Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces a forthcoming joint meeting of public

advisory committees of the Food and Drug Administration (FDA). This

notice also summarizes the procedures for the meeting and methods by

which interested persons may participate in open public hearings before

FDA's advisory committees.

MEETING: The following advisory committee meeting is announced:

Joint Meeting of the Nonprescription Drugs and the Pulmonary-Allergy

Drugs Advisory Committees

Date, time, and place. November 14, 1994, 8:30 a.m., Parklawn

Bldg., conference rms. G through J, 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open committee discussion, 8:30

a.m. to 4 p.m.; open public hearing, 4 p.m. to 5 p.m., unless public

participation does not last that long; the agency anticipates that the

meeting will last only 1 day, but if there is sufficient interest in

participation, the meeting will be extended an additional day at the

discretion of the chairperson; Lee L. Zwanziger or Leander B. Madoo,

Center for Drug Evaluation and Research (HFD-9), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.

General function of the committees. The Nonprescription Drugs

Advisory Committee reviews and evaluates available data concerning the

safety and effectiveness of over-the-counter (nonprescription) human

drug products for use in the treatment of a broad spectrum of human

symptoms and diseases. The Pulmonary-Allergy Drugs Advisory Committee

reviews and evaluates data on the safety and effectiveness of marketed

and investigational human drugs for use in the treatment of pulmonary

disease and diseases with allergic and/or immunologic mechanisms.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committees. Those desiring to make formal presentations should

notify a contact person before September 30, 1994, 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 required to make their comments.

Open committee discussion. The committees will jointly discuss

over-the-counter (OTC) drug products for the treatment of asthma and

will address topics such as: (1) OTC bronchodilator drug products

currently available and possible pending changes in their marketing

status; (2) whether there is a population for which OTC antiasthma drug

products are appropriate; (3) the general question of whether

antiasthma drug products should be available OTC; (4) antiasthma drug

products currently available by prescription only that could be

considered for OTC status; and (5) data requirements necessary to

support conversion of prescription antiasthma drug products to OTC

status. Public comments are available for inspection in docket no. 94N-

0232 at the Dockets Management Branch (HFA-305), Food and Drug

Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FDA public advisory committee meetings may have as many as four

separable portions: (1) An open public hearing, (2) an open committee

discussion, (3) a closed presentation of data, and (4) a closed

committee deliberation. Every advisory committee meeting shall have an

open public hearing portion. Whether or not it also includes any of the

other three portions will depend upon the specific meeting involved.

There are no closed portions for the meetings announced in this notice.

The dates and times reserved for the open portions of each committee

meeting are listed above.

The open public hearing portion of each meeting shall be at least 1

hour long unless public participation does not last that long. It is

emphasized, however, that the 1 hour time limit for an open public

hearing represents a minimum rather than a maximum time for public

participation, and an open public hearing may last for whatever longer

period the committee chairperson determines will facilitate the

committee's work.

Public hearings are subject to FDA's guideline (subpart C of 21 CFR

part 10) concerning the policy and procedures for electronic media

coverage of FDA's public administrative proceedings, including hearings

before public advisory committees under 21 CFR part 14. Under 21 CFR

10.205, representatives of the electronic media may be permitted,

subject to certain limitations, to videotape, film, or otherwise record

FDA's public administrative proceedings, including presentations by

participants.

Meetings of advisory committees shall be conducted, insofar as is

practical, in accordance with the agenda published in this Federal

Register notice. Changes in the agenda will be announced at the

beginning of the open portion of a meeting.

Any interested person who wishes to be assured of the right to make

an oral presentation at the open public hearing portion of a meeting

shall inform the contact person listed above, either orally or in

writing, prior to the meeting. Any person attending the hearing who

does not in advance of the meeting request an opportunity to speak will

be allowed to make an oral presentation at the hearing's conclusion, if

time permits, at the chairperson's discretion.

The agenda, the questions to be addressed by the committee, and a

current list of committee members will be available at the meeting

location on the day of the meeting.

Transcripts of the open portion of the meeting may be requested in

writing from the Freedom of Information Office (HFI-35), Food and Drug

Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the meeting, at a cost of 10 cents

per page. The transcript may be viewed at the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15 working days after the meeting,

between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary

minutes of the open portion of the meeting may be requested in writing

from the Freedom of Information Office (address above) beginning

approximately 90 days after the meeting.

This notice is issued under section 10(a)(1) and (2) of the Federal

Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR

part 14) on advisory committees.

Dated: June 30,1994.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 94-16365 Filed 7-6-94; 8:45 am]

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