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

Forms and Documents

Document	Type	Status	Availability
CMS-R-26 Response_to_Public_Comments (002).doc	Supplementary Document	Uploaded 2017-02-26	Available
CMS-R-26 Final Supporting Statement 8-16-17.doc	Supporting Statement A	Uploaded 2017-08-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
8213	Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR Part 493.1-.2001 (CMS-R-26)		Removed
225813	Section 493.1269		New
225812	Section 493.1274		New
225811	Section 493.1263		New
225810	Section 493.1262		New
225809	Section 493.1261		New
225808	Section 493.1256		New
225807	Section 493.1255		New
225806	Sections 493.1252 and 493.1254		New
225805	Section 493.1251		New
225804	Section 493.1242		New
225803	Section 493.1299		New
225802	Section 493.801 and 493.803		New
180973	CLIA and ICRs contained in 493.1-.2001		Removed
180972	CLIA and ICRs contained in 42 CFR 493.1-.2001 (CMS-R-26)		Removed

ICR Details

OMB Control No: 0938-0612	ICR Reference No: 201702-0938-020
Status: Active	Previous ICR Reference No: 201401-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: 21125
Title: (CMS-R-26) Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/19/2017
	Date Received in OIRA: 02/27/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	79,172,009	0	756,240
Time Burden (Hours)	14,975,521	0	11,363,280
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): PL: Pub.L. 100 - 578 353 Name of Law: Health Service Act
   US Code: 42 USC 493 Name of Law: Laboratory Requirements
  

Citations for New Statutory Requirements: None

---

EO 13771 Designation: Deregulatory

---

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:
	81 FR 87039	12/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 11037	02/17/2017
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Section 493.801 and 493.803
Section 493.1299
Section 493.1242
Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR Part 493.1-.2001 (CMS-R-26)
CLIA and ICRs contained in 42 CFR 493.1-.2001 (CMS-R-26)
CLIA and ICRs contained in 493.1-.2001
Section 493.1251
Sections 493.1252 and 493.1254
Section 493.1255
Section 493.1256
Section 493.1261
Section 493.1262
Section 493.1263
Section 493.1274
Section 493.1269

---

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	79,172,009	756,240	0	78,415,769	0	0
Annual Time Burden (Hours)	14,975,521	11,363,280	0	3,612,241	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: The change in burden is due to the change in enrollment of the laboratories into the CLIA program. It is not related to any statute or regulatory change.

---

Annual Cost to Federal Government: $0

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? Uncollected

---

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: 02/27/2017

---