[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Page 43438-43439]
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 September 8 and 9, 2005, 
from 8 a.m. to 5 p.m.
    Location: Holiday Inn Washington Silver Spring, The Ballrooms, 8777 
Georgia Ave., Silver Spring, MD. The hotel telephone number is 301-589-
    Contact Person: Cathy Groupe, 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 FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512536. Please call the Information Line for up-to-date 
information on this meeting. When available, background materials for 
this meeting will be posted one business day prior to the meeting on 
FDA's Web 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 Endocrinologic and Metabolic 
Drugs Advisory Committee.)
    Agenda: On September 8, 2005, the committee will discuss new drug 
application (NDA) 21-868, proposed trade name EXUBERA (insulin 
recombinant deoxyribonucleic acid (rDNA) origin powder for oral 
inhalation), 1 milligram (mg) and 3 mg powder for inhalation, Pfizer, 
Inc., for the treatment of adult patients with diabetes mellitus. On 
September 9, 2005, the committee will discuss NDA 21-865, proposed 
trade name PARAGLUVA (muraglitazar) Tablets, 2.5 mg and 5 mg, Bristol-
Myers Squibb, for the treatment of type II diabetes mellitus.
    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 August 31, 
2005. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 31, 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 John Lauttman at 
least 7 days in advance of the meeting at 301-827-7001.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

[[Page 43439]]

    Dated: July 20, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14750 Filed 7-26-05; 8:45 am]