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OMB Control No: 0910-0814	ICR Reference No: 202610-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Expanded Access to Investigational Drugs for Treatment Use
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 10/16/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	2,143	13,910
Time Burden (Hours)	19,018	255,326
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,143	13,910	-11,767
Annual Time Burden (Hours)	19,018	255,326	-236,308
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: We have adjusted our burden estimate downward based upon our most recent review of the information collection. Over the past three years we have received fewer submissions from fewer respondents and have reduced our estimate by 11,767 responses and 236,308 burden hours annually.

Annual Cost to Federal Government: $11,795,000

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. Yes

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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