[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)]
[Notices]
[Pages 77351-77352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0112]


Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) announces the opening of 
a docket to obtain public comment on the draft CDC Guideline for 
Prescribing Opioids for Chronic Pain (Guideline). The Guideline 
provides recommendations regarding initiation or continuation of 
opioids for chronic pain; opioid selection, dosage, duration, follow-
up, and discontinuation; and assessment of risk and addressing harms of 
opioid use. The Guideline is intended to be used by primary care 
providers (e.g., family physicians or internists) who are treating 
patients with chronic pain (i.e., pain lasting longer than 3 months or 
past the time of normal tissue healing) in outpatient settings. The 
draft Guideline is intended to apply to patients aged 18 years of age 
or older with chronic pain outside of palliative and end-of-life care. 
The Guideline is not intended to apply to patients in treatment for 
active cancer. The Guideline is not a federal regulation; adherence to 
the Guideline will be voluntary.

DATES: Written comments must be received on or before January 13, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0112 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: National Center for Injury Prevention and Control, 
Centers for Disease Control and Prevention, 4770 Buford Highway NE., 
Mailstop F-63, Atlanta, GA 30341, Attn: Docket CDC-2015-0112.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center 
for Injury Prevention and Control, Centers for Disease Control and 
Prevention, 4770 Buford Highway NE., Mailstop F-63, Atlanta, GA 30341; 
Telephone: 770-488-4696.

SUPPLEMENTARY INFORMATION:

Background

    CDC developed the draft Guideline to provide recommendations about 
opioid prescribing for primary care providers who are treating adult 
patients with chronic pain in outpatient settings, outside of active 
cancer treatment, palliative care, and end-of-life care. The draft 
Guideline summarizes scientific knowledge about the effectiveness and 
risks of long-term opioid therapy, and provides recommendations for 
when to initiate or continue opioids for chronic pain; opioid 
selection, dosage, duration, follow-up, and discontinuation; and 
assessing risk and addressing harms of opioid use. The draft Guideline 
identifies important gaps in the literature where further research is 
needed.
    To develop the recommendations, CDC conducted a systematic review 
on benefits and harms of opioids and developed the draft Guideline 
using the Grading of Recommendations Assessment, Development, and 
Evaluation (GRADE) framework. CDC drafted recommendations and consulted 
with experts on the evidence to inform the recommendations. CDC hosted 
webinars in September 2015 and also provided opportunities for 
stakeholder and peer review of the draft Guideline. The Guideline is 
not a federal regulation; adherence to the Guideline will be voluntary. 
For additional information on prescription drug overdose, please visit 
http://www.cdc.gov/drugoverdose/prescribing/guideline.html.

Supporting and Related Material in the Docket

    The docket contains the following supporting and related materials 
to help inform public comment: The Guideline; the Clinical Evidence 
Review Appendix; the Contextual Evidence Review Appendix; and three 
documents that comprise the Comment Summaries and CDC Responses 
(Constituent Comment Summary, Peer Review Summary, and Stakeholder 
Review Group Summary). The Clinical Evidence Review Appendix and the 
Contextual Evidence Review Appendix include primary evidence, studies, 
and data tables that were used by CDC to develop the recommendations in 
the Guideline. The Constituent Comment Summary reflects input obtained 
in response to webinars hosted on September 16 and September 17, 2015, 
during which CDC shared an overview of the development process and 
draft recommendation statements. The Stakeholder Review Group Summary 
also reflects input obtained from stakeholders (comprised of 
professional and community organizations) following their review of a 
prior draft of the Guideline. Finally, the Peer Review Summary reflects 
input obtained from three scientific peer

[[Page 77352]]

reviewers following their review of a draft of the full Guideline, 
along with a summary of comments received and CDC responses.

    Dated: December 9, 2015.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2015-31375 Filed 12-11-15; 8:45 am]
 BILLING CODE 4163-18-P