[Federal Register Volume 89, Number 212 (Friday, November 1, 2024)]
[Notices]
[Pages 87380-87384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25506]


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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

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

ACTION: Notice.

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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 <a href="/cdn-cgi/l/email-protection#cebeafbeabbcb9a1bca58ea6bcbdafe0a9a1b8"><span class="__cf_email__" data-cfemail="bfcfdecfdacdc8d0cdd4ffd7cdccde91d8d0c9">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#8fffeeffeafdf8e0fde4cfe7fdfceea1e8e0f9"><span class="__cf_email__" data-cfemail="e89889988d9a9f879a83a8809a9b89c68f879e">[email protected]</span></a> 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

[[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                  Average
                                                                                    Number of       Number of         Total      burden per     Total
                   Form #                                  Form name               respondents    responses per     responses     response      burden
                                                                                                 respondent ****                 (in hours)     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                   149              38.50        5,737         0.90     5,162.85
                                               Registration.
7...........................................  Heart Transplant Recipient                   149              30.50        4,545         1.96     8,907.22
                                               Registration.
8...........................................  Heart Transplant Recipient Follow            149              27.79        4,141         0.40     1,656.28
                                               Up (6 Month).
9...........................................  Heart Transplant Recipient Follow            149             109.21       16,272         0.90    14,645.06
                                               Up (1-5 Year).
10..........................................  Heart Transplant Recipient Follow            149             183.73       27,376         0.50    13,687.89
                                               Up (Post 5 Year).
11..........................................  Heart Post-Transplant Malignancy             149              12.21        1,819         0.90     1,637.36
                                               Form.
12..........................................  Lung Transplant Candidate                     74              45.36        3,357         0.95     3,188.81
                                               Registration.
13..........................................  Lung Transplant Recipient                     74              40.85        3,023         1.14     3,446.11
                                               Registration.
14..........................................  Lung Transplant Recipient Follow Up           74              35.96        2,661         0.50     1,330.52
                                               (6 Month).
15..........................................  Lung Transplant Recipient Follow Up           74             135.61       10,035         1.10    11,038.65
                                               (1-5 Year).
16..........................................  Lung Transplant Recipient Follow Up           74             148.09       10,959         0.60     6,575.20
                                               (Post 5 Year).
17..........................................  Lung Post-Transplant Malignancy               74              18.39        1,361         0.40       544.34
                                               Form.
18..........................................  Heart/Lung Transplant Candidate               72               1.03           74         1.16        86.03
                                               Registration.
19..........................................  Heart/Lung Transplant Recipient               72               0.75           54         2.09       112.86
                                               Registration.
20..........................................  Heart/Lung Transplant Recipient               72               0.64           46         0.80        36.86
                                               Follow Up (6 Month).
21..........................................  Heart/Lung Transplant Recipient               72               2.46          177         1.10       194.83
                                               Follow Up (1-5 Year).
22..........................................  Heart/Lung Transplant Recipient               72               3.35          241         0.60       144.72
                                               Follow Up (Post 5 Year).
23..........................................  Heart/Lung Post-Transplant                    72               0.22           16         0.40         6.34
                                               Malignancy Form.
24..........................................  Liver Transplant Candidate                   142             103.39       14,681         0.80    11,745.10
                                               Registration.
25..........................................  Liver Transplant Recipient                   142              75.08       10,661         1.20    12,793.63
                                               Registration.

[[Page 87382]]

 
26..........................................  Liver Transplant Recipient Follow            142             344.55       48,926         1.00    48,926.10
                                               Up (6 Month-5 Year).
27..........................................  Liver Transplant Recipient Follow            142             427.56       60,714         0.50    30,356.76
                                               Up (Post 5 Year).
28..........................................  Liver Recipient Explant Pathology            142               7.17        1,018         0.60       610.88
                                               Form.
29..........................................  Liver Post-Transplant Malignancy             142              21.21        3,012         0.80     2,409.46
                                               Form.
30..........................................  Intestine Transplant Candidate                18               7.50          135         1.30       175.50
                                               Registration.
31..........................................  Intestine Transplant Recipient                18               5.28           95         1.80       171.07
                                               Registration.
32..........................................  Intestine Transplant Recipient                18              21.50          387         1.50       580.50
                                               Follow Up (6 Month-5 Year).
33..........................................  Intestine Transplant Recipient                18              49.61          893         0.40       357.19
                                               Follow Up (Post 5 Year).
34..........................................  Intestine Post-Transplant                     18               0.94           17         1.00        16.92
                                               Malignancy Form.
35..........................................  Kidney Transplant Candidate                  228             203.12       46,311         0.80    37,049.09
                                               Registration.
36..........................................  Kidney Transplant Recipient                  228             119.89       27,335         1.20    32,801.90
                                               Registration.
37..........................................  Kidney Transplant Recipient Follow           228             571.22      130,238         0.90   117,214.34
                                               Up (6 Month-5 Year).
38..........................................  Kidney Transplant Recipient Follow           228             565.59      128,955         0.50    64,477.26
                                               Up (Post 5 Year).
39..........................................  Kidney Post-Transplant Malignancy            228              25.60        5,837         0.80     4,669.44
                                               Form.
40..........................................  Pancreas Transplant Candidate                123               2.63          323         0.60       194.09
                                               Registration.
41..........................................  Pancreas Transplant Recipient                123               0.84          103         1.20       123.98
                                               Registration.
42..........................................  Pancreas Transplant Recipient                123               5.05          621         0.50       310.58
                                               Follow Up (6 Month-5 Year).
43..........................................  Pancreas Transplant Recipient                123              17.11        2,105         0.50     1,052.27
                                               Follow Up (Post 5 Year).
44..........................................  Pancreas Post-Transplant Malignancy          123               0.76           93         0.60        56.09
                                               Form.
45..........................................  Kidney/Pancreas Transplant                   123              12.94        1,592         0.60       954.97
                                               Candidate Registration.
46..........................................  Kidney/Pancreas Transplant                   123               6.59          811         1.20       972.68
                                               Recipient Registration.
47..........................................  Kidney/Pancreas Transplant                   123              38.12        4,689         0.50     2,344.38
                                               Recipient Follow Up (6 Month-5
                                               Year).
48..........................................  Kidney/Pancreas Transplant                   123              66.63        8,195         0.60     4,917.29
                                               Recipient Follow Up (Post 5 Year).
49..........................................  Kidney/Pancreas Post-Transplant              123               2.24          276         0.40       110.21
                                               Malignancy Form.
50..........................................  VCA Transplant Candidate                      23               1.00           23         0.40         9.20
                                               Registration.
51..........................................  VCA Transplant Recipient                      23               0.39            9         1.36        12.20
                                               Registration.
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             156               0.34           53         0.26        13.79
                                               Registration.
56..........................................  Kidney Paired Donation Donor                 156               0.99          154         1.08       166.80
                                               Registration.
57..........................................  Kidney Paired Donation Match Offer           156               0.59           92         0.67        61.67
                                               Management.
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                56              11.09          621         1.27       788.72
                                               Report.
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                        56               9.52          533         0.17        90.63
                                               Administration.
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                    248             808.10      200,409         0.06    12,024.53
                                               Management.
71..........................................  Adult Kidney Candidate Listing               228             204.93       46,724         0.52    24,296.50
                                               Registration ***.
72..........................................  Pediatric Kidney Candidate Listing           101              11.66        1,178         0.47       553.50
                                               Registration ***.
73..........................................  Adult Kidney Pancreas Candidate              123              12.93        1,590         0.37       588.44
                                               Listing Registration ***.
74..........................................  Pediatric Kidney Pancreas Candidate           29               0.07            2         0.30         0.61
                                               Listing Registration ***.
75..........................................  Adult Pancreas Candidate Listing             123              15.29        1,881         0.38       714.65
                                               Registration ***.
76..........................................  Pediatric Pancreas Candidate                  30               1.13           34         0.38        12.88
                                               Listing Registration ***.
77..........................................  Adult Pancreas Islet Listing                  16               2.06           33         0.38        12.52
                                               Registration.
78..........................................  Pediatric Pancreas Islet Listing              16               0.00            0         0.33         0.00
                                               Registration ***.
79..........................................  Adult Liver Candidate Listing                142              98.43       13,977         0.32     4,472.66
                                               Registration ***.
80..........................................  Pediatric Liver Candidate Listing             57              12.37          705         0.40       282.04
                                               Registration ***.
81..........................................  Adult Intestine Candidate Listing             18               4.94           89         0.38        33.79
                                               Registration ***.
82..........................................  Pediatric Intestine Candidate                 18               2.56           46         0.43        19.81
                                               Listing Registration ***.
83..........................................  Adult Heart Candidate Listing                149              33.58        5,003         0.83     4,152.84
                                               Registration ***.
84..........................................  Pediatric Heart Candidate Listing             64              11.47          734         0.58       425.77
                                               Registration ***.
85..........................................  Adult HeartLung Candidate Listing             72               0.97           70         0.85        59.36
                                               Registration ***.
86..........................................  Pediatric HeartLung Candidate                 27               0.15            4         0.93         3.77
                                               Listing Registration ***.
87..........................................  Adult Lung Candidate Listing                  74              44.85        3,319         1.00     3,318.90
                                               Registration ***.
88..........................................  Pediatric Lung Candidate Listing              45               0.84           38         0.83        31.37
                                               Registration ***.
89..........................................  Candidate Registration Listing               248             289.27       71,739         0.18    12,913.01
                                               Removal ***.
90..........................................  VCA Abdominal Wall Candidate                   8               0.38            3         0.33         1.00
                                               Listing Registration ***.
91..........................................  VCA External Male Genitalia                    2               0.00            0         0.33         0.00
                                               Candidate Listing Registration ***.
92..........................................  VCA Head and Neck Candidate Listing           10               0.50            5         0.33         1.65
                                               Registration ***.
93..........................................  VCA Lower Limb Candidate Listing               4               0.00            0         0.33         0.00
                                               Registration ***.
94..........................................  VCA Musculoskeletal Composite Graft            2               0.00            0         0.33         0.00
                                               Segment Candidate Listing
                                               Registration ***.
95..........................................  VCA Other Genitourinary Organ                  3               0.00            0         0.33         0.00
                                               Candidate Listing Registration ***.
96..........................................  VCA Spleen Candidate Listing                   0               0.00            0         0.33         0.00
                                               Registration ***.
97..........................................  VCA Upper Limb Candidate Listing              11               0.27            3         0.33         0.98
                                               Registration ***.
98..........................................  VCA Uterus Candidate Listing                   6               2.00           12         0.33         3.96
                                               Registration ***.
99..........................................  VCA Vascularized Gland Candidate               8               0.00            0         0.33         0.00
                                               Listing Registration ***.
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

[[Page 87383]]

 
102.........................................  OPTN Waiting Time Modification Form          248              59.40       14,731         0.22     3,240.86
                                               ***.
103.........................................  OPTN Renal Waiting Time                      228               1.21          276         0.27        74.49
                                               Reinstatement Form ***.
104.........................................  OPTN Pancreas Waiting Time                   123               0.03            4         0.20         0.74
                                               Reinstatement Form ***.
105.........................................  Intestinal Waiting Time                       18               0.00            0         0.25         0.00
                                               Reinstatement Form ***.
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                142               2.31          328         0.57       186.97
                                               Justification and Extension Form
                                               ***.
109.........................................  Pediatric Liver Status 1A Initial             57               2.30          131         0.57        74.73
                                               Justification and Extension Form
                                               ***.
110.........................................  Pediatric Liver Status 1B Initial             57               5.61          320         0.47       150.29
                                               Justification and Extension Form
                                               ***.
111.........................................  Liver Cholangiocarcinoma (CCA)               142               0.42           60         0.43        25.65
                                               Initial MELD/PELD Score Exception
                                               Form ***.
112.........................................  Liver Cholangiocarcinoma (CCA) MELD/         142               0.34           48         0.32        15.45
                                               PELD Score Exception Extension
                                               Form ***.
113.........................................  Liver Cystic Fibrosis (CF) Initial           142               0.10           14         0.33         4.69
                                               MELD/PELD Score Exception and
                                               Extension Form ***.
114.........................................  Liver Familial Amyloid                       142               0.04            6         0.40         2.27
                                               Polyneuropathy (FAP) Initial MELD/
                                               PELD Score Exception Form ***.
115.........................................  Liver Familial Amyloid                       142               0.05            7         0.30         2.13
                                               Polyneuropathy (FAP) MELD/PELD
                                               Score Exception Extension Form ***.
116.........................................  Liver Hepatic Artery Thrombosis              142               0.69           98         0.35        34.29
                                               (HAT) Initial MELD/PELD Score
                                               Exception and Extension Form ***.
117.........................................  Liver Hepatocellular Carcinoma               142              23.30        3,309         0.47     1,555.04
                                               (HCC) Initial MELD/PELD Score
                                               Exception Form ***.
118.........................................  Liver Hepatocellular Carcinoma               142              33.21        4,716         0.35     1,650.54
                                               (HCC) MELD/PELD Score Exception
                                               Extension Form ***.
119.........................................  Liver Hepatopulmonary Syndrome               142               1.39          197         0.32        63.16
                                               (HPS) Initial MELD/PELD Score
                                               Exception Form ***.
120.........................................  Liver Hepatopulmonary Syndrome               142               0.99          141         0.25        35.15
                                               (HPS) MELD/PELD Score Exception
                                               Extension Form ***.
121.........................................  Liver Metabolic Disease Initial              142               0.77          109         0.28        30.62
                                               MELD/PELD Score Exception and
                                               Extension Form ***.
122.........................................  Liver Portopulmonary Hypertension            142               0.51           72         0.42        30.42
                                               Initial MELD/PELD Score Exception
                                               Form ***.
123.........................................  Liver Portopulmonary Hypertension            142               0.36           51         0.33        16.87
                                               MELD/PELD Score Exception
                                               Extension Form ***.
124.........................................  Liver Primary Hyperoxaluria Initial          142               0.13           18         0.35         6.46
                                               MELD/PELD Score Exception and
                                               Extension Form ***.
125.........................................  Liver Other Diagnosis Initial MELD/          142              12.03        1,708         0.35       597.89
                                               PELD Score Exception and Extension
                                               Form ***.
126.........................................  Pediatric Heart and HeartLung                 64              16.06        1,028         0.52       534.48
                                               Status 1A Initial Justification
                                               Form ***.
127.........................................  Pediatric Heart and HeartLung                 64              54.61        3,495         0.47     1,642.67
                                               Status 1A Extension and Appeal
                                               Justification Forms ***.
128.........................................  Pediatric Heart and HeartLung                 64               7.31          468         0.42       196.49
                                               Status 1B Initial Justification
                                               Form ***.
129.........................................  Adult Heart and HeartLung Status 1-          149             135.78       20,231         0.32     6,473.99
                                               6 Justification Form Demographic
                                               Data ***.
130.........................................  Adult Heart and HeartLung Status 1-          149             135.78       20,231         0.72    14,566.48
                                               6 Justification Form Risk
                                               Stratification Data ***.
131.........................................  Adult Heart and HeartLung Status 1           149               5.69          848         0.58       491.73
                                               Initial Justification Form Medical
                                               Urgency Data ***.
132.........................................  Adult Heart and HeartLung Status 1           149               0.46           69         0.33        22.62
                                               Exception Extension Justification
                                               Form Medical Urgency Data ***.
133.........................................  Adult Heart and HeartLung Status 1           149               0.43           64         0.53        33.96
                                               Criteria 1 Extension Justification
                                               Form Medical Urgency Data ***.
134.........................................  Adult Heart and HeartLung Status 2           149              25.91        3,861         0.80     3,088.47
                                               Initial Justification Form Medical
                                               Urgency Data ***.
135.........................................  Adult Heart and HeartLung Status 2           149               9.87        1,471         0.33       485.31
                                               Exception Extension Justification
                                               Form Medical Urgency Data ***.
136.........................................  Adult Heart and HeartLung Status 2           149               0.03            4         0.42         1.88
                                               Criteria 1 Extension Justification
                                               Form Medical Urgency Data ***.
137.........................................  Adult Heart and HeartLung Status 2           149               3.05          454         0.63       286.30
                                               Criteria 4 Extension Justification
                                               Form Medical Urgency Data ***.
138.........................................  Adult Heart and HeartLung Status 2           149               1.70          253         0.60       151.98
                                               Criteria 5 Extension Justification
                                               Form Medical Urgency Data ***.
139.........................................  Adult Heart and HeartLung Status 3           149              11.91        1,775         0.63     1,117.99
                                               Initial Justification Form Medical
                                               Urgency Data ***.
140.........................................  Adult Heart and HeartLung Status 3           149               6.88        1,025         0.33       338.29
                                               Exception Extension Justification
                                               Form Medical Urgency Data ***.
141.........................................  Adult Heart and HeartLung Status 3           149               0.64           95         0.32        30.52
                                               Criteria 2 Extension Justification
                                               Form Medical Urgency Data ***.
142.........................................  Adult Heart and HeartLung Status 3           149               0.11           16         0.48         7.87
                                               Criteria 5 Extension Justification
                                               Form Medical Urgency Data ***.
143.........................................  Adult Heart and HeartLung Status 4           149              23.51        3,503         0.50     1,751.50
                                               Initial Justification Form Medical
                                               Urgency Data ***.

[[Page 87384]]

 
144.........................................  Adult Heart and HeartLung Status 4           149               1.73          258         0.25        64.44
                                               Exception Extension Justification
                                               Form Medical Urgency Data ***.
145.........................................  Adult Heart and HeartLung Status 4           149               0.56           83         0.40        33.38
                                               Criteria 2 Extension Justification
                                               Form Medical Urgency Data ***.
146.........................................  Adult and Pediatric Lung and                 149               3.72          554         0.75       415.71
                                               HeartLung Goal Exception Form ***.
147.........................................  Pediatric Lung Priority 1 Status              45               1.16           52         0.33        17.23
                                               Justification Form ***.
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             138               0.78          108         5.17       556.50
                                               Form ***.
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.

    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


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