Advisory Committees; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

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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:

National Task Force on Aids Drug Development

Date, time, and place. October 12, 1995, 8:30 a.m., Hubert H.

Humphrey Bldg., rm. 800, 200 Independence Ave. SW., Washington, DC.

Type of meeting and contact person. Open task force discussion,

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; Heidi C. Marchand

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 task force 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 task force will present, hear, and

discuss recommendations made at previous meetings and discuss the

future of the task force.

FDA is giving less than 15 days public notice of the advisory

committee meeting because of the urgent need to address the potential

risk of this disease to public health safety. The agency decided that

it was in the public interest to hold this scientific discussion on

October 12, 1995, even if there was not sufficient time for the

customary 15-day public notice.

Agenda--Open public hearing. Interested persons may present

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 October 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.

National Mammography Quality Assurance Advisory Committee

Date, time, and place. October 16, 1995, 10 a.m., and October 17

and 18, 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,

October 16, 1995, 10 a.m. to 12 m.; open subcommittee discussions, 12

m. to 5 p.m.; open public hearing, October 17, 1995, 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.; open subcommittee discussions, October

18, 1995, 9 a.m. to 1 p.m.; open committee discussion, 1 p.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 October 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. On October 16, 1995, the committee will

discuss a methodology of assessing the costs and benefits of the

Mammography Quality Standards Act (the MQSA). On October 17, 1995, the

committee will discuss facility inspection procedures and have a

briefing by FDA on facility inspections to date. Copies of the ``MQSA

Facility Inspection Procedures'' may be obtained by submitting a

written request to John L. McCrohan at the address given above for the

FDA contact person. On October 18, 1995, the committee will discuss the

ongoing work of the three subcommittees: Access to Mammography

Services, Physicists Availability, and Cost Benefit of Compliance.

Open subcommittee discussions. On October 16 and 18, 1995, the

three subcommittees will meet concurrently. The subcommittees will

discuss information that is necessary to make the determinations and

subsequently prepare the reports mandated by the MQSA. Upon completion,

the subcommittee reports will be reviewed by the committee prior to

submission to the Secretary of Health and Human Services and Congress.

Advisory Committee on Special Studies Relating to the Possible Long-

Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand

Advisory Committee)

Date, time, and place. October 25, 1995, 8:30 a.m., Hubert H.

Humphrey Bldg., rm. 405-A, 200 Independence Ave. SW., Washington, DC.

Type of meeting and contact person. Open committee discussion, 8:30

a.m. to 10:30 a.m.; open public hearing, 10:30 a.m. to 11:30 a.m.,

unless public participation does not last that long; open committee

discussion, 11:30 a.m. to 5 p.m.; Ronald F. Coene, National Center for

Toxicological Research (HFT-10), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-3155, or FDA Advisory

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

Washington, DC area), Ranch Hand Advisory Committee, code 12560.

General function of the committee. The committee shall advise the

Secretary and the Assistant Secretary for Health concerning its

oversight of the conduct of the Ranch Hand Study by the Air Force and

other studies in which the Secretary or the Assistant Secretary for

Health believes involvement by the advisory committee is desirable.

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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 October 16, 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 requested to make their comments.

Open committee discussion. The committee will review and provide

comments on the draft protocol and questionnaire for the Department of

Veterans Affairs, Army Chemical Corps Vietnam Veterans Health Study,

developed by the Environmental and Epidemiology Service, Department of

Veterans Affairs, Veterans Administration.

A final agenda will be available October 18, 1995, from the contact

person.

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: September 25, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95-24219 Filed 9-28-95; 8:45 am]

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