Unique Device Identification System

Forms and Documents

Document Name	Status
UDI PRA SS final reg draft version 9-20-13.doc Supporting Statement A	2013-09-28

IC Document Collections

IC ID	Document Title	Status
203301	Third-Party Disclosure (ongoing)	Modified
203300	Recordkeeping (ongoing)	Modified
203299	Reporting (ongoing)	Modified
203298	Third-Party Disclosure (Date Format)	Modified
203297	Third-Party Disclosure (UDI)	Modified
203296	Recordkeeping (first year)	Modified
203295	Reporting (first year)	Modified

ICR Details

OMB Control No: 0910-0720	ICR Reference No: 201309-0910-013
Status: Historical Active	Previous ICR Reference No: 201207-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: 20559
Title: Unique Device Identification System
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/02/2013
	Date Received in OIRA: 09/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved
Responses	1,830,553	0	0
Time Burden (Hours)	802,821	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA is issuing regulations establishing a unique device identification system for medical devices. The recordkeeping, reporting, and third-party disclosure requirements referenced in the UDI regulation are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.

---

Authorizing Statute(s): US Code: 21 USC 360i(f) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG31	Final or interim final rulemaking	78 FR 58786	09/24/2013

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Reporting (first year)
Recordkeeping (first year)
Third-Party Disclosure (UDI)
Third-Party Disclosure (Date Format)
Reporting (ongoing)
Recordkeeping (ongoing)
Third-Party Disclosure (ongoing)

---

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	1,830,553	0	0	1,830,553	0	0
Annual Time Burden (Hours)	802,821	0	0	802,821	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: No

Burden Reduction Due to:

Short Statement: This is a new regulation and information collection.

---

Annual Cost to Federal Government: $1,900,000

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

---

Common Form ICR:  No

---

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: 09/30/2013

---