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View ICR - OIRA Conclusion

OMB Control No: 0910-0816	ICR Reference No: 202404-0910-009
Status: Active	Previous ICR Reference No: 202308-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - Agricultural Water - FINAL RULE
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: 06/04/2024
	Date Received in OIRA: 04/30/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	09/30/2025
Responses	531,013	0	871,993
Time Burden (Hours)	858,920	0	1,521,594
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	531,013	871,993	-340,980
Annual Time Burden (Hours)	858,920	1,521,594	-662,674
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 is associated with new regulatory requirements for pre-harvest agricultural water assessments for non-sprout covered produce. As discussed more fully in Q-12, we modified our estimate from what we proposed originally to reflect updates to covered farm counts. The result is a decrease by 340,980 responses and 662,674 hours annually to the information collection.

Annual Cost to Federal Government: $10,734

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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