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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:
201411-0915-004
Status:
Historical Active
Previous ICR Reference No:
201202-0915-001
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:
02/18/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/16/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2018
36 Months From Approved
03/31/2015
Responses
472,418
0
477,327
Time Burden (Hours)
373,729
0
258,318
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:
79 FR 53203
09/08/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 71437
12/02/2014
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
26
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
Heart, Lung, Heart/Lung Follow Up (1-5 year)
21
Heart, Lung, Heart/Lung Follow Up (1-5 year)
Heart, Lung, Heart/Lung Follow Up (6 month)
20
Heart, Lung, Heart/Lung Follow Up (6 month)
Heart, Lung, Heart/Lung Follow Up (Post 5 year)
22
Heart, Lung, Heart/Lung Follow Up (Post 5 year)
Heart, Lung, Heart/Lung Recipient Registration
19
Heart, Lung, Heart/Lung Recipient Registration
Kidney/Pancreas
45, 46, 47, 48
Kidney/Pancreas Candidate Registration
,
Kidney/Pancreas Recipient Registration
,
Kidney/Pancreas Recipient Follow up (6 months - 5 years)
,
Kidney/Pancreas Recipient Follow up (Post 5 years)
Liver Explant Pathology
1
Liver Recipient Explant Pathology Worksheet
Liver Recipient Explant Pathology Form
28
Liver Recipient Explant Pathology Form
OPTN- Deceased Donor Registration Worksheet
1
Deceased Donor Registration
OPTN- Donor Histocompatibility
4
Donor Histocompatibility
OPTN- Heart Candidate Registration
6
Heart Transplant Candidate Registration
OPTN- Heart/Lung Candidate Registration
18
Heart/Lung Candidate Registration
OPTN- Intestine Candidate Registration
30
Intestine Candidate Registration
OPTN- Intestine Follow-up
32, 33
Intestine Recipient Follow Up (6 months - 5 years)
,
Intestine Recipient Follow Up (Post 5 years)
OPTN- Intestine Recipient Registration
31
Intestine Recipient Registration
OPTN- Kidney Candidate Registration
35
Kidney Candidate Registration
OPTN- Kidney Follow-up
37, 38
Kidney Follow-up (6 months - 5 years)
,
Kidney Follow-up (Post 5 years)
OPTN- Kidney Recipient Registration
36
Kidney Recipient Registration
OPTN- Kidney/Pancreas Registration
19, 19b
Kidney-Pancreas Adult Transplant Recipient Registration
,
Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet
OPTN- Liver Candidate Registration
24
Liver Candidate Registration
OPTN- Liver Follow-up
26, 27
Liver Recipient Follow up (6 months - 5 years)
,
Liver Recipient Follow up (Post 5 years)
OPTN- Liver Recipient Registration
25
Liver Recipient Registration
OPTN- Living Donor Registration
2
Living Donor Registration
OPTN- Lung Candidate Registration
12
Lung Candidate Registration
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
5
Recipient Histocompatibility
OPTN- Thoracic Follow-up
15, 16, 18, 3, 4, 6, 1, 2, 5, 7, 8, 11, 13, 14, 17, 9, 10, 12
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
20d, 20, 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
3
Living Donor Follow Up
Pancreas
40, 43, 41, 42
Pancreas Candidate Registration
,
Pancreas Recipient Registration
,
Pancreas Recipient Follow Up (6 months - 5 years)
,
Pancreas Recipient Follow Up (Post 5 years)
Pancreas Islet Candidate Registration
1, 2
Pancreas Islets Adult
,
Pancreas Islets Pediatric
Post-Transplant Malignancy Form
11
Post-Transplant Malignancy Form
Vascular Composite Allograft
50, 51, 52
Vascular Composit Allograft Candidate Registration
,
Vascular Composit Allograft Recipient Registration
,
Vascular Composit Allograft Recipient Follow Up
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
472,418
477,327
0
-4,909
0
0
Annual Time Burden (Hours)
373,729
258,318
0
115,411
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:
Currently, there are a total of 358,092.5 burden hours in the OMB inventory. The total burden hours has increased since 2011 by 79,326 hours. This increase represents a change in burden estimates based on analysis of the most recent trends in OPTN data form submissions. The current estimates should be a more accurate reflection of total burden since the forms were broken out in a more granular fashion. The pilot study participants provided feedback on each type of form as opposed to grouping them only by organ. For example, a 6 month heart follow up form is much shorter than a 1-5 year heart follow up form and should not require as much effort to complete. There are several factors that must be considered when analyzing the additional burden hours. OPTN policy mandates that transplant programs follow transplant recipients until graft failure, re-transplant or death. So as patient and graft survival increases the number of recipients still alive with a functioning graft increases, and the transplant centers will be responsible for completing more forms. Although it is a slight increase in the burden hours, the burden assessment took into account the three additional VCA forms. The frame work of the VCA forms is based on the current Liver Candidate Registration, Liver Recipient Registration and the Liver Recipient Follow Up. The burden hours for those forms were used for VCA as well since the forms are not currently active. Looking forward, the burden time should trend slightly downward after the modifications from this submission.
Annual Cost to Federal Government:
$263,047
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:
Jodi Duckhorn 301 443-1984
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:
12/16/2014