[Federal Register: June 25, 2002 (Volume 67, Number 122)]
[Notices]
[Page 42788-42789]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn02-63]
-----------------------------------------------------------------------
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 July 10, 2002, from 8:30
a.m. to 5 p.m., and on July 11, 2002, from 8:30 a.m. to 4 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 July 10, 2002, the committee will discuss the new drug
application (NDA) 21-242, artesunate rectal capsules, World Health
Organization, proposed for emergency treatment of acute malaria in
patients who cannot take oral medication and for whom parenteral
treatment is not available. On July 11, 2002, the committee will
discuss clinical trial design for studies of otitis media. Since the
publication of the 1998 ``Draft Guidance to Industry on Acute Otitis
Media--Developing Antimicrobial Drugs for Treatment'' (see the FDA
Internet Web site at http://www.fda.gov/cder/guidance/), the agency has
received advice from the public and the Anti-Infective Drugs Advisory
Committee on changes to clinical trial design (see transcripts from
November 19, 1997; July 29 to 31, 1998; January 30, 2001; and November
7, 2001, for various antimicrobials at the FDA Internet Web site at
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm). The
[[Page 42789]]
agency has compiled these comments into a plan for further discussion
by the committee.
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 July 2, 2002.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 1:30 p.m. on July 10, 2002, and between
approximately 1 p.m. and 2 p.m. on July 11, 2002. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 2, 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 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: June 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15897 Filed 6-24-02; 8:45 am]
BILLING CODE 4160-01-S