Hospital Conditions of Participation (COP) and Supporting Regulations (CMS-R-48)

Forms and Documents

Document Name	Status
CMS-R-48 (0938-0328) Hospitals Supporting Statement_508 Version_1.29.26.docx Supporting Statement A	2026-01-30

IC Document Collections

IC ID	Document Title	Status
7965	42CFR482.12(d)(1-2) and (d)(4)	Unchanged
278939	42CFR482.46 - Policy Updates	New
278938	42CFR482.46 - Hospital Notifications	New
271650	42 CFR 482.59(c)	Modified
271649	43 CFR 482.59(b) and (c)	Modified
271648	42 CFR 482.59(a)(2)	Removed
271647	42 CFR 482.55(c)	Modified
271646	42 CFR 482.43(c)	Modified
271645	42 CFR 482.42 (New)(High range)	Unchanged
271636	42 CFR 482.42(f)(new)	Unchanged
271635	42 CFR 482.23(b)(7)	Unchanged
271631	42 CFR 482.21(g)	Unchanged
271630	42 CFR 482.21(e)	Removed
271627	42 CFR 482.21(b)(4) - Data Analysis	Modified
271626	42 CFR 482.21(b)(4) - Ongoing IT System Maintenance	Modified
271624	42 CFR 482.21(b)(4) - Year 1 IT System Changes	Modified
271623	42 CFR 485.21	Unchanged
183637	42CFR482.12(e)(2)	Unchanged

ICR Details

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

---

Abstract: This is a reinstatement of the information collection request that expired on 11/30/2017. The previous iteration of this OMB No. 0938-0328 (approved November 14, 2014) had a burden of 14,424,655 annual hours. For this requested reinstatement, with changes, the adjusted annual hourly burden for industry is 3,566,521 hours at an annual cost of $310,989,894. The decrease in burden hours is primarily due to the fact that many of the information collections that were previously required as CoPs by CMS are now customary and usual industry practice and would take place in the absence of the Medicare and Medicaid programs. In addition, where possible, CMS reduced the burden of CoPs with prior information collections.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV37	Proposed rulemaking	90 FR 59463	12/19/2025

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 16

IC Title	Form No.	Form Name
42 CFR 482.21(b)(4) - Data Analysis
42 CFR 482.21(b)(4) - Ongoing IT System Maintenance
42 CFR 482.21(b)(4) - Year 1 IT System Changes
42 CFR 482.21(e)
42 CFR 482.21(g)
42 CFR 482.23(b)(7)
42 CFR 482.42 (New)(High range)
42 CFR 482.42(f)(new)
42 CFR 482.43(c)
42 CFR 482.55(c)
42 CFR 482.59(a)(2)
42 CFR 482.59(c)
42 CFR 485.21
42CFR482.12(d)(1-2) and (d)(4)
42CFR482.12(e)(2)
42CFR482.46 - Hospital Notifications
42CFR482.46 - Policy Updates
43 CFR 482.59(b) and (c)

---

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	71,240	69,034	0	2,206	0	0
Annual Time Burden (Hours)	3,619,870	3,566,521	0	53,349	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: 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

---

Common Form ICR:  No

---

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: 02/02/2026

---