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-Extension, 324-325 [2019-28370]
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Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Notices
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—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for an 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 March 3, 2020.
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
SUMMARY:
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–Extension.
Abstract: Section 372 of the Public
Health Service (PHS) Act (42 U.S.C.
274) requires that the Secretary, by
contract, provide for the establishment
and operation of an Organ Procurement
and Transplantation Network (OPTN).
This is a request for an extension of the
current OPTN data collection forms
associated with an individual’s clinical
characteristics at the time of
registration, transplant, and follow-up
after the transplant. Data are collected
from transplant hospitals, organ
procurement organizations, and
histocompatibility laboratories. The
information is used to indicate the
disease severity of transplant
candidates, to monitor compliance of
member organizations with OPTN rules
and requirements, and to report
periodically on the clinical and
scientific status of organ donation and
transplantation in this country.
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,
Number of
respondents
jbell on DSKJLSW7X2PROD 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 Follow Up (Post 5 Year) .............................................
Lung Post-Transplant Malignancy Form ..............................
Heart/Lung Candidate Registration .....................................
Heart/Lung Recipient Registration .......................................
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17:29 Jan 02, 2020
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Frm 00028
Number of
responses per
respondent *
58
300
300
147
147
140
140
140
140
140
140
71
71
71
71
71
71
69
69
Fmt 4703
Sfmt 4703
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.
Burden hours have increased since
the last reporting period due to an
increase in the number of transplant
programs for some organs and the
overall increase in transplant surgeries
at existing programs as well. An
increased number of transplants results
in an increasing number of forms that
require completion while the amount of
time it takes to complete the forms
remains the same.
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.
Total Estimated Annualized Burden
Hours:
Total
responses
185.0
22.9
62.2
124.0
225.1
33.7
24.3
22.0
90.6
154.0
12.8
45.2
35.7
32.4
118.8
116.5
19.7
1.0
0.5
E:\FR\FM\03JAN1.SGM
10,731
6,855
18,669
18,226
33,090
4,717
3,406
3,082
12,686
21,556
1,788
3,210
2,532
2,297
8,438
8,271
1,400
67
32
03JAN1
Average
burden per
response
(in hours)
1.1
1.8
1.3
0.2
0.4
0.9
1.2
0.4
0.9
0.5
0.9
0.9
1.2
0.5
1.1
0.6
0.4
1.1
1.3
Total burden
hours
11,804.1
12,339.0
24,269.7
3,645.2
13,236.0
4,245.3
4,087.2
1,232.8
11,417.4
10,778.0
1,609.2
2,889.0
3,038.4
1,148.5
9,281.8
4,962.6
560.0
73.7
41.6
325
Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Notices
Number of
respondents
Form name
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 (6 Month–5 Year) ...................................
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) ..........................
Kidney/Pancreas Post-Transplant Malignancy Form ..........
VCA Candidate Registration ................................................
VCA Recipient Registration .................................................
VCA Recipient Follow Up ....................................................
69
69
69
69
146
146
146
146
146
146
20
20
20
20
20
237
237
237
237
237
133
133
133
133
133
133
133
133
133
133
27
27
27
Total ..............................................................................
6,204
Number of
responses per
respondent *
0.4
1.1
3.3
0.3
90.3
56.5
266.6
316.6
10.6
16.3
7.0
5.2
26.2
37.2
2.1
168.8
89.4
431.9
449.4
22.6
2.8
1.5
7.9
15.9
0.7
9.8
7.7
32.8
57.8
2.2
0.9
1.6
0.7
Total
responses
31
79
228
21
13,183
8,256
38,919
46,225
1,544
2,387
139
104
524
744
42
39,998
21,195
102,350
106,507
5,365
368
194
1,047
2,119
97
1,297
1,028
4,363
7,688
292
24
43
18
567,472
Average
burden per
response
(in hours)
0.8
1.1
0.6
0.4
0.8
1.2
1.0
0.5
0.6
0.8
1.3
1.8
1.5
0.4
1.0
0.8
1.2
0.9
0.5
0.8
0.6
1.2
0.5
0.5
0.6
0.6
1.2
0.5
0.6
0.4
0.4
1.3
1.0
Total burden
hours
24.8
86.9
136.8
8.4
10,546.4
9,907.2
38,919.0
23,112.5
926.4
1,909.6
180.7
187.2
786.0
297.6
42.0
31,998.4
25,434.0
92,115.0
53,253.5
4,292.0
220.8
232.8
523.5
1,059.5
58.2
778.2
1,233.6
2,181.5
4,612.8
116.8
9.6
55.9
18.0
425,925.1
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to
the nearest tenth.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
AGENCY:
[FR Doc. 2019–28370 Filed 1–2–20; 8:45 am]
BILLING CODE 4165–15–P
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The National
Health Service Corps and Nurse Corps
Interest Capture Form OMB No. 0915–
0337—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:29 Jan 02, 2020
Jkt 250001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 3, 2020.
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:
The National Health Service Corps and
Nurse Corps Interest Capture Form OMB
No. 0915–0337—Extension
Abstract: The National Health Service
Corps (NHSC) and the Nurse Corps of
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 324-325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28370]
[[Page 324]]
-----------------------------------------------------------------------
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--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for an 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 March 3,
2020.
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-Extension.
Abstract: Section 372 of the Public Health Service (PHS) Act (42
U.S.C. 274) requires that the Secretary, by contract, provide for the
establishment and operation of an Organ Procurement and Transplantation
Network (OPTN). This is a request for an extension of the current OPTN
data collection forms associated with an individual's clinical
characteristics at the time of registration, transplant, and follow-up
after the transplant. Data are collected from transplant hospitals,
organ procurement organizations, and histocompatibility laboratories.
The information is used to indicate the disease severity of transplant
candidates, to monitor compliance of member organizations with OPTN
rules and requirements, and to report periodically on the clinical and
scientific status of organ donation and transplantation in this
country.
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.
Burden hours have increased since the last reporting period due to
an increase in the number of transplant programs for some organs and
the overall increase in transplant surgeries at existing programs as
well. An increased number of transplants results in an increasing
number of forms that require completion while the amount of time it
takes to complete the forms remains the same.
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.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent * hours)
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration..... 58 185.0 10,731 1.1 11,804.1
Living Donor Registration....... 300 22.9 6,855 1.8 12,339.0
Living Donor Follow Up.......... 300 62.2 18,669 1.3 24,269.7
Donor Histocompatibility........ 147 124.0 18,226 0.2 3,645.2
Recipient Histocompatibility.... 147 225.1 33,090 0.4 13,236.0
Heart Candidate Registration.... 140 33.7 4,717 0.9 4,245.3
Heart Recipient Registration.... 140 24.3 3,406 1.2 4,087.2
Heart Follow Up (6 Month)....... 140 22.0 3,082 0.4 1,232.8
Heart Follow Up (1-5 Year)...... 140 90.6 12,686 0.9 11,417.4
Heart Follow Up (Post 5 Year)... 140 154.0 21,556 0.5 10,778.0
Heart Post-Transplant Malignancy 140 12.8 1,788 0.9 1,609.2
Form...........................
Lung Candidate Registration..... 71 45.2 3,210 0.9 2,889.0
Lung Recipient Registration..... 71 35.7 2,532 1.2 3,038.4
Lung Follow Up (6 Month)........ 71 32.4 2,297 0.5 1,148.5
Lung Follow Up (1-5 Year)....... 71 118.8 8,438 1.1 9,281.8
Lung Follow Up (Post 5 Year).... 71 116.5 8,271 0.6 4,962.6
Lung Post-Transplant Malignancy 71 19.7 1,400 0.4 560.0
Form...........................
Heart/Lung Candidate 69 1.0 67 1.1 73.7
Registration...................
Heart/Lung Recipient 69 0.5 32 1.3 41.6
Registration...................
[[Page 325]]
Heart/Lung Follow Up (6 Month).. 69 0.4 31 0.8 24.8
Heart/Lung Follow Up (1-5 Year). 69 1.1 79 1.1 86.9
Heart/Lung Follow Up (Post 5 69 3.3 228 0.6 136.8
Year)..........................
Heart/Lung Post-Transplant 69 0.3 21 0.4 8.4
Malignancy Form................
Liver Candidate Registration.... 146 90.3 13,183 0.8 10,546.4
Liver Recipient Registration.... 146 56.5 8,256 1.2 9,907.2
Liver Follow-up (6 Month-5 Year) 146 266.6 38,919 1.0 38,919.0
Liver Follow-up (Post 5 Year)... 146 316.6 46,225 0.5 23,112.5
Liver Recipient Explant 146 10.6 1,544 0.6 926.4
Pathology Form.................
Liver Post-Transplant Malignancy 146 16.3 2,387 0.8 1,909.6
Intestine Candidate Registration 20 7.0 139 1.3 180.7
Intestine Recipient Registration 20 5.2 104 1.8 187.2
Intestine Follow Up (6 Month-5 20 26.2 524 1.5 786.0
Year)..........................
Intestine Follow Up (Post 5 20 37.2 744 0.4 297.6
Year)..........................
Intestine Post-Transplant 20 2.1 42 1.0 42.0
Malignancy Form................
Kidney Candidate Registration... 237 168.8 39,998 0.8 31,998.4
Kidney Recipient Registration... 237 89.4 21,195 1.2 25,434.0
Kidney Follow-Up (6 Month-5 237 431.9 102,350 0.9 92,115.0
Year)..........................
Kidney Follow-up (Post 5 Year).. 237 449.4 106,507 0.5 53,253.5
Kidney Post-Transplant 237 22.6 5,365 0.8 4,292.0
Malignancy Form................
Pancreas Candidate Registration. 133 2.8 368 0.6 220.8
Pancreas Recipient Registration. 133 1.5 194 1.2 232.8
Pancreas Follow-up (6 Month-5 133 7.9 1,047 0.5 523.5
Year)..........................
Pancreas Follow-up (Post 5 Year) 133 15.9 2,119 0.5 1,059.5
Pancreas Post-Transplant 133 0.7 97 0.6 58.2
Malignancy Form................
Kidney/Pancreas Candidate 133 9.8 1,297 0.6 778.2
Registration...................
Kidney/Pancreas Recipient 133 7.7 1,028 1.2 1,233.6
Registration...................
Kidney/Pancreas Follow-up (6 133 32.8 4,363 0.5 2,181.5
Month-5 Year)..................
Kidney/Pancreas Follow-up (Post 133 57.8 7,688 0.6 4,612.8
5 Year)........................
Kidney/Pancreas Post-Transplant 133 2.2 292 0.4 116.8
Malignancy Form................
VCA Candidate Registration...... 27 0.9 24 0.4 9.6
VCA Recipient Registration...... 27 1.6 43 1.3 55.9
VCA Recipient Follow Up......... 27 0.7 18 1.0 18.0
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... 6,204 .............. 567,472 .............. 425,925.1
----------------------------------------------------------------------------------------------------------------
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
Respondents and rounding to the nearest tenth.
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. 2019-28370 Filed 1-2-20; 8:45 am]
BILLING CODE 4165-15-P
