Data System for Organ Procurement and Transplantation Network

ICR 202506-0915-004

OMB: 0915-0157

Federal Form Document

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Supplementary Document
2025-06-25
Supplementary Document
2025-06-25
Supporting Statement A
2025-07-01
IC Document Collections
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ICR Details
0915-0157 202506-0915-004
Received in OIRA 202306-0915-003
HHS/HSA
Data System for Organ Procurement and Transplantation Network
Revision of a currently approved collection   No
Regular 07/02/2025
  Requested Previously Approved
36 Months From Approved 09/30/2026
3,184,246 2,352,737
851,578 647,633
0 0

Section 372 of the Public Health Service Act requires that the Secretary of Health and Human Services, by award, provide for the establishment and operation of the Organ Procurement and Transplantation Network (OPTN), which, under oversight of the HRSA, operates the U.S. Organ Procurement and Transplantation system. Significant changes to the collection include: 1) Adding data collection forms for candidates listed in the OPTN organ transplant waiting list to the existing OMB-approved information collection. These forms allow a transplant center to add, change, or remove candidates from the OPTN waiting list after a transplant center completes the patient evaluation. These forms contain information that the OPTN electronic organ matching system uses to match potential organ recipients with available deceased donor organs. There are 83 new data collection forms: candidate listing registration forms of all organs, candidate status justification forms of all applicable organs, Model for End-Stage Liver Disease or Pediatric End-Stage Liver Disease score exception and extension forms, and other forms. Additional revisions to existing OPTN data collection forms were made based on the OPTN Board of Directors (BOD)-approved changes to improve organ matching, allocation, and OPTN policy compliance; 2) Adding OPTN Board of Directors-approved revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance.

US Code: 42 USC 274(b)(2)(I), Sec 372(b)(2)(I) Name of Law: PHS Act
  
None

Not associated with rulemaking

  89 FR 87380 11/01/2024
90 FR 27037 06/25/2025
Yes

153
IC Title Form No. Form Name
Adult Heart Candidate Listing Registration 83 Adult Heart Candidate Listing Registration
Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data 133 Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data 132 Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data 131 Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data 129 Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data
Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data 130 Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data
Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data 136 Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data 137 Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data 138 Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data 135 Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data 134 Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data 141 Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data 142 Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data 140 Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data 139 Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data 145 Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data 144 Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data
Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data 143 Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data
Adult HeartLung Candidate Listing Registration 85 Adult HeartLung Candidate Listing Registration
Adult Intestine Candidate Listing Registration 81 Adult Intestine Candidate Listing Registration
Adult Kidney Candidate Listing Registration 71 Adult Kidney Candidate Listing Registration
Adult Kidney Pancreas Candidate Listing Registration 73 Adult Kidney Pancreas Candidate Listing Registration
Adult Liver Candidate Listing Registration 79 Adult Liver Candidate Listing Registration
Adult Liver Status 1A Initial Justification and Extension Form 108 Adult Liver Status 1A Initial Justification and Extension Form
Adult Lung Candidate Listing Registration 87 Adult Lung Candidate Listing Registration
Adult Pancreas Candidate Listing Registration 75 Adult Pancreas Candidate Listing Registration
Adult Pancreas Islet Listing Registration 77 Adult Pancreas Islet Listing Registration
Adult and Pediatric Lung and HeartLung Goal Exception Form 146 Adult and Pediatric Lung and HeartLung Goal Exception Form
Candidate Registration Listing Removal 89 Candidate Registration Listing Removal
Death Notification Registration 66 Death Notification Registration
Deceased Donor Death Referral 67 Deceased Donor Death Referral
Deceased Donor Registration (DDR) 1 Deceased Donor Registration (DDR)
Discrepant HLA Typings Reporting Form 152 Non-US Transplants Reporting Form
Disease Transmission Event 58 Disease Transmission Event_Form.xlsx
Donor Histocompatibility Form 4 Donor Histocompatibility_Form.xlsx
Donor Hospital Registration 68 Donor Hospital Registration
Donor Organ Disposition 69 Donor Organ Disposition
Extra Vessels Reporting Form 150 Extra Vessels Reporting Form
Heart Post-Transplant Malignancy Form 11 Heart Post Transplant Malignancy_Form.xlsx
Heart Transplant Candidate Registration (TCR) 6 Heart Transplant Candidate Registration_Form_clean.xlsx
Heart Transplant Recipient Follow Up (6 months) 8 Heart Transplant Recipient Follow Up 6 Month_Form.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 Transplant Recipient Registration (TRR) 7 Heart Transplant Recipient Registration_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
Interim Event Reporting Form 153 Interim Event Reporting Form
Intestinal Waiting Time Reinstatement Form 105 Intestinal Waiting Time Reinstatement Form
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 Minimum Acceptance Criteria 107 Kidney Minimum Acceptance Criteria
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 Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form 111 Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form
Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form 112 Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form
Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form 113 Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form
Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form 114 Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form
Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form 115 Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form
Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form 116 Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form
Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form 117 Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form
Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form 118 Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form
Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form 119 Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form
Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form 120 Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form
Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form 121 Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form
Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form 125 Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form
Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form 122 Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form
Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form 123 Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form
Liver Post Transplant Malignancy (PTM) Form 29 Liver Post Transplant Malignancy_Form.xlsx
Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form 124 Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form
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 Feedback Form 149 Living Donor Feedback Form
Living Donor Follow-up (LDF) 3 Living Donor Follow-Up Form
Living Donor Registration (LDR) 2 Living Donor Registration Form
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
Non-US Transplants Reporting Form 151 Non-US Transplants Reporting Form
OPO Notification Limit Administration 64 OPO Notification Limit Administration
OPTN Pancreas Waiting Time Reinstatement Form 104 OPTN Pancreas Waiting Time Reinstatement Form
OPTN Renal Waiting Time Reinstatement Form 103 Renal Waiting Time Reinstatement Form
OPTN Waiting Time Modification Form 102 OPTN Waiting Time Modification Form
OPTN Waiting Time Transfer Form 101 OPTN Waiting Time Transfer Form
Organ Export Verification Form 100 Organ Export Verification Form
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
Pediatric Heart Candidate Listing Registration 84 Pediatric Heart Candidate Listing Registration
Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms 127 Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms
Pediatric Heart and HeartLung Status 1A Initial Justification Form 126 Pediatric Heart and HeartLung Status 1A Initial Justification Form
Pediatric Heart and HeartLung Status 1B Initial Justification Form 128 Pediatric Heart and HeartLung Status 1B Initial Justification Form
Pediatric HeartLung Candidate Listing Registration 86 Pediatric HeartLung Candidate Listing Registration
Pediatric Intestine Candidate Listing Registration 82 Pediatric Intestine Candidate Listing Registration
Pediatric Kidney Candidate Listing Registration 72 Pediatric Kidney Candidate Listing Registration Form
Pediatric Kidney Pancreas Candidate Listing Registration 74 Pediatric Kidney Pancreas Candidate Listing Registration
Pediatric Liver Candidate Listing Registration 80 Pediatric Liver Candidate Listing Registration
Pediatric Liver Status 1A Initial Justification and Extension Form 109 Pediatric Liver Status 1A Initial Justification and Extension Form
Pediatric Liver Status 1B Initial Justification and Extension Form 110 Pediatric Liver Status 1B Initial Justification and Extension Form
Pediatric Lung Candidate Listing Registration 88 Pediatric Lung Candidate Listing Registration
Pediatric Lung Priority 1 Status Justification Form 147 Pediatric Lung Priority 1 Status Justification Form
Pediatric Pancreas Candidate Listing Registration 76 Pediatric Pancreas Candidate Listing Registration
Pediatric Pancreas Islet Listing Registration 78 Pediatric Pancreas Islet Listing Registration
Potential Disease Transmission Report 61 Potential Disease Transmission Report_Form.xlsx
Potential Transplant Recipient 65 Potential Transplant Recipient
Prior Living Donor Priority 106 Prior Living Donor Priority
Recipient Histocompatibility Form 5 Recipient Histocompatibility_Form._Clean.xlsx
Request to Unlock Form 62 Request to Unlock Form_Form.xlsx
Review Board Voter Form 148 Review Board Voter Form
Safety Situation 60 Safety Situation_Form.xlsx
Transplant Center Contact Management 70 Transplant Center Contact Management
VCA Abdominal Wall Candidate Listing Registration 90 VCA Abdominal Wall Candidate Listing Registration
VCA External Male Genitalia Candidate Listing Registration 91 VCA Head and Neck Candidate Listing Registration
VCA Head and Neck Candidate Listing Registration 92 VCA Head and Neck Candidate Listing Registration
VCA Lower Limb Candidate Listing Registration 93 VCA Lower Limb Candidate Listing Registration
VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration 94 VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration
VCA Other Genitourinary Organ Candidate Listing Registration 95 VCA Other Genitourinary Organ Candidate Listing Registration
VCA Spleen Candidate Listing Registration 96 VCA Spleen Candidate Listing Registration
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
VCA Upper Limb Candidate Listing Registration 97 VCA Upper Limb Candidate Listing Registration
VCA Uterus Candidate Listing Registration 98 VCA Uterus Candidate Listing Registration
VCA Vascularized Gland Candidate Listing Registration 99 VCA Vascularized Gland Candidate Listing Registration

  Total Request 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 3,184,246 2,352,737 0 831,509 0 0
Annual Time Burden (Hours) 851,578 647,633 0 203,945 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The estimated burden hours for this collection increased by 203,945 hours from the currently approved ICR package. This increase included 96,156 hours due to the addition of 83 new data collection forms for the OPTN waiting list and 107,789 hours due to OPTN BOD-approved data collection changes to existing forms and changes in the number of respondents. Any burden reductions to existing forms are due to adjustments in the average burden per response based on stakeholder consultation.

$600,530
No
    Yes
    Yes
No
No
No
No
Laura Cooper 301 443-2126 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/02/2025


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