Document ID: FDA-2015-N-0001-0046
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2015-04-30T04:00Z

[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Page 24256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10023]

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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 June 9, 2015, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Parkway, Gaithersburg, MD 20877. The hotel telephone number 
is 301-977-8900.
    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, 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 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: The committee will discuss the safety and efficacy of 
biologics license application 125559, proposed trade name PRALUENT 
(established name: Alirocumab) for injection, submitted by Sanofi 
Aventis, U.S., as an adjunct to diet, for long-term treatment of adult 
patients with primary hypercholesterolemia (non-familial and 
heterozygous familial) or mixed dyslipidemia including patients with 
type 2 diabetes mellitus, to reduce low-density lipoprotein 
cholesterol, total cholesterol, non-high-density lipoprotein 
cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to 
increase high-density lipoprotein cholesterol and apolipoprotein A-1 
either in combination with a statin or as monotherapy including in 
patients who cannot tolerate statins.
    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 May 
26, 2015. Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. to 2:15 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 May 15, 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 May 18, 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: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10023 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P