[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

[[Page 55113]]

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