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OMB Control No: 0910-0001	ICR Reference No: 202402-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202209-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Applications for FDA Approval to Market a New Drug
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 03/06/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2024
Responses	123,820	145,969
Time Burden (Hours)	3,476,650	4,202,464
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	123,820	145,969	-22,149
Annual Time Burden (Hours)	3,476,650	4,202,464	-725,814
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: Our estimated burden for the information collection reflects an overall decrease of 725,814 hours and 22,149 responses annually. The reporting period for this information collection renewal includes the 3 years of the COVID-19 pandemic. We attribute this adjustment to a decrease in the number of submissions received during the public health emergency.

Annual Cost to Federal Government: $271,665,580

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