94-16619. Advisory Committee; Notice of Meeting  

  • [Federal Register Volume 59, Number 131 (Monday, July 11, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-16619]
    
    
    [[Page Unknown]]
    
    [Federal Register: July 11, 1994]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
     
    
    Advisory Committee; Notice of 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.
    
    MEETING: The following advisory committee meeting is announced:
    Joint Subcommittee Meeting of the Nonprescription Drugs Advisory 
    Committee and Arthritis Advisory Committee on Over-the-Counter Internal 
    Analgesic, Antipyretic, and Antirheumatic Drug Products
        Date, time, and place. September 8 and 9, 1994, 8:30 a.m., Parklawn 
    Bldg., conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
         Type of meeting and contact person. Open committee discussion, 
    September 8, 1994, 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; open 
    committee discussion, September 9, 1994, 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; Lee L. Zwanziger, 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 Arthritis Advisory Committee reviews and 
    evaluates data on the safety and effectiveness of marketed and 
    investigational human drugs for use in arthritic conditions.
        Agenda--Open public hearing. Interested persons may present data, 
    information, or views, orally or in writing, on issues pending before 
    the joint subcommittee. Those desiring to make formal presentations 
    should notify the contact person before August 15, 1994, and submit a 
    brief statement of the general nature of the information or arguments 
    they wish to present, the names and addresses of proposed participants, 
    and an indication of the approximate time requested to make their 
    comments. In a subsequent issue of the Federal Register, FDA will 
    publish a notice announcing the availability of background information.
        Open committee discussion. On September 8 and 9, 1994, the joint 
    subcommittee will discuss effectiveness data requirements and proposed 
    labeling indications for OTC analgesic drug products. The joint 
    subcommittee will address topics such as: (1) Data requirements to 
    support specific types of indications for OTC analgesic drug products; 
    (2) recommendations for labeling indications for OTC analgesics; and 
    (3) the current state of scientific knowledge in the areas of pain 
    receptors, mechanism(s) of pain perception, and the basis for response 
    to analgesic drug classes.
        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: July 5, 1994.
     Linda A. Suydam,
     Interim Deputy Commissioner for Operations.
    [FR Doc. 94-16619 Filed 7-8-94; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
07/11/1994
Department:
Health and Human Services Department
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-16619
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: July 11, 1994