[Federal Register Volume 79, Number 165 (Tuesday, August 26, 2014)]
[Pages 50912-50913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20193]



Office of the Secretary

[Document Identifier: HHS-OS0990-new-60D]

Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.


SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary (OS), Department of 
Health and Human Services, announces plans to submit a new Information 
Collection Request (ICR), described below; to the Office of Management 
and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on the ICR must be received on or before October 27, 

ADDRESSES: Submit your comments to 
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the document identifier HHS-OS-0990-New-60D 
for reference.

[[Page 50913]]

    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Information Collection Request Title: Tissue and Organ Donor 
Epidemiology Study (TODES), OMB # 0990-New request, Office of 
the Assistant Secretary for Health.
    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.
    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.1 
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.

                                        Estimated Annualized Burden Hours
                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
OPOs............................................              17               1           85/60            24.1
Eye Banks.......................................               7               1           55/60             6.4
    Total.......................................  ..............  ..............  ..............            30.5

    OS 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.

Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2014-20193 Filed 8-25-14; 8:45 am]