Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision, 59103-59105 [2022-21119]
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59103
Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Notices
funding, but not all Part A/B grantees
will have Part C programs. Therefore,
there are likely to be 295 unique
respondents, but only 250 will have to
complete all three portions of the
application. This application covers all
three parts of Title VI.
Responses
per
respondent
Number of
respondents
Respondent/data collection activity
Hours per
response
Annual
burden hours
Title VI Application Part A/B ............................................................................
Title VI Application Part C ...............................................................................
295
250
1
1
2.75
1.5
270.4
125
Total ..........................................................................................................
........................
........................
4.25
395.4
The number of burden hours
associated with the Title VI, Part C, data
collection was calculated as 811.25.
However, since this instrument is
used only once every three years results
in an annualized number of 270.4 hours.
Similarly, the total hours associated
with the Title VI, Part C, application is
375.
Dated: September 23, 2022.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2022–21080 Filed 9–28–22; 8:45 am]
BILLING CODE 4154–01–P
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, OMB No.
0915–0157—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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 November 28,
2022.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
ACL estimates the burden associated
with this collection of information as
follows:
Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
ADDRESSES:
VerDate Sep<11>2014
17:52 Sep 28, 2022
Jkt 256001
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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 Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Data System for Organ Procurement and
Transplantation Network (OPTN), OMB
No. 0915–0157—Revision.
Abstract: Section 372 of the Public
Health Service Act requires that the
Secretary of HHS, by contract, provide
for the establishment and operation of a
private, non-profit entity the OPTN,
which on behalf of HRSA, oversees the
U.S. donation and transplantation
system. The OPTN Board of Directors
(BOD) determines what data must be
collected to appropriately fulfill their
responsibilities pursuant to their
regulatory authority in 42 CFR 121.11 of
the OPTN Final Rule. HRSA, on behalf
of the OPTN BOD and in alignment with
the Paperwork Reduction Act of 1995,
submits OPTN 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,
donation, 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, HHS, and
members of the public for evaluation,
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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 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. The
OPTN collects these specific data
elements from transplant hospitals,
organ procurement organizations, and
histocompatibility laboratories. The
OPTN uses 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 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 OPTN BOD-approved changes
to improve the OPTN organ matching
and allocation process and improve
OPTN member compliance with OPTN
requirements:
(1) Adding data collection forms from the
OPTN donor management and organ
matching system to the existing OMBapproved information collection. The system
allows an organ procurement organization to
add donors, run the donor/potential
transplant recipients matches, and place a
donated organ(s) with a computer-matched
potential transplant recipient. Transplant
centers will access the system to view posted
donor information to assist them with
accepting decisions, along with other donor/
potential transplant recipient functions such
as entering offer responses and verifying
organ offer refusals. The OPTN donor
management and organ matching system is
comprised of eight data collection forms:
E:\FR\FM\29SEN1.SGM
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Notices
initial donor registration, organ procurement
organization notification limit
administration, potential transplant
recipient, death notification registration,
deceased donor death referral, donor hospital
registration, donor organ disposition, and
transplant center contact management.
(2) The OPTN BOD-approved additional
revisions to existing data collection forms to
improve organ matching, allocation, and
OPTN policy compliance.
(3) Existing OPTN data collection forms
that collect a single race and ethnicity
variable will be revised to collect separate
race and ethnicity variables, following the
minimum standards for collecting and
presenting data on race and ethnicity for all
federal reporting found within Revisions of
Standards for the Classification of Federal
Data on Race and Ethnicity, OMB Statistical
Policy Directive No. 15 in Federal Register,
62 FR 58782 (Oct. 30, 1997). Improving data
collection around race and ethnicity
information of donors and candidates aligns
with Executive Order 13985, which calls on
agencies to advance equity through
identifying and addressing barriers to equal
opportunity that underserved communities
may face due to government policies and
programs.
Likely Respondents: Transplant
programs, 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.
Number of
respondents *
khammond on DSKJM1Z7X2PROD with NOTICES
Form name
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 Months) ..............
Heart Transplant Recipient Follow-Up (1–5 Years) ............
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 Months) ...............
Lung Transplant Recipient Follow-Up (1–5 Years) .............
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 Months) .....
Heart/Lung Transplant Recipient Follow-Up (1–5 Years) ...
Heart/Lung Transplant Recipient Follow-Up (Post 5 Year)
Heart/Lung Post-Transplant Malignancy Form ....................
Liver Transplant Candidate Registration .............................
Liver Transplant Recipient Registration ...............................
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 .......................................
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 .......................
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Number of
responses per
respondent
The estimated total estimated burden
hours for this collection increased by
213,662 hours from the currently
approved ICR package. This increase is
due to the addition of eight collection
forms from the OPTN donor
management and organ matching system
to this data collection package,
specifically the burden increase from
the Potential Transplant Recipient form.
While the data fields collected on the
Potential Transplant Recipient form are
limited, the volume of organ offer
responses is significant due to the large
number of potential transplant
recipients shown on the organ match
run results. The organ match run results
produce thousands of potential
transplant recipients that require
responses from OPOs and transplant
hospitals. This volume of candidates
significantly impacts the total burden
hours for this form.
Total Estimated Annualized Burden
Hours:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
57
216
216
141
141
145
145
145
145
145
145
72
72
72
72
72
72
70
70
70
70
70
70
143
143
143
143
143
143
21
21
243.560
28.106
90.550
149.184
264.950
34.586
26.324
24.400
104.140
171.100
13.170
42.970
35.010
33.630
139.940
136.280
22.630
0.960
0.640
0.600
2.100
3.360
0.290
96.920
64.580
320.266
384.320
7.300
19.060
6.860
4.570
13,883
6,071
19,559
21,035
37,358
5,015
3,817
3,538
15,100
24,810
1,910
3,094
2,521
2,421
10,076
9,812
1,629
67
45
42
147
235
20
13,860
9,235
45,798
54,958
1,044
2,726
144
96
1.09
2.19
1.52
0.20
0.40
0.90
1.40
0.40
0.90
0.50
0.90
0.90
1.20
0.50
1.10
0.60
0.40
1.10
1.30
0.80
1.10
0.60
0.40
0.80
1.20
1.00
0.50
0.60
0.80
1.30
1.80
15,132
13,295
29,730
4,207
14,943
4,514
5,344
1,415
13,590
12,405
1,719
2,785
3,025
1,211
11,084
5,887
652
74
59
34
162
141
8
11,088
11,082
45,798
27,479
626
2,181
187
173
21
21
21
234
234
234
234
234
120
120
20.050
40.190
0.620
177.000
105.397
517.124
525.103
24.474
2.650
1.190
421
844
13
41,418
24,663
121,007
122,874
5,727
318
143
1.50
0.40
1.00
0.80
1.20
0.90
0.50
0.80
0.60
1.20
632
338
13
33,134
29,596
108,906
61,437
4,582
191
172
Sfmt 4703
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Notices
Number of
respondents *
Form name
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 ..........................................
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 ............................
Total = 70 forms ...........................................................
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
120
120
120
120
120
6.680
17.820
1.060
12.450
6.840
802
2138
127
1,494
821
0.50
0.50
0.60
0.60
1.20
401
1,069
76
896
985
120
39.440
4,733
0.50
2,367
120
120
21
21
21
57
308
159
159
159
308
251
449
57
449
57
57
308
57
57
57
57
251
69.410
2.490
0.330
0.190
1.000
247.720
19.487
1.200
1.560
1.520
1.810
0.155
0.600
8.720
42.399
335.720
0.490
4,718.480
185.770
53.840
0.040
335.720
637.500
8,329
299
7
4
21
14,120
6,002
191
248
242
557
39
269
497
19,037
19,136
28
1,453,292
10,589
3,069
2
19,136
160,013
0.60
0.40
0.40
1.36
1.31
0.18
0.08
0.29
1.08
0.67
0.62
0.56
0.56
1.27
0.02
3.00
0.17
0.05
0.42
0.50
0.08
0.17
0.06
4,997
120
3
5
28
2,542
480
55
268
162
345
22
151
631
381
57,408
5
72,665
4,447
1,535
0
3,253
9,601
9,146
........................
2,352,736
........................
643,929
* The numbers of respondents and the numbers of total responses in the burden table were updated with 2021 OPTN data and reflect increases in the number of organ transplants and changes in the number of respondents (Transplant Hospitals, OPO, and Histocompatibility Labs).
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s and
the OPTN’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.
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Recourses and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 87 FR 229–230 dated
January 4, 2022). This reorganization
updates the functions of the Provider
Relief Bureau (RD).
Maria G. Button,
Director, Executive Secretariat.
Delete the organization for the
Provider Relief Bureau (RD) in its
entirety and replace with the following:
The Provider Relief Bureau (RD) is
headed by the Associate Administrator,
who reports directly to the
Administrator, HRSA. The Provider
Relief Bureau includes the following
components:
(1) Office of the Associate
Administrator (RD);
(2) Division of Customer Support
(RD2);
(3) Division of Program Operations
(RD4);
(4) Division of Data Analytics (RD5);
and
[FR Doc. 2022–21119 Filed 9–28–22; 8:45 am]
BILLING CODE 4165–15–P
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions,
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
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17:52 Sep 28, 2022
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Chapter RD—Provider Relief Bureau
Section RD.10
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Organization
Fmt 4703
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(5) Division of Program Integrity
(RD6).
Section RD.20 Function
Delete the functional statement for the
Provider Relief Bureau (RD) in its
entirety and replace with the following:
Provider Relief Bureau (RD)
The Provider Relief Bureau (PRB)
ensures resiliency of the nation’s health
care systems and infrastructure by
supporting health care entities in the
United States to prevent, prepare for,
and respond to coronavirus. PRB
reimburses health care providers for
health care-related expenses or lost
revenues attributable to coronavirus and
provides claims reimbursement for
health care entities for COVID–19
testing, treatment, and vaccine
administration for uninsured and under
insured individuals.
Office of the Associate Administrator
(RD)
The Office of the Associate
Administrator (OAA) provides overall
leadership, direction, coordination, and
planning in support of the programs
E:\FR\FM\29SEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59103-59105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21119]
-----------------------------------------------------------------------
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, OMB No. 0915-
0157--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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 November
28, 2022.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14N136B, 5600
Fishers Lane, Rockville, MD 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 Samantha Miller,
the HRSA Information Collection Clearance Officer at (301) 443-9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Data System for Organ
Procurement and Transplantation Network (OPTN), OMB No. 0915-0157--
Revision.
Abstract: Section 372 of the Public Health Service Act requires
that the Secretary of HHS, by contract, provide for the establishment
and operation of a private, non-profit entity the OPTN, which on behalf
of HRSA, oversees the U.S. donation and transplantation system. The
OPTN Board of Directors (BOD) determines what data must be collected to
appropriately fulfill their responsibilities pursuant to their
regulatory authority in 42 CFR 121.11 of the OPTN Final Rule. HRSA, on
behalf of the OPTN BOD and in alignment with the Paperwork Reduction
Act of 1995, submits OPTN 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, donation, 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, 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 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. The OPTN collects
these specific data elements from transplant hospitals, organ
procurement organizations, and histocompatibility laboratories. The
OPTN uses 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 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 OPTN BOD-approved changes
to improve the OPTN organ matching and allocation process and improve
OPTN member compliance with OPTN requirements:
(1) Adding data collection forms from the OPTN donor management
and organ matching system to the existing OMB-approved information
collection. The system allows an organ procurement organization to
add donors, run the donor/potential transplant recipients matches,
and place a donated organ(s) with a computer-matched potential
transplant recipient. Transplant centers will access the system to
view posted donor information to assist them with accepting
decisions, along with other donor/potential transplant recipient
functions such as entering offer responses and verifying organ offer
refusals. The OPTN donor management and organ matching system is
comprised of eight data collection forms:
[[Page 59104]]
initial donor registration, organ procurement organization
notification limit administration, potential transplant recipient,
death notification registration, deceased donor death referral,
donor hospital registration, donor organ disposition, and transplant
center contact management.
(2) The OPTN BOD-approved additional revisions to existing data
collection forms to improve organ matching, allocation, and OPTN
policy compliance.
(3) Existing OPTN data collection forms that collect a single
race and ethnicity variable will be revised to collect separate race
and ethnicity variables, following the minimum standards for
collecting and presenting data on race and ethnicity for all federal
reporting found within Revisions of Standards for the Classification
of Federal Data on Race and Ethnicity, OMB Statistical Policy
Directive No. 15 in Federal Register, 62 FR 58782 (Oct. 30, 1997).
Improving data collection around race and ethnicity information of
donors and candidates aligns with Executive Order 13985, which calls
on agencies to advance equity through identifying and addressing
barriers to equal opportunity that underserved communities may face
due to government policies and programs.
Likely Respondents: Transplant programs, 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 total estimated burden hours for this collection
increased by 213,662 hours from the currently approved ICR package.
This increase is due to the addition of eight collection forms from the
OPTN donor management and organ matching system to this data collection
package, specifically the burden increase from the Potential Transplant
Recipient form. While the data fields collected on the Potential
Transplant Recipient form are limited, the volume of organ offer
responses is significant due to the large number of potential
transplant recipients shown on the organ match run results. The organ
match run results produce thousands of potential transplant recipients
that require responses from OPOs and transplant hospitals. This volume
of candidates significantly impacts the total burden hours for this
form.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents * respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration..... 57 243.560 13,883 1.09 15,132
Living Donor Registration....... 216 28.106 6,071 2.19 13,295
Living Donor Follow-up.......... 216 90.550 19,559 1.52 29,730
Donor Histocompatibility........ 141 149.184 21,035 0.20 4,207
Recipient Histocompatibility.... 141 264.950 37,358 0.40 14,943
Heart Transplant Candidate 145 34.586 5,015 0.90 4,514
Registration...................
Heart Transplant Recipient 145 26.324 3,817 1.40 5,344
Registration...................
Heart Transplant Recipient 145 24.400 3,538 0.40 1,415
Follow-Up (6 Months)...........
Heart Transplant Recipient 145 104.140 15,100 0.90 13,590
Follow-Up (1-5 Years)..........
Heart Transplant Recipient 145 171.100 24,810 0.50 12,405
Follow-Up (Post 5 Year)........
Heart Post-Transplant Malignancy 145 13.170 1,910 0.90 1,719
Form...........................
Lung Transplant Candidate 72 42.970 3,094 0.90 2,785
Registration...................
Lung Transplant Recipient 72 35.010 2,521 1.20 3,025
Registration...................
Lung Transplant Recipient Follow- 72 33.630 2,421 0.50 1,211
Up (6 Months)..................
Lung Transplant Recipient Follow- 72 139.940 10,076 1.10 11,084
Up (1-5 Years).................
Lung Transplant Recipient Follow- 72 136.280 9,812 0.60 5,887
Up (Post 5 Year)...............
Lung Post-Transplant Malignancy 72 22.630 1,629 0.40 652
Form...........................
Heart/Lung Transplant Candidate 70 0.960 67 1.10 74
Registration...................
Heart/Lung Transplant Recipient 70 0.640 45 1.30 59
Registration...................
Heart/Lung Transplant Recipient 70 0.600 42 0.80 34
Follow-Up (6 Months)...........
Heart/Lung Transplant Recipient 70 2.100 147 1.10 162
Follow-Up (1-5 Years)..........
Heart/Lung Transplant Recipient 70 3.360 235 0.60 141
Follow-Up (Post 5 Year)........
Heart/Lung Post-Transplant 70 0.290 20 0.40 8
Malignancy Form................
Liver Transplant Candidate 143 96.920 13,860 0.80 11,088
Registration...................
Liver Transplant Recipient 143 64.580 9,235 1.20 11,082
Registration...................
Liver Transplant Recipient 143 320.266 45,798 1.00 45,798
Follow-Up (6 Month-5 Year).....
Liver Transplant Recipient 143 384.320 54,958 0.50 27,479
Follow-Up (Post 5 Year)........
Liver Recipient Explant 143 7.300 1,044 0.60 626
Pathology Form.................
Liver Post-Transplant Malignancy 143 19.060 2,726 0.80 2,181
Intestine Transplant Candidate 21 6.860 144 1.30 187
Registration...................
Intestine Transplant Recipient 21 4.570 96 1.80 173
Registration...................
Intestine Transplant Recipient 21 20.050 421 1.50 632
Follow-Up (6 Month-5 Year).....
Intestine Transplant Recipient 21 40.190 844 0.40 338
Follow-Up (Post 5 Year)........
Intestine Post-Transplant 21 0.620 13 1.00 13
Malignancy Form................
Kidney Transplant Candidate 234 177.000 41,418 0.80 33,134
Registration...................
Kidney Transplant Recipient 234 105.397 24,663 1.20 29,596
Registration...................
Kidney Transplant Recipient 234 517.124 121,007 0.90 108,906
Follow-Up (6 Month-5 Year).....
Kidney Transplant Recipient 234 525.103 122,874 0.50 61,437
Follow-Up (Post 5 Year)........
Kidney Post-Transplant 234 24.474 5,727 0.80 4,582
Malignancy Form................
Pancreas Transplant Candidate 120 2.650 318 0.60 191
Registration...................
Pancreas Transplant Recipient 120 1.190 143 1.20 172
Registration...................
[[Page 59105]]
Pancreas Transplant Recipient 120 6.680 802 0.50 401
Follow-Up (6 Month-5 Year).....
Pancreas Transplant Recipient 120 17.820 2138 0.50 1,069
Follow-Up (Post 5 Year)........
Pancreas Post-Transplant 120 1.060 127 0.60 76
Malignancy Form................
Kidney/Pancreas Transplant 120 12.450 1,494 0.60 896
Candidate Registration.........
Kidney/Pancreas Transplant 120 6.840 821 1.20 985
Recipient Registration.........
Kidney/Pancreas Transplant 120 39.440 4,733 0.50 2,367
Recipient Follow-Up (6 Month-5
Year)..........................
Kidney/Pancreas Transplant 120 69.410 8,329 0.60 4,997
Recipient Follow-Up (Post 5
Year)..........................
Kidney/Pancreas Post-Transplant 120 2.490 299 0.40 120
Malignancy Form................
VCA Transplant Candidate 21 0.330 7 0.40 3
Registration...................
VCA Transplant Recipient 21 0.190 4 1.36 5
Registration...................
VCA Transplant Recipient Follow 21 1.000 21 1.31 28
Up.............................
Organ Labeling and Packaging.... 57 247.720 14,120 0.18 2,542
Organ Tracking and Validating... 308 19.487 6,002 0.08 480
Kidney Paired Donation Candidate 159 1.200 191 0.29 55
Registration...................
Kidney Paired Donation Donor 159 1.560 248 1.08 268
Registration...................
Kidney Paired Donation Match 159 1.520 242 0.67 162
Offer Management...............
Disease Transmission Event...... 308 1.810 557 0.62 345
Living Donor Event.............. 251 0.155 39 0.56 22
Safety Situation................ 449 0.600 269 0.56 151
Potential Disease Transmission.. 57 8.720 497 1.27 631
Request to Unlock Form.......... 449 42.399 19,037 0.02 381
Initial Donor Registration...... 57 335.720 19,136 3.00 57,408
OPO Notification Limit 57 0.490 28 0.17 5
Administration.................
Potential Transplant Recipient.. 308 4,718.480 1,453,292 0.05 72,665
Death Notification Registration. 57 185.770 10,589 0.42 4,447
Deceased Donor Death Referral... 57 53.840 3,069 0.50 1,535
Donor Hospital Registration..... 57 0.040 2 0.08 0
Donor Organ Disposition......... 57 335.720 19,136 0.17 3,253
Transplant Center Contact 251 637.500 160,013 0.06 9,601
Management.....................
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Total = 70 forms............ 9,146 .............. 2,352,736 .............. 643,929
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* The numbers of respondents and the numbers of total responses in the burden table were updated with 2021 OPTN
data and reflect increases in the number of organ transplants and changes in the number of respondents
(Transplant Hospitals, OPO, and Histocompatibility Labs).
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's and the OPTN'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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-21119 Filed 9-28-22; 8:45 am]
BILLING CODE 4165-15-P
