Request for IC Under Generic Clearance

UNITED STATES FOOD & DRUG ADMINISTRATION

REQUEST FOR INFORMATION COLLECTION

UNDER AN APPROVED GENERIC CLEARANCE

OMB Control No. 0910-0360: Customer Satisfaction Surveys

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) continues to develop and provide industry resources, including guidance documents, checklists, and other tools to help food facilities safely continue operations and prevent potential disruptions in the food supply chain during the COVID-19 public health emergency. We have prepared a voluntary FDA Food Industry Customer Satisfaction Survey for COVID-19 Related Materials intended to help FDA: (1) determine customer awareness of, and satisfaction with, FDA’s COVID-19 related guidance documents 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.

We began administering the survey on November 16, 2020, however initial collection methods were limited against the implementation of public health safety practices. As a result the survey was administered by telephone. We are now seeking to re-administer the survey to continue our efforts. We also continue to monitor survey respondent feedback to identify any areas of unmet needs, and to plan for a longer-term collection if this is determined to be appropriate.

2. Intended use of information:

Results from the survey are intended to inform the development of FDA resources for regulated food facilities that may be experiencing COVID-19 related impacts on operations. Results from the survey are also intended to inform outreach, improve our engagement with stakeholders, and facilitate the dissemination of information to food facilities impacted by COVID-19.

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, based on forecasting by the Centers for Disease Control and Prevention. 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 for the duration of the generic approval, as needed.

5. How the Information is being collected:

Although previous collection methods were limited to telephone, we are now able to administer the survey 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 Information Collected and Respondent Privacy:

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 remuneration:

No remuneration is provided to respondents of the information collection.

8. Questions of a Sensitive Nature:
   
   

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.

REFERENCE MATERIALS:

• 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

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)
Registered Food Facility (Industry)	15,000	10	2,500

REQUESTED APPROVAL DATE: March 2022

NAME OF PRA ANALYST & PROGRAM CONTACT:

Domini Bean

Paperwork Reduction Act Staff

301-796-7726

Domini.Bean@fda.hhs.gov

Charlotte Christin

202-306-9390

Charlotte.Christin@fda.hhs.gov

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