[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87592-87593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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