Medical Devices; Device Tracking

Forms and Documents

Document Name	Status
0442_Supporting Statement_2018.docx Supporting Statement A	2018-01-18

IC Document Collections

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

ICR Details

OMB Control No: 0910-0442	ICR Reference No: 201801-0910-005
Status: Active	Previous ICR Reference No: 201409-0910-021
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
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 without change	Conclusion Date: 03/27/2018
	Date Received in OIRA: 01/23/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved	03/31/2018
Responses	613,736	0	613,736
Time Burden (Hours)	615,380	0	615,380
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)(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:
	82 FR 48516	10/18/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 2163	01/16/2018
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	613,736	0	0	0	0
Annual Time Burden (Hours)	615,380	615,380	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $20,690

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 01/23/2018

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