[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Rules and Regulations]
[Pages 55110-55113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26974]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 63a
RIN 0905-AD56
National Institutes of Health Training Grants
AGENCY: National Institutes of Health, Public Health Service,
Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: The National Institutes of Health (NIH) is issuing regulations
governing non-National Research Service Award (NRSA) training grants
awarded under sections 307(b)(3), 405(b)(1)(C), 485B(b), 2315(a)(1)(A),
and 2354(a)(3)(C) of the Public Health Service (PHS) Act, as amended,
and section 103(h)(2) of the Clean Air Act, as amended. Regulations
which at one time governed both NIH training grants and training grants
specific to the National Library of Medicine (NLM) were revised in June
of 1991 as part of the overall updating of all regulations concerning
NLM, and now govern only NLM-specific training grants. New regulations
are necessary to implement other non-NRSA research training grant
authorities set forth in the Public Health Service Act and the Clean
Air Act.
EFFECTIVE DATE: This final rule is effective November 25, 1996.
FOR FURTHER INFORMATION CONTACT: Mr. Jerry Moore, Regulatory Affairs
Officer, National Institutes of Health, 9000 Rockville Pike, Building
31, Room 1B-25, 31 Center Dr MSC 2075, Bethesda, MD 20892-2075,
telephone (301) 496-4606 (not a toll-free number). For program
information contact the Office of Extramural Research, National
Institutes of Health, 9000 Rockville Pike, Shannon Building, Room 144,
One Center Dr MSC 0152, Bethesda, MD 20892-0152, telephone (301) 496-
1096 (not a toll-free number).
SUPPLEMENTARY INFORMATION: The principal financial assistance support
mechanism for research training by NIH and its constituent award-making
organizations is through the NRSA program, authorized by section 487 of
the PHS Act and addressed in regulations codified at 42 CFR part 66.
The regulations which NIH is issuing concerning training grants do not
affect the NRSA Program or amend the regulations codified in part 66.
Prior to the advent of the NRSA program, the NIH institutes relied
upon provisions of the PHS Act that authorized the institutes to
conduct or support research training. The NRSA program generally
replaced this training authority, except in a few isolated cases.
In 1985, the Congress, in a major revision of NIH's authorities,
the Health Research Extension Act of 1985 (Pub. L. 99-158), authorized
the directors of the research institutes of NIH to conduct (at NIH) and
support non-NRSA research training. This authority, as set forth in
section 405(b)(1)(C) of the PHS Act, is limited to research training
for which fellowship support is not provided under the NRSA program and
which is not residency training of physicians or other health
professionals.
Subsequently, on June 26, 1991, NIH published a final rule in the
Federal Register (56 FR 29192) revising the regulations at 42 CFR part
64, (then) entitled National Institutes of Health and National Library
of Medicine Training Grants, as part of the overall updating of all
regulations concerning the National Library of Medicine. As a result,
part 64 now addresses only NLM training grants authorized by section
472 of the PHS Act. NIH needs to provide regulations for research
training grant authorities not otherwise addressed in the NLM-specific
regulations in part 64.
NIH also needs to provide regulations for training grants
authorized by section 901 of the Clean Air Act Amendments of 1990,
Public Law 101-549, which amended section 103(h)(2) of the Clean Air
Act. Section 901 directs the Director of the National Institute of
Environmental Health Sciences (NIEHS) to conduct a program for the
education and training of physicians in environmental health.
In 1993, the Congress, in the most recent major revision of NIH's
authorities, the National Institutes of Health Revitalization Act of
1993 (Pub. L. 103-43), authorized the Director of the National Center
for Human Genome Research (NCHGR), in PHS Act section 485B(b), to
conduct and support training in human genome research for which
fellowship support is not provided under PHS Act section 487 and that
is not residency training of physicians or other health professionals.
In codifying the establishment of the Office of AIDS Research (OAR),
Public Law 103-43 also authorized the Director of OAR, in carrying out
AIDS research, to support the training of American scientists abroad
and foreign scientists in the United States, as set forth in section
2354(a)(3)(C) of the PHS Act, as amended.
Additionally, section 2315(a)(1) of the PHS Act, as amended,
directs the Secretary, acting through the Director of NIH, to make
grants to international organizations concerned with public health to
promote and expedite international research and training concerning the
natural history and pathogenesis of the human immunodeficiency virus
and the development and evaluation of vaccines and treatments for
acquired immunodeficiency syndrome (AIDS) and opportunistic infections.
The John E. Fogarty International Center for Advanced Study in the
Health Sciences (FIC), NIH, also awards grants for training in
international cooperative biomedical research endeavors to public and
nonprofit private institutions in the United States and participating
foreign countries under section 307(b)(3) of the PHS Act, as amended.
NIH published a notice of proposed rulemaking (NPRM) in the Federal
Register of January 24, 1995 (60 FR 4742), in which it announced its
plans to issue new regulations at part 63a to govern implementation of
these training grant authorities. One comment supporting the
regulations was received. Consequently, except for a few minor
editorial changes, the final regulations are the same as those
announced in the NPRM.
The regulations can be adapted for future training grant programs
(both research training and non-research training). Since the rules for
training programs are largely the same irrespective of the funding
source, it makes sense to have a single set of uniform rules that
applies to all NIH training grant programs, other than NRSA and NLM
programs, with exceptions or special provisions for particular programs
as necessary.
Readers of this final rule should understand that in publishing the
new regulations, NIH is not initiating any new training programs.
Rather, NIH is simply establishing regulations to govern existing
training grant authorities.
This final rule sets forth what training is covered by the
regulations, the nature and purpose of the training, what
[[Page 55111]]
institutions are eligible to apply, how to apply, how grants are
awarded, and conditions imposed on recipients. Implementation of the
particular training grant programs encompassed by these regulations
rests with the statutorily authorized awarding NIH components and is
subject to the availability of funds for that purpose, as well as
programmatic priorities determined by the awarding components.
The following statements are provided for the information of the
public.
The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and promote the nonuse of all tobacco products,
and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Executive Order 12866
Executive Order 12866 requires that all regulatory actions reflect
consideration of the costs and benefits they generate, and that they
must meet certain standards, such as avoiding the imposition of
unnecessary burdens on the affected public. If a regulatory action is
deemed to fall within the scope of the definition of the term
``significant regulatory action'' contained in section 3(f) of the
Order, pre-publication review by the Office of Management and Budget's
Office of Information and Regulatory Affairs (OIRA) is necessary. This
rule was reviewed under Executive Order 12866 and was deemed not
significant.
Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6)
requires that regulatory actions be analyzed to determine whether they
create a significant impact on a substantial number of small entities.
I certify that this rule will not have a significant economic impact on
a substantial number of small entities and, therefore, a regulatory
flexibility analysis, as defined under the Regulatory Flexibility Act
of 1980, is not required.
Paperwork Reduction Act
This final rule does not contain any information collection
requirements which are subject to Office of Management and Budget (OMB)
approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter
35).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance (CFDA) numbered program
affected by this final rule is:
Sec. 93.837 Heart and Vascular Diseases Research.
List of Subjects in 42 CFR Part 63a
Environmental health; Grant programs--health; Health; Medical
research.
Dated: July 23, 1996.
Harold Varmus,
Director, NIH.
Accordingly, chapter 1 of title 42 of the Code of Federal
Regulations is amended by adding a new part 63a to read as set forth
below.
PART 63a--NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS
Sec.
63a.1 To what programs do these regulations apply?
63a.2 Definitions.
63a.3 What is the purpose of training grants?
63a.4 Who is eligible for a training grant?
63a.5 How to apply for a training grant.
63a.6 How are training grant applications evaluated?
63a.7 Awards.
63a.8 How long does grant support last?
63a.9 What are the terms and conditions of awards?
63a.10 How may training grant funds be spent?
63a.11 Other HHS regulations and policies that apply.
Authority: 42 U.S.C. 216, 242l(b)(3), 284(b)(1)(C), 287c(b),
300cc-15(a)(1), 300cc-41(a)(3)(C), 7403(h)(2).
Sec. 63a.1 To what programs do these regulations apply?
(a) The regulations of this part apply to:
(1) Grants awarded by the John E. Fogarty International Center for
Advanced Study in the Health Sciences, NIH, for training in
international cooperative biomedical research endeavors, as authorized
under section 307(b)(3) of the Act;
(2) Grants awarded by NIH for research training with respect to the
human diseases, disorders, or other aspects of human health or
biomedical research, for which the institute or other awarding
component was established, for which fellowship support is not provided
under section 487 of the Act and which is not residency training of
physicians or other health professionals, as authorized by sections
405(b)(1)(C), 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and,
(3) Grants awarded by the National Institute of Environmental
Health Sciences, NIH, for the education and training of physicians in
environmental health, as authorized under section 103(h)(2) of the
Clean Air Act, as amended.
(b) The regulations of this part also apply to cooperative
agreements awarded to support the training specified in paragraph (a)
of this section. References to ``grant(s)'' shall include ``cooperative
agreement(s).''
(c) The regulations of this part do not apply to:
(1) Research training support under the National Research Service
Awards Program (see part 66 of this chapter);
(2) Research training support under the NIH Center Grants programs
(see part 52a of this chapter);
(3) Research training support under traineeship programs (see part
63 of this chapter);
(4) Research training support under the NIH AIDS Research Loan
Repayment Program (see section 487A of the Act); or
(5) Research training support under the National Library of
Medicine training grant programs (see part 64 of this chapter).
Sec. 63a.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
HHS means the Department of Health and Human Services.
NIH means the National Institutes of Health and its organizational
components that award training grants.
Nonprofit as applied to any agency or institution, means an agency
or 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 the single individual named by the grantee
in the grant application and approved by the Secretary, who is
responsible for the management and conduct of the training program.
Project period See Sec. 63a.8(a).
Secretary means the Secretary of Health and Human Services and any
other official of HHS to whom the authority involved is delegated.
Stipend means a payment to an individual to help meet that
individual's subsistence expenses during the training period.
Training grant means an award of funds to an eligible agency or
institution for a training program authorized under Sec. 63a.1 to carry
out one or more of the purposes set forth in Sec. 63a.3.
[[Page 55112]]
Sec. 63a.3 What is the purpose of training grants?
The purpose of a training grant is to provide financial assistance
to an eligible agency or institution to enable it to provide research
training to individuals in the diagnosis, prevention, treatment, or
control of human diseases or disorders, or other aspects of human
health or biomedical research, or in environmental health, in order to
increase the number of facilities which provide qualified training and
the number of persons having special competence in these fields.
Sec. 63a.4 Who is eligible for a training grant?
(a) General. Except as otherwise provided in this section or as
prohibited by law, any public or private for-profit or nonprofit
agency, institution, or entity is eligible for a training grant.
(b) International training grants for AIDS research. Any
international organization concerned with public health is eligible for
a training grant to support individuals for research training relating
to acquired immunodeficiency syndrome (AIDS), as authorized under
section 2315(a)(1) of the Act. In awarding these grants, preference
shall be given to:
(1) Training activities conducted by, or in cooperation with, the
World Health Organization and
(2) With respect to training activities in the Western Hemisphere,
activities conducted by, or in cooperation with, the Pan American
Health Organization or the World Health Organization.
Sec. 63a.5 How to apply for a training grant.
Any agency, institution, or entity interested in applying for a
grant under this part must submit an application at the time and in the
form and manner that the Secretary may require.
Sec. 63a.6 How are training grant applications evaluated?
The Secretary shall evaluate applications through the officers and
employees, experts, consultants, or groups engaged by the Secretary for
that purpose, including review or consultation with the appropriate
advisory council or other body as may be required by law. The
Secretary's evaluation will be for merit and shall take into account,
among other pertinent factors, the significance of the program, the
qualifications and competency of the program director and proposed
staff, the adequacy of the selection criteria for trainees under the
program, the adequacy of the applicant's resources available for the
program, and the amount of grant funds necessary for completion of its
objectives.
Sec. 63a.7 Awards.
Criteria. Within the limits of available funds, the Secretary may
award training grants for training programs which:
(a) Are determined to be meritorious, and
(b) Best carry out the purposes of the particular statutory program
described in Sec. 63a.1 and the regulations of this part.
Sec. 63a.8 How long does grant support last?
(a) The notice of the grant award specifies how long the Secretary
intends to support the project without requiring the grantee to
recompete for funds. This period, called the ``project period,'' will
usually be for one to five years.
(b) Generally, the grant will be initially for one year and
subsequent continuation awards will be for one year at a time. A
grantee must submit a separate application at the time and in the form
and manner that the Secretary may require to have the support continued
for each subsequent year. Decisions regarding continuation awards and
the funding level of these awards will be made after consideration of
such factors as the grantee's progress and management practices, and
the availability of funds. In all cases, continuation awards require
determination by the Secretary that continued funding is in the best
interest of the Federal Government.
(c) Neither the approval of any application nor the award of any
grant commits or obligates the Federal Government in any way to make
any additional, supplemental, continuation, or other award with respect
to any approved application or portion of an approved application.
(d) Any balance of federally obligated grant funds remaining
unobligated by the grantee at the end of a budget period may be carried
forward to the next budget period, for use as prescribed by the
Secretary, provided that a continuation award is made. If at any time
during a budget period it becomes apparent to the Secretary that the
amount of Federal funds awarded and available to the grantee for that
period, including any unobligated balance carried forward from prior
periods, exceeds the grantee's needs for that period, the Secretary may
adjust the amounts awarded by withdrawing the excess.
Sec. 63a.9 What are the terms and conditions of awards?
In addition to the requirements imposed by law, grants awarded
under this part are subject to any terms and conditions imposed by the
Secretary to carry out the purpose of the grant or assure or protect
advancement of the approved program, the interests of the public
health, or the conservation of grant funds.
Sec. 63a.10 How may training grant funds be spent?
(a) Authorized expenditures; general. A grantee shall expend funds
it receives under this part solely in accordance with the approved
application and budget, the regulations of this part, the terms and
conditions of the grant award, and the applicable cost principles in 45
CFR 74.27.
(b) Authorized categories of expenditures. Subject to any
limitations imposed in the approved application and budget or as a
condition of the award, grant funds may be expended for the following
costs:
(1) Expenses of the grantee in providing training and instruction
under the particular program, including salaries of faculty and support
personnel, and the costs of equipment and supplies;
(2) Stipends and allowances to individuals during the period of
their training and instruction; and,
(3) If separately justified and authorized under the particular
program, tuition, fees, and trainee travel expenses which are necessary
to carry out the purpose of the training grant.
(c) Expenditures not authorized. Grant funds may not be expended
for:
(1) Compensation for employment or for the performance of personal
services by individuals receiving training and instruction; or
(2) Payments to any individual who does not meet the minimum
qualifications for training and instruction established by the grantee
and approved by the Secretary or who has failed to demonstrate
satisfactory participation in the training in accordance with the usual
standards and procedures of the grantee.
Sec. 63a.11 Other HHS regulations and policies that apply.
Several other HHS regulations and policies apply to 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
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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 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 change, and interested persons should contact the Office of
Research on Women's Health, NIH, Room 201, Building 1, MSC 0161,
Bethesda, MD 20892-0161 (301-402-1770; not a toll-free number) to
obtain references to the current version and any amendments.]
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, MSC 7010,
Bethesda, MD 20892-7010 (301-496-9838; not a toll-free number) to
obtain references to the current version and any amendments.]
``PHS Grants Policy Statement,'' DHHS Publication No. (OASH) 94-50,000
(Revised April 1, 1994), as amended by the Addendum, dated January 24,
1995. [Note: this policy is subject to change, and interested persons
should contact the Extramural Outreach and Information Resources Office
(EOIRO), Office of Extramural Research, 6701 Rockledge Drive, Room
6208, MSC 7910, Bethesda, MD 20892-7910 (301-435-0714; not a toll-free
number) to obtain references to the current version and any amendments.
Information may also be obtained by contacting the EOIRO via its e-mail
address ([email protected]) and by browsing the NIH Home Page
site on the World Wide Web (http://www.nih.gov).]
``Public Health Service Policy on Humane Care and Use of Laboratory
Animals,'' Office for Protection from Research Risks, NIH (Revised
September 1986). [Note: this policy is subject to change, and
interested persons should contact the Office for Protection from
Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507,
Rockville, MD 20852-7507 (301-496-7005; not a toll-free number) to
obtain references to the current version and any amendments.]
[FR Doc. 96-26974 Filed 10-23-96; 8:45 am]
BILLING CODE 4140-01-P