CDC Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022, 70823-70827 [2022-25264]
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Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / Notices
contracting officer when they purchase
foreign supplies, in order to determine
whether the supplies should be dutyfree. The notice shall identify the
foreign supplies, estimate the amount of
duty, and the country of origin. The
contractor is not required to identify
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nature to items purchased by the
contractor or any subcontractor in
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under Trade Agreements
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Buy American—Construction
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Materials Under Trade Agreements
The listed provisions and clauses
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C. Annual Burden
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Total Annual Responses: 69,165.
Total Burden Hours: 43,469.
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D. Public Comment
A 60-day notice was published within
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Amendments to the FAR Buy American
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OMB Control Number 9000–0024 as
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Reporting Requirement’’). However, as
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Obtaining Copies: Requesters may
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Janet Fry,
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Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2022–25236 Filed 11–18–22; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2022–0024]
CDC Clinical Practice Guideline for
Prescribing Opioids for Pain—United
States, 2022
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS), announces the
availability of the CDC Clinical Practice
Guideline for Prescribing Opioids for
Pain—United States, 2022 (2022
Clinical Practice Guideline). The 2022
Clinical Practice Guideline updates and
expands the CDC Guideline for
Prescribing Opioids for Chronic Pain—
United States, 2016 (2016 Guideline)
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 more than 3
months). The recommendations in the
2022 Clinical Practice Guideline do not
apply to pain management related to
sickle cell disease, cancer-related pain
treatment, palliative care, or end-of-life
care. The 2022 Clinical Practice
Guideline finalizes the draft clinical
practice guideline issued on February
10, 2022.
DATES: The 2022 Clinical Practice
Guideline is available November 21,
2022.
SUMMARY:
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: opioids@cdc.gov.
SUPPLEMENTARY INFORMATION:
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Background
In the 2016 Guideline, CDC
communicated the intent to evaluate
and reassess evidence and
recommendations for opioid prescribing
for adult patients 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 (e.g., exercise,
physical therapy, psychological
therapies), 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 on the
evidence described in these reviews, an
update to the 2016 Guideline was
warranted.
CDC developed the 2022 Clinical
Practice Guideline recommendations
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;
patient, caregiver, and clinician 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 2022
Clinical Practice Guideline to assist
clinicians in determining whether or not
to initiate opioids for pain, selecting
opioids and determining opioid
dosages, deciding duration of initial
opioid prescription and conducting
follow-up, and assessing risk and
addressing potential harms of opioid
use.
The 2022 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).
The 2022 Clinical Practice Guideline
is not a regulation or a law. It is a set
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of voluntary recommendations intended
to support clinicians as they work in
consultation with their patients to
address pain. It is intended to be
flexible to support, not supplant,
clinical judgment and individualized,
patient-centered decision-making. It 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 2022 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 reduction in the
risks associated with long-term opioid
therapy, including opioid use disorder,
overdose, and death.
To help ensure the 2022 Clinical
Practice Guideline’s integrity,
credibility, and consideration of patient,
caregiver, and clinician values and
preferences, CDC obtained input
through individual conversations with
patients, caregivers, experts, clinicians,
through public comment opportunities,
and a federally chartered advisory
committee, the Board of Scientific
Counselors of the National Center for
Injury Prevention and Control (BSC/
NCIPC). CDC also obtained feedback
from a panel of external peer reviewers
who are experts in topics related to
opioid prescribing.
Summary of Public Comment and CDC
Response
On February 10, 2022, CDC published
a notice in the Federal Register
announcing the availability of the draft
clinical practice guideline (87 FR 7838).
The notice gave the public an
opportunity to submit comments by
April 10, 2022. CDC received
approximately 5,500 unique comments
(including one comment submitted with
28,322 additional signatories) from the
public, including patients with acute
and chronic pain, caregivers, and
clinicians. Comments also included
organizational perspectives from
medical associations, professional
organizations, academic institutions,
state and local governments, and
advocacy and industry groups.
CDC carefully catalogued, reviewed,
and qualitatively analyzed all comments
submitted by members of the public. All
public comments were carefully
reviewed and considered when revising
the draft clinical practice guideline.
Most comments submitted to the public
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docket for the draft clinical practice
guideline were submitted by individuals
living with pain and their caregivers,
families, and friends.
CDC highly values insights gained
from these public comments and
especially thanks those patients living
with pain who shared their personal
experiences in this public forum.
Themes from the comments included:
(1) concerns about the 2016 Guideline;
(2) overall considerations for the 2022
Clinical Practice Guideline; (3)
considerations for Recommendation
Statements in the 2022 Clinical Practice
Guideline; and (4) suggestions for
scientific articles to include in
supporting rationales to supplement
information from the systematic reviews
about acute and chronic pain
management.
(1) Concerns about the 2016 Guideline
Respondents shared their personal
experiences with pain care, including
with misinterpretation and
misapplication of the 2016 Guideline. In
particular, they mentioned issues with
misapplication related to prescribed
dosing limits and forced tapers.
CDC Response
• CDC added language to the 2022
Clinical Practice Guideline emphasizing
that it provides voluntary clinical
practice recommendations that are not
intended to be inflexible standards of
care or implemented as absolute limits
of policy or practice for patients by
clinicians, healthcare systems, or
government entities.
• CDC added language throughout the
document that further emphasizes that
both the benefits and the risks of
continuing opioid therapy should be
considered by clinicians when
providing pain care for patients.
• CDC added discussion throughout
the document pertaining to changes
related to dosage thresholds and
appropriate application. For example,
the following was added to the
Rationale:
Importantly, to discourage the
misapplication of opioid pain
medication dosage thresholds as
inflexible standards, revised
recommendation statement language
emphasizes principles such as avoiding
increasing dosage above levels likely to
yield diminishing returns in benefits
relative to risks to patients. More
specific considerations related to dosage
have been moved to implementation
considerations that follow each
recommendation statement, where more
nuance is offered to inform clinical
decision-making and individualized
patient care.
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(2) Overall Considerations for the 2022
Clinical Practice Guideline
Respondents focused on the
importance of clinician judgment that
promotes flexible opioid prescribing
practices focused on the individual
patient. They were appreciative of
CDC’s inclusion of language
emphasizing open communication
between patients and clinicians and
updated language to discourage forced
tapers. Regarding the latter, respondents
encouraged CDC to further emphasize
and strengthen this language.
Many respondents expressed concern
that mention of specific morphine
milligram equivalents in the 2022
Clinical Practice Guideline would lead
to hard limits on opioid prescriptions.
Respondents also were concerned that
specific pain conditions were called out
as conditions to which the draft clinical
practice guideline was not applicable
while others went unmentioned.
Respondents noted that the length of
the draft clinical practice guideline was
a barrier to end users. However,
respondents also noted that several
organizational features of the draft
clinical practice guideline were helpful,
such as a call-out box that summarizes
its intended use, including conditions
for which it is not applicable.
Respondents suggested that additional
detail in these boxes would be
beneficial for those who may not read
beyond this content. In addition,
professional organizations suggested the
development of supplemental onepagers and supporting materials to
further increase the utility of the
document.
Finally, some respondents providing
comments on behalf on individuals with
non-pain related conditions that use
opioids for treatment (e.g., ostomyrelated conditions and restless leg
syndrome [RLS]) proposed that the 2022
Clinical Practice Guideline title should
be adjusted to better reflect its content
and intended use.
CDC Response
• CDC added language throughout the
document to emphasize that the 2022
Clinical Practice Guideline provides
voluntary clinical practice
recommendations that are not intended
to be inflexible standards of care or
implemented as absolute limits of
policy or practice for patients by
clinicians, healthcare systems, or
government entities.
• CDC added discussion throughout
the document pertaining to changes
related to dosage thresholds and
appropriate application. For example,
the following was added to the
Rationale:
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Importantly, to discourage the
misapplication of opioid pain
medication dosage thresholds as
inflexible standards, revised
recommendation statement language
emphasizes principles such as avoiding
increasing dosage above levels likely to
yield diminishing returns in benefits
relative to risks to patients. More
specific considerations related to dosage
have been moved to the Implementation
Considerations that follow each
recommendation statement, where more
nuance is offered to inform clinical
decision-making and individualized
patient care.
• CDC revised language in the scope
and audience section to further
emphasize that all types of pain need
effective treatment:
Although some principles in this
clinical practice guideline might be
helpful in the management of pain
related to sickle cell disease, cancerrelated pain treatment, palliative care,
and end-of-life care, some
recommendations might not be relevant
for pain management in these contexts.
Other guidelines more specifically
address pain management in these
situations; therefore, this clinical
practice guideline does not apply to
patients experiencing pain associated
with these conditions or types of care.
This does not imply that any other types
of pain are more or less worthy of
effective treatment, only that clinicians
are referred to existing clinical
guidelines that more specifically
address unique considerations for
management of pain related to sickle
cell disease, cancer-related pain
treatment, palliative care, and end-oflife care.
• CDC added call-out boxes to the
document to highlight critical
information:
Æ Box 1. Executive summary of the
CDC Clinical Practice Guideline for
Prescribing Opioids for Pain–
United States, 2022
Æ Box 2. Intended use of CDC’s
Clinical Practice Guideline for
Prescribing Opioids for Pain–
United States, 2022
Æ Box 3. Recommendations for
prescribing opioids for outpatients
with pain, excluding pain
management for sickle cell disease,
cancer-related pain treatment,
palliative care, and end-of-life care;
recommendation categories; and
evidence types, CDC Clinical
Practice Guideline for Prescribing
Opioids for Pain–United States,
2022
Æ Box 4. Guiding principles for
implementation of the CDC Clinical
Practice Guideline for Prescribing
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Opioids for Pain–United States,
2022 recommendations
Æ Box 5. Areas for additional research
to build the evidence base for
optimal pain management
• CDC is developing translation and
communication materials to support
accurate implementation of the 2022
Clinical Practice Guideline. These
resources will be short references and
‘‘at-a-glance’’ materials to support
appropriate application and
interpretation.
• CDC changed the name of the
document from the CDC Clinical
Practice Guideline for Prescribing
Opioids to the CDC Clinical Practice
Guideline for Prescribing Opioids for
Pain to further emphasize its focus on
prescription opioids for the treatment of
pain.
(3) Considerations for Recommendation
Statements in the 2022 Clinical Practice
Guideline
Respondents noted that frequent
follow-up appointments, office visits,
and drug screening requirements were
barriers to care and health equity. They
also expressed concern about stigma
related to toxicology testing.
CDC Response
• CDC added language to address
health equity and additional
considerations and context related to
health equity, such as language about
using virtual follow-up visits for
patients for whom virtual visits are part
of standard care (e.g., in remote areas
where distance or other context makes
follow-up visits challenging) or for
patients for whom in-person follow-up
visits are challenging (e.g., frail patients)
under Recommendation 7’s
implementation considerations and
supporting text.
• The second sentence of
Recommendation 7 has been changed
from ‘‘Clinicians should evaluate
benefits and risks of continued therapy
with patients every 3 months or more
frequently’’ to ‘‘Clinicians should
regularly reevaluate benefits and risks of
continued opioid therapy with
patients.’’ Of note, the more specific ‘‘3month’’ time frame is still discussed in
the Implementation Considerations and
Supporting Rationale, where more
nuanced considerations for flexibility
are discussed.
• CDC augmented language in the
implementation considerations for
Recommendation 10 to state:
Toxicology testing should not be used
in a punitive manner but should be used
in the context of other clinical
information to inform and improve
patient care. Clinicians should not
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dismiss patients from care on the basis
of a toxicology test result. Dismissal
could have adverse consequences for
patient safety, potentially including the
patient obtaining opioids or other drugs
from alternative sources and the
clinician missing opportunities to
facilitate treatment for substance use
disorder.
(4) Suggestions for Scientific Articles
About Acute and Chronic Pain
Management
Some respondents submitted
scientific articles about acute and
chronic pain management for CDC to
consider citing as additional informative
references in the supporting rationales.
CDC carefully reviewed each submitted
comment and made edits or added
additional citations to the draft clinical
practice guideline where appropriate.
Some examples of recommended
sources and revisions are below.
• To demonstrate the undertreatment
of sickle cell disease due to stigma and
racism, the organization Sick Cells
recommended that CDC cite this
reference: Phillips S, Chen Y, Masese R,
Noisette L, Jordan K, et al. (2022)
Perspectives of individuals with sickle
cell disease on barriers to care. PLOS
ONE 17(3): e0265342. https://doi.org/
10.1371/journal.pone.026534.
• The Michigan Opioid Prescribing
Engagement Network suggested that
CDC cite its OPEN Prescribing
Recommendations as an additional
reference for Recommendation 1. This
reference was already included in the
document: Michigan Opioid Prescribing
Engagement Network. Prescribing
recommendations. Ann Arbor, MI:
Michigan Opioid Prescribing
Engagement Network. https://michiganopen.org/prescribing-recommendations.
• The American Geriatric Society
noted that a reference to its 2009
American Geriatric Society
Recommendations for Chronic Pain
Medications in Older Adults (AGS
Guideline) was not current and
recommended CDC cite different
sources for its discussion of the use of
acetaminophen for the treatment of pain
among adults aged 18 and over.
• The National Pain Advocacy Center
stated that several studies finding
adverse outcomes after opioid stoppage,
dose reduction, or dose variation were
not cited or were cited inaccurately.
• The American Academy of
Addiction Psychiatry recommended the
inclusion of the Alcohol Use Disorders
Identification Consumption Test
(AUDIT–C), as done by the Veterans
Health Administration, instead of the
full Alcohol Use Disorders
Identification Test (AUDIT).
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• The American College of Obstetrics
and Gynecology (ACOG) recommended
that other critical concepts regarding
family planning and contraceptive
counseling from additional resources be
included in the document. ACOG also
recommended an additional reference
with safety data regarding
buprenorphine/naloxone combination
use in pregnancy: Link HM, Jones H,
Miller L, Kaltenbach K, Seligman N.
Buprenorphine-naloxone use in
pregnancy: a systematic review and
metaanalysis. Am J Obstet Gynecol
MFM. 2020 Aug;2(3):100179. doi:
10.1016/j.ajogmf.2020.100179. Epub
2020 Jul 3. PMID: 33345863.
CDC Response
• CDC included Phillips et. al. in the
references section.
• CDC added a citation to the Open
Prescribing Recommendations again in
reference to Recommendation 1.
• CDC deleted reference to the 2009
American Geriatric Society Guideline
throughout the document.
• CDC added the references from the
National Pain Advocacy Center. Several
recommended references were already
included in the draft clinical practice
guideline.
Æ Hallvik SE, El Ibrahimi S, Johnston
K, et al. Patient outcomes after
opioid dose reduction among
patients with chronic opioid
therapy. Pain. 2022;163(1):83–90.
Æ Binswanger IA, Glanz JM, Faul M,
et al. The Association between
Opioid Discontinuation and Heroin
Use: A Nested Case-Control Study.
Drug and Alcohol Dependence.
2020;217:108248.
Æ Perez HR, Buonora M, Cunningham
CO, Heo M, Starrels JL. Opioid
Taper Is Associated with
Subsequent Termination of Care: a
Retrospective Cohort Study. J Gen
Intern Med. 2020;35(1):36–42.
• CDC modified its inclusion from
full AUDIT to AUDIT–C in the
Supporting Rationale for
Recommendation 7.
• CDC added additional family
planning and contraceptive planning
concepts and the following sources:
Æ ACOG Committee Opinion No. 762.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2019;133:e78–89.
Æ Patient-Centered Contraceptive
Counseling. Committee Statement
No. 1. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2022;139:349–53.
Æ Interpregnancy care. Obstetric Care
Consensus No. 8. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2019;133:e51–72.
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• CDC added Link. et al.
For more information about CDC’s
response to peer reviewers’ and public
comments, please see the Supporting &
Related Materials tab of this docket.
For more information about the 2022
Clinical Practice Guideline or the
process of updating it, please visit
https://www.cdc.gov/opioids/guidelineupdate/.
Supporting and Related Material in the
Docket
The docket contains the following
supporting and related materials: (1) the
2022 Clinical Practice Guideline; (2) the
GRADE tables; (3) CDC’s response to
peer review of the draft clinical practice
guideline; (4) CDC’s response to public
comments on the draft clinical practice
guideline; (5) the draft clinical practice
guideline released for public comment
on February 10, 2022; (6) 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 (7) an Overview of
Community Engagement and Public
Comment Opportunities, which
describes key themes that emerged
about participant 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 an
initial draft clinical practice guideline
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,
and transparent input to the BSC/NCIPC
on the diverse and complex issues
addressed in the draft 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
clinical practice guideline.
The Overview of Community
Engagement and Public Comment
Opportunities document provides a
summary of efforts implemented
throughout the clinical practice
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guideline update process to better
understand the lived experiences and
perspectives of community members
and to ensure additional input from
patients, caregivers, clinicians, and the
public. This document also summarizes
CDC’s response to the themes and
findings that emerged throughout the
community engagement and public
comment opportunities and describes
how CDC carefully considered and
incorporated diverse perspectives and
input from multiple sources into the
draft clinical practice guideline that was
posted for public comment.
Availability of the 2022 Clinical
Practice Guideline
The CDC Clinical Practice Guideline
for Prescribing Opioids for Pain—United
States, 2022 can be found in the
Supporting & Related Materials tab of
this docket on the Federal eRulemaking
Portal: identified by Docket No. CDC–
2022–0024 and at https://www.cdc.gov/
mmwr/volumes/71/rr/rr7103a1.htm?s_
cid=rr7103a1_w.
Angela K. Oliver,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2022–25264 Filed 11–18–22; 8:45 am]
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Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘CDC
Fellowship Programs Assessments’’ to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on August 22, 2022, to obtain
comments from the public and affected
agencies. CDC received one nonsubstantive comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
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is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies’ estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Data Collection for CDC Fellowship
Programs (OMB Control No. 0920–1163,
Exp. 3/31/2023)—Extension—Center for
Surveillance, Epidemiology, and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC’s mission is to protect America
from health, safety, and security threats,
both foreign and in the U.S. To ensure
a competent, sustainable, and
empowered public health workforce
prepared to meet these challenges, CDC
plays a key role in developing,
implementing, and managing a large
number of fellowship programs. A
PO 00000
Frm 00058
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70827
fellowship is defined as a training or
work experience lasting at least one
month and consisting of primarily
experiential (i.e., on-the-job) learning, in
which the trainee has a designated
mentor or supervisor. CDC fellowships
are intended to develop public health
professionals, enhance the public health
workforce, and strengthen
collaborations with partners in public
health and healthcare organizations,
academia, and other stakeholders in
governmental and non-governmental
organizations. Assessing fellowship
activities is essential to ensure that the
public health workforce is equipped to
promote and protect the public’s health.
CDC requests a three-year extension of
a Generic Clearance to collect data about
its fellowship programs, as they relate to
public health workforce development.
Data collections will allow for ongoing,
collaborative, and actionable
communications between CDC
fellowship programs and stakeholders
(e.g., fellows, supervisors/mentors,
alumni). These collections might
include short surveys, interviews, and
focus groups. Intended use of the
resulting information is to:
• inform planning, implementation,
and continuous quality improvement of
fellowship activities and services;
• improve efficiencies in the delivery
of fellowship activities and services;
and
• determine to what extent fellowship
activities and services are achieving
established goals.
Collection and use of information
about CDC fellowship activities will
help ensure effective, efficient, and
satisfying experiences among fellowship
program participants and partners.
This Extension ICR contains a change
in burden estimate from the previously
approved package. This change is the
result of a review and evaluation of CDC
programming and fellowship needs.
CDC estimates that annually,
approximately one quarter of all CDC
fellowships (23 of 91) will conduct a
GenIC under this umbrella. This
estimate reflects the usage rate for CFPA
in its most recent approval period.
Burden estimates assume that a given
fellowship program will conduct one
query each with one of the three
respondent groups: fellowship
applicants or fellows; mentors,
supervisors, or employers; and alumni.
OMB approval is requested for three
years. CDC requests OMB approval for
an estimated 1,546 annual burden
hours. There are no costs to respondents
other than their time.
E:\FR\FM\21NON1.SGM
21NON1
Agencies
[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70823-70827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0024]
CDC Clinical Practice Guideline for Prescribing Opioids for
Pain--United States, 2022
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS), announces the
availability of the CDC Clinical Practice Guideline for Prescribing
Opioids for Pain--United States, 2022 (2022 Clinical Practice
Guideline). The 2022 Clinical Practice Guideline updates and expands
the CDC Guideline for Prescribing Opioids for Chronic Pain--United
States, 2016 (2016 Guideline) 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 more than 3 months). The
recommendations in the 2022 Clinical Practice Guideline do not apply to
pain management related to sickle cell disease, cancer-related pain
treatment, palliative care, or end-of-life care. The 2022 Clinical
Practice Guideline finalizes the draft clinical practice guideline
issued on February 10, 2022.
DATES: The 2022 Clinical Practice Guideline is available November 21,
2022.
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:
[[Page 70824]]
Background
In the 2016 Guideline, CDC communicated the intent to evaluate and
reassess evidence and recommendations for opioid prescribing for adult
patients 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 (e.g., exercise,
physical therapy, psychological therapies), 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
on the evidence described in these reviews, an update to the 2016
Guideline was warranted.
CDC developed the 2022 Clinical Practice Guideline recommendations
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; patient, caregiver, and
clinician 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 2022
Clinical Practice Guideline to assist clinicians in determining whether
or not to initiate opioids for pain, selecting opioids and determining
opioid dosages, deciding duration of initial opioid prescription and
conducting follow-up, and assessing risk and addressing potential harms
of opioid use.
The 2022 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).
The 2022 Clinical Practice Guideline is not a regulation or a law.
It is a set of voluntary recommendations intended to support clinicians
as they work in consultation with their patients to address pain. It is
intended to be flexible to support, not supplant, clinical judgment and
individualized, patient-centered decision-making. It 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 2022 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
reduction in the risks associated with long-term opioid therapy,
including opioid use disorder, overdose, and death.
To help ensure the 2022 Clinical Practice Guideline's integrity,
credibility, and consideration of patient, caregiver, and clinician
values and preferences, CDC obtained input through individual
conversations with patients, caregivers, experts, clinicians, through
public comment opportunities, and a federally chartered advisory
committee, the Board of Scientific Counselors of the National Center
for Injury Prevention and Control (BSC/NCIPC). CDC also obtained
feedback from a panel of external peer reviewers who are experts in
topics related to opioid prescribing.
Summary of Public Comment and CDC Response
On February 10, 2022, CDC published a notice in the Federal
Register announcing the availability of the draft clinical practice
guideline (87 FR 7838). The notice gave the public an opportunity to
submit comments by April 10, 2022. CDC received approximately 5,500
unique comments (including one comment submitted with 28,322 additional
signatories) from the public, including patients with acute and chronic
pain, caregivers, and clinicians. Comments also included organizational
perspectives from medical associations, professional organizations,
academic institutions, state and local governments, and advocacy and
industry groups.
CDC carefully catalogued, reviewed, and qualitatively analyzed all
comments submitted by members of the public. All public comments were
carefully reviewed and considered when revising the draft clinical
practice guideline. Most comments submitted to the public docket for
the draft clinical practice guideline were submitted by individuals
living with pain and their caregivers, families, and friends.
CDC highly values insights gained from these public comments and
especially thanks those patients living with pain who shared their
personal experiences in this public forum.
Themes from the comments included: (1) concerns about the 2016
Guideline; (2) overall considerations for the 2022 Clinical Practice
Guideline; (3) considerations for Recommendation Statements in the 2022
Clinical Practice Guideline; and (4) suggestions for scientific
articles to include in supporting rationales to supplement information
from the systematic reviews about acute and chronic pain management.
(1) Concerns about the 2016 Guideline
Respondents shared their personal experiences with pain care,
including with misinterpretation and misapplication of the 2016
Guideline. In particular, they mentioned issues with misapplication
related to prescribed dosing limits and forced tapers.
CDC Response
CDC added language to the 2022 Clinical Practice Guideline
emphasizing that it provides voluntary clinical practice
recommendations that are not intended to be inflexible standards of
care or implemented as absolute limits of policy or practice for
patients by clinicians, healthcare systems, or government entities.
CDC added language throughout the document that further
emphasizes that both the benefits and the risks of continuing opioid
therapy should be considered by clinicians when providing pain care for
patients.
CDC added discussion throughout the document pertaining to
changes related to dosage thresholds and appropriate application. For
example, the following was added to the Rationale:
Importantly, to discourage the misapplication of opioid pain
medication dosage thresholds as inflexible standards, revised
recommendation statement language emphasizes principles such as
avoiding increasing dosage above levels likely to yield diminishing
returns in benefits relative to risks to patients. More specific
considerations related to dosage have been moved to implementation
considerations that follow each recommendation statement, where more
nuance is offered to inform clinical decision-making and individualized
patient care.
[[Page 70825]]
(2) Overall Considerations for the 2022 Clinical Practice Guideline
Respondents focused on the importance of clinician judgment that
promotes flexible opioid prescribing practices focused on the
individual patient. They were appreciative of CDC's inclusion of
language emphasizing open communication between patients and clinicians
and updated language to discourage forced tapers. Regarding the latter,
respondents encouraged CDC to further emphasize and strengthen this
language.
Many respondents expressed concern that mention of specific
morphine milligram equivalents in the 2022 Clinical Practice Guideline
would lead to hard limits on opioid prescriptions. Respondents also
were concerned that specific pain conditions were called out as
conditions to which the draft clinical practice guideline was not
applicable while others went unmentioned.
Respondents noted that the length of the draft clinical practice
guideline was a barrier to end users. However, respondents also noted
that several organizational features of the draft clinical practice
guideline were helpful, such as a call-out box that summarizes its
intended use, including conditions for which it is not applicable.
Respondents suggested that additional detail in these boxes would be
beneficial for those who may not read beyond this content. In addition,
professional organizations suggested the development of supplemental
one-pagers and supporting materials to further increase the utility of
the document.
Finally, some respondents providing comments on behalf on
individuals with non-pain related conditions that use opioids for
treatment (e.g., ostomy-related conditions and restless leg syndrome
[RLS]) proposed that the 2022 Clinical Practice Guideline title should
be adjusted to better reflect its content and intended use.
CDC Response
CDC added language throughout the document to emphasize
that the 2022 Clinical Practice Guideline provides voluntary clinical
practice recommendations that are not intended to be inflexible
standards of care or implemented as absolute limits of policy or
practice for patients by clinicians, healthcare systems, or government
entities.
CDC added discussion throughout the document pertaining to
changes related to dosage thresholds and appropriate application. For
example, the following was added to the Rationale:
Importantly, to discourage the misapplication of opioid pain
medication dosage thresholds as inflexible standards, revised
recommendation statement language emphasizes principles such as
avoiding increasing dosage above levels likely to yield diminishing
returns in benefits relative to risks to patients. More specific
considerations related to dosage have been moved to the Implementation
Considerations that follow each recommendation statement, where more
nuance is offered to inform clinical decision-making and individualized
patient care.
CDC revised language in the scope and audience section to
further emphasize that all types of pain need effective treatment:
Although some principles in this clinical practice guideline might
be helpful in the management of pain related to sickle cell disease,
cancer-related pain treatment, palliative care, and end-of-life care,
some recommendations might not be relevant for pain management in these
contexts. Other guidelines more specifically address pain management in
these situations; therefore, this clinical practice guideline does not
apply to patients experiencing pain associated with these conditions or
types of care. This does not imply that any other types of pain are
more or less worthy of effective treatment, only that clinicians are
referred to existing clinical guidelines that more specifically address
unique considerations for management of pain related to sickle cell
disease, cancer-related pain treatment, palliative care, and end-of-
life care.
CDC added call-out boxes to the document to highlight
critical information:
[cir] Box 1. Executive summary of the CDC Clinical Practice
Guideline for Prescribing Opioids for Pain-United States, 2022
[cir] Box 2. Intended use of CDC's Clinical Practice Guideline for
Prescribing Opioids for Pain-United States, 2022
[cir] Box 3. Recommendations for prescribing opioids for
outpatients with pain, excluding pain management for sickle cell
disease, cancer-related pain treatment, palliative care, and end-of-
life care; recommendation categories; and evidence types, CDC Clinical
Practice Guideline for Prescribing Opioids for Pain-United States, 2022
[cir] Box 4. Guiding principles for implementation of the CDC
Clinical Practice Guideline for Prescribing Opioids for Pain-United
States, 2022 recommendations
[cir] Box 5. Areas for additional research to build the evidence
base for optimal pain management
CDC is developing translation and communication materials
to support accurate implementation of the 2022 Clinical Practice
Guideline. These resources will be short references and ``at-a-glance''
materials to support appropriate application and interpretation.
CDC changed the name of the document from the CDC Clinical
Practice Guideline for Prescribing Opioids to the CDC Clinical Practice
Guideline for Prescribing Opioids for Pain to further emphasize its
focus on prescription opioids for the treatment of pain.
(3) Considerations for Recommendation Statements in the 2022 Clinical
Practice Guideline
Respondents noted that frequent follow-up appointments, office
visits, and drug screening requirements were barriers to care and
health equity. They also expressed concern about stigma related to
toxicology testing.
CDC Response
CDC added language to address health equity and additional
considerations and context related to health equity, such as language
about using virtual follow-up visits for patients for whom virtual
visits are part of standard care (e.g., in remote areas where distance
or other context makes follow-up visits challenging) or for patients
for whom in-person follow-up visits are challenging (e.g., frail
patients) under Recommendation 7's implementation considerations and
supporting text.
The second sentence of Recommendation 7 has been changed
from ``Clinicians should evaluate benefits and risks of continued
therapy with patients every 3 months or more frequently'' to
``Clinicians should regularly reevaluate benefits and risks of
continued opioid therapy with patients.'' Of note, the more specific
``3-month'' time frame is still discussed in the Implementation
Considerations and Supporting Rationale, where more nuanced
considerations for flexibility are discussed.
CDC augmented language in the implementation
considerations for Recommendation 10 to state:
Toxicology testing should not be used in a punitive manner but
should be used in the context of other clinical information to inform
and improve patient care. Clinicians should not
[[Page 70826]]
dismiss patients from care on the basis of a toxicology test result.
Dismissal could have adverse consequences for patient safety,
potentially including the patient obtaining opioids or other drugs from
alternative sources and the clinician missing opportunities to
facilitate treatment for substance use disorder.
(4) Suggestions for Scientific Articles About Acute and Chronic Pain
Management
Some respondents submitted scientific articles about acute and
chronic pain management for CDC to consider citing as additional
informative references in the supporting rationales. CDC carefully
reviewed each submitted comment and made edits or added additional
citations to the draft clinical practice guideline where appropriate.
Some examples of recommended sources and revisions are below.
To demonstrate the undertreatment of sickle cell disease
due to stigma and racism, the organization Sick Cells recommended that
CDC cite this reference: Phillips S, Chen Y, Masese R, Noisette L,
Jordan K, et al. (2022) Perspectives of individuals with sickle cell
disease on barriers to care. PLOS ONE 17(3): e0265342. https://doi.org/10.1371/journal.pone.026534.
The Michigan Opioid Prescribing Engagement Network
suggested that CDC cite its OPEN Prescribing Recommendations as an
additional reference for Recommendation 1. This reference was already
included in the document: Michigan Opioid Prescribing Engagement
Network. Prescribing recommendations. Ann Arbor, MI: Michigan Opioid
Prescribing Engagement Network. https://michigan-open.org/prescribing-recommendations.
The American Geriatric Society noted that a reference to
its 2009 American Geriatric Society Recommendations for Chronic Pain
Medications in Older Adults (AGS Guideline) was not current and
recommended CDC cite different sources for its discussion of the use of
acetaminophen for the treatment of pain among adults aged 18 and over.
The National Pain Advocacy Center stated that several
studies finding adverse outcomes after opioid stoppage, dose reduction,
or dose variation were not cited or were cited inaccurately.
The American Academy of Addiction Psychiatry recommended
the inclusion of the Alcohol Use Disorders Identification Consumption
Test (AUDIT-C), as done by the Veterans Health Administration, instead
of the full Alcohol Use Disorders Identification Test (AUDIT).
The American College of Obstetrics and Gynecology (ACOG)
recommended that other critical concepts regarding family planning and
contraceptive counseling from additional resources be included in the
document. ACOG also recommended an additional reference with safety
data regarding buprenorphine/naloxone combination use in pregnancy:
Link HM, Jones H, Miller L, Kaltenbach K, Seligman N. Buprenorphine-
naloxone use in pregnancy: a systematic review and metaanalysis. Am J
Obstet Gynecol MFM. 2020 Aug;2(3):100179. doi: 10.1016/
j.ajogmf.2020.100179. Epub 2020 Jul 3. PMID: 33345863.
CDC Response
CDC included Phillips et. al. in the references section.
CDC added a citation to the Open Prescribing
Recommendations again in reference to Recommendation 1.
CDC deleted reference to the 2009 American Geriatric
Society Guideline throughout the document.
CDC added the references from the National Pain Advocacy
Center. Several recommended references were already included in the
draft clinical practice guideline.
[cir] Hallvik SE, El Ibrahimi S, Johnston K, et al. Patient
outcomes after opioid dose reduction among patients with chronic opioid
therapy. Pain. 2022;163(1):83-90.
[cir] Binswanger IA, Glanz JM, Faul M, et al. The Association
between Opioid Discontinuation and Heroin Use: A Nested Case-Control
Study. Drug and Alcohol Dependence. 2020;217:108248.
[cir] Perez HR, Buonora M, Cunningham CO, Heo M, Starrels JL.
Opioid Taper Is Associated with Subsequent Termination of Care: a
Retrospective Cohort Study. J Gen Intern Med. 2020;35(1):36-42.
CDC modified its inclusion from full AUDIT to AUDIT-C in
the Supporting Rationale for Recommendation 7.
CDC added additional family planning and contraceptive
planning concepts and the following sources:
[cir] ACOG Committee Opinion No. 762. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e78-89.
[cir] Patient-Centered Contraceptive Counseling. Committee
Statement No. 1. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2022;139:349-53.
[cir] Interpregnancy care. Obstetric Care Consensus No. 8. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2019;133:e51-72.
CDC added Link. et al.
For more information about CDC's response to peer reviewers' and
public comments, please see the Supporting & Related Materials tab of
this docket.
For more information about the 2022 Clinical Practice Guideline or
the process of updating it, please visit https://www.cdc.gov/opioids/guideline-update/.
Supporting and Related Material in the Docket
The docket contains the following supporting and related materials:
(1) the 2022 Clinical Practice Guideline; (2) the GRADE tables; (3)
CDC's response to peer review of the draft clinical practice guideline;
(4) CDC's response to public comments on the draft clinical practice
guideline; (5) the draft clinical practice guideline released for
public comment on February 10, 2022; (6) 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 (7) an Overview of
Community Engagement and Public Comment Opportunities, which describes
key themes that emerged about participant 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 an initial draft clinical
practice guideline 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, and transparent input to the BSC/NCIPC on the diverse and
complex issues addressed in the draft 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 clinical practice guideline.
The Overview of Community Engagement and Public Comment
Opportunities document provides a summary of efforts implemented
throughout the clinical practice
[[Page 70827]]
guideline update process to better understand the lived experiences and
perspectives of community members and to ensure additional input from
patients, caregivers, clinicians, and the public. This document also
summarizes CDC's response to the themes and findings that emerged
throughout the community engagement and public comment opportunities
and describes how CDC carefully considered and incorporated diverse
perspectives and input from multiple sources into the draft clinical
practice guideline that was posted for public comment.
Availability of the 2022 Clinical Practice Guideline
The CDC Clinical Practice Guideline for Prescribing Opioids for
Pain--United States, 2022 can be found in the Supporting & Related
Materials tab of this docket on the Federal eRulemaking Portal:
identified by Docket No. CDC-2022-0024 and at https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-25264 Filed 11-18-22; 8:45 am]
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