[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

[[Page 13656]]

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]
BILLING CODE 4160-01-F