[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37601-37602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13709]
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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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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Arthritis Advisory Committee.
The general function of the committee is to provide advice and
recommendations to the Agency on FDA's regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on July 13, 2016, from 7:30 a.m. to 5
p.m.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT: Moon Hee Choi, 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.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss biologics license application
761042, for GP2015, a proposed biosimilar to Amgen Inc.'s ENBREL
(etanercept) submitted by Sandoz, Inc. The proposed indications (uses)
for this product are: (1) Reducing signs and symptoms, inducing major
clinical response, inhibiting the progression of structural damage, and
improving physical function in patients with moderately to severely
active rheumatoid arthritis (in combination with methotrexate (MTX) or
used alone); (2) reducing signs and symptoms of moderately to severely
active polyarticular juvenile idiopathic arthritis in patients ages 2
and older; (3) reducing signs and symptoms, inhibiting the progression
of structural damage of active arthritis, and improving physical
function in patients with psoriatic arthritis (in combination with MTX
in patients who do not respond adequately to MTX alone); (4) reducing
signs and symptoms in patients with active ankylosing spondylitis; and
(5) treatment of adult patients (18 years or older) with chronic
[[Page 37602]]
moderate to severe plaque psoriasis who are candidates for systemic
therapy or phototherapy.
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 June
28, 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 June 20, 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 June 21, 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 Moon Hee Choi 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: June 6, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-13709 Filed 6-9-16; 8:45 am]
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