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View ICR - OIRA Conclusion

OMB Control No: 0910-0046	ICR Reference No: 202303-0910-006
Status: Active	Previous ICR Reference No: 202011-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Imports and Electronic Import Entries
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/18/2023
	Date Received in OIRA: 06/29/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	08/31/2023
Responses	45,625,880	0	42,558,387
Time Burden (Hours)	2,053,803	0	1,916,084
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	45,625,880	42,558,387	0	3,067,493
Annual Time Burden (Hours)	2,053,803	1,916,084	-23,442	161,161
Annual Cost Burden (Dollars)	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We are revising the information collection to add new forms for certain drug import activities. Also, we note an inadvertent error in our burden table denoting the number of new ITACS accounts created annually. Cumulatively these changes and adjustments result in an increase of 3,067,493 responses and 137,719 hours annually.

Annual Cost to Federal Government: $38,750,000

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. 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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