OMB approval memo

United States Food and Drug Administration

Generic Clearance: Customer Satisfaction Surveys

OMB Control Number 0910-0360

Gen IC Request for Approval

The generic clearance will only be used for customer satisfaction and website usability surveys where FDA seeks to gather information that is planned for internal use only and can provide a justification for qualitative or anecdotal collections that may nonetheless produce useful information for program and service improvement.

Title of Gen IC: Level 2 Training Course Evaluation Pilot

1. Statement of Need:

The FDA Office of Regulatory Affairs, Office of Training, Education and Development seeks to better understand how well students learn from FDA-sponsored courses after they return to their job, subsequently utilizing training on their own. Therefore, as a pilot program, we are requesting to send a 15-item survey to students from nine of our courses, selected as a cross-section of our offerings. 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 well students are learning and using skills from FDA-sponsored course instruction.

3. Description of Respondents:

Respondents include FDA employees as well as those students required to attend FDA-sponsored courses from our state, local, tribal, and territorial partners.

4. How the Information is Collected:

Data will be collected through web-based platform (SurveyMonkey) by an FDA employee three months post-participation in one of the nine pilot courses. The survey would only be sent to students once and will be set up in SurveyMonkey to be anonymous. An invitation requesting feedback will be sent via email to students through a link to an online survey using the SurveyMonkey platform.

5. Confidentiality of Respondents:

No personally identifiable information is requested, captured, or stored, and the survey will be set up to ensure anonymity. Only one demographic question is added which captures broad categories of position type, with an option for “prefer not to answer”. Only one FDA employee will be viewing and analyzing results, then providing aggregate summaries back to leadership and staff.

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

7. Questions of a Sensitive Nature:

There are no questions of a sensitive nature in this survey, only questions about satisfaction with utilizing training on the job. Only one demographic question is added which captures broad categories of position type, with an option for “prefer not to answer”.

8. Description of Statistical Methods:

Based on an estimation of the number of participants in the same courses in FY21, we estimate approximately 400 students would be sent the survey. At an average response rate of 50%, we hope to expect ~200 respondents. The survey would be given to all students who participated in each pilot course. Data would be analyzed using SPSS and reported as an aggregate looking at things like percent favorable, items most correlated with course quality, any differences by position, and how it compares to other course satisfaction data we may have.

9. Burden:

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)
Webform Satisfaction Survey	400	5/60	34

10. Date(s) to be Conducted: April 26, 2022 to August 6, 2022

11. Requested Approval Date: February 2022

12. FDA Contacts:

Program Office Contact	FDA PRA Contact
Amber Beckes Office of Regulatory Affairs Office of Training, Education, & Development Mobile: (240) 447-8601	Ila S. Mizrachi Paperwork Reduction Act Staff 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.

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