(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 passback2 071817 Clean.docx Supporting Statement A	2017-07-18

IC Document Collections

IC ID	Document Title	Status
209063	Requirements in 482.94 (c)(1) & (2)	Modified
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)	Modified

ICR Details

OMB Control No: 0938-1069	ICR Reference No: 201702-0938-014
Status: Historical Active	Previous ICR Reference No: 201310-0938-009
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/15/2017
	Date Received in OIRA: 02/27/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	08/31/2017
Responses	425	0	528
Time Burden (Hours)	2,593	0	2,523
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): 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 1302 Name of Law: Regulation
   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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 90360	12/14/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 11037	02/17/2017
Did the Agency receive public comments on this ICR? No

---

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)

---

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	528	0	-103	0	0
Annual Time Burden (Hours)	2,593	2,523	0	70	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: No

Burden Reduction Due to:

Short Statement: We have modified our estimates based upon our experience with transplant centers since the final rule was published. For §488.61(a) and (b), we had originally estimated that only 10 new transplant centers would apply for Medicare approval each year. However, we now estimate that an average of 12 new programs apply each year.

---

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]? 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

---

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: 02/27/2017

---