December 22, 2023
GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
Harmful Algal Blooms Communication Evaluation
OMB Control No. 0920-1154
Contact: Amy Jacobi, MPH
Waterborne Disease Prevention Branch
Division of Foodborne, Waterborne, and Environmental Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Phone: (404) 718.3715
Email: [email protected]
TABLE OF CONTENTS
1 Circumstances Making the Collection of Information Necessary 3
2 Purpose and Use of the Information Collection 5
3 Use of Improved Information Technology and Burden Reduction 5
4 Efforts to Identify Duplication and Use of Similar Information 5
5 Impact on Small Businesses or Other Small Entities 6
6 Consequences of Collecting the Information Less Frequently 6
7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 6
8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 6
9 Explanation of Any Payment or Gift to Respondents 7
10 Assurance of Privacy Provided to Respondents 7
11 Institutional Review Board (IRB) and Justification for Sensitive Questions 8
12 Estimates of Annualized Burden Hours and Costs 9
13 Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers 10
14 Annualized Cost to the Federal Government 10
15 Explanation for Program Changes or Adjustments 11
16 Plans for Tabulation and Publication and Project Time Schedule 11
17 Reason(s) Display of OMB Expiration Date Is Inappropriate 11
18 Exceptions to Certification for Paperwork Reduction Act Submissions 11
Goal
of the study: CDC wants to test communication materials related
to harmful algal blooms and health with intended audiences to see
if they are clear, resonate, and actionable. CDC would also like to
understand how to best disseminate these communication materials to
reach intended audiences.
Intended
use of the resulting data: CDC will use the data to create
communication materials, update existing content, and develop
communication dissemination strategies. Methods
to be used to collect: Qualitative data collection (focus group
discussions) The
subpopulation to be studied: U.S. adults who visit freshwater
bodies, parents who visit freshwater bodies with their kids or
teens, and dog owners who visit freshwater bodies with their dogs How
data will be analyzed: Iterative
thematic analysis to identify key themes and subthemes captured in
the data
Exhibits
Exhibit A.8.1. Individuals Consulted During A-6
Exhibit A.12.1. Estimated Annualized Burden Hours A-8
Exhibit A.12.2 Estimated Annualized Burden Costs A-9
LIST OF ATTACHMENTS
Eligibility Screener
Recruitment Materials
Eligible Participant Screener
Privacy Agreement
Respondent Consent Form for Focus Groups
Standard Invitation for FGs
Participant Confirmation Email
Focus Group Moderator Guide
Messages/Materials to be Tested
Human Subjects Determination
CDC is charged with communicating information about harmful algal blooms (HABs) and health to the general public. This information is primarily disseminated through social media and through the Harmful Algal Bloom (HAB)-Associated Illness website. The website serves to educate the public on steps they can take to prevent HAB-associated illness and provides information on symptoms, causes, and reporting of HAB-associated illnesses.
Through recent quantitative HABs-focused surveys conducted by DFWED (September 2021, September 2022, July 2023), nationally-representative audience feedback provided useful information about preferred terminology, preferred illness prevention measures, information seeking and reporting, risk perception, and behaviors around visiting water bodies. However, there is a need for additional qualitative information to provide context and understanding to these findings. Focus group information collected by the Vermont Department of Health (May 2019) provided information on Vermont residents’ knowledge and perceptions about cyanobacteria and their health risks; how much of the Vermont population recreates in HABs; what messages have reached Vermont residents; and certain groups in Vermont that should be targeted for messaging. Focus group information collected by the Michigan Department of Health and Human Services (2021) provided useful audience feedback from Michigan residents on several descriptions of HABs and informational signs, as well as their perceptions, understanding, and experiences with HABs. The qualitative information collected in Vermont and Michigan, due to the local messages tested and local contexts, is limited in its application to communications for general consumers. Building on the existing information, CDC is interested in collecting additional qualitative information to further explore and understand the context and rationale behind audience preferences, perceptions, and behaviors related to HABs, as well as testing specific CDC HAB-related messages and materials with audiences.
Objectives of this evaluation are to:
Obtain information about how current messages and materials disseminated from the CDC resonate and lead to action.
Understand why and how people interpret communication content.
Obtain findings on information gaps among adults, with and without children or dogs, who visit freshwater bodies for recreation.
Obtain insights about group norms and societal or cultural factors that may influence the attitudes, perceptions, and behaviors of participants.
Data collection will be used to:
Provide updates to CDC’s website content and linked materials, in conjunction with Clean Slate, and inform the messaging strategy to better meet the needs of the general population visiting natural bodies of water for recreation.
Inform the development of a 30-second video about HABs.
Enhance CDC's HAB communication resources available for use by the public, health departments, federal agencies, and other partners.
CDC’s contractor, Banyan Communications, will implement qualitative focus groups. The focus group respondents for this project will be a maximum of 40 individuals recruited by Banyan Communications. The project will work with volunteer respondents. Participants must meet a set of criteria to ensure all focus groups will include a maximally diverse group of participants considering age, educational level, and socioeconomic status, gender, and ethnicity and include a mix of geographical areas and urban/rural residents. The focus groups will be conducted between adults (18+) and at least one project staff member. The goal is to obtain feedback to support HABs communication initiatives.
Data to be collected include the following: sociodemographics; knowledge, attitudes, beliefs, and perceptions related to HABs; and reactions and receptivity to HABs messages and content. Questions shall assess ways in which participants obtain and/or seek information related to HABs and HABs-associated illness prevention, how they interpret this information, message receptivity and whether/how the participants intend to change their behavior based on the message. Participants shall also elaborate on ways in which the presented messages, through text or presentation changes, could be improved so that they are more effective.
The data collection will use
a 5-minute Eligibility Screener before the virtual focus group (Attachment 1)
a 10-minute Eligible participant screener (Attachment 3)
a virtual 60-minute focus group (Attachment 8).
This information collection does not involve websites or website content directed at children less than 13 years of age.
The purpose of this project is to conduct focus group discussions (FGDs) with U.S. adults (general population who visit freshwater bodies, parents who visit freshwater bodies with their kids/teens, dog owners who visit freshwater bodies with their dogs) to improve HABs messages and web content. Banyan Communications will conduct the focus groups.
Objectives of this project are to:
Obtain information about how current messages and materials disseminated from the CDC resonate and lead to action.
Understand why and how people interpret communication content.
Obtain findings on information gaps among adults, with and without children or dogs, who visit freshwater bodies for recreation.
Obtain insights about group norms and societal or cultural factors that may influence the attitudes, perceptions, and behaviors of participants.
Data collection will be used to:
Provide updates to CDC’s website content and linked materials and inform the messaging strategy to better meet the needs of the general population visiting freshwater bodies for recreation.
Inform the development of a 30-second video about HABs.
Enhance CDC's HAB communication resources available for use by the public, health departments, federal agencies, and other partners.
We will record each focus group to use for preparing reports. Our data collection requires that we employ qualitative methods using one-time virtual focus group discussions. We will receive recorded verbal confirmation from participants to record the discussion. Questions (within the focus group discussions) will be kept to a minimum required for the intended use of the data.
There are no other federal generic collections that duplicate the project types included in this request. Health messages developed by CDC are unique in their mix of intended audience, health behavior, concept, and execution. Therefore, in most cases, there are no similar data available. We have reviewed existing published data and consulted with outside experts to identify information that could facilitate message development prior to conducting any data collection.
DFWED works consistently with other U.S. government agencies to ensure there isn’t any redundancy.
This project does not have an impact on small businesses or other small entities.
The activities involve a one-time collection of data over a 12-month period.
This request fully complies with regulation 5 CFR 1320.5.
For subcollection requests under an approved generic ICR, Federal Register notices are not required, and none were published.
Exhibit A.8.1. Outside Consultation
Name |
Affiliation |
Phone |
|
Sara Bresee |
CDC |
Office: 404.639.3371 |
|
Amy Jacobi |
CDC |
Office: 404.718.3715 |
|
Candace Rutt |
CDC |
Office: 916.710.0212 |
|
Linda West |
CDC |
Office: 404.639.1369 |
|
Maureen Oginga |
CDC |
Office: 813.951.4712 |
|
Amanda MacGurn |
CDC |
Office: 404.639.0801 |
|
Nora Kuiper |
Banyan Communication |
Office: 404.682.3008 x 344 |
|
Tola Aina |
Banyan Communication |
Office: 404.682.3008 |
|
Amanda White |
Banyan Communications |
Office: 404.682.3008 |
|
Sharanya Thummalapally |
Banyan Communications |
Office: 404.682.3008 |
|
Bria Berry |
Banyan Communications |
Office: 404.682.3008 |
To ensure there is no duplication or redundancy of effort across projects and programs, program staff will consult with a variety of sources on the availability of data, frequency of collection, clarity of instructions, and record keeping, disclosure, and reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
We will provide a token of appreciation of $75 for each individual who participates in a focus group. Tokens of appreciation were determined based on previous projects and experience with conducting focus groups with individuals. The range of monetary reward is consistent with current rates for participation in formative projects. Tokens of appreciation will take the form of gift cards.
Reviewed literature revealed the payment of incentives can provide significant advantages to the government in terms of direct cost savings and improved data quality (see references). As participants often have competing demands for their time, a token of appreciation for participation in a study is warranted. The use of a token of appreciation treats participants justly and with respect by recognizing and acknowledging the effort participants expend to participate. Numerous empirical studies have also shown that a token of appreciation can significantly increase response rates in cross-sectional studies and reduce attrition in longitudinal studies (e.g., Abreu & Winters, 1999; Castiglioni et al., 2008). It also should be noted that message testing is a marketing technique, and it is standard practice among commercial market researchers to offer incentives as part of respondent recruitment.
A similar communication evaluation project that was conducted in the summer of 2023 proposed and was approved for $75 per person for a 60-minute focus group discussion (OMB Co. Number: 0920-1154, Food Safety Communication Evaluation Assessing Food Safety Messages, Knowledge, and Attitudes). During this project, the team was successful and was able to recruit 115 individuals (the goal was to recruit 144).
Contractors and anyone listening to the project will be required to sign a privacy agreement prior to the start of the project (Attachment 4). CDC’s contractor, Banyan Communications, will retain notes, audio/video files, and any other project-related documents on secure servers or in locked file cabinets; only project staff members will be able to access the servers via password-protected computers. Focus group findings will be reported in summary form, and participants’ names and identifying information will not be included in the findings. Identifiable information will be kept separate from focus group data, so that participants’ responses cannot be linked with their names. All audio and video files will be destroyed three years after completion of the project. No identifiable information describing individual respondents will be included in the analyzed data and aggregate reports provided to CDC.
In review of this application, it has been determined that the Privacy Act is not applicable.
Banyan Communications will identify, screen, and recruit potential participants through a recruitment firm, using a proprietary recruitment list/database. Banyan Communications will use additional recruitment methods, such as including social media notices and snowball sampling as needed.
Individuals will first be screened to assess if they are eligible to be a part of the focus groups (Attachment 1). Those who meet the screening criteria for the focus groups will then receive a second demographic screener to assess which focus groups they will be put into (Attachment 3). Finally, they will be invited to attend a virtual 60-minute focus group. Participants will be asked to give verbal consent on a recording prior to the start of the focus group and will also fill out a consent form (Attachment 5) before starting. They will receive a copy for their records.
The screeners will be stored in an encrypted online file hosted by Banyan Communications throughout the project’s duration. Once the project ends, the screeners will be destroyed. Banyan Communications will retain notes, video files, and any other project-related documents on secure servers; only project staff members will have access to the servers via password-protected computers. Findings will be reported in summary form and participants’ names and identifying information will not be included in the findings. Identifiable information is kept separate from focus group data so that participants’ responses cannot be linked with their names. All video files will be destroyed at the completion of the project.
During the focus group, the moderator will go over key parts of the informed consent during the introduction to the focus group. The moderator will inform participants that the focus group is voluntary, and that they may choose not to answer any question and end participation at any time. The moderator also will inform participants that Banyan Communications will report findings in summary form so that participants cannot be identified and that their identifiable information will be kept secure and separate from the focus group notes and video recordings. The moderator will inform the participant that there is a notetaker listening and taking notes. The informed consent includes the phone numbers for both Banyan Communications, in case participants have questions about their rights as a participant, as well as the principal investigator, in case participants have questions about the project itself.
This data collection was reviewed by NCEZID’s Human Subjects Advisor, and it was not deemed as human subjects’ research and given a non-research determination (Attachment 10).
There is a minimal risk that some questions may make respondents feel uncomfortable. There will be potentially sensitive information collected such as race and income. These questions are critical to the project to ensure a demographically diverse sample. Therefore, the team needs to gather data surrounding race, ethnicity, income, etc.
The respondent consent form includes a statement about this risk and informs participants that they may choose not to answer a particular question if they wish and/or end the session at any time without penalty.
We estimate the total annualized response burden at 80 hours (Exhibit A.12.1). For the focus group discussions, every individual will be pre-screened using a 5-minute Eligibility and Demographic Screener. This process will be used to get the final focus group participants not to exceed 32 participants. Those who screen in and agree to participate in the project will participate in a 60-minute focus group; consent activities will be included in the 60 minutes. Timing is based on our previous experience conducting evaluations with this population using these methods to determine the overall burden per respondent.
Exhibit A.12.1. Estimated Annualized Burden Hours
Type of Respondent |
Form Name |
No. of Respondents |
Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden Hours |
Individual |
Eligibility Screener (Focus Group) Attachment 1 |
420 |
1 |
5/60 |
35 |
Eligible Participant Screener for Focus Group Attachment 3 |
80 |
1 |
10/60 |
13 |
|
Focus Group Moderator Guide Attachment 8 |
32 |
1 |
60/60 |
32 |
|
Total |
|
|
|
80 |
The estimates of the annualized cost to respondents for the burden hours for the collection of information is derived from the 2022 mean hourly wage of $29.76 across all occupations, per the U.S. Department of Labor (DOL) December 2022 (the most up-to-date non-provisional data) National Occupational Employment and Wage Estimates. The total annualized burden cost is estimated at $2,380.80 per year.
Exhibit A.12.2 Estimated Annualized Burden Costs
Activity |
No. of Respondents |
No. of Responses per Respondent |
Average Burden per Response (in Hours) |
Total Burden Hours |
Hourly Wage Rate |
Total |
Eligibility Screener Attachment 1 |
420 |
1 |
5/60 |
35 |
$29.76 |
$1,041.60
|
Eligible Participant Screener for Focus Group Attachment 3 |
80 |
1 |
10/60 |
13 |
$29.76 |
$386.88 |
Focus Group Discussion Attachment 8 |
32 |
1 |
60/60 |
32 |
$29.76 |
$952.32 |
Total |
|
|
|
80 |
|
$2,380.80 |
There are no costs to respondents other than their time for participation.
The contractor’s costs are based on estimates provided by the contractor, who will carry out the data collection activities. With the expected period of performance, the annual cost to the federal government is estimated to be $78,533 (Exhibit A.14.1). This is the cost estimated by the contractor, Banyan Communications, and includes the estimated cost of coordination with CDC, data collection, analysis, and reporting.
Exhibit A.14.1. Estimated Cost to the Government
Expense Type |
Expense Explanation |
Annual Costs (dollars) |
Direct cost to the federal government |
||
CDC oversight of contractor and project |
CDC Project Officer |
$23,703.00 |
|
CDC Co-Principal Investigator |
$26,250.00 |
Subtotal, Direct Costs to the Government |
|
|
Contractor and Other Expenses |
||
Recruitment, data collection, analysis and reporting (contractor) |
Labor hours and other direct costs |
$28,580.00 |
Subtotal, contracted services |
|
|
Total cost to the government |
$78,533 |
No change in burden is requested, as this is a new information collection.
During qualitative data collection, the Banyan Communications note taker will enter data from the focus group discussion into ATLAS.ti, which will be stored on a password-protected computer. Analysis of the focus group data will start immediately after completion of data collection and will be conducted under the supervision of a senior staff member with extensive experience in qualitative methods. Banyan Communications will conduct thematic or grounded theory analysis of the data to understand participants’ reactions to the messages in as rigorous and detailed manner as possible. Banyan Communications will summarize results in a final report. The final report will include key data from the online eligibility and demographic screener and report it in descriptive data tables with accompanying narrative in the summary and final reports. Exhibit 16.1 lists the key events and reports.
Exhibit A.16.1. Project Time Schedule
Activity |
Time Schedule |
Begin recruitment |
April 30, 2024 |
Conduct focus groups |
Weeks of 5/13, 5/20, 5/27, 6/3, 6/10 of 2024 |
Report due |
September 18, 2024 |
The display of the OMB Expiration date is not inappropriate.
There are no exceptions to the certification.
Abreu, D.A., & Winters, F. (1999). Using monetary incentives to reduce attrition in the survey of income and program participation. Proceedings of the Survey Research Methods Section of the American Statistical Association.
Bonevski, B., Randell, M., Paul, C., Chapman, K., Twyman, L., Bryant, J., ... & Hughes, C. (2014).
Reaching the hard-to-reach: a systematic review of strategies for improving health and medical
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Castiglioni, L., Pforr, K., Krieger, U. (2008). The effect of incentives on response rates and panel
attrition: Results of a controlled experiment. Survey Research Methods, 2(3), 151-158.
Krueger, R. and Casey, M. (2009) Focus Groups: A Practical Guide for Applied Research. Sage
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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Jacobi, Amy (CDC/NCEZID/DFWED/WDPB) |
File Modified | 0000-00-00 |
File Created | 2024-08-01 |