Supporting Statement A_final

Pilot Plan for the Interim Local Health Department Strategy for Response, Control, and Prevention of Healthcare Associated Infections (HAI) and Antibiotic Resistance (AR)  

Request for OMB approval of a New Information Collection

September 22, 2022

Supporting Statement A

Contact:

Thomas J. “Chip” Daymude

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (470) 553-3567

Email: [email protected]

Table of Contents

1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of Information Collection 3

3. Use of Improved Information Technology and Burden Reduction 3

4. Efforts to Identify Duplication and Use of Similar Information 4

5. Impact on Small Businesses or Other Small Entities 4

6. Consequences of Collecting the Information Less Frequently 4

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 4

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 4

9. Explanation of Any Payment or Gift to Respondents 4

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 5

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 5

12. Estimates of Annualized Burden Hours and Costs 5

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 6

14. Annualized Cost to the Government 6

15. Explanation for Program Changes or Adjustments 6

16. Plans for Tabulation and Publication and Project Time Schedule 6

17. Reason(s) Display of OMB Expiration Date is Inappropriate 7

18. Exceptions to Certification for Paperwork Reduction Act Submissions 7

Attachments 7

• Goal of the study: Through piloting the Interim Local Strategy, DHQP aims to understand Local Health Departments (LHDs) experience implementing the strategy and collect their feedback for refinement. A secondary goal of this study is to create a network of LHDs working in HAI and AR activities to learn from one another and share best practices.

• Intended use of the resulting data: Data collected during the pilot will be used to assess the extent to which the strategy materials and resources help local health departments to (1) grow and expand their HAI/AR partner networks and collaboration, (2) build operational capacity to conduct and promote sustainable HAI/AR infection prevention and control practices, and (3) expand HAI/AR infection prevention, outbreak response, and stewardship activities. Furthermore, data will inform any necessary refinements of the materials and resources.

• Methods to be used to collect CDC will conduct data collection through interviews and electronic surveys, to capture feedback on the strategy’s usability and effectiveness as a whole, as well as on each individual material and resource.

• The subpopulation to be studied: Local Health Departments (LHDs)

• How data will be analyzed: CDC will use a mixed methods approach with both deductive and inductive analysis of qualitative data collected through surveys and structured interviews, and aggregate quantitative survey data.

1. Circumstances Making the Collection of Information Necessary

This is a new Information Collection Request (ICR). We are requesting approval for a 3-year period for the proposed new ICR. This study is authorized under Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment 1).

The Centers for Disease Control and Prevention’s (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP) requests approval for information collection from local health departments who will pilot the recently developed Interim Local Health Department Strategy for Response, Control, and Prevention of HAI/AR. The strategy was developed to highlight and support the important role that LHDs play in preventing, responding to, and controlling HAI and AR related events. The COVID-19 pandemic has further highlighted the important and unique role of LHDs. LHDs play important roles in the prevention and control of HAI/AR in their jurisdictions. The HAI/AR activities that are conducted by LHDs vary widely and depend on many factors such as staff capacity and expertise, governance structures and public health authorities, prevalence of emerging HAI/AR diseases, types, and organization of healthcare facilities in the jurisdiction, population demographics, local relationships, and nature of collaborations with the state HAI/AR program. There is much to be learned and many best practices to be shared from LHDs working in HAI/AR. Engaging with LHDs is essential for DHQP to connect to other priority areas such as focusing on rural areas, healthcare preparedness, and equity considerations. A local engagement strategy will help DHQP expand their activities to focus on connecting with LHDs that directly work between healthcare and public health groups, including to continue work and partnerships begun by COVID-19 task forces.  CDC has two approaches to piloting the interim local health department strategy including recruiting interested local health departments and conducting interviews and survey tools to be administered by the State Strategy and Evaluation Team (SSET) at CDC as well as piloting the strategy through additional interviews and survey tools with local health departments as part of the Strengthening Public Health Systems and Services through the National Partnerships to Improve and Protect the Nation's Health Cooperative Agreement (e.g., OT18-1802) Fiscal Year 2022 continuation project in partnership with the National Association of County and City Health Officials (NACCHO). Data collection and subsequent data analysis will identify themes and commonalities that will be used to make updates to the strategy and identify areas of support for LHDs seeking to grow their capacity for HAI/AR activities. Because this is a new strategy, it is imperative for CDC to pilot the strategy in the field and gather feedback and input from the intended end users. Data collection during the pilot is critical to assessing the usefulness and feasibility of using the strategy for local health departments and to being able to update and make changes to the Local Strategy to ensure it is effective in supporting LHD’s HAI/AR program development.

2. Purpose and Use of Information Collection

DHQP’s State Strategy and Evaluation Team (SSET) will be collecting information from local health departments (LHDs) through online surveys and video call interviews (e.g. Zoom). Survey instruments are built and administered through REDCap to allow for ease of distribution, participation, and analysis. Through this platform, participants can start and return to the survey at a later time, providing flexibility and limiting response burden. Interviews are to be conducted by the CDC team and/or NACCHO via Zoom or Microsoft Teams, which will provide an in-person feel and make respondents more comfortable, compared to speaking over the phone. Participants have been broken into two groups: those with Review Only capacity and those with Review and Implement capacity. All participants will have six weeks to review the strategy and accompanying materials and submit their initial feedback via the Feedback Form survey on REDCap. LHDs with Review Only capacity will participate in a video interview shortly after submitting their survey to provide additional input on recommended areas for strengthening the strategy, including descriptions of when, how, and for what purposes the strategy framework is useful to LHDs and suggested changes to the strategy to improve utility for LHDs. Participating LHDs with Review and Implement Capacity will continue piloting the strategy over the next 12 months by implementing the strategic plan they developed using the strategy resources and tools during their six-week review. At the end of their 12-month pilot period, participants with Review and Implement capacity will complete a final survey via REDCap to provide additional feedback on the implementation process, including descriptions of how LHDs used the strategy, successes and challenges with implementing the strategy, best practices or lessons learned from experiences as a pilot participant, and descriptions of how CDC and its partners can support LHDs in HAI and AR efforts in the short and long term.

The purpose of these data collection activities is to yield specific feedback on the Interim Local Strategy documents and resources, as well as reflection on the experience of implementing the strategy. Throughout development of the strategy, various subject matter experts and health department staff were consulted to give insights and recommendations on content and needs. Now that the strategy has been fully drafted, DHQP is ready for LHDs to pilot the strategy and its implementation. Through this deeper assessment of the strategy and specific feedback opportunities, DHQP will be able to make further modifications to the strategy documents for eventual national roll-out of materials. With insights from implementation staff on the ground, there is greater assurance that the strategy is widely applicable to other LHDs around the nation. The information being collected is essential to refining the strategy so it will best serve LHDs in advancing their work in HAI/AR in alignment with their capacity, priorities and resources. Collecting and incorporating the data will ensure that CDC is creating a product that is relevant and has utility.

Specifically, the initial ‘Feedback Form’ survey, to be completed by health departments with Review Only and Review and Implement capacity, is designed to gather feedback specific to the goals, objectives and activities outlined in the strategy. Participants are asked if these items seem relevant to their work in HAI/AR at their LHD and useful for moving that work forward; and if the developed materials are helpful for continuing to enhance their HAI/AR work. The survey also asks participants about which tools are most helpful in progressing their work.

The interview guide will be used with LHDs who are Review Only as a final check in to understand their thoughts on how useful the strategy and corresponding documents were in supporting LHDs to define strategic priorities. It also asks for feedback on the supporting materials and how they could be improved to be more useful. The interview guide is designed to collect LHD input on recommended areas for strengthening the strategy, including descriptions of when, how, and for what purposes the strategy framework is useful to LHDs and suggested changes to the strategy to improve utility for LHDs.

The final survey will be conducted only with LHDs who have agreed to participate in the Review and Implement pilot. By the end of their 12-months as a pilot participant, these LHDs will have used the interim local strategy resources to outline and implement a strategic plan to enhance their LHD’s work in HAI/AR. Questions include how the LHD used the strategy and corresponding documents to prioritize activities. These questions will help DHQP understand how they can support other LHDs in the future when they are implementing the strategy. This section also asks for feedback on the supporting materials and how they could be improved to be more useful. The next part of the survey covers successes and challenges to implementing the strategy. Acknowledging that some LHDs have very limited capacity to engage in HAI/AR work, some of the information collected in this area is trying to understand the specific barriers to implementation of these activities and where CDC might be able to support LHD efforts. Following these questions, the guide asks participants to expand on any best practices they would recommend for implementing the strategy. For example, where to start in the strategy, any helpful partners to engage, and how to collaborate with the State HAI/AR program. Responses to these questions will be informative for providing technical assistance to new LHDs who choose to implement the strategy. Finally, the survey wraps up with requesting feedback on any specific ways that CDC can support HAI and AR work in their jurisdiction. Some examples include providing any additional materials or connecting to other existing resources.

3. Use of Improved Information Technology and Burden Reduction

All survey data (100%) is being distributed and collected using an electronic system. The survey instrument was built in REDCap and a public link to complete the survey was used in an email distribution to participants. REDCap survey settings were adjusted to allow participants to start and stop the survey at any point and return later for completion. Use of both an electronic system and providing the ability to return to the survey help in reducing respondent burden. Additionally, utilization of an online platform for data collection provided greater ease for distribution and collection.

4. Efforts to Identify Duplication and Use of Similar Information

CDC is not aware of the availability of any similar information. The Interim Local Strategy for HAI/AR is a new product that has not been piloted or evaluated before.

5. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.

6. Consequences of Collecting the Information Less Frequently

This is a one-time information collection. Collecting the information less frequently would delay making timely updates to the strategy and reduce the effectiveness.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. A 60-day Federal Register Notice was published in the Federal Register on June 17, 2022, vol. 87, No. 117, pp. 36504 (Attachment 2). CDC did not receive public comments related to this notice.

B. The development of the Interim Local Strategy for HAI/AR was a collaborative effort as input was provided by the National Association of City and County Health Officials (NACCHO), and Local and State Health Departments to CDC.

9. Explanation of Any Payment or Gift to Respondents

No payments nor gifts will be provided to respondents.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

CDC’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does apply. A Privacy Impact Assessment is included as part of this submission (Attachment 5). No SORN is required.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

Institutional Review Board (IRB)

NCEZID’s Human Subjects Advisor has determined that information collection is not research involving human subjects. IRB approval is not required.

Justification for Sensitive Questions

There are no planned sensitive questions. Respondents can choose to skip any questions they do not feel comfortable answering.

12. Estimates of Annualized Burden Hours and Costs

Estimated annualized burden hours were determined using the number of respondents, the frequency of requests to respondents, and the average time to submit response. Pilot participants may start at different times during the pilot period; however, all participants will only complete the surveys and/or interviews one time each. Types of requests include data collection instruments to be completed by respondents including responding to 2 of the following: (1) LHD HAI/AR Strategy Pilot Survey Template (2) LHD HAI/AR Strategy Pilot Feedback Form (3) LHD HAI/AR Strategy Pilot Interview Guide. The feedback will be used to help refine the strategy, based on the needs and experiences of LHDs. Data Collection instruments will be administered at the beginning and at the end of the pilot period.

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Voluntary LHD Participants/NACCHO Coag LHD participants	LHD HAI/AR Strategy Pilot FEEDBACK FORM	60	1	4	240
Voluntary LHD Participants	LHD HAI/AR Strategy Pilot Interview Guide Survey (review or review and implement)	30	1	2	60
NACCHO CoAg LHD Participants	LHD HAI/AR Strategy Pilot SURVEY FOR REVIEW AND IMPLEMENT	30	1	2	60
Total		120	3 forms	8	360

B. Estimated Annualized Burden Costs

The mean hourly wage for a Local Health Department Epidemiologist is $36.38, according to the US Department of Labor https://www.bls.gov/oes/current/oes191041.htm.

The estimated total respondent cost is $13,096.80.

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Voluntary LHD Participants (Epi)/NACCHO CoAg Participants	LHD HAI/AR Strategy Pilot FEEDBACK FORM	240	$36.38	$8,731.20
Voluntary LHD Participants (Epi)	LHD HAI/AR Strategy Pilot Interview Guide Survey Review or review and Implement	60	$36.38	$2,182.80
Voluntary LHD Participants (Epi)/ //NACCHO CoAg LHD Participants	LHD HAI/AR Strategy Pilot SURVEY FOR REVIEW AND IMPLEMENT	60	$36.38	$2,182.80
Total				$13,096.80

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no costs to respondents other than their time to participate.

14. Annualized Cost to the Government

The estimated annualized cost to the federal government includes (2) GS-685-11 Public Health Analysts time and a GS-685-13 Public Health Analysts time communicating with local health departments by email and phone, conducting data entry, and performing data analysis and interpretation. These activities are estimated to take 416 hours (8 hours per week for 52 weeks per year), at an hourly wage of $52.85 for GS-685-13; and $47.97 for GS-685-11, resulting in a total annualized cost of $61,895.

E.g.: 20% time/ 8 hour per person out of 40 per week

Estimated Annualized Cost to the Government per Activity
Cost Category	Estimated Annualized Cost
GS-13 Public Health Analysts time	$21,985
GS-685-11 Public Health Analysts time	$19,955
GS-685-11 Public Health Analysts Time	$19,955

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

The project will involve data collection from Local Health Departments during a period of 2-15 months. Data collection will take up to 15 months. We are requesting OMB approval for a period of 36 months, which will account for delays or unforeseen circumstances in data collection and publication.

Project Time Schedule
Activity	Time Schedule
Data Information/Collection	2 -15 months after OMB approval
Data Analysis	3- 18 months after OMB approval
Preparation of Final Report	18-21 months after OMB approval
Final Report	21 -24 months after OMB approval

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The display of the OMB Expiration date is not inappropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

1. Authorizing Legislation

2. Published 60-Day FRN

3. Information Collection instruments and script (Att 3a-Att 3c)

4. Non-Research Determination

5. Privacy Impact Assessment

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