[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Rules and Regulations]
[Pages 10718-10720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4637]
[[Page 10717]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
_______________________________________________________________________
42 CFR Part 63
Traineeships; Final Rule
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 /
Rules and Regulations
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[[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
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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
