[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80318-80319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected] 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 [email protected] 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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[[Page 80319]]

 
    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