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.

-----------------------------------------------------------------------

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.

MEETINGS: The following advisory committee meetings are announced:

Antiviral Drugs Advisory Committee

Date, time, and place. September 12 and 13, 1994, 8:30 a.m.;

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

Type of meeting and contact person. Open committee discussion,

September 12, 1994, 8:30 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 5 p.m.; open committee discussion,

September 13, 1994, 8:30 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 4 p.m.; Lee L. Zwanziger or Valerie

Mealy, Center for Drug Evaluation and Research (HFD-9), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.

General function of the committee. The committee reviews and

evaluates available data concerning the safety and effectiveness of

marketed and investigational human drug products for use in the

treatment of acquired immune deficiency syndrome (AIDS), AIDS-related

complex (ARC), and other viral, fungal, and mycobacterial infections.

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 2, 1994, 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 scientific

and medical issues relevant to the validation of surrogate markers for

use as criteria in regulatory decisionmaking.

Anti-Infective Drugs Advisory Committee

Date, time, and place. September 23, 1994, 8 a.m., Holiday Inn,

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

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 11:30 a.m.; Ermona B. McGoodwin or Mary

Elizabeth Donahue, Center for Drug Evaluation and Research (HFD-9),

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,

301-443-5455.

General function of the committee. The Anti-Infective Drugs

Advisory Committee reviews and evaluates data relating to the safety

and effectiveness of marketed and investigational human drugs for use

in infectious and ophthalmic disorders.

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 16, 1994, 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 surrogate

markers, such as pharmacokinetic parameters and microbiological

inhibitory and cidal data, and whether these parameters can be used

instead of clinical efficacy data to support an alternative dosing

regimen for oral metronidazole in the treatment of Trichomonas

vaginalis vaginitis.

Joint Meeting of the Dermatologic Drugs and Anti-Infective Drugs

Advisory Committees

Date, time, and place. September 23, 1994, 1 p.m., conference rms.

D and E , Parklawn Bldg., 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open public hearing, 1 p.m. to

2 p.m., unless public participation does not last that long; open

committee discussion, 2 p.m. to 5 p.m.; Ermona B. McGoodwin or Valerie

Mealy, Center for Drug Evaluation and Research (HFD-9), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455.

General function of the committees. The Dermatologic Drugs Advisory

Committee reviews and evaluates data on the safety and effectiveness of

marketed and investigational human drugs for use in the treatment of

dermatologic diseases. The Anti-Infective Drugs Advisory Committee

reviews and evaluates data relating to the safety and effectiveness of

marketed and investigational human drugs for use in infectious and

ophthalmic disorders.

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 16, 1994, 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 committees will discuss the

potential for development of antibiotic resistance with over-the-

counter use of topical erythromycin in the treatment of acne.

Peripheral and Central Nervous System Drugs Advisory Committee

Date, time, and place. September 26 and 27, 1994, 8:30 a.m.,

conference rms. D and E, Parklawn Bldg., 5600 Fishers Lane, Rockville,

MD.

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

26, 1994, 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

public hearing, September 27, 1994, 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.; Michael A. Bernstein, Center for Drug

Evaluation and Research (HFD-120), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-2775.

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 neurological 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, 1994, 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 discussions. On September 26, 1994, the committee

will discuss the safety and effectiveness of Freedox

(tirilazad mesylate), new drug application (NDA) 20-399, The Upjohn

Co., for use in the treatment of subarachnoid hemorrhage. On September

27, 1994, the committee will discuss the safety and effectiveness of

Tegretol (carbamazepine), NDA 18-927, Basel Pharmaceuticals,

for use as an anticonvulsant in children under 6 years old.

Additionally, the committee will reconsider the relative risks and

benefits of Felbatol (felbamate), NDA 20-189, Carter-Wallace,

for use in the treatment of epilepsy.

National Mammography Quality Assurance Advisory Committee

Date, time, and place. September 28, 1994, 10 a.m., and September

29 and 30, 1994, 8:30 a.m., Gaithersburg Hilton Hotel, 620 Perry Pkwy.,

Gaithersburg, MD. A limited number of overnight accommodations have

been reserved at the Gaithersburg Hilton Hotel. Attendees requiring

overnight accommodations may contact the hotel at 301-977-8900 and

reference the FDA committee meeting block. Reservations will be

confirmed at the group rate based on availability.

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

28, 1994, 10 a.m. to 11 a.m., unless public participation does not last

that long; open committee discussion, 11 a.m. to 5 p.m.; open committee

discussion, September 29, 1994, 8:30 a.m. to 5 p.m.; open committee

discussion, September 30, 1994, 8:30 a.m. to 5 p.m.; Charles K.

Showalter, Center for Devices and Radiological Health (HFZ-240), Food

and Drug Administration, 1901 Chapman Ave., Rockville, MD 20857, 301-

594-3311.

General function of the committee. The committee advises on

developing appropriate quality standards and regulations for the use of

mammography facilities.

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 23, 1994, 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 draft

final standards for accreditation bodies and the draft final standards

for facilities. Specific topics to be discussed include: States as

certifying bodies, mobile units, breast implant imaging, consumer

complaint mechanism, and equipment other than the x-ray unit.

FDA public advisory committee meetings 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.

There are no closed portions for the meetings announced in this notice.

The dates and times reserved for the open 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.

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 15, 1994.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 94-20510 Filed 8-19-94; 8:45 am]

BILLING CODE 4160-01-F