Notice2025-11668
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network
Primary source
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Published
June 25, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Full Text
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<title>Federal Register, Volume 90 Issue 120 (Wednesday, June 25, 2025)</title>
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[Federal Register Volume 90, Number 120 (Wednesday, June 25, 2025)]
[Notices]
[Pages 27037-27042]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11668]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Data System for Organ
Procurement and Transplantation Network
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than July 25,
2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, HRSA
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#4a3a2b3a2f383d2538210a2238392b642d253c"><span class="__cf_email__" data-cfemail="740415041106031b061f341c0607155a131b02">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
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 HHS, by award, provide for the establishment and
operation of the Organ Procurement and Transplantation Network (OPTN),
which, under oversight of the HRSA, 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 approval.
A 60-day notice was published in the Federal Register on November
1, 2024, Vol. 89, No. 212, pp. 87380-85. There were six comments,
including feedback from OPTN Members and Transplant Centers. Public
comments raised concerns about the financial burden of additional data
collection. The commenters called for greater collaboration between
transplant professionals, HRSA, and the Scientific Registry of
Transplant Recipients to eliminate redundancies and improve efficiency.
Commenters expressed concern that changes were communicated via the
Federal Register instead of the OPTN public comment process, limiting
input from the transplant community. Additionally, the commenters
sought clarification on discrepancies regarding which forms were
designated as new, and they requested access to the data collection
plans and draft instruments.
HRSA carefully reviewed all public feedback submitted during the
60-day comment period. Through its policy development process, OPTN had
previously solicited input on each of the data collection instruments
through four channels:
(1) Targeted outreach to relevant stakeholder organizations,
including
[[Page 27038]]
transplant professionals and patient groups.
(2) Comments submitted by other OPTN committees.
(3) In-person meetings across 11 OPTN regions.
(4) An online OPTN public comment forum open to all on the OPTN
website.
HRSA welcomes participation from all interested individuals. HRSA
seeks input from transplant candidates directly affected by policy
changes and strongly encourages transplant professionals to provide
input on the potential financial impacts of proposals. HRSA values all
feedback and remains committed to reviewing and refining data
collection efforts in collaboration with the OPTN.
Finally, in response to commenter concerns regarding potential
burden, the OPTN contract requires the OPTN Contractor to implement a
direct electronic data submission plan and supplement official OPTN
data with external sources. This approach aims to reduce the burden of
data collection on OPTN members.
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. The regulatory
authority in 42 CFR 121.11 (<a href="https://www.ecfr.gov/current/title-42/section-121.11">https://www.ecfr.gov/current/title-42/section-121.11</a>) 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, 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. 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 that
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-Stage 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 (OPO), 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
includes 96,148.84 hours due to adding 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 the number of
respondents.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total
Form No. Form name respondents responses per responses response burden
respondent * **** (in hours) hours
----------------------------------------------------------------------------------------------------------------
1................ Deceased Donor 56 414.71 23,223.76 0.48 11,147.40
Registration.
2................ Living Donor 207 33.42 6,917.94 2.19 15,150.29
Registration.
3................ Living Donor Follow- 207 94.86 19,636.02 1.52 29,846.75
up.
4................ Donor 138 173.31 23,916.78 0.20 4,783.36
Histocompatibility.
5................ Recipient 138 307.09 42,378.42 0.40 16,951.37
Histocompatibility.
6................ Heart Transplant 149 38.50 5,736.50 0.90 5,162.85
Candidate
Registration.
7................ Heart Transplant 149 30.50 4,544.50 1.96 8,907.22
Recipient
Registration.
8................ Heart Transplant 149 27.79 4,140.71 0.40 1,656.28
Recipient Follow
Up (6-month).
9................ Heart Transplant 149 109.21 16,272.29 0.90 14,645.06
Recipient Follow
Up (1-5 year).
10............... Heart Transplant 149 183.73 27,375.77 0.50 13,687.89
Recipient Follow
Up (Post 5 year).
11............... Heart Post- 149 12.21 1,819.29 0.90 1,637.36
Transplant
Malignancy Form.
12............... Lung Transplant 74 45.36 3,356.64 0.95 3,188.81
Candidate
Registration.
13............... Lung Transplant 74 40.85 3,022.90 1.14 3,446.11
Recipient
Registration.
[[Page 27039]]
14............... Lung Transplant 74 35.96 2,661.04 0.50 1,330.52
Recipient Follow
Up (6-month).
15............... Lung Transplant 74 135.61 10,035.14 1.10 11,038.65
Recipient Follow
Up (1-5 year).
16............... Lung Transplant 74 148.09 10,958.66 0.60 6,575.20
Recipient Follow
Up (Post 5 year).
17............... Lung Post- 74 18.39 1,360.86 0.40 544.34
Transplant
Malignancy Form.
18............... Heart/Lung 72 1.03 74.16 1.16 86.03
Transplant
Candidate
Registration.
19............... Heart/Lung 72 0.75 54.00 2.09 112.86
Transplant
Recipient
Registration.
20............... Heart/Lung 72 0.64 46.08 0.80 36.86
Transplant
Recipient Follow
Up (6-month).
21............... Heart/Lung 72 2.46 177.12 1.10 194.83
Transplant
Recipient Follow
Up (1-5 year).
22............... Heart/Lung 72 3.35 241.20 0.60 144.72
Transplant
Recipient Follow
Up (Post 5 year).
23............... Heart/Lung Post- 72 0.22 15.84 0.40 6.34
Transplant
Malignancy Form.
24............... Liver Transplant 142 103.39 14,681.38 0.80 11,745.10
Candidate
Registration.
25............... Liver Transplant 142 75.08 10,661.36 1.20 12,793.63
Recipient
Registration.
26............... Liver Transplant 142 344.55 48,926.10 1.00 48,926.10
Recipient Follow
Up (6-month-5
year).
27............... Liver Transplant 142 427.56 60,713.52 0.50 30,356.76
Recipient Follow
Up (Post 5 year).
28............... Liver Recipient 142 7.17 1,018.14 0.60 610.88
Explant Pathology
Form.
29............... Liver Post- 142 21.21 3,011.82 0.80 2,409.46
Transplant
Malignancy Form.
30............... Intestine 18 7.50 135.00 1.30 175.50
Transplant
Candidate
Registration.
31............... Intestine 18 5.28 95.04 1.80 171.07
Transplant
Recipient
Registration.
32............... Intestine 18 21.50 387.00 1.50 580.50
Transplant
Recipient Follow
Up (6-month-5
year).
33............... Intestine 18 49.61 892.98 0.40 357.19
Transplant
Recipient Follow
Up (Post 5 year).
34............... Intestine Post- 18 0.94 16.92 1.00 16.92
Transplant
Malignancy Form.
35............... Kidney Transplant 228 203.12 46,311.36 0.80 37,049.09
Candidate
Registration.
36............... Kidney Transplant 228 119.89 27,334.92 1.20 32,801.90
Recipient
Registration.
37............... Kidney Transplant 228 571.22 130,238.16 0.90 117,214.34
Recipient Follow
Up (6-month-5
year).
38............... Kidney Transplant 228 565.59 128,954.52 0.50 64,477.26
Recipient Follow
Up (Post 5 year).
39............... Kidney Post- 228 25.60 5,836.80 0.80 4,669.44
Transplant
Malignancy Form.
40............... Pancreas Transplant 123 2.63 323.49 0.60 194.09
Candidate
Registration.
41............... Pancreas Transplant 123 0.84 103.32 1.20 123.98
Recipient
Registration.
42............... Pancreas Transplant 123 5.05 621.15 0.50 310.58
Recipient Follow
Up (6-month-5
year).
43............... Pancreas Transplant 123 17.11 2,104.53 0.50 1,052.27
Recipient Follow
Up (Post 5 year).
44............... Pancreas Post- 123 0.76 93.48 0.60 56.09
Transplant
Malignancy Form.
45............... Kidney/Pancreas 123 12.94 1,591.62 0.60 954.97
Transplant
Candidate
Registration.
46............... Kidney/Pancreas 123 6.59 810.57 1.20 972.68
Transplant
Recipient
Registration.
47............... Kidney/Pancreas 123 38.12 4,688.76 0.50 2,344.38
Transplant
Recipient Follow
Up (6-month-5
year).
48............... Kidney/Pancreas 123 66.63 8,195.49 0.60 4,917.29
Transplant
Recipient Follow
Up (Post 5 year).
49............... Kidney/Pancreas 123 2.24 275.52 0.40 110.21
Post-Transplant
Malignancy Form.
50............... VCA Transplant 23 1.00 23.00 0.40 9.20
Candidate
Registration.
51............... VCA Transplant 23 0.39 8.97 1.36 12.20
Recipient
Registration.
52............... VCA Transplant 23 2.30 52.90 1.31 69.30
Recipient Follow
Up.
53............... Organ Labeling and 56 298.27 16,703.12 0.18 3,006.56
Packaging.
54............... Organ Tracking and 304 20.36 6,189.44 0.08 495.16
Validating.
55............... Kidney Paired 156 0.34 53.04 0.26 13.79
Donation Candidate
Registration.
56............... Kidney Paired 156 0.99 154.44 1.08 166.80
Donation Donor
Registration.
57............... Kidney Paired 156 0.59 92.04 0.67 61.67
Donation Match
Offer Management.
58............... Disease 304 2.33 708.32 0.60 424.99
Transmission Event.
59............... Living Donor Event. 207 0.15 31.05 0.56 17.39
60............... Safety Situation... 442 0.93 411.06 0.24 98.65
61............... Potential Disease 56 11.09 621.04 1.27 788.72
Transmission
Report.
62............... Request to Unlock 442 174.67 77,204.14 0.02 1,544.08
Form.
63............... Initial Donor 56 414.71 23,223.76 4.61 107,061.53
Registration.
64............... OPO Notification 56 9.52 533.12 0.17 90.63
Limit
Administration.
[[Page 27040]]
65............... Potential 304 6,017.74 1,829,392.96 0.05 91,469.65
Transplant
Recipient.
66............... Death Notification 56 289.70 16,223.20 0.42 6,813.74
Registration **.
67............... Deceased Donor 56 58.11 3,254.16 0.50 1,627.08
Death Referral **.
68............... Donor Hospital 56 0.04 2.24 0.08 0.18
Registration.
69............... Donor Organ 56 414.71 23,223.76 0.17 3,948.04
Disposition.
70............... Transplant Center 248 808.10 200,408.80 0.06 12,024.53
Contact Management.
71............... Adult Kidney 228 204.93 46,724.04 0.52 24,296.50
Candidate Listing
Registration ***.
72............... Pediatric Kidney 101 11.66 1,177.66 0.47 553.50
Candidate Listing
Registration ***.
73............... Adult Kidney 123 12.93 1,590.39 0.37 588.44
Pancreas Candidate
Listing
Registration ***.
74............... Pediatric Kidney 29 0.07 2.03 0.30 0.61
Pancreas Candidate
Listing
Registration ***.
75............... Adult Pancreas 123 15.29 1,880.67 0.38 714.65
Candidate Listing
Registration ***.
76............... Pediatric Pancreas 30 1.13 33.90 0.38 12.88
Candidate Listing
Registration ***.
77............... Adult Pancreas 16 2.06 32.96 0.38 12.52
Islet Listing
Registration ***.
78............... Pediatric Pancreas 16 0.00 0.00 0.33 0.00
Islet Listing
Registration ***.
79............... Adult Liver 142 98.43 13,977.06 0.32 4,472.66
Candidate Listing
Registration ***.
80............... Pediatric Liver 57 12.37 705.09 0.40 282.04
Candidate Listing
Registration ***.
81............... Adult Intestine 18 4.94 88.92 0.38 33.79
Candidate Listing
Registration ***.
82............... Pediatric Intestine 18 2.56 46.08 0.43 19.81
Candidate Listing
Registration ***.
83............... Adult Heart 149 33.58 5,003.42 0.83 4,152.84
Candidate Listing
Registration ***.
84............... Pediatric Heart 64 11.47 734.08 0.58 425.77
Candidate Listing
Registration ***.
85............... Adult HeartLung 72 0.97 69.84 0.85 59.36
Candidate Listing
Registration ***.
86............... Pediatric HeartLung 27 0.15 4.05 0.93 3.77
Candidate Listing
Registration ***.
87............... Adult Lung 74 44.85 3,318.90 1.00 3,318.90
Candidate Listing
Registration ***.
88............... Pediatric Lung 45 0.84 37.80 0.83 31.37
Candidate Listing
Registration ***.
89............... Candidate 248 289.27 71,738.96 0.18 12,913.01
Registration
Listing Removal
***.
90............... VCA Abdominal Wall 8 0.38 3.04 0.33 1.00
Candidate Listing
Registration ***.
91............... VCA External Male 2 0.00 0.00 0.33 0.00
Genitalia
Candidate Listing
Registration ***.
92............... VCA Head and Neck 10 0.50 5.00 0.33 1.65
Candidate Listing
Registration ***.
93............... VCA Lower Limb 4 0.00 0.00 0.33 0.00
Candidate Listing
Registration ***.
94............... VCA Musculoskeletal 2 0.00 0.00 0.33 0.00
Composite Graft
Segment Candidate
Listing
Registration ***.
95............... VCA Other 3 0.00 0.00 0.33 0.00
Genitourinary
Organ Candidate
Listing
Registration ***.
96............... VCA Spleen 0 0.00 0.00 0.33 0.00
Candidate Listing
Registration ***.
97............... VCA Upper Limb 11 0.27 2.97 0.33 0.98
Candidate Listing
Registration ***.
98............... VCA Uterus 6 2.00 12.00 0.33 3.96
Candidate Listing
Registration ***.
99............... VCA Vascularized 8 0.00 0.00 0.33 0.00
Gland Candidate
Listing
Registration ***.
100.............. Organ Export 56 0.46 25.76 0.03 0.77
Verification Form
***.
101.............. OPTN Waiting Time 248 5.54 1,373.92 0.23 316.00
Transfer Form ***.
102.............. OPTN Waiting Time 248 59.40 14,731.20 0.22 3,240.86
Modification Form
***.
103.............. OPTN Renal Waiting 228 1.21 275.88 0.27 74.49
Time Reinstatement
Form ***.
104.............. OPTN Pancreas 123 0.03 3.69 0.20 0.74
Waiting Time
Reinstatement Form
***.
105.............. Intestinal Waiting 18 0.00 0.00 0.25 0.00
Time Reinstatement
Form ***.
106.............. Prior Living Donor 228 0.25 57.00 0.27 15.39
Priority ***.
107.............. Kidney Minimum 228 0.47 107.16 0.30 32.15
Acceptance
Criteria ***.
108.............. Adult Liver Status 142 2.31 328.02 0.57 186.97
1A Initial
Justification and
Extension Form ***.
109.............. Pediatric Liver 57 2.30 131.10 0.57 74.73
Status 1A Initial
Justification and
Extension Form ***.
110.............. Pediatric Liver 57 5.61 319.77 0.47 150.29
Status 1B Initial
Justification and
Extension Form ***.
111.............. Liver 142 0.42 59.64 0.43 25.65
Cholangiocarcinoma
(CCA) Initial MELD/
PELD Score
Exception Form ***.
[[Page 27041]]
112.............. Liver 142 0.34 48.28 0.32 15.45
Cholangiocarcinoma
(CCA) MELD/PELD
Score Exception
Extension Form ***.
113.............. Liver Cystic 142 0.10 14.20 0.33 4.69
Fibrosis (CF)
Initial MELD/PELD
Score Exception
and Extension Form
***.
114.............. Liver Familial 142 0.04 5.68 0.40 2.27
Amyloid
Polyneuropathy
(FAP) Initial MELD/
PELD Score
Exception Form ***.
115.............. Liver Familial 142 0.05 7.10 0.30 2.13
Amyloid
Polyneuropathy
(FAP) MELD/PELD
Score Exception
Extension Form ***.
116.............. Liver Hepatic 142 0.69 97.98 0.35 34.29
Artery Thrombosis
(HAT) Initial MELD/
PELD Score
Exception and
Extension Form ***.
117.............. Liver 142 23.30 3,308.60 0.47 1,555.04
Hepatocellular
Carcinoma (HCC)
Initial MELD/PELD
Score Exception
Form ***.
118.............. Liver 142 33.21 4,715.82 0.35 1,650.54
Hepatocellular
Carcinoma (HCC)
MELD/PELD Score
Exception
Extension Form ***.
119.............. Liver 142 1.39 197.38 0.32 63.16
Hepatopulmonary
Syndrome (HPS)
Initial MELD/PELD
Score Exception
Form ***.
120.............. Liver 142 0.99 140.58 0.25 35.15
Hepatopulmonary
Syndrome (HPS)
MELD/PELD Score
Exception
Extension Form ***.
121.............. Liver Metabolic 142 0.77 109.34 0.28 30.62
Disease Initial
MELD/PELD Score
Exception and
Extension Form ***.
122.............. Liver 142 0.51 72.42 0.42 30.42
Portopulmonary
Hypertension
Initial MELD/PELD
Score Exception
Form ***.
123.............. Liver 142 0.36 51.12 0.33 16.87
Portopulmonary
Hypertension MELD/
PELD Score
Exception
Extension Form ***.
124.............. Liver Primary 142 0.13 18.46 0.35 6.46
Hyperoxaluria
Initial MELD/PELD
Score Exception
and Extension Form
***.
125.............. Liver Other 142 12.03 1,708.26 0.35 597.89
Diagnosis Initial
MELD/PELD Score
Exception and
Extension Form ***.
126.............. Pediatric Heart and 64 16.06 1,027.84 0.52 534.48
HeartLung Status
1A Initial
Justification Form
***.
127.............. Pediatric Heart and 64 54.61 3,495.04 0.47 1,642.67
HeartLung Status
1A Extension and
Appeal
Justification
Forms ***.
128.............. Pediatric Heart and 64 7.31 467.84 0.42 196.49
HeartLung Status
1B Initial
Justification Form
***.
129.............. Adult Heart and 149 135.78 20,231.22 0.32 6,473.99
HeartLung Status 1-
6 Justification
Form Demographic
Data ***.
130.............. Adult Heart and 149 135.78 20,231.22 0.72 14,566.48
HeartLung Status 1-
6 Justification
Form Risk
Stratification
Data ***.
131.............. Adult Heart and 149 5.69 847.81 0.58 491.73
HeartLung Status 1
Initial
Justification Form
Medical Urgency
Data ***.
132.............. Adult Heart and 149 0.46 68.54 0.33 22.62
HeartLung Status 1
Exception
Extension
Justification Form
Medical Urgency
Data ***.
133.............. Adult Heart and 149 0.43 64.07 0.53 33.96
HeartLung Status 1
Criteria 1
Extension
Justification Form
Medical Urgency
Data ***.
134.............. Adult Heart and 149 25.91 3,860.59 0.80 3,088.47
HeartLung Status 2
Initial
Justification Form
Medical Urgency
Data ***.
135.............. Adult Heart and 149 9.87 1,470.63 0.33 485.31
HeartLung Status 2
Exception
Extension
Justification Form
Medical Urgency
Data ***.
136.............. Adult Heart and 149 0.03 4.47 0.42 1.88
HeartLung Status 2
Criteria 1
Extension
Justification Form
Medical Urgency
Data ***.
137.............. Adult Heart and 149 3.05 454.45 0.63 286.30
HeartLung Status 2
Criteria 4
Extension
Justification Form
Medical Urgency
Data ***.
138.............. Adult Heart and 149 1.70 253.30 0.60 151.98
HeartLung Status 2
Criteria 5
Extension
Justification Form
Medical Urgency
Data ***.
139.............. Adult Heart and 149 11.91 1,774.59 0.63 1,117.99
HeartLung Status 3
Initial
Justification Form
Medical Urgency
Data ***.
140.............. Adult Heart and 149 6.88 1,025.12 0.33 338.29
HeartLung Status 3
Exception
Extension
Justification Form
Medical Urgency
Data ***.
[[Page 27042]]
141.............. Adult Heart and 149 0.64 95.36 0.32 30.52
HeartLung Status 3
Criteria 2
Extension
Justification Form
Medical Urgency
Data ***.
142.............. Adult Heart and 149 0.11 16.39 0.48 7.87
HeartLung Status 3
Criteria 5
Extension
Justification Form
Medical Urgency
Data ***.
143.............. Adult Heart and 149 23.51 3,502.99 0.50 1,751.50
HeartLung Status 4
Initial
Justification Form
Medical Urgency
Data ***.
144.............. Adult Heart and 149 1.73 257.77 0.25 64.44
HeartLung Status 4
Exception
Extension
Justification Form
Medical Urgency
Data ***.
145.............. Adult Heart and 149 0.56 83.44 0.40 33.38
HeartLung Status 4
Criteria 2
Extension
Justification Form
Medical Urgency
Data ***.
146.............. Adult and Pediatric 149 3.72 554.28 0.75 415.71
Lung and HeartLung
Goal Exception
Form ***.
147.............. Pediatric Lung 45 1.16 52.20 0.33 17.23
Priority 1 Status
Justification Form
***.
148.............. Review Board Voter 248 22.46 5,570.08 0.23 1,281.12
Form ***.
149.............. Living Donor 207 37.73 7,810.11 0.13 1,015.31
Feedback Form ***.
150.............. Extra Vessels 248 53.71 13,320.08 0.03 399.60
Reporting Form ***.
151.............. Non-US Transplants 228 0.00 0.00 0.03 0.00
Reporting Form ***.
152.............. Discrepant HLA 138 0.78 107.64 5.17 556.50
Typings Reporting
Form ***.
153.............. Interim Event 248 72.58 17,999.84 0.06 1,079.99
Reporting Form ***.
-------------------------------------------------------------------------
Total........... 18,697 ................. 3,184,247.26 ........... 851,565.51
----------------------------------------------------------------------------------------------------------------
* The numbers of respondents and 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 indicates no submissions in calendar year 2023.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-11668 Filed 6-24-25; 8:45 am]
BILLING CODE 4165-15-P
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