[Federal Register Volume 66, Number 165 (Friday, August 24, 2001)]
[Notices]
[Pages 44638-44640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21392]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of Biotechnology Activities; Recombinant DNA Research: 
Proposed Actions Under the NIH Guidelines

AGENCY: National Institutes of Health (NIH), PHS, DHHS.

ACTION: Notice of proposed actions under the NIH Guidelines for 
Research Involving Recombinant DNA Molecules (NIH Guidelines).

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SUMMARY: The NIH is proposing to amend the provisions of the NIH 
Guidelines relating to the Recombinant DNA Advisory Committee (RAC) by 
authorizing a minimum of 15 voting members and establishing the charter 
of the committee as the controlling document for the membership and 
procedures of the RAC.

DATES: The public is encouraged to submit written comments on the

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proposed change. Comments may be submitted to the NIH Office of 
Biotechnology Activities (OBA) in paper or electronic form. Comments 
received on or before September 24, 2001 will be considered by NIH.
    All comments received in response to this notice will be available 
for public inspection in the NIH OBA office, 6705 Rockledge Drive, 
Suite 750, MSC 7985, Bethesda, MD 20892-7985, 301-496-9838, weekdays 
between the hours of 8:30 a.m. and 5 p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions, or want 
additional information about these proposed changes, please contact OBA 
by e-mail at [email protected] or telephone at 301-496-9838. Comments 
should be addressed to the Dockets Manager and may be submitted to the 
same e-mail address, by fax to 301-496-9839, or by mail to the Office 
of Biotechnology Activities address above.

SUPPLEMENTARY INFORMATION
    Section IV-C-2 of the NIH Guidelines provides that the RAC consists 
of 15 voting members including the Chair, appointed by the DHHS 
Secretary or designee, at least 8 of whom are selected from authorities 
knowledgeable in the fields of molecular genetics, molecular biology, 
recombinant DNA research, or other scientific fields. At least 4 
members of 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 designated Federal agencies serve as nonvoting 
members.
    On January 23, 1997, the NIH Guidelines were amended to reduce the 
RAC from 25 to 15 voting members. This change was made in conjunction 
with the discontinuation of RAC's role in recommending approval or 
disapproval of individual gene transfer protocols. As stated in the 
November 22, 1996, Notice of Proposed Actions that included this 
reduction of RAC membership (61 FR 59725), the reduction was intended 
to ``increase efficiency while ensuring sufficient representation from 
scientific, ethical, and legal communities.'' Although RAC members no 
longer recommend approval or disapproval of gene transfer protocols, 
they review them to determine if they raise scientific, medical, 
safety, or ethical issues that require public discussion at a meeting 
of the RAC (see Appendix M and Appendix M-I-B-2 of the NIH Guidelines).
    In the years since the number of RAC members was reduced, the 
number of gene transfer trials has dramatically increased, and those 
trials now encompass a broader array of clinical applications. Current 
trials address cancer, inborn errors of metabolism, cardiovascular 
diseases, autoimmune disorders, and neurologic diseases. In addition, 
current trials employ an increasing array of viral vectors, including 
vaccinia, fowl pox, canary pox, herpes simplex virus, adeno-associated 
virus, adenovirus, and retroviruses.
    Thus, a broader range of expertise is needed on the RAC in order to 
adequately assess the issues raised by the many and increasingly varied 
proposed gene transfer trials submitted to the NIH. Given the dynamism 
of the field, flexibility in how this expertise is achieved is key to 
the effective and efficient functioning of the RAC. To this end, the 
NIH is proposing to amend Section IV-C-2 of the NIH Guidelines to 
authorize a minimum of 15 voting members with no maximum number of 
voting members specified. The maximum number of voting members will be 
established through the charter for the RAC, which is the controlling 
document for the membership and procedures of the RAC, in the event of 
any conflict with the NIH Guidelines. This will enable NIH to respond 
promptly to the need for additional expertise on the RAC through 
appropriate amendments to the charter.
    Section IV-C-2 would also be amended to establish the RAC charter 
as the controlling document for the membership and functions of the 
RAC. In addition, the listing of specific types of knowledge for 
members who are not biomedical scientists would be broadened by 
changing ``applicable law'' to ``law,'' and ``standards of professional 
conduct and practice'' to ``ethics.''
    Section IV-C-2 currently refers to the charter of the RAC, but it 
does not indicate that the charter sets forth the membership and 
procedures of the RAC, as well as its functions, or establish the 
charter as the controlling document in the event of a conflict with the 
NIH Guidelines. Under the proposed change, the NIH Guidelines would 
establish a minimum number of RAC members and the size of the RAC could 
vary according to need. The broad discretion of the Director, NIH, to 
choose members knowledgeable in certain fields would be retained, but 
the types of knowledge listed may periodically be changed.

Proposed Amendments to the NIH Guidelines

    I. For the reasons stated above, it is proposed to amend Section 
IV-C-2 Recombinant DNA Advisory Committee (RAC) to state:

Section IV-C-2. Recombinant DNA Advisory Committee (RAC)

    The RAC is responsible for carrying out the functions specified in 
the NIH Guidelines, as well as others specified in its charter or 
assigned by the Secretary of Health and Human Services or the NIH 
Director. The RAC membership and procedures, in addition to those set 
forth in the NIH Guidelines, are specified in the charter for the RAC, 
which is filed as provided in the General Services Administration 
Federal Advisory Committee Management regulations, 41 CFR Parts 101-6 
and 102-3, and is available on the OBA website, http://www4.od.nih.gov/oba/rac/. In the event of a conflict between the NIH Guidelines and the 
charter, the charter shall control.
    The RAC will consist of not less than 15 voting members, including 
the Chair, appointed under the procedures of the NIH and the Department 
of Health and Human Services. The maximum number and expertise of 
voting members will be established in the charter of the RAC. A 
majority of the voting members must be knowledgeable in relevant 
scientific fields, e.g., molecular genetics, molecular biology, 
recombinant DNA research, including clinical gene transfer research. At 
least 4 members of the RAC must be knowledgeable in fields such as 
public health, laboratory safety, occupational health, protection of 
human subjects of research, the environment, ethics, law, public 
attitudes or related fields. Representatives of the Federal agencies 
listed in the charter shall serve as nonvoting members. Nominations for 
RAC members may be submitted to the Office of Biotechnology Activities, 
National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 
7985, Bethesda, MD 20892-7985 (20817 for non-USPS mail), 301-496-9838, 
301-496-9838 (fax).
    All meetings of the RAC shall be announced in the Federal Register, 
including tentative agenda items, at least 15 calendar days before the 
meeting. Final agendas, if modified, shall be available at least 72 
hours before the meeting. No item defined as a Major Action under 
Section IV-C-1-b-(1) may be added to an agenda following Federal 
Register publication.
    OMB's ``Mandatory Information Requirement for Federal Assistance 
Program Announcements'' (45 FR 39592) requires a statement concerning 
the official Government programs contained in the Catalog of Federal

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Domestic Assistance. Normally, NIH lists in its announcements the 
number and title of affected individual programs for the guidance of 
the public. Because the proposed guidance in this notice covers 
virtually every NIH and Federal research program in which recombinant 
DNA techniques could be used, it has been determined not to be cost 
effective or in the public interest to attempt to list these programs. 
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.

    Dated: August 16, 2001.
Ruth L. Kirschstein,
Acting Director, National Institutes of Health.
[FR Doc. 01-21392 Filed 8-23-01; 8:45 am]
BILLING CODE 4140-01-P