[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47605-47606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19462]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Vaccines and Related Biological Products 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 21, 2010, from
2 p.m. to approximately 6 p.m.
Location: National Institutes of Health (NIH), Building 29B/
Conference Room C. The public is welcome to attend the meeting at the
specified location where a speakerphone will be provided. Public
participation in the meeting is limited to the use of the speakerphone
in the conference room. Important information about transportation and
directions to the NIH campus, parking, and security procedures is
available on the Internet at http://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Visitors must show two
forms of identification, one of which must be a government-issued photo
identification such as a Federal employee badge, driver's license,
passport, green card, etc. Detailed information about security
procedures is located at http://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking, visitors are encouraged to use
public transportation.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512391. 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 September 21, 2010, the committee will meet in open
session to hear updates of the research programs in the Laboratory of
Respiratory & Special Pathogens, Division of Bacterial, Parasitic, &
Allergenic Products; Laboratory of Hepatitis Viruses, and Laboratory of
Vector Borne Virus Diseases, Division of Viral Products, Office of
Vaccines Research and Review, Center for Biologics Evaluation and
Research, FDA.
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: On September 21, 2010, from 2 p.m. to approximately 5:10
p.m., the meeting is open to the public. 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 September 15, 2010. Oral presentations from the
public will be scheduled between approximately 4:10 p.m. and 5:10 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 September 9, 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,
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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 September 10, 2010.
Closed Committee Deliberations: On September 21, 2010, from
approximately 5:10 p.m. to approximately 6 p.m., the meeting will be
closed to permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the report of the intramural research programs
and make recommendations regarding personnel staffing decisions.
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 Christine Walsh or
Denise Royster 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.
Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-19462 Filed 8-5-10; 8:45 am]
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