
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Page 2873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00823]



[[Page 2873]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Arthritis Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    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 February 9, 2016, from 
7:30 a.m. to 5 p.m.
    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: Stephanie L. Begansky, 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, 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 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) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech 
Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed 
indications (uses) for this product are: (1) Reducing signs and 
symptoms and inducing and maintaining clinical remission in adult 
patients with moderately to severely active Crohn's disease who have 
had an inadequate response to conventional therapy; (2) reducing the 
number of draining enterocutaneous and rectovaginal fistulas and 
maintaining fistula closure in adult patients with fistulizing Crohn's 
disease; (3) reducing signs and symptoms and inducing and maintaining 
clinical remission in pediatric patients 6 years of age and older with 
moderately to severely active Crohn's disease who have had an 
inadequate response to conventional therapy; (4) reducing signs and 
symptoms, inducing and maintaining clinical remission and mucosal 
healing, and eliminating corticosteroid use in adult patients with 
moderately to severely active ulcerative colitis who have had an 
inadequate response to conventional therapy; (5) reducing signs and 
symptoms and inducing and maintaining clinical remission in pediatric 
patients 6 years of age and older with moderately to severely active 
ulcerative colitis who have had an inadequate response to conventional 
therapy; \1\ (6) in combination with methotrexate, reducing signs and 
symptoms, inhibiting the progression of structural damage, and 
improving physical function in patients with moderately to severely 
active rheumatoid arthritis; (7) reducing signs and symptoms in 
patients with active ankylosing spondylitis; (8) reducing signs and 
symptoms of active arthritis, inhibiting the progression of structural 
damage, and improving physical function in patients with psoriatic 
arthritis; and (9) treatment of adult patients with chronic severe 
(i.e., extensive and/or disabling) plaque psoriasis who are candidates 
for systemic therapy and when other systemic therapies are medically 
less appropriate.
---------------------------------------------------------------------------

    \1\ This indication is protected by orphan drug exclusivity 
expiring on September 23, 2018. See the Orphan Drug Designations and 
Approvals database at http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm.
---------------------------------------------------------------------------

    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 
January 26, 2016. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 3 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 January 25, 2016. 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 January 15, 2016.
    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 
disabilities. If you require accommodations due to a disability, please 
contact Stephanie L. Begansky 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: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-00823 Filed 1-15-16; 8:45 am]
 BILLING CODE 4164-01-P


