[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]



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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.


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    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