Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 8253 

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 

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. 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

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 

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 


jspears on DSK121TN23PROD with NOTICES1
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

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Patient ............................................................................................................ Patient Survey ................................... 667 1 10/60 

Treatment facility staff (Including primary care clinicians, health system 

leaders, and other system staff and representatives).

Clinician Survey ................................

Invitation/Follow up Email .................

1,313 

1,980 

1 

2 

10/60 

3/60 

System Leaders Interview Guide ...... 17 1 1 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60–Day–22–1283; Docket No. CDC–2022– 

0019] 

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. 

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 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). 

DATES: CDC must receive written 

comments on or before April 15, 2022. 

ADDRESSES: 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. 


jspears on DSK121TN23PROD with NOTICES1