# 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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2026-09804

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** May 15, 2026
- **Citation:** 91 FR 27964

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
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

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
paperwork@hrsa.gov
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
paperwork@hrsa.gov
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.

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

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

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

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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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2026-09804. Public record. Not legal advice.