MedWatch: The FDA Medical Products Reporting Program

Forms and Documents

Document Name	Status
Form FDA 3500 MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors Form and Instruction	Removed
Form FDA 3500B All Centers - Form 3500B (Consumer Reporting) Form and Instruction	New
Form FDA 3500 Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	New
Form FDA 3500A Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Form and Instruction	New
Form FDA 3500 Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	New
Form FDA 3500A Center for Devices and Radiological Health - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Form and Instruction	New
Form FDA 3500 Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	New
Form FDA 3500A Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities) Form and Instruction	New
Form FDA 3500A 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 Form and Instruction	New
Form FDA 3500 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 and Instruction	New
Form FDA 3500a MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting Form and Instruction	Removed
Form FDA 3500b MedWatch 3500B Consumer reporting Form and Instruction	Removed
0291_Supporting Statement.doc Supporting Statement A	2015-06-08

IC Document Collections

IC ID	Document Title	Status
5858	MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors Form and Instruction	Removed
216812	All Centers - Form 3500B (Consumer Reporting) Form and Instruction	New
216808	Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	New
216806	Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Form and Instruction	New
216802	Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	New
216801	Center for Devices and Radiological Health - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Form and Instruction	New
216800	Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form and Instruction	New
216799	Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities) Form and Instruction	New
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 Form and Instruction	New
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 and Instruction	New
202917	MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting Form and Instruction	Removed
202916	MedWatch 3500B Consumer reporting Form and Instruction	Removed

ICR Details

OMB Control No: 0910-0291	ICR Reference No: 201505-0910-002
Status: Historical Active	Previous ICR Reference No: 201206-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: MedWatch: The FDA Medical Products Reporting Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/30/2015
	Date Received in OIRA: 06/11/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	09/30/2015
Responses	769,995	0	786,773
Time Burden (Hours)	909,395	0	853,585
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection covers the reporting associated with the MedWatch program.

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Authorizing Statute(s): US Code: 21 USC 301 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 73591	12/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 31042	06/01/2015
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
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities)	FDA 3500A	MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Devices and Radiological Health - 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
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
MedWatch 3500B Consumer reporting	FDA 3500b	MedWatch Consumer Reporting
MedWatch 3500 for 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
MedWatch 3500a 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 Biologics Evaluation and Research/Center for Drug Evaluation and Research - 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
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 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	MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Devices and Radiological Health - 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 Food Safety and Applied Nutrition - 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
All Centers - Form 3500B (Consumer Reporting)	FDA 3500B	MedWatch Consumer Reporting

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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	769,995	786,773	0	-16,778	0	0
Annual Time Burden (Hours)	909,395	853,585	0	55,810	0	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: FDA is requesting a renewal with adjustments to the existing Forms FDA 3500, 3500A and 3500B.

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Annual Cost to Federal Government: $12,267,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 06/11/2015

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