MedWatch: The FDA Medical Products Reporting Program

Forms and Documents

Document	Type	Status	Availability
Form FDA 3500 Form 3500 Consumer Reporting Form	Form and Instruction	Modified	Repair queued
Form FDA 3500A Form 3500A Medwatch for user facilities, importers, distributors, and manufacturers for MANDATORY reporting	Form and Instruction	New	Available
0291 ss 11-2011.doc	Supporting Statement A	Uploaded 2011-12-02	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
5858	Form 3500 Consumer Reporting Form	Form and Instruction	Modified
200368	Form 3500A Medwatch for user facilities, importers, distributors, and manufacturers for MANDATORY reporting	Form and Instruction	New

ICR Details

OMB Control No: 0910-0291	ICR Reference No: 201112-0910-001
Status: Historical Inactive	Previous ICR Reference No: 200810-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
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OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 06/27/2012
	Date Received in OIRA: 12/08/2011
Terms of Clearance: This submission is withdrawn to correct a technical error in the collection. The agency will resubmit within 1 business day.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	06/30/2012
Responses	636,116	0	636,116
Time Burden (Hours)	682,483	0	682,483
Cost Burden (Dollars)	0	0	0

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Abstract: To ensure the safety, and identify any risks, harms, or other dangers to health, for all FDA-regulated human healthcare products, the Agency needs to be informed whenever an adverse event, product quality problem or product use error occurs. This risk identification process is the first necessary step that allows the agency to gather the information necessary to be able to evaluate the risk associated with the product, and take whatever action is necessary to mitigate or eliminate the public's exposure to the risk.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
  

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:
	76 FR 55919	09/09/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 76417	12/07/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Form 3500 Consumer Reporting Form	FDA 3500	FDA Medwatch Consumer Reporting Form
Form 3500A Medwatch for user facilities, importers, distributors, and manufacturers for MANDATORY reporting	FDA 3500A	Medwatch for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting

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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 both a program change and minor adjustments in the existing Forms FDA 3500 and 3500A. The program change is a result of an Agency intention and goal of improving the number and quality of voluntary reports from consumers of serious adverse events and product quality problems by introducing a consumer-friendly version of the existing From FDA 3500. The Agency estimates that the hour burden with use of a consumer version of the existing voluntary reporting form can be reduced based on informal testing of the final, proposed version of the form, from the current 36 minutes per report to 25 minutes, a reduction of 30%. It is estimated that in CY2011, 35% of the 40,000 direct, voluntary reports submitted using the Form FDA 3500 will be from consumers/patients. The reduction in reporting burden hours for that population of voluntary consumer-reporters would be 14,000 reporters x 0.183 hours, or a total annual burden-hour reduction of 2,562 hours. The existing Forms FDA 3500 and 3500A have proposed minor changes to each form, with no additional questions added and several questions omitted as redundant information that is able to be addressed in other questions. Several fields have had the label or title modified in response to a change in law, rule or regulation or to clarify the type of information to be entered in a given field. The agency estimates that these changes will have no substantial impact on either reporting burden-hours or costs.

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Annual Cost to Federal Government: $8,831,000

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: 12/08/2011

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