Document ID: FDA-2017-D-2497-0001
Agency: fda
Document Type: Notice
Title: Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability
Posted Date: 2017-05-10T04:00Z

[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Notices]
[Pages 21818-21819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09442]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2497]

Draft Revisions to the Food and Drug Administration Blueprint for 
Prescriber Education for Extended-Release and Long-Acting Opioids; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of draft revisions to the ``FDA Blueprint for 
Prescriber Education for Extended-Release and Long-Acting Opioid 
Analgesics'' (Blueprint). The Blueprint is part of the FDA-approved 
risk evaluation and mitigation strategy (REMS) for extended release 
(ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid 
Analgesics REMS).
    FDA is seeking comment on the draft revisions to the Blueprint and 
has added sections of draft revised Blueprint to the background 
materials for the public workshop scheduled for May 9-10, 2017. 
Although the draft revisions to the Blueprint will not be a discussion 
topic at the workshop, FDA expects the draft revisions to provide 
important context for discussions during the workshop.

DATES: To ensure that FDA considers your comments on the draft 
revisions to the Blueprint, submit either electronic or written 
comments by July 10, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-2497 for ``Draft Revisions to FDA Blueprint for Prescriber 
Education for Extended-Release and Long-Acting Opioids; Request for 
Comments.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your

[[Page 21819]]

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.
    Submit written requests for single copies of the draft revised 
Blueprint to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft revised Blueprint.

FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug 
Evaluation and Research (HFD-1), Food and Drug Administration 20 North 
Michigan Ave., Suite 510, Chicago, IL 60602, 312-596-6516.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of draft 
revisions to the ``FDA Blueprint for Prescriber Education for Extended-
Release and Long-Acting Opioid Analgesics'' (draft revisions to the 
Blueprint). In addition to seeking comment on the draft revisions to 
the Blueprint, FDA expects the draft revisions to create important 
context for discussions at a public workshop 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 opioids) for health care providers. That workshop, which is 
scheduled for May 9-10, 2017, was previously announced in the Federal 
Register on April 18, 2017 (82 FR 18300).

I. Background

    On July 12, 2012, FDA approved an ER/LA Opioid Analgesics REMS, 
including an FDA-created ``Blueprint for Prescriber Education for 
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics.'' The goal 
of the REMS is to reduce serious adverse outcomes resulting from 
inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics 
while maintaining patient access to pain medications.
    The ER/LA Opioid Analgesics REMS requires that training in the form 
of accredited continuing education be made available to health care 
providers who prescribe ER/LA opioid analgesics. The accredited 
continuing education must include all elements of the FDA Blueprint, 
which includes a basic outline and the core messages related to ER/LA 
opioid analgesics. FDA developed the Blueprint following extensive 
input from stakeholders and sought input on a draft version on November 
7, 2011 (76 FR 68766), before approving it in 2012 as part of the ER/LA 
Opioid Analgesics REMS.
    On May 3-4, 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 or not it is unduly burdensome to 
patient access to the drugs; and whether it (to the extent practicable) 
minimizes the burden to the health care delivery system (March 14, 
2016, 81 FR 13372). FDA also 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. Advisory 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. The majority of the members were in favor of a 
requirement for all prescribers to complete training. Many of the 
members recommended that the required training program be implemented 
through mechanisms outside the FDA REMS authority. The majority of 
members 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.

II. Potential Modifications to the FDA Blueprint

    FDA is considering modifications to the existing Blueprint in light 
of recommendations from the May 2016 Advisory Committee meeting. The 
draft revisions to the Blueprint being made available pursuant to this 
notice would broaden the Blueprint to include information on pain 
management, including the principles of acute and chronic pain 
management; non-pharmacologic treatments for pain; and pharmacologic 
treatments for pain (both non-opioid analgesic and opioid analgesic). 
FDA intends to consider public input as it considers modifications to 
the ER/LA Opioid Analgesics REMS.

III. May 2017 Public Workshop

    On April 18, 2017, FDA published a notice announcing a public 
workshop scheduled for May 9-10, 2017, to seek 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 opioids) for health care providers. Through the 
public workshop, FDA hopes to obtain additional insight from a variety 
of stakeholders on how best to ensure that health care providers 
receive training in pain management and the safe use of opioids. The 
draft revisions to the Blueprint being made available at https://www.fda.gov/Drugs/NewsEvents/ucm553931.htm are intended to provide 
important context for the public workshop's discussion. However, the 
Blueprint itself will not be a discussion topic at the workshop. FDA 
intends to consider any comments submitted to this docket as it 
considers possible modifications to the ER/LA Opioid Analgesics REMS.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09442 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P