[Federal Register Volume 63, Number 38 (Thursday, February 26, 1998)]
[Notices]
[Page 9794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Dermatologic and Ophthalmic Drugs
Subcommittee and the Endocrinologic and Metabolic 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 public advisory
committees of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committees: Joint meeting of the Dermatologic and
Ophthalmic Drugs Subcommittee and the Endocrinologic and Metabolic
Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on March 11, 1998, 8 a.m.
to 5 p.m.
Location: Holiday Inn, Walker Room, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Tracy Riley or Kathleen R. Reedy, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), codes 12534 and 12536. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss scientific clinical trial design
for products intended for the treatment of diabetic retinopathy.
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 March 4, 1998.
Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m., and between approximately 1 p.m.
and 1:30 p.m. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before March 4, 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the joint meeting of the Dermatologic and Opthalmic Drugs
Subcommittee and the Endocrinologic and Metabolic Drugs Advisory
Committee. Because the agency believes there is some urgency to bring
this issue to public discussion and qualified members of the
Dermatologic and Opthalmic Drugs Subcommittee and the Endocrinologic
and Metabolic 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: February 20, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-5050 Filed 2-24-98; 11:42 am]
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