Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting

Forms and Documents

Document Name	Status
Form 3419 Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting Form and Instruction	Modified
SS 0910-0437 #2A.doc Supporting Statement A	2009-05-18

IC Document Collections

IC ID	Document Title	Status
6116	Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0437	ICR Reference No: 200905-0910-004
Status: Historical Active	Previous ICR Reference No: 200603-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/24/2009
	Date Received in OIRA: 05/28/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	36 Months From Approved	07/31/2009
Responses	244,537	0	122,325
Time Burden (Hours)	294,194	0	138,271
Cost Burden (Dollars)	0	0	0

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Abstract: This regulation will eliminate MDR reporting requirements for distributors (who are not importers) of medical devices; eliminate annual certification requirements for manufacturers and distributors (including importers) of medical devices; and reduce the frequency of user facility summary from semi-annual to annual.

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Authorizing Statute(s): US Code: 21 USC 360(a)(1) 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:
	74 FR 8547	02/25/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 23413	05/19/2009
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
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting	3419	Medical Device Reporting Annual User Facility Report

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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	244,537	122,325	0	0	122,212	0
Annual Time Burden (Hours)	294,194	138,271	0	0	155,923	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:

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Annual Cost to Federal Government: $3,072,600

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 05/28/2009

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