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 (RAC), including a Safety Symposium on Recombinant DNA Research with Pathogenic Viruses.

The Symposium entitled “Safety Considerations in Recombinant DNA Research with Pathogenic Viruses” will be held on September 21, 2004 from 8 a.m. to 5 p.m. and September 22nd from 8 a.m. to 12 p.m. at the Bethesda Marriott Hotel, 5151 Pooks Hill Road, Bethesda, Maryland 20814.

The RAC meeting will be held from 8 a.m. to 3 p.m. on September 23, 2004 at the Bethesda Marriott Hotel, 5151 Pooks Hill Road, Bethesda, Maryland 20814. The Committee will review human gene transfer protocol for use of an adeno-associated virus expressing the 293 bp human neuropeptide Y (NPY) open reading frame DNA under the transcriptional control of the CMV enhancer/chicken b-actin (CBA) hybrid promoter in subjects with intractable mesial temporal lobe epilepsy. The RAC meeting also includes the Data Management report and an update from the Clinical Trial Design Working Group.

Contact Person: Stephen M. Rose, Ph.D., Executive Secretary, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892, (301) 496-9838. sr8j@nih.gov.

Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

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 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 molecules techniques could be used, it has been determined not too 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.

The meetings will be open to the public as indicated above, 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 notify the Contact Person listed above in advance of the meeting.