Adverse Event Program for Medical Devices

Forms and Documents

Document Name	Status
Form FDA Form 3670 MedSun Form	Modified
OMB ATTACHMENT A TO 2010 MedSun renewal 3-24-11.doc Supplementary Document	2011-03-25
0471 ss Part B FINALREWRITE 3-24-11.doc Supporting Statement B	2011-03-25
0471 ss Part A FINALREWRITE 3-24-11.doc Supporting Statement A	2011-03-25

IC Document Collections

IC ID	Document Title	Status
37668	MedSun Form	Modified

ICR Details

OMB Control No: 0910-0471	ICR Reference No: 201012-0910-002
Status: Historical Active	Previous ICR Reference No: 200709-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Adverse Event Program for Medical Devices
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: 05/19/2011
	Date Received in OIRA: 12/16/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2014	36 Months From Approved	05/31/2011
Responses	6,000	0	7,000
Time Burden (Hours)	4,500	0	5,001
Cost Burden (Dollars)	0	0	0

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Abstract: This is an electronic reporting system for hospitals to inform FDA of problems with the use of medical devices. This system involves not only reporting but sharing of information between the participants.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: null
  

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:
	75 FR 39535	07/09/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 76009	12/07/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
MedSun	FDA Form 3670	Medsun Submission (Screenshots)

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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	6,000	7,000	0	-1,000	0	0
Annual Time Burden (Hours)	4,500	5,001	0	-501	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden estimate for this information collection is decreased 500 hours and 1000 respondents to reflect the removal of the Device Safety Exchange from MedSun.

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Annual Cost to Federal Government: $5,100,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 12/16/2010

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