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. December 5, 1995, 1:30 p.m., Food and Drug

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

Bethesda, MD.

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. Closed

committee deliberations, 1:30 p.m. to 4 p.m.; open public hearing, 4

p.m. to 5 p.m., unless public participation does not last that long;

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.

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.

Closed committee deliberations. The committee will review trade

secret and/or confidential commercial information relevant to current

and pending products. This portion of the meeting will be closed to

permit discussion of this information (5 USC 552b(c)(4)).

Radiological Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. December 11, 1995, 8:30 a.m., Holiday Inn--

Gaithersburg, Goshen Room, Two Montgomery Village Ave., Gaithersburg,

MD. A limited number of overnight accommodations have been reserved at

the hotel. Attendees requiring overnight accommodations may contact the

hotel at 301-948-8900 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 Gloria Williams, 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, 8:30 a.m.

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

committee

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discussion, 9:45 a.m. to 12:30 p.m.; closed committee deliberations,

12:30 p.m. to 1:30 p.m.; open committee discussion, 1:30 p.m. to 4:30

p.m.; John C. Monahan, Center for Devices and Radiological Health (HFZ-

470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD

20850, 301-594-1212, or FDA Advisory Committee Information Hotline, 1-

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

Devices Panel, code 12526.

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 December 6, 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 ultrasound

imaging device indicated for use on the breast in women with

abnormalities based on prior mammography and/or physical examination.

This device will be used to further evaluate solid mass characteristics

in order to reduce the number of biopsies.

Closed committee deliberations. FDA staff will present to the

committee trade secret and/or confidential commercial information

regarding present and future FDA issues. This portion of the meeting

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

552b(c)(4)).

Anesthetic and Life Support Drugs Advisory Committee

Date, time, and place. December 11 and 12, 1995, 8:30 a.m., Holiday

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

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

11, 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.; open

committee discussion, December 12, 1995, 8:30 a.m. to 11 a.m.; closed

committee deliberations, 11 a.m. to 1 p.m.; Stephen P. Pollitt, 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), Anesthetic and Life Support Drugs

Advisory Committee, code 12529.

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 the field of anesthesiology and

surgery.

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 December 1, 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 the new drug

application (NDA) 20-533, Naropin , Astra Laboratories, for

use as a local anesthetic and a report of the postmarket surveillance

of NDA 27-428, Oralet, Anesta.

-Closed committee deliberations. On December 12, 1995, the

committee will review trade secret and/or confidential commercial

information. This portion of the meeting will be closed to permit

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

Blood Products Advisory Committee

Date, time, and place. December 14 and 15, 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,

December 14, 1995, 8 a.m. to 8:40 a.m.; open public hearing, 8:40 a.m.

to 9:10 a.m., unless public participation does not last that long; open

committee discussion, 9:10 a.m. to 11:30 a.m.; open public hearing,

11:30 a.m. to 12 m., unless public participation does not last that

long; open committee discussion, 12 m. to 3:30 p.m.; open public

hearing, 3:30 p.m. to 4 p.m., unless public participation does not last

that long; open committee discussion, 4 p.m. to 5 p.m.; open committee

discussion, December 15, 1995, 8 a.m. to 10:30 a.m.; open public

hearing, 10:30 a.m. to 11 a.m., unless public participation does not

last that long; open committee discussion, 11 a.m. to 2 p.m.; closed

committee deliberations, 2 p.m. to 3 p.m.; Linda A. Smallwood, Center

for Biologics Evaluation and Research (HFM-350), Food and Drug

Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-

6700, FAX 301-594-6764, or FDA Advisory Committee Information Hotline,

1-800-741-8138 (301-443-0572 in the Washington, DC area) Blood Products

Advisory Committee, code 12388.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness, and appropriate use of

blood 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 December 8, 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 the morning of December 14, 1995, the

committee will hear agency updates on Creutzfeldt-Jakob Disease and

blood safety, and Human Immune Deficiency Virus, Type 1 (HIV-1) antigen

screening of donors; review the report of the FDA/Health Resources

Services Administration contract study of the Tissue Procurement and

Distribution System in the United States, and hear scientific

presentations on testing for Chagas disease (infection with Trypanosoma

cruzi) in blood donors. In the afternoon, the committee will hear a

summary of the Workshop on Cord Blood Derived Hematopoietic Stem Cells

and presentation on Peripheral Blood Derived Hematopoietic Stem Cell

Products Intended for Transfusion. A draft document for discussion

concerning the application of current statutory authorities to

peripheral blood hematopoietic stem cell products intended for

transfusion will be made available. On the morning of December 15,

1995, the committee will review and make recommendations on issues

related to respiratory syncytial virus immune globulin intravenous,

MedImmune. In the afternoon, the committee will review and discuss the

site visit reports of the Laboratories of Molecular Virology and

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Immunochemistry, Division of Transfusion Transmitted Diseases.

Closed committee deliberations. The committee will 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)).

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: November 14, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95-28521 Filed 11-21-95; 8:45 am]

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