[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Page 15344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7007]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 (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 April 26, 2000, 8:30 
a.m. to 5:30 p.m.
    Location: 5630 Fishers Lane, Center for Drug Evaluation and 
Research Advisory Committee conference room 1066, Rockville, MD.
    Contact Person: Kimberly Littleton Topper, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
[email protected], 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 will discuss specific scientific issues 
where the additional expertise of the subcommittee is needed to aid the 
agency in refining draft guidances for orally inhaled and nasal drug 
products in the areas of: (1) Chemistry, manufacturing, and controls; 
and (2) in vitro and in vivo bioavailability/bioequivalence.
    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 19, 
2000. Oral presentations from the public will be scheduled between 
approximately 1 p.m. to 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before April 19, 2000, 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: March 14, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-7007 Filed 3-21-00; 8:45 am]
BILLING CODE 4160-01-F