[Federal Register: December 13, 2002 (Volume 67, Number 240)]

[Notices]               

[Page 76748]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13de02-64]                         





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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: 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 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(Appendix A of the ``Draft Guidance for Industry: Evaluating the Safety 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]



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