[Federal Register Volume 66, Number 238 (Tuesday, December 11, 2001)]
[Notices]
[Pages 64052-64054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30514]


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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 final action under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules (NIH Guidelines).

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SUMMARY: The NIH is amending 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: This Final Action is effective as of January 10, 2002.

FOR FURTHER INFORMATION: Documentation and additional information can 
be obtained from the Office of Biotechnology Activities, National 
Institutes of Health, MSC 7985, 6705 Rockledge Drive, Suite 750, 
Bethesda, Maryland 20892, Phone 301-496-9838, FAX 301-496-9839. The NIH 
OBA Web site is located at http://www4.od.nih.gov/oba/.

SUPPLEMENTARY INFORMATION:

Background

    The RAC serves a unique role in promoting awareness and 
understanding of the scientific, medical, safety, and ethical issues 
associated with human gene transfer research. This occurs through 
review and public discussion of protocols, as well as through specific 
recommendations for improving trials that are conveyed to investigators 
and their institutions. To fulfill these functions and address all 
dimensions of human gene transfer research as fully as possible, the 
RAC has historically been constituted in a manner that allows for 
diverse perspectives and necessary expertise in relevant disciplines.
    Section IV-C-2 of the NIH Guidelines has provided that the RAC 
consist of 15 voting members including the Chair, appointed by the DHHS 
Secretary or designee, at least 8 of whom must be authorities 
knowledgeable in the fields of molecular genetics, molecular biology, 
recombinant DNA research, or other scientific fields. At least 4 
members of RAC, according to this section, shall be persons 
knowledgeable

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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 non-voting members.
    In recent years, not only has the number of gene transfer trials 
dramatically increased, but these trials now encompass a much more 
expansive array of clinical applications than was previously possible. 
Current trials address, for example, cancer, inborn errors of 
metabolism, cardiovascular diseases, autoimmune disorders, and 
neurologic diseases. In addition, trials employ a growing variety of 
viral vectors, including vaccinia, fowl pox, canary pox, herpes simplex 
virus, adeno-associated virus, adenovirus, and retroviruses. Thus, an 
increasingly broad range of expertise is needed on the RAC to 
adequately assess the issues raised by the progressively more diverse 
gene transfer trials being proposed and 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.
    In recognition of the rapidly evolving field of human gene 
transfer, the NIH is now amending 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 will now be the 
controlling document for the membership and procedures of the Committee 
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. The present requirement 
that at least 8 of the voting members be knowledgeable in the fields of 
molecular genetics, molecular biology, recombinant DNA research or 
other scientific fields, is changed to ``at least a majority of the 
voting members,'' and clinical gene transfer research is added as an 
example of a relevant scientific field. Finally, the listing of 
specific types of knowledge for members other than those knowledgeable 
in relevant scientific fields is broadened by adding laboratory safety 
and protection of human subjects and by changing ``applicable law'' to 
``law,'' and ``standards of professional conduct and practice'' to 
``ethics.''

Public Comments

    These changes were published as a proposal in the August 24, 2001, 
Federal Register (66 FR 44638) with a 30-day period for comment public. 
Two sets of comments were received in response, one from a biosafety 
officer at a large academic institution, the other from private company 
engaged in gene transfer research. Both commenters expressed the view 
that it was unnecessary to allow for more than 15 voting members, 
suggesting instead that additional expertise could be obtained through 
the use of ad hoc experts. Neither commenter addressed the proposal to 
make the RAC charter the controlling document for the membership and 
procedures of the RAC.

Response to Public Commentary

    Ad hoc members are only intermittently involved in the RAC process, 
and while they do serve an important function, they do not benefit from 
the longitudinal perspective that officially appointed RAC members 
bring to the review and discussion of human gene transfer protocols by 
virtue of their ongoing participation. Furthermore, because ad hoc 
experts do not vote, the NIH believes that they do not have as direct a 
voice in the final recommendations concerning these protocols as do 
voting members. The ability to vote ensures that the perspectives of 
RAC members are fully reflected in the outcome of RAC discussions. For 
these reasons, the use of ad hoc members is not an optimal means of 
durably enhancing the range of expertise and intellectual continuity on 
the RAC.
    Thus, no changes are being made in the proposed amendments in 
response to these two sets of comments. Two changes have been made in 
the proposed amendments in order to clarify their intent, however. The 
statement that the charter of the RAC would establish the expertise of 
voting members has been deleted. That statement implied incorrectly 
that the RAC charter would be more specific than the NIH Guidelines in 
specifying the expertise of RAC members. The charter will repeat the 
provisions of the NIH Guidelines on the expertise of RAC members. The 
reference to a ``majority of the voting members'' in the third sentence 
of the second paragraph of Section IV-C-2 has been changed to ``At 
least a majority of the voting members * * *'' Consistent with the 
current provision, this change clarifies that more than a majority may 
be knowledgeable in scientific fields, so long as at least four members 
are knowledgeable in the other fields listed. On November 1, the RAC 
met by teleconference and voted unanimously to recommend implementation 
of the proposal.

Amendments to the NIH Guidelines

    Section IV-C-2 of the NIH Guidelines is amended 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 part 101-6, 
and is available on the OBA web site, http://www4.od.nih.gov/oba/rac/RACCharter.htm. 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 of voting members will 
be established in the charter of the RAC. At least 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 non-voting 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, 15 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

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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 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: November 21, 2001.
Ruth L. Kirschstein,
Acting Director, National Institutes of Health.
[FR Doc. 01-30514 Filed 12-10-01; 8:45 am]
BILLING CODE 4140-01-P