OMB Memo / Abbreviated Supporting Statement

United States Food and Drug Administration

Generic Clearance: Customer Satisfaction Surveys

OMB Control Number 0910-0360

Gen IC Request for Approval

Title of Gen IC: (ORA) OTED Self-Paced Course Evaluation

1. Statement of Need

The FDA Office of Regulatory Affairs, Office of Training, Education and Development seeks to gather feedback on user satisfaction with self-paced online (no instructor) courses we provide. We are requesting to send a 26-item survey to students who access these courses. Completion of the survey and items within is voluntary and no incentives are offered to complete it.

2. Intended Use of the Information
   
   This information will provide the Office of Training, Education and Development (OTED) a better understanding of how we might improve our self-paced online courses.

3. Description of Respondents

Respondents include state, local, tribal, and territorial partners who take OTED’s self-paced online courses.

4. How the Information is Collected

Data will be collected through web-based platform (Cornerstone). The survey will be anonymous. Email requesting feedback will be sent to those who take OTED’s self-paced online courses, containing a link to the voluntary survey.

5. Confidentiality of Respondents

No personally identifiable information is requested, captured, or stored, and the survey is set up to ensure anonymity. Nine demographic questions are asked, with an option for “prefer not to answer”. Respondents are not required to answer any questions, and may decline to take the survey, or skip any question. One FDA employee will be viewing and analyzing results, providing aggregate summaries back to leadership.

6. Amount and Justification for Proposed Incentive

No incentive is proposed for this survey.

7. Questions of a Sensitive Nature

There are no questions of a sensitive nature in this survey. Any demographic items may be skipped or answered with an option of “prefer not to answer”. The survey and all items are voluntary.

8. Description of Statistical Methods

Based on an estimation of the number of students in previous years we expect approximately 2,000 students not employed by the FDA or federal government would receive an invitation to participate in the survey. At an average response rate of 50%, we expect approximately 1,000 respondents will complete it. Data would be analyzed using SPSS or Tableau and reported as an aggregate looking at things like percent favorable, items most correlated with course quality, any differences by demographic, and how it compares to other course satisfaction data we may have.

9. Burden
   
   
   

Type of information collection/Category of Respondent	No. of Respondents	Participation Time (minutes)	Total Burden (hours)
Website Satisfaction Survey	1,000	5	83

10. Date(s) to be Conducted

April 2024 – October 2026.

11. Requested Approval Date

April 2024

12. FDA Contacts

Program Office Contact	FDA PRA Contact
Amber Beckes Office of Regulatory Affairs Office of Training, Education, & Development 240-447-8601 amber.beckes@fda.hhs.gov	JonnaLynn Capezzuto Paperwork Reduction Act Staff Office of Enterprise Management Services Office of Operations 301-796-3794 jonnalynn.capezzuto@fda.hhs.gov

3