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OMB Control No: 0910-0799	ICR Reference No: 201506-0910-021
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Survey on the Occurrence of Foodborne Illness Risks Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/29/2015
	Date Received in OIRA: 06/25/2015
Terms of Clearance: When the Program is ready for the 2019 collection (and future iterations), a reinstatement of this ICR should be submitted to continue the collection under the same OMB control number.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved
Responses	2,424	0	0
Time Burden (Hours)	3,602	0	0
Cost Burden (Dollars)	0	0	0

Abstract: This ICR collects information on the occurrence of foodborne illness risk factors in select healthcare facilities, schools (K-12), and retail food stores. 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 will enter the information into a secure web-based data platform. For the 2015-2016 data collection, FDA plans to pilot the use of handheld technology for collecting the data on-site during the data collection visits. 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.

Authorizing Statute(s): US Code: 42 USC 243 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: Economic Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 75158	12/17/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 36367	06/19/2015
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	2,424	2,424
Annual Time Burden (Hours)	3,602	3,602
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

Annual Cost to Federal Government: $317,740

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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