View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0751	ICR Reference No: 202108-0910-008
Status: Historical Active	Previous ICR Reference No: 202107-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals
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: 11/01/2021
	Date Received in OIRA: 09/30/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2024	36 Months From Approved	10/31/2021
Responses	20,175,345	0	8,333,247
Time Burden (Hours)	7,456,374	0	6,265,274
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	20,175,345	8,333,247	11,842,098
Annual Time Burden (Hours)	7,456,374	6,265,274	1,191,100
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 changes and adjustments. We have revised the information collection to include related activities associated with food for animals, currently approved under 0910-0789. This results in an increase to the collection by 11,842,098 responses and 1,191,100 burden hours annually.

Annual Cost to Federal Government: $0

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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