Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74, 482.94, 482.100, 482.102, 488.61

Forms and Documents

Document Name	Status
CMS-10266.Supporting Statement - Part A.doc Supporting Statement A	2008-08-26

IC Document Collections

IC ID	Document Title	Status
186447	Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 488.61	New
186446	Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.102	New
186445	Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.100	New
186444	Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.94	New
186443	Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74	New
186442	Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 488.61	New

ICR Details

OMB Control No: 0938-1069	ICR Reference No: 200809-0938-008
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74, 482.94, 482.100, 482.102, 488.61
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 01/08/2009
	Date Received in OIRA: 09/04/2008
Terms of Clearance: This ICR is withdrawn per 1/2/09 memo. CMS acknowledges that this ICR constitutes a PRA violation because the ICR was not submitted and approved before the rule which authorized the collection of information went into effect. CMS agrees to resubmit this ICR as "existing collection in use without OMB control number."

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
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 1302 Name of Law: Regulation
   US Code: 42 USC 1395hh Name of Law: Regulations
   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 1395bb Name of Law: Use of Joint Commission on Accreditation 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-AH17	Final or interim final rulemaking	72 FR 15198	03/30/2007

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 31120	05/30/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 49677	08/22/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 488.61
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.94
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.100
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.102
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 488.61

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The information collection requirements described herein are needed to implement the Medicare CoPs for 514 Medicare-approved organ transplant centers: 504 currently approved centers and an estimated 10 centers that apply for approval every year.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/04/2008

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