Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods

Forms and Documents

Document Name	Status
Form 2541 Food Canning Form	Modified
Form 2541g Food process filing for low-acid aseptic systems Form	Modified
Form 2541f Food process filing for water activity/formulation control method Form	Modified
Form 2541d Food process filing for low-acid retorted method Form	Modified
Form 2541e Process filing for acidified method Form	Modified
0037_Supporting Statement_2023.docx Supporting Statement A	2023-09-29

IC Document Collections

IC ID	Document Title	Status
5692	Food Canning Form	Modified
212868	Report of any instance of potential health-endangering spoilage, process deviation or contamination	Unchanged
212867	Food process filing for low-acid aseptic systems Form	Modified
198057	Food process filing for water activity/formulation control method Form	Modified
185242	Records under 21 CFR 113.100 and 114.100	Unchanged
185241	Food process filing for low-acid retorted method Form	Modified
185240	Process filing for acidified method Form	Modified

ICR Details

OMB Control No: 0910-0037	ICR Reference No: 202303-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202009-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/12/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2023
Responses	34,343	24,202
Time Burden (Hours)	2,606,489	2,602,883
Cost Burden (Dollars)	0	0

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Abstract: This information collections request collects information which is necessary to ensure safe manufacturing, processing, and packing procedures for acidified foods and low-acids in hermetically sealed containers, and to permit FDA to verify that required procedures are followed.

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

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:
	88 FR 16990	03/31/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 70663	10/12/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Food Canning	2541	Food Canning Establishment Registration
Food process filing for low-acid aseptic systems	2541g	Food Process Filing for Low-Acid Aseptic Systems
Food process filing for low-acid retorted method	2541d	Food Process Filing for Low-Acid Retorted Method
Food process filing for water activity/formulation control method	2541f	Food Process Filing for Water Activity/Formulation Control Method
Process filing for acidified method	2541e	Food Process Filing for Acidified Method
Records under 21 CFR 113.100 and 114.100
Report of any instance of potential health-endangering spoilage, process deviation or contamination

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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	34,343	24,202	0	0	10,141	0
Annual Time Burden (Hours)	2,606,489	2,602,883	0	0	3,606	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: Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate as an adjustment. Based on our experience with the program and actual submissions, we expect the number of responses to increase by 10,141 (34,343 – 24,202) and the number of burden hours to increase by 3,606 (2,606,489 – 2,602,883). The adjustment is limited to the reporting burden, and we retain the estimates for recordkeeping.

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Annual Cost to Federal Government: $991,722

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: 10/12/2023

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