[Federal Register: February 12, 2003 (Volume 68, Number 29)]
[Notices]               
[Page 7126-7127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe03-48]                         


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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). At least one 
portion of the meeting will be closed 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 March 4, 2003, from 8 
a.m. to 5 p.m., and March 5, 2003, from 9 a.m. to 5 p.m., and March 6, 
2003, from 8 a.m. to 12 noon.
    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 March 4, 2003, the committee will discuss new drug 
application (NDA) 21-158, Factiver (gemifloxacin mesylate) Tablets, 
Parexel International, U.S. Agent for LG Life Sciences, Ltd., proposed 
for the treatment of Community-Acquired Pneumonia (CAP) and Acute 
Bacterial Exacerbation of Chronic Bronchitis (ABECB). On March 5, 2003, 
the committee will discuss the formation of a list of pathogens of 
public health importance for which antimicrobial drug development would 
be desirable. The committee also will discuss the concept of how 
preclinical data and clinical data from one disease state may support 
approval of antimicrobial drugs in another, separate disease state.
    Procedure: On March 4 and 5, 2003, 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 February 25, 2003. 
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 25, 
2003, 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 March 6, 2003, from 8 a.m. to 12 
noon, the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    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


[[Page 7127]]


a disability, please contact Tara 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: February 3, 2002.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-3437 Filed 2-11-03; 8:45 am]

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