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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

89 Fed. Reg. 87380 (Nov. 1, 2024)

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network

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Federal RegisterNov 1, 2024
89 Fed. Reg. 87380 (Nov. 1, 2024)
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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 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 hours
    1 Deceased Donor Registration 56 414.71 23,224 0.48 11,147.40
    2 Living Donor Registration 207 33.42 6,918 2.19 15,150.29
    3 Living Donor Follow-up 207 94.86 19,636 1.52 29,846.75
    4 Donor Histocompatibility 138 173.31 23,917 0.20 4,783.36
    5 Recipient Histocompatibility 138 307.09 42,378 0.40 16,951.37
    6 Heart Transplant Candidate Registration 149 38.50 5,737 0.90 5,162.85
    7 Heart Transplant Recipient Registration 149 30.50 4,545 1.96 8,907.22
    8 Heart Transplant Recipient Follow Up (6 Month) 149 27.79 4,141 0.40 1,656.28
    9 Heart Transplant Recipient Follow Up (1-5 Year) 149 109.21 16,272 0.90 14,645.06
    10 Heart Transplant Recipient Follow Up (Post 5 Year) 149 183.73 27,376 0.50 13,687.89
    11 Heart Post-Transplant Malignancy Form 149 12.21 1,819 0.90 1,637.36
    12 Lung Transplant Candidate Registration 74 45.36 3,357 0.95 3,188.81
    13 Lung Transplant Recipient Registration 74 40.85 3,023 1.14 3,446.11
    14 Lung Transplant Recipient Follow Up (6 Month) 74 35.96 2,661 0.50 1,330.52
    15 Lung Transplant Recipient Follow Up (1-5 Year) 74 135.61 10,035 1.10 11,038.65
    16 Lung Transplant Recipient Follow Up (Post 5 Year) 74 148.09 10,959 0.60 6,575.20
    17 Lung Post-Transplant Malignancy Form 74 18.39 1,361 0.40 544.34
    18 Heart/Lung Transplant Candidate Registration 72 1.03 74 1.16 86.03
    19 Heart/Lung Transplant Recipient Registration 72 0.75 54 2.09 112.86
    20 Heart/Lung Transplant Recipient Follow Up (6 Month) 72 0.64 46 0.80 36.86
    21 Heart/Lung Transplant Recipient Follow Up (1-5 Year) 72 2.46 177 1.10 194.83
    22 Heart/Lung Transplant Recipient Follow Up (Post 5 Year) 72 3.35 241 0.60 144.72
    23 Heart/Lung Post-Transplant Malignancy Form 72 0.22 16 0.40 6.34
    24 Liver Transplant Candidate Registration 142 103.39 14,681 0.80 11,745.10
    25 Liver Transplant Recipient Registration 142 75.08 10,661 1.20 12,793.63
    26 Liver Transplant Recipient Follow Up (6 Month-5 Year) 142 344.55 48,926 1.00 48,926.10
    27 Liver Transplant Recipient Follow Up (Post 5 Year) 142 427.56 60,714 0.50 30,356.76
    28 Liver Recipient Explant Pathology Form 142 7.17 1,018 0.60 610.88
    29 Liver Post-Transplant Malignancy Form 142 21.21 3,012 0.80 2,409.46
    30 Intestine Transplant Candidate Registration 18 7.50 135 1.30 175.50
    31 Intestine Transplant Recipient Registration 18 5.28 95 1.80 171.07
    32 Intestine Transplant Recipient Follow Up (6 Month-5 Year) 18 21.50 387 1.50 580.50
    33 Intestine Transplant Recipient Follow Up (Post 5 Year) 18 49.61 893 0.40 357.19
    34 Intestine Post-Transplant Malignancy Form 18 0.94 17 1.00 16.92
    35 Kidney Transplant Candidate Registration 228 203.12 46,311 0.80 37,049.09
    36 Kidney Transplant Recipient Registration 228 119.89 27,335 1.20 32,801.90
    37 Kidney Transplant Recipient Follow Up (6 Month-5 Year) 228 571.22 130,238 0.90 117,214.34
    38 Kidney Transplant Recipient Follow Up (Post 5 Year) 228 565.59 128,955 0.50 64,477.26
    39 Kidney Post-Transplant Malignancy Form 228 25.60 5,837 0.80 4,669.44
    40 Pancreas Transplant Candidate Registration 123 2.63 323 0.60 194.09
    41 Pancreas Transplant Recipient Registration 123 0.84 103 1.20 123.98
    42 Pancreas Transplant Recipient Follow Up (6 Month-5 Year) 123 5.05 621 0.50 310.58
    43 Pancreas Transplant Recipient Follow Up (Post 5 Year) 123 17.11 2,105 0.50 1,052.27
    44 Pancreas Post-Transplant Malignancy Form 123 0.76 93 0.60 56.09
    45 Kidney/Pancreas Transplant Candidate Registration 123 12.94 1,592 0.60 954.97
    46 Kidney/Pancreas Transplant Recipient Registration 123 6.59 811 1.20 972.68
    47 Kidney/Pancreas Transplant Recipient Follow Up (6 Month-5 Year) 123 38.12 4,689 0.50 2,344.38
    48 Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year) 123 66.63 8,195 0.60 4,917.29
    49 Kidney/Pancreas Post-Transplant Malignancy Form 123 2.24 276 0.40 110.21
    50 VCA Transplant Candidate Registration 23 1.00 23 0.40 9.20
    51 VCA Transplant Recipient Registration 23 0.39 9 1.36 12.20
    52 VCA Transplant Recipient Follow Up 23 2.30 53 1.31 69.30
    53 Organ Labeling and Packaging 56 298.27 16,703 0.18 3,006.56
    54 Organ Tracking and Validating 304 20.36 6,189 0.08 495.16
    55 Kidney Paired Donation Candidate Registration 156 0.34 53 0.26 13.79
    56 Kidney Paired Donation Donor Registration 156 0.99 154 1.08 166.80
    57 Kidney Paired Donation Match Offer Management 156 0.59 92 0.67 61.67
    58 Disease Transmission Event 304 2.33 708 0.60 424.99
    59 Living Donor Event 207 0.15 31 0.56 17.39
    60 Safety Situation 442 0.93 411 0.24 98.65
    61 Potential Disease Transmission Report 56 11.09 621 1.27 788.72
    62 Request to Unlock Form 442 174.67 77,204 0.02 1,544.08
    63 Initial Donor Registration 56 414.71 23,224 4.61 107,061.53
    64 OPO Notification Limit Administration 56 9.52 533 0.17 90.63
    65 Potential Transplant Recipient 304 6,017.74 1,829,393 0.05 91,469.65
    66 Death Notification Registration ** 56 289.70 16,223 0.42 6,813.74
    67 Deceased Donor Death Referral ** 56 58.11 3,254 0.50 1,627.08
    68 Donor Hospital Registration 56 0.04 2 0.08 0.18
    69 Donor Organ Disposition 56 414.71 23,224 0.17 3,948.04
    70 Transplant Center Contact Management 248 808.10 200,409 0.06 12,024.53
    71 Adult Kidney Candidate Listing Registration *** 228 204.93 46,724 0.52 24,296.50
    72 Pediatric Kidney Candidate Listing Registration *** 101 11.66 1,178 0.47 553.50
    73 Adult Kidney Pancreas Candidate Listing Registration *** 123 12.93 1,590 0.37 588.44
    74 Pediatric Kidney Pancreas Candidate Listing Registration *** 29 0.07 2 0.30 0.61
    75 Adult Pancreas Candidate Listing Registration *** 123 15.29 1,881 0.38 714.65
    76 Pediatric Pancreas Candidate Listing Registration *** 30 1.13 34 0.38 12.88
    77 Adult Pancreas Islet Listing Registration 16 2.06 33 0.38 12.52
    78 Pediatric Pancreas Islet Listing Registration *** 16 0.00 0 0.33 0.00
    79 Adult Liver Candidate Listing Registration *** 142 98.43 13,977 0.32 4,472.66
    80 Pediatric Liver Candidate Listing Registration *** 57 12.37 705 0.40 282.04
    81 Adult Intestine Candidate Listing Registration *** 18 4.94 89 0.38 33.79
    82 Pediatric Intestine Candidate Listing Registration *** 18 2.56 46 0.43 19.81
    83 Adult Heart Candidate Listing Registration *** 149 33.58 5,003 0.83 4,152.84
    84 Pediatric Heart Candidate Listing Registration *** 64 11.47 734 0.58 425.77
    85 Adult HeartLung Candidate Listing Registration *** 72 0.97 70 0.85 59.36
    86 Pediatric HeartLung Candidate Listing Registration *** 27 0.15 4 0.93 3.77
    87 Adult Lung Candidate Listing Registration *** 74 44.85 3,319 1.00 3,318.90
    88 Pediatric Lung Candidate Listing Registration *** 45 0.84 38 0.83 31.37
    89 Candidate Registration Listing Removal *** 248 289.27 71,739 0.18 12,913.01
    90 VCA Abdominal Wall Candidate Listing Registration *** 8 0.38 3 0.33 1.00
    91 VCA External Male Genitalia Candidate Listing Registration *** 2 0.00 0 0.33 0.00
    92 VCA Head and Neck Candidate Listing Registration *** 10 0.50 5 0.33 1.65
    93 VCA Lower Limb Candidate Listing Registration *** 4 0.00 0 0.33 0.00
    94 VCA Musculoskeletal Composite Graft Segment Candidate Listing Registration *** 2 0.00 0 0.33 0.00
    95 VCA Other Genitourinary Organ Candidate Listing Registration *** 3 0.00 0 0.33 0.00
    96 VCA Spleen Candidate Listing Registration *** 0 0.00 0 0.33 0.00
    97 VCA Upper Limb Candidate Listing Registration *** 11 0.27 3 0.33 0.98
    98 VCA Uterus Candidate Listing Registration *** 6 2.00 12 0.33 3.96
    99 VCA Vascularized Gland Candidate Listing Registration *** 8 0.00 0 0.33 0.00
    100 Organ Export Verification Form *** 56 0.46 26 0.03 0.77
    101 OPTN Waiting Time Transfer Form *** 248 5.54 1,374 0.23 316.00
    102 OPTN Waiting Time Modification Form *** 248 59.40 14,731 0.22 3,240.86
    103 OPTN Renal Waiting Time Reinstatement Form *** 228 1.21 276 0.27 74.49
    104 OPTN Pancreas Waiting Time Reinstatement Form *** 123 0.03 4 0.20 0.74
    105 Intestinal Waiting Time Reinstatement Form *** 18 0.00 0 0.25 0.00
    106 Prior Living Donor Priority *** 228 0.25 57 0.27 15.39
    107 Kidney Minimum Acceptance Criteria *** 228 0.47 107 0.30 32.15
    108 Adult Liver Status 1A Initial Justification and Extension Form *** 142 2.31 328 0.57 186.97
    109 Pediatric Liver Status 1A Initial Justification and Extension Form *** 57 2.30 131 0.57 74.73
    110 Pediatric Liver Status 1B Initial Justification and Extension Form *** 57 5.61 320 0.47 150.29
    111 Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form *** 142 0.42 60 0.43 25.65
    112 Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception Extension Form *** 142 0.34 48 0.32 15.45
    113 Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and Extension Form *** 142 0.10 14 0.33 4.69
    114 Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD Score Exception Form *** 142 0.04 6 0.40 2.27
    115 Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score Exception Extension Form *** 142 0.05 7 0.30 2.13
    116 Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score Exception and Extension Form *** 142 0.69 98 0.35 34.29
    117 Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score Exception Form *** 142 23.30 3,309 0.47 1,555.04
    118 Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form *** 142 33.21 4,716 0.35 1,650.54
    119 Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD Score Exception Form *** 142 1.39 197 0.32 63.16
    120 Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form *** 142 0.99 141 0.25 35.15
    121 Liver Metabolic Disease Initial MELD/PELD Score Exception and Extension Form *** 142 0.77 109 0.28 30.62
    122 Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form *** 142 0.51 72 0.42 30.42
    123 Liver Portopulmonary Hypertension MELD/PELD Score Exception Extension Form *** 142 0.36 51 0.33 16.87
    124 Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form *** 142 0.13 18 0.35 6.46
    125 Liver Other Diagnosis Initial MELD/PELD Score Exception and Extension Form *** 142 12.03 1,708 0.35 597.89
    126 Pediatric Heart and HeartLung Status 1A Initial Justification Form *** 64 16.06 1,028 0.52 534.48
    127 Pediatric Heart and HeartLung Status 1A Extension and Appeal Justification Forms *** 64 54.61 3,495 0.47 1,642.67
    128 Pediatric Heart and HeartLung Status 1B Initial Justification Form *** 64 7.31 468 0.42 196.49
    129 Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data *** 149 135.78 20,231 0.32 6,473.99
    130 Adult Heart and HeartLung Status 1-6 Justification Form Risk Stratification Data *** 149 135.78 20,231 0.72 14,566.48
    131 Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data *** 149 5.69 848 0.58 491.73
    132 Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data *** 149 0.46 69 0.33 22.62
    133 Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data *** 149 0.43 64 0.53 33.96
    134 Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data *** 149 25.91 3,861 0.80 3,088.47
    135 Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data *** 149 9.87 1,471 0.33 485.31
    136 Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data *** 149 0.03 4 0.42 1.88
    137 Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data *** 149 3.05 454 0.63 286.30
    138 Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data *** 149 1.70 253 0.60 151.98
    139 Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data *** 149 11.91 1,775 0.63 1,117.99
    140 Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data *** 149 6.88 1,025 0.33 338.29
    141 Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data *** 149 0.64 95 0.32 30.52
    142 Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data *** 149 0.11 16 0.48 7.87
    143 Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data *** 149 23.51 3,503 0.50 1,751.50
    144 Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data *** 149 1.73 258 0.25 64.44
    145 Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data *** 149 0.56 83 0.40 33.38
    146 Adult and Pediatric Lung and HeartLung Goal Exception Form *** 149 3.72 554 0.75 415.71
    147 Pediatric Lung Priority 1 Status Justification Form *** 45 1.16 52 0.33 17.23
    148 Review Board Voter Form *** 248 22.46 5,570 0.23 1,281.12
    149 Living Donor Feedback Form *** 207 37.73 7,810 0.13 1,015.31
    150 Extra Vessels Reporting Form *** 248 53.71 13,320 0.03 399.60
    151 Non-US Transplants Reporting Form *** 228 0.00 0 0.03 0.00
    152 Discrepant HLA Typings Reporting Form *** 138 0.78 108 5.17 556.50
    153 Interim Event Reporting Form *** 248 72.58 18,000 0.06 1,079.99
        Total 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.