Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting, 13372-13373 [2016-05573]
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Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
Management (see DATES and ADDRESSES)
for public review and comment for 30
days. Oxitec Ltd. prepared the draft EA.
The preliminary FONSI is based upon
Oxitec Ltd.’s draft EA. FDA is
considering the draft EA and tentatively
agrees with its conclusion that conduct
of this trial will result in no significant
impacts on the environment. If nothing
changes FDA’s tentative determination,
FDA will prepare and release its own
revised, final EA and final FONSI. The
Agency intends to take comments
received under advisement in
determining whether to prepare a
revised, final EA and FONSI. If FDA
does not agree with the preliminary
conclusion that conduct of this trial will
result in no significant impacts on the
environment, it will prepare an
environmental impact statement.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05622 Filed 3–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0820]
Drug Safety and Risk Management
Advisory Committee and the
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jstallworth on DSK7TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 3, 2016, from 8 a.m. to 5
p.m. and May 4, 2016, from 8 a.m. to 5
p.m.
ADDRESSES: FDA is opening a docket for
public comment on this meeting. The
docket number is FDA–2016–N–0820.
The docket will open for public
comment on March 14, 2016. The
docket will close on June 4, 2016.
Interested persons may submit either
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
electronic or written comments
regarding this meeting. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments received will be posted
without change, including any personal
information provided. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Comments received on or before April
19, 2016, will be provided to the
committees before the meeting.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: 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.
Agenda: The Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) requires FDA to
bring, at least annually, one or more
drugs with Risk Evaluation and
Mitigation Strategies (REMS) with
Elements to Assure Safe Use (ETASU)
before its Drug Safety and Risk
Management Advisory Committee
(DSaRM). On May 3 and 4, 2016, the
committees will discuss results from
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assessments of the extended-release and
long-acting (ER/LA) Opioid Analgesics
REMS. The Agency will seek the
committees’ comments as to whether
this REMS with ETASU assures safe
use, is not unduly burdensome to
patient access to the drugs, and to the
extent practicable, minimizes the
burden to the healthcare delivery
system.
The ER/LA Opioid Analgesics REMS
requires that prescriber training will be
made available to healthcare providers
who prescribe ER/LA opioid analgesics.
Training is considered ‘‘REMScompliant’’ if: (1) It, for training
provided by continuing education
providers, is offered by an accredited
provider to licensed prescribers, (2) it
includes all elements of the FDA
Blueprint for Prescriber Education for
ER/LA Opioid Analgesics (Blueprint),
(3) it includes a knowledge assessment
of all the sections of the Blueprint, and
(4) it is subject to independent audit to
confirm that conditions of the REMS
training have been met. The Agency will
seek the committees’ input on possible
modifications to the ER/LA Opioid
Analgesics REMS, including expansion
of the scope and content of prescriber
training and expansion of the REMS
program to include immediate-release
opioids.
Comments from the public can be
submitted to the docket (see the
ADDRESSES section) on a broad
evaluation of the ER/LA Opioid
Analgesics REMS program and whether
the ER/LA opioid analgesics REMS
should be modified as well as any
proposed modifications. Comments may
include but are not limited to: (1)
Alternative methodologies for
evaluating the overall impact of the
program on knowledge and behavior by
prescribers and patients, (2) the overall
impact of the REMS on the adverse
events it is intended to mitigate; (3)
whether the FDA Blueprint or other
tools (e.g., Medication Guide or Patient
Counseling Document) should be
revised and/or expanded; (4) the use of
the continuing education as a
component of the REMS as a
mechanism for providing prescriber
training; (5) whether to expand the
REMS program to include immediaterelease opioids; and (6) how additional
REMS tools or ETASU (e.g., required
prescriber or pharmacist training,
required patient agreements), if
recommended, may impact the
healthcare delivery system and patient
access to ER/LA opioid analgesics.
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
E:\FR\FM\14MRN1.SGM
14MRN1
jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
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 committees. All electronic
and written submissions submitted to
the Docket (see the ADDRESSES section)
on or before April 19, 2016, will be
provided to the committees. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. and 12:30 p.m. on May 4, 2016.
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 April 11, 2016. 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 April 12, 2016.
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 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).
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
Dated: March 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–05573 Filed 3–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4750]
Implementation of the ‘‘Deemed To Be
a License’’ Provision of the Biologics
Price Competition and Innovation Act
of 2009; Draft Guidance for Industry;
Availability and Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Implementation of the ‘Deemed to be a
License’ Provision of the Biologics Price
Competition and Innovation Act of
2009.’’ This draft guidance describes
FDA’s approach to implementation of
the statutory provision under which an
application for a biological product
approved under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) on or
before March 23, 2020, will be deemed
to be a license for the biological product
under the Public Health Service Act
(PHS Act) on March 23, 2020.
Specifically, this draft guidance
describes FDA’s interpretation of the
‘‘deemed to be a license’’ provision of
the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) for
biological products that have been or
will be approved under the FD&C Act
on or before March 23, 2020. This draft
guidance also provides
recommendations to sponsors of
proposed protein products intended for
submission in an application that may
not receive final approval under the
FD&C Act on or before March 23, 2020,
to facilitate alignment of product
development plans with FDA’s
interpretation the transition provisions
of the BPCI Act.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 13, 2016.
SUMMARY:
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ADDRESSES:
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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–
2015–D–4750 for ‘‘Implementation of
the ‘Deemed to be a License’ Provision
of the Biologics Price Competition and
Innovation Act of 2009; Draft Guidance
for Industry; Availability and 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
E:\FR\FM\14MRN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13372-13373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05573]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0820]
Drug Safety and Risk Management Advisory Committee and the
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committees: Drug Safety and Risk Management Advisory
Committee and the Anesthetic and Analgesic Drug Products Advisory
Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 3, 2016, from 8 a.m.
to 5 p.m. and May 4, 2016, from 8 a.m. to 5 p.m.
ADDRESSES: FDA is opening a docket for public comment on this meeting.
The docket number is FDA-2016-N-0820. The docket will open for public
comment on March 14, 2016. The docket will close on June 4, 2016.
Interested persons may submit either electronic or written comments
regarding this meeting. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments received will be posted
without change, including any personal information provided. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Comments received on
or before April 19, 2016, will be provided to the committees before the
meeting.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: 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.
Agenda: The Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) requires FDA to bring, at least annually, one or more
drugs with Risk Evaluation and Mitigation Strategies (REMS) with
Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk
Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the
committees will discuss results from assessments of the extended-
release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will
seek the committees' comments as to whether this REMS with ETASU
assures safe use, is not unduly burdensome to patient access to the
drugs, and to the extent practicable, minimizes the burden to the
healthcare delivery system.
The ER/LA Opioid Analgesics REMS requires that prescriber training
will be made available to healthcare providers who prescribe ER/LA
opioid analgesics. Training is considered ``REMS-compliant'' if: (1)
It, for training provided by continuing education providers, is offered
by an accredited provider to licensed prescribers, (2) it includes all
elements of the FDA Blueprint for Prescriber Education for ER/LA Opioid
Analgesics (Blueprint), (3) it includes a knowledge assessment of all
the sections of the Blueprint, and (4) it is subject to independent
audit to confirm that conditions of the REMS training have been met.
The Agency will seek the committees' input on possible modifications to
the ER/LA Opioid Analgesics REMS, including expansion of the scope and
content of prescriber training and expansion of the REMS program to
include immediate-release opioids.
Comments from the public can be submitted to the docket (see the
ADDRESSES section) on a broad evaluation of the ER/LA Opioid Analgesics
REMS program and whether the ER/LA opioid analgesics REMS should be
modified as well as any proposed modifications. Comments may include
but are not limited to: (1) Alternative methodologies for evaluating
the overall impact of the program on knowledge and behavior by
prescribers and patients, (2) the overall impact of the REMS on the
adverse events it is intended to mitigate; (3) whether the FDA
Blueprint or other tools (e.g., Medication Guide or Patient Counseling
Document) should be revised and/or expanded; (4) the use of the
continuing education as a component of the REMS as a mechanism for
providing prescriber training; (5) whether to expand the REMS program
to include immediate-release opioids; and (6) how additional REMS tools
or ETASU (e.g., required prescriber or pharmacist training, required
patient agreements), if recommended, may impact the healthcare delivery
system and patient access to ER/LA opioid analgesics.
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
[[Page 13373]]
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 committees.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before April 19, 2016, will be provided to the
committees. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 12:30 p.m. on May 4, 2016. 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
April 11, 2016. 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 April 12, 2016.
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 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 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05573 Filed 3-11-16; 8:45 am]
BILLING CODE 4164-01-P
