82 FR 46509 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

In compliance with 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.

[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46509-46510]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[OMB No. 0906-xxxx--New]


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Information Collection 
Request Title: Scientific Registry of Transplant Recipients Information 
Collection Effort for Potential Donors for Living Organ Donation

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 
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

[[Page 46510]]

of this ICR will be provided to OMB. OMB will accept further comments 
from the public during the review and approval period.

DATES: Comments on this ICR should be received no later than November 
6, 2017.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to 202-395-5806.

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 information request collection title 
for reference, in compliance with Section 3506(c)(2)(A) of 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--OMB No. 0906-xxxx--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 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                        14           55.43             776               1             776
 Registration form..............
Reasons Did not Donate Form                   14           27.71             388             .50             194
 (liver or kidney)..............
Potential Living Donor Follow-up             776               1             776             .50             388
 form...........................
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    Total.......................           * 804  ..............           1,940  ..............           1,358
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* Number of respondents for potential living donor registration and reasons did not donate forms based on number
  of programs participating in the pilot registry. Number of respondents for potential living donor follow-up
  forms based on 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 technology to 
minimize the information collection burden.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-21490 Filed 10-4-17; 8:45 am]
 BILLING CODE 4165-15-P