[Federal Register Volume 65, Number 106 (Thursday, June 1, 2000)]
[Notices]
[Page 35100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Nonprescription Drugs Advisory Committee 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 a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.

    Name of Committees: Nonprescription Drugs Advisory Committee and 
the Endocrinologic and Metabolic Drugs 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 on July 13 and 14, 2000, 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I, II, III, and IV, 
8120 Wisconsin Ave., Bethesda, 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 13 and 14, 2000, the committees will consider 
new drug applications (NDA) proposing over-the-counter (OTC) use of 
cholesterol lowering agents. On July 13, 2000, the committees will 
consider OTC availability of Mevacor, NDA 21-213, 
(lovastatin, 10 milligrams (mg) tablets), Merck and Co., proposed to 
treat individuals with total cholesterol levels of 200-240 mg/dl 
(deciliter) and low density lipoprotein levels (LDL) over 130 mg/dl. 
The proposed indication is for men over 40 years of age and 
postmenopausal women who do not have established cardiovascular 
disease or diabetes. On July 14, 2000, the committees will consider 
OTC availability of Pravachol NDA 21-198, (pravastatin 
sodium, 10 mg tablets), Bristol-Myers Squibb, proposed to treat 
individuals with total cholesterol levels of 200 and 240 mg/dl and 
LDL over 130 mg/dl. The proposed indication is for individuals who 
do not have established cardiovascular disease or diabetes.
    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 6, 
2000. Oral presentations from the public will be scheduled between 
approximately 8 a.m. to 9 a.m. on July 13, 2000. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 6, 2000, 
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 17, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-13741 Filed 5-31-00; 8:45 am]
BILLING CODE 4160-01-F