[Federal Register Volume 74, Number 187 (Tuesday, September 29, 2009)]
[Notices]
[Pages 49881-49882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23427]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


``CORRECTED Version of Request for Information Regarding 
Development and Operation of a Transplantation Sentinel Network''

AGENCY: Office of Blood, Organ and Other Tissue Safety, Division of 
Healthcare Quality Promotion, Center for Preparedness, Detection, and 
Control of Infectious Diseases, Centers for Disease Control and 
Prevention, Department of Health and Human Services.

ACTION: Request for information notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) is 
seeking information on development and operation of a national 
transplantation sentinel network (TSN) for the United States, including 
resources needed for management of such a system. The purpose of the 
network is to detect and prevent disease transmission from organ and 
tissue allografts recovered for transplantation.
    In June 2005, the CDC announced a Request for Application (RFA) 
through a cooperative agreement for development of a TSN for 
organizations that recover, process, distribute, and implant organs and 
tissues. The overall goal of the system was to improve patient safety 
for organ and tissue recipients. The RFA objectives were to: (1) 
Identify and track organs and tissues to facilitate intervention 
following recognition of infections among recipients or donors; (2) 
improve communication among those in the transplant community, 
healthcare facilities and public health agencies concerning potential 
risks for transmission of infections; and (3) improve pathologic and 
microbiologic capabilities on cadaveric donor specimen samples through 
shared resources. Development and field testing of the prototype was 
completed in 2008.
    For this RFI, respondents are asked to describe experiences, plans 
or opinions regarding aspects of completing and operating a TSN system; 
system governance, security, and marketing; user training; and 
operational and infrastructure management. Responses need not address 
every aspect of this RFI; responses may be limited to address specific 
components or portions of a section. The specific sections requested 
for comments are: (1) Transition of Transplantation Transmission 
Sentinel Network (TTSN) Prototype to Full Production; (2) 
Standardization and Compatibility Issues; (3) Reporting Criteria; (4) 
Interoperability and Interfacing with Existing Data Sources; (5) System 
Operation and Infrastructure Management; (6) Analysis Plan including 
Feedback to Users; (7) Patient Health Information Privacy and Security; 
and (8) System Governance.

DATES: Comments must be submitted on or before December 11, 2009.

ADDRESSES: The entire TSN RFI can be accessed at http://www.cdc.gov/ncidod/dhqp/pdf/ttsn/RFI_TSN_FedRegDoc_9909.pdf. Electronic 
responses are preferred and should be sent to [email protected]. 
Responses sent in hard copy format must be securely bound and sent to 
Debbie Seem, Office of Blood, Organ and Other Tissue Safety, Division 
of Healthcare Quality Promotion, Centers for Disease Control and 
Prevention, Building 16, MS-A07, 1600 Clifton Road, NE., Atlanta, GA 
30329-4018, Telephone number: 404-639-3234, E-mail Address: 
[email protected].

SUPPLEMENTARY INFORMATION: Each year in the United States, more than 
28,000 solid organs and 2 million tissues are transplanted, including 
heart, lung, liver, kidneys, pancreas, intestine, bone, skin, heart 
valves, tendons, fascia and corneas. Donor-derived infections have been 
identified as a source of morbidity and mortality among both solid 
organ and tissue transplant recipients.
    Infectious transmission identified in the past few years among 
solid organs have reflected a broad array of viruses, bacteria, and 
parasites, resulting in a high proportion of mortality amongst infected 
recipients; examples include HIV, hepatitis C virus (HCV), lymphocytic 
choriomeningitis virus, Mycobacterium tuberculosis, Pseudomonas 
aeruginosa, Strongyloides spp, and Trypanosoma cruzi, the etiologic 
agent of Chagas Disease. Malignancies also have been transmitted by 
solid organs. The Health Resources and Services Administration (HRSA) 
oversees the transplantation of solid organs through the Organ 
Procurement and Transplantation Network (OPTN) administered by the 
United Network for Organ Sharing (UNOS). OPTN policy requires reporting 
of all potential donor-derived infections to UNOS and

[[Page 49882]]

notification of institutions that recovered organs and tissues from 
that donor.
    For tissues, disease transmission reports are less frequent but 
include transmission of HCV, Group A streptococcus, Clostridium spp, 
and Chryseobacterium meningosepticum. Unlike solid organs, risk of 
disease transmission depends on multiple factors related to the graft, 
including the feasibility and effectiveness of processing, which may 
vary according to tissue type and specific processing or manipulation 
procedures. The Food and Drug Administration (FDA), Center for 
Biologics Evaluation and Research, regulates articles containing or 
consisting of human cells or tissues intended for implantation, 
transplantation, infusion, or transfer into a human recipient as human 
cells, tissues, or cellular or tissue-based products (HCT/Ps). HCT/P 
establishments are required to report to FDA all serious infections 
following graft transplantation. However, healthcare providers are not 
required to report adverse events, and healthcare facilities that do 
not perform any steps in tissue manufacture (recovery, processing, 
storage, labeling, packaging, distribution, or donor screening or 
testing) are not subject to any FDA regulation for HCT/Ps.
    Because organs and tissues can come from the same donor, a TSN 
should provide the mechanism for standardizing allograft identifiers, 
tracking of organ and tissue receipt, rapid notification of and 
response to potential disease transmissions, benchmarking of sentinel 
events and integration into a national biovigilance network. 
Specifically utilizing these system characteristics, all relevant 
recovery, processing, distributing and implanting institutions could 
rapidly communicate when a possible disease transmission is identified. 
This may prevent any further use of allografts with transmissible 
diseases in additional recipients after a problem is recognized and 
allow for earlier initiation of treatment or prophylaxis of recipients, 
potentially resulting in reduction of transmission events or resulting 
morbidity and mortality.
    A national TSN needs to avoid duplication of the OPTN or of FDA 
reporting mechanisms; however, interfacing with these existing systems 
is critical. A national TSN could be coordinated by CDC in 
collaboration with other agencies of the Department of Health and Human 
Services (HHS) and external partners. In addition, HHS has recognized 
health information technology (IT) data and exchange standards to 
promote the exchange of health information across the healthcare 
landscape. The National Health IT activities initiated by the HHS 
Office of the National Coordinator for Health IT (ONC) has examined 
incorporating reporting criteria into Electronic Health Records (EHRs) 
which could assist in the possible identification and reporting of 
public health cases and adverse events. Reporting criteria which are 
incorporated and utilized by EHRs may include: general and specific 
reporting considerations, as well as the identification of data and 
events that may trigger a report, additional questions that may need to 
be asked of reporters, and the identification of specific data that may 
need to be reported. Integrating these requirements into a national TSN 
system is vital to the long term viability of the program.

Tanja Popovic,
Chief Science Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-23427 Filed 9-28-09; 8:45 am]
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