[Federal Register Volume 75, Number 108 (Monday, June 7, 2010)]
[Notices]
[Pages 32189-32190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13533]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-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 July 13, 2010, from 8
a.m. to 6 p.m. and on July 14, 2010, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
Contact Person: Paul Tran, c/o Melanie Whelan, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver
Spring, MD 20993-0002, FAX: 301-847-8737, to reach by telephone before
June 8, 2010, please call 301-827-7001; to reach by telephone after
June 8, 2010, please call 301-796-9001, e-mail: [email protected],
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), codes 3014512536 and 3014512535.
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 both days, the committees will focus primarily on the
cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets,
GlaxoSmithKline, a drug approved for blood glucose control in adults
with type 2 diabetes mellitus. Data specific to rosiglitazone to be
presented will include results from the Rosiglitazone Evaluated for
Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial,
observational data, health claims data, and a meta-analysis of
controlled clinical trials. In addition, the FDA will present its meta-
analysis of several trials of ACTOS (pioglitazone hydrochloride)
Tablets, Takeda Pharmaceuticals North America, Inc., another
thiazolidinedione for the same indication, in response to public
documents comparing the safety of rosiglitazone to pioglitazone based
on different meta-analyses performed on each of these two drugs.
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
[[Page 32190]]
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 June
28, 2010. Oral presentations from the public will be scheduled between
approximately 8:15 a.m. and 9:15 a.m. on July 14, 2010. 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 June 18, 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 June 21, 2010.
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 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: June 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-13533 Filed 6-4-10; 8:45 am]
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