[Federal Register Volume 59, Number 180 (Monday, September 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23151]


[[Page Unknown]]

[Federal Register: September 19, 1994]


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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