[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