Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision, 1151-1153 [2022-00239]
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Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Data System for Organ
Procurement and Transplantation
Network, OMB No. 0915–0157—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than February 9, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call (301)
443–9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Data System for Organ Procurement and
Transplantation Network, OMB No.
0915–0157—Revision.
Abstract: Section 372 of the Public
Health Service Act requires that the
Secretary, 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 will be collected through
OMB-approved data collection forms.
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:16 Jan 07, 2022
Jkt 256001
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.
A 60-day notice was published in the
Federal Register, 86 FR 48743 (Aug. 31,
2021). One comment was received. The
commenter supported the necessity and
utility of the proposed information
collection and the use of automated
collection techniques. The commenter
recommended that HRSA account for
anticipated increased staff hours and
recommended emphasizing collecting
data pertaining to race, ethnicity, social
determinants of health, and any other
characteristics that will help achieve
equity in organ donation and
transplantation. HRSA appreciates all
feedback, and we will continue to
review and evaluate all data collection
efforts going forward in consultation
with the OPTN.
The 60-day notice proposed data
collection changes to existing data
collection forms related to Vascularized
Composite Allograft (VCA)
transplantation, to implement policies
approved by the OPTN Board of
Directors. The OPTN expects to make
additional changes to these VCA data
collection forms in the near future so
implementation of data collection
changes has been postponed. These data
collection changes are not included in
this 30-day notice and will be included
for review in a future submission.
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.
This is a request to revise 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
1151
includes OPTN Board of Directorsapproved 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 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,
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 OMBapproved 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.
E:\FR\FM\10JAN1.SGM
10JAN1
1152
Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Notices
(3) Adding data collection forms in
the OPTN PSRP to the existing OMBapproved 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) Adding a request to unlock form
(5) 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.
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 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 total burden hours in the OMB
inventory increased by 4,337 hours from
the previously OMB-approved data
collection package from August 25,
2020. This increase is due to including
new data collection forms and
additional data to existing data
collection forms. However, the total
burden hours of this request is less than
the total burden hours presented in the
60-day notice, because of the removal of
the proposed data collection changes
associated with implementing the
‘‘Modify Data Collection on VCA Living
Donors’’ and ‘‘Programming VCA
Allocation in UNet’’ policies.
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 Candidate Registration ..............................................
Heart Recipient Registration ................................................
Heart Follow Up (6 Month) ..................................................
Heart Follow Up (1–5 Year) .................................................
Heart Follow Up (Post 5 Year) ............................................
Heart Post-Transplant Malignancy Form .............................
Lung Candidate Registration ...............................................
Lung Recipient Registration .................................................
Lung Follow Up (6 Month) ...................................................
Lung Follow Up (1–5 Year) .................................................
Lung Post-Transplant Malignancy Form ..............................
Heart/Lung Candidate Registration .....................................
Heart/Lung Recipient Registration .......................................
Heart/Lung Follow Up (6 Month) .........................................
Heart/Lung Follow Up (1–5 Year) ........................................
Heart/Lung Follow Up (Post 5 Year) ...................................
Heart/Lung Post-Transplant Malignancy Form ....................
Liver Candidate Registration ...............................................
Liver Recipient Registration .................................................
Liver Follow-up (6 Month–5 Year) .......................................
Liver Follow-up (Post 5 Year) ..............................................
Liver Recipient Explant Pathology Form .............................
Liver Post-Transplant Malignancy .......................................
Intestine Candidate Registration ..........................................
Intestine Recipient Registration ...........................................
Intestine Follow Up (6 Month–5 Year) .................................
Intestine Follow Up (Post 5 Year) .......................................
Intestine Post-Transplant Malignancy Form ........................
Kidney Candidate Registration ............................................
Kidney Recipient Registration ..............................................
Kidney Follow-up (Post 5 Year) ...........................................
Kidney Post-Transplant Malignancy Form ...........................
Pancreas Candidate Registration ........................................
Pancreas Recipient Registration .........................................
Pancreas Follow-up (6 Month–5 Year) ................................
Pancreas Follow-up (Post 5 Year) ......................................
Pancreas Post-Transplant Malignancy Form ......................
Kidney/Pancreas Candidate Registration ............................
Kidney/Pancreas Recipient Registration .............................
Kidney/Pancreas Follow-up (6 Month–5 Year) ....................
Kidney/Pancreas Follow-up (Post 5 Year) ..........................
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18:16 Jan 07, 2022
Jkt 256001
PO 00000
Frm 00047
Number of
responses per
respondent *
57
300
300
147
147
140
140
140
140
140
140
71
71
71
71
71
69
69
69
69
69
69
146
146
146
146
146
146
20
20
20
20
20
237
237
237
237
133
133
133
133
133
133
133
133
133
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
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
89.43
449.40
22.64
2.77
1.46
7.87
15.93
0.73
9.75
7.73
32.80
57.80
Total
responses
10,731
6,855
18,669
18,226
33,090
4,717
3,406
3,081
12,685
21,556
1,788
3,210
2,532
2,297
8,438
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
21,195
106,508
5,366
368
194
1,047
2,119
97
1,297
1,028
4,362
7,687
E:\FR\FM\10JAN1.SGM
10JAN1
Average
burden per
response
(in hours)
1.10
1.80
1.30
0.20
0.40
0.90
1.20
0.40
0.90
0.50
0.90
0.90
1.20
0.50
1.10
0.40
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
1.20
0.50
0.80
0.60
1.20
0.50
0.50
0.60
0.60
1.20
0.50
0.60
Total burden
hours
11,804
a 12,339
b 24,270
3,645
13,236
4,245
4,087
1,232
11,417
10,778
1,609
2,889
3,038
1,148
9,282
560
74
42
25
87
137
8
10,546
9,907
38,919
23,113
927
1,910
181
187
786
298
42
31,998
25,434
53,254
4,292
221
233
524
1,060
58
778
1,234
2,181
4,612
1153
Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / 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/Pancreas Post-Transplant Malignancy Form ..........
VCA Candidate Registration ................................................
VCA Recipient Registration .................................................
VCA Recipient Follow Up ....................................................
Organ Labeling and Packaging System ..............................
Organ Tracking and Validating System ...............................
Kidney Paired Donation Candidate Registration .................
Kidney Paired Donation Donor Registration ........................
Kidney Paired Donation Match Offer Management .............
Living Donor Event ..............................................................
Safety Situation ....................................................................
Potential Disease Transmission Report ..............................
Request to Unlock Form ......................................................
133
27
27
27
57
34
160
160
160
251
450
57
450
2.20
0.89
1.59
0.67
208.25
169.06
1.38
1.46
1.51
0.12
0.48
6.88
39.22
293
24
43
18
11,870
5,748
221
234
242
30
216
392
17,649
0.40
0.40
1.30
1.00
0.18
0.08
0.29
1.07
0.67
0.56
0.56
1.27
0.02
117
10
c 56
d 18
2,137
460
64
250
162
17
121
498
353
Total ..............................................................................
8,290
........................
604,519
........................
430,267
* The Number of Reponses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to
the nearest tenth.
a b c d Total burden hours in these forms decreased from estimates provided in the 60-day Notice due to the removal of the proposed data collection changes associated with implementing the ‘‘Modify Data Collection on VCA Living Donors’’ and ‘‘Programming VCA Allocation in UNet’’
policies.
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. 2022–00239 Filed 1–7–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Extension of the Deadline for
Nomination of Delegates; Center for
Indigenous Innovation and Health
Equity Tribal Advisory Committee;
Solicitation of Nominations for
Delegates
Office of Minority Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Deadline extension for notice of
solicitation of nominations for delegates
for the Center for Indigenous Innovation
and Health Equity Tribal Advisory
Committee.
khammond on DSKJM1Z7X2PROD with NOTICES
AGENCY:
On October 1, 2021, the U.S.
Department of Health and Human
Services (HHS) Office of Minority
Health (OMH) published a notice in the
Federal Register inviting nominations
SUMMARY:
VerDate Sep<11>2014
18:16 Jan 07, 2022
Jkt 256001
of qualified candidates to serve as
delegates for the Center for Indigenous
Innovation and Health Equity Tribal
Advisory Committee (Center TAC,
previously referred to as CIIHE TAC),
including a submission deadline of
October 29, 2021. An extension for the
submission deadline of nominations to
January 7, 2022, was published on
November 19, 2021. This notice extends
the deadline date for submission of
nominations to March 11, 2022, at 11:59
p.m. EST.
DATES: Nomination letters for the Center
TAC must be sent to the address noted
below no later than 11:59 p.m. EST on
March 11, 2022.
ADDRESSES: All nominations should be
emailed to: Violet Woo, Designated
Federal Officer for the Center TAC, at
Violet.Woo@hhs.gov. Please use the
subject line ‘‘OMH Center Tribal
Advisory Committee.’’
FOR FURTHER INFORMATION CONTACT: For
information and guidance about the
nomination process for Center TAC
delegates, please contact Violet Woo,
Designated Federal Officer at
Violet.Woo@hhs.gov. Center TAC
nomination guidance and sample
nomination letters also are available on
the OMH website’s Tribal Leader Letters
section: https://www.minority
health.hhs.gov/omh/
browse.aspx?lvl=3&lvlid=62#triballeader-letters.
SUPPLEMENTARY INFORMATION: On
October 1, 2021, the notice of
solicitation of nominations for delegates
for the Center TAC was published in the
Federal Register (86 FR 54462: available
at https://www.federalregister.gov/
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
documents/2021/10/01/2021-21253/
center-for-indigenous-innovation-andhealth-equity-tribal-advisory-committeesolicitation-of). The deadline for
submission of nomination letters is
being extended to March 11, 2022.
Note: All information in the notice of
solicitation of nominations for delegates
for the Center for Indigenous Innovation
and Health Equity Tribal Advisory
Committee remains the same, except for
the deadline for the submission of
nominations and the date the nominees
will be notified of the status of delegate
selection.
Authorized under Section 1707 of the
Public Health Service Act, 42 U.S.C.
300u–6, as amended, the mission of
OMH is to improve the health of racial
and ethnic minority populations
through the development of health
policies and programs that help
eliminate health disparities. OMH
awards and other activities are intended
to support the identification of effective
policies, programs, and practices for
improving health outcomes and to
promote the sustainability and
dissemination of these approaches.
Under the authority of Public Law
116–260 (2021 Consolidated
Appropriations Act), Congress directed
OMH to create a Center to support
research, education, service, and policy
development advancing Indigenous
solutions that ultimately address health
disparities in American Indian/Alaska
Native (AI/AN) and Native Hawaiian
and Pacific Islander (NHPI) populations.
OMH is establishing the Center TAC to
ensure that Tribal Leaders have
meaningful and timely input in the
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Notices]
[Pages 1151-1153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00239]
[[Page 1151]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Data System for Organ
Procurement and Transplantation Network, 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 Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than February
9, 2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the acting
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Data System for Organ
Procurement and Transplantation Network, OMB No. 0915-0157--Revision.
Abstract: Section 372 of the Public Health Service Act requires
that the Secretary, 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
will be 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.
A 60-day notice was published in the Federal Register, 86 FR 48743
(Aug. 31, 2021). One comment was received. The commenter supported the
necessity and utility of the proposed information collection and the
use of automated collection techniques. The commenter recommended that
HRSA account for anticipated increased staff hours and recommended
emphasizing collecting data pertaining to race, ethnicity, social
determinants of health, and any other characteristics that will help
achieve equity in organ donation and transplantation. HRSA appreciates
all feedback, and we will continue to review and evaluate all data
collection efforts going forward in consultation with the OPTN.
The 60-day notice proposed data collection changes to existing data
collection forms related to Vascularized Composite Allograft (VCA)
transplantation, to implement policies approved by the OPTN Board of
Directors. The OPTN expects to make additional changes to these VCA
data collection forms in the near future so implementation of data
collection changes has been postponed. These data collection changes
are not included in this 30-day notice and will be included for review
in a future submission.
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.
This is a request to revise 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 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,
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.
[[Page 1152]]
(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) Adding a request to unlock form
(5) 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.
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 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 total burden hours in the OMB inventory increased by 4,337
hours from the previously OMB-approved data collection package from
August 25, 2020. This increase is due to including new data collection
forms and additional data to existing data collection forms. However,
the total burden hours of this request is less than the total burden
hours presented in the 60-day notice, because of the removal of the
proposed data collection changes associated with implementing the
``Modify Data Collection on VCA Living Donors'' and ``Programming VCA
Allocation in UNet'' policies.
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 1.80 \a\ 12,339
Living Donor Follow-up.......... 300 62.23 18,669 1.30 \b\ 24,270
Donor Histocompatibility........ 147 123.99 18,226 0.20 3,645
Recipient Histocompatibility.... 147 225.10 33,090 0.40 13,236
Heart Candidate Registration.... 140 33.69 4,717 0.90 4,245
Heart Recipient Registration.... 140 24.33 3,406 1.20 4,087
Heart Follow Up (6 Month)....... 140 22.01 3,081 0.40 1,232
Heart Follow Up (1-5 Year)...... 140 90.61 12,685 0.90 11,417
Heart Follow Up (Post 5 Year)... 140 153.97 21,556 0.50 10,778
Heart Post-Transplant Malignancy 140 12.77 1,788 0.90 1,609
Form...........................
Lung Candidate Registration..... 71 45.21 3,210 0.90 2,889
Lung Recipient Registration..... 71 35.66 2,532 1.20 3,038
Lung Follow Up (6 Month)........ 71 32.35 2,297 0.50 1,148
Lung Follow Up (1-5 Year)....... 71 118.85 8,438 1.10 9,282
Lung Post-Transplant Malignancy 71 19.72 1,400 0.40 560
Form...........................
Heart/Lung Candidate 69 0.97 67 1.10 74
Registration...................
Heart/Lung Recipient 69 0.46 32 1.30 42
Registration...................
Heart/Lung Follow Up (6 Month).. 69 0.45 31 0.80 25
Heart/Lung Follow Up (1-5 Year). 69 1.14 79 1.10 87
Heart/Lung Follow Up (Post 5 69 3.30 228 0.60 137
Year)..........................
Heart/Lung Post-Transplant 69 0.30 21 0.40 8
Malignancy Form................
Liver Candidate Registration.... 146 90.29 13,182 0.80 10,546
Liver Recipient Registration.... 146 56.55 8,256 1.20 9,907
Liver Follow-up (6 Month-5 Year) 146 266.57 38,919 1.00 38,919
Liver Follow-up (Post 5 Year)... 146 316.61 46,225 0.50 23,113
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 Candidate Registration 20 6.95 139 1.30 181
Intestine Recipient Registration 20 5.20 104 1.80 187
Intestine Follow Up (6 Month-5 20 26.20 524 1.50 786
Year)..........................
Intestine Follow Up (Post 5 20 37.20 744 0.40 298
Year)..........................
Intestine Post-Transplant 20 2.10 42 1.00 42
Malignancy Form................
Kidney Candidate Registration... 237 168.77 39,998 0.80 31,998
Kidney Recipient Registration... 237 89.43 21,195 1.20 25,434
Kidney Follow-up (Post 5 Year).. 237 449.40 106,508 0.50 53,254
Kidney Post-Transplant 237 22.64 5,366 0.80 4,292
Malignancy Form................
Pancreas Candidate Registration. 133 2.77 368 0.60 221
Pancreas Recipient Registration. 133 1.46 194 1.20 233
Pancreas Follow-up (6 Month-5 133 7.87 1,047 0.50 524
Year)..........................
Pancreas Follow-up (Post 5 Year) 133 15.93 2,119 0.50 1,060
Pancreas Post-Transplant 133 0.73 97 0.60 58
Malignancy Form................
Kidney/Pancreas Candidate 133 9.75 1,297 0.60 778
Registration...................
Kidney/Pancreas Recipient 133 7.73 1,028 1.20 1,234
Registration...................
Kidney/Pancreas Follow-up (6 133 32.80 4,362 0.50 2,181
Month-5 Year)..................
Kidney/Pancreas Follow-up (Post 133 57.80 7,687 0.60 4,612
5 Year)........................
[[Page 1153]]
Kidney/Pancreas Post-Transplant 133 2.20 293 0.40 117
Malignancy Form................
VCA Candidate Registration...... 27 0.89 24 0.40 10
VCA Recipient Registration...... 27 1.59 43 1.30 \c\ 56
VCA Recipient Follow Up......... 27 0.67 18 1.00 \d\ 18
Organ Labeling and Packaging 57 208.25 11,870 0.18 2,137
System.........................
Organ Tracking and Validating 34 169.06 5,748 0.08 460
System.........................
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...............
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
Report.........................
Request to Unlock Form.......... 450 39.22 17,649 0.02 353
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Total....................... 8,290 .............. 604,519 .............. 430,267
----------------------------------------------------------------------------------------------------------------
* The Number of Reponses per Respondent was calculated by dividing the Total Responses by the Number of
Respondents and rounding to the nearest tenth.
\a\ \b\ \c\ \d\ Total burden hours in these forms decreased from estimates provided in the 60-day Notice due to
the removal of the proposed data collection changes associated with implementing the ``Modify Data Collection
on VCA Living Donors'' and ``Programming VCA Allocation in UNet'' policies.
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. 2022-00239 Filed 1-7-22; 8:45 am]
BILLING CODE 4165-15-P
