Fellowships, internships, training: National Institutes of Health research traineeships,

[Federal Register: October 30, 1998 (Volume 63, Number 210)]

[Proposed Rules]

[Page 58336-58338]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr30oc98-35]

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.

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.

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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. 98-28712Filed10-29-98; 8:45 am]

   BILLING CODE 4140-01-M