Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 47178-47180 [2018-20233]
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47178
Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices
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 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
Kenneth Quinto, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5145, Silver Spring,
MD 20993, 240–402–2221,
kenneth.quinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
responsible for protecting the public
health by assuring the safety, efficacy,
and security of human and veterinary
drugs, biological products, medical
devices, our Nation’s food supply,
cosmetics, and products that emit
radiation. FDA also has responsibility
for regulating the manufacturing,
marketing, and distribution of tobacco
products to protect the public health
and to reduce tobacco use by minors.
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FDA has established a public docket,
Docket No. FDA–2017–N–7022, to
receive input on post-marketing
pediatric-focused safety reviews of
products posted between April 2, 2018,
and September 14, 2018, available on
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm but not presented at the
September 20, 2018, PAC meeting. FDA
welcomes comments by members of the
PAC, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act of 2003 (Pub. L. 108–155),
interested parties (such as academic
researchers, regulated industries,
consortia, and patient groups), and the
general public. The docket number is
FDA–2017–N–7022. The docket will
open for comments on September 17,
2018, and remain open until September
28, 2018. The post-marketing pediatricfocused safety reviews are for the
following products from the following
centers at FDA:
19. PANCREAZE (pancrelipase) and
PERTZYE (pancrelipase)
20. PRILOSEC (omeprazole)
21. PROAIR RESPICLICK (abuterol
sulfate)
22. PROCYSBI (cysteamine bitartrate)
23. RENVELA (sevelamer carbonate)
24. SPIRIVA (tiotropium bromide)
25. TEFLARO (ceftaroline fosamil)
26. TETRACAINE HYDROCHLORIDE
Ophthalmic Solution (tetracaine
hydrochloride)
27. XOPENEX (levalbuterol)
28. ZOMIG Nasal Spray (zolmitriptan)
Center for Biologics Evaluation and
Research
1. BEXSERO (Meningococcal Group B
Vaccine)
2. QUADRACEL (Diphtheria and
Tetanus Toxoids and Acellular
Pertussis Adsorbed and Inactivated
Poliovirus Vaccine)
Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Center for Drug Evaluation and
Research
1. ADZENYS XR–ODT (amphetamine
tablet) and DYANAVEL XR
(amphetamine suspension)
2. ANTHIM (obiltoxaximab)
3. APTENSIO XR (methylphenidate
hydrochloride) and QUILLICHEW
ER (methylphenidate
hydrochloride)
4. BANZEL (rufinamide)
5. CINQAIR (reslizumab)
6. CUTIVATE (fluticasone propionate)
7. DESCOVY (emtricitabine and
tenofovir alafenamide)
8. ENTOCORT EC (budesonide)
9. EPIVIR (lamivudine)
10. EPZICOM (abacavir sulfate and
lamivudine) and ZIAGEN (abacavir
sulfate)
11. KALETRA (lopinavir and ritonavir)
12. KOVANAZE (tetracaine
hydrochloride and oxymetazoline
hydrochloride)
13. LAMICTAL (lamotrigine)
14. NATROBA (spinosad)
15. NOXAFIL (posaconazole)
16. ORALTAG (iohexol)
17. ORAVERSE (phentolamine
mesylate)
18. OTOVEL (ciprofloxacin and
fluocinolone acetonide)
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Center for Devices and Radiological
Health
1. CONTEGRA PULMONARY VALVED
CONDUIT (Humanitarian Device
Exemption (HDE))
2. ELANA SURGICAL KIT (HDE)
3. ENTERRA THERAPY SYSTEM (HDE)
4. LIPOSORBER LA–15 SYSTEM (HDE)
5. MEDTRONIC ACTIVA DYSTONIA
THERAPY (HDE)
6. PLEXIMMUNE (HDE)
7. PULSERIDER ANEURYSM NECK
RECONSTRUCTION DEVICE (HDE)
[FR Doc. 2018–20214 Filed 9–17–18; 8:45 a.m.]
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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.
Notice; establishment of a
public docket; request for comments.
ACTION:
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
SUMMARY:
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Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices
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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/AboutAdvisory
Committees/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’’).
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Written/Paper Submissions
47179
electronic and written/paper comments
received, go to https://
Submit written/paper submissions as
www.regulations.gov and insert the
follows:
docket number, found in brackets in the
• Mail/Hand Delivery/Courier (for
heading of this document, into the
written/paper submissions): Dockets
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Drug Administration, 5630 Fishers
Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852.
Rockville, MD 20852.
• For written/paper comments
FOR FURTHER INFORMATION CONTACT:
submitted to the Dockets Management
LaToya Bonner, Center for Drug
Staff, FDA will post your comment, as
Evaluation and Research, Food and
well as any attachments, except for
Drug Administration, 10903 New
information submitted, marked and
Hampshire Ave. Bldg. 31, Rm. 2417,
identified, as confidential, if submitted
Silver Spring, MD 20993–0002, 301–
as detailed in ‘‘Instructions.’’
Instructions: All submissions received 796–9001, Fax: 301–847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
must include the Docket No. FDA–
Committee Information Line, 1–800–
2018–N–3159 for ‘‘Endocrinologic and
741–8138 (301–443–0572 in the
Metabolic Drugs Advisory Committee;
Washington, DC area). A notice in the
Notice of Meeting; Establishment of a
Federal Register about last minute
Public Docket; Request for Comments.’’
modifications that impact a previously
Received comments, those filed in a
announced advisory committee meeting
timely manner (see ADDRESSES), will be
cannot always be published quickly
placed in the docket and, except for
enough to provide timely notice.
those submitted as ‘‘Confidential
Therefore, you should always check the
Submissions,’’ publicly viewable at
FDA’s website at https://www.fda.gov/
https://www.regulations.gov or at the
AdvisoryCommittees/default.htm and
Dockets Management Staff between 9
scroll down to the appropriate advisory
a.m. and 4 p.m., Monday through
committee meeting link, or call the
Friday.
advisory committee information line to
• Confidential Submissions—To
learn about possible modifications
submit a comment with confidential
before coming to the meeting.
information that you do not wish to be
made publicly available, submit your
SUPPLEMENTARY INFORMATION: Agenda:
comments only as a written/paper
On both days, the committee will
submission. You should submit two
discuss the ‘‘Guidance for Industry:
copies total. One copy will include the
Diabetes Mellitus—Evaluating
information you claim to be confidential Cardiovascular Risk in New
with a heading or cover note that states
Antidiabetic Therapies to Treat Type 2
‘‘THIS DOCUMENT CONTAINS
Diabetes’’ (https://www.fda.gov/
CONFIDENTIAL INFORMATION.’’ FDA downloads/Drugs/Guidances/
will review this copy, including the
ucm071627.pdf), and the cardiovascular
claimed confidential information, in its
risk assessment of drugs and biologics
consideration of comments. The second for the treatment of type 2 diabetes
copy, which will have the claimed
mellitus.
confidential information redacted/
FDA intends to make background
blacked out, will be available for public material available to the public no later
viewing and posted on https://
than 2 business days before the meeting.
www.regulations.gov. Submit both
If FDA is unable to post the background
copies to the Dockets Management Staff. material on its website prior to the
If you do not wish your name and
meeting, the background material will
contact information be made publicly
be made publicly available at the
available, you can provide this
location of the advisory committee
information on the cover sheet and not
meeting, and the background material
in the body of your comments and you
will be posted on FDA’s website after
must identify the information as
the meeting. Background material is
‘‘confidential.’’ Any information marked available at https://www.fda.gov/
as ‘‘confidential’’ will not be disclosed
AdvisoryCommittees/Calendar/
except in accordance with 21 CFR 10.20 default.htm. Scroll down to the
and other applicable disclosure law. For appropriate advisory committee meeting
more information about FDA’s posting
link.
Procedure: Interested persons may
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access present data, information, or views,
the information at: https://www.gpo.gov/ orally or in writing, on issues pending
before the committee. All electronic and
fdsys/pkg/FR-2015-09-18/pdf/2015written submissions submitted to the
23389.pdf.
Docket: For access to the docket to
Docket (see ADDRESSES) on or before
read background documents or the
October 10, 2018, will be provided to
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Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices
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 fdaoma@
fda.hhs.gov 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)/HRSA
Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and
Treatment (CHACHSPT) has scheduled
a public meeting. Information about the
CHACHSPT can be found here: https://
www.cdc.gov/maso/facm/
facmchachspt.html. An agenda may be
requested by emailing
CHACAdvisoryComm@hrsa.gov.
DATES: November 7, 2018, 8:30 a.m.–
5:00 p.m. ET and November 8, 2018,
8:30 a.m.–3:30 p.m. ET.
ADDRESSES: This meeting will be held
in-person and by webinar and
teleconference. The address for the
meeting is DoubleTree by Hilton,
Bethesda, 8120 Wisconsin Avenue,
Bethesda, Maryland 20814.
• Adobe Connect URL link: https://
hrsa.connectsolutions.com/chac_
meeting/.
• Conference call-in number: 888–
324–9617, Passcode 9245865.
FOR FURTHER INFORMATION CONTACT:
Theresa Jumento, Chief, Policy
Development Branch, HRSA, HIV/AIDS
Bureau (HAB), Division of Policy and
Data, 5600 Fishers Lane, Room 9N156,
or by email at CHACAdvisoryComm@
hrsa.gov.
SUMMARY:
The
CHACHSPT was established under
Section 222 of the Public Health Service
(PHS) Act, [42 U.S.C. Section 217a], as
amended.
The purpose of the CHACHSPT is to
advise the Secretary of HHS, the
Director of the CDC, and the
Administrator of HRSA on the
objectives, strategies, policies, and
priorities for HIV, viral hepatitis, and
other STD prevention and treatment
efforts. This includes, but is not limited
to, surveillance of HIV infection, viral
hepatitis, and other STDs; responses to
related emerging health needs; and
epidemiologic, behavioral, health
services, and laboratory research on
HIV/AIDS, viral hepatitis, and other
STDs. The CHACHSPT also provides
advice regarding policy issues related to
HIV/viral hepatitis/STD professional
education, patient healthcare delivery,
research and training, and prevention
services.
During the November 7–8, 2018,
meeting, the CHACHSPT will discuss
the following topics:
• CHACHSPT workgroup reports and
findings;
• updates from CDC, HRSA, and
HRSA HAB;
• strategies for serving women,
infants, children, and youth;
• agencies’ responses to the opioid
crisis; and
• telemedicine initiatives.
Agenda items are subject to change as
priorities dictate. Refer to the
CHACHSPT website for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to CHACHSPT
should be sent by email to
CHACAdvisoryComm@hrsa.gov or by
mail to Theresa Jumento at the address
above at least 3 business days prior to
the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Theresa Jumento at the address
listed above at least 10 business days
prior to the meeting.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
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SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Council on Migrant
Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Meeting notice.
AGENCY:
The Secretary’s National
Advisory Council on Migrant Health
(NACMH) has scheduled a public
meeting. Information about NACMH
and the agenda for this meeting can be
found on the NACMH website at:
https://bphc.hrsa.gov/quality
improvement/strategicpartnerships/
nacmh/.
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47178-47180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20233]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.gpo.gov/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]ov 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
