Notice2024-25522
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Process Data for Organ Procurement and Transplantation Network
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
November 4, 2024
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 and any other aspect of the ICR.
Full Text
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<title>Federal Register, Volume 89 Issue 213 (Monday, November 4, 2024)</title>
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[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87592-87593]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-25522]
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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: Process
Data for Organ Procurement and Transplantation Network
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
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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 and any other aspect of the ICR.
DATES: Comments on this ICR should be received no later than January 3,
2025.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#1666776673646179647d567e64657738717960"><span class="__cf_email__" data-cfemail="186879687d6a6f776a7358706a6b79367f776e">[email protected]</span></a> or by mail to the
HRSA Information Collection Clearance Officer, Room 14NWH04, 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#ef9f8e9f8a9d98809d84af879d9c8ec1888099"><span class="__cf_email__" data-cfemail="92e2f3e2f7e0e5fde0f9d2fae0e1f3bcf5fde4">[email protected]</span></a> or call Joella Roland, the
HRSA Information Collection Clearance Officer at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Process Data for Organ
Procurement and Transplantation Network, OMB No. 0906-xxxx--New.
Abstract: Section 372 of the Public Health Service Act requires
that the Secretary of HHS, by awards, provide for the establishment and
operation of the Organ Procurement and Transplantation Network (OPTN),
which, under oversight of the HRSA, operates the U.S. procurement and
transplantation system. The Secretary and/or HRSA may direct the
collection of data in accordance with the regulatory authority in 42
CFR 121.11 of the OPTN Final Rule. HRSA, in alignment with the
Paperwork Reduction Act of 1995, submits data elements for collection
to OMB for official federal approval.
Need and Proposed Use of the Information: HRSA and the OPTN Board
of Directors use data to develop transplant, procurement, 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 regulatory authority in 42 CFR 121.11 of the OPTN Final
Rule allows the Secretary of HHS to prescribe data collection. This
regulatory authority requires OPTN data to be made available,
consistent with applicable laws, for use by OPTN members, the
Scientific Registry of Transplant Recipients, and members of the public
for evaluation, research, patient information, and other purposes.
This is a request to expand the current OPTN data collection,
approved under OMB No. 0915-0157. HRSA is submitting this new data
collection, separate from OMB No. 0915-0157, since it includes new
forms developed in response to an HHS Secretarial Data Directive that
are not in use by OPTN. HRSA believes that separating these data
collections will minimize confusion, increase clarity among OPTN
members and stakeholders, and enable more direct feedback on the new
forms. Both data collections include time-sensitive, life-critical data
on transplant candidates and potential organ donor patients, the organ
matching process, histocompatibility results, organ labeling and
packaging, and pre-and post-transplantation data on recipients and
donors. The OPTN collects these specific data elements from transplant
centers.
HRSA and the OPTN use 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, procurement, 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.
This new collection consists of three new data forms as directed by
the HHS Secretary, which were developed to improve the OPTN organ
matching and allocation process and OPTN member compliance with OPTN
requirements:
<bullet> One new form will collect data from the point of referral
of a patient to an organ procurement organization (OPO) for potential
deceased organ donation. These data will provide a more objective
source of information on procurement practices, the management of donor
patients, and how these practices inform the supply of deceased donor
organs available for transplant. These data may also help to improve
monitoring of OPO performance and would facilitate quality assurance
and performance improvement efforts to reduce the variation in the
quality-of-care OPOs provide to donors and donor families.
<bullet> Two new forms will expand data collection from the point
of patient registration, referral, and evaluation at transplant
centers. These data will enable collection of data from the point of
referral. Pre-waitlisting data will provide insight into who gets
referred
[[Page 87593]]
and by whom, who gets evaluated, and who gets placed on the organ
transplantation waiting list. These data will also facilitate the
OPTN's ability to address disparities in processes of care, improve
access to organ transplantation, and assess overall system performance.
Once this collection is approved, HRSA will cease the use of the
Death Notification Registration and the Deceased Donor Death Referral
forms that are included within the existing OMB-approved Data System
for Organ Procurement and Transplantation Network OMB No. 0915-0157.
This decision was made to avoid unnecessary burden and redundancy in
the data collected by this package and the existing OMB data collection
instrument.
Likely Respondents: Transplant Centers, OPOs, 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
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Average
Number of Number of Total burden per Total burden
Form No. Form name respondents responses per responses response hours
respondent (in hours)
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1................... Pre-Waitlist 248 1,164.68 288,840.64 0.35 101,094.22
Transplant
Referral Form.
2................... Pre-Waitlist 248 594.22 147,366.56 0.40 58,946.62
Transplant
Evaluation Form.
3................... Ventilated 56 3,292.00 184,352.00 0.50 92,176.00
Patient Form.
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Total........... ................ 552 .............. 620,559.20 ........... 252,216.84
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The average burden estimates of both new pre-waitlist forms are
based on the 2023 burden estimates of existing OMB-approved Transplant
Candidate Registration forms, approved under 0915-0157. The average
burden estimate of the Ventilated Patient Form is based on the average
burden estimate of the 2024 burden estimates of existing OMB-approved
Death Notification Registration form with an additional 0.08 hour per
collected form burden to reflect an increase in total data fields.
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.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2024-25522 Filed 11-1-24; 8:45 am]
BILLING CODE 4165-15-P
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