(CMS-R-13) Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
8295	42 CFR, Section 486.306(a)	Modified
46277	42 CFR, Section 486.328 (a)	Removed
279119	42 CFR Section 486.348(e) review of medical complex donor policies	New
279118	42 CFR Section 486.330 non-pancreata research data	New
279117	42 CFR Section 486.330 pancreata data research	New
279116	42 CFR Section 486.316(c)-(d)	New

ICR Details

OMB Control No: 0938-0688	ICR Reference No: 202509-0938-010
Status: Received in OIRA	Previous ICR Reference No: 202012-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: (CMS-R-13) Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations
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: 02/19/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	8,352	0
Time Burden (Hours)	4,975	0
Cost Burden (Dollars)	0	0

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Abstract: OPOs are required to submit accurate data to CMS, through the Organ Procurement and Transplantation Network (OPTN), concerning its organ procurement activities, as well as various OPO business activities, including information on its designated service area; structure; various policies, procedures, and protocols; and its quality assessment and performance improvement (QAPI) program. This information is necessary to assure maximum effectiveness in the procurement and distribution of organs.

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Authorizing Statute(s): PL: Pub.L. 99 - 509 9318 Name of Law: Omnibus Budget Reconcilation Act of 1986
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU54	Proposed rulemaking	91 FR 4190	01/30/2026

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
42 CFR Section 486.316(c)-(d)
42 CFR Section 486.330 non-pancreata research data
42 CFR Section 486.330 pancreata data research
42 CFR Section 486.348(e) review of medical complex donor policies
42 CFR, Section 486.306(a)
42 CFR, Section 486.328 (a)

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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	8,352	0	0	8,238	0	114
Annual Time Burden (Hours)	4,975	0	0	4,234	0	741
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 741 hours to 4,975 hours, a 571% increase. Note that the estimated number of OPOs decreased from 57 in the last version to 55. In addition, the burden associated with §486.328(a) for Reporting Data was removed in this reinstatement to accurately reflect that it is a usual and customary practice for OPOs as part of their OPTN membership. The increase in burden hours from 741 to 4,975 is primarily due to the following changes to the CfCs: • 3,397 hours related to applications for open DSAs were not in effect during the last PRA approval period (IC-2: §§486.316(c) and (d)); • 680 hours related to increased reporting for organ procurement related to research studies from the 2025 proposed rule [CMS-3409-P] (IC-3: §486.330); • 843 hours related to initial and ongoing review of medically complex donation policies under existing QAPI programs from the 2025 proposed rule [CMS-3409-P] (IC-4:§486.348(e)).

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Annual Cost to Federal Government: $15,123

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: 02/19/2026

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