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:

Drug Abuse Advisory Committee

Date, time, and place. April 6 and 7, 1995, 8 a.m., Parklawn Bldg.,

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

Type of meeting and contact person. Closed committee deliberations,

April 6, 1995, 8 a.m. to 5 p.m.; open public hearing, April 7, 1995, 8

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

open committee discussion, 9 a.m. to 4 p.m.; Stephen P. Pollitt, Center

for Drug Evaluation and Research (HFD-9), 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), Drug Abuse Advisory Committee, code 12535.

General function of the committee. The committee advises on the

scientific and medical evaluation of information gathered by the

Department of Health and Human Services and the Department of Justice

on the safety, [[Page 15148]] efficacy, and abuse potential of drugs

and recommends actions to be taken on the marketing, investigation, and

control of such drugs.

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 March 23, 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.

Closed committee deliberations. On April 6, 1995, the committee

will review trade secret and/or confidential commercial information

relevant to pending investigational new drug applications (IND's). This

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

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

Open committee discussion. On April 7, 1995, the committee will

discuss the 1995 Institute of Medicine Report on the Development of

Medications for the Treatment of Opiate and Cocaine Addiction.

Biological Response Modifiers Advisory Committee

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

1995, 8 a.m. to 8:30 a.m., unless public participation does not last

that long; open committee discussion, 8:30 a.m. to 5:30 p.m.; open

public hearing, April 11, 1995, 8 a.m. to 8:30 a.m., unless public

participation does not last that long; open committee discussion, 8:30

a.m. to 1 p.m.; closed committee deliberations, 1 p.m. to 5 p.m.;

William Freas or Pearline Muckelvene, 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.

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 April 3, 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 April 10, 1995, the committee will

discuss: (1) Product license application supplement, reference number

94-0381, for Roferon A (Interferon-alpha-2a) Hoffman La Roche Inc., for

treatment of chronic phase, Philadelphia chromosome positive chronic

myelogenous leukemia; and (2) product license application supplements

94-0291 and 93-0287, for Sargramostim (GM-CSF), Immunex Corp., for

acceleration of neutrophil recovery following chemotherapy in acute

nonlymphoblastic leukemia and for chemotherapy-induced neutropenia

(this discussion will continue on the following morning). On the

morning of April 11, 1995, the committee will also discuss perspectives

on xenotransplantation. In the afternoon, the committee will discuss

the intramural scientific program of the Laboratory of Bone Marrow

Growth Factors and research programs of individuals in the Division of

Hematologic Products and Division of Cytokine Biology.

Closed committee deliberations. On April 11, 1995, 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)).

Gastroenterology and Urology Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. April 21, 1995, 8 a.m., Corporate Bldg.,

Main Conference Room, 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 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 a.m. to

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

committee discussion, 9 a.m. to 5 p.m.; closed committee deliberations,

5 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 April 14, 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 two premarket approval applications for devices

intended for the extracorporeal removal of low-density lipoprotein

(LDL) to lower LDL cholesterol in patients with familial

hypercholesterolemia.

Closed committee deliberations. The committee may discuss 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. April 24, 1995, 8:30 a.m., Corporate Bldg.,

Main Conference Room, 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 and reference the FDA Panel meeting

block. Reservations will [[Page 15149]] be confirmed at the group rate

based on availability.

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 2 p.m.; closed committee

deliberations, 2 p.m. to 4 p.m.; Colin M. Pollard, 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 April 10, 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 regarding home uterine activity monitors (HUAM's), in light of

new published information on HUAM's.

Closed committee deliberations. The committee may discuss 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)).

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 [[Page 15150]] FDA's

regulations (21 CFR part 14) on advisory committees.

Dated: March 16, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-7078 Filed 3-21-95; 8:45 am]

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