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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0910-0291	ICR Reference No: 202411-0910-004
Status: Received in OIRA	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	Date Submitted to OIRA: 06/25/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2025
Responses	179,857	43,126
Time Burden (Hours)	142,668	26,654
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

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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

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Number of Information Collection (IC) in this ICR: 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

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ICR Summary of Burden

	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

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.

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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

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Common Form ICR:  No

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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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