Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301 - 486.348

Forms and Documents

Document Name	Status
CMS-R-13 Supporting Statement 05-31-12 compliant 508.pdf Supporting Statement A	2013-08-29

IC Document Collections

IC ID	Document Title	Status
8295	42 CFR, Section 486.306 (c)(1)-(3)	Modified
46280	42 CFR, Section 486.316 (d)	Modified
46279	Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301-325	Removed
46278	42 CFR, Section 486.348(b)	Modified
46277	42 CFR, Section 486.328 (a)	Modified
46276	Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301-348	Removed
46275	Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301-348	Removed

ICR Details

OMB Control No: 0938-0688	ICR Reference No: 201309-0938-025
Status: Historical Active	Previous ICR Reference No: 200611-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: 20422
Title: Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301 - 486.348
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/21/2014
	Date Received in OIRA: 09/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved
Responses	137	0	0
Time Burden (Hours)	13,546	0	0
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:
	78 FR 29137	05/17/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 45203	07/26/2013
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
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)
Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301-348
Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301-348
Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR, Section 486.301-325

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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	137	0	0	-169	0	306
Annual Time Burden (Hours)	13,546	0	0	-7,881	0	21,427
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There has been a decrease in burden hours since the previous submittal. We are not including a burden analysis for the ICRs for 42 CFR 308 (d) and (e), 486.310 (a) (1) and (2), 486.312 (a), and 486.314 because we believe these requirements are exempt from the PRA because less than 10 respondents or entities would be affected by these ICRs.

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Annual Cost to Federal Government: $43

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

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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: 09/20/2013

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