[Federal Register Volume 65, Number 215 (Monday, November 6, 2000)]
[Rules and Regulations]
[Pages 66511-66513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28341]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 63

RIN 0925-AA11


Traineeships

AGENCY: National Institutes of Health, HHS.

ACTION: Final rule.

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SUMMARY: The National Institutes of Health (NIH) is amending the 
regulations governing traineeships to add conditions under which NIH 
may terminate traineeship awards and revise the authorities for the 
awards.

EFFECTIVE DATE: This final rule is effective on December 6, 2000.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,

[[Page 66512]]

National Institutes of Health, 6011 Executive Boulevard, Room 601, MSC 
7669, Rockville, MD 20852; telephone 301-496-4607 (not a toll-free 
number; Fax 301-402-0169; or E-mail ([email protected])). For information 
about traineeship awards contact James Alexander, Acting Director, 
Office of Education, Office of Intramural Research, National Institutes 
of Health, Building 10, Room 1C-129, 10 Center Drive, MSC 1158, 
Bethesda, MD 20892-1158; telephone 301-496-2427 (not a toll-free 
number).

SUPPLEMENTARY INFORMATION: Section 405(b)(1)(C) of the Public Health 
Service (PHS) Act, as amended, authorizes the Secretary, acting through 
the directors of the national research institutes of NIH, to conduct 
and support 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 Director, 
NIH, has similar authority under section 402(b)(13) of the PHS Act. 
Additionally, section 485D(a) of the PHS Act authorizes the Director of 
the National Center for Complementary and Alternative Medicine to 
support research training; section 472 of the PHS Act authorizes the 
award of traineeships in medical library science and related fields; 
and section 413(b)(3) of the PHS Act authorizes the Director of the 
National Cancer Institute (NCI), in carrying out the National Cancer 
Program, to support appropriate programs of education and training 
(including continuing education and laboratory and clinical research 
training). Unlike the NIH authority set forth in section 405(b)(1)(C) 
of the PHS Act, the NCI authority does not exclude residency training. 
Under these authorities, NIH awards research traineeships to qualified 
individuals. The regulations codified at 42 CFR part 63 govern these 
traineeships. NIH revised the regulations in their entirety, February 
27, 1995 (60 FR 10718).
    NIH proposed amendments to Part 63 in a notice of proposed 
rulemaking (NPRM) published in the Federal Register, October 30, 1998 
(63 FR 58336). The NPRM provided for a 60-day comment period. The 
comment period expired December 29, 1998. NIH received no comments. 
Consequently, except for minor clarifying and editorial changes, the 
final regulations described below are the same as those proposed in 
October 1998.
    In these final regulations, NIH is revising Sec. 63.9 by amending 
paragraph (b) to add scientific misconduct as a ground for termination 
and by adding new paragraphs (c) and (d), which add conviction of a 
felony and certain other criminal offenses and programmatic changes or 
lack of funds, respectively, as grounds for termination.
    Additionally, NIH is amending the authority citation by adding a 
reference to section 413(b)(3) of the PHS Act pertaining to the 
National Cancer Program that was inadvertently excluded from the 
proposed rule and removing the reference to section 485B(b) of the PHS 
Act and the parallel U.S. Code citation to reflect the renaming of the 
National Center for Human Genome Research as the National Human Genome 
Research Institute (NHGRI), effective January 27, 1997 (62 FR 3900). As 
a result of the establishment of this new research institute, the 
current reference to section 485B is redundant and unnecessary. The 
current references to the National Center for Human Genome Research and 
section 485B of the PHS Act in Sec. 63.1 and Sec. 63.2 are also 
redundant and unnecessary as a result of the renaming. Consequently, 
NIH is removing the references to the National Center for Human Genome 
Research and section 485B of the PHS Act in paragraph (a) of Sec. 63.1 
and in the definitions set forth in Sec. 63.2 of the terms ``award,'' 
``awardee,'' ``director,'' and ``traineeship.'' Also NIH is adding to 
Sec. 63.2 the definition of ``misconduct in science,'' as set forth in 
the PHS regulations governing the responsibility of awardees and 
applicants for dealing with misconduct in science, 42 CFR part 50, 
subpart A.
    Finally, NIH is revising the references set forth in unnumbered 
paragraphs 8, 9, and 10 of Sec. 63.10 to comply with Federal Register 
format requirements.
    NIH provides the following statements as public information.

Executive Order 12866

    The Office of Management and Budget's (OMB) Office of Information 
and Regulatory Affairs (OIRA) reviewed this rule as required under 
Executive Order 12866, Regulatory Planning and Review. The OMB deemed 
it to be not significant, as defined under the Order.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that 
regulatory actions be analyzed to determine whether they will have a 
significant impact on a substantial number of small entities. The 
Director, NIH, certifies that the changes in the traineeship 
regulations will not have a significant economic impact on a 
substantial number of small entities and, therefore, a regulatory 
flexibility analysis, as defined under the Regulatory Flexibility Act, 
is not required.

Executive Order 13132

    Executive Order 13132, Federalism, requires that Federal agencies 
consult with State and local government officials in the development of 
regulatory policies with federalism implications. We reviewed the rule 
as required under the Order and determined that it does not have any 
federalism implications. The Director, NIH, certifies that the changes 
in the traineeships regulations will not have an effect on the States 
or on the distribution of power and responsibilities among the various 
levels of government.

Paperwork Reduction Act

    This rule does not contain any information collection requirements 
that are subject to OMB approval under the Paperwork Reduction Act of 
1995 (44 U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance (CFDA) numbered program 
affected by this rule is: 93.140--Intramural Research Training Award.

List of Subjects in 42 CFR Part 63

    Grant programs--health, Health professions, Libraries, Manpower 
training programs, Medical research, Students.

    Dated: August 3, 2000.
Ruth L. Kirschstein,
Principal Deputy Director, National Institutes of Health.

    Accordingly, part 63 of title 42 of the Code of Federal Regulations 
is amended as set forth below.

PART 63--TRAINEESHIPS

    1. The authority citation for part 63 is revised to read as 
follows:

    Authority: 42 U.S.C. 216, 282(b)(13), 284(b)(1)(C), 285a-
2(b)(3), 286b-3, 287c-21(a).

    2. Section 63.1 is revised to read as follows:


Sec. 63.1  To what programs do these regulations apply?

    (a) The regulations in this part apply to research traineeships 
awarded by the Director, NIH, each director of a national research 
institute of NIH, the Director of the National Library of Medicine, and 
the Director of the National Center for Complementary and Alternative 
Medicine, or their designees, pursuant to sections 402(b)(13), 
405(b)(1)(C), 413(b)(3), 472, and 485(D)(a) of the Act, respectively.

[[Page 66513]]

    (b) The regulations of this part do not apply to research training 
under the National Research Service Award Program governed by 42 CFR 
part 66 or to the Mental Health Traineeship Program governed by 42 CFR 
part 64a.
    (c) Except as otherwise permitted under section 413(b)(3) of the 
Act, the regulations of this part do not apply to residency training of 
physicians or other health professionals.

    3. Section 63.2 is amended by revising the definitions of 
``Award,'' ``Awardee,'' ``Director,'' and ``Traineeship,'' and adding 
in alphabetical order a new definition of ``Misconduct in science,'' to 
read as follows:


Sec. 63.2  Definitions.

* * * * *
    Award means an award of funds under sections 402(b)(13), 
405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of the Act 
which authorize research training or traineeships.
    Awardee means an individual awarded a traineeship under sections 
402(b)(13), 405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of 
the Act which authorize research training or traineeships.
    Director means the Director, NIH, the director of a national 
research institute of NIH, the Director of the National Library of 
Medicine, and the Director of the National Center for Complementary and 
Alternative Medicine, or any official of NIH to whom the authority 
involved has been delegated.
* * * * *
    Misconduct in science shall have the same meaning as prescribed in 
Sec. 50.102 of this chapter.
* * * * *
    Traineeship means an award under the regulations of this part to a 
qualified individual for that person's subsistence and other expenses 
during the period that person is participating in the research training 
approved under the award.

    4. Section 63.9 is revised to read as follows:


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 has committed misconduct 
in science, is ineligible, or has materially failed to comply with the 
terms and conditions of the award or to carry out the purpose for which 
the award was made; or
    (c) If the awardee is convicted of a felony, or an offense 
involving any illegal drug or substance, or any offense involving a 
lack of financial integrity or business honesty; or
    (d) Because of programmatic changes or lack of funds.

    5. Section 63.10 is amended by removing the last three entries in 
the list of policies and regulations and adding three new entries in 
their place to read as follows:


Sec. 63.10  Other HHS regulations and policies that apply.

* * * * *
    59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of 
Women and Minorities as Subjects in Clinical Research. (Note: 
Interested persons should contact the Office of Research on Women's 
Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-
0161; telephone 301-402-1770 (not a toll-free number) to obtain 
copies of this policy.)
    59 FR 34496 (July 5, 1994)--NIH Guidelines for Research 
Involving Recombinant DNA Molecules. (Note: Interested persons 
should contact the Office of Biotechnology Activities, NIH, Suite 
323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010; 
telephone 301-496-9838 (not a toll-free number) to obtain copies of 
the policy.)
    ``Public Health Service Policy on Humane Care and Use of 
Laboratory Animals'' (Revised September 1986), Office of Laboratory 
Animal Welfare, NIH. (Note: Interested persons should contact the 
Office of Laboratory Animal Welfare, NIH, Rockledge Building I, 6705 
Rockledge Drive, Suite 1050, MSC 7982, Bethesda, MD 20892-7982; 
telephone 301-496-7163 (not a toll-free number) to obtain copies of 
the policy.)

[FR Doc. 00-28341 Filed 11-3-00; 8:45 am]
BILLING CODE 4140-01-P