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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:
202306-0915-003
Status:
Active
Previous ICR Reference No:
202202-0915-002
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:
09/13/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/27/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2026
36 Months From Approved
03/31/2025
Responses
2,352,737
0
604,519
Time Burden (Hours)
647,633
0
430,267
Cost Burden (Dollars)
0
0
0
Abstract:
These forms, which collect data on donors and potential transplant recipients, and the information gathered from the forms, are needed to enable the OPTN to operate a computerized matching system to facilitate matching organs from donors to those who are in need of organs based on medical criteria. In addition, the OPTN shares this data with the Scientific Registry of Transplant Recipients (SRTR) to enable the SRTR to provide statistical and analytic support for the OPTN Board of Directors and committees, HRSA, and the Department of Health and Human Services (HHS) Advisory Committee on Organ Transplantation (ACOT). Respondents include transplant hospitals, organ procurement organizations, and histocompatibility laboratories.
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:
87 FR 59103
09/29/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 38873
06/14/2023
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
70
IC Title
Form No.
Form Name
Death Notification Registration
66
Death Notification Registration
Deceased Donor Death Referral
67
Deceased Donor Death Referral
Deceased Donor Registration (DDR)
1
Deceased Donor Registration_Form_Clean.xlsx
Disease Transmission Event
58
Disease Transmission Event_Form.xlsx
Donor Histocompatibility Form
4
Donor Histocompatibility_Form_Clean.xlsx
Donor Hospital Registration
68
Donor Hospital Registration
Donor Organ Disposition
69
Donor Organ Disposition
Heart Follow Up (6 months)
8
Heart Transplant Recipient Follow Up 6 Month_Form.xlsx
Heart Post-Transplant Malignancy Form
11
Heart Post Transplant Malignancy_Form.xlsx
Heart Recepient Registration
7
Heart Transplant Recipient Registration_Form_clean.xlsx
Heart Transplant Candidate Registration (TCR)
6
Heart Transplant Candidate Registration_Form_clean.xlsx
Heart Transplant Recipient Follow Up 1-5 Year
9
Heart Transplant Recipient Follow Up 1_5 Year _Form_Clean.xlsx
Heart Transplant Recipient Follow Up Post 5 Year
10
Heart Transplant Recipient Follow Up Post 5 Year_Form_Clean.xlsx
Heart/Lung Post Transplant Malignancy (PTM) Form
23
HeartLung Post Transplant Malignancy_Form.xlsx
Heart/Lung Recipient Registration
19
Heart/Lung Transplant Recipient Registration_Form_clean.xlsx
Heart/Lung Transplant Candidate Registration (TCR)
18
Heart/Lung Transplant Candidate Registration_Form_clean.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
Initial Donor Registration
63
Initial Donor Registration
Intestine Post Transplant Malignancy (PTM) Form
34
Intestine Post Transplant Malignancy_Form.xlsx
Intestine Transplant Candidate Registration (TCR)
30
Intestine Transplant Candidate Registration_Form_clean.xlsx
Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF)
32
Intestine Transplant Recipient Follow Up 6 Month_5 Year_Form_clean.xlsx
Intestine Transplant Recipient Follow Up Post 5 Year (TRF)
33
Liver Transplant Recipient Follow Up Post 5 Year_Form_clean.xlsx
Intestine Transplant Recipient Registration (TRR)
31
Intestine Transplant Recipient Registration_Form_clean.xlsx
Kidney Paired Donation Candidate Registration
55
Kidney Paired Donation Candidate Registration_Form_clean.xlsx
Kidney Paired Donation Donor Registration
56
Kidney Paired Donation Donor Registration_Form_clean.xlsx
Kidney Paired Donation Match Offer Management
57
Kidney Paired Donation Match Offer Management_Form.xlsx
Kidney Post Transplant Malignancy (PTM) Form
39
Kidney Post Transplant Malignancy_Form.xlsx
Kidney Transplant Candidate Registration (TCR)
35
Kidney Transplant Candidate Registration_Form_clean.xlsx
Kidney Transplant Recipient Follow Up 6 Month -5 Year (TRF)
37
Kidney Transplant Recipient Follow Up 6 Month_5 Year_Form_clean.xlsx
Kidney Transplant Recipient Follow Up Post 5 Year (TRF)
38
Kidney Transplant Recipient Follow Up Post 5 Year_Form_clean.xlsx
Kidney Transplant Recipient Registration (TRR)
36
Kidney Transplant Recipient Registration_Form_clean.xlsx
Kidney/Pancreas Post Transplant Malignancy (PTM) Form
49
Kidney/Pancreas Post Transplant Malignancy_Form.xlsx
Kidney/Pancreas Transplant Candidate Registration (TCR)
45
Kidney/Pancreas Transplant Candidate Registration_Form_clean.xlsx
Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF)
47
Kidney/Pancreas Transplant Recipient Follow Up 6 Month_5 Year_Form_clean.xlsx
Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)
48
Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year_Form_clean.xlsx
Kidney/Pancreas Transplant Recipient Registration (TRR)
46
Kidney/Pancreas Transplant Recipient Registration_Form_clean.xlsx
Liver Post Transplant Malignancy (PTM) Form
29
Liver Post Transplant Malignancy_Form.xlsx
Liver Recipient Explant Pathology Form
28
Liver 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_clean.xlsx
Liver Transplant Recipient Follow Up Post 5 Year (TRF)
27
Liver Transplant Recipient Follow Up Post 5 Year_Form_clean.xlsx
Liver Transplant Recipient Registration (TRR)
25
Liver Transplant Recipient Registration_Form_clean.xlsx
Living Donor Event
59
Living Donor Event_Form.xlsx
Living Donor Follow-up (LDF)
3
Living Donor Follow Up_Form_Clean.xlsx
Living Donor Registration (LDR)
2
Living Donor Registration_Form_clean
Lung - Post Transplant Malignancy (PTM) Form
17
Lung Post Transplant Malignancy_Form.xlsx
Lung Transplant Candidate Registration (TCR)
12
Lung Transplant Candidate Registration_Form
Lung Transplant Recipient Follow Up 1-5 Year (TRF)
15
Lung Transplant Recipient Follow Up 1_5 Year_Form
Lung Transplant Recipient Follow Up 6 Month (TRF)
14
Lung Transplant Recipient Follow Up 6 Month_Form.xlsx
Lung Transplant Recipient Follow Up Post 5 Year (TRF)
16
Lung Transplant Recipient Follow Up Post 5 Year_Form
Lung Transplant Recipient Registration (TRR)
13
Lung Transplant Recipient Registration_Form_clean.xlsx
OPO Notification Limit Administration
64
OPO Notification Limit Administration
Organ Labeling and Packaging System
53
Organ Labeling and Packaging_Form.xlsx
Organ Tracking and Validating System
54
Organ Tracking and Validating_Form.xlsx
Pancreas Post Transplant Malignancy (PTM) Form
44
Pancreas Post Transplant Malignancy_Form.xlsx
Pancreas Transplant Candidate Registration (TCR)
40
Pancreas Transplant Candidate Registration_Form_clean.xlsx
Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF)
42
Pancreas Transplant Recipient Follow Up 6 Month_5 Year_Form_clean.xlsx
Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)
43
Pancreas Transplant Recipient Follow Up Post 5 Year_ Form_clean.xlsx
Pancreas Transplant Recipient Registration (TRR)
41
Pancreas Transplant Recipient Registration_Form_clean.xlsx
Potential Disease Transmission Report
61
Potential Disease Transmission Report_Form.xlsx
Potential Transplant Recipient
65
Potential Transplant Recipient
Recipient Histocompatibility Form
5
Recipient Histocompatibility_Form._Clean.xlsx
Request to Unlock Form
62
Request to Unlock Form_Form.xlsx
Safety Situation
60
Safety Situation_Form.xlsx
Transplant Center Contact Management
70
Transplant Center Contact Management
VCA Transplant Candidate Registration (TCR)
50
VCA Transplant Candidate Registration_Form.xlsx
VCA Transplant Recipient Follow Up (TRF)
52
VCA Transplant Recipient Follow Up_Form_clean.xlsx
VCA Transplant Recipient Registration (TRR)
51
VCA Transplant Recipient Registration_Form_clean.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
2,352,737
604,519
0
1,748,218
0
0
Annual Time Burden (Hours)
647,633
430,267
0
217,366
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:
The increase in burden hours is mostly due to the addition of eight collection forms from the OPTN donor management and organ matching system to this data collection package. Burden hours for each form are updated based off of annual data, which is the reason for burden increases in some forms and decreases in others.
Annual Cost to Federal Government:
$600,500
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
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?
No
Agency Contact:
Laura Cooper 301 443-2126 lcooper@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:
06/27/2023
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