03-2620. Office of the Director, National Institutes of Health; Notice of Meeting

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Recombinant DNA Advisory Committee.

The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting.

Name of Committee: Recombinant DNA Advisory Committee (RAC).

Date: February 10, 2003.

Time: 8:30 am to 4:30 pm.

Agenda: The Committee will review new data from a retroviral-mediated gene transfer clinical trial in Severe Combined Immunodeficiency (SCID) that could be important to the safety of participants in gene transfer clinical trials that use retroviral vectors. The discussion of this new information may lead to changes in the recommendations on the safety of the clinical gene transfer trials in SCID formulated by the RAC at its December 2002 meeting. In addition, the RAC may make recommendations pertaining to the safety and conduct of gene transfer clinical trials using retroviral vectors.

The RAC is meeting due to the potential significance of this new data and the need for expeditious deliberation and public discussion of its potential implications for the safety and conduct of clinical gene transfer trials using retroviral vectors.

Place: National Institutes of Health, 9000 Rockville Pike, Building 45, Main Auditorium, Bethesda, Maryland 20892.

Contact: Stephen Rose, Ph.D., Executive Secretary, Recombinant DNA Advisory Committee, Office of Biotechnology Activities, Rockledge 1, Room 750, Bethesda MD 20892, [phone].

This notice is being published less than 15 days before the meeting due to the emergency nature of the actions involved.

Information is also available on the Institute's/Center's home page: http://www4.od.nih.gov/​oba/​,, where an agenda and any additional information for the meeting will be posted when available.

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 in its announcements the number and title of affected individual programs for the guidance of the public. Because the guidance in this notice covers virtually every NIH and Federal research program in which DNA recombinant molecules 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 and national and international, have elected to follow the NIH Guidelines. In lieu of the individual programs listed in the Catalog of Federal Domestic Assistance are affected.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally, 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program, National Institutes of Health, HHS)

Dated: January 27, 2003.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory Committee Policy.