[Federal Register: April 19, 2004 (Volume 69, Number 75)]
[Notices]
[Page 20940]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap04-78]
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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 May 10, 2004, from 8:30
a.m. to 5:30 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, 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 3014512530. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss new drug application (NDA) 21-
678, gatifloxacin (proposed tradename, TEQUIN) for oral suspension,
Bristol-Myers Squibb, studied in the treatment of recurrent bacterial
otitis media and treatment failures of acute bacterial otitis media in
pediatric patients.
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 April 30,
2004. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before April 30, 2004,
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 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: April 9, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-8719 Filed 4-16-04; 8:45 am]
BILLING CODE 4160-01-S