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View ICR - OIRA Conclusion

OMB Control No: 0910-0751	ICR Reference No: 202410-0910-013
Status: Active	Previous ICR Reference No: 202108-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/19/2025
	Date Received in OIRA: 10/29/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2028	36 Months From Approved	02/28/2025
Responses	20,151,907	0	20,175,345
Time Burden (Hours)	7,441,861	0	7,456,374
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	20,151,907	20,175,345	-23,438
Annual Time Burden (Hours)	7,441,861	7,456,374	-14,513
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: The information collection reflects adjustment. First, with regard to human foods, we removed the individual element “Reporting: qualified facilities,” as the attendant burden is captured in the line item “Quality Facility Attestation.” For animal foods, we combined two individual IC elements for §§ 507.7(e)(1) and 507.7(e)(2) into one line item for 507.7(e), further decreasing the overall burden by 5,174 hours and 4,334 responses annually. We attribute the latter adjustment to animal food respondents complying with manufacturing address disclosures. We also corrected some inadvertent rounding and calculation errors. Cumulatively the adjustments result in a decrease of 23,438 responses and 14,513 hours annually to our estimate.

Annual Cost to Federal Government: $50,000

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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