83_FR_61873 83 FR 61642 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 61642 - Endocrinologic and Metabolic Drugs 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 231 (November 30, 2018)

Page Range61642-61643
FR Document2018-25990

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The general function of the Committee 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 231 (Friday, November 30, 2018) 
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61642-61643]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4282]


Endocrinologic and Metabolic Drugs 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 Endocrinologic and Metabolic 
Drugs Advisory Committee (the Committee). The general function of the 
Committee 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 January 17, 2019, 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-4282. The docket will close on January 
16, 2019. Submit either electronic or written comments on this public 
meeting by January 16, 2019. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before January 16, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of January 16, 2019. 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 January 3, 2019, will be provided to 
the Committee. 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-4282 for ``Endocrinologic and Metabolic Drugs 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

[[Page 61643]]

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 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 the 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: LaToya Bonner, 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 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 Committee will discuss new drug application 210934 for 
sotagliflozin oral tablet, sponsored by Sanofi-Aventis U.S. LLC, for 
the proposed indication: Adjunct to insulin therapy to improve glycemic 
control in adults with type 1 diabetes mellitus.
    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 Committee. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before January 3, 2019, will be provided to the 
Committee. Oral presentations from the public will be scheduled between 
approximately 1 p.m. to 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 December 27, 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 December 28, 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 accommodations due to a disability, please 
contact LaToya Bonner (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: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25990 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P

61642 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices Health guidance documents is available for Over-the-Counter Use’’ may send an information. These collections of at https://www.fda.gov/MedicalDevices/ email request to CDRH-Guidance@ information are subject to review by the DeviceRegulationandGuidance/ fda.hhs.gov to receive an electronic Office of Management and Budget GuidanceDocuments/default.htm. This copy of the document. Please use the (OMB) under the Paperwork Reduction draft guidance document is also document number GUD 1756 to identify Act of 1995 (44 U.S.C. 3501–3520). The available at https:// the guidance you are requesting. collections of information in the www.regulations.gov. Persons unable to IV. Paperwork Reduction Act of 1995 following FDA guidance and regulations download an electronic copy of ‘‘Self- have been approved by OMB as listed in This draft guidance refers to Monitoring Blood Glucose Test Systems previously approved collections of the following table: OMB control 21 CFR part or guidance Topic no. 807, subpart E ............................................................................ Premarket Notification ................................................................ 0910–0120 ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submissions ........................................................................... 0910–0756 Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 800, 801, and 809 ...................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System 0910–0073 (QS) Regulation. Dated: November 26, 2018. FDA is establishing a docket for that if you include your name, contact Leslie Kux, public comment on this meeting. The information, or other information that Associate Commissioner for Policy. docket number is FDA–2018–N–4282. identifies you in the body of your [FR Doc. 2018–26028 Filed 11–29–18; 8:45 am] The docket will close on January 16, comments, that information will be BILLING CODE 4164–01–P 2019. Submit either electronic or posted on https://www.regulations.gov. written comments on this public • If you want to submit a comment meeting by January 16, 2019. Please with confidential information that you DEPARTMENT OF HEALTH AND note that late, untimely filed comments do not wish to be made available to the HUMAN SERVICES will not be considered. Electronic public, submit the comment as a comments must be submitted on or written/paper submission and in the Food and Drug Administration before January 16, 2019. The https:// manner detailed (see ‘‘Written/Paper [Docket No. FDA–2018–N–4282] www.regulations.gov electronic filing Submissions’’ and ‘‘Instructions’’). system will accept comments until Written/Paper Submissions Endocrinologic and Metabolic Drugs 11:59 p.m. Eastern Time at the end of Advisory Committee; Notice of January 16, 2019. Comments received by Submit written/paper submissions as Meeting; Establishment of a Public mail/hand delivery/courier (for written/ follows: paper submissions) will be considered • Mail/Hand delivery/Courier (for Docket; Request for Comments timely if they are postmarked or the written/paper submissions): Dockets AGENCY: Food and Drug Administration, delivery service acceptance receipt is on Management Staff (HFA–305), Food and HHS. or before that date. Drug Administration, 5630 Fishers ACTION: Notice; establishment of a Comments received on or before Lane, Rm. 1061, Rockville, MD 20852. public docket; request for comments. January 3, 2019, will be provided to the • For written/paper comments Committee. Comments received after submitted to the Dockets Management SUMMARY: The Food and Drug that date will be taken into Staff, FDA will post your comment, as Administration (FDA) announces a consideration by FDA. well as any attachments, except for forthcoming public advisory committee You may submit comments as information submitted, marked and meeting of the Endocrinologic and follows: identified, as confidential, if submitted Metabolic Drugs Advisory Committee as detailed in ‘‘Instructions.’’ (the Committee). The general function of Electronic Submissions Instructions: All submissions received the Committee is to provide advice and Submit electronic comments in the must include the Docket No. FDA– recommendations to FDA on regulatory following way: 2018–N–4282 for ‘‘Endocrinologic and issues. The meeting will be open to the • Federal eRulemaking Portal: Metabolic Drugs Advisory Committee; public. FDA is establishing a docket for https://www.regulations.gov. Follow the Notice of Meeting; Establishment of a public comment on this document. instructions for submitting comments. Public Docket; Request for Comments.’’ DATES: The meeting will be held on Comments submitted electronically, Received comments, those filed in a January 17, 2019, from 8 a.m. to 5 p.m. including attachments, to https:// timely manner (see ADDRESSES), will be ADDRESSES: FDA White Oak Campus, www.regulations.gov will be posted to placed in the docket and, except for 10903 New Hampshire Ave., Bldg. 31 the docket unchanged. Because your those submitted as ‘‘Confidential Conference Center, the Great Room (Rm. comment will be made public, you are Submissions,’’ publicly viewable at 1503), Silver Spring, MD 20993–0002. solely responsible for ensuring that your https://www.regulations.gov or at the amozie on DSK3GDR082PROD with NOTICES1 Answers to commonly asked questions comment does not include any Dockets Management Staff between 9 including information regarding special confidential information that you or a a.m. and 4 p.m., Monday through accommodations due to a disability, third party may not wish to be posted, Friday. visitor parking, and transportation may such as medical information, your or • Confidential Submissions—To be accessed at: https://www.fda.gov/ anyone else’s Social Security number, or submit a comment with confidential AdvisoryCommittees/AboutAdvisory confidential business information, such information that you do not wish to be Committees/ucm408555.htm. as a manufacturing process. Please note made publicly available, submit your VerDate Sep<11>2014 17:00 Nov 29, 2018 Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1

Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61643 comments only as a written/paper Agenda: The Committee will discuss at least 7 days in advance of the submission. You should submit two new drug application 210934 for meeting. copies total. One copy will include the sotagliflozin oral tablet, sponsored by FDA is committed to the orderly information you claim to be confidential Sanofi-Aventis U.S. LLC, for the conduct of its advisory committee with a heading or cover note that states proposed indication: Adjunct to insulin meetings. Please visit our website at ‘‘THIS DOCUMENT CONTAINS therapy to improve glycemic control in https://www.fda.gov/ CONFIDENTIAL INFORMATION.’’ FDA adults with type 1 diabetes mellitus. AdvisoryCommittees/AboutAdvi will review this copy, including the FDA intends to make background soryCommittees/ucm111462.htm for claimed confidential information, in its material available to the public no later procedures on public conduct during consideration of comments. The second than 2 business days before the meeting. advisory committee meetings. copy, which will have the claimed If FDA is unable to post the background Notice of this meeting is given under confidential information redacted/ material on its website prior to the the Federal Advisory Committee Act (5 blacked out, will be available for public meeting, the background material will U.S.C. app. 2). viewing and posted on https:// be made publicly available at the Dated: November 26, 2018. www.regulations.gov. Submit both location of the advisory committee Leslie Kux, copies to the Dockets Management Staff. meeting, and the background material Associate Commissioner for Policy. If you do not wish your name and will be posted on FDA’s website after [FR Doc. 2018–25990 Filed 11–29–18; 8:45 am] contact information be made publicly the meeting. Background material is BILLING CODE 4164–01–P available, you can provide this available at https://www.fda.gov/ information on the cover sheet and not AdvisoryCommittees/Calendar/ in the body of your comments and you default.htm. Scroll down to the DEPARTMENT OF HEALTH AND must identify the information as appropriate advisory committee meeting HUMAN SERVICES ‘‘confidential.’’ Any information marked link. as ‘‘confidential’’ will not be disclosed Procedure: Interested persons may Food and Drug Administration except in accordance with 21 CFR 10.20 present data, information, or views, and other applicable disclosure law. For orally or in writing, on issues pending [Docket Nos. FDA–2017–E–6603 and FDA– more information about FDA’s posting 2017–E–6604] before the Committee. All electronic and of comments to public dockets, see 80 written submissions submitted to the Determination of Regulatory Review FR 56469, September 18, 2015, or access Docket (see ADDRESSES) on or before Period for Purposes of Patent the information at: https://www.gpo.gov/ January 3, 2019, will be provided to the Extension; KEVZARA fdsys/pkg/FR-2015-09-18/pdf/2015- Committee. Oral presentations from the 23389.pdf. public will be scheduled between AGENCY: Food and Drug Administration, Docket: For access to the docket to approximately 1 p.m. to 2 p.m. Those HHS. read background documents or the individuals interested in making formal ACTION: Notice. electronic and written/paper comments oral presentations should notify the received, go to https:// contact person and submit a brief SUMMARY: The Food and Drug www.regulations.gov and insert the statement of the general nature of the Administration (FDA or the Agency) has docket number, found in brackets in the evidence or arguments they wish to determined the regulatory review period heading of this document, into the present, the names and addresses of for KEVZARA and is publishing this ‘‘Search’’ box and follow the prompts proposed participants, and an notice of that determination as required and/or go to the Dockets Management indication of the approximate time by law. FDA has made the Staff, 5630 Fishers Lane, Rm. 1061, requested to make their presentation on determination because of the Rockville, MD 20852. or before December 27, 2018. Time submission of applications to the FOR FURTHER INFORMATION CONTACT: allotted for each presentation may be Director of the U.S. Patent and LaToya Bonner, Center for Drug limited. If the number of registrants Trademark Office (USPTO), Department Evaluation and Research, Food and requesting to speak is greater than can of Commerce, for the extension of a Drug Administration, 10903 New be reasonably accommodated during the patent which claims that human Hampshire Ave., Bldg. 31, Rm. 2417, scheduled open public hearing session, biological product. Silver Spring, MD 20993–0002, 301– FDA may conduct a lottery to determine DATES: Anyone with knowledge that any 796–9001, Fax: 301–847–8533, email: the speakers for the scheduled open of the dates as published (see the EMDAC@fda.hhs.gov, or FDA Advisory public hearing session. The contact SUPPLEMENTARY INFORMATION section) are Committee Information Line, 1–800– person will notify interested persons incorrect may submit either electronic 741–8138 (301–443–0572 in the regarding their request to speak by or written comments and ask for a Washington, DC area). A notice in the December 28, 2018. redetermination by January 29, 2019. Federal Register about last minute Persons attending FDA’s advisory Furthermore, any interested person may modifications that impact a previously committee meetings are advised that petition FDA for a determination announced advisory committee meeting FDA is not responsible for providing regarding whether the applicant for cannot always be published quickly access to electrical outlets. extension acted with due diligence enough to provide timely notice. For press inquiries, please contact the during the regulatory review period by Therefore, you should always check the Office of Media Affairs at fdaoma@ May 29, 2019. See ‘‘Petitions’’ in the FDA’s website at https://www.fda.gov/ fda.hhs.gov or 301–796–4540. SUPPLEMENTARY INFORMATION section for amozie on DSK3GDR082PROD with NOTICES1 AdvisoryCommittees/default.htm and FDA welcomes the attendance of the more information. scroll down to the appropriate advisory public at its advisory committee ADDRESSES: You may submit comments committee meeting link, or call the meetings and will make every effort to as follows. Please note that late, advisory committee information line to accommodate persons with disabilities. untimely filed comments will not be learn about possible modifications If you require accommodations due to a considered. Electronic comments must before coming to the meeting. disability, please contact LaToya Bonner be submitted on or before January 29, SUPPLEMENTARY INFORMATION: (see FOR FURTHER INFORMATION CONTACT) 2019. The https://www.regulations.gov VerDate Sep<11>2014 17:00 Nov 29, 2018 Jkt 247001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1


Document Created: 2018-11-30 04:35:47
Document Modified: 2018-11-30 04:35:47
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 January 17, 2019, from 8 a.m. to 5 p.m.
ContactLaToya Bonner, 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 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 61642 
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