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

Forms and Documents

Document Name	Status
Form FDA-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 Reporting: Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541c 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 2541 a Form and Instruction	Modified
SS-0910-0037-2012 Jan 23 Clean Copy.doc Supporting Statement A	2012-02-02

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
198057	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	Reporting: Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541c 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 2541 a Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0037	ICR Reference No: 201106-0910-005
Status: Historical Active	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: Approved with change	Conclusion Date: 02/27/2012
	Date Received in OIRA: 06/10/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. In future requests, the agency should make sure that burden changes are correctly classified in the data entered in ROCIS.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved	02/29/2012
Responses	86,878	0	21,457
Time Burden (Hours)	2,380,467	0	1,868,352
Cost Burden (Dollars)	0	0	0

---

Abstract: The information is necessary to ensure safe manufacturing, processing, and packing procedures and to permit FDA to verify that these procedures are being followed.

---

Authorizing Statute(s): US Code: 21 USC 342 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

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

---

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	1, FDA-2541	FDA-2541 ,   Register Food Canning Establishment
Reporting: - Food Canning Establishment, Process Filing for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 a	2541a	Process Filing For All Methods Except Low - Acid Aseptic
Reporting: Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541c	2541c	Food Processing for Low Acid Aseptic
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

---

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	86,878	21,457	0	63,375	2,046	0
Annual Time Burden (Hours)	2,380,467	1,868,352	0	615	511,500	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The increased burden associated with the program change is the result of new recordkeeping requirements. The revision also includes an adjustment based on the increase in the number of recordkeepers.

---

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

---

Common Form ICR:  No

---

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: 06/10/2011

---