Sanitary Transportation of Human and Animal Food

Forms and Documents

Document Name	Status
0773 Sanitary Transportation FR SS 2016.pdf Supporting Statement A	2016-04-20

IC Document Collections

IC ID	Document Title	Status
211879	RECORDKEEPING; Training records	Modified
211877	Disclosure of bulk cleaning under 1.908(d)(5)	Removed
211876	Disclosure of previous cargoes under 1.908(d)(4)	Removed
211875	Temperature disclosure under 1.908(d)(2)(i)	Removed
211874	Necessary temperature conditions under 1.908(b)(3)	Removed
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	Modified
211869	Training Records (first year only)	Removed
211868	Written procedures; bulk vehicles (first year only)	Removed
211867	Written procedures; temperature control (first year only)	Removed
211866	Written procedures, cleaning and sanitation (first year only)	Removed
211865	Agreement regarding disclosure of bulk vehicle cleaning (first year only)	Removed
211864	Agreement regarding disclosure of previous cargoes (first year only)	Removed
211861	Agreement establishing responsibility for temperature monitoring (first year only)	Removed
211855	RECORDKEEPING First Year Only; developing written procedures	Modified
211853	REPORTS; Waiver Petitions	Modified
211852	REPORTS First Year Only; Waiver Petitions	Modified

ICR Details

OMB Control No: 0910-0773	ICR Reference No: 201604-0910-006
Status: Historical Active	Previous ICR Reference No: 201406-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Sanitary Transportation of Human and Animal Food
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 without change	Conclusion Date: 06/08/2016
	Date Received in OIRA: 04/20/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	3,280,611	0	0
Time Burden (Hours)	375,265	0	0
Cost Burden (Dollars)	3,929,115	0	0

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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:
0910-AG98	Final or interim final rulemaking	81 FR 20091	04/06/2016

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Disclosure of bulk cleaning under 1.908(d)(5)
Agreement regarding disclosure of previous cargoes (first year only)
Agreement regarding disclosure of bulk vehicle cleaning (first year only)
Written procedures, cleaning and sanitation (first year only)
Written procedures; temperature control (first year only)
Training Records (first year only)
Disclosure of previous cargoes under 1.908(d)(4)
REPORTS; Waiver Petitions
RECORDKEEPING First Year Only; developing written procedures
REPORTS First Year Only; Waiver Petitions
Necessary temperature conditions under 1.908(b)(3)
Temperature disclosure under 1.908(d)(2)(i)
Agreement establishing responsibility for temperature monitoring (first year only)
THIRD PARTY DISCLOSURE: Transportation Operations; sanitary specifications, operating temperature conditions
Written procedures; bulk vehicles (first year only)
THIRD PARTY DISCLOSURE First Year Only; sanitary specifications, notification of operating temperature, disclosure records
RECORDKEEPING; Training records

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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	3,280,611	0	0	3,280,611	0	0
Annual Time Burden (Hours)	375,265	0	0	375,265	0	0
Annual Cost Burden (Dollars)	3,929,115	0	0	3,929,115	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $0

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

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: 04/20/2016

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