National Institutes of Health Training Grants

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

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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.

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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