[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Page 59782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28559]


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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). 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 November 22, 1999, 8 
a.m. to 5 p.m. and November 23, 1999, 7:45 a.m. to 4 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8210 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Leander B. Madoo, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, 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 November 22, 1999, FDA will discuss its regulations 
related to ozone-depleting substances. In this discussion, FDA will 
review the Montreal Protocol on substances that deplete the ozone layer 
and the advanced notice of proposed rulemaking published on March 6, 
1997 (62 FR 10242), as discussed at the April 11, 1997, committee 
meeting. FDA will provide an overview and detailed discussion of the 
proposed rule published on September 1, 1999 (64 FR 47719), related to 
the phase-out of chlorofluorocarbons (CFC's) in metered-dose inhalers. 
The proposed rule outlines the mechanism by which FDA will determine 
when the use of ozone-depleting substances, including CFC's in metered-
dose, inhalers, in any product regulated by FDA is no longer essential 
under the Clear Air Act. The proposed rule can be downloaded at http://
www.fda.gov/ohrma/dockets/98fr/090199b.pdf. FDA has also created a 
website at http://www.fda.gov/cder/mdi to provide information to the 
public regarding this proposal and the issues related to CFC use in 
medical products. The committee will discuss and comment on the 
proposed rule and on the presentations made during the public hearing.
     On November 23, 1999, the committee will discuss the safety and 
efficacy of new drug application (NDA) 21-077 for three products: (1) 
AdvairTM Diskus 100 micrograms (g) 
(salmeterol xinafoate 50 g/fluticasone propionate 100 
g inhalation powder), (2) AdvairTM Diskus 
250 g (salmeterol xinafoate 50 g/fluticasone 
inhalation powder), and (3) AdvairTM Diskus 500 
g (salmeterol xinafoate 50 g/fluticasone propionate 
500 g inhalation powder), Glaxo Wellcome, for the maintenance 
treatment of asthma as prophylatic therapy in patients 12 years of age 
and older.
     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 November 12, 
1999. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 12:30 p.m. on November 22, 1999, and 
between approximately 8 a.m. and 8:30 a.m. on November 23, 1999. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
November 12, 1999, 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: October 22, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-28559 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F