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:

Dermatologic and Ophthalmic Drugs Advisory Committee

Date, time, and place. November 7 and 8, 1996, 8:30 a.m., Quality

Suites, Main Ballroom, Three Research Ct., Rockville, MD.

Type of meeting and contact person. Closed presentation of data,

November 7, 1996, 8:30 a.m. to 11 a.m.; closed committee deliberations,

11 a.m. to 1 p.m.; open committee discussion, 1 p.m. to 5 p.m.; open

public hearing, November 8, 1996, 8:30 a.m. to 11:30 a.m., unless

public participation does not last that long; open committee

discussion, 11:30 a.m. to 5 p.m.; Tracy K. Riley or Danyiel A.

D'Antonio, 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), Dermatologic and Ophthalmic

Drugs Advisory Committee, code 12534. Please call the hotline for

information concerning any possible changes.

General function of the committee. The committee reviews and

evaluates available data concerning the safety and effectiveness of

marketed and investigational human drug products for use in the

treatment of dermatologic 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 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.

Closed presentation of data. On November 7, 1996, the committee

will hear trade secret and/or confidential commercial information

relevant to pending investigational new drug applications (IND's) and/

or new drug applications (NDA's). This portion of the meeting will be

closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).

Closed committee deliberations. On November 7, 1996, the committee

will review trade secret and/or confidential commercial information

relevant to pending IND's and/or NDA's. This portion of the meeting

will be closed to permit discussion of this information (5 U.S.C.

552b(c)(4)).

Open committee discussion. On November 7, 1996, the committee will

hear presentations and discuss the potential for neurotoxicity of

thalidomide raised by the investigational use and possible eventual

approval of thalidomide for dermatologic and other indications. On

November 8, 1996, the committee will hear presentations and discuss the

teratogenicity of thalidomide and issues of pregnancy prevention raised

by the investigational use and possible eventual approval of

thalidomide for dermatologic and other indications.

FDA regrets that it was unable to publish this notice 15 days prior

to the Dermatologic and Ophthalmic Drugs Advisory Committee meeting.

Because the agency believes there is some urgency to bring these issues

to public discussion and qualified members of the Dermatologic and

Ophthalmic Drugs Advisory Committee were available at this time, the

Commissioner of Food and Drugs (the Commissioner) concluded that it was

in the public interest to hold this meeting even if there was not

sufficient time for the customary 15-day public notice.

Allergenic Products Advisory Committee

Date, time, and place. November 15, 1996, 2 p.m., Food and Drug

Administration, Bldg. 29, conference room 121, 8800 Rockville Pike,

Bethesda, MD.

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Type of meeting and contact person. This meeting will be held by a

telephone conference call. A speaker telephone will be provided in the

conference room to allow public participation in the meeting. Open

public hearing, 2 p.m. to 3 p.m., unless public participation does not

last that long; open committee discussion, 3 p.m. to 3:30 p.m.; closed

committee deliberations, 3:30 p.m. to 5:30 p.m.; William Freas or

Sheila D. Langford, Center for Biologics Evaluation and Research (HFM-

21), Food and Drug Administration, 1401 Rockville Pike, Bethesda, MD

20852, 301-827-0314, or FDA Advisory Committee Information Hotline, 1-

800-741-8138 (301-443-0572 in the Washington, DC area), Allergenic

Products Advisory Committee, code 12388. Please call the hotline for

information concerning any possible changes.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness of allergenic biological

products intended for use in the diagnosis, prevention, or treatment 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 November 12, 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 the

indication of the approximate time to make their comments.

Open committee discussion. The committee will discuss the

intramural research program for the Laboratory of Immunoregulation in

the Division of Allergenic Products.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information relevant to pending

IND's in the Center for Biologics Evaluation and Research. This portion

of the meeting will be closed to permit discussion of this information

(5 U.S.C. 552b(c)(4)). The committee will also discuss the intramural

scientific program. This portion of the meeting will be closed to

prevent disclosure of personal information concerning individuals

associated with the research program, disclosure of which would

constitute a clearly unwarranted invasion of personal privacy (5 U.S.C.

552b(c)(6)).

Anti-Infective Drugs Advisory Committee

Date, time, and place. November 20, 1996, 8 a.m., Holiday Inn--

Gaithersburg, The Ballroom, Two Montgomery Village Ave., Gaithersburg,

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; closed

committee deliberations, 9 a.m. to 12 m.; Ermona B. McGoodwin or

Danyiel A. D'Antonio, 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), Anti-Infective Drugs

Advisory Committee, code 12530. Please call the hotline for information

concerning any possible changes.

General function of the committee. The committee reviews and

evaluates available data concerning the safety and effectiveness of

marketed and investigational human drug products for use in the

treatment of infectious diseases and 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 15, 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.

Closed committee deliberations. The committee will hear trade

secret and/or confidential commercial information relevant to pending

IND's and NDA's. This portion of the meeting will be closed to permit

discussion of this information (5 U.S.C. 552b(c)(4)).

Each public advisory committee meeting listed above 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. The dates and times reserved for the separate portions of

each committee meeting are listed above.

The open public hearing portion of the meeting(s) 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23,

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.

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The Commissioner has determined for the reasons stated that those

portions of the advisory committee meetings so designated in this

notice shall be closed. The Federal Advisory Committee Act (FACA) (5

U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings

in certain circumstances. Those portions of a meeting designated as

closed, however, shall be closed for the shortest possible time,

consistent with the intent of the cited statutes.

The FACA, as amended, provides that a portion of a meeting may be

closed where the matter for discussion involves a trade secret;

commercial or financial information that is privileged or confidential;

information of a personal nature, disclosure of which would be a

clearly unwarranted invasion of personal privacy; investigatory files

compiled for law enforcement purposes; information the premature

disclosure of which would be likely to significantly frustrate

implementation of a proposed agency action; and information in certain

other instances not generally relevant to FDA matters.

Examples of portions of FDA advisory committee meetings that

ordinarily may be closed, where necessary and in accordance with FACA

criteria, include the review, discussion, and evaluation of drafts of

regulations or guidelines or similar preexisting internal agency

documents, but only if their premature disclosure is likely to

significantly frustrate implementation of proposed agency action;

review of trade secrets and confidential commercial or financial

information submitted to the agency; consideration of matters involving

investigatory files compiled for law enforcement purposes; and review

of matters, such as personnel records or individual patient records,

where disclosure would constitute a clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory committee meetings that

ordinarily shall not be closed include the review, discussion, and

evaluation of general preclinical and clinical test protocols and

procedures for a class of drugs or devices; consideration of labeling

requirements for a class of marketed drugs or devices; review of data

and information on specific investigational or marketed drugs and

devices that have previously been made public; presentation of any

other data or information that is not exempt from public disclosure

pursuant to the FACA, as amended; and, deliberation to formulate advice

and recommendations to the agency on matters that do not independently

justify closing.

This notice is issued under section 10(a)(1) and (a)(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 21, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-27489 Filed 10-24-96; 8:45 am]

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