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OMB Control No: 0910-0822	ICR Reference No: 202501-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202203-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Tropical Disease Priority Review Vouchers
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 07/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	6	14
Time Burden (Hours)	42	88
Cost Burden (Dollars)	1,904	7,616

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	6	14	0	-8
Annual Time Burden (Hours)	42	88	0	-46
Annual Cost Burden (Dollars)	1,904	7,616	-5,712	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: Based on our evaluation of the information collection since the last OMB review and approval, the burden estimate decreased by 46 hours based on receipt of fewer vouchers request and other information collection activities.

Annual Cost to Federal Government: $2,220

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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov