[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Page 65959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26359]



[[Page 65959]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: HHS-OS-20883-30D]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary (OS), Department of 
Health and Human Services, has submitted an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB) for review and approval. The ICR is for a new collection. 
Comments submitted during the first public review of this ICR will be 
provided to OMB. OMB will accept further comments from the public on 
this ICR during the review and approval period.

DATES: Comments on the ICR must be received on or before December 8, 
2014.

ADDRESSES: Submit your comments to [email protected] or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, [email protected] or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the Information Collection Request Title 
and document identifier HHS-OS-0990-new 30D for reference.
    Information Collection Request Title: Tissue and Organ Donor 
epidemiology Study (TODES).
    Abstract: This Study is a request for a new data collection OMB 
Number: 0990-new TODES is being conducted in order to better understand 
the impact of donor screening and selection procedures, and to 
determine the extent of donor-donation level data that are collected 
for organ and tissue (including ocular) donors. The data that are 
obtained from Organ Procurement Organizations (OPOs) and Eye Banks will 
provide a better characterization of the deceased donor pool; 
information regarding data management and storage practices; and a 
measure of the degree of standardization of data collected by various 
organizations across the U.S. TODES may provide better estimates of the 
risk of HIV, HBV and HCV infections associated with organ and tissue 
transplantation and the potential for disease transmission; illustrate 
differences in laboratory screening methods and the impact of protocol 
variations; and serve as a pilot for future studies. This retrospective 
study will provide a framework for future, prospective studies of organ 
and tissue donors that could inform policy decisions regarding donor 
qualification procedures and, potentially, increase the donor pool.
    Need and Proposed Use of the Information: A workshop in June 2005 
(``Preventing Organ and Tissue Allograft-Transmitted Infection: 
Priorities for Public Health Intervention'') identified gaps in organ 
and tissue safety in the United States. Participants developed a series 
of allograft safety initiatives, assessed progress, and identified 
priorities for future interventions. Despite progress, improved 
recognition and prevention of donor-derived transmission events is 
needed. It was concluded that this requires systems integration across 
the organ and tissue transplantation communities including organ 
procurement organizations, eye and tissue banks, and transplant 
infectious disease experts. Commitment of resources and improved 
coordination of efforts are required to develop essential tools to 
enhance safety for transplant recipients.
    Likely Respondents: organ procurement organizations, tissue banks, 
eye banks

                                     Total Estimated Annualized Burden Hours
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                                                             Number of        Average burden
         Type of respondents              Number of        responses per    per response  (in     Total burden
                                         respondents         respondent           hours)             hours
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OPOs................................                 17                  1              85/60               24.1
Eye Banks...........................                  7                  1              55/60                6.4
    Total...........................  .................  .................  .................               30.5
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Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2014-26359 Filed 11-5-14; 8:45 am]
BILLING CODE 4150-05-P