81_FR_2884 81 FR 2873 - Arthritis Advisory Committee; Notice of Meeting

81 FR 2873 - Arthritis Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 11 (January 19, 2016)

Page Range2873-2873
FR Document2016-00823

Federal Register, Volume 81 Issue 11 (Tuesday, January 19, 2016)
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Page 2873]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                                  Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices                                                  2873

                                                    DEPARTMENT OF HEALTH AND                                (uses) for this product are: (1) Reducing              AdvisoryCommittees/Calendar/
                                                    HUMAN SERVICES                                          signs and symptoms and inducing and                    default.htm. Scroll down to the
                                                                                                            maintaining clinical remission in adult                appropriate advisory committee meeting
                                                    Food and Drug Administration                            patients with moderately to severely                   link.
                                                    [Docket No. FDA–2016–N–0001]                            active Crohn’s disease who have had an                    Procedure: Interested persons may
                                                                                                            inadequate response to conventional
                                                                                                                                                                   present data, information, or views,
                                                    Arthritis Advisory Committee; Notice                    therapy; (2) reducing the number of
                                                                                                                                                                   orally or in writing, on issues pending
                                                    of Meeting                                              draining enterocutaneous and
                                                                                                            rectovaginal fistulas and maintaining                  before the committee. Written
                                                    AGENCY:    Food and Drug Administration,                fistula closure in adult patients with                 submissions may be made to the contact
                                                    HHS.                                                    fistulizing Crohn’s disease; (3) reducing              person on or before January 26, 2016.
                                                    ACTION:   Notice.                                       signs and symptoms and inducing and                    Oral presentations from the public will
                                                                                                            maintaining clinical remission in                      be scheduled between approximately
                                                       This notice announces a forthcoming                                                                         1:30 p.m. and 3 p.m. Those individuals
                                                                                                            pediatric patients 6 years of age and
                                                    meeting of a public advisory committee                                                                         interested in making formal oral
                                                                                                            older with moderately to severely active
                                                    of the Food and Drug Administration                                                                            presentations should notify the contact
                                                                                                            Crohn’s disease who have had an
                                                    (FDA). The meeting will be open to the                                                                         person and submit a brief statement of
                                                                                                            inadequate response to conventional
                                                    public.                                                                                                        the general nature of the evidence or
                                                                                                            therapy; (4) reducing signs and
                                                       Name of Committee: Arthritis
                                                                                                            symptoms, inducing and maintaining                     arguments they wish to present, the
                                                    Advisory Committee.
                                                       General Function of the Committee:                   clinical remission and mucosal healing,                names and addresses of proposed
                                                    To provide advice and                                   and eliminating corticosteroid use in                  participants, and an indication of the
                                                    recommendations to the Agency on                        adult patients with moderately to                      approximate time requested to make
                                                    FDA’s regulatory issues.                                severely active ulcerative colitis who                 their presentation on or before January
                                                       Date and Time: The meeting will be                   have had an inadequate response to                     25, 2016. Time allotted for each
                                                    held on February 9, 2016, from 7:30 a.m.                conventional therapy; (5) reducing signs               presentation may be limited. If the
                                                    to 5 p.m.                                               and symptoms and inducing and                          number of registrants requesting to
                                                       Location: FDA White Oak Campus,                      maintaining clinical remission in                      speak is greater than can be reasonably
                                                    10903 New Hampshire Ave., Bldg. 31                      pediatric patients 6 years of age and                  accommodated during the scheduled
                                                    Conference Center, the Great Room (Rm.                  older with moderately to severely active               open public hearing session, FDA may
                                                    1503), Silver Spring, MD 20993–0002.                    ulcerative colitis who have had an                     conduct a lottery to determine the
                                                    Answers to commonly asked questions                     inadequate response to conventional                    speakers for the scheduled open public
                                                    including information regarding special                 therapy; 1 (6) in combination with
                                                                                                                                                                   hearing session. The contact person will
                                                    accommodations due to a disability,                     methotrexate, reducing signs and
                                                                                                                                                                   notify interested persons regarding their
                                                    visitor parking, and transportation may                 symptoms, inhibiting the progression of
                                                                                                                                                                   request to speak by January 15, 2016.
                                                    be accessed at: http://www.fda.gov/                     structural damage, and improving
                                                    AdvisoryCommittees/                                     physical function in patients with                        Persons attending FDA’s advisory
                                                    AboutAdvisoryCommittees/                                moderately to severely active                          committee meetings are advised that the
                                                    ucm408555.htm.                                          rheumatoid arthritis; (7) reducing signs               Agency is not responsible for providing
                                                       Contact Person: Stephanie L.                         and symptoms in patients with active                   access to electrical outlets.
                                                    Begansky, Center for Drug Evaluation                    ankylosing spondylitis; (8) reducing                      FDA welcomes the attendance of the
                                                    and Research, Food and Drug                             signs and symptoms of active arthritis,                public at its advisory committee
                                                    Administration, 10903 New Hampshire                     inhibiting the progression of structural               meetings and will make every effort to
                                                    Ave., Bldg. 31, Rm. 2417, Silver Spring,                damage, and improving physical                         accommodate persons with disabilities.
                                                    MD 20993–0002, 301–796–9001, FAX:                       function in patients with psoriatic
                                                                                                                                                                   If you require accommodations due to a
                                                    301–847–8533, AAC@fda.hhs.gov, or                       arthritis; and (9) treatment of adult
                                                                                                                                                                   disability, please contact Stephanie L.
                                                    FDA Advisory Committee Information                      patients with chronic severe (i.e.,
                                                                                                            extensive and/or disabling) plaque                     Begansky at least 7 days in advance of
                                                    Line, 1–800–741–8138 (301–443–0572                                                                             the meeting.
                                                    in the Washington, DC area). A notice in                psoriasis who are candidates for
                                                    the Federal Register about last minute                  systemic therapy and when other                           FDA is committed to the orderly
                                                    modifications that impact a previously                  systemic therapies are medically less                  conduct of its advisory committee
                                                    announced advisory committee meeting                    appropriate.                                           meetings. Please visit our Web site at
                                                    cannot always be published quickly                         FDA intends to make background                      http://www.fda.gov/
                                                    enough to provide timely notice.                        material available to the public no later              AdvisoryCommittees/
                                                    Therefore, you should always check the                  than 2 business days before the meeting.               AboutAdvisoryCommittees/
                                                    Agency’s Web site at http://                            If FDA is unable to post the background                ucm111462.htm for procedures on
                                                    www.fda.gov/AdvisoryCommittees/                         material on its Web site prior to the                  public conduct during advisory
                                                    default.htm and scroll down to the                      meeting, the background material will                  committee meetings.
                                                    appropriate advisory committee meeting                  be made publicly available at the
                                                                                                            location of the advisory committee                        Notice of this meeting is given under
                                                    link, or call the advisory committee                                                                           the Federal Advisory Committee Act (5
                                                    information line to learn about possible                meeting, and the background material
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                            will be posted on FDA’s Web site after                 U.S.C. app. 2).
                                                    modifications before coming to the
                                                    meeting.                                                the meeting. Background material is                       Dated: January 11, 2016.
                                                       Agenda: The committee will discuss                   available at http://www.fda.gov/                       Jill Hartzler Warner,
                                                    biologics license application (BLA)                                                                            Associate Commissioner for Special Medical
                                                                                                               1 This indication is protected by orphan drug
                                                    125544, for CT–P13, a proposed                                                                                 Programs.
                                                                                                            exclusivity expiring on September 23, 2018. See the
                                                    biosimilar to Janssen Biotech Inc.’s                    Orphan Drug Designations and Approvals database        [FR Doc. 2016–00823 Filed 1–15–16; 8:45 am]
                                                    REMICADE (infliximab), submitted by                     at http://www.accessdata.fda.gov/scripts/              BILLING CODE 4164–01–P
                                                    Celltrion, Inc. The proposed indications                opdlisting/oopd/index.cfm.



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Document Created: 2016-01-16 01:10:35
Document Modified: 2016-01-16 01:10:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation81 FR 2873 

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