Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations (CMS-1557)

Forms and Documents

Document Name	Status
Form CMS-1557 Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 Form and Instruction	Modified
Form CMS-1557 Federal Government - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 Form and Instruction	Removed
Form CMS-1557 State, Local, or Tribal Governments - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 Form and Instruction	Removed
CMS-1557 Supporting Statement. 7-2-2021.docx Supporting Statement A	2021-11-02

IC Document Collections

IC ID	Document Title	Status
8149	Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 Form and Instruction	Modified
202101	Federal Government - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 Form and Instruction	Removed
202100	State, Local, or Tribal Governments - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 Form and Instruction	Removed

ICR Details

OMB Control No: 0938-0544	ICR Reference No: 202111-0938-003
Status: Received in OIRA	Previous ICR Reference No: 201805-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations (CMS-1557)
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: 11/02/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2021
Responses	7,988	9,593
Time Burden (Hours)	3,994	4,796
Cost Burden (Dollars)	0	0

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Abstract: This survey form is an instrument used by the State agency to record data collected in order to determine compliance with CLIA. This information is needed for laboratory certification and recertification.

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Authorizing Statute(s): PL: Pub.L. 100 - 578 353 Name of Law: Certification of Laboratories
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 46854	08/20/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 60244	11/01/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Federal Government - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001	CMS-1557	Survey Report Form (CLIA)
State, Local, or Tribal Governments - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001	CMS-1557	Survey Report Form (CLIA)
Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001	CMS-1557	Survey Report Form (CLIA)

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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	7,988	9,593	0	-688	-917	0
Annual Time Burden (Hours)	3,994	4,796	0	-343	-459	0
Annual Cost Burden (Dollars)	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Changes in burden are the result of decrease in the number of respondents in the CLIA program and an increase in the ICR. The respondents decreased from 19,183 to 15,975. The burden hours decreased from 4796 to 3,994. The wage rate increased from $29.00 to $36.29 thus the total costs increased from $139,084. to $289,885. There are no program changes.

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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? No

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Common Form ICR:  No

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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: 11/02/2021

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