[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13655-13657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7136]
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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 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:
Technical Electronic Product Radiation Safety Standards Committee
Date, time, and place. April 8 and 9, 1997, 8:30 a.m., Corporate
Bldg., conference rm. 020B, 9200 Corporate Blvd., Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd.,
Gaithersburg, MD. Attendees requiring overnight accommodations may
contact the hotel at 800-228-9290 or 301-590-0044 and reference the FDA
Advisory Committee meeting block. Reservations will be confirmed at the
group rate based on availability. Attendees with a disability requiring
special accommodations should contact Christie Wyatt, KRA Corp., 301-
495-1591, ext. 267.
Type of meeting and contact person. Open committee discussion,
April 8, 1997, 8:30 a.m. to 10:15 a.m.; open public hearing, 10:15 a.m.
to 11 a.m., unless public participation does not last that long; open
committee discussion, 11 a.m. to 3 p.m.; open public hearing, 3 p.m. to
4 p.m., unless public participation does not last that long; open
committee discussion, 4 p.m. to 5 p.m.; open committee discussion,
April 9, 1997, 8:30 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 2:15 p.m.; Orhan H. Suleiman, 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), Technical Electronic Product Radiation Safety
Standards Committee, code 12399. Please call the hotline for
information concerning any possible changes.
General function of the committee. The committee advises on
technical feasibility, reasonableness, and practicability of
performance standards for electronic products to control the emission
of radiation under 42 U.S.C. 263f(f)(1)(A).
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
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contact person before March 28, 1997, 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 specifically discuss
draft amendments to performance standards for ionizing radiation-
emitting products (i.e., mammography equipment (21 CFR 1020.31), and
laser products (21 CFR 1040.10). There will be updates to the committee
on cellular telephone research, environmental electromagnetic
radiation, diagnostic ultrasound, microwave clothes dryers, and
commercially used mercury lamps. In addition, a notice of intent to
propose amendments to fluoroscopic equipment will be discussed (21 CFR
1020.32).
Pulmonary Allergy Drugs Advisory Committee
Date, time, and place. April 11, 1997, 8 a.m., Quality Hotel,
Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion, 8
a.m. to 9:30 a.m.; open public hearing, 9:30 a.m. to 12:30 p.m., unless
public participation does not last that long; open committee
discussion, 12:30 p.m. to 4:30 p.m.; Leander B. Madoo, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Pulmonary-Allergy Drugs Advisory Committee, code
12545. Please call the hotline for information concerning any possible
changes.
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 April 4, 1997, 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. FDA staff will present to the committee
the agency's advance notice of proposed rulemaking, which proposes a
strategy for the withdrawal of the essential use status of marketed
chlorofluorocarbon (CFC) products as proven alternatives become
available. A representative from the U.S. Environmental Protection
Agency will present an overview of the environmental impact of CFC's
and a review of the Montreal Protocol on ozone-depleting substances.
The committee will discuss and comment upon the agency's proposed
strategy for the CFC-transition process and on presentations made
during the open public hearing. Advisory committee input, in addition
to open public hearing comments, will be considered by the agency as it
formulates subsequent rulemaking related to the CFC-transition process.
Advisory Committee for Pharmaceutical Science
Date, time, and place. May 7, 1997, 8:30 a.m., and May 8, 1997, 8
a.m., Holiday Inn--Gaithersburg, Goshen Ballroom, Two Montgomery
Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open committee discussion, May
7, 1997, 8:30 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2 p.m.,
unless public participation does not last that long; open committee
discussion, 2 p.m. to 5:30 p.m.; open committee discussion, May 8,
1997, 8 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2 p.m., unless
public participation does not last that long; open committee
discussion, 2 p.m. to 5:30 p.m.; Kimberly L. Topper, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, e-mail:
[email protected], or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), Advisory
Committee for Pharmaceutical Science, code 12539. Please call the
hotline for information concerning any possible changes.
General function of the committee. The committee gives advice on
scientific and technical issues concerning the safety and effectiveness
of human generic drug products for use in the treatment of a broad
spectrum 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 April 1, 1997, 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 May 7, 1997, the committee will
discuss the Biopharmaceutics Research and Policy Issues and Chemistry
Research and Policy Issues. On May 8, 1997, the committee will discuss
Pharmacology/Toxicology Research Programs: Objectives and Status.
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 the meeting(s) 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
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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 (a)(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, 1997.
Michael A. Friedman, M.D.,
Deputy Commissioner for Operations.
[FR Doc. 97-7136 Filed 3-20-97; 8:45 am]
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