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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices f. FDA consider modifying the survey to include trends for hot-holding and online delivery due to the COVID19
pandemic.
The Academy also provided comments related to statistical analysis and data sharing:
g. FDA make the dataset public for further analysis.
h. FDA consider peer review of the report.
Response FDA thanks the submitter for their comments and appreciates their support. Regarding general areas of the study, FDA provides the following responses:
a. The current 10-year study estimates 90 minutes as the average time needed to adequately collect necessary information, taking into account both small and large facilities. This average time is consistent with the amount of time burden estimated for the previous data collection periods and provides a sufficient timeframe to observe food safety practices and procedures that are the focus of the study.
b. Based on the methodology of the study, the information collection is performed during hours of operation of the randomly selected facility. Data collections are scheduled at times that provide the best opportunity to observe food preparation activities, which often include peak operations.
c. Information collection related to handwashing and no bare hand contact with ready-to-eat foods, which may include use of gloves, is based on assessment of observations against the most current addition of the FDA Model Food Code. Provisions of the FDA Food Code identify when handwashing and no bare hand contact with ready-to-eat food are required during food preparation and service. The current FDA Food Code does not recognize the use of hand antiseptics in lieu of handwashing during food preparation and service.

d. The scope of this data collection focuses on foodborne illness risk factors and does not include assessment of expiration dates of manufactured foods as part of this research assessment.
Related to foodservice operations at the retail level, FDA provides the following responses:
e. The study design accounts for a variety of food conveyances in the retail food setting. The study includes four major segments of the retail and foodservice industries that account for over a million varied and diverse types of operations in the United States:
Restaurants Healthcare Facilities Schools K12
Retail Food Stores Related to the Academys comments on pandemic-related considerations, FDA provides the following response:
f. The study design is based on operations regardless of extenuating circumstances. While there is utility in investigating the trends in food service, this study must focus its efforts throughout the 10-year period to ensure data can be adequately trended. Two of the three data collections for this trending were already complete before the pandemic and a singular data point with these new metrics would not be of much utility. FDA fully supports the New Era of Smarter Food Safety blueprint and endeavors to collect data to support that effort.
Regarding statistical analysis and data sharing, FDA provides the following responses:
g. FDA strives to ensure the data is available to parties upon request.
Additionally, a new Topline Summary is published to https www.fda.gov/
food/retail-food-protection/retail-foodrisk-factor-study along with the technical report, with much of the data commonly requested for independent analysis.
h. FDA acknowledges the benefit of peer review. For any manuscripts
published resulting from the dataset, peer review is sought. For the technical report of the data, FDA will continue to utilize the format which is familiar to and accepted by our stakeholders.
To calculate the estimate of the hours per response, FDA will use the average data collection duration for the same facility types during the 20152016 data collection. FDA estimates that it will take the persons in charge of full-service restaurants and fast-food restaurants 104
minutes 1.73 hours and 82 minutes 1.36 hours, respectively, to accompany the data collectors while they complete Sections 1 and 3 of the form. In comparison, for the 20172018 data collection, the burden estimate was 106
minutes 1.76 hours in full-service restaurants and 73 minutes 1.21 hours in fast-food restaurants. FDA estimates that it will take the program director or designated individual of the respective regulatory authority 30 minutes 0.5
hours to answer the questions related to Section 2 of the form. This burden estimate is unchanged from the last data collection. Hence, the total burden estimate for a data collection in a fullservice restaurant, including both the program directors and the person in charges responses, is 134 minutes 104
+ 30 2.23 hours. The total burden estimate for a data collection in a fastfood restaurant, including both the program directors and the person in charges responses, is 112 minutes 82 +
30 1.86 hours.
Based on the number of entry refusals from the 20172018 data collection, we estimate a refusal rate of 2 percent for the data collections within restaurant facility types. The estimate of the time per non-respondent is 5 minutes 0.08
hours for the person in charge to listen to the purpose of the visit and provide a verbal refusal of entry.
FDA estimates the burden of this collection of information as follows:

TABLE 2ESTIMATED ANNUAL REPORTING BURDEN 1

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Activity
Number of respondents
20212022 Data Collection Fast-Food RestaurantsCompletion of Sections 1 and 3
20212022 Data Collection Full-Service RestaurantsCompletion of Sections 1 and 3

VerDate Sep<11>2014

19:19 Jul 28, 2021

Number of responses per respondent
Total annual responses
Number of nonrespondents
Number of responses per nonrespondent
Total annual nonresponses
Average burden per response
Total hours
400

1

400

1.36

544

400

1

400

1.73

692

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