Data System for Organ Procurement and Transplantation Network

Forms and Documents

Document Name	Status
Form 1 Deceased Donor Registration (DDR) Form	Modified
Form 153 Interim Event Reporting Form Form	New
Form 151 Non-US Transplants Reporting Form Form	New
Form 149 Living Donor Feedback Form Form	New
Form 147 Pediatric Lung Priority 1 Status Justification Form Form	New
Form 145 Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data Form	New
Form 143 Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data Form	New
Form 141 Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data Form	New
Form 139 Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data Form	New
Form 137 Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data Form	New
Form 135 Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data Form	New
Form 133 Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data Form	New
Form 131 Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data Form	New
Form 129 Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data Form	New
Form 127 Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms Form	New
Form 125 Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form Form	New
Form 123 Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form Form	New
Form 121 Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form Form	New
Form 119 Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form Form	New
Form 117 Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form Form	New
Form 115 Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form Form	New
Form 113 Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form Form	New
Form 111 Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form Form	New
Form 109 Pediatric Liver Status 1A Initial Justification and Extension Form Form	New
Form 107 Kidney Minimum Acceptance Criteria Form	New
Form 105 Intestinal Waiting Time Reinstatement Form Form	New
Form 103 OPTN Renal Waiting Time Reinstatement Form Form	New
Form 101 OPTN Waiting Time Transfer Form Form	New
Form 100 Organ Export Verification Form Form	New
Form 98 VCA Uterus Candidate Listing Registration Form	New
Form 96 VCA Spleen Candidate Listing Registration Form	New
Form 94 VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration Form	New
Form 92 VCA Head and Neck Candidate Listing Registration Form	New
Form 91 VCA External Male Genitalia Candidate Listing Registration Form	New
Form 89 Candidate Registration Listing Removal Form	New
Form 87 Adult Lung Candidate Listing Registration Form	New
Form 85 Adult HeartLung Candidate Listing Registration Form	New
Form 82 Pediatric Intestine Candidate Listing Registration Form	New
Form 80 Pediatric Liver Candidate Listing Registration Form	New
Form 78 Pediatric Pancreas Islet Listing Registration Form	New
Form 76 Pediatric Pancreas Candidate Listing Registration Form	New
Form 74 Pediatric Kidney Pancreas Candidate Listing Registration Form	New
Form 72 Pediatric Kidney Candidate Listing Registration Form	New
Form 71 Adult Kidney Candidate Listing Registration Form	New
Form 3 Living Donor Follow-up (LDF) Form	Modified
Privacy Act Statement - OPTN 0915-0157 Revision 06.25.2025.docx Supplementary Document	2025-06-25
Burden Statement - OPTN 0915-0157 Revision CLEAN 06.25.2025.docx Supplementary Document	2025-06-25
Supporting Statement A - OPTN Data System 0915-0157 Revision 06.25.2025.docx Supporting Statement A	2025-07-01

IC Document Collections

IC ID	Document Title	Status
6389	Deceased Donor Registration (DDR) Form	Modified
276081	Interim Event Reporting Form Form	New
276080	Discrepant HLA Typings Reporting Form Instruction	New
276079	Non-US Transplants Reporting Form Form	New
276078	Extra Vessels Reporting Form Instruction	New
276077	Living Donor Feedback Form Form	New
276076	Review Board Voter Form Instruction	New
276075	Pediatric Lung Priority 1 Status Justification Form Form	New
276073	Adult and Pediatric Lung and HeartLung Goal Exception Form Instruction	New
276072	Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data Form	New
276070	Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data Instruction	New
276069	Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data Form	New
276068	Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data Instruction	New
276066	Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data Form	New
276064	Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data Instruction	New
276063	Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data Form	New
276062	Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data Instruction	New
276061	Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data Form	New
276060	Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data Instruction	New
276059	Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data Form	New
276058	Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data Instruction	New
276057	Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data Form	New
276056	Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data Instruction	New
276055	Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data Form	New
276054	Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data Instruction	New
276050	Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data Form	New
276049	Pediatric Heart and HeartLung Status 1B Initial Justification Form Instruction	New
276048	Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms Form	New
276047	Pediatric Heart and HeartLung Status 1A Initial Justification Form Instruction	New
276046	Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form Form	New
276045	Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form Instruction	New
276044	Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form Form	New
276043	Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form Instruction	New
276042	Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form Form	New
276041	Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form Instruction	New
276040	Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form Form	New
276039	Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form Instruction	New
276038	Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form Form	New
276037	Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form Instruction	New
276036	Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form Form	New
276035	Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form Instruction	New
276034	Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form Form	New
276033	Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form Instruction	New
276032	Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form Form	New
276028	Pediatric Liver Status 1B Initial Justification and Extension Form Instruction	New
276027	Pediatric Liver Status 1A Initial Justification and Extension Form Form	New
276026	Adult Liver Status 1A Initial Justification and Extension Form Instruction	New
276024	Kidney Minimum Acceptance Criteria Form	New
276023	Prior Living Donor Priority Instruction	New
276022	Intestinal Waiting Time Reinstatement Form Form	New
276020	OPTN Pancreas Waiting Time Reinstatement Form Instruction	New
276019	OPTN Renal Waiting Time Reinstatement Form Form	New
276018	OPTN Waiting Time Modification Form Instruction	New
276017	OPTN Waiting Time Transfer Form Form	New
276006	Organ Export Verification Form Form	New
276005	VCA Vascularized Gland Candidate Listing Registration Instruction	New
276004	VCA Uterus Candidate Listing Registration Form	New
276003	VCA Upper Limb Candidate Listing Registration Instruction	New
276002	VCA Spleen Candidate Listing Registration Form	New
275999	VCA Other Genitourinary Organ Candidate Listing Registration Instruction	New
275998	VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration Form	New
275997	VCA Lower Limb Candidate Listing Registration Instruction	New
275996	VCA Head and Neck Candidate Listing Registration Form	New
275995	VCA External Male Genitalia Candidate Listing Registration Form	New
275994	VCA Abdominal Wall Candidate Listing Registration Instruction	New
275993	Candidate Registration Listing Removal Form	New
275992	Pediatric Lung Candidate Listing Registration Instruction	New
275991	Adult Lung Candidate Listing Registration Form	New
275990	Pediatric HeartLung Candidate Listing Registration Instruction	New
275988	Adult HeartLung Candidate Listing Registration Form	New
275987	Pediatric Heart Candidate Listing Registration Instruction	New
275968	Adult Heart Candidate Listing Registration Instruction	New
275967	Pediatric Intestine Candidate Listing Registration Form	New
275966	Adult Intestine Candidate Listing Registration Instruction	New
275965	Pediatric Liver Candidate Listing Registration Form	New
275964	Adult Liver Candidate Listing Registration Instruction	New
275963	Pediatric Pancreas Islet Listing Registration Form	New
275962	Adult Pancreas Islet Listing Registration Instruction	New
275961	Pediatric Pancreas Candidate Listing Registration Form	New
275960	Adult Pancreas Candidate Listing Registration Instruction	New
275959	Pediatric Kidney Pancreas Candidate Listing Registration Form	New
275957	Adult Kidney Pancreas Candidate Listing Registration Instruction	New
275956	Pediatric Kidney Candidate Listing Registration Form	New
275955	Adult Kidney Candidate Listing Registration Form	New
260702	Transplant Center Contact Management Instruction	Modified
260701	Donor Organ Disposition Instruction	Modified
260700	Donor Hospital Registration Instruction	Modified
260699	Deceased Donor Death Referral Instruction	Modified
260698	Death Notification Registration Instruction	Modified
260697	Potential Transplant Recipient Instruction	Modified
260696	OPO Notification Limit Administration Instruction	Modified
260695	Initial Donor Registration Instruction	Modified
251650	Request to Unlock Form Instruction	Modified
251649	Potential Disease Transmission Report Instruction	Modified
251648	Safety Situation Instruction	Modified
251647	Living Donor Event Instruction	Modified
251645	Disease Transmission Event Instruction	Modified
251644	Kidney Paired Donation Match Offer Management Instruction	Modified
251643	Kidney Paired Donation Donor Registration Instruction	Modified
251642	Kidney Paired Donation Candidate Registration Instruction	Modified
251641	Organ Tracking and Validating System Instruction	Modified
251640	Organ Labeling and Packaging System Instruction	Modified
226455	VCA Transplant Recipient Follow Up (TRF) Instruction	Modified
226454	VCA Transplant Recipient Registration (TRR) Instruction	Modified
226453	Kidney/Pancreas Post Transplant Malignancy (PTM) Form Instruction	Modified
226452	Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226451	Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
226449	Kidney/Pancreas Transplant Recipient Registration (TRR) Instruction	Modified
226448	Pancreas Post Transplant Malignancy (PTM) Form Instruction	Modified
226447	Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226446	Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
226445	Pancreas Transplant Recipient Registration (TRR) Instruction	Modified
226443	Kidney Post Transplant Malignancy (PTM) Form Instruction	Modified
226442	Kidney Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226441	Intestine Post Transplant Malignancy (PTM) Form Instruction	Modified
226440	Intestine Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226439	Liver Post Transplant Malignancy (PTM) Form Instruction	Modified
226438	Liver Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226431	Heart/Lung Post Transplant Malignancy (PTM) Form Instruction	Modified
226430	Lung - Post Transplant Malignancy (PTM) Form Instruction	Modified
226428	Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226426	Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	Modified
226425	Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	Modified
226424	Lung Transplant Recipient Registration (TRR) Instruction	Modified
226422	Heart Post-Transplant Malignancy Form Instruction	Modified
226418	Heart Transplant Recipient Follow Up Post 5 Year Instruction	Modified
226417	Heart Transplant Recipient Follow Up 1-5 Year Instruction	Modified
226416	Heart Transplant Recipient Follow Up (6 months) Instruction	Modified
226415	Heart Transplant Recipient Registration (TRR) Instruction	Modified
214131	VCA Transplant Candidate Registration (TCR) Instruction	Modified
214130	Liver Recipient Explant Pathology Form Instruction	Modified
214128	Heart/Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
214127	Heart/Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	Modified
214126	Heart/Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	Modified
214124	Heart/Lung Recipient Registration Instruction	Modified
181750	Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
181749	Intestine Transplant Recipient Registration (TRR) Instruction	Modified
181748	Intestine Transplant Candidate Registration (TCR) Instruction	Modified
181745	Pancreas Transplant Candidate Registration (TCR) Instruction	Modified
181742	Kidney/Pancreas Transplant Candidate Registration (TCR) Instruction	Modified
181741	Liver Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
181740	Liver Transplant Recipient Registration (TRR) Instruction	Modified
181739	Liver Transplant Candidate Registration (TCR) Instruction	Modified
181738	Kidney Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
181737	Kidney Transplant Recipient Registration (TRR) Instruction	Modified
181736	Kidney Transplant Candidate Registration (TCR) Instruction	Modified
181733	Heart/Lung Transplant Candidate Registration (TCR) Instruction	Modified
181732	Lung Transplant Candidate Registration (TCR) Instruction	Modified
181731	Heart Transplant Candidate Registration (TCR) Instruction	Modified
181730	Recipient Histocompatibility Form Instruction	Modified
181729	Donor Histocompatibility Form Instruction	Modified
181728	Living Donor Follow-up (LDF) Form	Modified
181727	Living Donor Registration (LDR) Instruction	Modified

ICR Details

OMB Control No: 0915-0157	ICR Reference No: 202506-0915-004
Status: Received in OIRA	Previous ICR Reference No: 202306-0915-003
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	Date Submitted to OIRA: 07/02/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2026
Responses	3,184,246	2,352,737
Time Burden (Hours)	851,578	647,633
Cost Burden (Dollars)	0	0

---

Abstract: 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.

---

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:
	89 FR 87380	11/01/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 27037	06/25/2025
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 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

---

ICR Summary of Burden

	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

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 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.

---

Annual Cost to Federal Government: $600,530

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

---

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: 07/02/2025

---