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:

Generic Drugs Advisory Committee

Date, time, and place. September 6 and 7, 1995, 8:30 a.m., Holiday

Inn--Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD.

Type of meeting and contact person. Open committee discussion,

September 6, 1995, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m.

to 12 m., unless public participation does not last that long; open

committee discussion, 12 m. to 5 p.m.; open committee discussion,

September 7, 1995, 8:30 a.m. to 12 m.; closed committee deliberations,

12 m. to 5 p.m.; Kimberly L. Topper or Angie Whitacre, 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), Generic Drugs Advisory Committee, code 12539.

General function of the committee. The committee gives advice on

scientific and technical issues concerning the safety and effectiveness

of human generic drug products for use in the treatment of a broad

spectrum of human diseases and makes appropriate recommendations to the

Secretary of Health and Human Services, the Assistant Secretary for

Health, the Commissioner of Food and Drugs, and the Director of the

Center for Drug Evaluation and Research. The committee may also review

agency-sponsored intramural and extramural biomedical research programs

in support of FDA's generic drugs regulatory responsibilities.

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 August 22, 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 September 6 and 7, 1995, the

committee will review and advise on the status of Center for Drug

Evaluation and Research (CDER) quality and performance initiatives

related to formulation dissolution and bioequivalence. The committee

will also discuss its relationship to, and interaction with, CDER's new

Office of Pharmaceutical Sciences.

Closed committee deliberations. On September 7, 1995, the committee

will discuss trade secret and/or confidential commercial information

relevant to pending abbreviated new drug applications (ANDA's). This

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

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

Radiological Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. September 11, 1995, 9:30 a.m., Corporate

Bldg., conference room 20B, 9200 Corporate Blvd., Rockville, MD. A

limited number of overnight accommodations have been reserved at the

Gaithersburg Marriott

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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, 9:30 a.m.

to 10:30 a.m., unless public participation does not last that long;

open committee discussion, 10:30 a.m. to 12 m.; closed committee

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

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 September 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 a draft

guidance document entitled ``Magnetic Resonance Imaging Guidance Update

for Rate of Change of Gradient Fields.'' Single copies of the draft

guidance are available from John C. Monahan (address above).

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)).

Neurological Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. September 15, 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 may 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 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 1:30 p.m.; closed committee

deliberations, 1:30 p.m. to 4 p.m.; Jerilyn K. Glass, Center for

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

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

8517, or FDA Advisory Committee Information Hotline, 1-800-741-8138

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

code 12513.

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 September 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. The committee will discuss the following

topics: (1) Clinical perspectives on the use of balloon catheters,

coils, and liquid occlusive devices for the treatment of aneurysms,

arterio-venous malformations, or bleeding in the cerebrovascular

circulation; and (2) research considerations when designing studies to

evaluate these devices.

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)).

Immunology Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. September 21 and 22, 1995, 8 a.m., Holiday

Inn--Gaithersburg, Walker and Whetstone Ballrooms, 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 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, September

21, 1995, 8 a.m. to 9 a.m., unless public participation does not last

that long; open committee discussion, 9 a.m. to 1:30 p.m.; open public

hearing; 1:30 p.m. to 2:30 p.m., unless public participation does not

last that long; open committee discussion, 2:30 p.m. to 6 p.m.; closed

committee deliberations, September 22, 1995, 8 a.m. to 9 a.m.; open

public hearing, 9 a.m. to 10 a.m., unless public participation does not

last that long; open committee discussion, 10 a.m. to 5 p.m.; Peter E.

Maxim, Center for Devices and Radiological Health (HFZ-440), Food and

Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-

1293, or FDA Advisory Committee Information Hotline, 1-800-741-8138

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

code 12516.

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 September 1, 1995, and submit a brief

statement of

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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 the review of three premarket approval applications

for: (1) An in situ hybridization assay to measure a prognostic marker

in breast tumor tissues; (2) a serum tumor marker to aid in the

detection of recurrence in Stage 2 and 3 breast cancer patients; and

(3) an assay to measure a urinary marker to aid in the detection of

recurrence in bladder cancer patients.

Closed committee deliberations. FDA staff will present to the

committee trade secret and/or confidential commercial information

regarding pending or future device submissions. This portion of the

meeting will be closed to permit discussion of this information (5

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

Joint Meetings of Nonprescription Drugs Advisory Committee with

Endocrinologic and Metabolic Drugs Advisory Committee, Drug Abuse

Advisory Committee, and Gastrointestinal Drugs Advisory Committee

Date, time, and place. September 27 and 28, 1995, 8:30 a.m., and

September 29, 1995, 3 p.m., conference rms. D and E, Parklawn Bldg.,

5600 Fishers Lane, Rockville, MD.

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

27, 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, 5 p.m. to 6 p.m.; open public hearing,

September 28, 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 4

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

participation does not last that long; open committee discussion, 4:30

p.m. to 6:30 p.m.; open committee discussion, September 29, 1995, 3

p.m. to 4 p.m.; Lee L. Zwanziger, Stephen Pollitt, or Liz Ortuzar,

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), Nonprescription Drugs Advisory

Committee, code 12541.

General functions of the committees. The Nonprescription Drugs

Advisory Committee reviews and evaluates data concerning the safety and

effectiveness of over-the-counter (nonprescription) human drug products

for use in the treatment of a broad spectrum of human symptoms and

diseases. The Endocrinologic and Metabolic Drugs Advisory Committee

reviews and evaluates data on the safety and effectiveness of marketed

and investigational human drugs for use in endocrine and metabolic

disorders. The Drug Abuse Advisory 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,

efficacy, and abuse potential of drugs and recommends actions to be

taken on the marketing, investigation, and control of such drugs. The

Gastrointestinal Drugs Advisory Committee reviews and evaluates data on

the safety and effectiveness of marketed and investigational human

drugs for use in gastrointestinal 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 September 19, 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 September 27, 1995, the

Nonprescription Drugs Advisory Committee and some members of the

Endocrinologic and Metabolic Drugs Advisory Committee will discuss

public health issues relevant to cholesterol lowering regimens and data

relevant to new drug application (NDA) 16-640 for cholestyramine

(Questran powder) and NDA 19-669 for cholestyramine

(Questran Light with aspartame), sponsored by Bristol-Myers

Squibb to switch the products from prescription to over-the-counter

marketing status for use as adjunctive therapy to diet for the

reduction of elevated serum cholesterol in patients with primary

hypercholesterolemia (elevated low density lipoprotein (LDL)

cholesterol) who do not respond adequately to diet. On September 28,

1995, the Nonprescription Drugs Advisory Committee and the Drug Abuse

Advisory Committee will discuss data relevant to NDA 20-066

(Nicorette 4 milligrams (mg) and NDA 18-612

(Nicorette 2 mg) to switch nicotine polacrilex

(Nicorette, SmithKline Beecham Consumer Healthcare Products)

from prescription to over-the-counter status for use as an aid to

smoking cessation for the relief of nicotine withdrawal symptoms. Later

on September 28, 1995 the Nonprescription Drugs Advisory Committee and

some members of the Gastrointestinal Drugs Advisory Committee will

discuss data relevant to NDA 20-555 for nizatidine tablets, 75 mg,

sponsored by Whitehall-Robins Healthcare to switch the product from

prescription to over-the-counter status for the prevention of meal and

beverage induced heartburn. During the afternoon of September 29, 1995,

the Nonprescription Drugs Advisory Committee will discuss issues raised

during the Public Hearing before the Commissioner on Over-The-Counter

Drug Labeling held earlier during the same day.

Closed committee deliberations. On September 27, 1995, the

Nonprescription Drugs Advisory Committee will discuss trade secret and/

or confidential commercial information relevant to pending new drug

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 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

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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: August 16, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-20730 Filed 8-21-95; 8:45 am]

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