OMB approval memo

United States Food and Drug Administration
Generic Clearance: Quantitative Testing for the Development of FDA Communications
OMB Control Number 0910-0865
Gen IC Request for Approval

Title of Gen IC: Consumer Feedback Survey on CFSAN Outbreak and Response Evaluation Investigation Table (CIT)

1. Statement of Need:

In November 2020, FDA Center for Food Safety and Applied Nutrition’s Coordinated Outbreak Response and Evaluation team (CORE) launched the “CORE Investigation Table” (CIT) on the FDA.gov webpage pertaining to foodborne illness outbreaks (Investigations of Foodborne Illness Outbreaks), to publicly share the existence and status of active outbreak investigations being managed by the CORE Response Teams. This table, which is updated weekly, addresses an identified need: to share information about foodborne illness outbreaks quickly and accurately, even at the early stages of an outbreak investigation when significant details are not yet known.

Although the CIT’s audience is expected to be industry, state health departments, the media and other stakeholders as well as general consumers, the expectation is that the information shared on the CIT will be shared broadly and, ultimately, reinforce consumers’ adherence to general food safety advice and therefore, minimize their likelihood of getting a foodborne illness.

This survey is the second request for audience feedback on the CIT since its launch. The results of this survey, along with the results of the previous survey, will be used to make any necessary revisions to the CIT table.

2. Intended Use of the Information:
   
   

This survey is the second request for audience feedback on the CIT since its launch. The first request for was a survey of consumer groups, industry groups, and federal, state and local partners cleared by OMB through the 0910-0865 generic on 10-1-2021 [ICR Reference Number 201911-0910-011] and administered in November and December 2021. Results from that survey will be combined with those of this survey which will sample CIT email list members described in detail in item 3 below. This survey is largely the same survey used previously which assessed usage and table usability and comprehension. The results of this survey, along with the results of the previous survey, will be used to make any necessary revisions to the CIT table.

The data will be used to inform CORE management and staff about current CIT usage and stakeholder understanding. If the data indicate a need, the CIT will be modified to improve appearance and understanding.

The proposed research is designed to answer the following questions:

1. What are reactions to the CIT? Is the CIT useful and usable to the sampled audience? How can the CIT be made more useful or usable?

2. What part of the CIT is considered most/least important?

3. Is any desired information missing from the CIT? If desired, what form should the additional information take (text, links, etc.)?

4. What kind of changes would improve the CIT?

   1. Are the column headers (Sample analysis, reference ID#, etc.) in the table understandable? Which columns work/do not work and why?

5. What is stakeholder reaction to the frequency of the updates (currently, weekly)?

6. How is the information in the CIT shared? What could improve CIT information sharing?

7. What actions does the CIT prompt the reader to take?

3. Description of Respondents:

FDA intends to conduct convenience sampling to obtain feedback from 500 subscribers to an FDA email list dedicated to sending updates on current outbreak investigations being conducted by FDA. Survey respondents will be “consumers” of the CIT; based on the questions FDA has received in response to our emails. We are aware that this email group consists of, but is not limited to general consumers, trade press media and news outlet representatives.

4. Type of Collection: (Check one box below. If you are requesting approval of other instruments under the generic, complete this justification for each instrument.)

[ ] Experiment [X] Survey

Survey Monkey will be used to disseminate the survey to list of stakeholders described in the section above. The ten-minute survey questions will consist mainly closed-ended response options.

5. Confidentiality of Respondents:

FDA does not keep any information beyond the email addresses of the list subscribers, so the survey respondents will consist only of individuals who have provided their email address to FDA and are interested in receiving outbreak updates. Participants will be invited to complete this survey because they were signed up to receive weekly CIT updates. This survey is completely voluntary, and the information provided will be kept secure to the extent provided by law. The participant’s participation or non-participation is completely voluntary, and the participant’s responses will not have an effect on their eligibility for receipt of any FDA services. If any instances occur where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.

6. Amount and Justification for Proposed Incentive:

Is an incentive (e.g., stipend, reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X] No

If yes, describe the incentive and provide a justification for the amount. If no, delete this instruction.]

7. Questions of a Sensitive Nature:

This survey is intended for audiences familiar with the CIT. If the participants have not seen the CIT before, many of the survey questions will not apply to them. Participants may quit the survey at any time by simply closing their web browser. We will use any feedback that participants provide.

8. Description of Statistical Methods

The data compiled in an Excel spreadsheet will be imported to SPSS where it will be reviewed and cleaned, as necessary. Frequencies and cross tabulations will be calculated and will be reported in table or graphic format to CORE partners as part of a presentation of the results.

The data will be used to inform CORE management and staff about current CIT usage and stakeholder understanding. If the data indicate a need, the CIT will be modified to improve appearance and understanding.

9. Burden: [Complete the table below.]

Burden Hour Computation -- (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours).

Type of information collection/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
Survey	500	10	83

10. Date(s) to be Conducted: When approved by OMB (April to May 2022)

11. Requested Approval Date: March, 2022

12. FDA Contacts:

Program Office Contact	FDA PRA Contact
Linda Verrill, Ph.D. Linda.verrill@fda.hhs.gov 240-472-1983 Center for Food Safety and Applied Nutrition	Ila S. Mizrachi Ila.mizrachi@fda.hhs.gov 301-796-7726

13. Certification: In submitting this request, I certify the following to be true:

1. The collections are voluntary;

2. The collections are low-burden for participants and are low-cost for both the participants and the Federal Government;

3. The collections are noncontroversial;

4. Personally identifiable information (PII) is collected only to the extent necessary and is not retained; and

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.