[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Pages 7838-7840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02802]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2022-0024]


Proposed 2022 CDC Clinical Practice Guideline for Prescribing 
Opioids

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

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC) within 
the Department of Health and Human Services (HHS), announces the 
opening of a docket to obtain comment on the proposed clinical practice 
guideline, CDC Clinical Practice Guideline for

[[Page 7839]]

Prescribing Opioids--United States, 2022 (the clinical practice 
guideline). The clinical practice guideline updates and expands the CDC 
Guideline for Prescribing Opioids for Chronic Pain--United States, 
2016, and provides evidence-based recommendations for clinicians who 
provide pain care, including those prescribing opioids, for outpatients 
age 18 years and older with acute pain (duration less than 1 month), 
subacute pain (duration of 1-3 months), or chronic pain (duration of 3 
months or more), not including sickle cell disease-related pain 
management, cancer pain treatment, palliative care, and end-of-life 
care. The clinical practice guideline includes recommendations for 
primary care clinicians (including physicians, nurse practitioners, and 
physician assistants) as well as for outpatient clinicians in other 
specialties (including those managing dental and postsurgical pain in 
outpatient settings and emergency clinicians providing pain management 
for patients being discharged from emergency departments). This 
voluntary clinical practice guideline provides recommendations and does 
not require mandatory compliance; and the clinical practice guideline 
is intended to be flexible so as to support, not supplant, clinical 
judgment and individualized, patient-centered decision-making.

DATES: Written comments must be received on or before April 11, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0024, by either 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 S106-9, Atlanta, GA 30341, Attn: Docket No. CDC-2022-0024.
    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. Do not submit comments by email. CDC does not 
accept comments by email. 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, MS S106-9, Atlanta, GA 30341; 
Telephone: 770-488-4696. Email: [email protected].

SUPPLEMENTARY INFORMATION:

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data. Please note that 
comments received, including attachments and other supporting 
materials, are part of the public record and are subject to public 
disclosure. Comments will be posted on https://www.regulations.gov. 
Therefore, do not include any information in your comment or supporting 
materials that you consider confidential or inappropriate for public 
disclosure. If you include your name, contact information, or other 
information that identifies you in the body of your comments, that 
information will be on public display. Do not submit comments by email. 
CDC does not accept comments by email. CDC will review all submissions 
and may choose to redact, or withhold, submissions containing private 
or proprietary information such as Social Security numbers, medical 
information, inappropriate language, or duplicate/near duplicate 
examples of a mass-mail campaign.

Background

    In the CDC Guideline for Prescribing Opioids for Chronic Pain--
United States, 2016, CDC communicated the intent to evaluate and 
reassess evidence and recommendations as new evidence became available 
and to determine when new evidence would prompt an update. To achieve 
these aims, CDC funded the Evidence-based Practice Centers at the 
Agency for Healthcare Research and Quality (AHRQ) to conduct systematic 
reviews of the scientific evidence in the following five areas: (1) 
Noninvasive nonpharmacological treatments for chronic pain; (2) 
nonopioid pharmacologic treatments for chronic pain; (3) opioid 
treatments for chronic pain; (4) treatments for acute pain; and (5) 
acute treatments for episodic migraine. Based upon the new evidence 
described in these reviews, an update to the CDC Guideline for 
Prescribing Opioids for Chronic Pain--United States, 2016 was 
warranted.
    CDC developed the clinical practice guideline using the Grading of 
Recommendations, Assessment, Development, and Evaluation (GRADE) 
framework, which specifies the systematic review of scientific evidence 
and offers a transparent approach to grading quality of evidence and 
strength of recommendations. Recommendations were made based on 
systematic reviews of the available scientific evidence while 
considering benefits and harms; patients', caregivers', and clinicians' 
values and preferences for pain treatment; and resource allocation 
(e.g., costs to patients or health systems, including clinician time). 
CDC drafted recommendation statements in the clinical practice 
guideline focused on assisting clinicians in determining whether to 
initiate opioids for pain; opioid selection and dosage; opioid duration 
and follow-up; and assessing risk and addressing potential harms of 
opioid use.
    This clinical practice guideline is voluntary; it provides 
recommendations and does not require mandatory compliance. It is 
intended to be flexible to support, not supplant, clinical judgment and 
individualized, patient-centered decision-making. This clinical 
practice guideline is not intended to be applied as inflexible 
standards of care across patient populations by healthcare 
professionals, health systems, third-party payers, organizations, or 
governmental jurisdictions. The clinical practice guideline is intended 
to achieve the following: Improved communication between clinicians and 
patients about the risks and benefits of pain treatment, including 
opioid therapy for pain; improved safety and effectiveness for pain 
treatment, resulting in improved function and quality of life for 
patients experiencing pain; and a reduction in the risks associated 
with long-term opioid therapy, including opioid use disorder, overdose, 
and death.
    To help assure the clinical practice guideline's integrity, 
credibility, and consideration of patients', caregivers', and 
providers' values and preferences, CDC obtained input from patients, 
caregivers, experts, clinicians, the public, and a federally chartered 
advisory committee, the Board of Scientific Counselors of the National 
Center for Injury Prevention and Control (BSC/NCIPC). CDC is also 
currently obtaining feedback from a panel of external peer reviewers 
who are experts in topic areas related to opioid prescribing. The panel 
of external peer reviewers' feedback will be addressed and incorporated 
into the final clinical practice guideline at the same time that public 
comments received in response to this Notice are considered.
    For more information about the clinical practice guideline or the 
process of updating it, please visit https://www.cdc.gov/opioids/guideline-update/index.html.

Supporting and Related Material in the Docket

    The docket contains the following supporting and related materials 
to help

[[Page 7840]]

inform public comment: (1) The draft clinical practice guideline; (2) 
the GRADE tables; (3) the Opioid Workgroup (OWG) Report, prepared at 
the request of the BSC/NCIPC and which the BSC/NCIPC unanimously voted 
to have CDC adopt, and CDC's response to observations outlined in the 
OWG Report; and (4) an Overview of Community Engagement and Public 
Comment Opportunities, which describes key themes that emerged about 
stakeholders' values and preferences regarding pain management, as well 
as CDC's response to input obtained from these efforts. The GRADE 
tables include clinical evidence review ratings of the evidence for the 
key clinical questions. The OWG Report describes the workgroup's 
findings and observations about the initial draft clinical practice 
guideline as presented to the BSC/NCIPC at a public meeting on July 16, 
2021. The OWG, comprising three BSC/NCIPC members in accordance with 
federal advisory committee policy, as well as patients with pain, 
caregivers, and family members of patients with pain, and clinicians 
and subject matter experts with a variety of relevant pain management 
expertise, was designed to provide independent, broad, external, 
transparent input to the BSC/NCIPC on the diverse and complex issues 
addressed in the clinical practice guideline. OWG meetings were 
coordinated by an NCIPC subject matter expert who served as the 
Designated Federal Official. CDC's response to the OWG Report reflects 
and describes how CDC incorporated OWG observations and comments in the 
revised draft of the clinical practice guideline. The Overview of 
Community Engagement and Public Comment Opportunities document provides 
a summary of efforts implemented throughout the clinical practice 
guideline update process to better understand the lived experiences and 
perspectives of community members that we serve and to ensure 
additional input from patients, caregivers, clinicians, and the public. 
CDC's response to the themes and findings that emerged throughout the 
community engagement and public comment opportunities describes how CDC 
carefully considered and incorporated diverse perspectives and input 
from multiple sources and stakeholders into the clinical practice 
guideline.

    Dated: February 7, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-02802 Filed 2-9-22; 8:45 am]
BILLING CODE 4163-18-P