[Title 42 CFR D]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter D - GRANTS]
[From the U.S. Government Printing Office]
42PUBLIC HEALTH12008-10-012008-10-01falseGRANTSDSUBCHAPTER DPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER D_GRANTS
PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents
Subpart A [Reserved]
Subpart B_Sterilization of Persons in Federally Assisted Family Planning
Projects
Sec.
50.201 Applicability.
50.202 Definitions.
50.203 Sterilization of a mentally competent individual aged 21 or
older.
50.204 Informed consent requirement.
50.205 Consent form requirements.
50.206 Sterilization of a mentally incompetent individual or of an
institutionalized individual.
50.207 Sterilization by hysterectomy.
50.208 Program or project requirements.
50.209 Use of Federal financial assistance.
50.210 Review of regulation.
Appendix to Subpart B of Part 50--Required Consent Form
Subpart C_Abortions and Related Medical Services in Federally Assisted
Programs of the Public Health Service
50.301 Applicability.
50.302 Definitions.
50.303 General rule.
50.304 Life of the mother would be endangered.
50.305 [Reserved]
50.306 Rape and incest.
50.307 Documentation needed by programs or projects.
50.308 Drugs and devices and termination of ectopic pregnancies.
50.309 Recordkeeping requirements.
50.310 Confidentiality.
Subpart D_Public Health Service Grant Appeals Procedure
50.401 What is the purpose of this subpart?
50.402 To what program do these regulations apply?
50.403 What is the policy basis for these procedures?
50.404 What disputes are covered by these procedures?
50.405 What is the structure of review committees?
50.406 What are the steps in the process?
Subpart E_Maximum Allowable Cost for Drugs
50.501 Applicability.
50.502 Definitions.
50.503 Policy.
50.504 Allowable cost of drugs.
Subpart F_Responsibility of Applicants for Promoting Objectivity in
Research for Which PHS Funding Is Sought
50.601 Purpose.
50.602 Applicability.
50.603 Definitions.
50.604 Institutional responsibility regarding conflicting interests of
investigators
50.605 Management of conflicting interests.
50.606 Remedies.
50.607 Other HHS regulations that apply.
Authority: 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.
Source: 43 FR 52165, Nov. 8, 1978, unless otherwise noted.
Subpart A [Reserved]
Subpart B_Sterilization of Persons in Federally Assisted Family Planning
Projects
Sec. 50.201 Applicability.
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.
Sec. 50.202 Definitions.
As used in this subpart:
Arrange for means to make arrangements (other than mere referral of
an individual to, or the mere making of an appointment for him or her
with, another health care provider) for the performance of a medical
procedure on an individual by a health care provider other than the
program or project.
Hysterectomy means a medical procedure or operation for the purpose
of removing the uterus.
Institutionalized individual means an individual who is (1)
involuntarily confined or detained, under a civil or criminal statute,
in a correctional or rehabilitative facility, including a mental
hospital or other facility for
[[Page 139]]
the care and treatment of mental illness, or (2) confined, under a
voluntary commitment, in a mental hospital or other facility for the
care and treatment of mental illness.
Mentally incompetent individual means an individual who has been
declared mentally incompetent by a Federal, State, or local court of
competent jurisdiction for any purpose unless he or she has been
declared competent for purposes which include the ability to consent to
sterilization.
Public Health Service means the Office of the Assistant Secretary
for Health, Health Resources and Services Administration, National
Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse
and Mental Health Administration and all of their constituent agencies.
The Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
Sterilization means any medical procedure, treatment, or operation
for the purpose of rendering an individual permanently incapable of
reproducing.
[43 FR 52165, Nov. 8, 1978, as amended at 49 FR 38109, Sept. 27, 1984]
Sec. 50.203 Sterilization of a mentally competent individual aged 21 or
older.
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 Sec. 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.
Sec. 50.204 Informed consent requirement.
Informed consent does not exist unless a consent form is completed
voluntarily and in accordance with all the requirements of this section
and Sec. 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 Sec. 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.
[[Page 140]]
(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.
Sec. 50.205 Consent form requirements.
(a) Required consent form. The consent form appended to this subpart
or another consent form approved by the Secretary must be used.
(b) Required signatures. The consent form must be signed and dated
by:
(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) Required certifications. (1) The person obtaining the consent
must certify by signing the consent form that:
(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.
Sec. 50.206 Sterilization of a mentally incompetent individual or of an
institutionalized individual.
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.
Sec. 50.207 Sterilization by hysterectomy.
(a) Programs or projects to which this subpart applies shall not
perform or arrange for the performance of any
[[Page 141]]
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.
[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]
Sec. 50.208 Program or project requirements.
(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.
Sec. 50.209 Use of Federal financial assistance.
(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.
[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]
Sec. 50.210 Review of regulation.
The Secretary will request public comment on the operation of the
provisions of this subpart not later than 3 years after their effective
date.
Sec. Appendix to Subpart B of Part 50--Required Consent Form
Notice: YOUR DECISION AT ANY TIME NOT TO BE STERILIZED WILL NOT
RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED BY
PROGRAMS OR PROJECTS RECEIVING FEDERAL FUNDS.
Consent to Sterilization
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
[[Page 142]]
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.
Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)
You are requested to supply the following information, but it is not
required:
Ethnicity and Race Designation
Ethnicity:
[squ] Hispanic or Latino
[squ] Not Hispanic or Latino
Race (mark one or more):
[squ] American Indian or Alaska Native
[squ] Asian
[squ] Black or African American
[squ] Native Hawaiian or Other Pacific Islander
[squ] White
Interpreter's Statement
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.
Interpreter_____________________________________________________________
Date____________________________________________________________________
State of Person Obtaining Consent
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.
Signature of person obtaining consent___________________________________
Date____________________________________________________________________
Facility________________________________________________________________
Address_________________________________________________________________
Physician's Statement
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.
[[Page 143]]
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.
(Instructions for use of alternative final paragraphs: Use the first
paragraph below except in the case of premature delivery or emergency
abdominal surgery where the sterilization is performed less than 30 days
after the date of the individual's signature on the consent form. In
those cases, the second paragraph below must be used. Cross out the
paragraph which is not used.)
(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):
[squ] Premature delivery
Individual's expected date of delivery:_________________________________
[squ] Emergency abdominal surgery:
(Describe circumstances):_______________________________________________
Physician_______________________________________________________________
Date____________________________________________________________________
Paperwork Reduction Act Statement
A Federal agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
the currently valid OMB control number. Public reporting burden for this
collection of information will vary; however, we estimate an average of
one hour per response, including for reviewing instructions, gathering
and maintaining the necessary data, and disclosing the information. Send
any comment regarding the burden estimate or any other aspect of this
collection of information to the OS Reports Clearance Officer, ASBTF/
Budget Room 503 HHH Building, 200 Independence Avenue, SW., Washington,
DC 20201.
Respondents should be informed that the collection of information
requested on this form is authorized by 42 CFR part 50, subpart B,
relating to the sterilization of persons in federally assisted public
health programs. The purpose of requesting this information is to ensure
that individuals requesting sterilization receive information regarding
the risks, benefits and consequences, and to assure the voluntary and
informed consent of all persons undergoing sterilization procedures in
federally assisted public health programs. Although not required,
respondents are requested to supply information on their race and
ethnicity. Failure to provide the other information requested on this
consent form, and to sign this consent form, may result in an inability
to receive sterilization procedures funded through federally assisted
public health programs.
All information as to personal facts and circumstances obtained
through this form will be held confidential, and not disclosed without
the individual's consent, pursuant to any applicable confidentiality
regulations.
[43 FR 52165, Nov. 8, 1978, as amended at 58 FR 33343, June 17, 1993; 68
FR 12308, Mar. 14, 2003]
Subpart C_Abortions and Related Medical Services in Federally Assisted
Programs of the Public Health Service
Authority: Sec. 118, Pub. L. 96-86, Oct. 12, 1979, unless otherwise
noted.
Source: 43 FR 4570, Feb. 2, 1978, unless otherwise noted.
Sec. 50.301 Applicability.
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.
Sec. 50.302 Definitions.
As used in this subpart: (a) Law enforcement agency means an agency,
or any part thereof, charged under applicable law with enforcement of
the general penal statutes of the United States, or of any State or
local jurisdiction.
(b) Medical procedures performed upon a victim of rape or incest
means any medical service, including an abortion, performed for the
purpose of preventing or terminating a pregnancy arising out of an
incident of rape or incest.
(c) Physician means a doctor of medicine or osteopathy legally
authorized to practice medicine and surgery by the State in which he or
she practices.
(d) Public health service means: (1) An agency of the United States
or of a State or local government, that provides health or medical
services; and
(2) A rural health clinic, as defined under section 1(d)(aa)(2) of
Pub. L. 95-
[[Page 144]]
210, 91 Stat. 1485; except that any agency or facility whose principal
function is the performance of abortions is specifically excluded from
this definition.
Sec. 50.303 General rule.
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 Sec. 50.304 or Sec. 50.306.
[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]
Sec. 50.304 Life of the mother would be endangered.
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.
(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)
[43 FR 13868, July 21, 1978]
Sec. 50.305 [Reserved]
Sec. 50.306 Rape and incest.
Federal financial participation is available in expenditures for
medical procedures performed upon a victim of rape or incest if the
program or project 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 also available in expenditures for
abortions for victims of rape or incest under the circumstances
described in Sec. 50.304 without regard to the requirements of the
preceding sentence.
(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)
[43 FR 13868, July 21, 1978, as amended at 44 FR 61598, Oct. 26, 1979]
Sec. 50.307 Documentation needed by programs or projects.
Federal financial participation is unavailable for the performance
of abortions or other medical procedures otherwise provided for under
Sec. Sec. 50.304 and 50.306 if the program or project has paid without
first having received the certifications and documentation specified in
those sections.
[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]
Sec. 50.308 Drugs and devices and termination of ectopic pregnancies.
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.
Sec. 50.309 Recordkeeping requirements.
Programs or projects to which this subpart applies must maintain
copies of the certifications and documentation specified in Sec. Sec.
50.304 and 50.306 for three years pursuant to the retention and
custodial requirements for records at 45 CFR 74.20 et seq.
[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]
Sec. 50.310 Confidentiality.
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
[[Page 145]]
which will minimize the likelihood of disclosures of personal
information in identifiable form.
Subpart D_Public Health Service Grant Appeals Procedure
Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216); 45 CFR 16.3(c).
Source: 54 FR 34770, Aug. 22, 1989, unless otherwise noted.
Sec. 50.401 What is the purpose of this subpart?
This subpart establishes an informal procedure for the resolution of
certain postaward grant and cooperative agreement disputes within the
agencies and offices identified in Sec. 50.402.
[63 FR 66062, Dec. 1, 1998]
Sec. 50.402 To what program do these regulations apply?
This subpart applies to all grant and cooperative agreement
programs, except block grants, which are administered by the National
Institutes of Health; The Centers for Disease Control and Prevention;
the Agency for Toxic Substances and Disease Registry; the Food and Drug
Administration; and the Office of Public Health and Science. For
purposes of this subpart, these entities are hereinafter referred to as
``agencies.''
[70 FR 76175, Dec. 23, 2005]
Sec. 50.403 What is the policy basis for these procedures?
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
establishes the circumstances under which the Board will accept an
appeal (45 CFR 16.3) provides, among other things, that the appellant
must have exhausted any preliminary appeal process required by
regulation before a formal appeal to the Departmental Board will be
allowed. This subpart provides such an informal preliminary procedure
for resolution of disputes in order to preclude submission of cases to
the Departmental Appeals Board before an agency identified in Sec.
50.402 has had an opportunity to review decisions of its officials and
to settle disputes with grantees.
[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]
Sec. 50.404 What disputes are covered by these procedures?
(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 Sec. 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 Sec. 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.
[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]
[[Page 146]]
Sec. 50.405 What is the structure of review committees?
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).
[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]
Sec. 50.406 What are the steps in the process?
(a) A grantee with respect to whom an adverse determination
described in Sec. 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 agency pursuant to such determination until the request has
been disposed of, except that the filing of the request shall not affect
any authority which the agency may have to suspend assistance or
otherwise to withhold or defer payments under the grant during
proceedings under this subpart. This paragraph does not require the
awarding agency to provide continuation funding during the appeal
process to a grantee whose noncompeting continuation award has been
denied.
(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 Sec. 50.405.
(e) The agency involved will provide the review committee appointed
under Sec. 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
[[Page 147]]
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.
[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66063, Dec. 1, 1998]
Subpart E_Maximum Allowable Cost for Drugs
Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216).
Source: 40 FR 34514, Aug. 15, 1975, unless otherwise noted.
Sec. 50.501 Applicability.
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.
Sec. 50.502 Definitions.
As used in this subpart:
(a) Public Health Service means the Office of the Assistant
Secretary for Health, Health Resources and Services Administration,
National Institutes of Health, Centers for Disease Control, Alcohol,
Drug Abuse and Mental Health Administration, Food and Drug
Administration, and all of their constituent agencies.
(b) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
(c) Program funds means (1) Federal funds provided through grant or
contract to support a program or project covered by Sec. 50.501, and
(2) any non-Federal funds that are required as a condition of such grant
or contract to be expended to carry out such program or project.
(d) Provider means one who furnishes medical or pharmaceutical
services or supplies for which program funds may be expended under any
of the programs or projects described in Sec. 50.501.
(e) Acquisition cost means the price generally and currently paid by
providers for a drug marketed or sold by a particular formulator or
labeler in the package size of drug most frequently purchased by
providers, as determined by the Secretary on the basis of drug price
information furnished by the Department.
[40 FR 34514, Aug. 15, 1975, as amended at 49 FR 38109, Sept. 27, 1984]
Sec. 50.503 Policy.
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.
Sec. 50.504 Allowable cost of drugs.
(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; Provided, That the MAC established for any drug shall not apply to
a brand of that drug prescribed for a patient which the prescriber has
certified, in accordance with paragraph (c) of this section, is
medically necessary for that patient; And Provided further, That where
compensation for drug dispensing is included in other costs allowable
under the applicable program statute and regulations, the terms and
conditions of the grant or contract, and the applicable cost principles
prescribed in 45 CFR part 74, no separate dispensing fee will be
recognized.
[[Page 148]]
(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.
Subpart F_Responsibility of Applicants for Promoting Objectivity in
Research for Which PHS Funding Is Sought
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Source: 60 FR 35815, July 11, 1995; 60 FR 39076, July 31, 1995,
unless otherwise noted.
Sec. 50.601 Purpose.
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.
Sec. 50.602 Applicability.
This subpart is applicable to each Institution that applies for PHS
grants or cooperative agreements for research and, through the
implementation of this subpart by each Institution, to each Investigator
participating in such research (see Sec. 50.604(a)); provided, that
this subpart does not apply to SBIR Program Phase I applications. In
those few cases where an individual, rather than an institution, is an
applicant for PHS grants or cooperative agreements for research, PHS
Awarding Components will make case-by-case determinations on the steps
to be taken to ensure that the design, conduct, and reporting of the
research will not be biased by any conflicting financial interest of the
individual.
Sec. 50.603 Definitions.
As used in this subpart:
HHS means the United States Department of Health and Human Services,
and any components of the Department to which the authority involved may
be delegated.
Institution means any domestic or foreign, public or private, entity
or organization (excluding a Federal agency).
Investigator means the principal investigator and any other person
who is responsible for the design, conduct, or reporting of research
funded by PHS, or proposed for such funding. For purposes of the
requirements of this subpart relating to financial interests,
``Investigator'' includes the Investigator's spouse and dependent
children.
PHS means the Public Health Service, an operating division of the
U.S. Department of Health and Human Services, and any components of the
PHS to which the authority involved may be delegated.
PHS Awarding Component means the organizational unit of the PHS that
funds the research that is subject to this subpart.
Public Health Service Act or PHS Act means the statute codified at
42 U.S.C. 201 et seq.
Research means a systematic investigation designed to develop or
contribute to generalizable knowledge relating broadly to public health,
including behavioral and social-sciences research. The term encompasses
basic and applied research and product development. As used in this
subpart, the term includes any such activity for which research funding
is available from a PHS Awarding Component through a grant or
cooperative agreement, whether authorized under the PHS Act or other
statutory authority.
Significant Financial Interest means anything of monetary value,
including but not limited to, salary or other payments for services
(e.g., consulting fees
[[Page 149]]
or honoraria); equity interests (e.g., stocks, stock options or other
ownership interests); and intellectual property rights (e.g., patents,
copyrights and royalties from such rights). The term does not include:
(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.
Small Business Innovation Research (SBIR) Program means the
extramural research program for small business that is established by
the Awarding Components of the Public Health Service and certain other
Federal agencies under Pub. L. 97-219, the Small Business Innovation
Development Act, as amended. For purposes of this subpart, the term SBIR
Program includes the Small Business Technology Transfer (STTR) Program,
which was established by Pub. L. 102-564.
Sec. 50.604 Institutional responsibility regarding conflicting interests of
investigators.
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:
[[Page 150]]
(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.
Sec. 50.605 Management of conflicting interests.
(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-funded research. Examples
of conditions or restrictions that might be imposed to manage conflicts
of interest include, but are not limited to:
(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.
Sec. 50.606 Remedies.
(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
[[Page 151]]
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.
Sec. 50.607 Other HHS regulations that apply.
Several other regulations and policies apply to this subpart.
They include, but are not necessarily limited to:
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Uniform Administrative Requirements for Awards and
Subawards to Institutions of Higher Education, Hospitals, Other Non-
Profit Organizations, and Commercial Organizations; and Certain Grants
and Agreements with States, Local Governments and Indian Tribal
Governments
45 CFR part 76--Government-wide debarment and suspension (non-
procurement)
45 CFR part 79--Program Fraud Civil Remedies
45 CFR part 92--Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments
PART 51_REQUIREMENTS APPLICABLE TO THE PROTECTION AND ADVOCACY FOR INDIVIDUALS
WITH MENTAL ILLNESS PROGRAM--Table of Contents
Sec.
51.1 Scope.
51.2 Defintitions.
Subpart A_Basic Requirements
51.3 Formula for determining allotments.
51.4 Grants administration requirements.
51.5 Eligibility for allotment.
51.6 Use of allotments.
51.7 Eligibility for protection and advocacy services.
51.8 Annual reports.
51.9 [Reserved]
51.10 Remedial actions.
51.11-51.20 [Reserved]
Subpart B_Program Administration and Priorities
51.21 Contracts for program operations.
51.22 Governing authority.
51.23 Advisory council.
51.24 Program priorities.
51.25 Grievance procedure.
51.26 Conflicts of interest.
51.27 Training.
51.28-51.30 [Reserved]
Subpart C_Protection and Advocacy Services
51.31 Conduct of protection and advocacy activities.
51.32 Resolving disputes.
51.33-51.40 [Reserved]
Subpart D_Access to Records, Facilities and Individuals
51.41 Access to records.
51.42 Access to facilities and residents.
51.43 Denial of delay or access.
51.44 [Reserved]
51.45 Confidentiality of protection and advocacy system records.
51.46 Disclosing information obtained from a provider of mental health
services.
Authority: 42 U.S.C. 10801, et seq.
Source: 63 FR 53564, Oct. 15, 1997, unless otherwise noted.
Sec. 51.1 Scope.
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.
Sec. 51.2 Definitions.
In addition to the definitions in section 102 of the Act, as
amended, the following definitions apply:
Abuse means any act or failure to act by an employee of a facility
rendering care or treatment which was performed, or which was failed to
be performed, knowingly, recklessly, or intentionally, and which caused,
or may have caused, injury or death to an individual with mental
illness, and includes but is not limited to acts such as: rape or sexual
assault; striking; the use of excessive force when placing an individual
with mental illness in bodily restrains; the use of bodily or chemical
restraints which is not in compliance with Federal and State laws and
regulations; verbal, nonverbal, mental and emotional harassment; and any
other practice which is likely to cause immediate physical or
psychological harm or
[[Page 152]]
result in long-term harm if such practices continue.
Act means the Protection and Advocacy for Mentally Ill Individuals
Act of 1986, as amended, also referred to as Protection and Advocacy for
Individuals with Mental Illness Act.
ADD means the Administration on Developmental Disabilities within
the Administration for Children and Families, Department of Health and
Human Services.
Care or Treatment means services provided to prevent, identify,
reduce or stabilize mental illness or emotional impairment such as
mental health screening, evaluation, counseling, biomedical, behavioral
and psychotherapies, supportive or other adjunctive therapies,
medication supervision, special education and rehabilitation, even if
only ``as needed'' or under a contractual arrangement.
Center or CMHS means the Center for Mental Health Services, a
component of the Substance Abuse and Mental Health Services
Administration.
Complaint includes, but is not limited to any report or
communication, whether formal or informal, written or oral, received by
the P&A system, including media accounts, newspaper articles, telephone
calls (including anonymous calls) from any source alleging abuse or
neglect of an individual with mental illness.
Department or HHS means the U.S. Department of Health and Human
Services.
Designated Official is the State official or public or private
entity empowered by the Governor or State legislature to be accountable
for the proper use of funds by the P&A system.
Director means the Director of the Center for Mental Health
Services, Substance Abuse and Mental Health Services Administration, or
his or her designee.
Facility includes any public or private residential setting that
provides overnight care accompanied by treatment services. Facilities
include, but are not limited to the following: general and psychiatric
hospitals, nursing homes, board and care homes, community housing,
juvenile detention facilities, homeless shelters, and jails and prisons,
including all general areas as well as special mental health or forensic
units.
Fiscal Year or FY means the Federal fiscal year (October 1-September
30) unless otherwise specified.
Full Investigation is based upon a complaint or a determination of
probable cause and means the access to facilities, clients and records
authorized under this part that is necessary for a P&A system to make a
determination about whether an allegation of abuse or neglect is taking
place or has taken place. Full investigations may be conducted
independently or in cooperation with other agencies authorized to
conduct similar investigations.
Governor means the chief executive officer of the State, Territory
or the District of Columbia, or his or her designee, who has been
formally designated to act for the Governor in carrying out the
requirements of the Act and this part.
Individual with Mental Illness means an individual who has a
significant mental illness or emotional impairment, as determined by a
mental health professional qualified under the laws and regulations of
the State and
(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.
Legal Guardian, Conservator, and Legal Representative all mean an
individual whose appointment is made and regularly reviewed by a State
court or agency empowered under State law to appoint and review such
officers, and having authority to consent to health/mental health care
or treatment of an individual with mental illness. It does not include
persons acting only as a representative payee, persons acting only to
handle financial payments, attorneys or persons acting on behalf of an
individual with mental illness only in individual legal matters, or
officials responsible for the provision of health or mental health
services to an individual with mental illness, or their designees.
[[Page 153]]
Neglect means a negligent act or omission by an individual
responsible for providing services in a facility rendering care or
treatment which caused or may have caused injury or death to an
individual with mental illness or which placed an individual with mental
illness at risk of injury or death, and includes, but is not limited to,
acts or omissions such as failure to: establish or carry out an
appropriate individual program or treatment plan (including a discharge
plan); provide adequate nutrition, clothing, or health care; and the
failure to provide a safe environment which also includes failure to
maintain adequate numbers of appropriately trained staff.
Private Entity means a nonprofit or for-profit corporation,
partnership or other nongovernmental organization.
Probable cause means reasonable grounds for belief that an
individual with mental illness has been, or may be at significant risk
of being subject to abuse or neglect. The individual making such
determination may base the decision on reasonable inferences drawn from
his or her experience or training regarding similar incidents,
conditions or problems that are usually associated with abuse or
neglect.
Program means activities carried out by the P&A system and operating
as part of a P&A system to meet the requirements of the Act.
Public Entity means an organizational unit of a State or local
government or a quasi-governmental entity with one or more governmental
powers.
System means the organization or agency designated in a State to
administer and operate a protection and advocacy program under Part C of
the Developmental Disabilities Assistance and Bill of Rights Act (42
U.S.C. 6041, 6042) and thereby eligible to administer a program for
individuals with mental illness.
Subpart A_Basic Requirements
Sec. 51.3 Formula for determining allotments.
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).
Sec. 51.4 Grants administration requirements.
The following parts of titles 42 and 45 CFR apply to grants funded
under this part.
42 CFR Part 50, Subpart D.
45 CFR Part 16--Procedures of the Departmental Grant Appeal Board.
45 CFR Part 74--Administration of Grants.
45 CFR Part 75--Informal Grant Appeals Procedures.
45 CFR Part 76--Government-wide Debarment and Suspension
(Nonprocurement) and Government-wide Requirements for Drug-Free
Workplace.
45 CFR Part 80--Nondiscrimination under Programs Receiving Federal
Assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964.
45 CFR Part 81--Practice and Procedure for Hearings under Part 80 of
This Title.
45 CFR Part 84--Nondiscrimination on the Basis of Handicap in Programs
and Activities Receiving or Benefiting from Federal Financial
Assistance.
45 CFR Part 86--Nondiscrimination on the Basis of Sex in Education
Programs and Activities Receiving Federal Financial Assistance.
45 CFR Part 91--Nondiscrimination on the Basis of Age in Education
Programs and Activities Receiving Federal Financial Assistance from HHS.
45 CFR Part 92--Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments.
45 CFR Part 93--New Restrictions on Lobbying.
45 CFR Part 1386, subpart A.
Sec. 51.5 Eligibility for allotment.
(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, et seq.)
and designated in accordance with 45 CFR part 1386, subpart B.
(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
[[Page 154]]
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.
Sec. 51.6 Use of allotments.
(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 Sec. 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.
Sec. 51.7 Eligibility for protection and advocacy services.
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
[[Page 155]]
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.
Sec. 51.8 Annual reports.
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.
Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 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.
Sec. 51.9 [Reserved]
Sec. 51.10 Remedial actions.
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.
Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 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.
Sec. Sec. 51.11-51.20 [Reserved]
Subpart B_Program Administration and Priorities
Sec. 51.21 Contracts for program operations.
(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;
[[Page 156]]
(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.
Sec. 51.22 Governing authority.
(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 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 governing board during the 2-year period beginning on the date on
which such 4-year term expired.
(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.
Sec. 51.23 Advisory council.
(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
Sec. 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;
[[Page 157]]
(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 needs of individual council members, available resources, and
applicable restrictions on use of grant funds, including the
restrictions in Sec. Sec. 51.31(e) and 51.6(e).
Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 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.
Sec. 51.24 Program priorities.
(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.
Sec. 51.25 Grievance procedure.
(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
[[Page 158]]
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.
Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 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.
Sec. 51.26 Conflicts of interest.
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.
Sec. 51.27 Training.
A P&A system shall provide training for program staff, and may also
provide training for contractors, governing board and advisory council
members to enhance the development and implementation of effective
protection and advocacy services for individuals with mental illness,
including at a minimum:
(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.
Sec. Sec. 51.28-51.30 [Reserved]
Subpart C_Protection and Advocacy Services
Sec. 51.31 Conduct of protection and advocacy activities.
(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:
[[Page 159]]
(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 other reports prepared by
others whether pertaining to individuals with mental illness or to
general conditions affecting their health or safety.
(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.
Sec. 51.32 Resolving disputes.
(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.
[[Page 160]]
Sec. Sec. 51.33-51.40 [Reserved]
Subpart D_Access to Records, Facilities and Individuals
Sec. 51.41 Access to records.
(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.
(c) Information and individual records, whether written or in another
medium, draft or final, including handwritten notes, electronic files,
photographs or video or audio tape records, which shall be available to
the P&A system under the Act shall include, but not be limited to:
(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.
[[Page 161]]
(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.
Sec. 51.42 Access to facilities and residents.
(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 Sec. 51.41(b)(3).
(f) A P&A system providing representation to individuals with mental
illness in Federal facilities shall have all
[[Page 162]]
the rights and authority accorded other representatives of residents of
such facilities pursuant to State and Federal laws.
Sec. 51.43 Denial or delay of access.
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.
Sec. 51.44 [Reserved]
Sec. 51.45 Confidentiality of protection and advocacy system records.
(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
[[Page 163]]
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.
Sec. 51.46 Disclosing information obtained from a provider of mental health
services.
(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.
PART 51a_PROJECT GRANTS FOR MATERNAL AND CHILD HEALTH--Table of Contents
Sec.
51a.1 To which programs does this regulation apply?
51a.2 Definitions.
51a.3 Who is eligible to apply for Federal funding?
51a.4 How is application made for Federal funding?
51a.5 What criteria will DHHS use to decide which projects to fund?
51a.6 What confidentiality requirements must be met?
51a.7 What other DHHS regulations apply?
51a.8 What other conditions apply to these grants?
Authority: 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)).
Source: 51 FR 7727, Mar. 5, 1986, unless otherwise noted.
Sec. 51a.1 To which programs does this regulation apply?
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
[[Page 164]]
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.
[59 FR 36706, July 19, 1994]
Sec. 51a.2 Definitions.
Act means the Social Security Act, as amended.
Genetic diseases means inherited disorders caused by the
transmission of certain aberrant genes from one generation to another.
Hemophilia means a genetically transmitted bleeding disorder
resulting from a deficiency of a plasma clotting factor.
Institution of higher learning means any college or university
accredited by a regionalized body or bodies approved for such purpose by
the Secretary of Education, and any teaching hospital which has higher
learning among its purposes and functions and which has a formal
affiliation with an accredited school of medicine and a full-time
academic medical staff holding faculty status in such school of
medicine.
Secretary means the Secretary of Health and Human Services or his or
her designee.
Sec. 51a.3 Who is eligible to apply for Federal funding?
(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.
[59 FR 36706, July 19, 1994]
Sec. 51a.4 How is application made for Federal funding?
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.
(Approved by the Office of Management and Budget under control number
0915-0050)
[59 FR 36706, July 19, 1994]
Sec. 51a.5 What criteria will DHHS use to decide which projects to fund?
(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 Sec. 51a.1.
(b) Within the limit of funds determined by the Secretary to be
available for each of the activities described in Sec. 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\ taking, the following factors into
account:
---------------------------------------------------------------------------
\1\ Healthy Children 2000: National Health Promotion and Disease
Prevention Objectives Related to Mothers, Infants, Children,
Adolescents, and Youth is a special compendium of health status goals
and national health objectives affecting mothers, infants, children,
adolescents, and youth originally published in Healthy People 2000 in
September 1990. Potential applicants may obtain a copy of Healthy People
2000 (Full Report: Stock No. 017-001-00474-0 or Healthy People 2000
(Summary Report; Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office Washington, DC 20402-9325,
(telephone: 202 512-1800).
---------------------------------------------------------------------------
[[Page 165]]
(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.
[59 FR 36706, July 19, 1994]
Sec. 51a.6 What confidentiality requirements must be met?
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.
Sec. 51a.7 What other DHHS regulations apply?
(a) Several other DHHS regulations apply to awards under this part.
These include, but are not limited to:
42 CFR part 50--Policies of general applicability:
subpart B--Sterilization of persons in federally assisted family
planning projects.
subpart C--Abortions and related medical services in federally
assisted programs of the Public Health Service.
subpart E--Maximum allowable cost for drugs.
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement)
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Service--
Effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under Part 80 of
this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefiting from Federal financial
assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance.
45 CFR part 93--New restrictions on lobbying.
(b) In addition to the above regulations, the following apply to
projects funded through grants:
42 CFR part 50--Policies of general applicability:
[[Page 166]]
subpart D--Public Health Service grant appeals procedure.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 74--Administration of grants to nonprofit organizations.
45 CFR part 75--Informal grant appeals procedures.
45 CFR part 92--Administration of grants to State and local governments.
[59 FR 36707, July 19, 1994]
Sec. 51a.8 What other conditions apply to these 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.
(c) Grant recipients of Healthy Tomorrows Partnership for Children
Program, a Community Integrated Service System-funded initiative, must
contribute non-Federal matching funds in years 2 through 5 of the
project period equal to two times the amount of the Federal Grant Award
or such lesser amount determined by the Secretary for good cause shown.
Reimbursement for services provided to an individual under a State plan
under Title XIX will not be deemed ``non-Federal matching funds'' for
the purposes of this provision.
[59 FR 36707, July 19, 1994, as amended at 72 FR 3080, Jan. 24, 2007]
PART 51b_PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES--Table of Contents
Subpart A_General Provisions
Sec.
51b.101 To which programs do these regulations apply?
51b.102 Definitions.
51b.103 What are the general application requirements?
51b.104 Can personnel, supplies, and related items be provided in lieu
of cash?
51b.105 Which other HHS regulations apply to these grants?
51b.106 What other conditions apply to these grants?
51b.107 Is participation in preventive health service programs required
by these regulations?
Subpart B_Grants for Childhood Immunization Programs
51b.201 To which programs does this subpart apply?
51b.202 Definitions.
51b.203 Who is eligible for a grant under this subpart?
51b.204 What information is required in the application?
51b.205 How will grant applications be evaluated and the grants awarded?
51b.206 How can grant funds be used?
Subpart C [Reserved]
Subpart D_Grants for Venereal Disease Control Programs
51b.401 To which programs does this subpart apply?
51b.402 Definitions.
51b.403 Who is eligible for a grant under this subpart?
51b.404 What are the confidentiality requirements?
51b.405 What information is required in the application?
51b.406 How will grant applications be evaluated and the grants awarded?
51b.407 How can grant funds be used?
Subpart E [Reserved]
Subpart F_Grants for Research, Demonstrations, and Public Information
and Education for the Prevention and Control of Venereal Disease
51b.601 To which programs does this subpart apply?
51b.602 Who is eligible for a grant under this subpart?
51b.603 What are the confidentiality requirements?
[[Page 167]]
51b.604 What information is required in the application?
51b.605 How will grant applications be evaluated and the grants awarded?
51b.606 How can grant funds be used?
Authority: 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).
Subpart A_General Provisions
Source: 48 FR 4473, Feb. 1, 1983, unless otherwise noted.
Sec. 51b.101 To which programs do these regulations apply?
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.
Sec. 51b.102 Definitions.
As used in these regulations:
Act means the Public Health Service Act, as amended.
Secretary means the Secretary of Health and Human Services (HHS) or
any other officer or employee of that Department to whom the authority
involved has been delegated.
State means one of the 50 States, the District of Columbia, Guam,
the Commonwealth of Puerto Rico, the Northern Mariana Islands, the
Virgin Islands, American Samoa, and the Trust Territory of the Pacific
Islands.
Sec. 51b.103 What are the general application requirements?
(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.
Sec. 51b.104 Can personnel, supplies, and related items be provided in lieu
of cash?
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.
Sec. 51b.105 Which other HHS regulations apply to these grants?
Several other HHS regulations apply to grants under this part. These
include, but are not limited to:
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
[[Page 168]]
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Debarment and suspension from eligibility for financial
assistance
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
[49 FR 38109, Sept. 27, 1984]
Sec. 51b.106 What other conditions apply to these grants?
(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 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.
(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.
Sec. 51b.107 Is participation in preventive health service programs required
by these regulations?
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.
Subpart B_Grants for Childhood Immunization Programs
Source: 44 FR 40501, July 11, 1979, unless otherwise noted.
Sec. 51b.201 To which programs does this subpart apply?
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.
Sec. 51b.202 Definitions.
As used in this subpart:
Childhood immunization program means a preventive health service
program to immunize children against vaccine preventable diseases
including poliomyelitis, measles, mumps, rubella, diphtheria, pertussis,
and tetanus.
Sec. 51b.203 Who is eligible for a grant under 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.
[[Page 169]]
Sec. 51b.204 What information is required in the application?
(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.
[48 FR 4474, Feb. 1, 1983]
Sec. 51b.205 How will grant applications be evaluated and the grants awarded?
(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.
[44 FR 40501, July 11, 1979, as amended at 48 FR 4475, Feb. 1, 1983]
Sec. 51b.206 How can grant funds be used?
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.
[[Page 170]]
Subpart C [Reserved]
Subpart D_Grants for Venereal Disease Control Programs
Source: 48 FR 4475, Feb. 1, 1983, unless otherwise noted.
Sec. 51b.401 To which programs does this subpart apply?
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.
Sec. 51b.402 Definitions.
As used in this subpart:
Venereal disease means gonorrhea, syphilis, or any other disease
which can be sexually transmitted and which the Secretary determines is
or may be amenable to control with assistance provided under this
authority and which is of national significance.
Venereal disease control program means a program designed to carry
out activities or to provide services to systematically detect and
prevent venereal disease as distinguished from those activities or
services which are designed to diagnose or treat venereal disease
patients or suspects.
Sec. 51b.403 Who is eligible for a grant under 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.
Sec. 51b.404 What are the confidentiality requirements?
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.
Sec. 51b.405 What information is required in the application?
(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.
[[Page 171]]
(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.
Sec. 51b.406 How will grant applications be evaluated and the grants awarded?
(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.
Sec. 51b.407 How can grant funds be used?
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),
maintaining central registries, purchasing data processing equipment, or
providing diagnostic and treatment facilities and services. The
applicant must provide assurances, however, that these services will be
available as needed as an adjunct to control program activities
supported with grant funds. To obtain special approval for grant support
of such activities, the grantee shall justify the exception to the
satisfaction of the Secretary that funds for this purpose are necessary
for the proper conduct of the program and are otherwise unavailable.
Support of these services will generally be approved only in the
following situations:
(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.
Subpart E [Reserved]
Subpart F_Grants for Research, Demonstrations, and Public Information
and Education for the Prevention and Control of Venereal Disease
Source: 48 FR 4476, Feb. 1, 1983, unless otherwise noted.
Sec. 51b.601 To which programs does this subpart apply?
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.
Sec. 51b.602 Who is eligible for a grant under this subpart?
An applicant must be a State, political subdivision of any State, or
any other public or nonprofit private entity.
[[Page 172]]
Sec. 51b.603 What are the confidentiality requirements?
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.
Sec. 51b.604 What information is required in the application?
(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.
Sec. 51b.605 How will grant applications be evaluated and the grants awarded?
(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?
[[Page 173]]
Sec. 51b.606 How can grant funds be used?
(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.
PART 51c_GRANTS FOR COMMUNITY HEALTH SERVICES--Table of Contents
Subpart A_General Provisions
Sec.
51c.101 Applicability.
51c.102 Definitions.
51c.103 Eligibility.
51c.104 Application.
51c.105 Accord with health planning.
51c.106 Amount of grant.
51c.107 Use of project funds.
51c.108 Grant payments.
51c.109 Nondiscrimination.
51c.110 Confidentiality.
51c.111 Publications and copyright.
51c.112 Grantee accountability.
51c.113 Applicability of 45 CFR part 74.
Subpart B_Grants for Planning and Developing Community Health Centers
51c.201 Applicability.
51c.202 Application.
51c.203 Project elements.
51c.204 Grant evaluation and award.
Subpart C_Grants for Operating Community Health Centers
51c.301 Applicability.
51c.302 Application.
51c.303 Project elements.
51c.304 Governing board.
51c.305 Grant evaluation and award.
Subpart D_Grants for Operating Community Health Projects
51c.401 Applicability.
51c.402 Application.
51c.403 Project elements.
51c.404 Grant evaluation and award.
Subpart E_Acquisition and Modernization of Existing Buildings
51c.501 Applicability.
51c.502 Definitions.
51c.503 Application.
51c.504 Project elements.
51c.505 Determination of cost.
51c.506 Use of grant funds.
51c.507 Facility which has previously received Federal grant.
Authority: 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).
Source: 41 FR 53205, Dec. 3, 1976, unless otherwise noted.
Subpart A_General Provisions
Sec. 51c.101 Applicability.
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).
Sec. 51c.102 Definitions.
As used in this part:
(a) Act means the Public Health Service Act.
(b) Catchment area means the area served by a project funded under
section 330 of the Act.
(c)(1) Community health center or center means an entity which,
through its staff and supporting resources or through contracts or
cooperative arrangements with other public or private entities, provides
for all residents of its catchment area:
(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
[[Page 174]]
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) Environmental health services means the detection and
alleviation of unhealthful conditions of the environment of the
catchment area, such as problems associated with water supply, sewage
treatment, solid waste disposal, rodent and parasite infestation, and
housing conditions. For the purposes of this part, the detection and
alleviation of unhealthful conditions of the environment includes the
notification of and making of arrangements with appropriate Federal,
State, or local authorities responsible for correcting such conditions.
(e) Medically underserved population means the population of an
urban or rural area designated by the Secretary as an area with a
shortage of personal health services or a population group designated by
the Secretary as having a shortage of such services. Medically
underserved areas will be designated by the Secretary and a list of
those designated will be published in the Federal Register from time to
time, taking into consideration the following factors, among others:
(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 with incomes below the
poverty level; and
(4) Demographic factors affecting the population's need and demand
for health services, such as percentage of the population age 65 and
over.
(f) Nonprofit, as applied to any private agency, institution, or
organization, means one which is a corporation or association, or is
owned and operated by one or more corporations or associations, no part
of the net earnings of which inures, or may lawfully inure, to the
benefit of any private shareholder or individual.
(g) Physician means a licensed doctor of medicine or doctor of
osteopathy.
(h) Primary health services means:
(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) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
(j) Supplemental health services means health services which are not
included
[[Page 175]]
as primary health services and which are:
(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.
Sec. 51c.103 Eligibility.
Any public or nonprofit private entity is eligible to apply for a
grant under this part.
Sec. 51c.104 Application.
(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 Sec. 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.
[[Page 176]]
(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.
(Sec. 330, Public Health Service Act, 89 Stat. 342, (42 U.S.C. 254c);
sec. 215, Public Health Service Act, 58 Stat. 690, 67 Stat. 63 (42
U.S.C. 216))
[41 FR 53205, Dec. 3, 1976, as amended at 48 FR 29201, June 24, 1983; 48
FR 45558, Oct. 6, 1983]
Sec. 51c.105 Accord with health planning.
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.
Sec. 51c.106 Amount of grant.
(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: Provided, however, That no grant shall
be made for an amount in excess of the total cost found necessary by the
Secretary to carry out the project.
(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.
[[Page 177]]
(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 project 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.
Sec. 51c.107 Use of project funds.
(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; Provided, That (i) charges will be made to
such individuals and families in accordance with Sec. 51c.303(f) of
subpart C; (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;
(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.
Sec. 51c.108 Grant payments.
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.
[[Page 178]]
Sec. 51c.109 Nondiscrimination.
(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.
Sec. 51c.110 Confidentiality.
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.
Sec. 51c.111 Publications and copyright.
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.
Sec. 51c.112 Grantee accountability.
(a) Accounting for grant award payments. All payments made by the
Secretary shall be recorded by the grantee in accounting records
separate from the records of all other funds, including funds derived
from other grant awards. With respect to each approved project, the
grantee shall account for the sum total of all amounts paid as well as
other funds and in-kind contributions by presenting or otherwise making
available evidence satisfactory to the Secretary of expenditure for
direct and indirect costs meeting the requirements of this part:
Provided, however, That when the amount awarded for indirect costs was
based on a predetermined fixed-percentage of estimated direct costs, the
amount allowed for indirect costs shall be computed on the basis of such
predetermined fixed-percentage rates applied to the total, or a selected
element thereof, of the reimbursable direct costs incurred.
(b) Accounting for interest earned on grant funds. Pursuant to
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C.
4213), a State will not be held accountable for interest earned on grant
funds, pending their disbursement for grant purposes. A State, as
defined in section 102 of the Intergovernmental Cooperation Act, means
any one of the several States, the District of Columbia, Puerto Rico,
any territory or possession of the United States, or any agency or
instrumentality of a State, but does not include the government of the
political subdivisions of the State. All grantees other than a State, as
defined, must return all interest earned on grant funds to the Federal
Government.
(c) Grant closeout--(1) Date of final accounting. A grantee shall
render, with respect to each approved project, a full
[[Page 179]]
account, as provided herein, as of the date of the termination of grant
support. The Secretary may require other special and periodic
accounting.
(2) Final settlement. There shall be payable to the Federal
Government as final settlement with respect to each approved project the
total sum of:
(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.
Sec. 51c.113 Applicability 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:
45 CFR Part 74
Subpart
A General.
B Cash depositories.
C Bonding and insurance.
D Retention and custodial requirements for records.
F Grant-related income.
G Matching and cost sharing.
K Grant payment requirements.
L Budget revision procedures.
M Grant closeout, suspension, and termination.
O Property.
Q Cost principles.
Subpart B_Grants for Planning and Developing Community Health Centers
Sec. 51c.201 Applicability.
The regulations of this subpart, in addition to the regulations of
subpart A of this part, are applicable to grants awarded pursuant to
section 330(c) of the Act for projects for planning and developing
community health centers which will serve medically underserved
populations.
Sec. 51c.202 Application.
To be approved by the Secretary under this subpart, an application
for a grant must, in addition to meeting the requirements of Sec.
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 Sec. 51c.203.
Sec. 51c.203 Project elements.
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
Sec. 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 Sec.
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.
[[Page 180]]
(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.
Sec. 51c.204 Grant evaluation and award.
(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 Sec. 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
project;
(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.
Subpart C_Grants for Operating Community Health Centers
Sec. 51c.301 Applicability.
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.
Sec. 51c.302 Application.
To be approved by the Secretary under this subpart, an application
for a grant must, in addition to meeting the requirements of Sec.
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 Sec. 51c.103.
[41 FR 53205, Dec. 3, 1976, as amended at 42 FR 60418, Nov. 25, 1977]
Sec. 51c.303 Project elements.
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 Sec. 51c.110 of
subpart A.
(c) Have an ongoing quality assurance program which provides for the
following:
[[Page 181]]
(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
project 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. Provided, That such schedule of discounts
shall provide for a full discount to individuals and families with
annual incomes at or below those set forth in the most recent CSA
Proverty Income Guidelines (45 CFR 1060.2) and for no discount to
individuals and families with annual incomes greater than twice those
set forth in such Guidelines, except that nominal fees for services may
be collected from individuals with annual incomes at or below such
levels where imposition of such fees is consistent with project goals.
(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 Sec.
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
[[Page 182]]
(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 Sec. 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 project 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: Provided, however, That a
charge for the provision of services will be made to the extent that a
third party (including a Government agency) is authorized or is under
legal obligation to pay such charges.
(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.
[[Page 183]]
Sec. 51c.304 Governing board.
A governing board for the center shall be established by an
applicant as follows:
(a) Size. The board shall consist of at least 9 but not more than 25
members, except that this requirement may be waived by the Secretary for
good cause shown.
(b) Composition. (1) A majority of the board members shall be
individuals who are or will be served by the center and who, as a group,
represent the individuals being or to be served in terms of demographic
factors, such as race, ethnicity, sex.
(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) Selection of members. The method of selection of all governing
board members shall be prescribed in the by-laws or other internal
governing rules of the center. Such by-laws or other rules must specify
a process of selection of individuals on the governing board who
represent the population served or to be served by the center so that
such individuals, as a group, are representative of such population.
Such process of selection in the by-laws or other rules is subject to
approval by the Secretary.
(d) Functions and responsibilities. (1) The governing board for the
center shall have authority for the establishment of policy in the
conduct of the center.
(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.
Sec. 51c.305 Grant evaluation and award.
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 Sec. 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
[[Page 184]]
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
project;
(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.
Subpart D_Grants for Operating Community Health Projects
Sec. 51c.401 Applicability.
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.
Sec. 51c.402 Application.
To be approved by the Secretary under this subpart, an application
for a grant must, in addition to meeting the requirements of Sec.
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 Sec. 51c.403 of this subpart.
Sec. 51c.403 Project elements.
A project for the operation of a community health project supported
under this subpart must:
(a) Meet all of the requirements of Sec. 51c.303 of this part
except for paragraph (h).
(b) Provide those services enumerated in Sec. 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 Sec.
51c.304 by the end of the period of support under section 330(d)(1)(B)
of the Act and this subpart.
Sec. 51c.404 Grant evaluation and award.
(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 Sec. 51c.403(a);
and
(2) Taking into consideration the following:
(i) The degree to which the project would provide the services
enumerated in Sec. 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 Sec. 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
[[Page 185]]
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 project.
(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.
Subpart E_Acquisition and Modernization of Existing Buildings
Sec. 51c.501 Applicability.
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.
[43 FR 5352, Feb. 7, 1978]
Sec. 51c.502 Definitions.
(a) Equipment means nonexpendable personal property as defined in 45
CFR 74.132.
(b) Existing building means a completed or substantially completed
structure, and may include the realty on which it is or is to be
located.
(c) Modernization means the alteration, repair, remodeling and/or
renovation of a building (including the initial equipment thereof and
improvements to the building's site) which, when completed, will render
the building suitable for use by the project for which the grant is
made.
[43 FR 5352, Feb. 7, 1978]
Sec. 51c.503 Application.
(a) General requirements. An application for a grant under this part
for a project under subparts B, C, or D which includes the acquisition
and/or modernization of an existing building must include the following:
(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;
[[Page 186]]
(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 project;
(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) Requirement for acquisition grants. Except for a grant solely
for amortization of principal and payment of interest on an existing
loan, an application for a grant for a project which includes the
acquisition of an existing building must include, in addition to the
requirements of paragraph (a) of this section, evidence satisfactory to
the Secretary that the applicant has explored other alternatives to the
proposed acquisition (such as leasing facilities or acquiring other
facilities in the project's catchment area) and that the proposed
acquisition constitutes the soundest alternative from a financial and
program standpoint.
(c) Requirements for modernization grants. In addition to the
requirements of paragraph (a) of this section, an application for a
grant for a project which includes modernization of an existing building
must include the following:
(1) Plans and specifications for the proposed modernization which
conform to the standards specified in Sec. 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 et seq.)
and will receive compensation at a rate not less than one and one-half
times his basic rate of pay for all hours worked in any workweek in
excess of 8 hours in any calendar day; and
(3) Copies of any construction and materials contracts already
entered into for the proposed modernization.
[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]
Sec. 51c.504 Project elements.
(a) General requirements. A grantee which has received a grant under
section 330 of the Act for a project which includes the acquisition and/
or modernization of an existing building must:
(1) Assurances. Comply with the assurances provided pursuant to this
subpart.
(2) Approval of estimated cost. Not enter into any contract for the
acquisition and/or modernization funded under this subpart where the
cost of such acquisition and/or modernization exceeds the estimates in
the application, without the prior approval of the Secretary.
[[Page 187]]
(3) Non-default. Make every effort to prevent any default on any
loan secured by the building and, in the event of a default, promptly
notify the Secretary of the default and make every effort on a timely
basis to cure the default.
(b) Requirements for acquisition grants. In addition to the
requirements of paragraph (a) of this section, a grantee which has
received a grant under section 330 of the Act for a project which
includes the acquisition of an existing building must:
(1) Bona-fide sale. Acquire or, in the case of a grant solely for
amortization of principal and payment of interest on an existing loan,
have acquired the existing building pursuant to a bona-fide sale
involving an actual cost to the applicant and resulting in additional or
improved facilities for the purposes of the project.
(2) Standards of construction and equipment. Except in the case of a
grant solely for amortization of principal and payment of interest on an
existing loan, obtain a determination by the Secretary that the facility
conforms (or upon completion of any necessary alteration and renovation
or modernization will conform) to the standards set forth in Sec.
51c.503(a)(7)(iii) of this subpart before entering into a final or
unconditional contract for the acquisition. Where the Secretary finds
that exceptions to or modifications of any such standards would be
consistent with the purposes of the Act and of the program, he may
authorize such exceptions or modifications.
(3) Financing. Where the grantee will obtain a loan secured by the
building in order to acquire the building, obtain such financing at the
lowest current rate prevailing in the area for comparable loans on
comparable facilities.
(c) Requirements for modernization grants. In addition to the
requirements of paragraph (a) of this section, a grantee which has
received a grant under section 330 of the Act for a project which
includes the modernization of an existing building must:
(1) Costs in excess of approved costs. Finance all costs in excess
of the estimated costs approved in the application and submit to the
Secretary for prior approval any changes that substantially alter the
scope of the function, utilities, or safety of the facility.
(2) Competitive bids. (i) Obtain the approval of the Secretary
before the project is advertised or placed on the market for bidding;
such approval must include a determination by the Secretary that the
final plans and specifications conform to the standards set forth in
Sec. 51c.503(a)(7)(iii) of these regulations.
(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) Construction contracts. (i) Include the following conditions and
provisions in all construction contracts for the modernization project:
(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:
Provided, however, That in
[[Page 188]]
the case of a State or local unit of government which enters into a
construction contract of less than $100,000, State or local provisions
with respect to performance and payment bonds shall be deemed to meet
the requirements of this paragraph; and
(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) Executive Order 11246. Comply with the applicable requirements
of Executive Order 11246, 30 FR 12319 (September 24, 1965) as amended,
relating to nondiscrimination in construction contract employment, and
the applicable rules, regulations, and procedures prescribed pursuant
thereto.
(4) Modernization supervision. Provide and maintain competent and
adequate architectural or engineering supervision and inspection at the
modernization site to insure that the completed work conforms with the
plans and specifications.
(5) Completion responsibility. Complete the modernization in
accordance with the grant application and the approved plans and
specifications.
(6) Progress reports. Furnish progress reports and such other
information concerning the modernization as the Secretary may require.
(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.
[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]
Sec. 51c.505 Determination of cost.
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 building
necessary for the operation of the approved project.
[41 FR 5700, Dec. 30, 1976]
Sec. 51c.506 Use of grant funds.
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.
[41 FR 5700, Dec. 30, 1976]
Sec. 51c.507 Facility which has previously received Federal grant.
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.
[41 FR 5700, Dec. 30, 1976]
PART 51d_MENTAL HEALTH AND SUBSTANCE ABUSE EMERGENCY RESPONSE PROCEDURES--
Table of Contents
Sec.
51d.1 To what does this subpart apply?
51d.2 Definitions.
51d.3 Who is eligible for an award under this subpart?
51d.4 What information is required in the application?
51d.5 How is an emergency determined to exist?
51d.6 How will applications be evaluated and awarded?
51d.7 What are the limitations on how award funds may be used?
51d.8 Which other HHS regulations apply to these awards?
51d.9 What other conditions apply to these awards?
51d.10 What are the reporting requirements?
Authority: 42 U.S.C. 290aa(m).
Source: 66 FR 51877, Oct. 11, 2001, unless otherwise noted.
[[Page 189]]
Sec. 51d.1 To what does this subpart apply?
The regulations in this subpart apply to grants that enable public
entities to respond to needs in local communities created by mental
health or substance abuse emergencies, as authorized under section
501(m) of the Public Health Service Act (42 U.S.C. 290aa(m)).
Sec. 51d.2 Definitions.
As used in this part:
Federally recognized Indian Tribal government means the governing
body of any Indian tribe, band, nation, or other organized group or
community, including any Native village as defined in, or established
pursuant to, the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et
seq.), which is recognized as eligible for the special programs and
services provided by the United States to Indians because of their
status as Indians;
Immediate award means a short term award of up to $50,000, or such
greater amount as determined by the Secretary on a case-by-case basis,
to address the immediate needs resulting from a mental health or
substance abuse emergency. Such funding may be provided for a period of
up to 90 days.
Intermediate award means an award intended to meet the more ongoing
needs resulting from a mental health or substance abuse emergency than
is possible under an Immediate award. Intermediate awards may fund up to
one year of services, although in some exceptional circumstances, and to
the extent that funding is available, such funding may be continued for
an additional period of up to one year.
Public entity means any State, any political subdivision of a State,
any Federally recognized Indian tribal government or tribal
organization.
Secretary means the Secretary of Health and Human Services (HHS) or
any other officer or employee of that Department to whom the authority
involved has been delegated.
State means one of the 50 States, the District of Columbia, Guam,
the Commonwealth of Puerto Rico, the Northern Mariana Islands, the
Virgin Islands, American Samoa, and the Trust Territory of the Pacific
Islands.
Tribal organization means the recognized governing body of any
Indian tribe; any legally established organization of Indians which is
controlled, sanctioned, or chartered by such governing body or which is
democratically elected by the adult members of the Indian community to
be served by such organization and which includes the maximum
participation of Indians in all phases of its activities.
[66 FR 51877, Oct. 11, 2001, as amended at 67 FR 56931, Sept. 6, 2002]
Sec. 51d.3 Who is eligible for an award under this subpart?
An applicant must be a public entity as defined by this subpart.
Applicants are eligible for either or both Immediate and Intermediate
awards.
Sec. 51d.4 What information is required in the application?
(a) Application for Immediate awards: The application is to contain
the following information:
(1) A certification by the State's chief executive officer, or, for
the purposes of a Federally recognized Indian tribal government, the
principal elected official, or such officer's or official's designee,
that a mental health or substance abuse emergency exists, as well as a
written statement setting out the basis for the certification;
(2) A brief program plan describing needs;
(3) An estimate of the number of people to be served and the
geographical area to be served;
(4) A description of the types of services to be provided;
(5) A budget justifying the amount of the request;
(6) Required certifications; and
(7) Such other pertinent information as the Secretary may require.
(b) Application for Intermediate awards: The application is to be
submitted on an OMB-approved application form and contain the following:
(1) If the applicant has not applied previously for an Immediate
award, a certification by the State's chief executive officer, or, for
the purposes of a Federally recognized Indian tribal government, the
principal elected official, or such officer's or official's designee,
that a mental health or substance
[[Page 190]]
abuse emergency exists, as well as a written statement setting out the
basis for the certification;
(2) An application submission date within three months of the date
of the event that precipitated the mental health or substance abuse
emergency, as certified in accordance with 51d.4(a)(1) or (b)(1), except
that upon the request of a State, the Secretary may provide a waiver of
this application submission deadline if the Secretary determines there
is good cause to justify the waiver;
(3) A detailed and comprehensive assessment of need;
(4) Demographics specific to the estimated number of people to be
served;
(5) A description of the services that were provided up to the date
of the submission of the Intermediate award application;
(6) The geographical area to be served;
(7) A detailed implementation program plan and related time line,
including a description of outreach to special population groups
affected by the crisis;
(8) A budget justifying the amount of the request for personnel,
equipment, supplies, travel, training, data collection and any technical
assistance required; the budget shall include an identification of the
resources the applicant is able to commit to the project, if any,
including any in-kind contributions;
(9) Any information that has changed since an Immediate application
was submitted, if one was submitted; and
(10) such other pertinent information as the Secretary may require.
(c) Signature on Award Applications. 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, all
applicable regulations, and any additional conditions of the grant.
Sec. 51d.5 How is an emergency determined to exist?
(a) In making a decision as to whether a mental health or substance
abuse emergency exists for purposes of section 501(m) of the PHS Act,
the Secretary, using discretion, will consider all relevant factors, but
at a minimum the following must exist:
(1) Existing State, Tribal and local systems for mental health and/
or substance abuse services are overwhelmed or unable to meet the
existing mental health or substance abuse needs of the local community
at issue; and
(2) This inability to meet the mental health and/or substance abuse
service needs of a local community is the direct consequence of a clear
precipitating event. This precipitating event must:
(i) Have a sudden, rapid onset and a definite conclusion, such as:
(A) A natural disaster (including, but not limited to, a hurricane,
tornado, storm, flood, earthquake, fire, drought, or other natural
catastrophe); or
(B) A technological disaster (including, but not limited to, a
chemical spill, a major industrial accident, or a transportation
accident); or
(C) A criminal act with significant casualties (including, but not
limited to, a domestic act of terrorism, a hostage situation, or an
incident of mass violence including school shootings and riots); and
(ii) Result in significant:
(A) Death,
(B) Injury,
(C) Exposure to life-threatening circumstances,
(D) Hardship,
(E) Suffering,
(F) Loss of property, or
(G) Loss of community infrastructure (e.g., loss of treatment
facilities, staff, public transportation and/or utilities, or isolation
from services); and
(3) No other local, State, Tribal or Federal funding is available to
adequately address the specific level of need resulting from the
precipitating event and resulting emergency mental health and/or
substance abuse service needs of the impacted community.
(b) In making a determination that a mental health or substance
abuse emergency exists, the Secretary will consider the certification
and written statements provided in accordance with Sec. 51d.4(a)(1) or
(b)(1), and other information independently available to the Secretary.
(c) Once the Secretary determines that a mental health or substance
[[Page 191]]
abuse emergency exists, the Secretary may exercise discretion to make
awards to enable public entities to respond to the emergency, within the
limits of funds available.
Sec. 51d.6 How will applications be evaluated and awarded?
(a) In assessing applications for funding, the Secretary will
utilize the following criteria.
(1) Documentation of Need. Applicant has demonstrated mental health
and/or substance abuse needs directly resulting from the precipitating
event. The precipitating event is clearly identified along with
information regarding its impact. Applicant has identified any high risk
groups or populations with special concerns that may impact the delivery
of services (e.g., children, adolescents, older adults, ethnic and
cultural groups, lower income populations). This documentation of need
shall include the extent of physical, psychological and social problems
observed, and a description of how the estimate of the number of people
to be served was made. Applicant has clearly documented that no other
local, State, Tribal or Federal funding sources are available to address
the need.
(2) Plan of Services. Applicant has a clear plan of services to
address documented needs within a defined geographic area and in a
specified time period. The plan of services is appropriate to the type
of grant requested (e.g., Immediate or Intermediate) and specifically
addresses the needs of any high risk groups or populations with special
concerns identified in the assessment of need. The plan of services
clearly identifies the following:
(a) The types of services to be provided (e.g., outreach, crisis
counseling, public education on stress management and crisis mental
health, public education on substance abuse prevention, information and
referral services, short term substance abuse or mental health
prevention and/or treatment services);
(b) Strategies for targeting those identified as needing services,
including high risk groups or populations with special concerns
identified in the needs assessment;
(c) Appropriate training to be provided to staff to assure that
services are appropriate to the crisis situation and the plans for
community recovery;
(d) Quality control methods in place to assure appropriate services
to the target population;
(e) Staff support mechanisms that are available;
(f) Plans for coordination of services with key local, State, Tribal
and Federal partners involved in addressing the precipitating event
(e.g., emergency management agencies, law enforcement, education
agencies, public health agencies, and other agencies active in crisis
response); and
(g) An estimate of the length of time for which said services
requiring Federal funding will be needed, and the manner in which long-
term cases will be referred for continued assistance after Federal funds
have ended.
(3) Organizational Capability. Applicant is a public entity with
demonstrated organizational capacity to deliver services as described in
the plan of services. The applicant should also have a demonstrated
history of service delivery to the target population within the defined
service area for the program. The budget submitted shall provide
sufficient justification and demonstrate that it is consistent with the
documentation of need and plan of services. This shall include a
description of the facilities to be utilized, including plans for
securing office space if necessary to the project.
(b) In determining the appropriateness and necessity of funding, the
Secretary may consult with other Federal agencies responsible for
responding to crisis incidents, including the Readiness, Response and
Recovery Directorate within the Federal Emergency Management Agency
(FEMA), the Safe and Drug Free Schools Program within the U.S.
Department of Education, the Office for Victims of Crime (OVC) within
the U.S. Department of Justice, the National Transportation Safety Board
(NTSB) within the U.S. Department of Transportation, the Emergency
Response Program within the Environmental Protection Agency (EPA), the
Bureau of Indian Affairs (BIA) within the U.S. Department of the
Interior, the Animal and Plant Health Inspection Service within the U.S.
Department of Agriculture, the Indian Health
[[Page 192]]
Service (IHS) within the U.S. Department of Health and Human Services,
and other Federal agencies with jurisdiction over specific types of
crisis response.
Sec. 51d.7 What are the limitations on how award funds may be used?
Unallowable Expenses: The following expenses will not be reimbursed
under section 501(m) of the PHS Act:
(1) Major construction costs;
(2) Childcare services, unless provided by the institution or entity
providing mental health or substance abuse treatment and integral to the
treatment program;
(3) Services outside of the geographic area specified in the
application, except to the extent that the precipitating event requires
physical relocation of either affected parties or facilities;
(4) Any mental health or substance abuse services not directly
related to the mental health or substance abuse emergency;
(5) Any expenses that supplant ongoing local, State, Tribal or
Federal expenditures; and
(6) Any other costs unallowable by Federal law or regulation.
Sec. 51d.8 Which other HHS regulations apply to these awards?
Several other HHS regulations apply to grants under this part. These
include, but are not limited to:
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Debarment and suspension from eligibility for financial
assistance
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefitting from Federal financial
assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefitting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to state and local governments
[66 FR 51877, Oct. 11, 2001, as amended at 67 FR 56931, Sept. 6, 2002]
Sec. 51d.9 What other conditions apply to these awards?
Award funding made under this authority is to be supplemental in
nature. Consistent with the criteria in Sec. 51d.5 and the
certification in Sec. 51d.4(a)(1), such funds will only be made
available if no other local, State, Tribal or Federal source is
available to adequately address the emergency mental health and/or
substance abuse service needs of the impacted community.
Sec. 51d.10 What are the reporting requirements?
(a) For immediate awards:
(1) A mid-program report only if an Intermediate award application
is being prepared and submitted. This report shall be included as part
of the Intermediate award application,
(2) Quarterly financial status reports of expenditures to date, due
30 days following the end of the reporting period, as permitted by 45
CFR 92.41(b),
(3) A final program report, a financial status report, and a final
voucher 90 days after the last day of Immediate award services, in
accordance with 45 CFR 92.50(b).
(b) For intermediate awards:
(1) Quarterly progress reports, due 30 days following the end of the
reporting period, as permitted by 45 CFR 92.40(b),
(2) Quarterly financial status reports of expenditures to date, due
30 days following the end of the reporting period, as permitted by 45
CFR 92.41(b),
(3) A final program report, to be submitted within 90 days after the
end of
[[Page 193]]
the program services period, in accordance with 45 CFR 92.50(b),
(4) A financial status report, to be submitted within 90 days after
the end of the program services period, in accordance with 45 CFR
92.50(b),
(5) Such additional reports as the Secretary may require.
(c) The following shall be specifically addressed in final program
reports:
(1) Description of services provided,
(2) Number of individuals assisted,
(3) Amount of funding expended and for what purposes,
(4) Personnel costs,
(5) Training costs,
(6) Technical consultation costs,
(7) Equipment costs,
(8) Travel and transportation costs, and
(9) A narrative describing lessons learned and exemplary practices,
and a description of the transition plan, for how services will be
funded or provided when Federal funds have been exhausted.
PARTS 51e-51g [RESERVED]
PART 52_GRANTS FOR RESEARCH PROJECTS--Table of Contents
Sec.
52.1 To which programs do these regulations apply?
52.2 Definitions.
52.3 Who is eligible to apply for a grant?
52.4 How to apply for a grant.
52.5 Evaluation and disposition of applications.
52.6 Grant awards.
52.7 Use of funds; changes.
52.8 Other HHS policies and regulations that apply.
52.9 Additional conditions.
Authority: 42 U.S.C. 216.
Sec. 52.1 To which programs do these regulations apply?
(a) General. The regulations of this party apply to all health-
related research project grants administered by the PHS or its
components, except for grants for health services research,
demonstration, and evaluation projects administered by the Agency for
Health Care Policy and Research. These regulations do not apply to
research grants that are not for the support of an identified research
project (sometimes referred to as general research support grants),
grants for the construction or operation of research facilities, grants
for prevention or educational programs, demonstration grants,
traineeships, training grants, or to the support of research training
under the National Research Service Awards program.
(b) Specific programs covered. From time to time the Secretary will
publish a list of the research project grant programs covered by this
part. The list is for informational purposes only and is not intended to
restrict the statement of applicability in paragraph (a) of this
section. In addition, information on particular research project grant
programs, including applications and instructions, may be obtained from
the component of the PHS that administers the program.
[61 FR 55105, Oct. 24, 1996.]
Sec. 52.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
Grantee means the institution, organization, individual or other
person designated in the grant award document as the responsible legal
entity to whom a grant is awarded under this part. The term shall also
mean the recipient of a cooperative agreement awarded under this part.
HHS means the Department of Health and Human Services.
Principal investigator means a single individual designated by the
grantee in the grant application and approved by the Secretary, who is
responsible for the scientific and technical direction of the project.
Project means the particular activity for which funding is sought
under this part as described in the application for grant award.
Public Health Service and PHS means the operating division of the
Department that consists of the Agency for Health Care Policy and
Research, the Centers for Disease Control and Prevention, the Food and
Drug Administration, the Health Resources and Services Administration,
the Indian Health Service, the National Institutes of Health, the Office
of the Assistant Secretary for Health, the Substance
[[Page 194]]
Abuse and Mental Health Administration, and the Agency for Toxic
Substances and Disease Registry.
Research means a systematic investigation, study or experiment
designed to contribute to general knowledge relating broadly to public
health by establishing, discovering, developing, elucidating or
confirming information about, or the underlying mechanisms relating to,
the biological functions, diseases, or related matters to be studied.
Secretary means the Secretary of HHS and any other officer or
employee of the HHS to whom the authority involved may be delegated.
[61 FR 55105, Oct. 24, 1996]
Sec. 52.3 Who is eligible to apply for a grant?
(a) Persons eligible. Any individual, corporation, public or private
institution or agency, or other legal entity shall be eligible for a
grant award, except:
(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) Permissible activities within research projects. Any project
found by the Secretary to be a research project within the meaning of
this part shall be eligible for a grant award. Eligible projects may
consist of laboratory, clinical, population, field, statistical, basic,
applied or other types of investigations, studies or experiments, or
combinations thereof, and may either be limited to one, or a particular
aspect of a problem or subject, or may consist of two or more related
problems or subjects for concurrent or consecutive investigation and
involving multiple disciplines, facilities and resources.
(c) Preferences. In the award of grants for international research
relating to the development and evaluation of vaccines and treatments
for AIDS under section 2315 of the Act, preference shall be given to:
(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.
[61 FR 55105, Oct. 24, 1996]
Sec. 52.4 How to apply for a grant.
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.
[61 FR 55105, Oct. 24, 1996]
Sec. 52.5 Evaluation and disposition of applications.
(a) Evaluation. All applications filed in accordance with Sec. 52.4
shall be evaluated by the Secretary through such officers and employees
and such experts or consultants engaged for this purpose as the
Secretary determines are specially qualified in the areas of research
involved in the project, including review by an appropriate National
Advisory Council or other body as may be required by law. The
Secretary's evaluation shall take into account among other pertinent
factors the scientific merit and significance of the project, the
competency of the proposed staff in relation to the type of research
involved, the feasibility of the project, the likelihood of its
producing meaningful results, the proposed project period, and the
adequacy of the applicant's resources available for the project and the
amount of grant funds necessary for completion, and in the case of
applications for support of research in emergency medical services,
special consideration shall be given to applications for grants for
research relating to the delivery of emergency medical services in rural
areas.
(b) Disposition. On the basis of the Secretary's evaluation of an
application in accordance with paragraph (a) of this section and subject
to approvals, recommendations or consultations by the appropriate
National Advisory Council or other body as may be required by law, the
Secretary will (1) approve, (2) defer because of either lack
[[Page 195]]
of funds or a need for further evaluation, or (3) disapprove support of
the proposed project in whole or in part. With respect to approved
projects, the Secretary will determine the project period (subject to
extension as provided in Sec. 52.7(c)) during which the project may be
supported. Any deferral and disapproval of an application will not
preclude its reconsideration or a reapplication.
[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]
Sec. 52.6 Grant awards.
(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) Evaluation of unapproved drug treatments for AIDS. Grants under
section 2314 of the Act to support research relating to the evaluation
of drug treatments for AIDS not approved by the Commissioner of Food and
Drugs, shall be subject to appropriate scientific and ethical guidelines
established by the Secretary for each project, pursuant to section
2314(c) of the Act. In order to receive a grant, the applicant must
agree to comply with those guidelines.
(c) Notice of grant award. (1) 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 1-5 years.
(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) Multiple or concurrent awards. Whenever a research project
involves a number of different but related problems, activities or
disciplines which require evaluation by different groups, or whenever
support for a project could be more effectively administered by separate
handling of separate aspects of the project, the Secretary may evaluate,
approve and make awards pursuant to two or more concurrent applications,
each dealing with one or more specified aspects of the project.
(e) Unobligated balances. 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.
(f) Award for continuation of project under new grantee. The
Secretary, upon application in accordance with the provisions of Sec.
52.4 and without further action by a Council or other body, may make a
grant to any institution or other person eligible under Sec. 52.3 for
continuation of a currently supported project for which a grant was
previously made to another institution or person, provided the Secretary
finds that the change in the conduct of the project is consonant with
the previous evaluation and approval of the project under Sec. 52.5.
[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 61 FR 55105,
Oct. 24, 1996]
[[Page 196]]
Sec. 52.7 Use of funds; changes.
(a) Delegation of fiscal responsibility. The grantee may not in
whole or in part delegate or transfer to another person responsibility
for the use or expenditure of grant funds.
(b) Changes in project. The permissible changes by the principal
investigator in the approved project shall be limited to changes in
methodology, approach or other aspects of the project to expedite
achievement of the project's research objectives, including changes that
grow out of the approved project and serve the best scientific strategy.
If the grantee and the principal investigator are uncertain whether a
change complies with this provision, the question must be referred to
the Secretary for a final determination.
(c) Changes in project period. The project period determined
pursuant to Sec. 52.5(b) may be extended by the Secretary, with or
without additional grant support, for such an additional period as the
Secretary determines may be required to complete, or fulfill the
purposes of, the approved project.
[45 FR 12240, Feb. 25, 1980]
Sec. 52.8 Other HHS regulations and policies that apply.
Several other HHS policies and regulations apply to grants under
this part. These include, but are not necessarily limited to:
37 CFR part 401--Rights to inventions made by nonprofit organizations
and small business firms under government grants, contracts, and
cooperative agreements
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant
institutions for dealing with and reporting possible misconduct in
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
42 CFR part 50, subpart F--Responsibility of applicants for promoting
objectively in research for which PHS funding is sought
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement)
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women
and Minorities as Subjects in Clinical Research.
Note: 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.]
59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving
Recombinant DNA Molecules.
Note: 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.]
``PHS Grants Policy Statement,'' DHHS Publication No. (OASH) 94-50,000
(Rev.) April 1, 1994.
Note: 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.]
``Public Health Service Policy on Humane Care and Use of Laboratory
Animals,'' Office for Protection from Research Risks, NIH (Revised
September 1986).
Note: 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-
[[Page 197]]
7005; not a toll-free number) to obtain references to the current
version and any amendments.]
[61 FR 55106 Oct. 24, 1996]
Sec. 52.9 Additional conditions.
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.
[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]
PART 52a_NATIONAL INSTITUTES OF HEALTH CENTER GRANTS--Table of Contents
Sec.
52a.1 To which programs do these regulations apply?
52a.2 Definitions.
52a.3 Who is eligible to apply?
52a.4 What information must each application contain?
52a.5 How will NIH evaluate applications?
52a.6 Information about grant awards.
52a.7 For what purposes may a grantee spend grant funds?
52a.8 Other HHS regulations and policies that apply.
52a.9 Additional conditions.
Authority: 42 U.S.C. 216, 284g, 285a-6(c)(1)(E), 285a-7(c)(1)(G),
285b-4, 285c-5, 285c-8, 285d-6, 285e-2, 285e-3, 285e-10a, 285f-1, 285g-
5, 285g-7, 285g-9, 285m-3, 285o-2, 286a-7(c)(1)(G), 287c-32(c), 300cc-
16.
Source: 57 FR 61006, Dec. 23, 1992, unless otherwise noted.
Sec. 52a.1 To which programs do these regulations apply?
(a) The regulations of this part apply to grants by the National
Institutes of Health and its organizational components to support the
planning, establishment, expansion, and operation of research and
demonstration and/or multipurpose centers in health fields described in
this paragraph. Specifically, these regulations apply to:
(1) National Institute of Mental Health centers of excellence with
respect to research on autism, as authorized by section 409C of the Act
(42 U.S.C. 284g);
(2) National cancer research and demonstration centers (including
payments for construction), as authorized by section 414 of the Act (42
U.S.C. 285a-3);
(3) National cancer research and demonstration centers with respect
to breast cancer, as authorized by section 417 of the Act (42 U.S.C.
285a-6);
(4) National cancer and demonstration centers with respect to
prostate cancer, as authorized by section 417A of the Act (42 U.S.C.
285a-7);
(5) 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), as authorized by section 422 of the Act (42 U.S.C. 485b-
4);
(6) Research and training centers (including diabetes mellitus, and
digestive, endocrine, metabolic, kidney and urologic diseases), as
authorized by section 431 of the Act (42 U.S.C. 285c-5);
(7) Research and training centers regarding nutritional disorders,
as authorized by section 434 of the Act (42 U.S.C. 285c-8);
(8) Multipurpose arthritis and musculoskeletal diseases centers
(including payments for alteration, but not construction), as authorized
by section 441 of the Act (42 U.S.C. 285d-6);
(9) Alzheimer's disease centers, as authorized by section 445 of the
Act (42 U.S.C. 285e-2);
(10) Claude D. Peppers Older Americans Independence Centers, as
authorized by section 445A of the Act (42 U.S.C. 285e-3);
(11) Centers of excellence in Alzheimer's disease research and
treatment, as authorized by section 445I of the Act (42 U.S.C. 285e-
10a);
(12) Research centers regarding chronic fatigue syndrome, as
authorized by section 447 of the Act (42 U.S.C. 285f-1);
(13) Research centers with respect to contraception and infertility,
as authorized by section 452A of the Act (42 U.S.C. 285g-5);
(14) Child health research centers, as authorized by section 452C of
the Act (42 U.S.C. 285g-7);
(15) Fragile X research centers, as authorized by 452E of the Act
(42 U.S.C. 285g-9);
[[Page 198]]
(16) Multipurpose deafness and other communication disorders
centers, as authorized by section 464C of the Act (42 U.S.C. 285m-3);
(17) National drug abuse research centers, as authorized by section
464N of the Act (42 U.S.C. 285o-2);
(18) Centers of excellence in biomedical and behavioral research
training for individuals who are members of minority health disparity
populations or other health disparity populations, as authorized by
section 485F of the Act (42 U.S.C. 287c-32); and
(19) Centers for acquired immunodeficiency syndrome (AIDS) research,
as authorized by section 2316 of the Act (42 U.S.C. 300cc-16).
(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.''
[61 FR 55108, Oct. 24, 1996, as amended at 68 FR 69621, Dec. 15, 2003]
Sec. 52a.2 Definitions.
As used in this part:
Act means the Public Health Services Act, as amended (42 U.S.C. 201
et seq.).
Center means:
(a) For purposes of grants authorized by section 409C of the Act, a
public or nonprofit private entity which provides for planning and
conducting basic and clinical research into the cause, diagnosis, early
detection, prevention, control, and treatment of autism, including the
fields of developmental neurobiology, genetics, and psychopharmacology;
(b) 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;
(c) For purposes of grants authorized by section 417 of the Act, an
agency or institution which provides for planning and conducting basic,
clinical, epidemiological, psychological, prevention and treatment
research and related activities on breast cancer;
(d) For purposes of grants authorized by section 417A of the Act, an
agency or institution which provides for planning and conducting basic,
clinical, and epidemiological, psychosocial, prevention and control,
treatment, research, and related activities on prostate cancer;
(e) 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;
(f) 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;
(g) For purposes of grants authorized by section 434 of the Act, a
single institution or a consortium of cooperating institutions which
conducts basic and clinical research, training, and information programs
in nutritional disorders, including obesity;
(h) For purposes of grants authorized by section 441 of the Act, a
facility which conducts basic and clinical research into arthritis and
musculosketal diseases; and orthopedic procedures, training, and
information programs for the health community and the general public;
(i) For purposes of grants authorized by section 445 of the Act, a
public or private nonprofit entity (including university medical
centers) which conducts basic and clinical research (including
multidisciplinary research) into, training in, and demonstration of
[[Page 199]]
advanced diagnostic, prevention, and treatment methods for Alzheimer's
disease;
(j) For purposes of grants authorized by section 445A of the Act, a
single public or private nonprofit institution or entity or a consortium
of cooperating institutions or entities which conducts research into the
aging processes and into the diagnosis and treatment of diseases,
disorders, and complications related to aging, including menopause,
which research includes research on such treatments, and on medical
devices and other medical interventions regarding such diseases,
disorders, and complications, that can assist individuals in avoiding
institutionalization and prolonged hospitalization and in otherwise
increasing the independence of the individuals.
(k) For the purposes of section 445I of the Act, a single
institution or consortium of cooperating institutions which conducts
basic and clinical research on Alzheimer's disease.
(l) 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;
(m) For purposes of grants authorized by section 452A of the Act, a
single institution or consortium of cooperating institutions which
conducts clinical and other applied research, training programs,
continuing education programs, and information programs with respect to
methods of contraception, and infertility;
(n) 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;
(o) For purposes of grants authorized by section 452E of the Act, a
single institution or a consortium of cooperating institutions which
conducts research for the purposes of improving the diagnosis and
treatment of, and finding the cure for, fragile X;
(p) 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 the health community 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;
(q) For purposes of grants authorized by section 464N of the Act,
institutions designated as National Drug Abuse Research Centers for
interdisciplinary research relating to drug abuse and other biomedical,
behavioral, and social issues related to drug abuse;
(r) For purposes of grants authorized by section 485F of the Act, a
biomedical or behavioral research institution or consortia that:
(1) Have a significant number of members of minority health
disparity populations or other health disparity populations enrolled as
students in the institution (including individuals accepted for
enrollment in the institution);
(2) Have been effective in assisting such students of the
institution to complete the program of education or training and receive
the degree involved;
(3) Have made significant efforts to recruit minority students to
enroll in and graduate from the institution, which may include providing
means-tested scholarships and other financial assistance as appropriate;
and
(4) Have made significant recruitment efforts to increase the number
of minority or other members of health disparity populations serving in
faculty or administrative positions at the institution; or
(s) For the purposes of grants authorized in 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 (AIDS).
Director means the Director of NIH or the organizational component
authorized to award grants to support centers under this part.
Grant(s) means, unless the context otherwise requires, an award of
funds
[[Page 200]]
to support a center authorized under Sec. 52a.1. The term includes
cooperative agreement(s).
NIH means the National Institutes of Health and its organizational
components that award grants.
Nonprofit as applied to any agency or institution means an agency or
institution which is a corporation or an association, no part of the net
earnings of which inures or may lawfully inure to the benefit of any
private shareholder or individual.
Project period means the period of time, from one to five years,
specified in the notice of grant award that the NIH or the awarding
component intends to support a proposed center without requiring the
center to recompete for funds.
[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55108, Oct. 24, 1996;
68 FR 69621, Dec. 15, 2003]
Sec. 52a.3 Who is eligible to apply?
(a) Any public or private nonprofit agency, institution, or
consortium of agencies is eligible to apply for a grant under sections
409C, 414, 417, 417A, 422, 445, 445A, 445I, 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 428, 431, 434, 441, 452C, 452E, 464C, 464J, 464N, and
485F 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).
[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996;
68 FR 69622, Dec. 15, 2003]
Sec. 52a.4 What information must each application contain?
Each application under this part must include detailed information
as to the following:
(a) The personnel, facilities, and other resources available to the
applicant with which to initiate and maintain the proposed center grants
program;
(b) Any research, training, demonstration, or information
dissemination activities in which the applicant is currently engaged;
the sources of funding for these activities; and the relevance of these
activities to the proposed center grants program;
(c) Proposed research, training, demonstration, and information
dissemination activities;
(d) The proposed organizational structure of the center and the
relationship of the proposed center to the applicant organization(s);
(e) The names and qualifications of the center director and key
staff members who would be responsible for conducting the proposed
activities;
(f) Proposed methods for monitoring and evaluating individual
activities and the overall center program;
(g) Proposed methods for coordinating the center's activities, where
appropriate, with similar efforts by other public and private
organizations;
(h) The availability of any community resources necessary to carry
out proposed activities; and
(i) Efforts to be made to generate and collect income from sources
other than NIH to be used to further the purposes of the center program.
NIH encourages these efforts. Income may include, but is not limited to,
that generated from the sale or rental of products or services produced
by grant-supported activities, such as laboratory tests, computer time,
and payments received from patients or third parties, where appropriate
(the disposition of grant-related income is governed by 45 CFR 74.40
through 74.47 and 45 CFR 92.25);
(j) The proposed budget for the center and a justification for the
amount of the grant funds requested; and
(k) Any other information that the Director of the awarding
institute may request.
(Approved under OMB Control Number 0925-0001)
Sec. 52a.5 How will NIH evaluate applications?
(a) NIH considers the following in evaluating Center grant
applications:
(1) The scientific and technical merit of the proposed program;
[[Page 201]]
(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.
Sec. 52a.6 Information about grant awards.
(a) The notice of grant award specifies how long NIH intends to
support the project without requiring the project to recompete for
funds. This period, called the project period, will usually be for 1-5
years.
(b) Generally, the grant will initially be for one year, and
subsequent continuation awards will also be for one year at a time. A
grantee must submit a separate application to have the support continued
for each subsequent year. Decisions regarding continuation awards and
the funding level of such awards will be made after consideration of
such factors as the grantee's progress and management practices, and the
availability of funds. In all cases, continuation awards require a
determination by the NIH that continued funding is in the best interest
of the Federal Government.
(c) Neither the approval of any application, nor the award of any
grant commits or obligates the Federal Government in any way to make any
additional, supplemental, continuation, or other award with respect to
any approved application or portion of an approved application.
[Approved under OMB Control Number 0925-0001]
Sec. 52a.7 For what purposes may a grantee spend grant funds?
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.
[61 FR 55109, Oct. 24, 1996]
Sec. 52a.8 Other HHS regulations and policies that apply.
Several other regulations and policies apply to this part. These
include, but are not necessarily limited to:
42 CFR part 50, Subpart A--Responsibilities of PHS awardee and applicant
institutions for dealing with and reporting possible misconduct in
science
42 CFR part 50, Subpart D--Public Health Service grant appeals
procedures
42 CFR part 50, subpart F--Responsibility of applicants for promoting
objectivity in research for which PHS funding is sought
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Uniform administrative requirements for awards and
subawards to institutions of higher education, hospitals, other
nonprofit organizations, and commercial organizations; and certain
grants and agreements with states, local governments and Indian tribal
governments
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement)
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefiting from Federal financial assistance
[[Page 202]]
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women
and Minorities as Subjects in Clinical Research.
[Note: 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.]
59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving
Recombinant DNA Molecules.
[Note: 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.]
Public Health Service Policy on Humane Care and Use of Laboratory
Animals, Office of Laboratory Animal Welfare, Office of Extramural
Research, NIH (Revised September 1986).
Note: This policy is subject to change, and interested persons
should contact the Office of Laboratory Animal Welfare, Office of
Extramural Research, NIH, Rockledge 1, 6705 Rockledge Drive, Bethesda,
Maryland 20817, telephone 301-594-2382 (not a toll-free number) to
obtain references to the current version and any amendments.
[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996;
68 FR 69622, Dec. 15, 2003]
Sec. 52a.9 Additional conditions.
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.
[61 FR 55110, Oct. 24, 1996]
PART 52b_NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS--Table of Contents
Sec.
52b.1 To what programs do these regulations apply?
52b.2 Definitions.
52b.3 Who is eligible to apply?
52b.4 How to apply.
52b.5 How will NIH evaluate applications?
52b.6 What is the rate of federal financial participation?
52b.7 How is the grantee obligated to use the facility?
52b.8 How will NIH monitor the use of facilities constructed with
federal funds?
52b.9 What is the right of the United States to recover federal funds
when facilities are not used for research or are transferred?
52b.10 What are the terms and conditions of awards?
52b.11 What are the requirements for acquisition and modernization of
existing facilities?
52b.12 What are the minimum requirements of construction and equipment?
52b.13 Additional conditions.
52b.14 Other federal laws, regulations, executive orders, and policies
that apply.
Authority: 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.
Source: 64 FR 63722, Nov. 22, 1999, unless otherwise noted.
Sec. 52b.1 To what programs do these regulations apply?
(a) General. Except as provided in paragraph (c) of this section,
this part applies to all grants awarded by NIH and its components for
construction of new buildings and the alteration, renovation,
remodeling, improvement, expansion, and repair of existing buildings,
including the provision of equipment necessary to make the building (or
applicable part of the building) suitable for the purpose for which it
was constructed.
(b) Specific programs covered. From time to time the Director may
publish a list of the construction grant programs covered by this part.
The list is for informational purposes only and is not intended to
restrict the statement of applicability in paragraph (a) of this
section. In addition, information on
[[Page 203]]
particular construction grant programs, including applications and
instructions, may be obtained from the component of NIH that administers
the program.
(c) Specific programs excluded. The regulations of this part do not
apply to minor alterations, renovations, or repairs funded under a
research project grant (see part 52 of this chapter) or alterations or
renovations funded under an NIH center grant (see part 52a of this
chapter).
Sec. 52b.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
Construction means the construction of new buildings or the
modernization of, or the completion of shell space in, existing
buildings (including the installation of fixed equipment), but excluding
the cost of land acquisition and off-site improvements.
Construction grant means funds awarded for construction in
accordance with the applicable provisions of the Act and this part.
Director means the Director of NIH or the director of an NIH
national research institute, center, or other component of NIH,
authorized to award grants for construction under the applicable
provisions of the Act, and any official to whom the authority involved
is delegated.
Federal share with respect to any construction project means the
proportion, expressed as a percentage, of the cost of a project to be
paid by a grant award under the Act.
HHS, DHHS, and Department mean the Department of Health and Human
Services.
Institute means any national research institute, center, or other
agency of the National Institutes of Health.
Modernization means the alteration, renovation, remodeling,
improvement, expansion, and/or repair of existing buildings and the
provision of equipment necessary to make the building suitable for use
for the purposes of the particular program.
NIH means the National Institutes of Health and its organizational
components that award construction grants.
Nonprofit as applied to any agency or institution means an agency or
institution which is a corporation or an association, no part of the net
earnings of which inures or may lawfully inure to the benefit of any
private shareholder or individual.
Project means the particular construction activity which is
supported by a grant under this part.
Secretary means the Secretary of Health and Human Services and any
official to whom the authority involved is delegated.
Sec. 52b.3 Who is eligible to apply?
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.
Sec. 52b.4 How to apply.
Applications for construction grants under this part shall be made
at the times and in the form and manner as the Secretary may prescribe.
Sec. 52b.5 How will NIH evaluate applications?
(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
[[Page 204]]
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.
Sec. 52b.6 What is the rate of federal financial participation?
(a) Unless otherwise specified by statute, the rate of federal
financial participation in a construction project supported by a grant
under this part shall not be more than 50 percent of the necessary
allowable costs of construction as determined by the Director, except
that when the Director finds good cause for waiving this limitation, the
amount of the construction grant may be more than 50 percent of the
necessary allowable costs of construction.
(b) Subject to paragraph (a) of this section, the Director shall set
the actual rate of federal financial participation in the necessary
allowable costs of construction, taking into consideration the most
effective use of available federal funds to further the purposes of the
applicable provisions of the Act.
Sec. 52b.7 How is the grantee obligated to use the facility?
(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 Sec. 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 Sec. 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 Sec. 52b.9(c)(1).
(c) Sale or transfer. In the form and manner as the Director may
prescribe, the grantee may request the Director's approval to sell the
facility or transfer title to a third party eligible under Sec. 52b.3
for continued use of the facility for an authorized purpose in
accordance with paragraphs (a) and (b) of this section. If approval is
permissible under the Act or other federal statute and is granted, the
terms of the transfer shall provide that the transferee shall assume all
the rights and obligations of the transferor set forth in 45 CFR part
74, the regulations of this part, and the other terms and conditions of
the grant.
Sec. 52b.8 How will NIH monitor the use of facilities constructed with
federal funds?
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.
[[Page 205]]
Sec. 52b.9 What is the right of the United States to recover Federal funds
when facilities are not used for research or are transferred?
(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 Sec. 52b.7 (or alternate use authorized
under Sec. 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 Sec. 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.
(Approved by the Office of Management and Budget under Control Number
0925-0424; expires November 30, 2001)
Sec. 52b.10 What are the terms and conditions of awards?
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
[[Page 206]]
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) Title. The applicant must have a fee simple or other estate or
interest in the site, including necessary easements and rights-of-way,
sufficient to assure for the estimated useful life of the facility, as
determined by the Director, undisturbed use and possession for the
purpose of the construction and operation of the facility.
(b) Plans and specifications. Approval by the Director of the final
working drawings, specifications, and cost estimates must be obtained
before the project is advertised or placed on the market for bidding.
The approval must include a determination by the Director that the final
plans and specifications conform to the minimum standards of
construction and equipment as set forth in Sec. 52b.12.
(c) Relocation assistance. An applicant with an approved project
which involves the displacement of persons or businesses shall comply
with the provisions of the Uniform Relocation Assistance and Real
Property Acquisition Policies Act of 1970, as amended (42 U.S.C. 4601 et
seq.) and the applicable regulations issued under that Act (45 CFR part
15; 49 CFR part 24).
(d) Approval of changes in estimated cost. Unless approved by the
Director, the applicant shall not enter into any construction contracts
for the project or a part of the project, the cost of which exceeds the
estimated cost approved in the terms of an award for that portion of the
work covered by the plans and specifications. Exceptions shall be
requested in the form and manner as the Director may prescribe.
(e) Completion responsibility. The applicant must construct the
project, or cause it to be constructed, to final completion in
accordance with the grant application, the terms and conditions of the
award, and the approved plans and specifications.
(f) Construction schedule inspection. Prior to the start of
construction, the grantee shall submit an approved copy of the
construction schedule (critical path method) to the Director in the form
and manner as the Director may prescribe.
(g) Construction management. The applicant must provide and maintain
competent and adequate construction management services for inspection
at the construction site to ensure that the completed work conforms with
the approved plans and specifications. Construction management services
shall include daily construction logs and monthly status reports which
shall be maintained at the job site and shall be submitted to the
Director at the times and in the form and manner as the Director may
prescribe.
(h) Nonfederal share. Sufficient funds must be available to meet the
nonfederal share of the costs of constructing the facility.
(i) Funds for operation. Sufficient funds must be available when
construction is completed for effective use of the facility for the
purposes for which it is being constructed.
(j) Inspection. The Director and the Director's representatives
shall have access at all reasonable times to all work areas and
documents during any stage of construction and the contractor shall
provide proper facilities for this access and inspection.
(k) Accessibility to handicapped persons. The facility must be
designed to comply with the Uniform Federal Accessibility Standards (41
CFR part 101-19, subpart 101-19.6, Appendix A), as modified by other
standards prescribed by the Director or the Administrator of General
Services. The applicant shall conduct inspections to ensure compliance
with these specifications by the contractor.
(l) Notice of Federal Interest. The grantee shall record a Notice of
Federal Interest in the appropriate official land records of the
jurisdiction in which the property is located.
(m) Title insurance. The grantee shall purchase a title insurance
policy unless a legal opinion has been provided which certifies that the
grantee institution has fee simple title to the site free and clear of
all liens, easements, rights-of-way, and any other adverse interests
which would encumber the project. The Director may waive this
requirement upon a request from the grantee adequately documenting self-
insurance
[[Page 207]]
against the risks involved and containing such other information as the
Director may prescribe.
(n) Physical destruction insurance. At the time construction is
completed or at the time of beneficial occupancy, whichever comes first,
the grantee shall purchase an insurance policy which insures the
facility for the full appraised value of the property using state
certified appraisers. The insurance policy must protect the property
from total and partial physical destruction. The insurance policy must
be maintained throughout the period of federal interest. The Director
may waive this requirement upon a written request from the grantee
adequately documenting self-insurance against the risks involved and
containing such other information as the Director may prescribe.
(Approved by the Office of Management and Budget under Control Number
0925-0424; expires November 30, 2001)
Sec. 52b.11 What are the requirements for acquisition and modernization of
existing facilities?
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) Minimum standards of construction and equipment. A determination
by the Director that the facility conforms (or upon completion of any
necessary construction will conform) to the minimum standards of
construction and equipment as set forth in Sec. 52b.12 shall be
obtained before entering into a final or unconditional contract for the
acquisition and/or modernization of facilities. Where the Director finds
that exceptions to or modifications of these minimum standards would be
consistent with the purposes of the applicable section of the Act under
which the acquisition or modernization is supported, the Director may
authorize the exceptions or modifications.
(b) Estimated cost of acquisition and remodeling: suitability of
facility. Each application for a project involving the acquisition of
existing facilities shall include in the detailed estimates of the costs
of the project, the cost of acquiring the facilities, and any cost of
remodeling, renovating or altering the facilities to serve the purposes
for which they are acquired. The application shall demonstrate to the
satisfaction of the Director that the architectural, mechanical,
electrical, plumbing, structural, and other pertinent features of the
facility, as modified by any proposed expansion, remodeling, renovation,
or alteration, will be suitable for the purposes of the applicable
sections of the Act.
(c) Bona fide sale. Grant awards for the acquisition of existing
facilities shall be subject to the condition that the acquisition
constitutes a bona fide sale involving an actual cost to the applicant
and will result in additional or improved facilities for purposes of the
applicable provisions of the Act.
(d) Facility previously funded by a federal grant. No grant for the
acquisition or modernization of a facility which has previously been
funded in whole or in part by 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 the prior grant.
(Approved by the Office of Management and Budget under Control Number
0925-0424; expires November 30, 2001)
Sec. 52b.12 What are the minimum requirements of construction and equipment?
(a) General. In addition to being subject to other laws,
regulations, executive orders, and policies referred to in Sec. 52b.14,
the standards set forth in this section have been determined by the
Director to constitute minimum requirements of construction and
equipment, including the expansion, remodeling, renovation, or
alteration of existing buildings, and these standards, as may be
amended, or any revisions or successors of these standards, shall apply
to all projects for which federal assistance is requested under this
part. The publications referenced in this section are hereby
incorporated by reference and made a part of the regulations in this
part.
[[Page 208]]
(b) Incorporation by reference. The Director of the Federal Register
approves the incorporations by reference in paragraph (c) of this
section in accordance with 5 U.S.C. 552(a)(1) and 1 CFR part 51. Copies
may also be obtained from the organizations at the addresses listed in
paragraph (c) of this section. Copies may be inspected at the National
Cancer Institute, Executive Plaza North, Room 539, 6130 Executive
Boulevard, Rockville, MD 20852 (telephone 301-496-8534; not a toll-free
number); the National Center for Research Services, Building 31, Room
3B11, 9000 Rockville Pike, Bethesda, MD 20892 (telephone 301-496-5793);
not a toll-free number); and at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
The Director may for good cause shown, approve plans and specifications
which contain deviations from the requirements prescribed in paragraph
(c) of this section, if the Director is satisfied that the purposes of
the requirements have been fulfilled. In addition to these requirements,
each project shall meet the requirements of the applicable state and
local codes and ordinances relating to construction.
(c) Design and construction standards. The facility shall comply
with the following mandatory design and construction standards:
(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).
[[Page 209]]
(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).
[64 FR 63722, Nov. 22, 1999, as amended at 69 FR 18803, Apr. 9, 2004]
Sec. 52b.13 Additional conditions.
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.
Sec. 52b.14 Other federal laws, regulations, executive orders, and policies
that apply.
Other federal laws, regulations, executive orders, and policies
apply to grants under this part. These include, but are not necessarily
limited to:
(a) Laws.
An Act to Provide for the Preservation of Historical and
Archeological Data (and other purposes), as amended (16 U.S.C. 469 et
seq.).
Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151 et seq.).
Earthquake Hazards Reduction Act of 1977, as amended (42 U.S.C. 7701 et
seq.).
Flood Disaster Protection Act of 1973, section 202, as amended (42
U.S.C. 4106).
National Historic Preservation Act, section 106, as amended (16 U.S.C.
470f).
Safe Drinking Water Act, as amended (42 U.S.C. 300f et seq.).
(b) Regulations.
9 CFR part 3--Standards (Animal Welfare).
29 CFR 1910.1450--Occupational exposure to hazardous chemicals in
laboratories.
36 CFR part 1190--Minimum guidelines and requirements for accessible
design.
41 CFR part 101-19, subpart 101-19.6--Accommodations for the physically
handicapped.
41 CFR part 101-19, subpart 101-19.6, Appendix A--Uniform Federal
accessibility standards.
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant
institutions for dealing with and reporting possible misconduct in
science.
42 CFR part 50, subpart D--Public Health Service grant appeals
procedure.
45 CFR part 15--Uniform relocation assistance and real property
acquisition for Federal and federally assisted programs.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 46--Protection of human subjects.
45 CFR part 74--Uniform administrative requirements for awards and
subawards to institutions of higher education, hospitals, other
nonprofit organizations, and commercial organizations; and certain
grants and agreements with states, local governments and Indian tribal
governments.
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement)
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under part 80 of
this chapter.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving Federal financial assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefitting from Federal financial
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance.
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to State and local governments.
45 CFR part 93--New restrictions on lobbying.
49 CFR part 24--Uniform relocation assistance and real property
acquisition for Federal and federally assisted programs.
(c) Executive orders.
Executive Order 11988, Floodplain Management (May 24, 1977)(3 CFR, 1977
Comp., p. 117).
Executive Order 11990, Protection of Wetlands (May 24, 1977)(3 CFR, 1977
Comp., p. 121).
Executive Order 12699, Seismic Safety of Federal and Federally Assisted
or Regulated New Building Construction (January 5, 1990)(3 CFR, 1990
Comp., p. 269).
(d) Policies. (1) Design Policy and Guidelines (1996). Division of
Engineering Services, National Institutes of Health (Note: To obtain
copies of the
[[Page 210]]
policy, interested persons should contact the Division of Engineering
Services, 9000 Rockville Pike, Building 13, Room 2E43, Bethesda, MD
20892 (telephone 301-496-6186; not a toll-free number) or visit the
following site on the World Wide Web (http://des.od.nih/gov/
nihpol.html).).
(2) NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research (1994) (Note: To obtain copies of the
policy, interested persons should contact the Office of Research on
Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-
0161 (telephone 301-402-1770; not a toll-free number).).
(3) NIH Guidelines for Research Involving Recombinant DNA Molecules
(1994) (Note: To obtain copies of the policy, interested persons should
contact the Office of Recombinant DNA Activities, NIH, 6000 Executive
Boulevard, Suite 323, MSC 7010, Bethesda, MD 20892-7010 (telephone 301-
496-9838; not a toll-free number).).
(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 (Note: To obtain copies of the policy,
interested persons should contact the Office for Protection from
Research Risks, NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507,
Rockville, MD 20852-7507 (telephone 301-496-7005; not a toll-free
number).).
(6) ``Public Health Service Policy on Humane Care and Use of
Laboratory Animals.'' (Rev. Sept. 1986). Office for Protection from
Research Risks, NIH (Note: To obtain copies of the policy, interested
persons should contact the Office for Protection from Research Risks,
NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD
20852-7507 (telephone 301-496-7005; not a toll-free number).).
(7) ``Biosafety in Microbiological and Biomedical Laboratories.''
DHHS Publication No. (CDC) 88-8395 (1993). Centers for Disease Control
and Prevention (CDC) (Note: To obtain copies of the policy, interested
persons should contact the Division of Safety, Occupational Safety and
Health Branch, NIH, 13 South Drive, Room 3K04, MSC 5760, Bethesda, MD
20892-5760 (telephone 301-496-2960; not a toll-free number).).
(8) ``NIH Guidelines for the Laboratory Use of Chemical
Carcinogens,'' DHHS Publication No. (NIH) 81-2385 (May 1981) (Note: To
obtain copies of the policy, interested persons should contact the
Division of Safety, Occupational Safety and Health Branch, NIH, 13 South
Drive, Room 3K04, MSC 5760, Bethesda, MD 20892-5760 (telephone 301-496-
2960; not a toll-free number).).
(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 (Note: To obtain copies of the policy,
interested persons should contact the Office of Extramural Research,
NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20817-7910
(telephone 301-435-0714; not a toll-free number). Information may also
be obtained by browsing the NIH Home Page site on the World Wide Web
(http://www.nih.gov).).
PART 52c_MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM--Table of Contents
Sec.
52c.1 Applicability.
52c.2 Definitions.
52c.3 Eligibility.
52c.4 Application.
52c.5 Grant awards.
52c.6 Expenditure of grant funds.
52c.7 Other HHS regulations that apply.
52c.8 Additional conditions.
Authority: 42 U.S.C. 216, 241(a)(3).
Source: 45 FR 12246, Feb. 25, 1980, unless otherwise noted.
[[Page 211]]
Sec. 52c.1 Applicability.
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.
[58 FR 61030, Nov. 19, 1993]
Sec. 52c.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
Ethnic minorities includes but is not limited to such groups as
Black Americans, Hispanic Americans, Asian/Pacific Islanders, and
American Indians/Native Alaskans (Native Americans).
HHS means the Department of Health and Human Services.
Nonprofit as applied to any institution means an institution which
is a corporation or association no part of the net earnings of which
inures or may lawfully inure to the benefit of any private shareholder
or individual.
Program director means a single individual, designated in the grant
application, who is scientifically trained and has research experience
and who is responsible for the overall execution of the program
supported under this part at the grantee institution.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human Services
to whom the authority involved has been delegated.
[58 FR 61030, Nov. 19, 1993]
Sec. 52c.3 Eligibility.
To be eligible for a grant under this Program, an applicant must be:
(a) One of the following:
(1) A public or private nonprofit university, four year college, or
other institution offering undergraduate, graduate, or health
professional degrees, with a traditionally high (more than 50 percent)
minority student enrollment;
(2) A public or private nonprofit two year college with a
traditionally high (more than 50 percent) minority student enrollment;
(3) A public or private nonprofit university, four year college, or
other institution offering undergraduate, graduate, or health
professional degrees, with a student enrollment a significant proportion
(but not necessarily more than 50 percent) of which is derived from
ethnic minorities, provided the Secretary determines that said
institution has a demonstrated commitment to the special encouragement
of and assistance to ethnic minority faculty, students, and
investigators; or
(4) An Indian tribe which has a recognized governing body which
performs substantial governmental functions, or an Alaska Regional
Corporation as defined in the Alaska Native Claims Settlement Act (43
U.S.C. 1601 et seq.), and
(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).
[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030,
Nov. 19, 1993]
Sec. 52c.4 Application.
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.
[58 FR 61030, Nov. 19, 1993]
Sec. 52c.5 Grant awards.
(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:
[[Page 212]]
(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 project 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.
[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030,
Nov. 19, 1993]
Sec. 52c.6 Expenditure of grant funds.
(a) Any funds granted pursuant to this part shall be expended solely
for the purposes for which the funds were granted in accordance with the
approved application and budget, the regulations of this part, the terms
and conditions of the award, and the applicable cost principles
prescribed by subpart Q of 45 CFR part 74.
(b) The Secretary may permit unobligated grant funds remaining in
the grant account at the close of a budget period to be carried forward
for obligation during a subsequent budget period, provided a
continuation award is made for that period and the Secretary's written
approval is obtained. The amount of any subsequent award will take into
consideration unobligated grant funds remaining in the grant account.
[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 45 FR 68392,
Oct. 15, 1980]
Sec. 52c.7 Other HHS regulations that apply.
Several other regulations and policies apply to grants under this
part. These include, but are not necessarily limited to:
37 CFR part 401--Rights to inventions made by nonprofit organizations
and small business firms under government grants, contracts, and
cooperative agreements
42 CFR part 50, subpart A--Responsibilities of PHS awardee and applicant
institutions for dealing with and reporting possible misconduct in
science
42 CFR part 50, subpart D--Public Health Service grant appeals
procedures
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement)
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving Federal financial assistance
[[Page 213]]
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs
and activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
51 FR 16958, or successor--NIH Guidelines for Research Involving
Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory
Animals,'' Office for Protection from Research Risks, NIH (Revised
September 1986), or successor
[58 FR 61030, Nov. 19, 1993]
Sec. 52c.8 Additional conditions.
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.
PART 52d_NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM--Table of
Contents
Sec.
52d.1 Applicability.
52d.2 Definitions.
52d.3 Eligibility.
52d.4 Application.
52d.5 Program requirements.
52d.6 Grant awards.
52d.7 Expenditure of grant funds.
52d.8 Other HHS regulations that apply.
52d.9 Additional conditions.
Authority: 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).
Source: 45 FR 12247, Feb. 25, 1980, unless otherwise noted.
Sec. 52d.1 Applicability.
The regulations in this part apply to grants under the Clinical
Cancer Education Program authorized by section 404(a)(4) of the Public
Health Service Act, to encourage planning and development of
multidisciplinary educational programs aimed at achieving optimal care
of cancer patients and to enable students in the health professions to
acquire basic knowledge of neoplastic disease and the preventive
measures and diagnostic and therapeutic skills necessary to the
provision of such care.
Sec. 52d.2 Definitions.
(a) Act means the Public Health Service Act, as amended.
(b) Director, NCI, means the Director of the National Cancer
Institute and any other officer or employee of said Institute to whom
the authority involved has been delegated.
(c) [Reserved]
(d) Board means the National Cancer Advisory Board established by
section 407 of the Act (42 U.S.C. 286b).
(e) Affiliated teaching hospital means a hospital which, although
not owned by such school, has a written agreement with a school of
medicine, osteopathy, dentistry, or public health eligible for
assistance under this part, providing for effective control by the
school of the teaching in the hospital.
(f) Specialized cancer institute means an institution which has as
its primary mission the diagnosis, prevention, or treatment of cancer.
[45 FR 12247, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980, as amended at
47 FR 53012, Nov. 24, 1982]
Sec. 52d.3 Eligibility.
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.
[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]
Sec. 52d.4 Application.
(a) Application for a grant under this subpart shall be made on an
authorized
[[Page 214]]
form. \1\ Applicants shall submit completed forms, on or before the
dates the Director, NCI, may prescribe.
---------------------------------------------------------------------------
\1\ Applications and instructions are available from the Division of
Cancer Research Resources and Centers, Education Branch, Westwood
Building, 5333 Westbard Avenue, Bethesda, MD 20205.
---------------------------------------------------------------------------
(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.
[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]
Sec. 52d.5 Program requirements.
(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.
Sec. 52d.6 Grant awards.
(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
[[Page 215]]
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 Sec. 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.
Sec. 52d.7 Expenditure of grant funds.
(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.
Sec. 52d.8 Other HHS regulations that apply.
Several other regulations apply to grants under this subpart. These
include, but are not limited to:
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
[49 FR 38111, Sept. 27, 1984]
[[Page 216]]
Sec. 52d.9 Additional conditions.
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.
PART 52e_NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND
CONTROL PROJECTS--Table of Contents
Sec.
52e.1 To what programs do these regulations apply?
52e.2 Definitions.
52e.3 Who is eligible to apply?
52e.4 How to apply.
52e.5 What are the project requirements?
52e.6 How will NIH evaluate applications?
52e.7 What are the terms and conditions of awards?
52e.8 Other HHS regulations and policies that apply.
52e.9 Additional conditions.
Authority: 42 U.S.C. 216, 285b-1.
Source: 45 FR 12249, Feb. 25, 1980, unless otherwise noted.
Sec. 52e.1 To what programs do these regulations apply?
(a) This part applies to grants under section 419 of the Act (42
U.S.C. 285b-1) for projects to:
(1) Demonstrate and evaluate the effectiveness of new techniques or
procedures for the prevention and control of heart, blood vessel, lung,
and blood diseases, with special consideration given to the prevention
and control of these diseases in children, and in populations that are
at increased risk with respect to such diseases;
(2) Develop and evaluate methods of educating health practitioners
concerning the prevention and control of these diseases; and
(3) Develop and evaluate methods of educating the public concerning
the prevention and control of these diseases.
(b) For purposes of this part, prevention and control projects shall
include community-based and population-based programs carried out in
cooperation with other Federal agencies, with public health agencies of
State or local governments, with nonprofit private entities that are
community-based health agencies, or with other appropriate public or
nonprofit private entities.
[45 FR 12249, Feb. 25, 1980; 45 FR 20097, Mar. 27, 1980, as amended at
58 FR 54298, Oct. 21, 1993; 59 FR 59372, Nov. 17, 1994]
Sec. 52e.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
Council means the National Heart, Lung, and Blood Advisory Council,
established under section 406 of the Act (42 U.S.C. 284a).
Director means the Director of the National Heart, Lung, and Blood
Institute and any official to whom the authority involved may be
delegated.
Emergency medical services means the services utilized in responding
to the perceived individual need for immediate medical care in order to
prevent loss of life or aggravation of physiological or psychological
illness or injury.
HHS means the Department of Health and Human Services.
National program means the National Heart, Blood Vessel, Lung, and
Blood Diseases and Blood Resources Program referred to in section 421 of
the Act (42 U.S.C. 285b-3).
Nonprofit as applied to any agency or institution means an agency or
institution which is a corporation or an association, no part of the net
earnings of which inures or may lawfully inure to the benefit of any
private shareholder or individual.
PHS means the Public Health Service.
[58 FR 54298, Oct. 21, 1993]
Sec. 52e.3 Who is eligible to apply?
To be eligible for a grant under this part, an applicant must be a
public or nonprofit private agency or institution.
[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]
[[Page 217]]
Sec. 52e.4 How to apply.
(a) Application for a grant under this subpart shall be made on an
authorized form. \2\ Applicants shall submit completed forms on or
before the dates the Director may prescribe.
---------------------------------------------------------------------------
\2\ Applications and instructions are available from the Division of
Extramural Affairs, National Heart, Lung, and Blood Institute, National
Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20205.
---------------------------------------------------------------------------
(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
Sec. 52e.1(a)(1), prior research findings on which the proposed project
is based;
(5) The personnel, facilities, and other resources, including
community resources, available to carry out the proposed project;
(6) Current activities of the applicant involving prevention or
control of heart, blood vessel, lung, and blood diseases, the sources of
funding for such activities, and the anticipated relationship of these
activities to the proposed project;
(7) The names and qualifications of the project director and key
staff members who would be responsible for conducting the proposed
project;
(8) Proposed methods for monitoring and evaluating the project; and
(9) The proposed project period; a detailed budget for the first
budget period, including a list of other anticipated sources of support
and anticipated total needs for each of the succeeding budget periods of
the requested project period; and a justification for the amount of
grant funds requested.
[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]
Sec. 52e.5 What are the project requirements?
(a) An approvable application must demonstrate to the satisfaction
of the Director that:
(1) With respect to applications relating to projects covered by
Sec. 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
Sec. 52e.1(a)(2) and Sec. 52e.1(a)(3), the project 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.
[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct.
21, 1993]
Sec. 52e.6 How will NIH evaluate applications?
(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;
[[Page 218]]
(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 Sec. Sec. 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 project 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 the award, and the applicable cost principles
prescribed in subpart Q of 45 CFR part 74.
[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]
Sec. 52e.7 What are the terms and conditions of awards?
(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.
[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct.
21, 1993]
Sec. 52e.8 Other HHS regulations and policies that apply.
Several other regulations apply to grants under this part. These
include but are not necessarily limited to:
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant
institutions for dealing with and reporting possible misconduct in
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement)
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
[[Page 219]]
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
51 FR 16958 or successor--NIH Guidelines for Research Involving
Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory
Animals,'' Office for Protection from Research Risks, NIH (Revised
September 1986), or successor
59 FR 14508 (as republished March 28, 1994), as may be amended, or its
successor--NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research.
[58 FR 54298, Oct. 21, 1993, as amended at 59 FR 59372, Nov. 17, 1994]
Sec. 52e.9 Additional conditions.
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.
[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54299, Oct. 21, 1993]
PART 52h_SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH
AND DEVELOPMENT CONTRACT PROJECTS--Table of Contents
Sec.
52h.1 Applicability.
52h.2 Definitions.
52h.3 Establishment and operation of peer review groups.
52h.4 Composition of peer review groups.
52h.5 Conflict of interest.
52h.6 Availability of information.
52h.7 What matters must be reviewed for grants?
52h.8 What are the review criteria for grants?
52h.9 What matters must be reviewed for unsolicited contract proposals?
52h.10 What matters must be reviewed for solicited contract proposals?
52h.11 What are the review criteria for contract projects and proposals?
52h.12 Other regulations that apply.
Authority: 42 U.S.C. 216; 42 U.S.C. 282 (b)(6); 42 U.S.C. 284
(c)(3); 42 U.S.C. 289a.
Source: 69 FR 275, Jan. 5, 2004, unless otherwise noted.
Sec. 52h.1 Applicability.
(a) This part applies to:
(1) Applications of the National Institutes of Health for grants or
cooperative agreements (a reference in this part to grants includes
cooperative agreements) for biomedical and behavioral research; and
(2) Biomedical and behavioral research and development contract
project concepts and proposals for contract projects administered by the
National Institutes of Health.
(b) This part does 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.
Sec. 52h.2 Definitions.
As used in this part:
(a) Act means the Public Health Service Act, as amended (42 U.S.C.
201 et seq.).
(b) Appearance of a conflict of interest means that a reviewer or
close relative or professional associate of the reviewer has a financial
or other interest in an application or proposal that is known to the
reviewer or the government official managing the review and would cause
a reasonable person to question the reviewer's impartiality if he or she
were to participate in the review; the government official managing the
review (the Scientific Review Administrator or equivalent) will evaluate
the appearance of a conflict of interest and determine, in accordance
with this subpart, whether or not the interest would likely bias the
reviewer's evaluation of the application or proposal.
[[Page 220]]
(c) Awarding official means the Secretary of Health and Human
Services and any other officer or employee of the Department of Health
and Human Services to whom the authority involved has been delegated;
except that, where the Act specifically authorizes another official to
make awards in connection with a particular program, the awarding
official shall mean that official and any other officer or employee of
the Department of Health and Human Services to whom the authority
involved has been delegated.
(d) Budget period means the interval of time (usually 12 months)
into which the project period is divided for budgetary and reporting
purposes.
(e) Close relative means a parent, spouse, domestic partner, or son
or daughter.
(f) Contract proposal means a written offer to enter into a contract
that is submitted to the appropriate agency official by an individual or
nonfederal organization which includes, at a minimum, a description of
the nature, purpose, duration, and cost of the project, and the methods,
personnel, and facilities to be utilized in carrying it out. A contract
proposal may be unsolicited by the federal government or submitted in
response to a request for proposals.
(g) Development means the systematic use of knowledge gained from
research to create useful materials, devices, systems, or methods.
(h) DHHS means the Department of Health and Human Services.
(i) Director means the Director of the National Institutes of Health
and any other official or employee of the National Institutes of Health
to whom the authority involved has been delegated.
(j) Grant as used in this part, includes cooperative agreements.
(k) Peer review group means a group of primarily nongovernment
experts qualified by training and experience in particular scientific or
technical fields, or as authorities knowledgeable in the various
disciplines and fields related to the scientific areas under review, to
give expert advice on the scientific and technical merit of grant
applications or contract proposals, or the concept of contract projects,
in accordance with this part.
(l) Principal investigator has the same meaning as in 42 CFR part
52.
(m) Professional associate means any colleague, scientific mentor,
or student with whom the peer reviewer is currently conducting research
or other significant professional activities or with whom the member has
conducted such activities within three years of the date of the review.
(n) Project approach means the methodology to be followed and the
resources needed in carrying out the project.
(o) Project concept means the basic purpose, scope, and objectives
of the project.
(p) Project period has the same meaning as in 42 CFR part 52.
(q) Real conflict of interest means a reviewer or a close relative
or professional associate of the reviewer has a financial or other
interest in an application or proposal that is known to the reviewer and
is likely to bias the reviewer's evaluation of that application or
proposal as determined by the government official managing the review
(the Scientific Review Administrator, or equivalent), as acknowledged by
the reviewer, or as prescribed by this part. A reviewer shall have a
real conflict of interest if he/she or a close relative or professional
associate of the reviewer:
(1) Has received or could receive a direct financial benefit of any
amount deriving from an application or proposal under review;
(2) Apart from any direct financial benefit deriving from an
application or proposal under review, has received or could receive a
financial benefit from the applicant institution, offeror or principal
investigator that in the aggregate exceeds $10,000 per year; this amount
includes honoraria, fees, stock or other financial benefit, and
additionally includes the current value of the reviewer's already
existing stock holdings. The Director, NIH, may amend the dollar
threshold periodically, as appropriate, after public notice and comment;
or
(3) Has any other interest in the application or proposal that is
likely to bias the reviewer's evaluation of that application or
proposal. Regardless of the level of financial involvement or
[[Page 221]]
other interest, if the reviewer feels unable to provide objective
advice, he/she must recuse him/herself from the review of the
application or proposal at issue. The peer review system relies on the
professionalism of each reviewer to identify to the designated
government official any real or apparent conflicts of interest that are
likely to bias the reviewer's evaluation of an application or proposal.
(r) Request for proposals means a Government solicitation to
prospective offerors, under procedures for negotiated contracts, to
submit a proposal to fulfill specific agency requirements based on terms
and conditions defined in the request for proposals. The request for
proposals contains information sufficient to enable all offerors to
prepare proposals, and is as complete as possible with respect to:
nature of work to be performed; descriptions and specifications of items
to be delivered; performance schedule; special requirements clauses, or
other circumstances affecting the contract; format for cost proposals;
and evaluation criteria by which the proposals will be evaluated.
(s) Research has the same meaning as in 42 CFR part 52.
(t) Research and development contract project means an identified,
circumscribed activity, involving a single contract or two or more
similar, related, or interdependent contracts, intended and designed to
acquire new or fuller knowledge and understanding in the areas of
biomedical or behavioral research and/or to use such knowledge and
understanding to develop useful materials, devices, systems, or methods.
(u) Scientific review group has the same meaning as peer review
group, which is defined in paragraph (k) of this section.
(v) Solicited contract proposal has the same meaning as the
definition of offer in 48 CFR 2.101.
(w) Unsolicited contract proposal has the same meaning as
unsolicited proposal in 48 CFR 15.601.
Sec. 52h.3 Establishment and operation of peer review groups.
(a) To the extent applicable, the Federal Advisory Committee Act, as
amended (5 U.S.C. appendix 2) and chapter 9 of the DHHS General
Administration Manual \1\ shall govern the establishment and operation
of peer review groups.
---------------------------------------------------------------------------
\1\ The DHHS General Administration Manual is available for public
inspection and copying at the Department's information centers listed in
45 CFR 5.31 and may be purchased from the Superintendent of Documents,
U.S. Government Printing Office, Washington, DC 20402.
---------------------------------------------------------------------------
(b) Subject to Sec. 52h.5 and paragraph (a) of this section, the
Director will adopt procedures for the conduct of reviews and the
formulation of recommendations under Sec. Sec. 52h.7, 52h.9, and
52h.10.
Sec. 52h.4 Composition of peer review groups.
(a) To the extent applicable, the selection and appointment of
members of peer review groups and their terms of service shall be
governed by chapter 9 of the DHHS 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, or upon their qualifications as authorities
knowledgeable in the various disciplines and fields related to the
scientific areas under review, 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 the research;
(3) Recognition as reflected by awards and other honors received
from scientific and professional organizations; 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, or authorities knowledgeable in the various
disciplines and fields related to the scientific areas under review.
(c) Except as otherwise provided by law, not more than one-fourth of
the members of any peer review group to
[[Page 222]]
which this part applies may be officers or employees of the United
States. Being a member of a scientific peer review group does not make
an individual an officer or employee of the United States.
Sec. 52h.5 Conflict of interest.
(a) This section applies only to conflicts of interest involving
members of peer review groups. This section does not cover individuals
serving on National Advisory Councils or Boards, Boards of Scientific
Counselors, or Program Advisory Committees who, if not already officers
or employees of the United States, are special Government employees and
covered by title 18 of the United States Code, the Office of Government
Ethics Standards of Ethical Conduct for Employees of the Executive
Branch (5 CFR part 2635), and Executive Order 11222, as amended. For
those federal employees serving on peer review groups, in accordance
with Sec. 52h.4, the requirements of title 18 of the United States
Code, 5 CFR part 2635 and Executive Order 12674, as modified by
Executive Order 12731, apply.
(b) A reviewer with a real conflict of interest must recuse him/
herself from the review of the application or proposal, except as
otherwise provided in this section.
(1) A reviewer who is a salaried employee, whether full-time or
part-time, of the applicant institution, offeror, or principal
investigator, or is negotiating for employment, shall be considered to
have a real conflict of interest with regard to an application/proposal
from that organization or principal investigator, except that the
Director may determine there is no real conflict of interest or an
appearance of a conflict of interest where the components of a large or
multicomponent organization are sufficiently independent to constitute,
in effect, separate organizations, provided that the reviewer has no
responsibilities at the institution that would significantly affect the
other component.
(2) Where a reviewer's real conflict of interest is based upon the
financial or other interest of a close relative or professional
associate of the reviewer, that reviewer must recuse him/herself, unless
the Director provides a waiver in accordance with paragraph (b)(4) of
this section.
(3) For contract proposal reviews, an individual with a real
conflict of interest in a particular proposal(s) is generally not
permitted to participate in the review of any proposals responding to
the same request for proposals. However, if there is no other qualified
reviewer available having that individual's expertise and that expertise
is essential to ensure a competent and fair review, a waiver may be
granted by the Director to permit that individual to serve as a reviewer
of those proposals with which the reviewer has no conflict, while
recusing him/herself from the review of any particular proposal(s) in
which there is a conflict of interest.
(4) The Director may waive any of the requirements in paragraph (b)
of this section relating to a real conflict of interest if the Director
determines that there are no other practical means for securing
appropriate expert advice on a particular grant or cooperative agreement
application, contract project, or contract proposal, and that the real
conflict of interest is not so substantial as to be likely to affect the
integrity of the advice to be provided by the reviewer.
(c) Any appearance of a conflict of interest will result in recusal
of the reviewer, unless the Director provides a waiver, determining that
it would be difficult or impractical to carry out the review otherwise,
and the integrity of the review process would not be impaired by the
reviewer's participation.
(d) When a peer review group meets regularly it is assumed that a
relationship among individual reviewers in the group exists and that the
group as a whole may not be objective about evaluating the work of one
of its members. In such a case, a member's application or proposal shall
be reviewed by another qualified review group to ensure that a competent
and objective review is obtained.
(e) When a member of a peer review group participates in or is
present during the concept review of a contract proposal that occurs
after release of the solicitation, as described under Sec. 52h.10(b),
but before receipt of proposals, the member is not considered to
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have a real conflict of interest as described in paragraph (b) of this
section, but is subject to paragraph (c) of this section concerning
appearance of conflict of interest if the member is planning to respond
to the solicitation. When the concept review occurs after receipt of
proposals, paragraph (b) applies.
(f) No member of a peer review group may participate in any review
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 pre-award or post-award) as an officer or employee of the
United States.
(g) The Director may periodically issue guidance to the government
officials responsible for managing reviews and reviewers on what
interests would constitute a real conflict of interest or an appearance
of a conflict of interest.
Sec. 52h.6 Availability of information.
(a) Transcripts, minutes, and other documents made available to or
prepared for or by a peer review group will be available for public
inspection and copying to the extent provided by the Freedom of
Information Act, as amended (5 U.S.C. 552), the Federal Advisory
Committee Act, as amended (5 U.S.C. appendix 2), the Privacy Act of
1974, as amended (5 U.S.C. 552a), and implementing DHHS regulations (45
CFR parts 5, 5b).
(b) Meetings of peer review groups reviewing grant applications or
contract proposals are closed to the public in accordance with sections
552b(c)(4) and 552b(c)(6) of the Government in the Sunshine Act, as
amended (5 U.S.C. 552b(c)(4) and 552b(c)(6)) and section 10(d) of the
Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2).
Documents made available to, or prepared for or by peer review groups
that contain trade secrets or commercial or financial information
obtained from a person that is privileged or confidential, and personal
information concerning individuals associated with applications or
proposals, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy, are exempt from disclosure in
accordance with the Freedom of Information Act, as amended (5 U.S.C.
552(b)(4) and 552(b)(6)).
(c) Meetings of peer review groups reviewing contract project
concepts are open to the public in accordance with the provisions of the
Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2) and the
Government in the Sunshine Act, as amended (5 U.S.C. 552b).