Requirements to Notify FSIS of Adulterated or Misbranded Products, Prepare and Maintain Written Recall Procedures, and Document Certain HACCP Plan Reassessments

Forms and Documents

Document Name	Status
Form 5720-16 Notification, Documentation, and Recordkeeping Form	Modified
supporting statement notification documentation and recordkeeping072021.docx Supporting Statement A	2021-07-22

IC Document Collections

IC ID	Document Title	Status
188892	Notification, Documentation, and Recordkeeping Form	Modified

ICR Details

OMB Control No: 0583-0144	ICR Reference No: 202103-0583-006
Status: Received in OIRA	Previous ICR Reference No: 201904-0583-001
Agency/Subagency: USDA/FSIS	Agency Tracking No:
Title: Requirements to Notify FSIS of Adulterated or Misbranded Products, Prepare and Maintain Written Recall Procedures, and Document Certain HACCP Plan Reassessments
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/02/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2021
Responses	42,900	39,960
Time Burden (Hours)	9,960	47,475
Cost Burden (Dollars)	0	0

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Abstract: To collect information related to the notification of FSIS of adulterated or misbranded product, the development and maintenance of recall procedures, and the documentation of HACCP plan reassessments.

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Authorizing Statute(s): PL: Pub.L. 110 - 246 11017 Name of Law: Food, Conservation, and Energy 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:
	86 FR 19214	04/13/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 41434	08/02/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Notification, Documentation, and Recordkeeping	5720-16	Industry Report of Adulteration

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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	42,900	39,960	0	0	2,940	0
Annual Time Burden (Hours)	9,960	47,475	0	0	-37,515	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: There is a decrease in the overall burden hours from 47,474 hours to 9,960 hours due to decrease in the estimated number of respondents that develop recall procedures. There is also an increase in the number of responses from 39,960 to 42,900 due to the increased number of notifications of adulterated or misbranded product that occur with better of information technology data collection tools.

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Annual Cost to Federal Government: $50,120

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: 08/02/2021

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