Medical Device Labeling Regulations; Unique Device Identification

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0485 Medical Device Labeling to add UDI 2023 SSA.docx	Supporting Statement A	Uploaded 2023-02-26	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
258774	Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile		New
258139	Labeling requirements for UDI		New
255349	OTC Hearing Aids Final Rule - New Requirements	Other-Agency Guidance	Unchanged
255348	OTC Hearing Aids Final Rule - One Time Burden		Unchanged

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 202301-0910-017
Status: Historical Active	Previous ICR Reference No: 202208-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Regulations; Unique Device Identification
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/31/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2023
Terms of Clearance: Upon approval, the agency agrees to discontinue 0910-0614.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	36 Months From Approved	11/30/2025
Responses	318,776	0	2,625
Time Burden (Hours)	420,567	0	104,370
Cost Burden (Dollars)	10,100,000	0	10,100,000

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Abstract: This information collection request supports FDA implementation of statutory provisions under the Federal Food, Drug, and Cosmetic Act (FD&C Act) governing medical device labeling. We are revising the information collection to include burden that may be attributable to activities associated with provisions found in section 519(f) of the FD&C Act, implemented in 21 CFR part 830 (21 CFR 830), establishing the use of a Unique Device Identifier (UDI). These provisions were currently approved in OMB control no. 0910-0720 and established through rulemaking on September 24, 2013 (0910-AG31).

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

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:
	87 FR 51989	08/24/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 9524	02/14/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Labeling requirements for UDI
OTC Hearing Aids Final Rule - New Requirements
OTC Hearing Aids Final Rule - One Time Burden

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ICR Summary of Burden

table that charts list 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	318,776	2,625	0	0	316,151	0
Annual Time Burden (Hours)	420,567	104,370	0	0	316,197	0
Annual Cost Burden (Dollars)	10,100,000	10,100,000	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: We have adjusted our estimate to reflect an increase of 316,151 responses and 316,197 hours to account for program changes resulting from the implementation of rulemaking in 2007 and 2014 pertaining to SNS product labeling and UDI requirements, respectively.

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Annual Cost to Federal Government: $2,633,260

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? No

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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: 02/28/2023

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