truth in Lending Regulation Z (12 CFR part 226).
(a) Health professions student loans from any fund may be paid to or on behalf of student borrowers in installments considered appropriate by the school except that a school may not pay to or on behalf of any borrower more during any given installment period (e.g., semester, term, or quarter) than the school determines the student needs for that period.
(b) No payment may be made from a fund to or on behalf of any student borrower if at the time of the payment the borrower is not a full-time student.
(a) Each health professions student loan, including accrued interests, will be repayable in equal or graduated periodic installments in amounts calculated on the basis of a 10-year repayment period. Except as otherwise provided in this paragraph, repayment of a loan must begin one year after the student ceases to be a full-time student.
(1) If a borrower reenters the same or another school as a full-time student within the 1-year period, the date upon which interest will accrue and the repayment period will begin will be determined by the date on which the student last ceases to be a full-time student at that school.
(2) The following periods will be excluded from the 10-year repayment period:
(i) All periods for up to a total of 3 years of active duty performed by the borrower as a member of the Army, Navy, Air Force, Marine Corps, Coast Guard, National Oceanic and Atmospheric Administration Corps or the U.S. Public Health Service Corps;
(ii) All periods for up to a total of 3 years of service as a volunteer under the Peace Corps Act;
(iii) All periods of advanced professional training including internships and residencies, except as specified in paragraph (a)(2)(vi) of this section;
(iv) All periods during which the borrower is pursuing a full-time course of study at an eligible health professions school;
(v) A period not in excess of 2 years during which a borrower who is a full-time student in a health professions school leaves the school, with the intent to return to such school as a full-time student, to engage in a full-time educational activity which is directly related to the health profession for which the individual is preparing. To qualify for such deferment, the full-time educational activity must be one which:
(A) Is part of a joint-degree program or a formal program of joint study in conjunction with the health profession for which the borrower is preparing at the school; or
(B) Is an activity which will enhance the borrower's knowledge and skills in the health profession for which the borrower is preparing at the school, as determined by the school.
(vi) A period not in excess of 2 years during which a borrower who is a graduate of a health professions school participates in:
(A) A fellowship training program which is directly related to the health profession for which the borrower prepared at the school, as determined by the school from which the borrower received his or her loan, and is engaged in by the borrower no later than 12 months after the completion of the borrower's participation in advanced professional training as described in paragraph (a)(2)(iii) of this section, or prior to the completion of such borrower's participation in such training. To qualify for such deferment, the fellowship training program must be one which:
(
(
(B) A full-time educational activity which is directly related to the health profession for which the borrower prepared at the school, as determined by the school from which the borrower received his or her loan, and is engaged in by the borrower no later than 12 months after the completion of the borrower's participation in advanced professional training as described in paragraph (a)(2)(iii) of this section, or prior to the completion of the borrower's participation in such training. To qualify for such deferment, the full-time educational activity must be one which:
(
(
(
(3) To receive a deferment, a borrower must, no later than 30 days prior to the onset of the activity (or no later than 30 days prior to the due date of the first payment if the borrower begins the activity during the grace period), and annually thereafter, provide the lending school with evidence of his or her status in the deferrable activity, and evidence that verifies deferment eligibility of the activity. This evidence must include certification by the Program Director or other authorized official that the borrower's activity meets the deferment requirements. The borrower must also notify the school upon completion or termination of the activity. It is the responsibility of the borrower to provide the lending school with all required information or other information regarding the requested deferment. The school may deny a request for deferment if it is not filed in accordance with the requirements of this section.
(4) Subject to the provisions of paragraph (b)(3) of this section, a borrower must establish a repayment schedule with the school providing for payments not less often than quarterly. Any borrower whose repayment is delinquent more than 60 days must establish a monthly repayment schedule with the school. However, a borrower may at his or her option and without penalty, prepay all or part of the principal and accrued interest at any time.
(5) A school may grant forbearance whenever extraordinary circumstances such as unemployment, poor health or other personal problems temporarily affect the borrower's ability to make scheduled loan repayments.
(b)(1) Each school at which a fund is established must exercise due diligence in the collection of health professions student loans due the fund. In the exercise of due diligence, a school must follow procedures which are at least as extensive and effective as those used in the collection of other student loan accounts due the school, and must use the steps outlined below in accordance with collection practices which are generally accepted among institutions of higher education:
(i) Conduct and document an entrance interview (individually or in groups) with the borrower prior to disbursing HPSL funds in an academic year. During the entrance interview the school must obtain documentation
(ii) Conduct and document an exit interview (individually or in groups) with the borrower. During the exit interview, the school must provide each borrower with information necessary to carry out the terms of repayment, remind the borrower of the rights and responsibilities associated with HPSL funds, and update the personal information collected prior to disbursing HPSL funds which would assist in locating the borrower if he or she fails to keep the school informed of his or her current address. If the borrower terminates studies without advance notice, the school must document attempts to inform the borrower of the substance of the exit interview and to secure exit interview information from the borrower by mail.
(iii) Notify the borrower in writing of the impending repayment obligation at least twice during the grace period;
(iv) Notify a borrower who is in deferment status in writing of the impending repayment obligation 1 to 3 months prior to the expiration of the approved period of deferment;
(v) Perform regular billing;
(vi) Follow up past due payments with a series of at least four documented and reasonably spaced attempts to contact the borrower, at least three of which must be in writing at not more than 30-day intervals, prior to the loan becoming 120 days past due, provided that the school has a current address for the borrower;
(vii) Perform address searches when necessary;
(viii) Use collection agents, which may include the use of an internal collection agent;
(ix) Institute legal proceedings against borrowers after all other attempts at collection have failed, unless the school determines, subject to the approval of the Secretary, that such litigation would not be cost-effective; and
(x) Become a member of a credit bureau and notify the credit bureau of accounts past due by more than 120 days.
(2)
(ii) For any health professions student loan made on or after October 22, 1985, the school shall assess a charge for failure of the borrower to pay all or any part of an installment when the loan is more than 60 days past due and, in the case of a borrower who is entitled to deferment under section 722(c) of the Act, for any failure to file satisfactory evidence of the entitlement within 60 days of the date payment would otherwise be due. No charge may be made if the loan is less than 61 days past due. The amount of this charge may not exceed an amount equal to 6 percent of the amount due at the time the charge is calculated. The school may elect to add the amount of this charge to the principal amount of the loan as of the day on which the charge is calculated, or to make the amount of
(3) With respect to any health professions student loan made after June 30, 1969, the school may require the borrower to make payments of at least $15 per month on all outstanding health professions student loans during the repayment period.
(4) A school must, on an annual basis, review and assess the collectibility of any loan more than 3 years past due. If the school determines that the prospects of future collection are promising enough to justify periodic review of the debt, and neither the statute of limitations nor the 10-year repayment period has expired, the school may retain the account for continued collections, provided that it makes an attempt at least semi-annually to collect from the borrower. When the due diligence procedures required by paragraph (b)(1) of this section have been exhausted, the school is responsible for determining the collection methods it will use for the semi-annual collection effort required on these loans. If the school determines that the prospects of future collection are not promising, or when the statute of limitations or the 10-year repayment period has expired, the loan must be considered uncollectible. A school may determine a loan to be uncollectible sooner than 3 years past due when it has evidence that the loan cannot be collected, but in no case should a school consider a loan as uncollectible if it has not been in default for a least 120 days. A school is not subject to the requirements in paragraphs (b)(4) (i) and (iii) of this section for loans that became uncollectible, as determined by the school, before August 1, 1985.
(i) A school must request permission to write off an uncollectible loan within 30 days of the determination that it is uncollectible or reimburse the fund in the full amount of the loan, pursuant to § 57.210(b)(4)(iii). The 30-day period for submitting the loan for write-off review begins on the date that the determination of uncollectibility is made, in accordance with paragraph (b)(4) of this section. In any instance where the Secretary determines that a school has failed to exercise due diligence in the collection of a loan, in accordance with the applicable regulatory requirements, the school will be required to place in the fund the full amount of principal, interest, and penalty charges that remains uncollected on the loan. Reimbursement must be made by the following June 30 or December 31, whichever is sooner, except that in no case will a school be required to reimburse the fund in less than 30 days following the Secretary's disapproval of the request for write-off approval.
(ii) If the Secretary determines that a school has exercised due diligence in the collection of a loan, in accordance with the applicable regulatory requirements, or if the school determines that the loan was uncollectible prior to August 1, 1985, the school will be permitted to reduce its accounts receivable for the HPSL fund by the full amount of principal, interest, and penalty charges that remains uncollected on that loan and will not be required to return the Federal share of the loss to the Secretary.
(iii) If a school does not request permission to write off an uncollectible loan within the required timeframe, it must reimburse the fund for the full amount of principal, interest, and penalty charges that remains uncollected on that loan. This reimbursement must be made by the following June 30 or December 31, whichever is sooner, except that in no case will a school be required to reimburse the fund in less than 30 days following its determination that a loan is uncollectible.
(iv) Failure to comply with the requirement of this section will subject a school to the noncompliance provisions of § 57.218 and the Department's Claims Collection regulations (45 CFR part 30), as appropriate.
(5)
(a)
(b)
Individuals who received health professions student loans as students of medicine, osteopathic medicine, dentistry or optometry prior to November 18, 1971, may still receive cancellation of these loans for practicing in a shortage area or for practicing in a rural shortage area characterized by low family income. The regulations set forth in 42 CFR 57.215(b) (1976), as adopted on February 7, 1974 remain applicable to cancellation on this basis. The provisions can be found at 39 FR 4774 (February 7, 1974) and a copy can be obtained by writing to the Division of Student Assistance, Bureau of Health Professions, Room 8-34, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
(a) For loans made prior to October 22, 1985, in the event that insufficient funds are available to the Secretary in any fiscal year to enable him or her to pay to all schools their proportionate shares of all loans and interest canceled under this subpart for practice in a shortage area, death, or disability:
(1) Each school will be paid an amount bearing the same ratio to the total of the funds available for that purpose as the principal of loans canceled by that school in that fiscal year bears to the total principal of loans canceled by all schools in that year; and
(2) Any additional amounts to which a school is entitled will be paid by the Secretary at the time of distribution of the assets of the school's Fund under section 728 of the Act.
(b) For loans made on or after October 22, 1985, a school may assess the borrower a charge to insure against the loss of the institutional share of a loan canceled due to the borrower's death or permanent and total disability. The school must develop annually a rate
In the event that the Secretary undertakes to repay educational loans under section 722(k) of the Act, he or she will use the following criteria to make a determination as to each applicant's eligibility:
(a) An applicant will be considered to have failed to complete the course of study leading to the first professional degree for which an eligible education loan was made upon certification by a health professions school that the individual ceased to be enrolled in the school subsequent to November 17, 1971;
(b) An applicant will be considered to be in exceptionally needy circumstances if, upon comparison of the income and other financial resources of the applicant with his or her expenses and financial obligations, the Secretary determines that repayment of the loan would constitute a serious economic burden on the applicant. In making this determination, the Secretary will take into consideration the applicant's net financial assets, his or her potential earning capacity, and the relationship of the income available to the applicant to the low-income levels published annually by the Secretary under paragraph (c) of this section;
(c) An applicant will be considered to be from a low-income family if the applicant comes from a family with an annual income below a level based on low-income thresholds according to family size published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index, and adjusted by the Secretary for use in this program, and the family has no substantial net financial assets. Income levels as adjusted will be published annually by the Secretary in the
(d) An applicant will be considered to be from a disadvantaged family if the individual comes from a family in which the annual income minus unusual expenses which contribute to the economic burdens borne by the family does not exceed the low-income levels published by the Secretary under paragraph (c) of this section and the family has no substantial net financial assets;
(e) An applicant will be considered as not having resumed his or her health professions studies within two years following the date the individual ceased to be a student upon a certification so stating from the applicant; and
(f) An applicant will be considered as not reasonably expected to resume his or her health professions studies within two years following the date upon which he or she terminated these studies, based upon consideration of the reasons for the applicant's failure to complete these studies, taking into account such factors as academic, medical, or financial difficulties.
(a) Each Federal capital contribution and Federal capital loan is subject to the condition that the school must maintain those records and file with the Secretary those reports relating to the operation of its health professions student loan funds as the Secretary may find necessary to carry out the purposes of the Act and these regualtions. A school must submit required reports to the Secretary within 45 days of the close of the reporting period.
(1) A school which fails to submit a required report for its Federal capital
(i) Shall be prohibited from receiving new Federal capital contributions;
(ii) Must place the revolving fund and all subsequent collections in an insured interest-bearing account; and
(iii) May make no loan disbursements.
(2) A school that fails to submit a complete report within 6 months of the close of the reporting period will be subject to termination. The Secretary will provide the school with a written notice specifying his or her intention to terminate the school's participation in the program and stating that the school may request, within 30 days of the receipt of this notice, a formal hearing. If the school requests a hearing, it must within 90 days of the receipt of the notice, submit material, factual issues in dispute to demonstrate that there is cause for a hearing. These issues must be both substantive and relevant. The hearing will be held in the Washington, DC metropolitan area. The Secretary will deny a hearing if:
(i) The request for a hearing is untimely (i.e., fails to meet the 30-day requirement);
(ii) The school does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(iii) The statement of factual issues in dispute is frivolous or inconsequential.
(3) The school must also comply with the requirements of 45 CFR part 74 and section 798(e) of the Act concerning recordkeeping, audit, and inspection.
(b) The following student records must be retained by the school for 5 years after an individual student ceases to be a full-time student:
(1) Approved student applications for health professions student loans;
(2) Documentation of the financial need of applicants; and
(3) Copy of financial aid transcript(s).
(c) The following repayment records for each individual borrower must be retained for at least 5 years from the date of retirement of a loan:
(1) The amount and date of each loan;
(2) The amount and date of each payment or cancellation;
(3) Records of periods of deferment;
(4) Date, nature and result of each contact with the borrower or proper endorser in the collection of an overdue loan;
(5) Copies of all correspondence to or from the borrower and endorser;
(6) Copies of all correspondence with collection agents related to the individual borrower;
(7) Copies of all correspondence with a credit bureau related to an individual borrower; and
(8) Copies of all correspondence relating to uncollectible loans which have been written off by the Federal Government or repaid by the school.
(d) The school must also retain other records as the Secretary may prescribe. In all cases where questions have arisen as a result of a Federal audit, the records must be retained until resolution of all questions.
(e) Institutional officials who have information which indicates the potential or actual commission of fraud or other offenses against the United States, involving these loan funds, should promptly provide this information to the appropriate Regional Office of Inspector General for Investigations.
(a) Participating schools are advised that in addition to complying with the terms and conditions of these regulations, several other regulations apply under this subpart. These include, but are not limited to:
(b) The recipient may not discriminate on the basis of religion in the admission of individuals to its training programs.
On June 30, 1984, and on each June 30 thereafter, except as provided in paragraph (b) of this section, each school must have a default rate (as calculated under paragraph (a) of this section) of not more than 5 percent.
(a) The default rate for each school shall be the ratio (stated as a percentage) that the defaulted principal amount outstanding of the school bears to the matured loans of the school. For this purpose:
(1) The term
(2) The term
(i) Enrolled in a full-time course of study at the school; or
(ii) In their grace period.
(b) Any school that has a default rate greater than 5 percent on June 30 of any year will be required to:
(1) Reduce its default rate by 50 percent (or a school with a default rate below 10 percent must reduce its rate to 5 percent) by the close of the following 6-month period; and
(2) By the end of each succeeding 6-month period, reduce its default rate to 50 percent of the required rate for the previous 6-month period, until it reaches 5 percent.
(c) Any school subject to the provisions of paragraph (b) of this section which fails to comply with those requirements will receive no new HPSL funds and will be required to:
(1) Place the revolving fund monies and all subsequent collections into an insured interest-bearing account;
(2) Make no loan disbursements; and
(3) By the end of the succeeding 6-month period, reduce its default rate to 50 percent of the rate it failed to achieve under paragraph (b) of this section, or 5 percent. A school that meets this requirement wil be permitted to resume the use of its health professions student loan funds, but must continue to comply with the requirements of paragraph (b)(2) of this section if its default rate is still greater than 5 percent.
(d) Any school subject to the provisions of paragraph (c)(3) of this section which fails to comply with those requirements will be subject to termination. The Secretary will provide the school with a written notice specifying his or her intention to terminate the school's participation in the program and stating that the school may request, within 30 days of the receipt of this notice, a formal hearing. If the school requests a hearing, it must within 90 days of the receipt of the notice, submit material, factual issues in
(1) The request for a hearing is untimely (i.e., fails to meet the 30-day requirement);
(2) The school does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(3) The statement of factual issues in dispute is frivolous or inconsequential.
The Secretary may with respect to any agreement entered into with any school under § 57.205, impose additional conditions prior to or at the time of any award when in his or her judgment these conditions are necessary to assure or protect the advancement of the purposes of the agreement, the interest of the public health, or the conservation of funds awarded.
Wherever the Secretary finds that a participating school has failed to comply with the applicable provisions of the Act or the regulations of this subpart, he or she may, on reasonable notice to the school, withhold further payment of Federal capital contributions, and take such other action, including the termination of any agreement, as he or she finds necessary to enforce the Act and regulations. In this case no further expenditures shall be made from the health professions student loan fund or funds involved until the Secretary determines that there is no longer any failure of compliance.
Sec. 215 of the Public Health Service Act, 58 Stat. 690, 67 Stat. 631 (42 U.S.C. 216); secs. 835-842 of the Public Health Service Act, 77 Stat. 913-916, as amended by 99 Stat. 397-400, 536-537, and 102 Stat. 3160-3161 (42 U.S.C. 297 a-i).
The regulations in this subpart apply to the Federal capital contributions made by the Secretary to public or other nonprofit schools of nursing for the establishment of nursing student loan funds and to loans made to students from these funds.
As used in this subpart:
(a) Which is organized under the laws of the State of Hawaii,
(b) Which provides or arranges for health care services through practitioners licensed by the State of Hawaii, where licensure requirements are applicable,
(c) Which is a public or private nonprofit entity, and
(d) In which Native Hawaiian health practitioners significantly participate in the planning, management, monitoring, and evaluation of health services.
(a) Each school seeking a Federal capital contribution must submit an application at the time and in the form and manner that the Secretary may require. The application must be signed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the statute, the regulations of this subpart, and the terms and conditions of the award.
(b) Each application will be reviewed to determine eligibility and the reasonableness of the amount of Federal support requested. The Secretary may require the applicant to submit additional data for this purpose.
(c) An application will not be approved unless an agreement between the Secretary and the applicant school for a Federal capital contribution under section 835 of the Act is reached.
(a)
(1) For any fiscal year for which “set-aside” funds are available, the Secretary will first make payments in the manner described in (a)(2) of this section of not less than $1,000,000 of the amount of Federal funds determined by the Secretary at the time of payment to be available for making loans under this subpart. These funds will be paid to schools submitting an application for “set-aside” funds to be used only for the purpose of making loans to individuals qualified to receive loans under this subpart who, on the date they receive the loan, have not been employed on a full-time basis or been enrolled in any educational institution on a full-time basis for at least 7 years. An individual may not receive a loan under this subparagraph that exceeds $500 for any academic year.
(2) If the total of the amounts requested for any fiscal year by all schools for Federal capital contributions minus the amount received under paragraph (a)(1) of this section exceeds the amount of Federal funds determined by the Secretary at the time of payment to be available for this purpose, the payment to each school will be reduced to whichever is smaller: (i) The amount requested in the application, or (ii) an amount which bears the same ratio to the total amount of Federal funds determined by the Secretary at the time of payment to be available for that fiscal year for the Nursing Student Loan program as the number of full-time students estimated by the Secretary to be enrolled in that school bears to the estimated total number of full-time students in all participating schools during that year.
(3) Amounts remaining after these payments are made will be distributed in accordance with this paragraph among schools whose applications requested more than the amount paid to them, but with whatever adjustments that may be necessary to prevent the total paid to any school from exceeding the total requested by it.
(b)
(c)
(2)
(i) The amount requested in the application, or
(ii) An amount which bears the same ratio to the total amount of returned funds determined by the Secretary at the time of payment to be available for that fiscal year for the Nursing Student Loan program as the number of full-time students estimated by the Secretary to be enrolled in that school bears to the estimated total number of full-time students in these eligible schools during that year.
(3)
(i) The amount requested in the application, or
(ii) An amount which bears the same ratio to the total amount of returned funds determined by the Secretary at the time of payment to be available for that fiscal year for the Nursing Student Loan program as the number of full-time students estimated by the Secretary to be enrolled in that school bears to the estimated total number of full-time students in these eligible schools during that year.
(a)
(1) The Federal capital contribution fund is to be used by the school only for:
(i) Nursing student loans to full-time or half-time students;
(ii) Capital distribution as provided in section 839 of the Act or as agreed to by the school and the Secretary; and
(iii) Costs of litigation, costs associated with membership in credit bureaus, and to the extent specifically approved by the Secretary, other collection costs that exceed the usual expenses incurred in the collection of nursing student loans.
(2) A school must review the balance in the fund on at least a semi-annual basis to determine whether the fund balance compared with projected levels of expenditures and collections exceeds its needs. A school in closing status must review the balance in the fund on a quarterly basis. Monies identified as in excess of the school's needs must be reported, and the Federal share returned to the Federal Government, by the due date of the required report which identifies the excess monies. The school's determination is subject to the review and approval of the Secretary.
(b)
(2) The Federal capital loans must be carried in a special account of the school, to be used by the school only for: (i) Repayments of principal and interest on Federal capital loans; and (ii) costs of litigation, costs associated with membership in credit bureaus, and, to the extent specifically approved by the Secretary, other collection costs that exceed the usual expenses incurred in the collection of nursing student loans.
(c) Failure to comply with the requirements of this section will subject a school to the noncompliance provisions of § 57.318 and the Department's Claims Collections regulations (45 CFR part 30), as appropriate.
(a)
(i) Residents of the United States and either a citizen or national of the United States, an alien lawfully admitted for permanent residence in the United States, a citizen of the Commonwealth of the Northern Mariana Islands, a citizen of the Republic of Palau, a citizen of the Republic of the Marshall Islands, or a citizen of the Federated States of Micronesia;
(ii) Enrolled, or accepted for enrollment in the school as full-time or half-time students;
(iii) In need of the amount of the loan to pursue the course of study at the school; and
(iv) Capable, in the opinion of the school, of maintaining good standing in the course of study.
(2) An applicant who has previously attended an institution of higher education must submit a financial aid transcript which includes at least the following data:
(i) Applicant's name and social security number;
(ii) Amounts and sources of loans and grants previously received by the applicant for study at an institution of higher education;
(iii) Whether the applicant is in default on any of these loans, or owes a refund on any grants;
(iv) Certification from each institution previously attended by the applicant that the applicant has received no financial aid, if applicable; and
(v) From each institution previously attended, the signature of an official authorized by the institution to sign such transcripts on behalf of the institution.
(b)
(1) In selecting nursing student loan applicants the school will give preference to licensed practical nurses, and to persons with exceptional financial need. For purposes of this preference, a student will be considered to demonstrate exceptional financial need if the school determines that the student's resources, as described in paragraph (b)(2)(i) of this section, do not exceed one-half of the costs of attendance at the school. Summer earnings, educational loans, veterans (G.I.) benefits, earnings during the school year, and Aid to Families with Dependent Children (AFDC) will not be considered as resources in determining whether an applicant meets these criteria for exceptional financial need, but will be considered in determining the amount of funds a student may receive.
(2) In determining whether a student is in need of a nursing student loan to pursue a full-time or half-time course of study at the school, the school will take into consideration:
(i) The financial resources available to the student by using one of the national need analysis systems or any other procedure approved by the Secretary of Education in combination with other information which the school has regarding the student's financial status; and
(ii) The costs reasonably necessary for the student's attendance at the school, including any special needs and obligations which directly affect the student's financial ability to attend the school on a full-time or half-time basis. The school must document the criteria used for determining these costs.
(c)
The total of the nursing student loans made from the fund to any student for an academic year may not exceed $2,500, except that for each of the final 2 academic years of the program, the total must not exceed $4,000. The maximum amount loaned during a 12-month period to any student enrolled in a school which provides a course of study longer than the 9-month academic year may be proportionately increased. The total of all nursing student loans to any student must not exceed $13,000.
(a)
(1) Each promissory note must state that the loan will bear interest on the unpaid balance computed only for periods during which repayment of the loan is required, at the rate of 5 percent per year.
(2) Each promissory note must contain an acceleration clause provided by the Secretary, which will permit the acceleration of delinquent loans at the school's option.
(3) A copy of each executed note must be supplied by the school to the student borrower.
(b)
(a) Nursing student loans from any fund may be paid to or on behalf of student borrowers in installments considered appropriate by the school except that a school may not pay to or on behalf of any borrower more during any given installment period (e.g., semester, term, or quarter) than the school determines the student needs for that period.
(b) No payment may be made from a fund to or on behalf of any student borrower if at the time of the payment the borrower is not a full-time or half-time student.
(a) Each nursing student loan, including accrued interest, will be repayable in equal or graduated periodic installments in amounts calculated on the basis of a 10-year repayment period. Repayment of a loan must begin 9 months after the student ceases to be a full-time or half-time student, except that if a borrower reenters the same or another school as a full-time or half-time student within the 9-month period, the date upon which interest will accrue and the repayment period will begin will be determined by the date upon which the student last ceases to be a full-time or half-time student at that school.
(1) The following periods will be excluded from the 10-year repayment period: (i) All periods up to a total of 3 years of active duty performed by the borrower as a member of the Army, Navy, Air Force, Marine Corps, Coast Guard, National Oceanic and Atmospheric Administration Corps or the U.S. Public Health Service Commissioned Corps;
(ii) All periods up to a total of 3 years of service as a volunteer under the Peace Corps Act; and
(iii) All periods up to a total of 10 years during which the borrower is pursuing a full-time or half-time course of study at a school leading to a baccalaureate degree in nursing or an equivalent degree, or to a graduate degree in nursing, or is otherwise pursuing advanced professional training in nursing (or training to be a nurse anesthetist). For purposes of this paragraph, “otherwise pursuing advanced professional training in nursing” shall include full-time or half-time training, beyond the first diploma or degree in nursing received by the particular borrower, of at least 1 academic year which will advance the borrower's knowledge of and strengthen his or her skills in the provision of nursing services.
(2) Subject to the provisions of paragraph (b)(3) of this section, a borrower must establish a repayment schedule with the school providing for payments not less often than quarterly. Any borrower whose repayment becomes more than 60 days past due must be placed on a monthly repayment schedule by the school. A borrower may at his or her option and without penalty, prepay all or part of the principal and accrued interest at any time.
(3) A school may grant forbearance whenever extraordinary circumstances such as unemployment, poor health or other personal problems temporarily affect the borrower's ability to make scheduled loan repayments.
(b)
(i) Conduct and document an entrance interview (individually or in groups) with the borrower prior to disbursing NSL funds in any academic year. During the entrance interview the school must obtain documentation which indicates that the borrower is aware of the rights and responsibilities associated with NSL funds and personal information which would assist in locating the borrower if he or she fails to keep the school informed of his or her current address. The requirement of this subparagraph may be met by correspondence if the school determines that a face-to-face meeting (individually or in groups) is impracticable.
(ii) Conduct and document an exit interview (individually or in groups) with the borrower. During the exit interview, the school must provide each borrower with information necessary to carry out the terms of repayment, remind the borrower of the rights and responsibilities associated with NSL funds, and update the personal information collected prior to disbursing NSL funds which would assist in locating the borrower if he or she fails to keep the school informed of his or her current address. If the borrower terminates studies without advance notice, the school must document attempts to inform the borrower of the substance of the exit interview and to secure exit interview information from the borrower by mail.
(iii) Notify the borrower in writing of the impending repayment obligation at least twice during the grace period;
(iv) Notify a borrower who is in deferment status in writing of the impending repayment obligation 1 to 3 months prior to the expiration of the approved period of deferment;
(v) Perform regular billing;
(vi) Follow up past due payments with a series of at least four documented and reasonably spaced attempts to contact the borrower, at least three of which must be in writing at not more than 30-day intervals, prior to the loan becoming 120 days past due, provided that the school has a current address for the borrower;
(vii) Perform address searches when necessary;
(viii) Use collection agents, which may include the use of an internal collection agent;
(ix) Institute legal proceedings against borrowers after all other attempts at collection have failed, unless the school determines, subject to the approval of the Secretary, that such litigation would not be cost-effective; and
(x) Become a member of a credit bureau and notify the credit bureau of accounts past due by more than 120 days.
(2)
(ii) For any nursing student loan made on or after October 1, 1985, the school shall assess a charge for failure of the borrower to pay all or any part of an installment when the loan is more than 60 days past due and, in the case of a borrower who is entitled to deferment under section 836(b)(2) of the Act, for any failure to file satisfactory
(3) With respect to any nursing student loan made after June 30, 1969, the school may require the borrower to make payments of at least $15 per month on all outstanding nursing student loans during the repayment period.
(4) A school must, on an annual basis, review and assess the collectibility of any loan more than 3 years past due. If the school determines that the prospects of future collection are promising enough to justify periodic review of the debt, and neither the statute of limitations nor the 10-year repayment period has expired, the school may retain the account for continued collections, provided that it makes an attempt at least semi-annually to collect from the borrower. When the due diligence procedures required by paragraph (b)(1) of this section have been exhausted, the school is responsible for determining the collection methods it will use for the semi-annual collection effort required on these loans. If the school determines that the prospects of future collection are not promising, or when the statute of limitations or the 10-year repayment period has expired, the loan must be considered uncollectible. A school may determine a loan to be uncollectible sooner than 3 years past due when it has evidence that the loan cannot be collected, but in no case should a school consider a loan as uncollectible if it has not been in default for at least 120 days. A school is not subject to the requirements in paragraphs (b)(4) (i) and (iii) of this section for loans that became uncollectible, as determined by the school, before January 1, 1983.
(i) A school must request permission to write off an uncollectible loan within 30 days of the determination that it is uncollectible or reimburse the fund in the full amount of the loan, pursuant to § 57.310(b)(4)(iii). The 30-day period for submitting the loan for write-off review begins on the date that the determination of uncollectibility is made, in accordance with paragraph (b)(4) of this section. In any instance where the Secretary determines that a school has failed to exercise due diligence in the collection of a loan, in accordance with the applicable regulatory requirements, the school will be required to place in the fund the full amount of principal, interest, and penalty charges that remains uncollected on the loan. Reimbursement must be made by the following June 30 or December 31, whichever is sooner, except that in no case will a school be required to reimburse the fund in less than 30 days following the Secretary's disapproval of the request for write-off approval.
(ii) If the Secretary determines that a school has exercised due diligence in the collection of a loan, in accordance with the applicable regulatory requirements, or if the school determines that the loan was uncollectible prior to January 1, 1983, the school will be permitted to reduce its accounts receivable for the NSL fund by the full amount of principal, interest, and penalty charges that remains uncollected on that loan and will not be required to return the Federal share of the loss to the Secretary.
(iii) If a school does not request permission to write off an uncollectible loan within the required timeframe, it must reimburse the fund for the full amount of principal, interest, and penalty charges that remains uncollected on that loan. This reimbursement must be made by the following June 30 or December 31, whichever is sooner, except that in no case will a school be required to reimburse the fund in less than 30 days following its determination that a loan is uncollectible.
(iv) Failure to comply with the requirements of this section will subject a school to the noncompliance provisions of § 57.318 and the Department's
(5)
(a)
(b)
(a)
(1) Has obtained a degree as specified in section 846(a)(1) of the Act;
(2) Has obtained one or more nursing student loans or any other loans necessary for costs (including tuition, books, fees, equipment, living and other expenses which the Secretary determines were necessary) of attending a school of nursing; and
(3) Enters into an agreement with the Secretary to serve as a full-time registered nurse for a period of not less than 2 years in an Indian Health Service health center, a Native Hawaiian health center, a public hospital, a migrant health center, a community health center, a nursing facility, a rural health clinic, or in a health facility determined by the Secretary to have a critical shortage of nurses, will have a portion of these loans repaid by the Secretary in accordance with paragraph (c) of this section. Prior to entering an agreement for repayment of loans, other than nursing student loans, the Secretary will require that satisfactory evidence be provided of the existence and reasonableness of the education loans (i.e., a copy of the written loan agreement establishing the loan).
(b) When entering into agreements under paragraph (a) of this section, the Secretary shall give priority to:
(1) Applicants with the greatest financial need; and
(2) Applicants that, with respect to health facilities described in paragraph (a)(3) of this section, agree to serve in such facilities located in geographic areas with a shortage of and need for nurses, as determined by the Secretary.
(3) In addition to the priorities under paragraphs (b) (1) and (2) of this section, should specific needs warrant, the Secretary may establish additional
(c)
(1) Upon completion by the borrower of the first year of service as specified in the agreement, the Secretary will pay 30 percent of the principal of, and the interest on, each loan which was unpaid as of the date the borrower began his or her service;
(2) Upon completion by the borrower of the second year of service, the Secretary will pay another 30 percent of the principal of, and the interest on, each loan which was unpaid as of the date the borrower began his or her service;
(3) Upon completion by the borrower of a third year of service, the Secretary will pay another 25 percent of the principal of, and the interest on, each loan which was unpaid as of the date the borrower began his or her service; and
(4) No more than 85 percent of the principal of any loan will be paid under this section.
(a)
(b)
(c) The determination of whether a person is entitled to have any portion of his or her nursing student loan canceled for full-time employment as a registered nurse will be made by the institution to whose fund his or her loan is payable, upon receipt and evaluation of an application for cancellation from that person.
In the event that insufficient funds are available to the Secretary in any fiscal year to enable him or her to pay to all schools their proportionate shares of all loans and interest canceled under this subpart for full-time employment as a nurse, death, or disability:
(a) Each school will be paid an amount bearing the same ratio to the total of the funds available for that purpose as the principal of loans canceled by that school in that fiscal year bears to the total principal of loans canceled by all schools in that year; and
(b) Any additional amounts to which a school is entitled will be paid by the
In the event that the Secretary undertakes to repay educational loans under section 836(i) of the Act, he or she will use the following criteria to make a determination as to each applicant's eligibility:
(a) An applicant will be considered to have failed to complete the course of study in nursing for which an eligible education loan was made upon certification by a school of nursing that the individual ceased to be enrolled in the school subsequent to November 17, 1971;
(b) An applicant will be considered to be in exceptionally needy circumstances if, upon comparison of the income and other financial resources of the applicant with his or her expenses and financial obligations, the Secretary determines that repayment of the loan would constitute a serious economic burden on the applicant. In making this determination, the Secretary will take into consideration the applicant's net financial assets, his or her potential earning capacity, and the relationship of the income available to the applicant to the low-income levels published annually by the Secretary in the
(c) An applicant will be considered as not having resumed his or her nursing studies within 2 years following the date the individual ceased to be a student upon certification so stating from the applicant; and
(d) An applicant will be considered as not reasonably expected to resume his or her nursing studies within 2 years following the date upon which he or she terminated these studies, based upon consideration of the reasons for the applicant's failure to complete these studies, taking into account such factors as academic, medical, or financial difficulties. The Secretary will only repay education loans made after November 17, 1971.
(a)
(i) A school which fails to submit a required report for its Federal capital contribution fund within 45 days of the close of the reporting period:
(A) Shall be prohibited from receiving new Federal capital contributions;
(B) Must place the revolving fund and all subsequent collections in an insured interest-bearing account; and
(C) May make no loan disbursements.
(ii) A school that fails to submit a complete report within 6 months of the close of the reporting period will be subject to termination. The Secretary will provide the school with a written notice specifying his or her intention to terminate the school's participation in the program and stating that the school may request, within 30 days of the receipt of this notice, a formal hearing. If the school requests a hearing, it must within 90 days of the receipt of the notice, submit material, factual issues in dispute to demonstrate that there is cause for a hearing. These issues must be both substantive and relevant. The hearing will be held in the Washington, DC metropolitan area. The Secretary will deny a hearing if:
(A) The request for a hearing is untimely (ie., fails to meet the 30-day requirement);
(B) The school does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(C) The statement of factual issues in dispute is frivolous or inconsequential.
(2) The following student records must be retained by the school for 5 years after the individual student ceases to be a full-time or half-time student:
(i) Approved student applications for nursing student loans;
(ii) Documentation of the financial need of applicants; and
(iii) Copy of financial aid transcripts.
(3) The following repayment records for each individual borrower must be retained for at least 5 years from the date of retirement of a loan:
(i) The amount and date of each loan;
(ii) The amount and date of each payment or cancellation;
(iii) Records of periods of deferment;
(iv) Date, nature, and result of each contract with the borrower or proper endorser in the collection of an overdue loan;
(v) Copies of all correspondence to or from the borrower and endorser;
(vi) Copies of all correspondence with a collection agency related to the individual borrower;
(vii) Copies of all correspondence with a credit bureau related to an individual borrower; and
(viii) Copies of all correspondence relating to uncollectible loans which have been written off by the Federal Government or repaid by the school.
(4) The school must also retain other records as the Secretary may prescribe. In all cases where questions have arisen as a result of a Federal audit, the records must be retained until resolution of all questions.
(b)
(2) The school must comply with the audit requirements of the Department of Health and Human Services' Administration of Grants regulations which are set forth in 45 CFR part 74.
(c) Institutional officials who have information which indicates the potential or actual commission of fraud or other offenses against the United States, involving these loan funds, should promptly provide this information to the appropriate Regional Office of Inspector General for Investigations.
Participating schools are advised that in addition to complying with the terms and conditions of these regulations, several other regulations apply under this subpart. These include, but are not limited to:
On June 30, 1986, and on each June 30 thereafter, except as provided in paragraph (b) of this section, each school must have a default rate (as calculated under paragraph (a) of this section) of not more than 5 percent.
(a) The default rate for each school shall be the ratio (stated as a percentage) that the defaulted principal amount outstanding of the school bears to the matured loans of the school. For this purpose:
(1) The term “defaulted principal amount outstanding” means the total amount borrowed from the loan fund of a school that has reached the repayment stage (minus any principal amount repaid or canceled) on loans in default for more than 120 days; and
(2) The term “matured loans” means the total principal amount of all loans made by a school under this subpart minus the total principal amount of loans made by the school to students who are:
(i) Enrolled in a full-time or half-time course of study at the school; or
(ii) In their grace period.
(b) Any school that has a default rate greater than 5 percent on June 30, 1986, or on June 30 of any year thereafter will be required to:
(1) Reduce its default rate by 50 percent (or a school with a default rate below 10 percent must reduce its rate to 5 percent) by the close of the following 6-month period; and
(2) By the end of each succeeding 6-month period, reduce its default rate to 50 percent of the required rate for the previous 6-month period, until it reaches 5 percent.
(c) Any school subject to the provisions of paragraph (b) of this section which fails to comply with those requirements will receive no new NSL funds and will be required to:
(1) Place the revolving fund monies and all subsequent collections into an insured interest-bearing account;
(2) Make no loan disbursements; and
(3) By the end of the succeeding 6-month period, reduce its default rate to 50 percent of the rate it failed to achieve under paragraph(b) of this section, or 5 percent. A school that meets this requirement will be permitted to resume the use of its nursing student loan funds, but must continue to comply with the requirements of paragraph (b)(2) of this section if its default rate is still greater than 5 percent.
(d) Any school subject to the provisions of paragraph (c)(3) of this section which fails to comply with those requirements will be subject to termination. The Secretary will provide the school with a written notice specifying his or her intention to terminate the school's participation in the program and stating that the school may request, within 30 days of the receipt of this notice, a formal hearing. If the school requests a hearing, it must within 90 days of the receipt of the notice, submit material, factual issues in dispute to demonstrate that there is cause for a hearing. These issues must be both substantive and relevant. The hearing will be held in the Washington, DC metropolitan area. The Secretary will deny a hearing if:
(1) The request for a hearing is untimely (i.e., fails to meet the 30-day requirement);
(2) The school does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(3) The statement of factual issues in dispute is frivolous or inconsequential.
The Secretary may, with respect to any agreement entered into with any school under § 57.305, impose additional conditions prior to or at the time of any award when in his or her judgment the conditions are necessary to assure or protect advancement of the purposes of the agreement, the interest of the public health, or the conservation of funds awarded.
Whenever the Secretary finds that a participating school has failed to comply with the applicable provisions of the Act or the regulations of this subpart he or she may, on reasonable notice to the school, withhold further payments of Federal capital contributions and take other action, including the termination of any agreement, as he or she finds necessary to enforce the Act and regulations. In such case no further expenditures shall be made from the nursing student loan fund or funds involved until the Secretary determines that there is no longer any failure of compliance.
Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216.
If, within 20 years after completion of construction (or, in the case of interim facilities prior to the time at which teaching in such facilities is moved to a permanent facility, whichever comes first), the facility shall cease to be used for any one or more of the purposes for which it was constructed, the Secretary, in determining whether there is good cause for releasing the applicant or other owner of the facility from the obligation so to use the facility, shall take into consideration the extent to which:
(a) The facility will be devoted by the applicant or other owner to the teaching of other health personnel;
(b) There are reasonable assurances that for the remainder of such period other facilities not previously utilized for nurse training will be so utilized and are substantially the equivalent in nature and extent for such purposes.
Sec. 727, Public Health Service Act. 77 Stat. 170, as amended (42 U.S.C. 293g).
The regulations of this subpart are applicable to loan guarantees and interest subsidy payments made pursuant to section 729 of the Public Health Service Act (42 U.S.C. 293i) to assist nonprofit private entities which are eligible for grants under subpart B of this part in carrying out projects for construction of teaching facilities for health professions personnel.
As used in this subpart:
(a) All terms not defined herein shall have the same meanings as given them in section 724 of the Act.
(b)
(c)
(d)
(e)
(f)
(g)
(a)
(1) Be a nonprofit private school of medicine, dentistry, osteopathy, pharmacy, optometry, podiatry, veterinary medicine, or public health, or any combination of such schools, or a nonprofit private affiliated hospital or affiliated outpatient facility:
(2) Otherwise meet the applicable requirements set forth in section 721(b) of the Act and § 57.103 with respect to eligiblity for grants for construction of teaching facilities for health professions personnel.
(b)
Each applicant desiring to have a loan guaranteed or to have interest subsidies paid on its behalf, or any combination of such loan guarantee or interest subsidies, shall submit an application for such assistance in such form and manner and at such time as the Secretary may require.
(a) The application shall contain or be supported by such information as the Secretary may require to enable him to make the determinations required of him under the Act and this subpart.
(b) The application shall be executed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of any loan guarantee or agreement to pay interest subsidies, including the applicable regulations of this subpart.
(a)
(1) Any such approval shall be subject to compliance by the applicant with the applicable provisions set forth in §§ 57.106, 57.107, 57.108, and 57.110:
(2) Any such application may be approved by the Secretary only if he determines:
(i) That the applicant will have sufficient financial resources to enable him to comply with the terms and conditions of the loan;
(ii) That the applicant has the necessary legal authority to finance, construct, and maintain the proposed proj-ect, to apply for and receive the loan, and to pledge or mortgage any assets or revenues to be given as security for such loan;
(iii) That the loan will be made only with respect to the initial permanent financing of the project;
(iv) That the loan will be secured by a lien against the facilities to be constructed or against other security satisfactory to the Secretary specified in § 57.2210;
(v) That the rate of interest on the loan does not exceed such percent per annum as the Secretary determines to be reasonable, taking into account the range of interest rates prevailing in the private market for similar loans and the risks assumed by the United States; and
(vi) Such additional determinations as the Secretary finds necessary with respect to particular applications in order to protect the financial interests of the United States.
(b)
(c)
(a) Priority in approving applications for loan guarantee and/or interest subsidies shall be determined in accordance with the factors specified in section 721(d) of the Act, and the following: (1) The relative need for increased enrollment and the availability of students; (2) the relative effectiveness of the project relative to the cost to the Federal Government; and (3) the relative ability of the applicant to make efficient and productive use of the facility constructed.
(b) In the case of applications to aid in the construction of new schools of medicine, osteopathy, or dentistry, the
(a) The amount of loan with respect to which a guarantee is made under this subpart shall be determined by the Secretary based upon such considerations as the availability of funds and the applicant's need therefor;
(2) Notwithstanding paragraph (a)(1) of this section, the Secretary may in particular cases guarantee loans in excess of the amount specified in paragraph (a)(1) of this section where he determines that, because of special circumstances, such additional loan guarantee will further the purposes of part B of title VII of the Act. In making such determinations, the Secretary will in each case consider the following factors:
(i) The need for the project in the area to be served;
(ii) The availability of financing for the project on reasonable terms and conditions without such additional loan guarantee;
(iii) Whether the project can be constructed without such additional loan guarantee; and
(iv) Other relevant factors consistent with the purpose of part B of title VII of the Act and this subpart.
(3) In determining the cost of construction of the project there shall be excluded from such cost all fees, interest, and other charges relating or attributable to the financing of the proj-ect except the following:
(i) Reasonable fees attributable to services rendered by legal counsel in connection with such loan;
(ii) With the approval of the Secretary, reasonable fees attributable to the services of a financial advisor in assisting the applicant in securing the loan and arranging for repayment thereof; and
(iii) Interest attributable to the interim financing of construction of the project prior to the initial permanent financing thereof.
(b) No loan guarantee under this subpart shall apply to more than 90 percent of the loss of principal of and interest on such loan incurred by the holder of such loan upon default by the applicant.
The length of time for which interest subsidy payments will be made under the agreement, the amount of loan with respect to which such payments will be made, and the level of such payments shall be determined by the Secretary on the basis of the availability of funds and his determination of the applicant's need therefor taking into consideration his analysis of the present and reasonable projected future financial ability of the applicant to repay the principal and interest of the loan without jeopardizing the quality of its educational program:
Each loan with respect to which a guarantee is made or interest subsidies are paid under this subpart shall be evidenced by a credit instrument and secured by a security instrument in such forms as may be acceptable to the Secretary.
Each loan with respect to which a guarantee is made or interest subsidies are paid under this subpart shall be secured in a manner which the Secretary finds reasonably sufficient to insure repayment. The security may be one or a combination of the following:
(a) A first mortgage on the facility and site thereof.
(b) Negotiable stocks or bonds of a quality and value acceptable to the Secretary.
(c) A pledge of unrestricted and unencumbered income from an endowment or other trust fund acceptable to the Secretary.
(d) A pledge of a specified portion of annual general or special revenues of the applicant acceptable to the Secretary.
(e) Such other security as the Secretary may find acceptable in specific instances.
At appropriate stages in the application and approval procedure for a loan guarantee or interest subsidy, the applicant shall furnish to the Secretary a memorandum or opinion of legal counsel with respect to the legality of any proposed note issue, the legal authority of the applicant to issue the note and secure it by the proposed collateral, and the legality of the issue upon delivery. “Legal counsel” means either a law firm or individual lawyer, thoroughly experienced in the long-term financing of construction projects, and whose approving opinions have previously been accepted by lenders or lending institutions. The legal memorandum or opinion to be provided by legal counsel in each case shall be as follows:
(a) A memorandum, submitted with the application for a loan guarantee or interest subsidy, stating that the applicant is or will be lawfully authorized to finance, construct, and maintain the project, and to issue the proposed obligations and to pledge or mortgage the assets and/or revenues offered to secure the loan, citing the basis for such authority; and
(b) A final approving opinion, delivered to the Secretary at the time of delivery of the evidence of indebtedness to the lender, stating that the credit and security instruments executed by the applicant are duly authorized and delivered and that the indebtedness of the applicant is valid, binding, and payable in accordance with the terms on which the loan guarantee was approved by the Secretary.
The repayment period for loans with respect to which guarantees are made or interest subsidies paid under this subpart shall be limited to 30 years:
(a) The Secretary may, in particular cases where he determines that a repayment period of less than 30 years is more appropriate to an applicant's total financial plan, approve such shorter repayment period;
(b) The Secretary may, in particular cases where he determines that, because of unusual circumstances, the applicant would be financially unable to amortize the loan over a repayment period of 30 years, approve a longer requirement period which shall in no case exceed 40 years; and
(c) In no case shall a loan repayment period exceed the useful life of the facility to be constructed with the assistance of the loan.
Unless otherwise specifically authorized by the Secretary, each loan with respect to which a guarantee is made or interest subsidies are paid shall be repayable in substantially level total annual installments of principal and interest, sufficient to amortize the loan through the final year of the life of the loan.
For each application for a loan guarantee or interest subsidy, or combination thereof, which is approved by the Secretary under this subpart, an offer to guarantee such loan and/or make interest subsidy payments with respect thereto will be sent to the applicant, setting forth the pertinent terms and conditions for the loan guarantee and/or interest subsidy, and will be conditioned upon the fulfillment of such
(a)
(1) That the loan guarantee evidenced by the agreement shall be incontestable (i) in the hands of the applicant on whose behalf such loan guarantee is made except for fraud or misrepresentation on the part of such applicant, and (ii) as to any person who makes or contracts to make a loan to such applicant in reliance on such guarantee, except for fraud or misrepresentation on the part of such other person.
(2) That the applicant shall be permitted to prepay up to 15 percent of the original principal amount of such loan in any calendar year without additional charge. The applicant and the lender may further agree that the applicant shall be permitted to prepay in excess of 15 percent of the original amount of the loan in any calendar year without additional charge, but no such payment in excess of 15 percent shall be made without the prior written approval of the Secretary.
(3) That if the applicant shall default in making periodic payment, when due, of the principal and interest on the loan guaranteed under the agreement, the holder of the loan shall promptly give the Secretary written notification of such default. The Secretary shall, immediately upon receipt of such notice, provide the holder with written acknowledgement of such receipt.
(4) That if such default in making periodic payment when due of the principal and interest on the guaranteed loan is not cured within 90 days after receipt by the Secretary of notice of such default, the holder of the loan shall have the right to make demand upon the Secretary, in such form and manner as the Secretary may prescribe, for payment of 90 percent of the amount of the overdue payments of principal and accrued interest, together with such reasonable late charges as are made in accordance with the terms of the credit instrument or security instrument evidencing or securing such loan. The Secretary shall pay such amount from funds available to him for these purposes.
(5) That in the event of exercise by the holder of the loan of any right to accelerate payment of such loan as a result of the applicants default in making periodic payment when due of the principal and interest on the guaranteed loan, the Secretary shall, upon demand by the holder not less than 90 days after receipt by the Secretary of notification of such default, pay to such holder 90 percent of the total amount of principal and of interest on the loan remaining unpaid after the holder has exercised his right to foreclose upon and dispose of the security and has applied the proceeds thereby received to reduce the outstanding balance of the loan, in accordance with applicable law and the terms of the security instrument.
(6) That the Secretary shall not guarantee any funds which are disbursed by a lender following notification by the Secretary to such lender that the Assurance executed by the Applicant under section 799A of the Act is no longer satisfactory.
(b)
(1) That the holder of the loan shall have a contractual right to receive from the United States interest subsidy payments in amounts sufficient to reduce by up to 3 percent per annum the net effective interest rate determined by the Secretary to be otherwise payable on such loan.
(2) That payments of interest subsidies pursuant to paragraph (b)(1) of this section will be made by the Secretary, in accordance with the terms of the loan with respect to which the interest subsidies are paid, directly to the holder of such loan, or to a trustee or agent designated in writing to the Secretary by such holder, until such time as the Secretary is notified in writing by the holder that such loan has been transferred. Pursuant to such written notification of transfer, the Secretary will make such interest payments directly to the new holder
(3) That the holder of the loan will promptly notify the Secretary of any default or prepayment by the applicant with respect to the loan.
(4) In the event of any exercise by the holder of the loan of the right to accelerate payment of such loan, whether as a result of default on the part of the applicant or otherwise, the Secretary's obligations with respect to the payment of interest subsidies shall cease.
(5) Where, during the life of the loan with respect to which interest subsidies are to be paid, the applicant ceases to use the facility for the purposes for which constructed, the Secretary's obligation with respect to the payment of interest subsidies shall cease:
(6) Where during the life of the loan with respect to which interest subsidies are to be paid, it is determined, after an opportunity for a hearing pursuant to 45 CFR part 83, that the Assurance executed by the applicant under section 704 (or its predecessor, section 799A) of the Act, is no longer satisfactory, the Secretary's obligation with respect to the payment of interest subsidies shall cease:
(7) Where during the life of the loan with respect to which interest subsidies are to be paid, it is determined by the Secretary, after an opportunity for a hearing pursuant to 45 CFR parts 80 and 81, that the applicant has ceased to comply with the Assurance it has executed under 45 CFR 80.4(d) concerning nondiscrimination on the basis of race, color or national origin, the Secretary's obligation with respect to the payment of interest subsidies shall cease:
(8) Where during the life of the loan with respect to which interest subsidies are to be paid, it is determined by the Secretary after an opportunity for a hearing pursuant to title IX of the Education Amendments of 1972, that the applicant has ceased to comply with such title, and its implementing regulations, the Secretary's obligation with respect to the payment of interest subsidies shall cease:
(c)
Closing of any loan with respect to which a guarantee is made or interest subsidies are paid under this subpart shall be accomplished at such time as may be agreed upon by the parties to such loan and found acceptable to the Secretary.
(a) The United States shall be entitled to recover from the applicant for a loan guarantee under this subpart the amount of any payment made pursuant to such guarantee, unless the Secretary waives such right of recovery as provided in § 57.1517.
(b) Upon making of any payments pursuant to a loan guarantee under this subpart, the United States shall be subrogated to all of the rights of the recipient of the payments with respect to which the guarantee was made.
In determining whether there is good cause for waiver of any right of recovery which he may have against any applicant by reason of any payments made pursuant to a loan guarantee under this subpart, the Secretary shall take into consideration the extent to which:
(a) The facility with respect to which the loan guarantee was made will continue to be devoted by the applicant or other owner to the teaching of health professions personnel, or to other purposes in the sciences related to health for which funds are available under part B of title VII of the act and these regulations;
(b) A hospital or outpatient facility will be used as provided for under title VI of the act;
(c) There are reasonable assurances that for the remainder of the repayment period of the loan other facilities not previously utilized for the purpose for which the facility was constructed will be so utilized and are substantially equivalent in nature and extent for such purposes; and
(d) Such recovery would seriously curtail the training of qualified health professions personnel in the area served by the facility.
No official of the Department of Health and Human Services will approve any proposal to modify the terms of a loan guaranteed under title VII of the Public Health Service Act (42 U.S.C. 293
Sec. 2(a), Pub. L. 92-426, 86 Stat. 719 (10 U.S.C. 2127(d)).
In the event the Secretary of Defense decides to enter into one or more contracts under 10 U.S.C. 2127(d), the regulations in this subpart outline considerations the Secretary of Defense will take into account in determining whether an accredited civilian educational institution has increased its total enrollment for the sole purpose of accepting members of the Armed Forces health professions scholarship program.
As used in this subpart:
(a)
(b)
(c)
(d)
In the event the Secretary of Defense decides to enter into one or more contracts under 10 U.S.C. 2127(d), his determination as to whether an institution has increased its total enrollment in any fiscal year for the sole purpose of accepting members of the program will take into account the following considerations:
(a) A comparison of the total enrollment in said fiscal year with the total enrollments in immediately preceding fiscal years;
(b) Any increases in enrollment to which the institution has directly or indirectly committed itself in said fiscal year under: (1) Other Federal programs, such as those set forth in title VII and VIII of the Public Health Service Act (42 U.S.C. 292
(c) Any unusual factors, such as: (1) An institution having been newly established or (2) an institution experiencing what is for it an abnormal rate of attrition and/or admission.
Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216).
The regulations of this subpart are applicable to scholarship grants awarded under section 784 of the Public Health Service Act, which authorizes the Secretary to award scholarship grants to students of medicine and osteopathy who agree to engage in the full-time practice of primary care for a prescribed period of time (a) in a physician shortage area or (b) in such manner as to assure that of the patients receiving medical care in such practice a substantial portion will consist of migratory agricultural workers or members of their families.
As used in this subpart, the following terms shall have the following meanings:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
To be eligible for a scholarship grant under this subpart, the applicant must:
(a) Be a national of the United States or a permanent resident of the Trust Territory of the Pacific Islands or a lawful permanent resident of the United States, Puerto Rico, the Virgin Islands or Guam;
(b) Be a full-time student in a school located in the United States, the Trust Territory of the Pacific Islands, Puerto Rico, the Virgin Islands, the Canal Zone, American Samoa or Guam; and
(c) Agree to engage in the full-time practice of primary care as defined in § 57.2202(j) in accord with conditions specified in § 57.2209.
Each eligible applicant desiring a scholarship grant under this subpart shall submit an application at such time and in such form as the Secretary may prescribe.
(a) When funds determined by the Secretary to be available for scholarship grants under this subpart are insufficient to permit the awarding of scholarships to all individuals applying therefor, the Secretary shall accord priority to eligible applicants as follows:
(1) First priority for scholarship grants shall be accorded to applicants who (i) are from a low-income background as defined in § 57.2202 (i), (ii) reside in a physician shortage area and (iii) agree to return to such area and engage in the full-time practice of primary care. For purposes of this paragraph, an individual resides in a physician shortage area if he presently is residing in such an area or if he (or his parents) resided in such an area in the year prior to his admission to an institution of higher education.
(2) Second priority shall be accorded to applicants meeting the criteria in paragraphs (a)(1) (ii) and (iii) of this section.
(3) Third priority shall be accorded to applicants meeting the criterion in paragraph (a)(1)(i) of this section.
(4) Fourth priority shall be accorded to other applicants.
(b) Where there are insufficient funds available to make scholarship grants to all members of any single priority grouping enumerated in paragraph (a) of this section, the following criteria
(1) Within the priority groupings specified in paragraphs (a) (1) and (2) of this section, the Secretary shall rank recipients according to the degree of the severity of shortage of physicians practicing primary care in such area. Scholarship grants shall be awarded within each priority group first to applicants within that grouping from physician shortage areas with the least favorable ratio of such physicians to the population to be served.
(2) Within the priority groupings specified in paragraphs (a) (3) and (4) of this section, the Secretary shall award scholarship grants within each priority group first to applicants who agree to practice primary care in a physician shortage area with a substantial portion of migratory agricultural workers in such area; second, to applicants within that grouping who agree to practice in a physician shortage area; and third, to applicants within that grouping who agree to practice in such place or places, facility or facilities, and in such manner as the Secretary finds necessary to assure that, of the patients receiving medical care in such practice, a substantial portion will consist of persons who are migratory agricultural workers or members of their families.
The Secretary may award scholarship grants to individuals who have been selected to receive scholarship grants in accordance with § 57.2205. Any such award under this subpart shall state the specific conditions under which the award is being made and shall indicate the distribution between funds awarded to cover the costs of tuition and fees payable to the school and funds awarded for the costs of equipment, supplies, books, and living expenses payable to the individual.
(a) The amount of the scholarship grant to any student for any academic year shall be the total of (1) the lesser of (i) $5,000 or (ii) the amount determined by the Secretary to be the cost of tuition and fees; plus (2) an allowance for equipment, supplies, books and living expenses which shall be the lesser of (i) $3,600 or (ii) the difference between $5,000 and the amount determined pursuant to paragraph (a)(1) of this section.
(b) The maximum amount of a scholarship grant during a 12-month period to any student enrolled in a school which provides a course of study longer than the traditional 9-month academic year may be proportionately increased.
The portion of a scholarship grant awarded for the costs of tuition and fees as indicated on the notice of grant award document will be paid directly to the school upon receipt of an invoice from the school. The portion of the scholarship grant awarded for the costs of equipment, supplies, books, and living expenses will be paid to the individual in equal monthly installments.
(a) Any scholarship grant made to any individual under this subpart shall be awarded upon the condition that such individual will, following completion of his professional training, engage in the full-time practice of primary care for a period of 12 continuous months for each academic year (i.e., 9 months) for which a scholarship grant was made, as follows:
(1) In the case of any individual selected pursuant to § 57.2205(a) (1) or (2), such practice must be in the physician shortage area to which such individual agreed to return:
(2) In the case of any individual selected pursuant to § 57.2205(a) (3) or (4), such practice must be in accordance with the agreement described in § 57.2205(b)(2) (i.e., in a physician shortage area with a substantial portion of migratory agricultural workers in such area; a physician shortage area; or in such place or places, facility or facilities, and in such manner as may be necessary to assure that, of the patients receiving medical care in such practice, a substantial portion will consist of persons who are migratory agricultural workers or members of their families; as the case may be).
(b) Subject to the provision of § 57.2211(f) and except as provided in paragraph (c) of this section, any individual to whom the conditions of this section apply must complete the practice required by paragraph (a) of this section within a period beginning on the date of completion by the individual of his professional training, as determined by the Secretary, and not to exceed the period of practice determined in accordance with such paragraph (a) of this section, plus 6 months.
(c) Where an individual to whom the conditions of this section apply is currently performing an active duty service obligation under section 235 of the Act, the individual must complete the practice required by paragraph (a) of this section within a period beginning on the date of completion by the individual of his service obligation under section 225 of the Act or completion of his internship and residency training (not to exceed four years) if not previously received, whichever comes later, and not to exceed the period of practice determined in accordance with paragraph (a) of this section, plus 6 months.
(d) Where an individual has received scholarship grant support for four academic years, such individual shall be considered to have received scholarship grant support for only three academic years if the Secretary determines (1) that such individual has served his internship or residency in a hospital (i) which is located in a physician shortage area, or (ii) in which a substantial portion of the patients of such hospital consists of persons who are migratory agricultural workers or members of the families of such workers and (2) that while so serving such internship or residency, he has received training or professional experience designed to prepare him to engage in the practice of primary care.
(e) For purposes of paragraph (c)(2) of this section, (1) internships which will be recognized by the Secretary as providing training or professional experience designed to prepare an individual to engage in the practice of primary care are: Rotating internships without a major emphasis, rotating internships with an emphasis on internal medicine, rotating internships with an emphasis on pediatrics, rotating internships with an emphasis on obstetrics and gynecology, straight internships in internal medicine, straight internships in pediatrics and straight internships in obstetrics and gynecology;
(2) Residencies which will be recognized as providing such training or experience are those in general practice, family practice, general internal medicine, general pediatrics and general obstetrics and gynecology;
(f) No individual who has received a scholarship grant under this subpart may enter into an agreement with the Secretary pursuant to section 741(f) of the Act until either (1) such individual has completed the practice required by paragraph (a) of this section, or (2) the Secretary has determined that the United States is entitled to recover from such individual an amount determined in accordance with § 57.2210. In no case, however, shall a scholarship grant under this subpart be considered an educational loan for purposes of section 741(f) of the Act.
(a) Subject to the provision of § 57.2211, if any individual fails to complete the course of study or fails, within the time period set forth in § 57.2209(b), to meet the applicable conditions of practice imposed by receipt of a scholarship grant for the full number of months to which such condition is applicable, the United States shall be entitled to recover from such individual an amount determined in accordance with section 784(c)(3) of the Act;
(a) Any obligation of any individual under this subpart will be cancelled upon the death of such individual as documented by a certification of death, or such other official proof as is conclusive under State law, and submitted to the Secretary.
(b) Subject to the provision of paragraph (f) of this section, where an individual fails to complete the practice required by § 57.2209(a) within the period prescribed in § 57.2209(b), the Secretary may waive or suspend for such period as determined by the Secretary the obligation of such individual to repay pursuant to § 57.2210 where the Secretary determines that compliance by such individual with such obligation (1) is impossible, or (2) would involve extreme hardship to such individual and enforcement of such obligation with respect to such individual would be against equity and good conscience.
(c) For purposes of paragraph (b)(1) of this section, compliance by an individual will be deemed impossible where the Secretary determines, on the basis of such information and documentation as he may require, that the individual is permanently and totally disabled.
(d) For purposes of paragraph (b)(2) of this section, in determining whether compliance by an individual would involve extreme hardship to such individual and would be against equity and good conscience, the Secretary will take into consideration the following:
(1) The individual's present financial resources and obligations;
(2) The individual's estimated future financial resources and obligations;
(3) The reasons for the individual's failure to complete such practice within the prescribed period, such as problems of a personal nature; and
(4) The extent to which the individual is practicing his profession in a manner consistent with the purposes of section 784 of the Act.
(e) Where the Secretary determines that compliance by an individual with his obligation to engage in the practice of primary care in a specified shortage area pursuant to § 57.2209(a) is impossible or would involve extreme hardship to such individual and enforcement of such obligation with respect to such individual would be against equity and good conscience, the Secretary may waive such obligation and permit the individual at his option to practice either in any then current physician shortage area, or in such place or places, facility or facilities, and in such manner as the Secretary finds necessary to assure that, of the patients receiving medical care in such practice, a substantial portion will consist of persons who are migratory agricultural workers or members of their families. The Secretary will take into consideration in determining whether to grant a waiver under this paragraph the extent to which the individual has problems of a personal nature, e.g., physical or mental disability, terminal illness in the family, or need for financial support that cannot be supplied by the required service, which intrude upon the individual's ability to perform the required service in the specified shortage area.
(f) The Secretary may extend the period (prescribed in § 57.2209(b)) within which an individual must complete the practice required pursuant to § 57.2209(a) for a period not to exceed one year where the Secretary finds that (1) such individual is unable to complete such practice within such period because of a temporary physical or mental disability, or (2) completion by such individual of such practice within such period would involve extreme hardship to such individual and that
Sec. 215, Public Health Service Act, 58 Stat. 690, as amended by 63 Stat. 35 (42 U.S.C. 216); sec. 711, Public Health Service Act, 90 Stat. 2253; section 710, PHS Act, as redesignated by Pub. L. 97-35, 95 Stat. 915 (42 U.S.C. 292k).
The regulations in this subpart establish the criteria to be used in determining allowable increases in tuition and other educational costs for which the Secretary is responsible for payment under the following sections of the Public Health Service Act: The National Health Service Corps Scholarship Program (sec. 338A) (42 U.S.C. 254l) and the Indian Health Scholarship Program (awarded pursuant to sec. 338A-339G of the PHS Act) (25 U.S.C. 1613a). These programs are referred to herein as the “scholarship programs.” The regulations apply to increases in tuition and other educational costs occurring after the school year beginning immediately before October 1, 1981.
(a) The Secretary is responsible for increases in tuition and other educational costs only if the same increase is charged to all students in the same category (for example, the same class year or place of residence) and without regard to whether the student is receiving support under the scholarship programs. A student participating in the scholarship programs may not be denied eligibility because of this participation for any discounts or rebates in tuition or other educational costs given to all other students in the same category at the institution.
(b) Institutions whose enrollment contains 25 percent or more students participating in the scholarship programs, and whose percentage increase in tuition and other educational costs in any school year exceeds the previous calendar year's average inflation rate as indicated by the
(c) In the case of a school which is requested to provide the Secretary with cost increase justification under paragraph (b) of this section, the Secretary will be responsible for increases in tuition and other educational costs charged to students participating in the scholarship programs over the amount charged for the school year immediately preceding the increase only to the extent that they are: (1) Attributable to uncontrollable costs, such as fuel costs, mandated cost-of-living increases in wages, salaries and fringe benefits, (2) attributable to costs of maintaining and improving the quality of the health professions education provided by the institution, such as hiring additional faculty to improve the faculty-student ratio, costs incurred in off-site training of students, and necessary improvements in teaching equipment. Increases in patient care and research costs are allowable as part of an increase in tuition and other educational costs only to the extent that they can be documented as clearly necessary to maintain and improve the quality of the education being supported; or (3) attributable to loss of revenue from other sources which was used solely for the maintenance and improvement of the educational system.
(d) If the Secretary, after reviewing all available data, information, and justifications submitted by an institution, determines that an increase in tuition and other educational costs is not allowable under the criteria described in paragraph (a) or (c) of this section, the Secretary will provide the affected institution a detailed written explanation of the basis of that determination. The Secretary will be responsible for that portion of tuition
42 U.S.C. 300a-4.
The regulations of this subpart are applicable to the award of grants under section 1001 of the Public Health Service Act (42 U.S.C. 300) to assist in the establishment and operation of voluntary family planning projects. These projects shall consist of the educational, comprehensive medical, and social services necessary to aid individuals to determine freely the number and spacing of their children.
As used in this subpart:
Any public or nonprofit private entity in a State may apply for a grant under this subpart.
(a) Application for a grant under this subpart shall be made on an authorized form.
(b) An individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of the grant, including the regulations of this subpart, must sign the application.
(c) The application shall contain—
(1) A description, satisfactory to the Secretary, of the project and how it will meet the requirements of this subpart;
(2) A budget and justification of the amount of grant funds requested;
(3) A description of the standards and qualifications which will be required for all personnel and for all facilities to be used by the project; and
(4) Such other pertinent information as the Secretary may require.
(a) Each project supported under this part must:
(1) Provide a broad range of acceptable and effective medically approved family planning methods (including natural family planning methods) and services (including infertility services and services for adolescents). If an organization offers only a single method of family planning, it may participate as part of a project as long as the entire project offers a broad range of family planning services.
(2) Provide services without subjecting individuals to any coercion to accept services or to employ or not to employ any particular methods of family planning. Acceptance of services must be solely on a voluntary basis and may not be made a prerequisite to eligibility for, or receipt of, any other services, assistance from or participation in any other program of the applicant.
(3) Provide services in a manner which protects the dignity of the individual.
(4) Provide services without regard to religion, race, color, national origin, handicapping condition, age, sex, number of pregnancies, or marital status.
(5) Not provide abortion as a method of family planning. A project must:
(i) Offer pregnant women the opportunity to be provided information and counseling regarding each of the following options:
(A) Prenatal care and delivery;
(B) Infant care, foster care, or adoption; and
(C) Pregnancy termination.
(ii) If requested to provide such information and counseling, provide neutral, factual information and nondirective counseling on each of the options, and referral upon request, except with respect to any option(s) about which the pregnant woman indicates she does not wish to receive such information and counseling.
(6) Provide that priority in the provision of services will be given to persons from low-income families.
(7) Provide that no charge will be made for services provided to any persons from a low-income family except
(8) Provide that charges will be made for services to persons other than those from low-income families in accordance with a schedule of discounts based on ability to pay, except that charges to persons from families whose annual income exceeds 250 percent of the levels set forth in the most recent Poverty Guidelines issued pursuant to 42 U.S.C. 9902(2) will be made in accordance with a schedule of fees designed to recover the reasonable cost of providing services.
(9) If a third party (including a Government agency) is authorized or legally obligated to pay for services, all reasonable efforts must be made to obtain the third-party payment without application of any discounts. Where the cost of services is to be reimbursed under title XIX, XX, or XXI of the Social Security Act, a written agreement with the title XIX, XX or XXI agency is required.
(10)(i) Provide that if an application relates to consolidation of service areas or health resources or would otherwise affect the operations of local or regional entities, the applicant must document that these entities have been given, to the maximum feasible extent, an opportunity to participate in the development of the application. Local and regional entities include existing or potential subgrantees which have previously provided or propose to provide family planning services to the area proposed to be served by the applicant.
(ii) Provide an opportunity for maximum participation by existing or potential subgrantees in the ongoing policy decisionmaking of the project.
(11) Provide for an Advisory Committee as required by § 59.6.
(b) In addition to the requirements of paragraph (a) of this section, each project must meet each of the following requirements unless the Secretary determines that the project has established good cause for its omission. Each project must:
(1) Provide for medical services related to family planning (including physician's consultation, examination prescription, and continuing supervision, laboratory examination, contraceptive supplies) and necessary referral to other medical facilities when medically indicated, and provide for the effective usage of contraceptive devices and practices.
(2) Provide for social services related to family planning, including counseling, referral to and from other social and medical services agencies, and any ancillary services which may be necessary to facilitate clinic attendance.
(3) Provide for informational and educational programs designed to—
(i) Achieve community understanding of the objectives of the program;
(ii) Inform the community of the availability of services; and
(iii) Promote continued participation in the project by persons to whom family planning services may be beneficial.
(4) Provide for orientation and in-service training for all project personnel.
(5) Provide services without the imposition of any durational residency requirement or requirement that the patient be referred by a physician.
(6) Provide that family planning medical services will be performed under the direction of a physician with special training or experience in family planning.
(7) Provide that all services purchased for project participants will be authorized by the project director or his designee on the project staff.
(8) Provide for coordination and use of referral arrangements with other providers of health care services, local health and welfare departments, hospitals, voluntary agencies, and health services projects supported by other federal programs.
(9) Provide that if family planning services are provided by contract or other similar arrangements with actual providers of services, services will be provided in accordance with a plan which establishes rates and method of payment for medical care. These payments must be made under agreements with a schedule of rates and payment procedures maintained by the grantee.
(10) Provide, to the maximum feasible extent, an opportunity for participation in the development, implementation, and evaluation of the project by persons broadly representative of all significant elements of the population to be served, and by others in the community knowledgeable about the community's needs for family planning services.
(a) A grant under this section may be made only upon assurance satisfactory to the Secretary that the project shall provide for the review and approval of informational and educational materials developed or made available under the project by an Advisory Committee prior to their distribution, to assure that the materials are suitable for the population or community to which they are to be made available and the purposes of title X of the Act. The project shall not disseminate any such materials which are not approved by the Advisory Committee.
(b) The Advisory Committee referred to in paragraph (a) of this section shall be established as follows:
(1)
(2)
(3)
(i) Consider the educational and cultural backgrounds of individuals to whom the materials are addressed;
(ii) Consider the standards of the population or community to be served with respect to such materials;
(iii) Review the content of the material to assure that the information is factually correct;
(iv) Determine whether the material is suitable for the population or community to which is to be made available; and
(v) Establish a written record of its determinations.
(a) Within the limits of funds available for these purposes, the Secretary may award grants for the establishment and operation of those projects which will in the Department's judgment best promote the purposes of section 1001 of the Act, taking into account:
(1) The number of patients, and, in particular, the number of low-income patients to be served;
(2) The extent to which family planning services are needed locally;
(3) The relative need of the applicant;
(4) The capacity of the applicant to make rapid and effective use of the federal assistance;
(5) The adequacy of the applicant's facilities and staff;
(6) The relative availability of non-federal resources within the community to be served and the degree to which those resources are committed to the project; and
(7) The degree to which the project plan adequately provides for the requirements set forth in these regulations.
(b) The Secretary shall determine the amount of any award on the basis of his estimate of the sum necessary for the performance of the project. No grant may be made for less than 90 percent of the project's costs, as so estimated, unless the grant is to be made for a project which was supported, under section 1001, for less than 90 percent of its costs in fiscal year 1975. In that case, the grant shall not be for less than the percentage of costs covered by the grant in fiscal year 1975.
(c) No grant may be made for an amount equal to 100 percent for the project's estimated costs.
(a) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for three to five years.
(b) Generally the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(c) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
Any funds granted under this subpart shall be expended solely for the purpose for which the funds were granted in accordance with the approved application and budget, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed in 45 CFR Part 74 or Part 92, as applicable.
Attention is drawn to the following HHS Department-wide regulations which apply to grants under this subpart. These include:
All information as to personal facts and circumstances obtained by the project staff about individuals receiving services must be held confidential and must not be disclosed without the individual's documented consent, except as may be necessary to provide services to the patient or as required by law, with appropriate safeguards for confidentiality. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.
The Secretary may, with respect to any grant, impose additional conditions prior to or at the time of any award, when in the Department's judgment these conditions are necessary to assure or protect advancement of the approved program, the interests of public health, or the proper use of grant funds.
Sec. 6(c), 84 Stat. 1507, 42 U.S.C. 300a-4; sec. 6(c), 84 Stat. 1507, 42 U.S.C. 300a-1.
The regulations in this subpart are applicable to the award of grants pursuant to section 1003 of the Public Health Service Act (42 U.S.C. 300a-1) to provide the training for personnel to carry out family planning service programs described in sections 1001 and 1002 of the Public Health Service Act (42 U.S.C. 300, 300a).
As used in this subpart:
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(a) An application for a grant under this subpart shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe.
(b) The application shall be executed by an individual authorized to act for the applicant and to assume for the applicant the obligations imposed by the regulations of this subpart and any additional conditions of the grant.
An approvable application must contain each of the following unless the Secretary determines that the applicant has established good cause for its omission:
(a) Assurances that:
(1) No portion of the Federal funds will be used to train personnel for programs where abortion is a method of family planning.
(2) No portion of the Federal funds will be used to provide professional training to any student as part of his
(3) No project personnel or trainees shall on the grounds of sex, religion, or creed be excluded from participation in, be denied the benefits of, or be subjected to discrimination under the project.
(b) Provision of a methodology to assess the particular training (e.g., skills, attitudes, or knowledge) that prospective trainees in the area to be served need to improve their delivery of family planning services.
(c) Provision of a methodology to define the objectives of the training program in light of the particular needs of trainees defined pursuant to paragraph (b) of this section.
(d) Provision of a method for development of the training curriculum and any attendant training materials and resources.
(e) Provision of a method for implementation of the needed training.
(f) Provision of an evaluation methodology, including the manner in which such methodology will be employed, to measure the achievement of the objectives of the training program.
(g) Provision of a method and criteria by which trainees will be selected.
(a) Within the limits of funds available for such purpose, the Secretary may award grants to assist in the establishment and operation of those projects which will in his judgment best promote the purposes of section 1003 of the Act, taking into account:
(1) The extent to which a training program will increase the delivery of services to people, particularly low-income groups, with a high percentage of unmet need for family planning services;
(2) The extent to which the training program promises to fulfill the family planning services delivery needs of the area to be served, which may include, among other things:
(i) Development of a capability within family planning service projects to provide pre- and in-service training to their own staffs;
(ii) Improvement of the family planning services delivery skills of family planning and health services personnel;
(iii) Improvement in the utilization and career development of paraprofessional and paramedical manpower in family planning services;
(iv) Expansion of family planning services, particularly in rural areas, through new or improved approaches to program planning and deployment of resources;
(3) The capacity of the applicant to make rapid and effective use of such assistance;
(4) The administrative and management capability and competence of the applicant;
(5) The competence of the project staff in relation to the services to be provided; and
(6) The degree to which the project plan adequately provides for the requirements set forth in § 59.205.
(b) The amount of any award shall be determined by the Secretary on the basis of his estimate of the sum necessary for all or a designated portion of direct project costs plus an additional amount for indirect costs, if any, which will be calculated by the Secretary either: (1) On the basis of his estimate of the actual indirect costs reasonably related to the project, or (2) on the basis of a percentage of all, or a portion of, the estimated direct costs of the project when there are reasonable assurances that the use of such percentage will not exceed the approximate actual indirect costs. Such award may include an estimated provisional amount for indirect costs or for designated direct costs (such as travel or supply costs) subject to upward (within the limits of available funds) as well as downward adjustments to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary.
(c) Allowability of costs shall be in conformance with the applicable cost principles prescribed by Subpart Q of 35 CFR part 74.
(d) All grant awards shall be in writing, shall set forth the amount of funds granted and the period for which support is recommended.
(e) Neither the approval of any proj-ect nor any grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation, or other award
The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement for expenses incurred or to be incurred in the performance of the project to the extent he determines such payments necessary to promote prompt initiation and advancement of the approved project.
(a) Any funds granted pursuant to this subpart as well as other funds to be used in performance of the approved project shall be expended solely for carrying out the approved project in accordance with the statute, the regulations of this subpart, the terms and conditions of the award, and, except as may otherwise be provided in this subpart, the applicable cost principles prescribed by subpart Q of 45 CFR part 74.
(b) Prior approval by the Secretary of revision of the budget and project plan is required whenever there is to be a significant change in the scope or nature of project activities.
(c) The Secretary may approve the payment of grant funds to trainees for:
(1) Return travel to the trainee's point of origin.
(2) Per diem during the training program, and during travel to and from the program, at the prevailing institutional or governmental rate, whichever is lower.
Attention is called to the requirements of Title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d
Any grant award pursuant to § 59.206 is subject to the regulations of the Department of Health and Human Services as set forth in 45 CFR parts 6 and 8, as amended. Such regulations shall apply to any activity for which grant funds are in fact used whether within the scope of the project as approved or otherwise. Appropriate measures shall be taken by the grantee and by the Secretary to assure that no contracts, assignments or other arrangements inconsistent with the grant obligation are continued or entered into and that all personnel involved in the supported activity are aware of and comply with such obligations. Laboratory notes, related technical data, and information pertaining to inventions and discoveries shall be maintained for such periods, and filed with or otherwise made available to the Secretary, or those he may designate at such times and in such manner, as he may determine necessary to carry out such Department regulations.
Except as may otherwise be provided under the terms and conditions of the award, the grantee may copyright without prior approval any publications, films or similar materials developed or resulting from a project supported by a grant under this part, subject, however, to a royalty-free, nonexclusive, and irrevocable license or right in the Government to reproduce, translate, publish, use, disseminate, and dispose of such materials and to authorize others to do so.
(a)
(b) [Reserved]
(c)
(d)
(2)
(i) Any amount not accounted for pursuant to paragraph (a) of this section;
(ii) Any credits for earned interest pursuant to paragraph (c)(1) of this section;
(iii) Any other amounts due pursuant to subparts F, M, and O of 45 CFR part 74.
The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of public health, or the conservation of grant funds.
The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this subpart to State and local governments as those terms are defined in subpart A of that part 74. The relevant provisions of the following subparts of part 74 shall also apply to grants to all other grantee organizations under this subpart.
42 U.S.C. 286b-2, 286b-5.
(a) The regulations of this subpart apply to grants of funds, materials, or both, for establishing, expanding, and improving basic medical library resources as authorized by section 474 of the Act (42 U.S.C. 286b-5).
(b) This subpart also applies to cooperative agreements awarded for this purpose. In these circumstances, references to “grant(s)” shall include “cooperative agreements(s).”
Undefined terms have the same meaning as provided in the Act. As used in this subpart:
Except as otherwise prohibited by law, any public or private nonprofit institution, organization, or agency authorized or qualified to carry on the functions of a medical library, and any public or private related instrumentality, is eligible for a grant under this subpart.
The Secretary shall evaluate grant applications using the officers and employees, and experts, consultants, or groups engaged by the Secretary for that purpose. The Secretary's evaluation shall consider the scope of library or related services for the population and purposes served by the applicant. This evaluation shall include consideration of the following information which must be set forth in the grant application and such other information the Secretary considers pertinent:
(a) Evidence of the applicant's efficiency in providing services,
(b) Amount of available equipment and other resources on hand to satisfy the needs of the area served by the facility,
(c) Extent of coordination with other libraries and related facilities, and
(d) Potential for testing or demonstration of new or improved techniques in health-sciences informational services.
(a)
(b)
(1) The scope of medical-library or related services provided by the applicant for the population and purposes it serves considering:
(i) The number of graduate and undergraduate students, and physicians and other practitioners in health-related sciences making use of the applicant's library resources;
(ii) The type and availability of library support staff;
(iii) The type, size, and qualifications of the faculty of any school with which the applicant is affiliated;
(iv) The staff of any hospitals or clinics with which the applicant's library is affiliated;
(v) The geographic area served and, within that area, the medical-library or related services otherwise available; and
(2) The amount adequate to insure continuing financial support from non-Federal sources of the applicant's proposed activity during and after the period of award. The Secretary shall consider the level of non-Federal support for the proposed activity for periods prior to the fiscal year in which a grant is made. The Secretary shall require the applicant's assurance that non-Federal support will not be diminished as a result of the award and that adequate support for this activity will be continued during and after the period of Federal assistance.
(c)
(2) Generally, the grant will initially be for one year at a time and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.
(3) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award for any approved application or portion of an approved application.
The grantee shall expend funds or use materials provided by a grant under this subpart solely for the purposes for which the funds or materials were granted, in accordance with the pertinent provisions of the approved application and budget, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles in subpart Q of 45 CFR part 74.
Several other regulations apply to grants under this subpart. These include, but are not necessarily limited to:
42 U.S.C. 286b-2, 286b-6.
(a) This subpart applies to grants made under section 475 of the Act (42 U.S.C. 286b-6). Grants are awarded to medical libraries to enable them to serve as regional medical libraries for their geographic areas. The purpose of the program is to develop a national system of regional medical libraries, each of which would have sufficient facilities to supplement the services of other medical libraries in its region.
(b) The purpose of the program may also be supported by contracts. Since the primary purpose of these contracts is to assist regional libraries and is not for the purpose of acquiring supplies or services for use of the Federal Government, the provisions of the Federal Acquisition Regulation (48 CFR chapter 1) do not apply. Any contract awarded pursuant to section 475 of the Act shall be subject to the applicable provisions of this subpart.
Underfined terms have the same meaning as provided in the Act.
As used in this subpart:
Except as otherwise prohibited by law, any public or private nonprofit organization which is authorized and qualified to operate a medical library is eligible for a grant under this subpart.
In addition to any other pertinent information which the Secretary may require, the applicant shall submit a grant application containing a detailed description of a program to provide health-sciences informational services for the geographic area in which it is located. The description shall include:
(a) The need for services;
(b) The adequacy of the applicant's existing or proposed facilities and resources to attain the purposes stated in the application;
(c) The size and nature of the population to be served;
(d) The region to be served;
(e) Cooperative arrangements in effect, or proposed, with other qualified organizations; and
(f) The justification for the funds requested.
(a)
(1) The adequacy of the applicant's library in terms of collections, personnel, equipment, and other facilities; and
(2) The size and nature of the population to be served in the applicant's region.
(b)
(2) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.
(3) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award for any approved application or portion of an approved application.
Although the Secretary may approve exceptions which are consistent with program purposes, in addition to other terms, conditions, and assurances required by law, each grantee must meet the following requirements:
(a)
(b)
(2)
Several other regulations apply to grants under this subpart. These include, but are not necessarily limited to:
Sec. 215, of the Public Health Service Act, 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); secs. 727-739A of the Public Health Service Act, 90 Stat. 2243, as amended, 93 Stat. 582, 99 Stat. 529-532, 102 Stat. 3122-3125 (42 U.S.C. 294-294
(a) The Health Education Assistance Loan (HEAL) program is a program of Federal insurance of educational loans to graduate students in the fields of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public health, chiropractic, health administration and clinical psychology. The basic purpose of the program is to encourage lenders to make loans to students in these fields who desire to borrow money to pay for their educational costs. In addition, certain nonstudents (such as doctors serving as interns or residents) can borrow in order to pay the current interest charges accruing on earlier HEAL loans. By taking a HEAL loan, the borrower is obligated
(b) HEAL loans may be made by schools, banks, credit unions, State agencies, and other institutions eligible as lenders under § 60.30. HEAL school eligibility is described in § 60.50.
(c) The Secretary insures each lender or holder for the losses of principal and interest it may incur in the event that a borrower dies; becomes totally and permanently disabled; files for bankruptcy under chapter 11 or 13 of the Bankruptcy Act; files for bankruptcy under chapter 7 of the Bankruptcy Act and files a compliant to determine the dischargeability of the HEAL loan; or defaults on his or her loan. In these instances, if the lender or holder has complied with all HEAL statutes and regulations, and with the lender's or holder's insurance contract, and the Secretary pays the amount of the loss to the lender or holder, the borrower's loan is then assigned to the Secretary. Only at that time, the United States Government becomes the borrower's direct creditor and will actively pursue the borrower for repayment of the debt, including reporting the borrower's default on the loan to consumer credit reporting agencies or to the Internal Revenue Service for purposes of locating such taxpayer or for income tax refund offset, and referral to the Department of Justice for litigation.
(d) Any person who knowingly makes a false statement or misrepresentation in a HEAL loan transaction, bribes or attempts to bribe a Federal official, fraudulently obtains a HEAL loan, or commits any other illegal action in connection with a HEAL loan is subject to possible fine and imprisonment under Federal statute.
(e)
To receive a HEAL loan, a student must satisfy the following requirements:
(a) He or she must be a citizen, national, or lawful permanent resident of the United States, permanent resident of the Trust Territory of the Pacific Islands (the Republic of Palau), the Republic of the Marshall Islands, the Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, or American Samoa, or lawful permanent resident of the Commonwealth of Puerto Rico, the Virgin Islands or Guam;
(b) He or she must be enrolled or accepted for enrollment at a HEAL school in a course of study that leads to one of the following degrees:
(c) He or she must be carrying or plan to carry, during the period for which the loan is intended, the normal work load of a full-time student, as determined by the school. The student's work load may include any combination of courses, work experience, research or special studies that the school considers sufficient to classify the student as full time.
(d) If currently enrolled in school, he or she must be in good standing, as determined by the school.
(e)(1) In the case of a pharmacy student, he or she must have satisfactorily completed 3 years of training toward the pharmacy degree. These 3 years of training may have been taken at the pharmacy school or at a different school whose credits are accepted on transfer by the pharmacy school.
(2) The Doctor of Pharmacy degree is considered to be an equivalent degree if it is taken in a school that does not require the Bachelor or Master of Science in pharmacy as a prerequisite for the Doctor of Pharmacy degree.
(f) In the case of a medical, dental or osteopathic student enrolled in a 6-year program that the student may enter directly from secondary school, the student must be enrolled in the last 4 years of the program.
(g) He or she must agree that all funds received under the proposed loan will be used solely for tuition, other reasonable educational expenses, including fees, books, supplies and equipment, and laboratory expenses, reasonable living expenses, reasonable transportation costs (only to the extent that they are directly related to the borrower's education), and the HEAL insurance premium.
(h) He or she must require the loan to pursue the course of study at the school. This determination of the maximum amount of the loan will be made by the school, applying the considerations in § 60.51(f).
(i) If required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he must have presented himself and submitted to registration under such section.
To receive a HEAL loan, a person who is not a student must satisfy all of the following requirements:
(a) He or she must have received a HEAL loan prior to August 13, 1981, for which he or she is required to make payments of interest, but not principal, during the period for which the new loan is intended. This may be the grace period or a period of internship, residency or deferment.
(b) He or she must continue to meet the citizenship, nationality, or residency qualifications required of student borrowers.
(c) He or she must agree that all funds received under the proposed loan will be used solely for payment of currently accruing interest on HEAL loans and the HEAL insurance premium.
(d) If required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he must have presented himself and submitted to registration under such section.
(a)(1)(i) A student seeking a HEAL loan applies to a participating lender for a HEAL loan by submitting an application form supplied by the school.
(ii) The applicant must fill out the applicant sections of the form completely and accurately.
(2) The student applicant must be informed of the Federal debt collection policies and procedures in accordance with the Department's Claims Collection Regulation (45 CFR part 30) prior to the student receiving the loan. The applicant must sign a certification statement attesting that the applicant has been notified of the actions the Federal Government can take in the event that the applicant fails to meet the scheduled payments. This signed statement must be maintained by the school and the lender or holder as part of the borrower's official record.
(3) A student applicant must have his or her school complete a portion of the application providing information relating to:
(i) The applicant's eligibility for the loan.
(ii) The cost of his or her education; and
(iii) The total financial resources that are actually available to the applicant for his or her costs of education for the period covered by the proposed HEAL loan, as determined in accordance with § 60.51(f), and other student aid that the applicant has received or will receive for the period covered by the proposed HEAL loan.
(4) The student applicant must certify on the application that the information provided reflects the applicant's total financial resources actually available for his or her costs of education for the period covered by the
(5) A student applicant must certify on the application that if required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he has presented himself and submitted to registration under such section.
(b) The applicant pursuing a full-time course of study at an institution of higher education that is a “participating school” in the Guaranteed Student Loan Program but is not pursuing a course of study listed in § 60.5(b), applies for a HEAL loan as a nonstudent under paragraph (c) of this section.
(c)(1)(i) A nonstudent seeking a HEAL loan applies to a participating lender for a HEAL loan by submitting an application form supplied by the lender.
(ii) The applicant must fill out the applicant sections of the form completely and accurately.
(2) The nonstudent applicant must be informed of the Federal debt collection policies and procedures in accordance with the Department's Claims Collection Regulation (45 CFR part 30) prior to the nonstudent receiving the loan. The applicant must sign a certification statement attesting that the applicant has been notified of the actions the Federal Government can take in the event that the applicant fails to meet the scheduled payments. This signed statement will be maintained by the lender or holder as part of the borrower's official record.
(3) A nonstudent applicant must have his or her employer or institution, whichever is relevant, certify on the application that the applicant is:
(i) Enrolled as a full-time student in an eligible school, as described in § 60.12;
(ii) A participant in an accredited internship or residency program, as described in § 60.11(a);
(iii) A member of the Armed Forces of the United States;
(iv) A Peace Corps volunteer;
(v) A member of the National Health Service Corps; or
(vi) A full-time VISTA volunteer under Title I of the Domestic Volunteer Service Act of 1973.
(4) The nonstudent applicant seeking a HEAL loan during the grace period applies to the lender directly.
(5) A nonstudent applicant must certify on the application that if required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he has presented himself and submitted to registration under such section.
(6) The nonstudent applicant must certify on the application that the information provided reflects the applicant's total financial resources and indebtedness.
(a)
(2) The lender must provide the borrower with a copy of the completed promissory note when the loan is made. The lender or holder must return the original note to the borrower when the loan is paid in full.
(3) A lender must disburse HEAL loan proceeds as described in § 60.33(f).
(4) The lender or holder must provide the borrower with a copy of the repayment schedule before repayment begins.
(5) If the loan is sold from one lender or holder to another lender or holder, or if the loan is serviced by a party other than the lender or holder, the buyer must notify the borrower within 30 days of the transaction.
(6) The borrower does not have to begin repayment until 9 full months after leaving school or an accredited internship or residency program as described in § 60.11.
(7) The borrower is entitled to deferment from repayment of the principal and interest installments during periods described in § 60.12.
(8) The borrower may prepay the whole or any portion of the loan at any time without penalty.
(9) The lender or holder must allow the borrower to repay a HEAL loan according to a graduated repayment schedule.
(10) The borrower's total loan obligation is cancelled in the event of death or total and permanent disability.
(11) To assist the borrower in avoiding default, the lender or holder may grant the borrower forbearance. Forbearance, including circumstances in which the lender or holder must grant forbearance, is more fully described in § 60.37.
(12) Any borrower who received a fixed interest rate HEAL loan in excess of 12 percent per year may enter into an agreement with the lender which made this loan for the reissuance of the loan in accordance with section 739A of the Public Health Service Act.
(b)
(2) The borrower must pay all interest charges on the loan as required by the lender or holder.
(3) The borrower must immediately notify the lender or holder in writing in the event of:
(i) Change of address;
(ii) Change of name;
(iii) Failure to enroll in a HEAL school for the period for which the loan is intended;
(iv) Transfer to another school;
(v) Withdrawal from a HEAL school or change in status to less than full-time attendance at a HEAL school;
(vi) Graduation;
(vii) Failure to enter into or interruption in an internship or residency program; or
(viii) Change of status that authorizes deferment.
(4) The borrower must repay the loan in accordance with the repayment schedule.
(5) A borrower may not have a HEAL loan discharged in bankruptcy during the first 5 years of the repayment period. This prohibition against the discharge of a HEAL loan applies to bankruptcy under
(6) If the borrower fails to make payments on the loan on time, the total amount to be repaid by the borrower may be increased by additional interest, late charges, attorney's fees, court costs, and other collection charges. In addition, the Secretary may offset amounts attributable to an unpaid loan from reimbursements or payment for health services provided under any Federal law to a defaulted borrower practicing his or her profession.
(a)
(1) A student enrolled in a school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry or podiatric medicine may borrow up to $80,000 under this part. The amount received may not exceed $20,000 in any academic year.
(2) A student enrolled in a school of public health, pharmacy, chiropractic, or a graduate program in health administration, clinical psychology, or
(3) For purposes of this paragraph, an academic year means the traditional approximately 9-month September-to-June annual session. For the purpose of computing academic year equivalents for students who, during a 12-month period, attend for a longer period than the traditional academic year, the academic year will be considered to be 9 months in length.
(4) The student's estimated cost of attendance shall not exceed the estimated cost of attendance of all students in like circumstances pursuing a similar curriculum at that school.
(b)
(1) In no case may an eligible nonstudent borrower receive a loan that is greater than the sum of the HEAL insurance premium plus the interest that is expected to accrue and must be paid on the borrower's HEAL loans during the period for which the new loan is intended.
(2) An eligible nonstudent in the field of medicine, ostepathic medicine, dentistry, veterinary medicine, optometry, or podiatric medicine may borrow up to $80,000 under this part including loans obtained while the borrower was a student. The loan amount may not exceed $20,000 in any 12-month period.
(3) An eligible nonstudent in the field of pharmacy, public health, chiropractic, health administration, or clinical psychology may borrow up to $50,000 under this part including loans obtained while the borrower was a student. The loan amount received under this part may not exceed $12,500 in any 12-month period.
(a)
(i)
(ii)
(iii)
(2) An accredited internship or residency program must be approved by one of the following accrediting agencies:
(i) Accreditation Council for Graduate Medical Education.
(ii) Council on Optometric Education.
(iii) Commission on Accreditation of Dental and Dental Auxiliary Programs.
(iv) American Osteopathic Association.
(v) Council on Podiatry Education.
(vi) American Council on Pharmaceutical Education.
(vii) Council on Education for Public Health.
(viii) American College of Veterinary Surgeons.
(ix) Council on Chiropractic Education.
(b)
(1) For a HEAL borrower who received any HEAL loan prior to October 22, 1985, periods of deferment (as described in § 60.12) are not included when calculating the 10 to 25 or 33 year limitations.
(2) For a borrower who receives his or her first HEAL loan on or after October 22, 1985, periods of deferment (as described in § 60.12) are included when calculating the 33 year limitation, but are not included when calculating the 10 to 25 year limitation.
(c)
(d)
(e)
(f)
(2) The purpose of a supplemental repayment agreement is to permit a lender or holder, at its option, to offer a borrower a repayment schedule based on other than equal or graduated payments. (For example, a supplemental repayment agreement may base the amount of the borrower's payments on his or her income.)
(3) The supplemental schedule must contain terms which, according to the Secretary, do not unduly burden the borrower and do not extend the Secretary's insurance liability beyond the number of years specified in paragraph (b) of this section. The supplemental schedule must be approved by the Secretary prior to the start of repayment.
(4) The lender or holder may establish a supplemental repayment agreement over the borrower's objection only if the borrower's written consent to enter into a supplemental agreement was obtained by the lender at the time the loan was made.
(5) A lender or holder may assign a loan subject to a supplemental repayment agreement only if it specifically notifies the buyer of the terms of the supplemental agreement. In such cases, the loan and the supplemental agreement must be assigned together.
(a) After the repayment period has commenced, installments of principal and interest need not be paid during any period:
(1) During which the borrower is pursuing a full-time course of study at a HEAL school or at an institution of higher education that is a “participating school” in the Guaranteed Student Loan Program;
(2) Up to 4 years during which the borrower is a participant in an accredited internship or residency program, as described in § 60.11(a)(2). For a borrower who receives his or her first HEAL loan on or after October 22, 1985, this total of 4 years for an internship or residency program includes any period of postponement of the repayment period, as described in § 60.11(a)(1);
(3) Up to 3 years during which the borrower is a member of the Armed Forces of the United States;
(4) Up to 3 years during which the borrower is in service as a volunteer under the Peace Corps Act;
(5) Up to 3 years during which the borrower is a member of the National Health Service Corps; or
(6) Up to 3 years during which the borrower is a full-time volunteer under title I of the Domestic Volunteer Service Act of 1973.
(b) For any HEAL loan received on or after October 22, 1985, after the repayment period has commenced, installments of principal and interest need not be paid during any period for up to 2 years during which the borrower is a participant in:
(1) A fellowship training program, which:
(i) Is directly related to the discipline for which the borrower received the HEAL loan;
(ii) Begins within 12 months after the borrower ceases to be a participant in an accredited internship or residency program, as described in § 60.11(a)(2), or prior to the completion of the borrower's participation in such program;
(iii) Is a full-time activity in reasearch or reserch training or health care policy;
(iv) Is not a part of, an extension of, or associated with an internship or residency program, as described in § 60.11(a)(2);
(v) Pays no stipend or one which is not more than the annual stipend level established by the Public Health Service for the payment of uniform levels of financial support for trainees receiving graduate and professional training under Public Health Service grants, as in effect at the time the borrower requests the deferment; and
(vi) Is a formally established fellowship program which was not created for a specific individual; or
(2) A full-time educational activity at an institution defined by section 435(b) of the Higher Education Act of 1965 which:
(i) Is directly related to the discipline for which the borrower received the HEAL loan;
(ii) Begins within 12 months after the borrower ceases to be a participant in an accredited internship or residency program, as described in § 60.11(a)(2), or prior to the completion of the borrower's participation in such program;
(iii) Is not a part of, an extension of, or associated with an internship or residency program, as described in § 60.11(a)(2); and
(iv) Is required for licensure, registration, or certification in the State in which the borrower intends to practice the discipline for which the borrower received the HEAL program loan.
(c) (1) To receive a deferment, including a deferral of the onset of the repayment period (see § 60.11(a)), a borrower must at least 30 days prior to, but not more than 60 days prior to, the onset of the activity and annually thereafter, submit to the lender or holder evidence of his or her status in the deferment activity and evidence that verifies deferment eligibility of the activity (with the full expectation that the borrower will begin the activity). It is the responsibility of the borrower to provide the lender or holder with all required information or other information regarding the requested deferment. If written evidence that verifies eligibility of the activity and the borrower for the deferment, including a certification from an authorized official (e.g., the director of the fellowship activity, the dean of the school, etc.), is received by the lender or holder within the required time limit, the lender or holder must approve the deferment. The lender or holder may rely in good faith upon statements of the borrower and the authorized official, except where those statements or
(2) For those activities described in paragraphs (b)(1) or (b)(2) of this section, the borrower may request that the Secretary review a decision by the lender or holder denying the deferment by sending to the Secretary copies of the application for deferment and the lender's or holder's denial of the request. However, if information submitted to the lender or holder conflicts with other information available to the lender or holder, to indicate that the borrower fails to meet the requirements for deferment, the borrower may not request a review until such conflicts have been resolved. During the review process, the lender or holder must comply with any requests for information made by the Secretary. If the Secretary determines that the fellowship or educational activity is eligible for deferment and so notifies the lender or holder, the lender or holder must approve the deferment.
(a)
(1) For all loans made on or after October 22, 1985, for each calendar quarter, the Secretary determines the maximum annual HEAL interest rate by determining the average of the bond equivalent rates reported for the 91-day U.S. Treasury bills auctioned for the preceding calendar quarter, adding 3 percentage points, and rounding that amount to the next higher one-eighth of 1 percent.
(2) Interest that is calculated on a fixed rate basis is determined for the life of the loan during the calendar quarter in which the loan is executed. It may not exceed the rate determined for that quarter by the Secretary under paragraph (a)(1) of this section.
(3) Interest that is calculated on a variable rate basis varies every calendar quarter throughout the life of the loan as the market price of U.S. Treasury bills changes. For any quarter it may not exceed the rate determined by the Secretary under paragraph (a)(1) of this section.
(4) The Secretary announces the rate determined under paragraph (a)(1) of this section on a quarterly basis through a notice published in the
(b)
(c)
(d)
(a)
(2) The lender may charge the borrower an amount equal to the cost of the insurance premium. The cost of the insurance premium may be charged to the borrower by the lender in the form of a one-time special charge with no subsequent adjustments required. The lender may bill the borrower separately for the insurance premium or may deduct an amount attributable to it from the loan proceeds before the loan is disbursed. In either case, the lender must clearly identify to the borrower the amount of the insurance premium and the method of calculation.
(3) If the lender does not pay the insurance premium on or before 30 days after disbursement of the loan, a late fee will be charged on a daily basis at the same rate as the interest rate that the lender charges for the HEAL loan for which the insurance premium is past due. The lender may not pass on this late fee to the borrower.
(4) HEAL insurance coverage ceases to be effective if the insurance premium is not paid within 60 days of the disbursement of the loan.
(5) Except in cases of error, premiums are not refundable by the Secretary, and need not be refunded by the lender to the borrower, even if the borrower graduates or withdraws from the school, defaults, dies or becomes totally and permanently disabled.
(b)
(c)
(2)
(3)
(a)
(b)
(c)
Neither a lender nor a school may obtain a borrower's power of attorney or other authorization to endorse a disbursement check on behalf of a borrower. The borrower must personally endorse the check and may not authorize anyone else to endorse it on his or her behalf.
(a) A HEAL loan must be made without security.
(b) With one exception, it must also be made without endorsement. If a borrower is a minor and cannot under State law create a legally binding obligation by his or her own signature, a lender may require an endorsement by another person on the borrower's HEAL note. For purposes of this paragraph, an “endorsement” means a signature of anyone other than the borrower who is to assume either primary or secondary liability on the note.
HEAL loans may be consolidated as follows provided that the lender or holder must first inform the borrower of the effect of the consolidation on the interest rate and explain to the borrower that he or she is not required to agree to the consolidation:
(a) If a lender or holder holds two or more HEAL loans made to the same borrower, the lender or holder and the borrower may agree to consolidate the loans into a single HEAL loan obligation evidenced by one promissory note.
(b) A HEAL loan may be consolidated with any other loan only if:
(1) The consolidation will not result in terms less favorable to the borrower than if no consolidation had occurred, and
(2) The Federal Government does not, as a result of the consolidation, become liable for any payment of principal or interest for a Guaranteed Student Loan under the provisions of section 439(o) of the Higher Education Act of 1965.
All HEAL forms are approved by the Secretary and may not be changed without prior approval by the Secretary. HEAL forms shall not be signed in blank by a borrower, a school, a lender or holder, or an agent of any of these. The Secretary may prescribe who must complete the forms, and when and to whom the forms must be sent. All HEAL forms must contain a statement that any person who knowingly makes a false statement or misrepresentation in a HEAL loan transaction, bribes or attempts to bribe a Federal official, fraudulently obtains a HEAL loan, or commits any other illegal action in connection with a HEAL loan is subject to possible fine and imprisonment under Federal statute.
After paying a default claim on a HEAL loan, the Secretary attempts to collect from the borrower and any valid endorser in accordance with the Federal Claims Collection Standards (4 CFR parts 101 through 105), the Office of Management and Budget Circular A-129, issued May 9, 1985, and the Department's Claims Collection Regulation (45 CFR part 30). The Secretary attempts collection of all unpaid principal, interest, penalties, administrative costs, and other charges or fees, except in the following situations:
(a)
(b)
(c)
(d)
(a)
(b)
(2) When a lender receives a school refund check for a loan it no longer holds, the lender must transfer that payment to the holder of the loan and either inform the borrower about the refund check and where it was sent or, if the borrower's address is unknown, notify the current holder that the borrower was not informed. The current holder must provide the borrower with a written notice of the refund payment.
(a) A HEAL lender may make and hold loans under the HEAL program.
(b) The following types of organizations are eligible to apply to the Secretary to be HEAL lenders:
(1) A financial or credit institution (including a bank, savings and loan association, credit union, or insurance company) which is subject to examination and supervision in its capacity as a lender by an agency of the United States or of the State in which it has its principal place of business;
(2) A pension fund approved by the Secretary;
(3) An agency or instrumentality of a State;
(4) A HEAL school; and
(5) A private nonprofit entity, designated by the State, regulated by the State, and approved by the Secretary.
(c) The following types of organizations are eligible to apply to the Secretary to be HEAL holders:
(1) Public entities in the business of purchasing student loans;
(2) The Student Loan Marketing Association (popularly known as “Sallie Mae”); and
(3) Other eligible lenders.
(d) HEAL holders must comply with any provisions in the regulations required of HEAL lenders including, but not limited to, provisions regarding applications, contracts, and due diligence.
(a) In order to be a HEAL lender or holder, an eligible organization must submit an application to the Secretary annually.
(b) In determining whether to enter into an insurance contract with an applicant and what the terms of that contract should be, the Secretary may consider the following criteria:
(1) Whether the applicant is capable of complying with the requirements in the HEAL regulations applicable to lenders and holders;
(2) The amount and rate of loans which are currently delinquent or in default, if the applicant has had prior experience with similar Federal or State student loan programs; and
(3) The financial resources of the applicant.
(c) The applicant must develop and follow written procedures for making, servicing and collecting HEAL loans. These procedures must be reviewed during the biennial audit required by § 60.42(d). If the applicant uses procedures more stringent than those required by §§ 60.34 and 60.35 for its other loans of comparable dollar value, on which it has no Federal, State, or other third party guarantee, it must include those more stringent procedures in its written procedures for servicing and collecting its HEAL loans.
(d) The applicant must submit sufficient materials with his or her application to enable the Secretary to fairly evaluate the application in accordance with these criteria.
(a)(1) If the Secretary approves an application to be a HEAL lender or holder, the Secretary and the lender or holder must sign an insurance contract. Under this contract, the lender or holder agrees to comply with all the laws, regulations, and other requirements applicable to its participation in the HEAL program and the Secretary agrees to insure each eligible HEAL loan held by the lender or holder against the borrower's default, death, total and permanent disability, bankruptcy under chapter 11 or 13 of the Bankruptcy Act, or bankruptcy under chapter 7 of the Bankruptcy Act when the borrower files a complaint to determine the dischargeability of the HEAL loan. The Secretary's insurance covers 100 percent of the lender's or holder's losses on both unpaid principal and interest, except to the extent that a borrower may have a defense on the loan other than infancy.
(2) HEAL insurance, however, is not unconditional. The Secretary issues HEAL insurance on the implied representations of the lender that all the requirements for the initial insurability of the loan have been met. HEAL insurance is further conditioned upon compliance by the holder of the loan with the HEAL statute and regulations, the lender's or holder's insurance contract, and its own loan management procedures set forth in writing pursuant to § 60.31(c). The contract may contain a limit on the duration of the contract and the number or amount of HEAL loans a lender may make or hold. Each HEAL lender has either a standard insurance contract or a comprehensive insurance contract with the Secretary, as described below.
(b)
(c)(1)
(2) The Secretary will revoke the comprehensive contract of any lender who utilizes procedures which are inconsistent with the HEAL statute and regulations, the lender's insurance contract, or its own loan management procedures set forth in writing pursuant to § 60.31(c), and require that such lenders disburse HEAL loans only under a standard contract. When the Secretary determines that the lender is in compliance with the HEAL statute and regulations and its own loan management procedures set forth in writing pursuant to § 60.31(c), the lender may reapply for a comprehensive contract.
(3) In providing comprehensive contracts, the Secretary shall give priority to eligible lenders that:
(i) Make loans to students at interest rates below the rates prevailing during the period involved; or
(ii) Make loans under terms that are otherwise favorable to the student relative to the terms under which eligible lenders are generally making loans during the period involved.
The loan-making process includes the processing of necessary forms, the approval of a borrower for a loan, determination of a borrower's creditworthiness, the determination of the loan amount (not to exceed the amount approved by the school), the explanation to a borrower of his or her responsibilities under the loan, the execution of the promissory note, and the disbursement of the loan proceeds. A lender may rely in good faith upon statements of an applicant and the HEAL school contained in the loan application papers, except where those statements are in conflict with information obtained from the report on the applicant's credit history, or other information available to the lender. Except where the statements are in conflict with information obtained from the applicant's credit history or other information available to the lender, a lender making loans to nonstudent borrowers may rely in good faith upon statements by the borrower and authorizing officials of internship, residency, or other programs for which a borrower may receive a deferment.
(a)
(b)
(c)
(1) A report of the applicant's credit history obtained from an appropriate consumer credit reporting agency, which must be used in making the determinations required by paragraph (c) of this section; and
(2) For student applicants only, the certification made by the applicant's school under § 60.51(e).
(d)
(e)
(2) The lender must explain to the borrower that the loan must be repaid and that the loan proceeds may be applied toward educational expenses only.
(f)
(i) To a student borrower, by means of a check or draft payable jointly to the student borrower and the HEAL school. Except where a lender is also a school, a lender must mail the check or draft to the school. A lender may not disburse the loan proceeds earlier than is reasonably necessary to meet the cost of education for the period for which the loan is made.
(ii) To a nonstudent borrower, by means of a check or draft payable to the borrower. However, when a previous loan is held by a different lender, the current lender must make the HEAL loan disbursement check or draft payable jointly to the borrower and the holder of the previous HEAL loan for which interest is payable.
(2) Effective July 1, 1987, a lender must disburse the HEAL loan proceeds in two or more installments unless the loan is intended to cover a period of no more than one-half an academic year. The amount disbursed at one time must correspond to the borrower's educational expenses for the period for which the disbursement is made, and must be indicated by the school on the borrower's application. If the loan is intended for more than one-half an academic year, the school must indicate on the borrower's application both the approximate dates of disbursement and the amount the borrower will need on each such date. In no case may the lender disburse the proceeds earlier than is reasonably necessary to meet the costs of education for the period for which the disbursement or the loan is made.
(g) If the lender determines that the applicant is not creditworthy, pursuant to paragraph (c) of this section, the lender must not approve the HEAL loan request. If the applicant is a student, the lender must notify the applicant and the applicant's school named on the application form of the denial of a HEAL loan, stating the reason for the denial.
(h) The lender must report a borrower's HEAL indebtedness to one or more national credit bureaus within 120 days of the date the final disbursement on the loan is made.
HEAL loan account servicing involves the proper maintenance of records, and the proper review and management of accounts. Generally accepted account servicing standards ensure that collections are received and accounted for, delinquent accounts are identified promptly, and reports are produced comparing actual results to previously established objectives.
(a)
(b)
(2) Terms of repayment are established in a written schedule that is made a part of, and subject to the terms of, the borrower's original HEAL note.
(3) The lender or holder may not surrender the original promissory note to the borrower until the loan is paid in full. At that time, the lender or holder must give the borrower the original promissory note.
(c)
(d)
A lender or holder must exercise due diligence in the collection of a HEAL loan with respect to both a borrower and any endorser. In order to exercise due diligence, a lender or holder must implement the following procedures when a borrower fails to honor his or her payment obligations:
(a)(1) When a borrower is delinquent in making a payment, the lender or holder must remind the borrower within 15 days of the date the payment was due by means of a written contact. If payments do not resume, the lender or holder must contact both the borrower and any endorser at least 3 more times at regular intervals during the 120-day delinquent period following the first missed payment of that 120-day period. The second demand notice for a delinquent account must inform the borrower that the continued delinquent status of the account will be reported to consumer credit reporting agencies if payment is not made. Each of the required four contacts must consist of at least a written contact which has an address correction request on the envelope. The last contact must consist of a telephone contact, in addition to the required letter, unless the borrower cannot be contacted by telephone. The lender or holder may choose to substitute a personal contact for a telephone contact. A record must be made of each attempt to contact and each actual contact, and that record must be placed in the borrower's file. Each contact must become progressively firmer in tone. If the lender or holder is unable to locate the borrower and any endorser at any time during the period when the borrower is delinquent, the lender or holder must initiate the skip-tracing procedures described in paragraph (a)(2) of this section.
(2) If the lender or holder is unable to locate either the borrower or the endorser at any time, the lender or holder must initiate and use skip-tracing activities which are at least as extensive and effective as those it uses to locate borrowers delinquent in the repayment of its other loans of comparable dollar value. To determine the correct address of the borrower, these skip-tracing procedures should include, but need not be limited to, contacting any other individual named on the borrower's HEAL application or promissory note, using such sources as telephone directories, city directories, postmasters, drivers license records in State and local government agencies, records of members of professional associations,
(b) When a borrower is 90 days delinquent in making a payment, the lender or holder must immediately request preclaim assistance from the Public Health Service. The Secretary does not pay a default claim if the lender or holder fails to request preclaim assistance.
(c) Prior to the filing of a default claim, a lender or holder must use, at a minimum, collection practices that are at least as extensive and effective as those used by the lender or holder in the collection of its other loans. These practices must include, but need not be limited to:
(1) Using collection agents, which may include its own collection department or other internal collection agents;
(2) Immediately notifying an appropriate consumer credit reporting agency regarding accounts overdue by more than 60 days; and
(3) Commencing and prosecuting an action for default unless:
(i) In the determination of the Secretary that:
(A) The lender or holder has made reasonable efforts to serve process on the borrower involved and has been unsuccessful in these efforts; or
(B) Prosecution of such an action would be fruitless because of the financial or other circumstances of the borrower;
(ii) For loans made before November 4, 1988, the loan involved was made in an amount of less than $5,000; or
(iii) For loans made on or after November 4, 1988, the loan involved was made in an amount of less than $2,500.
(d) If the Secretary's preclaim assistance locates the borrower, the lender or holder must implement the loan collection procedures described in this section. When the Secretary's preclaim assistance is unable to locate the borrower, a default claim may be filed by the lender as described in § 60.40. The Secretary does not pay a default claim if the lender or holder has not complied with the HEAL statute and regulations or the lender's or holder's insurance contract.
(e) If a lender or holder does not sue the borrower, it must send a final demand letter to the borrower and any endorser at least 30 days before a default claim is filed.
(f) If a lender or holder sues a defaulted borrower or endorser, it may first apply the proceeds of any judgment against its reasonable attorney's fees and court costs, whether or not the judgment provides for these fees and costs.
(g)
(i) For any loan for which the lender or holder had not begun to litigate against the borrower prior to the imposition of the automatic stay, the period of the automatic stay is to be considered as an extended forbearance authorized by the Secretary, in addition to the 2-year period of forbearance which lenders and holders are authorized to grant without prior approval from the Secretary. Only periods of delinquency following the date of receipt (as documented by a date stamp) of the discharge of debtor notice (or other written notification from the court or the borrower's attorney of the end of the automatic stay imposed by the Bankruptcy Court) can be included in determining default, as described in § 60.40(c)(1)(i). The lender or holder must attempt to reestablish repayment terms with the borrower in writing no more than 30 days after receipt of the discharge of debtor notice (or other written notification from the court or the borrower's attorney of the end of the automatic stay imposed by the Bankruptcy Court), in accordance with the procedures followed at the end of a forbearance period. If the borrower
(ii) For any loan for which the lender or holder had begun to litigate against the borrower prior to the imposition of the automatic stay, the lender or holder must, upon written notification from the court or the borrower's attorney that the bankruptcy proceedings have been completed, either resume litigation or treat the loan in accordance with paragraph (g)(1)(i) of this section.
(2) If the lender or holder has not received written notification of discharge within 12 months of the date that the borrower filed for bankruptcy, the lender or holder must contact the court and the borrower's attorney (if known) within 30 days to determine if the bankruptcy proceedings have been completed. If no response is received within 30 days of the date of these contacts, the lender or holder must resume its collection efforts, in accordance with paragraph (g)(1) of this section. If a written response from the court or the borrower's attorney indicates that the bankruptcy proceedings are still underway, the lender or holder is not to pursue further collection efforts until receipt of written notice of discharge, except that follow-up in accordance with this paragraph must be done at least once every 12 months until the bankruptcy proceedings have been completed.
(3) If, despite the lender or holder's compliance with required procedures, a loan subject to the requirements of paragraph (g)(1) of this section is discharged, the lender or holder must file a claim with the Secretary within 10 days of the initial date of receipt (as documented by a date stamp) of written notification of the discharge from the court or the borrower's attorney, in accordance with the procedures set forth in § 60.40(c)(4). The lender or holder also must file with the bankruptcy court an objection to the discharge of the HEAL loan, and must include with the claim documentation showing that the bankruptcy proceedings were handled properly and expeditiously (e.g., all documents sent to or received from the bankruptcy court, including evidence which shows the period of the bankruptcy proceedings).
The delegation of functions to a servicing agency or other party does not relieve a lender or holder of its responsibilities under the HEAL program.
(a)
(1) Except as provided in paragraph (a)(2) of this section, a lender or holder must grant forbearance whenever the borrower is temporarily unable to make scheduled payments on a HEAL loan and the borrower continues to repay the loan in an amount commensurate with his or her ability to repay the loan. Any circumstance which affects the borrower's ability to repay the loan must be fully documented.
(2) If the lender or holder determines that the default of the borrower is inevitable and that forbearance will be ineffective in preventing default, the lender or holder may submit a claim to the Secretary rather than grant forbearance. If the Secretary is not in agreement with the determination of the lender or holder, the claim will be returned to the lender or holder as disapproved and forbearance must be granted.
(b) A lender or holder must exercise forbearance in accordance with terms that are consistent with the 25- and 33-year limitations on the length of repayment (described in § 60.11) if the lender or holder and borrower agree in
(c) A lender or holder may also exercise forbearance for periods of up to 6 months in accordance with terms that are inconsistent with the minimum annual payment requirement if the lender or holder complies with the requirements listed in paragraphs (c) (1) through (4) of this section. Subsequent renewals of the forbearance must also be documented in accordance with the following requirements:
(1) The lender or holder must reasonably believe that the borrower intends to repay the loan but is currently unable to make payments in accordance with the terms of the loan note. The lender or holder must state the basis for its belief in writing and maintain that statement in its loan file on that borrower.
(2) Both the borrower and an authorized official of the lender or holder must sign a written agreement of forbearance.
(3) If the agreement between the borrower and lender or holder provides for deferment of all payments, the lender or holder must contact the borrower at least every 3 months during the period of forbearance in order to remind the borrower of the outstanding obligation to repay.
(4) The total period of forbearance (with or without interruption) granted by the lender or holder to any borrower must not exceed 2 years. However, when the borrower and the lender or holder believe that there are bona fide reasons why this period should be extended, the lender or holder may request a reasonable extension beyond the 2-year period from the Secretary. This request must document the reasons why the extension should be granted. The lender or holder may grant the extension for the approved time period if the Secretary approves the extension request.
A HEAL note may not be assigned except to another HEAL lender, the Student Loan Marketing Association (popularly known as “Sallie Mae”), or a public entity in the business of purchasing student loans, and except as provided in § 60.40. In this section “seller” means any kind of assignor and “buyer” means any kind of assignee.
(a)
(1) The Secretary;
(2) The borrower. The notice to the borrower must contain a clear statement of all the borrower's rights and responsibilities which arise from the assignment of the loan, including a statement regarding the consequences of making payments to the seller subsequent to receipt of the notice; and
(3) The borrower's school, as shown on the application form supporting the loan purchased by the buyer, if the borrower is enrolled in school.
(b)
(c)
(d)
(a)
(b)
(2) After being notified by the borrower or the borrower's representative that the borrower claims to be totally and permanently disabled, the holder of the loan may not attempt to collect on the loan from the borrower or any endorser. The holder must promptly request that the Secretary determine whether a borrower has become totally and permanently disabled. With its request, the holder must submit medical evidence no more than 4 months old that it has obtained from the borrower or the borrower's representative.
(3) If the Secretary determines that the borrower is totally and permanently disabled, the lender or holder must return to the borrower any payments, except for refunds under § 60.21, that it receives after being notified that the borrower claims to be totally and permanently disabled.
(a) A lender or holder must file an insurance claim on a form approved by the Secretary. The lender or holder must attach to the claim all documentation necessary to litigate a default, including any documents required to be submitted by the Federal Claims Collection Standards, and which the Secretary may require. Failure to submit the required documentation and to comply with the HEAL statute and regulations or the lender's
(1) The original promissory note;
(2) An assignment to the United States of America of all right, title, and interest of the lender or holder in the note;
(3) The loan application;
(4) The history of the loan activities from the date of loan disbursement through the date of claim, including any payments made; and
(5) A Borrower Status Form (HRSA-508), documenting each deferment granted under § 60.12 or a written statement from an appropriate official stating that the borrower was engaged in an activity for which he or she was entitled to receive a deferment at the time the deferment was granted.
(b) The Secretary's payment of a claim is contingent upon receipt of all required documentation and an assignment to the United States of America of all right, title, and interest of the lender or holder in the note underlying the claim. The lender or holder must warrant that the loan is eligible for HEAL insurance.
(c) In addition, the lender or holder must comply with the following requirements for the filing of default, death, disability, and bankruptcy claims:
(1)
(i) If a lender or holder determines that it is not appropriate to commence and prosecute an action against a default borrower pursuant to § 60.35(c)(3), it must file a default claim with the Secretary within 30 days after a loan has been determined to be in default.
(ii) If a lender files suit against a defaulted borrower and does not pursue collection of the judgment obtained as a result of the suit, it must file a default claim with the Secretary within 60 days of the date of issuance of the judgment. If a lender or holder files suit against a defaulted borrower, and pursues collection of the judgment obtained as a result of the suit, these collection activities must begin within 60 days of the date of issuance of the judgment. If the lender or holder is unable to collect the full amount of principal and interest owed, a claim must be filed within 30 days of completion of the post-judgment collection activities. In either case, the lender or holder must assign the judgment to the Secretary as part of the default claim.
(iii) In addition to the documentation required for all claims, the lender or holder must submit with its default claim at least the following:
(A) Repayment schedule(s);
(B) A collection history, if any;
(C) A final demand letter;
(D) The original or a copy of all correspondence relevant to the HEAL loan to or from the borrower (whether received by the original lender, a subsequent holder, or an independent servicing agent);
(E) A claims collection litigation report; and
(F) If the defaulted borrower filed for bankruptcy under chapter 7 of the Bankruptcy Act and did not file a complaint to determine the dischargeability of the loan, all documents sent to or received from the bankruptcy court, including evidence which shows the period of the bankruptcy proceedings.
(iv) If a lender or holder files a default claim on a loan and subsequently
(2)
(3)
(4)
(i) Repayment schedule(s);
(ii) A collection history, if any;
(iii) A proof of claim, where applicable;
(iv) An assignment to the United States of America of its proof of claim, where applicable;
(v) All pertinent documents sent to or received from the bankruptcy court; and
(vi) A statement of any facts of which the lender is aware that may form the basis for an objection to the bankrupt's discharge or an exception to the discharge.
(vii) The notice of the first meeting or creditors, or an explanation as to why this is not included;
(viii) In cases where there is defective service, a declaration or affidavit attesting to the fact that the lender or holder was not directly served with the notice of meeting of creditors. This declaration or affidavit must also indicate when and how the lender or holder learned of the bankruptcy; and
(ix) In cases where there is defective service due to the borrower's failure to list the proper creditor, a copy of the letter sent to the borrower at the time of purchase of the HEAL loan by the current holder, or a sample letter with
(a)
(b)
(c)
(2) If the loan for which a claim is filed was originally made by a school but the claim is filed by another lender of holder that obtained the note by assignment, the Secretary deducts from the claim an amount equal to any unpaid refund that the school owed the borrower prior to the assignment.
(d)
(e)
(1) If the lender or holder failed to submit a claim within the required period after the borrower's default; death; total and permanent disability; or filing of a petition in bankrupty under chapter 11 or 13 of the Bankruptcy Act, or under chapter 7 where the borrower files a complaint to determine the dischargeability of the HEAL loan; the Secretary does not pay interest that accrued between the end of that period and the date the Secretary received the claim.
(2) If the Secretary returned the claim to the lender or holder for additional documentation necessary for the approval of the claim, the Secretary pays interest only for the first 30 days following the return of the claim to the lender or holder.
(a)
(i) The loan application;
(ii) The original promissory note;
(iii) The repayment schedule agreement;
(iv) Evidence of each disbursement of loan proceeds;
(v) Notices of changes in a borrower's address and status as a full-time student;
(vi) Evidence of the borrower's eligibility for a deferment;
(vii) The borrower's signed statement describing his or her rights and responsibilities in connection with a HEAL loan;
(viii) The documents required for the exercise of forbearance;
(ix) Documentation of the assignment of the loan; and
(x) Evidence of a borrower's creditworthiness, including the borrower's credit report.
(2) The lender or holder must maintain for each borrower a payment history showing the date and amount of each payment received on the borrower's behalf, and the amounts of each payment attributable to principal and interest. A lender or holder must also maintain for each loan a collection history showing the date and subject of each communication with a borrower or endorser for collection of a delinquent loan. Furthermore, a lender or holder must keep any additional records which are necessary to make any reports required by the Secretary.
(3) A lender or holder must retain the records required for each loan for not less than 5 years following the date the loan is repaid in full by the borrower. However, in particular cases the Secretary may require the retention of records beyond this minimum period. A lender or holder must keep the original copy of an unpaid promissory note, but may store all other records in microform or computer format.
(4) The lender or holder must maintain accurate and complete records on each HEAL borrower and related school activities required by the HEAL program. All HEAL records shall be maintained under security and protected from fire, flood, water leakage, other environmental threats, electronic data system failures or power fluctuations, unauthorized intrusion for use, and theft.
(b)
(c)
(d) The lender or holder must comply with the Department's biennial audit requirements of section 705 of the Act.
(e) Any lender or holder who has information which indicates potential or actual commission of fraud or other offenses against the United States, involving these loan funds, must promptly provide this information to the appropriate Regional Office of Inspector General for Investigations.
(a) The Secretary may limit, suspend, or terminate the eligibility under the HEAL program of an otherwise eligible lender or holder that violates or fails to comply with any provision of title VII, part A, subpart I of the Act as amended (42 U.S.C. 292-292p), these regulations, or agreements with the Secretary concerning the HEAL program. Prior to terminating a lender or holder's participation in the program, the Secretary will provide the entity an opportunity for a hearing in accordance with the procedures under paragraph (b) of this section.
(b) The Secretary will provide any lender or holder subject to termination
(1) The request for a hearing is untimely (i.e., fails to meet the 30-day requirement);
(2) The lender or holder does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(3) The statement of factual issues in dispute is frivolous or inconsequential.
(c) This section does not apply to a determination that a HEAL lender fails to meet the statutory definition of an “eligible lender.”
(d) This section also does not apply to administrative action by the Department of Health and Human Services based on any alleged violation of:
(1) Title VI of the Civil Rights Act of 1964, which is governed by 45 CFR part 80;
(2) Title IX of the Education Amendments of 1972, which is governed by 45 CFR part 86;
(3) The Family Educational Rights and Privacy Act of 1974 (section 438 of the General Education Provisions Act, as amended), which is governed by 34 CFR part 99; or
(4) Title XI of the Right to Financial Privacy Act of 1978, Pub. L. 95-630 (12 U.S.C. 3401-3422).
(a) In order to participate in the HEAL program, a school must enter into a written agreement with the Secretary. In the agreement, the school promises to comply with provisions of the HEAL law and the HEAL regulations. For initial entry into this agreement and for the agreement to remain in effect, a school must satisfy the following requirements:
(1) The school must be legally authorized within a State to conduct a course of study leading to one of the following degrees:
(2)(i) The school must be accredited by a recognized agency approved for that course of study by the Secretary of Education, as described in paragraph (a)(2)(ii) of this section, except where a
(ii) The approved accrediting agencies are:
(A) Liaison Committee on Medical Education.
(B) American Osteopathic Association.
(C) Commission on Dental Accreditation.
(D) Council on Education of American Veterinary Medical Association.
(E) Council on Optometric Education.
(F) Council on Podiatric Medical Education.
(G) American Council on Pharmaceutical Education.
(H) Council on Education for Public Health.
(I) Council on Chiropractic Education.
(J) Accrediting Commission on Education for Health Services Administration.
(K) Committee on Accreditation of American Psychological Association.
(b) If a HEAL school undergoes a change of controlling ownership or form of control, its agreement automatically expires at the time of that change. The school must enter into a new agreement with the Secretary in order to continue its participation in the HEAL program.
When the student completes his or her portion of the student loan application and submits it to the school, the school must do the following:
(a) Accurately and completely fill out its portion of the HEAL application;
(b) Verify, to the best of its ability, the information provided by the student on the HEAL application, including, but not limited to, citizenship status and Social Security number. To comply with this requirement, the school may request that the student provide a certified copy of his or her birth certificate, his or her naturalization papers, and an original Social Security card or copy issued by the Federal Government, or other documentation that the school may require. The school must assure that the applicant's I-151 or I-551 is attached to the application, if the applicant is required to possess such identification by the United States;
(c) Certify that the student is eligible to receive a HEAL loan, according to the requirements of § 60.5;
(d) Review the financial aid transcript from each institution previously attended by the applicant on at least a half-time basis to determine whether the applicant is in default on any loans or owes a refund on any grants. The school may not approve the HEAL application or disburse HEAL funds if the borrower is in default on any loans or owes a refund on any educational grants, unless satisfactory arrangements have been made between the borrower and the affected lender or school to resolve the default or the refund on the grant. If the financial aid transcript has been requested, but has not been received at the time the applicant submits his or her first HEAL application, the school may approve the application and disburse the first HEAL installment prior to receipt of the transcript. Each financial aid transcript must include at least the following data:
(1) Student's name;
(2) Amounts and sources of loans and grants previously received by the student for study at an institution of higher education;
(3) Whether the student is in default on any of these loans, or owes a refund on any grants;
(4) Certification from each institution attended by the student that the student has received no financial aid, if applicable; and
(5) From each institution attended, the signature of an official authorized by the institution to sign such transcripts on behalf of the institution.
(e) State that it has no reason to believe that the borrower may not be willing to repay the HEAL loan;
(f) Make reasonable determinations of the maximum loan amount approvable, based on the student's circumstances. The student applicant determines the amount he or she wishes to borrow, up to this maximum amount. Only then may the school certify an eligible application. In determining the maximum loan amount approvable, the school will calculate the difference between:
(1) The total financial resources available to the applicant for his or her costs of education for the period covered by the proposed HEAL loan, and other student aid that the applicant has received or will receive during the period covered by the proposed HEAL loan. To determine the total financial resources available to the applicant for his or her costs of education for the period covered by the proposed HEAL loan (including familial, spousal, or personal income or other financial assistance that the applicant has received or will receive), the school must consider information provided through one of the national need analysis systems or any other procedure approved by the Secretary of Education, in addition to any other information which the school has regarding the student's financial situation. The school may make adjustments to the need analysis information only when necessary to accurately reflect the applicant's actual resources, and must maintain in the borrower's record documentation to support the basis for any adjustments to the need analysis information; and
(2) The costs reasonably necessary for each student to pursue the same or similar curriculum or program within the same class year at the school for the period covered by the proposed HEAL loan, using a standard student budget. The school must maintain in its general office records the criteria used to develop each standard student budget. Adjustments to the standard student budget may be made only to the extent that they are necessary for the student to complete his or her education, and documentation must be maintained in the borrower's record to support the basis for any adjustments to the standard student budget.
(g) Comply with the requirements of § 60.61.
(a) When a school receives from a HEAL lender a loan disbursement check or draft payable jointly to the school and to one of its students, it must:
(1) If the school receives the instrument after the student is enrolled, obtain the student's endorsement, retain that portion of funds due the school, and disburse the remaining funds to the student.
(2) If the school receives the instrument before the student is enrolled, it must, prior to endorsing the instrument, send the instrument to the student to endorse and return to the school. The school may then retain that portion of funds then due the school but must hold the remaining funds for disbursement to the student at the time of enrollment. However, if the student is unable to meet other educational expenses due before the time of enrollment, the school may obtain the student's endorsement and disburse to the student that portion of funds required to meet these other educational expenses.
(b) If a school determines that a student does not plan to enroll, the school must return a loan disbursement check or draft to the lender within 30 days of this determination.
Each school must notify the holder of a HEAL loan of any change in the student's enrollment status within 30 days following the change in status. Each notice must contain the student's full name under which the loan was received, the student's current name (if different), the student's Social Security number, the date of the change in
A participating school must pay that portion of a refund that is allocable to a HEAL loan directly to the original lender (or to a subsequent holder of the loan note, if the school has knowledge of the holder's identity). At the same time, the school must provide to the borrower written notice that it is doing so.
Each school must establish and maintain administrative and fiscal procedures necessary to achieve the following objectives:
(a) Proper and efficient administration of the funds received from students who have HEAL loans;
(b) Protection of the rights of students under the HEAL program;
(c) Protection of the United States from unreasonable risk of loss due to defaults; and
(d) Compliance with applicable requirements for HEAL schools.
(a) In addition to complying with the requirements of section 739(b) of the Act, each school must maintain an accurate, complete, and easily retrievable record with respect to each student who has a HEAL loan. The record must contain all of the following information:
(1) Student's name, address, academic standing and period of attendance;
(2) Name of the HEAL lender, amount of the loan, and the period for which the HEAL loan was intended;
(3) If a noncitizen, documentation of the student's alien registration status.
(4) Amount and source of other financial assistance received by the student during the period for which the HEAL loan was made;
(5) Date the school receives the HEAL check or draft and the date it either gives it to the student or returns it to the lender (if the school is not the lender);
(6) Date the school disburses the loan to a student (if the school is the lender);
(7) Date the school signs the loan check or draft (if the school is a copayee);
(8) Amount of tuition, fees and other charges paid by the student to the school for the academic period covered by the loan and the dates of payment;
(9) Photocopy of each HEAL check or draft received by the student;
(10) Documentation of each entrance interview, including the date of the entrance interview and the signature of the borrower indicating that the entrance interview was conducted;
(11) Documentation of the exit interview, including the date of the exit interview and the signature of the borrower indicating that the exit interview was conducted, or documentation of the date that the school mailed exit interview materials to the borrower if the borrower failed to report for the exit interview;
(12) A photocopy made by the school of the borrower's I-151 or I-551, if the borrower is required to possess such identification by the United States, or other documentation, if obtained by the school, to verify citizenship status and Social Security number (e.g., a certified copy of the borrower's birth certificate or a photocopy made by the school of the borrower's original Social Security card or copy issued by the Federal government);
(13) Documentation of the calculations made which compare the financial resources of the applicant with the cost of his or her education at the school;
(14) Copy(s) of the borrower's financial aid transcript(s);
(15) The standard budget used for the student, and documentation to support the basis for any deviations made to the standard budget;
(16) Copies of all correspondence between the school and the borrower or between the school and the lender or its assignee regarding the loan;
(17) Copy of each form used by the school in connection with the loan; and
(18) Expected postgraduate destination of borrower.
(b) The school must maintain the record for not less than 5 years following the date the student graduates, withdraws or fails to enroll as a full-time student. The school may store the records in microform or computer format.
(c) The school must comply with the Department's biennial audit requirements of section 705 of the Act.
(d) The school must develop and follow written procedures for the receipt, verification of amount, and disbursement of HEAL checks or drafts. These procedures must be maintained in the school's policies and procedures manuals or other general office records.
A school must submit reports to the Secretary at the times and in the manner the Secretary may reasonably prescribe. The school must retain a copy of each report for not less than 5 years following the report's completion, unless otherwise directed by the Secretary. A school must also make available to a HEAL lender or holder, upon the lender's or holder's request, the name, address, postgraduate destination and other reasonable identifying information for each of the school's students who has a HEAL loan.
For the purposes of audit and examination, a HEAL school must provide the Secretary of Health and Human Services, the Comptroller General of the United States, and any of their authorized representatives access to the records that the school is required to keep and to any documents and records pertinent to the administration of the HEAL Program.
In the event a school ceases to participate in the HEAL program, the school (or its successor, in the case of a school which undergoes a change in ownership) must retain all required HEAL records and provide the Secretary of Health and Human Services, the Comptroller General of the United States, and any of their authorized representatives access to them.
(a) The Secretary may limit, suspend, or terminate the eligibility under the HEAL program of an otherwise eligible school that violates or fails to comply with any provision of title VII, part A, subpart I of the Act as amended (42 U.S.C. 292-292p), these regulations, or agreements with the Secretary concerning the HEAL program. Prior to terminating a school's participation in the program, the Secretary will provide the school an opportunity for a hearing in accordance with the procedures under paragraph (b) of this section.
(b) The Secretary will provide any school subject to termination with a written notice, sent by certified mail, specifying his or her intention to terminate the school's participation in the program and stating that the
(1) The request for a hearing is untimely (i.e., fails to meet the 30-day requirement);
(2) The school does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(3) The statement of factual issues in dispute is frivolous or inconsequential.
(c) This section does not apply to a determination that a HEAL school fails to meet the statutory definition of an “eligible school.”
(d) This section does not apply to administrative action by the Department of Health and Human Services based on any alleged violation of The Family Educational Rights and Privacy Act of 1974 (section 438 of the General Education Provisions Act, as amended), as governed by 34 CFR part 99.
(a) A HEAL school is required to carry out the following activities for each HEAL applicant or borrower:
(1) Conduct and document an entrance interview with each student (individually or in groups) no later than prior to the loan recipient's first HEAL disbursement in each academic year that the loan recipient obtains a HEAL loan. The school must inform the loan recipient during the entrance interview of his or her rights and responsibilities under a HEAL loan, including the consequences for noncompliance with those responsibilities, and must gather personal information which would assist in locating the loan recipient should he or she depart from the school without receiving an exit interview. A school may meet this requirement through correspondence where the school determines that a face-to-face meeting is impracticable.
(2) Conduct and document an exit interview with each HEAL loan recipient (individually or in groups) within the final academic term of the loan recipient's enrollment prior to his or her anticipated graduation date or other departure date from the school. The school must inform the loan recipient in the exit interview of his or her rights and responsibilities under each HEAL loan, including the consequences for noncompliance with those responsibilities. The school must also collect personal information from the loan recipient which would assist the school or the lender or holder in skiptracing activities and to direct the loan recipient to contact the lender or holder concerning specific repayment terms and options. A copy of the documentation of the exit interview, including the personal information collected for skiptracing activities, and any other information required by the Secretary regarding the exit interview must be sent to the lender or holder of each HEAL loan within 30 days of the exit interview. If the loan recipient departs from the school prior to the anticipated date or does not receive an exit interview, the exit interview information must be mailed to the loan recipient by the school within 30 days of the school's knowledge of the departure or the anticipated departure date, whichever is earlier. The school must request that the loan recipient forward any required information (e.g., skiptracing information, request for deferment, etc.) to the lender or holder. The school must notify the lender or holder of the
(3) Verify the accuracy and completeness of information provided by each student on the HEAL loan application, particularly in regard to the HEAL eligibility requirements, by comparing the information with previous loan applications or other records or information provided by the student to the school. Notify the potential lender of any discrepancies which were not resolved between the school and the student.
(4) Develop and implement procedures relating to check receipt and release which keep these functions separate from the application preparation and approval process and assure that the amount of the HEAL loan check(s) does(do) not exceed the approved total amount of the loan and the statutory maximums. Checks must not be cashed without the borrower's personal endorsement. Documentation of these procedures and their usage shall be maintained by the school.
(5) Maintain accurate and complete records on each HEAL borrower and related school activities required by the HEAL program. All HEAL records shall be properly safeguarded and protected from environmental threats and unauthorized intrusion for use and theft.
(6) Maintain documentation of the criteria used to develop the school's standard student budgets in the school's general records, readily available for audit purposes, and maintain in each HEAL borrower's record a copy of the standard budget which was actually used in the determination of the maximum loan amount approvable for the student, as described in § 60.51.
(7) Notify the lender or its assignee of any changes in the student's name, address, status, or other information pertinent to the HEAL loan not more than 30 days after receiving information indicating such a change.
(b) Any school which has information which indicates potential or actual commission of fraud or other offenses against the United States involving these loan funds must promptly provide this information to the appropriate Regional Office of Inspector General for Investigations.
(c) The school will be considered responsible and the Secretary may seek reimbursement from any school for the amount of a loan in default on which the Secretary has paid an insurance claim, if the Secretary finds that the school did not comply with the applicable HEAL statute and regulations, or its written agreement with the Secretary. The Secretary may excuse certain defects if the school satisfies the Secretary that the defect did not contribute to the default or prejudice the Secretary's attempt to collect the loan from the borrower.
(d) A school is authorized to withhold services from a HEAL borrower who is in default on a HEAL loan received while enrolled in that school, except in instances where the borrower has filed for bankruptcy. Such services may include, but are not limited to academic transcripts and alumni services. Defaulted HEAL borrowers who have filed for bankruptcy shall provide court documentation that verifies the filing for bankruptcy upon the request of the school. Schools will also supply this information to the Secretary upon request. All academic and financial aid transcripts that are released on a defaulted HEAL borrower must indicate on the transcript that the borrower is in default on a HEAL loan. It is the responsibility of the borrower to provide the school with documentation from the lender, holder, or Department when a default has been satisfactorily resolved, in order to obtain access to services that are being withheld, or to have the reference to default removed from the academic and financial aid transcripts.
Sec. 215, 58 Stat. 690, as amended, sec. 8, 77 Stat. 400; 42 U.S.C. 216, 1857g; secs. 301, 402, 58 Stat. 691, as amended, 707, secs. 412, 422, 62 Stat. 464, 598, sec. 433, 64 Stat. 444, as amended, sec. 308, 74 Stat. 364, sec. 444, 76 Stat. 1073, sec. 3, 77 Stat. 394, secs. 394, 395, 79 Stat. 1062; 42 U.S.C. 241, 282, 287a, 288a, 289c, 242f, 289g, 1857b, 280b-4, 280b-5.
As used in this part:
(a)
(b)
(c)
(d)
(e)
The regulations in this subpart apply to the establishment, award, and operation of all regular fellowships awarded under the Public Health Service Act and the Clean Air Act.
Regular fellowships are provided to encourage and promote:
(a) Research and training for research relating to (1) the physical and mental diseases and impairments of man, (2) the organization, provision, and financing of health services, (3) the causes, prevention, and control of air pollution, and (4) medical library and related health sciences and communication of information.
(b) Special scientific projects for the compilation of existing, or writing of original, contributions relating to scientific, social, or cultural advancements in sciences related to health.
All regular fellowships in the Public Health Service shall be established by the Surgeon General. In establishing a fellowship or series of fellowships, the Surgeon General shall prescribe in
In order to qualify for a regular fellowship, an applicant must:
(a) Meet the Public Health Service requirements of general suitability, including professional and personal fitness.
(b) Have been accepted by a public or other nonprofit institution for the purpose of the activity for which the fellowship is sought.
(c) Be free from any disease or disability that would interfere with the accomplishment of the fellowship purpose.
(d) If a citizen or noncitizen national of the United States, sign and file with the Surgeon General the following statement:
I do solemnly swear (or affirm) that I bear true faith and allegiance to the United States of America and will support and defend the Constitution and laws of the United States against all its enemies, foreign and domestic.
(e) Comply with such other requirements as may be prescribed by the Surgeon General.
Application for a regular fellowship shall be made on forms prescribed by the Surgeon General. In addition to the information supplied by the applicant in his application, such further information may be required as is necessary to determine his qualifications and fitness.
The Surgeon General shall appoint one or more fellowship committees to examine the qualifications of applicants for fellowships and the merits of their proposals for research, training, or special scientific projects. A fellowship committee shall submit to the Surgeon General its recommendations concerning appointments. Awards of regular fellowships shall be made in writing by the Surgeon General.
Individuals awarded regular fellowships shall be entitled to such of the following benefits as are authorized for the particular series of fellowship:
(a) Stipend.
(b) Dependency allowances.
(c) When authorized in advance, separate allowances for travel. Such allowances may not exceed amounts prescribed by the Surgeon General for
(1) Travel to the place where the fellow is to be located during the fellowship term, and
(2) Travel to return the fellow at the end of the fellowship term to his home or other place he left to carry out the fellowship, provided that (unless otherwise prescribed by the Surgeon General) such return travel is to or from a place outside the continental United States.
(d) Vacation. Stipends and allow-ances will not be increased, or be paid beyond the term of a fellowship, on account of vacation an individual might have been entitled to but did not take.
Payments for stipends, dependency allowances, and the travel allowances specified in § 61.8 may be made directly to the fellow or to the sponsoring institution for payment to the fellow.
The Surgeon General may authorize allowances for payment of expenses, in whole or in part, of tuition, fees, equipment, supplies, attendance at meetings required to carry out the purposes of
(a)
(b)
(c)
(d)
Payments shall be subject to such requirements relating to accountability as may be specified by the Surgeon General.
An award period may be any period not in excess of 2 years. The Surgeon General may make one or more continuation awards for an additional period upon a finding of satisfactory progress toward accomplishment of the purposes of the initial fellowship award. Additional support may be provided on appropriate justification after expiration of the period of support involved in the previous award.
No information in the records or possession of the Public Health Service concerning the moral character or loyalty of a fellow will be made available to any fellowship committee involved in recommending appointments of fellows.
(a)
(b)
(c)
(d)
If, after review of the recommendation of the Special Review Committee, the Surgeon General believes that the award should be terminated or should not be continued, he shall notify the fellow and sponsoring institution in writing that unless a request for a hearing is made by the fellow within 20 days after the fellow's receipt of such notice, his fellowship will be terminated or his application for continuation of the award denied. A copy of the regulations under this subpart and a copy of part 10 of title 45, Code of Federal Regulations, shall be enclosed with the notice. The notice shall set forth, as specifically as security permits, the grounds for the questions pertaining to moral character or loyalty. Any such request for a hearing shall be promptly submitted by the Surgeon General to the Chairman of the Departmental Fellowship Review Panel for handling in accordance with such part 10.
The Surgeon General may terminate a fellowship upon receipt from the fellow of a written request for termination. The Surgeon General shall terminate any fellowship prior to the date it would otherwise expire if he determines that the fellow's performance is unsatisfactory or that the fellow or the sponsoring institution is unfit or unable to carry out the purpose of the fellowship. The fellow and the sponsoring institution shall be notified in writing of such termination.
Publication, distribution, and disposition of all manuscripts and other materials resulting from a fellowship awarded hereunder shall be subject to the conditions that all such materials shall bear appropriate acknowledgment of Public Health Service support, that fellows shall furnish copies of such publications or other materials as may be requested by the Surgeon General, and to such other conditions as the Surgeon General may prescribe.
Where the work accomplished under a fellowship award results in a book or other copyrightable material, the author is free to copyright the work, but the Public Health Service reserves a royalty-free, nonexclusive, and irrevocable license to reproduce, publish, or otherwise use, and to authorize others to use, all copyrightable or copyrighted material resulting from the fellowship award.
Any fellowship award made hereunder is subject to the regulations of the Department of Health and Human Services set forth in title 45 CFR parts 6 and 8, as amended. Such regulations shall apply to any activity for which fellowship funds are in fact used, whether within the scope of the fellowship as approved or otherwise. Appropriate measures shall be taken by the fellow, the sponsoring institution, and the Surgeon General to assure that no contracts, assignments, or other arrangements inconsistent with the fellowship obligation are entered into or continued and that all personnel involved in the supported activity are aware of and comply with such obligation. Laboratory notes, related technical data and information pertaining to inventions or discoveries shall be maintained for such periods, and filed with or otherwise made available to the Surgeon General or those whom he may designate at such times and in such manner as he may determine necessary to comply with such Department regulations.
Any interest earned through deposit or investment by the sponsoring institution of funds paid pursuant to the provisions of this subpart shall be paid to the United States as such interest is received by the sponsoring institution.
Attention is called to the fact that funds paid to a sponsoring institution
42 U.S.C. 209, 210, 216.
As used in this part:
The regulations in this part apply to the establishment of service fellowships in the Public Health Service, the designation of persons to receive such fellowships, and the appointment of service fellows under authority of section 207(g) of the Public Health Service Act.
Service fellowships in the Public Health Service are for the purpose of encouraging and promoting research, studies, and investigations related to health. Such fellowships may be provided to secure the services of talented scientists for a period of limited duration for health-related research, studies, and investigations where the nature of the work or the character of the individual's services render customary employing methods impracticable or less effective.
All service fellowships shall be established by the Secretary. In establishing a service fellowship, or a series of service fellowships, the Secretary shall prescribe in writing the conditions (in addition to those provided in the regulations in this part) under which service fellows will be appointed and will hold their fellowships.
Scholastic and other qualifications shall be prescribed by the Secretary for each service fellowship, or series of service fellowships. Each individual appointed to a service fellowship shall:
(a) Have presented satisfactory evidence of general suitability, including professional and personal fitness; and
(b) Possess any other qualifications as reasonably may be prescribed.
Application for a service fellowship shall be made in accordance with procedures established by the Secretary.
The Secretary shall:
(a) Prescribe a suitable professional and personal fitness review and an examination of the applicant's qualifications;
(b) Designate in writing persons to receive service fellowships; and
(c) Establish procedures for the appointment of service fellows.
(a)
(b)
(1) From place of residence, within or outside the continental United States, to first duty station,
(2) For any change of duty station ordered by the Service during the term of the fellowship, and
(3) From last duty station to the place of residence which he left to accept the fellowship, or to some other place at no greater cost to the Government.
(4) A service fellow shall be entitled to travel allowances or transportation and per diem while traveling on official business away from his or her permanent duty station during the term of the fellowship. Except as otherwise provided herein, a service fellow shall be entitled to travel and transportation allowances authorized in this part at the same rates as may be authorized by law and regulations for other civilian employees of the Public Health Service. If a service fellow dies during the term of a fellowship, and the place of residence that was left by the service fellow to accept the fellowship was outside the continental United States, the payment of expenses of preparing the remains for burial and transporting them to the place of residence for interment may be authorized. In the case of deceased service fellows whose place of residence was within the continental United States, payment of the expenses of preparing the remains and transporting them to the place of residence for interment may be authorized as provided for other civilian employees of the Public Health Service.
(c)
(d)
Initial appointments to service fellowships may be made for varying periods not in excess of 5 years. Such an appointment may be extended for varying periods not in excess of 5 years for each period in accordance with procedures and requirements established by the Secretary.
Sec. 215 of the Public Health Service Act, 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 751 of the Public Health Service Act, 90 Stat. 2281 (42 U.S.C. 294t), unless otherwise noted.
These regulations apply to the award of scholarships under the National Health Service Corps Scholarship Program authorized by section 751 of the Public Health Service Act (42 U.S.C. 294t) to students receiving academic training in medicine, osteopathy, dentistry, and other health professions. The purpose of this program is to assure an adequate supply of trained health professionals for the National Health Service Corps which is used by the Secretary to improve the delivery of health services in health manpower shortage areas.
As used in this part:
(a) To be eligible for a scholarship under this part an applicant must:
(1) Be accepted for enrollment, or be enrolled, as a full-time student in a school located in a State;
(2) Be pursuing a course of study or program offered by the school leading to a degree in medicine, osteopathy, dentistry, or an equivalent credential for a particular health profession;
(3) Be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the National Health Service Corps;
(4) Be a National of the United States; and
(5) Submit an application to participate in the Scholarship Program together with a signed contract as described in section 751(f) of the Act.
(b) Any applicant who owes an obligation for professional practice to a State or other entity under an agreement entered into before filing an application under this part is ineligible for an award unless a written statement satisfactory to the Secretary is submitted from the State or entity that (1) there is no potential conflict in fulfilling the service obligation to the State or entity and the Scholarship Program, and that (2) the Scholarship Program service obligation will be served before the service obligation for professional practice owed to the State or entity.
(c) Any individual who receives a scholarship under the Indian Health Service Scholarship Program (section 757 of the Act) or the Scholarship Program for First-Year Students of Exceptional Financial Need (section 758 of the Act) is ineligible to participate in the Scholarship Program during the
The Secretary will, from time-to-time, publish in the
Each individual desiring a scholarship under this part must submit an application (including a signed contract as required under section 751(f) of the Act) in the form and at the time prescribed by the Secretary.
(a)
(b)
(c)
(2) Special consideration will be given to (i) medical and osteopathic students who indicate their intention to enter family practice, internal medicine, pediatrics, or osteopathic general practice residencies, (ii) dental students who indicate their intention to undertake general practice training following graduation or who plan no postgraduate training, and (iii) those individuals who indicate an intent to pursue other types of clinical practice or specialized training for which the National Health Service Corps has a particular need.
(d)
(e)
(a)
(2) The Secretary may enter into a contract with the school in which the participant is enrolled for the direct payment of tuition and reasonable educational expenses in the participant's behalf.
(b)
(a)
(b)
(2) For purposes of this paragraph, “appointment” means only those appointments as Commissioned Officers in the Regular or Reserve Corps of the Service or as civilian members of the National Health Service Corps made specifically for the purpose of serving a participant's period of obligated service.
(c)
(d)
(e)
(f)
(2) Exceptional promise for medical research will be demonstrated if the participant applies for a National Research Service Award for individual postdoctoral fellows, is selected to participate in this research program, and accepts the offer of participation. A Scholarship Program participant in the National Research Service Award Program will receive credit toward satisfying the period of obligated service incurred under this section for any period of time he or she is engaged in activities which meet the service requirements of the National Research Service Award Program.
(3) If the time served under the National Research Service Award Program is less than the total period of obligated service owed under the Scholarship Program, the participant will serve the remainder of the Scholarship Program service obligation (i) in activities which meet the criteria for service under the National Research Service Award Program, as approved by the Secretary or (ii) as a member of the National Health Service Corps providing health services in the full-time clinical practice of his or her health profession. A participant who fails to begin or complete the service requirements under the National Research Service Award Program may be subject to the default penalty under § 62.10(c) of this part and the default penalties under the National Research Service Award Program.
(g)
(a)
(b)
(c)
(d)
(e)
(a) If a participant, other than one described in paragraph (b) of this section, fails to accept payment or instructs the school not to accept payment of the scholarship provided by the Secretary, the participant must, in addition to any service or other obligation incurred under the contract, pay to the United States the amount of $1,500 liquidated damages. Payment of this amount must be made within 30 days of the date on which the participant fails to accept payment of the scholarship award or instructs the school not to accept payment.
(b) When a participant fails to maintain an acceptable level of academic standing, is dismissed from the school for disciplinary reasons, or voluntarily terminates the course of study or program for which the scholarship was awarded before completing the course of study or program, the participant must, instead of performing any service obligation, pay to the United States an amount equal to all scholarship funds awarded under § 62.7. Payment of this amount must be made within 3 years of the date the participant becomes liable to make payment under this paragraph.
(c) If a participant fails to begin or complete the period of obligated service incurred under § 62.8, including failing to comply with the applicable terms and conditions of a deferment granted by the Secretary, the participant must pay to the United States an amount determined by the formula set forth in section 754(c) of the Act. Payment of this amount shall be made within 1 year of the date that the participant failed to begin or complete the period of obligated service, as determined by the Secretary.
In accordance with section 754(d)(3) of the Act, any payment obligation incurred under § 62.10 may not be discharged in bankruptcy under title XI of the United States Code until 5 years after the date on which the payment obligation is due.
(a) Any obligation of a participant for service or payment will be canceled upon the death of the participant.
(b)(1) A participation may seek a waiver or suspension of the service or payment obligations incurred under this part by written request to the Secretary setting forth the bases, circumstances, and causes which support the requested action. The Secretary may approve a request for a suspension for a period of 1 year. A renewal of this suspension may also be granted.
(2) The Secretary may waive or suspend any service or payment obligation incurred by a participant whenever compliance by the participant (i) is impossible, or (ii) would involve extreme hardship to the participant and if enforcement of the service or payment obligation would be against equity and good conscience.
(c) Compliance by a participant with a service or payment obligation will be considered impossible if the Secretary
(d) In determining whether to waive or suspend any or all of the service or payment obligations of a participant as imposing an undue hardship and being against equity and good conscience, the Secretary, on the basis of information and documentation as may be required, will consider:
(1) The participant's present financial resources and obligations;
(2) The participant's estimated future financial resources and obligations; and
(3) The extent to which the participant has problems of a personal nature, such as physical or mental disability, terminal illness in the immediate family which so intrude on the participant's present and future ability to perform as to raise a presumption that the individual will be unable to perform the obligation incurred.
Under section 741(f) or 836(h) of the Act, the Secretary may agree to repay a portion of an individual's educational loans in return for the individual's agreement to practice his or her profession in an area in need of health manpower. However, a Scholarship Program participant may not enter into an agreement with the Secretary under section 741(f) or 836(h) of the Act, until either:
(a) The participant has completed the service obligation under the Scholarship Program,
(b) The Secretary has recovered from the participant an amount determined under § 62.10, or
(c) Any service or payment obligation has been waived under § 62.12.
(a) Except as provided in paragraph (b) of this section, if a participant has previously received an award under the PH/NHSC Scholarship Training Program and also receives an award under the Scholarship Program, the terms and conditions of these regulations will apply to the participant's entire obligation incurred under both the PH/NHSC Scholarship Training Program and the Scholarship Program.
(b) If a participant has received an award under the PH/NHSC Scholarship Training Program and also receives an award under the Scholarship Program, the following conditions apply:
(1)
(2)
(ii) If a participant received a scholarship for the first time during the 1977-78 school year under the PH/NHSC Scholarship Training Program, the participant will only receive 1 year of credit toward satisfying the period of obligated service incurred under the PH/NHSC Scholarship Training Program for internship or residency training served in a Service or National Health Service Corps facility.
(3)
Sec. 215 of the Public Health Service Act, 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 338B of the Public Health Service Act, 101 Stat. 992 (42 U.S.C. 2541-1).
The regulations of this subpart apply to the award of health professions educational loan payments under the National Health Service Corps Loan Repayment Program authorized by section 338B of the Public Health Service Act (42 U.S.C. 2541-1). The purpose of the Program is to assure an adequate supply of trained health professionals for the National Health Service Corps. These professionals will be assigned by the Secretary to provide necessary health services to persons living in designated health manpower shortage areas.
The definitions in § 62.2 of this part will apply for the purpose of this subpart, except for the definition of
(a) In determining which applications from eligible individuals for participation in the Loan Repayment Program will be accepted for consideration, the Secretary will apply the following criteria:
(1) The extent to which an individual's training is in a health profession or specialty determined by the Secretary to be needed by the National Health Service Corps;
(2) The individual's commitment to serve in medically underserved areas;
(3) The availability of the individual for service, with highest consideration being given to individuals who will be available for service at the earliest dates;
(4) The length of the individual's proposed service obligation, with greatest consideration being given to persons who agree to serve for longer periods of time; and
(5) The individual's academic standing, prior professional experience in a health manpower shortage area, board certification, residency achievements, peer recommendations, depth of past residency practice experience and other criteria related to professional competence or conduct.
(b) Among qualified applicants, the Secretary will give priority to applications from individuals whose health professions or specialties are most needed by the NHSC and who are, in the Secretary's judgement, most committed to practice in medically underserved areas.
(c) By notice published in the
(a) To be eligible to participate in the Loan Repayment Program an individual must:
(1)(i) Be enrolled as a full-time student in the final year of a course of study or program approved by the Secretary which leads to a degree in allopathic or osteopathic medicine, dentistry or other health profession and which is offered by an accredited school in a State or
(ii) Be enrolled in an approved graduate training program in allopathic or osteopathic medicine or dentistry or other health profession in a State, or
(iii) Have a degree in allopathic or osteopathic medicine or dentistry or
(2) Be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Public Health Service or be eligible for selection for civilian service in the National Health Service Corps;
(3) Submit an application to participate in the Loan Repayment Program; and
(4) Sign and submit to the Secretary, at the time of the submission of such application, a written contract agreeing to accept repayment of health professions educational loans and to serve (in accordance with this subpart) for the applicable period of obligated service in a health manpower shortage area as determined by the Secretary.
(b) Any individual who owes an obligation for health professional service to the Federal Government or a State or other entity under an agreement with such Federal, State or other entity is ineligible for the Loan Repayment Program unless such obligation will be completely satisfied prior to the beginning of service under this Program.
(c) Individuals in breach of a written contract entered into under section 338A of the Act and liable to the United States under section 338E(b) of the Act, in breach of a written contract entered into under section 225 of the Act (as in effect on September 30, 1977) and liable to the United States under section 225(f)(1) of the Act (as in effect on September 30, 1977) or in breach of any other obligation for health professional service to a Federal, State or local government entity are not eligible for participation in the Loan Repayment Program.
(a)
(1) Except as provided in paragraph (a)(2) of this section, up to $20,000 per year of a Program participant's qualifying loans or
(2) Up to $25,000 per year for a Program participant's qualifying loans if the Program participant agrees to provide obligated service in the Indian Health Service or a health facility or program operated by a tribe or tribal organization under the Indian Self-Determination Act.
(b)
(c)
(a) A Program participant whose eligibility for the Loan Repayment Program is based on § 62.24(a)(1)(i) of this subpart must maintain full-time enrollment, at an acceptable level of academic standing, in that course of study until its completion. Upon completion of that course of study, a Program participant who received a degree in allopathic or osteopathic medicine must enter approved graduate training and a Program participant who received a degree in a health profession other than allopathic or osteopathic medicine may enter approved graduate training. Once a Program participant enters approved graduate training, he or she must also meet the requirements set forth in paragraphs (b) (1), (2), (3), and (4) of this section. If a Program participant who received a degree in a health profession other than allopathic or osteopathic medicine does not enter approved graduate training; service, in accordance with paragraph (e) of this section, must commence as soon as possible upon the Program participant's completion of the course of study leading to his or her health professions degree.
(b) A Program participant whose eligibility for the Loan Repayment Program is based on § 62.24(a)(1)(ii) of this subpart must: (1) Continue in his or her approved graduate training program at an acceptable level of academic standing; (2) provide the Secretary with annual documentation of continued participation in that approved graduate training program at an acceptable level of academic standing; (3) successfully complete that approved graduate training program; and (4) commence service, in accordance with paragraph (e) of this section, as soon as possible upon completion of approved graduate training.
(c) A Program participant whose eligibility for the Loan Repayment Program is based on § 62.24(a)(1)(iii) of this subpart must commence service, in accordance with paragraph (e) of this section, as soon as possible after the effective date of the Loan Repayment Program Contract.
(d) If a Program participant fails to complete approved graduate training, the Secretary may, on his or her own initiative or at the Program participant's request, waive, for good cause, the completion requirement. Good cause will be deemed to exist if the Secretary determines that the Program participant has sufficient health professions training to be utilized by and make a substantial contribution to the National Health Service Corps. If waiver of the completion requirement in paragraph (b) of this section is granted; service, in accordance with paragraph (e) of this section, must commence as soon as possible after the granting of the waiver.
(e) Except for Program participants who fail to complete their course of study leading to a health professions degree or who fail to complete approved graduate training and do not receive a waiver pursuant to paragraph (d) of this section, each program participant must:
(1) Serve in a health manpower shortage area to which he or she is assigned by the Secretary as a member of the National Health Service Corps or serve pursuant to section 338D of the Act in a health manpower shortage area selected by the Secretary and
(2) Accept employment in a full-time clinical practice of the Program participant's profession, as
(i) A commissioned officer in the Regular or Reserve Corps of the Public Health Service,
(ii) A civilian member of the National Health Service Corps who is an employee of the United States,
(iii) A member of the National Health Service Corps who is not an employee of the United States, or
(iv) A private practitioner who is providing obligated service under the provisions of section 338D of the Act.
(f) The minimum length of obligated service is two years, or such longer period as the Program participant may agree to. The maximum length of obligated service is four years. If a Program participant agrees to an original contract of two or three years, such contract may be extended, subject to the availability of appropriated funding, for one year or two years (up to the four-year maximum). A one-year extension will not reactivate the statutory minimum requirement of two years of service.
Program participants who default on their Loan Repayment Program Contracts will be subject to the applicable monetary payment provisions set forth at section 338E of the Act. Payment of any amount owed under section 338E of the Act shall be made within one year of the date the participant breached his or her Loan Repayment Contract, as determined by the Secretary.
A service or payment obligation under the Loan Repayment Program will be canceled or may be waived or suspended as provided in § 62.12 of this part of the regulations.
Any payment obligation incurred under § 62.27 of this subpart may be released by a discharge in bankruptcy under title 11 of the United States Code only if such discharge is granted after the expiration of the five-year period beginning on the first date that payment was required, and only if the bankruptcy court finds that nondischarge of the obligation would be unconscionable.
Other regulations and statutes which apply to this subpart include but are not limited to:
Sec. 215 of the Public Health Service Act, 58 Stat. 690 as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 338H of the Public Health Service Act, 101 Stat. 999 (42 U.S.C. 254q-1).
The regulations of this subpart apply to the award of grants authorized by section 338H of the Public Health Service Act (42 U.S.C. 254q-1) to support the establishment of State programs similar to the National Health Service Corps Loan Repayment Program authorized by section 338B of the Public Health Service Act (42 U.S.C. 2541-1). The purpose of this program is to improve the delivery of health services in medically underserved areas.
In addition to the definitions in § 62.2 of this part, the following definitions will apply for purposes of this subpart:
The definitions of
Any State is eligible to apply for a grant under this subpart.
(a) An application for a grant under this subpart shall be submitted to the Secretary at such time and in such form and manner as the Secretary requires.
(b) The application shall contain a budget and narrative statement describing the manner in which the applicant intends to conduct the project and carry out the requirements of this subpart. In addition, applications must include:
(1) A description of the State's standards for the designation of medically underserved areas, except that no description of designation standards will be required if the State elects to use health manpower shortage areas designated by the Secretary;
(2) An assessment of the need and demand in medically underserved areas within the State for health professions manpower with special emphasis on individuals whose training is in a health profession or specialty identified by the Secretary pursuant to § 62.23(b) of this part. This assessment should include such demographic indicators of the need as the economic accessibility of health care services in the State as measured by poverty levels, the percentage of the service area population without health insurance, and the health status of the population as measured by the rates of infant mortality, low birth weight, geographic barriers and other indicators;
(3) A proposal for the placement of the health profession providers in medically underserved areas with the greatest need and demand in accordance with the need/demand assessment completed in compliance with paragraph (b)(2) of this section;
(4) Adequate assurances that sufficient current year State funds are available to cover the non-Federal share of State Loan Repayment Program costs;
(5) A description of how the program would meet the requirements of § 62.55 to demonstrate its similarity to the NHSC Loan Repayment program;
(6) A description of the source of, and plans for the use of, State matching funds;
(7) A description of how the program would be coordinated with Federal, State and other organized activities within the State which relate to health manpower services and resources;
(8) Identification of the State entity and key personnel who would administer the grant and a description of the qualifications and experience of that entity and its personnel concerning the State's health service delivery system and health manpower needs;
(9) A description of the State's plans for administration of the State's Loan Repayment Program which may include such provisions as annual levels of loan repayment to be made under the program, the number of health professionals to be funded, the frequency and timing of the loan repayments, program incentives for longer periods of service, procedures for monitoring the service of program participants and placing professionals in default for failure to complete their service obligation, penalties for default, provisions for waivers and suspensions, and a description of the contract/obligation process to be used by the State to obligate individuals receiving State loan repayments;
(10) A description of the State's need for Federal assistance in obtaining health professions resources and demonstrated inability to obtain such resources without Federal assistance;
(11) A description of how the State will accord special consideration to medically underserved areas with large minority populations; and
(12) The signature of an individual authorized to act for the State and to assume on behalf of the State the obligations imposed by the statute, the applicable regulations of this subpart and any additional conditions of the grant.
A State Loan Repayment Program supported under this subpart must:
(a) Establish priorities for loan repayment applicants consistent with the provisions of § 62.23 of this part;
(b) Contract only with a person who is (1) enrolled as a full-time student in the final year of a course of study or program in an accredited school in a State leading to a degree in allopathic or osteopathic medicine, dentistry or other health profession, or (2) enrolled in an accredited graduate training program in a State in allopathic or osteopathic medicine or dentistry or other health profession, or (3) a practitioner licensed by a State who has completed training in an accredited graduate training program in allopathic or osteopathic medicine, dentistry or other health profession;
(c) Provide that health professionals participating in a State Loan Repayment Program shall:
(1) Serve for at least 2 years in a medically underserved area identified pursuant to § 62.54(b)(3) of this subpart in the full-time clinical practice of their profession,
(2) Charge for his or her professional services at the usual and customary rate prevailing in the area in which such services are provided, except that if a person is unable to pay such charge, such person shall be charged at a reduced rate or not charged any fee,
(3) In providing health services, not discriminate against any person on the basis of such person's ability to pay for such services or because payment for the health services provided to such person will be made under the insurance program established under part A or B of title XVIII of the Social Security Act or under a State plan for medical assistance approved under title XIX of such Act, and
(4) Agree to accept an assignment under section 1842(b)(3)(B)(ii) of such Act for all services for which payment may be made under part B of title XVIII of such Act and enter into an appropriate agreement with the State agency which administers the State plan for medical assistance under title XIX of such Act to provide service to individuals entitled to medical assistance under the plan;
(d) Repay qualifying loans for participating health professionals;
(e) Provide that the loans of health professionals will be repaid on a periodic basis after the receipt of obligated services by such participant for such period; and
The Federal share of any program shall not exceed 75 percent of the cost of the approved State program. The Federal share must be used to repay the qualifying loans of health professionals. No portion of the Federal share shall be used to pay for administrative costs of any State Loan Repayment Program. The State's share of the program may be used to repay qualifying loans of health professionals or administrative costs of the State's Loan Repayment Program, or a combination of both. All program administrative costs are to be borne by the State. No portion of the State's share of the program shall consist of Federal funds.
Within the limits of funds available under section 338H of the Act, the Secretary may award grants to State applicants whose proposed Loan Repayment Programs will, in his or her judgment, best promote the purposes of section 338H of the Act, taking into account, among other pertinent factors:
(a) The need of the State for health professions manpower;
(b) The number and type of providers the State proposes to support through this program;
(c) The acceptableness of the State's standards for the designation of medically underserved areas and the appropriateness of the proposed placements of obligated providers;
(d) The degree of similarity between the proposed State Loan Repayment Program and the National Health Service Corps Loan Repayment Program;
(e) The adequacy of the qualifications, the administrative and managerial ability and the experience of the State staff to administer and carry out the proposed project;
(f) The suitability of the applicant's approach and the degree to which the applicant's project is coordinated with Federal, State and other organized activities for meeting the State's health professions manpower needs and resources, including mechanisms for an ongoing evaluation of the program's activities;
(g) The source and plans for use of the State match (including the percentage of the State's match that is proposed to be used for loan repayments), the degree to which the State match exceeds 25% or has increased over time, and the amount of the match relative to the needs and resources of the States; and
(h) The extent to which special consideration will be extended to medically underserved areas with large minority populations.
Other regulations which apply to this subpart include but are not limited to:
Sec. 215 of the Public Health Service Act 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 204, Pub. L. 100-177, 101 Stat. 1000.
These regulations apply to the Special Repayment Program authorized under section 204 of Pub. L. 100-177, which provides a time-limited opportunity for persons who were, on November 1, 1987, in breach of a written contract under the Public Health and National Health Service Corps Scholarship Training Program or the National Health Service Corps Scholarship Program to satisfy their scholarship obligations through full-time clinical service. These regulations do not apply to any Public Health and National Health Service Corps Scholarship Training Program or National Health Service Corps Scholarship Program obligation which the Secretary has determined was completely satisfied through service or monetary payment prior to November 1, 1987. The purpose of this program is to supply trained health professionals for the National Health Service Corps, which is used by the Secretary to improve the delivery of health services in health manpower shortage areas.
In addition to the definitions in § 62.2 of this part, the following definitions will apply for purposes of this subpart:
(1) In breach of a written contract entered into under section 338A of the Act and liable to the United States under section 338E(b) of the Act and/or in breach of a written contract entered into under section 225 of the Act (as in effect on September 30, 1977) and liable to the United States under section 225(f)(1) of the Act (as in effect on September 30, 1977); and
(2) Not already serving their obligations on December 1, 1987, under a judgment, forbearance agreement, or other written agreement to serve.
(1) An offer of employment from a HPOL or SHPOL site which specifies at least the agreed upon salary and start date; and
(2) The Program participant's acceptance of that offer. Provided, however, that if the Program participant would be self-employed, a
(1) As a member of the National Health Service Corps pursuant to an assignment by the Secretary under section 333 of the Act;
(2) Under a written private practice option agreement signed by the Secretary pursuant to section 338D of the Act; or
(3) In compliance with section 338C(e) of the Act.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(a) Prior approved service performed by a Program participant will be credited to the Program participant for the purpose of calculating the Program participant's remaining service obligation under this Program. Thus, the Program participant's remaining service obligation will be calculated by subtracting the number of days of the Program participant's prior approved service from the number of days of the Program participant's original service obligation under the PH/NHSC Scholarship Training Program and/or the Scholarship Program. If a Program participant has made monetary payments, his or her remaining service obligation will be reduced by converting the monetary payments into days of service credit as set forth in paragraph (b) or (c) of this section, whichever is applicable.
(b) Program participants who elect to serve pursuant to section 204(b) and section 204(c)(2) of Pub. L. 100-177, will not receive a refund of any amounts previously paid but will receive service credit for those payments as follows:
(1) The number of days of service credit will be calculated by dividing the total amount paid by the Program participant prior to the Program participant's service start date by the total debt as of the service start date and multiplying the result of that division by the number of days of the participant's remaining service obligation (as determined by the formula set forth in the second sentence of paragraph (a) of this section).
(2) If the Program participant defaults on a contract under this Program, prior monetary payments will not be credited to service but will be applied to the monetary debt owed by the Program participant.
(c) Program participants who elect to serve under section 204(c)(1) of Pub. L. 100-177 must pay an amount equal to the scholarship amount. Any amounts paid by the Program participant prior to or after entry into the Program, in accordance with § 62.76 of this subpart, will be used to reduce the Program participant's financial obligation incurred under section 204(c)(1) of Pub. L. 100-177. In some cases, the amounts paid before or after entry into the Program will exceed the scholarship amount. These payments in excess of the scholarship amount will be converted into days of service credit under the formula set forth in paragraph (b)(1) of this section. If a Program participant defaults on a contract under this option, the monies paid in excess of the
(a) With respect to obligations under the Scholarship Program, a credit will be allowed for partial service under the Special Repayment Program and will result in a reduction of the Program participant's financial obligation in accordance with the following formula:
(b) With respect to obligations under the PH/NHSC Scholarship Training Program, if a Program participant fails to complete the period of obligated service under the Program (including any additional months of service incurred pursuant to section 204(c)(1) of Pub. L. 100-177), no credit for partial service under this Program will be allowed.
(c) Where participants have obligations under both the Scholarship Program and the PH/NHSC Scholarship Training Program, credit for service will be applied against the scholarship obligations in the order in which they were incurred.
Program participants who elect to serve under section 204(c)(1) of Pub. L. 100-177 will be required to pay the full scholarship amount at least 60 days prior to the service start date specified in the documentation submitted to the Secretary.
42 U.S.C. 216, 282(b)(13), 284(b)(1)(C), 285a-2(b)(3), 286b-3, 287c-21(a).
(a) The regulations in this part apply to research traineeships awarded by the Director, NIH, each director of a national research institute of NIH, the Director of the National Library of Medicine, and the Director of the National Center for Complementary and Alternative Medicine, or their designees, pursuant to sections 402(b)(13), 405(b)(1)(C), 413(b)(3), 472, and 485(D)(a) of the Act, respectively.
(b) The regulations of this part do not apply to research training under the National Research Service Award Program governed by 42 CFR part 66 or to the Mental Health Traineeship Program governed by 42 CFR part 64a.
(c) Except as otherwise permitted under section 413(b)(3) of the Act, the regulations of this part do not apply to residency training of physicians or other health professionals.
As used in this part:
The purpose of an NIH research traineeship is to provide support for financial subsistence to an individual during a period in which the awardee is acquiring training in:
(a) Basic and/or clinical biomedical or behavioral research relating to human health, including extending healthy life and reducing the burdens of illness, or
(b) Medical library science or related fields pertaining to sciences related to health or the communication of health sciences information.
Traineeships are intended to make available in the United States an increased number of persons having special competence in these research fields through developmental training and practical research experience in the facilities of NIH, with supplemental training at other qualified institutions (see § 63.8(a)).
Minimum qualifications for any traineeship shall be established by the Director and shall be uniformly applicable to all applicants in each traineeship program. These minimum qualifications may include requirements as to citizenship, medical standards, academic degrees, professional or other training or experience, and other factors as may be necessary to the fulfillment of the purpose of the traineeship. The Director may, as a matter of general policy or, in individual cases, waive compliance with any minimum qualification so established to the extent that the applicant or applicants have substantially equivalent qualifications or have such special training, experience or opportunity for service as to make an award
Subject to the regulations of this part, the Director may award traineeships to those qualified applicants who are best able in that official's judgment to carry out the purpose of the traineeships. These awards may be made for a period of one (1) year or other period, including extensions or renewals, as may be specified.
(a) Application for a traineeship shall be made in writing as prescribed by the Director.
(b) In addition to other pertinent information, the Director may require each applicant to submit the following information:
(1) Certification of the applicant's citizenship status;
(2) The applicant's educational background and other qualifications and experience, including previous academic and professional degrees, if any; and
(3) The subject area of the proposed training.
(c) By applying, eligible individuals agree to abide by HHS, PHS, and NIH regulations, and the terms and conditions of the traineeship award which may require compliance with policies and procedures that apply to the proper conduct of research, such as research involving human and animal subjects, patient care, hospital and laboratory procedures, handling of confidential information, and outside employment.
(a) Subject to the availability of funds, each individual awarded a traineeship may receive a stipend fixed in an amount determined by the Director.
(b) Additional allowances and benefits may be authorized by and at the discretion of the Director, taking into account the cost of living and other factors such as the requirements of the training program and availability of discretionary funds. Discretionary allowances and benefits may include: health benefits coverage; dependents' allowance; travel to pre-award interviews, to first duty station, and return to the place of origin upon conclusion of the traineeship; tuition and institution fees; and other specific costs as may be necessary to fulfill the purpose of the training program.
All traineeships shall be subject to the following terms and conditions:
(a) Training must be carried out at a facility of the NIH, but may be supplemented by additional training acquired at another institution which is found by the Director to be directly related to the purpose of the traineeship and necessary to its successful completion.
(b) Payments shall be made to the awardee or to the institution for payment to the awardee in accordance with payment schedules as prescribed by the Director for each traineeship program.
(c) The awardee shall reimburse NIH for any overpayment of stipends or other allowances because of early termination of the traineeship or any other reason, unless waived for good cause shown by the awardee.
(d) The Director may establish procedures and requirements applicable to traineeship awards, consistent with the regulations in this part, regarding: (1) The proper conduct of research investigations, including research involving human and animal subjects; (2) patient care; (3) hospital and laboratory procedures; (4) handling of confidential information; (5) outside employment; and (6) additional conditions the Director finds necessary to fulfill the purpose of the traineeship.
(e) The awardee shall sign an agreement to comply with the terms and conditions of the traineeship.
The Director may terminate a traineeship at any time:
(a) Upon written request of the awardee; or
(b) If it is determined that the awardee has committed misconduct in science, is ineligible, or has materially failed to comply with the terms and
(c) If the awardee is convicted of a felony, or an offense involving any illegal drug or substance, or any offense involving a lack of financial integrity or business honesty; or
(d) Because of programmatic changes or lack of funds.
Several other policies and regulations apply to awards under this part. These include, but are not necessarily limited to:
42 U.S.C. 216, 242
(a) The regulations of this part apply to:
(1) Grants awarded by the John E. Fogarty International Center for Advanced Study in the Health Sciences, NIH, for training in international cooperative biomedical research endeavors, as authorized under section 307(b)(3) of the Act;
(2) Grants awarded by NIH for research training with respect to the human diseases, disorders, or other aspects of human health or biomedical research, for which the institute or other awarding component was established, for which fellowship support is not provided under section 487 of the Act and which is not residency training of physicians or other health professionals, as authorized by sections 405(b)(1)(C), 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and,
(3) Grants awarded by the National Institute of Environmental Health
(b) The regulations of this part also apply to cooperative agreements awarded to support the training specified in paragraph (a) of this section. References to ``grant(s)'' shall include ``cooperative agreement(s).''
(c) The regulations of this part do not apply to:
(1) Research training support under the National Research Service Awards Program (see part 66 of this chapter);
(2) Research training support under the NIH Center Grants programs (see part 52a of this chapter);
(3) Research training support under traineeship programs (see part 63 of this chapter);
(4) Research training support under the NIH AIDS Research Loan Repayment Program (see section 487A of the Act); or
(5) Research training support under the National Library of Medicine training grant programs (see part 64 of this chapter).
As used in this part:
The purpose of a training grant is to provide financial assistance to an eligible agency or institution to enable it to provide research training to individuals in the diagnosis, prevention, treatment, or control of human diseases or disorders, or other aspects of human health or biomedical research, or in environmental health, in order to increase the number of facilities which provide qualified training and the number of persons having special competence in these fields.
(a)
(b)
(1) Training activities conducted by, or in cooperation with, the World Health Organization and
(2) With respect to training activities in the Western Hemisphere, activities conducted by, or in cooperation with, the Pan American Health Organization or the World Health Organization.
Any agency, institution, or entity interested in applying for a grant under this part must submit an application at the time and in the form and manner that the Secretary may require.
The Secretary shall evaluate applications through the officers and employees, experts, consultants, or groups engaged by the Secretary for that purpose, including review or consultation with the appropriate advisory council or other body as may be required by law. The Secretary's evaluation will be for merit and shall take into account, among other pertinent factors, the significance of the program, the qualifications and competency of the program director and proposed staff, the adequacy of the selection criteria for trainees under the program, the adequacy of the applicant's resources available for the program, and the amount of grant funds necessary for completion of its objectives.
(a) Are determined to be meritorious, and
(b) Best carry out the purposes of the particular statutory program described in § 63a.1 and the regulations of this part.
(a) The notice of the grant award specifies how long the Secretary intends to support the project without requiring the grantee to recompete for funds. This period, called the ``project period,'' will usually be for one to five years.
(b) Generally, the grant will be initially for one year and subsequent continuation awards will be for one year at a time. A grantee must submit a separate application at the time and in the form and manner that the Secretary may require to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require determination by the Secretary that continued funding is in the best interest of the Federal Government.
(c) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(d) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward to the next budget period, for use as prescribed by the Secretary, provided that a continuation award is made. If at any time during a budget period it becomes apparent to the Secretary that the amount of Federal funds awarded and available to the grantee for that period, including any unobligated balance carried forward from prior periods, exceeds the grantee's needs for that period, the Secretary may adjust the amounts awarded by withdrawing the excess.
In addition to the requirements imposed by law, grants awarded under this part are subject to any terms and conditions imposed by the Secretary to carry out the purpose of the grant or assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.
(a)
(b)
(1) Expenses of the grantee in providing training and instruction under
(2) Stipends and allowances to individuals during the period of their training and instruction; and,
(3) If separately justified and authorized under the particular program, tuition, fees, and trainee travel expenses which are necessary to carry out the purpose of the training grant.
(c)
(1) Compensation for employment or for the performance of personal services by individuals receiving training and instruction; or
(2) Payments to any individual who does not meet the minimum qualifications for training and instruction established by the grantee and approved by the Secretary or who has failed to demonstrate satisfactory participation in the training in accordance with the usual standards and procedures of the grantee.
Several other HHS regulations and policies apply to this part. These include, but are not necessarily limited to:
This policy is subject to change, and interested persons should contact the Office for Protection from Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-496-7005; not a toll-free number) to obtain references to the current version and any amendments.]
42 U.S.C. 216, 286b-3.
(a) The regulations of this part apply to grants under section 472 of the Public Health Service Act (42 U.S.C. 286b-3) to public and private nonprofit institutions to assist in developing, expanding, and improving training programs (excluding training in a biomedical specialty and residency training) in library science and the field of communications of information pertaining to sciences relating to health.
(b) The regulations of this part also apply to cooperative agreements awarded for these purposes. References to “grant(s)” shall include “cooperative agreement(s).”
(c) The regulations of this part do not apply to research training support under the National Research Service Awards Program (see part 66 of this chapter).
As used in this part:
Except as otherwise prohibited by law, any public or private nonprofit entity is eligible for a training grant.
Applications for grants must include the following information:
(a)
(2) The name and qualifications of the project director and any key personnel responsible for the proposed project.
(3) A description of the facilities, staff, support services, and other organizational resources available to carry out the project.
(4) The intended number of trainees and the minimum qualifications and criteria for their selection.
(5) A description of the plan for evaluating the proposed project.
(6) Other pertinent information the Secretary may require to evaluate the proposed project.
(b)
(2) If institutional expenses are requested, a separate statement of the amounts requested for personal services, equipment, supplies, or other non-personal services.
(3) If stipend costs are requested, a statement for each grant year of the estimated number of individuals to whom stipends will be provided and the length of time for which the stipend support will be provided. If other trainee costs are requested, they must be separately stated and justified.
The Secretary shall evaluate applications through the officers and employees, experts, consultants, or groups engaged by the Secretary for that purpose. The Secretary's evaluation will be for technical merit and shall take into account, among other pertinent factors, the significance of the project, the qualifications and competency of the project director and proposed staff, the adequacy of selection criteria for trainees for the project, the adequacy of the applicant's resources available for the project, and the amount of grant funds necessary for completion of its objectives.
(a)
(1) Are determined by the Secretary to be technically meritorious; and
(2) In the judgment of the Secretary best promote the purpose of the grant program as authorized by section 472 of the Act (42 U.S.C. 286b-3), the regulations of this part (see § 64.1), and address program priorities.
(b)
(2) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.
(3) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
(4) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward to the next budget period, for use as prescribed by the Secretary, provided a continuation award is made. If at any time during a budget period it becomes apparent to the Secretary that the amount of Federal funds awarded and available to the grantee for that period, including any unobligated balance carried forward from prior periods, exceeds the grantee's needs for that period, the Secretary may adjust the amounts awarded by withdrawing the excess.
(a) Grants awarded under this part are subject to the following conditions:
(1) The grantee may not materially change the quality, nature, or duration of the project unless the written approval of the Secretary is obtained prior to the change.
(2) The grantee must submit to the Secretary, in the manner prescribed by the Secretary, the name and other pertinent information regarding each individual who is awarded a stipend under a grant.
(b) The Secretary may impose additional conditions prior to the award of any grant under this part if it is determined by the Secretary that the conditions are necessary to carry out the purpose of the grant.
A grantee shall expend funds it receives under this part solely in accordance with the approved application and
(a) Compensation for employment or for the performance of personal services by individuals receiving training and instruction; or
(b) Payments to any individual who does not meet the minimum qualifications for training and instruction established by the grantee and approved by the Secretary or who has failed to demonstrate satisfactory participation in the training in accordance with the usual standards and procedures of the grantee.
Several other regulations apply to grants under this part. These include, but are not necessarily limited to:
Sec. 803, Pub. L. 96-398, 94 Stat. 1607-1608 (42 U.S.C. 242a).
This part establishes requirements to implement the service payback obligation of individuals who receive clinical traineeships in pyschology, psychiatry, social work, or nursing (that are not of limited duration or experimental nature) under section 303 of the Public Health Service Act.
This part applies to any institution which receives a training grant under section 303 of the Public Health Service Act and to any individual who receives a stipend or other trainee allowances under such a grant for any period beginning on or after July 1, 1981, for clincial training in the field of psychology, psychiatry, nursing, or social work, except for training that is of a limited duration or experimental nature.
As used in this part:
Recipients of training grants under section 303 of the Act that provide a clinical traineeship to any individual must:
(a) Give each such individual written notice of the service payback and recovery requirements of this part at the time the individual becomes a candidate for the traineeship;
(b) Before awarding a clinical traineeship, conduct an entrance interview with the individual in order to explain and emphasize the service obligation the individual is incurring, obtain the individual's written assurance that he or she will satisfy the requirements of § 64a.105, and document, in accordance with paragraph (d) of this section, the entrance interview on the form containing the individual's written assurance.
(c) At the time of termination of the clinical traineeship,
(1) Notify the Secretary in writing of the date on which the individual's traineeship is terminated;
(2) Conduct an exit interview with the individual to remind the trainee of the service obligation, to fully explain the consequences that will incur should the trainee fail to satisfy the obligation, and, to tell the individual that the Secretary has been notified of the date of termination of the traineeship; and
(3) Document, in accordance with paragraph (d) of this section, the exit interview on the form notifying the Secretary of the termination of the traineeship.
(d) Document the entrance and exit interviews with at least the following information: The date of the interview, the names of the participants involved in the interview, and a statement that the interview included an explanation to the individual of the service payback requirement and the consequences of failing to fulfill the service payback requirement.
In order to receive a clinical traineeship an individual must comply with the following conditions:
(a)
(b)
(2) Following termination of the traineeship, the individual must annually provide (in such form and manner as the Secretary prescribes) a written report describing those previous years' activities which are related to service that fulfills the payback obligation. The Secretary will review this report and credit all service performed in those categories specified in paragraph (d) of this section toward the individual's payback obligation, except any service which is performed:
(i) Before termination of the individual's clinical traineeship; and
(ii) As part of any activity, such as course work, preparation of a dissertation or thesis, or practicum, which is needed to complete the training for which the individual received the traineeship.
(c)
(d)
(2)
(i) A public inpatient mental institution;
(ii) Any entity which is receiving or has received a grant under the Mental Health Systems Act or the Community Mental Health Centers Act;
(iii) A psychiatric manpower shortage area designated by the Secretary under section 332 of the Public Health Service Act and 42 CFR part 5;
(iv) Any public or private nonprofit entity or in any nursing home (whether public, private nonprofit, or for profit) in which 50 percent or more of those served are within one or more of the following groups: Racial or ethnic minorities (American Indian or Alaskan Native, Asian or Pacific Islander, Black, Hispanic), chronically mentally ill, mentally retarded, criminal or delinquent populations, rape victims, physically handicapped, abusers of alcohol, or persons addicted to drugs or other substances, children and adolescents, the elderly, poverty populations, migrants, members of the armed forces (or veterans if seen in a Federal facility), residents of areas other than those defined as urbanized by the Department of Commerce, or any other special populations, such as groups of refugees or disaster victims, which are specifically designated by the Secretary for this purpose.
(3)
(i) Serving in any public or private nonprofit entity or in any nursing home (whether public, private nonprofit, or for profit) in which not less than 25 percent of those served are within one or more of the underserved population groups listed in paragraph (d)(2)(iv) of this section. The individual must demonstrate a service commitment of more than 50 percent of his or her time to the targeted populations.
(ii) Teaching, conducting research, or conducting evaluation directed at improving alcohol, drug abuse or mental health services to one or more of the priority population groups listed in paragraph (d)(2)(iv) of this section, or working in a position which fosters the closer collaboration of health and alcohol, drug abuse or mental health services.
(iii) Providing in a public or private nonprofit entity consultation, training and education, liaison, community support or other professional services for which the individual was trained when the individual's work is directed toward improving alcohol, drug abuse or mental health services to the priority populations listed in paragraph (d)(2)(iv) of this section.
(e)
(i) Extend the period for beginning the obligated service (24 months after termination of the clinical traineeship), permit breaks in the required continuous service or extend the period for repayment under paragraph (g)(2) of this section, if it is determined that:
(A) An extension or break in service is necessary for the completion of training;
(B) Performance of the obligation must be delayed because a temporary disability makes present performance impossible; or
(C) Performance of the obligation must be delayed because present performance would involve a substantial hardship and failure to extend the period would be against equity and good conscience.
(ii) Waive, in whole or in part, the service payback and recovery requirements of this section if it is determined that fulfillment would be impossible because the individual is permanently and totally disabled.
(iii) In making determinations under § 64a.105(e)(1)(i)(C), the Secretary will take into consideration the following factors:
(A) The individual's present financial resources and obligations;
(B) The individual's estimated future financial resources and obligations;
(C) The reasons for the individual's failure to complete the requirements within the prescribed period, such as problems of a personal nature;
(D) The unavailability of employment opportunities appropriate to the individual's education and training; and
(E) Any other extenuating circumstances.
(2) Upon receipt of written notice giving evidence of a conflicting obligation under section 752 or 753 of the Act or of an election to fulfill an obligation under section 472 of the Act prior to an obligation under this section, the Secretary will extend the period for beginning service (24 months after termination of the clinical traineeship), permit breaks in the required continuous service or extend the period for repayment under paragraph (g)(1), as appropriate.
(3) The service payback and recovery obligations of an individual will be cancelled upon the submission to the Secretary of a certificate of that individual's death or other evidence which the Secretary determines to be satisfactory.
(f)
(g)
(2) Unless the Secretary extends the repayment period as provided in paragraph (e) of this section, the individual shall pay to the United States the total amount which the United States is entitled to recover under paragraph (g)(1) of this section immediately upon the date that the individual fails to begin or complete the period of obligated service (including failing to comply with the applicable terms and conditions of an extension or break in service granted the individual) or upon the date that the individual indicates his or her intention not to fulfill the service obligation as determined by the Secretary. The amount is considered a debt owed to the United States, with interest accruing monthly upon the total debt as provided under paragraph (g)(1) of this section.
42 U.S.C. 9660a; 49 U.S.C. App. 1816.
(a) The regulations in this part apply to:
(1) The program of grants for the training and education of workers who are or are likely to be engaged in activities related to hazardous waste removal or containment, or emergency response that is authorized under section 126(g) of the SARA; and
(2) The program of grants to support qualified non-profit organizations for the purpose of providing training and education to hazardous materials employees regarding: the safe unloading, loading, handling, storage, and transportation of hazardous materials; and, emergency preparedness for responding to accidents or incidents involving the transportation of hazardous materials that is authorized under section 118 of the HMTA.
(b) Grants are available for curriculum and training materials development, technical support of training, direct student training, training program evaluation and related activities. Target populations for this training are workers and supervisors who are or are likely to be engaged in hazardous substance removal or other activities which expose or potentially expose these workers to hazardous substances in activities such as:
(1) Waste handling and processing at waste generators and active and inactive hazardous substance treatment, storage, and disposal facilities;
(2) Clean up, removal, containment, or remedial actions at waste sites;
(3) Hazardous substance emergency response;
(4) Hazardous substance disposal site risk assessment and investigation, clean up, or remedial actions; and
(5) Transportation of hazardous wastes.
Target populations may also be regulated under standards promulgated by the Secretary of Labor, the Secretary of Transportation, the Administrator of the Environmental Protection Agency, and other agencies under section 126(g) of the SARA or section 106(b) of the HMTA.
(c) Two types of grants are available: Program grants covering the full range of activities, including program development, direct worker training and education, and program evaluation; and planning grants under the SARA.
(1) Planning grants are intended to assist organizations which demonstrate potential for providing hazardous worker training, but need additional developmental efforts prior to initiation of full curriculum development and training activities. A limited number of one-year planning grants may be funded at a level determined appropriate by the Director. After successful completion of a one-year planning grant, a recipient may apply for a full program grant on a competitive basis.
(2) Full program grants will be awarded to organizations with demonstrated capability to provide worker health and safety training and education and demonstrated ability to identify, describe, and access target populations. Full program grantees must be able to immediately initiate curriculum development and worker training activities.
As used in this part:
Public and private nonprofit entities providing worker health and safety education and training may apply for grants under these regulations. Applicants for a grant may use services, as appropriate, of other public or private organizations necessary to develop, administer, or evaluate proposed worker training programs so long as the majority of the work is done by the applicant.
In addition to meeting the requirements specified in the application, the instructions accompanying it, and the regulations referred to in § 65.8, each applicant must meet the following requirements:
(a) Two or more nonprofit organizations may join in a single application and share grant resources in order to maximize worker group coverage, enhance the effectiveness of training, and bring together appropriate academic disciplines and talents. Joint applications must describe the cooperative arrangements for program integration and effectiveness. Specific expertise, facilities, or services to be provided by
(b) Each applicant must detail the nature, duration, and purpose of the training for which the application is filed. The proposed training program must meet the standards promulgated by the Secretary of Labor and Secretary of Transportation under section 126(g) of the SARA or section 106(b) of the HMTA, and such additional requirements as the Director may prescribe to ensure appropriate health and safety training.
(c) The applicant must provide assurance that the applicant will not discriminate in the selection of trainees or instructors on the basis of membership or nonmembership in a union.
(a) The Director shall evaluate applications through the officers and employees, and experts and consultants engaged by the Director for that purpose. The Director's first level of evaluation will be for technical merit and shall take into account, among other pertinent factors, the significance of the project, the qualifications and competency of the project director and proposed staff (including the ability to manage complex training programs), the adequacy of selection criteria for trainees for the project, the adequacy of the detailed training plan including provision for hands-on training, the adequacy of the applicant's resources available for the project, the amount of grant funds necessary for completion of its objectives, and how well the projects meet training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulation (29 CFR 1910.120) and/or how well they cover the target populations listed in § 65.1(b). A second level of review will be conducted for program relevance.
(b) Within the limits of funds available, the Director may award training grants to carry out those projects which have satisfied the requirements of the regulations of this part; are determined by the Director to be technically meritorious; and in the judgment of the Director best promote the purposes of the grant programs authorized by section 126(g) of the SARA or section 118 of the HMTA, the regulations of this part, and program priorities.
(a) The notice of grant award specifies how long NIEHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 1-5 years.
(b) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices and the availability of funds. In all cases, continuation awards require a determination by the NIEHS that continued funding is in the best interest of the Federal Government.
(c) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
Individuals receiving training shall be entitled only to the stipends and allowances included in a budget approved by the Director, taking into account the cost of living and such other factors as the needs of the program and the availability of funds.
Several other regulations and policies apply to grants under this part. These include, but are not limited to:
The Director may with respect to any award impose additional conditions prior to, or at the time of, any award when, in the Director's judgment, such conditions are necessary to assure the carrying out of the purposes of the award, the interest of the public health, or the conservation of funds awarded.
42 U.S.C. 216, 9660(a).
(a) The regulations of this part apply to the award of grants to support programs for basic research and training directed towards understanding, assessing, and attenuating the adverse effects on human health resulting from exposure to hazardous substances, as authorized under section 311(a) of the Act (42 U.S.C. 9660(a)). The purpose of these programs is to carry out coordinated, multi-component, interdisciplinary research consisting of at least three or more biomedical research projects relating to hazardous substances and at least one non-biomedical research project in the fields of ecology, hydrogeology, and/or engineering, and including the training of investigators as part of the grantee's overall program.
(b) The regulations of this part also apply to cooperative agreements awarded to support the programs described in paragraph (a) of this section. References to “grant(s)” shall include “cooperative agreement(s).”
(c) The regulations of this part do not apply to:
(1) Research training support under the National Research Service Awards Program (see part 66 of this chapter),
(2) Research, demonstration, and training support under the NIH Center Grants programs (see part 52a of this chapter),
(3) Research training support under traineeship programs (see parts 63 and 64a of this chapter), or
(4) Research training support under the NIH AIDS Research Loan Repayment Program authorized under section 487A of the Public Health Service Act, as amended (42 U.S.C. 288-1).
As used in this part:
This brochure is subject to change, and interested persons should contact the U.S. Department of Education Office of Post-Secondary Education, Accreditation and State Liaison Division, ROB 3, 7th and D Streets, S.W., Room 37-15, Washington, DC 20202-5244 (202-708-7417; not a toll-free number) to obtain a current version of the brochure and any amendments.]
(a) Except as otherwise prohibited by law, any public or private nonprofit institution of higher education may apply for an award under this part.
(b) Awardee institutions may carry out portions of the research or training components of an award through contracts with appropriate organizations, including:
(1) Generators of hazardous wastes;
(2) Persons involved in the detection, assessment, evaluation, and treatment of hazardous substances;
(3) Owners and operators of facilities at which hazardous substances are located; and
(4) State and local governments.
The applicant shall include the following in its proposed program for which support is requested under this part:
(a)
(1) Methods and technologies to detect hazardous substances in the environment;
(2) Advanced techniques for the detection, assessment, and evaluation of the effects of these substances on human health;
(3) Methods to assess the risks to human health presented by these substances; and
(4) Basic biological, chemical, and/or physical methods to reduce the amount and toxicity of these substances.
(b)
(1) Graduate training in environmental and occupational health and safety and in public health and engineering aspects of hazardous waste control; and/or
(2) Graduate training in the geosciences, including hydrogeology, geological engineering, geophysics, geochemistry, and related fields, necessary to meet professional personnel needs in the public and private sectors and to carry out the purposes of the Act; and
(3) Worker training relating to handling hazardous substances, which includes short courses and continuing education for state and local health and environmental agency personnel and other personnel engaged in the handling of hazardous substances, in the management of facilities at which hazardous substances are located, and in the evaluation of the hazards to human health presented by these facilities.
Each institution desiring a grant under this part must submit an application at the time and in the form and manner as the Secretary may require.
The Director shall evaluate applications through the officers and employees, experts, consultants, or groups engaged by the Director for that purpose, including review by the National Advisory Environmental Health Sciences Council in accordance with peer review requirements set forth in part 52h of this chapter. The Director's first level of evaluation will be for technical merit and shall take into account, among other pertinent factors, the significance of the program, the qualifications and competency of the program director and proposed staff, the adequacy of the applicant's resources available for the program, and the amount of grant funds necessary for completion of its objectives. A second
(a) Are determined by the Director to be meritorious; and
(b) In the judgment of the Director, best promote the purposes of the grant program, as authorized under section 311(a) of the Act and the regulations of this part, and best address program priorities.
(a) The notice of grant award specifies how long NIEHS intends to support the project without requiring the grantee to recompete for funds. This period, called the project period, may be for 1-5 years.
(b) Generally, the grant will initially be for one year, and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application at the time and in the form and manner as the Secretary may require to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Director that continued funding is in the best interest of the Federal Government.
(c) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation or other award with respect to any approved application or portion of an approved application.
(d) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward to the next budget period, for use as prescribed by the Director, provided a continuation award is made. If at any time during a budget period it becomes apparent to the Director that the amount of Federal funds awarded and available to the grantee for that period, including any unobligated balance carried forward from prior periods, exceeds the grantee's needs for that period, the Director may adjust the amounts awarded by withdrawing the excess.
In addition to being subject to other applicable regulations (see § 65a.11), grants awarded under this part are subject to the following terms and conditions:
(a)
(b)
A grantee shall spend funds it receives under this part solely in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed in 45 CFR 74.27.
Several other HHS regulations and policies apply to awards under this part. These include but are not necessarily limited to:
This policy is subject to change, and interested persons should contact the Office of Research on Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-0161 (301-402-1770; not a toll-free number) to obtain references to the current version and any amendments.]
This policy is subject to change, and interested persons should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (301-496-9838; not a toll-free number) to obtain references to the current version and any amendments.]
“PHS Grants Policy Statement,” DHHS Publication No. (OASH) 94-50,000 (Revised April 1, 1994), as amended by Addendum, dated January 24, 1995.
This policy is subject to change, and interested persons should contact the Extramural Outreach and Information Resources Office (EOIRO), Office of Extramural Research, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20892-7910 (301-435-0714; not a toll-free number) to obtain references to the current version and any amendments. Information may also be obtained by contacting the EOIRO via its e-mail address (asknih@odrockm1.od.nih.gov) and by browsing the NIH Home Page site on the World Wide Web (http://www.nih.gov).]
“Public Health service Policy on Humane Care and Use of Laboratory animals,” Office for Protection from Research Risks, HIH (Revised September 1986).
This policy is subject to change, and interested persons should contact the Office for Protection for Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-496-7005; not a toll-free number) to obtain references to the current version and any amendments.]
42 U.S.C. 216, 288.
The regulations in this subpart apply to National Research Service Awards made by the Secretary to individuals for research and training to undertake research, under section 487 of the Public Health Service Act, as amended (42 U.S.C. 288).
As used in this subpart:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
To be eligible for a National Research Service Award an individual must:
(a) Be a citizen, noncitizen national of the United States, or lawfully admitted to the United States for permanent residence at the time of the award.
(b) Propose to engage in such research, or training to undertake research, in a program specified in section 487(a)(1)(A) of the Act; and
(c) Propose to engage in such research or training to undertake research on a full-time basis except in cases of disability or pressing family need.
(a) Eligible individuals may apply for an Award using the form and by the dates the Secretary prescribes.
(b) In addition to any other pertinent information that the Secretary may require, each application shall detail:
(1) The applicant's educational background and other qualifications and experience, including previous academic and professional degrees;
(2) The subject area of the proposed research or training;
(3) The proposed period of Award:
(4) If the proposed period of Award would provide the individual with aggregate support in excess of five years at the predoctoral level or three years at the postdoctoral level, the justification for this request; and
(5) The availability of necessary resources and facilities at the institution
The Secretary shall make an Award to an individual under this subpart only if:
(a) For any Award made for an individual's initial twelve months of NRSA postdoctoral research or training, the individual has assured the Secretary, in the form and manner the Secretary may prescribe, that he or she will satisfy the requirements of § 66.110.
(b) If the proposed research or training would take place at an institution other than the National Institutes of Health, the institution has assured the Secretary, in the form and manner the Secretary may prescribe, that:
(1) The applicant has been accepted to the institution for the purpose of engaging in the research or training for which an Award is being sought;
(2) The Award will not be used to support a residency; and
(3) In the event an Award is made the institution will make available to the applicant any resources and facilities described in the application as necessary to carry out the research or training; and
(c) The individual has assured the Secretary, in the form and manner the Secretary may prescribe, that the Award to the individual will not be used to support a residency.
(a) Within the limits of funds available, the Secretary shall make Awards to those applicants:
(1) Who have satisfied the requirements of § 66.105; and
(2) Whose proposed research or training would, in the judgment of the Secretary, best promote the purposes of section 487(a)(1)(A) of the Act, taking into consideration among other pertinent factors:
(i) The scientific, technical, or educational merit of the particular proposal;
(ii) The availability of resources and facilities to carry it out;
(iii) The qualifications and experience of the applicant; and
(iv) The need for personnel in the subject area of the proposed research or training.
(b) In making Awards, the Secretary shall take account of the Nation's overall need for biomedical research by giving special consideration to physicians who agree to undertake a minimum of two years of biomedical research.
(c) All Awards shall be in writing. Each shall specify:
(1) The period of the Award;
(2) The total recommended stipends and allowances provided for the entire Award period;
(3) The amount awarded for the intitial year of that period (see § 66.107); and
(4) The amount of the payments to the institution for the cost of services provided the awardee by the institution during the initial year of that period (see § 66.108).
(d) Neither the approval of any application nor any Award shall commit or obligate the United States in any way to make additional, supplemental, continuation, or other Award with respect to any approved application or portion thereof.
(e) No individual may receive an aggregate of more than five years of support at the predoctoral level and three years at the postdoctoral level unless the Secretary waives, for good cause shown, this limitation for the individual. In determining what constitutes “good cause,” the Secretary shall take into account such factors as whether the applicant proposes to pursue a combined program leading to the degrees of doctor of medicine and doctor of philosophy.
(a) Individuals receiving Awards shall be entitled to the stipends, tuition, fees, and allowances the Secretary may designate, taking into account the cost
(b) The Secretary shall pay stipends, tuition, fees and allowances to the awardee or the sponsoring institution for payment to the awardee.
The institution shall be entitled to an allowance to help defray the cost of support services (including the cost of faculty salaries, supplies, equipment, general research support, and related items) provided to the individual by the institution. The Secretary shall determine the amount of payments based upon reasonable costs to the institution of establishing and maintaining the quality of research and training programs for which it receives support under this subpart. The Secretary may make payments to the institution either in advance or by way of reimbursement.
(a) The Secretary may terminate an Award prior to its normal expiration date:
(1) At the written request of the awardee; or
(2) If the Secretary finds that the awardee has materially failed to comply with the terms and conditions of the Award or to carry out the purpose for which it was made.
(b) In the event an Award is terminated, the Secretary shall notify the awardee in writing of this determination, the reasons for termination, the effective date, and any procedural rights available.
(a) Each individual who receives an Award for postdoctoral research or training shall engage in a month of research training, research, or teaching that is health-related (or any combination thereof) for each month of support received, up to a maximum of twelve months. Such period shall be served in accordance with the usual patterns of such employment or training.
(b) In any case in which an individual receives an Award for more than twelve months, the thirteenth month and each subsequent month of performing activities under the Award shall be considered to be activities toward satisfaction of the requirement established in paragraph (a) of this section.
(c) Except as provided in § 66.111, an individual subject to the requirements for service in paragraph (a) of this section must begin to undertake the service on a continuous basis within two years after the expiration or termination for his or her Award.
(d) If the individual fails to undertake or perform the service in accordance with the requirements of this section, the United States shall be entitled to recover from the individual an amount determined in accordance with the formula:
(e) Except as provided in § 66.111, the individual shall pay to the United States any amount which it is entitled to recover under paragraph (d) of this section within a three-year period beginning on the date the United States becomes entitled to recovery that amount. Interest shall accrue to the United States until any amount due it under paragraph (d) of the section is paid. The rate of interest will be fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date the United States becomes entitled to recovery.
(a) The Secretary may extend the period for undertaking service described in § 66.110(c), permit breaks in the continuous service required under
(1) An extension or break in service is necessary so the individual may complete his or her research training;
(2) Completion during the period would be impossible because the individual is temporarily disabled; or
(3) Completion during the period would involve a substantial hardship to the individual and failure to extend to the period would be against equity and good conscience.
(b) The Secretary may waive, in whole or in part, the obligation of the individual to repay pursuant to § 66.110(d) if the Secretary determines that:
(1) Fulfillment would be impossible because the individual is permanently and totally disabled; or
(2) Fulfillment would involve a substantial hardship to the individual and enforcement of the obligation would be against equity and good conscience.
(c) In making determinations under § 66.111 (a)(3) and (b)(2), the Secretary will take into consideration such factors as:
(1) The individual's present financial resources and obligations;
(2) The individual's estimated future financial resources and obligations;
(3) The reasons for the individual's failure to complete the requirements within the prescribed period, such as problems of a personal nature;
(4) The extent to which the individual has been engaged in activities encompassed by § 66.110(a) and (b);
(5) Whether the individual has received sufficient training to be qualified to perform any such activities;
(6) The unavailability of employment opportunities appropriate to the individual's education and training; and
(7) Any other extenuating circumstances.
(d) Any obligations of any individual under this subpart will be cancelled upon the death of that individual.
Several other regulations and policies may apply to individuals and institutions receiving payments under this subpart. These include, but are not limited to:
This policy is subject to change, and interested persons should contact the Office of Science Policy, Office of Biotechnology Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to obtain references to the current version and any amendments.
Publication, distribution, and disposition of all manuscripts and other materials resulting from an Award shall be subject to the conditions that all such materials shall bear appropriate acknowledgement of Department of Health and Human Services support and that the awardee shall furnish copies of these manuscripts or other materials as the Secretary may reasonably request.
Where the work accomplished under an Award results in a book or other copyrightable material, the author is
The Secretary may with respect to any Award or class of Awards impose additional conditions prior to or at the time of any Award when in the Secretary's judgment such conditions are necessary to assure the carrying out of the purposes of the Award, the interests of the public health, or the conservation of funds awarded.
The regulations in this subpart apply to grants under section 487 of the Public Health Service Act, as amended (42 U.S.C. 288), to public institutions and to nonprofit private institutions to enable those institutions to make National Research Service Awards to individuals for research and training to undertake research, in programs specified in section 487 of the Act.
The definitions in § 66.102 of subpart A of this part apply to this subpart.
To be eligible for a grant under this subpart, an applicant must be:
(a) A public or nonprofit private institution; and
(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust Territory of the Pacific Islands.
(a) Application for a grant under this subpart shall be made on a form approved for that purpose by the Secretary. Applicants shall submit completed forms on or before the dates the Secretary may prescribe.
(b) In addition to any other pertinent information that the Secretary may require, each application shall set forth in detail:
(1) The subject area or areas in which the proposed research or training will be conducted;
(2) The resources and facilities available for use by recipients of Awards in carrying out this research or training;
(3) The names, qualifications, and experience of the program director and principal staff members who will be responsible for the proposed program;
(4) The criteria to be employed in selecting recipients of Awards;
(5) The estimated number of recipients of Awards under the grant;
(6) The proposed project period and a detailed budget and justification for the amount of grant funds requested; and
(7) Proposed methods for monitoring and evaluating the performance of individual recipients of Awards, as well as the overall program.
(a) No Award shall be made to an individual from a grant under this subpart unless:
(1) For any award made for an individual's initial twelve months of NRSA postdoctoral research training, the individual has assured the Secretary, in the form and manner the Secretary may prescribe, that he or she will satisfy the requirements of § 66.110 of subpart A of this part;
(2) The individual is a citizen or noncitizen national of the United States or has been lawfully admitted to the United States for permanent residence at the time of the award;
(3) The Award includes a provision for termination in the event the recipient is found by the institution to have materially failed to comply with the terms and conditions of the Award or to carry out the purpose for which it was made; and
(4) The Award is not to be used to support a residency.
(b) No Award shall be made to an individual under such grant which would provide that individual with aggregate support in excess of five years for
(c) The provisions of §§ 66.110 and 66.111 of subpart A of this part constitute terms and conditions of any Award made from a grant under this subpart.
(a) Within the limits of funds available, the Secretary shall award grants to those applicants:
(1) Whose applications have been reviewed and recommended for approval by the appropriate national advisory council or board;
(2) Who have satisfied the requirements of § 66.105; and
(3) Whose proposed programs would, in the judgment of the Secretary, best promote the purposes of section 487(a)(1)(B) of the Act, taking into consideration among other pertinent factors:
(i) The scientific, technical, or educational merit of the proposed program;
(ii) The adequacy of the resources and facilities available to the applicant;
(iii) The qualifications and experience of the program director and principal staff members;
(iv) The degree of the need for personnel in the subject area or areas of the proposed research or training;
(v) The extent to which the applicant, in making Awards, gives special consideration to physicians who agree to undertake a minimum of two years of biomedical research;
(vi) The administrative and management capability of the applicant;
(vii) The reasonableness of the proposed budget in relation to the proposed program; and
(viii) The adequacy of the methods for monitoring and evaluating the performance of individual recipients and the overall program.
(b) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3-5 years.
(c) Generally the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of any approved application.
Several other regulations and policies apply to grants under this subpart. These include, but are not limited to:
This policy is subject to change, and interested persons should contact the Office of Biotechnology Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to obtain references to the current version and any amendments.
At 66 FR 20752, May 31, 2001, in § 66.207, the entry for 48 FR 24556 was revised. However, no new entry was set forth.
The Secretary may, with respect to any grant award, impose additional conditions prior to or at the time of any award when in the Secretary's judgment those conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.
Pub. L. 103-43, 107 Stat. 214-215, Pub. L. 102-410, 106 Stat. 2094-2101 and sec. 6103, Pub. L. 101-239, 103 Stat. 2189-2208, Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6); and sec. 1142, Social Security Act (42 U.S.C. 1320b-12).
The regulations of this subpart apply to the award by AHCPR of grants and cooperative agreements under:
(a) Title IX of the Public Health Service Act to support research, evaluation, demonstration, and dissemination projects, including conferences, on health care services and systems for the delivery of such services, as well as to establish and operate multidisciplinary health services research centers.
(b) Section 1142 of the Social Security Act to support research on the outcomes, effectiveness, and appropriateness of health care services and procedures, including but not limited to, evaluations of alternative services and procedures; projects to improve methods and data bases for outcomes, effectiveness, and other research; dissemination of research information and clinical guidelines, conferences, and research on dissemination methods.
As used in this subpart—
Any public or nonprofit private entity or any individual is eligible to apply for a grant under this subpart.
Projects for research, evaluations, demonstrations, dissemination of information (including research on dissemination), and conferences, related to health care services and the delivery of such services, are eligible for grant support. These include, but are not limited to, projects in the following categories:
(a) Effectiveness, efficiency, and quality of health care services;
(b) Outcomes of health care services and procedures;
(c) Clinical practice, including primary care and practice-oriented research;
(d) Health care technologies, facilities, and equipment, including assessments of health care technologies and innovative approaches to such assessments, and technology diffusion;
(e) Health care costs and financing, productivity, and market forces;
(f) Health promotion and disease prevention;
(g) Health statistics and epidemiology;
(h) Medical liability;
(i) AID/HIV infection, particularly with respect to issues of access and delivery of health care services;
(j) Rural health services;
(k) The health of low-income, minority, elderly, and other underserved populations, including women and children; and
(l) Information dissemination and research on dissemination methodologies, directed to health care providers, practitioners, consumers, educators, review organizations, and others.
(a) To apply for a grant, an entity or individual must submit an application in the form and at the time that the
(b) In addition to information requested on the application form, the applicant must provide such other information as the Administrator may request.
(a)
(2) Members of the peer review group will be selected based upon their training and experience in relevant scientific and technical fields, taking into account, among other factors:
(i) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) completed by the individual and/or the individual's pertinent experience and expertise;
(ii) The extent to which the individual has engaged in relevant research, the capacities (e.g., principal investigator, assistant) in which the individual has done so, and the quality of such research;
(iii) The extent of the professional recognition received by the individual as reflected by awards and other honors received from scientific and professional organizations outside the Department of Health and Human Services;
(iv) The need of the peer review group to include within its membership experts representing various areas of specialization within relevant scientific and technical fields, or specific health care issues; and
(v) Appropriate representation based on gender, racial/ethnic origin, and geography.
(3) Review by the peer review group under paragraph (a) of this section is conducted by using the criteria set out in paragraph (c) of this section.
(4) The peer review group to which an application has been submitted under paragraph (a) of this section shall make a written report to the Administrator on each application, which shall contain the following parts:
(i) The first part of the report shall consist of a factual summary of the proposed project, including a description of its purpose, scientific approach, location, and total budget.
(ii) The second part of the report shall address the scientific and technical merit of the proposed project with a critique of the proposed project with regard to the factors described in paragraphs (c)(1)(i) through (c)(1)(x) or (c)(2)(i) through (c)(2)(vii) of this section as applicable. This portion of the report shall include a set of recommendations to the Administrator with respect to the disposition of the application based upon its scientific and technical merit. The peer review panel may recommend to the Administrator that an application:
(A) Be given consideration for funding,
(B) Be deferred for a later decision, pending receipt of additional information, or
(C) Not be given further consideration.
(iii) For each application recommended for further consideration by the Administrator, the report shall also provide a priority score based on the scientific and technical merit of the proposed project, and make recommendations on the appropriate project period and level of support. The report may also address, as applicable, the degree to which the proposed project relates to AHCPR-announced priorities.
(b)
(2) Non-Federal and Federal experts will be selected by the Administrator for the review of small grant applications on the basis of their training and experience in particular scientific and technical fields, their knowledge of health services research and the application of research findings, and their special knowledge of the issue(s) being addressed or methods and technology being used in the specific proposal.
(3) Review of applications for small grants may be by a review group established in accordance with paragraph (a) of this section, or by individual field readers, or by an ad hoc group of reviewers.
(4) The review criteria set forth in paragraph (c) of this section shall be used for the review of small grant applications.
(5) Each reviewer or group of reviewers to whom an application has been submitted under paragraph (b) of this section shall make a written report to the Administrator on each application. Each report shall summarize the findings of the review and provide a recommendation to the Administrator on whether the application should be given further consideration. For applications recommended for further consideration, the report may also address, as applicable, the degree to which the proposed project relates to AHCPR-announced priorities.
(c)
(1)
(i) The significance and originality from a scientific or technical standpoint of the goals of the project;
(ii) The adequacy of the methodology proposed to carry out the project;
(iii) The availability of data or the adequacy of the proposed plan to collect data required in the analyses;
(iv) The adequacy and appropriateness of the plan for organizing and carrying out the project;
(v) The qualifications and experience of the principal investigator and proposed staff;
(vi) The reasonableness of the budget and the time frame for the project, in relation to the work proposed;
(vii) The adequacy of the facilities and resources available to the grantee;
(viii) The extent to which women and minorities are adequately represented in study populations;
(ix) Where an application involves activities which could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects; and
(x) Any additional criteria that may be announced by the Administrator from time to time for specific categories of grant applications (e.g., proposed projects for support of research centers) eligible for support under this subpart.
(xi) In addition to the scientific and technical criteria above, peer reviewers may be asked to consider the degree to which a proposed project addresses any special AHCPR priorities that have been announced by the Administrator, as applicable.
(2)
(i) The significance of the proposed conference, specifically the importance of the issue or problem being addressed, including methodological or technical issues for dealing with the development, conduct, or use of health services research;
(ii) The qualifications of the staff involved in planning and managing the conference;
(iii) The adequacy of the facilities and other resources available for the conference;
(iv) the appropriateness of the proposed budget, including other sources of funding;
(v) The extent to which the health concerns of women and minorities will be addressed in the conference topic(s), as appropriate;
(vi) The plan for evaluating and disseminating the results of the conference; and
(vii) Any additional criteria that may be announced by the Administrator.
(viii) In addition to the scientific and technical criteria above, peer reviewers may be asked to consider the degree to which a proposed project addresses any special AHCPR priorities that have been announced by the Administrator, as appropriate.
(d)
(2) In addition to any restrictions referenced under paragraph (d)(1) of this section:
(i) No member of a peer review group (or individual reviewer) may participate in or be present during any review by such group of a grant application in which, to the member's knowledge, any of the following has a financial interest:
(A) The member or his or her spouse, minor child, or partner;
(B) Any organization in which the member is serving as an officer, director, trustee, general partner, or employee; or
(C) Any organization with which the member is negotiating or has any arrangement concerning prospective employment or other similar association, and further;
(ii) In the event that any member of a peer review group or his or her spouse, parent, child, or partner is currently or expected to be the principal investigator or member of the staff responsible for carrying out any research or development activities contemplated as part of a grant application, that member of the group, or the group, may be disqualified from the review and the review conducted by another group with the expertise to do so. An ad hoc group selected in accordance with § 67.15(a), or § 67.15(b) as applicable, may also be used for the review. Any individual reviewer to whom the conditions of this paragraph apply would also be disqualified as a reviewer.
(iii) No member of a peer review group or individual may participate in any review under this subpart of a specific grant application for which the member has had or is expected to have any other responsibility or involvement (whether preaward or postaward) as an officer or employee of the United States.
(3) Where permissible under the standards and order(s) cited in paragraph (d)(1) of this section, the Administrator may waive the requirements in paragraph (d)(2) of this section if it is determined that there is no other practical means for securing appropriate expert advice on a particular grant application.
(a)
(1) The degree to which the purposes of Title IX of the PHS Act and section 1142 of the Social Security Act, as applicable, are being addressed;
(2) Recommendations made by reviewers pursuant to § 67.15;
(3) Any recommendations made by the National Advisory Council for Health Care Policy, Research, and Evaluation, as applicable;
(4) The appropriateness of the budget;
(5) The extent to which the research proposal and the fiscal plan provide assurance that effective use will be made of grant funds;
(6) The demonstrated business management capability of the applicant;
(7) The demonstrated competence and skill of the staff, especially the senior personnel, in light of the scope of the project;
(8) The probable usefulness of the results of the project for dealing with national health care issues, policies, and programs; and
(9) The degree to which AHCPR-announced priorities or purposes are being addressed.
(b)
(a) Within the limits of available funds, the Administrator may award grants to those applicants whose projects are being considered for funding, which in the judgment of the Administrator, will promote best the purposes of Title IX of the PHS Act and (if applicable) section 1142 of the Social Security Act, AHCPR priorities, and the regulations of this subpart.
(b) The Notice of Grant Award specifies how long the Administrator intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3-5 years, except for small grants, which usually are 1 year awards. The project period as specified in the Notice of Grant Award shall begin no later than 9 months following the date of the award, except that the project period must begin in the same fiscal year as that from which funds are being awarded.
(c) Upon request from the grantee, Department grants policy permits an extension of the project period for up to 12 months, without additional funds, when more time is needed to complete the research. The Administrator may approve a request for an additional extension of time based on unusual circumstances with written justification submitted by the grantee, prior to the completion of the project period. In no case will an additional extension of more than 12 months be approved.
(d) Generally, a grant award will be for 1 year, and subsequent continuation awards will be for 1 year at a time. A grantee must submit a separate continuation application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices and the availability of funds. In all cases, continuation awards require a determination by the Administrator that continuation is in the best interest of the Federal Government.
(e) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application.
(f)
(g)
(2) In the case of small grants, as defined in section 922(d)(2) of the PHS Act, the Administrator will not approve a supplemental award during the project period (excluding any supplemental award for preparation of data in suitable form for transmittal in accordance with § 67.21) that will, in the aggregate, exceed 10 percent of the
(h)
(1) The progress of the project in meeting project objectives;
(2) The appropriateness of the management of the project and allocation of resources within the project;
(3) The adequacy and appropriateness of the plan for carrying out the project during the budget period in light of the accomplishments during previous budget periods; and
(4) The reasonableness of the proposed budget for the subsequent budget period.
Grant funds must be spent solely for carrying out the approved project in accordance with Title IX of PHS Act, section 1142 of the Social Security Act (if applicable), the regulations of this subpart, the terms and conditions of the award, and the provisions of 45 CFR part 74, or part 92 for State and local government grantees.
Several other regulations apply to grants under this subpart. These include, but are not limited to:
The confidentiality of identifying information obtained in the course of conducting or supporting grant and cooperative agreement activities under this subpart is protected by section 903(c) of the PHS Act. Specifically:
(a) No information obtained in the course of conducting or supporting grant and cooperative agreement activities under this subpart, if the entity or individual supplying the information or described in it is identifiable, may be used for any purpose other than the purpose for which it was supplied, unless the identifiable entity or individual supplying the information or described in it has consented to such other use, in the recorded form and manner as the Administrator may require; and
(b) No information obtained in the course of grant and cooperative agreement activities conducted or supported under this subpart maybe published or released in other form if the individual who supplied the information or who is described in it is identifiable, unless such individual has consented, in the recorded form and manner as the Administrator may require, to such publication or release.
Except as otherwise provided in the terms and conditions of the award and subject to the confidentiality requirements of section 903(c) of the PHS Act, section 1142(d) of the Social Security Act, and § 67.20 of this subpart:
(a) All data collected or assembled for the purpose of carrying out health services research, evaluation, demonstration, or dissemination projects supported under this subpart shall be made available to the Administrator, upon request:
(b) All publications, reports, papers, statistics, or other materials developed from work supported, in whole or in part, by an award made under this subpart must be submitted to the Administrator in a timely manner. All such publications must include an acknowledgement that such materials are the results of, or describe, a grant activity supported by AHCPR;
(c) The AHCPR retains a royalty-free, non-exclusive, and irrevocable license to reproduce, publish, use, or disseminate any copyrightable material developed in the course of or under a grant for any purpose consistent with AHCPR's statutory responsibilities, and to authorize others to do so for the accomplishment of AHCPR purposes; and
(d) Except for identifying information protected by section 903(c) of the PHS Act, the Administrator, as appropriate, will make information obtained with AHCPR grant support available, and arrange for dissemination of such information and material on as broad a basis as practicable and in such form as to make them as useful as possible to a variety of audiences, including health care providers, practitioners, consumers, educators, and policymakers.
The Administrator may, with respect to any grant awarded under this subpart, impose additional conditions prior to or at the time of any award when in the Administrator's judgment such conditions are necessary to assure or protect advancement of the approved project, the interest of the public health, or the conservation of grant funds.
(a) The regulations of this subpart apply to the peer review of contracts under:
(1) Title IX of the Public Health Service Act to support research, evaluation, demonstration, and dissemination projects, including conferences, on health care services and systems for the delivery of such services; and development of clinical practice guidelines, quality standards, performance measures, and review criteria.
(2) Section 1142 of the Social Security Act to support research on the outcomes, effectiveness, and appropriateness of health care services and procedures, including, but not limited to, evaluations of alternative services and procedures; projects to improve methods and data bases for outcomes and effectiveness research; dissemination of research information and clinical practice guidelines, as well as quality standards, performance measures, and review criteria; conferences; and research on dissemination methods.
(b) The regulations of this subpart also contain provisions respecting confidentiality of research data, control of data, and availability of information.
(a) All contract proposals for AHCPR support will be submitted by the Administrator for review to a peer review group, as required in section 922(a) of the PHS Act. Proposals will be reviewed in accordance with the Federal Acquisition Regulations and the Health and Human Services Acquisition Regulations (48 CFR Ch. I and III) and the requirements of the pertinent Request for Proposal.
(b)
(c)
(1) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) completed by the individual and/or, as appropriate, the individual's pertinent experience and expertise;
(2) The extent to which the individual has engaged in relevant research, the capacities (e.g., principal investigator, assistant) in which the individual has done so, and the quality of such research;
(3) The extent of the professional recognition received by the individual as reflected by awards and other honors received from scientific and professional organizations outside the Department of Health and Human Services;
(4) The need of the peer review group to include in its membership experts representing various areas of specialization in relevant scientific and technical fields, or specific health care issues; and
(5) Appropriate representation based on gender, racial/ethnic origin, and geography, to the extent practicable.
(d)
(e)
(2) In addition to any restrictions referenced under paragraph (e)(1) of this section:
(i) No member of a peer review group may participate in or be present during any review by such group of a contract proposal in which, to the member's knowledge, any of the following has a financial interest:
(A) The member or his or her spouse, minor child, or partner;
(B) Any organization in which the member is serving as an officer, director, trustee, general partner, or employee; or
(C) Any organization with which the member is negotiating or has any arrangement concerning prospective employment or other similar association, and further;
(ii) In the event any member of a peer review group or his or her spouse, parent, child, or partner is currently or expected to be the project director or member of the staff responsible for carrying out any contract requirements as specified in the contract proposal, that member is disqualified and will be replaced as appropriate.
Identifying information obtained in the course of conducting AHCPR contract activities under this subpart is protected by section 903(c) of the PHS Act. Specifically:
(a) No information obtained in the course of conducting AHCPR contract activities under this subpart, if the entity or individual supplying the information or described in it is identifiable, may be used for any purpose other than the purpose for which it was supplied, unless the identifiable entity or individual supplying the information or described in it has consented to such other use, in the recorded form and manner as the Administrator may require.
(b) No information obtained in the course of conducting AHCPR contract activities under this subpart may be published or released in other form if the individual who supplied the information or who is described in it is identifiable, unless such individual has consented, in the recorded form and manner as the Administrator may require, to such publication or release.
(a) Data will be collected, maintained, and supplied as provided in each contract subject to the confidentiality requirements of section 903(c) of the PHS Act, section 1142(d) of the Social Security Act, and § 67.104 of this subpart.
(b) All publications, reports, papers, statistics, or other materials developed from work supported in whole or in part by contracts under Title IX of the PHS Act or section 1142 of the Social Security Act, if applicable, must be submitted to the Administrator in accordance with the terms of the contract. All publications must include an acknowledgment that such materials are the results of, or describe, a contractual activity supported by AHCPR.
(c) In accordance with 48 CFR 52.227-14, unless otherwise specified in the contract, AHCPR will retain a license to use, disclose, reproduce, prepare derivative works from, distribute copies to the public, and perform publicly and display publicly any copyrightable materials produced under a contract for any purpose consistent with AHCPR's statutory responsibilities, and to have or permit others to do so for accomplishment of AHCPR purposes.
(d) Except for identifying information protected by section 903(c) of the PHS Act, the Administrator, as appropriate, will make information provided in accordance with paragraphs (a) and (b) of this section available, and arrange for dissemination of such information and materials on as broad a basis as practicable and in such form as to make them as useful as possible to a variety of audiences, including health care providers, practitioners, consumers, educators, and policymakers.
42 U.S.C. 288-5.
This part applies to the award of educational loan payments under the NIH Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) authorized by section 487E of the Public Health Service Act (42 U.S.C. 288-5). The purpose of this program is to recruit and retain appropriately qualified health professionals, who are from disadvantaged backgrounds and have substantial educational debt relative to income, to conduct clinical research as NIH employees.
As used in this part:
(1) Comes from an environment that inhibited the individual from obtaining the knowledge, skill and ability required to enroll in and graduate from a health professions school; or
(2) Comes from a family with an annual income below a level based on low-income thresholds according to family size published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index, and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels in the
(1) Undergraduate, graduate, and health professional school tuition expenses;
(2) Other reasonable educational expenses required by the school(s) attended, including fees, books, supplies, educational equipment and materials, and laboratory expenses; and (3) reasonable living expenses, including the cost of room and board, transportation and commuting costs, and other reasonable living expenses incurred.
To be eligible to apply to the CR-LRP, an individual must be a citizen, national, or permanent resident of the United States; hold a M.D., Ph.D., D.O., D.D.S., D.M.D., A.D.N./B.S.N., or equivalent degree; have, on his/her program eligibility date, qualified educational debt equal to or in excess of the debt threshold; and be an individual from a disadvantaged background.
To be eligible to participate in the CR-LRP, an applicant must have the recommendation of the employing ICA Scientific Program Director, the concurrence of the employing ICA Director, and the approval of the CR-LRC. Since participation in the Program is contingent, in part, upon employment with NIH, a Program contract may not be awarded to an applicant until an employment commitment has been made by the employing ICA Personnel Department.
The following individuals are ineligible for CR-LRP participation:
(a) Persons who are not eligible applicants as specified under section 68a.3;
(b) Persons who owe an obligation of health professional service to the Federal Government, a State, or other entity, unless a deferral is granted for the length of his/her service obligation under the CR-LRP. The following are examples of programs which have a service obligation: Physicians Shortage Area Scholarship Program, National Research Service Award Program, Public Health Service Scholarship, National Health Service Corps Scholarship Program, Armed Forces (Army, Navy, or Air Force) Professions Scholarship Program, Indian Health Service Scholarship Program, and the NIH AIDS Research Loan Repayment Program.
(c) Persons who are not NIH employees, such as Intramural Research Training Award (IRTA) recipients, Visiting Fellows, National Research Service Award (NRSA) recipients, Guest Researchers or Special Volunteers, NIH-National Research Council (NRC) Biotechnology Research Associates Program participants, and Intergovernmental Personnel Act (IPA) participants; or
(d) Persons who do not have clinical privileges.
An application for participation in the CR-LRP shall be submitted to the NIH office which is responsible for the Program's administration, in such form and manner as the Secretary may prescribe.
To be selected for participation in the CR-LRP, applicants must satisfy the following requirements:
(a) Applicants must meet the eligibility requirements specified in § 68a.3 and § 68a.4.
(b) Applicants must not be ineligible for participation as specified in § 68a.5.
(c) Applicants must be selected for approval by the CR-LRC, based upon a review of their applications.
(a) Loan repayments: For each year of service the individual agrees to serve, with a minimum of 2 years of obligated service, the Secretary may pay up to $20,000 per year of a participant's repayable debt.
(b) Under § 68a.8(a), the Secretary will make payments in the discharge of debt to the extent appropriated funds are available for these purposes.
(a) The CR-LRP will repay participants' lenders the principal, interest, and related expenses of qualified Government and commercial educational loans obtained by participants for the following:
(1) Undergraduate, graduate, and health professional school tuition expenses;
(2) Other reasonable educational expenses required by the school(s) attended, including fees, books, supplies, educational equipment and materials, and laboratory expenses; and
(3) Reasonable living expenses, including the cost of room and board, transportation and commuting costs, and other living expenses as determined by the Secretary.
(b) The following educational loans are ineligible for repayment under the CR-LRP:
(1) Loans obtained from other than a government entity or commercial lending institution;
(2) Loans for which contemporaneous documentation is not available;
(3) Loans or portions of loans obtained for educational or living expenses which exceed the standard of reasonableness as determined by the participant's standard school budget for the year in which the loan was made, and are not determined by the Secretary to be reasonable based on additional documentation provided by the individual;
(4) Loans, financial debts, or service obligations incurred under the following programs: Physicians Shortage Area Scholarship Program (Federal or State), National Research Service Award Program, Public Health and National Health Service Corps Scholarship Training Program, National Health Service Corps Scholarship Program, Armed Forces (Army, Navy, or Air Force) Health Professions Scholarship Program, Indian Health Service Program, and similar programs, upon determination by the Secretary, which provide loans, scholarships, loan repayments, or other awards in exchange for a future service obligation;
(5) Any loan in default or not in a current payment status;
(6) Loan amounts which participants have paid or were due to have paid prior to the program eligibility date; and
(7) Loans for which promissory notes have been signed after the program eligibility date.
Individuals must agree to be engaged in approved clinical research, as employees of the NIH, for a minimum initial period of two consecutive years.
An individual may apply for and the Secretary may grant extension contracts for one-year periods, if there is sufficient debt remaining to be repaid and the individual is engaged in approved clinical research as an NIH employee.
(a) Absent withdrawal (see § 68a.2) or termination under paragraph (d) of this section, any participant who fails to complete the minimum two-year service obligation required under the Program contract will be considered to have breached the contract and will be subject to assessment of monetary damages and penalties as follows:
(1) Participants who leave during the first year of the initial contract are liable for amounts already paid by the NIH on behalf of the participant plus an amount equal to $1,000 multiplied by the number of months of the original service obligation.
(2) Participants who leave during the second year of the contract are liable for amounts already paid by the NIH on behalf of the participant plus $1,000 for each unserved month.
(b) Payments of any amount owed under paragraph (a) of this section shall be made within one year of the participant's breach (or such longer period as determined by the Secretary).
(c) Participants who sign a continuation contract for any year beyond the
(d) Terminations will not be considered a breach of contract in cases where such terminations are beyond the control of the participant as follows:
(1) Terminations for cause or for convenience of the Government will not be considered a breach of contract and monetary damages will not be assessed.
(2) Occasionally, a participant's research assignment may evolve and change to the extent that the individual is no longer engaged in approved clinical research. Similarly, the research needs and priorities of the ICA and/or the NIH may change to the extent that a determination is made that the health professional's skills may be better utilized in a non-clinical research assignment. Under these circumstances, the following will apply:
(i) Program participation and benefits will cease as of the date an individual is no longer engaged in approved clinical research; and
(ii) Normally, job changes of this nature will not be considered a breach of contract on the part of either the NIH or the participant. Based on the recommendation of the ICA Director and concurrence of the Secretary, the participant will be released from the remainder of his or her service obligation without assessment of monetary penalties. The participant in this case will be permitted to retain all Program benefits made or owed by NIH on his/her behalf up to the date the individual is no longer engaged in approved clinical research, except the pro rata amount of any benefits advanced beyond the period of completed service.
(a) Any obligation of a participant for service or payment to the Federal Government under this part will be canceled upon the death of the participant.
(b) The Secretary may waive or suspend any service or payment obligation incurred by the participant upon request whenever compliance by the participant:
(1) Is impossible,
(2) Would involve extreme hardship to the participant, or
(3) If enforcement of the service or payment obligation would be against equity and good conscience.
(4) The Secretary may approve a request for a suspension of the service or payment obligations for a period of 1 year. A renewal of this suspension may also be granted.
(c) Compliance by a participant with a service or payment obligation will be considered impossible if the Secretary determines, on the basis of such information and documentation as may be required, that the participant suffers from a physical or mental disability resulting in the permanent inability of the participant to perform the service or other activities which would be necessary to comply with the obligation.
(d) In determining whether to waive or suspend any or all of the service or payment obligations of a participant as imposing an undue hardship and being against equity and good conscience, the Secretary, on the basis of such information and documentation as may be required, will consider:
(1) The participant's present financial resources and obligations;
(2) The participant's estimated future financial resources and obligations; and
(3) The extent to which the participant has problems of a personal nature, such as a physical or mental disability or terminal illness in the immediate family, which so intrude on the participant's present and future ability to perform as to raise a presumption that the individual will be unable to perform the obligation incurred.
Any payment obligation incurred under § 68a.12 may be discharged in bankruptcy under Title 11 of the United States Code only if such discharge is granted after the expiration of the five-year period beginning on the first date that payment is required and only if the bankruptcy court finds that
When a shortage of funds exists, participants may be funded partially, as determined by the Secretary. However, once a CR-LRP contract has been signed by both parties, the Secretary will obligate such funds as necessary to ensure that sufficient funds will be available to pay benefits for the duration of the period of obligated service unless, by mutual written agreement between the Secretary and the applicant, specified otherwise. Benefits will be paid on a quarterly basis after each service period unless specified otherwise by mutual written agreement between the Secretary and the applicant. The Secretary may impose additional conditions as deemed necessary.
Several other regulations and statutes apply to this part. These include, but are not necessarily limited to:
42 U.S.C. 288-2.
This part applies to the award of educational loan payments under the National Institute of Child Health and Human Development (NICHD) Contraception and Infertility Research Loan Repayment Program (CIR-LRP) authorized by section 487B of the Public Health Service Act (42 U.S.C. 288-2). The purpose of this CIR-LRP is the recruitment and retention of highly qualified health professionals to conduct contraception and/or infertility research.
As used in this part:
(1) A physician assistant; or
(2) A research assistant with at least a bachelor's degree and applicable career goals.
(1) A Cooperative Specialized Contraception and Infertility Research Center;
(2) A Cooperative Specialized Research Center in Reproduction Research;
(3) A Women's Reproductive Health Research Career Development Center; and
(4) Reproductive Medicine Unit identified as a clinical site for the National Cooperative Reproductive Medicine Network, or other sites as designated by the Director.
(1) Undergraduate, graduate, and health professional school tuition expenses;
(2) Other reasonable educational expenses required by the school(s) attended, including fees, books, supplies, educational equipment and materials, and laboratory expenses; and
(3) Reasonable living expenses, including the cost of room and board, transportation and commuting costs, and other reasonable living expenses incurred.
To be eligible to apply to the CIR-LRP, an individual must be a qualified health or allied health professional who is at the time of application, or will be at the time of inception into the CIR-LRP, engaged in employment/training at an NICHD intramural laboratory or an eligible NICHD-supported extramural site.
To be eligible to participate in the CIR-LRP, the applicant must have institutional assurance of employment/affiliation with the NICHD intramural laboratory or eligible NICHD-supported extramural site and approval of the CIR-LRP Panel, must meet the criteria specified in § 68c.3, and not be ineligible to participate under § 68c.5.
The following individuals are ineligible for CIR-LRP participation:
(a) Persons who are not eligible applicants as specified under § 68c.3;
(b) Persons who owe an obligation of health professional service to the Federal Government, a State, or other entity. The following are examples of programs which have a service obligation: Physicians Shortage Area Scholarship Program, National Research Service Award Program, Public Health Service Scholarship, National Health Service Corps Scholarship Program, Armed Forces (Army, Navy, or Air Force) Professions Scholarship Program, Indian Health Service Scholarship Program, National Health Service Corp Loan Repayment Program, and NIH loan repayment programs.
An application for participation in the CIR-LRP shall be submitted to the Center for Population Research, NICHD, NIH, which is responsible for the Program's administration, in such form and manner as the Secretary may prescribe.
To be selected for participation in the CIR-LRP, applicants must satisfy the following requirements:
(a) Applicants must meet the eligibility requirements specified in § 68c.3 and § 68c.4.
(b) Applicants must not be ineligible for participation as specified in § 68c.5.
(c) Applicants must propose repayment of a loan that meets the requirements of § 68c.9.
(d) Applicants must be selected for approval by the CIR-LRP Panel based upon a review of their applications.
(a)
(b) Under paragraph (a) of this section, the Secretary will make payments in the discharge of debt to the extent appropriated funds are available for that purpose. When a shortage of funds exists, participants may be funded partially, as determined by the Secretary. However, once a CIR-LRP contract has been signed by both parties, the Secretary will obligate such funds as necessary to ensure that sufficient funds will be available to pay benefits for the duration of the period of obligated service unless otherwise specified by mutual written agreement between the Secretary and the applicant. Benefits will be paid on a quarterly basis after each service period unless otherwise specified by mutual written agreement between the Secretary and the applicant.
(a) The CIR-LRP will repay participants' lenders the principal, interest, and related expenses of qualified Government and commercial educational loans obtained by participants for the following:
(1) Undergraduate, graduate, and health professional school tuition expenses;
(2) Other reasonable educational expenses required by the school(s) attended, including fees, books, supplies, educational equipment and materials, and laboratory expenses; and
(3) Reasonable living expenses, including the cost of room and board, transportation and commuting costs, and other living expenses as determined by the Secretary.
(b) The following educational loans are ineligible for repayment under the CIR-LRP:
(1) Loans obtained from other than a government entity or commercial lending institution;
(2) Loans for which contemporaneous documentation is not available;
(3) Loans or portions of loans obtained for educational or living expenses which exceed the standard of reasonableness as determined by the participant's standard school budget for the year in which the loan was made, and are not determined by the Secretary to be reasonable based on additional documentation provided by the individual;
(4) Loans, financial debts, or service obligations incurred under the following programs: Physicians Shortage Area Scholarship Program (Federal or State), National Research Service Award Program, Public Health and National Health Service Corps Scholarship Training Program, National Health Service Corps Scholarship Program, Armed Forces (Army, Navy, or Air Force) Health Professions Scholarship Program, Indian Health Service Program, and similar programs, upon determination by the Secretary, which provide loans, scholarships, loan repayments, or other awards in exchange for a future service obligation;
(5) Any loan in default or not in a current payment status;
(6) Loan amounts which participants have paid or were due for payment prior to inception into the CIR-LRP; and
(7) Loans for which promissory notes have been signed after the individual's acceptance into the CIR-LRP.
Individuals must make a written commitment in accordance with this part to conduct, and must actually conduct research with respect to contraception and/or infertility at an NICHD intramural laboratory or an eligible NICHD-supported extramural site for a minimum initial period of two years.
An individual may apply for and the Secretary may grant extension contracts for one-year periods, if there is sufficient debt remaining to be repaid and the individual is engaged in research on infertility or contraceptive development at an NICHD intramural laboratory or eligible NICHD-supported extramural site.
(a) Absent withdrawal (see § 68c.2) or termination under paragraph (d) of this section, any participant who fails to begin or complete the minimum two-year service obligation required under the Program contract, will be considered to have breached the contract and will be subject to assessment of monetary damages and penalties as follows:
(1) Participants who leave during the first year of the initial contract are liable for amounts already paid by the CIR-LRP on behalf of the participant plus an amount equal to $1,000 multiplied by the number of months of the original two-year service obligation.
(2) Participants who leave during the second year of the contract are liable for amounts already paid by the NICHD on behalf of the participant plus $1,000 for each unserved month.
(b) Participants who sign a continuation contract for any year beyond the initial two-year period and fail to complete the one-year period specified are liable for the pro rata amount of any benefits advanced beyond the period of completed service plus an amount equal to the number of months of obligated service that were not completed by the participant multiplied by $1,000.
(c) Payments of any amount owed under paragraph (a) or (b) of this section shall be made within one year of the participant's breach (or such longer period as determined by the Secretary).
(d) Terminations will not be considered a breach of contract in cases where such terminations are beyond the control of the participant as follows:
(1) Terminations for cause or for convenience of the Government that are not based upon a breach or default of the participant will not be considered a breach of contract and monetary damages will not be assessed.
(2) The participant transfers to another NICHD intramural laboratory or eligible NICHD-supported extramural site, in which case the participant remains bound to any and all obligations of the contract.
(3) The participant transfers to a site other than an NICHD intramural laboratory or eligible NICHD-supported extramural site, in which case the participant may not be assessed monetary penalties if, in the judgement of the CIR-LRP Panel, the participant continues to engage in contraception and/or infertility research for any remaining period of obligated service as set forth in the contract.
(a) Any obligation of a participant for service or payment to the Federal Government under this part will be canceled upon the death of the participant.
(b)(1) The Secretary may waive or suspend any service or payment obligation incurred by the participant upon request whenever compliance by the participant:
(i) Is impossible;
(ii) Would involve extreme hardship to the participant; or
(iii) If enforcement of the service or payment obligation would be against equity and good conscience.
(2) The Secretary may approve a request for a suspension of the service or payment obligations for a period of 1 year. A renewal of this suspension may also be granted.
(c) Compliance by a participant with a service or payment obligation will be considered impossible if the Secretary determines, on the basis of information and documentation as may be required, that the participant suffers from a physical or mental disability resulting in the permanent inability of the participant to perform the service or other
(d) In determining whether to waive or suspend any or all of the service or payment obligations of a participant as imposing an undue hardship and being against equity and good conscience, the Secretary, on the basis of information and documentation as may be required, will consider:
(1) The participant's present financial resources and obligations;
(2) The participant's estimated future financial resources and obligations; and
(3) The extent to which the participant has problems of a personal nature, such as a physical or mental disability or terminal illness in the immediate family, which so intrude on the participant's present and future ability to perform as to raise a presumption that the individual will be unable to perform the obligation incurred.
Any payment obligation incurred under § 68c.12 may be discharged in bankruptcy under Title 11 of the United States Code only if such discharge is granted after the expiration of the five-year period beginning on the first date that payment is required and only if the bankruptcy court finds that a nondischarge of the obligation would be unconscionable.
In order to protect or conserve Federal funds or to carry out the purposes of section 487B of the Act, or of this subpart, the Secretary may impose additional conditions as a condition of any approval, waiver or suspension authorized by this subpart.
Several other regulations and statutes apply to this part. These include, but are not necessarily limited to:
Debt Collection Act of 1982, Public Law 97-365 (5 U.S.C. 5514);
Fair Credit Reporting Act (15 U.S.C. 1681
Federal Debt Collection Procedures Act of 1990, Public Law 101-647 (28 U.S.C. 1); and
Privacy Act of 1974 (5 U.S.C. 552a).
42 U.S.C. 216, 243, 264, 271.
As used in this part, terms shall have the following meaning:
(a)
(b)
(c)
(d)
(e)
(1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation that is entirely within a State or possession—
(i) From a point of origin in any State or possession to a point of destination in any other State or possession; or
(ii) Between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country.
(2) Interstate traffic does not include the following:
(i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country.
(ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage.
(f)
(g)
(h)
(1) Fishing boats including those used for shell-fishing;
(2) Tugs which operate only locally in specific harbors and adjacent waters;
(3) Barges without means of self-propulsion;
(4) Construction-equipment boats and dredges; and
(5) Sand and gravel dredging and handling boats.
Whenever the Director of the Centers for Disease Control and Prevention determines that the measures taken by health authorities of any State or possession (including political subdivisions thereof) are insufficient to prevent the spread of any of the communicable diseases from such State or possession to any other State or possession, he/she may take such measures to prevent such spread of the diseases as he/she deems reasonably necessary, including inspection, fumigation, disinfection, sanitation, pest extermination, and destruction of animals or articles believed to be sources of infection.
A person who has a communicable disease in the communicable period shall not travel from one State or possession to another without a permit from the health officer of the State, possession, or locality of destination, if such permit is required under the law applicable to the place of destination. Stop-overs other than those necessary for transportation connections shall be considered as places of destination.
The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs.
The following provisions are applicable with respect to any person who is in the communicable period of cholera, plague, smallpox, typhus or yellow fever, or who, having been exposed to any such disease, is in the incubation period thereof:
(a)
(2) Application for a permit may be made directly to the Surgeon General or to his/her representative authorized to issue permits.
(3) Upon receipt of an application, the Surgeon General or his/her authorized representative shall, taking into consideration the risk of introduction, transmission, or spread of the disease from one State or possession to another, reject it, or issue a permit that may be conditioned upon compliance with such precautionary measures as he/she shall prescribe.
(4) A person to whom a permit has been issued shall retain it in his/her possession throughout the course of his/her authorized travel and comply with all conditions prescribed therein, including presentation of the permit to the operators of conveyances as required by its terms.
(b)
(i) Accept for transportation any person who fails to present a permit as required by paragraph (a) of this section; or
(ii) Transport any person in violation of conditions prescribed in his/her permit.
(2) Whenever a person subject to the provisions of this section is transported on a conveyance engaged in interstate traffic, the operator thereof shall take such measures to prevent the spread of the disease, including submission of the conveyance to inspection, disinfection and the like, as an officer of the Public Health Service designated by the Surgeon General for such purposes deems reasonably necessary and directs.
Regulations prescribed in this part are not applicable to the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of the following diseases: Anthrax, chancroid, cholera, dengue, diphtheria, granuloma inguinale, infectious encephalitis, favus, gonorrhea, leprosy, lymphogranuloma venereum, meningococcus meningitis, plague, poliomyelitis, psittacosis, relapsing fever, ringworm of the scalp, scarlet fever, streptococcic sore throat, smallpox, syphilis, trachoma, tuberculosis, typhoid fever, typhus, and yellow fever.
A parent, guardian, physician, nurse, or other such person shall not transport, or procure or furnish transportation for any minor child or ward, patient or other such person who is in the communicable period of a communicable disease, except in accordance with provisions of this part.
The provisions of §§ 70.3, 70.4, 70.5, 70.7, and this section shall not apply to members of the military or naval forces, and medical care or hospital beneficiaries of the Army, Navy, Veterans' Administration, or Public Health Service, when traveling under competent orders:
Sec. 215 of Public Health Service (PHS) Act, as amended (42 U.S.C. 216); secs. 361-369, PHS Act, as amended (42 U.S.C. 264-272); E.O. 12452 of December 22, 1983, 48 FR 56927.
(a) The provisions of this part contain the regulations to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the States or possessions of the United States. Regulations pertaining to preventing the interstate spread of communicable diseases are contained in 21 CFR parts 1240 and 1250.
(b) As used in this part the term:
(1) Has a temperature of 100 °F. (or 38 °C.) or greater, accompanied by a rash, glandular swelling, or jaundice, or which has persisted for more than 48 hours; or
(2) Has diarrhea, defined as the occurrence in a 24-hour period of three or more loose stools or of a greater than normal (for the person) amount of loose stools.
Any person violating any provision of these regulations shall be subject to a fine of not more than $1,000 or to imprisonment for not more than 1 year, or both, as provided in section 368 of the Public Health Service Act (42 U.S.C. 271).
(a)
(2) A designated yellow fever vaccination center shall comply with the instruction issued by the Director or by a delegated officer or employee of a State or territorial health department for the handling, storage, and administration of yellow fever vaccine. If a designated center fails to comply with such instruction, after notice to the center, the Director or, for non-Federal centers, a State or territorial health department, may revoke designation.
(b)
(1) The Seal of the Public Health Service; or
(2) The Seal of the Department of State; or
(3) The stamp of the Department of Defense; or
(4) The stamp issued to the National Aeronautics and Space Administration; or
(5) The stamp issued by a State or territorial health department; or
(6) An official stamp of a design and size approved by the Director for such purpose.
A carrier at any foreign port clearing or departing for any U.S. port shall not be required to obtain or deliver a bill of health.
(a) The master of a ship destined for a U.S. port shall report immediately to the quarantine station at or nearest the port at which the ship will arrive, the occurrence, on board, of any death or any ill person among passengers or crew (including those who have disembarked or have been removed) during the 15-day period preceding the date of expected arrival or during the period since departure from a U.S. port (whichever period of time is shorter).
(b) The commander of an aircraft destined for a U.S. airport shall report immediately to the quarantine station at or nearest the airport at which the aircraft will arrive, the occurrence, on board, of any death or ill person among passengers or crew.
(c) In addition to paragraph (a) of this section, the master of a ship carrying 13 or more passengers must report by radio 24 hours before arrival the number of cases (including zero) of diarrhea in passengers and crew recorded in the ship's medical log during the current cruise. All cases of diarrhea that occur after the 24 hour report must also be reported not less than 4 hours before arrival.
(a) Upon arrival at a U.S. port, a carrier will not undergo inspection unless the Director determines that a failure to inspect will present a threat of introduction of communicable diseases into the United States, as may exist when the carrier has on board individual(s) reportable in accordance with § 71.21 or meets the circumstances described in § 71.42. Carriers not subject to inspection under this section will be subject to sanitary inspection under § 71.41 of this part.
(b) The Director may require detention of a carrier until the completion of the measures outlined in this part that are necessary to prevent the introduction or spread of a communicable disease. The Director may issue a controlled free pratique to the carrier stipulating what measures are to be met, but such issuance does not prevent the periodic boarding of a carrier and the inspection of persons and records to verify that the conditions have been met for granting the pratique.
(a) Whenever the Director has reason to believe that any arriving person is infected with or has been exposed to any of the communicable diseases listed in paragraph (b) of this section, he/she may detain, isolate, or place the person under surveillance and may order disinfection or disinfestation as he/she considers necessary to prevent the introduction, transmission, or spread of the listed communicable diseases.
(b) The communicable diseases authorizing the application of sanitary, detention, and/or isolation measures under paragraph (a) of this section are: cholera or suspected cholera, diphtheria, infectious tuberculosis, plague, suspected smallpox, yellow fever, or suspected viral hemorrhagic fevers (Lassa, Marburg, Ebola, Congo-Crimean, and others not yet isolated or named).
(c) Whenever the Director has reason to believe that any arriving carrier or article or thing on board the carrier is or may be infected or contaminated with a communicable disease, he/she may require detention, disinsection, disinfection, disinfestation, fumigation, or other related measures respecting the carrier or article or thing as he/she considers necessary to prevent the introduction, transmission, or spread of communicable diseases.
(a) Persons held in isolation under this subpart may be held in facilities suitable for isolation and treatment.
(b) The Director may require isolation where surveillance is authorized in this subpart whenever the Director considers the risk of transmission of infection to be exceptionally serious.
(c) Every person who is placed under surveillance by authority of this subpart shall, during the period of surveillance:
(1) Give information relative to his/her health and his/her intended destination and report, in person or by telephone, to the local health officer having jurisdiction over the areas to be visited, and report for medical examinations as may be required;
(2) Upon arrival at any address other than that stated as the intended destination when placed under surveillance, or prior to departure from the United States, inform, in person or by telephone, the health officer serving the health jurisdiction from which he/she is departing.
(d) From time to time the Director may, in accordance with section 322 of the Public Health Service Act, enter into agreements with public or private medical or hospital facilities for providing care and treatment for persons detained under this part.
(a) Carriers belonging to or operated by the military services of the United States may be exempted from inspection if the Director is satisfied that they have complied with regulations of
(b) Notwithstanding exemption from inspection of carriers under this section, animals or articles on board shall be required to comply with the applicable requirements of subpart F of this part.
The master of any carrier at a U.S. port shall report immediately to the quarantine station at or nearest the port the occurrence, on board, of any death or any ill person among passengers or crew.
Carriers arriving at a U.S. port from a foreign area shall be subject to a sanitary inspection to determine whether there exists rodent, insect, or other vermin infestation, contaminated food or water, or other insanitary conditions requiring measures for the prevention of the introduction, transmission, or spread of communicable disease.
When the cargo manifest of a carrier lists articles which may require disinfection under the provisions of this part, the Director shall disinfect them on board or request the appropriate customs officer to keep the articles separated from the other cargo pending appropriate disposition.
Except to the extent that mail contains any article or thing subject to restrictions under subpart F of this part, nothing in the regulations in this part shall render liable to detention, disinfection, or destruction any mail conveyed under the authority of the postal administration of the United States or of any other Government.
(a) The Director may require disinsection of an aircraft if it has left a foreign area that is infected with insect-borne communicable disease and the aircraft is suspected of harboring insects of public health importance.
(b) Disinsection shall be the responsibility of the air carrier or, in the case of aircraft not for hire, the pilot in command, and shall be subject to monitoring by the Director.
(c) Disinsection of the aircraft shall be accomplished immediately after landing and blocking.
(1) The cargo compartment shall be disinsected before the mail, baggage, and other cargo are discharged.
(2) The rest of the aircraft shall be disinsected after passengers and crew deplane.
(d) Disinsection shall be performed with an approved insecticide in accordance with the manufacturer's instructions. The current list of approved insecticides and sources may be obtained from the Division of Quarantine, Center for Prevention Services, Centers for Disease Control, Atlanta, GA 30333.
(a) Every seaport and airport shall be provided with a supply of potable water from a watering point approved by the Commissioner of Food and Drugs, Food and Drug Administration, in accordance with standards established in title 21, Code of Federal Regulations, parts 1240 and 1250.
(b) All food and potable water taken on board a ship or aircraft at any seaport or airport intended for human consumption thereon shall be obtained from sources approved in accordance with regulations cited in paragraph (a) of this section.
(c) Aircraft inbound or outbound on an international voyage shall not discharge over the United States any excrement, or waste water or other polluting materials. Arriving aircraft shall discharge such matter only at
Valid Deratting Certificates or Deratting Exemption Certificates are not required for ships to enter a U.S. seaport. In accordance with Article 17 of the International Health Regulations, the Public Health Service may perform rodent infestation inspections and issue Deratting Certificates and Deratting Exemption Certificates.
Each U.S. airport which receives international traffic shall provide without cost to the Government suitable office, isolation, and other exclusive space for carrying out the Federal responsibilities under this part.
Carriers, on an international voyage, which are in traffic between U.S. ports, shall be subject to inspection as described in §§ 71.31 and 71.41 when there occurs on board, among passengers or crew, any death, or any ill person, or when illness is suspected to be caused by insanitary conditions.
(a)
As used in this section the term:
(1) Identifies a dog on the basis of breed, sex, age, color, markings, and other identifying information.
(2) Specifies a date of rabies vaccination at least 30 days before the date of arrival of the dog at a U.S. port.
(3) Specifies a date of expiration which is after the date of arrival of the dog at a U.S. port. If no date of expiration is specified, then the date of vaccination shall be no more than 12 months before the date of arrival at a U.S. port.
(4) Bears the signature of a licensed veterinarian.
(b)
(2)
(3)
(ii) When, upon inspection, a dog or cat appears healthy but, during shipment, has been exposed to a sick or dead animal suspected of having a communicable disease, the exposed dog or cat shall be admitted only if examination or tests made on arrival reveal no evidence that the animal may be infected with a communicable disease. The provisions of paragraph (b)(2) of this section shall be applicable to the examination or tests.
(4)
(c)
(i) If a dog is less than 6 months of age, it has been only in a country determined by the Director to be rabies-free (a current list of rabies-free countries may be obtained from the Division of Quarantine, Center for Prevention Services, Centers for Disease Control, Atlanta, GA 30333); or
(ii) If a dog is 6 months of age or older, for the 6 months before arrival, it has been only in a country determined by the Director to be rabies-free; or
(iii) The dog is to be taken to a research facility to be used for research purposes and vaccination would interfere with its use for such purposes.
(2) Regardless of the provisions of paragraph (c)(1) of this section, the Director may authorize admission as follows:
(i) If the date of vaccination shown on the vaccination certificate is less than 30 days before the date of arrival, the dog may be admitted, but must be confined until at least 30 days have elapsed since the date of vaccination;
(ii) If the dog is less than 3 months of age, it may be admitted, but must be confined until vaccinated against rabies at 3 months of age and for at least 30 days after the date of vaccination;
(iii) If the dog is 3 months of age or older, it may be admitted, but must be confined until it is vaccinated against rabies. The dog must be vaccinated within 4 days after arrival at destination but no more than 10 days after arrival at a U.S. port. It must be kept in confinement for at least 30 days after the date of vaccination.
(3) When a dog is admitted under paragraph (c)(2) of this section, the Director shall notify the health department or other appropriate agency having jurisdiction at the point of destination and shall provide the address of the specified place of confinement and other pertinent information to facilitate surveillance and other appropriate action.
(d)
(e)
(f)
(1) Dogs and cats that appear healthy, but have been exposed to a sick or dead animal suspected of having a communicable disease, need not undergo examination or tests as provided in paragraph (b)(3) of this section if the Director determines that the conditions under which they are being transported will afford adequate protection against introduction of communicable disease.
(2) Rabies vaccination is not required for dogs that are transported by aircraft or ship and retained in custody of the carrier under conditions that would prevent transmission of rabies.
(g)
(a)
As used in this section the term:
(b)
(c)
(2) Seven or more live turtles with a carapace length of less than 4 inches, or seven or more viable turtle eggs or any combination of turtles and turtle eggs totaling seven or more, may be imported into the United States for bona fide scientific or educational purposes or for exhibition when accompanied by a permit issued by the Director.
(3) The requirements in paragraphs (c)(1) and (c)(2) of this section shall not apply to the eggs of marine turtles excluded from these regulations under § 71.52(a).
(d)
(e)
(f)
(g)
(a)
As used in this section the term:
(b)
(c)
(d)
(2) Documentary evidence that an importer will use all nonhuman primates solely for the permitted purposes is required.
(3) Registration shall inlcude certification that the nonhuman primates will not be shipped, sold, or otherwise transferred to other persons or organizations without adequate proof that the primates will be used only for the permitted purposes.
(4) Registration shall be for 2 years, effective the date the application for registration is approved by the Director.
(5) Registration may be renewed by filing a registration application form with the Director not less than 30 days nor more than 60 days before expiration of the current registration.
(e)
(2) Importers shall report to the Director by telephone within 24 hours the occurrence of any illness in nonhuman primates that is suspected of being yellow fever, monkeypox, or Marburg/Ebola disease.
(3) Importers also shall report to the Director by telephone within 24 hours the occurrence of illness in any member of their staff suspected of having an infectious disease acquired from nonhuman primates.
(f)
(g)
(h)
(2) The importer may file an answer within 20 days after receipt of the notice. Answers shall admit or deny specifically, and in detail, each allegation in the notice. Allegations in the notice not denied by answer shall be deemed admitted. Matters alleged as affirmative defenses shall be separately stated and numbered. Failure of the importer to file an answer within 20 days after receipt of the notice may be deemed an admission of all allegations of fact recited in the notice.
(3) The importer shall be entitled to a hearing with respect to the revocation upon filing a written request, either in the answer or in a separate document, with the Director within 20 days after the effective date of revocation. Failure to request a hearing shall be deemed a waiver of hearing and as consent to the submission of the case to the Director for decision based on the written record. The failure both to file an answer and to request a hearing shall be deemed to constitute consent to the making of a decision on the basis of available information.
(4) As soon as practicable after the completion of any hearing conducted pursuant to the provisions of this section, the Director shall render a final decision. A copy of such decision shall be served on the importer.
(5) An importer's registration which has been revoked may be reinstated by the Director upon inspection, examination of records, conference with the importer, and receipt of information and assurances of compliance with the requirements of this section.
(i)
(a) A person may not import into the United States, nor distribute after importation, any etiological agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accompanied by a permit issued by the Director.
(b) Any import coming within the provisions of this section will not be released from custody prior to receipt by the District Director of the U.S. Customs Service of a permit issued by the Director.
The remains of a person who died of a communicable disease listed in § 71.32(b) may not be brought into a U.S. port unless the body is (a) properly embalmed and placed in a hermetically sealed casket, (b) cremated, or (c) accompanied by a permit issued by the Director.
42 U.S.C. 264, 271; 31 U.S.C. 9701; 18 U.S.C. 3559, 3571; 42 U.S.C. 262 note.
As used in this part:
No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material including, but not limited to, diagnostic specimens and biological products which such person reasonably believes may contain an etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.
Notwithstanding the provisions of § 72.2, no person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material (other than biological products) known to contain, or reasonably believed by such person to contain, one or more of the following etiologic agents unless such material is packaged, labeled, and shipped in accordance with the requirements specified in paragraphs (a) through (f) of this section:
(a)
(b)
(c)
(d)(1) The outer shipping container of all materials containing etiologic agents transported in interstate traffic must bear a label as illustrated and described below:
(2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated.
(3) The label must be a rectangle measuring 51 millimeters (mm) (2 inches) high by 102.5 mm (4 inches) long.
(4) The red symbol measuring 38 mm (1
(5) Type size of the letters of label shall be as follows:
(e)
(f)
When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in § 72.3(f) is not received by the sender within 5 days following anticipated delivery of the package, the sender shall notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333 (telephone (404) 633-5313).
The Director, Center for Disease Control, may approve variations from the requirements of this section if, upon review and evaluation, it is found that such variations provide protection at least equivalent to that provided by compliance with the requirements specified in this section and such findings are made a matter of official record.
(a)
(2) Registration will include:
(i) Sufficient information provided by the responsible facility official indicating that the applicant facility, and its laboratory or laboratories, are equipped and capable of handling the agents at BL 2, 3, or 4, depending upon the agent, and the type of work being performed with the agents;
(ii) Inspection of the applicant facility at the discretion of the Secretary or the registering entity in consultation with the Secretary;
(iii) Issuance by the registering entity of a registration number unique to each facility;
(iv) Collection of a periodic site registration fee by the registering entity or the Secretary.
A schedule of fees collected by the Secretary to cover the direct costs (e.g., salaries, equipment, travel) and indirect costs (e.g., rent, telephone service and a proportionate share of management and administration costs) related to administration of this part will be published in the
(v) Follow-up inspections of the facility by the registering entity or the Secretary, as appropriate, to ensure the facility continues to meet approved standards and recordkeeping requirements.
(3) Such registration shall remain effective until relinquished by the facility or withdrawn by the Secretary or the registering entity.
(4) The registration may be denied or withdrawn by the registering entity or the Secretary based on:
(i) Evidence that the facility is not or is no longer capable of handling covered agents at the applicable biosafety level;
(ii) Evidence that the facility has handled covered agents in a manner in contravention of the applicable biosafety level requirements;
(iii) Evidence that the facility has or intends to use covered agents in a manner harmful to the health of humans;
(iv) Evidence that the facility has failed to comply with any provisions of this part or has acted in a manner in contravention of this part; or
(v) Failure to pay any required registration fee.
(5) The biosafety standards and requirements for BSL-2, 3, and 4 operations are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,” Fourth Edition, May 1999 which is hereby incorporated by reference. The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR part 51 the incorporation by reference of the above publication. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop A-13 Atlanta, Georgia, or at the Office of the Federal Register, 800 North Capitol Street NW, Suite 700, Washington, DC. The manual is also available on the CDC web site at
(6) Additional specific requirements for handling toxins subject to this part must be met and are found in 29 CFR § 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories.”
(b)
(c)
(2) A registering entity shall maintain:
(i) A database of all facilities formerly and currently registered as BL 2, 3, or 4 and capable of working with agents in Appendix A of this part. The database shall include the name and address of the registered facility, the date the facility was registered, the facility's registration number, and the name and phone number of the responsible facility official.
(ii) A copy of each CDC Form EA-101 transmitted by each transferor registered by that registering entity. Such forms shall be made readily accessible to the Secretary and to appropriate federal law enforcement authorities and/or authorized local law enforcement authorities.
(3) In the event the Secretary authorizes more than one registering entity, or if otherwise necessary, the Secretary may require the establishment of a consolidated database to carry out the provisions of § 72.6(c)(2).
(d)
(i) The name of the requestor and requesting facility;
(ii) The name of the transferor and transferring facility;
(iii) The names of the responsible facility officials for both the transferor and requestor;
(iv) The requesting facility's registration number;
(v) The transferring facility's registration number;
(vi) The name of the agent(s) being shipped;
(vii) The proposed use of the agent(s); and
(viii) The quantity (number of containers and amount per container) of the agent(s) being shipped.
(2) The form must be signed by the transferor and requestor, and the responsible facility officials representing both the transferring and requesting facilities.
(3) A copy of the completed CDC Form EA-101 must be retained by both transferring and requesting facilities for a period of five (5) years after the date of shipment or for five (5) years after the agents are consumed or properly disposed, whichever is longer.
(4) All CDC forms EA-101 must be produced upon request to appropriate federal and authorized local law enforcement authorities, officials authorized by the Secretary, and officials of the registering entity.
(e)
(i) That the requesting facility retains a valid, current registration;
(ii) That the requestor is an employee of the requesting facility; and
(iii) That the proposed use of the agent by the requestor is correctly indicated on CDC Form EA-101.
(2) In the event that any party is unable to verify the information required in paragraph (e)(1) of this section, or there is suspicion that the agent may not be used for the requested purpose, then the party shall immediately notify CDC.
(f)
(2) The requesting facility's responsible official must acknowledge receipt of the agent telephonically or otherwise electronically within 36 hours of receipt and provide a paper copy or facsimile transmission of receipt to the transferor within 3 business days of receipt of the agent.
(3) Upon telephonic acknowledgment of receipt of the agent, the transferor shall provide a completed paper copy or facsimile transmission of CDC Form EA-101 within 24 hours to the registering entity (holding that facility's registration), in accordance with § 72.6(c)(2) for filing in a centralized repository.
(g)
(2) In addition, the Secretary may conduct inspections of registering entities, and/or any consolidated database established in accordance with § 72.6(c)(3), to assure compliance with this part.
(h)
(i) The agent is part of a clinical specimen intended for diagnostic, reference, or verification purposes. Isolates of covered agents from clinical specimens shall be disposed of in accordance with § 72.6(i) after diagnostic, reference, or verification procedures have been completed;
(ii) The agent is a toxin having an LD
(iii) The agent(s) is an exempted strain specified in Appendix A of this part and/or CDC Form EA-101. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents (Appendix A of this part). Individuals seeking additions to the list of exemptions should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future changes to the list of exemptions will be published in the
(2)
(3)
(i) Prior to transferring a select agent subject to this part to a CLIA laboratory for diagnostic, reference, verification, or proficiency testing purposes, the
(A) Provide the following information on CDC Form EA-101:
(
(
(
(
(
(
(
(
(B) Verify receipt of the agent with the CLIA laboratory and note such receipt on CDC Form EA-101;
(C) Transmit a copy of the form, signed by the transferror and the responsible facility official representing the transfering facility, to the registering entity holding the transferring facility's registration; and
(D) Retain a copy of CDC Form EA-101 in accordance with § 72.6(d)(3) and § 72.6(d)(4).
(ii) Prior to receiving a select agent listed in Appendix A of this part from a CLIA laboratory, the
(A) Provide the following information on the CDC Form EA-101:
(
(
(
(
(
(
(
(
(B) Upon receiving the agent, note such receipt on CDC Form EA-101;
(C) Transmit a copy of CDC Form EA-101, signed by the requestor and the responsible facility official representing the requesting facility, to the registering entity holding the requesting facility's registration;
(D) Retain a copy of the CDC Form EA-101 in accordance with §§ 72.6(d)(3) and 72.6(d)(4);
(E) Comply with the disposal requirements of § 72.6(i) and all other sections of this part when subsequently transferring the agent.
(i)
(i) Securely stored in accordance with prudent laboratory practices,
(ii) Transferred to another registered facility in accordance with this part, or
(iii) Destroyed on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.
(2) When an agent, previously transferred to a facility in accordance with this part, is consumed or destroyed, the responsible facility official must formally notify the registering entity. Formal notification must be noted on CDC Form EA-101 and a copy kept on record by the responsible facility official for a period of five (5) years and is subject to paragraph (g) of this section.
(j)
(1) Genetically modified microorganisms or genetic elements from organisms on Appendix A of this part, shown to produce or encode for a factor associated with a disease, and
(2) Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins on Appendix A of this part, or their toxic submits.
(1) The conveyance or movement from a point or origination to a point of destination either:
(i) From one state or territory to another or;
(ii) Entirely within one contiguous state or territory.
(2) Intrafacility transfers within a registered facility located at a single geographic site are not covered by the provisions of § 72.6 (d), (e), and (f) provided that:
(i) The intended use of the agent remains consistent with that specified in the most current transfer form; and
(ii) For each intrafacility transfer, the facility maintains records that include the name and location of the recipient; the amount of agent transferred, and the date transferred. Such records must be maintained for a period of five (5) years after the date of transfer or for five (5) years after the agents are consumed or properly disposed, whichever is longer.
Individuals in violation of this part are subject to a fine of no more than $250,000 or one year in jail, or both. Violations by organizations are subject to a fine or no more than $500,000 per event. A false, fictitious, or fraudulent statement or representation on the Government forms required in the part for registration of facilities or for transfers of select agents is subject to a fine or imprisonment for not more than five years, or both for an individual; and a fine for an organization.
1. Genetically modified microorganisms or genetic elements from organisms on Appendix A, shown to produce or encode for a factor associated with a disease.
2. Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed in this Appendix, or their toxic subunits.
The deliberate transfer of a drug resistance trait to microorganisms listed in this Appendix that are not known to acquire the trait naturally is prohibited by NIH “Guidelines for Research Involving Recombinant DNA Molecules,” if such acquisition could compromise the use of the drug to control these disease agents in humans or veterinary medicine.
1. Products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. 136
2. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in this Appendix. Individuals seeking an exemption should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future exemptions will be published in the
Sec. 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, Pub. L. 97-35, 95 Stat. 599-600 (42 U.S.C. 10004).
(a) The purpose of these regulations is to implement the provisions of section 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10004, which requires the establishment by the Secretary of Health and Human Services of standards for the accreditation of programs for the education of certain persons who administer radiologic procedures and for the credentialing of such persons.
(b) Section 979 requires the Secretary, after consultation with specified Federal agencies, appropriate agencies of States, and appropriate professional organizations, to promulgate by regulation the minimum standards described above. These standards distinguish between the occupations of (1) radiographer, (2) dental hygienist, (3) dental assistant, (4) nuclear medicine technologist, and (5) radiation therapy technologist. In the interest of public safety and to prevent the hazards of improper use of medical radiation identified by Congress in its determination of the need for standards, the Secretary is also authorized to prepare standards for other occupational groups utilizing ionizing and non-ionizing radiation as he/she finds appropriate. However, the standards set out below are limited to the five occupational groups listed above, utilizing ionizing radiation. Nothing in these accreditation standards is intended to
All terms not defined herein shall have the meaning given them in the Act. As used in this part:
(a)
(1)
(2)
(3)
(4)
(5)
(6) The following persons are deemed to have met the requirements of these standards:
(i) Persons employed by the Federal government as radiologic personnel prior to the effective date of this regulation and who show evidence of current or fully satisfactory performance or certification of such from a licensed practitioner:
(ii) Uniformed military personnel who receive radiologic training from or through the Armed Forces of the United States and who meet standards established by the Department of Defense or components thereof, provided that those standards are determined by such Department or component to offer equivalent protection of patient health and safety:
(iii) Foreign national employed by the Federal government in positions outside of the United States who show evidence of training, experience, and competence determined by the employing agency to be equally protective of patients health and safety; and
(iv) Persons first employed by the Federal government as radiologic personnel after the effective date of this regulation who (
(7) The following persons are exempted from these standards:
(i) Persons who are trained to perform, or perform, covered radiologic procedures in emergency situations which preclude use of fully qualified personnel; and
(ii) Students in approved training programs.
(8) A department, agency, or instrumentality of the Federal government may, after consultation with the Secretary, use alternative criteria which it determines would offer equivalent protection of patient health and safety.
(b)
The radiographer shall perform effectively by:
1. Applying knowledge of the principles of radiation protection for the patient, self, and others.
2. Applying knowledge of anatomy, positioning, and radiographic techniques to accurately demonstrate anatomical structures on a radiograph.
3. Determining exposure factors to achieve optimum radiographic technique with a minimum of radiation exposure to the patient.
4. Examining radiographs for the purpose of evaluating technique, positioning, and other pertinent technical qualities.
5. Exercising discretion and judgment in the performance of medical imaging procedures.
6. Providing patient care essential to radiologic procedures.
7. Recognizing emergency patient conditions and initiating lifesaving first aid.
1. Accreditation will be granted to the institution that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and supervised clinical education; appoints faculty to the program; receives and processes applications for admission; and grants the degree or certificate documenting completion of the program.
2. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and universities;
(b) Hospitals;
(c) Medical schools;
(d) Postsecondary vocational/technical schools and institutions; and
(e) Other acceptable institutions which meet comparable standards.
3. The sponsoring institutions and affiliate(s) must be accredited by a recognized agency. When the sponsoring institution and affilitate(s) are not so recognized, they may be considered as meeting the requirements of accreditation if the institution meets or exceeds established equivalent standards.
1.
2.
3.
1. The clinical phase of the educational program shall provide an environment for supervised competency-based clinical education and experience and offer a sufficient and well-balanced variety of radiographic examinations and equipment.
2. An acceptable ratio of students to registered technologists shall be maintained in the clinical teaching environment.
3. A clinical instructor(s), who shall be responsible for supervising students according to objectives, shall be identified for each primary clinical education center.
4. The maximum student enrollment shall not exceed the capacity recommended on the basis of volume and variety of radiographic procedures, resources, and personnel available for teaching purposes.
5. In programs where didactic and clinical experience are not provided in the same institution, accreditation shall be given only to the institution responsible for admissions, curriculum, and academic credit. The accredited institution shall be responsible for coordinating the program and assuring that the activities assigned to the students in the clinical setting are educational. There shall be a uniform contract between the accredited institution and each of its affiliate hospitals, clearly defining the responsibilities and obligations of each.
1. The structure of the curriculum shall be based on not less than two calendar years of full-time study or its equivalent.
2. Instruction shall follow a planned outline that includes:
(a) The assignment of appropriate instructional materials;
(b) Classroom presentations, discussions and demonstrations; and
(c) Examinations in the didactic and clinical aspects of the program.
3. All professional courses, including clinical education, must include specific curriculum content that shall include, but shall not be limited to:
(a) Introduction to radiologic technology;
(b) Medical ethics;
(c) Imaging;
(d) Radiographic processing technique;
(e) Human structure and function;
(f) Medical terminology;
(g) Principals of radiographic exposure;
(h) Radiographic procedures;
(i) Principles of radiation protection;
(j) Radiographic film evaluation;
(k) Methods of patient care;
(l) Pathology;
(m) Radiologic physics; and
(n) Radiation biology.
Related subjects added to the professional curriculum shall meet the requirements of the degree-granting institution.
Financial resources for operation for the educational program shall be assured through regular budgets, gifts, grants, endowments, or fees.
1.
(a)
(b)
(2) Opportunities for continuing education shall be provided for all faculty members.
2.
(b)
3.
(a) Candidates for admission shall satisfy the following minimum requirements: Completion of four years of high school; successful completion of a standard equivalency test; or certification of equivalent education by an organization recognized by the United States Department of Education. Courses in physics, chemistry, biology, algebra, and geometry are strongly recommended.
(b) The number of students enrolled in each class shall be commensurate with the most effective learning and teaching practices and should also be consistent with acceptable student-teacher ratios.
Records shall be maintained as dictated by good educational practices.
Educational programs accredited by an organization recommended by the United States Department of Education are considered to have met these standards.
Sponsorship must be by an entity that assumes primary responsibility for the planning and conduct of competency-based didactic and clinical training in dental radiography.
1. This responsibility must include: defining the curriculum in terms of program goals, instructional objectives, learning experiences designed to achieve goals and objectives, and evaluation procedures to assess attainment of goals and objectives; coordinating classroom teaching and supervised clinical experiences; appointing faculty; receiving and processing applications for admission; and granting documents of successful completion of the program.
2. The formal training in dental radiography may be a part of a total program of dental hygiene education accredited by an organization recognized by the United States Department of Education.
3. The sponsoring entity and the dental radiography training must be approved by the State entity responsible for approving dental hygiene education programs or the State entity responsible for credentialing dental personnel in radiography.
Dental radiography training for dental hygienists must provide sufficient content and instructional time to assure competent performance.
1. The dental radiography curriculum content and learning experiences must include the theoretical aspects of the subject as well as practical application of techniques. The theoretical aspects should provide content necessary for dental hygienists to understand the critical nature of the radiological procedures they perform and of the judgments they make as related to patient and operator radiation safety.
2. The dental radiography curriculum must include content in seven areas: radiation physics; radiation biology; radiation health,
3. The curriculum must also include clinical practice assignments.
Evaluation procedures must be developed to assess performance and achievement of dental radiography program objectives.
The dental radiography training must be conducted by faculty who are qualified in the curriculum subject matter.
1. This may include a D.D.S./D.M.D. degree; graduation from an accredited dental assisting or dental hygiene education program with a certificate or an associate or baccalaureate degree; status as a Certified Dental Assistant certified by the Dental Assisting National Board; or recognition as equivalently qualified by the State entity which approved the training program in dental radiography.
2. The faculty-to-student ratio must be adequate to achieve the stated objectives of the curriculum.
Adequate radiographic facilities must be available to permit achievement of the dental radiography training objectives. The design, location, and construction of radiographic facilities must provide optimum protection from X-radiation for patients and operators. Equipment shall meet State and Federal laws related to radiation. Monitoring devices shall be worn by dental personnel. Lead aprons must be placed to protect patients. Safe storage for films must be provided. Darkroom facilities and equipment must be available and of a quality that assures that films will not be damaged or lost.
A wide range of printed materials, instructional aids, and equipment must be available to support instruction. Current specialized
Educational programs accredited by an organization recognized by the United States Department of Education are considered to have met these standards. Under existing licensure provisions in all States, becoming a dental hygienist requires graduation from a dental hygiene education program accredited by an organization recognized by the United States Department of Education. In lieu of this requirement, Alabama accepts graduation from a State-approved preceptorship program.
Sponsorship must be an entity that assumes primary responsibility for the planning and conduct of competency-based didactic and clinical training in dental radiography.
1. This responsibility must include: Defining the curriculum in terms of program goals, instructional objectives, learning experiences designed to achieve goals and objectives, and evaluation procedures to assess attainment of goals and objectives; coordinating classroom teaching and supervised clinical experiences; appointing faculty; receiving and processing applications for admission; and granting documents of successful completion of the program.
2. Dental radiography training may be freestanding (as a continuing education course offered by State dental/dental auxiliary societies, or by dental/dental auxiliary education programs); or be a part of an educational program in dental assisting. Such dental assisting education programs may be accredited by an organization recognized by the United States Department of Education; or located in a school accredited by an institutional accrediting agency recognized by the the United States Department of Education or approved by the State agency responsible for secondary and postsecondary education, or approved by a Federal agency conducting dental assistant education in that Agency.
3. The sponsoring entity and the dental radiography training must be approved by the State entity responsible for approving dental assisting education programs, or the State entity responsible for credentialing dental personnel in radiography.
Dental radiography training for dental assistants must provide sufficient content and instructional time to assure competent performance.
1. The dental radiography curriculum content and learning experiences must include the theoretical aspects of the subject as well as practical application of techniques. The theoretical aspects should provide content necessary for dental assistants to understand the critical nature of the radiological procedures they perform and of the judgments they make as related to patient and operator radiation safety.
2. The dental radiography curriculum must include content in seven areas: radiation physics; radiation biology; radiation health, safety, and protection; X-ray films and radiographic film quality; radiographic techniques; darkroom and processing techniques; and film mounting.
3. The curriculum must also include clinical practice assignments.
Evaluation procedures must be developed to assess performance and achievement of dental radiography program objectives.
The dental radiography training must be conducted by faculty who are qualified in the curriculum subject matter.
1. This may include a D.D.S./D.M.D. degree; graduation from an accredited dental assisting or dental hygiene education program with a certificate or an associate or baccalaureate degree; status as a Certified Dental Assistant certified by the Dental Assisting National Board; or recognition as equivalently qualified by the State entity (or Federal agency where appropriate) which approves the educational program in dental radiography.
2. The faculty-to-student ratio must be adequate to achieve the stated objectives of the curriculum.
Adequate radiographic facilities must be available to permit achievement of the dental radiography training objectives. The design, location, and construction of radiographic facilities must provide optimum protection from X-radiation for patients and operators. Equipment shall meet State and Federal laws related to radiation. Monitoring devices shall be worn by dental personnel. Lead aprons must be placed to protect patients. Safe storage for films must be provided. Darkroom facilities and equipment must be available and of a quality that assures that films will not be damaged or lost.
A wide range of printed materials, instructional aids, and equipment must be available to support instruction. Current specialized reference texts should be provided; and models, replicas, slides, and films which depict current techniques should be available for use in instruction. As appropriate self-instructional materials become available, they should be provided for the student's use.
Educational programs accredited by an organization recognized by the United States Department of Education are considered to have met these standards.
1. Accreditation will be granted to the institution that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and supervised clinical education; appoints faculty to the program; receives and processes applications for admission; and grants the degree or certificate documenting completion of the program.
2. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and universities;
(b) Hospitals and clinics;
(c) Laboratories;
(d) Medical schools;
(e) Postsecondary vocational/technical schools and institutions; and
(f) Other acceptable institutions which meet comparable standards.
3. The sponsoring institution and affiliate(s) must be accredited by a recognized agency. When the sponsoring institution and
4. Responsibilities of the sponsor and each affiliate for program administration, instruction, supervision, etc., must be carefully described in written affiliation agreements.
Instruction must follow a plan which documents:
1. A structured curriculum including clinical education with clearly written syllabi which describe learning objectives and competencies to be achieved. The curriculum shall be based on not less than one calendar year of full-time study or its equivalent.
2. The minimum professional curriculum that includes the following:
(a) Methods of patient care;
(b) Radiation safety and protection;
(c) Nuclear medicine physics;
(d) Radiation physics;
(e) Nuclear instrumentation;
(f) Statistics;
(g) Radionuclide chemistry;
(h) Radiopharmacology;
(i) Departmental organization and function;
(j) Radiation biology;
(k) Nuclear medicine
(l) Radionuclide therapy;
(m) Computer applications; and
(n) Clinical practicum.
3. Assignment of appropriate instructional materials.
4. Classroom presentations, discussions, and demonstrations.
5. Supervised practice, experience, and discussions. This shall include the following:
(a) Patient care and patient recordkeeping;
(b) Participation in the quality assurance program;
(c) The preparation, calculation, identification, administration, and disposal of radiopharmaceuticals;
(d) Radiation safety techniques that will minimize radiation exposure to the patient, public, fellow workers, and self;
(e) The performance of an adequate number and variety of imaging and non-imaging procedures; and
(f) Clinical correlation of nuclear medicine procedures.
6. Evaluation of student's knowledge, problem-solving skills, and motor and clinical competencies.
7. The competencies necessary for graduation.
1. The program must have qualified program officials. Primary responsibilities shall include program development, organization, administration, evaluation, and revision. The following program officials must be identified:
(a)
(2)
(b)
(2)
(c)
(1)
(2)
2.
(b)
(c)
(d)
3. Financial resoures for continued operation of the educational program must be assured.
4.
(b)
(c)
(d)
5.
Persons admitted into nuclear medicine technology programs shall have completed high school or its equivalent. They shall have completed postsecondary courses in the following areas:
(1) Human anatomy and physiology;
(2) Physics;
(3) Mathematics;
(4) Medical terminology;
(5) Oral and written communications;
(6) General chemistry; and
(7) Medical ethics.
Prerequisites may be completed during nuclear medicine training. Educational institutions such as junior colleges, universities, and technical vocational institutes may provide these prerequisite courses as part of an integrated program in nuclear medicine technology (i.e., two to four years).
Students may not take the responsibility nor the place of qualified staff. However, students may be permitted to perform procedures after demonstrating proficiency, with careful supervision.
1. Periodic and systematic review of the program's effectiveness must be documented.
2. One element of program evaluation shall be the initial employment of graduates of the program.
Educational programs accredited by an organization recognized by the United States Department of Education are considered to have met these standards.
1. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and universities;
(b) Hospitals, clinics, or autonomous radiation oncology centers meeting the criteria for major cancer management centers or meeting demonstrably equivalent standards;
(c) Medical schools; and
(d) Postsecondary vocational/technical schools and institutions.
2. The sponsoring institution and affiliates, if any, must be accredited by recognized agencies or meet equivalent standards. When more than one clinical education center is used, each must meet the standards of a major cancer management center.
3. When didactic preparation and supervised clinical education are not provided in the same institution, accreditation must be obtained by the sponsoring institution for the total program. This institution will be the one responsible for admission, curriculum, and academic credit. The accredited institution shall be responsible for coordinating the program and assuring that the activities assigned to the student in the clinical setting are educational. There shall be a uniform, written, affiliation agreement between the accredited institution and each clinical education center, clearly defining the responsibilities and obligations of each.
Educational programs of 24 months and 12 months or their equivalents may be developed. A 24-month program shall admit those candidates with a high school diploma (or equivalent) as outlined in D.1. The 12-month program shall be designed for those students admitted with backgrounds as outlined in D.2.
Instruction must follow a plan which documents:
1. A structured curriculum with clearly written course syllabi which describe competencies and learning objectives to be achieved. The curriculum shall include but not necessarily be limited to the following:
(a) Orientation to radiation therapy technology;
(b) Medical ethics and law;
(c) Methods of patient care;
(d) Medical terminology;
(e) Human structure and function;
(f) Oncologic pathology;
(g) Radiation oncology;
(h) Radiobiology;
(i) Mathematics;
(j) Radiation physics;
(k) Radiation protection;
(l) Radiation oncology technique;
(m) Radiographic imaging; and
(n) Clinical dosimetry.
2. Assignment of appropriate instructional materials.
3. Classroom presentations, discussions, and demonstrations.
4. Supervised clinical education and laboratory practicum.
5. Evaluation of students to assess knowledge, problem-solving skills, and motor and clinical competencies.
6. Program graduates must demonstrate competencies including, but not limited to, the following:
(a) Practice oral and written communications;
(b) Maintain records of treatment administered;
(c) Perform basic mathematical functions;
(d) Demonstrate knowledge of human structure, function, and pathology;
(e) Demonstrate knowledge of radiation physics in radiation interactions and radiation protection techniques;
(f) Provide basic patient care and cardiopulmonary resuscitation;
(g) Deliver a planned course of radiation therapy;
(h) Verify physician's prescribed course of radiation therapy and recognize errors in computation;
(i) Demonstrate awareness of patterns of physical and emotional stress exhibited by patients;
(j) Produces and utilize immobilization and beam directional devices;
(k) Prepare commonly used brachytherapy sources;
(l) Demonstrate knowledge of methods of calibration of equipment, and quality assurance;
(m) Prepare isodose summations;
(n) Detect malfunctioning equipment;
(o) Apply rules and regulations for radiation safety, and detect defects which might pose a radiation hazard;
(p) Understand the function of equipment and accessories;
(q) Demonstrate knowledge of methods of continuing patient evaluation (follow up);
(r) Apply wedge and compensating filters;
(s) Recognize patients' clinical progress, complications, and demonstrate knowledge of when to withhold treatment until consultation with the physician; and
(t) Interact with patients and families concerning the physical and psychological needs of patients.
1.
(a)
(2)
(b)
(1)
(2)
(c)
(1)
(2)
2.
(b)
(c)
(d)
3.
4.
(b)
(c)
(d)
(e)
5.
1. Applicants must be high school graduates (or equivalent) with an educational background in basic science and mathematics.
2. For admission to a 12-month program, the candidate must satisfy one of the following requirements:
(a) Graduation from an accredited or equivalent program in radiography.
(b) Successful completion or challenge of courses in the following prerequisite content areas:
(c) Successful demonstration of the following competencies:
1. A process for periodic and systematic review of the program's effectiveness must be documented and reflected in policies.
2. Program evaluation shall include the employment performance of recent graduates.
The following section describes basic elements to be incorporated in credentialing programs of States that choose to regulate personnel who perform radiologic procedures.
1. Only eligible applicants who have passed the licensure examination shall be licensed as Radiographers, Nuclear Medicine Technologists, or Radiation Therapy Technologists.
2. Licenses shall be renewed at periodic intervals.
1. For regular eligibility to take the licensure examination, applicants shall have successfully completed an accredited program of formal education in radiography, nuclear medicine technology, or radiation therapy technology.
2. Special eligibility to take the licensure examination shall be provided for applicants whose training and/or experience are equal
A criterion-referenced examination in radiography, nuclear medicine technology, or radiation therapy technology shall be utilized to test the knowledge and competencies of applicants.
The licensed Radiographer, Nuclear Medicine Technologist, or Radiation Therapy Technologist shall maintain continuing competency in the area in which he/she is practicing.
An organization that seeks to be recognized for the certifying of personnel shall adopt definite policies to ensure validity, objectivity, and fairness in the certifying process. The National Commission for Health Certifying Agencies (NCHCA) has published suitable criteria for a certifying organization to adopt with respect to policies for: (1) Determination of appropriate examination content (but not the actual content for any specific occupation); (2) construction of examinations; (3) administration of examinations; and (4) fulfilling responsibilities to applicants. An organization (whether an NCHCA member or not) that adopts these or equivalent criteria will meet all of the requirements of this section of these standards.
The following section describes basic elements to be incorporated in credentialing programs of States that choose to regulate personnel who perform radiologic procedures.
Currently, Dental Hygienists are credentialed through individual State licensure processes, all of which include assessment of competence in dental radiography. In all States, Dental Hygienists are required to be licensed prior to practicing. The existing State dental hygiene licensure processes meet the intent and purpose of the Consumer-Patient Radiation Health and Safety Act of 1981 and the standards for licensing Dental Hygienists in dental radiography set forth below.
1. To those who have passed a licensure or designated dental radiography examination, a license or permit shall be issued by the State entity responsible for credentialing dental personnel.
2. Licenses or permits shall be renewed at periodic intervals.
1. An individual shall provide proof of graduating student status or graduation from an accredited or approved dental hygiene or dental assisting education program.
2. For dental assistants, special eligibility to take the examination shall be provided to applicants with appropriate combinations of training and/or experience.
A criterion-referenced examination in dental radiography shall be utilized to test the knowledge and competencies of applicants.
The Dental Hygienist or Dental Assistant shall be required to maintain continuing competency in the area in which he/she is practicing.
An organization that seeks to be recognized for the certifying of personnel shall adopt definite policies to ensure validity, objectivity, and fairness in the certifying process. The National Commission for Health Certifying Agencies (NCHCA) has published suitable criteria for a certifying organization to adopt with respect to policies for: (1) Determination of appropriate examination content (but not the actual content for any specific occupation); (2) construction of examinations; (3) administration of examinations; and (4) fulfilling responsibilities to applicants. An organization (whether an NCHCA member or not) that adopts these or equivalent criteria will meet all of the requirements of this section of these standards.
Sec. 501, 65 Stat. 290; 31 U.S.C. 483a.
The provisions of this subpart set forth the policies of the National Institute for Occupational Safety and Health with respect to its charging fees for direct training in occupational safety or health.
Any term not defined herein shall have the same meaning as given it in the act. As used in this subpart:
(a)
(b)
(c)
(d)
In accordance with the provisions of the subpart, the National Institute for Occupational Safety and Health will charge fees for all students attending NIOSH direct training courses which commence on or after July 1, 1973.
(a) Tuition fees will be computed on the basis of the cost to the Government for the Institute's participation in the course, as determined by the Director of the Institute.
(b) Total tuition charges for each course will be set forth in the course announcement.
(a) Applications for direct training courses shall be completed and submitted to the registration office in accordance with the instructions issued by that office.
(b) Federal agency personnel shall, upon notification of their acceptance, submit a letter identifying the agency and office to be billed, the agency order number, and any code numbers or other information necessary for billing purposes.
(c) All other applicants shall, upon notification of their acceptance by NIOSH, submit a check payable to the National Institute for Occupational Safety and Health in the amount indicated by the course announcement prior to the commencement of the training course.
An applicant may withdraw his application and receive full reimbursement of the fee provided that written notification to the registration office is mailed no later than 10 days before the commencement of the course for which registration has been submitted.
42 U.S.C. 7384n(c); E.O. 13179, 65 FR 77487, 3 CFR, 2000 Comp., p. 321.
The Energy Employees Occupational Illness Compensation Program Act (EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the payment of compensation benefits to covered employees and, where applicable, survivors of such employees, of the United States Department of Energy, its predecessor agencies and certain of its contractors and subcontractors. Among the types of illnesses for which compensation may be provided are cancers. There are two categories of covered employees with cancer under EEOICPA for whom compensation may be provided. The regulations that follow under this part apply only to the category of employees described under paragraph (a) of this section.
(a) One category is employees with cancer for whom probability of causation must be estimated or determined, as required under 20 CFR 30.115.
(b) The second category is members of the Special Exposure Cohort seeking compensation for a specified cancer, as defined under EEOICPA. The U.S. Department of Labor (DOL) which has primary authority for implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 et seq. that identify current members of the Special Exposure Cohort and requirements for compensation. Pursuant to section 7384(q) of EEOICPA, the Secretary of HHS is authorized to add additional classes of employees to the Special Exposure Cohort.
(a) The purpose of this regulation is to establish guidelines DOL will apply to adjudicate cancer claims for covered employees seeking compensation for cancer, other than as members of the Special Exposure Cohort seeking compensation for a specified cancer. To award a claim, DOL must first determine that it is at least as likely as not that the cancer of the employee was caused by radiation doses incurred by the employee in the performance of duty. These guidelines provide the procedures DOL must apply and identify the information DOL will use.
(b) Section 7384(n)(b) of EEOICPA requires the President to promulgate these guidelines. Executive Order 13179 assigned responsibility for promulgating these guidelines to the Secretary of HHS.
EEOICPA imposes several general requirements concerning the development of these guidelines. It requires that the guidelines produce a determination as to whether it is at least as likely as not (a 50% or greater probability) that the cancer of the covered employee was related to radiation doses incurred by the employee in the performance of duty. It requires the guidelines be based on the radiation dose received by the employee, incorporating the methods of dose reconstruction to be established by HHS. It requires determinations be based on the upper 99 percent confidence interval (credibility limit) of the probability of causation in the RadioEpidemiological tables published under section 7(b) of the Orphan Drug Act (42 U.S.C. 241 note), as such tables may be updated. EEOICPA also requires HHS consider the type of cancer, past health-related activities, the risk of developing a radiation-related cancer from workplace exposure, and other relevant factors. Finally, it is important to note EEOICPA does not include a requirement limiting the types of cancers to be considered radiogenic for these guidelines.
(a) Covered employee, for purposes of this part, means an individual who is or was an employee of DOE, a DOE contractor or subcontractor, or an atomic weapons employer, and for whom DOL has requested HHS to perform a dose reconstruction.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(t)
(u)
(v)
Determining probability of causation may require the use of the following personal and medical information provided to DOL by claimants under DOL regulations 20 CFR part 30:
(a) Year of birth
(b) Cancer diagnosis (by ICD-9 code) for primary and secondary cancers
(c) Date of cancer diagnosis
(d) Gender
(e) Race/ethnicity (if the claim is for skin cancer or a secondary cancer for which skin cancer is a likely primary cancer)
(f) Smoking history (if the claim is for lung cancer or a secondary cancer for which lung cancer is a likely primary cancer)
Determining probability of causation will require the use of radiation dose information provided to DOL by the National Institute for Occupational Safety and Health (NIOSH) under HHS regulations 42 CFR part 82. This information will include annual dose estimates for each year in which a dose was incurred, together with uncertainty distributions associated with
(a) The risk models used to estimate probability of causation for covered employees under EEOICPA will be based on risk models updated from the 1985 NIH Radioepidemiological Tables. These 1985 tables were developed from analyses of cancer mortality risk among the Japanese atomic bomb survivor cohort. The National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are updating the tables, replacing them with a sophisticated analytic software program. This program, the Interactive RadioEpidemiological Program (IREP)
(b) NIOSH will change the risk models in IREP, as needed, to reflect the radiation exposure and disease experiences of employees covered under EEOICPA, which differ from the experiences of the Japanese atomic bomb survivor cohort. Changes will be incorporated in a version of IREP named NIOSH-IREP, specifically designed for adjudication of claims under EEOICPA. Possible changes in IREP risk models include the following:
(1) Addition of risk models to IREP, as needed, for claims under EEOICPA (e.g., malignant melanoma and other skin cancers)
(2) Modification of IREP risk models to incorporate radiation exposures unique to employees covered by EEOICPA (e.g., radon and low energy x rays from employer-required medical screening programs, adjustment of relative biological effectiveness distributions based on neutron energy).
(3) Modification of IREP risk models to incorporate new understanding of radiation-related cancer effects relevant to employees covered by EEOICPA (e.g., incorporation of inverse dose-rate relationship between high LET radiation exposures and cancer; adjustment of the low-dose effect reduction factor for acute exposures).
(4) Modification of IREP risk models to incorporate new understanding of the potential interaction between cancer risk associated with occupational exposures to chemical carcinogens and radiation-related cancer effects.
(5) Modification of IREP risk models to incorporate temporal, race and ethnicity-related differences in the frequency of certain cancers occurring generally among the U.S. population.
(6) Modifications of IREP to facilitate improved evaluation of the uncertainty distribution for the probability of causation for claims based on two or more primary cancers.
(a) EEOICPA requires use of the uncertainty associated with the probability of causation calculation, specifically requiring the use of the upper 99% confidence interval (credibility limit) estimate of the probability of causation estimate. As described in the NCI document,
(b) NIOSH-IREP will operate according to the same general protocol as IREP for the analysis of uncertainty. It will address the same possible sources of uncertainty affecting probability of causation estimates, and in most cases will apply the same assumptions incorporated in IREP risk models. Different procedures and assumptions will be incorporated into NIOSH-IREP as needed, according to the criteria outlined under § 81.10.
(a) NIOSH may periodically revise NIOSH-IREP to add, modify, or replace cancer risk models, improve the modeling of uncertainty, and improve the functionality and user-interface of NIOSH-IREP.
(b) Revisions to NIOSH-IREP may be recommended by the following sources:
(1) NIOSH,
(2) The Advisory Board on Radiation and Worker Health,
(3) Independent reviews of NIOSH-IREP or elements thereof by scientific organizations (e.g., National Academy of Sciences),
(4) DOL,
(5) Public comment.
(c) NIOSH will submit substantive changes to NIOSH-IREP (changes that would substantially affect estimates of probability of causation calculated using NIOSH-IREP, including the addition of new cancer risk models) to the Advisory Board on Radiation and Worker Health for review. NIOSH will obtain such review and address any recommendations of the review before completing and implementing the change.
(d) NIOSH will inform the public of proposed changes provided to the Advisory Board for review. HHS will provide instructions for obtaining relevant materials and providing public comment in the notice announcing the Advisory Board meeting, published in the
(e) NIOSH will publish periodically a notice in the
(f) NIOSH will notify DOL and publish a notice in the
(g) NIOSH may take into account other factors and employ other procedures than those specified in this section, if circumstances arise that require NIOSH to implement a change more immediately than the procedures in this section allow.
(a) NIOSH-IREP is an interactive software program for estimating probability of causation for covered employees seeking compensation for cancer under EEOICPA, other than as members of the Special Exposure Cohort seeking compensation for a specified cancer.
(b) DOL is required to use NIOSH-IREP to estimate probability of causation for all cancers, as identified under §§ 81.21 and 81.23.
(a) DOL will calculate probability of causation for all cancers, except chronic lymphocytic leukemia as provided under § 81.30, using NIOSH-IREP.
(b) Carcinoma in situ (ICD-9 codes 230-234), neoplasms of uncertain behavior (ICD-9 codes 235-238), and neoplasms of unspecified nature (ICD-9 code 239) are assumed to be malignant,
(c) All secondary and unspecified cancers of the lymph node (ICD-9 code 196) shall be considered secondary cancers (cancers resulting from metastasis of cancer from a primary site). For claims identifying cancers of the lymph node, Table 1 in § 81.23 provides guidance for assigning a primary site and calculating probability of causation using NIOSH-IREP.
DOL will use procedures specified in the NIOSH-IREP Operating Guide to calculate probability of causation estimates under EEOICPA. The guide provides current, step-by-step instructions for the operation of IREP. The procedures include entering personal, diagnostic, and exposure data; setting/confirming appropriate values for variables used in calculations; conducting the calculation; and, obtaining, evaluating, and reporting results.
(a) In claims for which the primary cancer site cannot be determined, but a site of metastasis is known, DOL will calculate probability of causation estimates for various likely primary sites. Table 1, below, indicates the primary cancer site(s) DOL will use in NIOSH-IREP when the primary cancer site is unknown.
Primary cancers (ICD-9 codes
(b) DOL will select the site producing the highest estimate for probability of causation to adjudicate the claim.
(a) For claims involving leukemia, DOL will calculate one or more probability of causation estimates from up to three of the four alternate leukemia risk models included in NIOSH-IREP, as specified in the NIOSH-IREP Operating Guide. These include: “Leukemia, all types except CLL” (IDC-9 codes: 204-208, except 204.1), “acute lymphocytic leukemia” (ICD-9 code: 204.0), and “acute myelogenous leukemia” (ICD-9 code: 205.0).
(b) For leukemia claims in which DOL calculates multiple probability of causation estimates, as specified in the NIOSH-IREP Operating Guide, the probability of causation estimate DOL assigns to the claim will be based on the leukemia risk model producing the highest estimate for probability of causation.
For claims including two or more primary cancers, DOL will use NIOSH-IREP to calculate the estimated probability of causation for each cancer individually. Then DOL will perform the following calculation using the probability of causation estimates produced by NIOSH-IREP:
The following cancers are considered non-radiogenic for the purposes of EEOICPA and this part. DOL will assign a probability of causation of zero to the following cancers:
(a) Chronic lymphocytic leukemia (ICD-9 code: 204.1)
(b) [Reserved]
42 U.S.C. 7384n(d) and (e); E.O. 13179, 65 FR 77487, 3 CFR, 2000 Comp., p. 321.
The Energy Employees Occupational Illness Compensation Program Act (EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the payment of compensation benefits to covered employees and, where applicable, survivors of such employees, of the United States Department of Energy (“DOE”), its predecessor agencies and certain of its contractors and subcontractors. Among the types of illnesses for which compensation may be provided are cancers. There are two categories of covered employees with cancer under EEOICPA for whom compensation may be provided. The regulations that follow under this part apply only to the category of employees described under paragraph (a) of this section.
(a) One category is employees with cancer for whom a dose reconstruction must be conducted, as required under 20 CFR 30.115.
(b) The second category is members of the Special Exposure Cohort seeking compensation for a specified cancer, as defined under EEOICPA. The U.S. Department of Labor (DOL) which has primary authority for implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 and 30.213 that identify current members of the Special Exposure Cohort and requirements for compensation. Pursuant to section 3626 of EEOICPA, the Secretary of HHS is authorized to add additional classes of employees to the Special Exposure Cohort.
The purpose of this part is to provide methods for determining a reasonable estimate of the radiation dose received by a covered employee with cancer under EEOICPA, through the completion of a dose reconstruction. These methods will be applied by the National Institute for Occupational Safety and Health (NIOSH) in a dose reconstruction program serving claimants under EEOICPA, as identified under § 82.0.
The basic principle of dose reconstruction is to characterize the radiation environments to which workers were exposed and to then place each worker in time and space within this exposure environment. Then methods are applied to translate exposure to radiation into quantified radiation doses at the specific organs or tissues relevant to the types of cancer occurring among the workers. A hierarchy of
(a) If found to be complete and adequate, individual worker monitoring data, such as dosimeter readings and bioassay sample results, are given the highest priority in assessing exposure. These monitoring data are interpreted using additional data characterizing the workplace radiation exposures. If radiation exposures in the workplace environment cannot be fully characterized based on available data, default values based on reasonable and scientific assumptions may be used as substitutes. For dose reconstructions conducted in occupational illness compensation programs, this practice may include use of assumptions that represent the worst case conditions. For example, if the solubility classification of an inhaled material can not be determined, the dose reconstruction would use the classification that results in the largest dose to the organ or tissue relevant to the cancer and that is possible given existing knowledge of the material and process.
(b) If individual monitoring data are not available or adequate, dose reconstructions may use monitoring results for groups of workers with comparable activities and relationships to the radiation environment. Alternatively, workplace area monitoring data may be used to estimate the dose. As with individual worker monitoring data, workplace exposure characteristics are used in combination with workplace monitoring data to estimate dose.
(c) If neither adequate worker nor workplace monitoring data are available, the dose reconstruction may rely substantially on process description information to analytically develop an exposure model. For internal exposures, this model includes such factors as the quantity and composition of the radioactive substance (the source term), the chemical form, particle size distribution, the level of containment, and the likelihood of dispersion.
(a) Dose reconstructions are to be conducted for the following covered employees with cancer seeking compensation under EEOICPA: An employee who was not monitored for exposure to radiation at DOE or Atomic Weapons Employer (AWE) facilities; an employee who was monitored inadequately for exposure to radiation at such facilities; or an employee whose records of exposure to radiation at such facility are missing or incomplete. Technical limitations of radiation monitoring technology and procedures will require HHS to evaluate each employee's recorded dose. In most, if not all cases, monitoring limitations will result in possibly undetected or unrecorded doses, which are estimated using commonly practiced dose reconstruction methods and would have to be added to the dose record.
(b) Section 7384(n)(e) of EEOICPA requires the reporting of radiation dose information resulting from dose reconstructions to the covered employees for whom claims are being adjudicated. DOE is specifically charged with this responsibility but the Department of Health and Human Services (HHS), which will be producing the dose reconstruction information, will report its findings directly to the claimant, as well as to DOL and DOE. HHS will also make available to researchers and the general public information on the assumptions, methodology, and data used in estimating radiation doses, as required by EEOICPA.
Under 42 CFR part 81, DOL will apply dose reconstruction results together with information on cancer diagnosis and other personal information provided to DOL by the claimant to calculate an estimated probability of causation. This estimate is the probability that the cancer of the covered employee was caused by radiation exposure at a covered facility of DOE or an Atomic Weapons Employer (AWE).
(a)
(1) processed or produced, for use by the United States, material that emitted radiation and was used in the production of an atomic weapon, excluding uranium mining and milling; and,
(2) is designated by the Secretary of Energy as an atomic weapons employer for purposes of EEOICPA.
(b)
(c)
(d)
(e)
(1) In which operations are, or have been, conducted by, or on behalf of, the DOE (except for buildings, structures, premises, grounds, or operations covered by Executive Order 12344, dated February 1, 1982, pertaining to the Naval Nuclear Propulsion Program); and,
(2) With regard to which the DOE has or had:
(i) A proprietary interest; or,
(ii) Entered into a contract with an entity to provide management and operation, management and integration, environmental remediation services, construction, or maintenance services; or
(3) A facility owned by an entity designated by the Secretary of Energy as an atomic weapons employer for purposes of EEOICPA that is or was used to process or produce, for use by the United States, material that emitted radiation and was used in the production of an atomic weapon, excluding uranium mining or milling.
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(a) Upon receipt of a claims package from the Department of Labor, as provided under 20 CFR part 30, NIOSH will request from DOE records on radiation dose monitoring and radiation exposures associated with the employment history of the covered employee. Additionally, NIOSH may compile data, and information from NIOSH records that may contribute to the dose reconstruction. For each dose reconstruction, NIOSH will include records relevant to internal and external exposures to ionizing radiation, including exposures from medical screening x rays that were required as a condition of employment.
(b) NIOSH will evaluate the initial radiation exposure record compiled to: Reconcile the exposure record with the reported employment history, as necessary; complete preliminary calculations of dose, based upon this initial record, and prepare to consult with the claimant. Any discrepancies in the employment history information will be reconciled with the assistance of DOE, as necessary.
(c) NIOSH will interview the claimant. The interview may be conducted in one or more sessions. The purpose of the interview is to:
(1) Explain the dose reconstruction process;
(2) Confirm elements of the employment history transmitted to NIOSH by DOL;
(3) Identify any relevant information on employment history that may have been omitted;
(4) Confirm or supplement monitoring information included in the initial radiation exposure record;
(5) Develop detailed information on work tasks, production processes, radiologic protection and monitoring practices, and incidents that may have resulted in undocumented radiation exposures, as necessary;
(6) Identify co-workers and other witnesses with information relevant to the radiation exposures of the covered worker to supplement or confirm information on work experiences, as necessary.
(d) NIOSH will provide a report to the claimant summarizing the findings of the interview, titled: “NIOSH Claimant Interview under EEOICPA.” The report will also notify the claimant of the opportunity to contact NIOSH if necessary, by a specified date, to make any written corrections or additions to information provided by the claimant during the interview process.
(e) Information provided by the claimant will be accepted and used for dose reconstruction, providing it is reasonable, supported by substantial evidence, and is not refuted by other evidence. In assessing whether the information provided by the claimant is
(1) Consistency of the information with other information in the possession of NIOSH, from radiation safety programs, research, medical screening programs, labor union documents, worksite investigations, dose reconstructions conducted by NIOSH under EEOICPA, or other reports relating to the circumstances at issue;
(2) Consistency of the information with medical records provided by the claimant;
(3) Consistency of the information with practices or exposures demonstrated by the dose reconstruction record developed for the claimant; and,
(4) Confirmation of information by co-workers or other witnesses.
(f) NIOSH will seek to confirm information provided by the claimant through review of available records and records requested from DOE.
(g) As necessary, NIOSH will request additional records from DOE to characterize processes and tasks potentially involving radiation exposure for which dose and exposure monitoring data is incomplete or insufficient for dose reconstruction.
(h) NIOSH will review the adequacy of monitoring data and completeness of records provided by DOE. NIOSH will request certification from DOE that record searches requested by NIOSH have been completed.
(i) As necessary, NIOSH will characterize the internal and external exposure environments for parameters known to influence the dose. For internal exposures, examples of these parameters include the mode of intake, the composition of the source term (i.e., the radionuclide type and quantity), the particle size distribution and the absorption type. When it is not possible to characterize these parameters, NIOSH may use default values, when they can be established reasonably, fairly, and based on relevant science. For external exposures, the radiation type (gamma, x-ray, neutron, beta, or other charged particle) and radiation energy spectrum will be evaluated. When possible, the effect of non-uniformity and geometry of the radiation exposure will be assessed.
(j) For individual monitoring records that are incomplete, NIOSH may assign doses using techniques discussed in § 82.16. Once the resulting data set is complete, NIOSH will construct an occupational exposure matrix, using the general hierarchical approach discussed in § 82.2. This matrix will contain the estimated annual equivalent dose(s) to the relevant organ(s) or tissue(s), for the period from the initial date of potential exposure at a covered facility until the date the cancer was diagnosed. The equivalent dose(s) will be calculated using the current, standard radiation weighting factors from the International Commission on Radiological Protection.
(k) At any point during steps of dose reconstruction described in paragraphs (f) through (j) of this section, NIOSH may determine that sufficient research and analysis has been conducted to complete the dose reconstruction. Research and analysis will be determined sufficient if one of the following three conditions is met:
(1) From acquired experience, it is evident the estimated cumulative dose is sufficient to qualify the claimant for compensation (
(2) Dose is determined using worst-case assumptions related to radiation exposure and intake, to substitute for further research and analyses; or,
(3) Research and analysis indicated under steps described in paragraphs (f)-(j) of this section have been completed. Worst-case assumptions will be employed under condition 2 to limit further research and analysis only for claims for which it is evident that further research and analysis will not produce a compensable level of radiation dose (a dose producing a probability of causation of 50% or greater), because using worst-case assumptions it can be determined that the employee could not have incurred a compensable level of radiation dose. For all claims in which worst-case assumptions are
(l) After providing the claimant with a copy of a draft of the dose reconstruction report to be provided to DOL, NIOSH will conduct a closing interview with the claimant to review the dose reconstruction results and the basis upon which the results were calculated. This will be the final opportunity during the dose reconstruction process for the claimant to provide additional relevant information that may affect the dose reconstruction. The closing interview may require multiple sessions, if the claimant requires time to obtain and provide additional information, and to allow NIOSH time to integrate the new information into a new draft of the dose reconstruction report. NIOSH will determine whether to grant requests for time to provide additional information, based on whether the requests are reasonable and the claimant is actively seeking the information specified.
(m) Subject to any additional information provided by the claimant and revision of the draft dose reconstruction report under § 82.10(l), the claimant is required to return form OCAS-1 to NIOSH, certifying that the claimant has completed providing information and that the record for dose reconstruction should be closed. Upon receipt of the form, NIOSH will forward a final dose reconstruction report to DOL, DOE, and to the claimant.
(n) NIOSH will not forward the dose reconstruction report to DOL for adjudication without receipt of form OCAS-1 signed by the claimant or a representative of the claimant authorized pursuant to 20 CFR 30.600. If the claimant or the authorized representative of the claimant fails to sign and return form OCAS-1 within 60 days, or 60 days following the claimant's final provision of additional information and receipt of a revised draft dose reconstruction report under § 82.10 (l), whichever occurs last, after notifying the claimant or the authorized representative, NIOSH may administratively close the dose reconstruction and notify DOL of this action. Upon receiving this notification by NIOSH, DOL may administratively close the claim.
(o) Once actions under § 82.10 (m) are completed, the record for dose reconstruction shall be closed unless reopened at the request of DOL under 20 CFR part 30.
NIOSH will conduct a dose reconstruction for each claim determined by DOL to be a claim for a covered employee with cancer under DOL regulations at 20 CFR 30.210(b), subject to the limitation and exception noted in § 82.12. Claims for covered employees who are members of the Special Exposure Cohort seeking compensation for a specified cancer, as determined by DOL under 20 CFR 30.210(a), do not require and will not receive a dose reconstruction under this rule.
It is uncertain whether adequate information of the types outlined under § 82.14 will be available to complete a dose reconstruction for every claim eligible under § 82.11.
(a) NIOSH will notify in writing any claimants for whom a dose reconstruction cannot be completed once that determination is made, as well as in the closing interview provided for under § 82.10(l).
(b) Notification will describe the basis for finding a dose reconstruction cannot be completed, including the following:
(1) A summary of the information obtained from DOE and other sources; and, (2) a summary of necessary information found to be unavailable from DOE and other sources.
(c) NIOSH will notify DOL and DOE when it is unable to complete a dose reconstruction for the claimant. This will result in DOL producing a recommended decision to deny the claim, since DOL cannot determine probability of causation without a dose estimate produced by NIOSH under this rule.
(d) A claimant for whom a dose reconstruction cannot be completed, as indicated under this section, may have recourse to seek compensation under provisions of the Special Exposure Cohort (see 20 CFR part 30). Pursuant to section 7384q of EEOICPA, the Secretary of HHS is authorized to add classes of employees to the Special Exposure Cohort. NIOSH will provide the claimant with any information and forms that HHS provides to classes of employees seeking to petition to be added to the Special Exposure Cohort.
NIOSH will use the following sources of information for dose reconstructions, as necessary:
(a) DOE and its contractors, including Atomic Weapons Employers and the former worker medical screening program;
(b) NIOSH and other records from health research on DOE worker populations;
(c) Interviews and records provided by claimants;
(d) Co-workers of covered employees, or others with information relevant to the covered employee's exposure, that the claimant identified during the initial interview with NIOSH;
(e) Labor union records from unions representing employees at covered facilities of DOE or AWEs; and,
(f) Any other relevant information.
NIOSH will obtain the types of information described in this section for dose reconstructions, as necessary and available:
(a)
(1) Gender;
(2) Date of birth; and,
(3) DOE and/or AWE employment history, including: job title held by year, and work location(s): including site names(s), building numbers(s), technical area(s), and duration of relevant employment or tasks.
(b)
(1) External dosimetry data, including external dosimeter readings (film badge, TLD, neutron dosimeters); and,
(2) Pocket ionization chamber data.
(c)
(1) Urinalysis results;
(2) Fecal sample results;
(3) In Vivo measurement results;
(4) Incident investigation reports;
(5) Breath radon and/or thoron results;
(6) Nasal smear results;
(7) External contamination measurements; and
(8) Other measurement results applicable to internal dosimetry.
(d)
(1) Analytical methods used for bioassay analyses;
(2) Performance characteristics of dosimeters for different radiation types;
(3) Historical detection limits for bioassay samples and dosimeter badges;
(4) Bioassay sample and dosimeter collection/exchange frequencies;
(5) Documentation of record keeping practices used to record data and/or administratively assign dose; and,
(6) Other information to characterize the monitoring program procedures and evaluate monitoring results.
(e)
(1) Surface contamination surveys;
(2) General area air sampling results;
(3) Breathing zone air sampling results;
(4) Radon and/or thoron monitoring results;
(5) Area radiation survey measurements (beta, gamma and neutron); and,
(6) Fixed location dosimeter results (beta, gamma and neutron); and,
(7) Other workplace monitoring results.
(f)
(1) Information on the external exposure environment, including: radiation type (gamma, x-ray, proton, neutron, beta, other charged particle); radiation energy spectrum; uniformity of exposure (whole body vs partial body exposure); irradiation geometry;
(2) Information on work-required medical screening x rays; and,
(3) Other information useful for characterizing workplace radiation exposures.
(g)
(1) Radionuclide(s) and associated chemical forms;
(2) Results of particle size distribution studies;
(3) Respiratory protection practices; and
(4) Other information useful for characterizing internal exposures.
(h)
(1) General description of the process;
(2) Characterization of the source term (i.e., the radionuclide and its quantity);
(3) Extent of encapsulation;
(4) Methods of containment;
(5) Other information to assess potential for irradiation by source or airborne dispersion radioactive material.
(a) NIOSH will evaluate the completeness and adequacy of an individual's monitoring data provided by DOE through one or more possible measures including, but not limited to:
(1) Comparisons with information provided by claimants, co-workers, and other witnesses;
(2) Comparisons with available information on area monitoring, production processes, and radiologic protection programs;
(3) Comparisons with information documented in the records of unions representing covered employees;
(4) Comparisons with data available on co-workers; and
(5) Reviews of DOE contractor record systems.
(b) NIOSH will evaluate the instruments and procedures used to collect individual monitoring data to determine whether they adequately characterized the radiation environments in which the covered employee worked, (adequately for the purpose of dose reconstruction,) based on present-day scientific understanding. For external dosimeter measurements, this includes an evaluation of the dosimeter response to the radiation types (gamma, x-ray, neutron, beta, or other charged particle) and the associated energy spectrum. For internal exposure, the methods used to analyze bioassay samples will be reviewed to determine their ability to detect the radionuclides present in the work environment. An analysis of the monitoring or exchange frequencies for the monitoring programs will also be conducted to determine the potential for undetected dose.
(a) For external dosimeter results that are incomplete due to historical record keeping practices, NIOSH will use commonly practiced techniques, such as those described in the NIOSH Research Issues Workshop,
(b) NIOSH will review historical bioassay sample detection limits and monitoring frequencies to determine, when possible, the minimum detectable dose for routine internal dose monitoring programs. This “missed dose” will establish the upper limit of internal dose that a worker could have received for periods when bioassay sample analysis results were below the detection limit. Using ICRP biokinetic models, NIOSH will estimate the internal dose and include an associated uncertainty distribution.
Three types of information could be used:
(a) Monitoring data from co-workers, if NIOSH determines they had a common relationship to the radiation environment; or,
(b) A quantitative characterization of the radiation environment in which the covered employee worked, based on an analysis of historical workplace monitoring information such as area dosimeter readings, general area radiation and radioactive contamination survey results, air sampling data; or,
(c) A quantitative characterization of the radiation environment in which the employee worked, based on analysis of data describing processes involving radioactive materials, the source materials, occupational tasks and locations, and radiation safety practices.
(a) The calculation of dose from ingested, inhaled or absorbed radioactivity involves the determination of the types and quantities of radionuclides that entered the body. NIOSH will use the results of all available bioassay monitoring information as appropriate, based on assessment of the technical characteristics of the monitoring program. If bioassay monitoring data are unavailable or inadequate, the dose reconstruction will rely on the results of air sampling measurements, radiation sources, work processes and practices, and incidents involving radiation contamination, as necessary.
(b) NIOSH will calculate the dose to the organ or tissue of concern using the appropriate current metabolic models published by ICRP. Using data available to NIOSH, the models will be based on exposure conditions representative of the work environment. When NIOSH cannot establish exposure conditions with sufficient specificity, the dose calculation will assume exposure conditions that maximize the dose to the organ under consideration. When the cancer covered by a claim is in a tissue not covered by existing ICRP models, NIOSH will use the ICRP model that best approximates the model needed, while giving the benefit of the doubt to the claimant. For internal exposures, NIOSH will select the highest dose estimate from among the modeled organs or tissues that do not concentrate the radionuclide.
(c) Internal doses will be calculated for each year of exposure from the date of initial exposure to the date of cancer diagnosis.
The estimate of each annual dose will be characterized with a probability distribution that accounts for the uncertainty of the estimate. This information will be used by DOL in the calculation of probability of causation, under HHS guidelines for calculating probability of causation estimates at 42 CFR 81. In this way, claimants will receive the benefit of the doubt in cases in which the actual dose may have exceeded the best estimate calculated by NIOSH.
NIOSH will report dose reconstruction results to DOL and to the claimant, as provided for under § 82.10. Draft results will be reported to the claimant upon tentative completion of the dose reconstruction. Final results will be reported to the claimant, DOL and DOE after NIOSH receives certification from the claimant that the claimant has completed providing information to NIOSH for the dose reconstruction (Form OCAS-1).
(a) NIOSH will provide dose reconstruction results to the claimant, DOL, and DOE in a report: “NIOSH Report of Dose Reconstruction under EEOICPA.” The report itself will not provide information on probability of causation, which DOL must calculate to determine a recommended decision on the claim.
(b) The report will include the following information, as relevant:
(1) Annual dose estimates (or a fraction thereof) related to covered employment for each year from the date of initial radiation exposure at a covered facility to the date of cancer diagnosis;
(2) Separate dose estimates for acute and chronic exposures, different types of ionizing radiation, and internal and external doses, providing internal dose information only for the organ or tissue relevant to the primary cancer site(s) established in the claim;
(3) Uncertainty distributions associated with each dose estimated, as necessary;
(4) Explanation of each type of dose estimate included in terms of its relevance for estimating probability of causation;
(5) Identification of any information provided by the claimant relevant to dose estimation that NIOSH decided to omit from the basis for dose reconstruction, justification for the decision, and if possible, a quantitative estimate of the effect of the omission on the dose reconstruction results; and
(6) A summary and explanation of information and methods applied to produce the dose reconstruction estimates, including any factual findings and the evidence upon which those findings are based.
(c) As provided under § 82.10(l), NIOSH staff will conduct a closing interview with claimants to explain the dose reconstruction report.
(a) Claimants can seek reviews of their dose reconstruction through the processes established by DOL under 20 CFR 30. DOL will request NIOSH to review dose reconstructions under the following conditions, as provided under 20 CFR 30.318:
(1) DOL may determine that factual findings of the dose reconstruction do not appear to be supported by substantial evidence; or,
(2) Although the methodology established by HHS under this Part is binding on DOL, DOL may determine that arguments concerning the
(b) NIOSH may review completed dose reconstructions on its own initiative and with the assistance of DOL to identify denied claims when either of the following circumstances arise:
(1) NIOSH obtains records or information on radiation exposures of DOE or AWE employees that could substantially increase the level of radiation doses estimated in the completed dose reconstructions; or
(2) NIOSH changes a scientific element underlying dose reconstructions according to the provisions of Subpart E of this rule and the change could substantially increase the level of radiation doses estimated in the completed dose reconstructions.
(c) When NIOSH completes the review of a dose reconstruction, NIOSH will provide a report describing the basis for the review, the methods employed in the review, and the review findings to the claimant, DOL, and DOE.
(a) Claimants and DOL will be provided individual dose reconstruction files, upon request. Claimants should note, however, that a complete summary of the data and methods used in a dose reconstruction will be included in the “NIOSH Report of Dose Reconstruction under EEOICPA''.
(b) Researchers and the public will be provided limited access to NIOSH dose reconstruction files, subject to provisions and restrictions of the Privacy Act for the protection of confidential information on individuals.
Periodically, NIOSH will publish a notice in the
(a) At any time, the public can submit written recommendations to NIOSH for changes to scientific elements underlying the dose reconstruction process, based on relevant new research findings and technological advances. NIOSH will provide these recommendations to the Advisory Board on Radiation and Worker Health to be addressed at a public meeting of the Advisory Board, with notification provided to the source of the recommendations. Recommendations should be addressed to: Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS-R45, Cincinnati, Ohio 45226.
(b) The public can also submit recommendations by e-mail. Instructions will be provided on the NIOSH Internet homepage at www.cdc.gov/niosh/ocas.
NIOSH will present proposed changes to the Advisory Board on Radiation and Worker Health prior to implementation. These proposed changes will be summarized in a notice published in the
(a) NIOSH will publish a notice in the
(b) NIOSH may take into account other factors and employ other procedures than those specified in this subpart, if circumstances arise that require NIOSH to implement a change more immediately than the procedures in this subpart allow.
29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C. 3, 5, 7, 811, 842(h), 844.
The purpose of the regulations contained in this part 84 is:
(a) To establish procedures and prescribe requirements which must be met in filing applications for approval by the National Institute for Occupational Safety and Health of respirators or changes or modifications of approved respirators;
(b) To establish a schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part;
(c) To provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part; and
(d) To specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres.
As used in this part—
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k) A
(l)
(m)
(n)
(o)
(1) Any atmosphere containing a toxic or disease producing gas, vapor, dust, fume, mist, or pesticide, either immediately or not immediately dangerous to life or health; or
(2) Any oxygen-deficient atmosphere.
(p) A
(q)
(r)
(s)
(t)
(u)
(v)
(w)
(x)
(y)
(z)
(aa)
(bb)
(cc)
(a)(1) NIOSH and the Mine Safety and Health Administration (MSHA), U.S. Department of Labor, shall jointly review and issue certifications for respirators used for mine emergencies and mine rescue, including any associated service-life plans, users' manuals and other supporting documentation.
(2) Each certification for a respirator designed for mine rescue or other emergency use in mines shall include, as a condition of approval, any use limitations related to mine safety and health.
(b) NIOSH and MSHA shall jointly determine appropriate recall and retrofit remedies for field complaints or identified deficiencies involving any respirators used in the mining environment.
(a) Inspection, examination, and testing leading to the approval of the types of respirators classified in subpart F of this part shall be undertaken by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B.
(b) Applications shall be submitted to the Certification and Quality Assurance Branch, and shall be accompanied by a check, bank draft, or money order in the amount specified in subpart C of this part, payable to the order of the National Institute for Occupational Safety and Health.
(c) Except as provided in § 84.64, the examination, inspection, and testing of all respirators shall be conducted by the Certification and Quality Assurance Branch.
(d) Applicants, manufacturers, or their representatives may visit or communicate with the Certification and Quality Assurance Branch in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge shall be made for such consultation and no written report shall be issued to applicants, manufacturers, or their representatives by the Institute as a result of such consultation.
(e) Respirators having electrical or electronic components that are required to be permissible under chapter I of title 30 shall be tested in accordance with 30 CFR part 18. Applications for approval of such respirators by MSHA shall be submitted in writing to: MSHA, Approval and Certification Center, Box 251, Industrial Park Road, Triadelphia, West Virginia 26059.
(a) Each application for approval shall contain a complete written description of the respirator for which approval is requested together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used.
(b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies.
(c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part.
(d) Each application shall contain a statement that the respirator has been pretested by the applicant as prescribed in § 84.64, and shall include the results of such tests.
(e) Each application for approval shall contain a statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.
(a) Each applicant shall, when an application is filed pursuant to § 84.10, be advised by the Institute of the total number of respirators and component parts required for testing.
(b) The applicant shall deliver, at his own expense, the number of completely assembled respirators and component parts required for testing, to the Certification and Quality Assurance Branch.
(c) Respirators and component parts submitted for approval must be made from materials specified in the application.
(d) One completely assembled respirator approved under the provisions of this part may be retained by the Institute as a laboratory exhibit, the remaining respirators may be returned to the applicant at his own expense, upon written request within 30 days after notice of approval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.
(e) Where a respirator fails to meet the requirements for approval set forth in this part, all respirators and components delivered in accordance with this section may be returned to the applicant at his own expense, upon written request within 30 days after notice of disapproval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.
Except as provided in § 84.22, the following fees shall be charged by the Institute for the examination, inspection and testing of complete respirator assemblies:
Except as provided in § 84.22, the following fees shall be charged by the Institute for the examination, inspection and testing of the individual respirator components or subassemblies:
(a) Applications for the examination, inspection and testing of complete respirator assemblies which are not listed in § 84.20, or for the examination, inspection, and testing of respirator components or subassemblies which are not listed in § 84.21, shall be accompanied by the following deposits:
(b) The Institute reserves the right to conduct any examination, inspection, or test it deems necessary to determine the quality and effectiveness of any listed or unlisted respirator assembly or respirator component or subassembly, and to assess the cost of such examinations, inspections, or tests against the applicant prior to the issuance of any approval for such assembly, component, or subassembly.
(c) The fees charged for the examination, inspection, and testing of unlisted respirator assemblies, unlisted individual respirator components or subassemblies, and for the additional examination, inspection, and testing of listed respirator assemblies and components or subassemblies shall be at the rate of $100 per day for each man-day required to be expended by the Institute.
(d) Upon completion of all examinations, inspections, and tests of unlisted respirator assemblies or components, or following the completion of any additional examination, inspections, or tests of listed assemblies, or components or subassemblies, including retesting subsequent to disapproval, the Institute shall advise the applicant in writing of the total cost assessed and the additional amount, if any, which must be paid to the Institute as a condition of approval.
(e) In the event the amount assessed by the Institute for unlisted assemblies, or components or subassemblies is less than the amount of the deposit submitted in accordance with paragraph (a) of this section, the Institute shall refund the overpayment upon the issuance of any approval or notice of disapproval.
(a) The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators which have been examined, inspected, and tested, and which meet the minimum requirements set forth in subparts H through L of this part, as applicable.
(b) The Institute will not issue certificates of approval for any respirator component or for any respirator subassembly.
(c) The Institute shall not issue an informal notification of approval. However, if the application for approval, submitted in accordance with § 84.11, states that the submitted respirator and component parts are only prototypes, the Institute will examine, inspect, and test such respirator and component parts in accordance with the provisions of this part. If, upon completion of such examinations, inspections and tests, it is found that the prototype meets the minimum requirements set forth in this part, the Institute may inform the applicant, in writing, of the results of the examinations, inspections, and tests, and may require him to resubmit respirators and component parts made on regular production tooling, with no operations included which will not be incorporated in regular production processing, for further examination, inspection, and testing, prior to issuance of the certificate of approval.
(d) Applicants required to resubmit respirators and component parts made on regular production tooling, with no operation included which will not be incorporated in regular production processing, shall be charged fees in accordance with subpart C of this part.
(a) The certificate of approval shall contain a classification and a description of the respirator or combination of respirators for which it is issued, as provided in this part.
(b) The certificate of approval shall specifically set forth any restrictions or limitations on the respirator's use in hazardous atmospheres.
(c) Each certificate of approval shall be accompanied by the drawings and specifications (and lists thereof) submitted by the applicant in accordance with § 84.11. These drawings and specifications shall be referenced in the certificate of approval, and shall be maintained by the applicant. The drawings and specifications listed in each certificate of approval shall set forth in detail the design and construction requirements which shall be met by the applicant during commercial production of the respirator.
(d) Each certificate of approval shall be accompanied by a reproduction of the approval label design to be employed by the applicant with each approved respirator, as provided in § 84.33.
(e) No test data or specific laboratory findings will accompany any certificate of approval, however, the Institute will release pertinent test data and specific findings upon written request by the applicant, or as required by statute or regulation.
(f) Each certificate of approval shall also contain the approved quality control plan as specified in § 84.42.
(a) If, upon the completion of the examinations, inspections, and tests required to be conducted in accordance with the provisions of this part, it is found that the respirator does not meet the minimum requirements set forth in this part, the Institute shall issue a written notice of disapproval to the applicant.
(b) Each notice of disapproval shall be accompanied by all pertinent data or findings with respect to the defects of the respirator for which approval
(c) The Institute shall not disclose, except to the applicant or as required by statute or regulation, any data, findings, or other information with respect to any respirator for which a notice of disapproval is issued.
(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to the Institute for approval.
(b) Approval labels shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.
(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.
(d) Approval labels and markings shall only be used by the applicant to whom they were issued.
(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:
(f) The use of any Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.
(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.
The Institute reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of this part. Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval.
(a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of the original certificate of approval issued by the Institute for such respirator by filing an application for
(b) Applications shall be submitted as for an original certificate of approval, with a request for a modification of the existing certificate to cover any proposed change.
(c) The application shall be accompanied by appropriate drawings and specifications, and by a proposed quality control plan which meets the requirements of subpart E of this part.
(d) The application for modification, together with the accompanying material, shall be examined by the Institute to determine whether testing will be required.
(e) The Institute shall inform the applicant of the fee required for any additional testing and the applicant will be charged for the actual cost of any examination, inspection, or test required, and such fees shall be submitted in accordance with the provisions of subpart C of this part.
(f) If the proposed change or modification meets the requirements of this part, a formal certificate of modification will be issued, accompanied, where necessary, by a list of new and revised drawings and specifications covering the change(s) and reproductions of revised approval labels.
An approved respirator for which a formal certificate of modification has been issued shall be delivered, with proper markings and containers, by the applicant to the Certification and Quality Assurance Branch, as soon as it is commercially produced.
As a part of each application for approval or modification of approval submitted pursuant to this part, each applicant shall file with the Institute a proposed quality control plan which shall be designed to assure the quality of respiratory protection provided by the respirator for which approval is sought.
(a) Each quality control plan shall contain provisions for the management of quality, including:
(1) Requirements for the production of quality data and the use of quality control records;
(2) Control of engineering drawings, documentations, and changes;
(3) Control and calibration of measuring and test equipment;
(4) Control of purchased material to include incoming inspection;
(5) Lot identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant;
(6) Audit of final inspection of the completed product; and
(7) The organizational structure necessary to carry out these provisions.
(b) Each provision for incoming and final inspection in the quality control plan shall include a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure, or an approved combination of sampling procedures. The procedure of Military Standard MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, Certification and Quality Assurance
(c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent.
(d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped into the following classes:
(1)
(2)
(3)
(4)
(e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail.
(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.
(g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be:
(1)
(2)
(3)
(h) Except as provided in paragraph (i) of this section, inspection level IV as described in MIL-STD-414, 11 June 1957, including Change Notice No.1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an equivalent procedure, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics. Inspection level II as described in MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent procedure.
(i) Subject to the approval of the Institute, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication, inspections are adequate to ensure control of finished article quality, destructive testing of finished articles may be conducted at a lower level of inspection than that specified in paragraph (h) of this section.
(a) Each proposed quality control plan submitted in accordance with this subpart shall be reviewed by the Institute to determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for which an approval is sought.
(b) If the Institute determines that the proposed quality control plan submitted by the applicant will not ensure adequate quality control, the Institute shall require the applicant to modify the procedures and testing requirements of the plan prior to approval of the plan and issuance of any certificate of approval.
(c) Approved quality control plans shall constitute a part of and be incorporated into any certificate of approval issued by the Institute, and compliance with such plans by the applicant shall be a condition of approval.
(a) The applicant shall keep quality control inspection records sufficient to carry out the procedures required in MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure. MIL-STD-105D, 29 April 1963,
(b) The Institute reserves the right to have its representatives inspect the applicant's quality control test methods, equipment, and records, and to interview any employee or agent of the applicant in regard to quality control test methods, equipment, and records.
(c) The Institute reserves the right to revoke, for cause, any certificate of approval where it is found that the applicant's quality control test methods, equipment, or records do not ensure effective quality control over the respirator for which the approval was issued.
Approvals shall be issued for the types of respirators which have been classified pursuant to this subpart F, have been inspected, examined and tested by the Institute, in accordance with the provisions of subparts G through L of this part, and have been found to provide respiratory protection for fixed periods of time against the hazards specified in such approval.
Respirators described in subparts H through L of this part shall be classified for use as follows:
(a)
(b)
Respirators described in subparts H through L of this part shall be classified as approved for use against any or all of the following respiratory hazards:
(a) Oxygen deficiency;
(b) Gases and vapors; and
(c) Particles, including dusts, fumes and mists.
(a) Respirators described in subparts H through L of this part shall be classified, where applicable, as approved for use during the following prescribed service times:
(1) Four hours;
(2) Three hours;
(3) Two hours;
(4) One hour;
(5) Forty-five minutes;
(6) Thirty minutes;
(7) Fifteen minutes;
(8) Ten minutes;
(9) Five minutes; or
(10) Three minutes.
(b) Other service times may be prescribed by the Institute.
(a) The Institute shall issue approvals for the types of respirators described in subparts H through L of this part which have met the minimum requirements set forth for such respirators in this part.
(b) In addition to the types of respirators specified in subparts H through L of this part, the Institute shall issue approvals for other respiratory protective devices not specifically described in this part subject to such additional requirements as may be imposed in accordance with § 84.63(c).
(a) Respirators will not be accepted by the Institute for examination, inspection and testing unless they are designed on sound engineering and scientific principles, constructed of suitable materials and evidence good workmanship.
(b) Respirator components which come into contact with the wearer's skin shall be made of nonirritating materials.
(c) Components replaced during or after use shall be constructed of materials which will not be damaged by normal handling.
(d) Mouthpieces, hoods, helmets, and facepieces, except those employed in single-use respirators, shall be constructed of materials which will withstand repeated disinfection as recommended by the applicant in his instructions for use of the device.
(a) The component parts of each respirator shall be:
(1) Designed, constructed, and fitted to insure against creation of any hazard to the wearer;
(2) Assembled to permit easy access for inspection and repair of functional parts; and
(3) Assembled to permit easy access to parts which require periodic cleaning and disinfecting.
(b) Replacement parts shall be designed and constructed to permit easy installation and to maintain the effectiveness of the respirator.
(a) Each respirator and respirator component shall when tested by the applicant and by the Institute, and meet the applicable requirements set forth in subparts H through L of this part.
(b) Where a combination respirator is assembled from two or more types of respirators, as described in this part, each of the individual respirator types which have been combined shall, as applicable, meet the minimum requirements for such respirators set forth in subparts H through L of this part, and such combination respirators, except as specified in § 84.70(b)(2), will be classified by the type of respirator in the combination which provides the least protection to the user.
(c) In addition to the minimum requirements set forth in subparts H through L of this part, the Institute reserves the right to require, as a further condition of approval, any additional requirements deemed necessary to establish the quality, effectiveness, and safety of any respirator used as protection against hazardous atmospheres.
(d) Where it is determined after receipt of an application that additional requirements will be required for approval, the Institute will notify the applicant in writing of these additional requirements, and necessary examinations, inspections, or tests, stating generally the reasons for such requirements, examinations, inspections, or tests.
(a) Prior to making or filing any application for approval or modification of approval, the applicant shall conduct, or cause to be conducted, examinations, inspections, and tests of respirator performance which are equal to or exceed the severity of those prescribed in this part.
(b) With the application, the applicant shall provide a statement to the Institute showing the types and results of the examinations, inspections, and tests required under paragraph (a) of this section and state that the respirator meets the minimum requirements of subparts H through L of this part, as applicable. Complete examination, inspection, and test data shall be retained on file by the applicant and be submitted, upon request, to the Institute.
(c) The Institute may, upon written request by the applicant, provide drawings and descriptions of its test equipment and otherwise assist the applicant in establishing a test laboratory or securing the services of a testing agency.
(d) No approval will be issued until the Institute has validated the applicant's test results.
(a) All examinations, inspections, and tests conducted pursuant to subparts H through L of this part will be under the sole direction and control of the Institute.
(b) The Institute may, as a condition of approval, require the assistance of the applicant or agents of the applicant during the assembly, disassembly, or preparation of any respirator or respirator component prior to testing or in the operation of such equipment during testing.
(c) Only Institute personnel, persons assisting the Institute pursuant to paragraph (b) of this section, and such other persons as are requested by the Institute or the applicant to be observers, shall be present during any examination, inspection, or test conducted prior to the issuance of an approval by the Institute for the equipment under consideration.
(d) The Institute shall hold as confidential any analyses, drawings, specifications, or materials submitted by the applicant and shall not disclose any principles or patentable features of such equipment, except as required by statute or regulation.
(e) As a condition of each approval issued for any respirator, the Institute reserves the right, following the issuance of such approval, to conduct such public tests and demonstrations of the approved respiratory equipment as is deemed appropriate.
(a) Any applicant may, upon a written request submitted to the Institute, withdraw any application for approval of any respirator.
(b) Upon receipt of a written request for the withdrawal of an application, the Institute shall determine the total man-days expended and the amount due for services already performed during the course of any examinations, inspections, or tests conducted pursuant to such application. The total amount due shall be determined in accordance with the provisions of § 84.22 and assessed against the fees submitted by the applicant. If the total amount assessed is less than the fees submitted, the Institute shall refund the balance together with a statement of the charges made for services rendered.
(a) Self-contained breathing apparatus, including all completely assembled, portable, self-contained devices designed for use as respiratory protection during entry into and escape from or escape only from hazardous atmospheres, are described as follows:
(1)
(i) Compressed oxygen; or
(ii) Chemical oxygen; or
(iii) Liquid-oxygen.
(2) Open-circuit apparatus. An apparatus of the following types from which exhalation is vented to the atmosphere and not rebreathed:
(i)
(ii)
(b) The following respirators may be classified as designed and approved for use during emergency entry into a hazardous atmosphere:
(1) A combination respirator which includes a self-contained breathing apparatus; and
(2) A Type “C” or Type “CE” supplied air respirator, where—
(i) The self-contained breathing apparatus is classified for 3-, 5-, or 10-minute service time and the air line supply is used during entry; or
(ii) The self-contained breathing apparatus is classified for 15 minutes or longer service time and not more than 20 percent of the rated capacity of the air supply is used during entry.
(c) Self-contained breathing apparatus classified for less than 1 hour service time will not be approved for use during underground mine rescue and recovery operations except as auxiliary equipment.
(d) Self-contained breathing apparatus classified for less than 30 minutes' service time will not be approved for use as auxiliary equipment during underground mine rescue and recovery operations.
(a) Each self-contained breathing apparatus described in § 84.70 shall, where its design requires, contain the following component parts:
(1) Facepiece or mouthpiece, and noseclip;
(2) Respirable breathing gas container;
(3) Supply of respirable breathing gas;
(4) Gas pressure or liquid level gages;
(5) Timer;
(6) Remaining service life indicator or warning device;
(7) Hand-operated valves;
(8) Breathing bag;
(9) Safety relief valve or safety relief system; and
(10) Harness.
(b) The components of each self-contained breathing apparatus shall meet the minimum construction requirements set forth in subpart G of this part.
Flexible breathing tubes used in conjunction with breathing apparatus shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces and mouthpieces;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
(a) Each apparatus shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the apparatus in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of apparatus parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.
(a) Apparatus may be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains, and all appropriate approval labels.
(b) Containers supplied by the applicant for carrying or storing self-contained breathing apparatus will be inspected, examined, and tested as components of the respirator for which approval is sought.
(c) Containers for self-contained breathing apparatus shall be designed and constructed to permit easy removal of the apparatus.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes, either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Full facepieces shall provide for the optional use of corrective spectacles or lenses which shall not reduce
(c) Apparatus with mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or apparatus and provide an airtight seal.
(d) Facepieces shall be designed to prevent eyepiece, spectacle, and lens fogging.
(a) Facepieces shall be designed and constructed to provide adequate vision which is not distorted by the eyepiece.
(b) All eyepieces shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
(a) Inhalation and exhalation valves shall be provided where necessary and protected against damage and distortion.
(b) Exhalation valves shall be—
(1) Protected against external influence; and
(2) Designed and constructed to prevent inward leakage of contaminated air.
(a) Facepieces shall be equipped with adjustable and replaceable head harnesses designed and constructed to provide adequate tension during suspension and an even distribution of pressure over the entire area in contact with the face.
(b) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses designed and constructed to hold the mouthpiece in place.
(a) Breathing gas used to supply apparatus shall be respirable and contain no less than 19.5 (dry atmosphere) volume percent of oxygen.
(b) Oxygen, including liquid oxygen, shall contain not less than 99.0 percent, by volume, of pure O
(c) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(d) Compressed, liquefied breathing air shall meet the applicable minimum grade requirements for Type II liquid air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade B or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
Approvals shall not be issued by the Institute for any apparatus, combination of respirator assemblies, or any apparatus or respirator component which is designed or constructed to permit the interchangeable use of oxygen and air.
(a) Compressed breathing gas and liquefied breathing gas containers shall meet the minimum requirements of the Department of Transportation for interstate shipment of such containers when fully charged.
(b) Such containers shall be permanently and legibly marked to identify their contents, e.g., compressed breathing air, compressed breathing oxygen, liquefied breathing air, or liquefied breathing oxygen.
(c) Containers normally removed from apparatus for refilling shall be equipped with a dial indicating gage which shows the pressure in the container.
(d) Compressed breathing gas contained valves or a separate charging system or adapter provided with each apparatus shall be equipped with outlet threads specified for the service by the American Standards Association, Compressed Gas Cylinder Valve Outlet and Inlet Connections, B57.1-1965. B57.1-1965 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(a) Gas pressure gages employed on compressed breathing gas containers shall be calibrated in pounds per square inch.
(b) Liquid-level gages shall be calibrated in fractions of total container capacity, or in units of liquid volume.
(c) Gas pressure gages other than those specified in paragraphs (a) and (b) of this section shall be calibrated in:
(1) Pounds per square inch; or
(2) In fractions of total container capacity; or
(3) Both in pounds per square inch and fractions of total container capacity.
(d)(1) Dial-indicating gages shall be reliable to within ±5 percent of full scale when tested both up and down the scale at each of 5 equal intervals.
(2) The full-scale graduation of dial-indicating gages shall not exceed 150 percent of the maximum rated cylinder pressures specified for the container in applicable Department of Transportation specifications or permits.
(e)(1) Stem-type gages shall be readable by sight and by touch and shall have a stem travel distance of not less than one-fourth inch between each graduation.
(2) A minimum of five graduations shall be engraved on the stem of each gage and these graduations shall include readings for empty, one-quarter, one-half, three-quarters, and full.
(3) Stem gage readings shall not vary from true readings by more than one-sixteenth inch per inch of stem travel.
(f) The loss of gas through a broken gage or severed gage connection shall not exceed 70 liters per minute when the cylinder pressure is 6,900 kN/m.
(g) Where gages are connected to the apparatus through a gage line, the gage and line shall be capable of being isolated from the apparatus except where the failure of the gage or line would not impair the performance or service life of the apparatus.
(h) Oxygen pressure gages shall have the words “Oxygen” and “Use No Oil” marked prominently on the gage.
(i)(1) Apparatus using compressed breathing gas, except apparatus classified for escape only, shall be equipped with gages visible to the wearer which indicate the remaining gas content in the container.
(2) Apparatus using liquefied breathing gas, except apparatus classified for escape only, shall be equipped with gages visible to the wearer which indicate the remaining liquid content in the container; however, where the liquid content cannot be rapidly vented, and the service time of the device begins immediately after filling, a timer shall be provided in place of a visible gage.
(a) Elapsed time indicators shall be provided for apparatus with a chemical oxygen source, except:
(1) Apparatus used for escape only; or
(2) Liquefied breathing gas apparatus equipped with gages visible to the wearer which indicate the remaining liquid content in the container.
(b) The timer or other indicator shall be accurately calibrated in minutes of remaining service life.
(c) Timers shall be readable by sight and by touch during use by the wearer.
(d) Timers shall be equipped with automatically preset alarms which will warn the wearer for a period of 7 seconds or more after the preset time has elapsed.
(e) Remaining service-life indicators or warning devices shall be provided in addition to a pressure gage on compressed gas self-contained breathing apparatus, except apparatus used for escape only, and shall operate automatically without preadjustment by the wearer.
(f) Each remaining service-life indicator or warning device shall give an alarm when the remaining service life of the apparatus is reduced within a range of 20 to 25 percent of its rated service time.
(a) Hand-operated valves shall be designed and constructed to prevent removal of the stem from the valve body during normal usage to insure against a sudden release of the full pressure of the container when the valve is opened.
(b) Valves shall be designed or positioned to prevent accidental opening and closing, and damage from external forces.
(c) Valves operated during use of the apparatus shall be installed in locations where they can be readily adjusted by the wearer.
(d) Main-line valves, designed and constructed to conserve gas in the event of a regulator or demand valve failure, shall be provided in addition to gas container valves, except when such failure will not affect performance.
(e) Hand-operated bypass systems designed and constructed to permit the wearer to breathe and to conserve his gas supply in the event of a regulator or demand valve failure, shall be provided where necessary.
(f) Valves installed on apparatus shall be clearly distinguishable from one another by sight and touch.
(g) The bypass system valve control shall be colored red.
(h) A main-line or bypass valve or system will not be required on apparatus for escape only.
(i) Safety relief valves or systems, designed and constructed to release excess pressure in the breathing circuit, shall be provided on closed-circuit apparatus, and shall meet the following requirements:
(1) The relief valve or system shall operate automatically when the pressure in the breathing circuit on the inhalation side of the breathing bag reaches 13 mm. (one-half inch) water-column height of pressure above the minimum pressure required to fill the breathing bag, within the breathing resistance requirements for the apparatus.
(2) The relief valve or system shall be designed to prevent external atmospheres from entering the breathing circuit.
(3) The relief valve or system shall be designed to permit manual overriding for test purposes and in the event of a failure in the valve or system.
(a) Breathing bags shall have sufficient volume to prevent gas waste during exhalation and to provide an adequate reserve for inhalation.
(b) Breathing bags shall be constructed of materials which are flexible and resistant to gasoline vapors.
(c) Breathing bags shall be installed in a location which will protect them from damage or collapse by external forces, except on apparatus classified for escape only.
Each applicant shall certify that the materials employed in the construction of component parts exposed to oxygen pressures above atmospheric pressure are safe and compatible for their intended use.
All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively remove particles from the gas stream.
(a) Breathing bags will be tested in an air atmosphere saturated with gasoline vapor at room temperature (24-30 °C./75-85 °F.) for a continuous period of twice the rated time of the apparatus (except for apparatus for escape only where the test period shall be the rated time of the apparatus).
(b) The bag will be operated during this test by a breathing machine with 24 respirations per minute and a minute-volume of 40 liters.
(c) A breathing machine cam with a work rate of 622 kp.-m./min. will be used. The dimensions of a suitable breathing machine cam are available from the Institute upon request.
(d) The air within the bag(s) shall not contain more than 100 parts per million of gasoline vapor at the end of the test.
(a) The completely assembled and fully charged apparatus shall not weigh more than 16 kg. (35 pounds); however, where the weight decreases by more than 25 percent of its initial charge weight during its rated service life, the maximum allowable weight of a completely assembled and fully charged apparatus shall be 18 kg. (40 pounds).
(b) Where an apparatus employs equipment which contributes materially to the wearer's comfort, e.g., a cooling system, the completely assembled and fully charged apparatus shall not weigh more than 18 kg. (40 pounds) regardless of the decrease in weight during use.
(a) Resistance to inhalation airflow will be measured in the facepiece or mouthpiece while the apparatus is operated by a breathing machine as described in § 84.88.
(b) The inhalation resistance of open-circuit apparatus shall not exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120 liters per minute).
(c) The inhalation resistance of closed-circuit apparatus shall not exceed the difference between exhalation resistance (§ 84.91(e)) and 10 cm. (4 inches) water-column height.
(a) Resistance to exhalation airflow will be measured in the facepiece or mouthpiece of open-circuit apparatus with air flowing at a continuous rate of 85 liters per minute.
(b) The exhalation resistance of demand apparatus shall not exceed 25 mm. (1 inch) water-column height.
(c) The exhalation resistance of pressure-demand apparatus shall not exceed the static pressure in the facepiece by more than 51 mm. (2 inches) water-column height.
(d) The static pressure (at zero flow) in the facepiece shall not exceed 38 mm. (1.5 inches) water-column height.
(e) Resistance to exhalation airflow will be measured in the facepiece or mouthpiece of closed-circuit apparatus with a breathing machine as described in § 84.88, and the exhalation resistance shall not exceed 51 mm. (2 inches) water-column height.
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. (1 inch) water-column height while in a normal operating position.
(b) Leakage between the valve and the valve seat shall not exceed 30 milliliters per minute.
(a) A static-flow test will be performed on all open-circuit apparatus.
(b) The flow from the apparatus shall be greater than 200 liters per minute when the pressure in the facepiece of demand-apparatus is lowered by 51 mm. (2 inches) water-column height when full container pressure is applied.
(c) Where pressure demand apparatus are tested, the flow will be measured at zero gage pressure in the facepiece.
(d) Where apparatus with compressed-breathing-gas containers are tested, the flow test shall also be made with 3,450 kN/m.
(a) Where oxygen is supplied by a constant-flow device only, the rate of flow shall be at least 3 liters per minute for the entire rated service time of the apparatus.
(b) Where constant flow is used in conjunction with demand flow, the constant flow shall be greater than 1.5 liters per minute for the entire rated service time.
(c) All demand-flow devices shall provide at least 30 liters of oxygen per minute when in the fully open position.
(a) Service time will be measured with a breathing machine as described in § 84.88.
(b) The open-circuit apparatus will be classified according to the length of time it supplies air or oxygen to the breathing machine.
(c) The service time obtained on this test will be used to classify the open-circuit apparatus in accordance with § 84.53.
(a) The closed-circuit apparatus will be classified according to the length of time it supplies adequate breathing gas to the wearer during man test No. 4 described in Table 4 of this subpart.
(b) The service time obtained on man test No. 4 will be used to classify the closed-circuit apparatus in accordance with § 84.53.
(a)
(2) The breathing rate will be 14.5 respirations per minute with a minute-volume of 10.5 liters.
(3) A sedentary breathing machine cam will be used.
(4) The apparatus will be tested at a temperature of 27 ±2 °C. (80 ±5 °F.).
(5) A concentration of 5 percent carbon dioxide in air will be exhaled into the facepiece.
(b)
(c) During the testing required by paragraphs (a) and (b) of this section, the concentration of carbon dioxide in inspired gas at the mouth will be continuously recorded, and the maximum average concentration during the inhalation portion of the breathing cycle shall not exceed the following limits:
(d) In addition to the test requirements for closed-circuit apparatus set forth in paragraph (b) of this section, gas samples will be taken during the course of the man tests described in Tables 1, 2, 3, and 4 of this subpart. These gas samples will be taken from the closed-circuit apparatus at a point downstream of the carbon dioxide sorbent, and they shall not contain more than 0.5 percent carbon dioxide at any time, except on apparatus for escape only, using a mouthpiece only, the sample shall not contain more than 1.5 percent carbon dioxide at any time.
(a) The applicant shall specify the minimum temperature for safe operation and two persons will perform the tests described in paragraphs (c) and (d) of this section, wearing the apparatus according to applicant's directions. At the specified temperature, the apparatus shall meet all the requirements described in paragraph (e) of this section.
(b) The apparatus will be precooled at the specified minimum temperature for 4 hours.
(c) The apparatus will be worn in the low temperature chamber for 30 minutes, or for the service time of the apparatus, whichever is less.
(d) During the test period, alternate 1-minute periods of exercise and rest will be required with the exercise periods consisting of stepping onto and off a box 21.5 cm. (8
(e)(1) The apparatus shall function satisfactorily at the specified minimum temperature on duplicate tests.
(2) The wearer shall have sufficient unobscured vision to perform the work.
(3) The wearer shall not experience undue discomfort because of airflow restriction or other physical or chemical changes in the operation of the apparatus.
(f) Auxiliary low-temperature parts which are commercially available to the user may be used on the apparatus to meet the requirements described in paragraph (e) of this section.
(a) The man tests described in Tables 1, 2, 3, and 4 of this subpart represent the workload performed in the mining, mineral, or allied industries by a person wearing the apparatus tested.
(b) The apparatus tested will be worn by Institute personnel trained in the use of self-contained breathing apparatus, and the wearer will, before participating in these tests, pass a physical examination conducted by a qualified physician.
(c) All man tests will be conducted by the Institute.
(d) The apparatus will be examined before each man test to ensure that it is in proper working order.
(e) Breathing resistance will be measured within the facepiece or mouthpiece and the wearer's pulse and respiration rate will be recorded during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.
(f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.
(g) If man tests are not completed through no fault of the apparatus, the test will be repeated.
Man tests 1, 2, 3, and 4, set forth in Tables 1, 2, 3, and 4 of this subpart, respectively, prescribe the duration and sequence of specific activities. These tests will be conducted to—
(a) Familiarize the wearer with the apparatus during use;
(b) Provide for a gradual increase in activity;
(c) Evaluate the apparatus under different types of work and physical orientation; and
(d) Provide information on the operating and breathing characteristics of the apparatus during actual use.
(a) Test 5 will be conducted to determine the maximum length of time the apparatus will supply the respiratory needs of the wearer while he is sitting at rest.
(b) The wearer will manipulate the devices controlling the supply of breathing gas to the advantage of the apparatus.
(c) Samples of inspiration from within the apparatus facepiece or mouthpiece shall be taken once every 15 minutes, and shall meet the minimum requirement for oxygen specified in § 84.79(a), and the maximum allowable average concentration of carbon dioxide specified in § 84.97(c).
(d) One sample of inspiration will be taken in the case of 3-, 5-, and 10-minute apparatus.
(a) Man test 6 will be conducted with respect to liquefied breathing gas apparatus only.
(b) This test will be conducted to evaluate operation of the apparatus in other than vertical positions.
(c) The wearer will lie face downward for one-fourth the service life of the apparatus with a full charge of liquefied breathing gas, and then a one-quarter full charge of liquefied breathing gas.
(d) The test will be repeated with the wearer lying on each side and on his back.
(e) The oxygen content of the gas supplied to the wearer by the apparatus will be continuously measured.
(a) The apparatus shall satisfy the respiratory requirements of the wearer for the classified service time.
(b) Fogging of the eyepiece shall not obscure the wearer's vision, and the wearer shall not experience undue discomfort because of fit or other characteristics of the apparatus.
(c) When the ambient temperature during testing is 24±6 °C. (75±10 °F.), the maximum temperature of inspired air recorded during man tests shall not exceed the following, after correction for deviation from 24 °C. (75 °F.):
(a) Each apparatus will be tested for tightness by persons wearing it in an atmosphere of 1,000 p.p.m. isoamyl acetate.
(b) Six persons will each wear the apparatus in the test concentrations specified in paragraph (a) of this section for 2 minutes and none shall detect the odor or taste of the test vapor.
(a) Gas masks including all completely assembled air purifying masks designed for use as respiratory protection during entry into atmospheres not immediately dangerous to life or health or escape only from hazardous atmospheres containing adequate oxygen to support life are described as follows:
(1)
(2)
(3)
(b) Gas masks shall be further described according to the types of gases or vapors against which they are designed to provide respiratory protection, as follows:
(c) Gas masks for respiratory protection against gases and vapors other than those specified in paragraph (b) of this section, may be approved upon submittal of an application in writing for approval to the Certification and Quality Assurance Branch listing the gas or vapor and suggested maximum use concentration for the specific type of gas mask. The Institute will consider the application and accept or reject it on the basis of effect on the wearer's health and safety and any field experience in use of gas masks for such exposures. If the application is accepted, the Institute will test such masks in accordance with the requirements of this subpart.
(a) Each gas mask described in § 84.110 shall, where its design requires, contain the following component parts:
(1) Facepiece or mouthpiece and noseclip;
(2) Canister or cartridge;
(3) Canister harness;
(4) External check valve; and
(5) Breathing tube.
(b) The components of each gas mask shall meet the minimum construction requirements set forth in subpart G of this part.
Where two or more canisters or cartridges are used in parallel, their resistance to airflow shall be essentially equal.
The color and markings of all canisters and cartridges or labels shall conform with the requirements of the American National Standards Institute, American National Standard for Identification of Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(a) Particulate matter filters used in conjunction with a canister or cartridge shall be located on the inlet side of the canister or cartridge.
(b) Filters shall be incorporated in or firmly attached to the canister or cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement in the canister or cartridge.
Flexible breathing tubes used in conjunction with gas masks shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces or mouthpieces;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
(a) Each gas mask shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the gas mask in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of gas mask parts, and where applicable, provide for holding a full facepiece in the ready position when not in use.
(a) Gas masks shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of mask it contains and all appropriate approval labels.
(b) Containers for gas masks shall be designed and constructed to permit easy removal of the mask.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the gas mask.
(c) Half-mask facepieces shall not interfere with the fit of common industrial safety spectacles, as determined by the Institute's facepiece tests in § 84.124.
(d) Gas masks with mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or gas mask and provide an airtight seal.
(e) Facepieces shall be designed to prevent eyepiece fogging.
(a) Full facepieces shall be designed and constructed to provide adequate vision which is not distorted by the eye.
(b) All eyepieces shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
(a) Inhalation and exhalation valves shall be provided where necessary and protected against damage and distortion.
(b) Inhalation valves shall be designed and constructed to prevent excessive exhaled air from adversely affecting cartridges, canisters, and filters.
(c) Exhalation valves shall be protected against external influence, and designed and constructed to prevent inward leakage of contaminated air.
(a) Facepieces shall be equipped with adjustable and replaceable head harnesses, designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.
(b) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses designed and constructed to hold the mouthpiece in place.
(a) Resistance to airflow will be measured in the facepiece or mouthpiece of a gas mask mounted on a breathing machine both before and after each test conducted in accordance with §§ 84.124, 84.125, and 84.126, with air
(b) The maximum allowable resistance requirements for gas masks are as follows:
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.
(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.
(a) The complete gas mask will be fitted to the faces of persons having varying facial shapes and sizes.
(b) Where the applicant specifies a facepiece size or sizes for the gas mask, together with the approximate measurements of faces they are designed to fit, the Institute will insure that test subjects suit such facial measurements.
(c) Any gas mask parts which must be removed to perform the facepiece or mouthpiece fit test shall be replaceable without special tools and without disturbing the facepiece or mouthpiece fit.
(d) The facepiece or mouthpiece fit test, using positive or negative pressure recommended by the applicant and described in his instructions will be used before each test specified in paragraph (e) of this section, and in § 84.125.
(e)(1) Each wearer will enter a chamber containing 100 p.p.m. isoamyl acetate vapor for a half-mask facepiece and 1,000 p.p.m. isoamyl acetate vapor for a full facepiece or mouthpiece.
(2) The facepiece or mouthpiece may be adjusted, if necessary, in the test chamber before starting the tests.
(3) Each wearer will remain in the chamber for 8 minutes while performing the following activities:
(i) Two minutes, nodding and turning head;
(ii) Two minutes, calisthenic arm movements;
(iii) Two minutes, running in place; and
(iv) Two minutes, pumping with a tire pump into a 28 liter (1 cubic foot) container.
(4) Each wearer shall not detect the odor of isoamyl acetate during the test.
Gas mask canisters containing filters for protection against particulates (e.g. dusts, fumes, mists, and smokes) in combination with gases, vapors, or gases and vapors, shall also comply with the requirements as prescribed in §§ 84.170 through 84.183, except for the airflow resistance test of § 84.181.
(a)(1) Bench tests, except for carbon monoxide tests, will be made on an apparatus that allows the test atmosphere at 50±5 percent relative humidity and room temperature (25±2.5 °C.) to enter the canister continuously at concentrations and rates of flow specified in Tables 5, 6, and 7 of this subpart.
(2) Three canisters will be removed from containers and tested as received from the applicant.
(3) Two canisters, other than those described in paragraph (a)(2) of this section, will be equilibrated at room temperature by passing 25 percent relative humidity air through them at 64 liters per minute for 6 hours.
(4) Two canisters, other than those described in paragraphs (a) (2) and (3) of this section, will be equilibrated at room temperature by passing 85 percent relative humidity air through them at 64 liters per minute for 6 hours.
(5) The equilibrated canisters will be resealed, kept in an upright position at room temperature, and tested within 18 hours.
(b) Front-mounted and back-mounted gas mask canisters will be tested and shall meet the minimum requirements set forth in Table 5 of this subpart.
(c)(1) Front-mounted, and back-mounted, and chin-style canisters designated as providing respiratory protection against gases, ammonia, organic vapors, carbon monoxide and particulate contaminants shall have a window or other indicator to warn the gas mask wearer when the canister will no longer satisfactorily remove carbon monoxide from the inhaled air.
(2) Other types of front- and back-mounted canisters may also be equipped with a window or other indicator to warn of imminent leakage of other gases or vapors.
(3) The window indicator canisters will be tested as regular canisters, but shall show a satisfactory indicator change or other warning before the allowable canister penetration has occurred.
(d) Chin-style gas mask canisters shall meet the minimum requirements set forth in Table 6 of this subpart.
(e) Escape gas mask canisters shall meet the minimum requirements set forth in Table 7 of this subpart.
Supplied-air respirators, including all completely assembled respirators designed for use as respiratory protection during entry into and escape from atmospheres not immediately dangerous to life or health are described as follows:
(a)
(b)
(c)
(d)
(e)
(f)
(a) Each supplied-air respirator described in § 84.130 shall, where its design requires, contain the following component parts:
(1) Facepiece, hood, or helmet;
(2) Air supply valve, orifice, or demand or pressure-demand regulator;
(3) Hand operated or motor driven air blower;
(4) Air supply hose;
(5) Detachable couplings;
(6) Flexible breathing tube; and
(7) Respirator harness.
(b) The component parts of each supplied-air respirator shall meet the minimum construction requirements set forth in subpart G of this part.
Flexible breathing tubes used in conjunction with supplied-air respirators shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
(a) Each supplied-air respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts, and where applicable, provide for holding a full facepiece in the ready position when not in use.
Supplied-air respirators shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains, and all appropriate approval labels.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.
(d) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.
(a) Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepiece.
(b) All eyepieces except those on Types B, BE, C, and CE supplied-air respirators shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
(c)(1) The eyepieces of AE, BE, and CE type supplied-air respirators shall be shielded by plastic, glass, woven wire, sheet metal, or other suitable material which does not interfere with the vision of the wearer.
(2) Shields shall be mounted and attached to the facepiece to provide easy access to the external surface of the eyepiece for cleaning.
(a) Inhalation and exhalation valves shall be provided where necessary and protected against distortion.
(b) Exhalation valves shall be:
(1) Protected against damage and external influence; and
(2) Designed and constructed to prevent inward leakage of contaminated air.
(c) Check valves designed and constructed to allow airflow toward the facepiece only shall be provided in the connections to the facepiece or in the hose fitting near the facepiece of all Type A, AE, B, and BE supplied-air respirators.
Facepieces shall be equipped with adjustable and replaceable head harnesses which are designed and constructed to provide adequate tension
Type AE, BE, and CE supplied-air respirators shall be designed and constructed to provide protection against impact and abrasion from rebounding abrasive materials to the wearer's head and neck.
Noise levels generated by the respirator will be measured inside the hood or helmet at maximum airflow obtainable within pressure and hose length requirements and shall not exceed 80 dBA.
(a) Breathing gas used to supply supplied-air respirators shall be respirable breathing air and contain no less than 19.5 volume-percent of oxygen.
(b) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(c) Compressed, liquefied breathing air shall meet the applicable minimum grade requirements for Type II liquid air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade B or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(a) Blowers shall be designed and constructed to deliver an adequate amount of air to the wearer with either direction of rotation, unless constructed to permit rotation in one direction only, and to permit the free entrance of air to the hose when the blower is not operated.
(b) No multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose line is connected directly to a manifold at the blower.
(a) Blowers or connections to air supplies providing positive pressures shall not be approved for use on Type B supplied-air respirators.
(b) Terminal fittings or chambers employed in Type B supplied-air respirators, shall be:
(1) Installed in the inlet of the hose.
(2) Designed and constructed to provide for the drawing of air through corrosion resistant material arranged so as to be capable of removing material larger than 0.149 mm. in diameter (149 micrometers, 100-mesh, U.S. Standard sieve).
(3) Installed to provide a means for fastening or anchoring the fitting or chamber in a fixed position in a zone of respirable air.
(a) Hand-operated blowers shall be tested by attaching them to a mechanical drive and operating them 6 to 8 hours daily for a period of 100 hours at a speed necessary to deliver 50 liters of
(b) The crank speed of the hand-operated blower shall not exceed 50 revolutions per minute in order to deliver the required 50 liters of air per minute to each facepiece.
(c) The power required to deliver 50 liters of air per minute to each wearer through the maximum length of hose shall not exceed one-fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. (5 pounds) on a 20 cm. (8-inch) crank, as defined in § 84.146.
(d) The blower shall operate throughout the period without failure or indication of excessive wear of bearings or other working parts.
(a) Motor-operated blowers shall be tested by operating them at their specified running speed 6 to 8 hours daily for a period of 100 hours when assembled with the kind and maximum length of hose for which the device is to be approved and when connected to each blower or manifold outlet designed for hose connections.
(b) The connection between the motor and the blower shall be so constructed that the motor may be disengaged from the blower when the blower is operated by hand.
(c) The blower shall operate throughout the period without failure or indication of excessive wear of bearings or other working parts.
(d) Where a blower, which is ordinarily motor driven, is operated by hand, the power required to deliver 50 liters of air per minute to each wearer through the maximum length of hose shall not exceed one-fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. (5 pounds) on a 20 cm. (8-inch) crank, as defined in § 84.146.
(e) Where the respirator is assembled with the facepiece and 15 m. (50 feet) of the hose for which it is to be approved, and when connected to one outlet with all other outlets closed and operated at a speed not exceeding 50 revolutions of the crank per minute, the amount of air delivered into the respiratory-inlet covering shall not exceed 150 liters per minute.
As shown in Figure 1 of this section, the blower crank is replaced by a wooden drum, a (13 cm. (5 inches) in diameter is convenient). This drum is wound with about 12 m. (40 feet) of No. 2 picture cord, b. A weight, c, of sufficient mass to rotate the blower at the desired speed is suspended from this wire cord. A mark is made on the cord about 3 to 4.5 m. (10 to 15 feet) from the weight, c. Another mark is placed at a measured distance (6-9 m./20-30 feet is convenient) from the first. These are used to facilitate timing. To determine the torque or horsepower required to operate the blower, the drum is started in rotation manually at or slightly above the speed at which the power measurement is to be made. The blower is then permitted to assume constant speed, and then as the first mark on the wire leaves the drum, a stopwatch is started. The watch is stopped when the second mark leaves the drum. From these data the foot-pounds per minute and the torque may be calculated.
No Type B supplied-air respirator shall be approved for use with a blower or with connection to an air supply device at positive pressures.
(a) Respirators tested under this section shall be approved only when they supply respirable air at the pressures and quantities required.
(b) The pressure at the inlet of the hose connection shall not exceed 863 kN/m.
(c) Where the pressure at any point in the supply system exceeds 863 kN/m.
(a) Respirators tested under this section shall be approved only when used to supply respirable air at the pressures and quantities required.
(b) The manufacturer shall specify the range of air pressure at the point of attachment of the air-supply hose to the air-supply system, and the range of hose length for the respirator. For example, he might specify that the respirator be used with compressed air at pressures ranging from 280-550 kN/m.
(c) The specified air pressure at the point of attachment of the hose to the air-supply system shall not exceed 863 kN/m.
(d)(1) Where the pressure in the air-supply system exceeds 863 kN/m.
(2) The pressure-release mechanism shall be set to operate at a pressure not more than 20 percent above the manufacturer's highest specified pressure. For example, if the highest specified pressure is 863 kN/m.
Air supply lines employed on Type A, Type B, and Type C supplied-air respirators shall meet the minimum test requirements set forth in Table 8 of this subpart.
(a)(1) Shoulder straps employed on Type A supplied-air respirators shall be tested for strength of material, joints, and seams and must separately withstand a pull of 113 kg. (250 pounds) for 30 minutes without failure.
(2) Belts, rings, and attachments for life lines must withstand a pull of 136 kg. (300 pounds) for 30 minutes without failure.
(3) The hose shall be firmly attached to the harness so as to withstand a pull of 113 kg. (250 pounds) for 30 minutes without separating, and the hose attachments shall be arranged so that the pull or drag of the hose behind an advancing wearer does not disarrange the harness or exert pull upon the facepiece.
(4) The arrangement and suitability of all harness accessories and fittings will be considered.
(b)(1) The harness employed on Type B supplied-air respirators shall not be uncomfortable, disturbing, or interfere with the movements of the wearer.
(2) The harness shall be easily adjustable to various sizes.
(3) The hose shall be attached to the harness in a manner that will withstand a pull of 45 kg. (100 pounds) for 30 minutes without separating or showing signs of failure.
(4) The design of the harness and attachment of the line shall permit dragging the maximum length of hose considered for approval over a concrete floor without disarranging the harness or exerting a pull on the facepiece.
(5) The arrangement and suitability of all harness accessories and fittings will be considered.
(c) The harness employed on Type C respirators shall be similar to that required on the Type B respirator, or, it may consist of a simple arrangement for attaching the hose to a part of the wearer's clothing in a practical manner that prevents a pull equivalent to dragging the maximum length of the hose over a concrete floor from exerting pull upon the respiratory-inlet covering.
(d) Where supplied-air respirators have a rigid or partly rigid head covering, a suitable harness shall be required to assist in holding this covering in place.
(a)(1) Type A and Type B supplied-air respirators shall employ one or two flexible breathing tubes of the nonkinking type which extend from the facepiece to a connecting hose coupling attached to the belt or harness.
(2) The breathing tubes employed shall permit free head movement, insure against closing off by kinking or by chin or arm pressure, and they shall not create a pull that will loosen the facepiece or disturb the wearer.
(b) Breathing tubes employed on Type C supplied-air respirators of the continuous flow class shall meet the minimum requirements set forth in paragraph (a) of this section, however, an extension of the connecting hose may be employed in lieu of the breathing tubes required.
(c)(1) A flexible, nonkinking type breathing tube shall:
(i) Be employed on Type C supplied-air respirators of the demand and pressure-demand class; and
(ii) Extend from the facepiece to the demand or pressure-demand valve, except where the valve is attached directly to the facepiece.
(2) The breathing tube shall permit free head movement, insure against closing off by kinking or by chin or arm pressure, and shall not create a pull that will loosen the facepiece or disturb the wearer.
(a) Airflow resistance will be determined when the respirator is completely assembled with the respiratory-inlet covering, the air-supply device, and the maximum length of air-supply hose coiled for one-half its length in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.
(b) The inhalation resistance, drawn at the rate of 85 liters (3 cubic feet) per minute when the blower is not operating or under any practical condition of blower operation shall not exceed the following amounts:
(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of water-column height at a flow rate of 85 liters (3 cubic feet) per minute when the blower is not operating or under any practical condition of blower operation.
(a) Airflow resistance shall be determined when the respirator is completely assembled with the respiratory-inlet covering and the hose in the maximum length to be considered for approval, coiled in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.
(b) Airflow resistance shall not exceed 38 mm. (1.5 inches) of water-column height to air drawn at the flow rate of 85 liters (3 cubic feet) per minute.
(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of water-column height at this flow rate.
The resistance to air flowing from the respirator shall not exceed 25 mm. (1 inch) of water-column height when the air flow into the respiratory-inlet covering is 115 liters (4 cubic feet) per minute.
(a) Inhalation resistance shall not exceed 50 millimeters (2 inches) of water at an air flow of 115 liters (4 cubic feet) per minute.
(b) The exhalation resistance to a flow of air at a rate of 85 liters (3 cubic feet) per minute shall not exceed 25 millimeters (1 inch) of water.
(a) The static pressure in the facepiece shall not exceed 38 mm. (1.5 inches) of water-column height.
(b) The pressure in the facepiece shall not fall below atmospheric at inhalation airflows less than 115 liters (4 cubic feet) per minute.
(c) The exhalation resistance to a flow of air at a rate of 85 liters (3 cubic feet) per minute shall not exceed the static pressure in the facepiece by more than 51 mm. (2 inches) of water-column height.
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.
(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.
(a) Wearers will enter a chamber containing a gas or vapor as prescribed in §§ 84.160, 84.161, 84.162, and 84.163.
(b) Each wearer will spend 10 minutes in work to provide observations on freedom of the device from leakage. The freedom and comfort allowed the wearer will also be considered.
(c) Time during the test period will be divided as follows:
(1)
(2)
(d) No odor of the test gas or vapor shall be detected by the wearer in the air breathed during any such test, and the wearer shall not be subjected to any undue discomfort or encumbrance because of the fit, air delivery, or other features of the respirator during the testing period.
(a) The completely assembled respirator will be worn in a chamber containing 0.1±0.025 percent isoamyl acetate vapor, and the blower, the intake of the hose, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.
(b) The man in the isoamyl acetate atmosphere will draw his inspired air through the hose, connections, and all parts of the air device by means of his lungs alone (blower not operating).
(c) The 10-minute work test will be repeated with the blower in operation at any practical speed up to 50 revolutions of the crank per minute.
(a) The completely assembled respirator will be worn in a chamber containing 0.1±0.025 percent isoamyl acetate vapor, and the intake of the hose, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.
(b) The man in the isoamyl acetate atmosphere will draw his inspired air through the hose and connections by means of his lungs alone.
(a) The completely assembled respirator will be worn in a chamber containing 0.1±0.025 percent isoamyl acetate vapor, the intake of the hose will be connected to a suitable source of respirable air, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.
(b) The minimum flow of air required to maintain a positive pressure in the respiratory-inlet covering throughout the entire breathing cycle will be supplied to the wearer, provided however, that airflow shall not be less than 115 liters per minute for tight-fitting and not less than 170 liters per minute for loose-fitting respiratory inlet-coverings.
(c) The test will be repeated with the maximum rate of flow attainable within specified operating pressures.
(a) The completely assembled respirator will be worn in a chamber containing 0.1±0.025 percent isoamyl acetate vapor, the intake of the hose will be connected to a suitable source of respirable air, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.
(b) The test will be conducted at the minimum pressure with the maximum hose length and will be repeated at the maximum pressure with the minimum hose length.
(a) Non-powered air-purifying particulate respirators utilize the wearer's negative inhalation pressure to draw the ambient air through the air-purifying filter elements (filters) to remove particulates from the ambient air. They are designed for use as respiratory protection against atmospheres with particulate contaminants (e.g., dusts, fumes, mists) that are not immediately dangerous to life or health and that contain adequate oxygen to support life.
(b) Non-powered air-purifying particulate respirators are classified into three series, N-, R-, and P-series. The N-series filters are restricted to use in those workplaces free of oil aerosols. The R- and P-series filters are intended for removal of any particulate that includes oil-based liquid particulates.
(c) Non-powered air-purifying particulate respirators are classified according to the efficiency level of the filter(s) as tested according to the requirements of this part.
(1) N100, R100, and P100 filters shall demonstrate a minimum efficiency level of 99.97 percent.
(2) N99, R99, and P99 filters shall demonstrate a minimum efficiency level of 99 percent.
(3) N95, R95, and P95 filters shall demonstrate a minimum efficiency level of 95 percent.
(a) Each non-powered air-purifying particulate respirator described in § 84.170 shall, where its design requires, contain the following component parts:
(1) Facepiece, mouthpiece with noseclip, hood, or helmet;
(2) Filter unit;
(3) Harness;
(4) Attached blower; and
(5) Breathing tube.
(b) The components of each non-powered air-purifying particulate respirator shall meet the minimum construction requirements set forth in subpart G of this part.
Flexible breathing tubes used in conjunction with respirators shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts, and, where applicable, provide for holding a full facepiece in the ready position when not in use.
(a) Except as provided in paragraph (b) of this section each respirator shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type of respirator it contains, and all appropriate approval labels.
(b) Containers for single-use respirators may provide for storage of more than one respirator, however, such containers shall be designed and constructed to prevent contamination of respirators which are not removed, and to prevent damage to respirators during transit.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.
(d) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight seal.
(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.
(f) Half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles.
Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.
(a) Inhalation and exhalation valves shall be protected against distortion.
(b) Inhalation valves shall be designed and constructed and provided where necessary to prevent excessive exhaled air from adversely affecting filters, except where filters are specifically designed to resist moisture.
(c) Exhalation valves shall be:
(1) Provided where necessary;
(2) Protected against damage and external influence; and
(3) Designed and constructed to prevent inward leakage of contaminated air.
(a) All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.
(b) Facepiece head harnesses, except those employed on single-use respirators, shall be adjustable and replaceable.
(c) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses, designed and constructed to hold the mouthpiece in place.
(a) The respirator manufacturer, as part of the application for certification, shall specify the filter series and the filter efficiency level (i.e., “N95”, “R95, “P95”, “N99, “R99”, “P99”, “N100”, “R100”, or “P100”) for which certification is being sought.
(b) Filters shall be prominently labeled as follows:
(1) N100 filters shall be labeled “N100 Particulate Filter (99.97% filter efficiency level)” and shall be a color other than magenta.
(2) R100 filters shall be labeled “R100 Particulate Filter (99.97% filter efficiency level)” and shall be a color other than magenta.
(3) P100 filters shall be labeled “P100 Particulate Filter (99.97% filter efficiency level)” and shall be color coded magenta.
(4) N99 filters shall be labeled “N99 Particulate Filter (99% filter efficiency level)” and shall be a color other than magenta.
(5) R99 filters shall be labeled “R99 Particulate Filter (99% filter efficiency level)” and shall be a color other than magenta.
(6) P99 filters shall be labeled “P99 Particulate Filter (99% filter efficiency level)” and shall be a color other than magenta.
(7) N95 filters shall be labeled as “N95 Particulate Filter (95% filter efficiency level)” and shall be a color other than magenta.
(8) R95 filters shall be labeled as “R95 Particulate Filter (95% filter efficiency level)” and shall be a color other than magenta.
(9) P95 filters shall be labeled as “P95 Particulate Filter (95% filter efficiency level)” and shall be a color other than magenta.
(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a particulate respirator (complete respirator) mounted on a test fixture with air flowing at continuous rate of 85±2 liters per minute, before each test conducted in accordance with § 84.182.
(b) The resistances for particulate respirators upon initial inhalation shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure.
(a) Twenty filters of each non-powered air-purifying particulate respirator model shall be tested for filter efficiency against:
(1) A solid sodium chloride particulate aerosol as per this section, if N-series certification is requested by the applicant.
(2) A dioctyl phthalate or equivalent liquid particulate aerosol as per this section, if R-series or P-series certification is requested by the applicant.
(b) Filters including holders and gaskets; when separable, shall be tested for filter efficiency level, as mounted on a test fixture in the manner as used on the respirator.
(c) Prior to filter efficiency testing of 20 N-series filters, the 20 to be tested shall be taken out of their packaging and placed in an environment of 85±5 percent relative humidity at 38±2.5 °C for 25±1 hours. Following the pre-conditioning, filters shall be sealed in a gas-tight container and tested within 10 hours.
(d) When the filters do not have separable holders and gaskets, the exhalation valves shall be blocked so as to ensure that leakage, if present, is not included in the filter efficiency level evaluation.
(e) For non-powered air-purifying particulate respirators with a single filter, filters shall be tested at a continuous airflow rate of 85±4 liters per minute. Where filters are to be used in pairs, the test-aerosol airflow rate shall be 42.5±2 liters per minute through each filter.
(f)
(2) When testing R-series and P-series filters, a neat cold-nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25±5 °C that has been neutralized to the Boltzmann equilibrium state shall be used. Each filter shall be challenged with a concentration not exceeding 200 mg/m
(3) The test shall continue until minimum efficiency is achieved or until an aerosol mass of at least 200±5 mg has contacted the filter. For P-series filters, if the filter efficiency is decreasing when the 200±5 mg challenge point is reached, the test shall be continued until there is no further decrease in efficiency.
(g) The sodium chloride test aerosol shall have a particle size distribution with count median diameter of 0.075±0.020 micrometer and a standard geometric deviation not exceeding 1.86 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent. The DOP aerosol shall have a particle size distribution with count median diameter of 0.185±0.020 micrometer and a standard geometric deviation not exceeding 1.60 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent.
(h) The efficiency of the filter shall be monitored and recorded throughout the test period by a suitable forward-light-scattering photometer or equivalent instrumentation.
(i) The minimum efficiency for each of the 20 filters shall be determined and recorded and be equal to or greater than the filter efficiency criterion listed for each level as follows:
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.
(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.
(a) Chemical cartridge respirators including all completely assembled respirators which are designed for use as respiratory protection during entry into or escape from atmospheres not immediately dangerous to life and health, are described according to the specific gases or vapors against which they are designed to provide respiratory protection, as follows:
(b) Chemical cartridge respirators for respiratory protection against gases or vapors, which are not specifically listed with their maximum use concentration, may be approved if the applicant
(a) Each chemical cartridge respirator described in § 84.190 shall, where its design requires, contain the following component parts:
(1) Facepiece, mouthpiece, and noseclip, hood, or helmet;
(2) Cartridge;
(3) Cartridge with filter;
(4) Harness;
(5) Breathing tube; and
(6) Attached blower.
(b) The components of each chemical cartridge respirator shall meet the minimum construction requirements set forth in subpart G of this part.
Where two or more cartridges are used in parallel, their resistance to airflow shall be essentially equal.
The color and markings of all cartridges or labels shall conform with the requirements of the American National Standards Institute, American National Standard for Identification of Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(a) Particulate matter filters used in conjunction with a chemical cartridge shall be located on the inlet side of the cartridge.
(b) Filters shall be incorporated in or firmly attached to the cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement on the cartridge.
Flexible breathing tubes used in conjunction with respirators shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.
Respirators shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains and all appropriate approval labels.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.
(c) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight fit.
(d) Full facepieces shall provide for optional use of corrective spectacles or lenses which shall not reduce the respiratory protective qualities of the respirator.
(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.
Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.
(a) Inhalation and exhalation valves shall be provided where necessary and protected against distortion.
(b) Inhalation valves shall be designed and constructed to prevent excessive exhaled air from entering cartridges or adversely affecting canisters.
(c) Exhalation valves shall be—
(1) Protected against damage and external influence; and
(2) Designed and constructed to prevent inward leakage of contaminated air.
(a)(1) Facepieces for chemical cartridge respirators other than single-use vinyl chloride shall be equipped with adjustable and replaceable head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.
(2) Facepieces for single-use vinyl chloride respirators shall be equipped with adjustable head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.
(b) Mouthpieces shall be equipped where applicable, with an adjustable and replaceable harness designed and constructed to hold the mouthpiece in place.
Noise levels generated by the respirator will be measured inside the hood or helmet at maximum airflow obtainable and shall not exceed 80 dBA.
(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a chemical cartridge respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with §§ 84.206 through 84.207.
(b) The maximum allowable resistance requirements for chemical cartridge respirators are as follows:
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.
(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.
(a) The complete chemical cartridge respirator will be fitted to the faces of persons having varying facial shapes and sizes.
(b) Where the applicant specifies a facepiece size or sizes for the respirator together with the approximate measurement of faces they are designed to fit, the Institute will provide test subjects to suit such facial measurements.
(c) Any chemical cartridge respirator part which must be removed to perform the facepiece or mouthpiece fit test shall be replaceable without special tools and without disturbing facepiece or mouthpiece fit.
(d) The facepiece or mouthpiece fit test using the positive or negative pressure recommended by the applicant and described in his instructions will be used before each test.
(e)(1) Each wearer will enter a chamber containing 100 p.p.m. isoamyl acetate vapor for half-mask facepieces, and 1,000 p.p.m. for full facepieces, mouthpieces, hoods, and helmets.
(2) The facepiece or mouthpiece may be adjusted, if necessary, in the test chamber before starting the test.
(3) Each wearer will remain in the chamber for 8 minutes while performing the following activities:
(i) Two minutes, nodding and turning head;
(ii) Two minutes, calisthenic arm movements;
(iii) Two minutes, running in place; and
(iv) Two minutes, pumping with a tire pump into a 28-liter (1 cubic-foot) container.
(4) Each wearer shall not detect the odor of isoamyl-acetate vapor during the test.
(a) Three respirators with cartridges containing, or having attached to them, filters for protection against particulates will be tested in accordance with the provisions of § 84.207.
(b) In addition to the test requirements set forth in paragraph (a) of this section, three such respirators will be tested, as appropriate, in accordance with the provisions of §§ 84.179 through 84.183; however, the maximum allowable resistance of complete particulate, and gas, vapor, or gas and vapor chemical cartridge respirators shall not exceed the maximum allowable limits set forth in § 84.203.
(a) Bench tests will be made on an apparatus that allows the test atmosphere at 50±5 percent relative humidity and room temperature, approximately 25 °C, to enter the cartridges continuously at predetermined concentrations and rates of flow, and that has means
(b) Where two cartridges are used in parallel on a chemical cartridge respirator, the bench test will be performed with the cartridges arranged in parallel, and the test requirements will apply to the combination rather than to the individual cartridges.
(c) Three cartridges or pairs of cartridges will be removed from containers and tested as received from the applicant.
(d) Two air purifying cartridges or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the flow rate of 25 liters per minute (l.p.m.) for 6 hours.
(e) Two air purifying cartridges or pairs of cartridges will be equilibrated by passing 85 percent relative humidity air through them at the flow rate of 25 l.p.m.
(f) All cartridges will be resealed, kept in an upright position, at room temperatures, and tested within 18 hours.
(g) Cartridges will be tested and shall meet the minimum requirements set forth in Table 11 of this subpart.
Vinyl chloride respirators, including all completely assembled respirators which are designed for use as respiratory protection during entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life, are described according to their construction as follows:
(a) Front-mounted or back-mounted gas masks;
(b) Chin-style gas masks;
(c) Chemical-cartridge respirators;
(d) Powered air-purifying respirators; and
(e) Other devices, including combination respirators.
(a) Each vinyl chloride respirator described in § 84.250 shall, where its design requires, contain the following component parts:
(1) Facepiece;
(2) Canister with end-of-service-life indicator;
(3) Cartridge with end-of-service-life indicator;
(4) Harness;
(5) Attached blower; and
(6) Breathing tube.
(b) The components of each vinyl chloride respirator shall meet the minimum construction requirements set forth in Subpart G of this part.
(a) Except for the tests prescribed in § 84.126, the minimum requirements and performance tests for gas masks, prescribed in Subpart I of this part, are applicable to vinyl chloride gas masks.
(b) The following bench tests are applicable to canisters designed for use with gas masks for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:
(1) Four canisters will be equilibrated at 25±5 °C by passing 85±5 percent relative humidity air through them at 64 liters per minute for six hours.
(2) The equilibrated canisters will be resealed, kept in an upright position at room temperature, and tested according to paragraph (b)(3) of this section within 18 hours.
(3) The canisters equilibrated and stored as described in paragraphs (b) (1) and (2) of this section will be tested on an apparatus that allows the test atmosphere at 85±5 percent relative humidity and 25±5 °C to enter the canister continuously at a concentration of 25 ppm vinyl chloride monomer at a total flow rate of 64 liters per minute.
(4) The maximum allowable penetration after six hours of testing according to paragraph (b)(3) of this section shall not exceed 1 ppm vinyl chloride.
(c) Where canisters are submitted for testing and approval with a service life of more than four hours, the period of time for testing for vinyl chloride penetration will be performed at 150% of the service life specified in the manufacturer's application. (Example: If a manufacturer requests approval of a respirator for six hours use against exposure to vinyl chloride, the maximum allowable penetration after nine hours of testing shall not exceed 1 ppm vinyl chloride.)
(a) Except for the tests prescribed in §§ 84.206 and 84.207, the minimum requirements and performance tests for chemical-cartridge respirators prescribed in Subpart L of this part are applicable to replaceable-cartridge and single-use vinyl chloride chemical-cartridge respirators.
(b) The following bench tests are applicable to cartridges designed for use with chemical-cartridge respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:
(1) Where two cartridges are used in parallel on a chemical-cartridge respirator, the bench test requirements will apply to the combination rather than the individual cartridges.
(2) Four cartridges or pairs of cartridges will be equilibrated at 25±5 °C by passing 85±5 percent relative humidity air through them at 25 liters per minute for six hours.
(3) The equilibrated cartridges will be resealed, kept in an upright position, at room temperature, and tested according to paragraphs (b)(4) and (b)(5) of this section for other than single-use respirators or according to paragraphs (b)(6) and (b)(7) of this section for single-use respirators within 18 hours.
(4) The cartridges or pairs of cartridges for other than single-use respirators, equilibrated and stored as described in paragraphs (b)(1), (b)(2), and (b)(3) of this section, will be tested on an apparatus that allows the test atmosphere at 85±5 percent relative humidity and 25±5 °C, to enter the cartridges or pairs of cartridges continuously at a concentration of 10 ppm vinyl chloride monomer at a total flowrate of 64 liters per minute.
(5) The maximum allowable penetration after 90 minutes testing of cartridges or pairs of cartridges for other than single-use respirators, according to paragraph (b)(4) of this section shall not exceed 1 ppm vinyl chloride.
(6) The single-use respirators, equilibrated and stored as described in paragraphs (b)(2) and (b)(3) of this section,
(7) The maximum allowable penetration after 144 minutes testing of respirators, according to paragraph (b)(6) of this section, shall not exceed 1 ppm vinyl chloride.
(a) Except for the tests prescribed in § 84.207, the minimum requirements and performance tests for powered air-purifying respirators prescribed in subpart L of this part are applicable to vinyl chloride powered air-purifying respirators.
(b) The following bench tests are applicable to cartridges designed for use with powered air-purifying respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:
(1) Four cartridges will be equilibrated at 25± °C by passing 85±5 percent relative humidity air through them at 115 liters per minute for tight-fitting facepieces and 170 liters per minute for loose-fitting hoods and helmets, for six hours.
(2) The equilibrated cartridges will be resealed, kept in an upright position at room temperature and tested according to paragraph (b)(3) of this section within 18 hours.
(3) The cartridges equilibrated and stored as described in paragraphs (b) (1) and (2) of this section will be tested on an apparatus that allows the test atmosphere at 85±5 percent relative humidity and 25±5 °C to enter the cartridge continuously at a concentration of 25 ppm vinyl chloride monomer at a total flow rate of 115 liters per minute for tight-fitting facepieces and 170 liters per minute for loose-fitting hoods and helmets.
(4) The maximum allowable penetration after six hours of testing according to paragraph (b)(3) of this section shall not exceed 1 ppm vinyl chloride.
(a) Each canister or cartridge submitted for testing and approval in accordance with §§ 84.252, 84.253, and 84.254 shall be equipped with a canister or cartridge end-of-service-life indicator which shows a satisfactory indicator change or other obvious warning before 1 ppm vinyl chloride penetration occurs. The indicator shall show such change or afford such warning at 80±10 percent of the total service life to 1 ppm leakage, as determined by continuing each test described in §§ 84.252(b), 84.253(b), and 84.254(b) until a 1 ppm leakage of vinyl chloride occurs.
(b) The applicant shall provide sufficient pretest data to verify the performance of the end-of-service-life indicator required in paragraph (a) of this section.
(a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs (b), (c), and (d) of this section apply to approval of gas masks, chemical cartridge respirators, and powered air-purifying respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life.
(b) The respirators submitted for approval as described in paragraph (a) of this section shall be accompanied by a complete quality control plan meeting the requirements of subpart E of this part.
(c)(1) The applicant shall specify in the plan that a sufficient number of samples will be drawn from each bulk container of sorbent material and that where activated carbon is used, the following specific tests will be performed:
(i) Apparent density;
(ii) Iodine number;
(iii) Moisture content;
(iv) Carbon tetrachloride number; and
(v) Mesh size.
(2) The tests in paragraph (c)(1) of this section shall be performed in a
(d) Final performance quality control tests on the complete canisters and cartridges shall be accomplished using the bench tests and procedures prescribed in §§ 84.252, 84.253, 84.254, and 84.255.
(a) A warning shall be placed on the label of each gas mask, chemical-cartridge respirator, and powered air-purifying respirator, and on the label of each canister and cartridge, alerting the wearer to the need for a fitting test in accordance with the manufacturer's facepiece fitting instructions, providing service life information, providing specific instructions for disposal, and advising that the wearer may communicate to NIOSH any difficulties that may be experienced in the design and performance of any gas mask, chemical-cartridge respirator, or powered air-purifying respirator approved under the requirements of this subpart. The service lives of respirators meeting the test requirements of this subpart shall be specified as follows:
(b) Where the service life of a respirator is approved for more than four hours, the service life for which the respirator has been approved will be specified.
The following fees shall be charged for the examination, inspection, and testing of complete assemblies and components of respirators described in §§ 84.250 and 84.251:
The purpose of this subpart KK is to establish procedures and requirements for issuing extensions of approval of particulate respirators certified prior to July 10, 1995 under the provisions of 30 CFR part 11 (See 30 CFR part 11 edition, as revised July 1, 1994.), new approvals and extensions of approval of particulate respirators for applications that are in NIOSH receipt on July 10, 1995, and approval of powered air-purifying respirators.
(a) Air-purifying respirators with particulate filters approved under the provisions of this subpart after July 10, 1995 will have a 30 CFR part 11 approval label.
(b) Only changes or modifications of non-powered air-purifying respirators with particulate filters approved under the provisions of subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this section and deemed necessary by NIOSH to ensure the health and safety of the wearer will be approved until July 10, 1998 and will have a 30 CFR part 11 approval label.
(c) Only changes or modifications of powered air-purifying respirators with particulate filters approved under the provisions of subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this section and deemed necessary by NIOSH to ensure the health and safety of the wearer will be approved under this subpart until July 10, 1998 and will have a 30 CFR part 11 label.
(d) Approval of powered air-purifying respirators will be issued under this subpart. Particulate filters for powered air-purifying respirators approved under the provisions of this subpart shall be only high-efficiency (HEPA) as described in § 84.1130(a)(4) and will carry a 42 CFR part 84 approval label. In addition, changes or modifications of powered HEPA air-purifying respirators approved under the provisions of this subpart KK will be approved under this subpart and will have a 42 CFR part 84 approval label.
As used in this subpart
(a)
(b)
(c)
(1) Any substance or mixture of substances (including solvents and impurities) intended to prevent, destroy, repel, or mitigate any insect, rodent, nematode, fungus, weed, or other form of plant or animal life or virus; and
(2) Any substance or mixture of substances (including solvents and impurities) intended for use as a plant regulator, defoliant, or desiccant, as defined in the Federal Insecticide, Fungicide, and Rodenticide Act of 1947, as amended (7 U.S.C. 135-135k), excluding fumigants which are applied as gases or vapors or in a solid or liquid form as pellets or poured liquids for subsequent release as gases or vapors.
(d)
(e)
The following fees shall be charged by the Institute for the examination, inspection and testing of complete respirator assemblies approved under this subpart:
(a) Gas masks with particulate filter, including pesticide gas masks—
(1) Single hazard—$1,100.
(2) Type N—$4,100.
(b) Dust, fume and mist respirators—
(1) Single particulate hazard having an Air Contamination Level more than 0.05 mg./m.
(2) Combination particulate hazards having an Air Contamination Level more than 0.05 mg./m.
(3) Particulate hazards having an Air Contamination Level less than 0.05 mg./m.
(4) All dusts, fumes and mists—$2,000.
(c) Paint spray respirators—$1,600.
(d) Pesticide respirators—$1,600.
(e) Chemical cartridge respirators with particulate filter—$1,150.
(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to MSHA and the Institute for approval.
(b) Approval labels for non-powered and powered air-purifying dust, fume, mist respirators approved prior to July 10, 1995 under the provisions of subpart K of 30 CFR part 11 (See 30 CFR Part 11 edition, revised as of July 1, 1994.) shall bear the emblem of the Mine Safety and Health Administration and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute, a statement that the respirator was tested and approved under subpart K of 30 CFR part 11 and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.
(c) Approval labels for powered air-purifying respirators approved under the provisions of this subpart shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department
(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.
(d) Approval labels and markings shall only be used by the applicant to whom they were issued.
(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:
(f) The use of any MSHA and Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.
(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.
At 60 FR 30388, June 8, 1995, § 84.1103 was added with two paragraph (c) designations.
(a) Dust, fume, and mist respirators, including all completely assembled respirators designed for use as respiratory protection during entry into and escape from atmospheres which contain adequate oxygen to support life and hazardous particulates, are described as follows:
(1) Air-purifying respirators, either with replaceable or reusable filters, designed as respiratory protection against dusts:
(i) Having an air contamination level not less than 0.05 milligram per cubic meter of air, including but not limited to coal, arsenic, cadmium, chromium, lead, and manganese; or
(ii) Having an air contamination level not less than 2 million particles per cubic foot of air, including but not limited to aluminum, flour, iron ore, and free silica, resulting principally from the disintegration of a solid, e.g., dust clouds produced in mining, quarrying, and tunneling, and in dusts produced during industrial operations, such as grinding, crushing, and the general processing of minerals and other materials.
(2) Air-purifying respirators, with replaceable filters, designed as respiratory protection against fumes of various metals having an air contamination level not less than 0.05 milligram per cubic meter, including but not limited to aluminum, antimony, arsenic, cadmium, chromium, copper, iron, lead, magnesium, manganese, mercury (except mercury vapor), and zinc, which result from the sublimation
(3) Air-purifying respirators, with replaceable filters, designed as respiratory protection against mists of materials having an air contamination level not less than 0.05 milligram per cubic meter or 2 million particles per cubic foot, e.g., mists produced by spray coating with vitreous enamels, chromic acid mist produced during chromium plating, and other mists of materials whose liquid vehicle does not produce harmful gases or vapors.
(4) Air-purifying respirators, with replaceable filters, designed as respiratory protection against dusts, fumes, and mists having an air contamination level less than 0.05 milligram per cubic meter, including but not limited to lithium hydride and beryllium, and against radionuclides.
(5) Air-purifying respirators, with replaceable filters, designed as respiratory protection against radon daughters, and radon daughters attached to dusts, fumes, and mists.
(6) Air-purifying respirators, with replaceable filters, designed as respiratory protection against asbestos-containing dusts and mists.
(7) Air-purifying respirators, with replaceable filters, designed as protection against various combinations of particulate matter.
(8) Air-purifying dust respirators designed as respiratory protection against pneumoconiosis- and fibrosis-producing dusts, or dusts and mists, including but not limited to aluminum, asbestos, coal, flour, iron ore, and free silica.
(b) Gas masks containing filters for protection against dusts, fumes, mists, and smokes in combination with gases, vapors, or gases and vapors. These respirators are not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate high heats of reaction with sorbent material in the canister.
(c) Pesticide respirators, including all completely assembled respirators which are designed for use as respiratory protection during entry into and escape from atmospheres which contain pesticide hazards, are described according to their construction as follows:
(1) Front-mounted or back-mounted gas masks;
(2) Chin-style gas mask;
(3) Chemical cartridge;
(4) Air-purifying respirator with attached blower; and,
(5) Other devices, including combination respirators.
(d) Respirators with cartridges containing or having attached to them, filters for protection against mists of paints, lacquers, and enamels. These respirators are not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate high heats of reaction with sorbent material in the cartridge.
(e) Respirators with cartridges containing or having attached to them filters for protection against dusts, fumes, and mists, except the mists of paints, lacquers, and enamels. These respirators are not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate high heats of reaction with sorbent material in the cartridge.
(a) Each respirator described in § 84.1130 shall, where its design requires, contain the following component parts:
(1) Facepiece, mouthpiece with noseclip, hood, or helmet;
(2) Filter unit, canister with filter, or cartridge with filter;
(3) Harness;
(4) Attached blower; and
(5) Breathing tube.
(b) The components of each respirator shall meet the minimum construction requirements set forth in Subpart G of this part.
(a) Flexible breathing tubes used in conjunction with respirators shall be designed and constructed to prevent:
(1) Restriction of free head movement;
(2) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;
(3) Interference with the wearer's activities; and
(4) Shutoff of airflow due to kinking, or from chin or arm pressure.
(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts, and, where applicable, provide for holding a full facepiece in the ready position when not in use.
(a) Except as provided in paragraph (b) of this section each respirator shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type of respirator it contains, and all appropriate approval labels. Except for dust, fume, and mist respirators, the commercial designation of the respirator it contains shall be shown.
(b) Containers for single-use respirators may provide for storage of more than one respirator, however, such containers shall be designed and constructed to prevent contamination of respirators which are not removed, and to prevent damage to respirators during transit.
(c) Containers for gas masks combinations shall be designed and constructed to permit easy removal of the mask.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.
(d) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight seal.
(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.
(f) Half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles, as determined by the Institute's facepiece tests in §§ 84.1141, 84.1142, and 84.1156(b).
(a) Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.
(b) All eyepieces of gas masks combinations shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965, with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the
(a) Inhalation and exhalation valves shall be protected against distortion.
(b) Inhalation valves shall be designed and constructed and provided where necessary to prevent excessive exhaled air from adversely affecting filters, cartridges, and canisters, except where filters of dust, fume, and mist respirators are specifically designed to resist moisture as prescribed in § 84.1145.
(c) Exhalation valves shall be:
(1) Provided where necessary;
(2) Protected against damage and external influence; and
(3) Designed and constructed to prevent inward leakage of contaminated air.
(a) All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.
(b) Facepiece head harnesses, except those employed on single-use dust, fume, and mist respirators, shall be adjustable and replaceable.
(c) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses, designed and constructed to hold the mouthpiece in place.
Noise levels generated by the respirator will be measured inside the hood or helmet at maximum airflow obtainable and shall not exceed 80 dBA.
Dust, fume, and mist respirators and the individual components of each such device shall, as appropriate, meet the requirements for performance and protection specified in the tests described in §§ 84.1141 through 84.1152 and prescribed in Tables 12 and 13.
(a) The respirator will be modified in such a manner that all of the air that normally would be inhaled through the inhalation port(s) is drawn through an efficient activated charcoal-filled canister, or cartridge(s), without interference with the face-contacting portion of the facepiece.
(b) The modified respirator will be worn by persons for at least 2 minutes each in a test chamber containing 100 parts (by volume) of isoamyl-acetate vapor per million parts of air.
(c) The odor of isoamyl-acetate shall not be detected by the wearers of the modified respirator while in the test atmosphere.
(a) The applicant shall provide a charcoal-filled canister or cartridge of a size and resistance similar to the filter unit with connectors which can be attached to the facepiece in the same manner as the filter unit.
(b)(1) The canister or cartridge will be used in place of the filter unit, and persons will each wear a modified half-mask facepiece for 5 minutes in a test chamber containing 100 parts (by volume) of isoamyl-acetate vapor per million parts of air.
(2) The following work schedule will be performed by each wearer in the test chamber:
(i) Two minutes walking, nodding, and shaking head in normal movements; and
(ii) Three minutes exercising and running in place.
(3) The facepiece shall be capable of adjustment, according to the applicant's instructions, to each wearer's
(c) Where the respirator is equipped with a full facepiece, hood, helmet, or mouthpiece, the canister or cartridge will be used in place of the filter unit, and persons will each wear the modified respiratory-inlet covering for 5 minutes in a test chamber containing 1,000 parts (by volume) of isoamyl-acetate vapor per million parts of air, performing the work schedule specified in paragraph (b)(2) of this section.
Dust, fume, and mist respirators will be tested in accordance with the schedule set forth in Table 13 of this subpart to determine their effectiveness as protection against the particulate hazards specified in Table 13.
(a) Three non-powered respirators with single-use filters will be tested for periods of 90 minutes each at a continuous airflow rate of 32 liters per minute.
(b) The relative humidity in the test chamber will be 20-80 percent, and the room temperature approximately 25° C.
(c) The test suspension in the chamber will not be less than 50 nor more than 60 milligrams of flint (99+ percent free silica) per cubic meter of air.
(d) The flint in suspension will be ground to pass 99+ percent through a 270-mesh sieve.
(e) The particle-size distribution of the test suspension will have a geometric mean of 0.4 to 0.6 micrometer, and the standard geometric deviation will not exceed 2.
(f) The total amount of unretained test suspension in samples taken during testing shall not exceed 1.5 milligrams for a non-powered air-purifying respirator.
(g) Three non-powered respirators with reusable filters will be tested and shall meet the requirements specified in paragraphs (a) through (f) of this section; each filter shall be tested three times: Once as received; once after cleaning; and once after recleaning. The applicant's instructions shall be followed for each cleaning.
(a) Three respirators will be tested.
(b) As described in § 84.1144, airflow will be cycled through the respirator by a breathing machine at the rate of 24 respirations per minute with a minute volume of 40 liters; a breathing machine cam with a work rate of 622 kg.-m.2/minute shall be used.
(c) Air exhaled through the respirator will be 35° ±2° C. with 94 ±3 percent relative humidity. #
(d) Air inhaled through the respirator will be sampled and analyzed for respirator leakage.
(e) The total amount of unretained test suspension, after drying, in samples taken during testing, shall not exceed 1.8 milligrams for any single test.
(a) Three non-powered respirators will be tested for a period of 312 minutes each at a continuous airflow rate of 32 liters per minute.
(b) The relative humidity in the test chamber will be 20-80 percent, and the room temperature approximately 25° C.
(c) The test suspension in the test chamber will not be less than 15 nor more than 20 milligrams of freshly generated lead-oxide fume, calculated as lead (Pb), per cubic meter of air.
(d) The fume will be generated by impinging an oxygen-gas flame on molten lead.
(e) Samples of the test suspension will be taken during each test period for analysis.
(f) The total amount of unretained test suspension in the samples taken during testing, which is analyzed and calculated as lead (Pb), shall not exceed 1.5 milligrams of lead for a non-powered air-purifying respirator.
(a) Three non-powered respirators will be tested for a period of 312 minutes each at a continuous airflow rate of 32 liters per minute.
(b) The room temperature in the test chamber will be approximately 25°C.
(c) The test suspension in the test chamber will not be less than 20 nor more than 25 milligrams of silica mist, weighed as silica dust, per cubic meter of air.
(d) Mist will be produced by spraying an aqueous suspension of flint (99+ percent free silica), and the flint shall be ground to pass 99+ percent through a 270-mesh sieve.
(e) Samples of the test suspension will be taken during each test period for analysis.
(f) The total amount of silica mist unretained in the samples taken during testing, weighed as silica dust, shall not exceed 2.5 milligrams for a non-powered air-purifying respirator.
Respirators designed as respiratory protection against more than one particulate hazard (dust, fume, or mist) shall comply with all the requirements of this part, with respect to each of the specific hazards involved.
(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a dust, fume, or mist respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with §§ 84.1144 through 84.1147.
(b) The maximum allowable resistance requirements for dust, fume, and mist respirators are as follows:
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.
(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.
(a) All single air-purifying respirator filter units will be tested in an atmosphere concentration of 100 micrograms of DOP per liter of air at continuous flow rates of 32 and 85 liters per minute for a period of 5 to 10 seconds.
(b) Where filters are to be used in pairs, the flow rates will be 16 and 42.5 liters per minute, respectively, through each filter.
(c) The filter will be mounted on a connector in the same manner as used on the respirator, and the total leakage for the connector and filter shall not exceed 0.03 percent of the ambient DOP concentration at either flow rate.
(a) Three non-powered respirators will be tested in accordance with the provisions of § 84.1144, or equivalent, and shall meet the minimum requirements of §§ 84.1144 and 84.1149.
(b) Three powered air-purifying respirators will be tested in accordance with the provisions of § 84.1144 except they will be tested for a period of 4 hours each at a flowrate not less than 115 liters per minute to tight-fitting facepieces, and not less than 170 liters per minute to loose-fitting hoods and helmets. The total amount of unretained test suspension in samples taken during testing shall not exceed 14.4 milligrams for a powered air-purifying respirator with tight-fitting facepiece, and 21.3 milligrams for a powered air-purifying respirator with loose-fitting hood or helmet. They shall meet the minimum requirements of § 84.1149.
(a) Gas mask canisters containing filters for protection against dusts, fumes, mists, and smokes in combination with gases, vapors, or gases and vapors, will be tested as prescribed in § 84.1140 except for the breathing resistance which will be in accordance with § 84.122.
(b) Gas mask canisters designed for protection against smokes will be tested in an atmospheric concentration of 100 micrograms of dioctyl phthalate per liter of air at continuous flow rates of 32 liters per minute and 85 liters per minute for a period of 5 to 10 seconds, and the DOP leakage through the canister shall not exceed 0.03 percent of the test concentration.
(c) Gas mask canisters containing filters for protection against dusts, fumes, mists, and smokes in combination with gases, vapors, or gases and vapors, will be tested as prescribed in § 84.126.
(a) Where two or more canisters or cartridges are used in parallel, their resistance to airflow shall be essentially equal.
(b) The color and markings of all canisters and cartridges or labels shall conform with the requirements of the American National Standards Institute, American National Standard for Identification of Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(a) Particulate matter filters used in conjunction with a canister or cartridge shall be located on the inlet side of the canister or cartridge.
(b) Filters shall be incorporated into or firmly attached to the canister or cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement on the canister or cartridge.
Pesticide respirators and the individual components of each such device shall, as appropriate, meet the following minimum requirements for performance and protection:
(a)
(2) The maximum allowable resistance requirements for pesticide respirators are as follows:
(b)
(2) Where the applicant specifies a facepiece size or sizes for his respirator together with the approximate measurements of faces they are designed to fit, the Institute will provide test subjects to suit such facial measurements.
(3) Any pesticide respirator part which must be removed to perform the facepiece fit test shall be replaceable without special tools and without disturbing facepiece fit.
(4) The facepiece or mouthpiece fit test using positive or negative pressure recommended by the applicant and described in his instructions will be used during each test.
(5)(i) Each wearer will enter a chamber containing 1,000 p.p.m. isoamyl-acetate vapor for a respirator equipped with a full facepiece, mouthpiece, hood, or helmet and 100 p.p.m. isoamyl-acetate vapor for a respirator equipped with a half-mask facepiece.
(ii) The facepiece, mouthpiece, hood, or helmet may be adjusted, if necessary, in the test chamber before starting the test.
(iii) Each wearer will remain in the chamber while performing the following activities:
(A) Two minutes, nodding and turning head;
(B) Two minutes, calisthenic arm movements;
(C) Two minutes, running in place; and
(D) Two minutes, pumping with a tire pump into a 28-liter (1 cubic foot) container.
(iv) Each wearer shall not detect the odor of isoamyl-acetate during the test.
(c)
(1) Temperature in the test chamber will be approximately 25° C.
(2) Continuous airflow through the respirator will be 32 liters per minute for front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators, and not less than 115 (4 cubic feet) liters per minute to tight-fitting facepieces and 170 liters (6 cubic feet) per minute to loose-fitting hoods and helmets of powered air-purifying respirators.
(3) The test aerosol will contain 50-60 milligrams of 99+ percent free silica per cubic meter of air.
(4) The particle size distribution of the test suspension will have a geometric mean diameter of 0.4 to 0.6 micrometer, with a standard geometric deviation less than 2.
(5) Front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators will be tested for 90 minutes and powered air-purifying respirators will be tested for 4 hours.
(d)
(1) Continuous airflow through the respirator will be 32 liters per minute for front-mounted, back-mounted, and
(2) The test aerosol will contain 15-20 milligrams of freshly generated lead-oxide fume, calculated as lead, per cubic meter of air.
(3) The fume will be generated by impinging an oxygen-gas flame on molten lead.
(4) Front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators will be tested for 90 minutes and powered air-purifying pesticide respirators will be tested for 4 hours.
(5) The total amount of unretained test suspension, which is analyzed and calculated as lead, shall not exceed:
(i) 0.43 milligram for any 90-minute test;
(ii) 4.8 milligrams for any 4-hour test made at 115 liters (4 cubic feet) per minute; or
(iii) 6.2 milligrams for any 4-hour test made at 170 liters (6 cubic feet) per minute.
(e)
(2) The DOP leakage through the canister shall not exceed 0.03 percent of the ambient DOP concentration.
(f)
(ii) Canisters and cartridges will be tested as they are used on each pesticide respirator, either singly or in pairs.
(iii) Three canisters or cartridges or pairs of cartridges will be removed from containers and tested as received from the applicant.
(iv) Two canisters, cartridges, or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the following flow rates (expressed as liters per minute (l.p.m.)) for 6 hours:
(v) Two canisters, cartridges, or pairs of cartridges will be equilibrated at room temperature by passing 85 percent relative humidity air through them at the flow rates stated in paragraph (f)(1)(iv) of this section for 6 hours.
(vi) The equilibrated canisters or cartridges will be resealed, kept in an upright position at room temperature, and tested within 18 hours.
(2) Canisters and cartridges tested in accordance with the provisions of this section shall meet the requirements specified in Table 14 of this subpart.
Chemical cartridge respirators with particulate filters and the individual components of each such device shall, as appropriate, meet the following minimum requirements for performance and protection:
(a)
(2) The maximum allowable resistance requirements for chemical cartridge respirators are as follows:
(b)
(c)
(2) In addition to the test requirements set forth in paragraph (c)(1) of this section, three such respirators will be tested against each aerosol in accordance with the provisions of paragraphs (d) and (e) of this section.
(d)
(2) Continuous airflow through the respirator will be 32 liters per minute for air-purifying respirators, and not less than 115 liters per minute to tight fitting facepieces and 170 liters per minute to loose-fitting hoods and helmets of powered air-purifying respirators.
(3) Airflow through the chamber will be 20-25 air changes per minute.
(4) The atomizer employed will be a No. 64-5 nozzle with setup 3, or equivalent, operating at 69 kN/m.
(5) The test aerosol will be prepared by atomizing a mixture of one volume of clear cellulose nitrate lacquer and one volume of lacquer thinner. The lacquer described in Federal Specification TT-L-31, October 7, 1953, is an example of an acceptable lacquer. Copies of TT-L-31 may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
(6) The concentration of cellulose nitrate in the test aerosol will be 95-125 milligrams per cubic meter.
(7) The test aerosol will be drawn to each respirator for a total of 156 minutes for air-purifying respirators and 240 minutes for powered air-purifying respirators.
(8) The total amount of unretained mist in the samples taken during testing, weighed as cellulose nitrate, shall not exceed 5 milligrams for an air-purifying respirator, 28 milligrams for a powered air-purifying respirator with tight-fitting facepiece, and 41 milligrams for a powered air-purifying respirator with loose-fitting hood or helmet.
(e)
(2) Continuous airflow through the respirator will be 32 liters per minute for air-purifying respirators, and not less than 115 liters per minute to tight-fitting facepieces and 170 liters per minute to loose-fitting hoods and helmets of powered air-purifying respirators.
(3) Airflow through the chamber will be 20-25 air changes per minute.
(4) The atomizer employed will be a No. 64 nozzle with setup 1A, or equivalent, operating at 69 kN/m.
(5) The test aerosol will be prepared by atomizing a mixture of 1 volume of white enamel and 1 volume of turpentine. The enamel described in Federal Specification TT-E-489b, May 12, 1953, with amendment-1 of 9 November 1955 is an example of an acceptable enamel. Copies of TT-E-489b may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
(6) The concentration of pigment in the test aerosol, weighed as ash, will be 95-125 milligrams per cubic meter.
(7) The test aerosol will be drawn to each respirator for a total of 156 minutes for air-purifying respirators and 240 minutes for power air-purifying respirators.
(8) The total amount of unretained mist in the samples taken during testing, weighed as ash, shall not exceed 1.5 milligrams for any air-purifying respirator, 8.3 milligrams for a powered air-purifying respirator with tight-fitting facepiece, and 12.3 milligrams for a powered air-purifying respirator with loose-fitting hood or helmet.
(f)
(2)(i) Two powered air-purifying cartridges or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the following flow rates (expressed in liters per minute (l.p.m.)) for 6 hours:
(ii) Two powered air-purifying cartridges or pairs of cartridges will be equilibrated by passing 85 percent relative humidity air through them at the flow rates stated in paragraph (f)(2)(i) of this section.
(iii) All cartridges will be resealed, kept in an upright position, at room temperatures, and tested within 18 hours.
(a) Three respirators with cartridges containing, or having attached to them, filters for protection against dusts, fumes, and mists, except the mists of paints, lacquers, and enamels, will be tested in accordance with the provisions of § 84.1157(f).
(b) In addition to the test requirements set forth in paragraph (a) of this section, three such respirators will be tested, as appropriate, in accordance with the provisions of §§ 84.1141 through 84.1152; however, the maximum allowable resistance of complete dust, fume, and mist, and gas, vapor, or gas and vapor chemical cartridge respirators shall not exceed the maximum allowable limits set forth in § 84.1157(a)(2).
Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec. 508, 83 Stat. 803; 30 U.S.C. 957.
This part 85 applies to health hazard evaluations requested by any employer or authorized representative of employees under section 20(a)(6) of the Occupational Safety and Health Act of 1970 or section 501(a)(11) of the Federal Mine Safety and Health Act of 1977. This part is not intended to preclude
Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined below shall have the meaning given it in the respective Acts. As used in this part:
(a) Requests for health hazard evaluations should be addressed to the National Institute for Occupational Safety and Health as follows:
(1)
(2)
(b) Requests for health hazard evaluations shall be submitted in writing and signed by either: (1) The employer in whose place of employment the substance or physical agent is normally found, or (2) an authorized representative of employees (see § 85.3-1(e)) in the place of employment where the substance or physical agent is normally found.
Each request for health hazard evaluation shall contain:
(a) The requester's name, address, and telephone number, if any.
(b) The name and address of the place of employment where the substance or physical agent is normally found.
(c) The specific process or type of work which is the source of the substance or physical agent, or in which the substance or physical agent is used.
(d) Details of the conditions or circumstances which prompted the request.
(e) A statement, if the requester is not the employer, that the requester is:
(1) An authorized representative or an officer of the organization representing the employees for purposes of collective bargaining; or
(2) An employee of the employer and is authorized by two or more employees employed in the same place of employment to represent them for purposes of these Acts (each such authorization shall be in writing and a copy submitted with the request for health hazard evaluation); or
(3) One of three or less employees employed in the place of employment where the substance or physical agent is normally found.
(f) A statement indicating whether or not the name(s) of the requester or those persons who have authorized the requester to represent them may be revealed to the employer by NIOSH.
(g) The following supplementary information if known to the requester:
(1) Identity of each substance or physical agent involved;
(2) The trade name, chemical name, and manufacturer of each substance involved;
(3) Whether the substance or its container or the source of the physical agent has a warning label; and
(4) The physical form of the substance or physical agent, number of people exposed, length of exposure (hours per day), and occupations of exposed employees.
NIOSH has developed two forms entitled “Request for Health Hazard Evaluation” and “Request for Mining Health Hazard Evaluation” to assist persons in requesting evaluations. The forms are available upon request from the offices listed in § 85.3(a) (1) and (2) or from the Regional Consultant for Occupational Safety and Health in any Regional Office of the Department of Health and Human Services.
(a) Upon receipt of a request for health hazard evaluation submitted under this part, NIOSH will determine whether or not there is reasonable cause to justify conducting an investigation.
(b) If NIOSH determines that an investigation is justified, a NIOSH officer will inspect the place of employment, collect samples where appropriate, and perform tests necessary to the conduct of a health hazard evaluation, including medical examinations of employees.
(c) If NIOSH determines that an investigation is not justified, the requester will be notified in writing of the decision.
(a) NIOSH officers who have been issued official NIOSH credentials (Form No. CDC/NIOSH 2.93) are authorized by the Director, NIOSH, under sections 20(a) (6) and 8 of the OSH Act and sections 501(a)(11) and 103 of the FMSH Act: To enter without delay any place of employment for the purpose of conducting investigations of all pertinent processes, conditions, structures, machines, apparatus, devices, equipment, records, and materials within the place of employment; and to conduct medical examinations, anthropometric measurements, and functional tests of employees within the place of employment as may be directly related to the specific health hazard evaluation being conducted. Investigations will be conducted in a reasonable manner, during regular working hours or at other reasonable times and within reasonable limits. In connection with any investigation, the NIOSH officers may question privately any employer, owner, operator, agent, or employee from the place of employment; and review, abstract, and duplicate records required by the Acts and regulations and any other related records.
(b) Areas under investigation which contain information classified by any agency of the United States Government in the interest of national security will be investigated only by NIOSH officers who have obtained the proper security clearance and authorization.
(a) Advance notice of visits to the place of employment may be given to expedite a thorough and effective investigation. Advance notice will not be given when, in the judgment of the NIOSH officer, giving such notice would adversely affect the validity and effectiveness of the investigation.
(b) Where a request in accordance with this part has been made by an authorized representative of employees, advance notice in accordance with paragraph (a) of this section will be given by NIOSH to the requester, the representative of the employees for purposes of collective bargaining if such representative is other than the requester, and to the employer.
(c) Where a request in accordance with this part has been made by any employer, advance notice will be given by NIOSH to the employer. Upon the request of the employer, NIOSH will inform the authorized representative of employees of the visit:
(a) Prior to beginning an investigation, NIOSH officers shall present their credentials to the owner, operator, or agent in charge at the place of employment, explain the nature, purpose, and scope of the investigation and the records specified in § 85.5 which they wish to review. Where the investigation is the result of a request submitted by an authorized representative of employees, a copy of the request shall be provided to the employer, except where the requester or any person authorizing the requester pursuant to § 85.3-1(e)(2) has indicated that NIOSH not reveal his name to the employer, in which case a summary of the basis for the request shall be provided to the employer.
(b) At the commencement of an investigation, the employer should precisely identify information which can be obtained in the workplace or workplaces to be inspected as trade secrets. If the NIOSH officer has no clear reason to question such identification, such information shall not be disclosed except in accordance with the provisions of section 20(a)(6) and section 15 of the OSH Act or section 501(a)(11) of the FMSH Act. However, if NIOSH at any time questions such identification by an employer, not less than 15 days' notice to an employer shall be given of the intention to remove the trade secret designation from such information. The employer may within that period submit a request to the Director, NIOSH, to reconsider this intention and may provide additional information in support of the trade secret designation. The Director, NIOSH, shall notify the employer in writing of the decision which will become effective no sooner than 15 days after the date of such notice.
(c) NIOSH officers are authorized to collect environmental samples and samples of substances or measurements of physical agents (including measurement of employee exposure by the attachment of personal sampling devices to employees with their consent), to take or obtain photographs related to the purpose of the investigation, employ other reasonable investigative techniques, including medical examinations of employees with the consent of such employees, and to question privately any employer, owner, operator, agent, or employee. The employer shall have the opportunity to review photographs taken or obtained for the purpose of identifying those which contain or might reveal a trade secret.
(d) NIOSH officers shall comply with all safety and health rules and practices at the place of employment being investigated, and they shall provide and use appropriate protective clothing and equipment. In situations requiring specialized or unique types of protective equipment, such equipment shall be furnished by the employer.
(e) The conduct of investigations shall be such as to preclude unreasonable disruption of the operations of the employer's establishment.
An employer shall, in request of the NIOSH officer, provide suitable space, if such space is reasonably available, to NIOSH to conduct private interviews with, and examinations of, employees. NIOSH officers shall consult with the employer as to the time and place of the medical examination and shall schedule such examinations so as to avoid undue disruption of the operations of the employer's establishment. NIOSH shall conduct, and assume the medical costs of, examinations conducted under this part.
(a) NIOSH officers shall be in charge of investigations. Where the request for a health hazard evaluation has been made by an authorized representative of employees, a representative of the employer and a representative authorized by his employees who is an employee of the employer shall be given an opportunity to accompany the NIOSH officer during the initial physical inspection of any workplace for the purpose of aiding the investigation by identifying the suspected hazard. The NIOSH officer may permit additional employer representatives and such additional representatives authorized by employees to accompany him where he determines that such additional representatives will further aid the investigation. However, if in the judgment of the NIOSH officer, good cause has been shown why accompaniment by a third party who is not an employee of the employer is reasonably necessary to the conduct of an effective and thorough investigation of the workplace, such third party may accompany the NIOSH officer during the inspection:
(b) NIOSH officers are authorized to resolve all disputes as to who is the representative authorized by the employer and employees for the purpose of this section. If there is no authorized representative of employees, or if the NIOSH officer is unable to determine with reasonable certainty who is such representative, he shall consult with a reasonable number of employees concerning matters directly related to the health hazard evaluation.
(c) NIOSH officers are authorized to deny the right of accompaniment under this section to any person whose conduct interferes with a fair and orderly physical inspection.
(d) With regard to information classified by an agency of the U.S. Government in the interest of national security, only persons authorized to have access to such information may accompany an officer in areas containing such information.
(e) Upon request of an employer, any representative authorized under this § 85.9 by employees in any area containing trade secrets shall be an employee in that area or an employee authorized by the employer to enter that area.
Whenever, during the course of, or as a result of, an investigation under this part, the NIOSH officer believes that there is a reasonable basis for an allegation of an imminent danger, NIOSH will immediately advise the employer and those employees who appear to be in immediate danger of such allegation and will inform appropriate representatives of the Department of Labor or the State agency designated under section 18(b) of the OSH Act.
(a) Upon conclusion of an investigation, NIOSH will make a determination concerning the potentially toxic or hazardous effects of each substance or physical agent investigated as a result of the request for health hazard evaluation. At a minimum, the determination will: (1) Identify each substance or physical agent involved and describe, where appropriate, the concentrations or levels of the substance or physical agent found in the place of employment and the conditions of use, and (2) state whether each substance or physical agent has potentially toxic or hazardous effects in the concentrations or levels found, as well as the basis for the judgments.
(b) Copies of the determination will be mailed to the employer and to the authorized representatives of employees.
(c) Except as hereinafter provided, the employer shall post a copy of the determination for a period of 30 calendar days at or near the workplace(s) of affected employees. The employer shall take steps to insure that the posted determinations are not altered, defaced, or covered by other material during such period. The employer will not be required to post the determination if the employer requests that copies of the determination be mailed to affected employees and furnishes NIOSH with a list of the names and mailing addresses of the employees employed in the workplace(s) designated by the NIOSH Officer. In the latter event, NIOSH will mail such copies to affected employees at the mailing addresses provided by the employer.
(d) For purposes of this section, the term “affected employees” means those employees determined by NIOSH to be exposed to the substance(s) or physical agent(s) which is the subject of the health hazard evaluation.
(e) Copies of determinations made under the OSH Act will be forwarded to the Department of Labor and the appropriate State agency designated under section 18(b) of the OSH Act. Copies of determinations made under the FMSH Act will be forwarded to the Mine Safety and Health Administration of the Department of Labor; the Bureau of Mines, Department of the Interior; and the State agency which, in the judgment of NIOSH, would benefit the most from the information. If NIOSH determines that any substance or physical agent has potentially toxic or hazardous effects at the concentrations or levels at which it is used or found in a place of employment, and the substance or physical agent is not covered by a safety or health standard established under section 6 of the OSH Act or section 101 of the FMSH Act, NIOSH will immediately submit the determination to the Secretary of Labor, together with all pertinent criteria.
If a request is received for a health hazard evaluation in a place of employment in which an evaluation under this part was made previously, NIOSH may make another investigation if, as a result of the passage of time or additional information, another investigation would be consistent with the purposes of the Acts.
Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec. 508, 83 Stat. 803; 30 U.S.C. 957.
(a) Except as otherwise provided in paragraph (b) of this section, the provisions of this part apply to investigations of places of employment which are conducted by NIOSH under sections 20 and 8 of the Occupational Safety and Health Act of 1970 and sections 501 and 103 of the Federal Mine Safety and Health Act of 1977.
(b) The provisions of this part do not apply to those activities covered by part 85 of this chapter.
Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined below shall have the meaning given it in the Acts. As used in this part:
(a)
(b)
(c)
(1) A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental;
(2) A description of any attendant discomforts and risks reasonably to be expected;
(3) A description of any benefits reasonably to be expected;
(4) A disclosure of any appropriate alternative procedures that might be advantageous for the subject;
(5) An offer to answer any inquiries concerning the procedures; and
(6) An instruction that the person is free to withdraw his consent and to discontinue participation in the investigation any time without prejudice to the subject.
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(a) NIOSH authorized representatives who have been issued official NIOSH credentials are authorized by the Director, NIOSH, under sections 20 and 8 of the OSH Act, sections 501 and 103 of the FMSH Act, and this part. To enter without delay any place of employment for the purpose of conducting investigations of all pertinent processes, conditions, structures, machines, apparatus, devices, equipment, and materials within the place of employment; and to conduct medical examinations, anthropometric measurements and functional tests of employees within the place of employment as may be directly related to the specific investigation being conducted. Such investigations will be conducted in a reasonable manner, during regular working hours or at other reasonable times and within reasonable limits. In connection with any investigations, such NIOSH authorized representatives may question privately any employer, owner, operator, agent, or employee from the place of employment; and review, abstract, or duplicate employment records, medical records, records required by the Act and regulations, and other related records. In those instances where systems of records subject to review, abstraction or duplication are of a confidential nature, such as medical records, and are abstracted or duplicated, NIOSH will maintain such systems in accordance with the Privacy Act of 1974 (5 U.S.C. 552a) and the implementing regulation of the Department of Health and Human Services (45 CFR part 5b).
(b) Areas under investigation which contain information classified by any agency of the United States Government in the interest of national security will be investigated only by NIOSH authorized representatives who have obtained the appropriate security clearance and authorization.
(a) Except as otherwise provided in paragraph (b) of this section, NIOSH authorized representatives will contact an official representative of the place of employment prior to any site visits and will provide the details of why an investigation of the place of employment is being conducted. Prior to the initiation of a site visit of a place of employment, representatives of the following organizations will be advised of the site visit and the reason for its conduct:
(1) The appropriate State agency designated under section 18(b) of the OSH Act, or if no State agency has been designated under the OSH Act and in the case of the FMSH Act, the State agency which, in the judgment of NIOSH, would benefit the most from the investigation's findings;
(2) If there is a local union at the place of employment, the local president, business manager or other appropriate individual;
(3) The appropriate Assistant Regional Director, when investigations are conducted under the OSH Act;
(4) The appropriate MSHA District Office; the Director, BOM, and the Assistant Director for Mining, BOM, when investigations are conducted under the FMSH Act.
(b) Advance notice of site visits will not be given to the place of employment or local union at the place of employment when, in the judgment of the NIOSH authorized representatives, giving such notice would adversely affect the validity and effectiveness of an investigation. Those individuals and organizations specified in § 85a.4(a)(1), (a)(3) and (a)(4) will be notified prior to the initiation of such a site visit. After the site visit has been initiated, and, as soon as possible thereafter, the NIOSH authorized representatives will contact those individuals specified in § 85a.4(a)(2) concerning the nature and details of the site visit.
(c) In those instances where site visits are not necessary to the conduct of an investigation, the NIOSH authorized representatives will contact an official representative of the place of employment either verbally or through a written communication and provide the details of why an investigation of the place of employment is being conducted. If appropriate, the NIOSH authorized representatives will contact
(a)(1) Prior to beginning a site visit, NIOSH authorized representatives will present their credentials to the employer, owner, operator or agent in charge at the place of employment, explain the nature, purpose and scope of the investigation and the records specified in § 85a.3 which they wish to review, abstract or duplicate.
(2) In those instances where site visits are not necessary to the conduct of an investigation and the initial contact is made verbally, NIOSH authorized representatives will, at the request of the employer, owner, operator or agent in charge at the place of employment, provide a written explanation of the nature, purpose and scope of the investigation and the records specified in § 85a.3 which they wish to review, abstract or duplicate.
(b)(1) At the commencement of an investigation, the employer, owner, operator or agent in charge at the place of employment shall precisely identify that information which is trade secret and might be seen or obtained by the NIOSH authorized representatives during the investigation. If the NIOSH authorized representatives have no clear reason to question such identification, such information will not be disclosed by NIOSH in accordance with the provisions of section 15 of the OSH Act. Generally, NIOSH will not question trade secret designations; however, if NIOSH at any time does question such identification, not less than 15 days' notice to the employer, owner, operator or agent will be given of the intention to remove the trade secret designation from such information. The employer, owner, operator or agent may within that period submit a request to the Director, NIOSH, to reconsider this intention and may provide additional information in support of the trade secret designation. The Director, NIOSH, will notify the employer, owner, operator or agent in writing of the decision which will become effective no sooner than 15 days after the date of such notice.
(2) In those instances where the NIOSH authorized representative is a person fulfilling a contact agreement with NIOSH or is serving as an expert or consultant to NIOSH pursuant to the Act, the employer, owner, operator or agent in charge at the place of employment may, after advising the NIOSH contractor or consultant in writing, elect to withhold information deemed to be a trade secret from such a NIOSH authorized representative or prohibit entry into the area of the place of employment where such entry will reveal trade secrets. In those instances, where the subject information is needed or access to the area of the place of employment is necessary, in the judgment of NIOSH, to fulfill the goals of the investigation, NIOSH regular employees will then obtain the information or enter the subject area of the place of employment.
(c)(1) NIOSH authorized representatives will be in charge of site visits conducted pursuant to this part.
(2) Where there is a request by the representative of the State agency and/or employees, who were notified pursuant to § 85a.4(a)(1) or § 85a.4(a)(2) to accompany the NIOSH authorized representatives during the site visit of the place of employment, the NIOSH authorized representatives will allow this request if they determine that this will aid the investigation; or where, in the judgment of the NIOSH authorized representatives, good cause has been shown why accompaniment by a third party who is not an employee of the employer is reasonably necessary to the conduct of an effective and thorough site visit, they may permit such third party to accompany them during the site visit:
(3) NIOSH authorized representatives are authorized to deny the right of accompaniment under this paragraph to
(4) With regard to information classified by an agency of the United States Government in the interest of national security, only persons authorized to have access to such information may accompany NIOSH authorized representatives in areas containing such information.
(d)(1) NIOSH authorized representatives are authorized: To collect environmental samples and samples of substances; to measure environmental conditions and employee exposures (including measurement of employee exposure by the attachment of personal sampling devices to employees with their consent); to take or obtain photographs, motion pictures or videotapes related to the purpose of the investigation; to employ other reasonable investigative techniques, including medical examinations, anthropometric measurements and standardized and experimental functional tests of employees with the informed consent of such employees; to review, abstract, and duplicate such personnel records as are pertinent to mortality, morbidity, injury, safety, and other similar studies; and to question and interview privately any employer, owner, operator, agency, or employee from the place of employment. The employer, owner, operator, or agency shall have the opportunity to review photographs, motion pictures, and videotapes taken or obtained for the purpose of identifying those which contain or might reveal a trade secret.
(2) Prior to the conduct of medical examinations, anthropometric measurements or functional tests of any employees, the NIOSH authorized representatives will obtain approval of the procedures to be utilized from the NIOSH Human Subjects Review Board and no employee examination, measurement or test will be undertaken without the informed consent of such employee.
(e) NIOSH authorized representatives will comply with all safety and health rules and practices at the place of employment and all NIOSH, Occupational Safety and Health Administration, and Mine Safety and Health Administration regulations and policies during a site visit and will provide and use appropriate protective clothing and equipment. In situations requiring specialized or unique types of protective equipment, such equipment shall be furnished by the employer, owner, operator or agent in charge at the place of employment.
(f) The conduct of site visits will be such as to preclude unreasonable disruption of the operations of the place of employment.
An employer, owner, operator or agent in charge at the place of employment shall, on request of the NIOSH authorized representatives, provide suitable space at the place of employment, if such space is reasonably available, to NIOSH to conduct private interviews with, and medical examinations, anthropometric measurements and functional tests of employees. NIOSH authorized representatives will consult with the employer, owner, operator or agent as to the time and place of the private interviews, medical examination, anthropometric measurements and functional tests and will schedule same so as to avoid undue disruption of work at the place of employment. NIOSH will conduct the medical interviews, measurements, examinations and tests specified under this part at its own expense.
Whenever, during the course of, or as a result of, an investigation under this part, the NIOSH authorized representatives believe there is a reasonable basis for an allegation of an imminent danger, NIOSH will immediately advise the employer, owner, operator or agent in charge at the place of employment and those employees who appear to be in immediate danger of such allegation
(a)(1) Specific reports of investigations of each place of employment under this part, with identification of the place of employment, will be made available by NIOSH to the employer, owner, operator or agent in charge at the place of employment, with copies to the appropriate officials and Agencies notified pursuant to § 85a.4(a). Prior to release of such reports, a preliminary report will be sent by NIOSH to the employer, owner, operator or agent for review for trade secret information and technical inaccuracies that may inadvertently be presented in the report. If requested in writing, the data used to compile the reports will be made available by NIOSH to the employer, owner, operator or agent in charge at the place of employment, except that data will not be released in a form that is individually identifiable.
(2) All specific reports of investigations of each place of employment under this part will be available to the public from the NIOSH Regional Consultant for Occupational Safety and Health in the appropriate NIOSH Regional Office.
(3) In certain instances, specific reports of investigations of each place of employment will not be prepared. In such instances, a closing conference at the place of employment will be conducted by the NIOSH authorized representatives and those individuals participating in the site visit to discuss the findings of the site visit and appropriate recommendations.
(b)(1) Any specific findings of individual employee medical examinations, anthropometric measurements and functional tests will be released by NIOSH authorized representatives to the company physician, private physician, or other person only pursuant to the written authorization of the employee; otherwise, the specific findings and other personal records concerning individuals will be maintained in accordance with 45 CFR part 5b and section 3 of the Privacy Act of 1974 (5 U.S.C. 552a). Notice of all NIOSH systems of records as defined in 45 CFR 5b.1(n) as a result of the investigations of places of employment pursuant to this part will be published in the
(2) In cases where an employee shows positive significant medical findings, the employee and the physician(s) designated by the employee under § 85a.8(b)(1) will be immediately notified by NIOSH.
(3) A summary of the findings of the examinations for each employee will be sent by NIOSH to the individual.
(c) The findings of a total investigation generally will be disseminated as part of NIOSH criteria documents, NIOSH technical reports, NIOSH information packets, scientific journals, presentations at technical meetings, or in other similar manners. These findings of a total investigation will be presented in a manner which does not identify any specific place of employment; however, it should be noted that the specific reports of investigations of each place of employment under this part are subject to mandatory disclosure, upon request, under the provisions of the Freedom of Information Act (5 U.S.C. 552).
Sec. 8(g), 84 Stat. 1600, 29 U.S.C. 657(g); sec. 21(a), 84 Stat. 1612, 29 U.S.C. 670(a).
The regulations of this part are applicable to the award of training grants and direct traineeships pursuant to section 21(a)(1) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 670(a)(1)) to assist in providing an adequate supply of qualified personnel to carry out the purposes of the Act.
Any term not defined herein shall have the same meaning as given it in the Act. As used in this part:
(a)
(b) [Reserved]
(c)
(d)
(e)
Any grant award pursuant to § 86.14 or § 86.33 is subject to the regulations of the Department of Health and Human Services as set forth in 45 CFR parts 6 and 8, as amended. Such regulations shall apply to any activity for which grant funds are in fact used whether within the scope of the proj-ect as approved or otherwise. Appropriate measures shall be taken by the grantee and by the Secretary to assure that no contracts, assignments or other arrangements inconsistent with the grant obligation are continued or entered into and that all personnel involved in the supported activity are aware of and comply with such obligations. Laboratory notes, related technical data, and information pertaining to inventions and discoveries shall be maintained for such periods, and filed with or otherwise made available to the Secretary, or those he may designate at such times and in such manner, as he may determine necessary to carry out such Department regulations.
Except as may otherwise be provided under the terms and conditions of the award, the grantee may copyright without prior approval any publications, films or similar materials developed or resulting from a project supported by a grant under this part, subject, however, to a royalty-free, nonexclusive, and irrevocable license or right in the Government to reproduce, translate, publish, use, disseminate, and dispose, of such materials and to authorize others to do so.
The informal Public Health Service procedure for resolution of post-award grant disputes set forth in subpart D of part 50 of this title and the Department post-award grant appeals procedure in 45 CFR part 16 are applicable to any award made pursuant to this part.
(a)
(b)
(1) To provide specialized instruction for occupational safety and health professional or career personnel which will increase their competence in an area in their respective fields.
(2) To prepare or expand the capabilities of occupational safety and health professional or career personnel for leadership roles as administrators or supervisors, and
(3) To prepare or expand the teaching capabilities of occupational safety and health professionals and career personnel.
(c)
(a)
(b)
(a) An application for a grant under this subpart shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe.
(b) The application shall be executed by an individual authorized to act for the applicant and to assume for the applicant the obligations imposed by the
(a) An approvable application for a long-term training grant must contain each of the following, unless the Secretary determines that the applicant has established good cause for its omission.
(1) Provision of a method for development of the training curriculum and any attendant training materials and resources;
(2) Provision of a method for implementation of the needed training;
(3) Provision of an evaluation methodology, including the manner in which such methodology will be employed, to measure the achievement of the objectives of the training program; and
(4) Provision of a method by which trainees will be selected.
(b) In addition to the requirements set forth in paragraph (a) of this section, an approvable application for a short-term training grant must contain each of the following, unless the Secretary determines that the applicant has established good cause for its omission.
(1) Provision of a methodology to assess the particular skills, or knowledge that prospective trainees need to develop;
(2) Provision of at least 18 hours of formal instruction for a period of not less than 2
(3) Assurances that no portion of the Federal funds will be used for (i) inservice training courses designed only for employees of a single agency, institution, or organization; (ii) correspondence courses; (iii) regular courses usually given for academic credit; or (iv) training the grantee's financial officers, program director, or the official who executed the application.
(c) In addition to the requirements set forth in paragraphs (a), (b)(1), and (b)(3) (ii), (iii) and (iv) of this section, an approvable application for an educational resource center grant must contain each of the following, unless the Secretary determines that the applicant has established good cause for its omission:
(1) A description, supported by appropriate documents, of cooperative arrangements to conduct an educational resource center among a medical school (with an established program in preventive or occupational medicine), a school of nursing, a school of public health or its equivalent, and a school of engineering or its equivalent. Other schools or departments with relevant disciplines and resources—e.g., toxicology, biostatistics, environmental health, law, business administration, education—may be represented and contribute as appropriate to the conduct of the total program.
(2) The identification of an educational resource center Director who possesses a demonstrated capacity for sustained productivity and leadership in occupational safety and health training who shall oversee the general operation of the educational resource center program and shall, to the extent possible, directly participate in training activities.
(3) A description of the full-time professional staff representing various disciplines and qualifications relevant to occupational safety and health and capable of planning, establishing, and carrying out or administering training projects undertaken by the educational resource center.
(4) A description of the training and research expertise, appropriate facilities and ongoing training and research activities in occupational safety and health areas.
(5) A description of its program for conducting education and training of occupational health physicians, occupational health nurses, industrial hygienists/engineers and safety personnel. There shall be full-time students in each of these core disciplines, with a goal of a minimum total of 30 full-time students. Training may also be conducted in other occupational safety and health career categories, e.g., industrial toxicology, biostatistics, epidemiology, and ergonomics. Training programs shall include appropriate field experience including experience with public health and safety agencies and labor-management health and safety activities.
(6) A specific plan for making an impact on the curriculum taught by relevant medical specialties, including radiology, orthopedics, dermatology, internal medicine, neurology, perinatal medicine, and pathology.
(7) A description of its program to assist other institutions or agencies located within the applicant's region including schools of medicine, nursing and engineering, among others, by providing curriculum materials and consultation for curriculum/course development in occupational safety and health, and by providing training opportunities for faculty members.
(8) A specific plan for preparing, distributing, and conducting courses, seminars and workshops to provide short-term and continuing education training courses for physicians, nurses, industrial hygienists, safety engineers and other occupational safety and health professionals, paraprofessionals and technicians, including personnel of labor-management health and safety committees, in the geographical region in which the educational resource center is located. The content and orientation of the curriculum/courses shall take into consideration and address problems relevant to the geographic region served. The goal shall be that the training be made available each year to a minimum of 200-250 trainees representing all of the above categories of personnel with priority given to providing occupational safety and health training to physicians in family practice, as well as in industrial practice, and industrial nurses. These courses shall be structured so that educational institutions, public health and safety agencies, professional societies or other appropriate agencies can utilize them to provide training at the local level to occupational safety and health personnel working in the workplace. Further, the educational resource center shall have a specific plan and demonstrated capability for implementing such training directly and through other institutions or agencies in the region including cooperative efforts with labor unions and industry trade associations where appropriate.
Within the limits of funds available for such purpose the Secretary may award grants to assist in the establishment and operation of those projects which will in his judgment best promote the purposes of section 21(a)(1) of the Act, taking into account:
(a) In the case of long-term training grants:
(1) The need for training in the area or areas of study outlined in the application;
(2) The degree to which the proposal represents a strengthening or expansion of the applicant's program in such areas;
(3) The record of the applicant's effectiveness in training in these or related areas as indicated, among other things, by the placement of its graduates;
(4) The competence of the project staff in relation to the service to be provided;
(5) The reasonableness of the budget in relation to the proposed project;
(6) The applicant's resources, including equipment, facilities, and funds, available for the project;
(7) The current and potential availability of students in the area of study to be offered and their prospective employability as a result of the proposed training;
(8) The extent to which the applicant expects to absorb faculty positions initiated as a result of the grant; and
(9) The degree to which the project adequately provides for the requirements set forth in § 86.13(a).
(b) In the case of short-term training:
(1) The relationship of the contents of the course to the current and emergency training needs to carry out the purposes of the Act;
(2) The qualifications of the instructional staff;
(3) The speed with which the training can be put to use by the persons proposed to be trained;
(4) The reasonableness of the budget in relation to the proposed project;
(5) The success of previous offerings of this course, or related courses;
(6) Evidence of ability to recruit trainees and the estimated number to be enrolled during each course offering; and
(7) The degree to which the proposed project adequately provides for the requirements set forth in § 86.13(b).
(c) In the case of educational resource center grants:
(1) The criteria set forth in paragraphs (a) and (b) of this section.
(2) The degree to which the proposed project adequately provides for the requirements set forth in § 86.13(c).
(d) The amount of any award shall be determined by the Secretary on the basis of his estimate of the sum necessary for all or a designated portion of direct project costs plus an additional amount for indirect costs, if any, which will be calculated by the Secretary either (1) on the basis of his estimate of the actual indirect costs reasonably related to the project, or (2) on the basis of a percentage, not to exceed 8 percent, of all, or a portion of, the estimated direct costs of the project when there are reasonable assurances that the use of such percentage will not exceed the approximate actual indirect costs. Such award may include an estimated provisional amount for indirect costs or for designated direct costs (such as travel or supply costs) subject to upward (within the limits of available funds) as well as downward adjustments to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary.
(e) All grant awards shall be in writing, shall set forth the amount of funds granted and the period for which support is recommended.
(f) Neither the approval of any proj-ect nor any grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved project or portion thereof. For continuation support, grantees must make separate application annually at such times and in such form as the Secretary may direct.
The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement for expenses incurred or to be incurred in the performance of the project to the extent he determines such payments necessary to promote prompt initiation and advancement of the approved project.
(a) Any funds granted pursuant to this subpart as well as other funds to be used in performance of the approved project shall be expended solely for carrying out the approved project in accordance with section 21(a) of the Act, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74.
(b) Prior written approval by the Secretary of revision of the budget and project plan is required whenever there is to be a significant change in the scope or nature of project activities, which in the case of short term training grants, includes any change in the course dates or training sites.
(c) Grant funds are available for trainee stipends and for tuition, including fees and instructional materials, for travel costs related to training allowances. Stipends and allowances may not be increased or be paid beyond the term of the stipend on account of vacation an individual might have been entitled to but did not take.
(d) Stipends may only be paid to a trainee who is a citizen of the United States, an alien lawfully admitted to the United States for permanent residence, or a permanent resident of Guam, American Samoa, or the Trust Territory of the Pacific Islands.
(e) In the case of short term training grants, stipends may not be paid to persons receiving lecture fees, salary, travel expenses, or payment in any form as members of the course instructional staff.
(f) Grant funds used for alterations and renovations shall be subject to the condition that the grantee shall comply with the requirements of Executive Order 11246, as amended, and with the applicable regulations prescribed pursuant thereto.
(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d
(b) Attention is called to the requirements of title IX of the Education Amendments of 1972 (86 Stat. 373, 20 U.S.C. 1681
(c) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.
(a)
(b)
(c)
(2)
(i) Any amount not accounted for pursuant to paragraph (a) of this section; and
(ii) Any credits for earned interest pursuant to paragraph (b) of this section; and
(iii) Any other amounts due pursuant to subparts F, M, and O of 45 CFR part 74.
No grant award may be made under this subpart unless the applicant has complied with:
(a) 45 CFR part 46 pertaining to the protection of human subjects; and
(b) Chapter 1-43 of the Department Grants Administration Manual
The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of public health, or the conservation of grant funds.
The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this part to States and local governments as those terms are defined in subpart A of that part 74. The relevant provisions of the following subparts of part 74 shall also apply to grants to all grantee organizations under this part:
A direct traineeship is an award of funds directly from the Federal Government to an individual (herein called the “trainee”) for his subsistence and other expenses during a period in which he is acquiring training (a) in the occupational safety and health professions, (b) for research relating to occupational safety and health, or (c) for teaching in occupational safety and health.
In order to be eligible for an award under this subpart an applicant must:
(a) Have been accepted by a public or private institution for the purpose of the activity for which the traineeship is sought.
(b) Be a U.S. citizen, an alien lawfully admitted to the United States for permanent residence or a permanent resident of Guam, American Samoa, or the Trust Territory of the Pacific Islands.
An application for a direct traineeship under this subpart shall be submitted to the Secretary at such times and in such form and manner as he may prescribe.
Where the application is for training at a non-Federal institution, no award may be made under this subpart unless said institution has complied with:
(a) 45 CFR part 46 pertaining to the protection of human subjects; and
(b) Chapter 1-43 of the Department Grants Administration Manual
Within the limits of funds available for such purpose and subject to the regulations of this part, the Secretary
(a) Individuals receiving awards shall be entitled to such stipends and allowances as the Secretary may designate, taking into account such factors as the needs of the program, the cost of living, and the availability of funds.
These are prescribed in chapter 3-140 of the Department Grants Administration Manual
(b) Payments of stipends and allowances will, at the discretion of the Secretary, be made directly to the trainee or to the sponsoring institution for payment directly to the trainee.
Direct traineeship awards may be made for varying periods not in excess of 2 years. The Secretary may make one or more continuation awards for an additional period if he finds that satisfactory progress is being made toward accomplishment of the purpose of the initial traineeship award. Additional support may be provided on appropriate justification after expiration of the period of support in the previous award.
All direct traineeship awards shall be subject to the following terms and conditions:
(a) Training must be carried out at an institution found by the Secretary to provide a well-rounded course of instruction in the particular area of training for which the traineeship is awarded.
(b) No direct traineeship may be utilized to compensate any trainee for personal services or employment on behalf of the United States or any person.
Accountability for payments will be subject to such requirements as may be specified by the Secretary.
(a) The Secretary may terminate a direct traineeship at any time upon request of the trainee.
(b) After reasonable notice to the trainee and an opportunity for the presentation of the trainee's views and relevant evidence, the Secretary may terminate any direct traineeship prior to the date it would otherwise expire upon a determination that the trainee's performance is unsatisfactory, that the trainee is no longer attending the sponsoring institution, or that he or she is unfit or unable to carry out the purpose of the traineeship.
(c) The views and evidence of the trainee shall be presented in writing unless the Secretary determines that an oral presentation is desirable.
Sec. 8(g), 84 Stat. 1600 (29 U.S.C. 657(g)), sec. 508, 83 Stat. 803 (30 U.S.C. 957).
This regulation applies to research and demonstration project grants under:
(a) Section 20(a)(1) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a)(1)) for the support of studies related to occupational safety and health, and
(b) Section 501 of the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 951) for the support of health research in mining. These grants are awarded and administered by the National Institute for Occupational Safety and Health, Centers for Disease Control, of the Public Health Service.
As used in this regulation:
Any public or private agency or institution is eligible to apply for a grant under this part, except Federal agencies or institutions not specifically authorized by law to receive such a grant.
(a) The Occupational Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority includes projects to develop innovative methods, techniques, and approaches for dealing with occupational safety and health problems.
(b) The Federal Mine Safety and Health Act authorizes grants for research projects designed to:
(1) Improve working conditions and practices affecting health in coal or other mines and to prevent occupational diseases originating in the mining industry.
(2) Develop epidemiological information to (i) identify and define positive factors involved in occupational diseases of miners, (ii) provide information on the incidence and prevalence of pneumoconiosis and other respiratory ailments of miners, and (iii) improve health standards.
(3) Develop techniques for the prevention and control of occupational diseases of miners, including tests for hypersusceptibility and early detection.
(4) Evaluate the effect on bodily impairment and occupational disability of miners afflicted with an occupational disease.
(5) Study the relationship between coal or other mine environments and occupational diseases of miners.
(6) Study matters involving the protection of life and the prevention of diseases in connection with persons who, although not miners, work with or around the products of coal or other mines in areas outside of such mines and under conditions which may adversely affect the health and well-being of such persons.
(7) Develop effective respiratory equipment.
The application must contain a complete description of the objective of the project and the plan for carrying out the research or demonstration, the name and qualifications of the principal investigator or project director and principal staff members, the total resources and facilities that will be available, and a justification of the amount of grant funds requested.
(a) The Secretary may award grants to those applicants whose approved
(b) This evaluation will take into account the scientific merit and significance of the project, the competency of the proposed staff in relation to the type of research or demonstration involved, the feasibility of the project, the likelihood of its producing meaningful results, the proposed project period, the adequacy of the applicant's resources available for the project, the amount of grant funds necessary for completion, and for mining grant applications, the recommendations of the Mine Health Research Advisory Committee.
(c) The Secretary may evaluate and approve two or more concurrent applications, each dealing with one or more specified aspects of the project, and make two or more concurrent grant awards for the project. This may be necessary when a project involves a number of different but related problems, activities, or disciplines which would require evaluation by different groups, or when support for a project could be more effectively administered by separate handling of various aspects of the project.
(a) The notice of grant award specifies how long the Secretary intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3-5 years.
(b) Generally, the grant will initially be for 1 year and subsequent continuation awards will also be for 1 year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.
(c) Neither the approval of any application, nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
A grantee shall only spend funds it receives under this part according to the approved application and budget, the authorizing legislation, the terms and conditions of the grant award, the applicable cost principles specified in subpart Q of 45 CFR part 74, and the regulations of this part.
Several other regulations apply to grants under this part. These include, but are not limited to:
42 U.S.C. 9615; 42 U.S.C. 6939a(c).
The provisions of this part set forth the policies and procedures of the Agency for Toxic Substances and Disease Registry (ATSDR) with respect to its conduct of health assessments and health effects studies under section 104(i) of Comprehensive Environmental Response, Compensation, and Liability Act, as amended by the Superfund Amendments and Reauthorization Act of 1986, and section 3019 of the Resource Conservation and Recovery Act. These provisions apply to ATSDR, as well as its contractors, agents, and those carrying out health assessments and health effects studies pursuant to agreements with ATSDR, such as other Federal agencies and States.
(a) ATSDR will accept requests to perform health assessments for a particular facility or release from any person or group of persons.
(b) All requests to ATSDR to perform health assessments should be addressed to: Assistant Administrator, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road NE., Atlanta, GA 30333.
(a) Each request for a health assessment shall contain:
(1) The name, address (including zip code), and telephone number of the requestor;
(2) The organization or group the requestor represents, if any;
(3) The name, location, and description of the facility or release of concern;
(4) A statement providing information that individuals have been exposed to a hazardous substance and that the probable source is a release, or sufficient information to allow the Administrator to make such a finding;
(5) A statement requesting ATSDR to perform a health assessment.
(b) At his or her discretion, consistent with the requirements of CERCLA, the Administrator may decide not to require the preceding information be submitted with a request for a health assessment.
(c) Each request for a health assessment should include, where possible:
(1) Any other information pertaining to the facility or release, such as the nature and amount of the hazardous substances of concern or the identities of parties believed to be potentially responsible for the release;
(2) Potential pathways for human exposure, including a description of the media contaminated (e.g. soil, groundwater, air, etc.);
(3) The demographic nature and proximity of the potentially affected human population; and
(4) Other Federal, State, or local governmental agencies which were notified or that investigated the facility or release.
(d) This data collection has been reviewed and approved by OMB in accordance with the Paperwork Reduction Act and assigned the control number 0920-0204.
(a) Upon receipt of a request for a health assessment submitted under this part, ATSDR will determine, in its discretion, whether or not there is a reasonable basis to justify conducting a health assessment. ATSDR will base this determination on, among other factors:
(1) Whether individuals have been exposed to a hazardous substance, for which the probable source of such exposure is a release;
(2) The location, concentration, and toxicity of the hazardous substances;
(3) The potential for further human exposure;
(4) The recommendations of other governmental agencies; and
(5) The ATSDR resources available and other ATSDR priorities, such as its responsibilities to conduct other health assessments and health effects studies.
(b) Where appropriate, ATSDR will request information from other Federal, State, and local governmental agencies, as well as other persons, pertaining to a facility or release which is the subject of a request from the public to ATSDR to conduct a health assessment.
(c) The requestor will be notified in writing of ATSDR's determination that either a health assessment will be performed, a health assessment will not be performed, or that further information concerning the facility or release is required before a decision can be made whether a health assessment will be performed.
(d) If a health assessment is not initiated in response to a request from the public, ATSDR shall provide a written explanation to the requestor of why a health assessment is not appropriate.
(a) Following a determination by ATSDR to conduct a health assessment in response to a request from the public, ATSDR shall notify in writing, at a minimum, the following parties of its intent to perform a health assessment:
(1) The U.S. Environmental Protection Agency;
(2) The appropriate State government environmental agency;
(3) The appropriate State and local health departments;
(4) The requestor;
(5) The owner or operator of the facility of concern, if their identity is readily available to ATSDR.
(b) At its discretion, ATSDR may notify any other persons which it feels may be affected by the release or have information pertaining to the release.
(a) ATSDR may decide, in its discretion, based upon the results of a health assessment or other available information, to conduct a health effects study for a particular site or sites. Such a decision may, in appropriate circumstances, be made prior to the completion of a health assessment for a site or sites. When deciding whether to conduct a health effects study, ATSDR will consider such factors as the results and recommendations of a health assessment for the site or sites and the need for additional information to determine whether individuals have been exposed to hazardous substances, the degree to which such exposure has occurred, and any possible health effects resulting from such exposure.
(b) Should ATSDR decide, in its discretion, to conduct a health effect study, it will notify the parties as specified in § 90.6.
(a) Any interested person or persons may submit data or information to ATSDR for it to consider in its conduct of a health assessment or a health effects study. In performing a health assessment or a health effects study, ATSDR will consider data and information it has independently generated or received from other parties, such as EPA, other Federal agencies, State and local governmental agencies, businesses, citizen organizations, and community groups.
(b) ATSDR may determine it is necessary to conduct a site visit in connection with a health assessment or health effects study. The ATSDR representative may allow the participation of any person in the site visit which he or she, at his or her discretion, determines will aid in the conduct of the health assessment or health effects study.
(c) In the event that the information necessary to perform a health assessment or health effects study is not readily available from other sources, ATSDR may arrange for sampling or additional data gathering at a facility or release for the limited purpose of determining the existence of current or potential health problems.
ATSDR may issue a public health advisory based on the findings of a health assessment, health effects, study, or other ATSDR involvement.
Following internal review by ATSDR and external peer review of a draft final report of the results of a health effects study, ATSDR will publish a notice that the draft final report is available for public review and comment. At
(a) ATSDR shall provide a report of the results of a health assessment or health effects study to EPA, the appropriate State and local governmental agencies, any person requesting ATSDR to conduct the health assessment, and parties potentially responsible for the release, if their identity is readily available to ATSDR. In addition, such reports shall be available to the general public upon request.
(b) In the event that ATSDR or its representatives conduct medical examinations of individuals in the course of a health effects study and the examination reveals a positive significant medical finding, the individual, and a physician if designated by the individual, will be promptly notified of that significant medical finding by ATSDR.
(c) A summary of the findings of all medical examinations for each individual will be sent by ATSDR to that individual.
(d) All studies and results of research conducted under this part (other than health assessments) shall be reported or adopted only after appropriate peer review.
(a) ATSDR shall consider any medical information in individually identifiable form to be confidential information and shall release such information only in accordance with the Privacy Act (5 U.S.C. 552a) or other applicable Federal law.
(b) As provided under section 104(e)(7) of CERCLA, any records, reports, or information obtained from any person under this section shall be available to the public, except that upon a showing satisfactory to ATSDR by any person that records, reports, or information, or particular part thereof (other than health or safety effects data), to which any officer, employee, or representative of ATSDR has access under this part if made public would divulge information entitled to protection under the Trade Secrets Act (18 U.S.C. 1905), such information or particular portion thereof shall be considered confidential in accordance with the purposes of that section, except that such record, report, document, or information may be disclosed to other officers, employees, or authorized representatives of the United States concerned with carrying out statutorily mandated duties.
(c) In submitting data to ATSDR, a person may designate the data which such person believes is entitled to protection under paragraph (b) of this section and submit such designated data separately from other data submitted under this part. A designation under this paragraph shall be made in writing to the Administrator. However, should ATSDR at any time question such designation, not less than 15 days notice to the person sumitting the information shall be given of the intention to remove such trade secret designation from such information. The person may submit a request to the Administrator to reconsider this intention and may provide additional information in support of the trade secret designation. The Administrator shall notify the person in writing of the decision which will become effective no sooner than 15 days after the date of such notice.
(a) ATSDR shall maintain a record of all health assessments and health effects studies. The Administrator shall, at his or her discretion, determine the contents of the record. At a minimum, the record shall include:
(1) The final ATSDR report of the health assessment or health effects study;
(2) Nonconfidential data and other information upon which that report is based or which was considered by ATSDR;
(3) Nonconfidential data or other information submitted by interested persons pertaining to the health assessment or health effects study;
(4) The protocol for the health effects study;
(5) A list of the individuals responsible for external peer review of the report of a health effects study, their comments, and ATSDR's response to the comments; and
(6) For health effects study, the notice announcing the availability of a draft final report for public review and comment, all comments received in response to the notice, and any responses to the comments by ATSDR.
(b) The record may contain a confidential portion which shall include all information determined to be confidential by the Administrator under this part.
(c) The Administrator may determine other documents are appropriate for inclusion in the record for health assessments or health effects studies.
(d) Predecisional documents, including draft documents, are not documents upon which ATSDR bases its conclusions in health assessments or health effects studies, and are not usually included in the record for health assessments or health effects studies.
(e) The record for ATSDR health assessments and health effects studies will be available for review, upon prior request, at ATSDR headquarters in Atlanta, Georgia.
(f) Nothing in this section is intended to imply that ATSDR's decisions to conduct health assessments or health effects studies, or the reports of health assessments or health effects studies, are subject to judicial review.
(a) During all phases of ATSDR health assessments and health effects studies, documentation shall be completed and maintained to form the basis for cost recovery, as specified in section 107 of CERCLA.
(b) Where appropriate, the information and reports compiled by ATSDR pertaining to costs shall be forwarded to the appropriate EPA regional office for cost recovery purposes.
Sec. 215 of the Public Health Service Act (42 U.S.C. 216); secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782 (42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act, 100 Stat. 3766 and 107 Stat. 645-646 (42 U.S.C. 300aa-14(c) and (e)); sec. 904(b) of Pub. L. 105-34, 111 Stat. 873; sec. 1503 of Pub. L. 105-277, 112 Stat. 2681-741; and sec. 523(a) of Pub. L. 106-170, 113 Stat. 1927-1928.
This part applies to the National Vaccine Injury Compensation Program (VICP) under subtitle 2 of title XXI of the Public Health Service (PHS) Act.
For purposes of determining the amount of compensation under the VICP, section 2115(a)(3)(B) of the PHS Act, 42 U.S.C. 300aa.15(a)(3)(B), provides that certain individuals are entitled to receive an amount reflecting lost earnings, less certain deductions. One of the deductions is the average cost of a health insurance policy, as determined by the Secretary of Health and Human Services. The Secretary has determined that the average cost of a health insurance policy is $158.00 per month. This amount will be revised to reflect the changes in the medical care component of the Consumer Price Index (All Urban Consumers, U.S. City Average), published by the United States Bureau of Labor Statistics, plus 2 percent per year. The revised amounts will be effective upon their delivery by the Secretary to the United States Claims Court, and the amounts will be published in a notice in the
(a) In accordance with section 312(b) of the National Childhood Vaccine Injury Act of 1986, title III of Pub. L. 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health Service Act (42 U.S.C. 300aa-14(c)), the following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program:
(b)
(1)
(2)
(i) An acute encephalopathy is one that is sufficiently severe so as to require hospitalization (whether or not hospitalization occurred).
(A)
(B)
(
(
(C) Increased intracranial pressure may be a clinical feature of acute encephalopathy in any age group.
(D) A “significantly decreased level of consciousness” is indicated by the presence of at least one of the following clinical signs for at least 24 hours or greater (see paragraphs (b)(2)(i)(A) and (b)(2)(i)(B) of this section for applicable timeframes):
(
(
(
(E) The following clinical features alone, or in combination, do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness as described above: Sleepiness, irritability (fussiness), high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle. Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy. In the absence of other evidence of an acute encephalopathy, seizures shall not be viewed as the first symptom or manifestation of the onset of an acute encephalopathy.
(ii)
(iii) An encephalopathy shall not be considered to be a condition set forth in the Table if in a proceeding on a petition, it is shown by a preponderance of the evidence that the encephalopathy was caused by an infection, a toxin, a metabolic disturbance, a structural lesion, a genetic disorder or trauma (without regard to whether the cause of the infection, toxin, trauma, metabolic disturbance, structural lesion or genetic disorder is known). If at the time a decision is made on a petition filed under section 2111(b) of the Act for a vaccine-related injury or death, it is not possible to determine the cause by a preponderance of the evidence of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition set forth in the Table, the Court shall consider the entire medical record.
(3) [Reserved]
(4)
(5)
(6)
(A) Medical documentation, recorded within 30 days after the onset, of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination;
(B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination; and
(C) Medical documentation of an antibody response to the rubella virus.
(ii) For purposes of paragraph (a) of this section, the following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/determatomyositis, fibromyalgia, necrotizing vascultitis and vasculopathies and Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction) metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's syndrome, or blood disorders.
(iii) Arthralgia (joint pain) or stiffness without joint swelling shall not be viewed as chronic arthritis for purposes of paragraph (a) of this section.
(7)
(ii) Weakness is required before the diagnosis can be made. Motor, sensory, and reflex findings on physical examination and the results of nerve conduction and electromyographic studies must be consistent in confirming that dysfunction is attributable to the brachial plexus. The condition should thereby be distinguishable from conditions that may give rise to dysfunction of nerve roots (i.e., radiculopathies) and peripheral nerves (i.e., including multiple monoeuropathies), as well as other peripheral and central nervous system structures (e.g., cranial neuropathies and myelopathies).
(8)
(9)
(10)
(c)
(2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X of the Table) are included in the Table as of August 6, 1997.
(3) Rotavirus vaccines (Item XI of the Table) are included in the Table as of October 22, 1998. Vaccines containing live, oral, rhesus-based rotavirus (Item XII of the Table) are included in the Table as of October 22, 1998, provided that they were administered on or before August 26, 2002.
(4) Pneumococcal conjugate vaccines (Item XIII of the Table) are included in the Table as of December 18, 1999.
(5) Other new vaccines (Item XIV of the Table) will be included in the Table as of the effective date of a tax enacted to provide funds for compensation paid with respect to such vaccines. An amendment to this section will be published in the
Sections 215, 371-376 of the Public Health Service Act (42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh).
(a) The provisions of this part apply to the operation of the Organ Procurement and Transplantation Network (OPTN) and to the Scientific Registry.
(b) In accordance with section 1138 of the Social Security Act, hospitals in which organ transplants are performed and which participate in the programs under titles XVIII or XIX of the Social Security Act, and organ procurement organizations designated under section 1138(b) of the Social Security Act, are subject to the requirements of this part.
As used in this part—
(a)
(i) Approximately 50 percent transplant surgeons or transplant physicians;
(ii) At least 25 percent transplant candidates, transplant recipients, organ donors and family members. These members should represent the diversity of the population of transplant candidates, transplant recipients, organ donors and family members served by the OPTN including, to the extent practicable, the minority and gender diversity of this population. These members shall not be employees of, or have a similar relationship with OPOs, transplant centers, voluntary health organizations, transplant coordinators, histocompatibility experts, or other non-physician transplant professionals; however, the Board may waive this requirement for not more than 50 percent of these members; and
(iii) Representatives of OPOs, transplant hospitals, voluntary health associations, transplant coordinators, histocompatibility experts, non-physician transplant professionals, and the general public.
(2) The Board of Directors shall elect an Executive Committee from the membership of the Board. The Executive Committee shall include at least one general public member, one OPO representative, approximately 50 percent transplant surgeons and transplant physicians, and at least 25 percent transplant candidates, transplant recipients, organ donors, and family members.
(3) The Board of Directors shall appoint an Executive Director of the OPTN. The Executive Director may be reappointed upon the Board's determination that the responsibilities of this position have been accomplished successfully.
(4) The Board of Directors shall establish such other committees as are necessary to perform the duties of the OPTN. Committees established by the Board of Directors shall include:
(i) Representation by transplant coordinators, organ procurement organizations, and transplant hospitals, and at least one transplant candidate, transplant recipient, organ donor or family member; and
(ii) To the extent practicable, minority and gender representation reflecting the diversity of the population of transplant candidates, transplant recipients, organ donors and family members served by the OPTN.
(b)
(i) All organ procurement organizations;
(ii) Transplant hospitals participating in the Medicare or Medicaid programs; and
(iii) Other organizations, institutions, and individuals that have an interest in the fields of organ donation or transplantation.
(2) To apply for membership in the OPTN:
(i) An OPO shall provide to the OPTN the name and address of the OPO, and the latest year of designation under section 1138(b) of the Social Security Act;
(ii) A transplant hospital shall provide to the OPTN the name and address of the hospital, a list of its transplant programs by type of organ; and
(iii) Any other organization, institution, or individual eligible under paragraph (c)(1)(iii) of this section shall demonstrate to the OPTN an interest in the fields of organ donation or transplantation.
(3) The OPTN shall accept or reject as members entities or individuals described in paragraph (c)(1)(iii) of this section within 90 days.
(4) Applicants rejected for membership in the OPTN may appeal to the
(i) Deny the appeal; or
(ii) Direct the OPTN to take action consistent with the Secretary's response to the appeal.
(c)
(2) The requirements of this section do not apply to any parent, sponsoring, or affiliated organization of the OPTN, or to any activities of the contracting organization that are not integral to the operation of the OPTN. Such an organization is free to establish its own corporate procedures.
(3) No OPTN member is required to become a member of any organization that is a parent, sponsor, contractor, or affiliated organization of the OPTN, to comply with the by-laws of any such organization, or to assume any corporate duties or obligations of any such organization.
(d)
(a) The OPTN Board of Directors shall be responsible for developing, with the advice of the OPTN membership and other interested parties, policies within the mission of the OPTN as set forth in section 372 of the Act and the Secretary's contract for the operation of the OPTN, including:
(1) Policies for the equitable allocation of cadaveric organs in accordance with § 121.8;
(2) Policies, consistent with recommendations of the Centers for Disease Control and Prevention, for the testing of organ donors and follow-up of transplant recipients to prevent the spread of infectious diseases;
(3) Policies that reduce inequities resulting from socioeconomic status, including, but not limited to:
(i) Ensuring that payment of the registration fee is not a barrier to listing for patients who are unable to pay the fee;
(ii) Procedures for transplant hospitals to make reasonable efforts to obtain from all available sources, financial resources for patients unable to pay such that these patients have an opportunity to obtain a transplant and necessary follow-up care;
(iii) Recommendations to private and public payers and service providers on ways to improve coverage of organ transplantation and necessary follow-up care; and
(iv) Reform of allocation policies based on assessment of their cumulative effect on socioeconomic inequities;
(4) Policies regarding the training and experience of transplant surgeons and transplant physicians in designated transplant programs as required by § 121.9;
(5) Policies for nominating officers and members of the Board of Directors; and
(6) Policies on such other matters as the Secretary directs.
(b) The Board of Directors shall:
(1) Provide opportunity for the OPTN membership and other interested parties to comment on proposed policies and shall take into account the comments received in developing and adopting policies for implementation by the OPTN; and
(2) Provide to the Secretary, at least 60 days prior to their proposed implementation, proposed policies it recommends to be enforceable under § 121.10 (including allocation policies). These policies will not be enforceable until approved by the Secretary. The Board of Directors shall also provide to the Secretary, at least 60 days prior to their proposed implementation, proposed policies on such other matters as the Secretary directs. The Secretary will refer significant proposed policies to the Advisory Committee on Organ Transplantation established under § 121.12, and publish them in the
(c) The OPTN Board of Directors shall provide the membership and the Secretary with copies of its policies as they are adopted, and make them available to the public upon request. The Secretary will publish lists of OPTN policies in the
(d) Any interested individual or entity may submit to the Secretary in writing critical comments related to the manner in which the OPTN is carrying out its duties or Secretarial policies regarding the OPTN. Any such comments shall include a statement of the basis for the comments. The Secretary will seek, as appropriate, the comments of the OPTN on the issues raised in the comments related to OPTN policies or practices. Policies or practices that are the subject of critical comments remain in effect during the Secretary's review, unless the Secretary directs otherwise based on possible risk to the health of patients or to public safety. The Secretary will consider the comments in light of the National Organ Transplant Act and the regulations under this part and may consult with the Advisory Committee on Organ Transplantation established under § 121.12. After this review, the Secretary may:
(1) Reject the comments;
(2) Direct the OPTN to revise the policies or practices consistent with the Secretary's response to the comments; or
(3) Take such other action as the Secretary determines appropriate.
(e) The OPTN shall implement policies and shall:
(1) Provide information to OPTN members about these policies and the rationale for them; and
(2) Update policies developed in accordance with this section to accommodate scientific and technological advances.
(a) A transplant hospital which is an OPTN member may list individuals, consistent with the OPTN's criteria under § 121.8(b)(1), only for a designated transplant program.
(b) Transplant hospitals shall assure that individuals are placed on the waiting list as soon as they are determined to be candidates for transplantation. The OPTN shall advise transplant hospitals of the information needed for such listing.
(c) An OPTN member shall pay a registration fee to the OPTN for each transplant candidate it places on the waiting list. The amount of such fee shall be calculated to cover (together with contract funds awarded by the Secretary) the reasonable costs of operating the OPTN and shall be determined by the OPTN with the approval of the Secretary. No less often than annually, and whether or not a change is proposed, the OPTN shall submit to the Secretary a statement of its proposed registration fee, together with such supporting information as the Secretary finds necessary to determine the
The suitability of organs donated for transplantation shall be determined as follows:
(a)
(b)
(c)
(a)
(2) The rank order of potential recipients shall be determined for each cadaveric organ using the organ specific allocation criteria established in accordance with § 121.8.
(3) When a donor or donor organ does not meet a transplant program's donor acceptance criteria, as established under § 121.6(c), transplant candidates of that program shall not be ranked among potential recipients of that organ and shall not appear on a roster of potential recipients of that organ.
(b)
(2) Organs may be offered only to potential recipients listed with transplant programs having designated transplant programs of the same type as the organ procured.
(3) An organ offer is made when all information necessary to determine whether to transplant the organ into the potential recipient has been given to the transplant hospital.
(4) A transplant program shall either accept or refuse the offered organ for the designated potential recipient within such time as the OPTN may prescribe. A transplant program shall document and provide to the OPO and to the OPTN the reasons for refusal and shall maintain this document for one year.
(c)
(2)
(3)
(d)
(e)
(a)
(1) Shall be based on sound medical judgment;
(2) Shall seek to achieve the best use of donated organs;
(3) Shall preserve the ability of a transplant program to decline an offer of an organ or not to use the organ for the potential recipient in accordance with § 121.7(b)(4)(d) and (e);
(4) Shall be specific for each organ type or combination of organ types to be transplanted into a transplant candidate;
(5) Shall be designed to avoid wasting organs, to avoid futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement;
(6) Shall be reviewed periodically and revised as appropriate;
(7) Shall include appropriate procedures to promote and review compliance including, to the extent appropriate, prospective and retrospective reviews of each transplant program's application of the policies to patients listed or proposed to be listed at the program; and
(8) Shall not be based on the candidate's place of residence or place of listing, except to the extent required by paragraphs (a)(1)-(5) of this section.
(b)
(1) Standardizing the criteria for determining suitable transplant candidates through the use of minimum criteria (expressed, to the extent possible, through objective and measurable medical criteria) for adding individuals to, and removing candidates from, organ transplant waiting lists;
(2) Setting priority rankings expressed, to the extent possible, through objective and measurable medical criteria, for patients or categories of patients who are medically suitable candidates for transplantation to receive transplants. These rankings shall be ordered from most to least medically urgent (taking into account, in accordance with paragraph (a) of this section, and in particular in accordance with sound medical judgment, that life sustaining technology allows alternative approaches to setting priority ranking for patients). There shall be a sufficient number of categories (if categories are used) to avoid grouping together patients with substantially different medical urgency;
(3) Distributing organs over as broad a geographic area as feasible under paragraphs (a)(1)-(5) of this section, and in order of decreasing medical urgency; and
(4) Applying appropriate performance indicators to assess transplant program performance under paragraphs (c)(2)(i) and (c)(2)(ii) of this section and reducing the inter-transplant program variance to as small as can reasonably be achieved in any performance indicator under paragraph (c)(2)(iii) of this section as the Board determines appropriate, and under paragraph (c)(2)(iv) of this section. If the performance indicator “waiting time in status” is used for allocation purposes, the OPTN shall seek to reduce the inter-transplant program variance in this indicator, as well as in other selected performance indicators, to as small as can reasonably be achieved, unless to do so would result in transplanting less medically urgent patients or less medically urgent patients within a category of patients.
(c)
(i) Achieving the performance goals set out in paragraph (b) of this section; and
(ii) Giving patients, their families, their physicians, and others timely and accurate information to assess the performance of transplant programs.
(2) Performance indicators shall include:
(i) Baseline data on how closely the results of current allocation policies approach the performance goals established under paragraph (b) of this section;
(ii) With respect to any proposed change, the amount of projected improvement in approaching the performance goals established under paragraph (b) of this section;
(iii) Such other indicators as the Board may propose and the Secretary approves; and
(iv) Such other indicators as the Secretary may require.
(3) For each organ-specific allocation policy, the OPTN shall provide to the Secretary data to assist the Secretary in assessing organ procurement and allocation, access to transplantation, the effect of allocation policies on programs performing different volumes of transplants, and the performance of OPOs and the OPTN contractor. Such data shall be required on performance by organ and status category, including program-specific data, OPO-specific data, data by program size, and data aggregated by organ procurement area, OPTN region, the Nation as a whole, and such other geographic areas as the Secretary may designate. Such data shall include the following measures of inter-transplant program variation: risk-adjusted total life-years pre-and post-transplant, risk-adjusted patient and graft survival rates following transplantation, risk-adjusted waiting time and risk-adjusted transplantation rates, as well as data regarding patients whose status or medical urgency was misclassified and patients who were inappropriately kept off a waiting list or retained on a waiting list. Such data shall cover such intervals of time, and be presented using confidence intervals or other measures of variance, as may be required to avoid spurious results or erroneous interpretation due to small numbers of patients covered.
(d)
(2)
(e)
(2) No later than March 16, 2000 the OPTN shall transmit revised policies and supporting documentation for liver allocation to meet the requirements of paragraphs (a) and (b) of this section to the Secretary for review in accordance with § 121.4. The OPTN may transmit these materials without seeking further public comment under § 121.4(b).
(f)
(g)
(h)
(a) To receive organs for transplantation, a transplant program in a hospital that is a member of the OPTN shall abide by these rules and shall:
(1) Be a transplant program approved by the Secretary for reimbursement under Medicare; or
(2) Be an organ transplant program which has adequate resources to provide transplant services to its patients and agrees promptly to notify the OPTN and patients awaiting transplants if it becomes inactive and which:
(i) Has letters of agreement or contracts with an OPO;
(ii) Has on site a transplant surgeon qualified in accordance with policies developed under § 121.4;
(iii) Has on site a transplant physician qualified in accordance with policies developed under § 121.4;
(iv) Has available operating and recovery room resources, intensive care resources and surgical beds and transplant program personnel;
(v) Shows evidence of collaborative involvement with experts in the fields of radiology, infectious disease, pathology, immunology, anesthesiology, physical therapy and rehabilitation medicine, histocompatibility, and immunogenetics and, as appropriate, hepatology, pediatrics, nephrology with dialysis capability, and pulmonary medicine with respiratory therapy support;
(vi) Has immediate access to microbiology, clinical chemistry, histocompatibility testing, radiology, and blood banking services, as well as the capacity to monitor treatment with immunosuppressive drugs; and
(vii) Makes available psychiatric and social support services for transplant candidates, transplant recipients, and their families; or
(3) Be a transplant program in a Department of Veterans Affairs, Department of Defense, or other Federal hospital.
(b) To apply to be a designated transplant program, transplant programs shall provide to the OPTN such documents as the OPTN may require which show that they meet the requirements of § 121.9(a) (1), (2), or (3).
(c) The OPTN shall, within 90 days, accept or reject applications to be a designated transplant program.
(d) Applicants rejected for designation may appeal to the Secretary. Appeals shall be submitted in writing within 30 days of rejection of the application. The Secretary may:
(1) Deny the appeal; or
(2) Direct the OPTN to take action consistent with the Secretary's response to the appeal.
(a)
(b)
(i) Reviewing applications submitted under § 121.3(c) for membership in the OPTN;
(ii) Reviewing applications submitted under § 121.9(b) to be a designated transplant program; and
(iii) Conducting ongoing and periodic reviews and evaluations of each member OPO and transplant hospital for compliance with these rules and OPTN policies.
(2) Upon the approval of the Secretary, the OPTN shall furnish review plans and procedures, including survey instruments and a description of data systems, to each member OPO and transplant hospital. The OPTN shall furnish any revisions of these documents to member OPOs and hospitals, after approval by the Secretary, prior to their implementation.
(3) At the request of the Secretary, the OPTN shall conduct special reviews of OPOs and transplant programs, where the Secretary has reason to believe that such entities may not be in compliance with these rules or OPTN policies or may be acting in a manner which poses a risk to the health of patients or to public safety. The OPTN shall conduct these reviews in accordance with such schedules as the Secretary specifies and shall make periodic reports to the Secretary of progress on such reviews and on other reviews conducted under the requirements of this paragraph.
(4) The OPTN shall notify the Secretary in a manner prescribed by the Secretary within 3 days of all committee and Board of Directors meetings in which transplant hospital and OPO compliance with these regulations or OPTN policies is considered.
(c)
(2)
(i) Request further information from the Board of Directors or the alleged violator, or both;
(ii) Decline to accept the recommendation;
(iii) Accept the recommendation, and notify the alleged violator of the Secretary's decision; or
(iv) Take such other action as the Secretary deems necessary.
(a)
(1) The OPTN and the Scientific Registry, as appropriate, shall:
(i) Maintain and operate an automated system for managing information about transplant candidates, transplant recipients, and organ donors, including a computerized list of individuals waiting for transplants;
(ii) Maintain records of all transplant candidates, all organ donors and all transplant recipients;
(iii) Operate, maintain, receive, publish, and transmit such records and information electronically, to the extent feasible, except when hard copy is requested; and
(iv) In making information available, provide manuals, forms, flow charts, operating instructions, or other explanatory materials as necessary to understand, interpret, and use the information accurately and efficiently.
(2)
(ii)
(b)
(i) In addition to special reports which the Secretary may require, submit to the Secretary a report not less than once every fiscal year on a schedule prescribed by the Secretary. The report shall include the following information in a form prescribed by the Secretary:
(A) Information that the Secretary prescribes as necessary to assess the effectiveness of the Nation's organ donation, procurement and transplantation system;
(B) Information that the Secretary deems necessary for the report to Congress required by Section 376 of the Act; and,
(C) Any other information that the Secretary prescribes.
(ii) Provide to the Scientific Registry data on transplant candidates and recipients, and other information that the Secretary deems appropriate. The information shall be provided in the form and on the schedule prescribed by the Secretary;
(iii) Provide to the Secretary any data that the Secretary requests;
(iv) Make available to the public timely and accurate program-specific information on the performance of transplant programs. This shall include free dissemination over the Internet, and shall be presented, explained, and organized as necessary to understand, interpret, and use the information accurately and efficiently. These data shall be updated no less frequently than every six months (or such longer period as the Secretary determines would provide more useful information to patients, their families, and their physicians), and shall include risk-adjusted probabilities of receiving a transplant or dying while awaiting a transplant, risk-adjusted graft and patient survival following the transplant, and risk-adjusted overall survival following listing for such intervals as the Secretary shall prescribe. These data shall include confidence intervals or other measures that provide information on the extent to which chance may influence transplant program-specific results. Such data shall also include such other cost or performance information as the Secretary may specify, including but not limited to transplant program-specific information on waiting time within medical status, organ wastage, and refusal of organ offers. These data shall also be presented no more than six months later than the period to which they apply;
(v) Respond to reasonable requests from the public for data needed for bona fide research or analysis purposes, to the extent that the OPTN's or Scientific Registry's resources permit, or as directed by the Secretary. The OPTN or the Scientific Registry may impose reasonable charges for the separable costs of responding to such requests. Patient-identified data may be made available to bona fide researchers upon a showing that the research design requires such data for matching or other purposes, and that appropriate confidentiality protections, including destruction of patient identifiers upon completion of matching, will be followed. All requests shall be processed expeditiously, with data normally made available within 30 days from the date of request;
(vi) Respond to reasonable requests from the public for data needed to assess the performance of the OPTN or Scientific Registry, to assess individual transplant programs, or for other purposes. The OPTN or Scientific Registry may impose charges for the separable costs of responding to such
(vii) Provide data to an OPTN member, without charge, that has been assembled, stored, or transformed from data originally supplied by that member.
(2) An organ procurement organization or transplant hospital shall, as specified from time to time by the Secretary, submit to the OPTN, to the Scientific Registry, as appropriate, and to the Secretary information regarding transplantation candidates, transplant recipients, donors of organs, transplant program costs and performance, and other information that the Secretary deems appropriate. Such information shall be in the form required and shall be submitted in accordance with the schedule prescribed. No restrictions on subsequent redisclosure may be imposed by any organ procurement organization or transplant hospital.
(c)
The Secretary will establish, consistent with the Federal Advisory Committee Act, the Advisory Committee on Organ Transplantation. The Secretary may seek the comments of the Advisory Committee on proposed OPTN policies and such other matters as the Secretary determines.
Secs. 215, 1602, 1625, Public Health Service Act (42 U.S.C. 216, 300o-1, 300r), unless otherwise noted.
The regulations of this subpart are applicable to grants under section 1625 of the Public Health Service Act for construction and modernization projects designed to:
(a) Eliminate or prevent imminent safety hazards as defined by Federal, State or local fire, building, or life safety codes or regulations, or
(b) Avoid noncompliance with State or voluntary licensure or accreditation standards.
As used in this subpart:
(a)
(b)
(c)
(d)
(e)
(1) Which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or tuberculosis patients) or is operated in connection with a hospital, or
(2) In which such care and medical services are prescribed by, or are performed under the general direction of, persons licensed to practice medicine or surgery in the State.
(f)
(g)
(h)
(i)
(j)
(k)
(1) Which is operated in connection with a hospital, or
(2) In which patient care of a specialized nature (such as in an eye clinic, dental clinic, or ambulatory surgical center) is provided under the professional supervision of persons licensed to practice medicine or surgery in the State, or in the case of dental diagnosis or treatment, under the professional supervision of persons licensed to practice dentistry in the State, or
(3) Which offers to patients not requiring hospitalization the services of licensed physicians in various medical specialties, and which provides to its patients a reasonably full range of diagnostic and treatment services.
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(a)
(b)
(1) Eliminate or prevent safety hazards which under Federal, State, and/or local fire, building or life safety codes or regulations, will, in the judgment of the Secretary result in one or more of the following:
(i) Loss of licensure for the facility.
(ii) Closing of all or a substantial part of the facility,
(iii) Loss of eligibility for reimbursement under title XVIII or title XIX of the Social Security Act; or
(2) Avoid noncompliance with State licensure or voluntary accreditation standards where noncompliance will, in the judgment of the Secretary, result in one or both of the following:
(i) Loss of licensure for the facility,
(ii) Loss of accreditation resulting in loss of eligibility for reimbursement under title XVIII or title XIX of the Social Security Act.
An application for a grant under this subpart must be submitted directly to the Secretary at such time and in such form and manner as the Secretary may prescribe. The application must be executed by an individual authorized to act for the applicant and assume on behalf of the applicant the obligations imposed by the Act, this subpart, and the terms and conditions of the grant. The application must contain the following:
(a) A description of the site of the project.
(b) A full description, with all appropriate documentation, of:
(1) The imminent safety hazards, licensure and/or accreditation problems of the facility;
(2) The type and amount of assistance sought under this subpart;
(3) The construction of modernization project for which funds are sought, describing how it will remedy the problems described pursuant to paragraph (b)(1) of this section, with a complete schedule for the proposed construction or modernization; and
(4) How failure to remedy the problems described pursuant to paragraph (b) (1) of this section will affect the population served by the facility.
(c) In the case of a modernization project for continuation of existing health services, a finding by the State Agency of the continued need for such services. In the case of a construction or modernization project for new health services, a finding by the State Agency of the need for such services. The finding of need shall be based on the following criteria:
(1) In a State which has a program approved by the Secretary under section 1523(a)(4)(B) of the Act, a State certificate of need program, or a program under section 1122 of the Social Security Act, the State Agency shall use the criteria used in conducting reviews under such program. In a State which has more than one such program, the State Agency shall use the criteria of one of the programs and notify the Secretary of the program criteria used.
(2) In a State which does not have a program approved by the Secretary under section 1523(a)(4)(B) of the Act, a State certificate of need program or a program under section 1122 of the Social Security Act, the State Agency shall base its finding of need on the following criteria:
(i) Whether the proposed project is needed or projected as necessary to meet the needs in the community in
(ii) Whether the proposed project can be adquately staffed and operated when completed;
(iii) Whether the proposed capital expenditure is economically feasible and can be accommodated in the patient charge structure of the health facility without unreasonable increases; and
(iv) Whether the project will foster cost containment or improved quality of care through improved effciency and productivity, including promotion of cost-effective factors such as ambulatory care, preventive health care services, home health care, and design and construction economies, or through increased competition between different health services delivery systems.
(d) [Reserved]
(e) An assurance that adequate financial support will be available for completion of the project, supported by a detailed project budget satisfactory to the Secretary which includes all existing and anticipated sources of funds for the project.
(f) An assurance that adequate financial support will be available for maintenance and operation of the project when completed, supported by budgets and detailed expenditure and revenue information satisfactory to the Secretary for both the facility and the applicant for the past three fiscal years and budget and projections of expenditures and revenue for the future three fiscal years. Where a certificate of need or a favorable finding under section 1122 of the Social Security Act is required in order for the project to operate and/or receive reimbursement from governmental programs for health services provided, assurance from the applicant satisfactory to the the Secretary that the applicant will submit, consistent with the provisions of § 124.5(d), any such required certificates of need and/or section 1122 finding.
(g) An assurance that the applicant would not be able to complete the project without the grant applied for, supported by a description of all efforts to obtain funds needed to complete the project and the results of such efforts.
(h) An assurance that all times after the application is approved there will be made available in the facility or portion thereof to be constructed or modernized, a reasonable volume of services to persons unable to pay therefor. The applicant shall comply with the standards and procedures of 42 CFR 53.111, except as the Secretary may prescribe pursuant to section 1602(6) of the Act. The functions of the State Agency designated under section 604 of the Act under 42 CFR 53.111 will be performed by the Secretary, except to the extent they are otherwise assigned.
(i) An assurance that at all times after the application is approved the facility or portion thereof to be constructed or modernized will be made available to all persons residing or employed in the area served by the facility. The applicant shall comply with the standards and procedures of 42 CFR 53.113, except as the Secretary may prescribe pursuant to section 1602(6) of the Act. The functions of the State Agency designated under section 604 of the Act under 42 CFR 53.113 will be performed by the Secretary, except to the extent they are otherwise assigned.
(j) An assurance that title to the project site is or will be vested in one or more of the entities filing the application or in a public or other nonprofit entity which is to operate the facility on completion of the project, with such documentation as the Secretary may require.
(k) In the case of an application for construction or modernization of an outpatient medical facility, an assurance, supported by a written transfer agreement (or written documentation that such agreement will be obtained) with identified hospitals, that the services of a general hospital will be available to patients at such facility who are in need of hospital care.
(l) Evidence that: (1) The appropriate health systems agency has been given the opportunity to review the application in accordance with section 1513(e) of the Act and the requirements of the appendix to this subpart, with the result of any such review.
(2) The application has been reviewed in accordance with the applicable requirements of OMB Circular A-95.
(m) An analysis satisfactory to the Secretary and such other information and materials as the Secretary may require concerning the environmental impact of the proposed construction or modernization project.
(n) An assessment satisfactory to the Secretary of the project site in light of the considerations set forth in Executive Order 11296 (31 FR 10663, August 10, 1966) concerning the evaluation of flood hazards in locating Federally supported facilities.
(o) In the case of a project which involves the displacement of persons or businesses, an assurance that the applicant will comply with the applicable provisions of the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 (42 U.S.C. 4601
(p)(1) An assurance that all laborers and mechanics employed by contractors or subcontractors in the performance of work on a project will be paid wages at rates not less than those prevailing on similar construction in the locality as determined by the Secretary of Labor in accordance with the Act of March 3, 1931 (40 U.S.C. 276a-276a-5, known as the Davis-Bacon Act); and
(2) An assurance that the following conditions and provisions will be included in all construction contracts:
(i) The provisions of “DHHS Requirements for Federally Assisted Construction Contracts Regarding Labor Standards and Equal Employment Opportunity,” Form DHHS 514 (rev. July 1976) (issued by the Office of Grants and Procurement Management, U.S. Department of Health and Human Services) pertaining to the Davis-Bacon Act, the Contract Work Hours Standards Act, and the Copeland Act (Anti-Kickback) regulations except in the case of contracts in the amount of $2,000 or less; and pertaining to Executive Order 11246, September 24, 1965 (30 FR 12319), relating to nondiscrimination in construction contract employment except in the case of contracts in the amount of $10,000 or less, and
(ii) Representatives of the Secretary will have access at all reasonable times to work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
(q) Such other information as the Secretary may require.
(a)(1) Within the limits of funds available for such purpose, the Secretary may award grants under this subpart for project costs to applicants with approvable applications therefor which will, in his judgment, best promote the purposes of section 1625 of the Act, taking into consideration:
(i) The severity and seriousness of the safety hazard, licensure or accreditation problem or problems.
(ii) The relative need of the population to be served for the services to be provided, including the availability of alternatives for meeting the need.
(iii) The financial need of the applicant.
(iv) The extent to which the facility will serve persons below the poverty level, as determined by the Secretary of Commerce.
(v) The extent to which the project will foster cost containment or improve the quality of care through enhanced efficiency and productivity.
(2) Priority for funding shall be based on the extent to which services will be made available relative to the cost of the project.
(b) The amount of any grant under this subpart may not exceed 75 percent of the cost of the project for which the grant is made unless the project is located in an area determined by the Secretary to be an urban or rural poverty area, in which case the grant may, as determined by the Secretary, cover up to 100 percent of such costs.
(c) If an applicant has not entered into a legally enforceable fixed price contract for the project for which funds are awarded under this subpart within 180 days of the date of the grant award, the grant award will automatically become null and void.
(d) Where a grant has been awarded to an applicant under this subpart on
Grant payments shall be made to the applicant in accordance with the requirements of subpart K of 45 CFR part 74.
Any funds granted pursuant to this subpart, as well as funds assured by the applicant for the project, shall be expended solely for carrying out the approved project in accordance with section 1625 of the Act, the regulations of this subpart, the terms and conditions of the grant award, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74.
(a)
(i) The amount of all payments received from the Secretary under this subpart,
(ii) Amounts and sources of all funds, in addition to funds received under this subpart, applied to the construction or modernization project funded under this subpart,
(iii) Disposition of all funds for the construction or modernization project funded under this subpart,
(iv) Total cost of the project approved under this subpart, and
(2) Upon request, applicants shall make such records, books, papers, or other documents available to the Secretary and the Comptroller General of the United States or any of their duly authorized representatives which, in their opinion, may be related or pertinent to the grant under this subpart.
(b)
(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d
(b) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of the handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. A regulation implementing section 504 has been issued (45 CFR part 84 (42 FR 22676, May 4, 1977)).
(c) All portions and services of the entire facility for the construction or modernization of which, or in connection with which aid under the Act is sought must be made available without discrimination on account of creed and the applicant may not discriminate against any qualified person on account of creed with respect to the privilege of professional practice in the facility.
(d) Attention is also called to the requirements of title IX of the Education amendments of 1972 and in particular to section 901 of such Act (20 U.S.C. 1681) which provides that no person in the United States shall, on the basis of sex be excluded from participation in,
(e) Each construction contract is subject to the condition that the applicant shall comply with the requirements of section 321 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970, as amended, which provides that alcohol abusers and alcoholics who are suffering from medical conditions shall not be discriminated against in admission or treatment, solely because of their alcohol abuse or alcoholism by any private or public general hospital that receives support in any form from any federally funded program.
(f) Each construction contract is subject to the condition that the applicant shall comply with the requirements of section 407 of the Drug Abuse Office and Treatment Act of 1972, as amended, which provides that drug abusers who are suffering from medical conditions shall not be discriminated against because of their drug abuse or drug dependence, by any private or public general hospital that receives support in any form from any federally funded program.
The Secretary may impose additional conditions prior to or at the time of any grant award when in the Secretary's judgment such conditions are necessary to assure or protect advancement of the project in accordance with the purposes of the Act and the regulations of this subpart or the conservation of grant funds.
The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this subpart to State and local governments as those terms are defined in subpart A of that part 74, except to the extent inconsistent with this subpart. The relevant provisions of the following subparts of part 74 shall also apply to grants to all other grantee organizations under this subpart.
42 U.S.C. 216; 42 U.S.C. 300s(3).
(a) The provisions of this subpart apply to any recipient of Federal assistance under title VI or XVI of the Public Health Service Act that gave an assurance that it would make available, in the facility or portion of the facility constructed, modernized or converted with that assistance, a reasonable volume of services to persons unable to pay for the services.
(b) The provisions of this subpart apply to facilities for the following periods:
(1)
(i) Twenty years after the completion of construction, in the case of a facility for which the Secretary provided grant assistance under section 606 of the Act; or
(ii) The period from completion of construction until the amount of a direct loan under sections 610 and 623 of the Act, or the amount of a loan with respect to which the Secretary provided a guarantee and interest subsidy under section 623 of the Act, is repaid, in the case of a facility for which such a loan was made.
(iii) “Completion of construction” means:
(A) The date on which the Secretary determines the facility was opened for service;
(B) If the opening date is not available, it means the date on which the Secretary approved the final part of the facility's application for assistance under title VI of the Act;
(C) If the date of final approval is not available, it means whatever date the Secretary determines most reasonably approximates the date of final approval.
(2)
As used in this subpart—
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(1) For facilities other than those certified under § 124.513, § 124.514,
(2) For facilities certified under § 124.513, § 124.514, § 124.515, or § 124.516, services as defined in paragraph (m)(1) of this section and services that are made available to persons unable to pay for them under programs described by the documentation provided under § 124.513(c)(2), § 124.514(c)(2), or § 124.516(c)(2), as applicable, or pursuant to the terms of the applicable grant or agreement as provided in § 124.515. Except as provided in § 124.516, excluded are services reimbursed by Medicare, Medicaid, or other third party programs, including services for which reimbursement was provided as payment in full, and services provided more than 96 hours following notification to the facility by a quality improvement organization that it disapproved the services under section 1155(a)(1) or section 1154(a)(1) of the Social Security Act.
(a)
(1) Three percent of its operating costs for the most recent fiscal year for which an audited financial statement is available;
(2) Ten percent of all Federal assistance provided to or on behalf of the facility, adjusted by a percentage equal to the percentage change in the CPI between the year in which the facility received assistance or 1979, whichever is later, and the most recent year for which a published index is available.
(b)
(1)
(i)
(ii)
(2)
(B) A facility assisted under title XVI of the Act is not required to make up a justifiable deficit.
(ii)
(B) A facility which claimed financial inability under § 124.509(a)(2)(iii) and is found by the Secretary, pursuant to § 124.511(c), to have been financially able to provide uncompensated services in the year in which the deficit was incurred shall begin to make up the deficit beginning in the fiscal year following the Secretary's finding.
(C) A facility required to make up a noncompliance deficit but which is determined by the Secretary, pursuant to § 124.511(c), to be financially unable to do so in the year following the Secretary's finding of noncompliance shall
(3)
(ii) The amount of a justifiable deficit must be adjusted by a percentage equal to the percentage change in the CPI between the CPI available in the fiscal year in which the deficit was incurred and the CPI available in the fiscal year in which it was made up.
(iii) An amount equal to the result of dividing the amount of any noncompliance deficit for a fiscal year by the number of years of obligation remaining and adjusting it by a percentage equal to the percentage change in the CPI between the CPI available in the fiscal year in which the deficit was incurred and the CPI available in the fiscal year in which it was made up shall be added to a facility's annual compliance level for each fiscal year following the fiscal year of the finding of noncompliance.
(4)
(c)
(2)
(ii) The amount of any excess compliance applied to reduce a facility's annual compliance level must be adjusted by a percentage equal to the percentage change in the CPI between the CPI available in the fiscal year in which the facility provided the excess, and the CPI available in the fiscal year in which the facility applies the excess to reduce its annual compliance level or satisfy its remaining obligation.
(3) Except as provided in subparagraph (1) of this paragraph, a facility assisted under title VI may in any fiscal year apply the amount of excess credited under this paragraph to satisfy the remainder of its obligation to provide uncompensated services. A facility's remaining obligation is determined as follows:
(i) Where the annual compliance level in such fiscal year is established under paragraph (a)(2) of this section, the remaining obligation is:
(A) For grant assistance, 10 percent of each grant under obligation, multiplied by the number of years remaining in its period of obligation, adjusted as provided for in paragraph (a)(2) of this section, plus any deficits required to be made up and less any unused excesses accrued in prior years; and
(B) For loan assistance, the facility's annual compliance level multiplied by the number of years remaining in the scheduled life of the loan, plus the sum of 10 percent of each yearly cumulative total of additional interest subsidy or other payments (which the Secretary will have made in connection with the guaranteed loan or a direct loan which has been sold) in each subsequent year remaining in the scheduled life of the loan, plus any deficits required to be
(ii) Where the annual compliance level in such fiscal year is established under paragraph (a)(1) of this section, the remaining obligation is the average of the facility's annual compliance levels in the previous three years, multiplied by the number of years remaining in its period of obligation, plus any deficits required to be made up under this section, and less any unused excesses accrued in prior years.
(a)
(1) The plan of allocation the facility proposes to adopt;
(2) The amount of uncompensated services the facility intends to make available in the fiscal year or a statement that the facility will provide uncompensated services to all persons unable to pay who request uncompensated services;
(3) An explanation, if the amount of uncompensated services the facility intends to make available in a fiscal year is less than the annual compliance level. If a facility has satisfied its remaining uncompensated services obligation since the last published notice under this paragraph, or will satisfy the remaining obligation during the fiscal year, the explanation must include this information; and
(4) A statement inviting interested parties to comment on the allocation plan.
(b)
(2) If in the service area of the facility the “usual language of households” of ten percent or more of the population according to the most recent figures published by the Bureau of the Census is other than English or Spanish, the facility shall translate the notice into that language and post the translated notice on signs substantially similar in size and legibility to and posted with those supplied under paragraph (b)(1) of this section.
(3) The facility shall make reasonable efforts to communicate the contents of the posted notice to persons who it has reason to believe cannot read the notice.
(c)
(i) State that the facility is required by law to provide a reasonable amount of care without or below charge to people who cannot afford care;
(ii) Set forth the criteria the facility uses for determining eligibility for uncompensated services (in accordance with the financial eligibility criteria and the allocation plan);
(iii) State the location in the facility where anyone seeking uncompensated services may request them; and
(iv) State that the facility will make a written determination of whether the person will receive uncompensated services, and the date by or period within which the determination will be made.
(2) The facility shall provide the individual written notice before providing services, except where the emergency nature of the services provided makes prior notice impractical. If this exception applies, the facility shall provide the individual written notice to the next of kin or to the patient as soon as practical, but not later than when first presenting a bill for services.
(3) The facility shall make reasonable efforts to communicate the contents of the individual written notice to persons who it has reason to believe cannot read the notice.
(a) A person unable to pay for health services is a person who—
(1) Is not covered, or receives services not covered, under a third-party insurer or governmental program, except where the person is not covered because the facility fails to participate in a program in which it is required to participate by § 124.603(c);
(2) Falls into one of the following categories:
(i)
(ii)
(iii)
(3) Requests services within the facility's allocation plan in effect at the time of the request.
(b) For purposes of determining eligibility for uncompensated services, revisions of the poverty line are effective 60 days from the date of their publication in the
(c) A person is eligible for uncompensated services if the person's individual or family annual income, as applicable, is at or below the level established under paragraph (a)(2) of this section, when calculated by either of the following methods:
(1) Multiplying by four the person's or family's income, as applicable, for the three months preceding the request for uncompensated services;
(2) Using the person's or family's income, as applicable, for the twelve months preceding the request for uncompensated services.
(a)(1) A facility shall provide its uncompensated services in accordance with a plan that sets out the method by which the facility will distribute its uncompensated services among persons unable to pay. The plan must:
(i) State the type of services that will be made available;
(ii) Specify the method, if any, for distributing those services in different periods of the year;
(iii) State whether Category B or, in the case of nursing homes only, Category C persons will be provided uncompensated services, and if so, whether the services will be available without charge or at a reduced charge;
(iv) If services will be made available to Category B persons at a reduced charge, specify the method used for reducing charges, and provide that the method is applicable to all persons in Category B;
(v) With respect to nursing homes only, if services will be made available to Category C persons at a reduced charge, specify the method used for reducing charges, provided that such method may not result in greater reductions than those afforded to Category B persons, and provide that this method is applicable to all persons in Category C; and
(vi) Provide that the facility provides uncompensated services to all persons eligible under the plan who request uncompensated services.
(2) A facility must adopt an allocation plan that meets the requirements of paragraph (a) by publishing the plan in a newspaper of general circulation in its area. The plan may take effect no earlier than 60 days following the date of publication.
(b)(1) If in any fiscal year a facility fails to adopt and publish a plan in accordance with paragraph (a) of this section, it shall provide uncompensated services in accordance with the last plan it published in a newspaper of general circulation in its area.
(2) If no plan was previously published in accordance with paragraph (a)(2) of this section, the facility must provide uncompensated services without charge to all applicants in Category A and Category B, and, with respect to nursing homes, Category C, who request service in the facility. This requirement applies until the facility ceases to provide uncompensated services under § 124.508 or until an allocation plan published in accordance with paragraph (a)(2) of this section becomes effective.
(c) A facility may revise its allocation plan during the fiscal year by publishing the revised plan in a newspaper of general circulation in the area it serves. A revised plan may take effect no earlier than 60 days following the date of publication.
(a) Determinations of eligibility must be in writing, be made in accordance with this section, and a copy of the determination must be provided to the applicant promptly.
(b)
(i) That the facility will provide uncompensated services at no charge or at a specified charge less than the allowable credit for the services;
(ii) The date on which services were requested;
(iii) The date on which the determination was made;
(iv) The applicant's individual or family income, as applicable, and family size; and
(v) The date on which services were or will be first provided to the applicant.
(2)
(A) Require the applicant to furnish any information that is reasonably necessary to substantiate eligibility; and
(B) Require the applicant to apply for any benefits under third party insurer or governmental programs to which he/she is or could be entitled upon proper application.
(ii) A conditional determination must:
(A) Comply with paragraph (b)(1) of this section; and
(B) State the condition(s) under which the applicant will be found eligible.
(iii) When a facility determines that the condition(s) upon which a conditional determination was made has been met, or will not be met, it shall make a favorable determination or denial on the request, as appropriate, in accordance with this section.
(3)
(c)
(ii) Nursing homes shall make a determination of eligibility within ten working days, but no later than two working days following the date of admission, following a request for uncompensated services made prior to admission.
(2)
(a)
(1) Cease providing uncompensated services;
(2) Cease providing individual notices in accordance with § 124.504(c);
(3) Remove the posted notices required by § 124.504(b); and
(4) Post an additional notice stating that it has satisfied its obligation for the fiscal year or appropriate period and when additional uncompensated services will be available.
(b)
(1) Cease providing uncompensated services; and
(2) Discontinue providing notice pursuant to § 124.514(b)(2).
(a)
(ii) A facility shall submit the required report more frequently than once every three years under the following circumstances:
(A) If the facility determines that in the preceding fiscal year it did not provide uncompensated services at the annual compliance level, it shall submit a report.
(B) If the Secretary determines, and notifies the facility in writing that a report is needed for proper administration of the program, the facility shall submit a report within 90 days after receiving notice from the Secretary, or within 90 days after the close of the fiscal year, whichever is later.
(iii) Except as specified in paragraph (a)(1)(ii)(B) of this section, the reports required by this section shall be submitted within 90 days after the close of the fiscal year, unless a longer period is approved by the Secretary for good cause.
(2)
(i) Information that the Secretary prescribes to permit a determination of whether a facility has met the annual compliance level for the fiscal years covered by the report;
(ii) The date on which the notice required by § 124.504(a) was published, and the name of the newspaper that printed the notice;
(iii) If the amount of uncompensated services provided by the facility in the preceding fiscal year was lower than the annual compliance level, an explanation of why the facility did not meet the required level. If the facility claims that it failed to meet the required compliance level because it was financially unable to do so, it shall explain and provide documentation prescribed by the Secretary;
(iv) If the facility is required to submit an affirmative action plan, a copy of the plan.
(v) Other information that the Secretary prescribes.
(3)
(b)
(1) A certification, signed by the responsible official of the facility, that there has been no material change in the factors upon which the certification was based; or
(2) A certification, signed by the responsible official of the facility and supported by appropriate documentation, that there has been a material change in the factors upon which the certification was based.
(c)
(1)(i) A certification, signed by the responsible official of the facility, that there has been no material change in the factors upon which the certification was based; or
(ii) A certification, signed by the responsible official of the facility and supported by appropriate documentation, that there has been a material change in the factors upon which the certification was based; and
(2) A certification, signed by the responsible official of the facility, of the amount of uncompensated services provided in the previous fiscal year.
(d)
(e)
(a)
(i) Any documents from which the information required to be reported under § 124.509(a) was obtained;
(ii) Accounts which clearly segregate uncompensated services from other accounts; and
(iii) Copies of written determinations of eligibility under § 124.507.
(2) A facility shall retain the records maintained pursuant to paragraph (a)(1) for three years after submission of the report required by § 124.509(a)(1), except where a longer period is required by the Secretary, or until 180 days following the close of the Secretary's assessment investigation under § 124.511(b), whichever is less.
(3) A facility shall, within 60 days of the end of each fiscal year, determine the amount of uncompensated services it provided in that fiscal year. Documents that support the facility's determination shall be made available to the public on request. If a report is or will be filed under § 124.509(a)(1), a facility may respond to a request by providing a copy of the report to the requester.
(b)
(c)
(a)
(1) A complaint is considered to be filed with the Secretary on the date the following information is received in the Office of the HHS Regional Health Administrator for the Region in which the facility is located:
(i) The name and address of the person making the complaint or on whose behalf the complaint is made;
(ii) The name and location of the facility;
(iii) The date or approximate date on which the event occurred; and
(iv) A statement of what actions the complainant considers to violate the requirements of this subpart.
(2) The Secretary promptly provides a copy of the complaint to the facility named in the complaint.
(3) When the Secretary investigates a facility, the facility, including a facility certified under § 124.513, § 124.514, § 124.515, § 124.516, or § 124.517, shall provide to the Secretary on request any documents, records and other information concerning its operation that relate to the requirements of this subpart. A facility will be presumed to be out of compliance with its assurance unless it supplies documentation sufficient to show compliance with the applicable provisions of this subpart.
(4) Section 1627 of the Act provides that if the Secretary dimisses a complaint or the Attorney General has not brought an action for compliance within six months from the date on which the compliant is filed, the person filing it may bring a private action to effectuate compliance with the assurance. If the Secretary determines that he/she will be unable to issue a decision on a complaint or otherwise take appropriate action within the six month period, the Secretary may, based on priorities for the disposition of complaints that are established to promote the most effective use of enforcement resources, or on the request of the applicant, dismiss the complaint without a finding as to compliance prior to the end of the six month period, but no earlier than 45 days after the complaint is filed.
(b)
(1)
(ii) A certification of substantial compliance shall be based on the amount properly claimed by the facility pursuant to § 124.509(a), utilizing procedures determined by the Secretary to be sufficient to establish that the facility has substantially complied with its assurance for the period covered by the certification. The procedures will include examination of individual account data to the extent deemed necessary by the Secretary.
(iii) A certification of substantial compliance will be made where the Secretary determines that, for the period covered by the certification, the facility provided uncompensated services to eligible persons who had equal opportunity to apply therefor. In making this determination, the Secretary will consider, in descending order of importance, whether—
(A) Corrective action prescribed pursuant to § 124.512(b) has been taken by the facility;
(B) Any noncompliance with the requirements of this subpart may be remedied by corrective action under § 124.512(b);
(C) The facility had procedures in place that complied with the requirements of § 124.504(c), § 124.505, § 124.507, § 124.509, 125.510, § 124.513(b)(2), § 124.514(b)(2), § 124.515, § 124.516(b)(1) or (b)(2), as applicable, or § 124.517(b), and systematically and correctly followed such procedures.
(2)
(c)
(1) The ratio of revenues to expenses;
(2) The occupancy rate;
(3) The ratio of current assets to current liabilities;
(4) The average cost per patient day;
(5) The number of days of operating expenses in accounts payable;
(6) The number of days of revenues in accounts receivable;
(7) The sinking fund (or depreciation fund) balance;
(8) The debt coverage ratio; and
(9) The availability of restricted or unrestricted funds (such as an endowment) available for charitable use.
(a) If the Secretary finds, based on his/her investigation under § 124.511, that a facility did not comply with the requirements of this subpart, the Secretary may take any action authorized by law to secure compliance, including but not limited to, voluntary agreement or a request to the Attorney General to bring an action against the facility for specific performance.
(b) A facility, including a facility certified under § 124.513, § 124.514, § 124.516, or § 124.517, that has denied uncompensated services to any person because it failed to comply with the requirements of this subpart will not be in compliance with its assurance until it takes whatever steps are necessary to remedy fully the noncompliance, including:
(1) Provision of uncompensated services to applicants improperly denied;
(2) Repayment of amounts improperly collected from persons eligible to receive uncompensated services; and
(3) Other corrective actions prescribed by the Secretary.
(c) The Secretary may disallow all of the uncompensated services claimed in a fiscal year where the Secretary finds that the facility was in substantial noncompliance with its assurance because it failed to:
(1) Have a system for providing notice to eligible persons as required by § 124.504(c), § 124.513(b)(2), § 124.514(b)(2), § 124.516 (b)(2)(ii)(A), or § 124.517(b)(2), as applicable;
(2) Comply with the applicable reporting requirements of § 124.509;
(3) Have a system for maintaining records of uncompensated services provided in accordance with § 124.510; or
(4) Take corrective action prescribed pursuant to paragraph (b) of this section.
(d) In the absence of a finding of substantial compliance or substantial noncompliance in a fiscal year, the Secretary may disallow uncompensated services claimed by a facility in that fiscal year to the extent that the Secretary finds that such services are not documented as uncompensated services under § 124.510 or are subject to disallowance under § 124.513(d) or § 124.514(d), as applicable.
(a)
(b)
(1) It is a facility which is owned and operated by a unit of State or local government or a quasi-public corporation as defined at 42 CFR 124.2(m).
(2) It provides health services without charge or at a substantially reduced rate to persons who are determined by the facility to qualify therefor under a program of discounted health services. A “program of discounted health services” must provide for financial and other objective eligibility criteria and procedures, including notice prior to nonemergency service, that assure effective opportunity for all persons to apply for and obtain a determination of eligibility for such services, including a determination prior to service where requested;
(3)(i) It received, for the three most recent fiscal years, at least 10 percent of its total operating revenue (net patient revenue plus other operating revenue, exclusive of any amounts received, or if not received, claimed, as reimbursement under titles XVIII and XIX of the Social Security Act) from State and local tax appropriations or other State and local government revenues, or from a quasi-public corporation as defined at 42 CFR 124.2(m), to cover operating deficits attributable to the provision of discounted services; or
(ii) If provided, in each of the three most recent fiscal years, uncompensated services under this subpart or under programs described by the documentation provided under § 124.513(c)(2) in an amount not less than twice the annual compliance level computed under § 124.503(a).
(c)
(1) Audited financial statements or official State or local government documents (such as annual reports or budget documents), for the three most recent fiscal years, sufficient to show that the facility meets the criteria in paragraph (b)(3)(i) or (ii) of this section.
(2) A complete description of its program(s) of discounted health services, including charging and collection policies of the facility, and eligibility criteria and notice and determination procedures used under its program(s) of discounted services.
(d)
(2)
(A) Demonstrating to the Secretary's satisfaction, that it met the requirements of paragraph (b) of this section for each year in which a deficit was assessed; or
(B) Providing an additional period of service under this section on the basis of one (or portion of a) year of certification for each year (or portion of a year) of deficit assessed. The period of obligation applicable to the facility under § 124.501(b) shall be extended until the deficit is made up in accordance with the preceding sentence.
(ii)
(A) Make up such deficit in accordance with paragraph (d)(2)(i) of this section; or
(B) Submit an independent certified audit, conducted in accordance with procedures specified by the Secretary, of the facility's records maintained pursuant to § 124.510. If the audit establishes to the Secretary's satisfaction that no, or a lesser, deficit exists for the period in question, the facility will receive credit for the period so justified. Any deficit which the Secretary determines still remains must be made up in accordance with paragraph (d)(2)(i) of this section.
(iii)
(B) A facility assisted under title XVI of the Act whose compliance with this subpart has not been completely assessed will be presumed to have no allowable credit for the unassessed period. The facility may make up the deficit by—
(
(
(a)
(b)
(1)(i) Title VI-assisted facilities. (A) For the facility's fiscal year in which this section becomes effective, the level, computed under § 124.503(c) (3), divided by the number of years remaining in its period of obligation (including an additional year or portion of a year for each year or portion of a year in which a deficit was incurred and has not been made up), is not more than $10,000;
(B) For a subsequent fiscal year, the level computed under paragraph (A) of this paragraph (b)(1)(i), is at or less than $10,000, adjusted by a percentage equal to the percentage change in the CPI available in the year in which this section becomes effective and the most recent year for which a published index is available.
(ii)
(B) For a subsequent fiscal year, the level, computed under paragraph (A) of this paragraph (b)(1)(ii), is at or less than $10,000, adjusted as provided in paragraph (b)(1)(i)(B) of this section.
(2) It provides health services without charge or at a substantially reduced rate to persons who are determined by the facility to qualify threrefor under a program of discounted health services. A “program of discounted health services” must provide for financial and other objective eligibility criteria and procedures, including notice prior to nonemergency service, that assure effective opportunity for all persons to apply for and
(c)
(d)
(e)
(2) Where a facility has been assessed as having a deficit under § 124.503(b) that has not been made up prior to withdrawal of certification under this section or fails to provide services as required by paragraph (d) of this section, the facility must make up the deficit in accordance with § 124.503(b) following withdrawal of certification.
(a)
(b)
(i) Demonstrating to the Secretary's satisfaction that it met the requirements of paragraph (a) of this section for each year in which a deficit was assessed; or
(ii) Providing an additional period of service under this section on the basis of one (or portion of a) year of certification for each year (or portion of a year) of deficit assessed. The period of obligation applicable to the facility under § 124.501(b) shall be extended until the deficit is made up in accordance with the preceding sentence.
(2)
(i) Make up such deficit in accordance with paragraph (b)(1) of this section; or
(ii) Submit an independent certified audit, conducted in accordance with procedures specified by the Secretary, of the facility's records maintained pursuant to § 124.510. If the audit establishes to the Secretary's satisfaction that no, or a lesser, deficit exists for the period in question, the facility will receive credit for the period so justified. Any deficit which the Secretary determines still remains must be made up in accordance with paragraph (b)(1) of this section.
(3)
(ii) A facility assisted under title XVI of the Act whose compliance with this subpart has not been completely assessed will be presumed to have no allowable credit for the unassessed period. The facility may make up the deficit by—
(A) Following the procedure of paragraph (b)(3)(i) of this section; or
(B) Submitting an independent certified audit, conducted in accordance with procedures specified by the Secretary, of the facility's records maintained pursuant to § 124.510. If the audit establishes to the Secretary's satisfaction that no, or a lesser, deficit exists for the period in question, the facility will receive credit for the period so justified. Any deficit which the Secretary determines still remains must be made up in accordance with paragraph (b)(3)(i) of this section.
(a)
(b)
(2) A facility may qualify for a provisional certification under this section if it provides an assurance that meets the requirements of paragraph (d)(2) of this section.
(c)
(1)(i)
(ii)
(2) It received at least 10 percent of its total operating revenue (net patient revenue plus other operating revenue, exclusive of any amounts received, or if not received, claimed, as reimbursement under Medicaid or Medicare) from philanthropic sources to cover operating deficits attributable to the provision of discounted services. Philanthropic sources include private trusts, foundations, churches, charitable organizations, state and/or local funding, and individual donors; and either—
(i) Provides health services without charge or at a substantially reduced rate (exclusive of amounts charged or received for purposes of claiming reimbursement under third party insurance or governmental programs, such as Medicaid or Medicare deductible or coinsurance amounts) to persons who are determined by the facility to qualify for such reduced charges under a program of discounted health services. A “program of discounted health services” must provide for financial and other objective eligibility criteria and procedures, including notice prior to nonemergency service, that assure effective opportunity for all persons to apply for and obtain a determination of eligibility for such services, including a determination prior to service where requested; or
(ii) Makes all services of the facility available to all persons at no more than a nominal charge, exclusive of amounts charged or received for purposes of claiming reimbursement under third party insurance or governmental programs, such as Medicaid or Medicare deductible or coinsurance amounts.
(d)
(i) An audited financial statement for the fiscal year preceding the request or other documents prescribed by the Secretary, sufficient to show that the facility meets the criteria of paragraph (c)(1) or (c)(2) of this section, as applicable;
(ii) Where a facility claims qualification under paragraph (c)(2)(i) of this section, a complete description, and documentation where requested, of its program of discounted health services, including charging and collection policies of the facility, and eligibility criteria and notice and determination procedures used under its program(s) of discounted health services;
(iii) Where the facility claims qualification under paragraph (c)(1) or paragraph (c)(2)(ii) of this section, a complete description, and documentation where requested, of its admission, charging, and collection policies.
(2)
(ii) No later than 90 days following the end of the fiscal year in which a facility has operated a provisionally certified program, the facility must submit to the Secretary, the documentation required, as applicable, under paragraph (d)(1) of this section.
(e)
(2)
(f)
(A) Demonstrating to the Secretary's satisfaction that it met the applicable requirements of paragraph (c) of this section for each year in which a deficit was assessed; or
(B) Providing an additional period of service under this section on the basis of one year (or portion of a year) of certification for each year (or portion of a year) of deficit assessed. The period of obligation applicable to the facility under § 124.501(b) shall be extended until the deficit is made up in accordance with the preceding sentence.
(ii)
(A) Make up such deficit in accordance with paragraph (f)(1)(i) of this section; or
(B) Submit an independent certified audit, conducted in accordance with procedures specified by the Secretary, of the facility's records maintained pursuant to § 124.510. If the audit establishes to the Secretary's satisfaction that no, or a lesser, deficit exists for the period in question, the facility will receive credit for the period so justified. Any deficit which the Secretary determines still remains must be made up in accordance with paragraph (f)(1)(i)(B) of this section.
(2)
(ii)
(A) Make up such deficit in accordance with paragraph (f)(1)(i) of this section; or
(B) Submit an independent certified audit, conducted in accordance with procedures specified by the Secretary, of the facility's records maintained pursuant to § 124.510. If the audit establishes to the Secretary's satisfaction that no, or a lesser, deficit exists for the period in question, the facility will receive credit for the period so justified. Any deficit which the Secretary determines still remains must be made up in accordance with paragraph (f)(2)(i) of this section.
(a)
(b)
(1) It makes all services of the facility available without charge to all persons requesting uncompensated services from the facility who are eligible under § 124.505, including all persons coming within Category B and, if applicable, Category C.
(2) It complies with the notice and allocation plan requirements of §§ 124.504 and 124.506, except that all notices published or provided must describe an allocation plan and program consistent with paragraph (b)(1) of this section.
(3) It makes written determinations in accordance with § 124.507, except that all favorable determinations must indicate that the facility will provide uncompensated services at no charge.
(4) It provides uncompensated services consistent with the requirements of this section for the entire fiscal year for which certification is sought, except that a facility may
(i) Cease providing such services and still receive credit, calculated in accordance with paragraph (d) of this section, where—
(A) The facility has completed its total uncompensated services obligation, including making up any deficit; or
(B) The facility determines, and submits documentation which the Secretary finds, taking into account the factors identified in § 124.511(c), sufficient to establish that it is financially unable to continue to meet the requirements of this section for the remainder of the fiscal year; and
(ii) Receive a portion of a year's credit for the first partial year in which it began operating a fully expanded program, as long as it continued to operate the fully expanded program in subsequent years.
(c)
(d)
(2) The number of “deficit years” of a facility shall be calculated as follows:
(i) Determine the number of years in the facility's total period of obligation pursuant to § 124.501;
(ii) Subtract the number of years in which the facility operated in compliance with this section and the applicable requirements of this subpart from the number of years derived under paragraph (d)(2)(i) of this section;
(iii) For all years in which the facility did not operate in compliance with this section, determine the ratio of the total compliance levels applicable under § 124.503(a) to the facility's total deficit under § 124.503(b);
(iv) Multiply the percentage derived under paragraph (d)(2)(iii) of this section by the number of years under obligation pursuant to § 124.501 but for which the facility did not operate in compliance with this section;
(v) Subtract the number derived under paragraph (d)(2)(iv) of this section from the number of years derived under paragraph (d)(2)(ii) of this section;
(vi) If the facility is still within the period described in § 124.501(b)(1), add the number of years derived under
(a) Where the Secretary finds that it will promote the purposes of this subpart and the State agency is able and willing to do so, the Secretary may enter into an agreement with an agency of a State to assist in administering this subpart in the State. An agreement may be terminated by the Secretary or the State agency on 60 days notice.
(b) Under an agreement the State agency will provide any assistance the Secretary requests in any one or more of the following areas, as set out in the agreement:
(1) Investigation of complaints regarding noncompliance;
(2) Monitoring compliance of facilities with the requirements of this subpart;
(3) Review of reports submitted under § 124.509, including affirmative action plans;
(4) Making initial decisions for the Secretary with respect to compliance, subject to appeal by any party to the Secretary, or review by the Secretary on the Secretary's initiative; and
(5) Application of any sanctions available to it under State law (such as license revocation or termination of State assistance) against facilities determined to be out of compliance with the requirements of this subpart.
(c) Nothing in this subpart precludes any State from taking any action authorized by State law regarding the provision of uncompensated services by facilities in the State as long as the action taken does not prevent the Secretary from enforcing the requirements of this subpart.
Secs. 215, 1525, 1602(6), Public Health Service Act as amended; 58 Stat 690, 88 Stat. 2249, 2259; 42 U.S.C. 216, 300m-4, 300o-1(6).
The provisions of this subpart apply to any recipient of Federal assistance under title VI or XVI of the Public Health Service Act that has given an assurance that it would make the facility or portion thereof assisted available to all persons residing (and, in the case of title XVI assisted applicants, employed), in the territorial area it serves. This assurance is referred to in this subpart as the “community service assurance.”
As used in this subpart:
(a)
(2) A person is residing in the facility's service area for purposes of this section if the person:
(i) Is living in the service area with the intention to remain there permanently or for an indefinite period;
(ii) Is living in the service area for purposes of employment; or
(iii) Is living with a family member who resides in the service area.
(b)
(2) A facility may discharge a person that has received emergency services, or may transfer the person to another facility able to provide necessary services, when the appropriate medical personnel determine that discharge or transfer will not subject the person to a substantial risk of deterioration in medical condition.
(c)
(i) Those principal State and local governmental third-party payors that provide reimbursement for services that is not less than the actual costs, as determined in accordance with accepted cost accounting principles; and
(ii) Federal governmental third-party programs, such as medicare and medicaid.
(2) The facility shall take any necessary steps to insure that admission to and services of the facility are available to beneficiaries of the governmental programs specified in paragraph (c)(1) of this section without discrimination or preference because they are beneficiaries of those programs.
(d)
(1) A facility has a policy or practice of admitting only those patients who are referred by physicians with staff privileges at the facility. If this policy or practice has the effect of excluding persons who reside (or for title XVI facilities, are employed) in the community from the facility because they do not have a private family doctor with staff privileges at the facility, the facility would not be in compliance with its assurance. The facility is not required to abolish its staff physician admissions policy as a usual method for admission. However, to be in compliance with its community service assurance it must make alternative arrangements to assist area residents who would otherwise be unable to gain admission to obtain services available in the facility. Examples of alternative arrangements a facility might use include:
(i) Authorizing the individual's physician, if licensed and otherwise qualified, to treat the patient at the facility even though the physician does not have staff privileges at the facility;
(ii) For those patients who have no physician, obtaining the voluntary agreement of physicians with staff privileges at the facility to accept referrals of such patients, perhaps on a rotating basis;
(iii) If an insufficient number of physicians with staff privileges agree to participate in a referral arrangement, requiring acceptance of referrals as a condition to obtaining or renewing staff privileges;
(iv) Establishing a hospital-based primary care clinic through which patients needing hospitalization may be admitted; or
(v) Hiring or contracting with qualified physicians to treat patients who do not have private physicians.
(2) A facility, as required, is a qualified provider under the title XIX medicaid program, but few or none of the physicians with staff privileges at the facility or in a particular department or sub-department of the facility will treat medicaid patients. If the effect is that some medicaid patients are excluded from the facility or from any service provided in the facility, the facility is not in compliance with its community service assurance. To be in compliance a facility does not have to require all of its staff physicians to accept medicaid. However, it must take steps to ensure that medicaid beneficiaries have full access to all of its available services. Examples of steps that may be taken include:
(i) Obtaining the voluntary agreement of a reasonable number of physicians with staff privileges at the facility and in each department or sub-department to accept referral of medicaid patients, perhaps on a rotating basis;
(ii) If an insufficient number of physicians with staff privileges agree to participate in a referral arrangement, requiring acceptance of referrals as a condition to obtaining or renewing staff privileges;
(iii) Establishing a clinic through which medicaid beneficiaries needing hospitalization may be admitted; or
(iv) Hiring or contracting with physicians to treat medicaid patients.
(3) A facility requires advance deposits (pre-admission or pre-service deposits) before admitting or serving patients. If the effect of this practice is that some persons are denied admission or service or face substantial delays in gaining admission or service solely because they do not have the necessary cash on hand, this would constitute a violation of the community service assurance. While the facility is not required to forego the use of a deposit policy in all situations, it is required to make alternative arrangements to ensure that persons who probably can pay for the services are not denied them simply because they do not have the available cash at the time services are requested. For example, many employed persons and persons with other collateral do not have savings, but can pay hospital bills on an installment basis, or can pay a small deposit. Such persons may not be excluded from admission or denied services because of their inability to pay a deposit.
(a) The facility shall post notices, which the Secretary supplies in English and Spanish, in appropriate areas of the facility, including but not limited to the admissions area, the business office and the emergency room.
(b) If in the service area of the facility the “usual language of households” of ten percent or more of the population, according to the most recent figures published by the Bureau of the Census, is other than English or Spanish, the facility shall translate the notice into that language and post the translated notice on signs substantially similar in size and legibility to, and posted with, those supplied under paragraph (a) of this section.
(c) The facility shall make reasonable efforts to communicate the contents of the posted notice to persons who it has reason to believe cannot read the notice.
(a)
(ii) A facility shall also submit the required report whenever the Secretary determines, and so notifies the facility in writing, that a report is needed for proper administration of the program. In this situation the facility shall submit the report specified in this section for the filing of reports, within 90 days after receiving notice from the Secretary, or within 90 days after the close of the fiscal year, whichever is later.
(2)
(3) The facility shall provide a copy of any report to the HSA for the area when submitting it to the Secretary.
(4)
(b)
(a)
(2)(i) A complaint is filed with the Secretary on the date on which the following information is received in the Office of the Regional Health Administrator for the Region of HHS in which the facility is located:
(A) The name and address of the person making the complaint or on whose behalf the complaint is made;
(B) The name and location of the facility;
(C) The date or approximate date on which the event complained of occurred, and
(D) A statement of what actions the complainant considers to violate the requirements of this subpart.
(ii) The Secretary promptly provides a copy of the complaint to each facility named in the complaint.
(3) When the Secretary investigates a facility, the facility shall provide to the Secretary on request any documents, records and other information concerning its operations that relate to the requirements of this subpart.
(4) The Act provides that if the Secretary dismisses a complaint or the Attorney General has not brought an action for compliance within six months from the date on which the complaint is filed, the person filing it may bring a private action to effectuate compliance with the assurance. If the Secretary determines that he will be unable to issue a decision on a complaint or otherwise take appropriate action within the six month period, he may, based on priorities for the disposition of complaints that are established to promote the most effective use of enforcement resources, or on the request of the complainant, dismiss the complaint without a finding as to compliance prior to the end of the six month period, but no earlier than 45 days after the complaint is filed.
(b)
(2) If the Secretary finds, based on his investigation under paragraph (a) of this section, that a facility has limited the availability of its services in a manner proscribed by this subpart, he may, in addition to any other action that he is authorized to take in accordance with the Act, require the facility to establish an effective affirmative action plan that in his judgment is designed to insure that its services are made available in accordance with the requirements of this subpart.
(a) Where the Secretary finds that it will promote the purposes of this subpart, and the State agency is able and willing to do so, he may enter into an agreement with the State agency for the State agency to assist him in administering this subpart in the State.
(b) Under an agreement, the State agency will provide the Secretary with any assistance he requests in any one or more of the following areas, as set out in the agreement:
(1) Investigation of complaints of noncompliance;
(2) Monitoring the compliance of facilities with the requirements of this subpart;
(3) Review of affirmative action plans submitted under § 124.606(b);
(4) Review of reports submitted under § 124.605;
(5) Making initial decisions for the Secretary with respect to compliance, subject to appeal by any party to the Secretary or review by the Secretary on his own initiative; and
(6) Application of any sanctions available to it under State law (such as license revocation or termination of State assistance) against facilities determined to be out of compliance with the requirements of this subpart.
(c) A State agency may use funds received under section 1525 of the Act to pay for expenses incurred in the course of carrying out this agreement.
(d) Nothing in this subpart precludes any State from taking any action authorized by State law regarding the provision of services by any facility in the State as long as the action taken does not prevent the Secretary from enforcing the requirements of this subpart.
In performing reviews under section 1513 (e) of the Public Health Service Act (42 U.S.C. 3001-2(c)) of applications for grants under section 1625 of the Act, health systems agencies shall use the procedures and criteria stated below. A health systems agency may not conduct such reviews until the procedures and criteria to be used in conducting the reviews have been adopted by the agency and published in newspapers of general circulation within the health service area or other public information channels.
The procedures adopted and utilized by a health systems agency for conducting reviews of applications for grants under section 1625 of the Act shall include at least the following: 1. Except as provided below, notification of the beginning of a review within seven days of the receipt by the health systems agency of the application. Where the application was received by the health systems agency prior to publication of this subpart in the
2. Schedules for reviews which provide that such reviews shall not exceed 60 days from the date of notification made in accordance with paragraph 1 of this section to the date of the written findings made in accordance with paragraph 4 of this section. This does not preclude a health systems agency from conducting its review in less than 60 days.
3. Provision for applicants to submit to the health systems agency (in such form and manner as the agency shall require) such information as the agency deems necessary in order to conduct its review.
4. Written findings which state the basis for the approval or disapproval of the application by the health systems agency. Such findings shall be sent to the applicant, the State health planning and development agency (or agencies), and the Secretary, and shall be available to other upon request.
5. Access by the general public to all such applications reviewed by the health systems agency and to all other written materials pertinent to the agency review.
6. Public hearings in the course of agency review, if requested by one or more persons directly affected by the review. For purposes of this paragraph, a “person directly affected by the review” is as defined in 42 CFR 122.306 (a)(7).
The specific criteria adopted and utilized by a health systems of this agency to conduct reviews of applications for grants under section 1625 of the Act shall include at least the following:
1. The relationship of the health services of the facility to the applicable health systems plan and annual implementation plan.
2. The relationship of the health services of the facility to the long-range development plan (if any) of the applicant.
3. The need that the population served or to be served by the facility has for the health services of such facility.
4. The availability of alternative, less costly, or more effective methods of providing the health services which the facility provides.
5. The relationship of the health services provided by the facility to the existing health care system of the area.
6. The availability of resources (including health manpower, management personnel, and funds for capital and operating needs) for the provision of services by the facility and the availability of alternative uses of such resources for the provision of other health services.
7. The special needs and circumstances of those entities which provide a substantial portion of their services or resources, or both, to individuals not residing in the health service area in which the entities are located or in adjacent health service areas. Such entities may include medical and other health professions schools, multidisciplinary clinics, and other speciality centers.
8. The special needs and circumstances of health maintenance organizations for which assistance may be provided under title XIII.
9. The costs and methods of the proposed construction or modernization, including the costs and methods of energy provision.
10. The probable impact of the project reviewed on the applicant's costs of providing health services.
Secs. 609 and 1622 of the Public Health Service Act as amended 98 Stat. 112 (42 U.S.C. 291i and 300s-1a).
The provisions of this subpart apply to facilities with respect to which grant funds were paid for construction or modernization—
(a) Under title VI or XVI of the Public Health Service Act; or
(b) Pursuant to the authority of the Secretary under any of the following statutes:
(1) The Public Works Acceleration Act of 1962, Pub. L. 87-658 (42 U.S.C. 2641
(2) The District of Columbia Medical Facilities Construction Act of 1968, 82 Stat. 631 (Pub. L. 90-457);
(3) The Appalachian Regional Development Act of 1965, as amended (40 U.S.C. App.).
As used in this subpart—
(a) If any facility is at any time within 20 years after the completion of the grant-assisted construction or modernization sold or transferred to any entity which is either not qualified for a grant under the statute pursuant to which the grant was awarded or not approved as a transferee by the State agency, the United States shall be entitled to recover on the basis of joint and several liability from any transferor, transferee, or successive transferee of the facility an amount determined in accordance with this subpart.
(b) If any facility at any time within 20 years after the completion of the grant-assisted construction or modernization ceases to be a public or other non-profit facility that would have been eligible for a grant under the statute pursuant to which the grant was awarded, the United States shall be entitled to recover from the owners of the facility an amount determined in accordance with this subpart.
(a) The transferor of a facility that is sold or transferred as described in § 124.703(a), or the owner of a facility which ceases to be a public or other nonprofit facility as described in § 124.703(b), shall provide the Secretary written notice of such sale, transfer, or other change not later than 10 days after the date on which the sale, transfer, or change occurs.
(1)
(2)
(i) A facility “ceases to be” a facility for which a grant could have been made under the statute pursuant to which the grant was awarded when it is no longer operated as such a facility; and
(ii) A facility “ceases to be a public or nonprofit facility” when an entity that is not a public or other non-profit corporation or association assumes management responsibilities with respect to the facility which, in the Secretary's judgment, are so pervasive as to constitute operation of the facility. The manager will not be deemed to be the operator of the facility if the management agreement contains both of the following provisions:
The Board of Directors of the facility retains authority to terminate the agreement at any time upon reasonable notice to the contractor.
No employee of the contractor may be a member of the facility's Board of Directors.
(b)
(1) The date of the sale, transfer, or other event that gives rise to the notice;
(2) Copies of any sales contracts, lease agreements, management contracts or other documents pertinent to the event giving rise to the notice;
(3) Estimates of current assets, current liabilities, book value of equipment, the expected value of land on the new owner's books, and the remaining depreciation for all fixed assets involved in the transaction calculated on a straight line basis using commonly adopted expected useful lifetimes.
(c)
(a) Except as provided in § 124.706, the amount that the United States shall be entitled to recover under this subpart is that amount bearing the same ratio to the then value of so much of the facility as constituted an approved project (or projects) as the amount of Federal participation bore to the cost of the construction or modernization under such project (or projects).
(b) The then value of the facility will be based on:
(1) The transaction value in the case of an arms-length sale or transfer, or
(2) A depreciated reproduction value in the absence of an arms-length sale or transfer or if the buyer fails to provide, within 60 days after the date of the Secretary's letter described in § 124.704(c), the information which, in the judgment of the Secretary, is necessary to establish, adjust, and apportion a transaction value. As used in this section, “transaction value” means in the case of a sale, the sale price, and in the case of a lease, the value of the lease plus the residual value of the facility at the termination of the lease (i.e., the reproduction value or, if appropriate, an alternative use value).
(c) The transaction value will be adjusted to account for the purchase or lease of other assets and the assumption of liabilities associated with the transaction. To determine the amount of Federal recovery, the adjusted value will be apportioned to the grant-aided assets by the ration of the remaining useful lifetime values of those assets to the sum of the remaining useful lifetime values of all assets not previously accounted for in adjusting the transaction value.
(d) A depreciated reproduction value will be established by calculating a reproduction value using construction cost indexes or current costs per square foot for construction, depending on which is more relevant to the type of construction associated with the grant. This reproduction value will then be adjusted by the ratio of the remaining useful life to the total useful life for the assets involved.
(e) In calculating the recovery amount, the Secretary will include as Federal participation any grant assistance received by the facility under an authority listed in § 124.701 and any assistance supplementary to that assistance received for the construction or modernization of the facility under the Public Works and Economic Development Act of 1965 (42 U.S.C. 3121,
(a) In addition to the amount of recovery calculated under § 124.705, the United States shall be entitled to recover interest on such amount in accordance with this section at the rate determined by the Secretary based on the average of the bond equivalent of the weekly ninety-day U.S. Treasury bill auction rate for the quarter previous to the quarter in which interest begins to accrue under this section.
(1)
(2)
(b) The Secretary may waive interest charges that result from delays caused solely by the Department.
(a)
(1) Has filed a written request for the waiver within the time limits prescribed by this section;
(2) Has established an irrevocable trust in accordance with this section, in an amount equal to the greater of the amount that would otherwise have been recovered pursuant to § 124.705 (including accrued interest as calculated under § 124.706) or twice the cost of the remaining uncompensated services obligation of the facility as of the date of the change of status, that will be used by the entity only to provide services to those unable to pay in accordance with the requirements of subpart F of this part; and
(3) Has agreed to comply with the community service regulations set out in subpart G of this part.
(b)
(i)
(B) For a facility which changes status after the date that subpart F of this part is effective for the facility, the Secretary will multiply the annual compliance level, computed under the 10% method specified in 42 CFR 124.503(a)(1)(ii), for the fiscal year in which the change of status occurs times the number of years remaining in the facility's uncompensated services obligation. From this amount, the Secretary will subtract amounts of excess or add amounts of deficit for each fiscal year prior to the change of status for which the Secretary has previously conducted an audit of uncompensated services accounts. Excess and deficits will be adjusted by the percent change in the National Consumer Price Index for Medical Care between the year in which the excess or deficit occurred and the year in which the status change occurred. For each fiscal year prior to the change of status which the Secretary has not audited, the Secretary will add to the remaining obligation an amount equal to the annual compliance level in each such year adjusted by the percent change in the National Consumer Price Index for Medical Care between that year and the year of the status change. The amount computed as the total remaining obligation will then be multiplied by two. If the transferee chooses to accept the Secretary's calculation, no further assessments will be made of uncompensated care provided prior to the change of status date. If the transferee does not accept the calculation, the transferor or transferee may hire, and may charge against the irrevocable trust established under this section, an independent auditor to certify the compliance level and any excess or deficit for the period from May 18, 1979, up to and including the date of the change of status, using standard Departmental procedures supplemented with instructions provided by the Secretary, and submit the results in accordance with paragraph (b)(2)(ii) of this section. The audit may be conducted for any years
(ii)
(2) Within 60 days following the date of the Secretary's letter provided pursuant to paragraph (b)(1) of this section, the owner of the facility shall notify the Secretary in writing that it either:
(i) Accepts the trust fund amount for the waiver as offered by the Secretary;
(ii) Provides a detailed statement of an alternative determination of the recovery amount or an independent audit of the remaining uncompensated services obligation as described in paragraph (b)(1)(i) of this section; or
(iii) Does not seek a waiver under § 124.707. Failure to provide a timely response to the Secretary under this subparagraph will be considered an election not to seek the waiver.
(3) Within 30 days following the receipt of the owner's views concerning the calculation, and after considering those views, the Secretary will send a final letter providing the Secretary's determination of twice the remaining uncompensated care obligation and the recovery amount under § 124.705. The amount to be placed in the irrevocable trust will be the higher of those two figures. (See paragraph (a)(2) of this section.)
(4) Within 30 days of the date of the final letter, the owner of the facility shall notify the Secretary in writing whether or not it accepts the terms of the waiver. Failure to provide timely notice to the Secretary under this subparagraph will be considered an election not to accept the waiver.
(c)
(i) The owner shall provide a copy of the trust documents to the Secretary and no trust shall be considered established until the trust documents have been approved by the Secretary; and
(ii) The owner may credit against the trust any uncompensated services provided in accordance with subpart F of this part between the date of the change of status of the facility and the establishment of the trust. For an owner to receive the credit before the establishment of the trust and deposit of funds therein, the auditor's report covering the post-transfer period shall be submitted with the notification of acceptance of the waiver, and in any event, not later than 30 days from the date of the Secretary's final letter described in paragraph (b)(3) of this section. Within 30 days following the receipt of the auditor's report, the Secretary will notify the owner of the allowable credit, if any. If the auditor's report is not timely submitted, the trust must be established and fully funded, in accordance with the time limits imposed by paragraph (c)(1) of this section, and the Secretary will notify the owner of the allowable credit, if any, within 30 days of the date of the establishment of the trust or within 30 days of the receipt of the report, whichever is later.
(2) The trust shall be administered by a Trustee who is neither an employee of the transferee nor an employee of a subsidiary or of the parent institution of the transferee.
(3) The trust shall provide that the trust corpus and income may be invested only in U.S. Government or U.S. Government insured securities.
(d)
The Secretary may for good cause waive the recovery rights of the United States arising under § 124.703(b). In determining whether there is good cause under this section for releasing the applicant or other owner of the facility from its obligation, the Secretary will take into consideration the extent to which:
(a) The facility will be devoted by the applicant or other owner to use for another public or nonprofit purpose whch will promote the purpose of the Act;
(b) There are reasonable assurances that for the remainder of the 20-year period other public or nonprofit facilities not previously utilized for the purpose for which the facility was constructed will be so utilized and are substantially equivalent in nature and purpose.
(c) The facility has been acquired from an agency of the United States (e.g., the Federal Housing Administration under its mortgage insurance commitment program) which has made a reasonable effort to dispose of it for operation as a public or nonprofit health care facility.
(a) Any waiver granted under this subpart is conditioned upon the recipient of the waiver carrying out the obligations imposed by § 124.707 or § 124.708 as applicable.
(b) The Secretary will monitor compliance with the community service and uncompensated care obligations of any entity that receives a waiver.
(c) Should a recipient of a waiver fail to comply with the applicable conditions, the Secretary will withdraw the waiver and seek recovery based on the value of the facility on the date the right of recovery first arose under § 124.703.
(d) No waiver will be withdrawn until the recipient has been notified in writing by the Secretary of the noncompliance and has failed to take corrective action within 90 days after the date of such notice.
(e) Should the waiver be withdrawn, the amount of the Government's recovery will be the amount set out in the Secretary's determination letter as described in § 124.707 (b)(1) or (b)(3) as applicable plus interest from the date of the notification sent in accordance with paragraph (d) of this section.
Secs. 101-108 of Pub. L. 105-369, 112 Stat. 3368 (42 U.S.C. 300c-22 note); sec. 215 of the Public Health Service Act (42 U.S.C. 216).
This part establishes criteria and procedures for implementation of the Ricky Ray Hemophilia Relief Fund Act of 1998 (the Act). This statute provides for compassionate payments to certain individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus (HIV) due to contaminated antihemophilic factor within a specified time period, as well as to certain persons who contracted HIV from these individuals. In the event the individual eligible for payment is deceased, the Act also provides for payments to certain survivors of this individual.
As used in this part:
(a)
(b)
(c)
(d)
(e)
(1) Was married according to the laws of the place where the person resided at any time after the date of the individual's treatment with antihemophilic factor (this date of treatment must have been between July 1, 1982, and December 31, 1987); and
(2) Is no longer married.
(f)
(g)
(h)
(i)
(1)
(2)
(i) HIV antibodies;
(ii) HIV viral antigens;
(iii) HIV viral cultures; or
(iv) Plasma HIV RNA; or
(3)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
If there are sufficient amounts in the Fund to make payments, the Secretary will make a single payment of $100,000 to eligible individuals, as defined in accordance with subpart B of this part.
The following individuals are eligible for payment under the Act if they are living at the time that payment is to be made on a petition and have an HIV infection:
(a) An individual who has any form of blood-clotting disorder, such as hemophilia, who was treated with antihemophilic factor at any place defined in § 130.2(o), or at any diplomatic area or military installation of the United States, at any time during the time period from July 1, 1982, to December 31, 1987.
(b) An individual who is:
(1) The lawful spouse of the individual with a blood-clotting disorder and HIV; or
(2) The former lawful spouse of the individual with a blood-clotting disorder and HIV, if the former lawful spouse can assert with reasonable certainty, through medical documentation, transmission of HIV from the individual with a blood-clotting disorder and HIV.
(c) An individual who acquired the HIV infection through perinatal transmission from a parent who is the individual with a blood-clotting disorder and HIV, the lawful spouse with HIV or the former lawful spouse with HIV.
(a) Survivors of persons with HIV, as described in § 130.10, are eligible for payment under the Act if:
(1) The person with HIV dies before filing a petition under the Act. In this case, an eligible survivor may file a petition as a survivor of the person with HIV, as set forth in § 130.22; or
(2) The person with HIV has filed a petition under the Act, but dies before payment is made. In this case, an eligible survivor must file an amendment to the petition in order to retain the assigned order number and to receive payment under the Act, as set forth in § 130.23.
(b) Payments to survivors shall be made in the following order:
(1) If the person with HIV is survived by a spouse who is living at the time of payment, the payment shall be made to the surviving spouse (
(2) If the person with HIV is not survived by a living spouse, the payment shall be made in equal shares to all children of the individual who are living at the time of payment (
(3) If the person with HIV is not survived by a spouse or children who are living at the time of payment, the payment shall be made in equal shares to the parents of the individual who are living at the time of payment (
(c) If the person with HIV is not survived at the time payment is to be made by any of the survivors listed in paragraph (b) of this section, no payments will be made for the person with HIV and the payment will revert back to the Fund.
(d) For purposes of this section, the following definitions apply:
(1) The term
(2) The term
(3) The term
In all instances in which medical documentation is referred to, medical documentation may be submitted in the following forms:
(a) Copies of relevant portions of medical records, records maintained by a physician, nurse, or other licensed health care provider, test results, prescription information, or other documentation deemed credible by the Secretary; or
(b) An affidavit, signed under penalty of perjury, by a physician, nurse practitioner or physician assistant, verifying that the medical criteria necessary for a petitioner to be eligible for payment under the Act are satisfied. Such an affidavit must include the physician's, nurse practitioner's or physician assistant's State of practice, and license, certification or registration number, as applicable. A sample affidavit is set forth at Appendix B to this part.
The following rules apply to all petitions filed by persons with HIV:
(a) All petitions filed under the Act must include written medical documentation showing the following:
(1) That the individual described in § 130.10(a) has (or had) a blood-clotting disorder, such as hemophilia;
(2) That the individual with a blood-clotting disorder and HIV was treated
(3) That the individual with a blood-clotting disorder and HIV has (or had) an HIV infection under any of the criteria set out in the definition of HIV infection at § 130.2(i).
(b)
(c)
(1) The documentation described in paragraph (a) of this section;
(2) Medical documentation showing that the lawful spouse with HIV has an HIV infection; and
(3) A marriage certificate or other proof of a lawful marriage, which shows that the lawful spouse with HIV and the individual with a blood-clotting disorder and HIV are married.
(d)
(1) The documentation described in paragraph (a) of this section;
(2) Medical documentation showing that the former lawful spouse with HIV has an HIV infection;
(3) A marriage certificate or other proof of a lawful marriage, which shows that the former lawful spouse with HIV and the individual with a blood-clotting disorder and HIV were married at any time after the date of the individual's treatment with antihemophilic factor (this date of treatment must have been between July 1, 1982, to December 31, 1987);
(4) A divorce certificate or other proof of termination of the marriage between the former lawful spouse with HIV and the individual with a blood-clotting disorder and HIV; and
(5) Medical documentation which shows with reasonable certainty that the former lawful spouse with HIV contracted HIV from the person with a blood-clotting disorder and HIV.
(e)
(1) The documentation described in paragraph (a) of this section;
(2) Medical documentation showing that the child with HIV has an HIV infection;
(3) A birth certificate or other proof, which shows that the child with HIV is the child of:
(i) The individual with a blood-clotting disorder and HIV;
(ii) The lawful spouse with HIV; or
(iii) The former lawful spouse with HIV;
(4) A marriage certificate or other proof of a lawful marriage, which shows that the lawful spouse with HIV or the former lawful spouse with HIV and the individual with a blood-clotting disorder and HIV are/were married,
(5) Medical documentation showing that the child with HIV acquired an HIV infection through perinatal transmission from a parent who is:
(i) The individual with a blood-clotting disorder and HIV;
(ii) The lawful spouse with HIV; or
(iii) The former lawful spouse with HIV; and
(6) Where the child with HIV acquired an HIV infection through perinatal transmission from the former lawful spouse with HIV, medical documentation which shows with reasonable certainty that the former lawful spouse with HIV contracted HIV from the person with the blood-clotting disorder and HIV.
(a) In those cases in which the person with HIV, as described in § 130.10, dies before filing a petition under the Act, a survivor of that person, as described in § 130.11, may file a petition.
(b) Petitions filed by survivors must include two types of information:
(1) Documentation regarding the person with HIV; and
(2) Documentation regarding the eligibility of the survivor to receive payments as a survivor of the person with HIV.
(c) Petitions filed by survivors must include the following information regarding the person with HIV:
(1)
(2)
(3)
(4)
(d) Petitions filed by survivors must include the following information regarding the relationship between the survivor and the person with HIV:
(1)
(i) A death certificate for the person with HIV, or other evidence of that individual's death;
(ii) A marriage certificate or other proof of a lawful marriage, which shows that the survivor was the spouse, as defined in § 130.11(d)(1), of the person with HIV; and
(iii) A sworn statement signed by the surviving spouse which states that the surviving spouse and the person with HIV were married at the time of that individual's death.
(2)
(i) A death certificate for the person with HIV, or other evidence of that individual's death;
(ii) A birth certificate, adoption certificate, documentation that shows that the survivor is the stepchild of the person with HIV (for example, a certificate of marriage between the survivor's parent and the person with HIV), or other documentation which shows that the survivor is the child, as defined in § 130.11(d)(2), of the person with HIV; and
(iii) A sworn statement signed by the surviving child/children which either:
(A) States that, to the best of the petitioner's knowledge, there are no other survivors who are eligible for payment under the Act, as described in § 130.11 (
(B) Provides information regarding other survivors who are eligible for payment under the Act.
(3)
(i) A death certificate for the person with HIV, or other evidence of that individual's death;
(ii) A birth certificate, adoption certificate or other documentation which shows that the survivor is the parent, as defined in § 130.11(d)(3), of the person with HIV; and
(iii) A sworn statement signed by the surviving parent(s) which either:
(A) States that, to the best of the petitioner's knowledge, there are no other survivors who are eligible for payment under the Act, as described in § 130.11 (
(B) Provides information regarding other survivors who are eligible for payment under the Act.
(a) The following survivors must file amendments to petitions in order to retain the assigned order number described in § 130.32 and to receive payment under the Act:
(1) A survivor of the person with HIV, when the person with HIV has filed a petition under the Act, but then died before receiving payment;
(2) The next-ranked survivor eligible to receive payment under the Act, as described in § 130.11(b), when a previously-ranked survivor has filed a petition or an amendment to a petition
(3) In the case of petitions filed by multiple survivors (
(b) Survivors described in paragraph (a) of this section shall amend the original petition by filing the petition form set forth at Appendix C to this part, including the section pertaining to amendments to petitions.
(c) Amendments to petitions filed by survivors must include the following documentation:
(1) Survivors described in paragraph (a)(1) of this section must include the documentation described in § 130.22(d), which shows that the survivor is eligible to file a petition as a survivor of the person with HIV.
(2) Survivors described in paragraph (a)(2) of this section must include:
(i) The documentation described in § 130.22(d), which shows that the survivor is eligible to file a petition as a survivor of the person with HIV; and
(ii) A death certificate for the survivor whose petition is being amended, or other evidence of that survivor's death.
(3) Survivors described in paragraph (a)(3) of this section must include a death certificate for the survivor who has died, or other evidence of that survivor's death.
(d) Amendments to petitions filed by survivors described in paragraph (a) of this section will retain the same order number assigned to the original petition.
(e) In those cases in which the Secretary has reviewed the original petition prior to receiving an amendment to the petition, the Secretary will determine whether to pay the survivors described in paragraph (a) as follows:
(1) If the Secretary has determined that the original petition does not include all of the documentation described in this Subpart C (
(2) If the Secretary has determined that the original petition does not meet the requirements of the Act, the survivor will be so notified and payment will not be made. The survivor may seek reconsideration under § 130.40.
(3) If the Secretary has determined that the original petition meets the requirements of the Act, and the survivor meets the survivor requirements of the Act, the survivor will receive payment as described in § 130.3.
(f) In those cases in which the Secretary has not yet made the determination whether the original petition meets the requirements of the Act, the Secretary will review the amended petition according to the order number assigned to the original petition, and then determine whether the petition is complete and whether to pay the petition as described in paragraph (e) of this section.
(a) In addition to the applicable documentation required under this subpart, the Secretary may require the petitioner to provide other documentation, as the Secretary deems appropriate, to resolve issues of eligibility, or of the procedure for payment, raised by a petition.
(b) Where a petition filed on behalf of a minor or other individual who is legally incompetent to receive payment has been approved for payment, the personal representative filing the petition on the individual's behalf must submit the following before payment can be made for the legally incompetent individual:
(1) Documentation of a guardianship or conservatorship, established in accordance with State and local law; and
(2) Information identifying a guardianship or conservatorship account.
The following individuals may file a petition for payment under the Act:
(a) All eligible individuals, as described in subpart B of this part, including living persons with HIV and survivors of persons with HIV; and
(b) Personal representatives of eligible individuals:
(1) Where the eligible individual does not have the legal capacity to receive payment under the Act, as described in § 130.35(e); or
(2) Where the eligible individual does have the legal capacity to receive payment under the Act and signs the sworn statement included at the end of the petition.
(a) In order to receive payment under the Act, all eligible individuals, as described in subpart B of this part, must file a complete petition with the Secretary. A complete petition is one that contains all of the required documentation described in Subpart C of this part.
(b) A copy of the petition form, which must be filed by all eligible individuals, including individuals with a blood-clotting disorder and HIV, the lawful spouse with HIV, the former lawful spouse with HIV, the child with HIV, and the survivors of persons with HIV, is set forth at Appendix C to this part. Appendix C includes the petition form, the instructions for filing the petition form, and a documentation checklist.
(c) Where there are multiple surviving children or surviving parents, payments on the petition will be made to each survivor separately. The survivors shall:
(1) File one petition form jointly, which will contain the required documentation for all survivors, and which will be signed by at least one survivor; or
(2) File separate petition forms, which together will contain all of the required documentation for all survivors, and which will be signed by each survivor.
(d) Petitions may be
(e) All petitions must be
(f) The date on which the Secretary will begin accepting petitions is July 31, 2000.
(1) In order to be eligible for review, petitions may be postmarked on or after this date. A legibly dated receipt from a commercial carrier or U.S. Postal Service will be accepted in lieu of a postmark. Petitions that are postmarked by a private meter will not be accepted.
(2) Petitions that are postmarked, or accompanied by a receipt from a commercial carrier or U.S. Postal Service, prior to this date
(g)
(1) If a petitioner submits a petition to the Secretary by November 13, 2001, and the Secretary has determined, in accordance with § 130.34, that the petition does not meet the requirements of the Act, the petitioner may submit a
(2) If a petitioner submits a petition to the Secretary by November 13, 2001, and the Secretary has not yet made the determination whether the petition meets the requirements of the Act, the petitioner may supplement the original petition with additional documentation at any time until the date of the Secretary's determination.
(3) If a petitioner files an amendment to a petition, as described in § 130.23, the deadline for filing this amendment is the date of the Secretary's determination of eligibility or the date of payment, whichever is later.
(h)
(1) If the petitioner submitted a claim in the Factor Concentrate Settlement which included all of the documents required to establish eligibility under the Act, he or she may submit original or duplicate copies of those documents to the Secretary.
(2) If the petitioner submitted a claim in the Factor Concentrate Settlement which included some, but not all, of the documents required to establish eligibility under the Act, he or she may submit original or duplicate documents as described in paragraph (h)(1) of this section, together with the additional documents required under the Act.
(3) If the petition is filed by someone other than an individual who filed a claim in the Factor Concentrate Settlement (
(a) The order that the petition was received by the Secretary will be determined by the postmark date or the date indicated by a commercial carrier or the U.S. Postal Service, in accordance with § 130.31(f).
(b) If the Secretary receives more than one petition which is either postmarked or dated by a commercial carrier or the U.S. Postal Service on the same date, the Department will conduct a random selection of each day's submissions to determine the order within each group of petitions.
(c) A number will be assigned to each petition indicating the order in which it is selected.
(a) If the Secretary determines that a petition does not include all of the documentation described in subpart C of this part (
(b) The petitioner will be notified that the Secretary has determined that the petition is incomplete and, for purposes of retaining the assigned order number described in § 130.32, will be given 60 calendar days from the date of the notice to submit the missing information. If the petitioner submits the missing information within 60 calendar days, and the Secretary determines that the petition meets the requirements of the Act, the petitioner will be paid according to the assigned order number.
(c) If the petitioner is unable to complete the petition, the petitioner may submit written documentation to the Secretary, within 60 calendar days, which shows good cause why the required medical or legal documentation is unavailable. If the Secretary determines that the petitioner has provided an adequate showing of good cause and is otherwise eligible for payment under the Act, the petitioner will be paid according to the assigned order number. The Secretary may allow additional time beyond the 60-day deadline, as the
(d) The Secretary will process the petition according to § 130.34 if:
(1) The petition does not include the required documentation, as described in subpart C, even after the opportunity is given to complete it;
(2) The 60-day deadline, or the extended deadline under § 130.33(c), as applicable, to complete the petition is not met; or
(3) An adequate showing of good cause why the required medical or legal documentation is unavailable is not provided.
(a) Subject to available resources, the Secretary will review each petition filed under the Act and make one of the following determinations:
(1) If the Secretary concludes that the petition does not meet the requirements of the Act, the petitioner will be so notified and payment will not be made. These petitioners may seek reconsideration under § 130.40.
(2) If the Secretary concludes that the petition does meet the requirements of the Act, the petitioner will receive payment as described in § 130.3.
(b) Petitions will be reviewed based upon the assigned number indicating the order of receipt, as described in § 130.32.
(a) To the extent practicable, determinations on complete petitions will be made not later than 120 calendar days after the date that the Secretary determines that the petition is complete.
(b) Payments on petitions will be made as soon as practicable after a determination that a complete petition meets the requirements of the Act.
(c) For each eligible individual, as described in subpart B of this part, the Secretary will make only one payment on a petition.
(d) Where there are multiple surviving children or surviving parents, survivors who have submitted all required documentation and are otherwise eligible for payment under the Act, will be paid their share(s) of the payment, as described in § 130.11(b)(2) and (3). If any surviving children or surviving parents who are otherwise eligible for payment have not submitted the required documentation, their share(s) of the payment will remain in the Fund until such time as they complete their petitions by submitting such documentation. If they have not submitted the required documentation by the time that the Fund terminates, their share(s) will revert back to the Treasury.
(e) Payments on petitions will be made to eligible individuals, as described in subpart B, unless the eligible individual is legally incompetent to receive payment. A personal representative may receive payment for a legally incompetent individual by submitting the following written documentation to the Secretary:
(1) Proof showing that the eligible individual does not have the legal capacity to receive payment under the Act, such as a birth certificate showing that the eligible individual is a minor, or other evidence showing that the eligible individual is legally incompetent; and
(2) Proof showing that the personal representative has the authority to receive payment for the eligible individual, such as proof of legal guardianship.
(a)
(b)
(c)
As provided by section 107 of the Act:
(a) Notwithstanding any contract, the representative of an individual may not receive, for services rendered in connection with the petition of an individual under this Act, more than 5 percent of a payment made under this Act (
(b) Any such representative who violates this section is subject to a fine of not more than $50,000.
25 U.S.C. 13; sec. 3, 68 Stat. 674 (42 U.S.C., 2001, 2003); Sec. 1, 42 Stat. 208 (25 U.S.C. 13); 42 U.S.C. 2001, unless otherwise noted.
When used in this part:
The regulations in this part establish general principles and program requirements for carrying out the Indian health programs.
The service periodically issues administrative instructions to its officers and employees, which are primarily found in the
(a)
(b)
(c)
(a)
(2) Generally, an individual may be regarded as within the scope of the Indian health and medical service program if he/she is regarded as an Indian by the community in which he/she lives as evidenced by such factors as tribal membership, enrollment, residence on tax-exempt land, ownership of restricted property, active participation in tribal affairs, or other relevant factors in keeping with general Bureau of Indian Affairs practices in the jurisdiction.
(b)
(2) If the applicant's condition is such that immediate care and treatment are necessary, services shall be provided pending identification as an Indian beneficiary.
(c)
(a) In case of an emergency, as an act of humanity, individuals not eligible under § 136.12 may be provided temporary care and treatment in Service facilities.
(b) Charging ineligible individuals. Where the Service Unit Director determines that an ineligible individual is able to defray the cost of care and treatment, the individual shall be charged at rates approved by the Assistant Secretary for Health and Surgeon General published in the
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(a) In accordance with the congressional intention that funds appropriated for the general support of the health program of the Indian Health Service be used to provide health services for Indians who live on or near Indian reservations, contract health service delivery areas are established as follows:
(1) The State of Alaska;
(2) The State of Nevada;
(3) the State of Oklahoma;
(4) Chippewa, Mackinac, Luce, Alger, Schoolcraft, Delta, and Marquette Counties in the State of Michigan;
(5) Clark, Eau Claire, Jackson, La Crosse, Monroe, Vernon, Crawford,
(6) With respect to all other reservations within the funded scope of the Indian health program, the contract health services delivery area shall consist of a county which includes all or part of a reservation, and any county or counties which have a common boundary with the reservation.
(b) The Secretary may from time to time, redesignate areas or communities within the United States as appropriate for inclusion or exclusion from a contract health service delivery area after consultation with the tribal governing body or bodies on those reservations included within the contract health service delivery area. The Secretary will take the following criteria into consideration:
(1) The number of Indians residing in the area proposed to be so included or excluded;
(2) Whether the tribal governing body has determined that Indians residing in the area near the reservation are socially and economically affiliated with the tribe;
(3) The geographic proximity to the reservation of the area whose inclusion or exclusion is being considered; and
(4) The level of funding which would be available for the provision of contract health services.
(c) Any redesignation under paragraph (b) of this section shall be made in accordance with the procedures of the Administrative Procedure Act (5 U.S.C. 553).
(a)
(1) Reside within the United States and on a reservation located within a contract health service delivery area; or
(2) Do not reside on a reservation but reside within a contract health service delivery area and:
(i) Are members of the tribe or tribes located on that reservation or of the tribe or tribes for which the reservation was established; or
(ii) Maintain close economic and social ties with that tribe or tribes.
(b)
(1) Student—during their full-time attendance at programs of vocational, technical, or academic education, including normal school breaks (such as vacations, semester or other scheduled breaks occurring during their attendance) and for a period not to exceed 180 days after the completion of the course of study.
(2) Transients (persons who are in travel or are temporarily employed, such as seasonal or migratory workers) during their absence.
(c)
(d)
(e)
(f)
(a) No payment will be made for medical care and services obtained from non-Service providers or in non-Service facilities unless the applicable requirements of paragraphs (b) and (c) of this section have been met and a purchase order for the care and services has been issued by the appropriate ordering official to the medical care provider.
(b) In nonemergency cases, a sick or disabled Indian, an individual or agency acting on behalf of the Indian, or the medical care provider shall, prior to the provision of medical care and services notify the appropriate ordering official of the need for services and supply information that the ordering official deems necessary to determine the relative medical need for the services and the individual's eligibility. The requirement for notice prior to providing medical care and services under this paragraph may be waived by the ordering official if:
(1) Such notice and information are provided within 72 hours after the beginning of treatment or admission to a health care facility; and
(2) The ordering official determines that giving of notice prior to obtaining the medical care and services was impracticable or that other good cause exists for the failure to provide prior notice.
(c) In emergency cases, a sick or disabled Indian, or an individual or agency acting on behalf of the Indian, or the medical care provider shall within 72 hours after the beginning of treatment for the condition or after admission to a health care facility notify the appropriate ordering official of the fact of the admission or treatment, together with information necessary to determine the relative medical need for the services and the eligibility of the Indian for the services. The 72-hour period may be extended if the ordering official determines that notification within the prescribed period was impracticable or that other good cause exists for the failure to comply.
(a) Any person to whom contract health services are denied shall be notified of the denial in writing together with a statement of the reason for the denial. The notice shall advise the applicant for contract health services that within 30 days from the receipt of the notice the applicant:
(1) May obtain a reconsideration by the appropriate Service Unit Director of the original denial if the applicant submits additional supporting information not previously submitted; or
(2) If no additional information is submitted, may appeal the original denial by the Service Unit Director to the appropriate Area or program director. A request for reconsideration or appeal shall be in writing and shall set forth the grounds supporting the request or appeal.
(b) If the original decision is affirmed on reconsideration, the applicant shall be so notified in writing and advised that an appeal may be taken to the Area or program director within 30 days of receipt of the notice of the reconsidered decision. The appeal shall be in writing and shall set forth the grounds supporting the appeal.
(c) If the original or reconsidered decision is affirmed on appeal by the Area or program director, the applicant shall be so notified in writing and advised that a further appeal may be taken to the Director, Indian Health Service, within 30 days of receipt of the notice. The appeal shall be in writing and shall set the grounds supporting the appeal. The decision of the Director, Indian Health Service, shall constitute final administrative action.
25 U.S.C. 44, 45, 46 and 472; Pub. L. 83-568, 68 Stat 674, 42 U.S.C. 2003.
For purposes of making appointments to vacancies in all positions in the Indian Health Service, a preference will be extended to persons of Indian descent who are:
(a) Members of any recognized Indian tribe now under Federal jurisdiction;
(b) Descendants of such members who were, on June 1, 1934, residing within the present boundaries of any Indian reservation;
(c) All others of one-half or more Indian blood of tribes indigenous to the United States;
(d) Eskimos and other aboriginal people of Alaska; or
(e) Until January 4, 1990, or until the Osage Tribe has formally organized, whichever comes first, a person of at least one-quarter degree Indian ancestry of the Osage Tribe of Indians, whose rolls were closed by an act of Congress.
(a) Preference will be afforded a person meeting any one of the definitions of § 136.41 whether the placement in the position involves initial appointment, reappointment, reinstatement, transfer, reassignment, promotion, or any other personnel action intended to fill a vacancy.
(b) Preference eligibles may be given a schedule A excepted appointment under 5 CFR 213.3116(b)(8). If the individuals are within reach on a Civil Service Register, they may be given a competitive appointment.[64 FR 58321, Oct. 28, 1999. Redesignated and amended at 67 35342, May 17, 2002]
To be considered a preference eligible, the person must submit with the employment application a Bureau of Indian Affairs certification that the person is an Indian as defined by § 136.41 except that an employee of the Indian Health Service who has a certificate of preference eligibility on file in the Official Personnel Folder is not required to resubmit such proof but may instead include a statement on the application that proof of eligibility is on file in the Official Personnel Folder.
Sec. 1, 42 Stat. 208, (25 U.S.C. 13); sec. 1, Stat. 674, (42 U.S.C. 2001); sec. 3, 68 Stat. 674, (42 U.S.C. 2003).
This subpart is applicable to the use of Federal funds in providing health services to Indians in accordance with the provisions of subparts A, B, and C of this part.
As used in this subpart:
Federal funds may not be used to pay for or otherwise provide for abortions in the programs described in § 136.51, except under the circumstances described in § 136.54.
Federal funds are available for an abortion when a physician has found and so certified in writing to the appropriate tribal or other contracting organization, or Service Unit or Area Director, that “on the basis of my professional judgment the life of the mother would be endangered if the fetus were carried to term.” The certification must contain the name and address of the patient.
Federal funds are available for drugs or devices to prevent implantation of the fertilized ovum, and for medical procedures necessary for the termination of an ectopic pregnancy.
Documents required by § 136.54 must be maintained for three years pursuant to the retention and custodial requirements for records at 45 CFR part 74, subpart C.[64 FR 58322, Oct. 28, 1999. Redesignated and amended at 67 35342, May 17, 2002]
Information which is acquired in connection with the requirements of this subpart may not be disclosed in a form which permits the identification of an individual without the individual's consent, except as may be necessary for the health of the individual or as may be necessary for the Secretary to monitor Indian Health Service program activities. In any event, any disclosure shall be subject to appropriate safeguards which will minimize the likelihood of disclosures of personal information in identifiable form.
(a) The Indian Health Service is the payor of last resort for persons defined as eligible for contract health services under the regulations in this part, notwithstanding any State or local law or regulation to the contrary.
(b) Accordingly, the Indian Health Service will not be responsible for or authorize payment for contract health services to the extent that:
(1) The Indian is eligible for alternate resources, as defined in paragraph (c) of this section, or
(2) The Indian would be eligible for alternate resources if he or she were to apply for them, or
(3) The Indian would be eligible for alternate resources under State or local law or regulation but for the Indian's eligibility for contract health services, or other health services, from the Indian Health Service or Indian Health Service funded programs.
(c)
Secs. 104, 107, 25 U.S.C. 450h(b), 450k; Sec. 3, Pub. L. 83-568, 42 U.S.C. 2003.
The regulations of this subpart are applicable to grants awarded pursuant to section 104(b) of Pub. L. 93-638, 25 U.S.C. 450h(b) for (a) projects for development including feasibility studies, construction, operation, provision, or maintenance of services and facilities provided to Indians and, (b) for projects for planning, training, evaluation or other activities designed to improve the capacity of a tribal organization to enter into a contract or contracts pursuant to section 103 of the Act. Such grants may include the cost of training personnel to perform grant related activities.
As used in this subpart:
(a)
(b)
(c)
(d)
(1) The recognized governing body of any Indian tribe; or
(2) Any legally established organization of Indians which is:
(i) Controlled, sanctioned or chartered by such governing body or bodies; or
(ii) Democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities.
(e)
(f)
(g)
Any Indian tribe or tribal organization is eligible to apply for a grant under this subpart.
(a) Forms for applying for grants are governed by 45 CFR part 74, subpart N.
(b) In addition to such other pertinent information as the Secretary may require, the application for a grant under this subpart shall contain the following:
(1) A description of the applicant including an indication whether the applicant is a Tribe or tribal organization, and if the latter:
(i) The legal and organizational relationship of the applicant to the Indians in the Area to be served or effected by the project.
(ii) A description of the current and proposed participation of Indians in the activities of applicant.
(iii) Whether applicant is controlled, sanctioned or chartered by the governing body of the Indians to be served, and if so, evidence of such fact.
(iv) If elected, a description of the election process, voting criteria, and extent of voter participation in the election designating the organization.
(2) A narrative description of the project including its goals and objectives and the manner in which the proposed project is compatible with published Indian Health Service statements of availability of funds, the manner in which those goals and objectives are to be attained, and a work and time schedule which will be utilized to accomplish each goal and objective.
(3) A description of applicant's staff, present or proposed, including their qualifications, academic training, responsibilities and functions.
(4) A description of the manner in which the staff is or will be organized and supervised to carry out proposed activities.
(5) A description of training to be provided as part of the proposed proj-ect.
(6) A description of the administrative, managerial, and organizational arrangements and resources to be utilized to conduct the proposed project.
(7) An itemized budget for the budget period (normally 12 months) for which support is sought and justification of the amount of grant funds requested.
(8) The intended financial participation, if any, of the applicant, specifying the type of contributions such as cash or services, loans of full or part-time staff, equipment, space materials or facilities, or other contributions.
(9) Where health services are to be provided, a description of the nature of the services to be provided and the population to be served.
(10) A description of the Federal property, real and personal, equipment,
(c) The application shall contain assurances satisfactory to the Secretary that the applicant will:
(1) Where applicant is providing services, provide such services at a level and range which is not less than that provided by the Indian Health Service or that identified by the Service after negotiation with the applicant, as an appropriate level, range and standard of care.
(2) Where providing services, provide services in accordance with law and applicable Indian Health Service policies and regulations.
(3) Where providing services, provide services in a fair and uniform manner, consistent with medical need, to all Indian people.
A project supported under this subpart must:
(a) Have sufficient, adequately trained staff in relation to the scope of the project.
(b) Maintain a mechanism for dealing with complaints regarding the delivery of health services or performance of project activities.
(c) Hold confidential all information obtained by the personnel of the proj-ect from participants in the project related to their examination, care, and treatment, and shall not release such information without the individuals' consent except as may be required by law, as may be necessary to provide service to the individual, or as may be necessary to monitor the operations of this program or otherwise protect the public health. Information may be disclosed in a form which does not identify particular individuals.
(d) Operate with the approval, support, and involvement of the tribe, tribes, or Indian communities in the area served by the local facility and program.
(e) Keep in force adequate liability insurance in accordance with the approved application unless the Secretary, for good cause shown, has determined that such insurance was not obtainable or appropriate or has determined that such insurance may be permitted to expire or lapse. The insurance shall provide that prior to cancellation the Secretary must be notified and must further provide that for each such policy of insurance the carrier shall waive any right it may have to raise as a defense the tribe's sovereign immunity from suit but such waiver shall extend only to claims the amount and nature of which are within the coverage and limits of the policy and shall not authorize or empower the insurance carrier to waive or otherwise limit the tribe's sovereign immunity outside or beyond the coverage and limits of the policy of insurance.
This provision is excepted from application of 45 CFR 74.15 by section 103(c) of Pub. L. 93-638.
(f) Provide services at a level and range which is not less than that provided by the Indian Health Service or that identified by the Service as an appropriate level, range, and standard of care.
(a) Within the limits of funds determined by the Secretary to be available for such purpose, the Secretary may award grants under this subpart to applicants whose project will, in the judgment of the Secretary, best promote the purposes of the Act, and the regulations of this subpart, taking into account:
(1) The apparent capability of the applicant to organize and manage the proposed project successfully considering, among other things the adequacy of staff, management systems, equipment and facilities.
(2) The soundness of the applicant's plan for conducting the project and for assuring effective utilization of grant funds.
(3) The adequacy of the budget in relation to the scope of the project and available funds.
(4) The relative effectiveness of the applicant's plan, as set forth in the application, to carry out each of the requirements § 136.105.
(5) The compatibility of the proposed project with the published goals and responsibilities of the IHS in carrying out its statutory mission.
(b) The Notice of Grant Awards specifies how long the Secretary intends to support the project period without requiring the project to re-compete for funds. This period, called the project period, will usually be for one to two years. The total project period comprises the original project period and any extension. Generally the grant will be for a one-year budget period, any subsequent award will also be a one-year budget period. A grantee must submit a separate application for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, awards require a determination by the Secretary that funding is in the best interest of the Federal Government.
(c) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation or other award with respect to any approved application or portion of an approved application.
(a) A grantee shall only spend funds it receives under this subpart according to the approved application and budget, the regulations of this subpart, the terms and conditions of the award and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.
(b) The provisions of any other Act notwithstanding, any funds made available to a tribal organization under grants pursuant to section 104(b) of the Act may be used as matching shares for any other Federal grant programs which contribute to the purposes for which grants under this section are made.
This provision is excepted from application of 45 CFR 74.53 by section 104(c) of Pub. L. 93-638.
The Secretary will from time to time publish a notice in the
In addition to other requirements of this subpart:
(a) An applicant for a construction grant to build, renovate, modernize, or remodel a hospital, clinic, health station or quarters for housing personnel associated with such facilities, must in its application:
(1) Provide its assessment of the environmental impact of the project as called for by section 102(2)(c) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(c)).
(2) Furnish its evaluation of the proj-ect site in accordance with the terms and conditions of E.O. 11296, 31 FR 10663 (August 10, 1966) relating to the evaluation of flood hazards in locating federally owned or financed facilities.
(b) The following requirements are applicable to each construction grant to build, renovate, modernize, or remodel a hospital, clinic, health station or quarters for housing personnel associated with such facilities.
(1) Competitive bids. The approval of the Secretary shall be obtained before the project is advertised or placed on the market for bidding. The approval shall include a determination by the Secretary that the final plan and specifications conform to the minimum standards of construction and equipment specified in the grant award or in
(2) There will be no preference given to local contractors or suppliers over non-local contractors or suppliers, except as otherwise provided in these regulations.
(3) Construction contracts and subcontracts under this program are subject to the Davis-Bacon Act (40 U.S.C. 276a et seq.). For requirements that grantees must observe for enforcing compliance by contractors and subcontractors, see the section on contract provisions in the procurement standards for HHS grantees made applicable by subpart P of 45 CFR part 74.
(4) Minimum standards of construction and equipment. The plans and specifications for the project will conform to the minimum standards of construction and equipment specified in the grant award or in HHS documents specified in the grant award.
(5) The following provision must be included in all construction contracts let by the grantee: “The Secretary of the Department of Health and Human Services shall have access at all reasonable times to work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.”
Tribes and Tribal organizations shall not be held accountable for interest earned on grant funds, pending disbursement by such organization.
This provision is excepted from application of 45 CFR 74.47(a) by section 106(b) of Pub. L. 93-638.
The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of public health, or the conservation of grant funds.
Services provided pursuant to a grant under this subpart shall be provided by the Grantee in a fair and uniform manner to all participants in the project consistent with their medical need, the policies and regulations of the Indian Health Service, and the Act.
Several other regulations apply to grants under this subpart. These include to the extent applicable but are not limited to:
To the extent they provide special benefits to Indians, grants under this subpart are exempted from the requirements of section 601 of the Civil Rights Act of 1964 [42 U.S.C. 200d], prohibiting discrimination on the basis of race, color or national origin, by regulation at 45 CFR 80.3(d) which provides, with respect to Indian health services, that, “An individual shall not be deemed subjected to discrimination by reasons of his exclusion from the benefits of a program limited by Federal law to individuals of a particular race, color, or national origin different from his.
(a) When the Secretary determines that the performance of a grantee under these regulations involves (1) the violation of the rights or endangerment of the health, safety, or welfare of any persons, or (2) gross negligence or the mismanagement in the handling or use of funds under the grant, the Secretary will, in writing,
(b) When the Secretary determines that a grantee has not taken corrective action (as prescribed by him under paragraph (a) of this section) to his satisfaction, he may, after providing the grantee an opportunity for a hearing in accordance with paragraph (c) of this section, rescind the grant in whole or in part and if he deems it appropriate, assume or resume control or operation of the program, activity, or service involved.
(c) When the Secretary has made a determination described in paragraph (b) of this section, he shall in writing notify the grantee of such determination and of the grantee's right to request a review of such determination (and of the determination described in paragraph (a) of this section) under the Public Health Service Grant Appeals Procedure (42 CFR part 50, subpart D). Such notification by the Secretary shall set forth the reasons for the determination in sufficient detail to enable the grantee to respond and shall inform the grantee of its opportunity for review under such subpart D. If the review held under subpart D results in a response adverse to the grantee's position, the grantee shall be informed of its right to have a hearing before the Department Grant Appeals Board, pursuant to 45 CFR part 16.
(d) Where the Secretary determines that a grantee's performance under a grant awarded under this subpart poses an immediate threat to the safety of any person, he may immediately rescind the grant in whole or in part and if he deems it appropriate, assume or resume control or operation of the program, activity, or service involved. Upon such recission he will immediately notify the grantee of such action and the basis or reasons therefor; and offer the grantee an opportunity for a hearing to be held within 10 days of such action. If the grantee requests such a hearing, the Secretary will designate three officers or employees of the Department to serve as a hearing panel. No officer or employee from the immediate office of the official who made the decision to rescind the grant under this paragraph may be designated to serve on the hearing panel.
(1) The hearing shall be commenced within 10 days after the recission of the grant, shall be held on the record and shall afford the grantee the right:
(i) To notice of the issues to be considered;
(ii) To be represented by counsel;
(iii) To present witnesses on grantee's behalf; and
(iv) To cross-examine other witnesses either orally or through written interrogatories.
(2) The hearing panel shall, within 25 days after the conclusion of the hearing, notify all parties in writing of its decision.
(3) Such decision shall not be subject to further hearing under 42 CFR part 50, subpart D or 45 CFR part 16.
(e) In any case where the Secretary has rescinded a grant under paragraph (b) or (d) of this section, he may decline to enter into a new grant agreement with the grantee until such time as he is satisfied that the basis for the recission has been corrected. Nothing in this section shall be construed as contravening the Occupational Safety and Health Act of 1970 (84 Stat. 1590), as amended (29 U.S.C. 651).
(f) In any case where the Secretary has rescinded a grant for the delivery of health services under this subpart, the grantee shall, upon the request of the Secretary, transfer to the Secretary all medical records compiled in the operation of the supported proj-ect.
This section is an exception to 45 CFR part 74, subpart M required by section 109 of Pub. L. 93-638.
In addition to the reporting and information requirements provided in subpart J of 45 CFR part 74 made applicable to grants under this subpart by § 136.114, each recipient of Federal financial assistance shall make such reports and information available to the Indian people served or represented by such recipient as and in a manner determined by the Secretary to be adequate.
This section is a requirement in addition to 45 CFR part 74 and is required by section 5(c) of Pub. L. 93-638.
Before revising or amending the regulations in this subpart, the Secretary shall take the following actions:
(a) Consult with Indian Tribes and national and regional Indian organizations to the extent practicable about the need for revision or amendment and consider their views in preparing the proposed revision or amendment.
(b) Present the proposed revision or amendment to the Committees on Interior and Insular Affairs of the United States Senate and House of Representatives.
(c) Publish the proposed revisions or amendments in the
(d) After consideration of all comments received, publish the regulations in the
The regulations in this part are not meant to and do not:
(a) Affect, modify, diminish, or otherwise impair the sovereign immunity from suit enjoyed by an Indian tribe;
(b) Authorize, require or permit the termination of any existing trust responsibility of the United States with respect to the Indian people;
(c) Permit significant reduction in services to Indian people as a result of this subpart.
Section 6 of Pub. L. 93-638, 25 U.S.C. 450(d) provides:
Whoever, being an officer, director, agent, or employee of, or connected in any capacity with, any recipient of a contract, subcontract, grant, or subgrant pursuant to this Act or the Act of April 16, 1934 (48 Stat. 596), as amended, embezzles, willfully misapplies, steals, or obtains by fraud any of the money, funds, assets, or property which are the subject of such a grant, subgrant, contract, or subcontract, shall be fined not more than $10,000 or imprisoned for not more than two years, or both, but if the amount so embezzled, misapplied, stolen, or obtained by fraud does not exceed $100, he shall be fined not more than $1,000 or imprisoned not more than one year, or both.
Grants awarded pursuant to this subpart will incorporate the following:
Use of Indian business concerns.
(a) As used in this clause, the term “Indian organizations of an Indian-owned economic enterprise” as defined in section 102(g) of this subpart.
(b) The grantee agrees to give preference to qualified Indian business concerns in the awarding of any contracts, subcontracts or subgrants entered into under the grant consistent with the efficient performance of the grant. The grantee shall comply with any preference requirements regarding Indian business concerns established by the tribe(s) receiving services under the grant to the extent that such requirements are consistent with the purpose and intent of this paragraph.
This section is an exception to 45 CFR part 74, required by section 7(b) of Pub. L. 93-638.
(a) Any grant made under this subpart, or a contract or subgrant made under such a grant shall require that, to the greatest extent feasible preferences and opportunities for training and employment in connection with the administration of such grant, or contract or subgrant made under such grant, shall be given to Indians.
(b) The grantee shall include the requirements of paragraph (a) of this section in all contracts and subgrants made under a grant awarded under this subpart.
Secs. 102, 103, 106, 502, 702, and 704 of Pub. L. 94-437 (25 U.S.C. 1612, 1613, 1615,
(a)
(2) The regulations of this subpart are intended to be consistent with principles of Indian self-determination and to supplement the responsibilities of the Indian Health Sevice for Indian health manpower planning and for assisting Indian tribes and tribal organizations in the development of Indian manpower programs.
(b)
(1) The award of health professions recruitment grants under section 102 of the Act to recruit Indians into the health professions (Subdivision J-2);
(2) The award of preparatory scholarship grants and pregraduate scholarship grants under section 103 of the Act, as amended, to Indians undertaking compensatory and preprofessional education (Subdivisions J-3 and J-8);
(3) The award of Indian Health Scholarship grants pursuant to section 338G of the Public Health Service Act (42 U.S.C. 254r) to Indian or other students in health professions schools (Subdivision J-4):
(4) The provision of continuing education allowances to health professionals employed by the Service under section 106 of the Act (Subdivision J-5);
(5) Contracts with urban Indian organizations under section 502 of the Act to establish programs in urban areas to make health services more accessible to the urban Indian population (Subdivision J-6); and
(6) Leases with Indian tribes under section 704 of the Act (Subdivision J-7).
As used in this subpart: (a)
(b)
(c) [Reserved]
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l) [Reserved]
(m)
(1) Which provides, or can provide, programs of education leading to a certificate, or to an associate or baccalaureate degree (or the equivalent or either), or to a higher degree for preparing personnel with responsibilities for supporting, complementing, or supplementing the professional functions of physicians, dentists, and other health professionals in the delivery of health care to patients or assisting environmental engineers and others in environmental health control and preventive medicine activities.
(2) Which, if in a college or univerisity which does not include a teaching hospital or in a junior college, is affiliated through a written agreement with one or more hospitals which provide the hospital component of the clinical training required for completion of such programs of education. The written agreement shall be executed by individuals authorized to act for their respective institutions and to assume on behalf of their institution the obligations imposed by such agreement. The agreement shall provide:
(i) A description of the responsibilities of the school of allied health professions, the responsibilities of the hospital, and their joint responsibilities with respect to the clinical components of such programs of education; and
(ii) A description of the procedure by which the school of allied health professions and the hospital will coordinate the academic and clinical training of students in such programs of education; and
(iii) That, with respect to the clinical component of each such program of education, the teaching plan and resources have been jointly examined and approved by the appropriate faculty of the school of allied health professions and the staff of the hospital.
(3) Which is accredited or assured accreditation by a recognized body or bodies approved for such purpose by the Commissioner of Education of the Department of Health and Human Services.
(n)
(o)
(1) The term
(2) The term
(3) The term
(4) The term
(p)
(q)
(r)
(s)
(t)
(u)
(v)
(1) Is governed by an Indian controlled board of directors:
(2) Has the provision of health programs as:
(i) Its principal function, or
(ii) One of its major functions and such health progams are administered by a distinct organizational unit within the organization.
(3) Provides for the maximum participation of all interested Indian groups and individuals; and
(4) Is capable of legally cooperating with other public and private entities for the purpose of performing the activities described in § 36.350(a) of Subdivision J-6 of this subpart. Except,
(a) For purposes of scholarship grants under Subdivisions J-3 and J-4 of this subpart, Indian applicants must submit evidence of their tribal membership (or other evidence that that applicant is an Indian as defined in paragraph (h) of § 136.302 of this subdivision) satisfactory to the Secretary.
(b) Where an applicant is a member of a tribe recognized by the Secretary of the Interior, the applicant must submit evidence of his or her tribal membership, such as:
(1) Certification of tribal enrollment by the Secretary of the Interior acting through the Bureau of Indian Affairs (BIA); or
(2) In the absence of such BIA certification, documentation that the applicant meets the requirements of tribal membership as prescribed by the charter, articles of incorporation or other legal instrument of the tribe and has been officially designated a tribal member by an authorized tribal official; or
(3) Other evidence of tribal membership satisfactory to the Secretary.
(c) Where the applicant is a member of a tribe terminated since 1940 or a State recognized tribe, the applicant must submit documentation that the applicant meets the requirements of tribal membership as prescribed by the charter, articles of incorporation or other legal instrument of the tribe and has been officially designated a tribal member by an authorized tribal official; or other evidence, satisfactory to the Secretary, that the applicant is a member of the tribe. In addition, if the terminated or State recognized tribe of which the applicant is a member is not on a list of such tribes published by the Secretary in the
(d) An applicant who is not a tribal member, but who is a natural child or grandchild of a tribal member as defined in paragraph (h) of § 36.302 of this subdivision must submit evidence of such fact which is satisfactory to the Secretary, in addition to evidence of his or her parent's or grandparent's tribal membership in accordance with paragraphs (b) and (c) of this section.
The Secretary, acting through the Service, shall publish from time to time in the
The Secretary may, with respect to any grant award under this subpart, impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of the public health, or the conservation of grant funds.
Grants awarded under this subdivision, in accordance with section 102 of the Act, are for the purpose of assisting in meeting the costs of projects to:
(a) Identify Indians with a potential for education or training in the health professions and encouraging and assisting them (1) To enroll in schools of medicine, osteopathy, dentistry, veterinary medicine, optometry, podiatry, pharmacy, public health, nursing, or allied health professions; or (2), if they are not qualified to enroll in any such school, to undertake such post-secondary education or training as may be required to qualify them for enrollment;
(b) Publicize existing sources of financial aid available to Indians enrolled in any school referred to in paragraph (a)(1) of this section or who are undertaking training necessary to qualify them to enroll in any such school; or
(c) Establish other programs which the Secretary determines will enhance and facilitate the enrollment of Indians, and the subsequent pursuit and completion by them of courses of study, in any school referred to in paragraph (a)(1) of this section.
Any Indian tribe, tribal organization, urban Indian organization, Indian health organization or any public or other nonprofit private health or educational entity is eligible to apply for a health professions recruitment grant under this subdivision.
(a) Forms for applying for grants are governed by 45 CFR part 74, subpart N.
(b) In addition to such other pertinent information as the Secretary may require, the application for a health professions recruitment grant shall contain the following:
(1) A description of the legal status and organization of the applicant;
(2) A description of the current and proposed participation of Indians (if any) in the applicant's organization.
(3) A description of the target Indian population to be served by the proposed project and the relationship of the applicant to that population;
(4) A narrative description of the nature, duration, purpose, need for and scope of the proposed project and of the manner in which the applicant intends to conduct the project including:
(i) Specific measurable objectives for the proposed project;
(ii) How the described objectives are consistent with the purposes of section 102 of the Act;
(iii) The work and time schedules which will be used to accomplish each of the objectives;
(iv) A description of the administrative, managerial, and organizational arrangements and the facilities and resources to be utilized to conduct the proposed project;
(v) The name and qualifications of the project director or other individual responsible for the conduct of the project; the qualifications of the prinicipal staff carrying out the project; and a description of the manner in which the applicant's staff is or will be organized and supervised to carry out the proposed project;
(5) An itemized budget for the budget period (normally 12 months) for which support is sought and justification of the amount of grant funds requested:
(6) The intended financial participation, if any, of the applicant in the proposed project specifying the type of contributions such as cash or services, loans of full or part-time staff, equipment, space, materials or facilities or other contributions;
(7) When the target population of a proposed project includes a particular Indian tribe or tribes, an official document in such form as is prescribed by the tribal governing body of each such tribe indicating that the tribe or tribes will cooperate with the applicant.
(c) In the case of proposed projects for identification of Indians with a potential for education or training in the
(1) Identifying Indian elementary and secondary school students through observations, aptitude or other testing, academic performance, performance in special projects and activities, and other methods as may be designed or developed;
(2) Identifying Indians in college or university programs, related employment, upward mobility programs or other areas of activity indicative of interest and potential;
(3) Review of the upward mobility plans, skills, banks etc. of organizations employing Indians to identify individuals with appropriate career orientations, expression of interest, or recognized potential;
(4) Conducting workshops, health career days, orientation projects or other activities to identify interested Indians at any age level;
(5) Performing liaison activities with Indian professional organizations, Indian education programs (including adult education), Indian school boards, Indian parent, youth recreation or community groups, or other Indian special interest or activity groups;
(6) Identifying those Indians with an interest and potential who cannot undertake compensatory education or training in the health professions because of financial need.
(d) Proposed projects designed to encourage and assist Indians to enroll in health professions schools; or, if not qualified to enroll, to undertake postsecondary education or training required to qualify them for enrollment may include, but are not limited to, the following activities:
(1) Providing technical assistance and counseling to encourage and assist Indians identified as having a potential for education or training in the health professions—
(i) To enroll in health professions schools.
(ii) To undertake any post-secondary education and training required to qualify them to enroll in health professions schools, and
(iii) To obtain financial aid to enable them to enroll in health professions schools or undertake post-secondary education or training required to qualify them to enroll in such schools;
(2) Conducting programs to (i) identify factors such as deficiencies in basic communication, research, academic subject matter (such as science, mathematics, etc.), or other skills which may prevent or discourage Indians from enrolling in health professions schools or undertaking the post-secondary education or training required to qualify them to enroll, and (ii) provide counseling and technical assistance to Indians to assist them in undertaking the necessary education, training or other activities to overcome such factors.
(e) Proposed projects to publicize existing kinds of financial aid available to Indians enrolled in health professions schools or to Indians undertaking training necessary to qualify them to enroll in such schools may include, but are not limited to, the following activities:
(1) Collecting information on available sources of financial aid and disseminating such information to Indian students, Indians, recruited under programs assisted by grants under this subdivision and to Indian tribes, tribal organizations, urban Indian organizations, Indian health organizations and other interested groups and communities throughout the United States;
(2) Providing information on available sources of financial aid which can be utilized by programs and counselors assisting Indians to obtain financial aid.
(f) Proposed projects for establishment of other programs which will enhance or facilitate enrollment of Indians in health professions schools and the subsequent pursuit and completion by them of courses of study in such schools may include, but are not limited to, the following activities:
(1) Compilation and dissemination of information on—
(i) Health professions education or training programs and the requirements for enrollment in such programs; and
(ii) Post-secondary education or training curricula and programs designed to qualify persons for enrollment in health professions schools;
(2) Developing and coordinating career orientation programs in local schools (including high schools) and colleges and universites;
(3) Developing programs to enable Indians to gain exposure to the health professions such as arranging for (i) visits to health care facilities and programs and meetings or seminars with health professionals, (ii) part-time summer or rotating employment in health care facilities, programs, or offices of health professionals, (iii) volunteer programs, or (iv) other means of providing such exposure;
(4) Developing programs which relate tribal culture and tradition, including native medicine, to careers in the health professions; and
(5) Developing programs to make Indians aware of projected health manpower needs, expected employment opportunities in the health professions, and other factors in order to orient and motivate Indians to pursue careers in the health professions.
(a) Within the limits of funds available for such purpose, the Secretary, acting through the Service, may award health professions recruitment grants to those eligible applicants whose proposed projects will in his judgment best promote the purposes of section 102 of the Act, taking into consideration:
(1) The potential effectiveness of the proposed project in carrying out such purposes;
(2) The capability of the applicant to successfully conduct the project;
(3) The accessibility of the applicant to target Indian communities or tribes, including evidence of past or potential cooperation between the applicant and such communities or tribes;
(4) The relationship of project objectives to known or anticipated Indian health manpower deficiencies;
(5) The soundness of the fiscal plan for assuring effective utilization of grant funds;
(6) The completeness of the application.
(b) Preference shall be given to applicants in the following order or priority: (1) Indian tribes, (2) tribal organizations, (3) urban Indian organizations and other Indian health organizations, and (4) public and other nonprofit profit private health or educational entities.
(c) The Notice of Grant Awards specifies how long the Secretary intends to support the project period without requiring the project to re-compete for funds. This period, called the project period, will usually be for one to two years. The total project period comprises the original project period and any extension. Generally the grant will be for a one year budget period, any subsequent award will also be a one year budget period. A grantee must submit a separate application for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, awards require a determination by the Secretary that funding is in the best interest of the Federal Government.
(d) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.
A grantee shall only spend funds it receives under this subpart according to the approved application and budget, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.
The Secretary acting through the Service shall publish annually in the
(a) The organization's name and address;
(b) The amount of the grant;
(c) A summary of the project's purposes and its geographic location.
Several other regulations apply to grants under this subdivision. These include but are not limited to:
Scholarship grants may be awarded under this subdivision and section 103 of the act for the period (not to exceed two academic years) necessary to complete a recipient's compensatory preprofessional education to enable the recipient to qualify for enrollment or re-enrollment in a health professions school. Examples of individuals eligible for such grants are the individual who:
(a) Has completed high school equivalency and needs compensatory preprofessional education to enroll in a health professions school;
(b) Has a baccalaureate degree and needs compensatory preprofessional education to qualify for enrollment in a health professions school; or
(c) Has been enrolled in a health professions school but is no longer so enrolled and needs preprofessional education to qualify for readmission to a health professions school.
To be eligible for a preparatory scholarship grant under this subdivision an applicant must:
(a) Be an Indian;
(b) Have successfully completed high school education or high school equivalency;
(c) Have demonstrated to the satisfaction of the Secretary the desire and capability to successfully complete courses of study in a health professions school;
(d) Be accepted for enrollment in or be enrolled in any compensatory preprofessional education course or curriculum meeting the criteria in § 136.320 of this subdivision; and
(e) Be a citizen of the United States.
(a) An application for a preparatory scholarship grant under this subdivision shall be submitted in such form and at such time as the Secretary acting through the Service may prescribe.
(1) The health profession which the applicant wishes to enter, and
(2) Whether the applicant intends to provide health services to Indians upon completion of health professions education or training by serving as described in § 136.332 or otherwise as indicated on the application.
(b) Within the limits of funds available for the purpose, the Secretary, acting through the Service, shall make scholarship grant awards for a period not to exceed two academic years of an individual's compensatory preprofessional education to eligible applicants taking into consideration:
(1) Academic performance;
(2) Work experience;
(3) Faculty recommendations;
(4) Stated reasons for asking for the scholarship; and
(5) The relative needs of the Service and Indian health organizations for persons in specific health professions.
(a) Scholarship grant awards under this subdivision shall consist of:
(1) A stipend of $400 per month adjusted in accordance with paragraph (c) of this section; and
(2) An amount determined by the Secretary for transportation, tuition, fees, books, laboratory expenses, and other necessary educational expenses.
(b) The portion of the scholarship for the costs of tuition and fees as indicated in the grant award will be paid directly to the school upon receipt of an invoice from the school. The stipend and remainder of the scholarship grant award will be paid monthly to the grantee under the conditions specified in the grant award.
(c) The amount of the monthly stipend specified in paragraph (a)(1) of this section shall be adjusted by the Secretary for each academic year ending in a fiscal year beginning after September 30, 1978, by an amount (rounded down to the next lowest multiple of $1) equal to the amount of such stipend multiplied by the overall percentage (as set forth in the report transmitted to the Congress under section 5305 of title 5, United States Code) of the adjustment in the rates of pay under the General Schedule made effective in the fiscal year in which such academic year ends.
The Indian Health Service will provide to any persons requesting it a list of the recipients of scholarship grants under this subdivision, including the school attended and tribal affiliation of each recipient.
Indian Health Scholarships will be awarded by the Secretary pursuant to 338A through 339G of the Public Health Service Act, and such implementing regulations as may be promulgated by the Secretary except as set out in this subdivision for the purpose of providing scholarships to Indian and other students at health professions schools in order to obtain health professionals to serve Indians.
(a) The Secretary, acting through the Service, shall determine the individuals who receive Indian Health Scholarships.
(b) Priority shall be given to applicants who are Indians.
The service obligation provided in section 338G(b)(2) of the Public Health Service Act shall be met by the recipient of an Indian Health Scholarship by service in:
(a) The Indian Health Service.
(b) An urban Indian organization assisted under Subdivision J-6.
(c) In private practice of his or her profession if, the practice (1) is situated in a health manpower shortage area, designated under section 332 of the Public Health Service Act and (2) addresses the health care needs of a substantial number of Indians as determined by the Secretary in accordance with guidelines of the Service.
The Secretary, acting through the Service, shall determine the distribution of Indian Health Scholarships among the health professions based upon the relative needs of Indians for additional service in specific health professions. In making that determination the needs of the Service will be
(a) The professional goals of recipients of scholarships under section 103 of the Indian Health Care Improvement Act; and
(b) The professional areas of study of Indian applicants.
The Secretary, acting through the Service, will publish annually in the
In order to encourage physicians, dentists and other health professionals to join or continue in the Service and to provide their services in the rural and remote areas where a significant portion of the Indian people reside, the Secretary, acting through the Service, may provide allowances to health professionals, employed in the Service in order to enable them to leave their duty stations for not to exceed 480 hours of professional consultation and refresher training courses in any one year.
(a) The Secretary, acting through the Service, to the extent that funds are available for the purpose, shall contract with urban Indian organizations selected under § 36.351 of this subdivision to carry out the following activities in the urban centers where such organizations are situated:
(1) Determine the population of urban Indians which are or could be recipients of health referral or care services;
(2) Identify all public and private health service resources within the urban center in which the organization is situated which are or may be available to urban Indians;
(3) Assist such resources in providing service to such urban Indians;
(4) Assist such urban Indians in becoming familiar with and utilizing such resources;
(5) Provide basic health education to such urban Indians;
(6) Establish and implement manpower training programs to accomplish the referral and education tasks set forth in paragraphs (a)(3) through (5) of this section;
(7) Identify gaps between unmet health needs of urban Indians and the resources available to meet such needs;
(8) Make recommendations to the Secretary and Federal, State, local, and other resource agencies on methods of improving health service programs to meet the needs of urban Indians; and
(9) Prove or contract for health care services to urban Indians where local health delivery resources are not available, not accessible, or not acceptable to the urban Indians to be served.
(b) Contracts with urban Indian organizations pursuant to this title shall be in accordance with all Federal contracting laws and regulations except that, in the discretion of the Secretary, such contracts may be negotiated without advertising and need not conform to the provisions of the Act of August 24, 1935 as amended, (The Miller Act, 40 U.S.C. 270a
(c) Payments under contracts may be made in advance or by way of reimbursement and in such installments and on such conditions as the Secretary deems necessary to carry out the purposes of title V of the Act.
(d) Notwithstanding any provision of law to the contrary, the Secretary may, at the request or consent of an urban Indian organization, revise or amend any contract made by him with such organization pursuant to this subdivision as necessary to carry out the purposes of title V of this Act: Provided, however, that whenever an urban Indian organization requests retrocession of the Secretary for any such contract, retrocession shall become effective upon a date specified by the Secretary not more than one hundred and twenty days from the date of the request by the organization or at such
(e) In connection with any contract made pursuant to this subdivision, the Secretary may permit an urban Indian organization to utilize, in carrying out such contract, existing facilities owned by the Federal Government within his jurisdiction under such terms and conditions as may be agreed upon for their use and maintenance.
(a) Proposals for contracts under this subdivision shall be submitted in such form and manner and at such time as the Secretary acting through the Service may prescribe.
(b) The Secretary, acting through the Service shall select urban Indian organizations with which to contract under this subdivision whose proposals will in his judgment best promote the purposes of title V of the Act taking into consideration the following factors:
(1) The extent of the unmet health care needs of the urban Indians in the urban center involved determined on the basis of the latest available statistics on disease incidence and prevalence, life expectancy, infant mortality, dental needs, housing conditions, family income, unemployment statistics, etc.
(2) The urban Indian population which is to receive assistance in the following order of priority:
(i) 9,000 or more;
(ii) 4,500 to 9,000;
(iii) 3,000 to 4,500;
(iv) 1,000 to 3,000;
(v) Under 1,000.
(3) The relative accessibility which the urban Indian population to be served has to health care services, in the urban center. Factors to be considered in determining relative accessibility include:
(i) Cultural barriers;
(ii) Discrimination against Indians;
(iii) Inability to pay for health care;
(iv) Lack of facilities which provide free care to indigent persons;
(v) Lack of state or local health programs;
(vi) Technical barriers created by State and local health agencies;
(vii) Availability of transportation to health care services;
(viii) Distance between Indian residences and the nearest health care facility.
(4) The extent to which required activities under § 136.350(a) of this subdivision would duplicate any previous or current public or private health services projects in the urban center funded by another source. Factors to be considered in determining duplication include:
(i) Urban Indian utilization of existing health services funded by other sources;
(ii) Urban Indian utilization of existing health services delivered by an urban Indian organization funded by other sources.
(5) The appropriateness and likely effectiveness of the activities required in § 136.350(a) of this subdivision in the urban center involved.
(6) The capability of the applicant urban Indian organization to perform satisfactorily the activities required in § 136.350(a) of this subdivision and to contract with the Secretary.
(7) The extent of existing or likely future participation in the activities required in § 136.350(a) of this subdivision by appropriate health and health related Federal, State, local, and other resource agencies.
(8) Whether the city has an existing urban Indian health program.
(9) The applicant organization's record of performance, if any, in regard to any of the activities required in § 136.350(a) of this subdivision.
(10) Letters demonstrating local support for the applicant organization from both the Indian and non-Indian communities in the urban center involved.
Contracts with urban Indian organizations under this subdivision shall incorporate the following clause:
The Contractor agrees, consistent with medical need, and the efficient provision of medical services to make no discriminatory distinctions against
For each fiscal year during which an urban Indian organization receives or expends funds pursuant to a contract under this title, such organization shall submit to the Secretary a report including information gathered pursuant to § 136.350(a) (7) and (8) of this subdivision, information on activities conducted by the organization pursuant to the contract, an accounting of the amounts and purposes for which Federal funds were expended, and such other information as the Secretary may request. The reports and records of the urban Indian organization with respect to such contract shall be subject to audit by the Secretary and the Comptroller General of the United States.
(a) Any land or facilities otherwise authorized to be acquired, constructed, or leased to carry out the purposes of the Act may be leased or subleased from Indian tribes for periods not in excess of twenty years.
(b) Leases entered into pursuant to paragraph (a) shall be subject to the requirements of section 322 of the Economy Act (40 U.S.C. 278a), which limits expenditures for rent and alterations, improvements and repairs on leased buildings.
(a) Pregraduate scholarship grants may be awarded under this subdivision and section 103 of the Act for the period (not to exceed four academic years) necessary to complete a recipient's pregraduate education leading to a baccalaureate degree in a premedicine, preoptometry, predentistry, preosteopathy, preveterinary medicine, or prepodiatry curriculum or equivalent.
(b) Students enrolled in accredited health professional or allied health professional programs which lead to eligibility for licensure, certification, registration or other types of credentials required for the practice of a health or allied health profession are ineligible for scholarships under this subdivision. Examples of health professions and allied health professions that will not be considered for funding include but are not limited to: nursing, audiology, medical technology, dental hygiene, dental technicians, engineering, radiologic technology, dietitian, nutritionist, social work, health education, physical therapy, occupational therapy and pharmacy. Scholarships for students in these programs are provided under Subdivision J-4 of this subpart.
To be eligible for a pregraduate scholarship grant under this subdivison an applicant must:
(a) Be an Indian;
(b) Have successfully completed high school education or high school equivalency;
(c) Have demonstrated to the satisfaction of the Secretary the desire and capability to successfully complete courses of study in a pregraduate education program meeting the criteria in § 136.370;
(d) Be accepted for enrollment in or be enrolled in any accredited pregraduate education curriculum meeting the criteria in § 16.370 of this subdivision; and
(e) Be a citizen of the United States.
(a) An application for a pregraduate scholarship grant under this subdivision shall be submitted in such form and at such time as the Secretary may
(1) The pregraduate program in which the applicant is or wishes to enter, and
(2) Whether the applicant intends to provide health services to Indians upon completion of health professions education or training by serving as described in § 136.332 or otherwise as indicated on the application.
(b) Within the limits of available funds, the Director, IHS, shall make pregraduate scholarship grant awards for a period not to exceed four academic years of an individual's pregraduate education to eligible applicants taking into consideration:
(1) Academic performance;
(2) Work experience;
(3) Faculty or employer recommendation;
(4) Stated reasons for asking for the scholarship; and
(5) The relative needs of the IHS and Indian health organizations for persons in specific health professions.
(a) Scholarship grant awards under this subdivision shall consist of:
(1) A stipend of $400 per month adjusted in accordance with paragraph (c) of this section; and
(2) An amount determined by the Secretary for transportation, tuition, fees, books, laboratory expenses and other necessary educational expenses.
(b) The portion of the scholarship for the costs of tuition and fees as indicated in the grant award will be paid directly to the school upon receipt of an invoice from the school. The stipend and remainder of the scholarship grant award will be paid monthly to the grantee under the conditions specified in the grant award.
(c) The amount of the monthly stipend specified in paragraph (a)(1) of this section shall be adjusted by the Secretary for each academic year ending in a fiscal year beginning after September 30, 1978, by an amount (rounded down to the next lowest multiple of $1) equal to the amount of such stipend multiplied by the overall percentage (as set forth in the report transmitted to the Congress under section 5305 of title 5, United States Code) of the adjustment in the rates of pay under the General Schedule made effective in the fiscal year in which such academic year ends.
The IHS will provide to any person requesting it a list of the recipients of scholarship grants under this subdivision, including the school attended and tribal affiliation of each recipient.
At 67 FR 59467, Sept. 23, 2002, §§ 136.401—136.418 (Subpart K) was added effective November 22, 2002.
(a) The purpose of the regulations in this subpart is to establish minimum standards for Federal employees working in the Indian HealthService (IHS), including standards of character to ensure that individuals having regular contact with or control over Indian children have not been convicted of certain types of crimes as mandated by section 408 of the Indian Child Protection and Family Violence Prevention Act (the “Act”),Public Law (Pub. L.) 101-630, 104 Stat. 4544, 25 U.S.C. 3201-3211, as amended by section 814 of the Native American Laws TechnicalCorrections Act of 2000. In order to implement these minimum standards of character, these regulations also address:
(1) The efficiency standards to ensure that individuals are qualified for the positions they hold or seek, as mandated by Section 408 of the Act.
(2) Fitness standards to ensure child care service employees are fit to have responsibility for the safety and well-being of children, as mandated by Section 231 of the Crime Control Act of 1990, Pub. L. 101-647,42 U.S.C. 13041.
(3) Suitability standards to ensure that individuals have not acted in a manner that places others at risk or raised questions about their trustworthiness, as mandated by 5 CFR part 731.
(b) The Act requires that Tribes or Tribal organizations who receive funds under the Indian Self-Determination and Education Assistance Act(ISDEA), Pub. L. 93-638, employ individuals in positions involving regular contact with or control over Indian children only if the individuals meet standards of character no less stringent than those prescribed under these regulations. Thus, the minimum standards of character as defined in these regulations will become the basis for Tribes or Tribal organizations to use when developing their own minimum standards of character that cannot be less stringent than as prescribed herein.
In enacting the Indian Child Protection and Family Violence Prevention Act, (the “Act”) the Congress recognized there is no resource more vital to the continued existence and integrity of Indian Tribes than their children and that the United States has a direct interest, as trustee, in protecting Indian children who are members of, or are eligible for membership in, an Indian Tribe. The minimum standards of character as prescribed by the regulations in this subpart are intended to ensure that Indian children are protected.
(a) Persons in the competitive or excepted service (including temporary employment), the Commissioned Corps, or the Senior ExecutiveService in the IHS;
(b) Persons who perform service for or under the supervision of the IHS while being permanently assigned to another IHS office or to another organization, such as a Federal agency, State, or Tribe;
(c) Persons who volunteer to perform services in IHS facilities;
(d) Persons who contract with the IHS to perform services in IHS facilities.
(a) The IHS must compile a list of all authorized positions with duties and responsibilities that involve regular contact with or control over Indian children; investigate the character of each individual who is employed or is being considered for employment in such a position; and prescribe minimum standards of character that each individual must meet to be appointed or employed in such positions.
(b) All Indian Tribes or Tribal organizations receiving funds under the authority of the ISDEA must identify those positions that permit regular contact with or control over Indian children; conduct an investigation of the character of each individual who is employed or is being considered for employment in a position that involves regular contact with or control over Indian children; and employ only individuals who meet standards of character that are no less stringent than those prescribed by regulations in this subpart.
The minimum standards of character shall mean a benchmark of moral, ethical, and emotional strengths established by character traits and past conduct to ensure that the individual is competent to complete his/her job without harm to Indian children. In order to protect Indian children, the IHS has established minimum standards of character requiring completion of a satisfactory background investigation that ensures that no individuals who have been found guilty of, or entered a plea of nolo contendere or guilty to, any felonious offense or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact, or prostitution; crimes against persons; or offenses committed against children, are placed in positions involving regular contact with or control over Indian children.
The minimum standards of character shall be considered met only after the individual has been the subject of a satisfactory background investigation. The background investigation shall include a review of:
(a) The individual's trustworthiness, through inquiries with the individual's references and places of employment and education;
(b) A criminal history background check, which includes a fingerprint check through the Criminal Justice Information Services Division of the Federal Bureau of Investigation (FBI), under procedures approved by the FBI, and inquiries to State and Tribal law enforcement agencies for the previous five years of residence listed on the individual's application; and
(c) A determination as to whether the individual has been found guilty of or entered a plea of nolo contendere or guilty to any felonious offense or any of two or more misdemeanor offenses
All convictions or pleas of nolo contendere or guilty to should be considered in making a determination unless a pardon, expungement, set aside or other court order reaches the plea of guilty, plea of nolo contendere, or the finding of guilt.
(a) All Federal employees are subject to suitability criteria contained in 5 CFR part 731 as a condition of employment.
(b) Section 231 of the Crime Control Act of 1990, Pub. L. 101-647, 42U.S.C. 13041, provides that an individual may be disqualified from consideration or continuing employment if such individual has been convicted of a sex crime, an offense involving a child victim or a drug felony, or any other crime if such conviction bears on an individual's fitness to have responsibility for the safety and well-being of children.
(c) Tribes or Tribal organizations may but are not required to apply additional criteria in determining whether an individual is suitable for a position with duties and responsibilities that involve regular contact with or control over Indian children. Any additional suitability criteria established by Tribes or Tribal organizations beyond the minimum standards of character described in § 136.405 and § 136.406 would be determined by each individual Tribe or Tribal organization in accordance with its own personnel policies and procedures.
(a) All positions that allow an individual regular contact with or control over Indian children are subject to a background investigation and determination of eligibility for employment. The IHS has compiled a list of positions within the agency in which the duties and responsibilities could involve regular contact with or control over Indian children. The list will be periodically updated and made available at all IHS Personnel Offices upon request. Positions should be reviewed on a case-by-case basis to determine whether the individual in that position has regular contact with or control over Indian children.
(b) Tribes and Tribal organizations may use the list compiled by the IHS or develop their own procedures to determine within their program those positions that involve regular contact with or control over Indian children.
(a) The IHS must use the Office of Personnel Management (OPM) to conduct background investigations for Federal employees. The IHS must designate qualified security personnel to adjudicate the results of background investigations.
(b) Indian Tribes and Tribal organizations may conduct their own background investigations, contract with private firms, or may request that a Federal or State agency conduct investigations. (FBI criminal history record information, however, may only be received or evaluated by governmental agencies, including Tribes or Tribal organizations as defined in these regulations at § 136.403, and may not be disseminated to private entities.)
Yes, in conducting background investigations and adjudicating eligibility for employment in Tribal positions
(a) Applications for employment with the IHS must include the following questions:
(1) Has the individual been arrested or charged with a crime involving a child? If yes, the individual must provide the date, explanation of the violation, disposition of the arrest or charge, place of occurrence, and the name and address of the police department or court involved.
(2) Has the individual ever been found guilty of, or entered a plea of nolo contendere or guilty to, any felonious or misdemeanor offense, under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact, or prostitution; crimes against persons; or offenses committed against children? If yes, the individual must provide an explanation of the violation, place of occurrence, date and disposition of the court proceeding, and the name and address of the police department or court involved.
(b) The IHS must require that the individual sign, under penalty of perjury, a statement verifying the truth of all information provided in the employment application and acknowledging that knowingly falsifying or concealing a material fact is a felony that may result in fines up to $10,000 or five years imprisonment, or both.
(c) The IHS must inform the individual that a criminal history record check is a condition of employment and require the individual to consent in writing to a criminal history record check.
(a) The IHS must comply with all policies, procedures, criteria, and guidance contained in other appropriate guidelines, such as the OPM policies, procedures, criteria, and guidance. Questions asked in § 136.412 will be added as an addendum to item #16 of the OPM Optional Form 306, “Declaration for Federal Employment.” The information is collected as part of the OPM Optional Form 306 and is safeguarded in accordance withPrivacy Act provisions.
(b) Indian Tribes and Tribal organizations must comply with the privacy requirements of the Federal, State, or other Tribal agency providing the background investigations. Indian Tribes and Tribal organizations may establish their own procedures that safeguard information derived from background investigations.
(a) Adjudication is the process IHS uses to determine eligibility for placement or retention of individuals in positions involving regular contact with Indian children. The adjudication process protects the interests of the employer and the right of applicants and employees. Adjudication requires uniform evaluation to ensure fair and consistent judgment.
(b) Each case is judged on its own merits. All available information, both favorable and unfavorable, should be considered and assessed in terms of accuracy, completeness, relevance, seriousness, overall significance, and how similar cases have been handled in the past.
(c) The adjudicating official who conducts the adjudication must first have been the subject of a favorable background investigation.
(d) Each adjudicating official must be thoroughly familiar with all laws, regulations, and criteria involved in making a determination for eligibility.
(e) The adjudicating official must review the background investigation to determine the character, reputation, and trustworthiness of the individual. At a minimum, the background investigation must:
(1) Review each security investigation form and employment application and compare the information provided.
(2) Review the results of written record searches requested from local law enforcement agencies, former employers, former supervisors, employment references, and schools.
(3) Review the results of the fingerprint charts maintained by the FBI or other law enforcement information maintained by other agencies.
(4) Review any other information obtained through a background investigation, including the results of searches by State human services agencies, the OPM National Agency Check and Inquiries, the OPMSecurity/Suitability Investigations Index, and the Defense Clearance andInvestigations Index.
(5) Determine whether the individual has been found guilty of, or entered a plea of nolo contendere or guilty to, any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law, involving crimes of violence; sexual assault, molestation, exploitation, contact, or prostitution; crimes against persons; or offenses committed against children.
(f) After an opportunity has been afforded the individual to respond, pursuant to § 136.415, and it is adjudicated that the individual has been found guilty of or entered a plea of nolo contendere or guilty to an enumerated offense under paragraph (e)(5) of this section, that individual shall not be placed or retained in a position involving regular contact with or control over Indian children.
(g) For individuals who have been determined to be ineligible for employment in positions having regular contact with or control over Indian children, the IHS may use Federal adjudicative standards to certify that an individual is suitable for employment in a position, if available, that does not involve regular contact with or control over Indian children. The adjudicating official must determine that the individual's prior conduct will not interfere with the performance of duties and will not create a potential risk to the safety and well-being of any Indian children after consideration of the following factors:
(1) The nature and seriousness of the conduct in question.
(2) The recency and circumstances surrounding the conduct in question.
(3) The age of the individual at the time of the incident.
(4) Societal conditions that may have contributed to the nature of the conduct.
(5) The probability that the individual will continue the type of behavior in question.
(6) The individual's commitment to rehabilitation and a change in the behavior in question.
(7) The degree of public trust and the possibility the public would be placed at risk if the individual is appointed to the position.
(a) The individual must be provided an opportunity to explain, deny, or refute unfavorable and incorrect information gathered in an investigation, before the adjudication is final. He/she should receive a written summary of all derogatory information and be informed of the process for explaining, denying, or refuting unfavorable information.
(b) The adjudicating officials must not release the actual background investigative report to an individual. However, they may issue a written summary of the derogatory information.
(c) The individual who is the subject of a background investigation may request, to the extent permissible by law, a copy of the reports from the originating (Federal, State, or other Tribal) agency and challenge the accuracy and completeness of any information maintained by that agency.
(d) The results of an investigation cannot be used for any purpose other than to determine eligibility for employment in a position that involves regular contact with or control over Indian children.
(e) Investigative reports contain information of a highly personal nature and must be maintained confidentially and secured in locked files. Investigative reports must be seen only by those officials who, in performing their official duties, need to know the information contained in the report.
The IHS must deny employment to an individual or dismiss an employee, when the duties and responsibilities of the position the individual person would hold or holds involve regular contact with or control over Indian children, and it has been adjudicated, pursuant to § 136.414 and § 136.415, that the individual has been found guilty of, or entered a plea of guilty or nolo contendere to, any felonious offense, or any of two or more misdemeanor offenses, under Federal, State or Tribal law involving a crime of violence; sexual assault, molestation, exploitation, contact, or prostitution; crimes against persons; or offenses committed against children. The IHS has the discretion to place such an individual in a position, if available, that does not involve regular contact with or control over Indian children, if a determination has been made that such placement would not put Indian children at risk and the individual would be able to perform the duties and responsibilities of this position.
Pursuant to section 231 of the Crime Control Act of 1990, Pub. L. 101-647, 42 U.S.C. 13041, as amended by Pub. L. 102-190, the IHS may hire provisionally individuals as defined in these regulations, prior to the completion of a background investigation if, at all times prior to receipt of the background investigation during which children are in the care of the individual, the individual is within the sight and under the supervision of a staff person and a satisfactory background investigation has been completed on that staff person.
(a) The IHS may deny the applicant employment until the charge has been resolved.
(b) The IHS may deny the employee any on-the-job contact with children until the charge is resolved.
(c) The IHS may detail or reassign the employee to other duties that do not involve regular contact with children.
(d) The IHS may place the employee on indefinite suspension, in accordance with statutory and regulatory requirements, until the court has disposed of the charge.
Sec. 3, 68 Stat. 674; 42 U.S.C. 2003, 42 Stat. 208, sec. 1, 68 Stat. 674; 25 U.S.C. 13, 42 U.S.C. 2001, unless otherwise noted.
At 64 FR 58318, 58319, Oct. 28, 1999, as corrected at 65 FR 53914, Sept. 6, 2000, Subparts A-G of part 36 were redesignated as part 36a and suspended indefinitely, effective Oct. 28, 1999.
These regulations establish general principles and program requirements for carrying out the Indian health program.
The Service periodically issues administrative instructions to its officers and employees which are primarily found in the Indian Health Service Manual and the Area Office and Program Office supplements. These instructions are operating procedures to assist officers and employees in carrying out their responsibilities, and are not regulations establishing program requirements which are binding upon members of the general public.
As used in this subpart:
(1) Students who are temporarily absent from the Health Service Delivery Area during full time attendance at programs of vocational, technical, or academic education including normal school breaks;
(2) Persons who are temporarily absent from the Health Service Delivery Area for purposes of travel or employment (such as seasonal or migratory workers);
(3) Indian children placed in foster care outside the Health Service Delivery Area by order of a court of competent jurisdiction and who were residents within the Health Service Delivery Area at the time of the court order.
(a)
(b)
(c)
(d)
(a) Subject to the requirements of this subpart, the Indian Health Service will provide direct services at its facilities, and contract health services, as medically indicated, and to the extent that funds and resources allocated to the particular Health Service Delivery Area permit, to persons of Indian or Alaska Native descent who:
(1) Are members of a federally recognized Indian tribe; and
(2) Reside within a Health Service Delivery Area designated under § 36a.15; or
(3) Are not members of a federally recognized Indian tribe but are the natural minor children (18 years old or under) of a member of a Federally recognized tribe and reside within a Health Service Delivery Area designated under § 36a.15.
(b) Subject to the requirements of this subpart, the Indian Health Service will also provide direct services at its facilities and, except where otherwise provided, contract health services, as medically indicated and to the extent that funds and resources allocated to the particular Health Service Delivery Area permit, to people in the circumstances listed below:
(1) To persons who meet the eligibility criteria in paragraph (a) of this section except for the residency requirement, who formerly resided within a Health Service Delivery area designated under § 36a.15, and who present themselves to any Indian Health Service or Indian Health Service funded facility (and to minor children of such persons if the children meet the eligibility criteria in paragraph (a) of this section except for the residency requirement). Contract health services may not be authorized for these individuals;
(2) To a non-Indian woman pregnant with an eligible Indian's child but only during the period of her pregnancy through post-partum (generally about 6 weeks after delivery). In cases where the woman is not married to the eligible Indian under applicable state or
(3) To non-Indian members of an eligible Indian's household if the medical officer in charge determines that the health services are necessary to control acute infectious disease or a public health hazard; and
(4) To an otherwise eligible person for up to 90 days after the person ceases to reside in a Health Service Delivery Area when the Service Unit Director has been notified of the move.
(c) Contract health services will not be authorized when and to the extent that Indian Health Service or Indian Health Service funded facilities are available to provide the needed care. When funds are insufficient to provide the volume of contract health services needed by the service population, the Indian Health Service shall determine service priorities on the basis of medical need.
(d) The Indian Health Service may provide direct services at its facilities on a fee-for-service basis to persons who are not beneficiaries under paragraphs (a) and (b) of this section under a number of authorities including the following:
(1) In emergencies under section 322(b) of the Public Health Service Act, 42 U.S.C. 249(b), and 42 CFR 32.111 of the regulations;
(2) To Public Health Service and other Federal beneficiaries under Economy Act (31 U.S.C. 1535) arrangements to the extent that providing services does not interfere with or restrict the provision of services to Indian and Alaska Native beneficiaries; and
(3) To non-beneficiaries residing within the Health Service Delivery Area when approved by the tribe or tribes located on the reservation but only to the extent that providing services does not interfere with or restrict the provision of services to Indian and Alaska Native beneficiaries.
(a) No payment will be made for medical care and services obtained from non-Service providers or in non-Service facilities unless the applicable requirements of paragraphs (b) and (c) below have been met and a purchase order for the care and services has been issued by the appropriate ordering official to the medical care provider.
(b) In non-emergency cases, a sick or disabled Indian, or an individual or agency acting on behalf of the Indian, or the medical care provider shall, prior to the provision of medical care and services, notify the appropriate ordering official of the need for services and supply information that the ordering official deems necessary to determine the relative medical need for the services and the individual's eligibility. The requirement for notice prior to providing medical care and services under this paragraph may be waived by the ordering official if:
(1) Such notice and information is provided within 72 hours after the beginning of treatment or admission to a health care facility; and
(2) The ordering official determines that giving of notice prior to obtaining the medical care and services was impracticable or that other good cause exists for the failure to provide prior notice.
(c) In emergency cases, a sick or disabled Indian, or an individual or agency acting on behalf of the Indian, or the medical care provider shall, within 72 hours after the beginning of treatment for the condition or after admission to a health care facility notify the appropriate ordering official of the fact of the admission or treatment, together with information necessary to determine the relative medical need for the services and the eligibility of the Indian for the services. The 72-hour period may be extended if the ordering official determines that notification within the prescribed period was impracticable or that other good cause exists for the failure to comply.
(a) Any person who has applied for and been denied health services or eligibility by the Indian Health Service or by any contractor contracting to administer an Indian Health Service program or portion of a program, including tribes and tribal organizations contracting under the Indian Self-Determination Act, shall be notified of the denial in writing together with a statement of all the reasons for the denial. The notice shall advise the applicant that within 30 days from the receipt of the notice the applicant.
(b) If the original decision is affirmed on reconsideration, the applicant shall be so notified in writing and advised that an appeal may be taken to the area or program director within 30 days of receipt of the notice of the reconsidered decision. The appeal shall be in writing and shall set forth the grounds supporting the appeal.
(c) If the original or reconsidered decision is affirmed on appeal by the area or program director, the applicant shall be so notified in writing and advised that a further appeal may be taken to the Director, Indian Health Service, within 30 days of receipt of the notice. The appeal shall be in writing and shall set forth the grounds supporting the appeal. The decision of the Director, Indian Health Service, shall constitute final administrative action.
(a) The Indian Health Service will designate and publish as a notice in the
(b) The Indian Health Service may, after consultation with all the Indian tribes affected, redesignate the boundaries of any Health Service Delivery Area followed by publication of a notice in the
(1) The number of persons residing in the off-reservation area who would be eligible under § 36a.12(a) (1) and (3).
(2) The number of persons residing in the off-reservation area who have traditionally received health services from the Indian Health Service and whose eligibility for services would be affected;
(3) The geographic proximity of the off-reservation area to the reservation; and
(4) Whether the Indians residing in the off-reservation area can be expected to need and to use health services provided by the Indian Health Service given the alternate resources (health facilities and payment sources) available and accessible to them.
(c) Notwithstanding paragraphs (a) and (b) of this section, the Indian Health Service may designate States, subdivisions of States such as counties or towns, or other identifiable geographic areas such as census divisions or zip code areas, as Health Service Delivery Areas where reservations are nonexistent, or so small and scattered and the eligible Indian population so widely dispersed that it is inappropriate to use reservations as the basis for defining the Health Service Delivery Area.
(d) Any Indian tribal government may request a change in the boundaries of the Health Service Delivery Area. Such a request should be supported by documentation related to the factors for consideration set out in paragraph (b) of this section and shall include documentation of any consultation with or notification of other affected or nearby tribes. The request shall be submitted to the appropriate Area Director(s) who shall afford all Indian tribes affected the opportunity to express their views orally and in writing. The Area Director(s) shall then submit the request, including all comments, together with the Area's recommendation and independent findings or verification of the factors set out in paragraph (b) of this section, to the Indian Health Service Director or to the
(a) The Indian Health Service will issue Beneficiary Identification Cards as evidence of beneficiary status to persons who are currently eligible for services under § 36a.12(a). Persons requesting Beneficiary Identification Cards must submit or have on file evidence satisfactory to the Indian Health Service of tribal membership and residence within a Health Service Delivery Area. The absence of a Beneficiary Identification Card will not preclude an otherwise eligible Indian from obtaining services though it may delay the administrative determination that an individual is eligible for services on a no charge basis.
(b) For establishing eligibility or obtaining a Beneficiary Identification Card, applicants must demonstrate that they are members of a federally recognized tribe. Membership in a federally recognized tribe is to be determined by the individual tribe or the Bureau of Indian Affairs. Therefore, the Indian Health Service will recognize two methods of demonstrating tribal membership:
(1) Documentation that the applicant meets the requirements of tribal membership as prescribed by the charter, articles of incorporation, or other legal instruments or traditional processes of the tribe and has been officially designated a tribal member by an authorized tribal official or body; or
(2) Certification of tribal enrollment or membership by the Secretary of the Interior acting through the Bureau of Indian Affairs.
(c) Demonstrating membership in a federally recognized tribe is the responsibility of the applicant. However, the Indian Health Service may consult with the appropriate tribe or the Bureau of Indian Affairs on outstanding questions regarding an applicant's tribal membership if the Indian Health Service has some documentation that it believes may be helpful to the tribe or the Bureau of Indian Affairs in making their determination.
(a) The transition period for full implementation of the new eligibility regulations consists of three parts;
(1) A six month delayed implementation;
(2) A six month grace period; and
(3) A health care continuity period determined by medical factors.
(a) The eligibility requirements in subparts A and B of this part become effective March 16, 1988.
(b) During the six month delayed implementation period the former eligibility regulations will apply.
(a) Upon the effective date referred to in § 36a.32(a), individuals who would lose their eligibility under the new eligilibity regulations published on September 16, 1987, and who have made use of an Indian Health Service of Indian Health Service funded service within three years prior to September 16, 1987 (date of publication of the new eligibility regulations) shall retain their eligibility for a six month grace period ending September 16, 1988. During this grace period such individual's eligibility will continue to be determined under the former regulations except that the new residency requirements established by subparts A and B
(b) All individuals who receive services during the grace period based on paragraph (a) of this section and whose eligibility will terminate on September 16, 1988, shall be notified in writing that after September 16, 1988 they will no longer the eligible for services as Indian Health Service beneficiaries. Such written notice should include an explanation of their appeal rights as provided in § 36a.14 of the part. These patients shall be offered assistance in locating other health care providers and medical assistance programs.
(a) Individuals who lose their eligibility on September 16, 1988, (end of the grace period) and on that date are actively undergoing treatment may still be provided services for a limited period in the following circumstances;
(1) Inpatients in IHS and IHS funded facilities and those receiving inpatient care under contract, including contract health services, may continue to receive such care and necessary follow-up services at Indian Health Service expense until the need for hospitalization and follow-up services has ended as determined by the responsible Indian Health Service or tribal physician, all other conditions being met including medical priorities;
(2) Those actively undergoing a course of outpatient treatment either in Indian Health Service and Indian Health Service funded facilities or through contract health services, termination of which would impair the health of the individual patient, may continue to receive the treatment at Indian Health Service expense for a reasonable length of time, until the course of treatment reaches a point where it may safely be terminated or the patient transferred to other providers as determined by the responsible Indian Health Service or tribal physician, all other conditions being met including medical priorities.
(3) Those under treatment for chronic degenerative conditions may be provided additional treatment at Indian Health Service expense for no longer than 1 year beyond the end of the grace period notwithstanding any determination that it was otherwise safe to transfer treatment to other providers, all other conditions being met including medical priorities.
(b) All patients receiving care under paragraph (a) of this section shall be notified in writing that, after discharge from care provided under any of the above circumstances, they will no longer be eligible for services as Indian Health Service beneficiaries. Such notice shall include an explanation of their appeal rights as provided in § 36a.14 of this part. These patients shall be offered assistance in locating other health care providers and medical assistance programs.
25 U.S.C. 44, 45, 46 and 472; Pub. L. 83-568, 42 U.S.C. 2003.
For purposes of making appointments to vacancies in all positions in the Indian Health Service a preference will be extended to persons of Indian descent who are:
(a) Members of any recognized Indian tribe now under Federal jurisdiction;
(b) Descendants of such members who were, on June 1, 1934, residing within the present boundaries of any Indian reservation;
(c) All others of one-half or more Indian blood of tribes indigenous to the United States;
(d) Eskimos and other aboriginal people of Alaska; or
(e) Until January 4, 1990 or until the Osage Tribe has formally organized, whichever comes first, a person of at least one-quarter degree Indian ancestry of the Osage Tribe of Indians, whose rolls were closed by an act of Congress.
(a) Preference will be afforded a person meeting any one of the definitions of § 36a.41 whether the placement in the position involves initial appointment, reappointment, reinstatement, transfer, reassignment, promotion, or any other personnel action intended to fill a vacancy.
(b) Preference eligibles may be given a schedule A excepted appointment under 5 CFR 213.3116(b)(8). If the individuals are within reach on a Civil Service Register, they may be given a competitive appointment.
To be considered a preference eligible, the person must submit with the employment application a Bureau of Indian Affairs certification that the person is an Indian as defined by § 36a.41 except that an employee of the Indian Health Service who has a certificate of preference eligibility on file in the Official Personnel Folder is not required to resubmit such proof but may instead include a statement on the application that proof of eligibility is on file in the Official Personnel Folder.
Sec. 1, 42 Stat. 208, 25 U.S.C. 13; sec. 1, 68 Stat. 674, 42 U.S.C. 2001; sec. 3, 68 Stat. 674, 42 U.S.C. 2003.
This subpart is applicable to the use of Federal funds in providing health services to Indians in accordance with the provisions of subparts A, B, C, H, I and J of this part.
As used in this subpart:
Federal funds may not be used to pay for or otherwise provide for abortions in the programs described in § 36a.51, except under the Circumstances discribed in § 36a.54.
Federal funds are available for an abortion when a physician has found and so certified in writing to the appropriate tribal or other contracting organization, or service unit or area director, that “on the basis of my professional judgement the life of the mother would be endangered if the fetus were carried to term.” The certification must contain the name and address of the patient.
Federal funds are available for drugs or devices to prevent implantation of the fertilized ovum, and for medical procedures necessary for the termination of an ectopic pregnancy.
Documents required by § 36a.54 must be maintained for three years pursuant to the retention and custodial requirements for records at 45 CFR 74.20
Information which is acquired in connection with the requirements of this subpart may not be disclosed in a form which permits the identification of an individual without the individual's consent, except as may be necessary for the health of the individual or as may be necessary for the Secretary to monitor Indian Health Service program
(a) The Indian Health Service is the payor of last resort of persons defined as eligible for contract health services under these regulations, notwithstanding any State or local law or regulation to the contrary.
(b) Accordingly, the Indian Health Service will not be responsible for or authorize payment for contract health services to the extent that:
(1) The Indian is eligible for alternate resources, as defined in paragraph (c), or
(2) The Indian would be eligible for alternate resources if he or she were to apply for them, or
(3) The Indian would be eligible for alternate resources under State or local law or regulation but for the Indian's eligibility for contract health services, or other health services, from the Indian Health Service or Indian Health Service funded programs.
(c)
25 U.S.C. 458
(a) Authority. These regulations are prepared, issued and maintained with the active participation and representation of Indian Tribes, Tribal organizations and inter-Tribal consortia pursuant to the guidance of the negotiated rulemaking procedures required by section 517 of the Act [25 U.S.C. 458aaa-16].
(b) Purpose. These regulations codify rules for self-governance compacts, funding agreements, and construction project agreements between the Department of Health and Human Services (DHHS) and Self-Governance Tribes to implement sections 2, 3, and 4 of Pub. L. 106-260.
(c) Scope. These regulations are binding on the Secretary and on Indian Tribes carrying out programs, services, functions, and activities (or portions thereof) (PSFAs) under Title V except as otherwise specifically authorized by a waiver under section 512(b) of the Act [25 U.S.C. 458aaa-11(b)].
(d) Information collection. The information collection requirements have been submitted to the Office of Management and Budget (OMB) and are pending OMB approval.
(a) According to section 2 of Pub. L. 106-260, Congress has declared that:
(1) The Tribal right of self-government flows from the inherent sovereignty of Indian Tribes and nations;
(2) The United States recognizes a special government-to-government relationship with Indian Tribes, including the right of the Indian Tribes to self-governance, as reflected in the Constitution, treaties, Federal statutes, and the course of dealings of the United States with Indian Tribes;
(3) Although progress has been made, the Federal bureaucracy, with its centralized rules and regulations, has eroded Tribal Self-Governance and dominates Tribal affairs.
(4) The Tribal Self-Governance Demonstration Project, established under title III of the Indian Self-Determination Act (ISDA) [25 U.S.C. 450f note] was designed to improve and perpetuate the government-to-government relationship between Indian Tribes and the United States and to strengthen Tribal control over Federal funding and program management;
(5) Although the Federal Government has made considerable strides in improving Indian health care, it has failed to fully meet its trust responsibilities and to satisfy its obligations to the Indian Tribes under treaties and other laws; and
(6) Congress has reviewed the results of the Tribal Self-Governance Demonstration Project and finds that transferring full control and funding to Tribal governments, upon Tribal request, over decision making for Federal PSFAs:
(i) Is an appropriate and effective means of implementing the Federal policy of government-to-government relations with Indian Tribes; and
(ii) Strengthens the Federal policy of Indian self-determination.
(b) According to section 3 of Pub. L. 106-260, Congress has declared its policy to:
(1) Permanently establish and implement Tribal Self-Governance within the DHHS;
(2) Call for full cooperation from the DHHS and its constituent agencies in the implementation of Tribal Self-Governance to—
(i) Enable the United States to maintain and improve its unique and continuing relationship with, and responsibility to, Indian Tribes;
(ii) Permit each Indian Tribe to choose the extent of its participation in self-governance in accordance with the provisions of the ISDA relating to the provision of Federal services to Indian Tribes;
(iii) Ensure the continuation of the trust responsibility of the United States to Indian Tribes and Indians;
(iv) Affirm and enable the United States to fulfill its obligations to the Indian Tribes under treaties and other laws;
(v) Strengthen the government-to-government relationship between the United States and Indian Tribes through direct and meaningful consultation with all Tribes;
(vi) Permit an orderly transition from Federal domination of programs and services to provide Indian Tribes with meaningful authority, control, funding, and discretion to plan, conduct, redesign, and administer PSFAs that meet the needs of the individual Tribal communities;
(vii) Provide for a measurable parallel reduction in the Federal bureaucracy as programs, services, functions, and activities (or portion thereof) are assumed by Indian Tribes;
(viii) Encourage the Secretary to identify all PSFAs of the DHHS that may be managed by an Indian Tribe under this Act and to assist Indian Tribes in assuming responsibility for such PSFAs; and
(ix) Provide Indian Tribes with the earliest opportunity to administer PSFAs from throughout the Department.
(c) According to section 512(a) of the Act [25 U.S.C. 458aaa-11(a)], Congress has declared, except as otherwise provided by law, the Secretary shall interpret all Federal laws, Executive Orders, and regulations in a manner that will facilitate:
(1) The inclusion of PSFAs and funds associated therewith, in the agreements entered into under this section;
(2) The implementation of compacts and funding agreements entered into under this title; and
(3) The achievement of Tribal health goals and objectives.
(d) According to section 512(f) of the Act [25 U.S.C. 458aaa-11(f)], Congress has declared that each provision of Title V and each provision of a compact or funding agreement shall be liberally construed for the benefit of the Indian Tribe participating in and any ambiguity shall be resolved in favor of the Indian Tribe.
(e) According to section 515(b) of the Act [25 U.S.C. 458aaa-14(b)], Congress has declared that nothing in the Act shall be construed to diminish in any way the trust responsibility of the United States to Indian Tribes and individual Indians that exists under treaties, Executive orders, or other laws and court decisions.
(f) According to section 507(g) of the Act [25 U.S.C. 458aaa-6(g)], Congress has declared that the Secretary is prohibited from waiving, modifying, or diminishing in any way the trust responsibility of the United States with respect to Indian Tribes and individual Indians that exists under treaties, Executive orders, other laws, or court decisions.
(g) According to section 515(c) of the Act [25 U.S.C. 458aaa-14(c)], Congress has declared that the Indian Health Service (IHS) under this Act shall neither bill nor charge those Indians who may have the economic means to pay
(h) According to section 507(e) of the Act [25 U.S.C. 458aaa-6(e)], Congress has declared that in the negotiation of compacts and funding agreements the Secretary shall at all times negotiate in good faith to maximize implementation of the self-governance policy. The Secretary shall carry out Title V in a manner that maximizes the policy of Tribal Self-Governance, and in a manner consistent with the purposes specified in section 3 of the Act.
Nothing in this part shall be construed as:
(a) Affecting, modifying, diminishing, or otherwise impairing the sovereign immunity from suit enjoyed by Indian Tribes;
(b) Terminating, waiving, modifying, or reducing the trust responsibility of the United States to the Indian Tribe(s) or individual Indians. The Secretary must act in good faith in upholding this trust responsibility;
(c) Mandating an Indian Tribe to apply for a compact(s) or grant(s) as described in the Act; or
(d) Impeding awards by other Departments and agencies of the United States to Indian Tribes to administer Indian programs under any other applicable law.
No, if an Indian Tribe alleges that a compact or funding agreement violates section 515(a) of the Act [25 U.S.C. 458aaa-14(a)], the Indian Tribe may apply the provisions of section 110 of the Act [25 U.S.C. 450m-1].
Unless expressly agreed to by the Self-Governance Tribe in the compact or funding agreement, the Self-Governance Tribe shall not be subject to any agency circular, policy, manual, guidance, or rule adopted by the IHS, except for the eligibility provisions of section 105(g) of the Act [25 U.S.C. 450j(g)] and regulations promulgated under section 517 of the Act [25 U.S.C. 458aaa-16(e)].
In carrying out Tribal self-governance under Title V, the Secretary recognizes the right of Tribes to self-government and supports Tribal sovereignty and self-determination. The Secretary recognizes a unique legal relationship with Tribal governments as set forth in the Constitution of the United States, treaties, statutes, Executive Orders, and court decisions. The Secretary supports the self-determination choices of each Tribe and will continue to work with all Tribes on a government-to-government basis to address issues concerning Tribal self-determination.
Unless otherwise provided in this part:
Act means sections 1 through 9 and Titles I and V of the Indian Self-Determination and Education Assistance Act of 1975, Public Law 93-638, as amended.
Appeal means a request by an Indian Tribe for an administrative review of an adverse decision by the Secretary.
Compact means a legally binding and mutually enforceable written agreement, including such terms as the parties intend shall control year after year, that affirms the government-to-government relationship between a Self-Governance Tribe and the United States.
Congressionally earmarked competitive grants as used in section 505(b)(1) of the Act [25 U.S.C. 458aaa-4(b)(1)] means statutorily mandated grants as
Contract means a self-determination contract as defined in section 4(j) of the Act [25 U.S.C. 450b].
Days means calendar days; except where the last day of any time period specified in these regulations falls on a Saturday, Sunday, or a Federal holiday, the period shall carry over to the next business day unless otherwise prohibited by law.
Department means the Department of Health and Human Services.
Director means the Director of the Indian Health Service.
Funding agreement means a legally binding and mutually enforceable written agreement that identifies the PSFAs that the Self-Governance Tribe will carry out, the funds being transferred from the Service Unit, Area, and Headquarter's levels in support of those PSFAs and such other terms as are required, or may be agreed upon, pursuant to Title V.
Gross mismanagement means a significant, clear, and convincing violation of a compact, funding agreement, or regulatory or statutory requirements applicable to Federal funds transferred to an Indian Tribe by a compact or funding agreement that results in a significant reduction of funds available for the PSFAs assumed by a Self-Governance Tribe.
IHS means Indian Health Service.
IHS discretionary grant means a grant established by IHS pursuant to the IHS' discretionary authority without any specific statutory directive.
Indian means a person who is a member of an Indian Tribe.
Indian Tribe means any Indian Tribe, band, nation, or other organized group, or community, including pueblos, rancherias, colonies, and any Alaska Native Village, or regional or village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act, which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians; provided that in any case in which an Indian Tribe has authorized another Indian Tribe, an inter-Tribal consortium, or a Tribal organization to plan for or carry out programs, services, functions, or activities (or portions thereof) on its behalf under Title V, the authorized Indian Tribe, inter-Tribal consortium or Tribal organization shall have the rights and responsibilities of the authorizing Indian Tribe (except as otherwise provided in the authorizing resolution or in this part). In such event, the term “Indian Tribe” as used in this part includes such other authorized Indian Tribe, inter-Tribal consortium, or Tribal organization.
Indirect costs shall have the same meaning as it has in 25 CFR 900.6 as applied to compacts, funding agreements and construction project agreements entered into under this part.
Inherent Federal functions means those Federal functions which cannot legally be delegated to Indian Tribes.
Inter-Tribal consortium means a coalition of two or more separate Indian Tribes that join together for the purpose of participating in self-governance, including Tribal organizations.
OMB means the Office of Management and Budget.
PSFA means programs, services, functions, and activities (or portions thereof).
Real property means any interest in land together with the improvements, structures, and fixtures and appurtenances thereto.
Reassumption means rescission, in whole or part, of a funding agreement and assuming or resuming control or operation of the PSFAs by the Secretary without consent of the Self-Governance Tribe.
Retained Tribal share means those funds that are available as a Tribal share but which the Self-Governance Tribe elects to leave with the IHS to administer.
Retrocession means the voluntary return to the Secretary of a self-governance program, service, function or activity (or portion thereof) for any reason, before or on the expiration of the term of the funding agreement.
Secretary means the Secretary of Health and Human Services (and his or her respective designees.)
Self-Governance means the program of self-governance established under section 502 of the Act [25 U.S.C. 458aaa-1].
Self-Governance Tribe means an Indian Tribe participating in the program of self-governance pursuant to section 503(a) of the Act [25 U.S.C. 458aaa-2(a)] or selected and participating in self-governance pursuant to section 503(b) of the Act [25 U.S.C. 458aaa-2(b)].
Statutorily mandated grant as used in this section and subpart F of this part means a grant specifically designated in a statute for a defined purpose.
Title I means sections 1 through 9 and Title I of the Indian Self-Determination and Education Assistance Act of 1975, Pub. L. 93-638, as amended.
Title V means Title V of the Indian Self-Determination and Education Assistance Act of 1975, Pub. L. 93-638, as amended.
Tribal organization means the recognized governing body of any Indian Tribe; any legally established organization of Indians which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities; provided, that in any case where a contract or compact is entered into, or a grant is made, to an organization to perform services benefitting more than one Indian Tribe, the approval of each such Indian Tribe shall be a prerequisite to the entering into or making of such contract, compact, or grant.
Tribal Self-Governance Advisory Committee means the Committee established by the Director of IHS that consists of Tribal representatives from each of the IHS Areas participating in Self-Governance, and that provides advocacy and policy guidance for implementation of Tribal Self-Governance within IHS.
Tribal share means an Indian Tribe's portion of all funds and resources that support secretarial PSFAs that are not required by the Secretary for the performance of inherent Federal functions.
Those Self-Governance Tribes described in 503(a) of the Act [25 U.S.C. 458aaa-2(a)] participating in the Title III Tribal Self-Governance Demonstration Project and up to 50 additional Indian Tribes per year that meet the criteria in § 137.18 may participate in self-governance.
The first Indian Tribes who apply and are determined to be eligible shall have the option to participate in self-governance. Any Indian Tribe denied participation due to the limitation in number of Indian Tribes that may take part is entitled to participate in the next fiscal year, provided the Indian Tribe continues to meet the financial stability and financial management capacity requirements.
Yes, Indian Tribes may either:
(a) Each sign the same compact and/or funding agreement, provided that each one meets the criteria to participate in self-governance and accepts legal responsibility for all financial and administrative decisions made under the compact or funding agreement, or
(b) Authorize another Indian Tribe to participate in self-governance on their behalf.
To be eligible to participate in self-governance, an Indian Tribe must have:
(a) Successfully completed the planning phase described in § 137.20;
(b) Requested participation in self-governance by resolution or other official action by the governing body of each Indian Tribe to be served; and
(c) Demonstrated, for three fiscal years, financial stability and financial management capability.
The planning phase must be conducted to the satisfaction of the Indian Tribe and must include:
(a) legal and budgetary research; and
(b) internal Tribal government planning and organizational preparation relating to the administration of health programs.
The Indian Tribe provides evidence that, for the three years prior to participation in self-governance, the Indian Tribe has had no uncorrected significant and material audit exceptions in the required annual audit of the Indian Tribe's self-determination contracts or self-governance funding agreements with any Federal agency.
Yes, if the Indian Tribe chooses to centralize its self-determination or self-governance financial and administrative functions with non-self-determination or non-self-governance financial and administrative functions, such as personnel, payroll, property management, etc., the Secretary may consider uncorrected significant and material audit exceptions related to the integrity of a cross-cutting centralized function in determining the Indian Tribe's eligibility for participation in the self-governance program.
No, meeting the criteria set forth in §§ 137.21 and 137.22, shall be conclusive evidence of the required stability and capability to participate in self-governance.
Yes, any Indian Tribe may apply, as provided in § 137.25, for a grant to assist it to:
(a) Plan to participate in self-governance; and
(b) Negotiate the terms of the compact and funding agreement between the Indian Tribe and Secretary.
Subject to the availability of funds, IHS will annually publish a notice of the number of planning and negotiation grants available, an explanation of the application process for such grants, and the criteria for award. Questions may be directed to the Office of Tribal Self-Governance.
No, an Indian Tribe may use other resources to meet the planning requirement and to negotiate.
A self-governance compact is a legally binding and mutually enforceable written agreement that affirms the government-to-government relationship between a Self-Governance Tribe and the United States.
A compact shall include general terms setting forth the government-to-government relationship consistent with the Federal Government's trust responsibility and statutory and treaty obligations to Indian Tribes and such other terms as the parties intend to control from year to year.
Yes, Tribes must have a compact in order to participate in self-governance.
Yes, at an Indian Tribe's option, a funding agreement may be negotiated prior to or at the same time as the negotiation of a compact.
No, a compact is a separate document from a funding agreement, and the compact must be executed before or at the same time as a funding agreement.
Upon approval and execution of a self-governance compact, the compact remains in effect for so long as permitted by Federal law or until terminated by mutual written agreement or retrocession or reassumption of all PSFAs.
A funding agreement is a legally binding and mutually enforceable written agreement that identifies the PSFAs that the Self-Governance Tribe will carry out, the funds being transferred from service unit, area and headquarters levels in support of those PSFAs and such other terms as are required or may be agreed upon pursuant to Title V.
At the Self-Governance Tribe's option, all PSFAs identified in and in accordance with section 505(b) of the Act must be included in a funding agreement, subject to section 507(c) of the Act [25 U.S.C. 458aaa-6(c)].
All Tribal shares identified in sections 505(b)(1) [25 U.S.C. 458aaa-4(b)(1)] and 508(c) of the Act [25 U.S.C. 458aaa-7(c)] may be included in a funding agreement, including Tribal shares of IHS discretionary grants.
Yes, at the discretion of the Self-Governance Tribe, Tribal shares may be left, in whole or in part, with IHS for certain PSFAs. These shares are referred to as a “retained Tribal shares.”
A funding agreement must include terms required under section 505(d) of the Act [25 U.S.C. 458aaa-4(d)] and provisions regarding mandatory reporting and reassumption pursuant to section 507(a) of the Act [25 U.S.C. 458aaa-6(a)], unless those provisions have been included in a compact.
Yes, at the Self-Governance Tribe's option, additional terms may be included as set forth in sections 506 [25 U.S.C. 458aaa-5] and 516(b) of the Act [25 U.S.C. 458aaa-15(b)]. In addition, any other terms to which the Self-Governance Tribe and the Secretary agree may be included.
(a) Yes, the provisions of Title I listed in section 516(a) of the Act [25 U.S.C. 458aaa-15(a)] and section 314 of Pub. L. 101-512, as amended, [25 U.S.C. 450f note] mandatorily apply to a compact, funding agreement and construction project agreement to the extent they are not in conflict with Title V. In addition, at the option of a Self-Governance Tribe, under section 516(b) of the Act [25 U.S.C. 458aaa-15(b)] any provisions of Title I may be included in the compact or funding agreement.
(b) The provisions of Title I referenced in section 516(a) of the Act [25 U.S.C. 458aaa-15(a)] are sections 5 [25 U.S.C. 450c], 6 [25 U.S.C. 450d], 7 [25
The incorporated Title I provision shall have the same force and effect as if it were set out in full in Title V.
In that event, such incorporation shall be deemed effective immediately and shall control the negotiation and resulting compact and funding agreement.
A funding agreement shall have the term mutually agreed to by the parties. Absent notification from an Indian Tribe that it is withdrawing or retroceding the operation of one or more PSFAs identified in the funding agreement, the funding agreement shall remain in full force and effect until a subsequent funding agreement is executed.
Yes, the provisions of a funding agreement, including all recurring increases received and continuing eligibility for other increases, remain in full force and effect until a subsequent funding agreement is executed. Upon execution of a subsequent funding agreement, the provisions of such a funding agreement are retroactive to the end of the term of the preceding funding agreement.
A funding agreement may be amended by the parties as provided for in the funding agreement, Title V, or this part.
Yes, in accordance with section 505(b)(2) of the Act [25 U.S.C. 458aaa-4(b)(2)], a statutorily mandated grant may be added to the funding agreement after award.
Yes, grant funds shall be added to the funding agreement as an annual lump sum advance payment after the grant is awarded.
Yes, a Self-Governance Tribe may keep Interest Earned on Statutorily Mandated Grant Funds.
Interest earned on such funds must be used to enhance the grant program including allowable administrative costs.
No, unless it is permitted under the statute authorizing the grant or under the terms and conditions of the grant award, funds from a statutorily mandated grant may not be reallocated.
No, unless it is permitted under the statute authorizing the grant or under the terms and conditions of the grant award, a program added to a funding agreement under a statutorily mandated grant may not be redesigned.
Yes, the reporting requirements for a statutorily mandated grant program added to a funding agreement are subject to the terms and conditions of the grant award.
Yes, the Secretary and the Self-Governance Tribe may develop separate programmatic reporting requirements for statutorily mandated grants.
Yes, Self-Governance Tribes and their employees carrying out statutorily mandated grant programs are added to a funding agreement covered by the FTCA. Regulations governing coverage under the FTCA are published at 25 CFR Part 900, Subpart M.
None of the provisions of Title V apply.
Subject to the terms of any compact or funding agreement, the Secretary must transfer to a Tribe all funds provided for in the funding agreement, pursuant to section 508(c) of the Act [25 U.S.C. 458aaa-7(c)] and § 137.80. The Secretary shall provide funding for periods covered by joint resolution adopted by Congress making continuing appropriations, to the extent permitted by such resolutions.
When a funding agreement requires an annual transfer of funding to be made at the beginning of a fiscal year, or requires semiannual or other periodic transfers of funding to be made commencing at the beginning of a fiscal year, the first such transfer shall be made not later than 10 days after the apportionment of such funds by the OMB to the Department, unless the funding agreement provides otherwise.
The Secretary must transfer any funds that were not paid in the initial lump sum payment within 10 days after distribution methodologies and other decisions regarding payment of those funds have been made by the IHS.
Yes, upon Tribal request, the Secretary must negotiate a funding agreement for a term longer or shorter than a year. All references in these regulations to funding agreements shall also include funding agreements for a term longer or shorter than one year.
The Secretary must include funds in a funding agreement in an amount equal to the amount that the Self-Governance Tribe would have been entitled to receive in a contract under Title I, including amounts for direct program costs specified under section 106(a)(1) of the Act and amounts for contract support costs specified under section 106(a) (2), (3), (5), and (6) of the Act [25 U.S.C. 450j-1(a)(2), (3), (5) and (6)]. In addition, the Secretary shall include any funds that are specifically or functionally related to the provision by the Secretary of services and benefits to the Self-Governance Tribe or its members, all without regard to the organizational
Yes, sections 508(d)(1)(A) and (B) of the Act [25 U.S.C. 458aaa-7(d)(1)(A) and (B)] expressly prohibit the Secretary from:
(a) Failing or refusing to transfer to a Self-Governance Tribe its full share of any central, headquarters, regional, area, or service unit office or other funds due under Title V, except as required by Federal law, and
(b) From withholding portions of such funds for transfer over a period of years.
Yes, the Secretary is prohibited from reducing the amount of funds required under Title V to make funding available for self-governance monitoring or administration.
No, in accordance with section 508(d)(1)(C)(ii) of the Act [25 U.S.C. 458aaa-7(d)(1)(C)(ii)], the Secretary is prohibited from reducing the amount of funds required under Title V in subsequent years, except pursuant to:
(a) A reduction in appropriations from the previous fiscal year for the program or function to be included in a compact or funding agreement;
(b) A Congressional directive in legislation or accompanying report;
(c) A Tribal authorization;
(d) A change in the amount of pass-through funds subject to the terms of the funding agreement; or
(e) Completion of a project, activity, or program for which such funds were provided.
No, the Secretary may not reduce the amount of funds required under Title V to pay for Federal functions, including Federal pay costs, Federal employee retirement benefits, automated data processing, technical assistance, and monitoring of activities under the Act.
No, the Secretary may not reduce the amount of funds required under Title V to pay for costs of Federal personnel displaced by contracts under Title I or Self-Governance under Title V.
Yes, the Secretary may increase the funds required under the funding agreement. However, the Self-Governance Tribe and the Secretary must agree to any transfer of funds to the Self-Governance Tribe unless otherwise provided for in the funding agreement.
Yes, a Self-Governance Tribe may choose to purchase from the IHS any goods and services transferred by the IHS to a Self-Governance Tribe in a compact or funding agreement. The IHS shall provide any such goods and services to the Self-Governance Tribe, on a reimbursable basis, including payment in advance with subsequent adjustment.
Yes, the Prompt Payment Act, 39 U.S.C. section 3901 et seq., applies to the transfer of all funds due under a compact or funding agreement authorized pursuant to Title V. See also § 137.76 through 137.78 and 137.341(f).
Yes, pursuant to section 508(h) of the Act [25 U.S.C. 458aaa-7(h)], a Self-Governance Tribe may retain and spend interest earned on any funds paid under a compact or funding agreement.
A Self-Governance Tribe is under a duty to invest and manage the funds as a prudent investor would, in light of the purpose, terms, distribution requirements, and provisions in the compact or funding agreement and Title V. This duty requires the exercise of reasonable care, skill, and caution, and is to be applied to investments not in isolation but in the context of the investment portfolio and as a part of an overall investment strategy, which should incorporate risk and return objectives reasonably suitable to the Self-Governance Tribe. In making and implementing investment decisions, the Self-Governance Tribe has a duty to diversify the investments unless, under the circumstances, it is prudent not to do so. In addition, the Self-Governance Tribe must:
(a) Conform to fundamental fiduciary duties of loyalty and impartiality;
(b) Act with prudence in deciding whether and how to delegate authority and in the selection and supervision of agents; and
(c) Incur only costs that are reasonable in amount and appropriate to the investment responsibilities of the Self-Governance Tribe.
Yes, pursuant to section 508(i) of the Act, a Self-Governance Tribe may carryover from one year to the next any funds that remain at the end of the funding agreement.
All Medicare, Medicaid, or other program income earned by a Self-Governance Tribe shall be treated as supplemental funding to that negotiated in the funding agreement. The Self-Governance Tribe may retain all such income and expend such funds in the current year or in future years except to the extent that the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.) provides otherwise for Medicare and Medicaid receipts. Such funds shall not result in any offset or reduction in the amount of funds the Self-Governance Tribe is authorized to receive under its funding agreement in the year the program income is received or for any subsequent fiscal year.
No, if a Self-Governance Tribe believes that the total amount of funds provided for a specific PSFA in a compact or funding agreement is insufficient, the Self-Governance Tribe must provide reasonable written notice of such insufficiency to the Secretary. If the Secretary does not increase the amount of funds transferred under the funding agreement in a quantity sufficient for the Self-Governance Tribe to complete the PSFA, as jointly determined by the Self-Governance Tribe and the Secretary, the Self-Governance
Yes, at the option of a Self-Governance Tribe, a funding agreement may provide for a stable base budget, specifying the recurring funds to be transferred to a Self-Governance Tribe for a period specified in the funding agreement.
The stable base budget amount may include, at the option of the Self-Governance Tribe,
(a) Recurring funds available under section 106(a) of the Act [25 U.S.C. 450j-1] ;
(b) Recurring Tribal shares; and
(c) Any recurring funds for new or expanded PSFAs not previously assumed by the Self-Governance Tribe.
Yes, the funding agreement may include non-recurring funds, other recurring funds, and other funds the Self-Governance Tribe is entitled to include in a funding agreement that are not included in the stable base budget amount.
Stable base funding amounts are subject to adjustment:
(a) Annually only to reflect changes in Congressional appropriations by sub-sub activity excluding earmarks;
(b) By mutual agreement of the Self-Governance Tribe and the Secretary; or
(c) As a result of full or partial retrocession or reassumption.
No, the Self-Governance Tribe may provide in its funding agreement that the effective period of the stable base budget will be either longer or shorter than the term of the funding agreement.
This subpart explains the final offer process provided by the statute for resolving, within a specific timeframe, disputes that may develop in negotiation of compacts, funding agreements, or amendments thereof.
A final offer should be submitted when the Secretary and an Indian Tribe are unable to agree, in whole or in part, on the terms of a compact or funding agreement (including funding levels).
(a) A written final offer should be submitted:
(1) During negotiations to the agency lead negotiator
(2) Thereafter to the Director.
(b) The document should be separate from the compact, funding agreement, or amendment and clearly identified as a “Final Offer.”
A final offer contains a description of the disagreement between the Secretary and the Indian Tribe and the Indian Tribe's final proposal to resolve the disagreement.
The 45 day review period begins from the date the IHS receives the final offer. Proof of receipt may include a date stamp, or postal return receipt, or hand delivery.
Yes, the Secretary may request an extension of time before the expiration of the 45 day review period. The Indian Tribe may either grant or deny the Secretary's request for an extension. To be effective, any grant of extension of time must be in writing and be signed by the person authorized by the Indian Tribe to grant the extension before the expiration of the 45 day review period.
The final offer is accepted automatically by operation of law.
No, there are no exceptions to this rule if the 45 day review period or extension thereto, has expired, and the Tribe's offer is deemed accepted by operation of law.
After the Indian Tribe's final offer is accepted or deemed accepted, the terms of the Indian Tribe's final offer and any funds included therein, shall be added to the funding agreement or compact within 10 days of the acceptance or the deemed acceptance.
The Secretary may reject an Indian Tribe's final offer for one of the following reasons:
(a) the amount of funds proposed in the final offer exceeds the applicable funding level to which the Indian Tribe is entitled under the Act;
(b) the PSFA that is the subject of the final offer is an inherent Federal function that cannot legally be delegated to an Indian Tribe;
(c) the Indian Tribe cannot carry out the PSFA in a manner that would not result in significant danger or risk to the public health; or
(d) the Indian Tribe is not eligible to participate in self-governance under section 503 of the Act [25 U.S.C. 458aaa-2].
The Secretary must reject a final offer by providing written notice to the Indian Tribe based on the criteria in § 137.140 not more than 45 days after receipt of a final offer, or within a longer time period as agreed by the Self-Governance Tribe consistent with this subpart.
A significant danger or risk is determined on a case-by-case basis in accordance with section 507(c) of the Act [25 U.S.C. 458aaa-6(c)].
The Secretary must provide funds under a funding agreement in an amount equal to the amount that the Indian Tribe would have been entitled to receive under self-determination contracts under this Act, including amounts for direct program costs specified under section 106(a)(1) of the Act [25 U.S.C. 450j-1(a)(1)] and amounts for contract support costs specified under section 106(a) (2), (3), (5), and (6) of the Act [25 U.S.C. 450j-1(a)(2), (3), (5) and (6)], including any funds that are specifically or functionally related to the provision by the Secretary of services and benefits to the Indian Tribe or its members, all without regard to the organizational level within the Department where such functions are carried out.
Yes, upon receiving a final offer, the Secretary must offer any necessary technical assistance, and must share
Yes, the Secretary must offer and, if requested by the Indian Tribe, provide additional technical assistance to overcome the stated grounds for rejection.
Yes, the Indian Tribe is entitled to appeal the decision of the Secretary, with an agency hearing on the record, and the right to engage in full discovery relevant to any issue raised in the matter. The procedures for appeals are found in subpart P of this part. Alternatively, at its option, the Indian Tribe has the right to sue pursuant to section 110 of the Act [25 U.S.C. 450m-1] in Federal district court to challenge the Secretary's decision.
Yes, subject to section 507(c)(1)(D) of the Act [25 U.S.C. 458aaa-6(c)(1)(D)].
No, appealing the decision of the Secretary does not prevent entering into the compact, funding agreement, or amendment.
With respect to any appeal, hearing or civil action, the Secretary shall have the burden of demonstrating by clear and convincing evidence the validity of the grounds for rejecting the final offer.
A final agency action shall consist of a written decision from the Department to the Indian Tribe either:
(a) By an official of the Department who holds a position at a higher organizational level within the Department than the level of the departmental agency in which the decision that is the subject of the appeal was made; or
(b) By an administrative judge.
Yes, self-Governance Tribes participating in self-governance under Title V must ensure that internal measures are in place to address conflicts of interest in the administration of self-governance PSFAs.
Yes, under the provisions of section 506(c) of the Act [25 U.S.C. 458aaa-5(c)], Self-Governance Tribes must undertake annual audits pursuant to the Single Audit Act, 31 U.S.C. 7501
Yes, the exceptions are described in 31 U.S.C. 7502 of the Single Audit Act.
A Self-Governance Tribe must apply the cost principles of the applicable OMB circular, except as modified by:
(a) Section 106 (k) of the Act [25 U.S.C. 450j-1],
(b) Other provisions of law, or
(c) Any exemptions to applicable OMB circulars subsequently granted by the OMB.
No, no other audit or accounting standards shall be required by the Secretary.
Any right of action or other remedy (other than those relating to a criminal offense) relating to any disallowance of costs is barred unless the Secretary provides notice of such a disallowance within 365 days from receiving any required annual agency single audit report or, for any period covered by law or regulation in force prior to enactment of the Single Agency Audit Act of 1984, any other required final audit report.
For the purpose of determining the 365 day period, an audit report is deemed received on the date of actual receipt by the Secretary, at the address specified in § 137.172, if, within 60 days after receiving the audit report, the Secretary does not give notice of a determination by the Secretary to reject the single-agency audit report as insufficient due to non-compliance with chapter 75 of title 31, United States Code or noncompliance with any other applicable law.
(a) For fiscal years ending on or before June 30, 1996, the audit report must be sent to: National External Audit Review Center, Lucas Place Room 514, 323 W. 8th St., Kansas City, MO 64105.
(b) For fiscal years, beginning after June 30, 1996, the audit report must be sent to: Single Audit Clearinghouse, 1201 E. 10th St., Jeffersonville, IN 47132.
Yes, the Self-Governance Tribe should also send the audit report to: National External Audit Review Center, Lucas Place Room 514, 323 W. 8th St., Kansas City, MO 64105.
Yes, the notice must set forth the right of appeal and hearing to the Interior Board of Contract Appeals, pursuant to section 110 of the Act [25 U.S.C. 450m-1].
Yes. Tribes are required to maintain records and provide Federal agency access to those records as provided in § 137.177.
No, except to the extent that a Self-Governance Tribe specifies otherwise in its compact or funding agreement, the records of the Self-Governance Tribe shall not be considered Federal records for purposes of chapter 5 of title 5, United States Code.
Yes, after 30 days advance written notice from the Secretary, the Self-Governance Tribe must provide the Secretary with reasonable access to such records to enable the Department to meet its minimum legal recordkeeping system requirements under sections 3101 through 3106 of title 44 United States Code.
Yes, at the option of a Self-Governance Tribe, patient records may be stored at Federal Records Centers to
Yes, a Self-Governance Tribe may make agreements with the Federal Records Centers regarding disclosure and release of the patient records stored pursuant to § 137.178.
Yes, a Tribe must consider the potential application of Tribal, Federal and state law and regulations that may apply to requests for access to Tribal patient records, such as the provisions 42 CFR 2.1-2.67 pertaining to records regarding drug and/or alcohol treatment.
Yes, a Self-Governance Tribe may redesign or consolidate PSFAs included in a funding agreement and reallocate or redirect funds for such PSFAs in any manner which the Self-Governance Tribe deems to be in the best interest of the health and welfare of the Indian community being served, only if the redesign or consolidation does not have the effect of denying eligibility for services to population groups otherwise eligible to be served under applicable Federal law.
For the period for which, and to the extent to which, funding is provided under the compact or funding agreement, the Self-Governance Tribe is not entitled to contract with the Secretary for the same funds or PSFA under section 102 of the Act [25 U.S.C. 450f]. Such Self-Governance Tribe is eligible for new programs on the same basis as other Indian Tribes.
Yes, compacts or funding agreements negotiated between the Secretary and a Self-Governance Tribe must include a provision that requires the Self-Governance Tribe to report on health status and services delivery. These reports may only impose minimal burdens on the Self-Governance Tribes.
Tribal reports enable the Secretary to prepare reports required under Title V and to develop the budget request. The reporting requirements are not intended as a quality assessment or monitoring tool, although such provision may be included at the option of the Self-Governance Tribe. Under no circumstances will the reporting requirement include any confidential, proprietary or commercial information. For example, while staffing levels may be a part of a report, pay levels for the staff are considered confidential between the Self-Governance Tribe and the employee.
Reports will be derived from existing minimal data elements currently collected by Self-Governance Tribes, and may include patient demographic and workload data. Not less than 60 days prior to the start of negotiations or a mutually agreed upon timeframe, the IHS will propose a list of recommended minimal data elements, along with justification for their inclusion, to be used as a basis for negotiating these requirements into the Self-Governance Tribe's compact or funding agreement.
Yes, in order to advance Indian health advocacy efforts, each Self-Governance Tribe will be encouraged to participate, at its option, in national IHS data reporting activities such as Government Performance Results Act, epidemiologic and surveillance reporting.
IHS will work with representatives of Self-Governance Tribes, in coordination with the Tribal Self Governance Advisory Committee (TSGAC), to develop a mutually-defined annual voluntary uniform subset of data that is consistent with Congressional intent, minimizes reporting burdens, and responds to the needs of the Self-Governance Tribe.
No, to the extent that specific resources are available or have not otherwise been provided to Self-Governance Tribes for this purpose, and if the Self-Governance Tribes choose to participate, the IHS will provide resources, hardware, software, and technical assistance to the Self-Governance Tribes to facilitate data gathering to ensure data consistency and integrity under this voluntary effort.
This information will be used to comply with sections 513 [25 U.S.C. 458aaa-12] and 514 [25 U.S.C. 458aaa-13] of the Act as well as to assist IHS in advocating for the Indian health system, budget formulation, and other reporting required by statute, development of partnerships with other organizations that benefit the health status of Indian Tribes, and sharing of best practices.
Yes, reporting requirements are subject to the Secretary providing specific funds for this purpose in the funding agreement.
To the extent that PSFAs carried out by Self-Governance Tribes under Title V reduce the administrative or other responsibilities of the Secretary with respect to the operation of Indian programs and result in savings that have not otherwise been included in the amount of Tribal shares and other funds determined under section 508(c) of the Act [25 U.S.C. 458aaa-7(c)], the Secretary must make such savings available to the Self-Governance Tribes, for the provision of additional services to program beneficiaries in a manner equitable to directly served, contracted, and compacted programs.
The annual report prepared pursuant to section 514(b)(2) [25 U.S.C. 458aaa-13(b)(2)] of the Act must specifically identify any such savings.
(a) For government-furnished real and personal property made available to a Self-Governance Tribe, the Self-Governance Tribe must take title to all real or personal property unless the Self-Governance Tribe requests that the United States retain the title.
(b) For government-furnished personal property made available to a Self-Governance Tribe:
(1) The Secretary, in consultation with each Self-Governance Tribe, must develop a list of the property used in a compact, funding agreement, or construction project agreement.
(2) The Self-Governance Tribe must indicate any items on the list to which the Self-Governance Tribe wants the Secretary to retain title.
(3) The Secretary must provide the Self-Governance Tribe with any documentation needed to transfer title to the remaining listed property to the Self-Governance Tribe.
(c) For government-furnished real property made available to a Self-Governance Tribe:
(1) The Secretary, in consultation with the Self-Governance Tribe, must develop a list of the property furnished for use in a compact, funding agreement, or construction project agreement.
(2) The Secretary must inspect any real property on the list to determine the presence of any hazardous substance activity, as defined in 41 CFR 101-47.202-2(b)(10).
(3) The Self-Governance Tribe must indicate on the list to the Secretary any items of real property to which the Self-Governance Tribe wants the Secretary to retain title and those items of property to which the Self-Governance Tribe wishes to obtain title. The Secretary must take such steps as necessary to transfer title to the Self-Governance Tribe those items of real property which the Self-Governance Tribe wishes to acquire.
Yes, funds provided under compacts, funding agreements, or grants made pursuant to Title V may be treated as non-Federal funds for purposes of meeting matching or cost participation requirements under any other Federal or non-Federal program.
Yes, regulations governing FTCA coverage are set out at 25 CFR Part 900, Subpart M.
A Self-Governance Tribe may request a waiver of regulation(s) promulgated under section 517 of the Act [25 U.S.C. 458aaa-16] or under the authorities specified in section 505(b) of the Act [25 U.S.C. 458aaa-4(b)] for a compact or funding agreement entered into with the IHS under Title V.
A Self-Governance Tribe may request a waiver by submitting a written request to the Secretary identifying the applicable Federal regulation(s) sought to be waived and the basis for the request.
The Secretary must either approve or deny the requested waiver in writing within 90 days after receipt by the Secretary.
A denial may be made only upon a specific finding by the Secretary that identified language in the regulation may not be waived because such waiver is prohibited by Federal law.
The waiver request is deemed approved.
Yes, the Secretary's decision on a waiver request is final for the Department.
The decision may not be appealed under these regulations but may be appealed by the Self-Governance Tribe in Federal Court under applicable law.
Yes, an Indian Tribe may fully or partially withdraw from a participating inter-Tribal consortium or Tribal organization its share of any PSFAs included in a compact or funding agreement.
A withdrawal becomes effective within the time frame specified in the resolution that authorizes withdrawal from the participating Tribal organization or inter-Tribal consortium. In the absence of a specific time frame set forth in the resolution, such withdrawal becomes effective on
(a) The earlier of 1 year after the date of submission of such request, or the date on which the funding agreement expires; or
(b) Such date as may be mutually agreed upon by the Secretary, the withdrawing Indian Tribe, and the participating Tribal organization or inter-Tribal consortium that has signed the compact or funding agreement on behalf of the withdrawing Indian Tribe, inter-Tribal consortium, or Tribal organization.
When an Indian Tribe eligible to enter into a contract under Title I or a compact or funding agreement under Title V fully or partially withdraws from a participating inter-Tribal consortium or Tribal organization, and has proposed to enter into a contract or compact and funding agreement covering the withdrawn funds:
(a) The withdrawing Indian Tribe is entitled to its Tribal share of funds supporting those PSFAs that the Indian Tribe will be carrying out under its own contract or compact and funding agreement (calculated on the same basis as the funds were initially allocated in the funding agreement of the inter-Tribal consortium or Tribal organization); and
(b) the funds referred to in paragraph (a) of this section must be transferred from the funding agreement of the inter-Tribal consortium or Tribal organization, on the condition that the provisions of sections 102 [25 U.S.C. 450f] and 105(i) of the Act [25 U.S.C. 450j], as appropriate, apply to the withdrawing Indian Tribe.
All funds not obligated by the inter-Tribal consortium or Tribal organization associated with the withdrawing Indian Tribe's returned PSFAs, less close out costs, shall be returned by the inter-Tribal consortium or Tribal organization to the IHS for operation of the PSFAs included in the withdrawal.
Yes, if the withdrawing Indian Tribe elects to operate PSFAs carried out under a compact or funding agreement under Title V through a contract under Title I, the resulting contract is considered a mature contract under section 4(h) of the Act [25 U.S.C. 450b(h)] at the option of the Indian Tribe.
Retrocession means the return by a Self-Governance Tribe to the Secretary of PSFAs, that are included in a compact or funding agreement, for any reason, before the expiration of the term of the compact or funding agreement.
The Self-Governance Tribe submits a written notice to the Director of its intent to retrocede. The notice must specifically identify those PSFAs being retroceded. The notice may also include a proposed effective date of the retrocession.
Unless the request for retrocession is rescinded, the retrocession becomes effective within the timeframe specified by the parties in the compact or funding agreement. In the absence of a specification, the retrocession becomes effective on:
(a) The earlier of 1 year after:
(1) The date of submission of the request, or
(2) The date on which the funding agreement expires; or
(b) Whatever date is mutually agreed upon by the Secretary and the retroceding Self-Governance Tribe.
A retrocession request shall not negatively affect:
(a) Any other contract or compact to which the retroceding Self-Governance Tribe is a party;
(b) Any other contracts or compacts the retroceding Self-Governance Tribe may request; and
(c) Any future request by such Self-Governance Tribe or an Indian Tribe to compact or contract for the same program.
No, the Secretary shall provide no less than the same level of funding that would have been available if there had been no retrocession.
Any funds not obligated by the Self-Governance Tribe and associated with the Self-Governance Tribe's returned PSFAs, less close out costs, must be returned by the Self-Governance Tribe to IHS for operation of the PSFA's associated with the compact or funding agreement from which the Self-Governance Tribe retroceded in whole or in part.
On the effective date of any retrocession, the retroceding Self-Governance Tribe, shall, at the option of the Secretary, deliver to the Secretary all requested property and equipment provided by the Secretary under the compact or funding agreement, to the extent used to carry out the retroceded PSFAs, which at the time of retrocession has a per item current fair market value, less the cost of improvements borne by the Self-Governance Tribe in
Reassumption means rescission by the Secretary without consent of the Self-Governance Tribe of PSFAs and associated funding in a compact or funding agreement and resuming responsibility to provide such PSFAs.
(a) Subject to the steps in § 137.257, the Secretary may reassume a program, service, function, or activity (or portion thereof) and associated funding if the Secretary makes a specific finding relative to that PSFA of :
(1) Imminent endangerment of the public health caused by an act or omission of the Self-Governance Tribe, and the imminent endangerment arises out of a failure to carry out the compact or funding agreement; or
(2) Gross mismanagement with respect to funds transferred to the Self-Governance Tribe by a compact or funding agreement, as determined by the Secretary, in consultation with the Inspector General, as appropriate.
(b) Immediate reassumption may occur under additional requirements set forth in § 137.261.
Except as provided in § 137.261 for immediate reassumption, prior to a reassumption becoming effective, the Secretary must:
(a) Notify the Self-Governance Tribe in writing by certified mail of the details of findings required under § 137.256(a)(1) and (2);
(b) Request specified corrective action within a reasonable period of time, which in no case may be less than 45 days;
(c) Offer and provide, if requested, the necessary technical assistance and advice to assist the Self-Governance Tribe to overcome the conditions that led to the findings described under (a); and
(d) Provide the Self-Governance Tribe with a hearing on the record as provided under Subpart P of this part.
Yes, at the Self-Governance Tribe's request, the Secretary must provide a hearing on the record prior to or in lieu of the corrective action period identified in § 137.257(b).
(a) The Secretary shall provide a second written notice by certified mail to the Self-Governance Tribe served by the compact or funding agreement that the compact or funding agreement will be rescinded, in whole or in part.
(b) The second notice shall include:
(1) The intended effective date of the reassumption;
(2) The details and facts supporting the intended reassumption; and
(3) Instructions that explain the Indian Tribe's right to a formal hearing within 30 days of receipt of the notice.
Except as provided in § 137.261, no PSFA may be reassumed by the Secretary until 30 days after the final resolution of the hearing and any subsequent appeals to provide the Self-Governance Tribe with an opportunity to take corrective action in response to any adverse final ruling.
Yes, the Secretary may immediately reassume operation of a program, service, function, or activity (or portion thereof) and associated funding upon providing to the Self-Governance Tribe written notice in which the Secretary makes a finding:
(a) of imminent substantial and irreparable endangerment of the public
(b) the endangerment arises out of a failure to carry out the compact or funding agreement.
If the Secretary immediately reassumes a PSFA, the Secretary must provide the Self-Governance Tribe with a hearing under Subpart P of this part not later than 10 days after such reassumption, unless the Self-Governance Tribe and the Secretary agree to an extension.
Yes, the Secretary may make a grant for the purpose of obtaining technical assistance as provided in section 103 of the Act [25 U.S.C. 458aaa-h].
On the effective date of any reassumption, the Self-Governance Tribe, shall, at the option of the Secretary and only to the extent requested by the Secretary, deliver to the Secretary property and equipment provided by the Secretary under the compact or funding agreement, to the extent the property was used to directly carry out the reassumed program, service, function, or activity (or portion thereof), provided that at the time of reassumption the property has a per item current fair market value, less the cost of improvements borne by the Self-Governance Tribe, in excess of $5,000 at the time of the reassumption.
Yes, a Tribe may be reimbursed for actual and reasonable close out costs incurred after the effective date of reassumption.
This subpart covers IHS construction projects carried out under section 509 of the Act [25 U.S.C. 458aaa-8].
Construction projects are separately defined in Title V and are subject to a separate proposal and review process. Provisions of a construction project agreement and this subpart shall be liberally construed in favor of the Self-Governance Tribe.
Self-Governance Tribes also have the option of performing IHS construction projects under a variety of other legal authorities, including but not limited to Title I of the Act, the Indian Health Care Improvement Act, Public Law 94-437, and Public Law 86-121. This subpart does not cover projects constructed pursuant to agreements entered into under these authorities.
IHS construction PSFAs are a combination of construction projects as defined in § 137.280 and construction programs.
No, except as provided in § 137.275, this subpart does not cover construction programs such as the:
(a) Maintenance and Improvement Program;
(b) Construction program functions; and,
(c) Planning services and construction management services.
Yes, Self-Governance Tribes may choose to assume construction programs in a construction project agreement, in a funding agreement, or in a combination of the two. These programs may include the following:
(a) Maintenance and improvement program;
(b) Construction program functions; and
(c) Planning services and construction management services.
ALJ means administrative law judge.
APA means Administrative Procedures Act, 5 U.S.C. 701—706.
Budget means a statement of the funds required to complete the scope of work in a construction project agreement. For cost reimbursement agreements, budgets may be stated using broad categories such as planning, design, construction, project administration, and contingency. For fixed price agreements, budgets may be stated as lump sums, unit cost pricing, or a combination thereof.
Categorical exclusion means a category of actions that do not individually or cumulatively have a significant effect on the human environment and that have been found to have no such effect in procedures adopted by a Federal agency in implementation of these regulations and for which, therefore, neither an environmental assessment nor an environmental impact statement is required. Any procedures under this section shall provide for extraordinary circumstances in which a normally excluded action may have a significant environmental effect.
CEQ means Council on Environmental Quality in the Office of the President.
Construction management services (CMS) means activities limited to administrative support services; coordination; and monitoring oversight of the planning, design, and construction process. CMS activities typically include:
(1) Coordination and information exchange between the Self-Governance Tribe and the Federal Government;
(2) Preparation of a Self-Governance Tribe's project agreement; and
(3) A Self-Governance Tribe's subcontract scope of work identification and subcontract preparation, and competitive selection of construction contract subcontractors.
Construction phase is the phase of a construction project agreement during which the project is constructed, and includes labor, materials, equipment and services necessary to complete the work, in accordance with the construction project agreement.
Construction project means:
(1) An organized noncontinuous undertaking to complete a specific set of predetermined objectives for the planning, environmental determination, design, construction, repair, improvement, or expansion of buildings or facilities described in a project agreement, and
(2) Does not include construction program administration and activities described in sections 4(m)(1) through (3) of the Act [25 U.S.C. 4b(m)(1) through (3)], that may otherwise be included in a funding agreement under section 505 of the Act [25 U.S.C. 458aaa-4].
Construction project agreement means a negotiated agreement between the Secretary and a Self-Governance Tribe, that at a minimum:
(1) Establishes project phase start and completion dates;
(2) Defines a specific scope of work and standards by which it will be accomplished;
(3) Identifies the responsibilities of the Self-Governance Tribe and the Secretary;
(4) Addresses environmental considerations;
(5) Identifies the owner and operations and maintenance entity of the proposed work;
(6) Provides a budget;
(7) Provides a payment process; and
(8) Establishes the duration of the agreement based on the time necessary to complete the specified scope of work, which may be 1 or more years.
Design phase is the phase of a construction project agreement during which project plans, specifications, and
Maintenance and improvement program:
(1) As used in this subpart means the program that provides funds for eligible facilities for the purpose of:
(i) Performing routine maintenance;
(ii) Achieving compliance with accreditation standards;
(iii) Improving and renovating facilities;
(iv) Ensuring that Indian health care facilities meet existing building codes and standards; and
(v) Ensuring compliance with public law building requirements.
(2) The maintenance and improvement program is comprised of routine maintenance and repair funding and project funding. Typical maintenance and improvement projects have historically been funded out of regional or national project pools and may include, but are not limited to, total replacement of a heating or cooling system, remodel of a medical laboratory, removal of lead based paint, abatement of asbestos and abatement of underground fuel storage tanks. Maintenance and repair program funding provided under a funding agreement is not covered under this subpart.
NEPA means the National Environmental Policy Act of 1969 [42 U.S.C. 4321
NHPA means the National Historic Preservation Act [16 U.S.C. 470
Planning phase is the phase of a construction project agreement during which planning services are provided.
Planning services may include performing a needs assessment, completing and/or verifying master plans, developing justification documents, conducting pre-design site investigations, developing budget cost estimates, conducting feasibility studies as needed, conducting environmental review activities and justifying the need for the project.
SHPO means State Historic Preservation Officer.
Scope of work or specific scope of work means a brief written description of the work to be accomplished under the construction project agreement, sufficient to confirm that the project is consistent with the purpose for which the Secretary has allocated funds.
THPO means Tribal Historic Preservation Officer.
Yes, under section 509 of the Act [25 U.S.C. 458aaa-8], Self-Governance Tribes must assume all Federal responsibilities under the NEPA of 1969 [42 U.S.C. 4321
No, while Self-Governance Tribes are required to assume Federal environmental responsibilities for projects in place of the Secretary, Self-Governance Tribes do not thereby become Federal agencies. However, because Self-Governance Tribes are assuming the responsibilities of the Secretary for the purposes of performing these Federal environmental responsibilities, Self-Governance Tribes will be considered the equivalent of Federal agencies for certain purposes as set forth in this subpart.
The NEPA is a procedural law that requires Federal agencies to follow established environmental review procedures, which include reviewing and documenting the environmental impact of their actions. NEPA establishes a comprehensive policy for protection and enhancement of the environment by the Federal Government; creates the Council on Environmental Quality
The NHPA requires Federal agencies to take into account the effects of their undertakings, such as construction projects, on properties covered by the NHPA, such as historic properties, properties eligible for listing on the National Register of Historic Places, or properties that an Indian Tribe regards as having religious and/or cultural importance. Section 106 of the NHPA [16 U.S.C. 470f] requires Federal agencies to afford the Advisory Council on Historic Preservation, acting through the SHPO or the THPO, a reasonable opportunity to comment on such undertakings.
The Advisory Council on Historic Preservation has defined a Federal undertaking in 36 CFR 800.16(y) as a project, activity, or program funded in whole or in part under the direct or indirect jurisdiction of a Federal agency, including those carried out by or on behalf of a Federal agency; those carried out with Federal financial assistance; those requiring a Federal permit, license or approval; and those subject to State or local regulation administered pursuant to a delegation or approval by a Federal agency.
(a) Depending upon the nature and the location of the construction project, environmental laws related to NEPA and NHPA may include:
(1) Archaeological and Historical Data Preservation Act [16 U.S.C. 469];
(2) Archeological Resources Protection Act [16 U.S.C. 470aa];
(3) Clean Air Act [42 U.S.C. 7401];
(4) Clean Water Act [33 U.S.C. 1251];
(5) Coastal Barrier Improvement Act [42 U.S.C. 4028 and 16 U.S.C. Sec. 3501];
(6) Coastal Barrier Resources Act [16 U.S.C. 3501];
(7) Coastal Zone Management Act [16 U.S.C. 1451];
(8) Comprehensive Environmental Response, Compensation, and Liability Act [42 U.S.C. 9601];
(9) Endangered Species Act [16 U.S.C. 1531
(10) Farmland Protection Policy Act [7 U.S.C. 4201
(11) Marine Protection, Research, and Sanctuaries Act [33 U.S.C. 1401-1445; 16 U.S.C. 1431-1447F; 33 U.S.C. 2801-2805];
(12) National Historic Preservation Act [16 U.S.C. 470
(13) National Trails System Act [16 U.S.C. 1241];
(14) Native American Graves Protection and Repatriation Act [25 U.S.C. 3001];
(15) Noise Control Act [42 U.S.C.4901];
(16) Resource Conservation and Recovery Act [42 U.S.C. 6901];
(17) Safe Drinking Water Act [42 U.S.C. 300F];
(18) Toxic Substance Control Act [15 U.S.C. 2601];
(19) Wild and Scenic Rivers Act [16 U.S.C. 1271]; and
(20) Wilderness Act [16 U.S.C. 1131].
(b) This section provides a list of environmental laws for informational purposes only and does not create any legal rights or remedies, or imply private rights of action.
Yes, but not under section 509 of the Act [25 U.S.C. 458aaa-8]. Self-Governance Tribes may otherwise elect to perform construction projects, or phases of construction projects, under other legal authorities (see § 137.272).
Self-Governance Tribes assume environmental responsibilities by:
(a) Adopting a resolution or taking an equivalent Tribal action which:
(1) Designates a certifying officer to represent the Self-Governance Tribe and to assume the status of a responsible Federal official under NEPA, NHPA, and related provisions of law; and
(2) Accepts the jurisdiction of the Federal court, as provided in § 137.310 and § 137.311 for purposes of enforcement of the Federal environmental responsibilities assumed by the Self-Governance Tribe; and
(b) Entering into a construction project agreement under section 509 of the Act [25 U.S.C. 458aaa-8].
No, the Self-Governance Tribe may adopt a single resolution or take equivalent Tribal action to assume environmental responsibilities for a single project, multiple projects, a class of projects, or all projects performed under section 509 of the Act [25 U.S.C. 458aaa-8].
(a) Most IHS construction projects normally do not have a significant impact on the environment, and therefore do not require environmental impact statements (EIS). Under current IHS procedures, an environmental review is performed on all construction projects. During the IHS environmental review process, the following activities may occur:
(1) Consult with appropriate Tribal, Federal, state, and local officials and interested parties on potential environmental effects;
(2) Document assessment of potential environmental effects; (IHS has developed a form to facilitate this process.)
(3) Perform necessary environmental surveys and inventories;
(4) Consult with the Advisory Council on Historic Preservation, acting through the SHPO or THPO, to ensure compliance with the NHPA;
(5) Determine if extraordinary or exceptional circumstances exist that would prevent the project from meeting the criteria for categorical exclusion from further environmental review under NEPA, or if an environmental assessment is required;
(6) Obtain environmental permits and approvals; and
(7) Identify methods to avoid or mitigate potential adverse effects;
(b) This section is for informational purposes only and does not create any legal rights or remedies, or imply private rights of action.
Yes, Self-Governance Tribes may develop their own environmental review process or adopt the procedures of the IHS or the procedures of another Federal agency.
Self-Governance Tribes comply with NEPA and the NHPA by adopting and following:
(a) their own environmental review procedures;
(b) the procedures of the IHS; and/or
(c) the procedures of another Federal agency.
No, the Federal agency is responsible for ensuring its own policies and procedures meet the requirements of NEPA, NHPA, and related environmental laws, not the Self-Governance Tribe.
No, but Self-Governance Tribes may at their option, choose to voluntarily comply with Executive Orders. For facilities where ownership will vest with the Federal Government upon completion of the construction, Tribes and the Secretary may agree to include the
Yes, funds are available:
(a) for project-specific environmental costs through the construction project agreement; and
(b) for environmental review program costs through a funding agreement and/or a construction project agreement.
Yes, the Secretary must transfer not less than the amount of funds that the Secretary would have otherwise used to carry out the Federal environmental responsibilities assumed by the Self-Governance Tribe.
(a) The Self-Governance Tribe and the Secretary should work together during the initial stages of project development to identify program and project related costs associated with carrying out environmental responsibilities for proposed projects. The goal in this process is to identify the costs associated with all foreseeable environmental review activities.
(b) If unforeseen environmental review and compliance costs are identified during the performance of the construction project, the Self-Governance Tribe or, at the request of the Self-Governance Tribe, the Self-Governance Tribe and the Secretary (with or without amendment as required by § 137.363) may do one or more of the following:
(1) Mitigate adverse environmental effects;
(2) Alter the project scope of work; and/or
(3) Add additional program and/or project funding, including seeking supplemental appropriations.
(a) Yes, start-up costs are available as provided in section 508(c) of the Act [25 U.S.C. 458aaa-7(c)]. During the initial year that these responsibilities are assumed, the amount required to be paid under section 106(a)(2) of the Act [25 U.S.C. 450j-1(a)(2)] must include startup costs consisting of the reasonable costs that have been incurred or will be incurred on a one-time basis pursuant to the agreement necessary:
(1) To plan, prepare for, and assume operation of the environmental responsibilities; and
(2) To ensure compliance with the terms of the agreement and prudent management.
(b) Costs incurred before the initial year that the agreement is in effect may not be included in the amount required to be paid under section 106(a)(2) of the Act [25 U.S.C. 450j-1(a)(2)] if the Secretary does not receive a written notification of the nature and extent of the costs prior to the date on which such costs are incurred.
Yes, Self-Governance Tribes may use construction program and project funds for training and program development. Training and program development funds may also be available from other Federal agencies, such as the Environmental Protection Agency and the National Park Service, state and local governments, and private organizations.
Yes, Self-Governance Tribes may “buy back” project related services in their construction project agreement, including design and construction engineering, and environmental compliance services from the IHS in accordance with Section 508(f) of the Act [25 U.S.C.
Yes, Self-Governance Tribes assuming Federal environmental responsibilities for construction projects under section 509 of the Act [25 U.S.C. 458aaa-8] are entitled to receive equal consideration, on the same basis as any Federal agency, for lead, cooperating, and joint lead agency status. For informational purposes, the terms “lead,” “cooperating,” and “joint lead agency” are defined in the CEQ regulations at 40 CFR 1508.16, 1508.5, and 1501.5 respectively.
Self-Governance Tribes may be recognized as having lead, cooperating, or joint lead agency status through funding or other agreements with other agencies. To the extent that resources are available, the Secretary will encourage and facilitate Federal, state, and local agencies to enter into agreements designating Tribes as lead, cooperating, or joint lead agencies for environmental review purposes.
(a) All environmental responsibilities for Federal actions not directly related to construction projects assumed by Tribes under section 509 of the Act [25 U.S.C. 458aaa-8] remain with the Secretary. Federal agencies, including the IHS, retain responsibility for ensuring their environmental review procedures meet the requirements of NEPA, NHPA and related provisions of law, as called for in § 137.297.
(b) The Secretary will provide information updating and changing IHS agency environmental review policy and procedures to all Self-Governance Tribes implementing a construction project agreement, and to other Indian Tribes upon request. If a Self-Governance Tribe participating under section 509 of the Act [25 U.S.C. 458aaa-8] does not wish to receive this information, it must notify the Secretary in writing. As resources permit, at the request of the Self-Governance Tribe, the Secretary will provide technical assistance to the Self-governance tribe to assist the Self-governance Tribe in carrying out Federal environmental responsibilities.
No, the Secretary does not have any enforcement authority for Federal environmental responsibilities assumed by Tribes under section 509 of the Act [25 U.S.C. 458aaa-8].
NEPA and NHPA obligations are typically enforced by interested parties who may file lawsuits against Federal agencies alleging that the agencies have not complied with their legal obligations under NEPA and NHPA. These lawsuits may only be filed in Federal court under the provisions of the APA, 5 U.S.C. 701-706. Under the APA, a Federal judge reviews the Federal agency's actions based upon an administrative record prepared by the Federal agency. The judge gives appropriate deference to the agency's decisions and does not substitute the court's views for those of the agency. Jury trials and civil discovery are not permitted in APA proceedings. If a Federal agency has failed to comply with NEPA or NHPA, the judge may grant declaratory or injunctive relief to the interested party. No money damages or fines are permitted in APA proceedings.
Yes, but only as provided in this section. Unless Self-Governance Tribes consent to the jurisdiction of a court, Self-Governance Tribes are immune from civil lawsuits. Self-Governance Tribes electing to assume Federal environmental responsibilities under section 509 of the Act [25 U.S.C. 458aaa-8] must provide a limited waiver of sovereign immunity solely for the purpose of enforcing a Tribal certifying officer's environmental responsibilities, as set forth in this subpart. Self-Governance Tribes are not required to waive any other immunity.
(a) Yes, Section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)] only requires that the waiver permit a civil enforcement action to be brought against the Tribal certifying officer in his or her official capacity in Federal district court for declaratory and injunctive relief in a procedure that is substantially equivalent to an APA enforcement action against a Federal agency. Self-Governance Tribes are not required to subject themselves to suit in their own name, to submit to trial by jury or civil discovery, or to waive immunity for money damages, attorneys fees, or fines.
(b) Self-Governance Tribes may base the grant of a limited waiver under this subpart on the understanding that:
(1) Judicial review of the Tribal certifying official's actions are based upon the administrative record prepared by the Tribal official in the course of performing the Federal environmental responsibilities; and
(2) Actions and decisions of the Tribal certifying officer will be granted deference on a similar basis as Federal officials performing similar functions.
Only the designated Tribal certifying officer acting in his or her official capacity may be sued. Self-Governance Tribes and other Tribal officials are not proper defendants in lawsuits brought under section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)].
Yes, before developing a new project resource allocation methodology and application process the Secretary must consult with all Indian Tribes. In addition, before spending any funds for planning, design, construction, or renovation projects, whether subject to a competitive application and ranking process or not, the Secretary must consult with any Indian Tribe that would be significantly affected by the expenditure to determine and honor Tribal preferences whenever practicable concerning the size, location, type, and other characteristics of the project.
In addition to the requirements contained in section 513 of the Act [25 U.S.C. 458aaa-12], Indian Tribes and the Secretary are encouraged to jointly identify health facility and sanitation needs at the earliest possible date for IHS budget formulation. In developing budget justifications for specific projects to be proposed to Congress, the Secretary shall follow the preferences of the affected Indian Tribe(s) to the greatest extent feasible concerning the size, location, type, and other characteristics of the project.
(a) Yes, within 30 days after the Secretary's allocation of funds for planning phase, design phase, or construction phase activities for a specific project, the Secretary shall notify, by registered mail with return receipt in order to document mailing, the Indian Tribe(s) to be benefitted by the availability of the funds for each phase of a project. The Secretarial notice of fund allocation shall offer technical assistance in the preparation of a construction project proposal.
(b) The Secretary shall, within 30 days after receiving a request from an Indian Tribe, furnish the Indian Tribe with all information available to the Secretary about the project including, but not limited to: construction drawings, maps, engineering reports, design reports, plans of requirements, cost estimates, environmental assessments, or environmental impact reports and archeological reports.
(c) An Indian Tribe is not required to request this information prior to either submitting a notification of intent or a construction project proposal.
(d) The Secretary shall have a continuing responsibility to furnish information to the Indian Tribes.
(a) A Self-Governance Tribe may start the process of developing a construction project agreement by:
(1) Notifying the Secretary in writing that the Self-Governance Tribe wishes to enter into a pre-agreement negotiation phase as set forth in section 105(m)(3) of the Act [25 U.S.C. 450j(m)(3)]; or
(2) Submitting a proposed construction project agreement. This proposed agreement may be the final proposal, or it may be a draft for consideration and negotiation, or
(3) A combination of the actions described in paragraphs (a)(1) and (2) of this section.
(b) Upon receiving a Self-Governance Tribe's request to enter into a pre-negotiation phase the Secretary shall take the steps outlined in section 105(m)(3) of the Act [25 U.S.C. 450j(m)(3)].
A construction project proposal must contain all of the required elements of a construction project agreement as defined in § 137.280. In addition to these minimum requirements, Self-Governance Tribes may propose additional items.
Yes, a Self-Governance Tribe may include multiple projects in a single construction project agreement proposal or may add additional approved projects by amendment(s) to an existing construction project agreement.
(a) No, the Self-Governance Tribe and the Secretary must agree upon and specify appropriate building codes and architectural and engineering standards (including health and safety) which must be in conformity with nationally recognized standards for comparable projects.
(b) The Secretary may provide, or the Self-Governance Tribe may request, Federal construction guidelines and manuals for consideration by the Self-Governance Tribe in the preparation of its construction project proposal. If Tribal construction codes and standards (including national, regional, State, or Tribal building codes or construction industry standards) are consistent with or exceed otherwise applicable nationally recognized standards, the Secretary must accept the Tribally proposed standards.
The construction project agreement must include:
(a) Identification of the Tribal certifying officer for environmental review purposes,
(b) Reference to the Tribal resolution or equivalent Tribal action appointing the Tribal certifying officer and accepting the jurisdiction of the Federal court for enforcement purposes as provided in §§ 137.310 and 137.311.
(c) Identification of the environmental review procedures adopted by the Self-Governance Tribe, and
(d) An assurance that no action will be taken on the construction phase of the project that would have an adverse environmental impact or limit the choice of reasonable alternatives prior to making an environmental determination in accordance with the Self-Governance Tribe's adopted procedures.
The Self-Governance Tribe may submit a final construction project proposal to the Secretary. No later than 30 days after the Secretary receives the final construction project proposal, or within a longer time agreed to by the Self-Governance Tribe in writing, the Secretary shall review and make a determination to approve or reject the construction project proposal in whole or in part.
No, the Secretary may not reject a final construction project proposal based on a determination of Tribal capacity or capability.
(a) The only basis for rejection of project activities in a final construction project proposal are:
(1) The amount of funds proposed in the final construction project proposal exceeds the applicable funding level for the construction project as determined under sections 508(c) [25 U.S.C. 458aaa-7(c)] and 106 of the Act [25 U.S.C. 450j-1].
(2) The final construction project proposal does not meet the minimum content requirements for construction project agreements set forth in section 501(a)(2) of the Act [25 U.S.C. 458aaa(a)(2)]; and
(3) The final construction project proposal on its face clearly demonstrates that the construction project cannot be completed as proposed.
(b) For construction programs proposed to be included in a construction project agreement, the Secretary may also reject that portion of the proposal that proposes to assume an inherently Federal function that cannot legally be delegated to the Self-Governance Tribe.
Whenever the Secretary rejects a final construction project proposal in whole or in part, the Secretary must:
(a) Send the Self-Governance Tribe a timely written notice of rejection that shall set forth specific finding(s) that clearly demonstrates, or that is supported by controlling legal authority supporting the rejection;
(b) Within 20 days, provide all documents relied on in making the rejection decision to the Self-Governance Tribe;
(c) Provide assistance to the Self-Governance Tribe to overcome any objections stated in the written notice of rejection;
(d) Provide the Self-Governance Tribe with a hearing on the record with the right to engage in full discovery relevant to any issue raised in the matter and the opportunity for appeal of the decision to reject the final construction contract proposal, under the regulations set forth in subpart P of this part, except that the Self-Governance Tribe may, in lieu of filing an appeal, initiate an action in Federal district court and proceed directly under sections 511 [25 U.S.C. 458aaa-10] and 110(a) of the Act [25 U.S.C. 450m-1(a)]. With respect to any hearing or appeal or civil action conducted pursuant to this section, the Secretary shall have
(e) Provide the Self-Governance Tribe with the option of entering into the severable portions of a final proposed construction project agreement (including a lesser funding amount) that the Secretary did not reject, subject to any additional alterations necessary to conform the construction project agreement to the severed provisions. Exercising this option does not affect the Self-Governance Tribe's right to appeal the portion of the final construction project proposal that was rejected by the Secretary.
If the Secretary fails to notify the Self-Governance Tribe of the decision to approve or reject within 30 days (or a longer period if agreed to by the Self-Governance Tribe in writing), then the proposal will be deemed approved by the Secretary.
(a) A Self-Governance Tribe may include costs allowed by applicable OMB Circulars, and costs allowed under sections 508(c) [25 U.S.C. 458aaa-7(c)], 106 [25 U.S.C. 450j-1] and 105 (m) of the Act [25 U.S.C. 450j(m)]. The costs incurred will vary depending on which phase of the construction process the Self-Governance Tribe is conducting and type of construction project agreement that will be used.
(b) Regardless of whether a construction project agreement is fixed price or cost-reimbursement, budgets may include costs or fees associated with the following:
(1) Construction project proposal preparation;
(2) Conducting community meetings to develop project documents;
(3) Architects, engineers, and other consultants to prepare project planning documents, to develop project plans and specifications, and to assist in oversight of the design during construction;
(4) Real property lease or acquisition;
(5) Development of project surveys including topographical surveys, site boundary descriptions, geotechnical surveys, archeological surveys, and NEPA compliance;
(6) Project management, superintendence, safety and inspection;
(7) Travel, including local travel incurred as a direct result of conducting the construction project agreement and remote travel in conjunction with the project;
(8) Consultants, such as demographic consultants, planning consultants, attorneys, accountants, and personnel who provide services, to include construction management services;
(9) Project site development;
(10) Project construction cost;
(11) General, administrative overhead, and indirect costs;
(12) Securing and installing moveable equipment, telecommunications and data processing equipment, furnishings, including works of art, and special purpose equipment when part of a construction contract;
(13) Other costs directly related to performing the construction project agreement;
(14) Project Contingency:
(i) A cost-reimbursement project agreement budgets contingency as a broad category. Project contingency remaining at the end of the project is considered savings.
(ii) Fixed-price agreements budget project contingency in the lump sum price or unit price.
(c) In the case of a fixed-price project agreement, a reasonable profit determined by taking into consideration the relevant risks and local market conditions.
(a) Cost-reimbursement agreements generally have one or more of the following characteristics:
(1) Risk is shared between IHS and the Self-Governance Tribe;
(2) Self-Governance Tribes are not required to perform beyond the amount of funds provided under the agreement;
(3) Self-Governance Tribes establish budgets based upon the actual costs of the project and are not allowed to include profit;
(4) Budgets are stated using broad categories, such as planning, design, construction project administration, and contingency;
(5) The agreement funding amount is stated as a “not to exceed” amount;
(6) Self-Governance Tribes provide notice to the IHS if they expect to exceed the amount of the agreement and require more funds;
(7) Excess funds remaining at the end of the project are considered savings; and
(8) Actual costs are subject to applicable OMB circulars and cost principles.
(b) Fixed Price agreements generally have one or more of the following characteristics:
(1) Self-Governance Tribes assume the risk for performance;
(2) Self-Governance Tribes are entitled to make a reasonable profit;
(3) Budgets may be stated as lump sums, unit cost pricing, or a combination thereof;
(4) For unit cost pricing, savings may occur if actual quantity is less than estimated; and,
(5) Excess funds remaining at the end of a lump sum fixed price project are considered profit, unless, at the option of the Self-Governance Tribe, such amounts are reclassified in whole or in part as savings.
The Secretary must provide funding for a construction project agreement in accordance with sections 106 [25 U.S.C. 450j-1] and 508(c) of the Act [25 U.S.C. 458aaa-7(c)].
Yes, at the request of the Self-Governance Tribe, the Secretary must include funds from other agencies as permitted by law, whether on an ongoing or a one-time basis.
Yes, notwithstanding any other provision of law, all funds provided under a construction project agreement may be treated as non-Federal funds for purposes of meeting matching or cost participation requirements under any other Federal or non-Federal program.
Yes, the Self-Governance Tribe and the Secretary may jointly fund projects. The construction project agreement should identify the Secretarial amount and any Tribal contribution amount that is being incorporated into the construction project agreement. The Self-Governance Tribe does not have to deposit its contribution with the Secretary.
(a) For all construction project agreements, advance payments shall be made annually or semiannually, at the Self-Governance Tribe's option. The initial payment shall include all contingency funding for the project or phase of the project to the extent that there are funds appropriated for that purpose.
(b) The amount of subsequent payments is based on the mutually agreeable project schedule reflecting:
(1) Work to be accomplished within the advance payment period,
(2) Work already accomplished, and
(3) Total prior payments for each annual or semiannual advance payment period.
(c) For lump sum, fixed price agreements, at the request of the Self-Governance Tribe, payments shall be based on an advance payment period measured as follows:
(1) One year; or
(2) Project Phase(e.g., planning, , design, construction.) If project phase is chosen as the payment period, the full amount of funds necessary to perform the work for that phase of the construction project agreement is payable
(d) For the purposes of payment, Sanitation Facilities Construction Projects authorized pursuant to Pub. L. 86-121, are considered to be a single construction phase and are payable in a single lump sum advance payment in accordance with paragraph (c)(2) of this section.
(e) For all other construction project agreements, the amount of advance payments shall include the funds necessary to perform the work identified in the advance payment period of one year.
(f) Any agreement to advance funds under paragraphs (b), (c) or (d) of this section is subject to the availability of appropriations.
(g) (1) Initial advance payments are due within 10 days of the effective date of the construction project agreement; and
(2) subsequent payments are due:
(i) Within 10 days of apportionment for annual payments or
(ii) Within 10 days of the start date of the project phase for phase payments.
All funds, including contingency funds, remaining at the conclusion of the project are considered savings and may be used by the Self-Governance Tribe to provide additional services for the purpose for which the funds were originally appropriated. No further approval or justifying documentation is required before the expenditure of the remaining funds.
(a) For lump sum fixed price construction project agreements, all funds remaining at the conclusion of the project are considered profits and belong to the Self-Governance Tribe.
(b) For fixed price construction project agreements with unit price components, all funds remaining that are associated with overestimated unit price quantities are savings and may be used by the Self-Governance Tribe in accordance with section 137.342. All other funds remaining at the conclusion of the project are considered profit and belong to the Self-Governance Tribe.
(c) At the option of the Self-Governance Tribe, funds otherwise identified in paragraphs (a) and (b) as “profit” may be reclassified, in whole or in part, as savings and to that extent may be used by the Self-Governance Tribe in accordance with section 137.142.
Yes, a Self-Governance Tribe may reallocate funds among construction project agreements to the extent not prohibited by applicable appropriation law(s).
Yes, a Self-Governance Tribe assumes responsibility for completing a construction project, including day-to-day on-site management and administration of the project, in accordance with the negotiated construction project agreement. However, Self-Governance Tribes are not required to perform beyond the amount of funds provided. For example, a Self-Governance Tribe may encounter unforeseen circumstances during the term of a construction project agreement. If this occurs, options available to the Self-Governance Tribe include, but are not limited to:
(a) Reallocating existing funding;
(b) Reducing/revising the scope of work that does not require an amendment because it does not result in a significant change;
(c) Utilizing savings from other projects;
(d) Requesting additional funds or appropriations;
(e) Utilizing interest earnings;
(f) Seeking funds from other sources; and/or
(g) Redesigning or re-scoping that does result in a significant change by amendment as provided in §§ 137.363 and 137.364.
Yes, a Self-Governance Tribe must provide the Secretary with construction project progress and financial reports semiannually or, at the option of the Self-Governance Tribe, on a more frequent basis. Self-Governance Tribes are only required to submit the reports, as negotiated in the Construction Project Agreement, after funds have been transferred to the Self-Governance Tribe for a construction project. Construction project progress reports and financial reports are only required for active construction projects.
Construction project progress reports contain information about accomplishments during the reporting period and issues and concerns of the Self-Governance Tribe, if any.
Construction project financial reports contain information regarding the amount of funds expended during the reporting period, and financial concerns of the Self-Governance Tribe, if any.
The Secretary shall have at least one opportunity to approve project planning and design documents prepared by the Self-Governance Tribe in advance of construction if the Self-Governance Tribe is required to submit planning or design documents as a part of the scope of work under a construction project agreement.
Yes, but only if there is an amendment to the construction project agreement that results in a significant change in the original scope of work.
Yes, the Self-Governance Tribe, at its discretion, may request the Secretary to amend a construction project agreement to include additional projects. In addition, amendments are required if there is a significant change from the original scope of work or if funds are added by the Secretary. The Self-Governance Tribe may make immaterial changes to the performance period and make budget adjustments within available funding without an amendment to the construction project agreement.
(a) The Secretary shall promptly notify the Self-Governance Tribe in writing of any concerns or issues that may lead to disapproval. The Secretary shall share relevant information and documents, and make a good faith effort to resolve all issues and concerns of the Self-Governance Tribe. If, after consultation with the Self-Governance Tribe, the Secretary intends to disapprove the proposed amendment, then the Secretary shall follow the procedures set forth in § 137.330 through 137.334.
(b) The time allowed for Secretarial review, comment, and approval of amendments is 30 days, or within a longer time if agreed to by the Self-Governance Tribe in writing. Absence of a written response by the Secretary within 30 days shall be deemed approved.
(c) The timeframe set forth in paragraph (b) of this section is intended to
A significant change in the original scope of work is:
(a) A change that would result in a cost that exceeds the total of the project funds available and the Self-Governance Tribe's contingency funds; or
(b) A material departure from the original scope of work, including substantial departure from timelines negotiated in the construction project agreement.
(a) The Secretary shall review and approve planning documents to ensure compliance with planning standards identified in the construction project agreement. The Secretary shall review and approve design documents for general compliance with requirements of the construction project agreement.
(b) The Secretary shall promptly notify the Self-Governance Tribe in writing of any concerns or issues that may lead to disapproval. The Secretary shall share relevant information and documents, and make a good faith effort to resolve all issues and concerns of the Self-Governance Tribe. If, after consultation with the Self-Governance Tribe, the Secretary intends to disapprove the documents, then the Secretary shall follow the procedures set forth in § 137.333.
(c) The time allowed for Secretarial review, comment, and approval of planning and design documents is 21 days, unless otherwise agreed to by the Self-Governance Tribe in writing. Absence of a written response by the Secretary within 21 days shall be deemed approved.
Yes, the Secretary may conduct onsite project oversight visits semiannually or on an alternate schedule negotiated in the construction project agreement. The Secretary must provide the Self-Governance Tribe with reasonable advance written notice to assist the Self-Governance Tribe in coordinating the visit. The purpose of the visit is review the progress under the construction project agreement. At the request of the Self-Governance Tribe, the Secretary must provide the Self-Governance Tribe a written site visit report.
No, the Secretary has no role in the day-to-day management of a construction project.
No, the Secretary is not responsible for oversight and compliance of health and safety codes during construction projects being performed by a Self-Governance Tribe under section 509 of the Act [25 U.S.C. 488aaa-8].
Yes, to the extent the provisions are not inconsistent with the provisions in this subpart. Provisions that do not apply include: programmatic reports and data requirements; reassumption; compact and funding agreement review, approval, and final offer process; and compact and funding agreement contents.
The Self-Governance Tribe takes title to the real property unless the
No, the Secretary does not have a role in the fee-to-trust process except to provide technical assistance if requested by the Self-Governance Tribe.
No, unless the Self-Governance Tribe has requested the Secretary to take fee title to the property.
No, unless the Self-Governance Tribe has requested the Secretary take fee title to the property. The Self-Governance Tribe is responsible for acquiring all real property needed to perform a construction project under a construction project agreement, not the Secretary. The Secretary shall not withhold funds or refuse to enter into a construction project agreement because of a disagreement between the Self-Governance Tribe and the Secretary over the Self-Governance Tribe's decisions to purchase or lease real property.
Yes, Tribally-owned facilities constructed under section 509 of the Act [25 U.S.C. 458aaa-8] are eligible for replacement, maintenance, and improvement funds on the same basis as if title to such property were vested in the United States.
No, however, the Self-Governance Tribe and the Secretary may negotiate the use of Federal metric requirements in the construction project agreement when the Self-Governance Tribe will design and/or construct an IHS facility that the Secretary will own and operate.
No, unless otherwise agreed to by the Tribe, no provision of the Office of Federal Procurement Policy Act, the Federal Acquisition Regulations issued pursuant thereto, or any other law or regulation pertaining to Federal procurement (including Executive Orders) shall apply to any construction project conducted under section 509 of the Act [25 U.S.C. 458aaa-8]. The Secretary and the Self-Governance Tribe may negotiate to apply specific provisions of the Office of Federal Procurement and Policy Act and Federal Acquisition Regulations to a construction project agreement or funding agreement. Absent a negotiated agreement, such provisions and regulatory requirements do not apply.
No, the Federal Davis-Bacon Act and wage rates do not apply to construction projects performed by Self-Governance Tribes using their own funds or other non-Federal funds.
Davis-Bacon Act wage rates only apply to laborers and mechanics employed by the contractors and subcontractors (excluding Indian Tribes,
The IHS will consult with Tribes on budget issues consistent with Administration policy on Tribal consultation.
Yes, no later than January 1 of each year after the date of enactment of the Tribal Self-Governance Amendments of 2000, the Secretary shall submit to the Committee on Indian Affairs of the Senate and the Committee on Resources of the House of Representatives a written report regarding the administration of Title V. The report shall include a detailed analysis of the funding requirements presently funded or unfunded for each Indian Tribe or Tribal organization, either directly by the Secretary, under self-determination contracts under Title I, or under compacts and funding agreements authorized under Title V.
No, in compiling reports pursuant to this section, the Secretary may not impose any reporting requirements on Self-Governance Tribes, not otherwise provided in Title V.
The report shall be compiled from information contained in funding agreements, annual audit reports, and data of the Secretary regarding the disposition of Federal funds. The report must identify:
(a) The relative costs and benefits of self-governance, including savings;
(b) With particularity, all funds that are specifically or functionally related to the provision by the Secretary of services and benefits to Self-Governance Tribes and their members;
(c) The funds transferred to each Self-Governance Tribe and the corresponding reduction in the Federal bureaucracy;
(d) The funding formula for individual Tribal shares of all headquarters' funds, together with the comments of affected Self-Governance Tribes, developed under § 137.405 of this subpart; and
(e) Amounts expended in the preceding fiscal year to carry out inherent Federal functions, including an identification of those functions by type and location.
Yes, for the purposes of section 110 of the Act [25 U.S.C. 450m-1] the term “contract” includes compacts, funding agreements, and construction project agreements entered into under Title V.
Yes, the regulations at 25 CFR Part 900, Subpart N apply to compacts, funding agreements, and construction project agreements entered into under Title V.
An Indian Tribe may appeal:
(a) A decision to reject a final offer, or a portion thereof, under section 507(b) of the Act [25 U.S.C. 458aaa-6(b)];
(b) A decision to reject a proposed amendment to a compact or funding agreement, or a portion thereof, under section 507(b) of the Act [25 U.S.C. 458aaa-6(b)];
(c) A decision to rescind and reassume a compact or funding agreement, in whole or in part, under section 507(a)(2) of the Act [25 U.S.C. 458aaa-6(a)(2)], except for immediate reassumptions under section 507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)];
(d) A decision to reject a final construction project proposal, or a portion thereof, under section 509(b) of the Act [25 U.S.C. 458aaa-8(b)] and subpart N of this part; and
(e) For construction project agreements carried out under section 509 of the Act [25 U.S.C. 458aaa-8], a decision to reject project planning documents, design documents, or proposed amendments submitted by a Self-Governance Tribe under section 509(f) of the Act [25 U.S.C. 458aaa-8(f)] and subpart N of this part.
No, §§ 137.415 through 137.436 only apply to decisions listed in § 137.415. Specifically, §§ 137.415 through 137.436 do not apply to any other dispute, including, but not limited to:
(a) Disputes arising under the terms of a compact, funding agreement, or construction project agreement that has been awarded;
(b) Disputes arising from immediate reassumptions under section 507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)] and § 137.261 and 137.262, which are covered under § 137.440 through 137.445.
(c) Other post-award contract disputes, which are covered under § 137.412.
(d) Denials under the Freedom of Information Act, 5 U.S.C. 552, which may be appealed under 45 CFR part 5.
(e) Decisions relating to the award of grants under section 503(e) of the Act [25 U.S.C. 458aaa-2(e)], which may be appealed under 45 CFR part 5.
The IBIA may use the procedures set forth in 43 CFR 4.22-4.27 as a guide.
Every decision in any of the areas listed in § 137.415 must contain information which shall tell the Indian Tribe where and when to file the Indian Tribe's appeal. Each decision shall include the following statement:
Within 30 days of the receipt of this decision, you may request an informal conference under 42 CFR 137.421, or appeal this decision under 42 CFR 137.425 to the Interior Board of Indian Appeals (IBIA). Should you decide to appeal this decision, you may request a hearing on the record. An appeal to the IBIA under 42 CFR 137.425 shall be filed with the IBIA by certified mail or by hand delivery at the following address: Board of Indian Appeals, U.S. Department of the Interior, 4015 Wilson Boulevard, Arlington, VA 22203. You shall serve copies of your Notice of Appeal on the Secretary and on the official whose decision is being appealed. You shall certify to the IBIA that you have served these copies.
The IBIA has the authority:
(a) to conduct a hearing on the record;
(b) to permit the parties to engage in full discovery relevant to any issue raised in the matter;
(c) to issue a recommended decision;
(d) to take such action as necessary to insure rights specified in § 137.430.
Yes, the Indian Tribe may request an informal conference. An informal conference is a way to resolve issues as quickly as possible, without the need for a formal hearing. Or, the Indian
The Indian Tribe must file its request for an informal conference with the office of the person whose decision it is appealing, within 30 days of the day it receives the decision. The Indian Tribe may either hand-deliver the request for an informal conference to that person's office, or mail it by certified mail, return receipt requested. If the Indian Tribe mails the request, it will be considered filed on the date the Indian Tribe mailed it by certified mail.
(a) The informal conference must be held within 30 days of the date the request was received, unless the Indian Tribe and the authorized representative of the Secretary agree on another date.
(b) If possible, the informal conference will be held at the Indian Tribe's office. If the meeting cannot be held at the Indian Tribe's office and is held more than fifty miles from its office, the Secretary must arrange to pay transportation costs and per diem for incidental expenses to allow for adequate representation of the Indian Tribe.
(c) The informal conference must be conducted by a designated representative of the Secretary.
(d) Only people who are the designated representatives of the Indian Tribe, or authorized by the Secretary are allowed to make presentations at the informal conference. Such designated representatives may include Office of Tribal Self-Governance.
(a) Within 10 days of the informal conference, the person who conducted the informal conference must prepare and mail to the Indian Tribe a written report which summarizes what happened at the informal conference and a recommended decision.
(b) Every report of an informal conference must contain the following language:
Within 30 days of the receipt of the recommended decision from the informal conference, you may file an appeal of the initial decision of the DHHS agency with the Interior Board of Indian Appeals (IBIA) under 42 CFR 137.425. You may request a hearing on the record. An appeal to the IBIA under 42 CFR 137.425 shall be filed with the IBIA by certified mail or hand delivery at the following address: Board of Indian Appeals, U.S. Department of the Interior, 4015 Wilson Boulevard, Arlington, VA 22203. You shall serve copies of your Notice of Appeal on the Secretary and on the official whose decision is being appealed. You shall certify to the IBIA that you have served these copies. Alternatively you may file an action in Federal court pursuant to section 110 of the Act. [25 U.S.C. 450m-1].
No. If the Indian Tribe is dissatisfied with the recommended decision from the informal conference, it may still appeal the initial decision within 30 days of receiving the recommended decision and the report of the informal conference. If the Indian Tribe does not file a notice of appeal within 30 days, or before the expiration of the extension it has received under § 137.426 , the recommended decision of the informal conference becomes final for the Secretary and may be appealed to Federal court pursuant to section 110 of the Act [25 U.S.C. 450m-1].
(a) If the Indian Tribe decides to appeal, it must file a notice of appeal with the IBIA within 30 days of receiving either the initial decision or the recommended decision from the informal conference.
(b) The Indian Tribe may either hand-deliver the notice of appeal to the IBIA, or mail it by certified mail, return receipt requested. If the Indian Tribe mails the Notice of Appeal, it
(c) The Notice of Appeal must:
(1) Briefly state why the Indian Tribe thinks the initial decision is wrong;
(2) Briefly identify the issues involved in the appeal; and
(3) State whether the Indian Tribe wants a hearing on the record, or whether the Indian Tribe wants to waive its right to a hearing.
(d) The Indian Tribe must serve a copy of the notice of appeal upon the official whose decision it is appealing. The Indian Tribe must certify to the IBIA that it has done so.
(e) The authorized representative of the Secretary will be considered a party to all appeals filed with the IBIA under the Act.
(f) In lieu of filing an administrative appeal an Indian Tribe may proceed directly to Federal court pursuant to section 110 of the Act [25 U.S.C. 450m-1].
Yes, if the Indian Tribe needs additional time, the Indian Tribe may request an extension of time to file its Notice of Appeal with the IBIA within 60 days of receiving either the initial decision or the recommended decision resulting from the informal conference. The request of the Indian Tribe must be in writing, and must give a reason for not filing its notice of appeal within the 30-day time period. If the Indian Tribe has a valid reason for not filing its notice of appeal on time, it may receive an extension.
(a) Within 5 days of receiving the Indian Tribe's notice of appeal, the IBIA will decide whether the appeal falls under § 137.415. If so, the Indian Tribe is entitled to a hearing.
(b) If the IBIA cannot make that decision based on the information included in the notice of appeal, the IBIA may ask for additional statements from the Indian Tribe, or from the appropriate Federal agency. If the IBIA asks for more statements, it will make its decision within 5 days of receiving those statements.
(c) If the IBIA decides that the Indian Tribe is not entitled to a hearing or if the Indian Tribe has waived its right to a hearing on the record, the IBIA will dismiss the appeal and inform the Indian Tribe that it is not entitled to a hearing or has waived its right to a hearing.
(a) If a hearing is to be held, the IBIA will refer the Indian Tribe's case to the Hearings Division of the Office of Hearings and Appeals of the U.S. Department of the Interior. The case will then be assigned to an Administrative Law Judge (ALJ), appointed under 5 U.S.C. 3105.
(b) Within 15 days of the date of the referral, the ALJ will hold a pre-hearing conference, by telephone or in person, to decide whether an evidentiary hearing is necessary, or whether it is possible to decide the appeal based on the written record. At the pre-hearing conference the ALJ will provide for:
(1) A briefing and discovery schedule;
(2) A schedule for the exchange of information, including, but not limited to witness and exhibit lists, if an evidentiary hearing is to be held;
(3) The simplification or clarification of issues;
(4) The limitation of the number of expert witnesses, or avoidance of similar cumulative evidence, if an evidentiary hearing is to be held;
(5) The possibility of agreement disposing of all or any of the issues in dispute; and
(6) Such other matters as may aid in the disposition of the appeal.
(c) The ALJ shall order a written record to be made of any conference results that are not reflected in a transcript.
(a) The ALJ must hold a hearing within 90 days of the date of the order referring the appeal to the ALJ, unless
(b) At least 30 days before the hearing, the Secretary must file and serve the Indian Tribe with a response to the notice of appeal.
(c) If the hearing is held more than 50 miles from the Indian Tribe's office, the Secretary must arrange to pay transportation costs and per diem for incidental expenses to allow for adequate representation of the Indian Tribe.
(d) The hearing shall be conducted in accordance with the Administrative Procedure Act, 5 U.S.C. 556.
As required by section 518 of the Act [25 U.S.C. 458aaa-17], the Secretary must demonstrate by clear and convincing evidence the validity of the grounds for the decision made and that the decision is fully consistent with provisions and policies of the Act.
Both the Indian Tribe and the Secretary have the same rights during the appeal process. These rights include the right to:
(a) Be represented by legal counsel;
(b) Have the parties provide witnesses who have knowledge of the relevant issues, including specific witnesses with that knowledge, who are requested by either party;
(c) Cross-examine witnesses;
(d) Introduce oral or documentary evidence, or both;
(e) Require that oral testimony be under oath;
(f) Receive a copy of the transcript of the hearing, and copies of all documentary evidence which is introduced at the hearing;
(g) Compel the presence of witnesses, or the production of documents, or both, by subpoena at hearings or at depositions;
(h) Take depositions, to request the production of documents, to serve interrogatories on other parties, and to request admissions; and
(i) Any other procedural rights under the Administrative Procedure Act, 5 U.S.C. 556.
(a) Within 30 days of the end of the formal hearing or any post-hearing briefing schedule established by the ALJ, the ALJ shall send all the parties a recommended decision, by certified mail, return receipt requested. The recommended decision must contain the ALJ's findings of fact and conclusions of law on all the issues. The recommended decision shall also state that the Indian Tribe has the right to object to the recommended decision.
(b) The recommended decision shall contain the following statement:
Within 30 days of the receipt of this recommended decision, you may file an objection to the recommended decision with the Secretary under 42 CFR 137.43. An appeal to the Secretary under 42 CFR 137.43 shall be filed at the following address: Department of Health and Human Services, 200 Independence Ave. S.W., Washington, DC, 20201. You shall serve copies of your notice of appeal on the official whose decision is being appealed. You shall certify to the Secretary that you have served this copy. If neither party files an objection to the recommended decision within 30 days, the recommended decision will become final.
No, any party to the appeal may file precise and specific written objections to the recommended decision, or any other comments, within 30 days of receiving the recommended decision. Objections must be served on all other parties. The recommended decision shall become final for the Secretary 30 days after the Indian Tribe receives the ALJs recommended decision, unless a written statement of objections is filed with the Secretary during the 30-day period. If no party files a written statement of objections within 30 days, the recommended decision shall become final for the Secretary.
(a) The Secretary has 45 days from the date it receives the final authorized
(b) When reviewing the recommended decision, the Secretary may consider and decide all issues properly raised by any party to the appeal, based on the record.
(c) The decision of the Secretary must:
(1) Be in writing;
(2) Specify the findings of fact or conclusions of law that are modified or reversed;
(3) Give reasons for the decision, based on the record; and
(4) State that the decision is final for the Department.
No, a pending appeal will not adversely affect or prevent the negotiation or award of another compact, funding agreement, or construction project agreement.
Yes, all final decisions must be published for the Department under this subpart. Decisions can be found on the Department's website.
(a) The Secretary may, upon written notification to the Self-Governance Tribe, immediately reassume operation of a program, service, function, or activity (or portion thereof) if:
(1) The Secretary makes a finding of imminent substantial and irreparable endangerment of the public health caused by an act or omission of the Self-Governance Tribe; and
(2) The endangerment arises out of a failure to carry out the compact or funding agreement.
(b) When the Secretary advises a Self-Governance Tribe that the Secretary intends to take an action referred to in paragraph (a) of this section, the Secretary must also notify the Deputy Director of the Office of Hearings and Appeals, Department of the Interior, 4015 Wilson Boulevard, Arlington, VA 22203.
Yes, unless the Self-Governance Tribe waives its right to a hearing in writing. The Deputy Director of the Office of Hearings and Appeals must appoint an Administrative Law Judge to hold a hearing,
(a) The hearing must be held within 10 days of the date of the notice referred to in § 137.440 unless the Self-Governance Tribe agrees to a later date.
(b) If possible, the hearing will be held at the office of the Self-Governance Tribe. If the hearing is held more than 50 miles from the office of the Self-Governance Tribe, the Secretary must arrange to pay transportation costs and per diem for incidental expenses. This will allow for adequate representation of the Self-Governance Tribe.
(a) Within 30 days after the end of the hearing or any post-hearing briefing schedule established by the ALJ, the ALJ must send all parties a recommended decision by certified mail, return receipt requested. The recommended decision shall contain the ALJs findings of fact and conclusions of law on all the issues. The recommended decision must also state that the Self-Governance Tribe has the right to object to the recommended decision.
(b) The recommended decision must contain the following statement:
Within 15 days of the receipt of this recommended decision, you may file an objection to the recommended decision with the Secretary under § 137.443. An appeal to the
No, any party to the appeal may file precise and specific written objections to the recommended decision, or any other comments, within 15 days of receiving the recommended decision. The objecting party must serve a copy of its objections on the other party. The recommended decision will become final 15 days after the Self-Governance Tribe receives the ALJs recommended decision, unless a written statement of objections is filed with the Secretary during the 15-day period. If no party files a written statement of objections within 15 days, the recommended decision will become final.
(a) The Secretary has 15 days from the date the Secretary receives timely written objections to modify, adopt, or reverse the recommended decision. If the Secretary does not modify or reverse the recommended decision during that time, the recommended decision automatically becomes final.
(b) When reviewing the recommended decision, the Secretary may consider and decide all issues properly raised by any party to the appeal, based on the record.
(c) The decision of the Secretary must:
(1) Be in writing;
(2) Specify the findings of fact or conclusions of law that are modified or reversed;
(3) Give reasons for the decision, based on the record; and
(4) State that the decision is final for the Secretary.
No, a pending appeal will not adversely affect or prevent the negotiation or award of another compact, funding agreement, or construction project agreement.
Yes, EAJA claims against the Department will be heard pursuant to 25 CFR 900.177.
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.
All changes in this volume of the Code of Federal Regulations which were made by documents published in the
For the period before January 1, 2001, see the “List of CFR Sections Affected, 1949-1963, 1964-1972, 1973-1985, 1986-2000” published in 11 separate volumes.