10718 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

42 CFR Part 63

RIN 0905–AD28

Traineeships

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Final rule.

SUMMARY: This final rule revises

regulations governing National

Institutes of Health (NIH) research

traineeship awards in their entirety. The

regulations are obsolete and require

revision. The revised regulations are

intended to provide NIH with the

flexibility needed to effectively support

the development and operation of a

variety of training programs essential to

the NIH research mission.

EFFECTIVE DATE: This final rule is

effective March 29, 1995.

FOR FURTHER INFORMATION CONTACT: Mr.

Jerry Moore, Regulatory Affairs Officer,

National Institutes of Health, Building

31, Room 1B25, 31 Center DR MSC,

9000 Rockville Pike, Bethesda,

Maryland 20892–2075, telephone (301)

496–4606 (not a toll-free number). For

information concerning the program

contact the Office of Education,

National Institutes of Health, Building

10, Room 1C129, 9000 Rockville Pike,

Bethesda, Maryland 20892–0001,

telephone (301) 496–2427 (not a toll-free

number).

SUPPLEMENTAL INFORMATION: On August

6, 1993 (58 FR 42039), NIH published a

notice of proposed rulemaking in the

Federal Register announcing its

intention to revise in their entirety the

regulations at 42 CFR part 63 governing

traineeships to cover traineeships

awarded under sections 404E(d)(2),

405(b)(1)(C), 472, and 484 of the Public

Health Service (PHS) Act, as amended.

Traineeships under part 63 are

designed to provide research training for

which fellowship support is not

provided under section 487 of the PHS

Act, and which is not residency training

of physicians or other health

professionals. The traineeships provide

opportunities for developmental

training and practical research

experience in the labs of NIH, and are

available to postdoctoral scientists at the

beginning stages of their professional

research careers, and to high school,

college, graduate and professional (e.g.

medical, dental, and other health fields)

school students pursuing studies in

academic disciplines related to

biomedical research and in medical

library science and related fields.

NIH received no comments

concerning the NPRM. However,

enactment of the NIH Revitalization Act

of 1993, Public Law 103–43,

necessitated making several technical

changes to the proposed regulations to

conform the regulations to Public Law

103–43. More specifically, Public Law

103–43 redesignated the National Center

for Nursing Research as the National

Institute of Nursing Research.

Accordingly, references to the National

Center for Nursing Research in

paragraph (a) of § 63.1 and in the

definition for the term ‘‘Director’’ in

§ 63.2 were deleted. This redesignation

also eliminated the need for the

reference to PHS Act section 484.

Accordingly, references to section 484

were deleted from the authority citation,

paragraph (a) of § 63.1, and the

definitions for the terms ‘‘Award,’’

‘‘Awardee’’ and ‘‘Traineeship’’ in § 63.2.

Public Law 103–43 also set forth new

traineeship authority for the Director of

the National Center for Human Genome

Research (NCHGR) in PHS Act section

485B and the Director of the Office of

Alternative Medicine (OAM) in PHS Act

section 404E(d)(2). Accordingly,

references to the NCHGR and OAM

authorities were added to paragraph (a)

of § 63.1 and to the definition for the

term ‘‘Director’’ in § 63.2. In addition,

references to PHS Act section 485B and

404E were added to the authority

citation, paragraph (a) of § 63.1, and to

the definitions for the terms ‘‘Award,’’

‘‘Awardee,’’ and ‘‘Traineeship’’ in

§ 63.2.

Additionally, Public Law 103–43

required NIH to establish guidelines on

the inclusion of women and minorities

and their subpopulations in research

involving human subjects, including

clinical trails, supported by NIH. These

guidelines, which were originally

published in the Federal Register on

March 9, 1994 (59 FR 1146), were

republished on March 28, 1994 (59 FR

14508) because of typesetting problems.

Section 63.10 of the regulations was

modified to include a reference for these

guidelines.

In accordance with section 553 of title

5 of the United States Code, NIH finds

that good cause exists for waiving

another NPRM. Delay of this rule would

be contrary to the public interest and

unnecessary given the technical nature

of these changes.

Further, PHS strongly encourages all

grant recipients to provide a smoke-free

workplace and to 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.

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, the

Secretary does not believe this rule is

economically significant nor does the

Secretary believe that it will have a

significant impact on a substantial

number of small entities. In addition,

this proposed rule is not inconsistent

with the actions of any other agency.

This proposed rule merely codifies

internal policies and procedures of the

Federal government currently used to

administer traineeship awards. The

program does not have a significant

economic or policy impact on a broad

cross-section of the public. Furthermore,

this rule will only affect those few

highly qualified health professionals

who are interested in participating in

the program, subject to the normal

accountability requirements for program

participation. No individual is obligated

to participate in the program. For these

same reasons, the Secretary certifies this

proposed rule 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.
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations 10719

Paperwork Reduction Act

This rule contains information

collection requirements subject to Office

of Management and Budget (OMB)

review and approval under the

Paperwork Reduction Act of 1980 (44

U.S.C. chapter 35).

Title: National Institutes of Health

Research Traineeships.

Description: The information collected is

used by NIH to determine an applicant’s

eligibility to apply for a traineeship, ensures

that an awardee agrees to comply with the

terms and conditions of the traineeship and

that an awardee shows good cause for not

reimbursing PHS for any overpayment of

stipends or other allowances because of early

termination of the traineeship or for any

other reason.

Respondent Description: Individuals or

households.

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Annual

number of

respondents

Annual frequency

Average

burden per

response

Annual burden hours

Reporting: § 63.6(b)

Summer Fellowship Applicants ................................................................................. 3,000 1 1 3,000

Predoctoral & Postdoctoral Applicants ..................................................................... 400 1 1 400

Summer Fellowship References ............................................................................... 6,000 1 .33 2,000

Predoctoral & Postdoctoral References .................................................................... 1,200 1 .33 400

Subtotal .............................................................................................................. 10,600 1 .55 1 5,800

§ 63.8(c) .................................................................................................................... 100 1 .25 25

§ 63.9(a) .................................................................................................................... 100 1 .25 25

Total ................................................................................................................... ................... ................... ................... 50

1This burden is approved under OMB Approval Number 0925–0299 (expires April 30, 1997).

The information collection in

§ 63.6(b) regarding application materials

and the associated burden are approved

under OMB Approval Number 0925–

0299 (expires April 30, 1997). The

information collection in § 63.8(c) and

§ 63.9(a), and the associated burden

have been reported to OMB for review

and approval under OMB Approval

Number 0925–0299.

Catalog of Federal Domestic Assistance

Catalog of Federal Domestic Assistance

program numbers affected by this rule are:

93.140 and 93.172.

List of Subjects in Part 63

Grant programs—health; Health;

Medical research.

Dated: December 16, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Approved: February 16, 1995.

Donna E. Shalala,

Secretary.

Accordingly, part 63 of title 42 of the

Code of Federal Regulations is revised

to read as set forth below.

PART 63—TRAINEESHIPS

Sec.

63.1 To what programs do these regulations

apply?

63.2 Definitions.

63.3 What is the purpose of traineeships?

63.4 What are the minimum qualifications

for awards?

63.5 How will NIH make awards?

63.6 How to apply.

63.7 What are the benefits of awards?

63.8 What are the terms and conditions of

awards?

63.9 How may NIH terminate awards?

63.10 Other HHS regulations and policies

that apply.

Authority: 42 U.S.C. 216, 283g(d),

284(b)(1)(C), 286b-3, 287c(b).

§ 63.1 To what programs do these

regulations apply?

(a) The regulations in this part apply

to research traineeships awarded by

each Director of a national research

institute of NIH, the Director of the

National Library of Medicine (NLM), the

Director of the National Center for

Human Genome Research (NCHGR), the

Director of the Office of Alternative

Medicine, or designees pursuant to

sections 404E(d)(2), 405(b)(1)(C), 472,

and 485B of the Public Health Service

Act, as amended.

(b) The regulations of this part do not

apply to research training which is part

of the National Research Service Award

Program provided under 42 CFR part 66,

the Mental Health Traineeship Program

provided under 42 CFR part 64a, or

residency training of physicians or other

health professionals.

§ 63.2 Definitions.

As used in this part:

‘‘Act’’ means the Public Health

Service Act, as amended (42 U.S.C. 201

et seq.).

‘‘Award’’ means an award of funds

under sections 404E(d)(2), 405(b)(1)(C),

472, or 485B of the Act, or other

sections of the Act which authorize

research training or traineeships.

‘‘Awardee’’ means an individual

awarded a traineeship under sections

404E(d)(2), 405(b)(1)(C), 472, or 485B of

the Act, or other sections of the Act

which authorize research training or

traineeships.

‘‘Director’’ means the director of one

of the national research institutes of NIH

specified in section 401(b)(1) of the Act,

the Director of the National Library of

Medicine, the Director of the National

Center for Human Genome Research, the

Director of the Office of Alternative

Medicine, or any official of NIH to

whom the authority involved has been

delegated.

‘‘HHS’’ means the Department of

Health and Human Services.

‘‘NIH’’ means the National Institutes

of Health.

‘‘PHS’’ means the Public Health

Service.

‘‘Traineeship’’ means an award of

funds under section 404E(d)(2),

405(b)(1)(C), 472, or 485B of the Act, or

other sections of the Act authorizing

research training or traineeships, and

the regulations of this part, to a

qualified individual for the person’s

subsistence and other expenses during a

period in which the awardee is

acquiring the research training approved

under the award.

§ 63.3 What is the purpose of

traineeships?

The purpose of an NIH research

traineeship is to provide support for

financial subsistence to an individual

during a period in which the awardee is

acquiring training in:

(a) Basic and/or clinical biomedical or

behavioral research relating to human

health, including extending healthy life

and reducing the burdens of illness, or
10720 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations

(b) Medical library science or related

fields pertaining to sciences related to

health or the communication of health

sciences information.

Traineeships are intended to make

available in the United States an

increased number of persons having

special competence in these research

fields through developmental training

and practical research experience in the

facilities of NIH, with supplemental

training at other qualified institutions

(see § 63.8(a)).

§ 63.4 What are the minimum

qualifications for awards?

Minimum qualifications for any

traineeship shall be established by the

Director and shall be uniformly

applicable to all applicants in each

traineeship program. These minimum

qualifications may include requirements

as to citizenship, medical standards,

academic degrees, professional or other

training or experience, and other factors

as may be necessary to the fulfillment of

the purpose of the traineeship. The

Director may, as a matter of general

policy or, in individual cases, waive

compliance with any minimum

qualification so established to the extent

that the applicant or applicants have

substantially equivalent qualifications

or have such special training,

experience or opportunity for service as

to make an award particularly

appropriate, and to the extent the

Director finds it is consistent with the

fulfillment of the purpose of the

traineeship.

§ 63.5 How will NIH make awards?

Subject to the regulations of this part,

the Director may award traineeships to

those qualified applicants who are best

able in that official’s judgment to carry

out the purpose of the traineeships.

These awards may be made for a period

of one (1) year or other period,

including extensions or renewals, as

may be specified.

§ 63.6 How to apply.

(a) Application for a traineeship shall

be made in writing as prescribed by the

Director.

(b) In addition to other pertinent

information, the Director may require

each applicant to submit the following

information:

(1) Certification of the applicant’s

citizenship status;

(2) The applicant’s educational

background and other qualifications and

experience, including previous

academic and professional degrees, if

any; and

(3) The subject area of the proposed

training.

(c) By applying, eligible individuals

agree to abide by HHS, PHS, and NIH

regulations, and the terms and

conditions of the traineeship award

which may require compliance with

policies and procedures that apply to

the proper conduct of research, such as

research involving human and animal

subjects, patient care, hospital and

laboratory procedures, handling of

confidential information, and outside

employment.

§ 63.7 What are the benefits of awards?

(a) Subject to the availability of funds,

each individual awarded a traineeship

may receive a stipend fixed in an

amount determined by the Director.

(b) Additional allowances and

benefits may be authorized by and at the

discretion of the Director, taking into

account the cost of living and other

factors such as the requirements of the

training program and availability of

discretionary funds. Discretionary

allowances and benefits may include:

health benefits coverage; dependents’

allowance; travel to pre-award

interviews, to first duty station, and

return to the place of origin upon

conclusion of the traineeship; tuition

and institution fees; and other specific

costs as may be necessary to fulfill the

purpose of the training program.

§ 63.8 What are the terms and conditions

of awards?

All traineeships shall be subject to the

following terms and conditions:

(a) Training must be carried out at a

facility of the NIH, but may be

supplemented by additional training

acquired at another institution which is

found by the Director to be directly

related to the purpose of the traineeship

and necessary to its successful

completion.

(b) Payments shall be made to the

awardee or to the institution for

payment to the awardee in accordance

with payment schedules as prescribed

by the Director for each traineeship

program.

(c) The awardee shall reimburse NIH

for any overpayment of stipends or

other allowances because of early

termination of the traineeship or any

other reason, unless waived for good

cause shown by the awardee.

(d) The Director may establish

procedures and requirements applicable

to traineeship awards, consistent with

the regulations in this part, regarding:

(1) The proper conduct of research

investigations, including research

involving human and animal subjects;

(2) patient care; (3) hospital and

laboratory procedures; (4) handling of

confidential information; (5) outside

employment; and (6) additional

conditions the Director finds necessary

to fulfill the purpose of the traineeship.

(e) The awardee shall sign an

agreement to comply with the terms and

conditions of the traineeship.

§ 63.9 How may NIH terminate awards?

The Director may terminate a

traineeship at any time:

(a) Upon written request of the

awardee; or

(b) If it is determined that the awardee

is ineligible, has materially failed to

comply with the terms and conditions

of the award, or to carry out the purpose

for which it was made.

§ 63.10 Other HHS regulations and policies

that apply.

Several other policies and regulations

apply to awards under this part. These

include, but are not necessarily limited

to:

45 CFR part 46—Protection of human

subjects

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

51 FR 16958 (May 7, 1986)—NIH

Guidelines for Research Involving

Recombinant DNA Molecules

‘‘Public Health Service Policy on

Humane Care and Use of Laboratory

Animals,’’ Office for Protection

from Research Risks, NIH (Revised

September 1986)

59 FR 14508 (March 28, 1994)—NIH

Guidelines on the Inclusion of

Women and Minorities as Subjects

in Clinical Research

[FR Doc. 95–4637 Filed 2–24–95; 8:45 am]

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