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.

MEETINGS: The following advisory committee meetings are announced:

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 4, 1994, 9 a.m., Hubert H. Humphrey

Bldg., Stonehenge Room, suite 615-F, 200 Independence Ave. SW.,

Washington, DC.

Type of meeting and contact person. 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 4 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.

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.

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 initiate the review

of the report analyzing the 1992 health examination of participants in

the Air Force Health study entitled ``An Epidemiologic Investigation of

Health Effects in Air Force Personnel Following Exposure to

Herbicides.'' This review will include the chapters dealing with

General Health, Dermatology, Renal Function, and Pulmonary Function.

Criteria for release of data sets from previous health examinations

conducted for the Air Force Health study will also be discussed.

Representatives from the Department of Veterans Affairs will present an

outline of their plan for conduct of a health study of Army veterans

assigned to Chemical Corps units in Vietnam.

Dental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs)

of the Medical Devices Advisory Committee

Date, time, and place. October 11 and 12, 1994, 9 a.m., Holiday

Inn--Silver Spring, International Ballroom, 8777 Georgia Ave., Silver

Spring, MD.

Type of meeting and contact person. Open committee discussion,

October 11, 1994, 9 a.m. to 12 m.; open public hearing, 12 m. to 3

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

committee discussion, 3 p.m. to 5 p.m.; open committee discussion,

October 12, 1994, 9 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 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.

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 September 30,

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 subcommittee will continue with its

discussions held during the June 28 and 29, 1994, meeting as follows:

(1) The possible relationship of alcohol-containing mouthwashes to the

development of oral and pharyngeal cancers, and (2) work on developing

general guidelines for determining the safety and effectiveness of

antiplaque and antiplaque-related drug products. The subcommittee will

also work on a draft document to be presented to the Dental Products

Panel at a future meeting.

Dental Device Ingredient Labeling Subcommittee of the Dental Products

Panel of the Medical Devices Advisory Committee

Date, time, and place. October 12, 1994, 9 a.m., Gaithersburg

Hilton Hotel, Salon C, 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 Panel

meeting block. Reservations will be confirmed at the group rate based

on availability.

Type of meeting and contact person. 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.; Carolyn A. Tylenda, Center for

Devices and Radiological Health (HFZ-410), Food and Drug

Administration, 1390 Piccard Dr., Rockville, MD, 301-594-3090.

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 October 1, 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 dental device

ingredient labeling.

Cardiovascular and Renal Drugs Advisory Committee

Date, time, and place. October 13 and 14, 1994, 9 a.m., National

Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium,

9000 Rockville Pike, Bethesda, MD.

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

13, 1994, 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 committee

discussion, October 14, 1994, 9 a.m. to 5 p.m.; Joan C. Standaert,

Center for Drug Evaluation and Research (HFD-110), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-259-6211 or

Valerie M. Mealy, Advisors and Consultants Staff, 301-443-4695.

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 cardiovascular and renal

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 October 1, 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. On October 13, 1994, the committee will

discuss drug interactions and antianginal guidelines. On October 14,

1994, the committee will discuss the new drug application (NDA) 20-377

for Cordarone, I.V. amiodarone HCl, Wyeth-Ayerst

Laboratories, to be indicated for life-threatening arrhythmias.

Dental Products Panel of the Medical Devices Advisory Committee

Date, time, and place. October 13 and 14, 1994, 9 a.m.,

Gaithersburg Hilton Hotel, Salon C, 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 Panel

meeting block. Reservations will be confirmed at the group rate based

on availability.

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

13, 1994, 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 public

hearing, October 14, 1994, 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., Carolyn A. Tylenda, Center for Devices and Radiological

Health (HFZ-410), Food and Drug Administration, 1390 Piccard Dr.,

Rockville, MD, 301-594-3090.

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 October 1, 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. On October 13 and 14, 1994, the

committee will discuss: (1) Classification of muscle monitor devices;

(2) reclassification of dental mercury; (3) bone filling and

augmentation materials; (4) dental device ingredient labeling; and (5)

draft guidance documents for dental endosseous implants and

temporomandibular joint implants. Copies of the draft guidance

documents are available from the Division of Small Manufacturers

Assistance, Center for Devices and Radiological Health (HFZ-220), Food

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 800-

638-2041 or 301-443-6597.

Blood Products Advisory Committee

Date, time, and place. October 20 and 21, 1994, 8 a.m., Holiday

Inn--Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring,

MD.

Type of meeting and contact person. Open committee discussion,

October 20, 1994, 8 a.m. to 9:20 a.m.; open public hearing, 9:20 a.m.

to 9:40 a.m., unless public participation does not last that long; open

committee discussion, 9:40 a.m. to 11:40 a.m.; open public hearing,

11:40 a.m. to 12 m., unless public participation does not last that

long; open committee discussion, 12 m. to 2:30 p.m.; open public

hearing, 2:30 p.m. to 3 p.m., unless public participation does not last

that long; open committee discussion, 3 p.m. to 5 p.m.; open committee

discussion, October 21, 1994, 8 a.m. to 9:30 a.m.; open public hearing,

9:30 a.m. to 10 a.m., unless public participation does not last that

long; open committee discussion, 10 a.m. to 12:30 p.m.; Linda A.

Smallwood, Office of Blood Research and Review (HFM-300), Center for

Biologics Evaluation and Research, Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852, 301-594-6700.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness, and appropriate use of

blood products intended for use in the diagnosis, prevention, or

treatment 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 October 10, 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. On October 20, 1994, the committee will

discuss and provide recommendations for: (1) Revised donor testing and

suitability criteria related to the use of treponemal screening tests

for syphilis, (2) issues related to the dating period for irradiated

red blood cells, and (3) issues concerning donor suitability. On

October 21, 1994, the committee will discuss public health issues

related to the use of gloves by phlebotomists in blood establishments.

Hematology and Pathology Devices Panel of the Medical Devices Advisory

Committee

Date, time, and place. October 21, 1994, 10 a.m., Holiday Inn--

Gaithersburg, Walker and Whetstone 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, 10 a.m. to

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

committee discussion, 11 a.m. to 4 p.m., Djuana Blagmon, Center for

Devices and Radiological Health (HFZ-440), Food and Drug

Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-2096.

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 October 14, 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

classification of immunohistochemical devices.

Science Board to the Food and Drug Administration

Date, time, and place. October 21, 1994, 8:30 a.m., Bethesda Ramada

Hotel and Conference Center, Ambassador Ballrooms I and II, 8400

Wisconsin Ave., Bethesda, MD.

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

a.m. to 2:30 p.m.; open public hearing, 2:30 p.m. to 3:30 p.m., unless

public participation does not last that long; open committee

discussion, 3:30 p.m. to 6 p.m.; Neil L. Wilcox, Office of the Senior

Advisor for Science (HF-33), Food and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301-443-5839.

General function of the board. The board shall provide advice

primarily to the agency's Senior Science Advisor and, as needed, to the

Commissioner and other appropriate officials on specific complex and

technical issues as well as emerging issues within the scientific

community in industry and academia. Additionally, the board will

provide advice to the agency on keeping pace with technical and

scientific evolutions in the fields of regulatory science; on

formulating an appropriate research agenda; and on upgrading its

scientific and research facilities to keep pace with these changes. It

will also provide the means for critical review of agency sponsored

intramural and extramural scientific research programs.

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

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

the board. Those desiring to make formal presentations must notify the

contact person before October 7, 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. Each presenter will

be limited in time and not all requests to speak may be able to be

accommodated. All written statements submitted in a timely fashion will

be provided to the board.

Open committee discussion. The board will continue to discuss

issues related to the test strategy for toxicity and carcinogenicity of

substances regulated by FDA. The primary agenda item will consist of

short presentations followed by general discussion on the development

and validation of alternatives to the 2-year rodent carcinogenicity

assay.

National Task Force on AIDS Drug Development

Date, time, and place. October 27, 1994, 9:30 a.m., October 28,

1994, 8:30 a.m., The Hyatt Regency--Crystal City, Regency Rooms C and

D, 2799 Jefferson Davis Hwy., Arlington, VA.

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

October 27, 1994, 9:30 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 task force discussion, October 28, 1994, 8:30 a.m. to 11:30 a.m.;

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.

General function of the task force. The 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 task force will present, hear, and

discuss issues on the barriers to acquired immune deficiency syndrome

(AIDS) drug development from the perspective of task force members,

members of the Federal government, and the public. The task force will

determine how to proceed with overcoming the barriers to AIDS drug

development.

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 October 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.

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 13, 1994.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 94-23151 Filed 9-16-94; 8:45 am]

BILLING CODE 4160-01-F