Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network
Federal RegisterJun 25, 2025
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network
AGENCY:
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
ACTION:
Notice.
SUMMARY:
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
DATES:
Comments on this ICR should be received no later than July 25, 2025.
ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
FOR FURTHER INFORMATION CONTACT:
To request a copy of the clearance requests submitted to OMB for review, email Samantha Miller, HRSA Information Collection Clearance Officer, at
paperwork@hrsa.gov
or call (301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157—Revision.
Abstract:
Section 372 of the Public Health Service Act requires that the Secretary of HHS, 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. HRSA, in alignment with the Paperwork Reduction Act of 1995, submits OPTN Board of Directors (BOD)-approved data elements for collection to OMB for approval.
A 60-day notice was published in the
Federal Register
on November 1, 2024, Vol. 89, No. 212, pp. 87380-85. There were six comments, including feedback from OPTN Members and Transplant Centers. Public comments raised concerns about the financial burden of additional data collection. The commenters called for greater collaboration between transplant professionals, HRSA, and the Scientific Registry of Transplant Recipients to eliminate redundancies and improve efficiency. Commenters expressed concern that changes were communicated via the
Federal Register
instead of the OPTN public comment process, limiting input from the transplant community. Additionally, the commenters sought clarification on discrepancies regarding which forms were designated as new, and they requested access to the data collection plans and draft instruments.
HRSA carefully reviewed all public feedback submitted during the 60-day comment period. Through its policy development process, OPTN had previously solicited input on each of the data collection instruments through four channels:
(1) Targeted outreach to relevant stakeholder organizations, including
transplant professionals and patient groups.
(2) Comments submitted by other OPTN committees.
(3) In-person meetings across 11 OPTN regions.
(4) An online OPTN public comment forum open to all on the OPTN website.
HRSA welcomes participation from all interested individuals. HRSA seeks input from transplant candidates directly affected by policy changes and strongly encourages transplant professionals to provide input on the potential financial impacts of proposals. HRSA values all feedback and remains committed to reviewing and refining data collection efforts in collaboration with the OPTN.
Finally, in response to commenter concerns regarding potential burden, the OPTN contract requires the OPTN Contractor to implement a direct electronic data submission plan and supplement official OPTN data with external sources. This approach aims to reduce the burden of data collection on OPTN members.
Need and Proposed Use of the Information:
HRSA and the OPTN BOD use data to develop transplant, procurement, and allocation policies; to determine whether institutional members are complying with policy; to determine member-specific performance; to ensure patient safety; and to fulfill the requirements of the OPTN Final Rule. The regulatory authority in 42 CFR 121.11 (
https://www.ecfr.gov/current/title-42/section-121.11
) of the OPTN Final Rule requires the OPTN data to be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, HHS, and members of the public for evaluation, research, patient information, and other important purposes.
This is a request to revise the current OPTN data collection, which includes time-sensitive, life-critical data on transplant candidates and potential organ donors, the organ matching process, histocompatibility results, organ labeling and packaging, and pre- and post-transplantation data on recipients and donors. This revision also includes OPTN BOD-approved changes to the existing OMB data collection forms. OPTN collects these specific data elements from transplant hospitals, organ procurement organizations, and histocompatibility laboratories.
HRSA and the OPTN use this information to (1) facilitate organ placement and match donor organs with recipients; (2) monitor compliance of member organizations with federal laws and regulations and with OPTN requirements; (3) review and report periodically to the public on the status of organ donation, procurement, and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; and (5) perform transplantation-related public health surveillance, including the possible transmission of donor disease.
HRSA is requesting to make the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements:
(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 (MELD/PELD) score exception and extension forms, and other forms.
(2) OPTN BOD-approved revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance.
Likely Respondents:
Transplant Centers, Organ Procurement Organizations (OPO), and Histocompatibility Laboratories.
Burden Statement:
Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
The estimated burden hours for this collection increased by 203,937.21 hours from the currently approved ICR package. This increase includes 96,148.84 hours due to adding 83 new data collection forms for the OPTN waiting list and 107,788.37 hours due to OPTN BOD-approved data collection changes to existing forms and the number of respondents.
Total Estimated Annualized Burden—Hours
Form No.
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
23,223.76
0.48
11,147.40
2
Living Donor Registration
207
33.42
6,917.94
2.19
15,150.29
3
Living Donor Follow-up
207
94.86
19,636.02
1.52
29,846.75
4
Donor Histocompatibility
138
173.31
23,916.78
0.20
4,783.36
5
Recipient Histocompatibility
138
307.09
42,378.42
0.40
16,951.37
6
Heart Transplant Candidate Registration
149
38.50
5,736.50
0.90
5,162.85
7
Heart Transplant Recipient Registration
149
30.50
4,544.50
1.96
8,907.22
8
Heart Transplant Recipient Follow Up (6-month)
149
27.79
4,140.71
0.40
1,656.28
9
Heart Transplant Recipient Follow Up (1-5 year)
149
109.21
16,272.29
0.90
14,645.06
10
Heart Transplant Recipient Follow Up (Post 5 year)
149
183.73
27,375.77
0.50
13,687.89
11
Heart Post-Transplant Malignancy Form
149
12.21
1,819.29
0.90
1,637.36
12
Lung Transplant Candidate Registration
74
45.36
3,356.64
0.95
3,188.81
13
Lung Transplant Recipient Registration
74
40.85
3,022.90
1.14
3,446.11
14
Lung Transplant Recipient Follow Up (6-month)
74
35.96
2,661.04
0.50
1,330.52
15
Lung Transplant Recipient Follow Up (1-5 year)
74
135.61
10,035.14
1.10
11,038.65
16
Lung Transplant Recipient Follow Up (Post 5 year)
74
148.09
10,958.66
0.60
6,575.20
17
Lung Post-Transplant Malignancy Form
74
18.39
1,360.86
0.40
544.34
18
Heart/Lung Transplant Candidate Registration
72
1.03
74.16
1.16
86.03
19
Heart/Lung Transplant Recipient Registration
72
0.75
54.00
2.09
112.86
20
Heart/Lung Transplant Recipient Follow Up (6-month)
72
0.64
46.08
0.80
36.86
21
Heart/Lung Transplant Recipient Follow Up (1-5 year)
72
2.46
177.12
1.10
194.83
22
Heart/Lung Transplant Recipient Follow Up (Post 5 year)
72
3.35
241.20
0.60
144.72
23
Heart/Lung Post-Transplant Malignancy Form
72
0.22
15.84
0.40
6.34
24
Liver Transplant Candidate Registration
142
103.39
14,681.38
0.80
11,745.10
25
Liver Transplant Recipient Registration
142
75.08
10,661.36
1.20
12,793.63
26
Liver Transplant Recipient Follow Up (6-month-5 year)
142
344.55
48,926.10
1.00
48,926.10
27
Liver Transplant Recipient Follow Up (Post 5 year)
142
427.56
60,713.52
0.50
30,356.76
28
Liver Recipient Explant Pathology Form
142
7.17
1,018.14
0.60
610.88
29
Liver Post-Transplant Malignancy Form
142
21.21
3,011.82
0.80
2,409.46
30
Intestine Transplant Candidate Registration
18
7.50
135.00
1.30
175.50
31
Intestine Transplant Recipient Registration
18
5.28
95.04
1.80
171.07
32
Intestine Transplant Recipient Follow Up (6-month-5 year)
18
21.50
387.00
1.50
580.50
33
Intestine Transplant Recipient Follow Up (Post 5 year)
18
49.61
892.98
0.40
357.19
34
Intestine Post-Transplant Malignancy Form
18
0.94
16.92
1.00
16.92
35
Kidney Transplant Candidate Registration
228
203.12
46,311.36
0.80
37,049.09
36
Kidney Transplant Recipient Registration
228
119.89
27,334.92
1.20
32,801.90
37
Kidney Transplant Recipient Follow Up (6-month-5 year)
228
571.22
130,238.16
0.90
117,214.34
38
Kidney Transplant Recipient Follow Up (Post 5 year)
228
565.59
128,954.52
0.50
64,477.26
39
Kidney Post-Transplant Malignancy Form
228
25.60
5,836.80
0.80
4,669.44
40
Pancreas Transplant Candidate Registration
123
2.63
323.49
0.60
194.09
41
Pancreas Transplant Recipient Registration
123
0.84
103.32
1.20
123.98
42
Pancreas Transplant Recipient Follow Up (6-month-5 year)
123
5.05
621.15
0.50
310.58
43
Pancreas Transplant Recipient Follow Up (Post 5 year)
123
17.11
2,104.53
0.50
1,052.27
44
Pancreas Post-Transplant Malignancy Form
123
0.76
93.48
0.60
56.09
45
Kidney/Pancreas Transplant Candidate Registration
123
12.94
1,591.62
0.60
954.97
46
Kidney/Pancreas Transplant Recipient Registration
123
6.59
810.57
1.20
972.68
47
Kidney/Pancreas Transplant Recipient Follow Up (6-month-5 year)
123
38.12
4,688.76
0.50
2,344.38
48
Kidney/Pancreas Transplant Recipient Follow Up (Post 5 year)
123
66.63
8,195.49
0.60
4,917.29
49
Kidney/Pancreas Post-Transplant Malignancy Form
123
2.24
275.52
0.40
110.21
50
VCA Transplant Candidate Registration
23
1.00
23.00
0.40
9.20
51
VCA Transplant Recipient Registration
23
0.39
8.97
1.36
12.20
52
VCA Transplant Recipient Follow Up
23
2.30
52.90
1.31
69.30
53
Organ Labeling and Packaging
56
298.27
16,703.12
0.18
3,006.56
54
Organ Tracking and Validating
304
20.36
6,189.44
0.08
495.16
55
Kidney Paired Donation Candidate Registration
156
0.34
53.04
0.26
13.79
56
Kidney Paired Donation Donor Registration
156
0.99
154.44
1.08
166.80
57
Kidney Paired Donation Match Offer Management
156
0.59
92.04
0.67
61.67
58
Disease Transmission Event
304
2.33
708.32
0.60
424.99
59
Living Donor Event
207
0.15
31.05
0.56
17.39
60
Safety Situation
442
0.93
411.06
0.24
98.65
61
Potential Disease Transmission Report
56
11.09
621.04
1.27
788.72
62
Request to Unlock Form
442
174.67
77,204.14
0.02
1,544.08
63
Initial Donor Registration
56
414.71
23,223.76
4.61
107,061.53
64
OPO Notification Limit Administration
56
9.52
533.12
0.17
90.63
65
Potential Transplant Recipient
304
6,017.74
1,829,392.96
0.05
91,469.65
66
Death Notification Registration **
56
289.70
16,223.20
0.42
6,813.74
67
Deceased Donor Death Referral **
56
58.11
3,254.16
0.50
1,627.08
68
Donor Hospital Registration
56
0.04
2.24
0.08
0.18
69
Donor Organ Disposition
56
414.71
23,223.76
0.17
3,948.04
70
Transplant Center Contact Management
248
808.10
200,408.80
0.06
12,024.53
71
Adult Kidney Candidate Listing Registration ***
228
204.93
46,724.04
0.52
24,296.50
72
Pediatric Kidney Candidate Listing Registration ***
101
11.66
1,177.66
0.47
553.50
73
Adult Kidney Pancreas Candidate Listing Registration ***
123
12.93
1,590.39
0.37
588.44
74
Pediatric Kidney Pancreas Candidate Listing Registration ***
29
0.07
2.03
0.30
0.61
75
Adult Pancreas Candidate Listing Registration ***
123
15.29
1,880.67
0.38
714.65
76
Pediatric Pancreas Candidate Listing Registration ***
30
1.13
33.90
0.38
12.88
77
Adult Pancreas Islet Listing Registration ***
16
2.06
32.96
0.38
12.52
78
Pediatric Pancreas Islet Listing Registration ***
16
0.00
0.00
0.33
0.00
79
Adult Liver Candidate Listing Registration ***
142
98.43
13,977.06
0.32
4,472.66
80
Pediatric Liver Candidate Listing Registration ***
57
12.37
705.09
0.40
282.04
81
Adult Intestine Candidate Listing Registration ***
18
4.94
88.92
0.38
33.79
82
Pediatric Intestine Candidate Listing Registration ***
18
2.56
46.08
0.43
19.81
83
Adult Heart Candidate Listing Registration ***
149
33.58
5,003.42
0.83
4,152.84
84
Pediatric Heart Candidate Listing Registration ***
64
11.47
734.08
0.58
425.77
85
Adult HeartLung Candidate Listing Registration ***
72
0.97
69.84
0.85
59.36
86
Pediatric HeartLung Candidate Listing Registration ***
27
0.15
4.05
0.93
3.77
87
Adult Lung Candidate Listing Registration ***
74
44.85
3,318.90
1.00
3,318.90
88
Pediatric Lung Candidate Listing Registration ***
45
0.84
37.80
0.83
31.37
89
Candidate Registration Listing Removal ***
248
289.27
71,738.96
0.18
12,913.01
90
VCA Abdominal Wall Candidate Listing Registration ***
8
0.38
3.04
0.33
1.00
91
VCA External Male Genitalia Candidate Listing Registration ***
2
0.00
0.00
0.33
0.00
92
VCA Head and Neck Candidate Listing Registration ***
10
0.50
5.00
0.33
1.65
93
VCA Lower Limb Candidate Listing Registration ***
4
0.00
0.00
0.33
0.00
94
VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration ***
2
0.00
0.00
0.33
0.00
95
VCA Other Genitourinary Organ Candidate Listing Registration ***
3
0.00
0.00
0.33
0.00
96
VCA Spleen Candidate Listing Registration ***
0
0.00
0.00
0.33
0.00
97
VCA Upper Limb Candidate Listing Registration ***
11
0.27
2.97
0.33
0.98
98
VCA Uterus Candidate Listing Registration ***
6
2.00
12.00
0.33
3.96
99
VCA Vascularized Gland Candidate Listing Registration ***
8
0.00
0.00
0.33
0.00
100
Organ Export Verification Form ***
56
0.46
25.76
0.03
0.77
101
OPTN Waiting Time Transfer Form ***
248
5.54
1,373.92
0.23
316.00
102
OPTN Waiting Time Modification Form ***
248
59.40
14,731.20
0.22
3,240.86
103
OPTN Renal Waiting Time Reinstatement Form ***
228
1.21
275.88
0.27
74.49
104
OPTN Pancreas Waiting Time Reinstatement Form ***
123
0.03
3.69
0.20
0.74
105
Intestinal Waiting Time Reinstatement Form ***
18
0.00
0.00
0.25
0.00
106
Prior Living Donor Priority ***
228
0.25
57.00
0.27
15.39
107
Kidney Minimum Acceptance Criteria ***
228
0.47
107.16
0.30
32.15
108
Adult Liver Status 1A Initial Justification and Extension Form ***
142
2.31
328.02
0.57
186.97
109
Pediatric Liver Status 1A Initial Justification and Extension Form ***
57
2.30
131.10
0.57
74.73
110
Pediatric Liver Status 1B Initial Justification and Extension Form ***
57
5.61
319.77
0.47
150.29
111
Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form ***
142
0.42
59.64
0.43
25.65
112
Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form ***
142
0.34
48.28
0.32
15.45
113
Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form ***
142
0.10
14.20
0.33
4.69
114
Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form ***
142
0.04
5.68
0.40
2.27
115
Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form ***
142
0.05
7.10
0.30
2.13
116
Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form ***
142
0.69
97.98
0.35
34.29
117
Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form ***
142
23.30
3,308.60
0.47
1,555.04
118
Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form ***
142
33.21
4,715.82
0.35
1,650.54
119
Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form ***
142
1.39
197.38
0.32
63.16
120
Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form ***
142
0.99
140.58
0.25
35.15
121
Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form ***
142
0.77
109.34
0.28
30.62
122
Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form ***
142
0.51
72.42
0.42
30.42
123
Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form ***
142
0.36
51.12
0.33
16.87
124
Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form ***
142
0.13
18.46
0.35
6.46
125
Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form ***
142
12.03
1,708.26
0.35
597.89
126
Pediatric Heart and HeartLung Status 1A Initial Justification Form ***
64
16.06
1,027.84
0.52
534.48
127
Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms ***
64
54.61
3,495.04
0.47
1,642.67
128
Pediatric Heart and HeartLung Status 1B Initial Justification Form ***
64
7.31
467.84
0.42
196.49
129
Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data ***
149
135.78
20,231.22
0.32
6,473.99
130
Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data ***
149
135.78
20,231.22
0.72
14,566.48
131
Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data ***
149
5.69
847.81
0.58
491.73
132
Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data ***
149
0.46
68.54
0.33
22.62
133
Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data ***
149
0.43
64.07
0.53
33.96
134
Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data ***
149
25.91
3,860.59
0.80
3,088.47
135
Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data ***
149
9.87
1,470.63
0.33
485.31
136
Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data ***
149
0.03
4.47
0.42
1.88
137
Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data ***
149
3.05
454.45
0.63
286.30
138
Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data ***
149
1.70
253.30
0.60
151.98
139
Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data ***
149
11.91
1,774.59
0.63
1,117.99
140
Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data ***
149
6.88
1,025.12
0.33
338.29
141
Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data ***
149
0.64
95.36
0.32
30.52
142
Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data ***
149
0.11
16.39
0.48
7.87
143
Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data ***
149
23.51
3,502.99
0.50
1,751.50
144
Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data ***
149
1.73
257.77
0.25
64.44
145
Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data ***
149
0.56
83.44
0.40
33.38
146
Adult and Pediatric Lung and HeartLung Goal Exception Form ***
149
3.72
554.28
0.75
415.71
147
Pediatric Lung Priority 1 Status Justification Form ***
45
1.16
52.20
0.33
17.23
148
Review Board Voter Form ***
248
22.46
5,570.08
0.23
1,281.12
149
Living Donor Feedback Form ***
207
37.73
7,810.11
0.13
1,015.31
150
Extra Vessels Reporting Form ***
248
53.71
13,320.08
0.03
399.60
151
Non-US Transplants Reporting Form ***
228
0.00
0.00
0.03
0.00
152
Discrepant HLA Typings Reporting Form ***
138
0.78
107.64
5.17
556.50
153
Interim Event Reporting Form ***
248
72.58
17,999.84
0.06
1,079.99
Total
18,697
3,184,247.26
851,565.51
* The numbers of respondents and 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 indicates no submissions in calendar year 2023.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-11668 Filed 6-24-25; 8:45 am]
BILLING CODE 4165-15-P
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.