Sanitary Transportation of Human and Animal Food

Forms and Documents

Document Name	Status
0773 Sanitary Transportation SSA 2022 Ext.docx Supporting Statement A	2022-06-28

IC Document Collections

IC ID	Document Title	Status
211879	RECORDKEEPING; Required record retention (1.912)	Modified
211873	THIRD PARTY DISCLOSURE: Transportation Operations; sanitary specifications, operating temperature conditions	Modified
211853	REPORTS; Waiver Petitions	Modified

ICR Details

OMB Control No: 0910-0773	ICR Reference No: 202206-0910-007
Status: Received in OIRA	Previous ICR Reference No: 201903-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Sanitary Transportation of Human and Animal Food
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/28/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2022
Responses	1,502,260	1,502,260
Time Burden (Hours)	124,848	124,848
Cost Burden (Dollars)	0	3,845,407

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Abstract: The Food and Drug Administration is establishing requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the FDA Food Safety Modernization Act of 2011 (FSMA).

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Authorizing Statute(s): US Code: 21 USC 371(a) et al. Name of Law: Food, Drug, & Cosmetic Act
  

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:
	87 FR 10369	02/24/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 36133	06/15/2022
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
RECORDKEEPING; Required record retention (1.912)
REPORTS; Waiver Petitions
THIRD PARTY DISCLOSURE: Transportation Operations; sanitary specifications, operating temperature conditions

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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	1,502,260	1,502,260	0	0	0	0
Annual Time Burden (Hours)	124,848	124,848	0	0	0	0
Annual Cost Burden (Dollars)	0	3,845,407	0	0	-3,845,407	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:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     No

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: 06/28/2022

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