[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65497-65498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Science Board Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
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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 (Science Board).
General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs 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 Science Board provides 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.
DATES: Date and Time: The meeting will be held on Monday, November 15,
2010, from 8:30 a.m. to 4 p.m.
ADDRESSES: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814.
Contact Person: Martha Monser, Office of the Commissioner, Food and
Drug Administration, WO Bldg. 32, rm. 4286, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 301-796-4627, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 301-451-2603. Please call the Information Line for up-to-
date information on this meeting. A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the agency's
Web site and call the appropriate advisory committee hot line/phone
line to learn about possible modifications before coming to the
meeting.
Agenda: The Science Board will receive information from the ongoing
review of the Pharmacovigilance Program at the Center for Drug
Evaluation and Research (CDER). The Center for Food Safety and Applied
Nutrition (CFSAN) will present its evaluation and review of the final
report of the CFSAN Research Review Subcommittee of the Science Board
to the Food and Drug Administration and provide an overview of its
strategic plan. New information and updates will be provided concerning
FDA's activities in support of Comparative Effectiveness Research. In
addition, the Board will be provided with updates on the development
and broad priorities of FDA's Strategic Science Plan, and the FDA
Medical Countermeasures Initiative, including planning for its
regulatory science component.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the
[[Page 65498]]
meeting, the background material will be made publicly available at the
location of the advisory committee meeting, and the background material
will be posted on FDA's Web site after the meeting. Background material
is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
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 on or before
Monday, November 8, 2010. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to
make formal oral presentations should notify the contact person 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 on or before Friday, October 29, 2010. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by Monday, November 1, 2010.
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 Martha Monser, at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisory Committee/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 15, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-26828 Filed 10-22-10; 8:45 am]
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