[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]]
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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.
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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 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, [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: 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.
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\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.
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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