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:

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical

Devices Advisory Committee

Date, time, and place. April 6 and 7, 1995, 9 a.m., Holiday Inn--

Gaithersburg, Whetston and Walker Rooms, 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, April 6,

1995, 9 a.m. to 10 a.m., unless public participation does not last that

long; open committee discussion, 10 a.m. to 4 p.m.; open public

hearing, April 7, 1995, 9 a.m. to 10 a.m., unless public participation

does not last that long; open committee discussion, 10 a.m. to 4 p.m.,

Cornelia B. Rooks, Center for Devices and Radiological Health (HFZ-

440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD

20850, 301-594-1243, or FDA Advisory Committee Information Hotline, 1-

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

Chemistry and Clinical Toxicology Devices Panel, code 12514.

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 March 30, 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 6, 1995, the committee will

discuss a premarket approval application for a fetal fibronectin enzyme

immunoassay which is to be used in symptomatic women as an aid in the

prediction of impending preterm delivery. On April 7, 1995, the

committee will discuss a group of 510(k) applications pertaining to

sweat patch collection of drugs of abuse and their measurement. The

collection devices are intended for use by professionals in drug

treatment programs.

Pulmonary-Allergy Drugs Advisory Committee

Date, time, and place. April 10, 1995, 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 5 p.m.; Leander B. Madoo, Center for

Drug Evaluation and Research (HFD-9), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857, 301-443-4695, or

[[Page 14437]] FDA Advisory Committee Information Hotline, 1-800-741-

8138 (301-443-0572 in the Washington, DC area) Pulmonary-Allergy Drugs

Advisory Committee, code 12545.

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 treatment of pulmonary

disease and diseases with allergic and/or immunologic mechanisms.

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 24, 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 new drug

application (NDA) 20-471, Abbott Laboratories, Leutrol (zileuton) as an

anti-asthmatic drug.

Dental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs)

of the Medical Devices Advisory Committee

Date, time, and place. April 10, 11, and 12, 1995, 9 a.m., Parklawn

Bldg., conference room G, 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open public hearing, April 10,

1995, 9 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 public

hearing, April 11, 1995, 9 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 public hearing, April 12, 1995, 9 a.m. to 11 a.m., unless public

participation does not last that long; open committee discussion, 11

a.m. to 4 p.m.; Jeanne L. Rippere or Stephanie A. Mason, Center for

Drug Evaluation and Research (HFD-813), Food and Drug Administration,

7520 Standish Pl., Rockville, MD 20855, 301-594-1003, or FDA Advisory

Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), Dental Products Panel of the Medical Devices

Advisory Committee, code 12518.

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.

The Dental Products Panel of the Medical Devices Advisory Committee

functions at times as a nonprescription drug advisory panel. As such,

the panel reviews and evaluates available data concerning the safety

and effectiveness of active ingredients, and combinations thereof, of

various currently marketed nonprescription drug products for human use,

the adequacy of their labeling, and advises the Commissioner of Food

and Drugs on the promulgation of monographs establishing conditions

under which these drugs are generally recognized as safe and effective

and not misbranded.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on the general issues

pending before the subcommittee. Those desiring to make formal

presentations should notify the contact person before April 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. The subcommittee will continue with its

discussion begun during the December 5 and 7, 1994, meeting on

developing general guidelines for determining the safety and

effectiveness of antiplaque and antiplaque-related drug products. The

subcommittee will also begin discussion on the safety and effectiveness

of the ingredients stannous fluoride, zinc citrate, peppermint oil, and

sage oil for antiplaque and antiplaque-related uses.

Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory

Committee

Date, time, and place. April 20, 1995, 8 a.m., Corporate Bldg.,

Main Conference Room, 9200 Corporate Blvd., Rockville, MD. A limited

number of overnight accommodations are available at the Holiday Inn--

Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. 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 a.m. to

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

committee discussion, 9 a.m. to 6 p.m.; Harry R. Sauberman, Center for

Devices and Radiological Health (HFZ-470), Food and Drug

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

2080, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Ear, Nose, and Throat

Devices Panel, code 12522. If anyone who is planning to attend the

meeting will need any special assistance as defined under the Americans

with Disabilities Act, please notify the contact person above.

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 a supplement

to a premarket approval application that seeks to expand the indication

for use for an approved cochlear implant device to include

postlinguistically hearing-impaired adults who demonstrate severe-to-

profound hearing loss and who obtain some minimal benefit from

conventional amplification. The discussion will include the review of

clinical data obtained with the use of various speech processors.

National Mammography Quality Assurance Advisory Committee

Date, time, and place. April 24, 1995, 10 a.m., and April 25 and

26, 1995, 9 a.m., Dupont Plaza Hotel, 1500 New Hampshire Ave. NW.,

Washington, DC. A limited number of overnight accommodations have been

reserved at the Dupont Plaza Hotel. Attendees requiring overnight

accommodations may contact the hotel at 202-483-6000 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 committee discussion,

April 24, 1995, 10 a.m. to 3 p.m.; open subcommittee discussions, 3

p.m. to 5 p.m.; open subcommittee discussions, April 25, 1995, 9 a.m.

to 5 p.m.; open [[Page 14438]] public hearing, April 26, 1995, 9 a.m.

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

committee discussion, 10 a.m. to 3 p.m.; Charles K. Showalter, Center

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

Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332, or

FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-

0572 in the Washington, DC area), National Mammography Quality

Assurance Advisory Committee, code 12397.

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 April 18, 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 24 and 26, 1995, the committee

will discuss: (1) The development of three working groups (i.e.,

subcommittees) to consider access to mammography services, physicists

availability, and cost benefit of compliance; (2) the Congressional

reports and determinations mandated in the Mammography Quality

Standards Act (the MQSA); (3) the work of the subcommittees; and (4) a

briefing on inspections to date.

Open subcommittee discussions. On April 24 and 25, 1995, the three

subcommittees will meet concurrently. The subcommittees will discuss

preliminary information which is necessary to make the determinations

and subsequently prepare the reports as mandated in the MQSA. Upon

completion, the subcommittee reports will be reviewed by the committee

prior to submission to the Secretary and Congress.

Subcommittees of the National Task Force on AIDS Drug Development

Date, time, and place. April 25, 1995, 8:30 a.m.; April 26, 1995,

10 a.m.; Salons 1, 2, and 3, Congressional Ballroom; Bethesda Marriott,

5151 Pooks Hill Rd., Bethesda, MD.

Type of meeting and contact person. Open subcommittee discussion,

April 25, 1995, 8:30 a.m. to 4:30 p.m.; open public hearing, 4:30 p.m.

to 5:30 p.m., unless public participation does not last that long; open

subcommittee discussions, April 26, 1995, 10 a.m. to 4:30 p.m.; open

public hearing, 4:30 p.m. to 5:30 p.m., unless public participation

does not last that long; Jean H. McKay or Kimberley M. Miles, Office of

AIDS and Special Health Issues (HF-12), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857, 301-443-0104, or FDA Advisory

Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), National Task Force on AIDS Drug Development,

code 12602.

General function of the task force. The National Task Force on AIDS

Drug Development shall identify any barriers and provide creative

options for the rapid development and evaluation of treatments for

human immunodeficiency virus (HIV) infection and its sequelae. It also

advises on issues related to such barriers, and provides options for

the elimination of these barriers.

Open task force discussion. The four subcommittees of the task

force will meet to discuss barriers related to the identification of

specific drug targets and solutions to these barriers in preparation

for the next full meeting of the task force. Members of the

subcommittees, Federal government, and the public will participate in

these discussions.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the task force. Those desiring to make formal presentations should

notify the contact person before April 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.

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)

[[Page 14439]] 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: March 13, 1995.

Lireka P. Joseph,

Acting Deputy Commissioner for Operations.

[FR Doc. 95-6692 Filed 3-16-95; 8:45 am]

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