[Federal Register: May 21, 2007 (Volume 72, Number 97)]
[Notices]
[Page 28499-28500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my07-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0195]
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 (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 June 14, 2007, from 8
a.m. to 4 p.m.
Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Select Docket No. 2007N-0195--Science
Board and follow prompts to submit your statement. Written comments
should be submitted to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1066, Rockville,
MD 20852, by close of business on June 7, 2007. All comments received
will be posted without change, including any personal information
provided. Comments received on or before June 7, 2007, will be provided
to the committee before or at the meeting.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD 20879, Grand Ballroom Conference Room.
Contact Person: Carlos Pe[ntilde]a, Office of the Commissioner,
Food and Drug Administration (HF-33), 5600 Fishers Lane, Rockville,
Maryland, 20857, 301-827-6687, carlos.Pe[ntilde]a@fda.hhs.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. 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 hear about and discuss the agency's
bioinformatics initiative and fellowship program. The Science Board
will then continue their discussion of the review of both the agency's
science programs and the National Antimicrobial Resistance Monitoring
System (NARMS) Program, from the March 31, 2006, Science Board meeting.
Discussions will first include a subcommittee update to the Science
Board on the progress of the review of the agency's science programs.
The Science Board will then hear about and discuss the subcommittee
review of the NARMS Program including the public meeting regarding the
NARMS Program on April 10, 2007, and subsequent deliberations. The
Science Board will also hear about and discuss the agency's updates on
drug safety, post approval surveillance, and food safety.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and 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 May
31, 2007. Two oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 p.m. and 3:15 p.m. and 4:15 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 May 23, 2007. 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 sessions. The contact person will notify interested
persons regarding their request to speak by May 24, 2007.
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 Carlos Pe[ntilde]a
at least 7 days in advance of the meeting.
[[Page 28500]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 15, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-9737 Filed 5-18-07; 8:45 am]
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