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OMB Control No: 0910-0014	ICR Reference No: 202608-0910-010
Status: Received in OIRA	Previous ICR Reference No: 202509-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 08/18/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2026
Responses	246,818	246,818
Time Burden (Hours)	32,670,413	32,670,413
Cost Burden (Dollars)	0	0

Annual Cost to Federal Government: $821,184

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

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