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OMB Control No: 0910-0291	ICR Reference No: 202603-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202411-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 04/13/2026

	Requested	Previously Approved
Expiration Date	09/30/2027	09/30/2027
Responses	179,857	179,857
Time Burden (Hours)	142,668	142,668
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved
Annual Number of Responses	179,857	179,857
Annual Time Burden (Hours)	142,668	142,668
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: Cumulatively, adjustments and modifications result in an overall increase of 136,731 responses and 116,014 hours annually. We discuss the changes more fully in our supporting statement at Question 15.

Annual Cost to Federal Government: $35,485,483

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. Yes

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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