Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013)

ICR 201507-0910-012

OMB: 0910-0744

Federal Form Document

Forms and Documents
ICR Details
0910-0744 201507-0910-012
Historical Active 201211-0910-005
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013)
Extension without change of a currently approved collection   No
Approved without change 09/28/2015
Retrieve Notice of Action (NOA) 08/18/2015
OMB continues to encourage FDA to work with CDC to find opportunities to minimize burden and combine collections when possible.
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved 09/30/2015
1,616 0 1,810
1,637 0 1,767
0 0 0

This ICR collects information on the occurrence of foodborne illness risk factors in full service and fast food restaurants. Foodborne illness risk factors are defined as the preparation practices and employee behaviors most commonly reported to the Centers for Disease Control and Prevention (CDC) as contributing factors to foodborne illness outbreaks at the retail level. They include: • Food from Unsafe Sources. • Poor Personal Hygiene. • Inadequate Cooking. • Improper Holding/Time and Temperature. • Contaminated Equipment/Protection from Contamination. The objectives of the study are to: • Identify the foodborne illness risk factors that are in most need of priority attention during each data collection period. • Track trends in the occurrence of foodborne illness risk factors over time. • Examine potential correlations between operational characteristics of food establishments and the control of foodborne illness risk factors. • Examine potential correlations between elements within regulatory retail food protection programs and the control of foodborne illness risk factors. • Evaluate the impact of industry food safety management systems in controlling the occurrence of foodborne illness risk factors. FDA Retail Food Specialists collect the information during site visits of randomly selected establishments. The data collection method involves interviews, observations, and record reviews. Data collectors enter the information into a web-based data platform from handheld tablet computers. Participation by industry is voluntary. FDA uses the study to: • Inform agency retail food safety policies and initiatives. • Identify retail food work plan priorities and allocate resources to enhance retail food safety nationwide. • Provide stakeholders with information about changes in the occurrence of foodborne illness risk factors in retail and foodservice establishments over time. • Inform recommendations on best practices and targeted intervention strategies for the retail and foodservice industry and state, local, and tribal regulators.

US Code: 42 USC 243,Section 311(a) Name of Law: Public Health Service Act
   US Code: 21 USC 301 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 31 USC 1535 Name of Law: The Economy Act of 1932

Not associated with rulemaking

  79 FR 73596 12/11/2014
80 FR 43096 07/21/2015

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,616 1,810 0 0 -194 0
Annual Time Burden (Hours) 1,637 1,767 0 0 -130 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The only program change is that rather than into data using pencil and paper and later entering the info in ACCESS database, the data collectors will now be entering data into a web-based platform from secured FDA handheld computers. A slight adjustment to the burden has also been made. Using the average data collection times during the 2013-2014 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), respectfully, to accompany the data collectors while they complete Sections 1 and 3 of the form. In comparison, for the 2013-2014 data colllection, the burden estimate was 106 minutes (1.76 hours) in full service restaruants and 73 minutes (1.21 hours) in fast food restaurants.

Yes Part B of Supporting Statement
Ila Mizrachi 301 796-7726 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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