[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Pages 38710-38711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14017]


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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 12, 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 V. 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 
761024, for ABP 501, a proposed biosimilar to AbbVie Inc.'s HUMIRA 
(adalimumab), submitted by Amgen, 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 adult patients with moderately to 
severely active rheumatoid arthritis (alone or in combination with 
methotrexate or other non-biologic disease-modifying anti-rheumatic 
drugs (DMARDs)); (2) reducing signs and symptoms of moderately to 
severely active polyarticular juvenile idiopathic arthritis in patients 
4 years of age and older (alone or in combination with methotrexate); 
(3) reducing signs and symptoms, inhibiting the progression of 
structural damage, and improving physical function in adult patients 
with active psoriatic arthritis (alone or in combination with non-
biologic DMARDs); (4) reducing signs and

[[Page 38711]]

symptoms in adult patients with active ankylosing spondylitis; (5) 
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 
(ABP 501 would be indicated for reducing signs and symptoms and 
inducing clinical remission in these patients if they have also lost 
response to or are intolerant to infliximab); (6) inducing and 
sustaining clinical remission in adult patients with moderately to 
severely active ulcerative colitis who have had an inadequate response 
to immunosuppressants such as corticosteroids, azathioprine or 6-
mercaptopurine (6-MP) (the effectiveness of ABP-501 would not be 
established in patients who have lost response to or were intolerant to 
TNF blockers); and (7) treatment of adult patients with moderate to 
severe chronic plaque psoriasis who are candidates for systemic therapy 
or phototherapy, and when other systemic therapies are medically less 
appropriate (only to be administered to patients who will be closely 
monitored and have regular follow-up visits with a physician).
    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 
27, 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 17, 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 20, 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 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14017 Filed 6-13-16; 8:45 am]
 BILLING CODE 4164-01-P