[Federal Register: December 9, 2004 (Volume 69, Number 236)]
[Notices]
[Page 71419-71420]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de04-62]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
Written
[[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
outlets.
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]
BILLING CODE 4160-01-S