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

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published

September 29, 2022

Issuing agencies

Health and Human Services DepartmentHealth Resources and Services Administration

Abstract

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 public regarding the burden estimate, below, or any other aspect of the ICR.

Full Text

<html>
<head>
<title>Federal Register, Volume 87 Issue 188 (Thursday, September 29, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59103-59105]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21119]

-----------------------------------------------------------------------

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 (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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
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
28, 2022.

ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#502031203522273f223b10382223317e373f26"><span class="__cf_email__" data-cfemail="90e0f1e0f5e2e7ffe2fbd0f8e2e3f1bef7ffe6">[email&#160;protected]</span></a> or by mail to 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#3f4f5e4f5a4d48504d547f574d4c5e11585049"><span class="__cf_email__" data-cfemail="e696879683949189948da68e949587c8818990">[email&#160;protected]</span></a> or call Samantha Miller,
the HRSA Information Collection Clearance Officer at (301) 443-9094.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Data System for Organ
Procurement and Transplantation Network (OPTN), OMB No. 0915-0157--
Revision.
Abstract: Section 372 of the Public Health Service Act requires
that the Secretary of HHS, by contract, provide for the establishment
and operation of a private, non-profit entity the OPTN, which on behalf
of HRSA, oversees the U.S. donation and transplantation system. The
OPTN Board of Directors (BOD) determines what data must be collected to
appropriately fulfill their responsibilities pursuant to their
regulatory authority in 42 CFR 121.11 of the OPTN Final Rule. HRSA, on
behalf of the OPTN BOD and in alignment with the Paperwork Reduction
Act of 1995, submits OPTN BOD-approved data elements for collection to
OMB for official federal approval.
Need and Proposed Use of the Information: HRSA and the OPTN BOD use
data 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. In addition, the
regulatory authority in 42 CFR 121.11 of the OPTN Final Rule requires
the OPTN data to be made available, consistent with applicable laws,
for use by OPTN members, the Scientific Registry of Transplant
Recipients, HHS, 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 which
includes time-sensitive, life-critical data on transplant candidates
and donors, the organ matching process, histocompatibility results,
organ labeling and packaging, and pre- and post-transplantation data on
recipients and donors. This revision also includes OPTN BOD-approved
changes to the existing OMB data collection forms. The OPTN collects
these specific data elements from transplant hospitals, organ
procurement organizations, and histocompatibility laboratories. The
OPTN uses this information 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, and (5)
perform transplantation-related public health surveillance including
the possible transmission of donor disease.
HRSA is requesting to make the following OPTN BOD-approved changes
to improve the OPTN organ matching and allocation process and improve
OPTN member compliance with OPTN requirements:

(1) Adding data collection forms from the OPTN donor management
and organ matching system to the existing OMB-approved information
collection. The system allows an organ procurement organization to
add donors, run the donor/potential transplant recipients matches,
and place a donated organ(s) with a computer-matched potential
transplant recipient. Transplant centers will access the system to
view posted donor information to assist them with accepting
decisions, along with other donor/potential transplant recipient
functions such as entering offer responses and verifying organ offer
refusals. The OPTN donor management and organ matching system is
comprised of eight data collection forms:

[[Page 59104]]

initial donor registration, organ procurement organization
notification limit administration, potential transplant recipient,
death notification registration, deceased donor death referral,
donor hospital registration, donor organ disposition, and transplant
center contact management.
(2) The OPTN BOD-approved additional revisions to existing data
collection forms to improve organ matching, allocation, and OPTN
policy compliance.
(3) Existing OPTN data collection forms that collect a single
race and ethnicity variable will be revised to collect separate race
and ethnicity variables, following the minimum standards for
collecting and presenting data on race and ethnicity for all federal
reporting found within Revisions of Standards for the Classification
of Federal Data on Race and Ethnicity, OMB Statistical Policy
Directive No. 15 in Federal Register, 62 FR 58782 (Oct. 30, 1997).
Improving data collection around race and ethnicity information of
donors and candidates aligns with Executive Order 13985, which calls
on agencies to advance equity through identifying and addressing
barriers to equal opportunity that underserved communities may face
due to government policies and programs.

Likely Respondents: Transplant programs, organ procurement
organizations (OPO), 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 estimated total estimated burden hours for this collection
increased by 213,662 hours from the currently approved ICR package.
This increase is due to the addition of eight collection forms from the
OPTN donor management and organ matching system to this data collection
package, specifically the burden increase from the Potential Transplant
Recipient form. While the data fields collected on the Potential
Transplant Recipient form are limited, the volume of organ offer
responses is significant due to the large number of potential
transplant recipients shown on the organ match run results. The organ
match run results produce thousands of potential transplant recipients
that require responses from OPOs and transplant hospitals. This volume
of candidates significantly impacts the total burden hours for this
form.
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..... 57 243.560 13,883 1.09 15,132
Living Donor Registration....... 216 28.106 6,071 2.19 13,295
Living Donor Follow-up.......... 216 90.550 19,559 1.52 29,730
Donor Histocompatibility........ 141 149.184 21,035 0.20 4,207
Recipient Histocompatibility.... 141 264.950 37,358 0.40 14,943
Heart Transplant Candidate 145 34.586 5,015 0.90 4,514
Registration...................
Heart Transplant Recipient 145 26.324 3,817 1.40 5,344
Registration...................
Heart Transplant Recipient 145 24.400 3,538 0.40 1,415
Follow-Up (6 Months)...........
Heart Transplant Recipient 145 104.140 15,100 0.90 13,590
Follow-Up (1-5 Years)..........
Heart Transplant Recipient 145 171.100 24,810 0.50 12,405
Follow-Up (Post 5 Year)........
Heart Post-Transplant Malignancy 145 13.170 1,910 0.90 1,719
Form...........................
Lung Transplant Candidate 72 42.970 3,094 0.90 2,785
Registration...................
Lung Transplant Recipient 72 35.010 2,521 1.20 3,025
Registration...................
Lung Transplant Recipient Follow- 72 33.630 2,421 0.50 1,211
Up (6 Months)..................
Lung Transplant Recipient Follow- 72 139.940 10,076 1.10 11,084
Up (1-5 Years).................
Lung Transplant Recipient Follow- 72 136.280 9,812 0.60 5,887
Up (Post 5 Year)...............
Lung Post-Transplant Malignancy 72 22.630 1,629 0.40 652
Form...........................
Heart/Lung Transplant Candidate 70 0.960 67 1.10 74
Registration...................
Heart/Lung Transplant Recipient 70 0.640 45 1.30 59
Registration...................
Heart/Lung Transplant Recipient 70 0.600 42 0.80 34
Follow-Up (6 Months)...........
Heart/Lung Transplant Recipient 70 2.100 147 1.10 162
Follow-Up (1-5 Years)..........
Heart/Lung Transplant Recipient 70 3.360 235 0.60 141
Follow-Up (Post 5 Year)........
Heart/Lung Post-Transplant 70 0.290 20 0.40 8
Malignancy Form................
Liver Transplant Candidate 143 96.920 13,860 0.80 11,088
Registration...................
Liver Transplant Recipient 143 64.580 9,235 1.20 11,082
Registration...................
Liver Transplant Recipient 143 320.266 45,798 1.00 45,798
Follow-Up (6 Month-5 Year).....
Liver Transplant Recipient 143 384.320 54,958 0.50 27,479
Follow-Up (Post 5 Year)........
Liver Recipient Explant 143 7.300 1,044 0.60 626
Pathology Form.................
Liver Post-Transplant Malignancy 143 19.060 2,726 0.80 2,181
Intestine Transplant Candidate 21 6.860 144 1.30 187
Registration...................
Intestine Transplant Recipient 21 4.570 96 1.80 173
Registration...................
Intestine Transplant Recipient 21 20.050 421 1.50 632
Follow-Up (6 Month-5 Year).....
Intestine Transplant Recipient 21 40.190 844 0.40 338
Follow-Up (Post 5 Year)........
Intestine Post-Transplant 21 0.620 13 1.00 13
Malignancy Form................
Kidney Transplant Candidate 234 177.000 41,418 0.80 33,134
Registration...................
Kidney Transplant Recipient 234 105.397 24,663 1.20 29,596
Registration...................
Kidney Transplant Recipient 234 517.124 121,007 0.90 108,906
Follow-Up (6 Month-5 Year).....
Kidney Transplant Recipient 234 525.103 122,874 0.50 61,437
Follow-Up (Post 5 Year)........
Kidney Post-Transplant 234 24.474 5,727 0.80 4,582
Malignancy Form................
Pancreas Transplant Candidate 120 2.650 318 0.60 191
Registration...................
Pancreas Transplant Recipient 120 1.190 143 1.20 172
Registration...................

[[Page 59105]]

Pancreas Transplant Recipient 120 6.680 802 0.50 401
Follow-Up (6 Month-5 Year).....
Pancreas Transplant Recipient 120 17.820 2138 0.50 1,069
Follow-Up (Post 5 Year)........
Pancreas Post-Transplant 120 1.060 127 0.60 76
Malignancy Form................
Kidney/Pancreas Transplant 120 12.450 1,494 0.60 896
Candidate Registration.........
Kidney/Pancreas Transplant 120 6.840 821 1.20 985
Recipient Registration.........
Kidney/Pancreas Transplant 120 39.440 4,733 0.50 2,367
Recipient Follow-Up (6 Month-5
Year)..........................
Kidney/Pancreas Transplant 120 69.410 8,329 0.60 4,997
Recipient Follow-Up (Post 5
Year)..........................
Kidney/Pancreas Post-Transplant 120 2.490 299 0.40 120
Malignancy Form................
VCA Transplant Candidate 21 0.330 7 0.40 3
Registration...................
VCA Transplant Recipient 21 0.190 4 1.36 5
Registration...................
VCA Transplant Recipient Follow 21 1.000 21 1.31 28
Up.............................
Organ Labeling and Packaging.... 57 247.720 14,120 0.18 2,542
Organ Tracking and Validating... 308 19.487 6,002 0.08 480
Kidney Paired Donation Candidate 159 1.200 191 0.29 55
Registration...................
Kidney Paired Donation Donor 159 1.560 248 1.08 268
Registration...................
Kidney Paired Donation Match 159 1.520 242 0.67 162
Offer Management...............
Disease Transmission Event...... 308 1.810 557 0.62 345
Living Donor Event.............. 251 0.155 39 0.56 22
Safety Situation................ 449 0.600 269 0.56 151
Potential Disease Transmission.. 57 8.720 497 1.27 631
Request to Unlock Form.......... 449 42.399 19,037 0.02 381
Initial Donor Registration...... 57 335.720 19,136 3.00 57,408
OPO Notification Limit 57 0.490 28 0.17 5
Administration.................
Potential Transplant Recipient.. 308 4,718.480 1,453,292 0.05 72,665
Death Notification Registration. 57 185.770 10,589 0.42 4,447
Deceased Donor Death Referral... 57 53.840 3,069 0.50 1,535
Donor Hospital Registration..... 57 0.040 2 0.08 0
Donor Organ Disposition......... 57 335.720 19,136 0.17 3,253
Transplant Center Contact 251 637.500 160,013 0.06 9,601
Management.....................
-------------------------------------------------------------------------------
Total = 70 forms............ 9,146 .............. 2,352,736 .............. 643,929
----------------------------------------------------------------------------------------------------------------
* The numbers of respondents and the numbers of total responses in the burden table were updated with 2021 OPTN
data and reflect increases in the number of organ transplants and changes in the number of respondents
(Transplant Hospitals, OPO, and Histocompatibility Labs).

HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's and the OPTN'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. 2022-21119 Filed 9-28-22; 8:45 am]
BILLING CODE 4165-15-P

</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on September 29, 2022.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.