82 FR 46068 - 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 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46068-46069 | |
| FR Document | 2017-21176 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46068-46069] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21176] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5891] 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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs 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 public meeting will be held on October 18, 2017, from 8 a.m. to 5 p.m. ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the Tommy Douglas Conference Center can be accessed at: http://www.tommydouglascenter.com/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-5891. The docket will close on October 17, 2017. Submit either electronic or written comments on this public meeting by October 17, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 17, 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 October 11, 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-5891for ``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 [[Page 46069]] 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: 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 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 the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 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 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 October 11, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 3, 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 October 4, 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 special accommodations due to a disability, please contact LaToya Bonner 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: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21176 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
![46068 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
goals are still dependent on several DEPARTMENT OF HEALTH AND that date will be taken into
factors. In general, under GDUFA II, HUMAN SERVICES consideration by the Agency. You may
amendments will be designated as submit comments as follows:
either standard or priority, will be Food and Drug Administration
Electronic Submissions
classified as major or minor, and will [Docket No. FDA–2017–N–5891]
receive a goal date based on the factors Submit electronic comments in the
discussed in the draft guidance, following way:
Endocrinologic and Metabolic Drugs
• Federal eRulemaking Portal:
including whether a preapproval Advisory Committee; Notice of
https://www.regulations.gov. Follow the
inspection is needed. When finalized, Meeting; Establishment of a Public
instructions for submitting comments.
this draft guidance will replace the Docket; Request for Comments
Comments submitted electronically,
December 2001 guidance for industry including attachments, to https://
AGENCY: Food and Drug Administration,
‘‘Major, Minor, and Telephone HHS. www.regulations.gov will be posted to
Amendments to Abbreviated New Drug the docket unchanged. Because your
ACTION: Notice; establishment of a
Applications.’’ This draft guidance comment will be made public, you are
public docket; request for comments.
supersedes the July 2014 draft guidance solely responsible for ensuring that your
for industry ‘‘ANDA Submissions— SUMMARY: The Food and Drug comment does not include any
Amendments and Easily Correctable Administration (FDA or Agency) confidential information that you or a
Deficiencies Under GDUFA.’’ announces a forthcoming public third party may not wish to be posted,
This draft guidance is being issued advisory committee meeting of the such as medical information, your or
consistent with FDA’s good guidance Endocrinologic and Metabolic Drugs anyone else’s Social Security number, or
practices regulation (21 CFR 10.115). Advisory Committee. The general confidential business information, such
The draft guidance, when finalized, will function of the committee is to provide as a manufacturing process. Please note
represent the current thinking of FDA advice and recommendations to the that if you include your name, contact
Agency on FDA’s regulatory issues. The information, or other information that
on ‘‘ANDA Submissions—Amendments
meeting will be open to the public. FDA identifies you in the body of your
to Abbreviated New Drug Applications
is establishing a docket for public comments, that information will be
Under GDUFA.’’ It does not establish posted on https://www.regulations.gov.
comment on this document.
any rights for any person and is not • If you want to submit a comment
binding on FDA or the public. You can DATES: The public meeting will be held
on October 18, 2017, from 8 a.m. to 5 with confidential information that you
use an alternative approach if it satisfies do not wish to be made available to the
p.m.
the requirements of the applicable public, submit the comment as a
statutes and regulations. This guidance ADDRESSES: Tommy Douglas Conference
written/paper submission and in the
is not subject to Executive Order 12866. Center, the Ballroom, 10000 New
manner detailed (see ‘‘Written/Paper
Hampshire Ave., Silver Spring, MD
Submissions’’ and ‘‘Instructions’’).
II. Paperwork Reduction Act of 1995 20903. The conference center’s
telephone number is 240–645–4000. Written/Paper Submissions
This draft guidance refers to Answers to commonly asked questions
previously approved collections of Submit written/paper submissions as
about FDA Advisory Committee follows:
information found in FDA regulations. meetings may be accessed at https:// • Mail/Hand delivery/Courier (for
These collections of information are www.fda.gov/AdvisoryCommittees/ written/paper submissions): Dockets
subject to review by the Office of AboutAdvisoryCommittees/ Management Staff (HFA–305), Food and
Management and Budget (OMB) under ucm408555.htm. Information about the Drug Administration, 5630 Fishers
the Paperwork Reduction Act of 1995 Tommy Douglas Conference Center can Lane, Rm. 1061, Rockville, MD 20852.
(44 U.S.C. 3501–3520). The collections be accessed at: http:// • For written/paper comments
of information in 21 CFR 314.96 have www.tommydouglascenter.com/. submitted to the Dockets Management
been approved under OMB control FDA is establishing a docket for Staff, FDA will post your comment, as
number 0910–0001. public comment on this meeting. The well as any attachments, except for
docket number is FDA–2017–N–5891. information submitted, marked and
III. Electronic Access The docket will close on October 17, identified, as confidential, if submitted
Persons with access to the Internet 2017. Submit either electronic or as detailed in ‘‘Instructions.’’
may obtain the draft guidance at either written comments on this public Instructions: All submissions received
https://www.fda.gov/Drugs/Guidance meeting by October 17, 2017. Late, must include the Docket No. FDA–
untimely filed comments will not be 2017–N–5891for ‘‘Endocrinologic and
ComplianceRegulatoryInformation/
considered. Electronic comments must Metabolic Drugs Advisory Committee;
Guidances/default.htm or https://
be submitted on or before October 17, Notice of Meeting; Establishment of a
www.regulations.gov.
2017. The https://www.regulations.gov Public Docket; Request for Comments.’’
Dated: September 27, 2017. electronic filing system will accept Received comments, those filed in a
Anna K. Abram, comments until midnight Eastern Time timely manner (see ADDRESSES), will be
Deputy Commissioner for Policy, Planning, at the end of October 17, 2017. placed in the docket and, except for
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Legislation, and Analysis. Comments received by mail/hand those submitted as ‘‘Confidential
[FR Doc. 2017–21175 Filed 10–2–17; 8:45 am] delivery/courier (for written/paper Submissions,’’ publicly viewable at
submissions) will be considered timely https://www.regulations.gov or at the
BILLING CODE 4164–01–P
if they are postmarked or the delivery Dockets Management Staff between 9
service acceptance receipt is on or a.m. and 4 p.m., Monday through
before that date. Friday.
Comments received on or before • Confidential Submissions—To
October 11, 2017, will be provided to submit a comment with confidential
the committee. Comments received after information that you do not wish to be
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![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46069
made publicly available, submit your modifications before coming to the LaToya Bonner at least 7 days in
comments only as a written/paper meeting. advance of the meeting.
submission. You should submit two FDA is committed to the orderly
SUPPLEMENTARY INFORMATION: conduct of its advisory committee
copies total. One copy will include the
information you claim to be confidential Agenda: The committee will discuss meetings. Please visit our Web site at
with a heading or cover note that states the safety and efficacy of new drug https://www.fda.gov/
‘‘THIS DOCUMENT CONTAINS application (NDA) 209637 for AdvisoryCommittees/
CONFIDENTIAL INFORMATION.’’ The semaglutide injection, submitted by AboutAdvisoryCommittees/
Agency will review this copy, including Novo Nordisk, as an adjunct to diet and ucm111462.htm for procedures on
the claimed confidential information, in exercise to improve glycemic control in public conduct during advisory
its consideration of comments. The adults with type 2 diabetes mellitus. committee meetings.
second copy, which will have the FDA intends to make background Notice of this meeting is given under
claimed confidential information material available to the public no later the Federal Advisory Committee Act (5
redacted/blacked out, will be available than 2 business days before the meeting. U.S.C. app. 2).
for public viewing and posted on If FDA is unable to post the background Dated: September 26, 2017.
https://www.regulations.gov. Submit material on its Web site prior to the Anna K. Abram,
both copies to the Dockets Management meeting, the background material will Deputy Commissioner for Policy, Planning,
Staff. If you do not wish your name and be made publicly available at the Legislation, and Analysis.
contact information to be made publicly location of the advisory committee [FR Doc. 2017–21176 Filed 10–2–17; 8:45 am]
available, you can provide this meeting, and the background material BILLING CODE 4164–01–P
information on the cover sheet and not will be posted on FDA’s Web site after
in the body of your comments and you the meeting. Background material is
must identify this information as available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
‘‘confidential.’’ Any information marked AdvisoryCommittees/Calendar/ HUMAN SERVICES
as ‘‘confidential’’ will not be disclosed default.htm. Scroll down to the
except in accordance with 21 CFR 10.20 appropriate advisory committee meeting Food and Drug Administration
and other applicable disclosure law. For link.
[Docket No. FDA–2017–N–0001]
more information about FDA’s posting Procedure: Interested persons may
of comments to public dockets, see 80 present data, information, or views, Request for Nominations for Voting
FR 56469, September 18, 2015, or access orally or in writing, on issues pending Members on a Public Advisory
the information at: https://www.gpo.gov/ before the committee. All electronic and Committee; the Tobacco Products
fdsys/pkg/FR-2015-09-18/pdf/2015- written submissions submitted to the Scientific Advisory Committee
23389.pdf. Docket (see the ADDRESSES section) on
or before October 11, 2017, will be AGENCY: Food and Drug Administration,
Docket: For access to the docket to provided to the committee. Oral HHS.
read background documents or the presentations from the public will be ACTION: Notice.
electronic and written/paper comments scheduled between approximately 1
received, go to https:// SUMMARY: The Food and Drug
p.m. and 2 p.m. Those individuals Administration (FDA) is requesting
www.regulations.gov and insert the interested in making formal oral
docket number, found in brackets in the nominations for members to serve on
presentations should notify the contact the Tobacco Products Scientific
heading of this document, into the person and submit a brief statement of
‘‘Search’’ box and follow the prompts Advisory Committee, Office of Science,
the general nature of the evidence or Center for Tobacco Products.
and/or go to the Dockets Management arguments they wish to present, the FDA seeks to include the views of
Staff, 5630 Fishers Lane, Rm. 1061, names and addresses of proposed women and men, members of all racial
Rockville, MD 20852. participants, and an indication of the and ethnic groups, and individuals with
FOR FURTHER INFORMATION CONTACT: approximate time requested to make and without disabilities on its advisory
LaToya Bonner, Center for Drug their presentation on or before October committees and, therefore, encourages
Evaluation and Research, Food and 3, 2017. Time allotted for each nominations of appropriately qualified
Drug Administration, 10903 New presentation may be limited. If the candidates from these groups.
Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to DATES: Nominations received on or
Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably before December 4, 2017 will be given
796–9001, Fax: 301–847–8533, email: accommodated during the scheduled first consideration for membership on
EMDAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may the Tobacco Products Scientific
Committee Information Line, 1–800– conduct a lottery to determine the Advisory Committee. Nominations
741–8138 (301–443–0572 in the speakers for the scheduled open public received after December 4, 2017 will be
Washington, DC area). A notice in the hearing session. The contact person will considered for nomination to the
Federal Register about last minute notify interested persons regarding their committee as later vacancies occur.
modifications that impact a previously request to speak by October 4, 2017. ADDRESSES: All nominations for
announced advisory committee meeting Persons attending FDA’s advisory membership should be sent
committee meetings are advised that the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
cannot always be published quickly electronically by logging into the FDA
enough to provide timely notice. Agency is not responsible for providing Advisory Nomination Portal: https://
Therefore, you should always check the access to electrical outlets. www.accessdata.fda.gov/scripts/
Agency’s Web site at https:// FDA welcomes the attendance of the FACTRSPortal/FACTRS/index.cfm or by
www.fda.gov/AdvisoryCommittees/ public at its advisory committee mail to Advisory Committee Oversight
default.htm and scroll down to the meetings and will make every effort to and Management Staff, Food and Drug
appropriate advisory committee meeting accommodate persons with disabilities. Administration, 10903 New Hampshire
link, or call the advisory committee If you require special accommodations Ave., Bldg. 32, Rm. 5103, Silver Spring,
information line to learn about possible due to a disability, please contact MD 20993–0002.
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Document Created: 2017-10-03 01:01:26
Document Modified: 2017-10-03 01:01:26
| 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 public meeting will be held on October 18, 2017, from 8 a.m. to 5 p.m. | |
| 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 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 46068 |
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