97-13821. Advisory Committee; Notice of Meeting  

  • [Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
    [Notices]
    [Pages 28717-28718]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-13821]
    
    
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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.
    
        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:
    Cardiovascular and Renal Drugs Advisory Committee
        Date, time, and place. June 26 and 27, 1997, 9 a.m., National 
    Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium, 
    9000 Rockville Pike, Bethesda, MD. Parking in the Clinical Center 
    visitor area is reserved for Clinical Center patients and their 
    visitors. If you must drive, please use an outlying lot such as Lot 
    41B. Free shuttle bus service is provided from Lot 41B to the Clinical 
    Center every 8 minutes during rush hour and every 15 minutes at other 
    times.
        Type of meeting and contact person. Open public hearing, June 26, 
    1997, 9 a.m. to 10 a.m., unless public participation does not last that 
    long; open committee discussion, 10 a.m. to 5:30 p.m.; closed committee 
    deliberations, June 27, 1997, 9 a.m. to 12 m.; Joan C. Standaert, 
    Center for Drug Evaluation and Research (HFD-110), 419-259-6211, or 
    Danyiel D'Antonio (HFD-21), 301-443-5455, Food and Drug Administration, 
    5600 Fishers Lane, Rockville, MD 20857, or FDA Advisory Committee 
    Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
    area), Cardiovascular and Renal Drugs Advisory Committee, code 12533. 
    Please call the hotline for information concerning any possible 
    changes.
        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 cardiovascular and renal 
    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 June 12, 1997, 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 June 26, 1997, the committee will 
    discuss new drug application (NDA) 19-922, CorlopamTM 
    (fenoldopam mesylate, Neurex), for the short-term treatment of 
    hypertension when oral therapy is not feasible or possible and for use 
    in hypertensive crisis; NDA 20-164, Lovenox Injection 
    (enoxaparin sodium, Rhone-Poulenc Rorer), to be indicated for the 
    treatment of unstable angina and non-Q-wave myocardial infarction, 
    concurrently administered with aspirin.
        Closed committee deliberations. On June 27, 1997, the committee 
    will review trade secret and/or confidential commercial information 
    relevant to pending investigational new drug applications and/or NDA's. 
    This portion
    
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    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 the meeting(s) 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23, 
    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 (a)(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 19, 1997.
    Michael A. Friedman,
    Deputy Commissioner for Operations.
    [FR Doc. 97-13821 Filed 5-23-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
05/27/1997
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-13821
Pages:
28717-28718 (2 pages)
PDF File:
97-13821.pdf