National Institutes of Health Training Grants

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]

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