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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1069
ICR Reference No:
200809-0938-008
Status:
Historical Inactive
Previous ICR Reference No:
Agency/Subagency:
HHS/CMS
Agency Tracking No:
Title:
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74, 482.94, 482.100, 482.102, 488.61
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Withdrawn
Conclusion Date:
01/08/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/04/2008
Terms of Clearance:
This ICR is withdrawn per 1/2/09 memo. CMS acknowledges that this ICR constitutes a PRA violation because the ICR was not submitted and approved before the rule which authorized the collection of information went into effect. CMS agrees to resubmit this ICR as "existing collection in use without OMB control number."
Inventory as of this Action
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The CoPs and accompanying requirements specified in the regulations are used by our surveyors as a basis for determining whether a transplant center qualifies for approval or re-approval under Medicare. CMS and the healthcare industry believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability.
Authorizing Statute(s):
US Code:
42 USC 1302
Name of Law: Regulation
US Code:
42 USC 1395hh
Name of Law: Regulations
US Code:
42 USC 1395aa
Name of Law: Use of State agencies to determine compliance by providers of services with CoPs
US Code:
42 USC 1395bb
Name of Law: Use of Joint Commission on Accreditation of Hospitals
US Code:
42 USC 1395bb
Name of Law: Limitation of the deeming authority of the Joint Commission
US Code:
42 USC 1395rr
Name of Law: Limitation of deeming authority of the Joint Commission
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0938-AH17
Final or interim final rulemaking
72 FR 15198
03/30/2007
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
73 FR 31120
05/30/2008
30-day Notice:
Federal Register Citation:
Citation Date:
73 FR 49677
08/22/2008
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.100
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.102
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.94
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 488.61
Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 488.61
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The information collection requirements described herein are needed to implement the Medicare CoPs for 514 Medicare-approved organ transplant centers: 504 currently approved centers and an estimated 10 centers that apply for approval every year.
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
Agency Contact:
William Parham 4107864669
Common Form ICR:
No
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:
09/04/2008
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