[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)]
[Proposed Rules]
[Pages 4742-4745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-113]




[[Page 4741]]

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Part IV





Department of Health and Human Services





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Public Health Service



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42 CFR Part 63a



National Institutes of Health Training Grants; Proposed Rule

Federal Register / Vol. 60, No. 15 / Tuesday, January 24, 1995 / 
Proposed Rules 
[[Page 4742]] 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

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: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to issue 
regulations governing non-National Research Service Award (NRSA) 
training grants awarded under Public Health Service (PHS) Act, and 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 required to implement 
other non-NRSA research training grant authorities set forth in the 
National Institutes of Health Revitalization Act of 1993, the Clean Air 
Act, and other health research-related legislation.

DATES: Comments must be received on or before March 27, 1995. Any 
regulations which are adopted will be effective 30 days after 
publication in the Federal Register.

ADDRESSES: Comments should be sent to Mr. Jerry Moore, Regulatory 
Affairs Officer, National Institutes of Health, Building 31, Room 1B-
25, 31 Center DR MSC 2075, 9000 Rockville Pike, Bethesda, Maryland 
20892-2340.

FOR FURTHER INFORMATION CONTACT: Mr. Jerry Moore at the address above, 
or telephone (301) 496-4606 (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 found at 42 CFR part 66. The 
regulations which NIH proposes to issue concerning training grants 
would not affect the NRSA Program or amend the regulations in part 66.
    Prior to the advent of the NRSA program, the NIH institutes had 
used training authority contained in section 301 of the PHS Act and 
related sections that authorized each institute 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 (Public Law 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 29187 et seq.) revising 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 NIH Revitalization Act of 1993 (Public Law 103-43), 
authorized the Director of the National Center for Human Genome 
Research (NCHGR), as set forth 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.
    Additionally, section 2315(a)(1) of the PHS Act 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.
    NIH proposes to issue new regulations at part 63a to govern 
implementation of these training grant authorities. The regulations are 
intended to serve as a permanent set of regulations that 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, with any exceptions or special provisions for particular 
programs as necessary.
    Readers of this notice 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 Notice of Proposed Rulemaking (NPRM) sets forth what training 
is covered by the regulations, the nature and purpose of the training, 
what institutions are eligible to apply, how to apply, how grants are 
awarded, and conditions imposed on recipients. The purpose of this NPRM 
is to invite public comment on the proposed regulations. Implementation 
of the particular training grant programs encompassed by these proposed 
regulations rests with the statutorily authorized awarding 
organizations and is subject to the availability of funding for the 
purpose, as well as programmatic priorities determined by the awarding 
organizations.
    Public Law 103-227, enacted on March 31, 1994, prohibits smoking in 
certain facilities in which minors will be present. The Department of 
Health and Human Services is now preparing to implement the provisions 
of that law. Until those implementation plans are in place, PHS 
continues to strongly encourage all grant recipients to provide a 
smoke-free workplace and promote the nonuse of all tobacco products. 
[[Page 4743]] 
    The following statements are provided for the information of the 
public.

Regulatory Impact Statement

    Executive Order 12866 of September 30, 1993, Regulatory Planning 
and Review, requires the Department to prepare an analysis for any rule 
that meets one of the E. O. 12866 criteria for a significant regulatory 
action; that is, that may--
    Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    Materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or
    Raise novel legal or policy issues arising out of legal mandates, 
the President's priorities, or the principles set forth in E.O. 12866.
    In addition, the Department prepares a regulatory flexibility 
analysis, in accordance with the Regulatory Flexibility Act of 1980 (5 
U.S.C. chapter 6), if the rule is expected to have a significant impact 
on a substantial number of small entities.
    For the reasons outlined below, we do not believe this NPRM is 
economically significant nor do we believe that it will have a 
significant impact on a substantial number of small entities. In 
addition, this NPRM is not inconsistent with the actions of any other 
agency.
    This NPRM merely codifies internal policies and procedures of the 
Federal government used to administer non-NRSA training grants awarded 
by the directors of the national research institutes of NIH under the 
authority set forth in section 405(b)(1)(C) of the PHS Act; the 
Director, FIC, under the authority in section 307 of the PHS Act 
delegated by the Secretary; the Director, NCHGR, under the authority 
set forth in section 485B(b) of the PHS Act; the Secretary, acting 
through the Director of NIH, under the authority set forth in section 
2315(a)(1) of the PHS Act; the Director of the Office of AIDS Research 
under the authority set forth in section 2354(a)(3)(C) of the PHS Act; 
and the Director of NIEHS under the authority set forth in section 
103(h)(2) of the Clean Air Act. These grants do not have a significant 
economic or policy impact on a broad cross-section of the public. 
Furthermore, the proposed regulations would only affect those highly 
qualified health professionals and institutions interested in 
participating in non-NRSA research training programs, subject to the 
normal accountability requirements for program participation. No 
individual or institution is obligated to participate in the program.
    For these same reasons, the Secretary certifies that this NPRM will 
not have a significant economic impact on a substantial number of small 
entities, and that a Regulatory Flexibility Analysis, as defined under 
the Regulatory Flexibility Act of 1980, is not required.

Paperwork Reduction Act

    This NPRM does not contain any information collection requirements 
which are subject to Office of Management and Budget (OMB) approval 
under the Paperwork Reduction Act of 1980 (44 U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance (CFDA) numbered program 
affected by these proposed regulations is:

93.837--Heart and Vascular Diseases Research

List of Subjects in 42 CFR Part 63a

    Environmental health; Grant programs--health; Health; Medical 
research.

    Dated: November 7, 1994.
Philip R. Lee,
Assistant Secretary for Health.

    Approved: December 27, 1994.
Donna E. Shalala,
Secretary.

    Accordingly, it is proposed to amend chapter 1 of title 42 of the 
Code of Federal Regulations 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) These regulations 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 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 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.).
    ``Cooperative agreement'' See Sec. 63a.1(b).
    ``HHS'' means the Department of Health and Human 
Services. [[Page 4744]] 
    ``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 that is intended 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.


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 
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 for projects to support individuals for research 
training relating to acquired immunodeficiency syndrome (AIDS) 
authorized under section 2315(b)(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, projects 
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 (program) 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 any 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 section 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 costs within 
the following expense categories:
    (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. [[Page 4745]] 
    (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
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
51 FR 16958 (May 7, 1986)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules
59 FR 14508 (as republished March 28, 1994)--NIH Guidelines on the 
Inclusion of Women and Minorities as Subjects in Clinical Research
Public Health Service Grants Policy Statement, DHHS Publication No. 
(OASH)94-50,000 (Rev.) April 1, 1994.
Public Health Service Policy on Humane Care and Use of Laboratory 
Animals, Office for Protection from Research Risks, NIH (Revised 
September 1986).

[FR Doc. 95-113 Filed 1-23-95; 8:45 am]
BILLING CODE 4140-01-P