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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.
 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 December 31, 2024.
 ADDRESSES: Submit your comments to 
                        *paperwork@hrsa.gov*
                         or mail the HRSA Information Collection Clearance Officer, Room 14NWH04, 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 Joella Roland, 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. 0915-0157—Revision. *Abstract:*
                     Section 372 of the Public Health Service Act requires that the Secretary of Health and Human Services, by awards, provide for the establishment and operation of the Organ Procurement and Transplantation Network (OPTN), which, under HRSA's 
                    ( print page 87381)
                    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 policy; to determine member-specific performance; to ensure patient safety; and to fulfill the requirements of the OPTN Final Rule. In addition, the regulatory authority in 42 CFR 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, the Department of Health and Human Services, 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 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 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 which 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-State 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 (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 estimated burden hours for this collection increased by 203,937.21 hours from the currently approved ICR package. This increase included 96,148.84 hours due to the addition of 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 changes in the number of respondents. 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 
                             hours1
Deceased Donor Registration
56
414.71
23,224
0.48
11,147.402
Living Donor Registration
207
33.42
6,918
2.19
15,150.293
Living Donor Follow-up
207
94.86
19,636
1.52
29,846.754
Donor Histocompatibility
138
173.31
23,917
0.20
4,783.365
Recipient Histocompatibility
138
307.09
42,378
0.40
16,951.376
Heart Transplant Candidate Registration
149
38.50
5,737
0.90
5,162.857
Heart Transplant Recipient Registration
149
30.50
4,545
1.96
8,907.228
Heart Transplant Recipient Follow Up (6 Month)
149
27.79
4,141
0.40
1,656.289
Heart Transplant Recipient Follow Up (1-5 Year)
149
109.21
16,272
0.90
14,645.0610
Heart Transplant Recipient Follow Up (Post 5 Year)
149
183.73
27,376
0.50
13,687.8911
Heart Post-Transplant Malignancy Form
149
12.21
1,819
0.90
1,637.3612
Lung Transplant Candidate Registration
74
45.36
3,357
0.95
3,188.8113
Lung Transplant Recipient Registration
74
40.85
3,023
1.14
3,446.1114
Lung Transplant Recipient Follow Up (6 Month)
74
35.96
2,661
0.50
1,330.5215
Lung Transplant Recipient Follow Up (1-5 Year)
74
135.61
10,035
1.10
11,038.6516
Lung Transplant Recipient Follow Up (Post 5 Year)
74
148.09
10,959
0.60
6,575.2017
Lung Post-Transplant Malignancy Form
74
18.39
1,361
0.40
544.3418
Heart/Lung Transplant Candidate Registration
72
1.03
74
1.16
86.0319
Heart/Lung Transplant Recipient Registration
72
0.75
54
2.09
112.8620
Heart/Lung Transplant Recipient Follow Up (6 Month)
72
0.64
46
0.80
36.8621
Heart/Lung Transplant Recipient Follow Up (1-5 Year)
72
2.46
177
1.10
194.8322
Heart/Lung Transplant Recipient Follow Up (Post 5 Year)
72
3.35
241
0.60
144.7223
Heart/Lung Post-Transplant Malignancy Form
72
0.22
16
0.40
6.3424
Liver Transplant Candidate Registration
142
103.39
14,681
0.80
11,745.1025
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
48,926.1027
Liver Transplant Recipient Follow Up (Post 5 Year)
142
427.56
60,714
0.50
30,356.7628
Liver Recipient Explant Pathology Form
142
7.17
1,018
0.60
610.8829
Liver Post-Transplant Malignancy Form
142
21.21
3,012
0.80
2,409.4630
Intestine Transplant Candidate Registration
18
7.50
135
1.30
175.5031
Intestine Transplant Recipient Registration
18
5.28
95
1.80
171.0732
Intestine Transplant Recipient Follow Up (6 Month-5 Year)
18
21.50
387
1.50
580.5033
Intestine Transplant Recipient Follow Up (Post 5 Year)
18
49.61
893
0.40
357.1934
Intestine Post-Transplant Malignancy Form
18
0.94
17
1.00
16.9235
Kidney Transplant Candidate Registration
228
203.12
46,311
0.80
37,049.0936
Kidney Transplant Recipient Registration
228
119.89
27,335
1.20
32,801.9037
Kidney Transplant Recipient Follow Up (6 Month-5 Year)
228
571.22
130,238
0.90
117,214.3438
Kidney Transplant Recipient Follow Up (Post 5 Year)
228
565.59
128,955
0.50
64,477.2639
Kidney Post-Transplant Malignancy Form
228
25.60
5,837
0.80
4,669.4440
Pancreas Transplant Candidate Registration
123
2.63
323
0.60
194.0941
Pancreas Transplant Recipient Registration
123
0.84
103
1.20
123.9842
Pancreas Transplant Recipient Follow Up (6 Month-5 Year)
123
5.05
621
0.50
310.5843
Pancreas Transplant Recipient Follow Up (Post 5 Year)
123
17.11
2,105
0.50
1,052.2744
Pancreas Post-Transplant Malignancy Form
123
0.76
93
0.60
56.0945
Kidney/Pancreas Transplant Candidate Registration
123
12.94
1,592
0.60
954.9746
Kidney/Pancreas Transplant Recipient Registration
123
6.59
811
1.20
972.6847
Kidney/Pancreas Transplant Recipient Follow Up (6 Month-5 Year)
123
38.12
4,689
0.50
2,344.3848
Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year)
123
66.63
8,195
0.60
4,917.2949
Kidney/Pancreas Post-Transplant Malignancy Form
123
2.24
276
0.40
110.2150
VCA Transplant Candidate Registration
23
1.00
23
0.40
9.2051
VCA Transplant Recipient Registration
23
0.39
9
1.36
12.2052
VCA Transplant Recipient Follow Up
23
2.30
53
1.31
69.3053
Organ Labeling and Packaging
56
298.27
16,703
0.18
3,006.5654
Organ Tracking and Validating
304
20.36
6,189
0.08
495.1655
Kidney Paired Donation Candidate Registration
156
0.34
53
0.26
13.7956
Kidney Paired Donation Donor Registration
156
0.99
154
1.08
166.8057
Kidney Paired Donation Match Offer Management
156
0.59
92
0.67
61.6758
Disease Transmission Event
304
2.33
708
0.60
424.9959
Living Donor Event
207
0.15
31
0.56
17.3960
Safety Situation
442
0.93
411
0.24
98.6561
Potential Disease Transmission Report
56
11.09
621
1.27
788.7262
Request to Unlock Form
442
174.67
77,204
0.02
1,544.0863
Initial Donor Registration
56
414.71
23,224
4.61
107,061.5364
OPO Notification Limit Administration
56
9.52
533
0.17
90.6365
Potential Transplant Recipient
304
6,017.74
1,829,393
0.05
91,469.6566
Death Notification Registration **
56
289.70
16,223
0.42
6,813.7467
Deceased Donor Death Referral **
56
58.11
3,254
0.50
1,627.0868
Donor Hospital Registration
56
0.04
2
0.08
0.1869
Donor Organ Disposition
56
414.71
23,224
0.17
3,948.0470
Transplant Center Contact Management
248
808.10
200,409
0.06
12,024.5371
Adult Kidney Candidate Listing Registration ***
228
204.93
46,724
0.52
24,296.5072
Pediatric Kidney Candidate Listing Registration ***
101
11.66
1,178
0.47
553.5073
Adult Kidney Pancreas Candidate Listing Registration ***
123
12.93
1,590
0.37
588.4474
Pediatric Kidney Pancreas Candidate Listing Registration ***
29
0.07
2
0.30
0.6175
Adult Pancreas Candidate Listing Registration ***
123
15.29
1,881
0.38
714.6576
Pediatric Pancreas Candidate Listing Registration ***
30
1.13
34
0.38
12.8877
Adult Pancreas Islet Listing Registration
16
2.06
33
0.38
12.5278
Pediatric Pancreas Islet Listing Registration ***
16
0.00
0
0.33
0.0079
Adult Liver Candidate Listing Registration ***
142
98.43
13,977
0.32
4,472.6680
Pediatric Liver Candidate Listing Registration ***
57
12.37
705
0.40
282.0481
Adult Intestine Candidate Listing Registration ***
18
4.94
89
0.38
33.7982
Pediatric Intestine Candidate Listing Registration ***
18
2.56
46
0.43
19.8183
Adult Heart Candidate Listing Registration ***
149
33.58
5,003
0.83
4,152.8484
Pediatric Heart Candidate Listing Registration ***
64
11.47
734
0.58
425.7785
Adult HeartLung Candidate Listing Registration ***
72
0.97
70
0.85
59.3686
Pediatric HeartLung Candidate Listing Registration ***
27
0.15
4
0.93
3.7787
Adult Lung Candidate Listing Registration ***
74
44.85
3,319
1.00
3,318.9088
Pediatric Lung Candidate Listing Registration ***
45
0.84
38
0.83
31.3789
Candidate Registration Listing Removal ***
248
289.27
71,739
0.18
12,913.0190
VCA Abdominal Wall Candidate Listing Registration ***
8
0.38
3
0.33
1.0091
VCA External Male Genitalia Candidate Listing Registration ***
2
0.00
0
0.33
0.0092
VCA Head and Neck Candidate Listing Registration ***
10
0.50
5
0.33
1.6593
VCA Lower Limb Candidate Listing Registration ***
4
0.00
0
0.33
0.0094
VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration ***
2
0.00
0
0.33
0.0095
VCA Other Genitourinary Organ Candidate Listing Registration ***
3
0.00
0
0.33
0.0096
VCA Spleen Candidate Listing Registration ***
0
0.00
0
0.33
0.0097
VCA Upper Limb Candidate Listing Registration ***
11
0.27
3
0.33
0.9898
VCA Uterus Candidate Listing Registration ***
6
2.00
12
0.33
3.9699
VCA Vascularized Gland Candidate Listing Registration ***
8
0.00
0
0.33
0.00100
Organ Export Verification Form ***
56
0.46
26
0.03
0.77101
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
3,240.86103
OPTN Renal Waiting Time Reinstatement Form ***
228
1.21
276
0.27
74.49104
OPTN Pancreas Waiting Time Reinstatement Form ***
123
0.03
4
0.20
0.74105
Intestinal Waiting Time Reinstatement Form ***
18
0.00
0
0.25
0.00106
Prior Living Donor Priority ***
228
0.25
57
0.27
15.39107
Kidney Minimum Acceptance Criteria ***
228
0.47
107
0.30
32.15108
Adult Liver Status 1A Initial Justification and Extension Form ***
142
2.31
328
0.57
186.97109
Pediatric Liver Status 1A Initial Justification and Extension Form ***
57
2.30
131
0.57
74.73110
Pediatric Liver Status 1B Initial Justification and Extension Form ***
57
5.61
320
0.47
150.29111
Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form ***
142
0.42
60
0.43
25.65112
Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form ***
142
0.34
48
0.32
15.45113
Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form ***
142
0.10
14
0.33
4.69114
Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form ***
142
0.04
6
0.40
2.27115
Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form ***
142
0.05
7
0.30
2.13116
Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form ***
142
0.69
98
0.35
34.29117
Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form ***
142
23.30
3,309
0.47
1,555.04118
Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form ***
142
33.21
4,716
0.35
1,650.54119
Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form ***
142
1.39
197
0.32
63.16120
Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form ***
142
0.99
141
0.25
35.15121
Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form ***
142
0.77
109
0.28
30.62122
Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form ***
142
0.51
72
0.42
30.42123
Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form ***
142
0.36
51
0.33
16.87124
Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form ***
142
0.13
18
0.35
6.46125
Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form ***
142
12.03
1,708
0.35
597.89126
Pediatric Heart and HeartLung Status 1A Initial Justification Form ***
64
16.06
1,028
0.52
534.48127
Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms ***
64
54.61
3,495
0.47
1,642.67128
Pediatric Heart and HeartLung Status 1B Initial Justification Form ***
64
7.31
468
0.42
196.49129
Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data ***
149
135.78
20,231
0.32
6,473.99130
Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data ***
149
135.78
20,231
0.72
14,566.48131
Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data ***
149
5.69
848
0.58
491.73132
Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data ***
149
0.46
69
0.33
22.62133
Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data ***
149
0.43
64
0.53
33.96134
Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data ***
149
25.91
3,861
0.80
3,088.47135
Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data ***
149
9.87
1,471
0.33
485.31136
Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data ***
149
0.03
4
0.42
1.88137
Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data ***
149
3.05
454
0.63
286.30138
Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data ***
149
1.70
253
0.60
151.98139
Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data ***
149
11.91
1,775
0.63
1,117.99140
Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data ***
149
6.88
1,025
0.33
338.29141
Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data ***
149
0.64
95
0.32
30.52142
Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data ***
149
0.11
16
0.48
7.87143
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
64.44145
Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data ***
149
0.56
83
0.40
33.38146
Adult and Pediatric Lung and HeartLung Goal Exception Form ***
149
3.72
554
0.75
415.71147
Pediatric Lung Priority 1 Status Justification Form ***
45
1.16
52
0.33
17.23148
Review Board Voter Form ***
248
22.46
5,570
0.23
1,281.12149
Living Donor Feedback Form ***
207
37.73
7,810
0.13
1,015.31150
Extra Vessels Reporting Form ***
248
53.71
13,320
0.03
399.60151
Non-US Transplants Reporting Form ***
228
0.00
0
0.03
0.00152
Discrepant HLA Typings Reporting Form ***
138
0.78
108
5.17
556.50153
Interim Event Reporting Form ***
248
72.58
18,000
0.06
1,079.99Total
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.
 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. Amy P. McNulty, Deputy Director, Executive Secretariat.


[FR Doc. 2024-25506 Filed 10-31-24; 8:45 am] BILLING CODE 4165-15-P