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

Forms and Documents

Document Name	Status
0744 Supporting Statement Part A 2024 (1).docx Supporting Statement A	2024-08-23
0744_Supporting Statement Part B 2024.docx Supporting Statement B	2024-08-23
ICR Attachment E_CDC-FDA Data Collection Collaboration.pdf Supplementary Document	2024-08-30
ICR Attachment D_Intro Letter combined 0744.pdf Supplementary Document	2024-08-30
ICR Attachment A_RiskFactorStudy_Protocol_ 2-22-24.pdf Supplementary Document	2024-08-30

IC Document Collections

IC ID	Document Title	Status
264415	Retail Food Stores - Form FDA 3967 Instruction	New
207991	Refusal Other-Instructions	Modified
207990	Fast-Food and Full-Service Restaurants--Form FDA 3966 Other-Instructions	Modified
204849	2021-2022 - Full Service Restaurants - Completion of Sections 1 and 3 Other-Instructions	Removed
204848	2021-2022 - Fast Food Restaurants - Completion of Sections 1 and 3 Other-Instructions	Removed

ICR Details

OMB Control No: 0910-0744	ICR Reference No: 202401-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202106-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/30/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	824	1,616
Time Burden (Hours)	1,602	1,637
Cost Burden (Dollars)	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.

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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: 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:
	89 FR 15996	03/06/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 70652	08/30/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
2021-2022 - Fast Food Restaurants - Completion of Sections 1 and 3
2021-2022 - Full Service Restaurants - Completion of Sections 1 and 3
Fast-Food and Full-Service Restaurants--Form FDA 3966	FDA 3966	Restaurant Data Collection Record
Refusal	FDA 3967, FDA 3966	Retail Food Store Data Collection Form ,   Restaurant Data Collection Record
Retail Food Stores - Form FDA 3967	FDA 3967	Retail Food Store Data Collection Form

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ICR Summary of Burden

	Total Request	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	824	1,616	0	0	-792	0
Annual Time Burden (Hours)	1,602	1,637	0	0	-35	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: Based on a review of the information collection since our last request for OMB approval, we have made adjustments to our burden estimate. On our own initiative, however, and for efficiency of Agency operations, we are revising the information collection to include and consolidate related information collection found in 0910-0799. Our estimated burden for the information collection reflects a decrease of 35 total burden hours and a corresponding decrease of 792 total annual responses.

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Annual Cost to Federal Government: $531,776

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 08/30/2024

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