[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Page 71539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 
    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]