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

Forms and Documents

Document Name	Status
NCFPD Risk Factor Study IT Project 5-8-12 .pdf Supplementary Document	2013-05-13
SUPPORTING STATEMENT Part B FOODBORNE IRFSR 7-18-13.doc Supporting Statement B	2013-07-31
INTRODUCTORY LETTER 5-8-13.doc Supplementary Document	2013-05-13
PROTOCOL FOODBORNE ILLNESS 5-8-13.doc Supplementary Document	2013-05-13
SUPPORTING STATEMENT Part A FOODBORNE IFSFR 7-18-13.doc Supporting Statement A	2013-07-31

IC Document Collections

IC ID	Document Title	Status
207995	FY14 Baseline Data Collection Entry Refusals – All Facility Types Other-Survey	New
207994	FY14 Baseline Data Collection – Completion of Section 2 – All Facility Types Other-Survey	New
207993	FY14 Baseline Data Collection (Full Service Restaurants) – Completion of Sections 1 and 3 Other-Survey	New
207992	FY14 Baseline Data Collection (Fast Food Restaurants) – Completion of Sections 1 and 3 Other-Survey	New
207991	FY13 Pilot – Entry Refusals – All Facility Types Other-Survey	New
207990	FY13 Pilot – Completion of Section 2 – All Facility Types Other-Survey	New
204849	FY13 Pilot – Completion of Sections 1 and 3 – Full Service Facility Type Other-SURVEY	New
204848	FY13 Pilot – Completion of Sections 1 and 3 – Fast Food Facility Type Other-SURVEY	New

ICR Details

OMB Control No: 0910-0744	ICR Reference No: 201211-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013)
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 with change	Conclusion Date: 08/06/2013
	Date Received in OIRA: 11/15/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB approves this collection of information for a period of two years. We note, however, that there may be areas of overlap and room for coordination with existing CDC collections on foodborne illness. Before submitting any similar collections to OMB for approval, FDA should work with CDC to determine whether it is possible to combine some or all of these questions into a single study. FDA should submit a report of this investigation to OMB. Further, we note that all future collections of information regarding investigations of foodborne illness should be submitted for PRA approval, regardless of whether the exact questions being asked are identical.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved
Responses	1,810	0	0
Time Burden (Hours)	1,767	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) is proposing a voluntary survey to measure trends in the occurrence of foodborne illness risk factors in nine select retail and foodservice facility types. The data will be used to determine the following: foodborne illness risk factors that are in most need of priority attention during each data collection period; trends of improvement or regression in foodborne illness risk factor occurrence over time; potential correlations between operational aspects of the industry; potential correlations between elements within regulatory retail food protection programs; and the impact of industry food safety management systems in controlling the occurrence of foodborne illness risk factors.

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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:
	77 FR 36544	06/19/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 65555	10/29/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
FY13 Pilot – Completion of Section 2 – All Facility Types
FY13 Pilot – Entry Refusals – All Facility Types
FY14 Baseline Data Collection (Fast Food Restaurants) – Completion of Sections 1 and 3
FY14 Baseline Data Collection (Full Service Restaurants) – Completion of Sections 1 and 3
FY14 Baseline Data Collection – Completion of Section 2 – All Facility Types
FY14 Baseline Data Collection Entry Refusals – All Facility Types
FY13 Pilot – Completion of Sections 1 and 3 – Fast Food Facility Type
FY13 Pilot – Completion of Sections 1 and 3 – Full Service Facility Type

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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	1,810	0	0	1,810	0	0
Annual Time Burden (Hours)	1,767	0	0	1,767	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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.

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Annual Cost to Federal Government: $236,308

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: 11/15/2012

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