Document ID: FDA-2010-N-0001-0027
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drugs Advisory Committee
Posted Date: 2010-03-22T04:00Z

[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]               
[Page 13559-13560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr10-77]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
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 Committee: Endocrinologic and Metabolic Drugs Advisory 
Committee.
    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 May 27, 2010, from 8 
a.m. to 5 p.m.
    Location: The Inn and Conference Center, University of Maryland 
University College (UMUC), 3501 University Blvd. East, Adelphi, MD. The 
hotel telephone number is 301-985-7300.
    Contact Person: Paul Tran, 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: paul.tran@fda.hhs.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. A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: On May 27, 2010, the committee will discuss the safety and 
efficacy of new drug application (NDA) 22-505, EGRIFTA (tesamorelin 
acetate), sterile lyophilized powder for injection, by 
Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound 
that resembles another compound in structure) of growth hormone 
releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in 
this application is to induce and maintain a reduction of excess 
visceral abdominal fat in human immunodeficiency virus (HIV)-infected 
patients with lipodystrophy (a condition in which abnormal deposits of 
fat are seen partly as a result of using certain drugs to treat HIV 
disease).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    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 on or before May 
13, 2010. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Those desiring to make formal oral 
presentations should notify the contact person 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 
on or before May 5, 2010. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by May 6, 
2010.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.

[[Page 13560]]

    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 Paul Tran at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 16, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-6169 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S