View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0793	ICR Reference No: 202107-0910-005
Status: Historical Active	Previous ICR Reference No: 201804-0910-017
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: 08/16/2021
	Date Received in OIRA: 07/14/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2024	36 Months From Approved	08/31/2021
Responses	4,551	0	5,215
Time Burden (Hours)	2,276	0	2,608
Cost Burden (Dollars)	45,510	0	52,150

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Cosmetics	FDA 3613d
Food (including seafood)	FDA 3613e, 3613k	,

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,551	5,215	-664
Annual Time Burden (Hours)	2,276	2,608	-332
Annual Cost Burden (Dollars)	45,510	52,150	-6,640

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: We have adjusted our estimate based on fewer submission received in the past 3 fiscal years. This results in a reduction of 664 responses and 332 hours annually, with a corresponding reduction in costs of $6,640.

Annual Cost to Federal Government: $1,550,000

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

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.