Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 13608-13609 [2017-04983]
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Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide
notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) Ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) Estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
transmit or otherwise disclose the
information.
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–04942 Filed 3–13–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1062]
Joint Meeting of the Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
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 Anesthetic and Analgesic
Drug Products Advisory Committee and
the Drug Safety and Risk Management
Advisory Committee. The general
function of the committees is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. At
least one portion of the meeting will be
closed to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on
April 5, 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
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. You may submit
comments as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
17:42 Mar 13, 2017
Jkt 241001
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–1062 for ‘‘Joint Meeting of the
Anesthetic and Analgesic Drug Products
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management 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.’’ The
E:\FR\FM\14MRN1.SGM
14MRN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Stephanie L. Begansky, 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:
AADPAC@fda.hhs.gov, 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 committees will discuss
new drug application (NDA) 209777, for
oxycodone hydrochloride immediaterelease oral tablets, submitted by
Inspirion Delivery Sciences, LLC., with
VerDate Sep<11>2014
17:42 Mar 13, 2017
Jkt 241001
the proposed indication of management
of moderate to severe pain where the
use of an opioid analgesic is
appropriate. The product has been
formulated with properties intended to
deter abuse, and the applicant has
submitted data to support these abusedeterrent properties for this product.
The committees will be asked to discuss
the overall risk-benefit profile of the
product, and whether the applicant has
demonstrated abuse-deterrent properties
for their product that would support
labeling.
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: On April 5, 2017, from
9:15 a.m. to 5 p.m., the meeting is open
to the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. All electronic
and written submissions submitted to
the Docket (see the Addresses section)
on or before March 22, 2017, will be
provided to the committees. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2:30 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 March
14, 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 March 15, 2017.
Closed Committee Deliberations: On
April 5, 2017, from 8 a.m. to 9:15 a.m.,
the meeting will be closed to permit
discussion and review of trade secret
and/or confidential commercial
information (5 U.S.C. 552b(c)(4)).
PO 00000
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Fmt 4703
Sfmt 4703
13609
During this session, the committees will
discuss the drug development program
of an investigational abuse-deterrent
opioid product.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–1062.
The docket will close on April 4, 2017.
Comments received on or before March
22, 2017, will be provided to the
committees. Comments received after
that date will be taken into
consideration by the Agency.
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 Stephanie L.
Begansky 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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04983 Filed 3–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1129]
Medical Devices; Exemptions From
Premarket Notification: Class II
Devices; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) has
identified a list of class II devices that,
when finalized, will be exempt from
premarket notification requirements,
subject to certain limitations. FDA is
publishing this notice of that
determination and requesting public
comment in accordance with
procedures established by the 21st
SUMMARY:
E:\FR\FM\14MRN1.SGM
14MRN1
Agencies
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13608-13609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04983]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1062]
Joint Meeting of the Anesthetic and Analgesic Drug Products
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Anesthetic and Analgesic Drug
Products Advisory Committee and the Drug Safety and Risk Management
Advisory Committee. The general function of the committees is to
provide advice and recommendations to the Agency on FDA's regulatory
issues. At least one portion of the meeting will be closed to the
public. FDA is establishing a docket for public comment on this
document.
DATES: The meeting will be held on April 5, 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
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. 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-1062 for ``Joint Meeting of the Anesthetic and Analgesic
Drug Products Advisory Committee and the Drug Safety and Risk
Management Advisory Committee; Notice of Meeting; Establishment of a
Public Docket; Request for Comments.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management 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.'' The
[[Page 13609]]
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 Division of Dockets
Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, 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: AADPAC@fda.hhs.gov, 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 committees will discuss new drug application (NDA)
209777, for oxycodone hydrochloride immediate-release oral tablets,
submitted by Inspirion Delivery Sciences, LLC., with the proposed
indication of management of moderate to severe pain where the use of an
opioid analgesic is appropriate. The product has been formulated with
properties intended to deter abuse, and the applicant has submitted
data to support these abuse-deterrent properties for this product. The
committees will be asked to discuss the overall risk-benefit profile of
the product, and whether the applicant has demonstrated abuse-deterrent
properties for their product that would support labeling.
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: On April 5, 2017, from 9:15 a.m. to 5 p.m., the meeting
is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committees. All electronic and written submissions submitted to the
Docket (see the Addresses section) on or before March 22, 2017, will be
provided to the committees. Oral presentations from the public will be
scheduled between approximately 1:30 p.m. and 2:30 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
March 14, 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 March 15, 2017.
Closed Committee Deliberations: On April 5, 2017, from 8 a.m. to
9:15 a.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). During this session, the committees will discuss the drug
development program of an investigational abuse-deterrent opioid
product.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1062. The docket will close on April 4,
2017. Comments received on or before March 22, 2017, will be provided
to the committees. Comments received after that date will be taken into
consideration by the Agency.
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 Stephanie L. Begansky 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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04983 Filed 3-13-17; 8:45 am]
BILLING CODE 4164-01-P