Office of the Director; Recombinant DNA Advisory Committee Meeting; Safety Symposium on Gene Transfer Research

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 (RAC) and a Safety Symposium on Gene Transfer Research.

The RAC meeting will be held from 8 a.m. to 5 p.m. on December 13 and 15, 2000 at the National Institutes of Health (NIH), Building 31, C Wing, Conference Room 10, 9000 Rockville Pike, Bethesda, MD 20892. The Committee will review changes to the process for submission and review of gene transfer research protocols; selected human gene transfer protocols; NIH policy on serious adverse event reporting; data management activities related to human gene transfer clinical trials; and other matters to be considered by the Committee.

The Safety Symposium on Gene Transfer Research will be held from 8 a.m. to 5 p.m. on December 14, 2000 at the NIH Natcher Auditorium, 9000 Rockville Pike, Bethesda, MD 20892. The symposium will explore safety considerations in gene transfer clinical research in cardiovascular diseases.

Both meetings are open to the public with attendance limited to space available. Draft meeting agendas and other information will be posted at the Office of Biotechnology Activities' website: http://www.nih.gov/od/oba.

Individuals who wish to provide public comments or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Kelly Fennington, Program Analyst, Office of Biotechnology Activities by telephone at 301-496-9838 or E-mail at FenningK@od.nih.gov

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 virtually every NIH and 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.