[Federal Register Volume 60, Number 222 (Friday, November 17, 1995)]
[Notices]
[Pages 57720-57722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee; Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting and methods by
which interested persons may participate in open public hearings before
FDA's advisory committees.
[[Page 57721]]
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.
MEETING: The following advisory committee meeting is announced:
Peripheral and Central Nervous System Drugs Advisory Committee
Date, time, and place. December 4, 1995, 8:30 a.m., Parklawn Bldg.,
conference rooms D and E, 5600 Fishers Lane, Rockville, 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 4 p.m.; William Freas or Sheila D.
Langford, Center for Biologics Evaluation and Research (HFM-21), Food
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-0314, Michael A. Bernstein, Center for Drug Evaluation and Research
(HFD-120), Food and Drug Administration, 5600 Fishers Lane, Rockville
MD 20857, 301-594-5521, or FDA Advisory Committee Information Hotline,
1-800-741-8138 (301-443-0572 in the Washington, DC area), Peripheral
and Central Nervous System Drugs Advisory Committee, code 12543.
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 neurological disease.
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, 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 product
license application 95-0979 from Biogen, Inc., for Interferon Beta-1a
(AvonexTM), for treatment of relapsing forms of multiple
sclerosis.
Dental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs)
of the Medical Devices Advisory Committee
Date, time, and place. December 4 and 5, 1995, 8:30 a.m.,
DoubleTree Hotel, Conference Center, Rockville, MD.
Type of meeting and contact person. Open public hearing, December
4, 1995, 8:30 a.m. to 11 a.m., unless public participation does not
last that long; open committee discussion, 11 a.m. to 5:30 p.m.; open
public hearing, December 5, 1995, 8:30 a.m. to 10:30 a.m., unless
public participation does not last that long; open committee
discussion, 10:30 a.m. to 4 p.m.; Jeanne L. Rippere or Stephanie A.
Mason, Center for Drug Evaluation and Research (HFD-560), 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 November 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. On December 4, 1995, the subcommittee
will discuss data and information submitted to support the safety and
effectiveness of hydrogen peroxide, sodium bicarbonate, and a
combination of these two ingredients for use in the prevention and/or
treatment of dental plaque and gingivitis. On December 5, 1995, if
necessary, the subcommittee will continue its discussion of hydrogen
peroxide and sodium bicarbonate. In addition, it will begin to discuss
data and information submitted to support the safety and effectiveness
of sanguinaria extract for use in the prevention and/or treatment of
dental plaque and gingivitis.
Dermatologic and Ophthalmic Drugs Advisory Committee Subcommittee on
Ophthalmic Drugs With Representation From the Antiviral Drugs Advisory
Committee
Date, time, and place. December 8, 1995, 8:30 a.m., Holiday Inn--
Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, 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., Ermona B. McGoodwin or
Valerie M. Mealy, 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), Dermatologic and
Ophthalmic Drugs Advisory Committee, code 12534.
General function of the committee. The committee reviews and
evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of dermatologic and ophthalmic 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 1, 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
[[Page 57722]]
approximate time required to make their comments.
Open committee discussion. The committee will discuss data relevant
to the new drug application (NDA) 20-569 ganciclovir intravitreal
implant (Vitrasert Sterile Intravitreal Implant, Chiron
Vision Corp.) for treatment of cytomegalovirus retinitis. The committee
will also discuss data relevant to NDA 20-597 latanoprost
(XalatanTM Sterile Ophthalmic Solution, Pharmacia, Inc.) a topical
ophthalmic drug indicated for the reduction of elevated intraocular
pressure in patients with open-angle glaucoma and ocular hypertension.
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: November 13, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-28366 Filed 11-16-95; 8:45 am]
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