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:

Vaccines and Related Biological Products Advisory Committee

Date, time, and place. July 10 and 11, 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,

July 10, l996, 8 a.m. to 10 a.m., open committee discussion, 10 a.m. to

3:45 p.m.; open public hearing, 3:45 p.m. to 4:30 p.m., unless public

participation does not last that long; closed committee deliberations,

July 11, 1996, 8 a.m. to 8:45 a.m.; open committee discussion, 8:45

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

participation does not last that long; open committee discussion, 12:30

p.m. to 2 p.m.; closed committee deliberations, 2 p.m. to 3:30 p.m.;

Nancy T. Cherry or Sandy M. 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 July 3, 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 July 10, 1996, the committee will

review safety and efficacy data pertaining to a diphtheria/tetanus/

acellular pertussis vaccine manufactured by SmithKline Beecham. On July

11, 1996, the committee will review safety and comparative

immunogenicity data pertaining to a liquid version of an Haemophilus b

conjugate vaccine manufactured by Merck & Co. The committee will also

hear a briefing on proposed changes in the polio vaccine

recommendations, and a briefing on a research program in the Division

of Viral Products.

Closed committee deliberations. On July 10 and 11, l996, the

committee will review trade secret and/or confidential commercial

information relevant to pending product licensing applications or

amendments. These portions of the meeting will be closed to permit

discussion of this information (5 U.S.C. 552b(c)(4)). On July 11, 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)).

Circulatory System Devices Panel of the Medical Devices Advisory

Committee

Date, time, and place. July 15, 1996, 7:30 a.m., Corporate Bldg.,

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

number of overnight accommodations have been reserved at the Courtyard

by Marriott, 2500 Research Blvd., Rockville, MD. Attendees requiring

overnight accommodations may contact the hotel at 301-670-6700, 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 notification

is received.

Type of meeting and contact person. Closed committee deliberations,

7:30 a.m. to 8:30 a.m.; 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 3:30 p.m.; Ramiah Subramanian, Center for

Devices and Radiological Health (HFZ-450), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-

8320, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Circulatory System Devices

Panel, code 12625. 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,

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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 July 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 committee will discuss and vote on a

premarket approval application (PMA) for a pacemaker lead. The

committee will also discuss issues related to the draft guidance for

Automatic Implantable Pacer Cardioverter Defibrillator (AIPCD)

submissions, primarily focusing on new suggested labeling changes.

Single copies of the draft guidance document are available from the

Division of Small Manufacturers Assistance, Center for Devices and

Radiological Health (HFZ-220), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 1-800-638-2041 or 301-443-6597.

Closed committee deliberations. FDA staff will present to the

committee trade secret and/or confidential commercial information

relevant to investigational device exemption applications and PMA's for

cardiovascular system devices. This portion of the meeting will be

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

Gastroenterology and Urology Devices Panel of the Medical Devices

Advisory Committee

-Date, time, and place. July 25, 1996, 8:30 a.m., Gaithersburg

Hilton, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. A limited number

of overnight accommodations have been reserved at the hotel. Attendees

requiring overnight accommodations may contact the hotel at 301-977-

8900 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

notification is received.

-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 4 p.m.; closed committee

deliberations, 4 p.m. to 5 p.m.; Mary J. Cornelius, Center for Devices

and Radiological Health (HFZ-470), Food and Drug Administration, 9200

Corporate Blvd. Rockville, MD 20850, 301-594-2194, or FDA Advisory

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

Washington, DC area), Gastroenterology and Urology Devices Panel, code

12523. 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 July 16, 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 general

issues related to a premarket approval application for a device

intended to manage female urinary incontinence.

-Closed committee deliberations. FDA staff will present to the

committee trade secret and/or confidential commercial information

regarding medical devices. This portion of the meeting will be closed

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

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

-Date, time, and place. July 26, 1996, 8:30 a.m., Gaithersburg

Hilton, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. A limited number

of overnight accommodations have been reserved at the hotel. Attendees

requiring overnight accommodations may contact the hotel at 301-977-

8900 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 Joanne Choy,

Conference Management, 301-594-1283, ext. 105. The availability of

appropriate accommodations cannot be assured unless prior notification

is received.

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

8:30 a.m. to 9 a.m.; open committee discussion (first session), 9 a.m.

to 10:30 a.m.; open public hearing, 10:30 a.m. to 11:30 a.m., unless

public participation does not last that long; open committee discussion

(second session), 11:30 a.m. to 5 p.m.; Sara M. Thornton, Center for

Devices and Radiological Health (HFZ-460), Food and Drug

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

2053, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Ophthalmic Devices Panel,

code 12396. 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 July 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 an

indication of the approximate time required to make their comments.

-Open committee discussion. First Session--The Vitreoretinal and

Extraocular Devices Branch will present a summary report of public

comments received on the proposed rule that published in the Federal

Register of April 1, 1996 (61 FR 14277), for reclassification of

contact lens care products. The committee will review and recommend the

classification status for currently unclassified devices which may

include corneal storage media and external eyelid weights. Second

Session--FDA staff will present to the committee the regulatory status

of lasers for the correction of refractive error currently in use in

the United States and FDA's policies and regulations regarding those

lasers.

Closed presentation of data. FDA staff will present to the

committee trade secret and/or confidential commercial information

relevant to investigational device exemption applications and premarket

approval applications. 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

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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. 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: June 19, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-16174 Filed 6-24-96; 8:45 am]

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