[Federal Register: November 15, 2002 (Volume 67, Number 221)]


[Page 69226]

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 17, 2002, from 

8:30 a.m. to 5 p.m.

    Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., Bethesda, 


    Contact Person: Jody G. Sachs or Denise H. Royster, Center for 

Biologics Evaluation and Research (HFM-71), Food and Drug 

Administration, 301-827-0314, or FDA Advisory Committee Information 

Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 

12391. Please call the Information Line for up-to-date information on 

this meeting.

    Agenda: The committee will review and discuss safety and efficacy 

and proposed indications for the product, FluMist, a cold-adapted, live 

attenuated, trivalent influenza vaccine for the prevention of influenza 

sponsored by MedImmune Vaccines, Inc.

    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 1, 

2002. Oral presentations from the public will be scheduled between 

approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 

be limited. Those desiring to make formal oral presentations should 

notify the contact person before December 1, 2002, 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 


    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 Jody G. Sachs or 

Denise H. 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 7, 2002.

Linda Arey Skladany,

Senior Associate Commissioner for External Relations.

[FR Doc. 02-28940 Filed 11-14-02; 8:45 am]