94-13468. Advisory Committee; Notice of Meeting  

  • [Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-13468]
    
    
    [[Page Unknown]]
    
    [Federal Register: June 3, 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 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:
    Drug Discovery Subcommittee Meeting of the National Task Force on Aids 
    Drug Development
        Date, time, and place. June 21, 1994, 8:30 a.m., Parklawn Bldg., 
    conference rm. I, 5600 Fishers Lane, Rockville, MD 20857.
        Type of meeting and contact person. Open subcommittee 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; Jean H. Mckay, Office of 
    AIDS and Special Health Issues (HF-12), Food and Drug Administration, 
    5600 Fishers Lane, Rockville, MD 20857, 301-443-0104.
        General functions of the subcommittee. The National Task Force on 
    AIDS Drug Development identifies any barriers and provides creative 
    options for the rapid development and evaluation of treatments for HIV 
    infection and its sequelae. It also advises on issues related to such 
    barriers and provides options for the elimination of these barriers.
        Open subcommittee discussion. The subcommittee will present, hear, 
    and discuss issues on the barriers to AIDS drug discovery from the 
    perspective of the subcommittee members, members of the Federal 
    Government, and the public.
        Agenda--Open public hearing. Interested persons may present data, 
    information, or views, orally or in writing, on issues pending before 
    the Task Force. Those desiring to make formal presentations should 
    notify the contact person before June 7, 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.
        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: May 27, 1994.
     Linda A. Suydam,
     Interim Deputy Commissioner for Operations.
    [FR Doc. 94-13468 Filed 6-2-94; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
06/03/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-13468
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: June 3, 1994