[Federal Register Volume 89, Number 37 (Friday, February 23, 2024)]
[Notices]
[Pages 13723-13724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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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