Recordkeeping and Records Access Requirements for Food Facilities

Forms and Documents

Document Name	Status
0560 Food Records SSA REV for Traceabililty Rule 2020.docx Supporting Statement A	2020-11-18
Reference 26 - FDA - PRIA - Docket No. FDA-2014-N-0053 - September 2020.pdf Supplementary Document	2020-11-18

IC Document Collections

IC ID	Document Title	Status
6282	Records Maintenance	Unchanged
244530	Traceability Additional Records	New
244529	One time Traceability Additional Records	New
183803	Recordkeeping : New Firms-Learning of Regulatory Requirements and Understanding of Records for Compliance with the B.T. Act of 2002	Unchanged

ICR Details

OMB Control No: 0910-0560	ICR Reference No: 202011-0910-006
Status: Historical Inactive	Previous ICR Reference No: 202009-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Recordkeeping and Records Access Requirements for Food Facilities
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 12/21/2020
	Date Received in OIRA: 11/18/2020
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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	10/31/2023
Responses	398,468	0	398,468
Time Burden (Hours)	2,593,837	0	2,593,837
Cost Burden (Dollars)	0	0	0

---

Abstract: This request collects information regarding the maintenance of records by persons (domestic and foreign) who manufacturer, process, pack, transport, distribute, receive, hold or import food or food packaging. It was implemented under The Bioterrorism Act to further ensure the safety of food.

---

Authorizing Statute(s): US Code: 21 USC 301 et. seq. Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI44	Proposed rulemaking	85 FR 59984	09/23/2020

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Records Maintenance
Recordkeeping : New Firms-Learning of Regulatory Requirements and Understanding of Records for Compliance with the B.T. Act of 2002
One time Traceability Additional Records
Traceability Additional Records

---

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: We are proposing to revise the information collection to correspond with amendments to regulatory requirements.

---

Annual Cost to Federal Government: $491,900

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

---

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: 11/18/2020

---