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[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Pages 11680-11681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04395]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 April 14, 2015, from 
7:30 a.m. to 5:15 p.m.

[[Page 11681]]

    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Philip Bautista, 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, [email protected], 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: During the morning session, the committee will discuss the 
results of the cardiovascular outcomes trial (CVOT), Saxagliptin 
Assessment of Vascular Outcomes Recorded in Patients with Diabetes 
Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) 
and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-
release) tablets manufactured/marketed by AstraZeneca AB.
    During the afternoon session, the committee will discuss the 
results of the CVOT, Examination of Cardiovascular Outcomes with 
Alogliptin versus Standard of Care, for NDA 22271, Nesina (ALOGLIPTIN); 
NDA 022426, Oseni (ALOGLIPTIN and PIOGLITAZONE); and NDA 203414, Kazano 
(ALOGLIPTIN and METFORMIN) tablets marketed by Takeda Pharmaceutical 
U.S.A., Inc.
    Saxagliptin and ALOGLIPTIN are dipeptidyl peptidase-4 inhibitors, 
both indicated as an adjunct to diet and exercise to improve glycemic 
control in adults with type 2 diabetes mellitus. Both CVOTs were 
submitted in accordance with the 2008 FDA Draft Guidance, ``Diabetes 
Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies 
to Treat Type 2 Diabetes,'' to demonstrate that a new antidiabetic 
therapy to treat type 2 diabetes is not associated with an unacceptable 
increase in cardiovascular risk.
    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 committee. 
Written submissions may be made to the contact person on or before 
March 31, 2015. Oral presentations from the public will be scheduled 
between approximately 10:10 a.m. to 10:40 a.m., and 3:30 p.m. to 4 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 
March 23, 2015. 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 March 24, 2015.
    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 Philip Bautista 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: February 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-04395 Filed 3-3-15; 8:45 am]
BILLING CODE 4164-01-P
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