Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 31781-31783 [2017-14364]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered on March 22, 2016 pursuant to Executive Order 13708, and will expire on September 30, 2017. This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. The agenda for the Advisory Board meeting includes: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; SEC Petitions Update; Site Profile reviews for Pantex Plant (Amarillo, Texas), Pacific Proving Grounds (Marshall Islands), Feed Materials Production Center (Fernald, Ohio), and possibly Nevada Test Site (Mercury, Nevada); SEC petitions for: Metals and Control Corp. (1968–1997; Attleboro, Massachusetts), Los Alamos National Laboratory (1996–2005; Los Alamos, New Mexico), Idaho National Laboratory (1970–1980; Scoville, Idaho), Area IV of Santa Susanna Field Laboratory (1991–1993; Ventura County, California), Savannah River Site (1973– 2007; Aiken, South Carolina), and possibly either Ames Laboratory (1971– undetermined ending date; Ames, Iowa) or Grand Junction Facilities (1986–2010; Grand Junction, CO); and Board Work Sessions. The agenda is subject to change as priorities dictate. In the event an individual cannot attend, written comments may be submitted to the contact person below well in advance of the meeting. Any written comments received will be provided at the meeting VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 in accordance with the redaction policy provided below. Policy on Redaction of Board Meeting Transcripts (Public Comment): (1) If a person making a comment gives his or her personal information, no attempt will be made to redact the name; however, NIOSH will redact other personally identifiable information, such as contact information, social security numbers, case numbers, etc., of the commenter. (2) If an individual in making a statement reveals personal information (e.g., medical or employment information) about themselves that information will not usually be redacted. The NIOSH Freedom of Information Act (FOIA) coordinator will, however, review such revelations in accordance with the Federal Advisory Committee Act and if deemed appropriate, will redact such information. (3) If a commenter reveals personal information concerning a living third party, that information will be reviewed by the NIOSH FOIA coordinator, and upon determination, if deemed appropriate, such information will be redacted, unless the disclosure is made by the third party’s authorized representative under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) program. (4) In general, information concerning a deceased third party may be disclosed; however, such information will be redacted if (a) the disclosure is made by an individual other than the survivor claimant, a parent, spouse, or child, or the authorized representative of the deceased third party; (b) it is unclear whether the third party is living or deceased; or (c) the information is unrelated or irrelevant to the purpose of the disclosure. The Board will take reasonable steps to ensure that individuals making public comment are aware of the fact that their comments (including their name, if provided) will appear in a transcript of the meeting posted on a public Web site. Such reasonable steps include: (a) A statement read at the start of each public comment period stating that transcripts will be posted and names of speakers will not be redacted; (b) A printed copy of the statement mentioned in (a) above will be displayed on the table where individuals sign up to make public comments; (c) A statement such as outlined in (a) above will also appear with the agenda for a Board Meeting when it is posted on the NIOSH Web site; (d) A statement such as in (a) above will appear in the Federal Register PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 31781 Notice that announces Board and Subcommittee meetings. CONTACT PERSON FOR MORE INFORMATION: Theodore Katz, Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road NE., MS E–20, Atlanta, Georgia 30333, telephone: (513)533–6800, toll free: 1– 800–CDC–INFO, email: dcas@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Claudette Grant, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2017–14515 Filed 7–6–17; 4:15 pm] BILLING CODE 4163–18–P 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. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) 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 3, 2017, from 8 a.m. to 1 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 document. The docket number is FDA–2017–N–3331. SUMMARY: E:\FR\FM\10JYN1.SGM 10JYN1 31782 Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices The docket will close on August 2, 2017. Submit either electronic or written comments on this public meeting by August 2, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 2, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 2, 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 20, 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: sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 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; 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 Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: AAC@fda.hhs.gov, 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 supplemental new drug applications (sNDAs) 203214 supplement 17, for XELJANZ (tofacitinib) tablets and THIS DOCUMENT CONTAINS CONFIDENTIAL 208246 supplement 3, for XELJANZ XR INFORMATION. The Agency will review (tofacitinib) extended release tablets this copy, including the claimed submitted by Pfizer Inc., for the confidential information, in its treatment of adult patients with active consideration of comments. The second psoriatic arthritis. The committee will copy, which will have the claimed discuss the efficacy and safety data and confidential information redacted/ benefit-risk considerations. blacked out, will be available for public FDA intends to make background viewing and posted on https:// material available to the public no later www.regulations.gov. Submit both than 2 business days before the meeting. copies to the Dockets Management Staff. If FDA is unable to post the background If you do not wish your name and material on its Web site prior to the contact information to be made publicly meeting, the background material will available, you can provide this be made publicly available at the information on the cover sheet and not location of the advisory committee in the body of your comments and you meeting, and the background material must identify this information as will be posted on FDA’s Web site after ‘‘confidential.’’ Any information marked the meeting. Background material is as ‘‘confidential’’ will not be disclosed available at https://www.fda.gov/ except in accordance with 21 CFR 10.20 AdvisoryCommittees/Calendar/ and other applicable disclosure law. For default.htm. Scroll down to the more information about FDA’s posting appropriate advisory committee meeting of comments to public dockets, see 80 link. FR 56469, September 18, 2015, or access Procedure: Interested persons may the information at: https://www.gpo.gov/ present data, information, or views, fdsys/pkg/FR-2015-09-18/pdf/2015orally or in writing, on issues pending 23389.pdf. before the committee. All electronic and Docket: For access to the docket to written submissions submitted to the read background documents or the Docket (see the ADDRESSES section) on electronic and written/paper comments or before August 2, 2017, will be received, go to https:// provided to the committee. Oral www.regulations.gov and insert the presentations from the public will be docket number, found in brackets in the scheduled between approximately 10:45 heading of this document, into the a.m. and 11:45 a.m. Those individuals ‘‘Search’’ box and follow the prompts interested in making formal oral and/or go to the Dockets Management presentations should notify the contact Staff, 5630 Fishers Lane, Rm. 1061, person and submit a brief statement of Rockville, MD 20852. the general nature of the evidence or arguments they wish to present, the FOR FURTHER INFORMATION CONTACT: names and addresses of proposed Philip Bautista, Center for Drug participants, and an indication of the Evaluation and Research, Food and approximate time requested to make Drug Administration, 10903 New PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\10JYN1.SGM 10JYN1 Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices their presentation on or before July 12, 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 13, 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). virus outbreak in the Americas. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 30, 2017, in FR Doc. 2017–13720, on page 29866, the following correction is made: 1. On page 29866, in the first column, in the headings section at the beginning of the document, the docket number is corrected to read ‘‘FDA–2016–N–1486’’. Dated: June 29, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. AGENCY: [FR Doc. 2017–14364 Filed 7–7–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1486] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability; Correction Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability’’ that appeared in the Federal Register of June 30, 2017 (82 FR 29886). The document announced the issuance of two Emergency Use Authorizations for in vitro diagnostic devices for detection of the Zika virus in response to the Zika sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 [FR Doc. 2017–14365 Filed 7–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Composition and Methods for Delivering Inhibitory Oligonucleotides for the Treatment of Pancreatic Cancer National Institutes of Health, Department of Health and Human Services. ACTION: Notice. The National Institute on Aging, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to VeriLuce Therapeutics (‘‘VLT’’) located in Toronto, ON, Canada. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before July 25, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Surekha Vathyam, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for SUMMARY: BILLING CODE 4164–01–P AGENCY: Dated: June 30, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 31783 business mail), Rockville, MD 20850– 9702 Telephone: (240) 276–5530; Facsimile: (240) 276–5504 Email: vathyams@mail.nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property • United States Provisional Patent Application No. 61/045,088, filed April 15, 2008, titled ‘‘Composition and methods for delivering inhibitory oligonucleotides’’, [HHS Reference No. E–051–2008/0–US–01], status: expired; • International Patent Application No. PCT/US2009/040607, filed April 15, 2009, titled ‘‘Composition and methods for delivering inhibitory oligonucleotides’’, [HHS Reference No. E–051–2008/0–PCT–02], status: converted; • Canadian Patent Application No. 2,720,363, filed April 15, 2009, titled ‘‘Composition and methods for delivering inhibitory oligonucleotides’’, [HHS Reference No. E–051–2008/0–CA– 04], status: pending; • United States Patent Application No. 12/988,148, filed March 8, 2011, titled ‘‘Compositions and methods for delivering inhibitory oligonucleotides’’ [HHS Reference No. E–051–2008/0–US– 07], status: issued as Patent No. 8,703,921; • United States Patent Application No. 14/220,726, filed March 20, 2014, titled ‘‘Compositions and Methods for delivering inhibitory oligonucleotides’’ [HHS Reference No. E–051–2008/0–US– 08], status: issued as Patent No. 9,415,116; and • United States Patent Application No. 15,204,789, filed July 7, 2016, titled ‘‘Compositions and Methods for delivering inhibitory oligonucleotides’’ [HHS Reference No. E–051–2008/0–US– 11], status: pending. The patent rights in these inventions have been assigned to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Treatment of pancreatic cancer by targeting regulatory T cells using complexes or fusion molecules comprising inhibitory nucleic acids, a nucleic acid binding moiety and a targeting polypeptide, wherein the targeting polypeptide contains either the TARC/CCL17 or RANTES/CCL5 cell surface receptor ligand.’’ Despite significant attractiveness of anti-sense oligonucleotide technology, its clinical application has been precluded by a lack of methods for targeted delivery and transduction of primary immune cells in vivo. Novel complexes and methods for delivering E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Notices]
[Pages 31781-31783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14364]


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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 or Agency) 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 3, 2017, from 8 a.m. to 1 
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 document. 
The docket number is FDA-2017-N-3331.

[[Page 31782]]

The docket will close on August 2, 2017. Submit either electronic or 
written comments on this public meeting by August 2, 2017. Late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 2, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 2, 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 20, 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; 
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.gpo.gov/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: AAC@fda.hhs.gov, 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 supplemental new drug 
applications (sNDAs) 203214 supplement 17, for XELJANZ (tofacitinib) 
tablets and 208246 supplement 3, for XELJANZ XR (tofacitinib) extended 
release tablets submitted by Pfizer Inc., for the treatment of adult 
patients with active psoriatic arthritis. The committee will discuss 
the efficacy and safety data and benefit-risk considerations.
    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 submitted to the Docket (see the 
ADDRESSES section) on or before August 2, 2017, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 10:45 a.m. and 11:45 a.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

[[Page 31783]]

their presentation on or before July 12, 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 13, 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 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14364 Filed 7-7-17; 8:45 am]
 BILLING CODE 4164-01-P

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