81 FR 37601 - Arthritis Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range		37601-37602
FR Document		2016-13709

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.

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016)

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37601-37602]
From the Federal Register Online  [www.thefederalregister.org]
[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]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37601

welfare agency recruitment and procedures as the previous two cohorts. welfare system. Child welfare agency
collection of files for sampling children, This Notice is specific to Phase 1. The recruitment will include: mail, email,
and Phase 2 includes baseline data overall goal is to recruit child welfare phone calls, and site visits with child
collection and an 18-month follow-up agencies in 83 primary sampling units welfare agency administrators.
data collection. The current data nationwide. Child welfare agencies will Respondents: Child welfare agency
collection plan calls for selecting a new be selected with probability administrators and other personnel.
cohort of 4,565 children and families proportional to size, based on the Data collection will take place over a 2-
and repeating similar data collection current distributions in the child year period.

ANNUAL BURDEN ESTIMATES
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response

Information package for agency administrators .................. 114 57 1 0.25 14
Initial call with agency staff .................................................. 114 57 1 1 57
In-person visit with agency staff .......................................... 20 10 1 1 10
Visit or call with agency staff explaining the sample file
process ............................................................................. 83 42 1 2 84
Agency staff monthly sample file generation and trans-
mission ............................................................................. 83 42 15 1 630

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND 741–8138 (301–443–0572 in the
Hours: 795. HUMAN SERVICES Washington, DC area). A notice in the
Additional Information: Copies of the Federal Register about last minute
Food and Drug Administration modifications that impact a previously
proposed collection may be obtained by
writing to the Administration for [Docket No. FDA–2016–N–0001] announced advisory committee meeting
cannot always be published quickly
Children and Families, Office of
Arthritis Advisory Committee; Notice enough to provide timely notice.
Planning, Research and Evaluation, 330
of Meeting Therefore, you should always check the
C Street, SW., Washington, DC 20201, Agency’s Web site at http://
Attn: OPRE Reports Clearance Officer. AGENCY: Food and Drug Administration, www.fda.gov/AdvisoryCommittees/
All requests should be identified by the HHS. default.htm and scroll down to the
title of the information collection. Email ACTION: Notice. appropriate advisory committee meeting
address: OPREinfocollection@ link, or call the advisory committee
acf.hhs.gov. SUMMARY: The Food and Drug information line to learn about possible
OMB Comment: OMB is required to Administration (FDA) announces a modifications before coming to the
make a decision concerning the forthcoming public advisory committee meeting.
meeting of the Arthritis Advisory
collection of information between 30 SUPPLEMENTARY INFORMATION:
Committee. The general function of the
and 60 days after publication of this Agenda: The committee will discuss
committee is to provide advice and
document in the Federal Register. recommendations to the Agency on biologics license application 761042, for
Therefore, a comment is best assured of FDA’s regulatory issues. The meeting GP2015, a proposed biosimilar to
having its full effect if OMB receives it will be open to the public. Amgen Inc.’s ENBREL (etanercept)
within 30 days of publication. Written submitted by Sandoz, Inc. The proposed
DATES: The meeting will be held on July
comments and recommendations for the indications (uses) for this product are:
13, 2016, from 7:30 a.m. to 5 p.m.
proposed information collection should (1) Reducing signs and symptoms,
ADDRESSES: FDA White Oak Campus,
be sent directly to the following: Office inducing major clinical response,
of Management and Budget, Paperwork 10903 New Hampshire Ave., Bldg. 31, inhibiting the progression of structural
Conference Center, the Great Room (Rm. damage, and improving physical
Reduction Project, Email: OIRA_
1503), Silver Spring, MD 20993–0002. function in patients with moderately to
SUBMISSION@OMB.EOP.GOV, Attn:
Answers to commonly asked questions severely active rheumatoid arthritis (in
Desk Officer for the Administration for including information regarding special
Children and Families. combination with methotrexate (MTX)
accommodations due to a disability, or used alone); (2) reducing signs and
Robert Sargis, visitor parking, and transportation may symptoms of moderately to severely
ACF Certifying Officer. be accessed at: http://www.fda.gov/ active polyarticular juvenile idiopathic
AdvisoryCommittees/ arthritis in patients ages 2 and older; (3)
[FR Doc. 2016–13682 Filed 6–9–16; 8:45 am]
AboutAdvisoryCommittees/ reducing signs and symptoms,
BILLING CODE 4184–01–P
ucm408555.htm. inhibiting the progression of structural
FOR FURTHER INFORMATION CONTACT: damage of active arthritis, and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Moon Hee Choi, Center for Drug improving physical function in patients
Evaluation and Research, Food and with psoriatic arthritis (in combination
Drug Administration, 10903 New with MTX in patients who do not
Hampshire Ave., Bldg. 31, Rm. 2417, respond adequately to MTX alone); (4)
Silver Spring, MD 20993–0002, 301– reducing signs and symptoms in
796–9001, FAX: 301–847–8533, AAC@ patients with active ankylosing
fda.hhs.gov, or FDA Advisory spondylitis; and (5) treatment of adult
Committee Information Line, 1–800– patients (18 years or older) with chronic

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Document Created: 2018-02-08 07:35:39
Document Modified: 2018-02-08 07:35:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on July 13, 2016, from 7:30 a.m. to 5 p.m.
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.
FR Citation		81 FR 37601

81 FR 37601 - Arthritis Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration