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View ICR - OIRA Conclusion

OMB Control No: 0910-0037	ICR Reference No: 202303-0910-003
Status: Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/14/2023
	Date Received in OIRA: 10/12/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2026	36 Months From Approved	11/30/2023
Responses	34,343	0	24,202
Time Burden (Hours)	2,606,489	0	2,602,883
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	34,343	24,202	10,141
Annual Time Burden (Hours)	2,606,489	2,602,883	3,606
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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