[Federal Register Volume 60, Number 52 (Friday, March 17, 1995)]
[Notices]
[Pages 14436-14439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6692]
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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.
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]
BILLING CODE 4160-01-F
