[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]
BILLING CODE 4160-01-F-----