Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

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