View Information Collection Request (ICR) Package
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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:
0910-0291
ICR Reference No:
202411-0910-004
Status:
Active
Previous ICR Reference No:
202306-0910-006
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:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
09/15/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/25/2025
Terms of Clearance:
FDA should revise its accounting to increase transparency. In particular, future requests should clarify how and why burden is increasing or decreasing.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2027
36 Months From Approved
09/30/2025
Responses
179,857
0
43,126
Time Burden (Hours)
142,668
0
26,654
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 301 et seq.
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 5900
01/17/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 27029
06/25/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
CBER, Form FDA 3500A
3500A
CBER/CDER Form FDA 3500
3500
CBER/CDER Form FDA 3500B
FDA 3500B, Form FDA 3500B
CDRH Forms FDA 3500, FDA 3500B
3500B, 3500
CTP Form FDA 3500
Electronic Submissions of Voluntary Submissions including via SRP
HFP Form FDA 3500
FDA 3500, Form FDA 3500B
HFP Form FDA 3500A
3500A
Submissions via SRP, including voluntary submissions
Written Request for temporary waiver of mandatory electronic reporting
ICR Summary of Burden
Total Approved
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
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:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
06/25/2025
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