Medical Devices; Device Tracking

Forms and Documents

Document Name	Status
0442 SS revised 10-31.doc Supporting Statement A	2011-11-01

IC Document Collections

IC ID	Document Title	Status
6125	Medical Devices; Device Tracking	Modified

ICR Details

OMB Control No: 0910-0442	ICR Reference No: 201105-0910-002
Status: Historical Active	Previous ICR Reference No: 200804-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Device Tracking
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 with change	Conclusion Date: 12/12/2011
	Date Received in OIRA: 05/10/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	36 Months From Approved	12/31/2011
Responses	17,915	0	259,177
Time Burden (Hours)	621,279	0	3,407,184
Cost Burden (Dollars)	0	0	0

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Abstract: Manufacturers receiving FDA orders to track a device, whose failure would likely have serious adverse health consequences, and which is implanted in humans for more than 1 year, or is life-sustaining or life-supporting and used outside a device user facility, are required to collect/maintain current tracking information about the identity and location of the device during distribution, and about the identity and location of patients receiving the device, including certain physician information. Distributors must report this data to manufacturers.

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Authorizing Statute(s): US Code: 21 USC 360(e)(2) Name of Law: null
   US Code: 21 USC 360(e)(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:
	75 FR 69447	11/12/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 26304	05/06/2011
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; Device Tracking

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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	17,915	259,177	0	0	-241,262	0
Annual Time Burden (Hours)	621,279	3,407,184	0	0	-2,785,905	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: The burden hours and responses have been adjusted as the result of re-estimating and re-evaluating submissions and tracking data by the agency. FDA attributes the reduction to the decreased number of tracking orders issued since original estimates were provided. More specifically, while the Safe Medical Devices Act of 1990 required tracking by all manufacturers of certain devices, FDAMA (enacted in 1997) provides that devices subject to tracking would be determined at the Agency's discretion and only upon order by FDA.

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Annual Cost to Federal Government: $6,292

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: 05/10/2011

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