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

Forms and Documents

Document Name	Status
CMS-R-13 OPO Supporting Statement 12.10.20.docx Supporting Statement A	2020-12-10

IC Document Collections

IC ID	Document Title	Status
8295	42 CFR, Section 486.306 (c)(1)-(3)	Unchanged
46278	42 CFR, Section 486.348(b)	Removed
46277	42 CFR, Section 486.328 (a)	Unchanged
244854	42 CFR Section 486.316(c)	New
244853	42 CFR Section 486.314(b)-(c)	New

ICR Details

OMB Control No: 0938-0688	ICR Reference No: 202012-0938-008
Status: Received in OIRA	Previous ICR Reference No: 201704-0938-008
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/10/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2021
Responses	170	128
Time Burden (Hours)	2,949	13,234
Cost Burden (Dollars)	0	0

---

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.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU02	Final or interim final rulemaking	85 FR 77898	12/02/2020

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 70628	12/23/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 77898	12/02/2020
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
42 CFR, Section 486.306 (c)(1)-(3)
42 CFR, Section 486.328 (a)
42 CFR Section 486.314(b)-(c)
42 CFR, Section 486.348(b)
42 CFR Section 486.316(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	170	128	0	42	0	0
Annual Time Burden (Hours)	2,949	13,234	0	-10,285	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: In regards to the revision request associated with this ICR, we are removing burden associated with death record reviews at 486.348(b). While this requirement is still in place, it is a usual and customary practice for OPOs that has been in effect since 2006. The previous burden estimate carried over from 2010 when OPOs were still adapting to this requirement and may have needed to increase staffing for this purpose. However, death record review is now considered normal usual and customary practice for OPOs. This reduces the burden by 12,480 hours and $923,520. However, we are adding burden associated with CMS-3380-F resulting a new total of 2,949 hours and $273,396. The overall change in burden from the previously approved package is 13,234 hours to 2,949.

---

Annual Cost to Federal Government: $2,748

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: 12/10/2020

---