CLIA Budget Workload Reports and Supporting Regulations (CMS-102, CMS-105)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-105 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS PROGRAM PLANNED WORKLOAD REPORT	Form	Modified	Available
Form CMS-102 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS PROGRAM BUDGET/EXPENDITURE REPORT	Form	Modified	Available
Form CMS-102 CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)	Form	Modified	Repair queued
CMS-102 105.Supporting Statement Part A (final).docx	Supporting Statement A	Uploaded 2024-02-28	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8201	CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)	Form	Modified	CLINICAL LABORATORY IMPROVEMENT AMENDMENTS PROGRAM PLANNED WORKLOAD REPORT
8201	CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)	Form	Modified	CLINICAL LABORATORY IMPROVEMENT AMENDMENTS PROGRAM BUDGET/EXPENDITURE REPORT
8201	CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)	Form	Modified
8201	CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)	Instruction	Modified

ICR Details

OMB Control No: 0938-0599	ICR Reference No: 202402-0938-011
Status: Active	Previous ICR Reference No: 201803-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: CLIA Budget Workload Reports and Supporting Regulations (CMS-102, CMS-105)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/02/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved
Responses	50	0	0
Time Burden (Hours)	1,700	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Information collected is used by CMS to determine the amount of Federal Reimbursement for compliance surveys. Use of the information includes program evaluation, audit, budget formulation and budget approval.

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Authorizing Statute(s): US Code: 42 USC 353 Name of Law: PHS Act
   PL: Pub.L. 100 - 578 5471 Name of Law: CLIA
  

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:
	88 FR 83133	11/28/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 13720	02/23/2024
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)	CMS-102, CMS-105	CLINICAL LABORATORY IMPROVEMENT AMENDMENTS PROGRAM BUDGET/EXPENDITURE REPORT ,   CLINICAL LABORATORY IMPROVEMENT AMENDMENTS PROGRAM PLANNED WORKLOAD REPORT

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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	50	0	0	0	0	50
Annual Time Burden (Hours)	1,700	0	0	0	0	1,700
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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $94,245

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.     Yes

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: 02/28/2024

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