[Federal Register: January 25, 2002 (Volume 67, Number 17)]
[Page 3726]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Anti-Infective Drugs 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: Anti-Infective Drugs 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 February 19, 2002, from 
8 a.m. to 5:30 p.m. and on February 20, 2002, from 8 a.m. to 4 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Tara P. Turner, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-
7001, e-mail: TurnerT@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12530. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On February 19, 2002, the committee will hear presentations 
on the proposed approach for selection of delta in noninferiority 
(equivalence) clinical trials. The impact of this approach on studies 
of anti-infective drug products will be considered, with a focus on 
acute exacerbation of chronic bronchitis and hospital-acquired-
pneumonia. On February 20, 2002, the committee will discuss approaches 
to the development of antimicrobial agents for the treatment of 
resistant pathogens.
    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 February 11, 
2002. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 11, 
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 presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 16, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-1814 Filed 1-24-02; 8:45 am]