Traineeships

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 ([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