[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
