View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0814	ICR Reference No: 202203-0910-005
Status: Historical Active	Previous ICR Reference No: 202106-0910-011
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: 06/01/2022
	Date Received in OIRA: 04/29/2022
Terms of Clearance: Approved with the understanding that 0910-0014 will be updated to account for the burden transfer/consolidation to this control number.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2025	36 Months From Approved	05/31/2022
Responses	13,910	0	2,394
Time Burden (Hours)	255,326	0	1,796
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	13,910	2,394	11,516
Annual Time Burden (Hours)	255,326	1,796	253,530
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 made no program changes, however, on our own initiative, and for efficiency Agency operations, we are revising the information collection to consolidate all of the expanded access programs from 0910-0014 into 0910-0814. The change of the reported burden in OMB Control No. 0910-0014 will be adjusted as appropriate. The information collection reflects an increase in 253,530 burden hours and 11,516 responses 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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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