[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Page 3907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Medical Imaging Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Medical Imaging Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on February 9, 1998, 8 a.m. 
to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Leander B. Madoo, Center for Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5455, or FDA Advisory Committee 
Information Line, 1-80-741-8138 (301-443-0572 in the Washington, DC 
area), code 12540. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss the safety and efficacy of new 
drug application (NDA) 20-887 AcuTect<SUP>TM</SUP>, Diatide, Inc., a 
radiopharmaceutical agent for the detection and localization of acute 
venous thrombosis.
    Procedure: On February 9, 1998, from 8 a.m. to 1 p.m. and from 2 
p.m. to 5 p.m. the meeting is open to the public. Interested persons 
may present data, information, or views, orally or in writing, on 
issues pending before the committee. Written submissions may be made to 
the contact person by February 2, 1998. Oral presentations from the 
public will be scheduled between approximately 8:30 a.m. and 9:30 a.m. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
February 2, 1998, 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 
requested to make their presentation.
    Closed Committee Deliberations: On February 9, 1998, from 1 p.m. to 
2 p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information relating to NDA 20-887 
AcuTect<SUP>TM</SUP> (5 U.S.C. 552b(c)(4)).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the February 9, 1998, Medical Imaging Drugs Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
this issue to public discussion and qualified members of the Medical 
Imaging Drugs Advisory Committee were available at this time, the 
Commissioner concluded that it was in the public interest to hold this 
meeting even if there was not sufficient time for the customary 15-day 
public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2022 Filed 1-23-98; 11:47 am]
BILLING CODE 4160-01-F