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, 66918-66920 [2019-26377]
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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
PALYNZIQ is 3,803 days. Of this time,
3,474 days occurred during the testing
phase of the regulatory review period,
while 329 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under section
505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) became
effective: December 27, 2007. FDA has
verified the applicant’s claim that the date
the investigational new drug application
became effective was on December 27, 2007.
2. The date the application was initially
submitted with respect to the human
biological product under section 351 of the
Public Health Service Act (42 U.S.C. 262):
June 30, 2017. FDA has verified the
applicant’s claim that the biologics license
application (BLA) for PALYNZIQ (BLA
B761079) was initially submitted on June 30,
2017.
3. The date the application was approved:
May 24, 2018. FDA has verified the
applicant’s claim that BLA B761079 was
approved on May 24, 2018.
lotter on DSKBCFDHB2PROD with NOTICES
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,743 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
VerDate Sep<11>2014
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Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26327 Filed 12–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5611]
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 joint 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
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
January 15, 2020, from 8 a.m. to 5:30
p.m.
ADDRESSES: 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.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–5611.
The docket will close on January 14,
2020. Submit either electronic or
written comments on this public
SUMMARY:
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meeting by January 14, 2020. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before January 14, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 14, 2020. 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
December 31, 2019, will be provided to
the committees. Comments received
after that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
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
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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
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–
2019–N–5611 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, 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/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
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Jkt 250001
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, 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
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: During the morning session,
the committees will discuss new drug
application (NDA) 213426, for tramadol
44 milligrams (mg) and celecoxib 56 mg
tablet, which contains a fixed-dose
combination of an opioid and a nonsteroid anti-inflammatory drug,
submitted by Esteve Pharmaceuticals,
S.A., for the management of acute pain
in adults that is severe enough to
require an opioid analgesic and for
which alternative treatments are
inadequate. The committees will be
asked to discuss the safety and efficacy
data as well as the overall risk-benefit
profile of the product.
During the afternoon session, the
committees will discuss NDA 209653,
for an extended-release oral tablet
formulation of oxycodone, submitted by
Intellipharmaceutics Corp., with the
management of moderate-to-severe pain
when a continuous, around-the-clock
opioid analgesic is needed for an
extended period of time. 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 whether the applicant has
demonstrated abuse-deterrent properties
for their product that would support
labeling, as well as to discuss the overall
risk-benefit profile of the product.
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
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66919
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 committees. Written
submissions may be made to the contact
person on or before December 31, 2019.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m. and 3:30 p.m. to
4 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 December 20, 2019. 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
December 23, 2019.
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 Moon Hee V.
Choi (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).
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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
Dated: December 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26377 Filed 12–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: The Division
of Independent Review Application
Reviewer Recruitment Form, OMB No.
0915–0295—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 4, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Division of Independent Review
Application Reviewer Recruitment
Form, OMB No. 0915–0295—Extension.
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SUMMARY:
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Abstract: HRSA’s Division of
Independent Review (DIR) is
responsible for administering the review
of eligible applications submitted for
grants under HRSA competitive
announcements. DIR ensures that the
objective review process is independent,
efficient, effective, economical, and
complies with the applicable statutes,
regulations, and policies. Applications
are reviewed by subject matter experts
knowledgeable in health and public
health disciplines. Review findings are
advisory to HRSA programs responsible
for making award decisions.
This ICR is for continuation of a webbased data collection system, the
Reviewer Recruitment Module (RRM),
used to gather critical reviewer
information. The RRM uses
standardized categories of information
in drop down menu format for data such
as the following: Degree, specialty,
occupation, work setting, and in select
instances, affiliations with organizations
and institutions that serve special
populations. Some program regulations
require that objective review panels
contain consumers of health services.
Other demographic data may be
voluntarily provided by a potential
reviewer. Defined data elements assist
HRSA in finding and selecting expert
reviewers for objective review
committees.
HRSA maintains a roster of
approximately 9,000 qualified
individuals who served on HRSA
objective review committees. The webbased RRM simplifies reviewer
registration entry using a user-friendly
Graphical User Interface with a few data
drop down menu choices, a search
engine that supports key word queries
in the actual resume or Curriculum
Vitae text, and also permits reviewers to
access and update their information as
needed. The RRM is 508 compliant and
accessible by the general public via a
link on the HRSA ‘‘Grants’’ internet site,
or by keying the RRM URL into their
browser. The RRM is accessible using
any of the commonly used internet
browsers.
Need and Proposed Use of the
Information: HRSA currently uses the
RRM to collect information from
individuals who wish to volunteer as
objective review committee participants
for the Agency’s discretionary and
competitive grant or cooperative
agreement funding opportunities. The
RRM provides HRSA with an effective
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search and communication functionality
with which to identify and contact
qualified potential reviewers. The RRM
has an enhanced search and reporting
capability to help DIR ensure that the
HRSA reviewer pool has the necessary
skills, education, and diversity to meet
the ever-evolving need for qualified
reviewers. If DIR identifies any other
specific needs that are underrepresented in the RRM pool, DIR is
able to recruit specifically to address
those needs as expertise is always the
primary determinant in selecting
potential reviewers for any specific
grant review. However, no reviewer is
required to provide demographic
information to join the reviewer pool or
be selected as a reviewer for any
competition.
All HRSA reviewers must possess the
technical skill and ability to access the
internet on a secure desktop laptop or
touch pad, and either a land line or
Voice Over Internet Protocol capability
in order to participate in HRSA
objective review committees. Reviewers
are professionals with expertise and
experience consistent with the HRSA
mission. Certain legislation requires
HRSA programs to include consumers
of specific health care services in the
objective review committee.
Likely Respondents: Potential
respondents are subject matter
professionals with expertise and
experience in the social, cultural, and
health care fields that are consistent
with the HRSA mission and competitive
program needs to address the
availability and delivery of quality
health care to all Americans.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. 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
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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]]>Agencies
[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Notices]
[Pages 66918-66920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5611]
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
joint 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 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 January 15, 2020, from 8 a.m. to
5:30 p.m.
ADDRESSES: 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.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-5611. The docket will close on January
14, 2020. Submit either electronic or written comments on this public
meeting by January 14, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before January 14, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of January 14, 2020. 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 December 31, 2019, will be provided
to the committees. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
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
[[Page 66919]]
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-2019-N-5611 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, 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: Moon Hee V. Choi, 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: During the morning session, the committees will discuss new
drug application (NDA) 213426, for tramadol 44 milligrams (mg) and
celecoxib 56 mg tablet, which contains a fixed-dose combination of an
opioid and a non-steroid anti-inflammatory drug, submitted by Esteve
Pharmaceuticals, S.A., for the management of acute pain in adults that
is severe enough to require an opioid analgesic and for which
alternative treatments are inadequate. The committees will be asked to
discuss the safety and efficacy data as well as the overall risk-
benefit profile of the product.
During the afternoon session, the committees will discuss NDA
209653, for an extended-release oral tablet formulation of oxycodone,
submitted by Intellipharmaceutics Corp., with the management of
moderate-to-severe pain when a continuous, around-the-clock opioid
analgesic is needed for an extended period of time. 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
whether the applicant has demonstrated abuse-deterrent properties for
their product that would support labeling, as well as to discuss the
overall risk-benefit profile of the product.
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 committees.
Written submissions may be made to the contact person on or before
December 31, 2019. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 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
December 20, 2019. 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 December 23,
2019.
Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Moon Hee V. Choi (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).
[[Page 66920]]
Dated: December 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26377 Filed 12-5-19; 8:45 am]
BILLING CODE 4164-01-P
