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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
Specialists. Given that participation in the study by industry is voluntary and the status of any given randomly selected establishment is subject to change, substitute establishments have been selected for each Specialist for cases where the restaurant facility is misclassified, closed, or otherwise unavailable, unable, or unwilling to participate.
Prior to conducting the data collection, Specialists contact the State or local jurisdiction that has regulatory responsibility for conducting retail food inspections for the selected establishment. The Specialist verifies with the jurisdiction that the facility has been properly classified for the purposes of the study and is still in operation. The Specialist ascertains whether the selected facility is under legal notice from the State or local regulatory authority. If the selected facility is under legal notice, the Specialist will not conduct a data collection, and a substitute establishment will be used. An invitation is extended to the State or local regulatory authority to accompany the Specialist on the data collection visit.
A standard form is used by the Specialists during each data collection.
The form is divided into three sections:
Section 1Establishment Information; Section 2Regulatory Authority Information; and Section 3
Foodborne Illness Risk Factor and Food Safety Management System Assessment. The information in Section 1 Establishment Information of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions.
The information in Section 2
Regulatory Authority Information is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment.
Section 3Foodborne Illness Risk Factor and Food Safety Management System Assessment includes three parts: Part A for tabulating the Specialists observations of the food employees behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management system being implemented by the facility; and Part C for assessing the frequency and extent of food employee handwashing. The information in Part A is collected from the Specialists direct observations of food employee behaviors and practices.

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Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed.
The information in Part B is collected by making direct observations and asking followup questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee handwashing. No questions are asked in the completion of Section 3, Part C of the form.
FDA collects the following information associated with the establishments identity: Establishment name, street address, city, State, ZIP
Code, county, industry segment, and facility type. The establishmentidentifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected.
Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.
FDA has collaborated with the Food Protection and Defense Institute to develop a web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. This platform is accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies.
For the 20152016 data collection, FDA
piloted the use of hand-held technology for capturing the data onsite during the data collection visits. The tablets that were made available for the data collections were part of a broader Agency initiative focused on internal uses of hand-held technology. The tablets provided for the data collection presented several technical and logistical challenges and increased the time burden associated with the data collection as compared to the manual entry of data collections. For these reasons, FDA will not be further evaluating hand-held technology in subsequent data collections during the 10-year study period.
When a data collector is assigned a specific establishment, he or she conducts the data collection and enters the information into the web-based data platform. The interface will support the manual entering of data, as well as the ability to directly enter information in the database via a web browser.
The burden for the 20212022 data collection is as follows. For each data
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collection, the respondents will include:
1 The person in charge of the selected facility whether it be a fastfood or fullservice restaurant; and 2 the program director or designated individual of the respective regulatory authority. In order to provide the sufficient number of observations needed to conduct a statistically significant analysis of the data, FDA has determined that 400 data collections will be required in each of the two restaurant facility types.
Therefore, the total number of responses will be 1,600 400 data collections 2
facility types 2 respondents per data collection.
The burden associated with the completion of Sections 1 and 3 of the form is specific to the persons in charge of the selected facilities. The burden includes the time it will take the person in charge to accompany the data collector during the site visit and answer the data collectors questions.
The burden related to the completion of Section 2 of the form is specific to the program directors or designated individuals of the respective regulatory authorities. The burden includes the time it will take to answer the data collectors questions and is the same regardless of the facility type.
In the Federal Register of March 16, 2021 86 FR 14433, FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two comments; only one comment we received was responsive to the four collection of information topics solicited.
Comment The Academy of Nutrition and Dietetics the Academy commented that they support the proposed information collection for the survey on the occurrence of foodborne illness risk factors in various settings. The Academy provided comments pertaining to the following general areas of the study:
a. Question whether 90 minutes is adequate for surveying larger facilities.
b. Request FDA evaluate the impact of conducting surveys during peak hours of operation.
c. Suggest that the use of gloves is not adequately addressed in the survey.
d. Encourage continued efforts to simplify and standardize expiration dates.
Related to foodservice operations at the retail level, the Academy provided the following comments:
e. FDA consider modifying the survey to account for new foods and new means of conveying food.
The Academy provided the following comment specific to pandemic-related considerations:

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