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View Supporting Statement and Other Documents
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:
201704-0915-007
Status:
Historical Active
Previous ICR Reference No:
201411-0915-004
Agency/Subagency:
HHS/HSA
Agency Tracking No:
Title:
Data System for Organ Procurement and Transplantation Network
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/19/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/21/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2020
36 Months From Approved
02/28/2018
Responses
488,980
0
472,418
Time Burden (Hours)
370,279
0
373,729
Cost Burden (Dollars)
0
0
0
Abstract:
Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country.
Authorizing Statute(s):
US Code:
42 USC 274(b)(2)(I), Sec 372(b)(2)(I)
Name of Law: PHS Act
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:
81 FR 13378
03/14/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 18001
04/14/2017
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
52
IC Title
Form No.
Form Name
Deceased Donor Registration (DDR)
1
UPDATED -Copy of Copy of Deceased Donor Registration Form-Jan2017.xlsx
Donor Histocompatibility Form
4
Donor Histocompatibility _Form.xlsx
Heart Follow Up (6 months)
8
Heart Transplant Recipient Follow Up 6 Month_Form.xlsx
Heart Post-Transplant Malignancy Form
11
Post Transplant Malignancy Form_All Organs.xlsx
Heart Recepient Registration
7
Heart Transplant Recipient Registration_Form.xlsx
Heart Transplant Candidate Registration (TCR)
6
Heart Transplant Candidate Registration_Form.xlsx
Heart Transplant Recipient Follow Up 1-5 Year
9
Heart Transplant Recipient Follow Up 1-5 Year_Form.xlsx
Heart Transplant Recipient Follow Up Post 5 Year
10
Heart Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Heart/Lung Post Transplant Malignancy (PTM) Form
23
Post Transplant Malignancy Form_All Organs.xlsx
Heart/Lung Recipient Registration
19
Heart_Lung Transplant Recipient Registration_Form.xlsx
Heart/Lung Transplant Candidate Registration (TCR)
18
Heart_Lung Transplant Candidate Registration_Form.xlsx
Heart/Lung Transplant Recipient Follow Up 1-5 Year (TRF)
21
Heart_Lung Transplant Recipient Follow Up 1-5 Year_Form.xlsx
Heart/Lung Transplant Recipient Follow Up 6 Month (TRF)
20
Heart_Lung Transplant Recipient Follow Up 6 Month_Form.xlsx
Heart/Lung Transplant Recipient Follow Up Post 5 Year (TRF)
22
Heart_Lung Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Intestine Post Transplant Malignancy (PTM) Form
34
Post Transplant Malignancy Form_All Organs.xlsx
Intestine Transplant Candidate Registration (TCR)
30
Intestine Transplant Candidate Registration_Form.xlsx
Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF)
32
Intestine Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Intestine Transplant Recipient Follow Up Post 5 Year (TRF)
33
Intestine Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Intestine Transplant Recipient Registration (TRR)
31
Intestine Transplant Recipient Registration_Form.xlsx
Kidney Post Transplant Malignancy (PTM) Form
39
Post Transplant Malignancy Form_All Organs.xlsx
Kidney Transplant Candidate Registration (TCR)
35
Kidney Transplant Candidate Registration_Form.xlsx
Kidney Transplant Recipient Follow Up 6 Month -5 Year (TRF)
37
Kidney Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Kidney Transplant Recipient Follow Up Post 5 Year (TRF)
38
Kidney Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Kidney Transplant Recipient Registration (TRR)
36
Kidney Transplant Recipient Registration_Form.xlsx
Kidney/Pancreas Post Transplant Malignancy (PTM) Form
49
Post Transplant Malignancy Form_All Organs.xlsx
Kidney/Pancreas Transplant Candidate Registration (TCR)
45
Kidney_Pancreas Transplant Candidate Registration_Form.xlsx
Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF)
47
Kidney_Pancreas Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)
48
Kidney_Pancreas Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Kidney/Pancreas Transplant Recipient Registration (TRR)
46
Kidney_Pancreas Transplant Recipient Registration_Form.xlsx
Liver Post Transplant Malignancy (PTM) Form
29
Post Transplant Malignancy Form_All Organs.xlsx
Liver Recipient Explant Pathology Form
28
Liver Recipient Explant Pathology_Form.xlsx
Liver Transplant Candidate Registration (TCR)
24
Liver Transplant Candidate Registration_Form.xlsx
Liver Transplant Recipient Follow Up 6 Month -5 Year (TRF)
26
Liver Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Liver Transplant Recipient Follow Up Post 5 Year (TRF)
27
Liver Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Liver Transplant Recipient Registration (TRR)
25
Liver Transplant Recipient Registration_Form.xlsx
Living Donor Follow-up (LDF)
3
Living Donor Follow Up Form.xlsx
Living Donor Registration (LDR)
2
Living Donor Registration Form.xlsx
Lung - Post Transplant Malignancy (PTM) Form
17
Post Transplant Malignancy Form_All Organs.xlsx
Lung Transplant Candidate Registration (TCR)
12
Lung Transplant Candidate Registration_Form.xlsx
Lung Transplant Recipient Follow Up 1-5 Year (TRF)
15
Heart_Lung Transplant Recipient Follow Up 1-5 Year_Instructions.docx
Lung Transplant Recipient Follow Up 6 Month (TRF)
14
Liver Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Lung Transplant Recipient Follow Up Post 5 Year (TRF)
16
Lung Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Lung Transplant Recipient Registration (TRR)
13
Lung Transplant Recipient Registration_Form.xlsx
Pancreas Post Transplant Malignancy (PTM) Form
44
Post Transplant Malignancy Form_All Organs.xlsx
Pancreas Transplant Candidate Registration (TCR)
40
Pancreas Transplant Candidate Registration_Form.xlsx
Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF)
42
Pancreas Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)
43
Pancreas Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Pancreas Transplant Recipient Registration (TRR)
41
Pancreas Transplant Recipient Registration_Form.xlsx
Post-Transplant Malignancy Form
11
Post-Transplant Malignancy Form
Recipient Histocompatibility Form
5
Recipient Histocompatibility_Form.xlsx
VCA Transplant Candidate Registration (TCR)
50
Vascular Composite Allograft (VCA) Transplant Candidate Registration_Form.xlsx
VCA Transplant Recipient Follow Up (TRF)
52
Vascular Composite Allograft Transplant Recipient Follow Up_Form.xlsx
VCA Transplant Recipient Registration (TRR)
51
Vascular Composite Allograft Transplant Recipient Registration_Form.xlsx
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
488,980
472,418
0
24,450
-7,888
0
Annual Time Burden (Hours)
370,279
373,729
0
2,857
-6,307
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:
Cutting Redundancy
Short Statement:
Burdens in ROCIS may differ from SSA as ROCIS automatically rounds up. Currently, there are a total of 370,274.9 burden hours in the OMB inventory. The total burden hours has decreased from the previous total burden of 373,729 by 3,454.1 hours. The decreased total burden may be attributable to the increase in the use of data import/export capabilities by OPTN members. This has lessened the manual data entry burden on OPTN member staff. Although the contractor submitted the entire form packet for review, the current submission only requires modifications to 16 forms. The changes in burden referenced in above table include all forms.
Annual Cost to Federal Government:
$212,524
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:
Elyana Bowman 301 443-3983 enadjem@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:
04/21/2017
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