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

Forms and Documents

Document Name	Status
CMS-10266 10-30-2019 clean.docx Supporting Statement A	2019-11-15

IC Document Collections

IC ID	Document Title	Status
209063	Requirements in 482.94 (c)(1) & (2)	Unchanged
186447	Requirements in 42 CFR 488.61(a-b)	Unchanged
186446	Requirements in 42 CFR 482.102	Unchanged
186443	Requirements in 42 CFR 482.74 (a)	Unchanged

ICR Details

OMB Control No: 0938-1069	ICR Reference No: 201911-0938-006
Status: Active	Previous ICR Reference No: 201810-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: 20736
Title: (CMS-10266) Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/29/2019
	Date Received in OIRA: 11/15/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	08/31/2020
Responses	425	0	425
Time Burden (Hours)	2,593	0	2,593
Cost Burden (Dollars)	0	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:
0938-AT23	Final or interim final rulemaking	84 FR 51732	09/30/2019

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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: 4

IC Title	Form No.	Form Name
Requirements in 42 CFR 482.74 (a)
Requirements in 42 CFR 482.102
Requirements in 42 CFR 488.61(a-b)
Requirements in 482.94 (c)(1) & (2)

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ICR Summary of Burden

	Total Approved	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	425	425	0	0	0	0
Annual Time Burden (Hours)	2,593	2,593	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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? Uncollected

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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: 11/15/2019

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