Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 3333-3335 [2017-00463]
Download as PDF
Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Emily Baker, Office of Unapproved
Drugs and Labeling Compliance, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–7524,
Emily.Baker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Recommended Warning for Over-theCounter Acetaminophen-Containing
Drug Products and Labeling Statements
Regarding Serious Skin Reactions.’’
Acetaminophen, included in many
prescription and OTC products, is a
common active ingredient indicated to
treat pain and reduce fever. On August
1, 2013, FDA issued a Drug Safety
Communication (DSC) informing the
public that use of acetaminophen has
been associated with a risk of rare but
serious skin reactions.1 These skin
reactions, including Stevens-Johnson
Syndrome, toxic epidermal necrolysis,
and acute generalized exanthematous
pustulosis, can be fatal.
The DSC explained that reddening of
the skin, rash, blisters, and detachment
of the upper surface of the skin can
occur with the use of drug products that
1 FDA Drug Safety Communication: FDA warns of
rare but serious skin reactions with the pain
reliever/fever reducer acetaminophen. https://
www.fda.gov/Drugs/DrugSafety/ucm363041.htm.
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
contain acetaminophen. These skin
reactions can occur with the first-time
use of acetaminophen or even if
acetaminophen has been used in the
past without any problems. FDA
advised health care professionals to be
aware of this rare risk and consider
acetaminophen, along with other drugs
already known to have such an
association, when assessing patients
with potentially drug-induced skin
reactions. FDA also advised that anyone
who develops a skin rash or reaction
while using acetaminophen or any other
pain reliever/fever reducer should stop
taking the drug and seek medical
attention right away. Furthermore, the
announcement advised that anyone who
has experienced a serious skin reaction
when taking acetaminophen in the past
should not take the drug again and
should contact their health care
professional to discuss alternative pain
relievers/fever reducers.
In response to FDA’s letters to
manufacturers holding new drug
applications and abbreviated new drug
applications, most manufacturers of
acetaminophen-containing prescription
and OTC drug products marketed under
an approved application now include a
warning statement on their product
labels to address the risk of serious skin
reactions. FDA recommends that
manufacturers of all acetaminophencontaining OTC drug products (both
single- and combination-ingredient
acetaminophen products) marketed
under the Tentative Final Monograph
(TFM) for Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products include in labeling the
language recommended in this guidance
to warn consumers that acetaminophen
may cause severe skin reactions. At this
time, FDA does not intend to take action
against the marketing of single- and
combination-ingredient,
acetaminophen-containing, OTC drug
products bearing the recommended
allergy warning that are otherwise
marketed in compliance with the TFM
and applicable regulations.
In the Federal Registerof November
28, 2014 (79 FR 70879), FDA published
a draft guidance entitled
‘‘Recommended Warning for Over-theCounter Acetaminophen-Containing
Drug Products and Labeling Statements
Regarding Serious Skin Reactions.’’ See:
https://www.fda.gov/downloads/drugs/
guidancecompliance
regulatoryinformation/guidances/
ucm424898.pdf. The November 2014
draft guidance gave interested persons
an opportunity to submit comments
through January 27, 2015. We have
made changes to the guidance in
response to comments received and
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
3333
have added labeling information about
products that contain both
acetaminophen and aspirin.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the recommended
warning for OTC acetaminophencontaining drug products and labeling
statements regarding serious skin
reactions. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
Under the guidance, manufacturers
may add to their drug product labeling
a warning statement supplied by FDA
that pertains to acetaminophen to
address the risk of serious skin
reactions. Inclusion of the warning
statement on the labels for these drug
products would be exempt from review
by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520)
because the public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public
is not included within the definition of
‘‘collection of information’’ (see 5 CFR
1320.3(c)(2)).
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00375 Filed 1–10–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0067]
Joint Meeting of the Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\11JAN1.SGM
11JAN1
3334
Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
Written/Paper Submissions
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 Drug Safety and Risk
Management Advisory Committee and
the Anesthetic and Analgesic Drug
Products 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
March 13, 2017, from 8 a.m. to 5 p.m.
and March 14, 2017, from 8 a.m. to 5
p.m.
SUMMARY:
College Park Marriott Hotel
and Conference Center, Potomac
Ballroom, 3501 University Blvd. East,
Hyattsville, MD 20783. The conference
center’s telephone number is 301–985–
7300. 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:
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
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’’).
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
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–0067 for ‘‘Joint Meeting of the
Drug Safety and Risk Management
Advisory Committee and the Anesthetic
and Analgesic Drug Products Advisory
Committee; Notice of Meeting; 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
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.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 be asked to discuss
safety issues for new drug application
(NDA) 201655, OPANA ER
(oxymorphone hydrochloride)
Extended-release Tablets, by Endo
Pharmaceuticals Inc., with the
indication of management of pain severe
enough to require daily, around-theclock, long-term opioid treatment and
for which alternative treatment options
are inadequate. The product is an
approved extended-release (ER)
formulation intended to have abusedeterrent properties based on its
physicochemical properties, however,
this information is not currently
reflected in product labeling. The
committees will be asked to discuss preand post-marketing data about the abuse
of OPANA ER, and the overall riskbenefit of this product. The committees
will also discuss abuse of generic
oxymorphone ER and oxymorphone
immediate-release (IR) products.
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
E:\FR\FM\11JAN1.SGM
11JAN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
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 March 13, 2017, from
9:15 a.m. to 5 p.m., and on March 14,
2017, from 8 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 February 27, 2017, will be
provided to the committees. Oral
presentations from the public will be
scheduled between approximately 8:30
a.m. and 10:30 a.m. on March 14, 2017.
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 February 16, 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
February 17, 2017.
Closed Committee Deliberations: On
March 13, 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 premarketing drug
development program of an extendedrelease 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–0067.
The docket will close on March 10,
2017. Comments received on or before
February 27, 2017, will be provided to
the committee. Comments received after
that date will be taken into
consideration by the Agency.
FDA welcomes the attendance of the
public at its advisory committee
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
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: January 6, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2017–00463 Filed 1–10–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0529]
Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With Cardiovascular
Related Imagery; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Recommended
Statement for Over-the-Counter AspirinContaining Drug Products Labeled With
Cardiovascular Related Imagery.’’ The
guidance is intended to promote the safe
use of nonprescription (also referred to
as over-the-counter or OTC) aspirin drug
products by encouraging drug
manufacturers, packagers, and labelers
marketing aspirin drug products with
cardiovascular related imagery to
include a statement that reminds
consumers to talk to their health care
provider before using aspirin for their
heart.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(a)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
DATES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
3335
on the draft guidance by March 13,
2017.
ADDRESSES: 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–
2012–D–0529 for ‘‘Recommended
Statement for Over-the-Counter AspirinContaining Drug Products Labeled With
Cardiovascular Related Imagery;
Guidance for Industry.’’ 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
E:\FR\FM\11JAN1.SGM
11JAN1
Agencies
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3333-3335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00463]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0067]
Joint Meeting of the Drug Safety and Risk Management Advisory
Committee and the Anesthetic and Analgesic Drug Products Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
[[Page 3334]]
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 Drug Safety and Risk
Management Advisory Committee and the Anesthetic and Analgesic Drug
Products 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 March 13, 2017, from 8 a.m. to 5
p.m. and March 14, 2017, from 8 a.m. to 5 p.m.
ADDRESSES: College Park Marriott Hotel and Conference Center, Potomac
Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The
conference center's telephone number is 301-985-7300. 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-0067 for ``Joint Meeting of the Drug Safety and Risk
Management Advisory Committee and the Anesthetic and Analgesic Drug
Products Advisory Committee; Notice of Meeting; 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 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 be asked to
discuss safety issues for new drug application (NDA) 201655, OPANA ER
(oxymorphone hydrochloride) Extended-release Tablets, by Endo
Pharmaceuticals Inc., with the indication of management of pain severe
enough to require daily, around-the-clock, long-term opioid treatment
and for which alternative treatment options are inadequate. The product
is an approved extended-release (ER) formulation intended to have
abuse-deterrent properties based on its physicochemical properties,
however, this information is not currently reflected in product
labeling. The committees will be asked to discuss pre- and post-
marketing data about the abuse of OPANA ER, and the overall risk-
benefit of this product. The committees will also discuss abuse of
generic oxymorphone ER and oxymorphone immediate-release (IR) products.
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
[[Page 3335]]
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 March 13, 2017, from 9:15 a.m. to 5 p.m., and on
March 14, 2017, from 8 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 February 27, 2017, will be provided to
the committees. Oral presentations from the public will be scheduled
between approximately 8:30 a.m. and 10:30 a.m. on March 14, 2017. 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
February 16, 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 February 17,
2017.
Closed Committee Deliberations: On March 13, 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
premarketing drug development program of an extended-release 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-0067. The docket will close on March
10, 2017. Comments received on or before February 27, 2017, will be
provided to the committee. 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: January 6, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-00463 Filed 1-10-17; 8:45 am]
BILLING CODE 4164-01-P