Medical Devices; Device Tracking

Forms and Documents

Document Name	Status
0442--supporting_statement.doc Supporting Statement A	2014-09-30

IC Document Collections

IC ID	Document Title	Status
6125	Discontinuation of business	Modified
214455	Multiple distributor data and distributor tracking records	New
214453	Acquisition of tracked devices and final distributor data	New
214432	Multiple distributor data and distributor tracking records	New
214431	Manufacturer data audit	New
214430	Standard operating procedures	New
214429	Record of tracking data	New
214428	Tracking information	New
214427	Multiple distributor data	New
214426	Notification of failure to comply	New
214425	Exemption or variance	New

ICR Details

OMB Control No: 0910-0442	ICR Reference No: 201409-0910-021
Status: Historical Active	Previous ICR Reference No: 201105-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Device Tracking
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: 02/03/2015
	Date Received in OIRA: 10/27/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	613,736	0	17,915
Time Burden (Hours)	615,380	0	621,279
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from device manufactures and distributors who are subject to the requirements for device tracking, tracking systems, and distributor reporting. Manufacturers must track a class II or class III device if its failure would be reasonable likely to have serious adverse health consequences, or it is intended to be implanted in the human body for more than one year, or it is life-sustaining or life-supporting and used outside a device user facility, or when FDA determines that tracking would be appropriate in order to protect the general public in the event of a device recall.

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Authorizing Statute(s): US Code: 21 USC 360(e)(1) Name of Law: null
   US Code: 21 USC 360(e)(2) 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:
	79 FR 22991	04/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 62161	10/16/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Tracking information
Multiple distributor data and distributor tracking records
Exemption or variance
Notification of failure to comply
Multiple distributor data
Record of tracking data
Standard operating procedures
Manufacturer data audit
Multiple distributor data and distributor tracking records
Acquisition of tracked devices and final distributor data
Discontinuation of business

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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	613,736	17,915	0	595,821	0	0
Annual Time Burden (Hours)	615,380	621,279	0	-5,899	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: Upon review of this ICR under the PRA, the burden for "Tracking information-821.25(a)" has been changed from reporting to recordkeeping. This resulted in an adjustment of the reporting burden being decreased by 17,911. As a result of parsing out estmiates for the different ICs, the number of respondents has increased.

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Annual Cost to Federal Government: $14,120

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: 10/27/2014

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