Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations (CMS-10266)

Forms and Documents

Document	Type	Status	Availability
CMS-2026-0133-0002.html.pdf	Public Comments	Uploaded 2026-03-23	Available
CMS-10266_Attachment A - Response to Comments.docx	Supplementary Document	Uploaded 2026-04-16	Available
CMS-10266_Supporting Statement for Transplant Programs_12.11.25(508)_.docx	Supporting Statement A	Uploaded 2026-04-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
209063	Requirements in 482.94 (c)(1) & (2)		Modified
186447	Requirements in 42 CFR 488.61(a-b)		Removed
186446	Requirements in 42 CFR 482.100		Modified
186443	Requirements in 42 CFR 482.74 (a)		Modified

ICR Details

OMB Control No: 0938-1069	ICR Reference No: 202604-0938-007
Status: Received in OIRA	Previous ICR Reference No: 201911-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations (CMS-10266)
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: 04/17/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	476	0
Time Burden (Hours)	3,340	0
Cost Burden (Dollars)	0	0

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Abstract: The CoPs and accompanying requirements specified in the regulations are used by our surveyors as a basis for determining whether a transplant center qualifies for approval or re-approval under Medicare. CMS and the healthcare industry believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability.

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Authorizing Statute(s): US Code: 42 USC 1395aa Name of Law: Use of State agencies to determine compliance by providers of services with CoPs
   US Code: 42 USC 1302 Name of Law: Regulation
   US Code: 42 USC 1395hh Name of Law: Regulations
   US Code: 42 USC 1395bb Name of Law: Use of Joint Commission on Accrediation of Hospitals
   US Code: 42 USC 1395bb Name of Law: Limitation of the deeming authority of the Joint Commission
   US Code: 42 USC 1395rr Name of Law: Limitation of deeming authority of the Joint Commission
  

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:
	91 FR 2536	03/23/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 20459	04/16/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Requirements in 42 CFR 482.100
Requirements in 42 CFR 482.74 (a)
Requirements in 42 CFR 488.61(a-b)
Requirements in 482.94 (c)(1) & (2)

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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	476	0	0	51	0	425
Annual Time Burden (Hours)	3,340	0	0	747	0	2,593
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: As shown in Table 11 above, the estimated annual burden hours to the industry increased from 2,593 to 3,340, an increase of 29%. The annual cost increased from $181,130 to $352,462, a 95% increase.

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Annual Cost to Federal Government: $34,222

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: 04/17/2026

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