02-26472. Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Science Board to the Food and Drug Administration.

General Function of the Committee: The Board shall provide advice primarily to the Commissioner and the Senior Associate Commissioner for Science and Health and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community. Additionally, the Board will provide advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, formulating an appropriate research agenda, and upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs.

Date and Time: The meeting will be held on October 25, 2002, 8 a.m. to 4:30 p.m.

Location: 5630 Fishers Lane, rm. 1066, Rockville, MD 20857.

Contact Person: Susan Bond, Office of the Commissioner (HF-33), Food and Drug Administration, rm. 17-35, 5600 Fishers Lane, Rockville, MD 20852, 301-827-6687, or e-mail: [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12603. Please call the Information Line for up-to-date information on this meeting.

Agenda: The Board will hear and discuss counter terrorism initiatives at FDA with emphasis on those initiatives from: The Center for Food Safety and Applied Nutrition, the new Office of Cellular and Gene Therapy in the Center for Biologics Evaluation and Research, current research and efforts in the pregnancy labeling initiative, an update of the pharmaceutical manufacturing initiative from The Center for Drug Evaluation and Research, and an update of the management oversight of products.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by October 18, 2002. Open committee discussion will be held from 8 a.m. to 1 p.m.; an open public hearing will be held from 1 p.m. to 2 p.m.; and an open committee discussion will be held from 2 p.m. to 4:30 p.m. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 18, 2002, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Susan Bond at least 7 days in advance of the meeting.

FDA regrets that it was unable to publish this notice 15 days prior to the October 25, 2002, Science Board to the Food and Drug Administration Advisory Committee Meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Science Board to the Food and Drug Administration Advisory Committee were available at this time, the Commissioner concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: October 10, 2002.

Linda Arey Skladany,

Senior Associate Commissioner for External Relations.