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
233178	Written Request for temporary waiver of mandatory electronic reporting	New
216812	All Centers - Form 3500B (Consumer Reporting)	Modified
216808	Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Modified
216806	Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)	Modified
216802	Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Modified
216801	Center for Devices and Radiological Health - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)	Removed
216800	Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Modified
216799	Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities)	Removed
216797	Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY report	Removed
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)	Modified

ICR Details

OMB Control No: 0910-0291	ICR Reference No: 201807-0910-001
Status: Active	Previous ICR Reference No: 201505-0910-002
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/14/2018
	Date Received in OIRA: 09/25/2018
Terms of Clearance: Upon approval, FDA will discontinue (or revise to eliminate the relevant responses and burden hours already accounted for under this collection and related collection 0910-0645) OMB control numbers: 0910-0635, 0910-0636, and 0910-0800.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved	11/30/2018
Responses	37,202	0	769,995
Time Burden (Hours)	22,716	0	909,395
Cost Burden (Dollars)	0	0	0

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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.

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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:
	83 FR 11756	03/16/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 46166	09/12/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

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

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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	37,202	769,995	0	1	-732,794	0
Annual Time Burden (Hours)	22,716	909,395	0	1	-886,680	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Regulations implementing mandatory reporting electronically have become effective since last OMB review of the collection but provide for written requests for temporary waivers. We have therefore increased the estimated burden by one hour and one response annually for potential waiver requests. This is explained more fully in our supporting statement.

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Annual Cost to Federal Government: $0

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? Uncollected

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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: 09/25/2018

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