Notice2025-12211
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Process Data for Organ Procurement and Transplantation Network, OMB No. 0906-xxxx-New
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
July 1, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with of the Paperwork Reduction Act of 1995, HRSA 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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Full Text
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<title>Federal Register, Volume 90 Issue 124 (Tuesday, July 1, 2025)</title>
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[Federal Register Volume 90, Number 124 (Tuesday, July 1, 2025)]
[Notices]
[Pages 28754-28755]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12211]
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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; Process Data for Organ
Procurement and Transplantation Network, OMB No. 0906-xxxx-New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA 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. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than July 31,
2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer at <a href="/cdn-cgi/l/email-protection#e696879683949189948da68e949587c8818990"><span class="__cf_email__" data-cfemail="81f1e0f1e4f3f6eef3eac1e9f3f2e0afe6eef7">[email protected]</span></a> or call
(301) 443-9094.
SUPPLEMENTARY INFORMATION:
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 Health Resources and Services
Administration (HRSA), operates the U.S. organ procurement and
transplantation system. The Secretary/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.
A 60-day Notice was published in the Federal Register, 89 FR 87592
(November 4, 2024). The 60-day Federal Register Notice publication
generated 53 public comments, with the majority submitted by transplant
centers. The public comments offered input to improve the quality and
clarity of the data forms, including by standardizing the definitions
of the terminology used on the forms and making additions and revisions
to response options and categories. The respondents also provided
feedback on the perceived burden of data collection. They suggested
submitting these data on a quarterly, semi-annual, or annual basis,
rather than in real-time, to reduce the time and staffing required to
report the data to HRSA. Nearly all respondents who commented on the
use of automated collection techniques supported efforts to automate
data collection in these forms, including coordinating updates with
Electronic Health Record vendors and other software developers. Others
recommended a phased-in approach with a pilot testing period.
HRSA conducted a thorough review of all the feedback provided by
the public during the 60-day publication period. HRSA will incorporate
many public comments into the new forms, including through the removal
and/or revision of current fields (for example, removing HIV status and
Primary Insurance from the Ventilated Patient Form) and explore options
to automate the data collection process and incorporate education and
training for data respondents to reduce burden and ensure data quality
and accuracy. Other suggestions may be further reviewed for
consideration in future OMB packages or non-substantive change memos.
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 the OPTN data to be made available,
consistent with applicable laws, for use by OPTN members, the
Scientific Registry of
[[Page 28755]]
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, as well as 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 Secretary of HHS, 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
potential donor patients, and how these practices inform the supply of
deceased donor organs available for transplant. These data may also
help improve the monitoring of OPO performance, facilitating quality
assurance and performance improvement efforts to reduce variation in
the quality of care that OPOs provide to prospective 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 the collection of data from the point
of referral. Pre-waitlisting data will provide insight into who is
referred and by whom, who is evaluated, and who is 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 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. HRSA
decided to decommission these forms 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.
The total estimated burden hours for this Secretary of HHS directed
data collection is 252,216.84 hours.
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 Patient 56 3,292.00 184,352.00 0.47 86,645.44.00
Form.
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Total.............. 552 .............. 620,559.20 ........... 246,686.28
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The average burden estimates for both new pre-waitlist forms are
based on the 2023 burden estimates of existing OMB-approved Transplant
Candidate Registration forms, which were approved under OMB control
number 0915-0157. The average burden estimate of the Ventilated Patient
Form is based on the average burden estimate of the 2024 burden
estimates of the 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. The burden estimate for the
Ventilated Patient Form has decreased since the publication of the 60-
day Federal Register Notice due to the removal of measures from the
form in response to public comment.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-12211 Filed 6-30-25; 8:45 am]
BILLING CODE 4165-15-P
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