[Federal Register: October 17, 2002 (Volume 67, Number 201)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Science Board to the Food and Drug Administration Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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
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
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: firstname.lastname@example.org, 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
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
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
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.
[FR Doc. 02-26472 Filed 10-11-02; 4:26 pm]
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