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
justificationchangerequest0583-0144.docx Justification for No Material/Nonsubstantive Change	2019-04-11
supporting statement notification documentation and recordkeeping2019.doc Supporting Statement A	2019-04-11

IC Document Collections

IC ID	Document Title	Status
188892	Notification, Documentation, and Recordkeeping	Unchanged

ICR Details

OMB Control No: 0583-0144	ICR Reference No: 201904-0583-001
Status: Active	Previous ICR Reference No: 201808-0583-002
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/17/2019
	Date Received in OIRA: 04/17/2019
Terms of Clearance: Upon the next revision, the agency will report to OMB the proportion of notifications submitted through PHIS versus verbal notification.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	09/30/2021	09/30/2021
Responses	39,960	0	39,960
Time Burden (Hours)	47,475	0	47,475
Cost Burden (Dollars)	0	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. The non-substantive change request is to add details to Supporting Statement A regarding the estimate of burden for notification of adulterated or misbranded product (9 CFR 418.2).

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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:
	83 FR 22612	05/16/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 42100	08/20/2018
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Notification, Documentation, and Recordkeeping

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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	39,960	39,960	0	0	0	0
Annual Time Burden (Hours)	47,475	47,475	0	0	0	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:

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Annual Cost to Federal Government: $39,000

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: 04/17/2019

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