Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, 87380-87384 [2024-25506]
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Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices
This leads to administrative burdens
and financial inefficiencies for the
Agency and can be confusing for
manufacturers that participate in other
user fee programs. To address this issue,
FDA is proposing that Congress shift the
facility fee due date to October and
change the liability period for annual
facility fees to be the 12 months
immediately preceding the start of the
fiscal year for which the fees are due.
The proposal also includes an option for
the facility to be paid in two
installments in the transition year to
ease the burden on fee-paying
companies.
To ensure that FDA is adequately
resourced with OMUFA fees, FDA is
also proposing that Congress authorize a
one-time adjustment in calculating
annual target revenue if the average
number of fee-liable facilities exceeds a
particular number in certain years of
OMUFA II. This would help
accommodate the additional work
required to oversee these facilities. If
this adjustment is made, FDA is
proposing it would be part of the base
revenue going forward. Additionally,
FDA is proposing that Congress reset the
starting base revenue for OMUFA II to
include the additional direct cost
adjustment from the final year of
OMUFA I, which reflects funding to
support information technology
operations and maintenance activities.
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H. Impact of OMUFA II Enhancements
on User Fee Revenue
To implement the proposed
enhancements for OMUFA II, user fee
funding for a cumulative total of 11 fulltime equivalent staff is proposed to be
phased in by Congress over the course
of OMUFA II. The proposed new
funding will be phased in as follows, as
an additional dollar amount in annual
fee setting:
• $2,373,000 for FY 2026.
• $1,233,000 for FY 2027.
• $854,000 for FY 2028.
In addition, to support the other
additional direct costs associated with
the OMUFA II enhancements, the
following amounts are proposed to be
added as an additional direct cost
adjustment:
• $135,000 for FY 2026.
• $300,000 for FY 2027.
• $55,000 for FY 2028.
• $30,000 for FY 2030.
IV. Public Meeting Information
A. Purpose and Scope of the Meeting
The public meeting will include a
presentation by FDA and a series of
invited panels representing different
interested parties. For members of the
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16:47 Oct 31, 2024
Jkt 265001
public who would like to make verbal
comments on the proposed
enhancements and other
recommendations (see instructions
below), there will be a public comment
period at the end of the meeting.
Individuals can also submit written
comments to the docket [LINK] before
and after the meeting until December
20, 2024.
Dated: October 28, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
B. Participating in the Public Meeting
Health Resources and Services
Administration
Registration: Persons interested in
attending this public meeting must
register online by 11:59 p.m. Eastern
Time on November 19, 2024, at https://
fda.zoomgov.com/webinar/register/WN_
aW5YWtFfQiyOSzkABY3G4A#/
registration. Provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Opportunity for Public Comment:
Those who register online by November
13, 2024, will have the opportunity to
participate in the public comment
session of the meeting. If you wish to
speak during the public comment
session, respond ‘‘yes’’ to that question
in the registration form. We will do our
best to accommodate requests to make
public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
comments and request time jointly. All
those who wish to make a public
comment during the meeting must be
registered by November 13, 2024, at
11:59 p.m. Eastern Time. We will
determine the amount of time allotted to
each commenter, the approximate time
each comment is to begin, and will
select and notify participants by
November 18, 2024. No commercial or
promotional material will be permitted
to be presented at the public meeting.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. You will be asked to
indicate in your registration if you plan
to attend in person or via the webcast.
The webcast for this public meeting is
available at https://fda.zoomgov.com/
webinar/register/WN_
aW5YWtFfQiyOSzkABY3G4A#/
registration.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/drugs/
news-events-human-drugs/publicmeeting-recommendations-overcounter-monograph-drug-user-feeprogram-omufa-reauthorization.
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[FR Doc. 2024–25458 Filed 10–31–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Data System
for Organ Procurement and
Transplantation Network
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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
SUMMARY:
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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 preand 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 EndState 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.
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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form #
Form name
1 .......................
2 .......................
3 .......................
4 .......................
5 .......................
6 .......................
7 .......................
8 .......................
9 .......................
10 .....................
11 .....................
12 .....................
13 .....................
14 .....................
15 .....................
16 .....................
17 .....................
18 .....................
19 .....................
20 .....................
21 .....................
22 .....................
23 .....................
24 .....................
25 .....................
Deceased Donor Registration ..........................................................
Living Donor Registration .................................................................
Living Donor Follow-up ....................................................................
Donor Histocompatibility ..................................................................
Recipient Histocompatibility .............................................................
Heart Transplant Candidate Registration ........................................
Heart Transplant Recipient Registration ..........................................
Heart Transplant Recipient Follow Up (6 Month) ............................
Heart Transplant Recipient Follow Up (1–5 Year) ...........................
Heart Transplant Recipient Follow Up (Post 5 Year) ......................
Heart Post-Transplant Malignancy Form .........................................
Lung Transplant Candidate Registration .........................................
Lung Transplant Recipient Registration ...........................................
Lung Transplant Recipient Follow Up (6 Month) .............................
Lung Transplant Recipient Follow Up (1–5 Year) ...........................
Lung Transplant Recipient Follow Up (Post 5 Year) .......................
Lung Post-Transplant Malignancy Form ..........................................
Heart/Lung Transplant Candidate Registration ...............................
Heart/Lung Transplant Recipient Registration .................................
Heart/Lung Transplant Recipient Follow Up (6 Month) ...................
Heart/Lung Transplant Recipient Follow Up (1–5 Year) .................
Heart/Lung Transplant Recipient Follow Up (Post 5 Year) .............
Heart/Lung Post-Transplant Malignancy Form ................................
Liver Transplant Candidate Registration .........................................
Liver Transplant Recipient Registration ...........................................
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56
207
207
138
138
149
149
149
149
149
149
74
74
74
74
74
74
72
72
72
72
72
72
142
142
Number of
responses per
respondent ****
Total
responses
414.71
33.42
94.86
173.31
307.09
38.50
30.50
27.79
109.21
183.73
12.21
45.36
40.85
35.96
135.61
148.09
18.39
1.03
0.75
0.64
2.46
3.35
0.22
103.39
75.08
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01NON1
23,224
6,918
19,636
23,917
42,378
5,737
4,545
4,141
16,272
27,376
1,819
3,357
3,023
2,661
10,035
10,959
1,361
74
54
46
177
241
16
14,681
10,661
Average
burden
per
response
(in hours)
0.48
2.19
1.52
0.20
0.40
0.90
1.96
0.40
0.90
0.50
0.90
0.95
1.14
0.50
1.10
0.60
0.40
1.16
2.09
0.80
1.10
0.60
0.40
0.80
1.20
Total
burden
hours
11,147.40
15,150.29
29,846.75
4,783.36
16,951.37
5,162.85
8,907.22
1,656.28
14,645.06
13,687.89
1,637.36
3,188.81
3,446.11
1,330.52
11,038.65
6,575.20
544.34
86.03
112.86
36.86
194.83
144.72
6.34
11,745.10
12,793.63
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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
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26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
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48
49
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52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
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95 .....................
96 .....................
97 .....................
98 .....................
99 .....................
100 ...................
101 ...................
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Number of
respondents
Form name
Liver Transplant Recipient Follow Up (6 Month–5 Year) ................
Liver Transplant Recipient Follow Up (Post 5 Year) .......................
Liver Recipient Explant Pathology Form .........................................
Liver Post-Transplant Malignancy Form ..........................................
Intestine Transplant Candidate Registration ....................................
Intestine Transplant Recipient Registration .....................................
Intestine Transplant Recipient Follow Up (6 Month–5 Year) ...........
Intestine Transplant Recipient Follow Up (Post 5 Year) .................
Intestine Post-Transplant Malignancy Form ....................................
Kidney Transplant Candidate Registration ......................................
Kidney Transplant Recipient Registration ........................................
Kidney Transplant Recipient Follow Up (6 Month–5 Year) .............
Kidney Transplant Recipient Follow Up (Post 5 Year) ....................
Kidney Post-Transplant Malignancy Form .......................................
Pancreas Transplant Candidate Registration ..................................
Pancreas Transplant Recipient Registration ...................................
Pancreas Transplant Recipient Follow Up (6 Month–5 Year) .........
Pancreas Transplant Recipient Follow Up (Post 5 Year) ................
Pancreas Post-Transplant Malignancy Form ...................................
Kidney/Pancreas Transplant Candidate Registration ......................
Kidney/Pancreas Transplant Recipient Registration .......................
Kidney/Pancreas Transplant Recipient Follow Up (6 Month–5
Year).
Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year) ....
Kidney/Pancreas Post-Transplant Malignancy Form .......................
VCA Transplant Candidate Registration ..........................................
VCA Transplant Recipient Registration ...........................................
VCA Transplant Recipient Follow Up ..............................................
Organ Labeling and Packaging .......................................................
Organ Tracking and Validating ........................................................
Kidney Paired Donation Candidate Registration .............................
Kidney Paired Donation Donor Registration ....................................
Kidney Paired Donation Match Offer Management .........................
Disease Transmission Event ...........................................................
Living Donor Event ...........................................................................
Safety Situation ................................................................................
Potential Disease Transmission Report ...........................................
Request to Unlock Form ..................................................................
Initial Donor Registration ..................................................................
OPO Notification Limit Administration ..............................................
Potential Transplant Recipient .........................................................
Death Notification Registration ** .....................................................
Deceased Donor Death Referral ** ..................................................
Donor Hospital Registration .............................................................
Donor Organ Disposition ..................................................................
Transplant Center Contact Management .........................................
Adult Kidney Candidate Listing Registration *** ...............................
Pediatric Kidney Candidate Listing Registration *** .........................
Adult Kidney Pancreas Candidate Listing Registration *** ..............
Pediatric Kidney Pancreas Candidate Listing Registration *** ........
Adult Pancreas Candidate Listing Registration *** ..........................
Pediatric Pancreas Candidate Listing Registration *** .....................
Adult Pancreas Islet Listing Registration .........................................
Pediatric Pancreas Islet Listing Registration *** ..............................
Adult Liver Candidate Listing Registration *** ..................................
Pediatric Liver Candidate Listing Registration *** ............................
Adult Intestine Candidate Listing Registration *** ............................
Pediatric Intestine Candidate Listing Registration *** ......................
Adult Heart Candidate Listing Registration *** .................................
Pediatric Heart Candidate Listing Registration *** ...........................
Adult HeartLung Candidate Listing Registration *** .........................
Pediatric HeartLung Candidate Listing Registration *** ...................
Adult Lung Candidate Listing Registration *** ..................................
Pediatric Lung Candidate Listing Registration *** ............................
Candidate Registration Listing Removal *** .....................................
VCA Abdominal Wall Candidate Listing Registration *** .................
VCA External Male Genitalia Candidate Listing Registration *** .....
VCA Head and Neck Candidate Listing Registration *** .................
VCA Lower Limb Candidate Listing Registration *** ........................
VCA Musculoskeletal Composite Graft Segment Candidate Listing
Registration ***.
VCA Other Genitourinary Organ Candidate Listing Registration ***
VCA Spleen Candidate Listing Registration *** ...............................
VCA Upper Limb Candidate Listing Registration *** ........................
VCA Uterus Candidate Listing Registration *** ................................
VCA Vascularized Gland Candidate Listing Registration *** ...........
Organ Export Verification Form *** ..................................................
OPTN Waiting Time Transfer Form *** ............................................
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Number of
responses per
respondent ****
Total
responses
Average
burden
per
response
(in hours)
Total
burden
hours
142
142
142
142
18
18
18
18
18
228
228
228
228
228
123
123
123
123
123
123
123
123
344.55
427.56
7.17
21.21
7.50
5.28
21.50
49.61
0.94
203.12
119.89
571.22
565.59
25.60
2.63
0.84
5.05
17.11
0.76
12.94
6.59
38.12
48,926
60,714
1,018
3,012
135
95
387
893
17
46,311
27,335
130,238
128,955
5,837
323
103
621
2,105
93
1,592
811
4,689
1.00
0.50
0.60
0.80
1.30
1.80
1.50
0.40
1.00
0.80
1.20
0.90
0.50
0.80
0.60
1.20
0.50
0.50
0.60
0.60
1.20
0.50
48,926.10
30,356.76
610.88
2,409.46
175.50
171.07
580.50
357.19
16.92
37,049.09
32,801.90
117,214.34
64,477.26
4,669.44
194.09
123.98
310.58
1,052.27
56.09
954.97
972.68
2,344.38
123
123
23
23
23
56
304
156
156
156
304
207
442
56
442
56
56
304
56
56
56
56
248
228
101
123
29
123
30
16
16
142
57
18
18
149
64
72
27
74
45
248
8
2
10
4
2
66.63
2.24
1.00
0.39
2.30
298.27
20.36
0.34
0.99
0.59
2.33
0.15
0.93
11.09
174.67
414.71
9.52
6,017.74
289.70
58.11
0.04
414.71
808.10
204.93
11.66
12.93
0.07
15.29
1.13
2.06
0.00
98.43
12.37
4.94
2.56
33.58
11.47
0.97
0.15
44.85
0.84
289.27
0.38
0.00
0.50
0.00
0.00
8,195
276
23
9
53
16,703
6,189
53
154
92
708
31
411
621
77,204
23,224
533
1,829,393
16,223
3,254
2
23,224
200,409
46,724
1,178
1,590
2
1,881
34
33
0
13,977
705
89
46
5,003
734
70
4
3,319
38
71,739
3
0
5
0
0
0.60
0.40
0.40
1.36
1.31
0.18
0.08
0.26
1.08
0.67
0.60
0.56
0.24
1.27
0.02
4.61
0.17
0.05
0.42
0.50
0.08
0.17
0.06
0.52
0.47
0.37
0.30
0.38
0.38
0.38
0.33
0.32
0.40
0.38
0.43
0.83
0.58
0.85
0.93
1.00
0.83
0.18
0.33
0.33
0.33
0.33
0.33
4,917.29
110.21
9.20
12.20
69.30
3,006.56
495.16
13.79
166.80
61.67
424.99
17.39
98.65
788.72
1,544.08
107,061.53
90.63
91,469.65
6,813.74
1,627.08
0.18
3,948.04
12,024.53
24,296.50
553.50
588.44
0.61
714.65
12.88
12.52
0.00
4,472.66
282.04
33.79
19.81
4,152.84
425.77
59.36
3.77
3,318.90
31.37
12,913.01
1.00
0.00
1.65
0.00
0.00
3
0
11
6
8
56
248
0.00
0.00
0.27
2.00
0.00
0.46
5.54
0
0
3
12
0
26
1,374
0.33
0.33
0.33
0.33
0.33
0.03
0.23
0.00
0.00
0.98
3.96
0.00
0.77
316.00
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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form #
102
103
104
105
106
107
108
109
...................
...................
...................
...................
...................
...................
...................
...................
110 ...................
111 ...................
112 ...................
113 ...................
114 ...................
115 ...................
116 ...................
117 ...................
118 ...................
119 ...................
120 ...................
121 ...................
122 ...................
123 ...................
124 ...................
125 ...................
126 ...................
127 ...................
128 ...................
129 ...................
130 ...................
131 ...................
132 ...................
133 ...................
134 ...................
135 ...................
136 ...................
137 ...................
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138 ...................
139 ...................
140 ...................
141 ...................
142 ...................
143 ...................
VerDate Sep<11>2014
Number of
respondents
Form name
OPTN Waiting Time Modification Form *** ......................................
OPTN Renal Waiting Time Reinstatement Form *** ........................
OPTN Pancreas Waiting Time Reinstatement Form *** ..................
Intestinal Waiting Time Reinstatement Form *** ..............................
Prior Living Donor Priority *** ...........................................................
Kidney Minimum Acceptance Criteria *** .........................................
Adult Liver Status 1A Initial Justification and Extension Form *** ...
Pediatric Liver Status 1A Initial Justification and Extension
Form ***.
Pediatric Liver Status 1B Initial Justification and Extension
Form ***.
Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form ***.
Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception
Extension Form ***.
Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and
Extension Form ***.
Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD
Score Exception Form ***.
Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score
Exception Extension Form ***.
Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score
Exception and Extension Form ***.
Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score
Exception Form ***.
Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form ***.
Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD
Score Exception Form ***.
Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form ***.
Liver Metabolic Disease Initial MELD/PELD Score Exception and
Extension Form ***.
Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form ***.
Liver Portopulmonary Hypertension MELD/PELD Score Exception
Extension Form ***.
Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception
and Extension Form ***.
Liver Other Diagnosis Initial MELD/PELD Score Exception and
Extension Form ***.
Pediatric Heart and HeartLung Status 1A Initial Justification
Form ***.
Pediatric Heart and HeartLung Status 1A Extension and Appeal
Justification Forms ***.
Pediatric Heart and HeartLung Status 1B Initial Justification
Form ***.
Adult Heart and HeartLung Status 1–6 Justification Form Demographic Data ***.
Adult Heart and HeartLung Status 1–6 Justification Form Risk
Stratification Data ***.
Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data ***.
16:47 Oct 31, 2024
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Fmt 4703
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Number of
responses per
respondent ****
Total
responses
Average
burden
per
response
(in hours)
Total
burden
hours
248
228
123
18
228
228
142
57
59.40
1.21
0.03
0.00
0.25
0.47
2.31
2.30
14,731
276
4
0
57
107
328
131
0.22
0.27
0.20
0.25
0.27
0.30
0.57
0.57
3,240.86
74.49
0.74
0.00
15.39
32.15
186.97
74.73
57
5.61
320
0.47
150.29
142
0.42
60
0.43
25.65
142
0.34
48
0.32
15.45
142
0.10
14
0.33
4.69
142
0.04
6
0.40
2.27
142
0.05
7
0.30
2.13
142
0.69
98
0.35
34.29
142
23.30
3,309
0.47
1,555.04
142
33.21
4,716
0.35
1,650.54
142
1.39
197
0.32
63.16
142
0.99
141
0.25
35.15
142
0.77
109
0.28
30.62
142
0.51
72
0.42
30.42
142
0.36
51
0.33
16.87
142
0.13
18
0.35
6.46
142
12.03
1,708
0.35
597.89
64
16.06
1,028
0.52
534.48
64
54.61
3,495
0.47
1,642.67
64
7.31
468
0.42
196.49
149
135.78
20,231
0.32
6,473.99
149
135.78
20,231
0.72
14,566.48
149
5.69
848
0.58
491.73
149
0.46
69
0.33
22.62
149
0.43
64
0.53
33.96
149
25.91
3,861
0.80
3,088.47
149
9.87
1,471
0.33
485.31
149
0.03
4
0.42
1.88
149
3.05
454
0.63
286.30
149
1.70
253
0.60
151.98
149
11.91
1,775
0.63
1,117.99
149
6.88
1,025
0.33
338.29
149
0.64
95
0.32
30.52
149
0.11
16
0.48
7.87
149
23.51
3,503
0.50
1,751.50
E:\FR\FM\01NON1.SGM
01NON1
87384
Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form #
Form name
144 ...................
Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data ***.
Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data ***.
Adult and Pediatric Lung and HeartLung Goal Exception Form ***
Pediatric Lung Priority 1 Status Justification Form *** .....................
Review Board Voter Form *** ...........................................................
Living Donor Feedback Form *** ......................................................
Extra Vessels Reporting Form *** ....................................................
Non-US Transplants Reporting Form *** .........................................
Discrepant HLA Typings Reporting Form *** ...................................
Interim Event Reporting Form *** .....................................................
Total ..........................................................................................
145 ...................
146
147
148
149
150
151
152
153
...................
...................
...................
...................
...................
...................
...................
...................
Number of
responses per
respondent ****
Total
responses
Average
burden
per
response
(in hours)
Total
burden
hours
149
1.73
258
0.25
64.44
149
0.56
83
0.40
33.38
149
45
248
207
248
228
138
248
3.72
1.16
22.46
37.73
53.71
0.00
0.78
72.58
554
52
5,570
7,810
13,320
0
108
18,000
0.75
0.33
0.23
0.13
0.03
0.03
5.17
0.06
415.71
17.23
1,281.12
1,015.31
399.60
0.00
556.50
1,079.99
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Child
Health and Human Development
Council. The meeting will be held as a
virtual meeting and will be open to the
public as indicated below. Individuals
who plan to view the virtual meeting
and need special assistance or other
reasonable accommodations to view the
meeting, should notify the Contact
Person listed below in advance of the
meeting. The meeting can be accessed
from the NIH Videocast at the following
link: https://videocast.nih.gov/.
VerDate Sep<11>2014
16:47 Oct 31, 2024
Jkt 265001
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Child Health and Human Development
Council.
Date: January 13–14, 2025.
Open: January 13, 2025, 12:00 p.m. to 5:00
p.m.
Agenda: NICHD Director’s Report and
other Council Business.
Address: Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Closed: January 14, 2025, 9:00 a.m. to 12:15
p.m.
Agenda: To review and evaluate grant
applications.
Address: Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Rebekah S. Rasooly, Ph.D.,
Director, Division of Extramural Activities,
Eunice Kennedy Shriver National Institute of
Child Health and Human Development,
National Institute of Health, 6710B Rockledge
Drive, Room: 2316, Bethesda, MD 20817.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Persons listed on
this notice. The statement should include the
name, address, telephone number and when
PO 00000
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Fmt 4703
Sfmt 4703
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nichd.nih.gov/about/advisory/council,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 28, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–25420 Filed 10–31–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NIDDK.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected] 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 [email protected] 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
