Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157, Revision, 18001-18002 [2017-07526]
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18001
Federal Register / Vol. 82, No. 71 / Friday, April 14, 2017 / 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; Information Collection
Request Title: Data System for Organ
Procurement and Transplantation
Network, OMB No. 0915–0157,
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice
AGENCY:
In compliance with the
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.
DATES: Comments on this ICR should be
received no later than May 15, 2017.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Data System for Organ Procurement and
Transplantation Network.
OMB No. 0915–0157—Revision
SUMMARY:
Abstract: Section 372 of the Public
Health Service (PHS) Act 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
revisions to a subset of the current
OPTN data collection forms associated
with donor organ procurement and an
individual’s clinical characteristics at
the time of registration, transplant, and
follow-up after transplant.
Need and Proposed Use of the
Information: Data for the OPTN data
system are collected from transplant
hospitals, organ procurement
organizations, and tissue-typing
laboratories. The information is used to
facilitate organ placement and match
donor organs with recipients, monitor
compliance of member organizations
with Federal laws and regulations and
with OPTN requirements, review and
report periodically to the public on the
status of organ donation and
transplantation in the United States,
provide data to researchers and
government agencies to study the
scientific and clinical status of organ
transplantation, and perform
transplantation-related public health
surveillance including possible
transmission of donor disease. This
request revises a subset of the current
OPTN data forms associated with donor
organ procurement and an individual’s
clinical characteristics at the time of
registration, transplant, and follow up.
In 2015, the OPTN Board of Directors
approved policies that necessitate the
addition of new data elements to
registration forms for heart, lung, heart/
lung, liver, intestine, kidney, pancreas,
and kidney/pancreas recipients. The
OPTN also approved policies that
impact the data collection for deceased
donor registration, pancreas candidate
registration, kidney/pancreas candidate
registration, pancreas follow-up, and
kidney/pancreas follow-up forms. The
policy modifications necessitate
changes to 17 of the 52 forms contained
in this data collection. For example, the
pancreas and kidney/pancreas
transplant recipient registration and
follow up forms were modified to be
consistent with an OPTN policy change
pertaining to data collected from
pancreas programs for pancreas graft
failure. Specifically, the ‘‘graft status’’
section of the pancreas forms was
updated to be consistent with a new
policy that helps transplant
professionals identify when pancreas
allograft failure has occurred and how to
document the pancreas graft failure
event. In addition, ‘‘drop down’’ menus
were added to facilitate reporting of
toxoplasma serology results and
infectious diseases, consistent with
revised scope of policy requirements for
infectious disease testing and reporting.
Finally, a policy modification to
improve collection of information on
lungs perfused prior to transplant
resulted in the creation of easy-tocomplete data fields on lung and heart/
lung recipient registration forms. The
modified forms allow transplant centers
to easily provide information on lung
perfusion, which contributes to
improved accuracy in monitoring of
lung allocation, recipient safety, and
organ and patient outcomes.
Likely Respondents: Transplant
programs, organ procurement
organizations, histocompatibility
laboratories, medical and scientific
organizations, and public organizations.
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
burden will decrease by approximately
3,500 hours.
sradovich on DSK3GMQ082PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Deceased Donor Registration ..............................................
Living Donor Registration ....................................................
Living Donor Follow-Up .......................................................
Donor Histocompatibility ......................................................
Recipient Histocompatibility .................................................
Heart Candidate Registration ..............................................
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Number of
responses per
respondent *
58
304
304
152
152
137
Fmt 4703
Sfmt 4703
Total
responses
176.9
19.5
58.2
102.7
183.0
32.4
E:\FR\FM\14APN1.SGM
10,262
5,936
17,686
15,611
27,810
4,439
14APN1
Average
burden per
response
(in hours)
1.1
1.8
1.3
0.2
0.4
0.9
Total burden
hours
11,288.2
10,684.8
22,991.8
3,122.2
11,124.0
3,995.1
18002
Federal Register / Vol. 82, No. 71 / Friday, April 14, 2017 / 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
Heart Recipient Registration ................................................
Heart Follow-Up (6 Months) ................................................
Heart Follow-Up (1–5 Years) ...............................................
Heart Follow-Up (Post 5 Years) ..........................................
Heart Post-Transplant Malignancy ......................................
Lung Candidate Registration ...............................................
Lung Recipient Registration .................................................
Lung Follow-Up (6 Months) .................................................
Lung Follow-Up (1–5 Years) ................................................
Lung Follow-Up (Post 5 Years) ...........................................
Lung Post-Transplant Malignancy .......................................
Heart/Lung Candidate Registration .....................................
Heart/Lung Recipient Registration .......................................
Heart/Lung Follow-Up (6 Months) .......................................
Heart/Lung Follow-Up (1–5 Years) ......................................
Heart/Lung Follow-Up (Post 5 Years) .................................
Heart/Lung Post-Transplant Malignancy .............................
Liver Candidate Registration ...............................................
Liver Recipient Registration .................................................
Liver Follow-Up (6 Months–5 Years) ...................................
Liver Follow-Up (Post 5 Years) ...........................................
Liver Recipient Explant Pathology .......................................
Liver Post-Transplant Malignancy .......................................
Intestine Candidate Registration ..........................................
Intestine Recipient Registration ...........................................
Intestine Follow-Up (6 Months–5 Years) .............................
Intestine Follow-Up (Post 5 Years) ......................................
Intestine Post-Transplant Malignancy ..................................
Kidney Candidate Registration ............................................
Kidney Recipient Registration ..............................................
Kidney Follow-Up (6 Months–5 Years) ................................
Kidney Follow-Up (Post 5 Years) ........................................
Kidney Post-Transplant Malignancy ....................................
Pancreas Candidate Registration ........................................
Pancreas Recipient Registration .........................................
Pancreas Follow-Up (6 Months–5 Years) ...........................
Pancreas Follow-Up (Post 5 Years) ....................................
Pancreas Post-Transplant Malignancy ................................
Kidney/Pancreas Candidate Registration ............................
Kidney/Pancreas Recipient Registration .............................
Kidney/Pancreas Follow-Up (6 Months–5 Years) ...............
Kidney/Pancreas Follow-Up (Post 5 Years) ........................
Kidney/Pancreas Post-Transplant Malignancy Form ..........
VCA Candidate Registration ................................................
VCA Recipient Registration .................................................
VCA Recipient Follow-Up ....................................................
137
137
137
137
137
70
70
70
70
70
70
68
68
68
68
68
68
140
140
140
140
140
140
40
40
40
40
40
238
238
238
238
238
133
133
133
133
133
133
133
133
133
133
28
28
28
20.5
16.5
77.3
117.4
11.8
37.0
29.4
25.8
99.1
70.0
15.8
0.7
0.2
0.2
1.4
2.9
0.3
85.9
50.9
235.6
279.3
12.9
14.2
5.0
3.5
13.3
16.4
0.6
151.6
75.2
383.3
375.9
22.4
2.9
1.8
9.4
14.7
0.9
9.5
5.4
32.0
51.7
2.1
1.8
1.8
1.8
2.805
2,261
10,595
16,085
1,623
2,592
2,058
1,809
6,939
4,898
1,106
46
14
13
94
199
21
12,026
7,125
32,985
39,108
1,812
1,985
200
141
530
655
24
36,076
17,899
91,234
89,453
5,327
389
233
1,252
1,953
120
1,265
718
4,262
6,876
283
49
49
49
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
0.8
1.1
0.6
0.4
0.8
1.2
1
0.5
0.6
0.8
1.3
1.8
1.5
0.4
1
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
3,366.0
904.4
9,535.5
8,042.5
1,460.7
2,332.8
2,469.6
904.5
7,632.9
2,938.8
442.4
50.6
18.2
10.4
103.4
119.4
8.4
9,620.8
8,550.0
32,985.0
19,554.0
1,087.2
1,588.0
260.0
253.8
795.0
262.0
24.0
28,860.8
21,478.8
82,110.6
44,726.5
4,261.6
233.4
279.6
626.0
976.5
72.0
759.0
861.6
2,131.0
4,125.6
113.2
19.6
63.7
49.0
Total ..............................................................................
** 463
........................
488,980
........................
370,274.9
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to
the nearest tenth.
** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate or recipient forms based on
the organ-specific programs associated with each form.
Amy McNulty,
Deputy Director, Division of the Executive
Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–07526 Filed 4–13–17; 8:45 am]
[Docket Number CDC–2016–0121; NIOSH–
285]
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4165–15–P
Closed-Circuit Escape Respirators;
Final Guidance for Industry;
Availability
Centers for Disease Control and
Prevention, HHS.
ACTION: Notice of availability.
AGENCY:
VerDate Sep<11>2014
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On December 28, 2016, the
National Institute for Occupational
Safety and Health (NIOSH), within the
Centers for Disease Control and
Prevention, Department of Health and
Human Services, published a notice in
the Federal Register announcing the
availability of an interim guidance
document addressing the availability of
closed-circuit escape respirators
(CCERs) for purchase, and the readiness
of respirator manufacturers to comply
with the regulatory provisions
SUMMARY:
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 82, Number 71 (Friday, April 14, 2017)]
[Notices]
[Pages 18001-18002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07526]
[[Page 18001]]
-----------------------------------------------------------------------
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; Information Collection
Request Title: Data System for Organ Procurement and Transplantation
Network, OMB No. 0915-0157, Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice
-----------------------------------------------------------------------
SUMMARY: In compliance with the 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.
DATES: Comments on this ICR should be received no later than May 15,
2017.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference, in compliance with Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995.
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 (PHS) Act
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 revisions to a subset of the current OPTN
data collection forms associated with donor organ procurement and an
individual's clinical characteristics at the time of registration,
transplant, and follow-up after transplant.
Need and Proposed Use of the Information: Data for the OPTN data
system are collected from transplant hospitals, organ procurement
organizations, and tissue-typing laboratories. The information is used
to facilitate organ placement and match donor organs with recipients,
monitor compliance of member organizations with Federal laws and
regulations and with OPTN requirements, review and report periodically
to the public on the status of organ donation and transplantation in
the United States, provide data to researchers and government agencies
to study the scientific and clinical status of organ transplantation,
and perform transplantation-related public health surveillance
including possible transmission of donor disease. This request revises
a subset of the current OPTN data forms associated with donor organ
procurement and an individual's clinical characteristics at the time of
registration, transplant, and follow up.
In 2015, the OPTN Board of Directors approved policies that
necessitate the addition of new data elements to registration forms for
heart, lung, heart/lung, liver, intestine, kidney, pancreas, and
kidney/pancreas recipients. The OPTN also approved policies that impact
the data collection for deceased donor registration, pancreas candidate
registration, kidney/pancreas candidate registration, pancreas follow-
up, and kidney/pancreas follow-up forms. The policy modifications
necessitate changes to 17 of the 52 forms contained in this data
collection. For example, the pancreas and kidney/pancreas transplant
recipient registration and follow up forms were modified to be
consistent with an OPTN policy change pertaining to data collected from
pancreas programs for pancreas graft failure. Specifically, the ``graft
status'' section of the pancreas forms was updated to be consistent
with a new policy that helps transplant professionals identify when
pancreas allograft failure has occurred and how to document the
pancreas graft failure event. In addition, ``drop down'' menus were
added to facilitate reporting of toxoplasma serology results and
infectious diseases, consistent with revised scope of policy
requirements for infectious disease testing and reporting. Finally, a
policy modification to improve collection of information on lungs
perfused prior to transplant resulted in the creation of easy-to-
complete data fields on lung and heart/lung recipient registration
forms. The modified forms allow transplant centers to easily provide
information on lung perfusion, which contributes to improved accuracy
in monitoring of lung allocation, recipient safety, and organ and
patient outcomes.
Likely Respondents: Transplant programs, organ procurement
organizations, histocompatibility laboratories, medical and scientific
organizations, and public organizations.
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 burden will decrease by
approximately 3,500 hours.
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..... 58 176.9 10,262 1.1 11,288.2
Living Donor Registration....... 304 19.5 5,936 1.8 10,684.8
Living Donor Follow-Up.......... 304 58.2 17,686 1.3 22,991.8
Donor Histocompatibility........ 152 102.7 15,611 0.2 3,122.2
Recipient Histocompatibility.... 152 183.0 27,810 0.4 11,124.0
Heart Candidate Registration.... 137 32.4 4,439 0.9 3,995.1
[[Page 18002]]
Heart Recipient Registration.... 137 20.5 2.805 1.2 3,366.0
Heart Follow-Up (6 Months)...... 137 16.5 2,261 0.4 904.4
Heart Follow-Up (1-5 Years)..... 137 77.3 10,595 0.9 9,535.5
Heart Follow-Up (Post 5 Years).. 137 117.4 16,085 0.5 8,042.5
Heart Post-Transplant Malignancy 137 11.8 1,623 0.9 1,460.7
Lung Candidate Registration..... 70 37.0 2,592 0.9 2,332.8
Lung Recipient Registration..... 70 29.4 2,058 1.2 2,469.6
Lung Follow-Up (6 Months)....... 70 25.8 1,809 0.5 904.5
Lung Follow-Up (1-5 Years)...... 70 99.1 6,939 1.1 7,632.9
Lung Follow-Up (Post 5 Years)... 70 70.0 4,898 0.6 2,938.8
Lung Post-Transplant Malignancy. 70 15.8 1,106 0.4 442.4
Heart/Lung Candidate 68 0.7 46 1.1 50.6
Registration...................
Heart/Lung Recipient 68 0.2 14 1.3 18.2
Registration...................
Heart/Lung Follow-Up (6 Months). 68 0.2 13 0.8 10.4
Heart/Lung Follow-Up (1-5 Years) 68 1.4 94 1.1 103.4
Heart/Lung Follow-Up (Post 5 68 2.9 199 0.6 119.4
Years).........................
Heart/Lung Post-Transplant 68 0.3 21 0.4 8.4
Malignancy.....................
Liver Candidate Registration.... 140 85.9 12,026 0.8 9,620.8
Liver Recipient Registration.... 140 50.9 7,125 1.2 8,550.0
Liver Follow-Up (6 Months-5 140 235.6 32,985 1 32,985.0
Years).........................
Liver Follow-Up (Post 5 Years).. 140 279.3 39,108 0.5 19,554.0
Liver Recipient Explant 140 12.9 1,812 0.6 1,087.2
Pathology......................
Liver Post-Transplant Malignancy 140 14.2 1,985 0.8 1,588.0
Intestine Candidate Registration 40 5.0 200 1.3 260.0
Intestine Recipient Registration 40 3.5 141 1.8 253.8
Intestine Follow-Up (6 Months-5 40 13.3 530 1.5 795.0
Years).........................
Intestine Follow-Up (Post 5 40 16.4 655 0.4 262.0
Years).........................
Intestine Post-Transplant 40 0.6 24 1 24.0
Malignancy.....................
Kidney Candidate Registration... 238 151.6 36,076 0.8 28,860.8
Kidney Recipient Registration... 238 75.2 17,899 1.2 21,478.8
Kidney Follow-Up (6 Months-5 238 383.3 91,234 0.9 82,110.6
Years).........................
Kidney Follow-Up (Post 5 Years). 238 375.9 89,453 0.5 44,726.5
Kidney Post-Transplant 238 22.4 5,327 0.8 4,261.6
Malignancy.....................
Pancreas Candidate Registration. 133 2.9 389 0.6 233.4
Pancreas Recipient Registration. 133 1.8 233 1.2 279.6
Pancreas Follow-Up (6 Months-5 133 9.4 1,252 0.5 626.0
Years).........................
Pancreas Follow-Up (Post 5 133 14.7 1,953 0.5 976.5
Years).........................
Pancreas Post-Transplant 133 0.9 120 0.6 72.0
Malignancy.....................
Kidney/Pancreas Candidate 133 9.5 1,265 0.6 759.0
Registration...................
Kidney/Pancreas Recipient 133 5.4 718 1.2 861.6
Registration...................
Kidney/Pancreas Follow-Up (6 133 32.0 4,262 0.5 2,131.0
Months-5 Years)................
Kidney/Pancreas Follow-Up (Post 133 51.7 6,876 0.6 4,125.6
5 Years).......................
Kidney/Pancreas Post-Transplant 133 2.1 283 0.4 113.2
Malignancy Form................
VCA Candidate Registration...... 28 1.8 49 0.4 19.6
VCA Recipient Registration...... 28 1.8 49 1.3 63.7
VCA Recipient Follow-Up......... 28 1.8 49 1 49.0
-------------------------------------------------------------------------------
Total....................... ** 463 .............. 488,980 .............. 370,274.9
----------------------------------------------------------------------------------------------------------------
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
Respondents and rounding to the nearest tenth.
** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate
or recipient forms based on the organ-specific programs associated with each form.
Amy McNulty,
Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2017-07526 Filed 4-13-17; 8:45 am]
BILLING CODE 4165-15-P
