OMB Memo

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UNITED STATES FOOD & DRUG ADMINISTRATION

Generic Clearance: Customer Satisfaction Surveys

OMB Control Number 0910-0360 – Request for Individual Collection Approval

Title of Collection:  Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) Event Feedback Survey

    1. Statement of Need

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) seeks to gather feedback on event satisfaction and future OTP event interests. We are requesting to send a 10-item survey to event registrants. 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 OTP with a better understanding of how we might improve our future events.

    3. Description of Respondents

Respondents include those who have registered for a recent OTP event. OTP holds a series of events for various audiences, and each survey request will be to an individual pool of registrants.
 
    4. How the Information is Collected

Data will be collected through a web-based platform (e.g., Survey Monkey). The survey will be anonymous. An email requesting participation in the survey will be sent to those who registered for a recent OTP event and will contain a link to the voluntary survey. Each survey request will only be sent to registrants of the recent OTP event and will be sent within 3 business days of the event.  

    5. Confidentiality of Respondents

No personally identifiable information is requested, captured, or stored, and the survey is set up to ensure anonymity. One demographic question is 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 to two FDA employees and FDA’s communications contracting firm, Palladian Partners, will be viewing and analyzing results, providing aggregate summaries back to FDA 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 questions 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 registrants in previous events, we expect approximately 1,695 registrants per event not employed by the FDA would receive an invitation to participate in the survey. At an average response rate of 50%, we expect approximately 848 respondents will complete it. OTP plans on holding approximately 11 events, totaling to 9,323. Data would be analyzed using SPSS or analytical tools through Survey Monkey 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)
Event Feedback Survey
9,323
3 (.05 hrs)
466

    10. Date(s) to be Conducted

August 2024 – September 2025

    11. Requested Approval Date

July 2024

    12. FDA Contacts

Program Office Contact
FDA PRA Contact
Amber Beckes
Office of Regulatory Affairs 
Office of Training, Education, & Development
240-447-8601
[email protected]
JonnaLynn Capezzuto
Paperwork Reduction Act Staff
Office of Enterprise Management Services
Office of Operations
301-796-3794
[email protected]