OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)

ICR 202411-0910-004 · OMB 0910-0291 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC IDCollectionTypeStatusForm
272442 CBER, Form FDA 3500A Instruction New
253752 Electronic Submissions of Voluntary Submissions including via SRP Removed
253750 Submissions via SRP, including voluntary submissions Modified
233178 Written Request for temporary waiver of mandatory electronic reporting Unchanged
216812 CBER/CDER Form FDA 3500B Form and Instruction Modified
216808 CTP Form FDA 3500 Modified
216806 HFP Form FDA 3500A Form Modified
216802 HFP Form FDA 3500 Form and Instruction Modified
216800 CDRH Forms FDA 3500, FDA 3500B Form and Instruction Modified
216796 CBER/CDER Form FDA 3500 Form Modified
ICR Details
0910-0291 202411-0910-004
Received in OIRA 202306-0910-006
HHS/FDA CROSS CENTER
FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)
Revision of a currently approved collection   No
Regular 06/25/2025
  Requested Previously Approved
36 Months From Approved 06/30/2025
179,857 43,126
142,668 26,654
0 0
This information collection supports implementation of FDA's adverse event reporting programs, including voluntary reports as well as reports utilizing paper-based submission. Respondents to the collection are those who submit event experience information to the agency regarding products regulated by FDA.
US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None
Not associated with rulemaking
Other Documents for OIRA Review
  90 FR 5900 01/17/2025
90 FR 27029 06/25/2025
Yes
9
IC Title Form No. Form Name
CBER, Form FDA 3500A 3500A MedWatch 3500A
CBER/CDER Form FDA 3500 3500 MedWatch
CBER/CDER Form FDA 3500B FDA 3500B, Form FDA 3500B MedWatch Voluntary Reporting - Spanish ,   MedWatch Consumer Reporting
CDRH Forms FDA 3500, FDA 3500B 3500B, 3500 MedWatch ,   MedWatch 3500B
CTP Form FDA 3500
Electronic Submissions of Voluntary Submissions including via SRP
HFP Form FDA 3500 FDA 3500, Form FDA 3500B MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors ,   MedWatch Voluntary Reporting - Spanish
HFP Form FDA 3500A 3500A MedWatch Form 3500A
Submissions via SRP, including voluntary submissions
Written Request for temporary waiver of mandatory electronic reporting
  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 179,857 43,126 0 0 136,731 0
Annual Time Burden (Hours) 142,668 26,654 0 0 116,014 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.
$35,485,483
No
    Yes
    Yes
No
No
No
No
Domini Bean 301 796-5733 [email protected]
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
06/25/2025