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OMB Control No: 0910-0595	ICR Reference No: 202504-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202405-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Authorization of Medical Products for Use Emergencies
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 12/04/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,040	0
Time Burden (Hours)	50,378	0
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,040	-7,087	10,127
Annual Time Burden (Hours)	50,378	-302,456	352,834
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 7,087 hours and a corresponding decrease of 302,456 responses. We have decreased our estimated burden to reflect a decrease in related submissions over the past 3 years

Annual Cost to Federal Government: $2,545,092

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? Yes

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov