[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Notices]
[Pages 56196-56197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28624]
[[Page 56196]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Recombinant DNA Research: Actions Under the Guidelines
AGENCY: National Institutes of Health (NIH), PHS, DHHS.
ACTION: Notice of Actions under the NIH Guidelines for Research
Involving Recombinant DNA Molecules (NIH Guidelines).
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SUMMARY: This notice sets forth actions to be taken by the Director,
National Institutes of Health (NIH), under the NIH Guidelines for
Research Involving Recombinant DNA Molecules (59 FR 34496, amended 59
FR 40170, 60 FR 20726, 61 FR 1482, 61 FR 10004, 62 FR 4782).
FOR FURTHER INFORMATION CONTACT:
Background documentation and additional information can be obtained
from the Office of Recombinant DNA Activities (ORDA), National
Institutes of Health, MSC 7010, 6000 Executive Boulevard, Suite 302,
Bethesda, Maryland 20892-7010, Phone 301-496-9838, FAX 301-496-9839.
The ORDA web site is located at http://www.nih.gov/od/orda/ for further
information about the office.
SUPPLEMENTARY INFORMATION: Today's actions are being promulgated under
the NIH Guidelines for Research Involving Recombinant DNA Molecules
(NIH Guidelines). The proposed actions were published for comment in
the Federal Register of August 20, 1997 (62 FR 44387), and reviewed by
the NIH Recombinant DNA Advisory Committee (RAC) at its meeting on
September 12, 1997.
I. Background Information and Decisions on Actions Under the NIH
Guidelines
Amendment to the Submission Requirements--Human Gene Transfer
Experiments Under Appendix M of the NIH Guidelines
During the June 12-13, 1997, RAC meeting, the following motions
were approved by the RAC: (1) A motion was made to eliminate the point-
by-point responses to Appendix M-II through M-V, Description of the
Proposal, Informed Consent, Privacy and Confidentiality, and Special
Issues; however, the questions raised in Appendix M-II through M-V must
be addressed in the clinical protocol. The motion passed by a vote of 8
in favor, 0 opposed, and 1 abstention. (2) A motion was made to amend
the Appendix M-I, Submission Requirements--Human Gene Transfer
Proposals of the NIH Guidelines with regard to: (i) The clinical
protocol (including discussion of issues in Appendix M-II through M-V),
and (ii) deletion of the requirement of three 3\1/2\ inch diskettes
with the complete vector nucleotide sequence in ASCII format. The
motion passed by a vote of 7 in favor, 0 opposed, and 1 abstention.
The RAC recommendations were published as proposed actions in the
Federal Register of August 20, 1997, for public comment. A letter dated
September 8, 1997, was received in response to the Federal Register
notice from Alexander E. Kuta, Ph.D., Director, Regulatory Affairs,
Genzyme Corporation, Framingham, Massachusetts. Genzyme disagreed with
the motion to incorporate the responses to Appendix M-II through M-V
into the clinical protocol stating that ``this action would compromise
the integrity of the clinical protocol without sufficiently addressing
industry's concerns regarding Appendix M. * * * The clinical protocol *
* * should be `directed primarily at providing an outline of the
investigation.' ''At the September 12, 1997, RAC meeting, the RAC
considered the comment from Genzyme and agreed to give the
investigators or the sponsors the option to provide the discussion of
all pertinent issues raised in Appendix M-II through M-V either in the
clinical protocol or as an appendix to the clinical protocol.
A motion was made to eliminate the point-by-point responses to
Appendix M-II through M-V, and discussion of all pertinent issues
raised in Appendix M-II through M-V must be provided either in the
clinical protocol or as an appendix to the clinical protocol. The
motion passed by a vote of 10 in favor, 2 opposed, and 0 abstention.
No comments were received from the public in response to the
proposed actions in the Federal Register of August 20, 1997, with
regard to the RAC recommendation to delete the requirement of three
3\1/2\ inch diskettes with the complete vector nucleotide sequence in
ASCII format from Appendix M-I, Submission Requirements--Human Gene
Transfer Proposals of the NIH Guidelines.
The actions are detailed in Section II--Summary of Actions. I
accept the RAC recommendations, and the NIH Guidelines will be amended
accordingly.
II. Summary of Actions
Appendix M-I, Submission Requirements--Human Gene Transfer
Proposals of the NIH Guidelines, is amended to read:
``Appendix M-I. Submission Requirements--Human Gene Transfer
Proposals
Investigators must submit the following material to the Office of
Recombinant DNA Activities, National Institutes of Health/MSC 7010,
6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010,
(301) 496-9838 (see exemption in Appendix M-IX-A, Footnotes of Appendix
M). Proposals will be submitted in the following order: (1) Scientific
abstract--1 page; (2) non-technical abstract--1 page; (3) Institutional
Biosafety Committee (IBC) and Institutional Review Board (IRB)
approvals and their deliberations pertaining to your protocol (the IBC
and IRB may, at their discretion, condition their approval on further
specific deliberation by the RAC); (4) Responses to Appendix M-II
through M-V, Description of the Proposal, Informed Consent, Privacy and
Confidentiality, and Special Issues (the pertinent responses can be
provided in the protocol or as an appendix to the protocol); (5)
protocol (as approved by the local IBC and IRB)--20 pages; (6) Informed
Consent document--approved by IRB (see Appendix M-III, Informed
Consent); (7) appendices (including tables, figures, and manuscripts);
and (8) curricula vitae--2 pages for each key professional person in
biographical sketch format.''
OMB's ``Mandatory Information Requirements for Federal Assistance
Program Announcements'' (45 FR 39592) 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 virtually every NIH
and 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.
[[Page 56197]]
Effective Date: October 20, 1997.
Harold Varmus,
Director, National Institutes of Health.
[FR Doc. 97-28624 Filed 10-28-97; 8:45 am]
BILLING CODE 4140-01-M
