[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: 
[email protected]; 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: 
[email protected].

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 
http://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 http://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