[Federal Register Volume 61, Number 49 (Tuesday, March 12, 1996)]
[Notices]
[Pages 10004-10005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5762]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Recombinant Research: Actions Under the Guidelines

agency: National Institutes of Health, PHS, DHHS.

action: Notice of Actions under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules (59 FR 34496, 59 FR 40170, 60 FR 
20726, 61 FR 1482).

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summary: This notice sets forth an action to be taken by the Director, 
National Institutes of Health (NIH), under the NIH Guidelines for 
Research Involving Recombinant DNA Molecules.

for further information contact: Additional information can be obtained 
from Dr. Nelson A. Wivel, Director, Office of Recombinant DNA 
Activities (ORDA), Office of Science Policy, National Institutes of 
Health, MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, 
Maryland 20892-7010, (301) 496-9838.

supplementary information: Today's action is being promulgated under 
the NIH Guidelines for Research Involving Recombinant DNA Molecules. 
This proposed action was published for comment in the Federal Register 
of November 15, 1995 (60 FR 57528), and reviewed and recommended for 
approval by the NIH Recombinant DNA Advisory Committee (RAC) at its 
meeting on December 4-5, 1995.

I. Background Information and Decisions on Actions Under the NIH 
Guidelines

A. Amendments to Section IV and Appendix M of the NIH Guidelines 
Regarding Semiannual/Annual Data Reporting

    In a letter dated June 16, 1995, Dr. Gary Nabel outlined the 
redundant and onerous reporting requirements of multiple Federal 
agencies and local institutions. At a minimum, amending the NIH 
Guidelines to accommodate annual data reporting requirements rather 
than semiannual reporting requirements should greatly reduce the burden 
currently placed on principal investigator of human gene transfer 
protocols.
    In a letter dated August 16, 1995, Ms. Debra Knorr, NIH Office of 
Recombinant DNA Activities, submitted to the Recombinant DNA Advisory 
Committee the intent to submit proposed amendments to the NIH 
Guidelines regarding annual data reporting. During the September 12, 
1995, Recombinant DNA Advisory Committee meeting, Dr. LeRoy Walters, 
Chair, invited members of the Recombinant DNA Advisory Committee and 
the public to provide comments on the proposed amendments. No comments 
on the proposed amendments were submitted to the Office of Recombinant 
DNA Activities.
    During the December 4-5, 1995, meeting, the Recombinant DNA 
Advisory Committee approved the amendments to the NIH Guidelines for 
annual data reporting using the current semiannual data reporting 
forms. The motion passed by a vote of 14 in favor, 0 opposed, and no 
abstentions.
    The actions are detailed in Section II--Summary of Actions. I 
accept these recommendations, and the NIH Guidelines will be amended 
accordingly.

II. Summary of Actions

A. Amendments to Section IV-B-4-e, Responsibilities of the Principal 
Investigator During the Conduct of the Research

    Section IV-B-4-e-(5) is amended to read:

    ``Section IV-B-4-e-(5). Comply with annual data reporting and 
adverse event reporting requirements for NIH-and FDA-approved human 
gene transfer experiments (see Appendix M-VIII, Reporting 
Requirements--Human Gene Transfer Protocols).''

B. Amendments to Section IV-C-3, Responsibilities of the Office of 
Recombinant DNA Activities

    Section IV-C-3-c is amended to read:

    ``Section IV-C-3-c. Administering the annual data reporting 
requirements (and subsequent review) for human gene transfer 
experiments, including experiments that are reviewed solely by the 
FDA (see Appendix M-VI, Categories of Human Gene Transfer 
Experiments that May Be Exempt from RAC Review).''

C. Amendments to Appendix M-VII, Categories of Human Gene Transfer 
Experiments That May Be Exempt for RAC Review

    Appendix M-VII is amended to read:

    ``Appendix M-VII. Categories of Human Gene Transfer Experiments 
that May Be Exempt from RAC Review.
    ``A proposed submitted under one of the following categories may 
be considered exempt from RAC review unless otherwise determined by 
NIH/ORDA and the FDA on a case-by-case basis (see Appendix M-VI-A, 
Categories of Human Gene Transfer Experiments that Require RAC 
Review).

    Note: For proposals that are exempt from RAC review, the 
documentation described in Appendices M-I through M-V will be 
maintained by NIH/ORDA for compliance with annual data reporting and 
adverse event reporting requirements (see Appendix M-VIII, Reporting 
Requirements--Human Gene Transfer Protocols). Any subsequent 
modifications to proposals that were not reviewed by the RAC must be 
submitted to NIH/ORDA in order to facilitate data reporting 
requirements.

D. Amendments to Appendix M-VIII, Reporting Requirements--Human Gene 
Transfer Protocols

    Appendix M-VIII-A is amended to read:

``Appendix M-VIII-A Annual Data Reporting

    ``Investigators who have received approval from the FDA to 
initiate a human gene transfer protocol (whether or not it has been 
reviewed by the RAC) shall be required to comply with the annual 
data reporting

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requirements. Annual Data Report forms will be forwarded by NIH/ORDA 
to investigators. Data submitted in these reports will be evaluated 
by the RAC, NIH/ORDA, and the FDA and reviewed by the RAC at its 
next regularly scheduled meeting.''

    OMB's ``Mandatory Information Requirements for Federal Assistance 
Program Announcements'' (45 FR 39592, June 11, 1980) requires a 
statement concerning the official government programs contained in the 
Catalog of Federal Domestic Assistance. Normally, NIH lists in its 
announcements the number and title of affected individual programs for 
the guidance of the public. Because the guidance in this notice covers 
not only virtually every NIH program but also essentially every Federal 
research program in which DNA recombinant molecule techniques could be 
used, it has been determined not to be cost effective or in the public 
interest to attempt to list these programs. Such a list would likely 
require several additional pages. In addition, NIH could not be certain 
that every Federal program would be included as many Federal agencies, 
as well as private organizations, both national and international, have 
elected to follow the NIH Guidelines. In lieu of the individual program 
listing, NIH invites readers to direct questions to the information 
address above about whether individual programs listed in the Catalog 
of Federal Domestic Assistance are affected.

Effective Date: March 1, 1996.
Harold Varmus,
Director, National Institutes of Health.
[FR Doc. 96-5762 Filed 3-11-96; 8:45 am]
BILLING CODE 4140-01-M