[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Notices]
[Page 71539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no05-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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). The meeting will
be open 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 December 14, 2005, from
9 a.m. to 4:30 p.m. and on December 15, 2005, from 9 a.m. to 4:30 p.m.
Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD.
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.
Agenda: On December 14, 2005, the committee will hear presentations
and make recommendations on the safety and efficacy of a rotavirus
vaccine manufactured by Merck. On December 15, 2005, the committee will
hear presentations and make recommendations on the safety and efficacy
of ZOSTAVAX (zoster vaccine live (Oka/Merck)) manufactured by Merck.
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 December 7,
2005. Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 1:45 p.m. on December 14, 2005, and from
approximately 1:30 p.m. and 2 p.m. on December 15, 2005. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before December 7,
2005, 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 Christine Walsh or
Denise Royster 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: November 17, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-23373 Filed 11-28-05; 8:45 am]
BILLING CODE 4160-01-S