[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Page 30526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14403]
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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). The meeting will
be open 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's regulatory issues.
Date and Time: The meeting will be held on June 28 and 29, 1999, 8
a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Leander B. Madoo, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12540. Please call the Information Line for up-to-date
information on this meeting.
Agenda: Section 121 of FDA's Modernization Act of 1997 directs FDA
to establish appropriate procedures for the approval of positron
emission tomography (PET) drugs under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C 355). At this meeting, FDA will
present its findings on the safety and effectiveness of three PET
drugs: (1) Fludeoxyglucose F 18 Injection, (2)Ammonia N 13 Injection,
and (3) Water 0 15 Injection, for particular indications based on
review of published literature. The committee will discuss the safety
and effectiveness data on these three drugs. FDA also will discuss its
proposed procedures for obtaining marketing approval for these three
PET drugs.
Procedure: 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 June 18, 1999.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9:30 a.m., June 28, 1999. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before June 18, 1999,
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 28, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
[FR Doc. 99-14403 Filed 6-7-99; 8:45 am]
BILLING CODE 4160-01-F
