[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8253-8254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-22-21IE]


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'' Understanding Health System Approaches to 
Chronic Pain Management'' 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 
Sept. 27, 2021 to obtain comments from the public and affected 
agencies. CDC did not receive comments 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 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

    Understanding Health System Approaches to Chronic Pain Management--
New--National Center for Injury Prevention and Control (NCIPC), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC requests OMB approval for three years for this new data 
collection. This study is designed to evaluate the effects of evidence-
based guidelines related to chronic pain management and opioid 
prescribing, including access to medications for opioid use disorder 
(MOUD), for patients and clinicians in primary care settings among a 
diverse sample of health systems.
    Since 1999, nearly 841,000 people have died from drug overdose in 
the United States. Over 70% of drug overdose deaths in 2019 involved an 
opioid. From 1999 to 2019, nearly 247,000 people died in the United 
States from overdoses involving

[[Page 8254]]

prescription opioids, with rates of deaths involving prescription 
opioids more than quadrupling from 1999 to 2019. In response, a range 
of clinical practice guidelines, policies, and regulations have been 
released in recent years to address the opioid overdose epidemic, with 
the goals of supporting safer opioid prescribing, improving diagnosis 
and treatment of OUD, and reducing overdose deaths in the United 
States.
    To design this evaluation, we previously conducted and completed a 
``Feasibility Assessment of Health Systems'' via surveys to determine 
the range of policies and guidelines being implemented by health 
systems, followed by an ``evaluability assessment'' by means of 
interviews with leaders of nine health systems. For the purposes of 
this evaluation, ``Chronic pain management policies/guidelines'' refers 
to policies/guidelines that may include prescribing of opioid 
medications, nonpharmacologic therapies, and/or non-opioid medications 
for chronic pain, as well as OUD assessment and treatment.
    In early 2020, CDC requested OMB approval for a Feasibility 
Assessment of Health Systems (``Feedback on the use of the CDC 
Guideline for Prescribing Opioids for Chronic Pain'') through the 
``Generic Clearance for the Collection of Routine Customer Feedback'' 
(OMB Control No. 0920-1050). This brief eligibility assessment 
consisting of surveys was sent to approximately 250 health systems to 
understand the landscape of health systems and the types of guidelines 
or policies implemented, and what strategies were used to do so. Of 250 
health systems contacted, 46 responded and were considered for the 
following preliminary phase, the evaluability assessment. Among the 46 
health systems who completed the feasibility assessment surveys, nine 
were selected for a more in-depth ``evaluability assessment'' based on 
several factors identified in the initial feasibility (survey) 
assessment, as well as other expert knowledge of potential systems.
    The purpose of this data collection effort is to: (1) Obtain an 
enhanced understanding of facilitators and barriers to guideline-
concordant management of chronic pain and opioid prescribing (including 
access to MOUD) at the health system level, in order to improve patient 
outcomes while maximizing patient safety and to facilitate uptake by 
clinicians and health systems, (2) describe unintended benefits and 
consequences to guideline/policy implementation, and (3) identify 
racial and ethnic disparities in guideline/policy implementation.
    This mixed-methods, pre-post evaluation of health systems' 
implementation of chronic pain management and opioid prescribing 
policies/guidelines and the resultant outcomes requires both primary 
data collection (such as surveys, key informant interviews, focus 
groups, etc.) and secondary data collection (such as administrative, 
EHR, pharmacy dispensing, prescribing data, etc.) efforts to adequately 
answer the research questions. While secondary data (QI measures) from 
health system EHRs will provide longitudinal pre-post measures, primary 
data is needed to understand the characteristics and mechanisms of 
practice and patient change that can be attributed to the policies and 
guidelines.
    CDC requests OMB approval for an estimated 577 annual burden hours. 
There are no direct costs to respondents other than their time to 
participate in the study.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Patient...............................  Patient Survey..........             667               1           10/60
Treatment facility staff (Including     Clinician Survey........           1,313               1           10/60
 primary care clinicians, health        Invitation/Follow up               1,980               2            3/60
 system leaders, and other system        Email.
 staff and representatives).
                                        System Leaders Interview              17               1               1
                                         Guide.
                                        Case Study..............              30               1           30/60
                                        Member Checking Sessions              17               1               1
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-03076 Filed 2-11-22; 8:45 am]
BILLING CODE 4163-18-P