MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)

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
253752	Electronic Submissions of Voluntary Submissions including via SRP	New
253750	Electronic Submissions via ESG - Mandatory Reports	New
233178	Written Request for temporary waiver of mandatory electronic reporting	Unchanged
216812	All Centers - Form 3500B (Consumer Reporting) Form and Instruction	Unchanged
216808	Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	Unchanged
216806	Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Other-Agency Guidance	Unchanged
216802	Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	Unchanged
216800	Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form	Unchanged
216796	Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form	Unchanged

ICR Details

OMB Control No: 0910-0291	ICR Reference No: 202205-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202110-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/23/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2025
Responses	43,126	37,202
Time Burden (Hours)	26,654	22,716
Cost Burden (Dollars)	0	0

---

Abstract: This information collection covers paper-based reporting under FDA's MedWatch safety reporting program. Respondents to the collection are those who submit event experience information to the agency regarding products regulated by FDA - both voluntarily and as prescribed in agency regulations.

---

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:
	86 FR 34754	06/30/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 14894	03/16/2022
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
All Centers - Form 3500B (Consumer Reporting)	FDA 3500B, Form FDA 3500B	MedWatch Voluntary Reporting - Spanish ,   MedWatch Consumer Reporting
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Form FDA 3500	MedWatch
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Form FDA 3500B, Form FDA 3500	MedWatch ,   MedWatch Voluntary Reporting - Spanish
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	FDA 3500, Form FDA 3500B	MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors ,   MedWatch Voluntary Reporting - Spanish
Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)	FDA 3500A	MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	FDA 3500	MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Electronic Submissions of Voluntary Submissions including via SRP
Electronic Submissions via ESG - Mandatory Reports
Written Request for temporary waiver of mandatory electronic reporting

---

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	43,126	37,202	0	0	5,924	0
Annual Time Burden (Hours)	26,654	22,716	0	0	3,938	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: As a result of revising the information collection to include electronic reporting, there is an increase of 5,924 responses and 3,938 hours annually to the information collection.

---

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

---

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: 05/23/2022

---