[Federal Register: October 22, 2004 (Volume 69, Number 204)]
[Notices]
[Page 62058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc04-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Science Board to the Food and Drug Administration; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 agency's Senior Science Advisor and, as
needed, to the Commissioner and other appropriate officials on
specific complex and technical issues as well as emerging issues
within the scientific community in industry and academia.
Additionally, the Board will provide advice to the agency on keeping
pace with technical and scientific evolutions in the fields of
regulatory science, on formulating an appropriate research agenda,
and on 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 November 5, 2004, 8
a.m. to 5 p.m.
Location: 5630 Fishers Lane, rm. 1066, Rockville, MD 20852.
Contact Person: Jan Johannessen, Office of the Commissioner (HF-
33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-6687, jjohannessen@fda.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512603. Please call the Information Line for up-to-
date information on this meeting.
Agenda: The Board will hear about and discuss: (1) An update on
the FDA Critical Path Initiative (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/initiatives/criticalpath/
), including an overview of docket submissions, current
status, reports on related activities (Medical Technology Innovation
Task Force and Foods Critical Path White Paper), and future plans;
(2) FDA's final report on pharmaceutical current good manufacturing
practices (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm
); and (3) an internal peer review of the Office
of Regulatory Affairs' pesticide program, including plans for the
establishment of a Science Board subcommittee to conduct an external
program peer review.
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 29,
2004. 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 29, 2004, 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 Jan Johannessen
at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 14, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-23625 Filed 10-21-04; 8:45 am]
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