[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