[Federal Register Volume 59, Number 246 (Friday, December 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31596]


[[Page Unknown]]

[Federal Register: December 23, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

 

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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.
MEETING: The following advisory committee meetings are announced:
Joint Meeting of the Antiviral Drugs Advisory Committee and 
Nonprescription Drugs Advisory Committee
    Date, time, and place. January 11, 1995, 9 a.m. and January 12, 
1995, 8 a.m., Parklawn Bldg., conference rooms D and E, 5600 Fishers 
Lane, Rockville, MD.
    Type of meeting and contact person. Closed committee deliberations, 
January 11, 1995, 9 a.m. to 5 p.m.; open committee discussion, January 
12, 1995, 8 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 5 p.m.; Lee L. Zwanziger or Liz Ortuzar, Center 
for Drug Evaluation and Research (HFD-9), 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), Antiviral Drugs Advisory Committee, code 12531.
    General function of the committees. The Antiviral Drugs Advisory 
Committee reviews and evaluates available data concerning the safety 
and effectiveness of marketed and investigational human drug products 
for use in the treatment of acquired immune deficiency syndrome (AIDS), 
AIDS-related complex (ARC), and other viral, fungal, and mycobacterial 
infections. The Nonprescription Drugs Advisory Committee reviews and 
evaluates available data concerning the safety and effectiveness of 
over-the-counter (nonprescription) human drug products for use in the 
treatment of a broad spectrum of human symptoms and 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 January 6, 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 committees will jointly discuss data 
submitted in support of supplementary new drug application (NDA) 18-
828/S-015, to switch acyclovir 200 milligrams (Zovirax, 
Burroughs Wellcome Co.) from prescription to over-the-counter status 
for the treatment of recurrent genital herpes. Issues and concerns 
relating to over-the-counter availability of acyclovir for the 
treatment of recurrent genital herpes were discussed publicly on May 
19, 1994; public comment is available for inspection in Docket No. 94N-
0006 in FDA's Dockets Management Branch (HFA-305), rm. 1-23, 12420 
Parklawn Dr., Rockville, MD.
    Closed committee deliberations. On January 11, 1995, the Antiviral 
Drugs Advisory Committee will discuss trade secret and/or confidential 
commercial information relevant to pending NDA's. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
Anesthetic and Life Support Drugs Advisory Committee
    Date, time, and place. January 17 and 18, 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, January 
17, 1995, 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 11 a.m.; closed 
committee deliberations, 11 a.m. to 12 m.; open committee discussion, 1 
p.m. to 5 p.m.; open committee discussion, January 18, 1995, 8:30 a.m. 
to 12 m.; closed committee deliberations, 12 m. to 3 p.m.; Isaac F. 
Roubein, Center for Drug Evaluation and Research (HFD-9), 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.
    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 January 9, 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 the NDA 20-
478, Sevoflurane, Abbott Laboratories, to be indicated as an 
inhalational anesthetic agent.
    Closed committee deliberations. The committee will review trade 
secret and/or confidential commercial information relevant to a pending 
investigational new drug application and NDA. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee
    Date, time, and place. January 20, 1995, 8:30 a.m., Holiday Inn--
Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. 
A limited number of overnight accommodations have been reserved at the 
Holiday Inn--Gaithersburg. Attendees requiring overnight accommodations 
may contact the hotel at 1-800-465-4329, or 301-948-8900 and reference 
the FDA panel meeting block. Reservations will be confirmed at the 
group rate based on availability.
    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 3 p.m.; closed committee 
deliberations, 3 p.m. to 5 p.m.; Mary J. Cornelius, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Gastroenterology and Urology Devices Panel, code 
12523.
    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 January 6, 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 general 
issues related to a premarket approval application for a metallic mesh 
stent intended for the relief of urinary obstruction secondary to 
urethral stricture disease.
    Closed committee deliberations. The committee may discuss trade 
secret and/or confidential commercial information regarding medical 
devices. This portion of the meeting will be closed to permit 
discussion of this information (5 U.S.C. 552b(c)(4)).
Vaccines and Related Biological Products Advisory Committee
    Date, time, and place. January 26 and 27, 1995; 8 a.m. Holiday 
Inn--Bethesda, Versailles Ballrooms I through III, 8120 Wisconsin Ave., 
Bethesda, MD.
    Type of meeting and contact person. Closed committee deliberations, 
January 26, 1995, 8 a.m. to 10:45 a.m.; open public hearing, 10:45 a.m. 
to 11:30 a.m., unless public participation does not last that long; 
open committee discussion, 11:30 a.m. to 6:30 p.m.; open public 
hearing, January 27, 1995, 8 a.m. to 8:45 a.m., unless public 
participation does not last that long; open committee discussion, 8:45 
a.m. to 6:15 p.m.; Nancy T. Cherry or Stephanie A. Milwit, Center for 
Biologics Evaluation and Research (HFM-21), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-594-1054, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Vaccines and Related Biological 
Products Advisory Committee, code 12388.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of vaccines intended for 
use in the diagnosis, prevention, or treatment 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 January 19, 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 January 26, 1995, the committee will 
consider available clinical data from completed trials and future 
clinical development of a therapeutic AIDS vaccine. On January 27, 
1995, the committee will discuss the influenza virus vaccine 
formulation for 1995 through 1996. The committee will also hear an 
update on a vaccine for the prevention of varicella.
    Closed committee deliberations. On January 26, 1995, the committee 
will review trade secret and/or confidential commercial information 
relevant to pending product licensing applications. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
    Each public advisory committee meeting listed above 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. The dates and times reserved for the separate 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.
    The Commissioner has determined for the reasons stated that those 
portions of the advisory committee meetings so designated in this 
notice shall be closed. The Federal Advisory Committee Act (FACA) (5 
U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings 
in certain circumstances. Those portions of a meeting designated as 
closed, however, shall be closed for the shortest possible time, 
consistent with the intent of the cited statutes.
    The FACA, as amended, provides that a portion of a meeting may be 
closed where the matter for discussion involves a trade secret; 
commercial or financial information that is privileged or confidential; 
information of a personal nature, disclosure of which would be a 
clearly unwarranted invasion of personal privacy; investigatory files 
compiled for law enforcement purposes; information the premature 
disclosure of which would be likely to significantly frustrate 
implementation of a proposed agency action; and information in certain 
other instances not generally relevant to FDA matters.
    Examples of portions of FDA advisory committee meetings that 
ordinarily may be closed, where necessary and in accordance with FACA 
criteria, include the review, discussion, and evaluation of drafts of 
regulations or guidelines or similar preexisting internal agency 
documents, but only if their premature disclosure is likely to 
significantly frustrate implementation of proposed agency action; 
review of trade secrets and confidential commercial or financial 
information submitted to the agency; consideration of matters involving 
investigatory files compiled for law enforcement purposes; and review 
of matters, such as personnel records or individual patient records, 
where disclosure would constitute a clearly unwarranted invasion of 
personal privacy.
    Examples of portions of FDA advisory committee meetings that 
ordinarily shall not be closed include the review, discussion, and 
evaluation of general preclinical and clinical test protocols and 
procedures for a class of drugs or devices; consideration of labeling 
requirements for a class of marketed drugs or devices; review of data 
and information on specific investigational or marketed drugs and 
devices that have previously been made public; presentation of any 
other data or information that is not exempt from public disclosure 
pursuant to the FACA, as amended; and, deliberation to formulate advice 
and recommendations to the agency on matters that do not independently 
justify closing.
    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: December 16, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operations.
[FR Doc. 94-31596 Filed 12-22-94; 8:45 am]
BILLING CODE 4160-01-F