[Federal Register Volume 63, Number 210 (Friday, October 30, 1998)]
[Proposed Rules]
[Pages 58336-58338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 63

RIN 0925-AA11


Traineeships

AGENCY: National Institutes of Health, DHHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to amend its 
regulations governing traineeships to reflect additional conditions 
under which NIH may terminate traineeship awards and to reflect changes 
in the authorities for the awards.

DATES: Comments on the proposed changes must be received on or before 
December 29, 1998 in order to ensure that NIH will be able to consider 
the comments in preparing the final rule.

ADDRESSES: Comments should be sent to Jerry Moore, NIH Regulations 
Officer, National Institutes of Health, 6011 Executive Blvd., Suite 
601, MSC 7669, Rockville, MD 20852. Comments may also be sent 
electronically by facsimile (301) 496-0169 or e-mail ([email protected]).

FOR FURTHER INFORMATION CONTACT:
Jerry Moore, NIH Regulations Officer, at the address above, or 
telephone (301) 496-4607 (not a toll-free number). 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 Dr 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

[[Page 58337]]

not provided under section 487 of the PHS Act, and which is not 
residency training of physicians or other health professionals. 
Additionally, section 404E(d)(2) of the PHS Act authorizes the Director 
of the Office of Alternative Medicine to support research training for 
which fellowship support is not provided under section 487 of the PHS 
Act, and that is not residency training of physicians or other health 
professionals; and section 472 of the PHS Act authorizes the award of 
traineeships in medical library science and related fields. Under these 
authorities, NIH awards research traineeships to qualified individuals. 
These traineeships are governed by the regulations codified at 42 CFR 
Part 63. The regulations were revised in their entirety, February 27, 
1995 (60 FR 10718). NIH proposes to amend Sec. 63.9 by revising 
paragraph (b) to identify scientific misconduct as a basis for 
termination, and 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 additional grounds for 
termination.
    Additionally, NIH proposes to amend the authority citation by 
removing the United States Code citation, 42 U.S.C. 287c(b), section 
485B(b) of the PHS Act, to reflect the renaming of the National Center 
for Human Genome Research (NCHGR) 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 reference 
to section 405(b)(1)(C) of the PHS Act (42 U.S.C. 284(b)(1)(C)) is 
sufficient, because it provides research training authority for all 
research institutes. 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 proposes to remove 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 for the terms ``award,'' ``awardee,'' ``director,'' and 
``traineeship.'' Also the definition of ``misconduct in science,'' as 
prescribed in the PHS regulations governing the responsibility of 
awardees and applicants for dealing with misconduct in science, 42 CFR 
part 50, subpart A, is added to Sec. 63.2.
    Finally, NIH proposes to revise the references set forth in 
subparagraphs 8, 9, and 10 of Sec. 63.10 to comply with Federal 
Register format requirements. The purpose of this Notice of Proposed 
Rulemaking (NPRM) is to invite public comment with regard to the 
proposed changes. The following statements are provided as public 
information.

Executive Order 12866

    This NPRM was reviewed by the Office of Management and Budget's 
(OMB) Office of Information and Regulatory Affairs (OIRA) as required 
under Executive Order 12866, Regulatory Planning and Review, and was 
deemed 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 certifies that the proposed changes to 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.

Paperwork Reduction Act

    This NPRM 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 NPRM is: 93.140 Intramural Research Training Award

List of subjects in 42 CFR Part 63

    Grant programs-health, Health, Medical research.

    Dated: August 14, 1998.
Harold Varmus,
Director, National Institutes of Health.

    Accordingly, it is proposed to amend part 63 of title 42 of the 
Code of Federal Regulations to read as set forth below.

PART 63--TRAINEESHIPS

    1. The authority citation would be revised to read as set forth 
below:

    Authority: 42 U.S.C. 216, 283g(d)(2), 284(b)(1)(C), 286b-3.

    2. Section 63.1 would be amended by revising paragraph (a) 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 each Director of a national research institute of NIH, the 
Director of the National Library of Medicine, and the Director of the 
Office of Alternative Medicine, or their designees, pursuant to 
sections 405(b)(1)(C), 472, and 404E(d)(2) of the Act, respectively.
* * * * *
    3. Section 63.2 would be amended by revising the definitions of 
``award,'' ``awardee,'' ``director,'' and ``traineeship,'' and adding a 
new definition of ``misconduct in science,'' to read as follows:


Sec. 63.2  Definitions.

* * * * *
    Award means an award of funds under section 404E(d)(2), 
405(b)(1)(C), 472, or other sections of the Act, which authorize 
research training or traineeships.
    Awardee means an individual awarded a traineeship under section 
404E(d)(2), 405(b)(1)(C), 472, 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, the Director of the National Library of Medicine, 
and the Director of the Office of 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 of funds under section 404E(d)(2), 
405(b)(1)(C), 472, 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.
    4. Section 63.9 would be amended by revising paragraph (b) and 
adding new paragraphs (c) and (d) to read as follows:


Sec. 63.9  How may NIH terminate awards?

* * * * *
    (b) If it is determined that the awardee has committed misconduct 
in science, is ineligible, 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.

[[Page 58338]]

    5. Section 63.10 would be amended by revising and rearranging 
unnumbered subparagraphs 8, 9, and 10 to read as follows:


Sec. 63.101  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. this policy is subject to change, and 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 reference to the current 
version and any amendments.

    59 FR 34496 (July 5, 1998)--NIH Guidelines for Research 
Involving Recombinant DNA Molecules.
    Note. this policy is subject to change, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 
323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010, 
telephone (301) 496-9838 (not a toll-free number) to obtain 
references to the current version and any amendments.

    ``Public Health Service Policy on Human Care and Use of 
Laboratory Animals,'' Office for Protection from Research Risks, NIH 
(Revised September 1986).

    Note. this policy is subject to change, and interested persons 
should contact the Office for Protection from Research Risks, NIH, 
Suite 3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-
7507, telephone (301) 496-7005 (not a toll-free number) to obtain 
references to the current version and any amendments.

[FR Doc. 98-28712 Filed 10-29-98; 8:45 am]
BILLING CODE 4140-01-M