[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Notices]
[Page 37452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15709]
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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.
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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.
Date and Time: The meeting will be held on Monday, August 16, 2010,
from 8 a.m. to 3:30 p.m.
Location: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD
20814.
Contact Person: Donna Mentch, Office of Medical and Scientific
Programs, Office of the Commissioner, Food and Drug Administration,
White Oak Bldg. 32, 10903 New Hampshire Ave., Silver Spring, MD 20993,
301-796-8523, 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: On August 16, 2010, the Science Board will hear about and
discuss a final report from its subcommittee reviewing research at the
Center for Food Safety and Applied Nutrition (CFSAN). The Science Board
will hear about an interim report from the subcommittee to review the
Pharmacovigilance Program at the Center for Drug Evaluation and
Research (CDER). The Science Board will also hear about and discuss
JANUS, FDA supported Data Standard Comparative Effectiveness Research,
and FDA's nanotechnology research program.
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 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
August 9, 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 August 2, 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 August 3,
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 Donna Mentch, 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/AboutAdvisoryCommittees/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: June 24, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15709 Filed 6-28-10; 8:45 am]
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