Organ Procurement Organization/Histocompatibility Laboratory Statement of Reimbursable Costs, manual instructions and supporting regulations contained in 42 CFR 413.20 and 413.24

Forms and Documents

Document	Type	Status	Availability
2010opohistolabOMB Supporting Statement [rev 05-06-11].docx	Supporting Statement A	Uploaded 2011-05-06	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
43650	Organ Procurement Organization/Histcompatibility Laboratory Statement of Reimbursable Costs, Manual Instructions (CMS-216-94)	Other-Cost Report	Modified

ICR Details

OMB Control No: 0938-0102	ICR Reference No: 201105-0938-003
Status: Historical Active	Previous ICR Reference No: 200805-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Organ Procurement Organization/Histocompatibility Laboratory Statement of Reimbursable Costs, manual instructions and supporting regulations contained in 42 CFR 413.20 and 413.24
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 without change	Conclusion Date: 07/24/2011
	Date Received in OIRA: 05/13/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved	07/31/2011
Responses	115	0	108
Time Burden (Hours)	5,175	0	4,860
Cost Burden (Dollars)	0	0	0

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Abstract: This form is required by statue and regulation for participation in the Medicare program. The information is used to determine payment for Medicare. Organ Procurement Organizations and Histocompatibility Laboratories are the users.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1861 Name of Statute: null
   Statute at Large: 18 Stat. 1881 Name of Statute: null
  

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:
	76 FR 3909	01/21/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 21370	04/15/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Organ Procurement Organization/Histcompatibility Laboratory Statement of Reimbursable Costs, Manual Instructions (CMS-216-94)

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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	115	108	0	0	7	0
Annual Time Burden (Hours)	5,175	4,860	0	0	315	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:

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Annual Cost to Federal Government: $12,951

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: 05/13/2011

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