[Federal Register Volume 59, Number 129 (Thursday, July 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16365]


[[Page Unknown]]

[Federal Register: July 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

 

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces a forthcoming joint meeting of public 
advisory committees 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.

MEETING: The following advisory committee meeting is announced:
Joint Meeting of the Nonprescription Drugs and the Pulmonary-Allergy 
Drugs Advisory Committees
    Date, time, and place. November 14, 1994, 8:30 a.m., Parklawn 
Bldg., conference rms. G through J, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open committee discussion, 8:30 
a.m. to 4 p.m.; open public hearing, 4 p.m. to 5 p.m., unless public 
participation does not last that long; the agency anticipates that the 
meeting will last only 1 day, but if there is sufficient interest in 
participation, the meeting will be extended an additional day at the 
discretion of the chairperson; Lee L. Zwanziger or Leander B. Madoo, 
Center for Drug Evaluation and Research (HFD-9), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.
    General function of the committees. 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. The Pulmonary-Allergy Drugs Advisory 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 committees. Those desiring to make formal presentations should 
notify a contact person before September 30, 1994, 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 
over-the-counter (OTC) drug products for the treatment of asthma and 
will address topics such as: (1) OTC bronchodilator drug products 
currently available and possible pending changes in their marketing 
status; (2) whether there is a population for which OTC antiasthma drug 
products are appropriate; (3) the general question of whether 
antiasthma drug products should be available OTC; (4) antiasthma drug 
products currently available by prescription only that could be 
considered for OTC status; and (5) data requirements necessary to 
support conversion of prescription antiasthma drug products to OTC 
status. Public comments are available for inspection in docket no. 94N-
0232 at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    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: June 30,1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-16365 Filed 7-6-94; 8:45 am]
BILLING CODE 4160-01-F