Sanitary Transportation of Human and Animal Food

Forms and Documents

Document	Type	Status	Availability
0773 Sanitary Transport SSA 2019 Ext.pdf	Supporting Statement A	Uploaded 2019-06-05	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
211879	RECORDKEEPING; Required record retention (1.912)		Modified
211873	THIRD PARTY DISCLOSURE: Transportation Operations; sanitary specifications, operating temperature conditions		Modified
211870	THIRD PARTY DISCLOSURE First Year Only; sanitary specifications, notification of operating temperature, disclosure records		Removed
211855	RECORDKEEPING First Year Only; developing written procedures		Removed
211853	REPORTS; Waiver Petitions		Modified
211852	REPORTS First Year Only; Waiver Petitions		Removed

ICR Details

OMB Control No: 0910-0773	ICR Reference No: 201903-0910-018
Status: Active	Previous ICR Reference No: 201604-0910-006
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/08/2019
	Date Received in OIRA: 06/05/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	07/31/2019
Responses	1,502,260	0	3,280,611
Time Burden (Hours)	124,848	0	375,265
Cost Burden (Dollars)	3,845,407	0	3,929,115

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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:
	84 FR 5807	02/20/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 25816	06/04/2019
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
THIRD PARTY DISCLOSURE: Transportation Operations; sanitary specifications, operating temperature conditions
RECORDKEEPING; Required record retention (1.912)
REPORTS First Year Only; Waiver Petitions
RECORDKEEPING First Year Only; developing written procedures
THIRD PARTY DISCLOSURE First Year Only; sanitary specifications, notification of operating temperature, disclosure records
REPORTS; Waiver Petitions

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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	1,502,260	3,280,611	0	0	-1,778,351	0
Annual Time Burden (Hours)	124,848	375,265	0	0	-250,417	0
Annual Cost Burden (Dollars)	3,845,407	3,929,115	0	0	-83,708	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 information collection reflects agency adjustments. Since last OMB review we have removed one-time burdens we previously attributed to implementation of the new regulations and realization of compliance dates. Because these milestones have been met, we have removed initial burden we ascribed to associated with activities. This results in an overall decrease to the information collection by 1,778,351 responses (from 3,280,611 to 1,502,260), by 250,416 burden hours (from 375,265 to 124,849), and by $83,708 in cost adjustments.

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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? 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: 06/05/2019

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