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

Forms and Documents

Document Name	Status
ATTACHMENT E FINAL CDC-FDA DATA COLLECTION COLLABORATION MATRIX 7-30-2015.doc Supplementary Document	2015-07-31
ATTACHMENT D INDUSTRY INTRODUCTORY LETTER 7-30-2015.doc Supplementary Document	2015-07-31
ATTACHMENT A STUDY PROTOCOL 7-30-2015.doc Supplementary Document	2015-07-31
SUPPORTING STATEMENT PART B 0744 FINAL 7-30-2015.doc Supporting Statement B	2015-07-31
SUPPORTING STATEMENT PART A 0744 FINAL 7-30-2015.doc Supporting Statement A	2015-07-31

IC Document Collections

IC ID	Document Title	Status
207995	FY14 Baseline Data Collection Entry Refusals – All Facility Types Other-Survey	Removed
207994	FY14 Baseline Data Collection – Completion of Section 2 – All Facility Types Other-Survey	Removed
207993	FY14 Baseline Data Collection (Full Service Restaurants) – Completion of Sections 1 and 3 Other-Survey	Removed
207992	FY14 Baseline Data Collection (Fast Food Restaurants) – Completion of Sections 1 and 3 Other-Survey	Removed
207991	2017-2018 - Refusals – All Facility Types Other-Survey	Modified
207990	2017-2018 - Completion of Section 2 – All Facility Types Other-Survey	Modified
204849	2017-2018 - Full Service Restaurants - Completion of Sections 1 and 3 Other-Survey	Modified
204848	2017-2018 - Fast Food Restaurants - Completion of Sections 1 and 3 Other-Survey	Modified

ICR Details

OMB Control No: 0910-0744	ICR Reference No: 201507-0910-012
Status: Historical Active	Previous ICR Reference No: 201211-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2015
	Date Received in OIRA: 08/18/2015
Terms of Clearance: 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
Expiration Date	09/30/2018	36 Months From Approved	09/30/2015
Responses	1,616	0	1,810
Time Burden (Hours)	1,637	0	1,767
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 73596	12/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 43096	07/21/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
2017-2018 - Completion of Section 2 – All Facility Types
2017-2018 - Refusals – All Facility Types
FY14 Baseline Data Collection (Full Service Restaurants) – Completion of Sections 1 and 3
FY14 Baseline Data Collection Entry Refusals – All Facility Types
2017-2018 - Fast Food Restaurants - Completion of Sections 1 and 3
2017-2018 - Full Service Restaurants - Completion of Sections 1 and 3
FY14 Baseline Data Collection (Fast Food Restaurants) – Completion of Sections 1 and 3
FY14 Baseline Data Collection – Completion of Section 2 – All Facility Types

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ICR Summary of Burden

	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

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $257,244

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

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 08/18/2015

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