[Federal Register Volume 63, Number 170 (Wednesday, September 2, 1998)] [Notices] [Page 46801] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-23573] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Recombinant DNA Advisory Committee; Notice of Meeting Pursuant to Public Law 92-463, notice is hereby given of a meeting of the Recombinant DNA Advisory Committee on September 24-25, 1998. The meeting will be held at the National Institutes of Health, Building 31C, 6th Floor, Conference Room 10, 9000 Rockville Pike, Bethesda, Maryland 20892, starting on September 24, 1998, at approximately 9 a.m., and will recess at approximately 5 p.m. The meeting will reconvene on September 25, 1998, at approximately 8:30 a.m. and will adjourn at approximately 5:00 p.m. The meeting will be open to the public. Agenda items will include: (1) Discussions of recently submitted human gene transfer protocols, including two prototypic in utero transfer protocols, (2) data management activities related to human gene transfer clinical trials, and (3) other matters to be considered by the Committee. The two prototypic in utero gene transfer protocols are entitled: In Utero Gene Transfer for the Treatment of ADA-Deficient SCID and In Utero Gene Transfer for the Treatment of Alpha-Thalassemia. The purpose for discussing these two protocols are: (1) To provide a framework for continued discussion of the science, safety, and ethical issues at the December 7-8 Gene Therapy Policy Conference (GTPC) entitled: Gene Transfer in Prenatal Medicine; and (2) to stimulate the development of a guidance document for this novel area of research within the context of the NIH Guidelines. The discussion at this meeting should be considered as the first of many deliberations on these two protocols, as well as on the general issue of in utero gene transfer research; subsequent discussions will deal more substantively with each of the issues identified in this initial discussion. Attendance by the public will be limited to space available. Debra W. Knorr, Acting Director, Office of Recombinant DNA Activities, National Institutes of Health, MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, Phone (301) 496- 9838, FAX (301) 496-9839, will provide summaries of the meeting and a roster of committee members upon request. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact Ms. Knorr in advance of the meeting. 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. Dated: August 26, 1998. LaVerne Y. Stringfield, Committee Management Officer, NIH. [FR Doc. 98-23573 Filed 9-1-98; 8:45 am] BILLING CODE 4140-01-M