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OMB Control No: 0938-0328	ICR Reference No: 202601-0938-008
Status: Received in OIRA	Previous ICR Reference No: 202410-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Hospital Conditions of Participation (COP) and Supporting Regulations (CMS-R-48)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 02/02/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2027
Responses	71,240	69,034
Time Burden (Hours)	3,619,870	3,566,521
Cost Burden (Dollars)	0	0

Authorizing Statute(s): US Code: 42 USC 1395f(a)(6) Name of Law: Conditions of and Limitations on Payment for Services
   US Code: 42 USC 1395x Name of Law: Definitions of Services, Institutions, Etc.
   US Code: 42 USC 1302 Name of Law: Rules and Regulations
   US Code: 42 USC 1395aa Name of Law: Use of State agencies to determine compliance by providers of services with CoP's
   US Code: 42 USC 1320b-8 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies

Citations for New Statutory Requirements: None

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	71,240	69,034	2,206
Annual Time Burden (Hours)	3,619,870	3,566,521	53,349
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: This revision adds two new information collections related to proposed § 482.46, which prohibits hospitals from performing sex-rejecting procedures on children: • IC-14: Hospital Notifications to Patients or Legal Guardians – 8,570 hours and $1,938,363 (one-time burden) • IC-15: Updating Hospital Policies and Procedures – 32,616 hours and $5,334,890 (one-time burden) The revised total burden is 3,619,870 hours and $319,770,039, representing an increase of 53,349 hours (1.15%) and $7,272,253 (2.33%) from the previously approved total burden of 3,566,521 hours and $312,497,786.

Annual Cost to Federal Government: $10,390,041

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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