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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:
0915-0157
ICR Reference No:
201202-0915-001
Status:
Historical Active
Previous ICR Reference No:
201010-0915-001
Agency/Subagency:
HHS/HSA
Agency Tracking No:
Title:
Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/23/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/17/2012
Terms of Clearance:
OMB notes that the revisions to this approved collection do not affect its burden. The burden change is appropriately characterized as an adjustment.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2015
36 Months From Approved
03/31/2012
Responses
477,327
0
522,815
Time Burden (Hours)
258,318
0
278,769
Cost Burden (Dollars)
0
0
0
Abstract:
The Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry for Transplant Recipients (SRTR) collect information on transplant recipients and transplant procedures in accordance with Section 372 of the Public Health Service Act. This information is required for to monitor and evaluate the scientific and clinical status of organ transplantation, and to ensure the distribution of organs equitably among transplant patients nationwide and adopt and use standards of quality for the acquisition and transportation of donated organs. The OPTN must maintain a national waiting list of individuals requiring organ transplants and maintain a computerized system for matching donor organs its transplant candidates list.
Authorizing Statute(s):
US Code:
42 USC 274
Name of Law: Organ Procurement and Transplantation Network
US Code:
42 USC 273
Name of Law: Organ Procurement Organizations
US Code:
42 USC 274a
Name of Law: Scientific Registry
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
76 FR 73650
11/29/2011
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 2732
01/19/2012
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
31
IC Title
Form No.
Form Name
Death Notification Referal - Eligible
1
Death Notification Referral Eligible
Death Notification Referral-Imminent
1
Death Notification Referral Imminent
Death Referral Data
1
Death Referral Data
Liver Explant Pathology
1
Liver Recipient Explant Pathology Worksheet
OPTN- Deceased Donor Registration Worksheet
1
Deceased Donor Registration
OPTN- Donor Histocompatibility
1
Donor Histocompatibility
OPTN- Heart Candidate Registration
7, 7b
Heart Adult Candidate Transplant Registration
,
Heart Pediatric Transplant Candidate Registration
OPTN- Heart/Lung Candidate Registration
9, 9b
Heart-Lung Adult Transplant Candidate Registration Worksheet
,
Heart-Lung Pediatric Transplant Candidate Registration Worksheet
OPTN- Intestine Candidate Registration
24, 24b
Intestine Adult Transplant Candidate Registration Worksheet
,
Intestine Pediatric Transplant Candidate Registration Worksheet
OPTN- Intestine Follow-up
26, 26b, 26c, 26d
Intestine Adult Post 5 Year Transplant Recipient Follow Up Worksheet
,
Intestine Adult Transplant Recipient Follow Up Worksheet
,
Intestine Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet
,
Intestine Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Intestine Registration
25, 25b
Intestine Adult Transplant Recipient Registration Worksheet
,
Intestine Pediatric Transplant Recipient Registration Worksheet
OPTN- Kidney Candidate Registration
1, 2
Kidney Adult Candidate Registration
,
Kidney Pediatric Transplant
OPTN- Kidney Follow-up
14c, 14d, 14, 14b
Kidney Adult Post 5 year Transplant Recipient Follow Up worksheet
,
Kidney Adult Transplant Recipient Follow Up Worksheet
,
Kidney Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet
,
Kidney Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Kidney Registration
1, 2
Kidney Adult Transplant Recipient Registration
,
Kidney Pediatric Transplant Recipient Registration
OPTN- Kidney/Pancreas Candidate Registration
18, 18b
Kidney-Pancreas Adult Transplant Candidate Registration Worksheet
,
Kidney-Pancreas Pediatric Transplant Candidate Registration Worksheet
OPTN- Kidney/Pancreas Registration
19, 19b
Kidney-Pancreas Adult Transplant Recipient Registration
,
Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet
OPTN- Liver Candidate Registration
15, 15b
Liver Adullt Transplant candidate Registration Worksheet
,
Liver Pediatric Transplant candidate Registration Worksheet
OPTN- Liver Follow-up
17b, 17d, 17, 17c
Liver Adult Post 5 year Transplant Recipient Follow Up Worksheet
,
Liver Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet
,
Liver Adult Transplant Recipient Follow Up Worksheet
,
Liver Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Liver Registration
16, 16b
Liver Adult Transplant Recipient Registration Worksheet
,
Liver Pediatric Transplant Recipient Registration Worksheet
OPTN- Living Donor Registration
1
Living Donor Registration
OPTN- Lung Candidate Registration
8, 8b
Lung Adult Transplant candidate Registration Worksheet
,
Lung Pediatric Transplant candidate Registration Worksheet
OPTN- Pancreas Candidate Registration
21, 21b
Pancreas and Pancreas Islets Adult Transplant Candidate Registration Worksheet
,
Pancreas and Pancreas Islets Pediatric Tranpslant Candidate Registration Worksheet
OPTN- Pancreas Follow-up
23, 23b, 23c, 23d
Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet
,
Pancreas Adult Transplant Recipient Follow Up Worksheet
,
Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet
,
Pancreas Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Pancreas Registration
22, 22b
Pancreas Adult Transplant Recipient Registration Worksheet
,
Pancreas Pediatric Transplant Recipient Registration Worksheet
OPTN- Post Transplant Malignancy
27, 27b
Adult Post Transplant Malignancy Worksheet
,
Pediatric Post Transplant Malignancy Worksheet
OPTN- Recipient Histocompatibility
1
Recipient Histocompatibility
OPTN- Thoracic Follow-up
9, 10, 12, 15, 16, 18, 3, 4, 6, 1, 2, 5, 7, 8, 11, 13, 14, 17
Thoracic Heart Adult 6 month Follow-up
,
Thoracic Heart Adult Post 5 year
,
Thoracic Heart Pediatric Post 5 Follow Up
,
Thoracic Heart Lung Adult Six month
,
Thoracic Heart Lung Adult Post 5
,
Thoracic Heart Lung Pediatric Post 5
,
Thoracic Lung Adult 6 month Follow UP
,
Thoracic Lung Adult Post 5 Follow Up
,
Thoracic Lung Pediatric Post 5
,
Thoracic Heart Adult Transplant Recipient Follow Up
,
Thoracic Heart Pediatric 6 Month Transplant Recipient Follow Up
,
Thoracic Heart Pediatric Transplant Recipient Follow Up
,
Thoracic Heart Lung Adult Transplant Recipient Follow Up
,
Thoracic Heart Lung Pediatric 6 Month Transplant Recipient Follow Up
,
Thoracic Heart Lung Pediatric Transplant Recipient Follow Up
,
Thoracic Lung Adult Transplant Recipient Follow Up
,
Thoracic Lung Pediatric 6 Month Transplant Recipient Follow Up
,
Thoracic Lung Pediatric Transplant Recipient Follow Up
OPTN- Thoracic Registration
10f, 10, 10b, 10c, 10d, 10e
Thoracic Heart Adult Transplant Recipient Registration Worksheet
,
Thoracic Heart Pediatric Transplant Recipient Registration Worksheet
,
Thoracic Heart-Lung Adult Transplant Recipient Regisration Worksheet
,
Thoracic Heart-Lung Pediatric Transplant Recipient Registration Worksheet
,
Thoracic Lung Adult Transplant Recipient Registration Worksheet
,
Thoracic Lung Pediatric Transplant Recipient Registration Worksheet
OPTN- Kidney/Pancreas Follow-up
20, 20d, 20b, 20c
Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet
,
Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet
,
Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet
,
Kidney-Pancreas Pediatric Transplant Recipient Follow Up Worksheet
OPTN- Living Donor Follow-up
1
Living Donor Follow-up
Pancreas Islet Candidate Registration
1, 2
Pancreas Islets Adult
,
Pancreas Islets Pediatric
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
477,327
522,815
0
0
-45,488
0
Annual Time Burden (Hours)
258,318
278,769
0
0
-20,451
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:
Annual Cost to Federal Government:
$103,289
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
Agency Contact:
Gerta Bardhoshi 301 443-1129 GBardhoshi@hrsa.gov
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:
02/17/2012
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