Hospital Conditions of Participation (COP) and Supporting Regulations (CMS-R-48)

Forms and Documents

Document Name	Status
CMS-R-48 Final Supporting Statement A.doc Supporting Statement A	2014-09-09

IC Document Collections

IC ID	Document Title	Status
7965	42CFR482.12(d)(1-2) and (d)(4)	Modified
213057	42CFR485.616(c)(3)	New
213056	42CFR485.616(c)(3)	New
213055	42CFR485.616(c)(2)	New
213054	42CFR485.616(c)(1)	New
213051	42CFR485.616(c)(1)	New
213050	42CFR482.92	New
213049	42CFR482.42	New
213047	42CFR482.24	New
213044	42CFR482.23	New
213043	42CFR482.21(d)	New
212996	42CFR482.21(b)	New
195095	42 CFR 482.13(h)	Unchanged
183648	42CFR482.45(b)(3)	Unchanged
183647	42CFR482.45(a)(1)	Removed
183646	42CFR482.45(a)(1)	Modified
183645	42CFR482.43	Modified
183644	42CFR482.27(c)	Removed
183643	42CFR482.27(b)(2)	Modified
183642	42CFR482.21(a)	Modified
183641	42CFR482.13(g)	Modified
183640	42CFR482.13(f)	Unchanged
183639	42CFR482.13(a)(1-2)	Modified
183638	42CFR482.12(f)(2)	Modified
183637	42CFR482.12(e)(2)	Unchanged

ICR Details

OMB Control No: 0938-0328	ICR Reference No: 201409-0938-004
Status: Historical Active	Previous ICR Reference No: 201011-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Hospital Conditions of Participation (COP) and Supporting Regulations (CMS-R-48)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/24/2014
	Date Received in OIRA: 09/17/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2017	36 Months From Approved
Responses	17,279,717	0	0
Time Burden (Hours)	14,424,655	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection package is a request for an reinstatement of the currently approved information collection requirements under CMS-R-48 (0938-0328). We have updated the burden estimates associated with the current hospital conditions of participation (CoPs) to include informaiton collection requirement contained in 42 CFR 482.13(h).

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Authorizing Statute(s): US Code: 42 USC 1395f(a)(6) Name of Law: Conditions of and Limitations on Payment for Services
   US Code: 42 USC 1395x Name of Law: Definitions of Services, Institutions, Etc.
   US Code: 42 USC 1302 Name of Law: Rules and Regulations
   US Code: 42 USC 1395aa Name of Law: Use of State agencies to determine compliance by providers of services with CoP's
   US Code: 42 USC 1320b-8 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
  

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:
	79 FR 5416	01/31/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 48169	08/15/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 23

IC Title	Form No.	Form Name
42CFR485.616(c)(1)
42CFR485.616(c)(1)
42CFR485.616(c)(2)
42CFR485.616(c)(3)
42CFR485.616(c)(3)
42CFR482.45(a)(1)
42CFR482.27(c)
42CFR482.23
42CFR482.24
42CFR482.42
42CFR482.92
42CFR482.12(f)(2)
42CFR482.13(a)(1-2)
42CFR482.13(f)
42CFR482.13(g)
42CFR482.21(a)
42CFR482.27(b)(2)
42CFR482.12(d)(1-2) and (d)(4)
42CFR482.12(e)(2)
42CFR482.43
42CFR482.45(a)(1)
42CFR482.21(b)
42CFR482.45(b)(3)
42 CFR 482.13(h)
42CFR482.21(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	17,279,717	0	0	-24,087,623	0	41,367,340
Annual Time Burden (Hours)	14,424,655	0	0	5,277,228	0	9,147,427
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: We are revising the currently approved information collection request to include the burden associated with the requirements in § 482.23, 482.24, 482.42, 482.92, and 485.616.. There was also a change in the burden in § 482.13(g). We have adjusted the burden accordingly.

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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]? 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: 09/17/2014

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