[Federal Register: December 9, 2004 (Volume 69, Number 236)]
[Page 71419-71420]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 (NDAC) 
and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
    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 January 13, 2005, from 8 
a.m. to 5 p.m., and January 14, 2005, from 8 a.m. to 3 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD 20814.
    Contact Person: Cathy A. Groupe, or Hilda F. Scharen, 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, e-mail 
GroupeC@cder.fda.gov or scharenh@cder.fda.gov, or FDA Advisory Committee Information Line, 1-

800-741-8138 (301-443-0572 in the Washington, DC area), codes 
3014512541 and 3014512536. Please call the Information Line for up-to-
date information on this meeting.
    Agenda: On both days, the committees will consider the safety and 
efficacy of new drug application (NDA) 21-213, proposing over-the-
counter (OTC) use of MEVACOR (lovastatin), 20 milligrams a day, Merck & 
Co., Inc., to help lower LDL ``bad'' cholesterol, which may prevent a 
first heart attack. The background material will become available no 
later than the day before the meeting and will be posted under the NDAC 
or the EMDAC Docket site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
 (click on the year 2005 and scroll down to NDAC or EMDAC).

    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 

[[Page 71420]]

submissions may be made to the contact person by January 6, 2005. Oral 
presentations from the public will be scheduled between approximately 
8:15 a.m. and 9:30 a.m. on January 14, 2005. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before January 6, 2005, 
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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact LaNise Giles at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 1, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-26995 Filed 12-8-04; 8:45 am]