Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics-Exploring the Path Forward; Public Workshop; Request for Comments, 18300-18303 [2017-07821]
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Instructions: All submissions received
must include the Docket No. FDA–
2017–N–1957 for ‘‘Medical Imaging
Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments will be placed in
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submitted as ‘‘Confidential
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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/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
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Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
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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 committee will discuss
new drug application (NDA) 208–630
for 5-Aminolevulinic Acid
Hydrochloride [5–ALA HCl], Powder,
for oral solution, submitted by NX
Development Corp., for the proposed
indication as an imaging agent to
facilitate the real time detection and
visualization of malignant tissue during
glioma surgery.
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: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
April 26, 2017, will be provided to the
committee. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 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
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indication of the approximate time
requested to make their presentation on
or before April 18, 2017. Time allotted
for each presentation may be limited. If
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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 19, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
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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 special accommodations
due to a disability, please contact
Jennifer Shepherd 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: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07767 Filed 4–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1094]
Training Health Care Providers on Pain
Management and Safe Use of Opioid
Analgesics—Exploring the Path
Forward; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
As part of the work by the
Federal Government to address the
epidemic of prescription and illicit
opioid abuse, the Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop to
obtain input on issues and challenges
associated with Federal efforts to
support training on pain management
and the safe prescribing, dispensing,
and patient use of opioids (safe use of
SUMMARY:
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opioids) for health care providers. As
discussed in this document, the
workshop has three main goals. First,
participants will be asked to discuss the
role that health care provider training
plays, within the broader context of
ongoing activities, to improve pain
management and the safe use of opioids.
Second, participants will be asked to
comment on how best to provide health
care providers, who prescribe or are
directly involved in the management or
support of patients with pain,
appropriate training in pain
management and the safe use of opioids.
Finally, participants will be asked about
the issues and challenges associated
with possible changes to Federal efforts
to educate health care providers on pain
management and the safe use of opioids.
Participants are expected to include
individuals from a broad set of Federal,
State, and private stakeholder groups
that are working on the challenges of
improving pain management while
addressing the opioid abuse epidemic.
The Federal Agencies participating
include FDA, the Drug Enforcement
Administration, the Department of
Veterans Affairs, the Centers for Disease
Control and Prevention, the Department
of Defense, the Centers for Medicare &
Medicaid Services, the National
Institute on Drug Abuse, and the
Substance Abuse and Mental Health
Services Administration, and the Indian
Health Service. Public participation and
comment are encouraged.
DATES: The public workshop will be
held on May 9 and 10, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic
or written comments on this public
workshop by July 10, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 10, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 10, 2017. 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. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910, 877–298–2066.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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–1094 for ‘‘Training Health Care
Providers on Pain Management and Safe
Use of Opioid Analgesics —Exploring
the Path Forward; Public Workshop;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see DATES), 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
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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.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 Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mary Gross, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6178, Silver Spring,
MD 20993–0002, 301–796–3519, email:
Mary.Gross@fda.hhs.gov; or Doris Auth,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 2480, Silver Spring,
MD 20993–0002; 301–796–0487, email:
Doris.Auth@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 12, 2012, FDA approved a
risk evaluation and mitigation strategy
(REMS) for extended release (ER) and
long-acting (LA) opioid analgesic
medications (ER/LA Opioid Analgesics
REMS). The goal of such REMS is to
reduce serious adverse outcomes
resulting from inappropriate
prescribing, misuse, and abuse of
extended-release or long-acting (ER/LA)
opioid analgesics while maintaining
patient access to pain medications.
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Adverse outcomes of concern include
addiction, unintentional overdose, and
death. The ER/LA Opioid Analgesics
REMS requires that prescriber training
in the form of accredited continuing
education be made available to health
care providers who prescribe ER/LA
opioid analgesics.
On May 3 and 4, 2016, FDA convened
a joint meeting of the Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee to discuss
whether this REMS assures safe use of
these products, whether it is not unduly
burdensome to patient access to the
drugs, and whether it (to the extent
practicable) minimizes the burden to the
health care delivery system (https://
www.gpo.gov/fdsys/pkg/FR-2016-03-14/
pdf/2016-05573.pdf). FDA sought input
on possible modifications to the ER/LA
Opioid Analgesic REMS, including
expansion of the scope and content of
prescriber training and expansion of the
REMS program to include immediate
release (IR) opioid analgesics. The
majority of committee members were in
favor of modifying the REMS program to
include the IR opioid analgesics as well
as broadening the training program to
include pain management. Though the
majority of the committee members
were in favor of a requirement for all
prescribers to complete training, they
recommended that the required training
program be implemented through
mechanisms outside of the FDA REMS
authority. The committees also stated
that other health care providers
involved in the management of pain
should be included as a target audience
for education, though they did not
specify that the training should be
mandatory for non-prescribing health
care providers.
In addition to the joint Advisory
Committee advice on prescriber
education, a Request for Information
(RFI) was posted by the Department of
Health and Human Services (HHS)
Assistant Secretary of Planning and
Education on July 8, 2016 (81 FR
44640), seeking comment on the most
promising approaches in prescriber
education and training programs and
effective ways to leverage HHS
programs to implement/expand them.
The 2017 public workshop on May 9
and 10 seeks to build on one of the
requests outlined in that RFI,
specifically, the request for suggestions
of additional activities HHS and its
federal partners could implement to
support universal prescriber education
on appropriate pain management and
opioid analgesic prescribing.
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II. Topics for Discussion at the Public
Workshop
On May 9 and 10, 2017, FDA on its
own behalf and in conjunction with the
other participating federal agencies will
hold a public workshop and convene
government experts, representatives
from State licensing boards, professional
associations, health care systems,
patient groups, and other relevant
stakeholder groups. The workshop has
three major goals. First, participants will
be asked to discuss the role that health
care provider training plays, within the
broader context of ongoing activities, to
improve pain management and the safe
use of opioids. Second, participants will
be asked to comment on how best to
provide health care providers, who
prescribe or are directly involved in the
management or support of patients with
pain, appropriate training in pain
management and the safe use of opioids.
As a part of this discussion, current
training efforts by States, hospitals and
health care systems, Federal Agencies,
professional associations and other
groups will be considered in order to
strategize how best to facilitate training
for these health care providers. Finally,
participants will also be asked about
issues and challenges associated with
possible changes to Federal efforts to
educate health care providers on pain
management and the safe use of opioids.
Participants include individuals from
a broad set of Federal, State, and private
stakeholders that are working on the
challenges of improving pain
management while addressing the
opioid abuse epidemic. The Federal
Agencies participating include FDA, the
Drug Enforcement Administration, the
Department of Veterans Affairs, the
Centers for Disease Control and
Prevention, the Department of Defense,
the Centers for Medicare & Medicaid
Services, the National Institute on Drug
Abuse, the Substance Abuse and Mental
Health Services Administration, and the
Indian Health Service. Public
participation and comment is
encouraged.
Panels will be drawn from Federal
and State agencies, as well as other
private and public groups working to
address pain management and/or opioid
abuse. During the panel discussions,
panelists will be asked to address the
following:
(1) The relative role of Federal
training/education efforts in the larger
landscape of activities aimed at
improving pain management, including
the use of opioid analgesics. This
includes a discussion of ongoing efforts
being led by States, hospitals and health
care systems, other Federal Agencies,
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and medical societies that focus on
other aspects of the issue, such as
Prescription Drug Monitoring Programs.
(2) The merits and challenges of
utilizing Federal mechanisms to provide
education on pain management and the
safe use of opioid analgesics. This
includes a discussion of the role, if any,
of mandatory Federal education efforts.
(3) The merits and challenges of
utilizing non-Federal mechanisms to
provide education on pain management
and the safe use of opioid analgesics.
This includes a discussion of current
State and other efforts and the role they
are playing in training/education on
pain management and the safe use of
opioid analgesics.
(4) The merits and challenges of
utilizing partnerships between Federal
Agencies and other groups to provide
education on pain management and the
safe use of opioid analgesics. This
includes a discussion of the role of the
Federal Government in formal publicprivate partnerships or other combined
approaches to training/education on
pain management and the safe use of
opioid analgesics for all prescribers. It
also includes a discussion of the
appropriate organizations (e.g., Federal
Agency, State medical board, other) to
include in such efforts.
(5) The aspects of the opioid epidemic
that can be most impacted by the
training of health care providers and
how outcomes of these training
programs can be measured.
III. Participating in the Public
Workshop
Registration: Persons interested in
attending this public workshop must
register online by sending an email to
https://nakamotoevents.wufoo.com/
forms/p1gsrzm80gd7lkd/ before May 1,
2017. Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by May 1, 2017. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation when their
registration has been accepted. If time
and space permit, onsite registration on
the day of the public workshop will be
provided beginning at 7:30 a.m.
If you need special accommodations
due to a disability, please contact Mary
Gross or Doris Auth (see FOR FURTHER
INFORMATION CONTACT) no later than May
1, 2017.
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Requests for Oral Comments: During
online registration you may indicate if
you wish to provide a statement during
the Open Public Comment Period. We
will do our best to accommodate
requests to make public comments
based on time allocated for public
comment. Individuals and organizations
with common interests are urged to
consolidate or coordinate their
comments, and request time for a joint
presentation. Following the close of
registration date, we will determine the
amount of time allotted to each
commenter and the approximate time
each oral comment is scheduled to
begin; commenters should arrive ahead
of their scheduled time in case the
agenda moves ahead of schedule so as
to be sure not to forfeit their speaking
time. All requests to make oral
comments must be received by the close
of registration on May 1, 2017. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. Additional information
will be made available regarding
accessing the Webcast 2 days prior to
the public workshop at https://
www.fda.gov/Drugs/NewsEvents/
ucm538047.htm.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A link to the
transcript will also be available on the
Internet at https://www.fda.gov/Drugs/
NewsEvents/ucm538047.htm.
Dated: April 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07821 Filed 4–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2017–N–1989]
Second Annual Workshop on Clinical
Outcome Assessments in Cancer
Clinical Trials; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research, in co-
SUMMARY:
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sponsorship with the Critical Path
Institute’s (C-Path) Patient-Reported
Outcome (PRO) Consortium, is
announcing a public workshop entitled
‘‘Second Annual Workshop on Clinical
Outcome Assessments in Cancer
Clinical Trials.’’ The purpose of the
public workshop is to provide a forum
for collaborative multidisciplinary
discussion to identify opportunities and
address challenges for clinical outcome
assessments, particularly patientreported outcome (PRO) assessments, in
oncology drug development. In this
public workshop, a broad array of
international stakeholders involved in
oncology drug development and PRO
measurement will provide perspectives
on the role of PRO measures to provide
complementary clinical data on the
symptomatic side effects of anti-cancer
agents. Speakers and panelists will
explore the utility of information
derived from existing and emerging PRO
measures and discuss potential ways to
improve the collection, analysis, and
presentation of the data to support drug
development and better inform
treatment decisions. In addition,
workshop participants will discuss
possible approaches to the patientreported assessment of an
investigational drug’s overall side effect
burden as a clinical trial endpoint. This
public workshop will include speakers
and panelists from regulatory agencies,
academia, patient advocacy groups, and
the medical product industry.
DATES: The public workshop will be
held on April 25, 2017, from 8 a.m. to
5 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Hyatt Regency Bethesda,
One Bethesda Metro Center, 7400
Wisconsin Ave., Bethesda, MD 20814,
301–657–1234.
FOR FURTHER INFORMATION CONTACT:
Theresa Hall, Patient-Reported Outcome
Consortium, Critical Path Institute, 1730
East River Road, Tucson, AZ 85718,
520–777–2875, FAX: 525–547–3456,
email: thall@c-path.org; and Valerie
Vashio, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–3710, FAX: 301–796–9909, email:
valerie.vashio@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical outcome assessment (COA)
tools are intended to capture how
patients experience a disease and its
treatment by assessing symptoms,
function, and other aspects of a patient’s
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health-related quality of life (HRQL).
PRO measures are one important type of
COA tool. There is growing interest in
optimizing the use of PRO measures to
better incorporate the patient
perspective into oncology drug
development. While PRO measures can
be used to evaluate the efficacy of
cancer treatments, there is increasing
interest in the use of PRO tools to assess
symptomatic side effects of treatment.
New PRO item banks and libraries are
becoming available that can provide
needed flexibility to tailor the PRO
assessment to the wide range of side
effects seen with the various
mechanistic classes utilized in
contemporary drug development. FDA
is interested in gaining feedback on
methods to integrate the patient into the
assessment of safety and tolerability of
cancer drugs through systematic patientreporting of side effects during clinical
trials. This public workshop will
discuss standard clinician reporting of
adverse events, the development and
implementation of the PRO-Common
Terminology Criteria for Adverse Events
(CTCAE) assessment tool, and explore
different analysis and presentation
methods for longitudinal patientreported adverse event data.
II. Registration and Accommodations
A. Registration
There is a registration fee to attend
this public workshop. The registration
fee is charged to help defray the costs
of the public workshop facility, speaker
and panelist expenses, audiovisual
equipment, materials, and food. Persons
interested in attending this public
workshop must register by April 21,
2017. If time and space permit, onsite
registration on the day of the public
workshop will be provided beginning at
8 a.m. Seats are limited, and registration
will be on a first-come, first-served
basis.
To register for the public workshop,
please complete registration online at
https://www.cvent.com/events/secondannual-workshop-on-clinical-outcomeassessments-coas-in-cancer-clinicaltrials/registration-270d8a5ee3ae4a
108938851e2a7d0ea7.aspx. (FDA has
verified the Web site addresses, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.) The costs
of registration for the different
categories of attendees are as follows:
Category
Industry Representatives.
Charitable Nonprofit/
Academic.
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Cost
$400.
$100 (Contact CPath).
Agencies
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18300-18303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07821]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1094]
Training Health Care Providers on Pain Management and Safe Use of
Opioid Analgesics--Exploring the Path Forward; Public Workshop; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: As part of the work by the Federal Government to address the
epidemic of prescription and illicit opioid abuse, the Food and Drug
Administration (FDA, the Agency, or we) is announcing a public workshop
to obtain input on issues and challenges associated with Federal
efforts to support training on pain management and the safe
prescribing, dispensing, and patient use of opioids (safe use of
[[Page 18301]]
opioids) for health care providers. As discussed in this document, the
workshop has three main goals. First, participants will be asked to
discuss the role that health care provider training plays, within the
broader context of ongoing activities, to improve pain management and
the safe use of opioids. Second, participants will be asked to comment
on how best to provide health care providers, who prescribe or are
directly involved in the management or support of patients with pain,
appropriate training in pain management and the safe use of opioids.
Finally, participants will be asked about the issues and challenges
associated with possible changes to Federal efforts to educate health
care providers on pain management and the safe use of opioids.
Participants are expected to include individuals from a broad set
of Federal, State, and private stakeholder groups that are working on
the challenges of improving pain management while addressing the opioid
abuse epidemic. The Federal Agencies participating include FDA, the
Drug Enforcement Administration, the Department of Veterans Affairs,
the Centers for Disease Control and Prevention, the Department of
Defense, the Centers for Medicare & Medicaid Services, the National
Institute on Drug Abuse, and the Substance Abuse and Mental Health
Services Administration, and the Indian Health Service. Public
participation and comment are encouraged.
DATES: The public workshop will be held on May 9 and 10, 2017, from
8:30 a.m. to 5 p.m. Submit either electronic or written comments on
this public workshop by July 10, 2017. Late, untimely filed comments
will not be considered. Electronic comments must be submitted on or
before July 10, 2017. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
July 10, 2017. 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. See the SUPPLEMENTARY INFORMATION section for registration
date and information.
ADDRESSES: The public workshop will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910, 877-298-2066.
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-1094 for ``Training Health Care Providers on Pain Management
and Safe Use of Opioid Analgesics --Exploring the Path Forward; Public
Workshop; Request for Comments.'' Received comments, those filed in a
timely manner (see DATES), 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.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 Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mary Gross, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6178, Silver Spring, MD 20993-0002, 301-796-3519, email:
Mary.Gross@fda.hhs.gov; or Doris Auth, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, rm. 2480, Silver Spring, MD 20993-0002; 301-796-0487, email:
Doris.Auth@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 12, 2012, FDA approved a risk evaluation and mitigation
strategy (REMS) for extended release (ER) and long-acting (LA) opioid
analgesic medications (ER/LA Opioid Analgesics REMS). The goal of such
REMS is to reduce serious adverse outcomes resulting from inappropriate
prescribing, misuse, and abuse of extended-release or long-acting (ER/
LA) opioid analgesics while maintaining patient access to pain
medications.
[[Page 18302]]
Adverse outcomes of concern include addiction, unintentional overdose,
and death. The ER/LA Opioid Analgesics REMS requires that prescriber
training in the form of accredited continuing education be made
available to health care providers who prescribe ER/LA opioid
analgesics.
On May 3 and 4, 2016, FDA convened a joint meeting of the Drug
Safety and Risk Management Advisory Committee and the Anesthetic and
Analgesic Drug Products Advisory Committee to discuss whether this REMS
assures safe use of these products, whether it is not unduly burdensome
to patient access to the drugs, and whether it (to the extent
practicable) minimizes the burden to the health care delivery system
(https://www.gpo.gov/fdsys/pkg/FR-2016-03-14/pdf/2016-05573.pdf). FDA
sought input on possible modifications to the ER/LA Opioid Analgesic
REMS, including expansion of the scope and content of prescriber
training and expansion of the REMS program to include immediate release
(IR) opioid analgesics. The majority of committee members were in favor
of modifying the REMS program to include the IR opioid analgesics as
well as broadening the training program to include pain management.
Though the majority of the committee members were in favor of a
requirement for all prescribers to complete training, they recommended
that the required training program be implemented through mechanisms
outside of the FDA REMS authority. The committees also stated that
other health care providers involved in the management of pain should
be included as a target audience for education, though they did not
specify that the training should be mandatory for non-prescribing
health care providers.
In addition to the joint Advisory Committee advice on prescriber
education, a Request for Information (RFI) was posted by the Department
of Health and Human Services (HHS) Assistant Secretary of Planning and
Education on July 8, 2016 (81 FR 44640), seeking comment on the most
promising approaches in prescriber education and training programs and
effective ways to leverage HHS programs to implement/expand them. The
2017 public workshop on May 9 and 10 seeks to build on one of the
requests outlined in that RFI, specifically, the request for
suggestions of additional activities HHS and its federal partners could
implement to support universal prescriber education on appropriate pain
management and opioid analgesic prescribing.
II. Topics for Discussion at the Public Workshop
On May 9 and 10, 2017, FDA on its own behalf and in conjunction
with the other participating federal agencies will hold a public
workshop and convene government experts, representatives from State
licensing boards, professional associations, health care systems,
patient groups, and other relevant stakeholder groups. The workshop has
three major goals. First, participants will be asked to discuss the
role that health care provider training plays, within the broader
context of ongoing activities, to improve pain management and the safe
use of opioids. Second, participants will be asked to comment on how
best to provide health care providers, who prescribe or are directly
involved in the management or support of patients with pain,
appropriate training in pain management and the safe use of opioids. As
a part of this discussion, current training efforts by States,
hospitals and health care systems, Federal Agencies, professional
associations and other groups will be considered in order to strategize
how best to facilitate training for these health care providers.
Finally, participants will also be asked about issues and challenges
associated with possible changes to Federal efforts to educate health
care providers on pain management and the safe use of opioids.
Participants include individuals from a broad set of Federal,
State, and private stakeholders that are working on the challenges of
improving pain management while addressing the opioid abuse epidemic.
The Federal Agencies participating include FDA, the Drug Enforcement
Administration, the Department of Veterans Affairs, the Centers for
Disease Control and Prevention, the Department of Defense, the Centers
for Medicare & Medicaid Services, the National Institute on Drug Abuse,
the Substance Abuse and Mental Health Services Administration, and the
Indian Health Service. Public participation and comment is encouraged.
Panels will be drawn from Federal and State agencies, as well as
other private and public groups working to address pain management and/
or opioid abuse. During the panel discussions, panelists will be asked
to address the following:
(1) The relative role of Federal training/education efforts in the
larger landscape of activities aimed at improving pain management,
including the use of opioid analgesics. This includes a discussion of
ongoing efforts being led by States, hospitals and health care systems,
other Federal Agencies, and medical societies that focus on other
aspects of the issue, such as Prescription Drug Monitoring Programs.
(2) The merits and challenges of utilizing Federal mechanisms to
provide education on pain management and the safe use of opioid
analgesics. This includes a discussion of the role, if any, of
mandatory Federal education efforts.
(3) The merits and challenges of utilizing non-Federal mechanisms
to provide education on pain management and the safe use of opioid
analgesics. This includes a discussion of current State and other
efforts and the role they are playing in training/education on pain
management and the safe use of opioid analgesics.
(4) The merits and challenges of utilizing partnerships between
Federal Agencies and other groups to provide education on pain
management and the safe use of opioid analgesics. This includes a
discussion of the role of the Federal Government in formal public-
private partnerships or other combined approaches to training/education
on pain management and the safe use of opioid analgesics for all
prescribers. It also includes a discussion of the appropriate
organizations (e.g., Federal Agency, State medical board, other) to
include in such efforts.
(5) The aspects of the opioid epidemic that can be most impacted by
the training of health care providers and how outcomes of these
training programs can be measured.
III. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop
must register online by sending an email to https://nakamotoevents.wufoo.com/forms/p1gsrzm80gd7lkd/ before May 1, 2017.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by May 1, 2017. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when their registration has been accepted. If time and
space permit, onsite registration on the day of the public workshop
will be provided beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Mary Gross or Doris Auth (see FOR FURTHER INFORMATION CONTACT)
no later than May 1, 2017.
[[Page 18303]]
Requests for Oral Comments: During online registration you may
indicate if you wish to provide a statement during the Open Public
Comment Period. We will do our best to accommodate requests to make
public comments based on time allocated for public comment. Individuals
and organizations with common interests are urged to consolidate or
coordinate their comments, and request time for a joint presentation.
Following the close of registration date, we will determine the amount
of time allotted to each commenter and the approximate time each oral
comment is scheduled to begin; commenters should arrive ahead of their
scheduled time in case the agenda moves ahead of schedule so as to be
sure not to forfeit their speaking time. All requests to make oral
comments must be received by the close of registration on May 1, 2017.
No commercial or promotional material will be permitted to be presented
or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Additional information will be made available
regarding accessing the Webcast 2 days prior to the public workshop at
https://www.fda.gov/Drugs/NewsEvents/ucm538047.htm.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm538047.htm.
Dated: April 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07821 Filed 4-17-17; 8:45 am]
BILLING CODE 4164-01-P