82 FR 31781 - 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 130 (July 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 130 (July 10, 2017)
| Page Range | 31781-31783 | |
| FR Document | 2017-14364 |
[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)] [Notices] [Pages 31781-31783] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14364] ----------------------------------------------------------------------- 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.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 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
![Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices 31781
promulgated by HHS as a final rule, in accordance with the redaction policy Notice that announces Board and
advice on the scientific validity and provided below. Subcommittee meetings.
quality of dose estimation and Policy on Redaction of Board Meeting CONTACT PERSON FOR MORE INFORMATION:
reconstruction efforts being performed Transcripts (Public Comment): Theodore Katz, Designated Federal
for purposes of the compensation (1) If a person making a comment Officer, NIOSH, CDC, 1600 Clifton Road
program, and advice on petitions to add gives his or her personal information, no NE., MS E–20, Atlanta, Georgia 30333,
classes of workers to the Special attempt will be made to redact the telephone: (513)533–6800, toll free: 1–
Exposure Cohort (SEC). name; however, NIOSH will redact 800–CDC–INFO, email: dcas@cdc.gov.
In December 2000, the President other personally identifiable The Director, Management Analysis
delegated responsibility for funding, information, such as contact and Services Office, has been delegated
staffing, and operating the Advisory information, social security numbers, the authority to sign Federal Register
Board to HHS, which subsequently case numbers, etc., of the commenter. notices pertaining to announcements of
delegated this authority to the CDC. (2) If an individual in making a meetings and other committee
NIOSH implements this responsibility statement reveals personal information management activities, for both the
for CDC. The charter was issued on (e.g., medical or employment Centers for Disease Control and
August 3, 2001, renewed at appropriate information) about themselves that Prevention and the Agency for Toxic
intervals, rechartered on March 22, 2016 information will not usually be Substances and Disease Registry.
pursuant to Executive Order 13708, and redacted. The NIOSH Freedom of
will expire on September 30, 2017. Claudette Grant,
Information Act (FOIA) coordinator
This Advisory Board is charged with will, however, review such revelations Acting Director, Management Analysis and
(a) providing advice to the Secretary, Services Office, Centers for Disease Control
in accordance with the Federal and Prevention.
HHS, on the development of guidelines
Advisory Committee Act and if deemed
under Executive Order 13179; (b) [FR Doc. 2017–14515 Filed 7–6–17; 4:15 pm]
appropriate, will redact such
providing advice to the Secretary, HHS, BILLING CODE 4163–18–P
information.
on the scientific validity and quality of
(3) If a commenter reveals personal
dose reconstruction efforts performed
for this program; and (c) upon request information concerning a living third DEPARTMENT OF HEALTH AND
by the Secretary, HHS, advising the party, that information will be reviewed HUMAN SERVICES
Secretary on whether there is a class of by the NIOSH FOIA coordinator, and
employees at any Department of Energy upon determination, if deemed Food and Drug Administration
facility who were exposed to radiation appropriate, such information will be
redacted, unless the disclosure is made [Docket No. FDA–2017–N–3331]
but for whom it is not feasible to
estimate their radiation dose, and on by the third party’s authorized Arthritis Advisory Committee; Notice
whether there is reasonable likelihood representative under the Energy of Meeting; Establishment of a Public
that such radiation doses may have Employees Occupational Illness Docket; Request for Comments
endangered the health of members of Compensation Program Act (EEOICPA)
this class. program. AGENCY: Food and Drug Administration,
The agenda for the Advisory Board (4) In general, information concerning HHS.
meeting includes: NIOSH Program a deceased third party may be disclosed; ACTION: Notice; establishment of a
Update; Department of Labor Program however, such information will be public docket; request for comments.
Update; Department of Energy Program redacted if (a) the disclosure is made by
Update; SEC Petitions Update; Site an individual other than the survivor SUMMARY: The Food and Drug
Profile reviews for Pantex Plant claimant, a parent, spouse, or child, or Administration (FDA or Agency)
(Amarillo, Texas), Pacific Proving the authorized representative of the announces a forthcoming public
Grounds (Marshall Islands), Feed deceased third party; (b) it is unclear advisory committee meeting of the
Materials Production Center (Fernald, whether the third party is living or Arthritis Advisory Committee. The
Ohio), and possibly Nevada Test Site deceased; or (c) the information is general function of the committee is to
(Mercury, Nevada); SEC petitions for: unrelated or irrelevant to the purpose of provide advice and recommendations to
Metals and Control Corp. (1968–1997; the disclosure. The Board will take the Agency on FDA’s regulatory issues.
Attleboro, Massachusetts), Los Alamos reasonable steps to ensure that The meeting will be open to the public.
National Laboratory (1996–2005; Los individuals making public comment are FDA is establishing a docket for public
Alamos, New Mexico), Idaho National aware of the fact that their comments comment on this document.
Laboratory (1970–1980; Scoville, Idaho), (including their name, if provided) will DATES: The meeting will be held on
Area IV of Santa Susanna Field appear in a transcript of the meeting August 3, 2017, from 8 a.m. to 1 p.m.
Laboratory (1991–1993; Ventura County, posted on a public Web site. Such ADDRESSES: FDA White Oak Campus,
California), Savannah River Site (1973– reasonable steps include: (a) A 10903 New Hampshire Ave., Bldg. 31
2007; Aiken, South Carolina), and statement read at the start of each public Conference Center, the Great Room (Rm.
possibly either Ames Laboratory (1971– comment period stating that transcripts 1503), Silver Spring, MD 20993.
undetermined ending date; Ames, Iowa) will be posted and names of speakers Answers to commonly asked questions
or Grand Junction Facilities (1986–2010; will not be redacted; (b) A printed copy including information regarding special
Grand Junction, CO); and Board Work of the statement mentioned in (a) above accommodations due to a disability,
will be displayed on the table where
sradovich on DSK3GMQ082PROD with NOTICES
Sessions. visitor parking, and transportation may
The agenda is subject to change as individuals sign up to make public be accessed at: https://www.fda.gov/
priorities dictate. In the event an comments; (c) A statement such as AdvisoryCommittees/
individual cannot attend, written outlined in (a) above will also appear AboutAdvisoryCommittees/
comments may be submitted to the with the agenda for a Board Meeting ucm408555.htm.
contact person below well in advance of when it is posted on the NIOSH Web FDA is establishing a docket for
the meeting. Any written comments site; (d) A statement such as in (a) above public comment on this document. The
received will be provided at the meeting will appear in the Federal Register docket number is FDA–2017–N–3331.
VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\10JYN1.SGM 10JYN1](https://thefederalregister.org/doc/82_FR_31911/page/1.svg)
![Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices 31783
their presentation on or before July 12, virus outbreak in the Americas. The business mail), Rockville, MD 20850–
2017. Time allotted for each document was published with the 9702 Telephone: (240) 276–5530;
presentation may be limited. If the incorrect docket number. This Facsimile: (240) 276–5504 Email:
number of registrants requesting to document corrects that error. vathyams@mail.nih.gov.
speak is greater than can be reasonably FOR FURTHER INFORMATION CONTACT: Lisa SUPPLEMENTARY INFORMATION:
accommodated during the scheduled Granger, Office of Policy and Planning,
open public hearing session, FDA may Intellectual Property
Food and Drug Administration, 10903
conduct a lottery to determine the New Hampshire Ave., Bldg. 32, Rm. • United States Provisional Patent
speakers for the scheduled open public 3330, Silver Spring, MD 20993–0002, Application No. 61/045,088, filed April
hearing session. The contact person will 301–796–9115. 15, 2008, titled ‘‘Composition and
notify interested persons regarding their SUPPLEMENTARY INFORMATION: In the
methods for delivering inhibitory
request to speak by July 13, 2017. Federal Register of Friday, June 30, oligonucleotides’’, [HHS Reference No.
Persons attending FDA’s advisory 2017, in FR Doc. 2017–13720, on page E–051–2008/0–US–01], status: expired;
committee meetings are advised that the • International Patent Application
29866, the following correction is made:
Agency is not responsible for providing 1. On page 29866, in the first column, No. PCT/US2009/040607, filed April 15,
access to electrical outlets. in the headings section at the beginning 2009, titled ‘‘Composition and methods
FDA welcomes the attendance of the of the document, the docket number is for delivering inhibitory
public at its advisory committee corrected to read ‘‘FDA–2016–N–1486’’. oligonucleotides’’, [HHS Reference No.
meetings and will make every effort to E–051–2008/0–PCT–02], status:
accommodate persons with disabilities. Dated: June 30, 2017. converted;
If you require accommodations due to a Anna K. Abram, • Canadian Patent Application No.
disability, please contact Philip Bautista Deputy Commissioner for Policy, Planning, 2,720,363, filed April 15, 2009, titled
at least 7 days in advance of the Legislation, and Analysis. ‘‘Composition and methods for
meeting. [FR Doc. 2017–14365 Filed 7–7–17; 8:45 am] delivering inhibitory oligonucleotides’’,
FDA is committed to the orderly BILLING CODE 4164–01–P [HHS Reference No. E–051–2008/0–CA–
conduct of its advisory committee 04], status: pending;
meetings. Please visit our Web site at • United States Patent Application
https://www.fda.gov/ DEPARTMENT OF HEALTH AND No. 12/988,148, filed March 8, 2011,
AdvisoryCommittees/ HUMAN SERVICES titled ‘‘Compositions and methods for
AboutAdvisoryCommittees/ delivering inhibitory oligonucleotides’’
ucm111462.htm for procedures on National Institutes of Health [HHS Reference No. E–051–2008/0–US–
public conduct during advisory 07], status: issued as Patent No.
Prospective Grant of Exclusive Patent 8,703,921;
committee meetings.
Notice of this meeting is given under License: Composition and Methods for • United States Patent Application
the Federal Advisory Committee Act (5 Delivering Inhibitory Oligonucleotides No. 14/220,726, filed March 20, 2014,
U.S.C. app. 2). for the Treatment of Pancreatic Cancer titled ‘‘Compositions and Methods for
Dated: June 29, 2017. AGENCY: National Institutes of Health, delivering inhibitory oligonucleotides’’
Anna K. Abram, Department of Health and Human [HHS Reference No. E–051–2008/0–US–
Services. 08], status: issued as Patent No.
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. ACTION: Notice. 9,415,116; and
• United States Patent Application
[FR Doc. 2017–14364 Filed 7–7–17; 8:45 am]
SUMMARY: The National Institute on No. 15,204,789, filed July 7, 2016, titled
BILLING CODE 4164–01–P
Aging, an institute of the National ‘‘Compositions and Methods for
Institutes of Health, Department of delivering inhibitory oligonucleotides’’
Health and Human Services, is [HHS Reference No. E–051–2008/0–US–
DEPARTMENT OF HEALTH AND
contemplating the grant of an Exclusive 11], status: pending.
HUMAN SERVICES The patent rights in these inventions
Patent License to practice the inventions
Food and Drug Administration embodied in the U.S. Patents and Patent have been assigned to the government of
Applications listed in the the United States of America.
[Docket No. FDA–2016–N–1486] Supplementary Information section of The prospective exclusive license
this notice to VeriLuce Therapeutics territory may be worldwide and the
Authorizations of Emergency Use of In field of use may be limited to the use
Vitro Diagnostic Devices for Detection (‘‘VLT’’) located in Toronto, ON,
Canada. of Licensed Patent Rights for the
of Zika Virus; Availability; Correction following: ‘‘Treatment of pancreatic
DATES: Only written comments and/or
AGENCY: Food and Drug Administration, cancer by targeting regulatory T cells
applications for a license which are using complexes or fusion molecules
HHS. received by the National Cancer
ACTION: Notice; correction. comprising inhibitory nucleic acids, a
Institute’s Technology Transfer Center nucleic acid binding moiety and a
SUMMARY: The Food and Drug on or before July 25, 2017 will be targeting polypeptide, wherein the
Administration is correcting a notice considered. targeting polypeptide contains either the
entitled ‘‘Authorizations of Emergency ADDRESSES: Requests for copies of the TARC/CCL17 or RANTES/CCL5 cell
Use of In Vitro Diagnostic Devices for patent application, inquiries, and
sradovich on DSK3GMQ082PROD with NOTICES
surface receptor ligand.’’
Detection of Zika Virus; Availability’’ comments relating to the contemplated Despite significant attractiveness of
that appeared in the Federal Register of Exclusive Patent License should be anti-sense oligonucleotide technology,
June 30, 2017 (82 FR 29886). The directed to: Surekha Vathyam, Ph.D., its clinical application has been
document announced the issuance of Senior Technology Transfer Manager, precluded by a lack of methods for
two Emergency Use Authorizations for NCI Technology Transfer Center, 9609 targeted delivery and transduction of
in vitro diagnostic devices for detection Medical Center Drive, RM 1E530 MSC primary immune cells in vivo. Novel
of the Zika virus in response to the Zika 9702, Bethesda, MD 20892–9702 (for complexes and methods for delivering
VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\10JYN1.SGM 10JYN1](https://thefederalregister.org/doc/82_FR_31911/page/3.svg)
Document Created: 2017-07-08 00:55:34
Document Modified: 2017-07-08 00:55:34
| 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 3, 2017, from 8 a.m. to 1 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 31781 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR