Document ID: FDA-2014-N-0001-0059
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drug Products Advisory Committee; Notice
of Meeting
Posted Date: 2014-07-22T04:00Z

[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Notices]
[Pages 42519-42520]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17086]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Endocrinologic and Metabolic Drug Products 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 September 12, 2014, from 
8 a.m. to 5 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College (UMUC), Potomac Ballroom, 3501 University 
Blvd. East, Hyattsville, MD 20783. The conference center's telephone 
number is 301-985-7300. Information regarding special accommodations 
due to a disability, visitor parking, and transportation may be 
accessed at:

[[Page 42520]]

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: Karen Abraham-Burrell, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
White Oak Bldg. 31, Rm. 2147, 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 
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 biologics license application 
(BLA) 125511, proposed trade name NATPARA (established name: 
Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), 
submitted by NPS Pharmaceuticals, Inc., for the proposed indication of 
replacement for endogenous parathyroid hormone (1-84) for the long-term 
treatment of hypoparathyroidism.
    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 
August 27, 2014. Oral presentations from the public will be scheduled 
between approximately between 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 August 19, 2014. 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 August 20, 2014.
    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 Karen Abraham-
Burrell 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: July 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17086 Filed 7-21-14; 8:45 am]
BILLING CODE 4164-01-P