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

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Published

August 31, 2021

Issuing agencies

Health and Human Services DepartmentHealth Resources and Services Administration

Abstract

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.

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<title>Federal Register, Volume 86 Issue 166 (Tuesday, August 31, 2021)</title>
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[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48743-48745]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18688]

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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.

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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 <a href="/cdn-cgi/l/email-protection#afdfcedfcaddd8c0ddc4efc7dddcce81c8c0d9"><span class="__cf_email__" data-cfemail="4f3f2e3f2a3d38203d240f273d3c2e61282039">[email&#160;protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#fd8d9c8d988f8a928f96bd958f8e9cd39a928b"><span class="__cf_email__" data-cfemail="0c7c6d7c697e7b637e674c647e7f6d226b637a">[email&#160;protected]</span></a> 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
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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
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* 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

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