Notice2024-03759
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 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
February 23, 2024
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with 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. The initial notice was published on November 17, 2023, with a 60-day comment period. No comments were received. OMB will accept comments from the public during the 30-day comment period for this notice. 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 89 Issue 37 (Friday, February 23, 2024)</title>
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[Federal Register Volume 89, Number 37 (Friday, February 23, 2024)]
[Notices]
[Pages 13723-13724]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03759]
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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; 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 Paperwork Reduction Act of 1995, HRSA
submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. The initial notice
was published on November 17, 2023, with a 60-day comment period. No
comments were received. OMB will accept comments from the public during
the 30-day comment period for this notice. 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 March 25,
2024.
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 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 Joella Roland, the HRSA
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#344455445146435b465f745c4647551a535b42"><span class="__cf_email__" data-cfemail="2757465742555048554c674f55544609404851">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
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). The Organ
Procurement and Transplantation Network final rule, 42 CFR part
121.11(b)(2), 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.''
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.
A 60-day notice published in the Federal Register on November 17,
2023, vol. 88, No. 221; pp. 80318-19. There were no public comments.
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
[[Page 13724]]
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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Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
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Potential Living Donor \a\ 16 \c\ 112 \c\ 1,792 \e\ 0.27 484
Registration Form..............
Potential Living Donor Follow-up \b\ 754 1 \d\ 754 \f\ 0.50 377
Form...........................
Reasons Did Not Donate Form \a\ 16 \c\ 106 \c\ 1,696 \g\ 0.23 390
(Liver or Kidney)..............
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Total....................... \a\ 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 donor candidates that submitted follow-up forms in 2019.
\c\ Derived from the number of forms submitted by transplant programs in 2019.
\d\ Total number of Living Donor Collective follow-up forms submitted by living donor candidates in 2019.
\e\ Based on a 2019 survey of transplant programs submitting data to the Living Donor Collective.
\f\ Based on internal testing and user feedback.
\g\ Based on discussion and interviews with staff at participating transplant programs in 2019-2020.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-03759 Filed 2-22-24; 8:45 am]
BILLING CODE 4165-15-P
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