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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

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

ICR Summary of Burden

	Total Request	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	476	51	425
Annual Time Burden (Hours)	3,340	747	2,593
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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