[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
