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View ICR - OIRA Conclusion

OMB Control No: 0910-0583	ICR Reference No: 202407-0910-007
Status: Active	Previous ICR Reference No: 202103-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: New Plant Varieties Intended for Food Use
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: 09/03/2024
	Date Received in OIRA: 07/29/2024
Terms of Clearance: Burden was moved from "Program Change Due to Agency Discretion" column to the "Change Due to Adjustment in Agency Estimate" column based on the descriptions of updates made to the ICs and overall burden estimates.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	08/31/2024
Responses	78	0	58
Time Burden (Hours)	2,160	0	2,080
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	78	58	20
Annual Time Burden (Hours)	2,160	2,080	80
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: We have made minor adjustments to update our burden estimate to reflect recent annual response rates (increased initial consultations under the New Plant Variety consultation procedures by 20 responses, which resulted in an additional 80 burden hours) and to clarify the total number of responses under the Early Food Safety Evaluation procedures.

Annual Cost to Federal Government: $838,237

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. Yes

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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