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: International On-Farm Readiness Review (OFRR) Training Satisfaction Survey

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. As part of the agency’s ongoing efforts to implement FSMA, the Produce Safety Rule (PSR) established science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The final rule went into effect January 26, 2016. The standards apply to fresh produce grown domestically, as well as fresh produce imported to the United States from foreign countries.  

The FDA has established the Produce Safety Network to support the efforts of farmers and other key stakeholders with complying with the Produce Safety Rule. One of the resources available to farmers is the On-Farm Readiness Review (OFRR) program. OFRR provides farmers real-time feedback on their current operations and facilities. These reviews can help farmers address any areas in need of improvement before a regulatory inspection takes place in the future. As part of this program for advance, readiness reviews, food safety professionals conduct voluntary, non-regulatory visits to farms and packinghouses. Their goal is to observe current practices and provide feedback on how those practices can be strengthened to better align with regulatory expectations. These reviews are not inspections.

Given the significant volume of imported produce, FDA uses this On-Farm Readiness Review tool for farms exporting fresh produce to the United States, to support farmers in achieving compliance with the PSR. In Latin America, FDA is providing OFRR training to foreign government personnel and university personnel. The training will enable foreign government and university personnel to offer OFRR to farmers in Latin America.

To assess foreign trainees’ satisfaction with the FDA international OFRR training and to make necessary adjustments to the training content, FDA has developed an International OFRR Training Satisfaction Survey. The survey asks trainees’ satisfaction with the training, trainees’ self-identified knowledge on PSR, whether the information provided during the training was easy to understand, areas for improvements, and general feedback on the training.

2. Intended use of information:

The satisfaction survey will serve as a formative testing. The results of the survey will be used to help FDA make needed improvements to future OFRR trainings. As such, FDA can ensure the foreign government and university personnel receive effective education and information and further provide support to foreign farmers for the implementation of the PSR under FSMA.

3. Description of respondents:

Responding to the International OFRR Training Satisfaction Survey will be completely voluntary. Respondents will be trainees of international OFRR trainings - foreign government and university personnel who are over 18 years old.

4. Date(s) to be Conducted:

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

For Fiscal Year 2020, the anticipated dates for trainings are November 12-15, 2019 (training will be provided in Chile) and March 16-20, 2020 (training will be provided in Mexico). These dates are contingent on corresponding approvals.

5. How the Information is being collected:

A 3^rd party contractor (University Extension Services) will help to administer the survey and collect data. Attendees of the international OFRR trainings will be notified at the beginning of their training about the data collection. Trainees who are willing to voluntarily take the survey will be recruited. At the last session of the training, recruited respondents will be instructed to complete the training satisfaction survey on paper.

The International OFRR Training Satisfaction Survey will be translated and administrated in the official language of the country where the training will be provided. For the FY 2020 trainings in Chile and Mexico, the survey will be translated and administrated in Spanish.

Estimated response rate would be 80% or higher.

6. Confidentiality of Respondents:

Respondents will complete the satisfaction survey anonymously. No Personally Identifiable Information (PII) will be collected.

The following language will be included on the survey:

“Your participation / nonparticipation 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-respondents), this information collection’s data will be kept secure to the fullest extent allowed by law.”

7. Amount and justification for any proposed incentive

No incentives will be offered to respondents of the International OFRR Training Satisfaction Survey.

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

None.

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 questions.

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)
OFRR Satisfaction Survey	150	12	30

REQUESTED APPROVAL DATE: November, 2019

NAME OF PRA ANALYST & PROGRAM CONTACT:

Ila S. Mizrachi

Ila.Mizrachi@fda.hhs.gov

301-796-7726

Program Contact: Fanfan, Ph.D.

Fanfan.Wu@fda.hhs.gov

240-402-1808

FDA CENTER: Center for Food Safety and Applied Nutrition

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