Document ID: FDA-2013-N-0001-0039
Agency: fda
Document Type: Notice
Title: Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Posted Date: 2013-04-15T04:00Z

[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Notices]
[Page 22270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08744]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory 
Committee and the Drug Safety and Risk Management 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 Committees: Endocrinologic and Metabolic Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee.
    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 June 5 and 6, 2013, from 
8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White 
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. Information regarding special accommodations due 
to a disability, visitor parking, and transportation may be accessed 
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the 
heading ``Resources for You,'' click on ``Public Meetings at the FDA 
White Oak Campus.'' Please note that visitors to the White Oak Campus 
must enter through Building 1.
    Contact Person: Minh Doan, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., WO31-2417, 
Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: 
EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area). 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 http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee link, or call the advisory committee information 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: On June 5 and 6, 2013, the committees will discuss the 
results of an independent readjudication of the Rosiglitazone Evaluated 
for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes 
(RECORD) trial, for new drug application (NDA) 21071, AVANDIA 
(rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, 
indicated as an adjunct to diet and exercise to improve glycemic 
control in adults with type 2 diabetes mellitus. AVANDIA is 
manufactured by GlaxoSmithKline.
    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 meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committees. 
Written submissions may be made to the contact person on or before May 
21, 2013. Oral presentations from the public will be scheduled between 
approximately 10:15 a.m. and 11:15 a.m. on June 6, 2013. Those 
individuals interested in making 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 
13, 2013. 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 14, 2013.
    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 Minh Doan 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: April 5, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-08744 Filed 4-12-13; 8:45 am]
BILLING CODE 4160-01-P