Justification Memo for OMB

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 Survey for FDA CFSAN Technical Assistance Network (TAN) web form for submitting 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 become 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; (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm). TAN subject matter experts respond to Web form users with answers to their questions.

The TAN needs to gather information from Web form users to gauge customer reaction to having used the TAN Web form to submit a FSMA query. Specifically, the TAN wants to know where the user learned about the Web form, whether the form instructions were clear, and users’ suggestions for improvements.

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. Based on responses to the Customer Satisfaction Survey, FDA TAN management will use the information to make needed improvements to the Web form.

3. Description of respondents:

Responding to the TAN FSMA Web form Customer Satisfaction Survey will be completely voluntary. Respondents will be individuals who access the TAN Web form to submit FSMA-related queries. 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:

This survey will be ongoing, beginning with OMB approval.

5. How the Information is being collected:

The information will be collected through a voluntary customer satisfaction survey administered online following Web form users submission of an online query to the FSMA TAN using the FSMA TAN Web form.

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 Appendix I for screenshots of the 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 Survey regarding the Web form will have no bearing in responses to FSMA Web form 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.  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 TAB Web form Customer Satisfaction Survey.

8. Questions of a Sensitive Nature (Data will be kept private to the extent allowed by the law)

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

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)
	5000	2	166.66

REQUESTED APPROVAL DATE: 09/01/2016

NAME OF PRA ANALYST & PROGRAM CONTACT:

PRA Analyst:

Ila S. Mizrachi

[email protected]

301-796-7726

Program Contact:

Linda Verrill, Ph.D.

Consumer Studies Branch

Center for Food Safety and Applied Nutrition

U.S. Food and Drug Administration

5100 Paint Branch Parkway, Rm 2C-095, HFS-013

College Park, MD 20740

240-402-1765, [email protected]

FDA CENTER: Center for Food Safety and Applied Nutrition

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