Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision
In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and app...
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
ACTION:
Notice.
SUMMARY:
In compliance with of 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 November 9, 2026.
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 30-day 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, the HRSA Information Collection Clearance Officer at
paperwork@hrsa.gov
or call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110— Revision.
Abstract:
Section 372(a) of the Public Health Service Act requires the Secretary of HHS to provide for the continued operation of the Organ Procurement and Transplantation Network (OPTN). Section 372(b)(1)(A) provides that the OPTN shall be operated through awards to public or private entities made by the Secretary. The OPTN is a unique public-private partnership that links professionals involved in the U.S. donation 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.
A 60-day Notice was published in the
Federal Register
, Vol. 91, No. 94, FR pp. 27964 (May 15, 2026). There was one comment from a Transplant Center. The commenter requested that HRSA identify the Board-approved revisions and the specific data collection forms affected. The commenter also requested clarification regarding whether the Patient Safety Contact Management and Patient Transfer forms are revisions to existing forms or new data collection requirements, the rationale for the new forms, and how duplicative data collection and additional administrative burden would be avoided. HRSA responded that draft data collection instruments may be requested at any time during the public comment period and will be made available in both clean and redline formats during the 30-day
Federal Register
Notice public comment period. HRSA clarified that the Patient Safety Contact Management and Patient Transfer forms are new data collection forms and that their inclusion is described in the notice and reflected in the Estimated Annualized Burden Hours table. HRSA also identified where stakeholders can find the rationale for the proposed revisions to existing forms and the addition of new forms. HRSA encourages interested stakeholders to review these materials for additional background on the OPTN policy development process (
www.hrsa.gov/optn/policies-bylaws/public-comment).
Need and Proposed Use of the Information:
HRSA and the OPTN BOD use data to develop organ procurement, allocation, and transplantation policies; evaluate member compliance with OPTN policies and HHS regulations; assess member performance; promote patient safety; and fulfill the requirements of the OPTN regulations at 42 CFR part 121. In particular, the regulatory authority in 42 CFR 121.11 (
www.ecfr.gov/current/title-42/section-121.11) requires the OPTN to maintain specified records and make OPTN data available, consistent with applicable laws, to OPTN members, the Scientific Registry of Transplant Recipients, HHS, and the public for evaluation, research, and other purposes.
This is a request to revise the currently approved OPTN information collection, which includes time-sensitive, life-critical information related to transplant candidates; potential organ donors, organ matching and allocation; histocompatibility testing; organ labeling and packaging; and pre- and post-transplant clinical information for transplant recipients and donors. These data are collected from transplant hospitals, organ procurement organizations, and histocompatibility laboratories.
HRSA and the OPTN use these data to (1) facilitate matching and placement
( printed page 64666)
of donor organs with transplant candidates; (2) monitor member compliance with federal laws, regulations, and OPTN requirements; (3) evaluate and periodically report on the status of organ donation, procurement, and transplantation in the United States; (4) provide data to researchers and government agencies to support scientific, clinical, and policy analyses related to organ transplantation; and (5) perform transplantation-related public health surveillance, including the monitoring of donor-derived infections.
HRSA is requesting approval for the following changes to improve organ matching and allocation, enhance patient safety, and support member compliance with OPTN requirements:
(1) Add two new data collection forms to the OPTN Computer System and the OMB-approved information collection:
a.
The Patient Safety Contact Management Form.
This form will be used by OPTN members to identify the organization's primary and secondary patient safety contacts consistent with the responsibilities outlined in OPTN policy 15.1.
b.
The Patient Transfer Form:
This form will be used by transplant centers to facilitate the transfer of post-transplant patients to another transplant center during ongoing follow-up.
(2) Remove the Vascularized Composite Allograft (VCA) Transplant Candidate Registration. Following implementation of new VCA waitlist registration forms in the OPTN Waiting List system, OPTN members will no longer need to validate the data on the VCA Transplant Candidate Registration form. The form is now read-only, and all updates and validations will be completed directly within the waitlist registration forms.
(3) Remove the Death Notification Registration and Deceased Donor Death Referral forms. Following OMB approval of the OPTN Ventilated Patient Form (OMB Control No: 0906-0112), these collections are no longer needed within the OPTN Data System since the Ventilated Patient Form contains the information previously collected under these forms.
(4) Incorporate minor edits to previously OMB-approved forms for clarity.
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 estimated annual burden for this information collection increased by 52,029.48 hours compared with the information collection package currently approved by OMB, which was approved June 25, 2025. This increase reflects updates to the number of respondents and responses based on actual OPTN data from calendar year 2025, the addition of two new data collection forms, and revisions to existing data collection forms approved by the OPTN BOD. These increases are partially offset by the reduction of 6,960.18 burden hours resulting from the removal of three forms from the OPTN Computer System.
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
452.4
24,882.00
0.48
11,943.36
2
Living Donor Registration
209
31.45
6,573.05
2.2
14,460.71
3
Living Donor Follow-up
209
100.33
20,968.97
1.52
31,872.83
4
Donor Histocompatibility
137
178.56
24,462.72
0.15
3,669.41
5
Recipient Histocompatibility +
137
323.81
44,361.97
0.32
14,195.83
6
Heart Transplant Candidate Registration
149
40.87
6,089.63
0.9
5,480.67
7
Heart Transplant Recipient Registration
149
30.78
4,586.22
1.96
8,988.99
8
Heart Transplant Recipient Follow Up (6 Month)
149
28.51
4,247.99
0.4
1,699.20
9
Heart Transplant Recipient Follow Up (1-5 Year)
149
122.62
18,270.38
0.9
16,443.34
10
Heart Transplant Recipient Follow Up (Post 5 Year)
149
202.66
30,196.34
0.5
15,098.17
11
Heart Post-Transplant Malignancy Form
149
14.58
2,172.42
0.9
1,955.18
12
Lung Transplant Candidate Registration
77
51.26
3,947.02
0.95
3,749.67
13
Lung Transplant Recipient Registration
77
45.34
3,491.18
1.14
3,979.95
14
Lung Transplant Recipient Follow Up (6 Month)
77
41.34
3,183.18
0.5
1,591.59
15
Lung Transplant Recipient Follow Up (1-5 Year)
77
147.7
11,372.90
1.1
12,510.19
16
Lung Transplant Recipient Follow Up (Post 5 Year)
77
162.26
12,494.02
0.6
7,496.41
17
Lung Post-Transplant Malignancy Form
77
22.73
1,750.21
0.4
700.08
18
Heart/Lung Transplant Candidate Registration
75
1.03
77.25
1.16
89.61
19
Heart/Lung Transplant Recipient Registration
75
0.8
60.00
2.09
125.40
20
Heart/Lung Transplant Recipient Follow Up (6 Month)
75
0.75
56.25
0.8
45.00
21
Heart/Lung Transplant Recipient Follow Up (1-5 Year)
75
2.69
201.75
1.1
221.93
22
Heart/Lung Transplant Recipient Follow Up (Post 5 Year)
75
3.64
273.00
0.6
163.80
23
Heart/Lung Post-Transplant Malignancy Form
75
0.2
15.00
0.4
6.00
24
Liver Transplant Candidate Registration
144
112.48
16,197.12
0.8
12,957.70
25
Liver Transplant Recipient Registration
144
85.72
12,343.68
1.2
14,812.42
26
Liver Transplant Recipient Follow Up (6 Month-5 Year)
144
384.5
55,368.00
1
55,368.00
27
Liver Transplant Recipient Follow Up (Post 5 Year)
144
466.79
67,217.76
0.5
33,608.88
28
Liver Recipient Explant Pathology Form
144
7.81
1,124.64
0.6
674.78
29
Liver Post-Transplant Malignancy Form
144
27.19
3,915.36
0.8
3,132.29
30
Intestine Transplant Candidate Registration
17
6.76
114.92
1.3
149.40
31
Intestine Transplant Recipient Registration
17
5.18
88.06
1.8
158.51
32
Intestine Transplant Recipient Follow Up (6 Month-5 Year)
17
23.29
395.93
1.5
593.90
33
Intestine Transplant Recipient Follow Up (Post 5 Year)
17
52.35
889.95
0.4
355.98
34
Intestine Post-Transplant Malignancy Form
17
0.35
5.95
1
5.95
35
Kidney Transplant Candidate Registration
232
225.83
52,392.56
0.8
41,914.05
36
Kidney Transplant Recipient Registration
232
118.94
27,594.08
1.2
33,112.90
( printed page 64667)
37
Kidney Transplant Recipient Follow Up (6 Month-5 Year)
232
610.62
141,663.84
0.9
127,497.46
38
Kidney Transplant Recipient Follow Up (Post 5 Year)
232
617.82
143,334.24
0.5
71,667.12
39
Kidney Post-Transplant Malignancy Form
232
31.57
7,324.24
0.8
5,859.39
40
Pancreas Transplant Candidate Registration
127
2.2
279.40
0.6
167.64
41
Pancreas Transplant Recipient Registration
127
0.84
106.68
1.2
128.02
42
Pancreas Transplant Recipient Follow Up (6 Month-5 Year)
127
4.2
533.40
0.5
266.70
43
Pancreas Transplant Recipient Follow Up (Post 5 Year)
127
15.71
1,995.17
0.5
997.59
44
Pancreas Post-Transplant Malignancy Form
127
0.72
91.44
0.6
54.86
45
Kidney/Pancreas Transplant Candidate Registration
127
13.35
1,695.45
0.6
1,017.27
46
Kidney/Pancreas Transplant Recipient Registration
127
6.34
805.18
1.2
966.22
47
Kidney/Pancreas Transplant Recipient Follow Up (6 Month-5 Year)
127
35.55
4,514.85
0.5
2,257.43
48
Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year)
Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form
144
0.01
1.44
0.3
0.43
113
Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form
144
0.55
79.20
0.35
27.72
114
Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form
144
22.18
3,193.92
0.47
1,501.14
115
Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form
144
28.84
4,152.96
0.35
1,453.54
116
Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form
144
1.42
204.48
0.32
65.43
117
Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form
144
0.81
116.64
0.25
29.16
118
Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form
144
0.84
120.96
0.28
33.87
119
Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form
144
0.52
74.88
0.42
31.45
120
Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form
144
0.38
54.72
0.33
18.06
121
Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form
144
0.1
14.40
0.35
5.04
122
Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form
144
14.33
2,063.52
0.35
722.23
123
Pediatric Heart and HeartLung Status 1A Initial Justification Form
63
15.56
980.28
0.52
509.75
124
Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms
63
73.57
4,634.91
0.47
2,178.41
125
Pediatric Heart and HeartLung Status 1B Initial Justification Form
63
7.05
444.15
0.42
186.54
126
Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data
149
161.57
24,073.93
0.32
7,703.66
127
Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data
149
161.57
24,073.93
0.72
17,333.23
128
Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data
149
8.32
1,239.68
0.58
719.01
129
Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data
149
1.1
163.90
0.33
54.09
130
Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data
149
0.87
129.63
0.53
68.70
131
Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data+
149
28.64
4,267.36
0.8
3,413.89
132
Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data
149
19.99
2,978.51
0.33
982.91
133
Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data
149
0.01
1.49
0.42
0.63
134
Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data
149
5.54
825.46
0.63
520.04
135
Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data
149
1.87
278.63
0.6
167.18
136
Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data +
149
11.25
1,676.25
0.63
1,056.04
137
Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data
149
7.5
1,117.50
0.33
368.78
138
Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data
149
0.54
80.46
0.32
25.75
139
Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data
149
0.04
5.96
0.48
2.86
140
Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data
149
23.41
3,488.09
0.5
1,744.05
141
Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data
149
2.17
323.33
0.25
80.83
142
Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data
149
0.78
116.22
0.4
46.49
143
Adult and Pediatric Lung and HeartLung Goal Exception Form
149
2.79
415.71
0.75
311.78
144
Pediatric Lung Priority 1 Status Justification Form
45
0.53
23.85
0.33
7.87
145
Review Board Voter Form
251
24.75
6,212.25
0.23
1,428.82
146
Living Donor Feedback Form
209
38.86
8,121.74
0.13
1,055.83
147
Extra Vessels Reporting Form
251
59.28
14,879.28
0.03
446.38
148
Non-US Transplants Reporting Form ***
232
0
0.00
0.03
0.00
149
Discrepant HLA Typings Reporting Form +
137
1.27
173.99
5.17
899.53
150
Interim Event Reporting Form
251
88.45
22,200.95
0.06
1,332.06
151
Patient Safety Contact Management Form **
306
42.2
12,913.20
0.14
1,807.85
152
Patient Transfer Form **
251
15.35
3,852.85
0.39
1,502.61
Total
19,314
3,085,444.60
903,607.48
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.
* The numbers of respondents and the numbers of total responses in the burden table were updated with 2025 OPTN data.
** 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 2025.
**** As a result of the removal of the Death Notification Registration and the Deceased Donor Death Referral, forms after 65 were renumbered.
+
Forms with minor edits to previously OMB-approved forms.
( printed page 64669)
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.
Use this for formal legal and research references to the published document.
91 FR 64665
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision,” thefederalregister.org (October 9, 2026), https://thefederalregister.org/documents/2026-20732/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment-request-data-system-fo.