[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Notices]
[Pages 55464-55465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19777]



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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 
- Revision

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 November 
9, 2020.

ADDRESSES: Submit your comments to [email protected].

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 Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection 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--Revision.
    Abstract: The Scientific Registry of Transplant Recipients (SRTR) 
is administered under contract with HRSA, an agency of HHS. HHS is 
authorized to establish and maintain mechanisms to evaluate the long-
term effects associated with living 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 donors who provide 
informed consent to participate in the pilot registry. The SRTR's 
authority to collect information concerning potential living organ 
donors is set forth in the HHS organ procurement and transplantation 
network regulation, 42 CFR part 121, requiring organ procurement 
organizations and transplant hospitals 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, an updated version of the data collection instrument was 
approved. The data collection modifications improve the quality of the 
data and reduce the administrative burden for respondents.
    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 
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 in their future donor selection process and aid potential 
living organ donors in their decision to pursue living donation.
    There were minor revisions to the burden per response as it has 
decreased from the current amount due to improvements to the efficiency 
of the processes used by programs for data submission, as well as the 
tools provided for program use by SRTR
    Likely Respondents: Potential living donors, transplant programs, 
medical and scientific organizations, and public organizations.
    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                         Average
                                     Number of       number of     Total  number    burden per     Total Burden
            Form name               respondents    responses per   of  responses   response  (in       Hours
                                                    respondent                        hours)
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Potential Living Donor                    \a\ 16             112           1,792             .27             484
 Registration form..............
Potential Living Donor Follow-up         \b\ 754               1             754             .50             377
 form...........................
Reasons Did not Donate form               \a\ 16             106           1,696             .23             390
 (liver or kidney)..............
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    Total.......................             786  ..............           4,245  ..............           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

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or other forms of information technology to minimize the information 
collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-19777 Filed 9-4-20; 8:45 am]
BILLING CODE 4165-15-P