Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations Contained in 42 CFR 405.2100-.2171

Forms and Documents

Document Name	Status
CMS-R-52.Supporting Statement (2006).doc Supporting Statement A	2007-01-03

IC Document Collections

IC ID	Document Title	Status
8031	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations Contained in 42 CFR 405.2100-.2171	Modified
46753	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46752	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46751	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100-.2171	New
46750	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46749	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46748	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46747	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46746	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46745	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46744	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46743	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46742	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46741	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46740	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46739	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46738	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46737	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46736	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46735	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46734	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46733	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46732	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46731	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46730	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46729	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46728	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New
46727	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	New

ICR Details

OMB Control No: 0938-0386	ICR Reference No: 200701-0938-010
Status: Historical Active	Previous ICR Reference No: 200304-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations Contained in 42 CFR 405.2100-.2171
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: 03/28/2007
	Date Received in OIRA: 01/12/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	36 Months From Approved	03/31/2007
Responses	68,605	0	4,297
Time Burden (Hours)	160,710	0	148,785
Cost Burden (Dollars)	0	0	0

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Abstract: This package is needed to encourage proper distribution and effective utilization of ESRD treatment sources while maintaining and improving the efficient delivery of care by physicians and dialysis facilities.

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Authorizing Statute(s): None

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:
	71 FR 17887	04/07/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 34939	06/16/2006
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 28

IC Title	Form No.	Form Name
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100-.2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations Contained in 42 CFR 405.2100-.2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171

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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	68,605	4,297	0	64,308	0	0
Annual Time Burden (Hours)	160,710	148,785	0	11,925	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: The number of ESRD facilities as of 2003 was approximately 4,297. In the first quarter of 2006 there are approximately 4,797 facilities. The burden for this request is based on 4,757 existing facilities due to an average increase of approximately 153 new facilities each year for the past three years. The burden has also been computed using the current number of ESRD networks which has remained at 18. Therefore, there has been an increase in burden due to the number of respondents. This is an adjustment.

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 01/09/2007

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