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. 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 Act; national cancer research and demonstration centers with respect to prostate cancer, as authorized by section 417A of the Act; national research and demonstration centers for heart, blood vessel, lung, and blood diseases, sickle cell anemia, blood resources and pediatric cardiovascular diseases (including payments for construction, but not including the acquisition of land), as authorized by section 422 of the Act; research and training centers in diabetes mellitus and related endocrine and metabolic diseases (including digestive, kidney, and urologic diseases), and research and training centers regarding nutritional disorders, including obesity, as authorized by section 431 of the Act; multipurpose arthritis and musculoskeletal diseases centers (including payments for alteration, remodeling, improvement, expansion, and repair of existing buildings, and the provision of equipment necessary to make them suitable for use as a center, but not construction), as authorized by Section 441 of the Act; Alzheimer's disease centers, as authorized by section 445 of the Act; Claude D. Pepper Older Americans Independence Centers, as authorized by section 445A of the Act; research centers regarding chronic fatigue syndrome, as authorized by section 447 of the Act; research centers with respect to contraception and infertility, as authorized by section 452A of the Act; child health research centers, as authorized by section 452C of the Act; multipurpose deafness and other communication disorders centers (including payments for alteration, remodeling, improvement, expansion, and repair of existing buildings, and the provision of equipment necessary to make them suitable for use as a center, but not construction), as authorized by section 464C of the Act; national alcohol research centers, as authorized by section 464J of the Act; national drug abuse research centers, as authorized by section 464N of the Act; and centers for acquired immunodeficiency syndrome research (including payments
(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 institutions which conducts research, training, information programs, epidemiological studies, data collection activities and development of model programs in: diabetes mellitus and related endocrine and metabolic diseases; kidney and urologic diseases; or nutritional disorders, including obesity;
(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
(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
(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
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
(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 (c) of this section), or the grantee decides to sell or transfer title to an entity ineligible for a grant under § 52b.3, the grantee shall request disposition instructions from NIH in the form and manner as the Director may prescribe. Those instructions shall provide for one of the following alternatives:
(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 time of any award when in the Director's judgment the conditions are necessary to assure or protect advancement of the approved project, the purposes of the applicable provisions of the Act, or the conservation of grant funds.
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,
(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,
(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
(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
(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
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
(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, 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.
(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
(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 relevant scientific or technical fields, taking into account, among other factors:
(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
(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
(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 group has made recommendations concerning the scientific merit of said concept. Where in the judgment of the awarding official the project approach has been sufficiently well defined by the time the review required by the preceding sentence is conducted, this review and the resulting recommendations shall include the proj-ect approach as well.
(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
(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 fiscal year and shall give due cognizance to probable increases in operating costs. Except in the case of a certification pursuant to paragraph (d)(2) of this section, if the budget statement does not conform to the presumptive compliance guideline, the applicant shall submit with its statement.
(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
(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 applicant or any person or persons residing or located within the area served by the applicant, or any organization on behalf of such person or persons, may submit to the State agency within 20 days of the publication and sending of the notice objections to the rate established by the State agency for the applicant. Such objections may be supported in writing by factual information and argument. The State agency shall give public notice of receipt of the objections and shall make the objections and their supporting documents available for public inspection and comment. It may, if it believes that determination of the objections will be assisted by oral evidence or by oral argument, set a public hearing on the objections and shall give notice of such hearing to all interested parties and to the public. The State agency shall within 60 days of the expiration of the period within which objections may be filed, rule upon the objections in writing, stating its reason for sustaining or overruling them, in whole or in part, and establishing finally the rate of uncompensated services either the same as, above, or below the rate previously established, as may best accord with all of the evidence on file with or heard by the State agency. Notice of the final determination shall be mailed to all parties who filed objections or who participated in the proceedings leading to the redetermination.
(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, the Secretary shall take into consideration the extent to which:
(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 supplement and not supplant existing services of the grantee.
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 the project as a condition of any such grant may not be used to provide services to individuals who are not migratory or seasonal agricultural workers or members of the families of such workers.
(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 part shall be made in accordance with the following priorities:
(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
(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 of discounts which, under such schedule, is uncompensated;
(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
(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 requirements of § 56.104 of subpart A of this part, 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 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
(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 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)(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
(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 Secretary), to be made by qualified individuals who are sufficiently independent of those who authorize the expenditure of Federal funds to produce unbiased opinions, conclusions, or judgments, and to determine, at a minimum, the fiscal integrity of grant financial transactions and reports, and compliance with the applicable 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 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
(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
(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 catchment area is located and shall be selected for their expertise in relevant subject areas, such as community affairs, local government, finance and banking, legal affairs, trade unions, and other commercial and industrial concerns, or social services 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 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
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
(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 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 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
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 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.
(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
(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 federally assisted health services or reimbursement programs or projects.
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
(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
(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 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 eligible schools during that year.
(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 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 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
(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 which indicates that the borrower is aware of the rights and responsibilities associated with HPSL 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 requirements 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 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 the charge payable to the school no later than the due date of the next installment following receipt of the notice of the charge by the borrower.
(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
(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 which reflects its cancellation experience. This charge shall not exceed .6 percent of the loan amount. Funds collected under this provision must be maintained by the school in an insured, interest-bearing account (with any earned interest credited to this insurance fund), and used only to reimburse the school for the institutional share of any HPSL loan made on or after October 22, 1985, that is canceled due to the borrower's death or permanent and total disability. A school is not required to establish a separate bank account, but is required to maintain separate accountability.
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
(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 contribution fund within 45 days of the close of the reporting period:
(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 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 § 57.205, 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
(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
(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
(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
(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 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 the charge payable to the school no later than the due date of the next installment following receipt of the notice of the charge by the borrower.
(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
(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 Claims Collection regulations (45 CFR part 30), as appropriate.
(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 preferences which will be announced from time to time in the
(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
(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 Secretary at the time of distribution of the assets of the school's fund under section 839 of the Act.
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
(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
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 Secretary shall give special consideration to those applications which contain or are reasonably supported by assurances that, because of the use that will be made by such school of already existing facilities (including Federal medical or dental facilities), the school will be able to accelerate the date on which it will begin its teaching program.
(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
(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
(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 terms and conditions. The accepted offer will constitute the loan guarantee agreement, the interest subsidy agreement, or the loan guarantee and interest subsidy agreement, as the case may be. Each such agreement shall include the applicable provisions set forth below:
(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 (transferee) of the loan:
(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
(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 will be used to accord priority within each affected priority group:
(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
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 failure to so extend such period would be against equity and good conscience.
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
(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 and other educational costs the Secretary determines to be allowable.
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
(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 to the extent that payment will be made by a third party (including a government agency) which is authorized to or is under legal obligation to pay this charge.
(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
(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. The grantee must be prepared to substantiate, that these rates are reasonable and necessary.
(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
(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 education in pursuit of an academic degree.
(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 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 the statute, the regulations of this subpart, the terms and conditions of the award, and, except as
(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
(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
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 to repay the lender or holder the full amount of the money borrowed, plus all interest which accrues on the loan.
(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,
(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 proposed HEAL loan and the applicant's total indebtedness, and that the applicant has no other financial resources that are available to the applicant or that the applicant will receive for the period covered by the proposed HEAL loan.
(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
(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 allied health may borrow up to $50,000 under this part. The amount received may not exceed $12,500 per academic year.
(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 other information conflict with information available to the lender or holder. When those verification statements or other information conflict with information available to the lender or holder, to indicate that the applicant fails to meet the requirements for deferment, the lender or holder may not approve the deferment until those conflicts are resolved.
(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
(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
(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
(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
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, consumer credit reporting agencies, skip locator services, and records at any school attended by the borrower. All skip-tracing activities used must be documented. This documentation must consist of a written record of the action taken and its date and must be presented to the Secretary when requesting preclaim assistance or when filing a default claim for HEAL insurance.
(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 fails to make a payment as scheduled, the lender or holder must attempt to obtain repayment through written and telephone contacts in accordance with the intervals established in paragraph (a)(1) of this section, and must perform the other HEAL loan collection activities required in this section, before filing a default claim.
(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
(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 writing to the new terms. Each forbearance period may not exceed 6 months.
(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 or holder's insurance contract will result in a claim not being honored. The Secretary may deny a claim that is not filed within the period specified in this section. The Secretary requires for all claims at least the following documentation:
(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
(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 receives written notice from the court or the borrower's attorney that the borrower has filed for bankruptcy under chapter 11 or 13 of the Bankruptcy Act, or under chapter 7 with a complaint to determine the dischargeability of the loan, the lender or holder must file that notice with the Secretary within 10 days of the lender or holder's initial date of receipt, as documented by a date stamp. If the borrower is declaring bankruptcy under chapter 7 of the Bankruptcy Act, and has not filed a complaint to determine the dischargeability of the loan, the lender or holder must file the written notice with the Secretary within 30 days of the lender's or holder's initial date of receipt, as documented by a date stamp. If the Secretary has not paid the claim at the time the lender or holder receives that notice, upon receipt of the notice, the lender or holder must file with the bankruptcy court a proof of claim, if applicable, and an objection to the discharge or compromise of the HEAL loan. If the Secretary has paid the claim, the lender or holder must file a statement with the court
(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 documentation indicating when the letter was sent to the borrower.
(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 with a written notice, sent by certified mail, specifying his or her intention to terminate the lender or holder's participation in the program and stating that the entity may request, within 30 days of the receipt of this notice, a formal hearing. if the entity 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 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 school is not eligible for accreditation solely because it is too new. A new school is eligible if the Secretary of Education determines that it can reasonably expect to be accredited before the beginning of the academic year following the normal graduation date of its first entering class. The Secretary of Education makes this determination after consulting with the appropriate accrediting agency and receiving reasonable assurance to that effect.
(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
(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 the enrollment status, or failure to enroll as scheduled for any academic period as a full-time student, the student's latest known permanent and temporary addresses, and other information which the school may decide is necessary to identify or locate the student. If the school does not know the identity of the current holder of the HEAL loan, it must notify the HEAL Program Office of a change in the student's enrollment status. This notification is not required for vacation periods and leaves of absence or other temporary interruptions which do not exceed one academic term.
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
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 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.
(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 loan recipient's departure at the same time it mails the exit interview material to the loan recipient.
(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.