2024-25506. Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network

Total Estimated Annualized Burden Hours

Form #	Form name	Number of respondents	Number of responses per respondent ****	Total responses	Average burden per response (in hours)	Total burden hours
1	Deceased Donor Registration	56	414.71	23,224	0.48	11,147.40
2	Living Donor Registration	207	33.42	6,918	2.19	15,150.29
3	Living Donor Follow-up	207	94.86	19,636	1.52	29,846.75
4	Donor Histocompatibility	138	173.31	23,917	0.20	4,783.36
5	Recipient Histocompatibility	138	307.09	42,378	0.40	16,951.37
6	Heart Transplant Candidate Registration	149	38.50	5,737	0.90	5,162.85
7	Heart Transplant Recipient Registration	149	30.50	4,545	1.96	8,907.22
8	Heart Transplant Recipient Follow Up (6 Month)	149	27.79	4,141	0.40	1,656.28
9	Heart Transplant Recipient Follow Up (1-5 Year)	149	109.21	16,272	0.90	14,645.06
10	Heart Transplant Recipient Follow Up (Post 5 Year)	149	183.73	27,376	0.50	13,687.89
11	Heart Post-Transplant Malignancy Form	149	12.21	1,819	0.90	1,637.36
12	Lung Transplant Candidate Registration	74	45.36	3,357	0.95	3,188.81
13	Lung Transplant Recipient Registration	74	40.85	3,023	1.14	3,446.11
14	Lung Transplant Recipient Follow Up (6 Month)	74	35.96	2,661	0.50	1,330.52
15	Lung Transplant Recipient Follow Up (1-5 Year)	74	135.61	10,035	1.10	11,038.65
16	Lung Transplant Recipient Follow Up (Post 5 Year)	74	148.09	10,959	0.60	6,575.20
17	Lung Post-Transplant Malignancy Form	74	18.39	1,361	0.40	544.34
18	Heart/Lung Transplant Candidate Registration	72	1.03	74	1.16	86.03
19	Heart/Lung Transplant Recipient Registration	72	0.75	54	2.09	112.86
20	Heart/Lung Transplant Recipient Follow Up (6 Month)	72	0.64	46	0.80	36.86
21	Heart/Lung Transplant Recipient Follow Up (1-5 Year)	72	2.46	177	1.10	194.83
22	Heart/Lung Transplant Recipient Follow Up (Post 5 Year)	72	3.35	241	0.60	144.72
23	Heart/Lung Post-Transplant Malignancy Form	72	0.22	16	0.40	6.34
24	Liver Transplant Candidate Registration	142	103.39	14,681	0.80	11,745.10
25	Liver Transplant Recipient Registration	142	75.08	10,661	1.20	12,793.63
( print page 87382)
26	Liver Transplant Recipient Follow Up (6 Month-5 Year)	142	344.55	48,926	1.00	48,926.10
27	Liver Transplant Recipient Follow Up (Post 5 Year)	142	427.56	60,714	0.50	30,356.76
28	Liver Recipient Explant Pathology Form	142	7.17	1,018	0.60	610.88
29	Liver Post-Transplant Malignancy Form	142	21.21	3,012	0.80	2,409.46
30	Intestine Transplant Candidate Registration	18	7.50	135	1.30	175.50
31	Intestine Transplant Recipient Registration	18	5.28	95	1.80	171.07
32	Intestine Transplant Recipient Follow Up (6 Month-5 Year)	18	21.50	387	1.50	580.50
33	Intestine Transplant Recipient Follow Up (Post 5 Year)	18	49.61	893	0.40	357.19
34	Intestine Post-Transplant Malignancy Form	18	0.94	17	1.00	16.92
35	Kidney Transplant Candidate Registration	228	203.12	46,311	0.80	37,049.09
36	Kidney Transplant Recipient Registration	228	119.89	27,335	1.20	32,801.90
37	Kidney Transplant Recipient Follow Up (6 Month-5 Year)	228	571.22	130,238	0.90	117,214.34
38	Kidney Transplant Recipient Follow Up (Post 5 Year)	228	565.59	128,955	0.50	64,477.26
39	Kidney Post-Transplant Malignancy Form	228	25.60	5,837	0.80	4,669.44
40	Pancreas Transplant Candidate Registration	123	2.63	323	0.60	194.09
41	Pancreas Transplant Recipient Registration	123	0.84	103	1.20	123.98
42	Pancreas Transplant Recipient Follow Up (6 Month-5 Year)	123	5.05	621	0.50	310.58
43	Pancreas Transplant Recipient Follow Up (Post 5 Year)	123	17.11	2,105	0.50	1,052.27
44	Pancreas Post-Transplant Malignancy Form	123	0.76	93	0.60	56.09
45	Kidney/Pancreas Transplant Candidate Registration	123	12.94	1,592	0.60	954.97
46	Kidney/Pancreas Transplant Recipient Registration	123	6.59	811	1.20	972.68
47	Kidney/Pancreas Transplant Recipient Follow Up (6 Month-5 Year)	123	38.12	4,689	0.50	2,344.38
48	Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year)	123	66.63	8,195	0.60	4,917.29
49	Kidney/Pancreas Post-Transplant Malignancy Form	123	2.24	276	0.40	110.21
50	VCA Transplant Candidate Registration	23	1.00	23	0.40	9.20
51	VCA Transplant Recipient Registration	23	0.39	9	1.36	12.20
52	VCA Transplant Recipient Follow Up	23	2.30	53	1.31	69.30
53	Organ Labeling and Packaging	56	298.27	16,703	0.18	3,006.56
54	Organ Tracking and Validating	304	20.36	6,189	0.08	495.16
55	Kidney Paired Donation Candidate Registration	156	0.34	53	0.26	13.79
56	Kidney Paired Donation Donor Registration	156	0.99	154	1.08	166.80
57	Kidney Paired Donation Match Offer Management	156	0.59	92	0.67	61.67
58	Disease Transmission Event	304	2.33	708	0.60	424.99
59	Living Donor Event	207	0.15	31	0.56	17.39
60	Safety Situation	442	0.93	411	0.24	98.65
61	Potential Disease Transmission Report	56	11.09	621	1.27	788.72
62	Request to Unlock Form	442	174.67	77,204	0.02	1,544.08
63	Initial Donor Registration	56	414.71	23,224	4.61	107,061.53
64	OPO Notification Limit Administration	56	9.52	533	0.17	90.63
65	Potential Transplant Recipient	304	6,017.74	1,829,393	0.05	91,469.65
66	Death Notification Registration **	56	289.70	16,223	0.42	6,813.74
67	Deceased Donor Death Referral **	56	58.11	3,254	0.50	1,627.08
68	Donor Hospital Registration	56	0.04	2	0.08	0.18
69	Donor Organ Disposition	56	414.71	23,224	0.17	3,948.04
70	Transplant Center Contact Management	248	808.10	200,409	0.06	12,024.53
71	Adult Kidney Candidate Listing Registration ***	228	204.93	46,724	0.52	24,296.50
72	Pediatric Kidney Candidate Listing Registration ***	101	11.66	1,178	0.47	553.50
73	Adult Kidney Pancreas Candidate Listing Registration ***	123	12.93	1,590	0.37	588.44
74	Pediatric Kidney Pancreas Candidate Listing Registration ***	29	0.07	2	0.30	0.61
75	Adult Pancreas Candidate Listing Registration ***	123	15.29	1,881	0.38	714.65
76	Pediatric Pancreas Candidate Listing Registration ***	30	1.13	34	0.38	12.88
77	Adult Pancreas Islet Listing Registration	16	2.06	33	0.38	12.52
78	Pediatric Pancreas Islet Listing Registration ***	16	0.00	0	0.33	0.00
79	Adult Liver Candidate Listing Registration ***	142	98.43	13,977	0.32	4,472.66
80	Pediatric Liver Candidate Listing Registration ***	57	12.37	705	0.40	282.04
81	Adult Intestine Candidate Listing Registration ***	18	4.94	89	0.38	33.79
82	Pediatric Intestine Candidate Listing Registration ***	18	2.56	46	0.43	19.81
83	Adult Heart Candidate Listing Registration ***	149	33.58	5,003	0.83	4,152.84
84	Pediatric Heart Candidate Listing Registration ***	64	11.47	734	0.58	425.77
85	Adult HeartLung Candidate Listing Registration ***	72	0.97	70	0.85	59.36
86	Pediatric HeartLung Candidate Listing Registration ***	27	0.15	4	0.93	3.77
87	Adult Lung Candidate Listing Registration ***	74	44.85	3,319	1.00	3,318.90
88	Pediatric Lung Candidate Listing Registration ***	45	0.84	38	0.83	31.37
89	Candidate Registration Listing Removal ***	248	289.27	71,739	0.18	12,913.01
90	VCA Abdominal Wall Candidate Listing Registration ***	8	0.38	3	0.33	1.00
91	VCA External Male Genitalia Candidate Listing Registration ***	2	0.00	0	0.33	0.00
92	VCA Head and Neck Candidate Listing Registration ***	10	0.50	5	0.33	1.65
93	VCA Lower Limb Candidate Listing Registration ***	4	0.00	0	0.33	0.00
94	VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration ***	2	0.00	0	0.33	0.00
95	VCA Other Genitourinary Organ Candidate Listing Registration ***	3	0.00	0	0.33	0.00
96	VCA Spleen Candidate Listing Registration ***	0	0.00	0	0.33	0.00
97	VCA Upper Limb Candidate Listing Registration ***	11	0.27	3	0.33	0.98
98	VCA Uterus Candidate Listing Registration ***	6	2.00	12	0.33	3.96
99	VCA Vascularized Gland Candidate Listing Registration ***	8	0.00	0	0.33	0.00
100	Organ Export Verification Form ***	56	0.46	26	0.03	0.77
101	OPTN Waiting Time Transfer Form ***	248	5.54	1,374	0.23	316.00
( print page 87383)
102	OPTN Waiting Time Modification Form ***	248	59.40	14,731	0.22	3,240.86
103	OPTN Renal Waiting Time Reinstatement Form ***	228	1.21	276	0.27	74.49
104	OPTN Pancreas Waiting Time Reinstatement Form ***	123	0.03	4	0.20	0.74
105	Intestinal Waiting Time Reinstatement Form ***	18	0.00	0	0.25	0.00
106	Prior Living Donor Priority ***	228	0.25	57	0.27	15.39
107	Kidney Minimum Acceptance Criteria ***	228	0.47	107	0.30	32.15
108	Adult Liver Status 1A Initial Justification and Extension Form ***	142	2.31	328	0.57	186.97
109	Pediatric Liver Status 1A Initial Justification and Extension Form ***	57	2.30	131	0.57	74.73
110	Pediatric Liver Status 1B Initial Justification and Extension Form ***	57	5.61	320	0.47	150.29
111	Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form ***	142	0.42	60	0.43	25.65
112	Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form ***	142	0.34	48	0.32	15.45
113	Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form ***	142	0.10	14	0.33	4.69
114	Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form ***	142	0.04	6	0.40	2.27
115	Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form ***	142	0.05	7	0.30	2.13
116	Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form ***	142	0.69	98	0.35	34.29
117	Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form ***	142	23.30	3,309	0.47	1,555.04
118	Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form ***	142	33.21	4,716	0.35	1,650.54
119	Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form ***	142	1.39	197	0.32	63.16
120	Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form ***	142	0.99	141	0.25	35.15
121	Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form ***	142	0.77	109	0.28	30.62
122	Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form ***	142	0.51	72	0.42	30.42
123	Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form ***	142	0.36	51	0.33	16.87
124	Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form ***	142	0.13	18	0.35	6.46
125	Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form ***	142	12.03	1,708	0.35	597.89
126	Pediatric Heart and HeartLung Status 1A Initial Justification Form ***	64	16.06	1,028	0.52	534.48
127	Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms ***	64	54.61	3,495	0.47	1,642.67
128	Pediatric Heart and HeartLung Status 1B Initial Justification Form ***	64	7.31	468	0.42	196.49
129	Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data ***	149	135.78	20,231	0.32	6,473.99
130	Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data ***	149	135.78	20,231	0.72	14,566.48
131	Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data ***	149	5.69	848	0.58	491.73
132	Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data ***	149	0.46	69	0.33	22.62
133	Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data ***	149	0.43	64	0.53	33.96
134	Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data ***	149	25.91	3,861	0.80	3,088.47
135	Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data ***	149	9.87	1,471	0.33	485.31
136	Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data ***	149	0.03	4	0.42	1.88
137	Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data ***	149	3.05	454	0.63	286.30
138	Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data ***	149	1.70	253	0.60	151.98
139	Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data ***	149	11.91	1,775	0.63	1,117.99
140	Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data ***	149	6.88	1,025	0.33	338.29
141	Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data ***	149	0.64	95	0.32	30.52
142	Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data ***	149	0.11	16	0.48	7.87
143	Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data ***	149	23.51	3,503	0.50	1,751.50
( print page 87384)
144	Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data ***	149	1.73	258	0.25	64.44
145	Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data ***	149	0.56	83	0.40	33.38
146	Adult and Pediatric Lung and HeartLung Goal Exception Form ***	149	3.72	554	0.75	415.71
147	Pediatric Lung Priority 1 Status Justification Form ***	45	1.16	52	0.33	17.23
148	Review Board Voter Form ***	248	22.46	5,570	0.23	1,281.12
149	Living Donor Feedback Form ***	207	37.73	7,810	0.13	1,015.31
150	Extra Vessels Reporting Form ***	248	53.71	13,320	0.03	399.60
151	Non-US Transplants Reporting Form ***	228	0.00	0	0.03	0.00
152	Discrepant HLA Typings Reporting Form ***	138	0.78	108	5.17	556.50
153	Interim Event Reporting Form ***	248	72.58	18,000	0.06	1,079.99
	Total	18,697		3,184,246		851,565.51
* The numbers of respondents and the numbers of total responses in the burden table were updated with 2023 OPTN data and reflect increases in the number of organ transplants and changes in the number of respondents (Transplant Centers, OPOs, and Histocompatibility Labs).
** These two forms will not be used once the OPTN Process Data OMB package is approved and implemented. The OPTN Process Data OMB package is new and will be considered separate from this package. We are including these forms in this collection to avoid any lapse in approval of these forms while the OPTN Process Data package is being approved.
*** These are new forms.
**** If a form has 0.00 under average number of responses, this is an indicator that there were no submissions in calendar year 2023.