[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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(Appendix A of the ``Draft Guidance for Industry: Evaluating the Safety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]
BILLING CODE 4160-01-S