View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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.
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
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).
Authorizing Statute(s):
US Code:
21 USC 360i(f)
Name of Law: Unique Device Identification
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
4
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
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
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.
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
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
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:
02/28/2023
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