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View ICR - OIRA Conclusion

OMB Control No: 0910-0643	ICR Reference No: 201708-0910-014
Status: Historical Active	Previous ICR Reference No: 201408-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Reporting and Recordkeeping Requirements for Reportable Food
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 without change	Conclusion Date: 10/30/2017
	Date Received in OIRA: 09/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	10/31/2017
Responses	2,404	0	6,600
Time Burden (Hours)	3,181	0	3,330
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,404	6,600	-4,196
Annual Time Burden (Hours)	3,181	3,330	-149
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 agency adjustments. Specifically we have decreased our recordkeeping estimate by 149 hours, with a corresponding [decrease in responses by 596 responses]. Because we expect fewer records to be maintained, we have adjusted our estimate accordingly. Also, in ROCIS, we have consolidated the third-party disclosure ICs into one element from four in this collection while we have listed the recordkeeping elements individually (i.e., we consolidated the total number for ICs from six to three). Therefore, for this submission of extension, this ICR now has three ICs in ROCIS, but the information collection activities and the burden associated with each IC remain broken down into six ICs in Item 12 of this supporting statement.

Annual Cost to Federal Government: $382

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? Uncollected

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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