[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83098-83099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28017]


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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 of the Paperwork Reduction Act of 1995, 
HRSA has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period. 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 January 
20, 2021.

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 30-day 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 Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

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, a sub agency of 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 
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.
    A 60-day notice published in the Federal Register on September 8, 
2020, vol. 85, No. 174; pp. 55464-65. 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 
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

[[Page 83099]]

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 number                  Average burden
            Form name                Number of     of responses    Total number    per response    Total burden
                                    respondents   per respondent   of responses    (in minutes)        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  ..............           4,242  ..............           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. 2020-28017 Filed 12-18-20; 8:45 am]
BILLING CODE 4165-15-P