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, 48743-48745 [2021-18688]
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oversight, coordination, and logistical
support for the Medical Expert Panel, as
well as Clinical Reviewer contracts; (10)
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pending and new legislation relating to
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providing programmatic outreach efforts
to maximize public exposure to private
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Division of National Hansen’s Disease
Program (RRH)
The National Hansen’s Disease
Program, in accordance with regulations
and the Public Health Service (PHS)
Act, Sec. 320 as amended by Public Law
105–78, Sec. 211, (1) provides care and
treatment for persons with Hansen’s
Disease (leprosy), including managing a
national short-term and outpatient
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specialized services to persons with
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(including clinical research),
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Hansen’s disease and other
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outpatient Hansen’s Disease Clinics and
to private physicians; (5) operates and
oversees the National Hansen’s Disease
Museum and Cemetery; (6) consults on
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HRSA and HHS, and with other federal
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operational activities with HRSA and
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Section R.30 Delegation of Authority
All prior delegations of authority and
re-delegations of authority consistent
with this reorganization are in effect. I
affirm and ratify any actions taken by
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HHS officials that involved the exercise
of those authorities prior to the effective
date of this reorganization.
(Authority: 44 U.S.C. 3101)
Dated: August 6, 2021.
Xavier Becerra,
Secretary.
[FR Doc. 2021–18075 Filed 8–27–21; 4:15 pm]
BILLING CODE 4165–15–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.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for the 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 1,
2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail 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 paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Data System for Organ Procurement and
Transplantation Network, OMB No.
0915–0157—Revision.
SUMMARY:
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48743
Abstract: Section 372 of the Public
Health Service Act requires that the
Secretary, by contract, provide for the
establishment and operation of a
private, non-profit entity: The Organ
Procurement and Transplantation
Network (OPTN). The data collected
pursuant to the OPTN’s regulatory
authority in 42 CFR 121.11 of the OPTN
Final Rule is collected through OMB
approved data collection forms.
Therefore, data approved for collection
by the OPTN Board of Directors are
submitted by HRSA for OMB approval
under the Paperwork Reduction Act of
1995.
This is a request for revising the
current OPTN data collection associated
with an individual’s clinical
characteristics at the time of
registration, transplant, and follow-up
after the transplant to include data
collection forms in the OPTN Organ
Labeling, Packaging, and Tracking
System, the OPTN Kidney Paired
Donation Pilot Program (KPDPP), and
the OPTN Patient Safety Reporting
Portal (PSRP). This revision also
includes OPTN Board of Directors
approved changes to the existing OMB
data collection forms. These specific
data elements of the OPTN data system
are collected from transplant hospitals,
organ procurement organizations, and
histocompatibility laboratories. The
information is used 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; (5) perform
transplantation-related public health
surveillance including the possible
transmission of donor disease.
HRSA is submitting the following
changes to improve the OPTN organ
matching and allocation process and
improve OPTN member compliance
with OPTN requirements. All of these
proposed changes have been approved
by the OPTN Board of Directors.
(1) Adding two data collection forms
for the OPTN Organ Labeling,
Packaging, and Tracking System to the
existing OMB approved Data System for
Organ Procurement and Transplantation
Network. The system has two forms that
are used through mobile and web-based
applications to ensure the correct organ
is transplanted into the correct patient,
minimize labeling and transport errors,
accelerate organ information transfer,
E:\FR\FM\31AUN1.SGM
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48744
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
and capture data regarding organ
procurement. OPTN Organ Labeling,
Packaging, and Tracking System is
comprised of two data collection forms:
Organ labeling and packaging, and
organ tracking and validating.
(2) Adding data collection forms for
the OPTN KPDPP to the existing OMB
approved Data System for Organ
Procurement and Transplantation
Network. Kidney paired donation is a
transplant option for those patients
waiting for a kidney transplant who
have a willing living donor who is
medically able but cannot donate a
kidney to their intended candidate
because they are incompatible. OPTN
KPDPP matches living donors, and their
intended candidates with other living
donors or intended candidate pairs
when the living donors cannot donate to
the person(s) they initially hoped would
receive their kidney. OPTN KPDPP is
comprised of three data collection
forms: Candidate registration, donor
registration, and match offer
management.
(3) Adding data collection forms in
the OPTN PSRP to the existing OMB
approved Data System for Organ
Procurement and Transplantation
Network. OPTN PSRP allows the OPTN
to collect reports on any event or
process variance that could cause
concerns from transplantation,
donation, safety, or quality perspective.
OPTN PSRP is comprised of four data
collection forms: Disease transmission
event, living donor event, safety
situation, and potential disease
transmission.
(4) Additional revisions to existing
data collection forms were made based
on the OPTN Board of Directorsapproved changes to improve organ
matching, allocation, and OPTN policy
compliance.
Need and Proposed Use of the
Information: Data are used to develop
transplant, donation, and allocation
policies, to determine whether
institutional members are complying
with policy, to determine memberspecific performance, to ensure patient
safety, and to fulfill the requirements of
the OPTN Final Rule. The practical
utility of the data collection is further
enhanced by requirements that the
OPTN data must 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.
Likely Respondents: Transplant
programs, Organ Procurement
Organizations, 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 to collect,
validate, and verify information, process
and maintain information, and disclose
and provide information; to train
personnel and 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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
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 Recipient Registration ................................................
Heart 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 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 ...............................
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 ..........................
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Number of
responses per
respondent *
57
300
300
147
147
140
140
140
140
140
140
71
71
71
71
71
71
69
69
69
69
69
69
146
146
146
146
146
146
20
20
20
20
20
237
Fmt 4703
Sfmt 4703
188.26
22.85
62.23
123.99
225.10
33.69
24.33
22.01
90.61
153.97
12.77
45.21
35.66
32.35
118.85
116.49
19.72
0.97
0.46
0.45
1.14
3.30
0.30
90.29
56.55
266.57
316.61
10.58
16.35
6.95
5.20
26.20
37.20
2.10
168.77
Total
responses
10,731
6,855
18,669
18,227
33,090
4,717
3,406
3,081
12,685
21,556
1,788
3,210
2,532
2,297
8,438
8,271
1,400
67
32
31
79
228
21
13,182
8,256
38,919
46,225
1,545
2,387
139
104
524
744
42
39,998
E:\FR\FM\31AUN1.SGM
31AUN1
Average
burden per
response
(in hours)
1.10
2.19
1.53
0.20
0.40
0.90
1.20
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
1.50
0.40
1.00
0.80
Total burden
hours
11,804
a 15,012
b 28,564
3,645
13,236
4,245
4,087
1,233
11,417
10,778
1,609
2,889
3,038
1,148
9,282
4,962
560
74
41
25
87
137
8
10,546
9,908
38,919
23,113
927
1,910
181
187
786
298
42
31,999
48745
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Number of
responses per
respondent *
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
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 ..........................................
Request to Unlock ...............................................................
237
237
237
237
133
133
89.43
431.86
449.40
22.64
2.77
1.46
21,195
102,351
106,508
5,366
368
194
1.20
0.90
0.50
0.80
0.60
1.20
25,434
92,116
53,254
4,293
221
233
133
133
133
133
133
7.87
15.93
0.73
9.75
7.73
1,047
2,119
97
1,297
1,028
0.50
0.50
0.60
0.60
1.20
523
1,059
58
778
1,234
133
32.80
4,362
0.50
2,181
133
133
27
27
27
57
34
160
160
160
308
251
450
57
450
57.80
2.20
0.89
1.59
0.67
208.25
169.06
1.38
1.46
1.51
1.44
0.12
0.48
6.88
39.22
7,687
293
24
43
18
11,870
5,748
221
234
242
444
30
216
392
17,649
0.60
0.40
0.40
1.36
1.31
0.18
0.08
0.29
1.07
0.67
0.62
0.56
0.56
1.27
0.02
4,612
117
11
c 58
d 24
2,137
460
64
250
162
275
17
121
498
353
Total ..............................................................................
8,290
........................
604,519
........................
437,240
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to
the nearest tenth.
a Total burden increased due to the approval of the ‘‘Modify Data Collection on VCA Living Donors’’ proposal approved by the OPTN Board of
Directors (BOD) in December of 2020. The proposal required adding 54 new data fields onto this form and removing 1 data field from this form.
b Total burden increased due to the approval of the ‘‘Modify Data Collection on VCA Living Donors’’ proposal approved by the OPTN BOD in
December of 2020. The proposal required adding 17 new data fields onto this form.
c Total burden increased due to the approval of the ‘‘Programming VCA Allocation in UNet’’ proposal approved by the OPTN BOD in December of 2020. The proposal required adding 16 new data fields onto this form and removing 10 data fields from this form.
d Total burden increased due to the approval of the ‘‘Programming VCA Allocation in UNet’’ proposal approved by the OPTN BOD in December of 2020. The proposal required adding 54 new data fields onto this form and removing 5 data fields from this form.
khammond on DSKJM1Z7X2PROD with NOTICES
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–18688 Filed 8–30–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Establishment of the Office of Climate
Change and Health Equity
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Statement of Organization, Functions,
and Delegations of Authority
Part A, Office of the Secretary,
Statement of Organization, Function,
and Delegation of Authority for the U.S.
Department of Health and Human
Services (HHS) is being amended at
Chapter AC, Office of the Assistant
Secretary for Health (OASH), as last
amended at 75 FR 53304, dated August
31, 2010, and 72 FR 58095–96, dated
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October 12, 2007. Executive Order
14008, Tackling the Climate Crisis at
Home and Abroad, section 222(d),
directs the Secretary of Health and
Human Services to establish an Office of
Climate Change and Health Equity to
address the impact of climate change on
the health of the American people. This
amendment reflects the establishment of
an office to address the impact of
climate change on the health of the
American people and to empower
individuals through information, data,
and scientific approaches to pursue
environmental justice. Specifically, this
notice establishes the Office of Climate
Change and Health Equity in the OASH.
The changes are as follows:
A. Under Part A, Chapter AC, under
the Office of the Assistant Secretary for
Health, add the following:
1. The Office of Climate Change and
Health Equity (OCCHE), is headed by a
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]]>Agencies
[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48743-48745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18688]
-----------------------------------------------------------------------
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.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for the 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
1, 2021.
ADDRESSES: Submit your comments to [email protected] or mail 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 Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection 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, by contract, provide for the establishment and
operation of a private, non-profit entity: The Organ Procurement and
Transplantation Network (OPTN). The data collected pursuant to the
OPTN's regulatory authority in 42 CFR 121.11 of the OPTN Final Rule is
collected through OMB approved data collection forms. Therefore, data
approved for collection by the OPTN Board of Directors are submitted by
HRSA for OMB approval under the Paperwork Reduction Act of 1995.
This is a request for revising the current OPTN data collection
associated with an individual's clinical characteristics at the time of
registration, transplant, and follow-up after the transplant to include
data collection forms in the OPTN Organ Labeling, Packaging, and
Tracking System, the OPTN Kidney Paired Donation Pilot Program (KPDPP),
and the OPTN Patient Safety Reporting Portal (PSRP). This revision also
includes OPTN Board of Directors approved changes to the existing OMB
data collection forms. These specific data elements of the OPTN data
system are collected from transplant hospitals, organ procurement
organizations, and histocompatibility laboratories. The information is
used 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; (5) perform transplantation-related public
health surveillance including the possible transmission of donor
disease.
HRSA is submitting the following changes to improve the OPTN organ
matching and allocation process and improve OPTN member compliance with
OPTN requirements. All of these proposed changes have been approved by
the OPTN Board of Directors.
(1) Adding two data collection forms for the OPTN Organ Labeling,
Packaging, and Tracking System to the existing OMB approved Data System
for Organ Procurement and Transplantation Network. The system has two
forms that are used through mobile and web-based applications to ensure
the correct organ is transplanted into the correct patient, minimize
labeling and transport errors, accelerate organ information transfer,
[[Page 48744]]
and capture data regarding organ procurement. OPTN Organ Labeling,
Packaging, and Tracking System is comprised of two data collection
forms: Organ labeling and packaging, and organ tracking and validating.
(2) Adding data collection forms for the OPTN KPDPP to the existing
OMB approved Data System for Organ Procurement and Transplantation
Network. Kidney paired donation is a transplant option for those
patients waiting for a kidney transplant who have a willing living
donor who is medically able but cannot donate a kidney to their
intended candidate because they are incompatible. OPTN KPDPP matches
living donors, and their intended candidates with other living donors
or intended candidate pairs when the living donors cannot donate to the
person(s) they initially hoped would receive their kidney. OPTN KPDPP
is comprised of three data collection forms: Candidate registration,
donor registration, and match offer management.
(3) Adding data collection forms in the OPTN PSRP to the existing
OMB approved Data System for Organ Procurement and Transplantation
Network. OPTN PSRP allows the OPTN to collect reports on any event or
process variance that could cause concerns from transplantation,
donation, safety, or quality perspective. OPTN PSRP is comprised of
four data collection forms: Disease transmission event, living donor
event, safety situation, and potential disease transmission.
(4) Additional revisions to existing data collection forms were
made based on the OPTN Board of Directors-approved changes to improve
organ matching, allocation, and OPTN policy compliance.
Need and Proposed Use of the Information: Data are used 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. The practical utility of the data
collection is further enhanced by requirements that the OPTN data must
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.
Likely Respondents: Transplant programs, Organ Procurement
Organizations, 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 to collect, validate, and verify information, process and
maintain information, and disclose and provide information; to train
personnel and 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.
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..... 57 188.26 10,731 1.10 11,804
Living Donor Registration....... 300 22.85 6,855 2.19 \a\ 15,012
Living Donor Follow-up.......... 300 62.23 18,669 1.53 \b\ 28,564
Donor Histocompatibility........ 147 123.99 18,227 0.20 3,645
Recipient Histocompatibility.... 147 225.10 33,090 0.40 13,236
Heart Transplant Candidate 140 33.69 4,717 0.90 4,245
Registration...................
Heart Recipient Registration.... 140 24.33 3,406 1.20 4,087
Heart Follow Up (6 Month)....... 140 22.01 3,081 0.40 1,233
Heart Transplant Recipient 140 90.61 12,685 0.90 11,417
Follow Up 1-5 Year.............
Heart Transplant Recipient 140 153.97 21,556 0.50 10,778
Follow Up Post 5 Year..........
Heart Post-Transplant Malignancy 140 12.77 1,788 0.90 1,609
Form...........................
Lung Transplant Candidate 71 45.21 3,210 0.90 2,889
Registration...................
Lung Transplant Recipient 71 35.66 2,532 1.20 3,038
Registration...................
Lung Transplant Recipient Follow 71 32.35 2,297 0.50 1,148
Up 6 Month.....................
Lung Transplant Recipient Follow 71 118.85 8,438 1.10 9,282
Up 1-5 Year....................
Lung Transplant Recipient Follow 71 116.49 8,271 0.60 4,962
Up Post 5 Year.................
Lung- Post-Transplant Malignancy 71 19.72 1,400 0.40 560
Form...........................
Heart/Lung Transplant Candidate 69 0.97 67 1.10 74
Registration...................
Heart/Lung Recipient 69 0.46 32 1.30 41
Registration...................
Heart/Lung Transplant Recipient 69 0.45 31 0.80 25
Follow Up 6 Month..............
Heart/Lung Transplant Recipient 69 1.14 79 1.10 87
Follow Up 1-5 Year.............
Heart/Lung Transplant Recipient 69 3.30 228 0.60 137
Follow Up Post 5 Year..........
Heart/Lung Post-Transplant 69 0.30 21 0.40 8
Malignancy Form................
Liver Transplant Candidate 146 90.29 13,182 0.80 10,546
Registration...................
Liver Transplant Recipient 146 56.55 8,256 1.20 9,908
Registration...................
Liver Transplant Recipient 146 266.57 38,919 1.00 38,919
Follow-Up 6 Month--5 Year......
Liver Transplant Recipient 146 316.61 46,225 0.50 23,113
Follow-up Post 5 Year..........
Liver Recipient Explant 146 10.58 1,545 0.60 927
Pathology Form.................
Liver Post-Transplant Malignancy 146 16.35 2,387 0.80 1,910
Intestine Transplant Candidate 20 6.95 139 1.30 181
Registration...................
Intestine Transplant Recipient 20 5.20 104 1.80 187
Registration...................
Intestine Transplant Recipient 20 26.20 524 1.50 786
Follow Up 6 Month--5 Year......
Intestine Transplant Recipient 20 37.20 744 0.40 298
Follow Up Post 5 Year..........
Intestine Post-Transplant 20 2.10 42 1.00 42
Malignancy Form................
Kidney Transplant Candidate 237 168.77 39,998 0.80 31,999
Registration...................
[[Page 48745]]
Kidney Transplant Recipient 237 89.43 21,195 1.20 25,434
Registration...................
Kidney Transplant Recipient 237 431.86 102,351 0.90 92,116
Follow-Up 6 Month--5 Year......
Kidney Transplant Recipient 237 449.40 106,508 0.50 53,254
Follow-Up Post 5 Year..........
Kidney Post-Transplant 237 22.64 5,366 0.80 4,293
Malignancy Form................
Pancreas Transplant Candidate 133 2.77 368 0.60 221
Registration...................
Pancreas Transplant Recipient 133 1.46 194 1.20 233
Registration...................
Pancreas Transplant Recipient 133 7.87 1,047 0.50 523
Follow-Up 6 Month--5 Year......
Pancreas Transplant Recipient 133 15.93 2,119 0.50 1,059
Follow-Up Post 5 Year..........
Pancreas Post-Transplant 133 0.73 97 0.60 58
Malignancy Form................
Kidney/Pancreas Transplant 133 9.75 1,297 0.60 778
Candidate Registration.........
Kidney/Pancreas Transplant 133 7.73 1,028 1.20 1,234
Recipient Registration.........
Kidney/Pancreas Transplant 133 32.80 4,362 0.50 2,181
Recipient Follow-Up 6 Month--5
Year...........................
Kidney/Pancreas Transplant 133 57.80 7,687 0.60 4,612
Recipient Follow-Up Post 5 Year
Kidney/Pancreas Post-Transplant 133 2.20 293 0.40 117
Malignancy Form................
VCA Transplant Candidate 27 0.89 24 0.40 11
Registration...................
VCA Transplant Recipient 27 1.59 43 1.36 \c\ 58
Registration...................
VCA Transplant Recipient Follow 27 0.67 18 1.31 \d\ 24
Up.............................
Organ Labeling and Packaging.... 57 208.25 11,870 0.18 2,137
Organ Tracking and Validating... 34 169.06 5,748 0.08 460
Kidney Paired Donation Candidate 160 1.38 221 0.29 64
Registration...................
Kidney Paired Donation Donor 160 1.46 234 1.07 250
Registration...................
Kidney Paired Donation Match 160 1.51 242 0.67 162
Offer Management...............
Disease Transmission Event...... 308 1.44 444 0.62 275
Living Donor Event.............. 251 0.12 30 0.56 17
Safety Situation................ 450 0.48 216 0.56 121
Potential Disease Transmission.. 57 6.88 392 1.27 498
Request to Unlock............... 450 39.22 17,649 0.02 353
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Total....................... 8,290 .............. 604,519 .............. 437,240
----------------------------------------------------------------------------------------------------------------
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
Respondents and rounding to the nearest tenth.
\a\ Total burden increased due to the approval of the ``Modify Data Collection on VCA Living Donors'' proposal
approved by the OPTN Board of Directors (BOD) in December of 2020. The proposal required adding 54 new data
fields onto this form and removing 1 data field from this form.
\b\ Total burden increased due to the approval of the ``Modify Data Collection on VCA Living Donors'' proposal
approved by the OPTN BOD in December of 2020. The proposal required adding 17 new data fields onto this form.
\c\ Total burden increased due to the approval of the ``Programming VCA Allocation in UNet'' proposal approved
by the OPTN BOD in December of 2020. The proposal required adding 16 new data fields onto this form and
removing 10 data fields from this form.
\d\ Total burden increased due to the approval of the ``Programming VCA Allocation in UNet'' proposal approved
by the OPTN BOD in December of 2020. The proposal required adding 54 new data fields onto this form and
removing 5 data fields from this form.
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-18688 Filed 8-30-21; 8:45 am]
BILLING CODE 4165-15-P
