Agency Forms Undergoing Paperwork Reduction Act Review, 8253-8254 [2022-03076]

Download as PDF 8253 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices social, educational, and quality of life outcomes beyond infancy and early childhood. However, existing U.S. population-based data are lacking on these outcomes among those born with CHD and the changes that may occur with time and age. U.S. data is needed to provide insight into the public health questions that remain for this population and to develop services and allocate resources to improve long-term health and well-being. For this project, we will use data from U.S. state birth defect surveillance systems, or population-based studies derived from them, to identify a population-based sample of children and adolescents 2–17 years of age born We estimate receiving completed surveys from 7,667 caregivers of children and adolescents with CHD in the birth defects surveillance systems. To generate sufficient sample size, accounting for non-response, from caregivers up to 17 years after the birth of their child with CHD, we intend to sample 100% of eligible CHD cases identified through select birth defect surveillance systems. The survey takes approximately 20 minutes to complete. Therefore, we estimate the total annual burden to be 2,556 hours. There are no costs to participants other than their time. with CHD. We will then use state databases and online search engines to find current addresses for those individuals and mail surveys to their caregivers inquiring about the child’s cardiac and other healthcare utilization, barriers to healthcare, quality of life, social and educational outcomes, and transition of care from childhood to adulthood, as well as needs and experiences of the caregivers. The information collected from this population-based survey will be used to inform current knowledge, allocate resources, develop services, and, ultimately, improve long-term health of children and adolescents born with CHD. ESTIMATED ANNUALIZED BURDEN HOURS Average burden per response (in hours) Total burden (in hours) Form name Caregivers of individuals aged 2–17 years with a CHD. Survey questionnaire ....................... 7,667 1 20/60 2,556 Total ........................................... ........................................................... ........................ ........................ ........................ 2,556 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2022–03077 Filed 2–11–22; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30–Day–22–21IE] Agency Forms Undergoing Paperwork Reduction Act Review jspears on DSK121TN23PROD with NOTICES1 Number of responses per respondent Number of respondents Type of respondents 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. VerDate Sep<11>2014 18:55 Feb 11, 2022 Jkt 256001 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 ‘‘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 E:\FR\FM\14FEN1.SGM 14FEN1 8254 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 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 Form name Patient ............................................................................................................ Treatment facility staff (Including primary care clinicians, health system leaders, and other system staff and representatives). Patient Survey ................................... Clinician Survey ................................ Invitation/Follow up Email ................. System Leaders Interview Guide ...... Case Study ....................................... Member Checking Sessions ............. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60–Day–22–1283; Docket No. CDC–2022– 0019] jspears on DSK121TN23PROD with NOTICES1 Number of respondents Type of respondent Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: VerDate Sep<11>2014 17:54 Feb 11, 2022 Jkt 256001 ACTION: Notice with comment period. 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 Monitoring and Reporting for the Overdose Data to Action Co-Operative Agreement. Information collected will provide crucial data for program performance monitoring, budget tracking, and where applicable, program success for programs funded under Overdose Data to Action (CDC–RFA– CE19–1904). SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 667 1,313 1,980 17 30 17 Number of responses per respondent 1 1 2 1 1 1 Average burden per response (in hours) 10/60 10/60 3/60 1 30/60 1 CDC must receive written comments on or before April 15, 2022. DATES: You may submit comments, identified by Docket No. CDC–2022– 0019 by either 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. ADDRESSES: E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[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]


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

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


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
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