View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0814	ICR Reference No: 202309-0910-005
Status: Active	Previous ICR Reference No: 202203-0910-005
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/24/2023
	Date Received in OIRA: 09/07/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2026	36 Months From Approved	06/30/2025
Responses	13,910	0	13,910
Time Burden (Hours)	255,326	0	255,326
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	13,910	13,910
Annual Time Burden (Hours)	255,326	255,326
Annual Cost Burden (Dollars)	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 made no changes to the approved burden estimate, however, on our own initiative, and for efficiency of agency operations, we are revising Form FDA 3926 to facilitate the submission of information.

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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