[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Notices]
[Pages 59448-59451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29831]
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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
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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:
Neurological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. December 3, 1996, 9:30 a.m., Corporate
Bldg., conference room 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
Panel meeting block. Reservations will be confirmed at the group rate
based on availability. Attendees with a disability requiring special
accommodations should contact Sue Bae, KRA Corp., at 301-495-1591, ext.
227. The availability of appropriate accommodations cannot be assured
unless prior notification is received.
Type of meeting and contact person. Open public hearing, 9:30 a.m.
to 10:30 a.m., unless public participation does not last that long;
open committee discussion, 10:30 a.m. to 3:30 p.m.; G. Levering Keely,
Center for Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8517, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Neurological Devices Panel,
code 12513. 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 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 November 25, 1996, 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 and vote on a
premarket approval application (PMA) for a cranial electrotherapy
stimulator for the management of anxiety disorders and short term
relief of symptoms of anxiety.
FDA regrets that it was unable to publish this notice 15 days prior
to the December 3, 1996, Neurological Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring this issue to public discussion and qualified
members of the Neurological Devices Panel of the Medical Devices
Advisory Committee were available at this time, the Commissioner
concluded that it was in the public interest to hold this meeting even
if there was not sufficient time for the customary 15-day public
notice.
Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. December 10 and 11, 1996, 8 a.m., Holiday
Inn--Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Open public hearing, December
10, 1996, 8 a.m. to 8:30 a.m., unless public participation does not
last that long; open committee discussion, 8:30 a.m. to 5 p.m.; open
public hearing, December 11, 1996, 8 a.m. to 8:30 a.m., unless public
participation does not last that long; open committee discussion, 8:30
a.m. to 5 p.m.; Kathleen R. Reedy or LaNise S. Giles, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Endocrinologic and Metabolic Drugs Advisory
Committee, code 12536. 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 endocrine and metabolic
disorders.
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 December 4, 1996, 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 December 10, 1996, the committee will
hear presentations and discuss data submitted regarding new drug
application (NDA) 20-656, Nutropin (somatropin [rDNA origin]
for injection, Genentech, Inc.) and NDA 19-640/S-018,
Humatrope (somatropin [rDNA origin] for injection, Eli Lilly
and Co.) for the treatment of Turner's Syndrome. On December 11, 1996,
the committee will hear presentations and discuss data submitted
regarding NDA 20-720, RezulinTM (troglidizone, Parke Davis
Pharmaceutical Research, a Division of Warner-Lambert) and NDA 20-719,
PrelayTM (troglidizone, Sankyo U.S.A.) for the treatment of type
II diabetes inadequately controlled with insulin therapy.
Drug Abuse Advisory Committee
Date, time, and place. December 12 and 13, 1996, 8 a.m., Holiday
Inn--Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Open public hearing, December
12, 1996, 8 a.m. to 8:30 a.m., unless public participation does not
last that long; open committee discussion, 8:30 a.m. to 5:30 p.m.; open
public hearing, December 13, 1996, 8 a.m. to 8:30 a.m., unless public
participation does not last that long; open committee discussion, 8:30
a.m. to 5:30 p.m.; Tracy Riley, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-443-5455, or FDA Advisory Committee Information Hotline,
1-800-741-8138 (301-443-0572 in the Washington, DC area), Drug Abuse
Advisory Committee, code 12535. Please call the hotline for
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information concerning any possible changes.
General function of committee. The committee advises on the
scientific and medical evaluation of information gathered by the
Department of Health and Human Services and the Department of Justice
on the safety, efficacy, and abuse potential of drugs and recommends
actions to be taken on the marketing, investigation, and control of
such drugs.
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 November 28, 1996, 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 December 12, 1996, the committee will
discuss NDA 20-711, bupropion hydrochloride sustained release tablets,
Glaxo Wellcome Inc., as an aid for smoking cessation. On December 13,
1996, the committee will discuss NDA 20-724, Nicotrol Inhaler
(nicotine inhalation system), Pharmacia and Upjohn, Inc., as an aid for
smoking cessation.
Oncologic Drugs Advisory Committee
Date, time, and place. December 16, 1996, 8:30 a.m., DoubleTree
Hotel, Plazas II and III, 1750 Rockville Pike, Rockville, MD.
Type of meeting and contact person. Open public hearing, 8:30 a.m.
to 9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 1 p.m.; open public hearing, 1 p.m. to
1:30 p.m., unless public participation does not last that long; open
committee discussion, 1:30 p.m. to 4:30 p.m.; Jannette O'Neill-
Gonzalez, Center for Drug Evaluation and Research (HFD-21), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
5455, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Oncologic Drugs Advisory
Committee, code 12542. 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 cancer.
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 December 2, 1996, 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: (1) NDA 20-
726 FemaraTM Tablets (letrozole, CGS 20267, Ciba-Geigy Corp.), for
the treatment of advanced breast cancer in women with natural or
artificially induced postmenopausal status, following antiestrogen
therapy; and (2) product license application (PLA) 92-0306
TICE (BCG Vaccine, Organon Teknika Corp.), for intravesical
installation for prophylaxis against recurrent papillary carcinoma of
the urinary bladder.
Dental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs)
of the Medical Devices Advisory Committee
Date, time, and place. December 16 and 17, 1996, 8:30 a.m., Holiday
Inn--Bethesda, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.
Type of meeting and contact person. Open public hearing, December
16, 1996, 8:30 a.m. to 12 m., unless public participation does not last
that long; open committee discussion, 12 m. to 5 p.m.; open public
hearing, December 17, 1996, 8:30 a.m. to 12 m., unless public
participation does not last that long; open committee discussion, 12 m.
to 5 p.m.; Robert L. Sherman or Stephanie A. Mason, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 9201
Corporate Blvd., Rockville, MD 20850, 301-827-2294, 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. 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 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 December 1, 1996,
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 subcommittee discussion. On December 16, 1996, the
subcommittee will discuss xylitol, C31G-Therasol, and the effectiveness
of menthol, thymol, methyl salicylate, and eucalyptol. On December 17,
1996, the subcommittee will discuss microdent, and continue its
discussion of sodium lauryl sulfate. In addition, the subcommittee will
continue its discussion and vote on cetylpyridinium chloride, stannous
fluoride, hydrogen peroxide, and sodium bicarbonate. If necessary, the
subcommittee will continue its discussion of the effectiveness of
menthol, thymol, methyl salicylate, and eucalyptol.
Subcommittee Meeting of the Anesthetic and Life Support Drugs Advisory
Committee
Date, time, and place. December 18, 1996, 8:30 a.m., Holiday Inn--
Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open public hearing, 8:30 a.m.
to 9:30 a.m., unless public participation does not last that long; open
committee discussion, 9:30 a.m. to 5 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,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Anesthetic and Life Support Drugs
Advisory Committee, code 12529. Please call the
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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 field of anesthesiology and
surgery.
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 December 4, 1996, 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 labeling for
NDA 18-654, Versed (midazolam HC1), Hoffmann La-Roche, for
pediatric sedation.
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 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23,
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: November 15, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-29831 Filed 11-21-96; 8:45 am]
BILLING CODE 4160-01-F
