83_FR_13554 83 FR 13493 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 13493 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management 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 83, Issue 61 (March 29, 2018)

Page Range13493-13494
FR Document2018-06309

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 83 Issue 61 (Thursday, March 29, 2018) 
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13493-13494]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1015]


Joint Meeting of the Arthritis Advisory Committee and the Drug 
Safety and Risk Management 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.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Arthritis Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee. The general 
function of the committees is to provide advice and recommendations to 
FDA on 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 April 24 and 25, 2018, 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-
0002. 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-2018-N-1015. The docket will close on April 
23, 2018. Submit either electronic or written comments on this public 
meeting by April 23, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before April 23, 2018. The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of April 23, 2018. 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 April 10, 2018, will be provided to 
the committees. Comments received after that date will be taken into 
consideration by FDA.
    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-2018-N-1015 for ``Joint Meeting of the Arthritis Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments.'' 
Received comments, those filed in a timely manner (see the ADDRESSES 
section), 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

[[Page 13494]]

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.'' FDA 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: Jennifer Shepherd, 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 FDA's website 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 committees will be asked to discuss supplemental new 
drug application (sNDA) 20998, for CELEBREX (celecoxib) capsules 
submitted by Pfizer, Inc., which includes the results from the 
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated 
Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes 
randomized controlled trial that compared celecoxib to ibuprofen and 
naproxen, and determine whether the findings of the trial change FDA's 
current understanding of the safety of these three NSAIDs. In order to 
interpret some of the PRECISION findings, the committees will also 
consider the clinical implications of the drug interactions between 
each of these three NSAIDs and aspirin in patients taking aspirin for 
secondary prevention of cardiovascular disease.
    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 website 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 website 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 committees. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before April 10, 2018, will be provided to the 
committees. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 9:30 a.m. on April 25, 2018. 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 
April 2, 2018. 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 April 3, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    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 special accommodations due to a 
disability, please contact Jennifer Shepherd (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06309 Filed 3-28-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices 13493 presentations, and request time for a DEPARTMENT OF HEALTH AND You may submit comments as joint presentation, or submit requests for HUMAN SERVICES follows: designated representatives to participate Electronic Submissions in the focused sessions. Following the Food and Drug Administration close of registration, we will determine Submit electronic comments in the [Docket No. FDA–2018–N–1015] the amount of time allotted to each following way: Joint Meeting of the Arthritis Advisory • Federal eRulemaking Portal: presenter and the approximate time Committee and the Drug Safety and https://www.regulations.gov. Follow the each oral presentation is to begin, and Risk Management Advisory instructions for submitting comments. will select and notify participants by Comments submitted electronically, May 8, 2018. All requests to make oral Committee; Notice of Meeting; Establishment of a Public Docket; including attachments, to https:// presentations must be received by the www.regulations.gov will be posted to close of registration on April 24, 2018, Request for Comments the docket unchanged. Because your midnight Eastern Time. If selected for AGENCY: Food and Drug Administration, comment will be made public, you are presentation, any presentation materials HHS. solely responsible for ensuring that your must be emailed to ACTION: Notice; establishment of a comment does not include any GDUFARegulatoryScience@fda.hhs.gov public docket; request for comments. confidential information that you or a no later than May 17, 2018, midnight third party may not wish to be posted, Eastern Time. No commercial or SUMMARY: The Food and Drug such as medical information, your or promotional material will be permitted Administration (FDA) announces a anyone else’s Social Security number, or forthcoming public advisory committee to be presented or distributed at the confidential business information, such meeting of the Arthritis Advisory public workshop. as a manufacturing process. Please note Committee and the Drug Safety and Risk Streaming Webcast of the Public that if you include your name, contact Management Advisory Committee. The Workshop: This public workshop will information, or other information that general function of the committees is to identifies you in the body of your also be webcast. Please register online provide advice and recommendations to comments, that information will be by April 24, 2018, midnight Eastern FDA on regulatory issues. The meeting posted on https://www.regulations.gov. Time to attend the workshop remotely. will be open to the public. FDA is • If you want to submit a comment Please note that remote attendees will establishing a docket for public with confidential information that you not be able to speak or make comment on this document. do not wish to be made available to the presentations during the public DATES: The meeting will be held on public, submit the comment as a comment period or during any other April 24 and 25, 2018, from 8 a.m. to 5 written/paper submission and in the session of the workshop. To join the p.m. manner detailed (see ‘‘Written/Paper workshop via the webcast, please go to ADDRESSES: FDA White Oak Campus, Submissions’’ and ‘‘Instructions’’). https://collaboration.fda.gov/ 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. Written/Paper Submissions gdufa2018/. 1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as If you have never attended a Connect Answers to commonly asked questions follows: Pro event before, test your connection at including information regarding special • Mail/Hand delivery/Courier (for https://collaboration.fda.gov/common/ accommodations due to a disability, written/paper submissions): Dockets help/en/support/meeting_test.htm. To visitor parking, and transportation may Management Staff (HFA–305), Food and get a quick overview of the Connect Pro be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers program, visit https://www.adobe.com/ AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852. go/connectpro_overview. FDA has Committees/ucm408555.htm. • For written/paper comments verified the website addresses in this FDA is establishing a docket for submitted to the Dockets Management document, as of the date this document public comment on this meeting. The Staff, FDA will post your comment, as publishes in the Federal Register, but docket number is FDA–2018–N–1015. well as any attachments, except for websites are subject to change over time. The docket will close on April 23, 2018. information submitted, marked and Transcripts: Please be advised that as Submit either electronic or written identified, as confidential, if submitted soon as a transcript of the public comments on this public meeting by as detailed in ‘‘Instructions.’’ April 23, 2018. Please note that late, Instructions: All submissions received workshop is available, it will be untimely filed comments will not be must include the Docket No. FDA– accessible at https:// considered. Electronic comments must 2018–N–1015 for ‘‘Joint Meeting of the www.regulations.gov or at https:// Arthritis Advisory Committee and the be submitted on or before April 23, www.fda.gov/gdufaregscience. It may be 2018. The https://www.regulations.gov Drug Safety and Risk Management viewed at the Dockets Management Staff electronic filing system will accept Advisory Committee; Notice of Meeting; (see ADDRESSES). A link to the transcript comments until midnight Eastern Time Establishment of a Public Docket; will also be available on the internet at at the end of April 23, 2018. Comments Request for Comments.’’ Received https://www.fda.gov/gdufaregscience. received by mail/hand delivery/courier comments, those filed in a timely Dated: March 21, 2018. (for written/paper submissions) will be manner (see the ADDRESSES section), Leslie Kux, considered timely if they are will be placed in the docket and, except sradovich on DSK3GMQ082PROD with NOTICES postmarked or the delivery service for those submitted as ‘‘Confidential Associate Commissioner for Policy. acceptance receipt is on or before that Submissions,’’ publicly viewable at [FR Doc. 2018–06260 Filed 3–28–18; 8:45 am] date. https://www.regulations.gov or at the BILLING CODE 4164–01–P Comments received on or before April Dockets Management Staff between 9 10, 2018, will be provided to the a.m. and 4 p.m., Monday through committees. Comments received after Friday. that date will be taken into • Confidential Submissions—To consideration by FDA. submit a comment with confidential VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1

13494 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices information that you do not wish to be learn about possible modifications conduct a lottery to determine the made publicly available, submit your before coming to the meeting. speakers for the scheduled open public comments only as a written/paper SUPPLEMENTARY INFORMATION: hearing session. The contact person will submission. You should submit two Agenda: The committees will be notify interested persons regarding their copies total. One copy will include the asked to discuss supplemental new drug request to speak by April 3, 2018. information you claim to be confidential application (sNDA) 20998, for Persons attending FDA’s advisory with a heading or cover note that states CELEBREX (celecoxib) capsules committee meetings are advised that ‘‘THIS DOCUMENT CONTAINS submitted by Pfizer, Inc., which FDA is not responsible for providing CONFIDENTIAL INFORMATION.’’ FDA includes the results from the access to electrical outlets. will review this copy, including the PRECISION (Prospective Randomized For press inquiries, please contact the claimed confidential information, in its Evaluation of Celecoxib Integrated Office of Media Affairs at fdaoma@ consideration of comments. The second Safety vs. Ibuprofen Or Naproxen) trial, fda.hhs.gov or 301–796–4540. copy, which will have the claimed a cardiovascular outcomes randomized FDA welcomes the attendance of the confidential information redacted/ controlled trial that compared celecoxib public at its advisory committee blacked out, will be available for public to ibuprofen and naproxen, and meetings and will make every effort to viewing and posted on https:// determine whether the findings of the accommodate persons with disabilities. www.regulations.gov. Submit both trial change FDA’s current If you require special accommodations copies to the Dockets Management Staff. understanding of the safety of these due to a disability, please contact If you do not wish your name and three NSAIDs. In order to interpret some Jennifer Shepherd (see FOR FURTHER contact information to be made publicly of the PRECISION findings, the INFORMATION CONTACT) at least 7 days in available, you can provide this committees will also consider the advance of the meeting. information on the cover sheet and not clinical implications of the drug FDA is committed to the orderly in the body of your comments and you interactions between each of these three conduct of its advisory committee must identify this information as NSAIDs and aspirin in patients taking meetings. Please visit our website at ‘‘confidential.’’ Any information marked aspirin for secondary prevention of https://www.fda.gov/Advisory as ‘‘confidential’’ will not be disclosed cardiovascular disease. Committees/AboutAdvisoryCommittees/ except in accordance with 21 CFR 10.20 FDA intends to make background ucm111462.htm for procedures on and other applicable disclosure law. For material available to the public no later public conduct during advisory more information about FDA’s posting than 2 business days before the meeting. committee meetings. of comments to public dockets, see 80 If FDA is unable to post the background Notice of this meeting is given under FR 56469, September 18, 2015, or access material on its website prior to the the Federal Advisory Committee Act the information at: https://www.gpo.gov/ meeting, the background material will (5 U.S.C. app. 2). fdsys/pkg/FR-2015-09-18/pdf/2015- be made publicly available at the Dated: March 21, 2018. 23389.pdf. location of the advisory committee Leslie Kux, Docket: For access to the docket to meeting, and the background material Associate Commissioner for Policy. will be posted on FDA’s website after read background documents or the [FR Doc. 2018–06309 Filed 3–28–18; 8:45 am] the meeting. Background material is electronic and written/paper comments BILLING CODE 4164–01–P available at https://www.fda.gov/ received, go to https:// AdvisoryCommittees/Calendar/ www.regulations.gov and insert the default.htm. Scroll down to the DEPARTMENT OF HEALTH AND docket number, found in brackets in the appropriate advisory committee meeting HUMAN SERVICES heading of this document, into the link. ‘‘Search’’ box and follow the prompts Procedure: Interested persons may National Institutes of Health and/or go to the Dockets Management present data, information, or views, Staff, 5630 Fishers Lane, Rm. 1061, Government-Owned Invention; orally or in writing, on issues pending Rockville, MD 20852. Availability for Licensing before the committees. All electronic FOR FURTHER INFORMATION CONTACT: and written submissions submitted to AGENCY: National Institutes of Health, Jennifer Shepherd, Center for Drug the Docket (see ADDRESSES) on or before HHS. Evaluation and Research, Food and April 10, 2018, will be provided to the Drug Administration, 10903 New committees. Oral presentations from the ACTION: Notice. Hampshire Ave., Bldg. 31, Rm. 2417, public will be scheduled between SUMMARY: The inventions listed below Silver Spring, MD 20993–0002, 301– approximately 8:30 a.m. and 9:30 a.m. are owned by an agency of the U.S. 796–9001, Fax: 301–847–8533, email: on April 25, 2018. Those individuals Government. AAC@fda.hhs.gov, or FDA Advisory interested in making formal oral Committee Information Line, 1–800– presentations should notify the contact FOR FURTHER INFORMATION CONTACT: 741–8138 (301–443–0572 in the person and submit a brief statement of Licensing information may be obtained Washington, DC area). A notice in the the general nature of the evidence or by emailing the indicated licensing Federal Register about last minute arguments they wish to present, the contact at the National Heart, Lung, and modifications that impact a previously names and addresses of proposed Blood, Office of Technology Transfer announced advisory committee meeting participants, and an indication of the and Development Office of Technology cannot always be published quickly approximate time requested to make Transfer, 31 Center Drive Room 4A29, sradovich on DSK3GMQ082PROD with NOTICES enough to provide timely notice. their presentation on or before April 2, MSC 2479, Bethesda, MD 20892–2479; Therefore, you should always check 2018. Time allotted for each telephone: 301- 402–5579. A signed FDA’s website at https://www.fda.gov/ presentation may be limited. If the Confidential Disclosure Agreement may AdvisoryCommittees/default.htm and number of registrants requesting to be required to receive any unpublished scroll down to the appropriate advisory speak is greater than can be reasonably information. committee meeting link, or call the accommodated during the scheduled SUPPLEMENTARY INFORMATION: The advisory committee information line to open public hearing session, FDA may following inventions are available for VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1


Document Created: 2018-03-29 00:26:07
Document Modified: 2018-03-29 00:26:07
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; establishment of a public docket; request for comments.
DatesThe meeting will be held on April 24 and 25, 2018, from 8 a.m. to 5 p.m.
ContactJennifer Shepherd, 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 FDA's website 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 Citation83 FR 13493 
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