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Supporting Statement A.docx

[OS] CDC/ATSDR Formative Research and Tool Development

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OMB: 0920-1154

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GenIC Clearance for CDC/ATSDR

Formative Research and Tool Development



CDC’s One Health Zoonotic Disease Prioritization (OHZDP) Evaluation Process


OMB Control No. 0920-1154


March 29, 2024








Supporting Statement A












Contact:

Rudith Vice

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404)718-7292

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 4

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 6

18. Exceptions to Certification for Paperwor’k Reduction Act Submissions 6

Attachments 7






Goal of the study: The goal is to evaluate the outcomes of the OHZDP process and if, and how, the OHZDP workshop outcomes may have impacted the current One Health progress in the location.


Intended use of the resulting data: The intended use of the resulting data is for improving the OHZDP Process and other One Health resources to support locations after conducting an OHZDP.


Methods to be used to collect: The methods include voluntary and convenience-based response sampling.


The subpopulation to be studied: The subpopulation to be studied is OHZDP Workshop Participants and OHZDP Facilitator Training Participants.


How data will be analyzed: Data will be analyzed through descriptive statistics.


  1. Circumstances Making the Collection of Information Necessary

CDC requests approval for a new Gen-IC under OMB Control No. 0920-1154.

CDC’s One Health Zoonotic Disease Prioritization (OHZDP) process brings together representatives (workshop attendees) from public health, animal, and environment sectors, as well as other relevant partners, in a country, region, or other area to prioritize zoonotic diseases of greatest concern and develop recommendations for next steps and action plans for One Health collaboration.

The OHZDP Workshop is a voluntary and collaborative process that allows countries, regions, and other areas to do the following:

  • Develop a list of priority zoonotic diseases of greatest concern agreed upon by all represented One Health sectors

  • Create recommendations for next steps and action plans for multisectoral, One Health engagement to address the priority zoonotic diseases

  • Understand the roles and responsibilities of all represented One Health sectors

  • Create or strengthen multisectoral, One Health coordination mechanisms and networks

  • Develop a report highlighting the outcomes of the workshop to help advocate for One Health priorities

Workshop participation can help strengthen multisectoral, One Health collaborations by connecting representatives from human, animal, and environmental health sectors and other relevant partners. During the workshop, participants prioritize zoonotic diseases using equal input from all represented One Health sectors through a transparent and collaborative process. The workshop helps participants focus limited resources to build capacity and collaboratively address the priority zoonotic diseases, and informs assessments, planning efforts, and strategy development relevant to One Health. The process is adaptable to local context and scalable for use at the subnational, national, and regional levels, and can be adapted to apply to other infectious diseases and One Health issues.

After the workshop, CDC experts continue to work with participating areas when needed and have provided support to develop their strategies to help mitigate their greatest zoonotic disease threats, implement and strengthen One Health approaches, address specific zoonotic diseases, and further the goal of a world safe and secure from health threats.

Currently, limited programmatic monitoring and evaluation efforts exist on the OHZDP process, particularly on how the implementation of the workshops impact locations’ One Health and zoonotic disease prevention and control activities. Activities for information collection are limited to formative work that will result in improving the OHZDP Process and other One Health resources to support locations after conducting an OHZDP.

  1. Purpose and Use of Information Collection



CDC’s OHZDP monitoring and evaluation activities collects information from workshop organizers or workshop attendees up to a maximum of six times dependent on the participant’s role in the workshop. The evaluation process takes an average of 3.5 years per workshop. We plan to seek additional PRA clearance before the genICR clearance is expired. Monitoring and evaluation activities are standardized based on the individual timelines of the OHZDP workshops. OHZDP monitoring and evaluation is an ongoing process as any number of locations decide to conduct an OHZDP workshop. None of this collection is intended to contribute to generalizable information. The negative consequences of not having the information include limited improvement of training resources for facilitators, limited understanding of workshop attendee’s satisfaction of the process, limited knowledge and understanding of how the workshop outcomes have support post-workshop impacts, and limited ability for CDC to support the development of additional resources to support post-workshop activities.

The various components of the OHZDP monitoring and evaluation process include:

  1. OHZDP Interest Form (Attachment 1)

    1. A form, delivered through Redcap, for locations to request access to CDC’s One Health Portal to initiate the process to plan and prepare for an OHZDP workshop.

  2. OHZDP Baseline Survey (Optional) (Attachment 2)

    1. A survey, delivered through CDC’s One Health Portal, for workshop organizers to measure perceptions on the current state of One Health activities for zoonotic disease in the workshop location.

  3. OHZDP Facilitator Training Survey (Optional) (Attachment 3)

    1. A survey, delivered through Redcap, for trained facilitators to complete at the end of an OHZDP facilitator training to measure perceived effectiveness and satisfaction. The facilitator trainings contain a standardized curriculum to prepare workshop facilitators to conduct the OHZDP workshop.

  4. OHZDP Participant Survey (Optional)(Attachment 4)

    1. A survey, delivered through Redcap, for workshop attendees to complete at the end of the OHZDP workshop to measure perceived effectiveness and satisfaction. The OHZDP workshops all contain a standardized methodology.

  5. OHZDP Next Steps Tracker (Optional) (Attachment 5)

    1. A progress tracker, delivered through CDC’s One Health Portal, for workshop organizers to monitor and track progress on the next steps and outcomes identified during the workshop. Workshop organizers will also have access to autogenerated visualizations of progress since the OHZDP workshop.

  6. OHZDP Post-Workshop Survey (Optional) (Attachment 6)

    1. A survey, delivered through CDC’s One Health Portal, for one of the workshop organizers to complete at 6 months, 1.5 years, and 3 years after the OHZDP workshop to measure if, and how, the workshop outcomes impacted the current One Health progress in the location. Workshop organizers will also have access to autogenerated visualizations of progress since the OHZDP workshop.

  7. OHZDP Retrospective Survey (Optional) (Attachment 7)

    1. A survey, delivered through Redcap, to measure if, and how, the OHZDP workshop outcomes impacted the current One Health progress in the location for the past OHZDP workshops conducted before the development of CDC’s One Health Portal.



CDC’s One Health Office designed the evaluation of the OHZDP process to assess the outcomes of the OHZDP process and if, and how, the OHZDP workshop outcomes may have impacted the current One Health progress in the location. The positive needs of the OHZDP evaluation process are described below.

Overall, CDC’s One Health Office is interested in understanding how and to what extent the OHZDP process impacts One Health progress for the identified priority zoonotic diseases.

The OHZDP process is expected to directly impact the following thematic areas that are foundational to a successful One Health approach to addressing priority zoonotic diseases:

  • One Health collaboration, communication, and coordination across public health, animal health, and environment sectors

  • Knowledge and awareness of One Health

  • Networking and partnership development or strengthening

  • Agreed-upon list of priority zoonotic diseases (process measure)

  • Identified next steps and action plans to address the priority zoonotic diseases.



Since the OHZDP workshops were conducted in 2014, partners have shared that the OHZDP process has supported increased levels of collaboration, communication, and coordination across public health, animal health, and environment sectors, and other relevant One Health partners. Additional examples include: due to improved collaboration and communication across public health, animal health, and environment sectors from the OHZDP workshops, partners convene on a more frequent, regular basis, have incorporated priority zoonotic diseases into national plans, developed One Health strategic plans, and have conducted sub-national prioritizations.

CDC’s OHZDP monitoring and evaluation activities also attempts to understand the indirect impacts of the OHZDP on the systems, structures, and/or processes that enable participating locations to address zoonotic diseases using a One Health approach. The OHZDP process directly and indirectly impacts the technical areas below:

  • One Health Coordination

  • Surveillance capacity

  • Laboratory capacity

  • Preparedness and Planning

  • Outbreak Response

  • Prevention and Control

  • Workforce

  • Risk Communication and Community Engagement



The OHZDP monitoring and evaluation activities aims to measure the outcomes of the OHZDP process over time. CDC’s One Health Portal (currently in development) will allow partner locations with more ownership of their results due to the ability to monitor their own progress since conducting the OHZDP workshop. CDC’s One Health Portal will enable locations to determine whether they have been able to achieve the goals they identified during the OHZDP workshops in the areas of One Health coordination, surveillance, laboratory, preparedness and planning, outbreak response, prevention and control, and workforce development.

  1. Use of Improved Information Technology and Burden Reduction

All the responses involve the use of electronic collection techniques. Electronic collection techniques facilitate the distribution of the evaluation process internationally, collects responses without needing to transcribe data into a digital format, and allows for development of customizable insights from workshop data for participants. Only the minimum amount of data/information is collected by using streamlined, universal, and easily accessible online data collection tools such as Redcap and CDC’s One Health Portal. Additionally, workshop organizers will already have access and be using CDC’s One Health Portal to conduct their OHZDP workshops, so the added evaluation component in this online tool reduces the burden on the organizers and facilitators since it will allow them to access everything in one location.

  1. Efforts to Identify Duplication and Use of Similar Information

CDC is not aware of the availability of any similar information. CDC’s OHZDP process was created by CDC’s One Health Office. CDC’s One Health Office collaborates with many global One Health partners, including the Food and Agriculture Organization of the United Nations (FAO), World Health Organization (WHO), World Organization for Animal Health (WOAH), and the United Nations Environment Programme (UNEP) to ensure that duplication of efforts for zoonotic disease prioritization is not occurring. Global partners are typically also workshop participants to ensure that the One Health work they are supporting is complimentary and not duplicative. These organizations are not collecting this information.

  1. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.

  1. Consequences of Collecting the Information Less Frequently

CDC’s OHZDP monitoring and evaluation activities collects information from workshop organizers or workshop attendees up to a maximum of six times dependent on the participant’s role in the workshop over an average of 3.5 years. Most of the OHZDP monitoring and evaluation activities are only administered once, however one survey is administered three times to capture longitudinal impacts from the workshop. CDC’s One Health Office would not be able to meet the needs of the evaluation with less frequent collections due to the need to understand impacts over time. If CDC’s One Health Office were to evaluate the OHZDP process using less components, opportunities to improve and support this dynamic process across sectors would be missed.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A. A Federal Register notice was published for this generic package on July 22, 2022, Vol. 87, No. 140, pp.438360. No public comments were received.

No consultations outside of CDC occurred.

  1. Explanation of Any Payment or Gift to Respondents

There are no incentives to respondents.

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

The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) reviewed this submission and determined that the Privacy Act does not apply. Participant name is the only PII that is optionally collected. The results will be stored in a password protected folder on the One Health Office share drive, which is behind the CDC firewall. Access to his folder will be limited to necessary One Health Office staff.

  1. 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 (Attachment 8).

Justification for Sensitive Questions

There are no planned sensitive questions.

  1. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

As this is a multisectoral, ongoing, location-led initiative, the number of respondents will vary by location. The following numbers are an annual estimate based on the total number of OHZDP workshops and facilitator trainings conducted in 2023. The OHZDP Post Workshop Survey is distributed at the following intervals after an OHZDP workshop: 6 months, 1.5 years, 3 years, but this only correlates to one ‘No. Responses per Respondent’ per year. The following forms have an average burden per response of 15 minutes: OHZDP Interest Intake Form, OHZDP Baseline Survey, OHZDP Facilitator Training Survey, OHZDP Participant Survey, OHZDP Post Workshop Survey, Retrospective Survey. The OHZDP Next Steps Tracker has an average burden per response of 30 minutes. Overall, the OHZDP Interest Intake Form has a total burden of 2 hours. The OHZDP Baseline Survey has a total burden of 2 hours as well. The OHZDP Facilitator Training has a total burden of 38 hours. The OHZDP Participant Survey has a total burden of 100 hours. The OHZDP Next Steps Tracker has a total burden of 12 hours. The Retrospective Survey has a total burden of 5 hours.

Type of Respondent

Form Name

No. of Respondents

No. Responses per Respondent

Avg. Burden per response (in hrs.)

Total Burden (in hrs.)

Workshop Organizer

OHZDP Interest Intake Form

(Attachment 1)

8

1

15/60

2

Workshop Organizer

OHZDP Baseline Survey

(Attachment 2)

8

1

15/60

2

Training Attendee

OHZDP Facilitator Training Survey

(Attachment 3)

150

1

15/60

38

Workshop Attendee

OHZDP Participant Survey

(Attachment 4)

400

1

15/60

100

Workshop Organizer

OHZDP Next Steps Tracker

(Attachment 5)

8

3

30/60

12

Workshop Organizer

OHZDP Post Workshop Survey

(Attachment 6)

8

1

15/60

2

Workshop Organizer

Retrospective Survey

(Attachment 7)

20

1

15/60

5

Total


161

B. Estimated Annualized Burden Costs

As this is a multisectoral, international, ongoing process, the hourly wage of past or future workshop attendees cannot be determined. We have based the estimate on the average salary for an Epidemiologist in the United States.

Type of Respondent

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Workshop Organizer

OHZDP Interest Intake Form

2

$ 41.29


$82.58


Workshop Organizer

OHZDP Baseline Survey

2

$ 41.29

$82.58

Training Attendee

OHZDP Facilitator Training Survey

38

$ 41.29

$1569.02

Workshop Attendee

OHZDP Participant Survey

100

$ 41.29

$4129.00

Workshop Organizer

OHZDP Next Steps Tracker

12

$ 41.29

$495.48

Workshop Organizer

OHZDP Post-Workshop Survey

2

$ 41.29

$82.58

Workshop Organizer

Retrospective Survey

5

$ 41.29

$206.45

Total


$6647.69

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

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

  1. Annualized Cost to the Government

Based on the GS level of One Health Office staff involved in this evaluation process, and the estimated hours on this project, the following is our estimated annualized cost to the government.

Estimated Annualized Cost to the Government per Activity

Cost Category

Estimated Annualized Cost

Support Staff

$12,238


  1. Explanation for Program Changes or Adjustments

No change in burden is requested as this is a new information collection.

  1. Plans for Tabulation and Publication and Project Time Schedule



Project Time Schedule

Activity

Time Schedule

OHZDP Interest Intake Form

The monitoring and evaluation activities is on a continual timeline since it is based on the individual timelines of each location’s OHZDP workshop, including workshops that are not yet scheduled or planned.

OHZDP Baseline Survey

OHZDP Facilitator Training Survey

OHZDP Participant Survey

OHZDP Next Steps Tracker

OHZDP Post Workshop Survey

OHZDP Retrospective Survey

The OHZDP Retrospective Survey is

focused on past locations that have conducted an OHZDP workshop, the time schedule for these activities are March 1, 2024 – December 31, 2025.


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

The display of the OMB Expiration date is not inappropriate.

  1. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

  1. OHZDP Interest Intake Form

  2. OHZDP Baseline Survey

  3. OHZDP Facilitator Training Survey

  4. OHZDP Participant Survey

  5. OHZDP Next Steps Tracker

  6. OHZDP Post Workshop Survey

  7. OHZDP Retrospective Survey

  8. Human Subjects Determination







File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorCourey, Elizabeth (CDC/NCEZID/OD)
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