[Federal Register Volume 67, Number 240 (Friday, December 13, 2002)]
[Notices]
[Page 76748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anti-Infective Drugs 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: 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 January 8, 2003, from 8 
a.m. to 5 p.m., and on January 9, 2003, from 9 a.m. to 5 p.m.
    Location: Marriott Washingtonian Center, Grand Ballroom, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: 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: [email protected], 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 January 8, 2003, the committee will discuss new drug 
application (NDA) 21-144, KETEK (telithromycin), Aventis 
Pharmaceuticals, Inc., proposed for treatment of community-acquired 
pneumonia, acute exacerbation of chronic bronchitis, and acute 
maxillary sinusitis. On January 9, 2003, the committee will discuss 
issues pertaining to the contents in the document entitled ``Ranking of 
Antimicrobial Drugs According to Their Importance in Human Medicine 
(Appendix A of the ``Draft Guidance for Industry: Evaluating the Safety 
of Antimicrobial New Animal Drugs With Regard to Their Microbiological 
Effects on Bacteria of Human Health Concern'') (see the FDA Internet 
site at: http://www.fda.gov/cvm/guidance/dguide152.doc) as it relates 
to the process for evaluating antimicrobial resistance concerns for the 
Center for Veterinary Medicine's preapproval safety evaluation of a new 
animal drug.
    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 31, 
2002. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on January 8, 2003, and between 
approximately 1 p.m. and 2 p.m. on January 9, 2003. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before December 31, 
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.
    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 Tara P. Turner 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: December 4, 2002.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 02-31443 Filed 12-12-02; 8:45 am]
BILLING CODE 4160-01-S