Notice2023-25368
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation, OMB No. 0906-0034-Extension
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 17, 2023
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
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<title>Federal Register, Volume 88 Issue 221 (Friday, November 17, 2023)</title>
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[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80318-80319]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25368]
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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:
Scientific Registry of Transplant Recipients Information Collection
Effort for Potential Donors for Living Organ Donation, OMB No. 0906-
0034--Extension
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, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than January
16, 2024.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#bbcbdacbdec9ccd4c9d0fbd3c9c8da95dcd4cd"><span class="__cf_email__" data-cfemail="a8d8c9d8cddadfc7dac3e8c0dadbc986cfc7de">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 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#afdfcedfcaddd8c0ddc4efc7dddcce81c8c0d9"><span class="__cf_email__" data-cfemail="fe8e9f8e9b8c89918c95be968c8d9fd0999188">[email protected]</span></a> or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 945-0232.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Scientific Registry of
Transplant Recipients Information Collection Effort for Potential
Donors for Living Organ Donation, OMB No. 0906-0034--Extension.
Abstract: The Scientific Registry of Transplant Recipients (SRTR)
is administered under contract with HRSA, an agency within HHS. HHS is
authorized to establish and maintain mechanisms to evaluate the long-
term effects associated with living organ donations (42 U.S.C. 273a)
and is required to submit to Congress an annual report on the long-term
health effects of living donation (42 U.S.C. 273b). In 2018, the SRTR
contractor implemented a pilot living donor registry in which
transplant programs registered all potential living organ donors who
provided informed consent to participate in the pilot registry. The
Organ Procurement and Transplantation Network final rule, 42 CFR part
121, requires organ procurement organizations and transplant hospitals,
``as specified from time to time by the Secretary,'' to submit to the
SRTR, as appropriate, information regarding ``donors of organs'' and
``other information that the Secretary deems appropriate.'' 42 CFR
121.11(b)(2).
In 2018, a pilot living donor registry was implemented by the SRTR,
and each participating transplant program registered all potential
candidates for living donation who provided informed consent to enroll.
In 2019, an updated version of the data collection instrument was
approved, followed by the latest data collection forms which were
approved on February 26, 2021. These data collection modifications were
intended to improve the quality of the data and reduce the
administrative burden for respondents. This Federal Register notice
requests an extension of the last approved data collection forms
(February 2021) with no changes to the total estimated annualized
burden hours.
Need and Proposed Use of the Information: The transplant programs
submit health information collected at the time of donation evaluation
through a secure web-based data collection tool developed by the SRTR
contractor. The SRTR contractor maintains contact with registry
participants and collects data on long-term health outcomes through
surveys. The data collection includes outcomes of evaluation, including
reasons for non-donation. The living donor registry is an ongoing
effort, and the goal is to continue to collect data on living organ
donor transplant programs in the United States over time. Monitoring
and reporting of long-term health outcomes of living organ donors post-
donation will continue to provide useful information to transplant
programs for their future donor selection process and to aid potential
living organ donors in their decision to pursue living donation.
Likely Respondents: Potential and actual living donors, transplant
programs, medical and scientific organizations, and public
organizations, including patient advocacy groups.
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 Total Average burden Total
Form name Number of of responses number of per response burden
respondents per respondent responses (in minutes) hours
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Potential Living Donor Registration form... \a\ 16 112 1,792 0.27 484
Potential Living Donor Follow-up form...... \b\ 754 1 754 0.50 377
Reasons Did not Donate form (liver or \a\ 16 106 1,696 0.23 390
kidney)...................................
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Total.................................. 786 .............. 4,242 .............. 1,251
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\a\ Number of respondents is based on the current number of transplant programs and is likely to increase as
additional programs decide to participate.
\b\ Number of living organ donor candidates submitting follow-up forms in 2019.
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. 2023-25368 Filed 11-16-23; 8:45 am]
BILLING CODE 4165-15-P
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