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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit...

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Department of Health and Human Services
Health Resources and Services Administration

AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

DATES:

Comments on this ICR should be received no later than July 14, 2026.

ADDRESSES:

Submit your comments to or mail the HRSA Information Collection Clearance Officer, Room 13N82, 5600 Fishers Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email or call Samantha Miller, the HRSA Information Collection Clearance Officer, at (301) 443-3983.

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the ICR title for reference.

Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110—Revision

Abstract: Section 372 of the Public Health Service Act requires that the Secretary of HHS, by awards, provide for the establishment and operation of the Organ Procurement and Transplantation Network (OPTN), which, under HRSA's oversight, 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 official federal approval.

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 OPTN policies and HHS regulations; to determine member-specific performance; to ensure patient safety; and to fulfill the requirements of the HHS OPTN regulations at 42 CFR 121. In addition, the regulatory authority in 42 CFR 121.11 ( https://www.ecfr.gov/​current/​title-42/​section-121.11) requires the OPTN to maintain certain records and to make OPTN data available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of 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. The 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 requests making the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements:

1. Add two data collection forms from the OPTN Computer System (UNet platform) to the existing OMB-approved information collection.

a. The Patient Safety Contact Management form is used by OPTN members to identify the OPTN member organization's primary and secondary patient safety contact who fulfills the duties as outlined in OPTN policy 15.1.

b. The Patient Transfer form is used by transplant centers to facilitate the transfer of patients to another transplant center after transplant and throughout the annual follow-up periods.

2. Remove vascularized composite allografts (VCA) Transplant Candidate Registration. With the implementation of new VCA waitlist registration forms in the OPTN Waiting List system (in UNet), OPTN members will no longer need to validate the data on the form. The form is now read only. All changes and validations will be performed directly on the new waitlist registration forms.

3. The OPTN BOD-approved additional revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance. ( printed page 27965)

Likely Respondents: Transplant Centers, Organ Procurement Organizations (OPOs), 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 total burden hours in the OMB inventory increased by 58,975.02 hours from the previously OMB-approved data collection package. This increase included 3,310.46 hours from the addition of two new data collection forms, an increase of 1,031.03 hours due to OPTN BOD-approved data collection changes, and an increase of 54,633.53 hours from updating the number of respondents and total responses using actual OPTN data from 2025.

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 55 452.40 24,882 0.48 11,943.36
2 Living Donor Registration 209 31.45 6,573 2.2 14,460.71
3 Living Donor Follow-up 209 100.325 20,968 1.52 31,871.25
4 Donor Histocompatibility 137 178.555 24,462 0.15 3,669.31
5 Recipient Histocompatibility 137 323.81 44,362 0.32 14,195.83
6 Heart Transplant Candidate Registration 149 40.87 6,090 0.9 5,481.67
7 Heart Transplant Recipient Registration 149 30.78 4,586 1.96 8,988.99
8 Heart Transplant Recipient Follow Up (6 Month) 149 28.51 4,248 0.4 1,699.20
9 Heart Transplant Recipient Follow Up (1-5 Year) 149 122.62 18,270 0.9 16,443.34
10 Heart Transplant Recipient Follow Up (Post 5 Year) 149 202.66 30,196 0.5 15,098.17
11 Heart Post-Transplant Malignancy Form 149 14.584 2,173 0.9 1,955.71
12 Lung Transplant Candidate Registration 77 51.26 3,947 0.95 3,749.67
13 Lung Transplant Recipient Registration 77 45.34 3,491 1.14 3,979.95
14 Lung Transplant Recipient Follow Up (6 Month) 77 41.34 3,183 0.5 1,591.59
15 Lung Transplant Recipient Follow Up (1-5 Year) 77 147.70 11,373 1.1 12,510.19
16 Lung Transplant Recipient Follow Up (Post 5 Year) 77 162.26 12,494 0.6 7,496.41
17 Lung Post-Transplant Malignancy Form 77 22.73 1,750 0.4 700.08
18 Heart/Lung Transplant Candidate Registration 75 1.03 77 1.16 89.61
19 Heart/Lung Transplant Recipient Registration 75 0.80 60 2.09 125.40
20 Heart/Lung Transplant Recipient Follow Up (6 Month) 75 0.75 56 0.8 45.00
21 Heart/Lung Transplant Recipient Follow Up (1-5 Year) 75 2.69 202 1.1 221.93
22 Heart/Lung Transplant Recipient Follow Up (Post 5 Year) 75 3.64 273 0.6 163.80
23 Heart/Lung Post-Transplant Malignancy Form 75 0.20 15 0.4 6.00
24 Liver Transplant Candidate Registration 144 112.48 16,197 0.8 12,957.70
25 Liver Transplant Recipient Registration 144 85.715 12,343 1.2 14,811.55
26 Liver Transplant Recipient Follow Up (6 Month-5 Year) 144 384.50 55,368 1 55,368.00
27 Liver Transplant Recipient Follow Up (Post 5 Year) 144 466.79 67,218 0.5 33,608.88
28 Liver Recipient Explant Pathology Form 144 7.806 1,124 0.6 674.44
29 Liver Post-Transplant Malignancy Form 144 27.19 3,915 0.8 3,132.29
30 Intestine Transplant Candidate Registration 17 6.76 115 1.3 149.40
31 Intestine Transplant Recipient Registration 17 5.18 88 1.8 158.51
32 Intestine Transplant Recipient Follow Up (6 Month-5 Year) 17 23.29 396 1.5 593.90
33 Intestine Transplant Recipient Follow Up (Post 5 Year) 17 52.35 890 0.4 355.98
34 Intestine Post-Transplant Malignancy Form 17 0.35 6 1 5.95
35 Kidney Transplant Candidate Registration 232 225.83 52,393 0.8 41,914.05
36 Kidney Transplant Recipient Registration 232 118.935 27,593 1.2 33,111.50
37 Kidney Transplant Recipient Follow Up (6 Month-5 Year) 232 610.616 141,663 0.9 127,496.62
38 Kidney Transplant Recipient Follow Up (Post 5 Year) 232 617.823 143,335 0.5 71,667.47
39 Kidney Post-Transplant Malignancy Form 232 31.573 7,325 0.8 5,859.95
40 Pancreas Transplant Candidate Registration 127 2.20 279 0.6 167.64
41 Pancreas Transplant Recipient Registration 127 0.84 107 1.2 128.02
42 Pancreas Transplant Recipient Follow Up (6 Month-5 Year) 127 4.20 533 0.5 266.70
43 Pancreas Transplant Recipient Follow Up (Post 5 Year) 127 15.71 1,995 0.5 997.59
44 Pancreas Post-Transplant Malignancy Form 127 0.724 92 0.6 55.17
45 Kidney/Pancreas Transplant Candidate Registration 127 13.35 1,695 0.6 1,017.27
46 Kidney/Pancreas Transplant Recipient Registration 127 6.34 805 1.2 966.22
47 Kidney/Pancreas Transplant Recipient Follow Up (6 Month-5 Year) 127 35.55 4,515 0.5 2,257.43
( printed page 27966)
48 Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year) 127 68.19 8,660 0.6 5,196.08
49 Kidney/Pancreas Post-Transplant Malignancy Form 127 2.315 294 0.4 117.60
50 VCA Transplant Recipient Registration 23 0.39 9 1.36 12.20
51 VCA Transplant Recipient Follow Up 23 2.91 67 1.31 87.68
52 Organ Labeling and Packaging 55 308.47 16,966 0.18 3,053.85
53 Organ Tracking and Validating 306 18.68 5,716 0.08 457.29
54 Kidney Paired Donation Candidate Registration 155 0.40 62 0.26 16.12
55 Kidney Paired Donation Donor Registration 155 0.74 115 1.08 123.88
56 Kidney Paired Donation Match Offer Management 155 0.86 133 0.67 89.31
57 Disease Transmission Event 306 2.958 905 0.6 543.09
58 Living Donor Event 209 0.24 50 0.56 28.09
59 Safety Situation 443 1.325 587 0.24 140.87
60 Potential Disease Transmission Report 55 14.78 813 1.27 1,032.38
61 Request to Unlock Form 443 156.156 69,177 0.02 1,383.54
62 Initial Donor Registration 55 453.870 24,963 4.75 118,573.54
63 OPO Notification Limit Administration 55 0.16 9 0.17 1.50
64 Potential Transplant Recipient 306 5332.24 1,631,665 0.05 81,583.27
65 Death Notification Registration 55 227.35 12,504 0.42 5,251.79
66 Deceased Donor Death Referral 55 61.80 3,399 0.5 1,699.50
67 Donor Hospital Registration 55 0.07 4 0.08 0.31
68 Donor Organ Disposition 55 453.87 24,963 0.17 4,243.68
69 Transplant Center Contact Management 251 863.462 216,729 0.06 13,003.74
70 Adult Kidney Candidate Listing Registration 232 227.927 52,879 0.52 27,497.11
71 Pediatric Kidney Candidate Listing Registration 103 11.66 1,201 0.47 564.46
72 Adult Kidney Pancreas Candidate Listing Registration 127 13.32 1,692 0.37 625.91
73 Pediatric Kidney Pancreas Candidate Listing Registration 29 0.10 3 0.3 0.87
74 Adult Pancreas Candidate Listing Registration 127 15.27 1,939 0.38 736.93
75 Pediatric Pancreas Candidate Listing Registration 30 1.17 35 0.38 13.34
76 Adult Pancreas Islet Listing Registration 18 4.44 80 0.38 30.37
77 Pediatric Pancreas Islet Listing Registration *** 18 0.00 0 0.33 0.00
78 Adult Liver Candidate Listing Registration 144 107.35 15,458 0.32 4,946.69
79 Pediatric Liver Candidate Listing Registration 59 12.51 738 0.4 295.24
80 Adult Intestine Candidate Listing Registration 17 4.53 77 0.38 29.26
81 Pediatric Intestine Candidate Listing Registration 17 2.24 38 0.43 16.37
82 Adult Heart Candidate Listing Registration 149 36.52 5,441 0.83 4,516.43
83 Pediatric Heart Candidate Listing Registration 63 10.30 649 0.58 376.36
84 Adult HeartLung Candidate Listing Registration 75 0.96 72 0.85 61.20
85 Pediatric HeartLung Candidate Listing Registration 25 0.20 5 0.93 4.65
86 Adult Lung Candidate Listing Registration 77 50.77 3,909 1.01 3,948.38
87 Pediatric Lung Candidate Listing Registration 45 0.84 38 0.84 31.75
88 Candidate Registration Listing Removal 251 305.653 76,719 0.18 13,809.40
89 VCA Abdominal Wall Candidate Listing Registration *** 8 0.00 0 0.33 0.00
90 VCA External Male Genitalia Candidate Listing Registration *** 2 0.00 0 0.33 0.00
91 VCA Head and Neck Candidate Listing Registration 9 0.11 1 0.33 0.33
92 VCA Lower Limb Candidate Listing Registration *** 4 0.00 0 0.33 0.00
93 VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration *** 2 0.00 0 0.33 0.00
94 VCA Other Genitourinary Organ Candidate Listing Registration 5 0.20 1 0.33 0.33
95 VCA Spleen Candidate Listing Registration *** 0 0.00 0 0.33 0.00
96 VCA Upper Limb Candidate Listing Registration *** 11 0.00 0 0.33 0.00
97 VCA Uterus Candidate Listing Registration 6 1.83 11 0.33 3.62
98 VCA Vascularized Gland Candidate Listing Registration *** 1 0.00 0 0.33 0.00
99 Organ Export Verification Form 55 0.29 16 0.03 0.48
100 OPTN Waiting Time Transfer Form 251 5.323 1,336 0.23 307.30
101 OPTN Waiting Time Modification Form 251 23.73 5,956 0.22 1,310.37
102 OPTN Renal Waiting Time Reinstatement Form 232 1.33 309 0.27 83.31
103 OPTN Pancreas Waiting Time Reinstatement Form 127 0.04 5 0.2 1.02
104 Intestinal Waiting Time Reinstatement Form 17 0.06 1 0.25 0.26
105 Prior Living Donor Priority 232 0.414 96 0.27 25.93
106 Kidney Minimum Acceptance Criteria 232 0.957 222 0.3 66.61
107 Adult Liver Status 1A Initial Justification and Extension Form 144 2.125 306 0.57 174.42
108 Pediatric Liver Status 1A Initial Justification and Extension Form 59 3.00 177 0.57 100.89
( printed page 27967)
109 Pediatric Liver Status 1B Initial Justification and Extension Form 59 7.10 419 0.47 196.88
110 Liver Cholangiocarcinoma Initial MELD/PELD Score Exception Form 144 0.83 120 0.43 51.39
111 Liver Cholangiocarcinoma MELD/PELD Score Exception Extension Form 144 0.674 97 0.32 31.06
112 Liver Cystic Fibrosis Initial MELD/PELD Score Exception and Extension Form 144 0.08 12 0.33 3.80
113 Liver Familial Amyloid Polyneuropathy Initial MELD/PELD Score Exception Form *** 144 0.00 0 0.4 0.00
114 Liver Familial Amyloid Polyneuropathy MELD/PELD Score Exception Extension Form 144 0.01 1 0.3 0.43
115 Liver Hepatic Artery Thrombosis Initial MELD/PELD Score Exception and Extension Form 144 0.55 79 0.35 27.72
116 Liver Hepatocellular Carcinoma Initial MELD/PELD Score Exception Form 144 22.18 3,194 0.47 1,501.14
117 Liver Hepatocellular Carcinoma MELD/PELD Score Exception Extension Form 144 28.84 4,153 0.35 1,453.54
118 Liver Hepatopulmonary Syndrome Initial MELD/PELD Score Exception Form 144 1.424 205 0.32 65.62
119 Liver Hepatopulmonary Syndrome MELD/PELD Score Exception Extension Form 144 0.806 116 0.25 29.02
120 Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form 144 0.84 121 0.28 33.87
121 Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form 144 0.52 75 0.42 31.45
122 Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form 144 0.375 54 0.33 17.82
123 Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form 144 0.104 15 0.35 5.24
124 Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form 144 14.326 2,063 0.35 722.03
125 Pediatric Heart and HeartLung Status 1A Initial Justification Form 63 15.56 980 0.52 509.75
126 Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms 63 73.57 4,635 0.47 2,178.41
127 Pediatric Heart and HeartLung Status 1B Initial Justification Form 63 7.05 444 0.42 186.54
128 Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data 149 161.57 24,074 0.32 7,703.66
129 Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data 149 161.57 24,074 0.72 17,333.23
130 Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data 149 8.315 1,239 0.58 718.58
131 Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data 149 1.10 164 0.33 54.09
132 Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data 149 0.87 130 0.53 68.70
133 Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data 149 28.644 4,268 0.8 3,414.36
134 Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data 149 19.987 2,978 0.33 982.76
135 Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data 149 0.013 2 0.42 0.81
136 Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data 149 5.54 825 0.63 520.04
137 Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data 149 1.87 279 0.6 167.18
138 Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data 149 11.25 1,676 0.63 1,056.04
139 Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data 149 7.497 1,117 0.33 368.63
140 Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data 149 0.544 81 0.32 25.94
141 Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data 149 0.04 6 0.48 2.86
142 Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data 149 23.41 3,488 0.5 1,744.05
( printed page 27968)
143 Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data 149 2.17 323 0.25 80.83
144 Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data 149 0.78 116 0.4 46.49
145 Adult and Pediatric Lung and HeartLung Goal Exception Form 149 2.785 415 0.75 311.22
146 Pediatric Lung Priority 1 Status Justification Form 45 0.53 24 0.33 7.87
147 Review Board Voter Form 251 24.745 6,211 0.23 1,428.53
148 Living Donor Feedback Form 209 38.856 8,121 0.13 1,055.72
149 Extra Vessels Reporting Form 251 59.28 14,879 0.03 446.38
150 Non-US Transplants Reporting Form  *** 232 0.00 0 0.03 0.00
151 Discrepant HLA Typings Reporting Form 137 1.27 174 5.17 899.53
152 Interim Event Reporting Form 251 88.454 22,202 0.06 1,332.12
153 Patient Safety Contact Management Form ** 306 42.20 12,913 0.14 1,807.85
154 Patient Transfer Form ** 251 15.35 3,853 0.39 1,502.61
   Total 19,424 3,101,339 910,553.02
*  Note: Totals for responses and burden hours may reflect minor discrepancies due to rounding; however, these rounding adjustments do not affect the overall burden estimates presented.
** New forms.
*** If a form has 0.00 under the average number of responses, this is an indicator that there were no submissions in calendar year 2025.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Maria G. Button,

Director, Executive Secretariat.

[FR Doc. 2026-09804 Filed 5-14-26; 8:45 am]

BILLING CODE 4165-15-P

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Use this for formal legal and research references to the published document.

91 FR 27964

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“Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision,” thefederalregister.org (May 15, 2026), https://thefederalregister.org/documents/2026-09804/agency-information-collection-activities-proposed-collection-public-comment-request-information-collection-request-title.