End State Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations (CMS-R-52)

Forms and Documents

Document Name	Status
CMS-R-52 Supporting Statement 508 Compliant 11-22-24.docx Supporting Statement A	2025-05-14

IC Document Collections

IC ID	Document Title	Status
224864	42 CFR 494.180(k)	Removed
224863	42 CFR 494.70(c) part 3	Removed
224858	42 CFR 494.70	Modified
224857	42 CFR 494.70(c) part 2	Removed
209405	42 CFR 494.60(d)(4) old facilities	Modified
209404	42 CFR 494.180 (h)	Modified
209403	42 CFR 494.180(g)(3) old facilities	Modified
209402	42 CFR 494.180(g)(3) new facilities	Modified
209401	42 CFR 494.180(g)(2)	Modified
209400	42 CFR 494.180 (f)(4)(iii)	Modified
209399	42 CFR 494.180(f)(4)(ii)	Modified
209398	42 CFR 494.180 (e)	Modified
209397	42 CFR 494.170 (d)	Modified
209396	42 CFR 494.110 all facilities	Modified
209395	42 CFR 494.110 new facilities	Modified
209394	42 CFR 494.100(C)(1)	Modified
209392	42 CFR 494.60(d)(4) new facilities	Modified
209391	42 CFR 494.40(c)	Modified
209390	42 CFR 494.30(b)(3) and 494.40 (b)b2)(ii)(c)	Modified
209389	42 CFR 494.30 (a)(1)(ii)	Modified
209388	42 CFR 488.60	Modified

ICR Details

OMB Control No: 0938-0386	ICR Reference No: 202504-0938-015
Status: Received in OIRA	Previous ICR Reference No: 202008-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: End State Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations (CMS-R-52)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/15/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	966,499	0
Time Burden (Hours)	800,621	0
Cost Burden (Dollars)	0	0

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Abstract: This package applies to existing Medicare End-stage Renal Disease (ESRD) conditions for coverage (CfCs) at 42 CFR 494.

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Authorizing Statute(s): PL: Pub.L. 92 - 603 2991 Name of Law: Social Security Amendments of 1972
   PL: Pub.L. 99 - 272 1881 Name of Law: Consolidated Omnibus Budget Reconciliation Act of 1975
  

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:
	89 FR 104547	12/23/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 20166	05/12/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
42 CFR 488.60
42 CFR 494.100(C)(1)
42 CFR 494.110 all facilities
42 CFR 494.110 new facilities
42 CFR 494.170 (d)
42 CFR 494.180 (e)
42 CFR 494.180 (f)(4)(iii)
42 CFR 494.180 (h)
42 CFR 494.180(f)(4)(ii)
42 CFR 494.180(g)(2)
42 CFR 494.180(g)(3) new facilities
42 CFR 494.180(g)(3) old facilities
42 CFR 494.180(k)
42 CFR 494.30 (a)(1)(ii)
42 CFR 494.30(b)(3) and 494.40 (b)b2)(ii)(c)
42 CFR 494.40(c)
42 CFR 494.60(d)(4) new facilities
42 CFR 494.60(d)(4) old facilities
42 CFR 494.70
42 CFR 494.70(c) part 2
42 CFR 494.70(c) part 3

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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	966,499	0	0	786,186	0	180,313
Annual Time Burden (Hours)	800,621	0	0	-459,870	0	1,260,491
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 overall change in burden from the previously approved package is a decrease of 459,870 hours, or 44.62%, from 1,260,491 hours to 800,621 hours. This is a result of the revision request associated with this ICR, we removed burden associated with §§ 414.330(a)(2)(iii)(C), 488.60, 494.62, 494.70(c), and 494.180(k).

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Annual Cost to Federal Government: $3,420

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]? Yes

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: 05/15/2025

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