Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability, 21818-21819 [2017-09442]

Download as PDF 21818 Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices CMS–10225 Disclosures Required of Certain Hospitals and Critical Access Hospitals Regarding Physician Ownership Dated: May 5, 2017 William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. [FR Doc. 2017–09478 Filed 5–9–17; 8:45 am] jstallworth on DSK7TPTVN1PROD with NOTICES Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Disclosures Required of Certain Hospitals and Critical Access Hospitals Regarding Physician Ownership; Use: This information collection relates to the required third party disclosures by certain Medicare-participating hospitals and Critical Access Hospitals (CAHs) and physicians to their patients. The intent of the disclosure notice is to assist the patient in making an informed decision regarding their care. The disclosure requires hospitals and CAHs to disclose to its patients whether the hospitals/CAHs are physician-owned and, if so, the names of the physicianowners. The second disclosure requires all hospitals and CAHs that do not have a Doctor of Medicine (MD) or a Doctor of Osteopathic Medicine (DO) on the premises at all times to disclose this to patients upon admission or registration for both inpatient and specified outpatient services. Form Number: CMS–10225 (OMB Control Number: 0938–1034); Frequency: Occasionally; Affected Public: Private sector— Business or other for-profits and Notfor-profit institutions; Number of Respondents: 2,556; Total Annual Responses: 162,993; Total Annual Hours: 6,435. (For policy questions regarding this collection contact Natalie Clybourn at 410–786–5642). VerDate Sep<11>2014 15:21 May 09, 2017 Jkt 241001 BILLING CODE 4120–01–P 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. Notice of availability; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing the availability of draft revisions to the ‘‘FDA Blueprint for Prescriber Education for ExtendedRelease 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: SUMMARY: 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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 E:\FR\FM\10MYN1.SGM 10MYN1 Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices 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. 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. FDA is announcing the availability of draft revisions to the ‘‘FDA Blueprint for Prescriber Education for ExtendedRelease 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). jstallworth on DSK7TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 15:21 May 09, 2017 Jkt 241001 I. Background On July 12, 2012, FDA approved an ER/LA Opioid Analgesics REMS, including an FDA-created ‘‘Blueprint for Prescriber Education for ExtendedRelease 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. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 21819 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; nonpharmacologic 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures Department of Health and Human Services, Office of the Secretary. ACTION: Notice. AGENCY: The Secretary is issuing a declaration pursuant to section 319F–3 of the Public Health Service Act to SUMMARY: E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[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
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