[Federal Register: June 14, 2001 (Volume 66, Number 115)]
[Page 32359-32360]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Orally Inhaled and Nasal Drug Products Subcommittee of the 
Advisory Committee for Pharmaceutical Science; 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

[[Page 32360]]

(FDA). The meeting will be open to the public.
    Name of Committee: Orally Inhaled and Nasal Drug Products 
Subcommittee of the Advisory Committee for Pharmaceutical Science.
    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 17, 2001, from 8:30 
a.m. to 5:30 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee conference room 1066, 5630 Fishers Lane, Rockville, MD.
    Contact: Nancy Chamberlin, 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, or e-mail: CHAMBERLINN@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12539. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The subcommittee meeting will discuss the issue of dose-
response of locally acting nasal sprays and nasal aerosols, with 
particular application to bioequivalence studies.
    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 10, 2001. 
Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. to 12:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 10, 2001, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 6, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-14929 Filed 6-13-01; 8:45 am]