[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53313-53315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21IE; Docket No. CDC-2021-0103]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

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), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Understanding Health System 
Approaches to Chronic Pain Management. The proposed study is designed 
to evaluate the effects of evidence-based guidelines related to chronic 
pain management and opioid prescribing.

DATES: CDC must receive written comments on or before November 26, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0103 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (regulations.gov) or by U.S. mail to the address 
listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS

[[Page 53314]]

H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

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 will 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 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.
    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.
    The total burden is estimated to be 577 hours annually. 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    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Patient.......................  Patient Survey..             667               1           10/60             111
Treatment facility staff        Primary Care               1,313               1           10/60             219
 (Including primary care         Clinician                 1,980               2            3/60             198
 clinicians, health system       Survey.
 leaders, and other system      Invitation/
 staff and representatives).     Follow up Email.
                                Health System                 17               1               1              17
                                 Leaders Group
                                 Interview Guide.
                                Case Study                    30               1           30/60              15
                                 Interview Guide.

[[Page 53315]]

 
                                Member Checking               17               1               1              17
                                 (Validation)
                                 Sessions
                                 Interview Guide.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             577
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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. 2021-20843 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P