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

Forms and Documents

Document Name	Status
Form 2541 Reporting - Food Canning Establishment Registration for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 Form and Instruction	Modified
Form 2541c Food Canning Establishment Food Process Filing for Low Acid Aseptic Systems Form and Instruction	Modified
Form 2541a Reporting : Food Canning Establishment Process Filing, for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541a Form and Instruction	Modified
SS-0910-0037 ( Rev.3-04-11).doc Supporting Statement A	2011-03-04

IC Document Collections

IC ID	Document Title	Status
5692	Reporting - Food Canning Establishment Registration for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 Form and Instruction	Modified
196949	Recordkeeping: - 21 CFR 113.100 (c ) and ( d ) - Food Canning Establishment Temperature Indicating Devices ; Thermally Processed Low- Acid Foods Packaged in Hermetically Sealed Containers	New
185242	Recordkeeping : 21 CFR 113 and 114 - Food Canning Establishment Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers	Modified
185241	Food Canning Establishment Food Process Filing for Low Acid Aseptic Systems Form and Instruction	Modified
185240	Reporting : Food Canning Establishment Process Filing, for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541a Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0037	ICR Reference No: 201103-0910-004
Status: Historical Inactive	Previous ICR Reference No: 200806-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
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
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 04/28/2011
	Date Received in OIRA: 03/16/2011
Terms of Clearance: In accordance with 5 CFR 1320, OMB considers this ICR to have been improperly submitted. In Question 15 of the Supporting Statement, the Agency states, "In addition, parts 113 and 144 reflect an increase in the total burden hours from 1,863,500 hours to 2,375,000, an increase of 511,500 hours. This increase is due to a large increase in the estimated number of recordkeepers, as compared with three years ago." This language (an increase in the number of recordkeepers not caused by Agency action) describes an adjustment. The burden is incorrectly listed as "program change." Please review the collection and resubmit to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2011	36 Months From Approved	02/29/2012
Responses	21,457	0	21,457
Time Burden (Hours)	1,868,352	0	1,868,352
Cost Burden (Dollars)	0	0	0

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Abstract: On March 3, 2011 (76 FR 11892) FDA published a final rule entitled "Temperature - Indicating Devices: Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers." This final rule revises the information collection requirements currently approved under OMB control number 0910-0037 by adding new recordkeeping requirements in a new 21 CFR 113.100 (c) and (d). The information to be recorded under these regulations is related to accuracy tests of temperature indicating devices and reference devices maintained by processors of low acid canned foods. The required recordkeeping requirements of this final rule are necessary to document that appropriate accuracy tests have been performed with the appropriate frequencies for each temperature -indicating device and each reference device maintained by the processor.

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Authorizing Statute(s): US Code: 21 USC 344 Name of Law: null
  

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:
	72 FR 11990	03/14/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 11783	03/03/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Reporting - Food Canning Establishment Registration for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541	2541	Food Canning Establishment Registration
Reporting : Food Canning Establishment Process Filing, for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541a	2541a	Food Process Filing For All Methods Except Low - Acid Aseptic
Food Canning Establishment Food Process Filing for Low Acid Aseptic Systems	2541c	Food Process Filing for Low-acid Aseptic Systems
Recordkeeping : 21 CFR 113 and 114 - Food Canning Establishment Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers
Recordkeeping: - 21 CFR 113.100 (c ) and ( d ) - Food Canning Establishment Temperature Indicating Devices ; Thermally Processed Low- Acid Foods Packaged in Hermetically Sealed Containers

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There was a program change due to agency discretion as a result of this final rule, i.e.(1) The addition of new recordkeeping requirements and (2) an increase in the Agency`s estimate for the number of recordkeepers under this collection of information for 0910-0037.(Please refer to item # 15 of supporting statement for further details).

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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: 03/16/2011

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