[Federal Register Volume 66, Number 249 (Friday, December 28, 2001)]
[Notices]
[Pages 67268-67269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pulmonary-Allergy 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Pulmonary-Allergy 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 17, 2002, from 8 
a.m. to 5 p.m., and January 18, 2002, from 8 a.m. to 3 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Kimberly L. Topper, 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 FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), code 12545. Please call 
the Information Line for up-to-date information on this meeting.
    Agenda: On January 17, 2002, the committee will discuss the use of 
two new drug applications (NDAs): NDA 20-833, Flovent Diskus, and NDA 
21-077, Advair Diskus, GlaxoSmithKline, as maintenance therapy in 
patients with chronic obstructive pulmonary disease (COPD). On January 
18, 2002, the meeting will be open to the public from 8 a.m. to 9 a.m., 
unless public participation does not last that long; from 9 a.m. to 3 
p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information.
    Procedure: On January 17, 2002, from 8 a.m. to 5 p.m. and on 
January 18, 2002, from 8 a.m. to 9 a.m., the meeting will be open to 
the public. 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 January 11, 2002. Oral 
presentations from the public will be scheduled between approximately 1 
p.m. and 2 p.m. on January 17, 2002, and between approximately 8 a.m. 
and 9 a.m. on January 18, 2002. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before January 11, 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.
    Closed Committee Deliberations: On January 18, 2002, from 9 a.m. to 
3 p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).


[[Page 67269]]


    Dated: December 19, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-31878 Filed 12-27-01; 8:45 am]
BILLING CODE 4160-01-S