Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regs (CMS-R-185)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-R-185-Supporting Statement A- 12-29-23_CLEAN.docx	Supporting Statement A	Uploaded 2024-01-11	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8288	Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regs (CMS-R-185)		Modified

ICR Details

OMB Control No: 0938-0686	ICR Reference No: 202401-0938-003
Status: Historical Active	Previous ICR Reference No: 202107-0938-019
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regs (CMS-R-185)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/17/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/11/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	36 Months From Approved	05/31/2025
Responses	9	0	9
Time Burden (Hours)	5,359	0	5,344
Cost Burden (Dollars)	0	0	0

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Abstract: The information required is necessary to determine whether a private accreditation organization's or State licensure program's standards and accreditation/licensure process is equal to or more stringent than those of CLIA.

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Authorizing Statute(s): US Code: 42 USC 493 Name of Law: Accreditation and Exemption Rule
   PL: Pub.L. 100 - 578 353 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 44131	07/11/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 89976	12/28/2023
Did the Agency receive public comments on this ICR? No

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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
Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regs (CMS-R-185)

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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	9	9	0	0	0	0
Annual Time Burden (Hours)	5,359	5,344	0	15	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: No

Burden Reduction Due to:

Short Statement: The previous burden hours were 5,344. The burden hours have increased from 5,344 to 5,359. It is important to note that the current burden hours and cost values were obtained from the accreditation organizations and exempt States based on their experience. The accreditation organizations and exempt States email the data to CMS as part of the information collection request process. Based on the data received, CMS updates the information collection request accordingly. As part of the update process, we have also updated the cost values to include the use of 100% of the hourly wage to account for fringe and overhead. The revised requirement for the AO/ESs to update their policies and procedures is a one-time cost, and is not recurring. It will be a one-time increase of 15 burden hours.

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Annual Cost to Federal Government: $3,500

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: 01/11/2024

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