[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Page 33723]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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 Committee: Endocrinologic and Metabolic Drugs Advisory 
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 9, 2003, from 8:30 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Dornette Spell-LeSane, 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, FAX: 301-827-6776, e-mail: 
spelllesaned@cder.fda.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12536. 
Please call the Information Line for up-to-date information on this 
    Agenda: The committee will discuss new drug application (NDA) 21-
366, CRESTOR (rosuvastatin calcium) tablets, AstraZeneca 
Pharmaceuticals LP, agent for iPR Pharmaceuticals, Inc., for the 
proposed indication of treatment of hypercholesterolemia and mixed 
    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 1, 2003. 
Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 1, 2003, 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 Dornette Spell-
LeSane 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: May 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-14214 Filed 6-4-03; 8:45 am]