OMB Memo

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE

OF CUSTOMER SATISFACTION SURVEYS (0910-0360)

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 INFORMATION COLLECTION: Customer Satisfaction Surveys for FDA CFSAN Technical Assistance Network (TAN) Food Safety Modernization Act (FSMA) Queries

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Since January 2013, FDA has proposed seven foundational rules to implement FSMA. Those rules became final in 2015 and 2016:

The FDA Food Safety Modernization Act (FSMA) Technical Assistance Network (TAN) provides technical assistance to industry, regulators, academia, consumers and others regarding FSMA implementation. The TAN addresses questions related to the FSMA rules, FSMA programs, and implementation strategies after the rules are final.

The TAN provides a method for submitting FSMA queries online through a Web form accessed at the FDA.gov website; (the online system will go live upon approval of this generic request by OMB.) TAN subject matter experts respond to Web form users with answers to their questions.

The TAN uses two separate surveys to gather information from Web form users to 1) gauge customer reaction to having used the TAN Web form to submit a FSMA query and 2) assess satisfaction with the FDA’s response to their inquiry. Specifically, the TAN wants to know where the user learned about the Web form, whether the form instructions were clear, users’ suggestions for improvements, and satisfaction with the response to their inquiry. One survey will be accessible at the time the inquiry is made and the other survey will be accessible at the time the response to the inquiry is received.

2. Intended use of information:

The information will help FDA TAN management know whether Web form users are satisfied with their experience using the Web form and whether the inquiry responses are satisfactory. Based on responses to the Customer Satisfaction Surveys, FDA TAN management will use the information to make needed improvements to the Web form and to the quality of FDA response to inquiries.

3. Description of respondents:

Responding to the TAN FSMA Web Form Customer Satisfaction Surveys will be completely voluntary. Respondents will be individuals who access the TAN Web form to submit FSMA-related queries and those who receive a response to their inquiry. These individuals will be from industry, government, academia, organizations, and the general public; anyone with a question about FSMA implementation who has accessed and completed the TAN FSMA Web form.

4. Date(s) to be Conducted:

Ongoing, beginning with OMB’s approval of this collection of information.

5. How the Information is being collected:

There will be two separate surveys to collect information – a customer satisfaction survey and a response satisfaction survey. The information will be collected through voluntary customer satisfaction surveys administered online following Web form users submission of an online query to the FSMA TAN using the FSMA TAN Web form and accessible when they receive a response from FDA to their FSMA inquiry.

The respondent will first see the survey when they hit the Web form submit button after they have filled in their question. After the respondent hits the submit button the survey will pop up. At this point the respondent can either complete the survey or choose not to complete it by clicking cancel. In any case, the Web form user will receive a receipt acknowledgement for their question. (See attached screenshot mock ups of the customer satisfaction survey questions.)

A web link to the response satisfaction survey will be inserted in FDA’s response to a FSMA inquiry. The inquirer can decide whether they want to go to the link to complete the feedback survey. (See Appendix I for screenshots of the Response Satisfaction Survey questions.)

6. Confidentiality of Respondents:

All respondents’ personally identifying information will be kept private to the fullest extent allowed by law. Comments on the Customer Satisfaction Surveys regarding the Web form will have no bearing in responses to FSMA Web form inquiries or subsequent inquiries.

The following language will be included on the survey:

“Your participation/nonparticipation in the following survey is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services. In instances where respondent identity is needed (e.g., for follow-up of non-responders), 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.”

7. Amount and justification for any proposed incentive

No incentives will be offered to respondents of the TAN Web form Customer Satisfaction Survey or Response Satisfaction Surveys.

8. Questions of a Sensitive Nature

No questions of a sensitive nature will be included on the TAN Web form Customer Satisfaction Surveys.

9. Description of Statistical Methods

Frequencies and percentages will be generated from the quantitative questions and verbatim responses will be compiled from the open-ended text boxes.

BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours):

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
WebForm Satisfaction Survey	5000	2	166.66
Response Satisfaction Survey	2000	2	66.66
Total			233.32

REQUESTED APPROVAL DATE: November, 2017

NAME OF PRA ANALYST & PROGRAM CONTACT:

PRA Analyst:

Ila S. Mizrachi

Office of Operations

U.S. Food and Drug Administration

Three White Flint North

10A63

North Bethesda, MD 20852

301-796-7726, [email protected]

Program Contact:

Linda Verrill, Ph.D.

Consumer Studies Branch

Center for Food Safety and Applied Nutrition

U.S. Food and Drug Administration

5001 Campus Drive, Rm 2C-095, HFS-013

College Park, MD 20740

240-402-1765, [email protected]

FDA CENTER: CFSAN

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