[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Notices]
[Pages 50628-50630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
[[Page 50629]]
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:
National Task Force on Aids Drug Development
Date, time, and place. October 12, 1995, 8:30 a.m., Hubert H.
Humphrey Bldg., rm. 800, 200 Independence Ave. SW., Washington, DC.
Type of meeting and contact person. Open task force discussion,
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; Heidi C. Marchand
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 task force 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 recommendations made at previous meetings and discuss the
future of the task force.
FDA is giving less than 15 days public notice of the advisory
committee meeting because of the urgent need to address the potential
risk of this disease to public health safety. The agency decided that
it was in the public interest to hold this scientific discussion on
October 12, 1995, even if there was not sufficient time for the
customary 15-day public notice.
Agenda--Open public hearing. Interested persons may present
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 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.
National Mammography Quality Assurance Advisory Committee
Date, time, and place. October 16, 1995, 10 a.m., and October 17
and 18, 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,
October 16, 1995, 10 a.m. to 12 m.; open subcommittee discussions, 12
m. to 5 p.m.; open public hearing, October 17, 1995, 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 subcommittee discussions, October
18, 1995, 9 a.m. to 1 p.m.; open committee discussion, 1 p.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 October 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. On October 16, 1995, the committee will
discuss a methodology of assessing the costs and benefits of the
Mammography Quality Standards Act (the MQSA). On October 17, 1995, the
committee will discuss facility inspection procedures and have a
briefing by FDA on facility inspections to date. Copies of the ``MQSA
Facility Inspection Procedures'' may be obtained by submitting a
written request to John L. McCrohan at the address given above for the
FDA contact person. On October 18, 1995, the committee will discuss the
ongoing work of the three subcommittees: Access to Mammography
Services, Physicists Availability, and Cost Benefit of Compliance.
Open subcommittee discussions. On October 16 and 18, 1995, the
three subcommittees will meet concurrently. The subcommittees will
discuss information that is necessary to make the determinations and
subsequently prepare the reports mandated by the MQSA. Upon completion,
the subcommittee reports will be reviewed by the committee prior to
submission to the Secretary of Health and Human Services and Congress.
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 25, 1995, 8:30 a.m., Hubert H.
Humphrey Bldg., rm. 405-A, 200 Independence Ave. SW., Washington, DC.
Type of meeting and contact person. Open committee discussion, 8:30
a.m. to 10:30 a.m.; open public hearing, 10:30 a.m. to 11:30 a.m.,
unless public participation does not last that long; open committee
discussion, 11:30 a.m. to 5 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, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Ranch Hand Advisory Committee, code 12560.
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.
[[Page 50630]]
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 16, 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 requested to make their comments.
Open committee discussion. The committee will review and provide
comments on the draft protocol and questionnaire for the Department of
Veterans Affairs, Army Chemical Corps Vietnam Veterans Health Study,
developed by the Environmental and Epidemiology Service, Department of
Veterans Affairs, Veterans Administration.
A final agenda will be available October 18, 1995, from the contact
person.
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 25, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-24219 Filed 9-28-95; 8:45 am]
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