Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-R-26-Supporting_Statement_ 1-10-24 clean.docx	Supporting Statement A	Uploaded 2024-01-11	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
264338	Section 493.1359- 493.1489-1491		New
264337	Section 493.1359- 493.1489-1491		New
264336	Section 493.1278		New
225813	Section 493.1269		Modified
225812	Section 493.1274		Modified
225811	Section 493.1263		Modified
225810	Section 493.1262		Modified
225809	Section 493.1261		Modified
225808	Section 493.1256		Modified
225807	Section 493.1255		Modified
225806	Sections 493.1252 and 493.1254		Modified
225805	Section 493.1251		Modified
225804	Section 493.1242		Modified
225803	Section 493.1299		Modified
225802	Section 493.801 and 493.803	Instruction	Modified

ICR Details

OMB Control No: 0938-0612	ICR Reference No: 202401-0938-001
Status: Active	Previous ICR Reference No: 202008-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: 21125
Title: Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/07/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/12/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	84,959,102	0	74,476,376
Time Burden (Hours)	15,839,779	0	14,514,802
Cost Burden (Dollars)	0	0	0

---

Abstract: The ICRs referenced in 42 CFR part 493 outline the requirements necessary to determine an entities compliance with CLIA. CLIA requires laboratories that perform testing on human beings to meet performance requirements (quality standards) in order to be certified by HHS. HHS conducts inspections to determine a laboratory's compliance with the CLIA requirements. CLIA implements the certificate, laboratory standards, and inspection requirements.

---

Authorizing Statute(s): US Code: 42 USC 493 Name of Law: Laboratory Requirements
   PL: Pub.L. 100 - 578 353 Name of Law: Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT47	Final or interim final rulemaking	88 FR 89976	12/28/2023

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 44131	07/10/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 89976	12/28/2023
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 15

table that charts list of burden

IC Title	Form No.	Form Name
Section 493.1278
Section 493.1242
Section 493.1251
Section 493.1255
Section 493.1256
Section 493.1261
Section 493.1262
Section 493.1263
Section 493.1269
Section 493.1274
Section 493.1299
Section 493.1359- 493.1489-1491
Section 493.1359- 493.1489-1491
Section 493.801 and 493.803
Sections 493.1252 and 493.1254

---

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	84,959,102	74,476,376	0	10,482,726	0	0
Annual Time Burden (Hours)	15,839,779	14,514,802	0	1,324,977	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This increase of 1,324,977 hours from the previous collection is a direct result from the significant increase in enrollment of laboratories into the CLIA program during the COVID-19 Public Health Emergency (PHE), due to the increased need for testing. Apart from the one-time it is not related to any statute or regulatory change.

---

Annual Cost to Federal Government: $35,000

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

---

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: 01/12/2024

---