Traineeships

[[Page 10718]]

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.

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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 Sec. 63.1 and

in the definition for the term ``Director'' in Sec. 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 Sec. 63.1, and the

definitions for the terms ``Award,'' ``Awardee'' and ``Traineeship'' in

Sec. 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

Sec. 63.1 and to the definition for the term ``Director'' in Sec. 63.2.

In addition, references to PHS Act section 485B and 404E were added to

the authority citation, paragraph (a) of Sec. 63.1, and to the

definitions for the terms ``Award,'' ``Awardee,'' and ``Traineeship''

in Sec. 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.

[[Page 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

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Annual Average Annual

number of Annual burden per burden

respondents frequency response hours

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Reporting: Sec.

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

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

===================================================

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

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

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

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\1\This burden is approved under OMB Approval Number 0925-0299 (expires

April 30, 1997).

The information collection in Sec. 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 Sec. 63.8(c) and Sec. 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).

Sec. 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.

Sec. 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.

Sec. 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 [[Page 10720]]

(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 Sec. 63.8(a)).

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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]

BILLING CODE 4140-01-P