83 FR 47178 - 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 181 (September 18, 2018)

Page Range		47178-47180
FR Document		2018-20233

The Food and Drug Administration (FDA) 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 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 181 (Tuesday, September 18, 2018)

[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47178-47180]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3159]


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 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 October 24 and 25, 2018, from 8 a.m. 
to 5 p.m.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31

[[Page 47179]]

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-3159. The docket will close on October 
23, 2018. Submit either electronic or written comments on this public 
meeting by October 23, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before October 23, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of October 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 October 10, 2018, 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-3159 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 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: On both days, the committee will 
discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating 
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 
Diabetes'' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and 
biologics for the treatment of 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 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 October 10, 2018, will be provided to

[[Page 47180]]

the committee. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 10:30 a.m. on October 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 
October 1, 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 October 2, 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: September 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20233 Filed 9-17-18; 8:45 am]
BILLING CODE 4164-01-P

47180 Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices

the committee. Oral presentations from DEPARTMENT OF HEALTH AND HIV/viral hepatitis/STD professional
the public will be scheduled between HUMAN SERVICES education, patient healthcare delivery,
approximately 8:30 a.m. and 10:30 a.m. research and training, and prevention
on October 25, 2018. Those individuals Health Resources and Services services.
interested in making formal oral Administration During the November 7–8, 2018,
presentations should notify the contact meeting, the CHACHSPT will discuss
Meeting of the CDC/HRSA Advisory the following topics:
person and submit a brief statement of
Committee on HIV, Viral Hepatitis and
the general nature of the evidence or • CHACHSPT workgroup reports and
STD Prevention and Treatment
arguments they wish to present, the findings;
names and addresses of proposed AGENCY: Health Resources and Services • updates from CDC, HRSA, and
participants, and an indication of the Administration (HRSA), Department of HRSA HAB;
approximate time requested to make Health and Human Services (HHS). • strategies for serving women,
their presentation on or before October ACTION: Notice. infants, children, and youth;
1, 2018. Time allotted for each • agencies’ responses to the opioid
presentation may be limited. If the SUMMARY: The Centers for Disease crisis; and
number of registrants requesting to Control and Prevention (CDC)/HRSA • telemedicine initiatives.
speak is greater than can be reasonably Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and Agenda items are subject to change as
accommodated during the scheduled priorities dictate. Refer to the
Treatment (CHACHSPT) has scheduled
open public hearing session, FDA may CHACHSPT website for any updated
a public meeting. Information about the
conduct a lottery to determine the CHACHSPT can be found here: https:// information concerning the meeting.
speakers for the scheduled open public www.cdc.gov/maso/facm/ Members of the public will have the
hearing session. The contact person will facmchachspt.html. An agenda may be opportunity to provide comments.
notify interested persons regarding their requested by emailing Public participants may submit written
request to speak by October 2, 2018. CHACAdvisoryComm@hrsa.gov. statements in advance of the scheduled
Persons attending FDA’s advisory DATES: November 7, 2018, 8:30 a.m.–
meeting. Oral comments will be
committee meetings are advised that 5:00 p.m. ET and November 8, 2018, honored in the order they are requested
FDA is not responsible for providing 8:30 a.m.–3:30 p.m. ET. and may be limited as time allows.
access to electrical outlets. Requests to submit a written statement
ADDRESSES: This meeting will be held
or make oral comments to CHACHSPT
For press inquiries, please contact the in-person and by webinar and should be sent by email to
Office of Media Affairs at fdaoma@ teleconference. The address for the CHACAdvisoryComm@hrsa.gov or by
fda.hhs.gov or 301–796–4540. meeting is DoubleTree by Hilton, mail to Theresa Jumento at the address
Bethesda, 8120 Wisconsin Avenue, above at least 3 business days prior to
FDA welcomes the attendance of the
Bethesda, Maryland 20814. the meeting.
public at its advisory committee
• Adobe Connect URL link: https://
meetings and will make every effort to Individuals who plan to attend and
hrsa.connectsolutions.com/chac_
accommodate persons with disabilities. need special assistance or another
meeting/.
If you require accommodations due to a reasonable accommodation should
• Conference call-in number: 888–
disability, please contact LaToya Bonner notify Theresa Jumento at the address
324–9617, Passcode 9245865.
(see FOR FURTHER INFORMATION CONTACT) listed above at least 10 business days
FOR FURTHER INFORMATION CONTACT: prior to the meeting.
at least 7 days in advance of the Theresa Jumento, Chief, Policy
meeting. Development Branch, HRSA, HIV/AIDS Amy P. McNulty,
FDA is committed to the orderly Bureau (HAB), Division of Policy and Acting Director, Division of the Executive
conduct of its advisory committee Data, 5600 Fishers Lane, Room 9N156, Secretariat.
meetings. Please visit our website at or by email at CHACAdvisoryComm@ [FR Doc. 2018–20269 Filed 9–17–18; 8:45 am]
https://www.fda.gov/ hrsa.gov. BILLING CODE 4165–15–P
AdvisoryCommittees/ SUPPLEMENTARY INFORMATION: The
AboutAdvisoryCommittees/ CHACHSPT was established under
ucm111462.htm for procedures on DEPARTMENT OF HEALTH AND
Section 222 of the Public Health Service HUMAN SERVICES
public conduct during advisory (PHS) Act, [42 U.S.C. Section 217a], as
committee meetings. amended. National Advisory Council on Migrant
Notice of this meeting is given under The purpose of the CHACHSPT is to Health
the Federal Advisory Committee Act (5 advise the Secretary of HHS, the
U.S.C. app. 2). Director of the CDC, and the AGENCY: Health Resources and Services
Administrator of HRSA on the Administration (HRSA), Department of
Dated: September 13, 2018. objectives, strategies, policies, and Health and Human Services (HHS).
Leslie Kux, priorities for HIV, viral hepatitis, and ACTION: Meeting notice.
Associate Commissioner for Policy. other STD prevention and treatment
[FR Doc. 2018–20233 Filed 9–17–18; 8:45 am] efforts. This includes, but is not limited SUMMARY: The Secretary’s National
to, surveillance of HIV infection, viral Advisory Council on Migrant Health
daltland on DSKBBV9HB2PROD with NOTICES

BILLING CODE 4164–01–P
hepatitis, and other STDs; responses to (NACMH) has scheduled a public
related emerging health needs; and meeting. Information about NACMH
epidemiologic, behavioral, health and the agenda for this meeting can be
services, and laboratory research on found on the NACMH website at:
HIV/AIDS, viral hepatitis, and other https://bphc.hrsa.gov/quality
STDs. The CHACHSPT also provides improvement/strategicpartnerships/
advice regarding policy issues related to nacmh/index.html.

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Document Created: 2018-09-18 01:18:48
Document Modified: 2018-09-18 01:18:48

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 October 24 and 25, 2018, 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 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 Citation		83 FR 47178

83 FR 47178 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 181 (September 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration