[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Notices]
[Page 13413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7055]


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

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.

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

    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: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on April 20, 1998, 8 a.m. 
to 5 p.m.
    Location: Gaithersburg Hilton, Ballrooms C, D, and E, 620 Perry 
Pkwy., Gaithersburg, MD.
    Contact Person: Leander B. Madoo, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5455, 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: The committee will discuss the safety and efficacy of new 
drug application (NDA) 20-929 for Pulmicort RespulesTM 
(budesonide suspension for nebulization, Astra USA) indicated for the 
maintenance treatment of asthma and as prophylactic therapy in children 
aged 6 months to 8 years. Pulmicort RespulesTM is also 
indicated for children aged 6 months to 8 years with asthma who require 
systemic corticosteroid administration where adding Pulmicort 
RespulesTM may reduce or eliminate the need for systemic 
corticosteroid administration.
    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 14, 
1998. Oral presentations from the public will be scheduled between 
approximately 8:05 a.m. and 9:05 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before April 14, 1998, 
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 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7055 Filed 3-18-98; 8:45 am]
BILLING CODE 4160-01-F