01-21392. 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).

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 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 [e-mail] 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 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.