[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34085-34086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14343]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 July 19, 2011, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910. The hotel's telephone number
is 301-589-5200.
Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm.
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX 301-847-8533, e-
mail: [email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), and follow the
prompts to the desired center or product area. 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 July 19, 2011, the committee will discuss new drug
application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers
Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of
sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an
adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus.
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 July
5, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. 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 June 24, 2011. 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 27, 2011.
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).
[[Page 34086]]
Dated: June 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-14343 Filed 6-9-11; 8:45 am]
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