[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