[Federal Register Volume 62, Number 21 (Friday, January 31, 1997)]
[Notices]
[Pages 4782-4783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Recombinant DNA Research: Action Under the Guidelines

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice of Action under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules (59 FR 34496, 59 FR 40170, 60 FR 
20726, 61 FR 1482, 61 FR 10004).

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SUMMARY: This notice sets forth an action 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 Ms. Debra Knorr, Acting 
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. 
The action was proposed and published for comment in the Federal 
Register of July 8, 1996 (61 FR 35774), then revised and proposed for 
comment in the Federal Register of November 22, 1996 (61 FR 59726), and 
reviewed and recommended for approval by the NIH Recombinant DNA 
Advisory Committee (RAC) at its meeting on December 9, 1996.

I. Background Information and Decision on Action Under the NIH 
Guidelines

A. Amendments to Section IV-C-2 of the NIH Guidelines Regarding the 
Recombinant DNA Advisory Committee

    On July 8, 1996, the Director, NIH, published a Notice of Intent to 
Propose Amendments to the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH Guidelines) Regarding Enhanced 
Mechanisms for NIH Oversight of Recombinant DNA Activities in the 
Federal Register (61 FR 35774). In the Notice of Intent, the NIH 
Director requested public comment on proposed mechanisms to enhance 
scientific, ethical, and societal oversight of human gene transfer 
research under the NIH Guidelines. Specifically, in part, the 
termination of the RAC and the establishment of the Office of 
Recombinant DNA Activities Advisory Committee (OAC) consisting of 6-10 
members.
    Comments in support of termination of the RAC reflected an interest 
in making substantive changes in the role of the RAC. Most of these 
comments supported the proposed restructuring of the functions of the 
RAC and did not specifically endorse termination of RAC. Opposing 
comments focused on the historical importance of retaining the RAC as 
an internationally recognized forum for public discussion of the 
science, safety, and ethics of human gene therapy research. These 
authors articulated the critical role that the RAC plays in maintaining 
public confidence in human gene therapy research.
    The importance of the continuation of the RAC, per se, was 
underscored by comments which specifically addressed the establishment 
of the OAC. Of the 53 comments which addressed this issue, 12 expressed 
support and 41 expressed opposition. The majority of comments submitted 
in opposition to the OAC stated that the proposed functions of the OAC 
could be accomplished by the RAC, or by a restructured version of the 
RAC. Several authors emphasized that, absent the historic credibility 
of the RAC, the OAC might suffer from an inability to attract and 
motivate the type of expertise and judgement needed for this important 
public forum.
    On November 22, 1996, the NIH Director published Notice of Proposed 
Actions Under the NIH Guidelines for Research Involving Recombinant DNA 
Molecules in the Federal Register (61 FR 59726). In these Proposed 
Actions, in part, the NIH Director proposed retaining the RAC, while 
modifying its roles and responsibilities relevant to human gene therapy 
research and reducing the membership from 25 members to 15 members, and 
requested comments.
    During the December 9, 1996, meeting, the RAC, which had reviewed 
the comments received, approved the overall concepts in the Proposed 
Actions. The RAC specifically approved reducing the membership of the 
RAC from 25 members to 15 members. The motion passed by a vote of 12 in 
favor, 0 opposed, and 2 abstentions.
    The action is detailed in Section II--Summary of Action. I accept 
this recommendation to reduce the membership of the RAC from 25 members 
to 15 members, and the NIH Guidelines will be amended accordingly.

II. Summary of Action

A. Amendments to Section IV-C-2, Recombinant DNA Advisory Committee 
(RAC)

    In Section IV-C-2, the first paragraph is amended to read:
``Section IV-C-2. Recombinant DNA Advisory Committee (RAC)
    ``The RAC is responsible for carrying out specified functions cited 
below as well as others assigned under its charter or by the DHHS 
Secretary and the NIH Director. The RAC consists of 15 members 
including the Chair, appointed by the DHHS Secretary or his/her 
designee, at least 8 of whom are selected from authorities 
knowledgeable in the fields of molecular genetics, molecular

[[Page 4783]]

biology, recombinant DNA research, or other scientific fields. At least 
4 members of the RAC shall be persons knowledgeable in applicable law, 
standards of professional conduct and practice, public attitudes, the 
environment, public health, occupational health, or related fields. 
Representatives from Federal agencies shall serve as non-voting 
members. Nominations for the RAC may be submitted 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.
    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: January 23, 1997.
Harold Varmus,
Director, National Institutes of Health.
[FR Doc. 97-2485 Filed 1-30-97; 8:45 am]
BILLING CODE 4140-01-M