Sanitary Transportation of Human and Animal Food

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Sanitary Transportation of Human and Animal Food SS Part A 23 JUNE 2014.doc	Supporting Statement A	Uploaded 2014-06-23	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
211879	Training records under 1.910(b)		New
211877	Disclosure of bulk cleaning under 1.908(d)(5)		New
211876	Disclosure of previous cargoes under 1.908(d)(4)		New
211875	Temperature disclosure under 1.908(d)(2)(i)		New
211874	Necessary temperature conditions under 1.908(b)(3)		New
211873	Sanitation requirements under 1.908(b)(1)		New
211870	Records pertaining to disclosure of information (first year only)		New
211869	Training Records (first year only)		New
211868	Written procedures; bulk vehicles (first year only)		New
211867	Written procedures; temperature control (first year only)		New
211866	Written procedures, cleaning and sanitation (first year only)		New
211865	Agreement regarding disclosure of bulk vehicle cleaning (first year only)		New
211864	Agreement regarding disclosure of previous cargoes (first year only)		New
211861	Agreement establishing responsibility for temperature monitoring (first year only)		New
211855	Written Sanitation Requirements (first year only)		New
211853	Waiver Petitions		New
211852	Waiver Petitions (first year only)		New

ICR Details

OMB Control No: 0910-0773	ICR Reference No: 201406-0910-007
Status: Historical Inactive	Previous ICR Reference No:
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: Comment filed on proposed rule	Conclusion Date: 08/27/2014
	Date Received in OIRA: 06/25/2014
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The Food and Drug Administration is proposing to establish 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).

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG98	Proposed rulemaking	79 FR 2005	02/05/2014

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 17

table that charts list of burden

IC Title	Form No.	Form Name
Records pertaining to disclosure of information (first year only)
Necessary temperature conditions under 1.908(b)(3)
Disclosure of previous cargoes under 1.908(d)(4)
Training records under 1.910(b)
Waiver Petitions
Written Sanitation Requirements (first year only)
Disclosure of bulk cleaning under 1.908(d)(5)
Waiver Petitions (first year only)
Temperature disclosure under 1.908(d)(2)(i)
Sanitation requirements under 1.908(b)(1)
Agreement establishing responsibility for temperature monitoring (first year only)
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)
Written procedures; bulk vehicles (first year only)
Training Records (first year only)

---

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 associated with a proposed rule.

---

Annual Cost to Federal Government: $43,090

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

---

Common Form ICR:  No

---

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: 06/25/2014

---