Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

# 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).  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 July 26, 2001, 8:30 a.m. to 5:30 p.m., and on July 27, 2001, 8:30 a.m. to 3:30 p.m.                

*Location*: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.                

*Contact*: Nancy T. Cherry or Denise H. 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 12391.  Please call the Information Line for up-to-date information on this meeting.                

*Agenda*: On July 26, 2001, the committee will hear presentations on the available safety and efficacy data for Aviron, Inc.’s cold adapted, live attenuated, trivalent influenza virus vaccine (FluMist                    TM                    ).  On July 27, 2001, the committee will discuss the available data and the proposed indications for FluMist                    TM                    .                

*Procedure*:  On July 26, 2001, from 10:15 a.m. to 5:30 p.m., and on July 27, 2001, from 8:30 a.m. to 3:30 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 by July 8, 2001.  On July 27, 2001, oral presentations will be held between approximately 9 a.m. and 10:15 a.m.  Time allotted for each presentation may be limited.  Those desiring to make formal oral presentations should notify the contact person before July 8, 2001, 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.                

*Closed Committee Deliberations*:  On July 26, 2001, from 8:30 a.m. to 10:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).                

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: June 19, 2001.

Bonnie Malkin,

Special Assistant to the Senior Associate Commissioner.

[FR Doc. 01-15912 Filed 6-25-01; 8:45 am]

BILLING CODE 4160-01-S