OMB approval 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: FDA Food Industry Survey for Coronavirus Disease 2019 (COVID-19) Related Materials

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

The Food and Drug Administration (FDA) has developed several guidances, checklists, and other tools to help food facilities safely continue operations and prevent potential disruptions in food supply chains during the COVID-19 pandemic. The voluntary FDA Food Industry Customer Satisfaction Survey for COVID-19 Related Materials would enable FDA to: (1) determine customer awareness of, and satisfaction with, FDA’s COVID-19 related guidances and other tools for the food industry; (2) identify and monitor trends around specific areas of satisfaction or dissatisfaction; (3) identify and address areas of unmet need; and (4) identify process improvements to increase the quality of FDA’s customer service.

Supporting references include:

• Food Safety and the Coronavirus Disease 2019

• Food and Agriculture: Considerations for Prioritization of PPE, Cloth Face Coverings, Disinfectants, and Sanitation Supplies During the COVID-19 Pandemic

• Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency

FDA began conducting this survey in December 2020, under a prior approval by OMB on 11/16/2020.

2. Intended use of information:

Results from the survey will be used to improve FDA resources for regulated food facilities that may be experiencing COVID-19 related impacts on operations. We also intend to use the results of the survey to enhance our outreach, improve our engagement with stakeholders, and better disseminate information to food facilities during the COVID-19 pandemic. The information collection will be used for these internal purposes and will not to influence policy or rulemaking.

Of the 4,171 registered food facilities that responded to the survey from December 2020 to date, 52 percent (n=2,151) of respondents were aware of FDA’s COVID-19 related resources for the food industry and 34 percent (n=1,400) were aware that FDA-regulated food facilities can request technical assistance from FDA on continuing or restarting safe food production during the pandemic. We continue to monitor survey respondent feedback to identify any areas of unmet needs and specific areas of satisfaction or dissatisfaction.

3. Description of respondents:

Respondents will be FDA-registered food facilities in areas that are experiencing a rise in COVID-19 cases or in areas that are expected to experience a rise in COVID-19 cases. Respondents will be contacted using telephone numbers and email addresses maintained in FDA databases.

4. Date(s) to be conducted:

FDA plans to launch the survey one business day after OMB approval and will proceed as described in the Burden Computation section below, until a maximum of 15,000 registered food facilities are contacted annually during the COVID-19 pandemic.

5. How the Information is being collected:

Surveys will be conducted electronically (administered by Survey Monkey) or by telephone (with FDA personnel contacting respondents and administering a short survey). Providing flexibility to administer the surveys in using both methods will allow FDA to better manage limited agency resources and more nimbly adapt its collection methods as appropriate to meet changing needs.

6. Confidentiality of Respondents:

Data will be kept secure to the fullest extent allowed by law.

The script includes the following statement, which will be read to participants:

“This call is not pre-announcing any inspections and is not a part of a regulatory inspection. Your participation or nonparticipation is completely voluntary. Your responses do not affect your eligibility for receipt of any FDA services and will not have an effect on future FDA inspections or your facility’s compliance status.”

7. Amount and justification for any proposed incentive

There is no proposed incentive being offered for completing this voluntary survey.

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

There are no questions of a sensitive nature being asked on the survey.

9. Description of Statistical Methods

The sample size for the survey is based on the number of FDA-regulated food facilities located in areas that are experiencing a rise in COVID-19 cases or in areas that are expected to experience a rise in COVID-19 cases. FDA will be conducting surveys of up to 15,000 FDA-regulated facilities and expects that at least 70% of the food facilities contacted will complete the survey. The information will be collected on a web-based form and analyzed using FDA computers.

BURDEN HOUR COMPUTATION:

Based on experience, FDA anticipates conducting a maximum of 15,000 surveys a year, representing the total number of responses collected electronically and by telephone. The survey takes approximately 10 minutes to complete (2,500 burden hours/year).

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
Food Industry	15,000	10	2,500

REQUESTED APPROVAL DATE: January 24, 2022

NAME OF PRA ANALYST & PROGRAM CONTACT:

Ila S. Mizrachi

Paperwork Reduction Act Staff

301-796-7726

[email protected]

Charlotte Christin

202-306-9390

[email protected]

FDA CENTER: Office of the Commissioner/Office of Food Policy and Response

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