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:

Gastroenterology and Urology Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. October 20, 1995, 8 a.m., Corporate Bldg.,

ground floor conference room, 9200 Corporate Blvd., Rockville, MD. A

limited number of overnight accommodations have been reserved at the

Gaithersburg Marriott Washingtonian Hotel, 9751 Washingtonian Blvd.,

Gaithersburg, MD. Attendees requiring overnight accommodations may

contact the hotel at 301-590-0044 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 Ed Rugenstein, Sociometrics, Inc., 301-

608-2151. The availability of appropriate accommodations cannot be

assured unless prior written notification is received.

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 3 p.m.; closed committee deliberations,

3 p.m. to 6 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.

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 13, 1995, 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 an

electromagnetic device intended to treat benign prostatic hyperplasia

using localized heat.

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)).

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory

Committee

Date, time, and place. October 23, 1995, 8:30 a.m., and October 24,

1995, 7:30 a.m., DoubleTree Hotel, Ballroom, 1750 Rockville Pike,

Rockville, MD. A limited number of overnight accommodations have been

reserved at the hotel. Attendees requiring overnight accommodations may

contact the hotel

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at 301-468-1100 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 Ed

Rugenstein, Sociometrics, Inc., 301-608-2151. The availability of

appropriate accommodations cannot be assured unless prior written

notification is received.

Type of meeting and contact person. Open public hearing, October

23, 1995, 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.; closed

committee deliberations, October 24, 1995, 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 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.

-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 4, 1995, 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 23, 1995, the committee will

consider a list of devices used for in vitro fertilization and other

assisted reproduction technologies. The committee will provide expert

advice on these devices that will be used to develop 510(k) guidance.

On October 24, 1995, the committee will consider a draft guidance

document on the preparation of an investigational device exemption for

thermal endometrial ablation devices. Single copies of the list of in

vitro fertilization devices and the guidance document for thermal

endometrial ablation devices are available to the public after October

1, 1995, by contacting the Division of Small Manufacturers Assistance,

1350 Piccard Dr., Rockville, MD 20851, 1-800-638-2041.

Closed committee deliberations. On October 24, 1995, FDA staff will

present to the committee trade secret and/or confidential commercial

information regarding various 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)).

Vaccines and Related Biological Products Advisory Committee

Date, time, and place. October 26 and 27, 1995, 8 a.m., Parklawn

Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open committee discussion,

October 26, 1995, 8 a.m. to 8:15 a.m.; open public hearing, 8:15 a.m.

to 8:45 a.m., unless public participation does not last that long; open

committee discussion, 8:45 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 6 p.m.; closed committee deliberations, October 27, 1995, 8

a.m. to 12:30 p.m.; open public hearing, 12:30 p.m. to 1 p.m., unless

public participation does not last that long; open committee

discussion, 1 p.m. to 5:15 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.

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 18, 1995, 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 26, 1995, the committee will

hear presentations on recent acellular pertussis trials sponsored by

the Public Health Service, and on a new strategic plan for the year

2004 developed by the Center for Biologics Evaluation and Research. The

committee will also consider whether a single formulation for

pneumococcal conjugate vaccines should be adopted for children in the

United States. On October 27, l995, the committee will discuss a draft

Points to Consider document addressing the evaluation of combination

vaccines. Copies of the document will be available at the meeting.

Closed committee deliberations. On October 26 and 27, l995, the

committee will review trade secret and/or confidential commercial

information relevant to pending investigational new drug applications

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)).

Medical Imaging Drugs Advisory Committee

Date, time, and place. October 26 and 27, 1995, 8 a.m., Holiday

Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.

-Type of meeting and contact person. Open public hearing, October

26, 1995, 8 a.m. to 9 a.m., unless public participation does not last

that long; closed committee deliberations, 9 a.m. to 11 a.m.; open

committee discussion, 11 a.m. to 4 p.m.; open committee discussion,

October 27, 1995, 8 a.m. to 4 p.m.; Leander B. Madoo (HFD-9), Center

for Drug Evaluation and Research, Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory

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

Washington, DC area), Medical Imaging Drugs Advisory Committee, code

12540.

General function of committee. The committee reviews and evaluates

data concerning the safety and effectiveness of marketed and

investigational human drug products for use in diagnostic and

therapeutic procedures using radioactive pharmaceuticals and contrast

media used in diagnostic radiology.

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 12, 1995, and submit a brief

statement of the general nature of the evidence or

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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 hold a preliminary

discussion in preparation for drafting of future ``Points to Consider

for Diagnostic Imaging Agents''.

Closed committee deliberations. The committee will be briefed on

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 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.

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 (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 26, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95-24354 Filed 9-29-95; 8:45 am]

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