View Information Collection Request (ICR) Package
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COMMENT
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OMB Control No:
0910-0607
ICR Reference No:
202504-0910-002
Status:
Received in OIRA
Previous ICR Reference No:
202210-0910-014
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
11/26/2025
Requested
Previously Approved
Expiration Date
36 Months From Approved
12/31/2025
Responses
450
413
Time Burden (Hours)
80,430
52,400
Cost Burden (Dollars)
542,150
115,750
Abstract:
This information collection helps support implementation of statutory provisions applicable to laboratories that conduct testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These requirements are codified in 42 U.S.C. 263a and implementing regulations are found in 42 CFR 493.
Authorizing Statute(s):
US Code:
42 USC 263a (353)
Name of Law: Certification of laboratories
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:
90 FR 29568
07/03/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 52960
11/24/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
CLIA waiver applications and associated records
Request for CLIA categorization
ICR Summary of Burden
Total Request
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
450
413
0
0
37
0
Annual Time Burden (Hours)
80,430
52,400
0
0
28,030
0
Annual Cost Burden (Dollars)
542,150
115,750
0
0
426,400
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:
FDA estimates an increase of 30 responses for requests for CLIA categorization and 7 responses for waiver application submission based on recent FDA receipt data to more accurately reflect recent receipts of requests for CLIA categorization and CLIA waiver application submissions. Our total burden for this collection will be 80,430 hours (24,430 reporting + 56,000 recordkeeping). Our estimated burden for the information collection reflects an overall increase of 28,030 hours
Annual Cost to Federal Government:
$4,009,995
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.
Yes
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:
Amber Sanford 301 796-8867 amber.sanford@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:
11/26/2025
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