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

Forms and Documents

Document Name	Status
Form Form FDA 2541g Food process filing for law-acid aseptic systems Form	Unchanged
Form Form FDA 2541f Food process filing for water activity/formulation control method Form	Unchanged
Form Form FDA 2541d Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541d Form	Unchanged
Form Form FDA 2541e Food Canning Establishment, Process Filing for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541e Form	Unchanged
FDA-2541g_508-edits.pdf Supplementary Document	2016-01-21
FDA-2541f_508-edits.pdf Supplementary Document	2016-01-21
FDA-2541d_508-edits.pdf Supplementary Document	2016-01-21
FDA-2541e_508-edits.pdf Supplementary Document	2016-01-21
0037 83C request DEC 2015.doc Justification for No Material/Nonsubstantive Change	2016-01-21
0037 Supporting Statement 2014.pdf Supporting Statement A	2014-08-28

IC Document Collections

IC ID	Document Title	Status
5692	Food Canning Establishment Registration for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 Instruction	Unchanged
212868	Report of any instance of potential health-endangering spoilage, process deviation or contamination	Unchanged
212867	Food process filing for law-acid aseptic systems Form	Unchanged
198057	Food process filing for water activity/formulation control method Form	Unchanged
185242	Records under 21 CFR 113.100 and 114.100	Unchanged
185241	Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541d Form	Unchanged
185240	Food Canning Establishment, Process Filing for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541e Form	Unchanged

ICR Details

OMB Control No: 0910-0037	ICR Reference No: 201601-0910-009
Status: Historical Active	Previous ICR Reference No: 201408-0910-004
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: 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: 01/26/2016
	Date Received in OIRA: 01/22/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	09/30/2017	09/30/2017
Responses	24,202	0	24,202
Time Burden (Hours)	2,602,883	0	2,602,883
Cost Burden (Dollars)	0	0	0

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Abstract: The information is necessary to ensure safe manufacturing, processing, and packing procedures for acidified foods and low-acid foods 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 342 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:
	78 FR 57393	09/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 47642	08/14/2014
Did the Agency receive public comments on this ICR? Yes

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

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

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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	24,202	24,202	0	0	0	0
Annual Time Burden (Hours)	2,602,883	2,602,883	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: Burden adjustments reflect an increase in the number of annual hours but a decreases in annual responses. These adjustments are explained more fully at Q15 of the supporting statement.

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Annual Cost to Federal Government: $895,820

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

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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: 01/22/2016

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