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: State Program Satisfaction Survey for Remote Assessments

1. Statement of Need:

To evaluate an alternative tool/process to assist in the oversight/assessment of Manufactured Food Regulatory Program Standards (MFRPS) and Animal Feed Regulatory Program Standards (AFRPS) enrolled states as a continuation of and in addition to on-site assessments.

2. Intended Use of the Information:
   
   The Office of Human and Animal Food Operations/Immediate Office/Audit Staff (AS) plans to use the data collected to determine if MFRPS and AFRPS enrolled state programs are satisfied with this alternative tool/process. The data collected will be used to identify possible areas of process improvements to ensure stakeholders receive the same value-added service they expect from the AS.

3. Description of Respondents:

Respondents take the survey voluntarily and are state MFRPS or AFRPS program coordinators.

4. How the Information is Collected:

The survey is emailed to state MFRPS or AFRPS coordinators with a notice that responses are voluntary.

5. Confidentiality of Respondents:

“Your participation / nonparticipation is completely voluntary, and your responses will not influence your MFRPS/AFRPS interval assessment results.  The data is tracked on an excel spreadsheet on an FDA secured system and your name is not included in this tracking mechanism. 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

7. Questions of a Sensitive Nature:

None.

8. Description of Statistical Methods:

100% of state programs audited per fiscal year (FY) that elect to participate in a remote (versus onsite) assessment. The first four questions are numerical scale responses. The sum of the responses for each question will be added together (numerator) and will be divided by the number of states that submitted responses (denominator) for each question to determine an average. The fifth question is free text and will be added line by line in the word cloud generating software from www.wordcloud.com in order to create a word cloud.

9. Burden:

Burden Hour Computation –

45 possible remote/onsite assessments per FY X 5 minutes / 60 min = 3.75 annual burden hrs

Type of information collection/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
State Program Satisfaction Survey for Remote Assessments/State MFRPS/AFRPS Coordinators	45	5 minutes	3.75

10. Date(s) to be Conducted: July 1, 2021 to Sep 30, 2022

11. Requested Approval Date: July 1, 2021

12. FDA Contacts:

Program Office Contact	FDA PRA Contact
Alex Turner 678-772-5271 Office of Regulatory Affairs Alexander.Turner@fda.hhs.gov	Ila S. Mizrachi 301-796-7726 Ila.mizrachi@fda.hhs.gov

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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