81_FR_38824 81 FR 38710 - Arthritis Advisory Committee; Notice of Meeting

81 FR 38710 - Arthritis Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 114 (June 14, 2016)

Page Range38710-38711
FR Document2016-14017

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 114 (Tuesday, June 14, 2016)
[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Pages 38710-38711]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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



                                                38710                                  Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices

                                                projects (Arkansas, Arizona, Colorado,                               National Study. The respondents to the                                  and Systems-Level Change telephone
                                                Hawaii, Illinois, Kentucky, Maine,                                   Well-Being telephone survey will be a                                   survey will be a purposive sample of 60
                                                Maryland, Massachusetts, Michigan,                                   purposive sample of 60 respondents                                      respondents identified from up to 12
                                                Nebraska, Nevada, New York,                                          identified from up to 12 waiver                                         waiver jurisdictions who are
                                                Oklahoma, Oregon, Pennsylvania, Port                                 jurisdictions who are involved with the                                 knowledgeable about practice, policy,
                                                Gamble S’Klallam Tribe, Rhode Island,                                assessment of child and family well-                                    and organizational changes in their
                                                Tennessee, Texas, Utah, Washington,                                  being in their waiver jurisdictions. The                                respective waiver jurisdictions. The
                                                Washington DC, West Virginia,                                        Well-Being telephone survey will be                                     Practice and Systems-Level Change
                                                Wisconsin). The Web-based survey will                                administered once during the National                                   telephone survey will be administered
                                                be administered once during the                                      Study. The respondents to the Practice                                  once during the National Study.

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

                                                Web-Based Survey ..........................................................................................                     250                           1                      0.33              82.5
                                                Telephone Survey: Well-Being ........................................................................                            60                           1                         1                60
                                                Telephone Survey: Practice and Systems-Level Change ...............................                                              60                           1                         1                60

                                                      Estimated Total Annual Burden Hours .....................................................               ........................   ........................   ........................          202.5



                                                  In compliance with the requirements                                DEPARTMENT OF HEALTH AND                                                741–8138 (301–443–0572 in the
                                                of section 506(c)(2)(A) of the Paperwork                             HUMAN SERVICES                                                          Washington, DC area). A notice in the
                                                Reduction Act of 1995, the                                                                                                                   Federal Register about last minute
                                                Administration for Children and                                      Food and Drug Administration                                            modifications that impact a previously
                                                Families is soliciting public comment                                [Docket No. FDA–2016–N–0001]                                            announced advisory committee meeting
                                                on the specific aspects of the                                                                                                               cannot always be published quickly
                                                information collected described above.                               Arthritis Advisory Committee; Notice                                    enough to provide timely notice.
                                                Copies of the proposed collection of                                 of Meeting                                                              Therefore, you should always check the
                                                information can be obtained and                                                                                                              Agency’s Web site at http://
                                                                                                                     AGENCY:       Food and Drug Administration,                             www.fda.gov/AdvisoryCommittees/
                                                comments may be forwarded by writing                                 HHS.
                                                to the Administration for Children and                                                                                                       default.htm and scroll down to the
                                                                                                                     ACTION:      Notice.                                                    appropriate advisory committee meeting
                                                Families, Office of Planning, Research
                                                                                                                                                                                             link, or call the advisory committee
                                                and Evaluation, 330 C St. SW.,                                       SUMMARY:   The Food and Drug                                            information line to learn about possible
                                                Washington, DC 20447, Attn: ACF                                      Administration (FDA) announces a                                        modifications before coming to the
                                                Reports Clearance Officer. Email                                     forthcoming public advisory committee                                   meeting.
                                                address: infocollection@acf.hhs.gov. All                             meeting of the Arthritis Advisory
                                                requests should be identified by the title                           Committee. The general function of the                                  SUPPLEMENTARY INFORMATION:
                                                of the information collection.                                       committee is to provide advice and                                         Agenda: The committee will discuss
                                                                                                                     recommendations to the Agency on                                        biologics license application 761024, for
                                                  The Department specifically requests                                                                                                       ABP 501, a proposed biosimilar to
                                                comments on: (a) Whether the proposed                                FDA’s regulatory issues. The meeting
                                                                                                                     will be open to the public.                                             AbbVie Inc.’s HUMIRA (adalimumab),
                                                collection of information is necessary                                                                                                       submitted by Amgen, Inc. The proposed
                                                for the proper performance of the                                    DATES: The meeting will be held on July
                                                                                                                     12, 2016, from 7:30 a.m. to 5 p.m.                                      indications (uses) for this product are:
                                                functions of the agency, including                                                                                                           (1) Reducing signs and symptoms,
                                                whether the information shall have                                   ADDRESSES: FDA White Oak Campus,
                                                                                                                                                                                             inducing major clinical response,
                                                practical utility; (b) the accuracy of the                           10903 New Hampshire Ave., Bldg. 31                                      inhibiting the progression of structural
                                                agency’s estimate of the burden of the                               Conference Center, the Great Room (Rm.                                  damage, and improving physical
                                                proposed collection of information (c)                               1503), Silver Spring, MD 20993–0002.                                    function in adult patients with
                                                the quality, utility and clarity of the                              Answers to commonly asked questions                                     moderately to severely active
                                                                                                                     including information regarding special                                 rheumatoid arthritis (alone or in
                                                information to be collected, and (d)
                                                                                                                     accommodations due to a disability,                                     combination with methotrexate or other
                                                ways to minimize the burden of the
                                                                                                                     visitor parking, and transportation may                                 non-biologic disease-modifying anti-
                                                collection of information on
                                                                                                                     be accessed at: http://www.fda.gov/                                     rheumatic drugs (DMARDs)); (2)
                                                respondents, including through the use                               AdvisoryCommittees/
                                                of automated collection techniques or                                                                                                        reducing signs and symptoms of
                                                                                                                     AboutAdvisoryCommittees/                                                moderately to severely active
                                                other forms of information technology.                               ucm408555.htm.
                                                Consideration will be given to                                                                                                               polyarticular juvenile idiopathic
                                                comments and suggestions submitted                                   FOR FURTHER INFORMATION CONTACT:                                        arthritis in patients 4 years of age and
                                                                                                                     Moon Hee V. Choi, Center for Drug                                       older (alone or in combination with
srobinson on DSK5SPTVN1PROD with NOTICES




                                                within 60 days of this publication.
                                                                                                                     Evaluation and Research, Food and                                       methotrexate); (3) reducing signs and
                                                Robert Sargis,                                                       Drug Administration, 10903 New                                          symptoms, inhibiting the progression of
                                                Reports Clearance Officer.                                           Hampshire Ave., Bldg. 31, Rm. 2417,                                     structural damage, and improving
                                                [FR Doc. 2016–13999 Filed 6–13–16; 8:45 am]                          Silver Spring, MD 20993–0002, 301–                                      physical function in adult patients with
                                                BILLING CODE 4184–01–P
                                                                                                                     796–9001, FAX: 301–847–8533, AAC@                                       active psoriatic arthritis (alone or in
                                                                                                                     fda.hhs.gov, or FDA Advisory                                            combination with non-biologic
                                                                                                                     Committee Information Line, 1–800–                                      DMARDs); (4) reducing signs and


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                                                                               Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices                                            38711

                                                symptoms in adult patients with active                  speak is greater than can be reasonably                DATES:  Although you can comment on
                                                ankylosing spondylitis; (5) reducing                    accommodated during the scheduled                      any guidance at any time (see 21 CFR
                                                signs and symptoms and inducing and                     open public hearing session, FDA may                   10.115(g)(5)), to ensure that the Agency
                                                maintaining clinical remission in adult                 conduct a lottery to determine the                     considers your comment on this draft
                                                patients with moderately to severely                    speakers for the scheduled open public                 guidance before it begins work on the
                                                active Crohn’s disease who have had an                  hearing session. The contact person will               final version of the guidance, submit
                                                inadequate response to conventional                     notify interested persons regarding their              either electronic or written comments
                                                therapy (ABP 501 would be indicated                     request to speak by June 20, 2016.                     on the draft guidance by August 15,
                                                for reducing signs and symptoms and                        Persons attending FDA’s advisory                    2016.
                                                inducing clinical remission in these                    committee meetings are advised that the                ADDRESSES:       You may submit comments
                                                patients if they have also lost response                Agency is not responsible for providing                as follows:
                                                to or are intolerant to infliximab); (6)                access to electrical outlets.
                                                inducing and sustaining clinical                           FDA welcomes the attendance of the                  Electronic Submissions
                                                remission in adult patients with                        public at its advisory committee                         Submit electronic comments in the
                                                moderately to severely active ulcerative                meetings and will make every effort to                 following way:
                                                colitis who have had an inadequate                      accommodate persons with disabilities.                   • Federal eRulemaking Portal: http://
                                                response to immunosuppressants such                     If you require accommodations due to a                 www.regulations.gov. Follow the
                                                as corticosteroids, azathioprine or 6-                  disability, please contact Moon Hee                    instructions for submitting comments.
                                                mercaptopurine (6–MP) (the                              Choi at least 7 days in advance of the                 Comments submitted electronically,
                                                effectiveness of ABP–501 would not be                   meeting.                                               including attachments, to http://
                                                established in patients who have lost                      FDA is committed to the orderly                     www.regulations.gov will be posted to
                                                response to or were intolerant to TNF                   conduct of its advisory committee                      the docket unchanged. Because your
                                                blockers); and (7) treatment of adult                   meetings. Please visit our Web site at                 comment will be made public, you are
                                                patients with moderate to severe                        http://www.fda.gov/                                    solely responsible for ensuring that your
                                                chronic plaque psoriasis who are                        AdvisoryCommittees/                                    comment does not include any
                                                candidates for systemic therapy or                      AboutAdvisoryCommittees/
                                                phototherapy, and when other systemic                                                                          confidential information that you or a
                                                                                                        ucm111462.htm for procedures on                        third party may not wish to be posted,
                                                therapies are medically less appropriate                public conduct during advisory
                                                (only to be administered to patients who                                                                       such as medical information, your or
                                                                                                        committee meetings.                                    anyone else’s Social Security number, or
                                                will be closely monitored and have                         Notice of this meeting is given under
                                                regular follow-up visits with a                                                                                confidential business information, such
                                                                                                        the Federal Advisory Committee Act (5                  as a manufacturing process. Please note
                                                physician).                                             U.S.C. app. 2).
                                                   FDA intends to make background                                                                              that if you include your name, contact
                                                material available to the public no later                  Dated: June 9, 2016.                                information, or other information that
                                                than 2 business days before the meeting.                Jill Hartzler Warner,                                  identifies you in the body of your
                                                If FDA is unable to post the background                 Associate Commissioner for Special Medical             comments, that information will be
                                                material on its Web site prior to the                   Programs.                                              posted on http://www.regulations.gov.
                                                meeting, the background material will                   [FR Doc. 2016–14017 Filed 6–13–16; 8:45 am]              • If you want to submit a comment
                                                be made publicly available at the                       BILLING CODE 4164–01–P
                                                                                                                                                               with confidential information that you
                                                location of the advisory committee                                                                             do not wish to be made available to the
                                                meeting, and the background material                                                                           public, submit the comment as a
                                                will be posted on FDA’s Web site after                  DEPARTMENT OF HEALTH AND                               written/paper submission and in the
                                                the meeting. Background material is                     HUMAN SERVICES                                         manner detailed (see ‘‘Written/Paper
                                                available at http://www.fda.gov/                                                                               Submissions’’ and ‘‘Instructions’’).
                                                AdvisoryCommittees/Calendar/                            Food and Drug Administration
                                                                                                                                                               Written/Paper Submissions
                                                default.htm. Scroll down to the                         [Docket No. FDA–2016–D–1273]
                                                appropriate advisory committee meeting                                                                            Submit written/paper submissions as
                                                link.                                                                                                          follows:
                                                                                                        Osteoporosis: Nonclinical Evaluation
                                                   Procedure: Interested persons may                                                                              • Mail/Hand delivery/Courier (for
                                                                                                        of Drugs Intended for Treatment; Draft
                                                present data, information, or views,                                                                           written/paper submissions): Division of
                                                                                                        Guidance for Industry; Availability
                                                orally or in writing, on issues pending                                                                        Dockets Management (HFA–305), Food
                                                before the committee. Written                           AGENCY:    Food and Drug Administration,               and Drug Administration, 5630 Fishers
                                                submissions may be made to the contact                  HHS.                                                   Lane, Rm. 1061, Rockville, MD 20852.
                                                person on or before June 27, 2016. Oral                 ACTION:   Notice of availability.                         • For written/paper comments
                                                presentations from the public will be                                                                          submitted to the Division of Dockets
                                                scheduled between approximately 1:30                    SUMMARY:   The Food and Drug                           Management, FDA will post your
                                                p.m. and 3 p.m. Those individuals                       Administration (FDA or Agency) is                      comment, as well as any attachments,
                                                interested in making formal oral                        announcing the availability of a draft                 except for information submitted,
                                                presentations should notify the contact                 guidance for industry entitled                         marked and identified, as confidential,
                                                person and submit a brief statement of                  ‘‘Osteoporosis: Nonclinical Evaluation                 if submitted as detailed in
                                                the general nature of the evidence or                   of Drugs Intended for Treatment.’’ This                ‘‘Instructions.’’
                                                arguments they wish to present, the                     draft guidance provides                                   Instructions: All submissions received
srobinson on DSK5SPTVN1PROD with NOTICES




                                                names and addresses of proposed                         recommendations to industry for                        must include the Docket No. FDA–
                                                participants, and an indication of the                  designing a nonclinical development                    2016–D–1273 for ‘‘Osteoporosis:
                                                approximate time requested to make                      program to support approval of drugs to                Nonclinical Evaluation of Drugs
                                                their presentation on or before June 17,                treat osteoporosis. This guidance also                 Intended for Treatment; Draft Guidance
                                                2016. Time allotted for each                            discusses the nonclinical development                  for Industry.’’ Received comments will
                                                presentation may be limited. If the                     of biopharmaceuticals (e.g., recombinant               be placed in the docket and, except for
                                                number of registrants requesting to                     proteins and monoclonal antibodies).                   those submitted as ‘‘Confidential


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Document Created: 2016-06-14 02:58:35
Document Modified: 2016-06-14 02:58:35
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.
DatesThe meeting will be held on July 12, 2016, from 7:30 a.m. to 5 p.m.
ContactMoon 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.
FR Citation81 FR 38710 

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