[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
