Advisory Committees; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces forthcoming meetings of public advisory

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

summarizes the procedures for the meetings and methods by which

interested persons may participate in open public hearings before FDA's

advisory committees.

FDA has established an Advisory Committee Information Hotline (the

hotline) using a voice-mail telephone system. The hotline provides the

public with access to the most current information on FDA advisory

committee meetings. The advisory committee hotline, which will

disseminate current information and information updates, can be

accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory

committee is assigned a 5-digit number. This 5-digit number will appear

in each individual notice of meeting. The hotline will enable the

public to obtain information about a particular advisory committee by

using the committee's 5-digit number. Information in the hotline is

preliminary and may change before a meeting is actually held. The

hotline will be updated when such changes are made.

MEETINGS: The following advisory committee meetings are announced:

Advisory Committee for Pharmaceutical Science (formerly Generic Drugs

Advisory Committee)

-Date, time, and place. August 15, 1996, 8 a.m., and August 16,

1996, 7:30 a.m., Holiday Inn--Gaithersburg, Goshen Ballroom, Two

Montgomery Village Ave., Gaithersburg, MD.

-Type of meeting and contact person. Open committee discussion,

August 15, 1996, 8 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2

p.m., unless public participation does not last that long; open

committee discussion, 2 p.m. to 6:30 p.m.; open committee discussion,

August 16, 1996, 7:30 a.m. to 10 a.m.; Kimberly L. Topper, 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 Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), Advisory Committee for Pharmaceutical Science,

code 12539. Please call the hotline for information concerning any

possible changes.

-General function of the committee. The committee gives advice on

scientific and technical issues concerning the safety and effectiveness

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

spectrum of human diseases.

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

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

the committee. Those desiring to make formal presentations should

notify the contact person before August 1, 1996, 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. On August 15, 1996, the committee will

discuss the Biopharmaceutics Drug Classification System and Individual

Bioequivalence. On August 16, 1996, the committee will discuss Product

Quality Research, Laboratory-Based Clinical Pharmacology Research, and

Clinic-Based Clinical Pharmacology Research.

Joint Meeting of the Advisory Committee for Pharmaceutical Science and

the Pulmonary and Allergy Drugs Advisory Committee

-Date, time, and place. August 16, 1996, 10 a.m., Holiday Inn--

Gaithersburg, Goshen Ballroom, Two Montgomery Village Ave.,

Gaithersburg, MD.

-Type of meeting and contact person. Open committee discussion, 10

a.m. to 11:30 a.m.; open public hearing, 11:30 a.m. to 12:30 p.m.,

unless public participation does not last that long; open committee

discussion, 12:30 p.m. to 3:30 p.m.; Kimberly L. Topper, 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 Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), Advisory Committee for Pharmaceutical Science,

code 12539. Please call the hotline for information concerning any

possible changes.

-General function of the committees. The Advisory Committee for

Pharmaceutical Science gives advice on scientific and technical issues

concerning the safety and effectiveness of human generic drug products

for use in the treatment of a broad spectrum of

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human 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 committee. Those desiring to make formal presentations should

notify the contact person before August 1, 1996, 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 discuss

Bioequivalence of Albuterol Metered Dose Inhalers (MDI's).

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: July 15, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-18614 Filed 7-23-96; 8:45 am]

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