[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 (jm40z@nih.gov).
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
