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:

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory

Committee

Date, time, and place. October 21, 1996, 8:30 a.m., Corporate

Bldg., conference room 020B, 9200 Corporate Blvd., Rockville, MD. A

limited number of overnight accommodations have been reserved at the

Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd.,

Gaithersburg, MD. Attendees requiring overnight accommodations may

contact the hotel at 301-590-0044 or 800-228-9290 and reference the FDA

Panel meeting block. Reservations will be confirmed at the group rate

based on availability. Attendees with a disability requiring special

accommodations should contact Shirley Meeks, Conference Management,

301-594-1283, ext. 113. The availability of appropriate accommodations

cannot be assured unless prior written notification is received.

Type of meeting and contact person. Closed committee deliberations,

8:30 a.m. to 9:30 a.m.; open public hearing, 9:30 a.m. to 10:30 a.m.,

unless public participation does not last that long; open committee

discussion, 10:30 a.m. to 5 p.m.; Alfred W. Montgomery, Center for

Devices and Radiological Health (HFZ-470), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

1180, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Obstetrics and Gynecology

Devices Panel, code 12524. 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 marketed and

investigational devices and makes recommendations for their regulation.

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 October 11, 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 committee will discuss and vote on a

premarket approval application for a silicone barrier contraceptive

device.

Closed committee deliberations. FDA staff will present to the

committee trade secret and/or confidential commercial information

regarding medical devices used in obstetrics and gynecology that are

currently being evaluated by FDA. This portion of the meeting will be

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

Biological Response Modifiers Advisory Committee

Date, time, and place. October 21, 1996, 10 a.m., Holiday Inn--

Bethesda, Versailles Ballrooms I, II, and III, 8120 Wisconsin Ave.,

Bethesda, MD.

Type of meeting and contact person. Open public hearing, 10 a.m. to

10:40 a.m., unless public participation does not last that long; open

committee discussion, 10:40 a.m. to 1:30 p.m.; closed committee

deliberations, 1:30 p.m. to 2:30 p.m.; open committee discussion, 2:30

p.m. to 3 p.m.; closed committee deliberations, 3 p.m. to 5 p.m.; open

public hearing, 5 p.m. to 5:30 p.m., unless public participation does

not last that long; William Freas, Pearline K. Muckelvene, or Sheila D.

Langford, Center for Biologics Evaluation and Research (HFM-21), Food

and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-

827-0314, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Biological Response

Modifiers 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 relating to the safety, effectiveness, and appropriate

use of biological response modifiers which are intended for use in the

prevention and 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 October 14, 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 committee will discuss the: (1) FDA

oncology initiative; (2) standards for approval of therapies for non-

Hodgkin's Lymphoma; and (3) intramural research program for the

Laboratory of Cell Biology, Laboratory of Immunobiology, and the

Laboratory of Cell and Viral Regulation in the Office of Therapeutics

Research and Review of the Center for Biologics Evaluation and

Research.

Closed committee deliberations. On October 21, 1996, the committee

will discuss trade secret and/or confidential commercial information

relevant to pending investigational new drug applications (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)).

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Cardiovascular and Renal Drugs Advisory Committee

Date, time, and place. October 24, 1996, 9 a.m., Woodmont Building

II, conference room F, 5th floor, 1451 Rockville Pike, Rockville, MD.

Type of meeting and contact person. Open public hearing, 9 a.m. to

10 a.m., unless public participation does not last that long; closed

committee deliberations, 10 a.m. to 5:30 p.m.; Joan Standaert, Center

for Drug Evaluation and Research (HFD-110), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-259-6211,

or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-

0572 in the Washington, DC area), Cardiovascular and Renal Drugs

Advisory Committee, code 12533. 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 marketed and

investigational human drugs for use in cardiovascular and renal

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 October 10, 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 review trade

secret and/or confidential commercial information relevant to pending

IND's or new drug applications. This portion of the meeting will be

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

Vaccines and Related Biological Products Advisory Committee

Date, time, and place. October 29 and 30, l996, 8 a.m., Holiday

Inn--Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave.,

Bethesda, MD.

Type of meeting and contact person. Closed committee deliberations,

October 29, l996, 8 a.m. to 8:30 a.m.; open committee discussion, 8:30

a.m. to 5 p.m.; open committee discussion, October 30, l996, 8 a.m. to

1:30 p.m.; closed committee deliberations, 1:30 p.m. to 2:30 p.m.; open

public hearing, 2:30 p.m. to 3:30 p.m., unless public participation

does not last that long; open committee discussion, 3:30 p.m. to 5:15

p.m.; Nancy Cherry or Sandy Salins, Center for Biologics Evaluation and

Research (HFM-21), Food and Drug Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee

Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC

area), Vaccines and Related Biological 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 vaccines 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 October 22, 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 October 29, 1996, the committee will

review safety and efficacy data pertaining to diphtheria/tetanus/

acellular pertussis vaccines manufactured by Amvax, Inc., and Lederle

Laboratories. On October 30, 1996, the committee will review the

possibility of using animal challenge studies (and the design of such

studies), in addition to human neutralizing antibody data, to support

the efficacy of the botulinum toxoid vaccine. The committee will also

hear a briefing on a research program in the Division of Viral Products

and a briefing on a new Points to Consider document on Plasmid DNA

Vaccines for Preventive Infectious Disease Indications.

Closed committee deliberations. On October 29, l996, the committee

will review trade secret and/or confidential commercial information

relevant to pending IND's or product licensing applications. These

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

information (5 U.S.C. 552b(c)(4)). On October 30, l996, the committee

will also review data of a personal nature where disclosure would

constitute a clearly unwarranted invasion of personal privacy. This

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

information (5 U.S.C. 552b(c)(6)).

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 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, 5600 Fishers Lane, rm.

[[Page 50830]]

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.

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: September 19, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-24755 Filed 9-26-96; 8:45 am]

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