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View ICR - OIRA Conclusion

OMB Control No: 0910-0793	ICR Reference No: 202404-0910-006
Status: Active	Previous ICR Reference No: 202107-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food and Cosmetic Export Certificates
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: 09/10/2024
	Date Received in OIRA: 08/09/2024
Terms of Clearance: Note: This latest update should have been characterized as a "revision" not an "extension without change."

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	09/30/2024
Responses	14,098	0	4,551
Time Burden (Hours)	4,709	0	2,276
Cost Burden (Dollars)	47,380	0	45,510

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	14,098	4,551	9,360	187
Annual Time Burden (Hours)	4,709	2,276	2,340	93
Annual Cost Burden (Dollars)	47,380	45,510	0	1,870

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: Since our last review of the information collection, we have adjusted our estimate of the number of respondents downward. At the same time, we have increased the number of responses per respondent and added new Form FDA 5077. Cumulatively these activities result in an estimated burden increase of 9,547 hours and 9,360 responses annually.

Annual Cost to Federal Government: $1,850,000

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. 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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