View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0498	ICR Reference No: 202308-0910-003
Status: Active	Previous ICR Reference No: 202303-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Export Certificates for FDA Regulated Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/04/2024
	Date Received in OIRA: 04/29/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	24,533	0	19,431
Time Burden (Hours)	35,708	0	30,606
Cost Burden (Dollars)	4,293,275	0	3,400,425

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	24,533	19,431	5,102
Annual Time Burden (Hours)	35,708	30,606	5,102
Annual Cost Burden (Dollars)	4,293,275	3,400,425	892,850

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 estimated burden for the information collection reflects an overall adjustment increase of 5,102 hours and a corresponding increase of 5,102 responses. The increase in CDER export application requests is attributable to the implementation of the eCPP and an increase in drug exports. The increase is offset by a decrease in CVM and CBER export applications attributable to consequences of the pandemic. In addition, revised form instructions related to medical device products are included in the information collection request.

Annual Cost to Federal Government: $5,000,000

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: Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

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