[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