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:

Oncologic Drugs Advisory Committee

Date, time, and place. June 8 and 9, 1995, 8 a.m., Parklawn Bldg.,

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

Type of meeting and contact person. Open public hearing, June 8,

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

long; open committee discussion, 9 a.m. to 5 p.m.; open committee

discussion, June 9, 1995, 8 a.m. to 11:30 a.m.; closed committee

deliberations, 11:30 a.m. to 4 p.m.; Adele S. Seifried, Center for Drug

Evaluation and Research (HFD-9), 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), Oncologic Drugs Advisory Committee, code 12542.

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 treatment of cancer.

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 June 5, 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 June 8, 1995, the committee will

discuss: (1) New drug application (NDA) 50-704, Daunoxome

Injection (liposomal daunorubicin, Vestar, Inc.) ``as the primary

therapy for the palliative management of advanced, HIV-associated

Kaposi's Sarcoma,'' and (2) NDA 20-449, Taxotere (docetaxel,

Rhone-Poulenc Rorer), for treatment of ``patients with locally advanced

or metastatic breast carcinoma in whom previous therapy has failed;

prior therapy should have included an anthracycline unless clinically

contraindicated.'' On June 9, 1995, the committee will discuss NDA 20-

221, Ethyol (amifostine injection, U.S. Bioscience, Inc.) ``as a

cytoprotective agent against the cumulative renal toxicities associated

with cisplatin and the cumulative hematologic toxicity associated with

cyclophosphamide and cisplatin in patients with advanced solid tumors

of non-germ cell origin.''

Closed committee deliberations. On June 9, 1995, the committee will

discuss trade secret and/or confidential commercial information

relevant to investigational new drugs (IND's) and pending NDA's. This

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

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

Orthopedic and Rehabilitation Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. June 12, 1995, 8:30 a.m., Holiday Inn--

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

A limited number of overnight accommodations have been reserved at the

Holiday Inn--Gaithersburg. 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.

Type of meeting and contact person. Open public hearing, 8:30 a.m.

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

committee discussion, 9 a.m. to 12 m.; closed committee deliberations,

12 m. to 1:30 p.m.; open public hearing, 1:30 p.m. to 2 p.m., unless

public participation does not last that long; open committee

discussion, 2 p.m. to 5 p.m.; Paula J. Wilkerson, [[Page 27531]] Center

for Devices and Radiological Health (HFZ-410), Food and Drug

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

2036, or FDA Advisory Committee Information Hotline, 1-800-741-8138

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

Rehabilitation Panel, code 12521.

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 June 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 general

issues relating to a premarket approval application for a total knee

replacement device. The committee will also hear an FDA presentation on

conditions of approval and the gathering of long-term data. The

afternoon session will include presentations and committee discussion

on hip replacement systems. Speakers will examine components of

clinical protocol design including: Medical and clinical aspects,

rating systems, patient selection, controls, and statistical

considerations.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information relating to

orthopedic devices. 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. June 23, 1995, 8 a.m., Marriott--Bethesda,

Congressional Salons I, II, and III, 5151 Pooks Hill Rd., Bethesda, MD.

Type of meeting and contact person. Open committee discussion, 8

a.m. to 10:45 a.m.; open public hearing, 10:45 a.m. to 11:45 a.m.,

unless public participation does not last that long; open committee

discussion, 11:45 a.m. to 3 p.m.; closed committee deliberations, 3

p.m. to 3:30 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, 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 June 12, 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. In the morning, the committee will

discuss and provide recommendations on human immunodeficiency virus

(HIV) antigen screening of blood donors. In the afternoon, the

committee will discuss and review the report of the intramural research

site visit of the Laboratory of Cellular Hematology, Division of

Hematology, Office of Blood Research and Review, Center for Biologics

Evaluation and Research.

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, a 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 [[Page 27532]] 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: May 17, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-12661 Filed 5-23-95; 8:45 am]

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