[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Page 30527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14402]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Nonprescription Drugs Advisory Committee and
the Arthritis 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: Nonprescription Drugs Advisory Committee and the
Arthritis Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held July 20, 1999, 8:30 a.m. to
5 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Sandra L. Titus or Kathleen R. Reedy, Center for
Drug Evaluation and Research (HFD-21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, or e-mail [email protected], or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 12541. Please call the Information
Line for up-to-date information on this meeting.
Agenda: On July 20, 1999, the committees will jointly consider an
over-the-counter, new drug application (NDA) 21-070, Flexeril
(cyclobenzaprine HCl, 5 milligrams tablets, three times a day, Merck
and Co.), proposed to treat muscle spasms.
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 July 12, 1999.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on July 20, 1999. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 12, 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. 99-14402 Filed 6-7-99; 8:45 am]
BILLING CODE 4160-01-F
