Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization

Forms and Documents

Document Name	Status
0607_Supporting Statement A_2025.docx Supporting Statement A	2025-11-25

IC Document Collections

IC ID	Document Title	Status
256591	CLIA waiver applications and associated records	Modified
180758	Request for CLIA categorization Other-Guidance; Administrative Procedures for CLIA Categorizatio	Modified

ICR Details

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	11/30/2025
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

---

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

---