Document ID: FDA-2013-N-0001-0050
Agency: fda
Document Type: Notice
Title: Arthritis Advisory Committee; Notice of Meeting
Posted Date: 2013-06-04T04:00Z

[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Pages 33423-33424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13082]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Arthritis 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: Arthritis 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 23, 2013, from 8 
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (rm.

[[Page 33424]]

1503), Silver Spring, MD 20993-0002. Information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: 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: Cindy Hong, 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: AAC@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 link, or call the advisory committee information 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: On July 23, 2013, during the morning session, the committee 
will discuss supplemental biologics license application (sBLA) 125057, 
HUMIRA (adalimumab) injection, by AbbVie Inc., for the proposed 
indication of reducing signs and symptoms in adult patients with active 
non-radiographic axial spondyloarthritis with objective signs of 
inflammation by elevated C-reactive protein or magnetic resonance 
imaging, who have had an inadequate response to, or are intolerant to, 
a nonsteroidal anti-inflammatory drug.
    During the afternoon session, the committee will discuss sBLA 
125160, certolizumab injection, by UCB, Inc., for the proposed 
indication of treatment of adult patients with active axial 
spondyloarthritis, including patients with ankylosing spondylitis.
    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 
8, 2013. Oral presentations from the public will be scheduled between 
approximately 10:35 a.m. to 11:05 a.m., and 3:45 p.m. to 4:15 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 June 
27, 2013. 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 28, 2013.
    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 Cindy Hong 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: May 28, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-13082 Filed 6-3-13; 8:45 am]
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