[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 AcuTectTM, 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
AcuTectTM (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
