[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22836-22837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10040]


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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--New

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 July 17, 
2017.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, 5600 Fishers 
Lane, Rockville, MD 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 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, pursuant to Section 3506(c)(2)(A), the Paperwork 
Reduction Act of 1995.
    Information Collection Request Title: Scientific Registry of 
Transplant Recipients Information Collection Effort for Potential 
Donors for Living Organ Donation--New.
    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). The SRTR contractor will 
establish a pilot living donor registry in which 14 transplant programs 
will register all potential living donors who provide informed consent 
to participate in the pilot registry. The SRTR's authority to collect 
information concerning potential living donors is set forth in the 
Organ Procurement and Transplantation Network final rule 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).
    Need and Proposed Use of the Information: The transplant programs 
will 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 will maintain contact with registry 
participants and collect data on long-term health outcomes through 
surveys. The data collection will also include outcomes of evaluation 
including reasons for non-donation. The goal of the pilot registry is 
to develop data collection tools and survey instruments that can be 
used to expand the registry to include most, if not all, living donor 
transplant programs in the United States over time. Monitoring and 
reporting of long-term health outcomes of living donors post donation 
will provide useful information to transplant programs in their future 
donor selection process and will aid potential living donors in their 
decision to pursue living donation.
    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: (1) Review 
instructions; 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; (2) train personnel to respond to a request for 
collection of information; (3) search data sources; (4) complete and 
review the collection of information; and (5) to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request 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 hours)         hours
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Potential Living Donor                        14              55             770               1             770
 Registration form..............
Potential Living Donor Follow-up             776               1             776             .50             388
 form...........................
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    Total.......................           * 790  ..............           1,546  ..............           1,158
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* Number of respondents for potential living donor registration forms is based on the number of programs
  participating in the pilot registry. Number of respondents for potential living donor follow-up forms is based
  on the number of potential living donors evaluated at the 14 participating programs in 2015.

    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

[[Page 22837]]

technology to minimize the information collection burden.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-10040 Filed 5-17-17; 8:45 am]
 BILLING CODE 4165-15-P