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OMB Control No: 0910-0297	ICR Reference No: 202407-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202202-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug User Fee Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 06/18/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	408	411
Time Burden (Hours)	3,829	3,626
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	408	411	-3
Annual Time Burden (Hours)	3,829	3,626	203
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: There is decrease of 3 responses and an increase of 203 burden hours annually. Because we are including the recently reauthorized PDUFA commitment goals letter, we have characterized our submission as a revision.

Annual Cost to Federal Government: $4,707,766

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