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.

MEETINGS: The following advisory committee meetings are announced:

Joint Meeting of the Food and Veterinary Medicine Advisory Committees

Date, time, and place. November 2 and 3, 1994, 8:30 a.m., Howard

Johnson Hotel-National Airport, Pentagon Ballroom, 2650 Jefferson Davis

Hwy., Arlington, VA.

Type of meeting and contact person. Open committee discussion,

November 2, 1994, 8:30 a.m. to 5:15 p.m.; open committee discussion,

November 3, 1994, 8:30 a.m. to 8:45 a.m.; open public hearing, 8:45

a.m. to 9:45 a.m., unless public participation does not last that long;

open committee discussion, 9:45 a.m. to 12:15 p.m.; Lynn A. Larsen,

Center for Food Safety and Applied Nutrition (HFS-5), Food and Drug

Administration, 200 C St. SW., Washington, DC 20204, 202-205-4727, or

Catherine M. DeRoever, Advisory Committee Staff (HFS-22), 202-205-4251,

FAX 202-205-4970.

General function of the committees. The Food Advisory Committee

provides advice on emerging food safety, food science, and nutrition

issues that FDA considers of primary importance in the next decade. The

Veterinary Medicine Advisory Committee reviews and evaluates available

data concerning safety and effectiveness of marketed and

investigational new animal drugs, feeds, and devices for use in the

treatment and prevention of animal disease and increased animal

production.

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 by close of business October 25, 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. If necessary, comments may be limited to 5

minutes.

Open committee discussion. The joint committees will discuss

possible future initiatives that impact on science and regulation in

areas such as biotechnology, food safety and processing,

compositionally enhanced foods, and food production and agriculture

sustainability. The biotechnology discussion will focus on FDA's 1992

policy statement on foods derived from new plant varieties developed by

new biotechnology methods. Also, because FDA is considering proposing a

premarket notification program, the committees will be asked to discuss

procedures that FDA might use to become aware of a developer's

intention to introduce such foods into commercial distribution. The

agency will present examples of the applications for products currently

approaching commercialization. In addition, the committees will be

asked to consider proposed criteria that would identify concerns for

which FDA might seek advisory committee assistance.

Joint Meeting of the Dermatologic Drugs and Anti-Infective Drugs

Advisory Committees With Nonprescription Drugs Advisory Committee

Representation

Date, time, and place. November 16, 1994, 8 a.m., Bethesda Holiday

Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.

Type of meeting and contact person. Open public hearing, 8 a.m. to

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

committee discussion, 9 a.m. to 5 p.m.; Ermona B. McGoodwin or Valerie

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

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-

5455.

General function of the committees. The Dermatologic Drugs Advisory

Committee reviews and evaluates data on the safety and effectiveness of

marketed and investigational human drugs for use in the treatment of

dermatologic diseases. The Anti-Infective Drugs Advisory Committee

reviews and evaluates data relating to the safety and effectiveness of

marketed and investigational human drugs for use in infectious and

ophthalmic disorders. 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.

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 November 9, 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 committee will jointly discuss the

potential for development of antibiotic resistance with over-the-

counter use of topical erythromycin in the treatment of acne.

Anti-Infective Drugs Advisory Committee

Date, time, and place. November 17, 1994, 8:30 a.m., Bethesda

Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.

Type of meeting and contact person. Open public hearing, 8:30 a.m.

to 9:30 a.m., unless public participation does not last that long; open

committee discussion, 9:30 a.m. to 5 p.m.; Ermona B. McGoodwin or Mary

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

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,

301-443-5455.

General function of the committee. The committee reviews and

evaluates data relating to the safety and effectiveness of marketed and

investigational human drugs for use in infectious and ophthalmic

disorders.

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 November 9, 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 committee will discuss the validity

of endoscopically-obtained maxillary sinus specimens versus antral

puncture for the microbiological diagnosis of sinusitis.

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: October 14, 1994.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 94-25945 Filed 10-17-94; 8:45 am]

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