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

Forms and Documents

Document Name	Status
CMS-R-13 PRA Supporting Statement - 022318 clean.docx Supporting Statement A	2018-02-26

IC Document Collections

IC ID	Document Title	Status
8295	42 CFR, Section 486.306 (c)(1)-(3)	Unchanged
46280	42 CFR, Section 486.316 (d)	Removed
46278	42 CFR, Section 486.348(b)	Unchanged
46277	42 CFR, Section 486.328 (a)	Unchanged

ICR Details

OMB Control No: 0938-0688	ICR Reference No: 201704-0938-008
Status: Active	Previous ICR Reference No: 201309-0938-025
Agency/Subagency: HHS/CMS	Agency Tracking No: 20422
Title: (CMS-R-13) Conditions of Coverage for Organ Procurement Organizations (OPOs) 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: 02/27/2018
	Date Received in OIRA: 04/28/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	02/28/2018
Responses	128	0	137
Time Burden (Hours)	13,234	0	13,546
Cost Burden (Dollars)	0	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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 11040	02/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 19734	04/28/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
42 CFR, Section 486.306 (c)(1)-(3)
42 CFR, Section 486.328 (a)
42 CFR, Section 486.348(b)
42 CFR, Section 486.316 (d)

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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	128	137	0	0	-9	0
Annual Time Burden (Hours)	13,234	13,546	0	0	-312	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: The burden hours decreased from 13,546 to 13,234 due to the removal of the estimate for 46.316(d). The estimated costs decreased from $964,894 to $950,403. These were increases due to an increase in the average hourly wage for some of the positions, but this was more than offset due to the removal of the $28,392 estimate for $486.316(d).

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Annual Cost to Federal Government: $46

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: 04/28/2017

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