82 FR 28861 - Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 121 (June 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 121 (June 26, 2017)
| Page Range | 28861-28862 | |
| FR Document | 2017-13203 |
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)] [Notices] [Pages 28861-28862] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13203] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3331] Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- 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. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on August 2, 2017, from 8 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. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-3331. The docket will close on August 1, 2017. Submit either electronic or written comments on this public meeting by August 1, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 1, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 1, 2017. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before July 19, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-3331 for ``Arthritis Advisory Committee; Notice of Meeting; [[Page 28862]] Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES) will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Philip Bautista, 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: [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 https://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 (BLA) 761057, for sirukumab injection (proposed trade name PLIVENSIA), submitted by Janssen Biotech, Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. The discussion will include dose selection, efficacy, radiographic progression study, and safety. 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 https://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. All electronic and written submissions must be submitted on or before August 1, 2017. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 July 11, 2017. 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 July 12, 2017. 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 Philip Bautista 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 https://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 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13203 Filed 6-23-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices 28861
• The potential for multiple units of In the Federal Register of September manufacturers should submit in the
a device type (limited to no more than 24, 2014 (79 FR 57112), FDA announced custom device annual report, and
five units per year) qualifying for the the availability of the guidance entitled provide recommendations on how to
custom device exemption; and ‘‘Custom Device Exemption.’’ FDA has submit an annual report for devices
• Annual reporting requirements by developed this document to provide distributed under the custom device
the manufacturer to FDA about devices guidance to industry and FDA staff exemption.
manufactured and distributed under about implementation of the custom
section 520(b) of the FD&C Act. In the Federal Register of March 21,
device exemption contained in the 2017 (82 FR 14518), FDA published a
Under FDASIA, ‘‘devices’’ that qualify
for the custom device exemption FD&C Act. The intent of the guidance is 60-day notice requesting public
contained in section 520(b) of the FD&C to define terms used in the custom comment on the proposed collection of
Act were clarified to include no more device exemption, explain how to information. No comments were
than ‘‘five units per year of a particular interpret the ‘‘five units per year of a received.
device type’’ that otherwise meet all the particular device type’’ language
FDA estimates the burden of this
requirements necessary to qualify for contained in the FD&C Act, describe
collection of information as follows:
the custom device exemption. information that FDA proposes
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Annual reporting for custom devices ................................... 33 1 33 40 1,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017. accommodations due to a disability, www.regulations.gov will be posted to
Anna K. Abram, visitor parking, and transportation may the docket unchanged. Because your
Deputy Commissioner for Policy, Planning, be accessed at: https://www.fda.gov/ comment will be made public, you are
Legislation, and Analysis. AdvisoryCommittees/ solely responsible for ensuring that your
[FR Doc. 2017–13245 Filed 6–23–17; 8:45 am] AboutAdvisoryCommittees/ comment does not include any
BILLING CODE 4164–01–P ucm408555.htm. confidential information that you or a
FDA is establishing a docket for third party may not wish to be posted,
public comment on this meeting. The such as medical information, your or
DEPARTMENT OF HEALTH AND docket number is FDA–2017–N–3331. anyone else’s Social Security number, or
HUMAN SERVICES The docket will close on August 1, confidential business information, such
2017. Submit either electronic or as a manufacturing process. Please note
Food and Drug Administration written comments on this public that if you include your name, contact
meeting by August 1, 2017. Late, information, or other information that
[Docket No. FDA–2017–N–3331] untimely filed comments will not be identifies you in the body of your
considered. Electronic comments must comments, that information will be
Arthritis Advisory Committee; Notice
be submitted on or before August 1, posted on https://www.regulations.gov.
of Meeting; Establishment of a Public
2017. The https://www.regulations.gov • If you want to submit a comment
Docket; Request for Comments
electronic filing system will accept with confidential information that you
AGENCY: Food and Drug Administration, comments until midnight Eastern Time do not wish to be made available to the
HHS. at the end of August 1, 2017. Comments public, submit the comment as a
ACTION: Notice; establishment of a received by mail/hand delivery/courier written/paper submission and in the
public docket; request for comments. (for written/paper submissions) will be manner detailed (see ‘‘Written/Paper
considered timely if they are Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug postmarked or the delivery service
Written/Paper Submissions
Administration (FDA) announces a acceptance receipt is on or before that
forthcoming public advisory committee date. Submit written/paper submissions as
meeting of the Arthritis Advisory Comments received on or before July follows:
Committee. The general function of the 19, 2017, will be provided to the • Mail/Hand delivery/Courier (for
committee is to provide advice and committee. written/paper submissions): Dockets
recommendations to the Agency on Comments received after that date Management Staff (HFA–305), Food and
FDA’s regulatory issues. The meeting will be taken into consideration by the Drug Administration, 5630 Fishers
will be open to the public. FDA is Agency. Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments as • For written/paper comments
establishing a docket for public
follows: submitted to the Dockets Management
comment on this document.
Staff, FDA will post your comment, as
DATES: The meeting will be held on Electronic Submissions
sradovich on DSK3GMQ082PROD with NOTICES
well as any attachments, except for
August 2, 2017, from 8 a.m. to 5 p.m. Submit electronic comments in the information submitted, marked and
ADDRESSES: FDA White Oak Campus, following way: identified, as confidential, if submitted
10903 New Hampshire Ave., Bldg. 31 • Federal eRulemaking Portal: as detailed in ‘‘Instructions.’’
Conference Center, the Great Room (Rm. https://www.regulations.gov. Follow the Instructions: All submissions received
1503), Silver Spring, MD 20993. instructions for submitting comments. must include the Docket No. FDA–
Answers to commonly asked questions Comments submitted electronically, 2017–N–3331 for ‘‘Arthritis Advisory
including information regarding special including attachments, to https:// Committee; Notice of Meeting;
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![28862 Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
Establishment of a Public Docket; Washington, DC area). A notice in the accommodated during the scheduled
Request for Comments.’’ Received Federal Register about last minute open public hearing session, FDA may
comments, those filed in a timely modifications that impact a previously conduct a lottery to determine the
manner (see ADDRESSES) will be placed announced advisory committee meeting speakers for the scheduled open public
in the docket and, except for those cannot always be published quickly hearing session. The contact person will
submitted as ‘‘Confidential enough to provide timely notice. notify interested persons regarding their
Submissions,’’ publicly viewable at Therefore, you should always check the request to speak by July 12, 2017.
https://www.regulations.gov or at the Agency’s Web site at https:// Persons attending FDA’s advisory
Dockets Management Staff between 9 www.fda.gov/AdvisoryCommittees/ committee meetings are advised that the
a.m. and 4 p.m., Monday through default.htm and scroll down to the Agency is not responsible for providing
Friday. appropriate advisory committee meeting access to electrical outlets.
• Confidential Submissions—To link, or call the advisory committee FDA welcomes the attendance of the
submit a comment with confidential information line to learn about possible public at its advisory committee
information that you do not wish to be modifications before coming to the meetings and will make every effort to
made publicly available, submit your meeting. accommodate persons with disabilities.
comments only as a written/paper If you require accommodations due to a
SUPPLEMENTARY INFORMATION:
submission. You should submit two Agenda: The committee will discuss disability, please contact Philip Bautista
copies total. One copy will include the biologics license application (BLA) at least 7 days in advance of the
information you claim to be confidential 761057, for sirukumab injection meeting.
with a heading or cover note that states FDA is committed to the orderly
(proposed trade name PLIVENSIA),
‘‘THIS DOCUMENT CONTAINS conduct of its advisory committee
submitted by Janssen Biotech, Inc., for
CONFIDENTIAL INFORMATION.’’ The meetings. Please visit our Web site at
the treatment of adult patients with
Agency will review this copy, including https://www.fda.gov/
moderately to severely active
the claimed confidential information, in AdvisoryCommittees/
rheumatoid arthritis who have had an
its consideration of comments. The AboutAdvisoryCommittees/
inadequate response or are intolerant to
second copy, which will have the ucm111462.htm for procedures on
one or more disease modifying anti-
claimed confidential information public conduct during advisory
rheumatic drugs. The discussion will
redacted/blacked out, will be available committee meetings.
include dose selection, efficacy,
for public viewing and posted on Notice of this meeting is given under
radiographic progression study, and
https://www.regulations.gov. Submit the Federal Advisory Committee Act (5
safety.
both copies to the Dockets Management U.S.C. app. 2).
FDA intends to make background
Staff. If you do not wish your name and material available to the public no later Dated: June 20, 2017.
contact information to be made publicly than 2 business days before the meeting. Anna K. Abram,
available, you can provide this If FDA is unable to post the background Deputy Commissioner for Policy, Planning,
information on the cover sheet and not material on its Web site prior to the Legislation, and Analysis.
in the body of your comments and you meeting, the background material will [FR Doc. 2017–13203 Filed 6–23–17; 8:45 am]
must identify this information as be made publicly available at the BILLING CODE 4164–01–P
‘‘confidential.’’ Any information marked location of the advisory committee
as ‘‘confidential’’ will not be disclosed meeting, and the background material
except in accordance with 21 CFR 10.20 will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
and other applicable disclosure law. For the meeting. Background material is HUMAN SERVICES
more information about FDA’s posting available at https://www.fda.gov/
of comments to public dockets, see 80 AdvisoryCommittees/Calendar/ Health Resources and Services
FR 56469, September 18, 2015, or access default.htm. Scroll down to the Administration
the information at: https://www.gpo.gov/ appropriate advisory committee meeting
fdsys/pkg/FR-2015-09-18/pdf/2015- link. Low-Income Levels Used for Various
23389.pdf. Procedure: Interested persons may Health Professions and Nursing
Docket: For access to the docket to present data, information, or views, Programs Authorized in Titles III, VII,
read background documents or the orally or in writing, on issues pending and VIII of the Public Health Service
electronic and written/paper comments before the committee. All electronic and Act
received, go to https:// written submissions must be submitted AGENCY: Health Resources and Services
www.regulations.gov and insert the on or before August 1, 2017. Oral Administration (HRSA), Department of
docket number, found in brackets in the presentations from the public will be Health and Human Services (HHS).
heading of this document, into the scheduled between approximately 1 ACTION: Notice.
‘‘Search’’ box and follow the prompts p.m. and 2 p.m. Those individuals
and/or go to the Dockets Management interested in making formal oral SUMMARY: HRSA is updating income
Staff, 5630 Fishers Lane, Rm. 1061, presentations should notify the contact levels used to identify a ‘‘low-income
Rockville, MD 20852. person and submit a brief statement of family’’ for the purpose of determining
FOR FURTHER INFORMATION CONTACT: the general nature of the evidence or eligibility for programs that provide
Philip Bautista, Center for Drug arguments they wish to present, the health professions and nursing training
Evaluation and Research, Food and names and addresses of proposed
sradovich on DSK3GMQ082PROD with NOTICES
to individuals from disadvantaged
Drug Administration, 10903 New participants, and an indication of the backgrounds. These various programs
Hampshire Ave., Bldg. 31, Rm. 2417, approximate time requested to make are authorized in Titles III, VII, and VIII
Silver Spring, MD 20993–0002, 301– their presentation on or before July 11, of the Public Health Service Act.
796–9001, Fax: 301–847–8533, email: 2017. Time allotted for each HHS periodically publishes in the
AAC@fda.hhs.gov, or FDA Advisory presentation may be limited. If the Federal Register low-income levels to
Committee Information Line, 1–800– number of registrants requesting to be used by institutions receiving federal
741–8138 (301–443–0572 in the speak is greater than can be reasonably grants and cooperative agreements to
VerDate Sep<11>2014 17:04 Jun 23, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1](https://thefederalregister.org/doc/82_FR_28982/page/2.svg)
Document Created: 2018-11-14 10:11:12
Document Modified: 2018-11-14 10:11:12
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on August 2, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Philip Bautista, 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: [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 https://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 | 82 FR 28861 |
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