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

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.

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.
Federal Register / Vol. 60, No. 15 / Tuesday, January 24, 1995 / Proposed Rules 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 nonNRSA 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).

§ 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).

§ 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

§ 63a.1(b).

‘‘HHS’’ means the Department of

Health and Human Services.
4744 Federal Register / Vol. 60, No. 15 / Tuesday, January 24, 1995 / Proposed Rules

‘‘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 § 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

§ 63a.1 to carry out one or more of the

purposes set forth in § 63a.3.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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 § 63a.1 and the regulations of this

part.

§ 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.

§ 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.

§ 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.
Federal Register / Vol. 60, No. 15 / Tuesday, January 24, 1995 / Proposed Rules 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.

§ 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 drugfree 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]

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