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Generic Clearance for CDC/ATSDR

Formative Research and Tool Development

CDC ENGAGE Functionality Project

Supporting Statement A

0920-1154

April 1, 2025

Contact Information:

Virginia Warren

Technology Implementation Office

Office of Public Health Data, Surveillance, and Technology (OPHDST)

Centers for Disease Control and Prevention (CDC)

Phone: 404-498-2724

Email: upe9@cdc.gov

Table of Contents

Section

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of the Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

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

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

9. Explanation of Any Payment or Gift to Respondents

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

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

12. Estimates of Annualized Burden Hours and Costs

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

14. Annualized Cost to the Federal Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

Attachments

Attachment 1_Project Determination for_CDC ENGAGE

Attachment 2_Conversation Guide_CDC ENGAGE

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

The Office of Public Health Data Science and Technology (OPHDST) at CDC requests approval under the established 0920-1154 generic information collection mechanism to conduct formative research for developing a new state, tribal, cocal, and territorial (STLT) public heath agency (PHA) engagement system named CDC ENGAGE.

This information collection supports formative, human-centered design research for the development of CDC ENGAGE, an online, centralized hub for engagement around STLT PHA data, surveillance, and technology efforts. CDC ENGAGE will include comprehensive STLT PHA profiles, a help desk, and extensive tooling for content and knowledge management, collaboration, reporting and analytics about technical implementation support, and communication with STLT PHAs. The mission of CDC ENGAGE is to unify and streamline engagements related to STLT PHA data, surveillance, and technology. The vision driving CDC ENGAGE is a cohesive customer experience for STLT PHA users and the CDC staff that support them.

The formative research for which we request approval is necessary because it will enable the CDC ENGAGE design team to understand the needs of CDC ENGAGE users. This is essential to achieving the mission and vision of CDC ENGAGE. If this information is not collected, input from future users of CDC ENGAGE will not be available to inform the design of the system and its development roadmap, which could result in a system that does not meet user needs.

2. Purpose and Use of Information Collection

The purpose of the unstructured, conversational interviews we plan to conduct is to facilitate the discovery, synthesis, and analysis of qualitative data that is a core component of human-centered design. In the interviews, we aim to understand the perspectives of users from various roles and types of PHAs (e.g., varying in technical maturity, size, and location).

There are two primary intended uses for the information collected from these interviews. First, the resulting information will be used to increase designers’ understanding of the current state of engagement (i.e., communication landscape) between the STLT PHAs, related partner organizations, and the CDC. This information will assist in design activities such as the development of user journeys.

Second, the information collected will be useful in determining the functions, features, and interactions that will best serve future users as well as which ones are most important.

3. Use of Improved Information Technology and Burden Reduction

Individual interviews covered under this generic clearance will be conducted virtually via Microsoft Teams, or similar technology, to eliminate the time and cost of travel. Virtual collaboration software will be used to facilitate the sharing of design concepts, gathering of specific user feedback, synthesis of findings, and thematic analysis.¹

4. Efforts to Identify Duplication and Use of Similar Information

Prior to interviews being planned, steps taken to minimize duplicative efforts included extensive investigation of STLT PHA needs through discussion with CDC staff who have experience working with or in STLT PHAs and review of qualitative research findings from a recent PRA-approved Case Service Design project involving STLT PHAs. Those previous data collections did not answer the questions that we are seeking answers to in this collection. (Examples of our questions include: What is the current state of engagement between the STLT PHAs, related partner organizations, and the CDC? What functions, features, and interactions will best serve future CDC ENGAGE users and which ones are the most important?) This new data collection is necessary to support the successful development of CDC ENGAGE.

5. Impact on Small Businesses or Other Small Entities

Some potential interviewees will be from smaller STLT PHAs or related partner organizations. Since smaller organizations have fewer human resources, we will seek to minimize burden by asking for no more interviews than are necessary to understand their perspective.

6. Consequences of Collecting the Information Less Frequently

Without these interviews of future users of CDC ENGAGE, OPHDST will not have the voice of the user to inform the design of the system. That is not in harmony with human-centered design best practices and could result in a system design that does not meet the needs of users or function in a way that encourages system adoption. This would then need to be addressed in future updates, thus increasing the overall time and cost of delivering this system.

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

There are no special circumstances with this information collection package. This information collection will fully comply with the guidelines in 5 CFR 1320.5 and will be voluntary.

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

1. This information collection request does not require publication of a 60-day notice in the Federal Register.

2. Booz Allen Hamilton (BAH), a contracted consulting firm, has been consulted in the development of the data collection plan, sampling parameters, and interview guide. Under the supervision of OPHDST, Booz Allen Hamilton will conduct thirty 60-minute-long online interviews with the individuals from STLT PHAs or other partner organizations in the U.S.

9. Explanation of Any Payment or Gift to Respondents

No incentives, payment, or other forms of remuneration will be offered.

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

OPHDST has determined that the Privacy Act does not apply to this information collection. Booz Allen Hamilton, a contracted firm, will manage recruitment and conduct the interviews for this initiative, and none of the information collected will be stored in a CDC system of record. Except for a respondent’s name and professional role, the interviews proposed under this generic clearance do not involve intentional collection of specific personally or individually identifiable information. The respondent’s name will be asked for the purpose of introduction at the beginning of the conversation and will not be documented; the respondent’s professional role will be asked and documented to help the interviewers understand the job the individual performs that informs his or her perspective.

Field notes will be taken during the interviews to capture key quotes or expressions. These notes will be aggregated and anonymized prior to being shared beyond the research team to system developers or others within CDC ENGAGE leadership with a need to be informed about design decisions.

Participation in development activities is strictly voluntary. Before conducting any interview activities, the design team will secure verbal consent from any interview participant. The team will inform participants of the project's purpose, the types of activities that will take place, how their privacy will be protected, and ask for consent to conduct the interview and capture written and electronic notes. Participants can withdraw their consent at any time, before, during, or after the interview or when the activity is completed.

Protecting personally identifiable information (PII), Protected Health Information (PHI) and other respondent data is crucial, and moderators adhere to all applicable law and CDC policy regarding PII and PHI.

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

Institutional Review Board (IRB)

This project was reviewed by OPHDST’s human subjects advisor and determined to not meet the definition of research under 45 CFR 46. IRB review is not required (Attachment 1).

Justification for Sensitive Questions

All the questions asked in the interviews will be non-sensitive in nature and will be limited to open-ended questions designed to get qualitative feedback about the individual’s professional role, work processes, challenges, needs, and desires so that CDC ENGAGE can be designed to meet and hopefully exceed user expectations for usability.

All participants will be informed that they need not answer any question that makes them feel uncomfortable or that they do not wish to answer.

12. Estimates of Annualized Burden Hours and Costs

The total estimated burden on respondents is 30 hours. Table 1 describes the burden associated with the information collection. The burden table assumes that interviews will last no more than one hour.

Table 1. Estimated Annualized Burden

Respondents	Form Name	No. of Respondents	No. of Interviews per Respondent	Average Burder per Interview (in hours)	Total Burden (in hours)
Individual future users of CDC ENGAGE	Conversation Guide_CDC ENGAGE (Attachment 2)	30	1	1	30
Total					30

The total estimated cost burden of this information collection is $944.40.

Because we expect respondents to be of varying occupations, the estimated annualized cost to respondents for the burden hours of this information collection are based on the mean of all hourly wages from the U.S. Department of Labor’s May 2023 National Occupational Employment and Wage Estimates (https://www.bls.gov/oes/current/oes_nat.htm). With the total estimated annual burden of 30 hours, and the average of all occupation average hourly wages of $31.48, the overall annual cost of respondents’ time is estimated to be $944.40 (see Table 2 for details).

Table 2. Cost Burden Associated with Information Collection

Form Name	Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Conversation Guide_CDC ENGAGE (Attachment 2)	STLT Public Health Personnel	30	31.48	944.40
Total				$944.40

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

There will be no direct costs to the respondents other than their time to participate in each information collection.

14. Annualized Costs to the Government

Because all interviews will be conducted virtually, there will be no travel or associated costs to the federal government. There are also no equipment or similar overhead costs. The cost to the federal government is the wage of the contractors facilitating the interviews, analyzing findings, reporting on them to federal government personnel, and the wage of the federal personnel overseeing the project. The estimated cost to the federal government is approximately $49,706.00, which is based on an assumption of 30 interviews, facilitated by 2 contractors, each spending 2 hours on recruiting and conducting per interview plus 4 hours on analysis and reporting at a $127.68 hourly rate. The estimate also includes 40 hours of federal personnel involvement at a $93.53 hourly rate.
Hourly rate tabulated based on the 2025 locality-adjusted general schedule pay table for Atlanta-area workers: Grade 15, Step 10 and a 2,087-hour divisor. See Table 3.

Table 3. Estimated Cost to the Federal Government

Cost Category	Estimated Annualized Cost
Contractor personnel costs: recruiting and conducting interviews	15,321.60
Contractor personnel costs: analysis and reporting	$30,643.20
Federal government personnel costs: oversight, report review, and meeting time	$3,741.20
Total	$49,706.00

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

This initiative is expected to take no more than 9 weeks from start to finish. Two weeks will be spent recruiting and scheduling interviews, four weeks will be spent conducting interviews, and three weeks will be spent on analysis and reporting. A timeline is in Table 4.

Table 4. Project Time Schedule

Activity	Time Schedule
Recruit interview participants	2 weeks, beginning immediately after GenIC is approved
Conduct interviews	4 weeks, following recruitment and scheduling
Analysis and report	3 weeks, following completion of interviews
Disseminate results/reports	As soon as summary report is approved

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.

1 Thematic analysis is a method of analyzing qualitative data. It is usually applied to a set of texts, such as an interview notes or transcripts. The researcher closely examines the data to identify common themes – topics, ideas and patterns of meaning that come up repeatedly.

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