``CORRECTED Version of Request for Information Regarding Development and Operation of a Transplantation Sentinel Network'', 49881-49882 [E9-23427]
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Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
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VerDate Nov<24>2008
16:18 Sep 28, 2009
Jkt 217001
Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23434 Filed 9–28–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
49881
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 https://www.cdc.gov/ncidod/
dhqp/pdf/ttsn/RFI_TSN_FedRegDoc_
9909.pdf. Electronic responses are
preferred and should be sent to
TransplantRFI@cdc.gov. 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:
gqi4@cdc.gov.
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 donorderived infections to UNOS and
E:\FR\FM\29SEN1.SGM
29SEN1
jlentini on DSKJ8SOYB1PROD with NOTICES
49882
Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
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
VerDate Nov<24>2008
16:18 Sep 28, 2009
Jkt 217001
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]
BILLING CODE P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2009–0038]
Privacy Act of 1974; Department of
Homeland Security/ALL–004 General
Information Technology Access
Account Records System of Records
Privacy Office; DHS.
Notice of Privacy Act system of
records update.
AGENCY:
ACTION:
SUMMARY: In accordance with the
Privacy Act of 1974 the Department of
Homeland Security proposes to update
and reissue a Department of Homeland
Security system of records notice titled,
Department of Homeland Security/ALL–
004 General Information Technology
Access Account Records System of
Records. As a result of the biennial
review of this system, the Department
proposes to include the addition of
social security numbers in the categories
of records covered by the system for the
purpose of identifying an individual for
system access. Additionally, a new
routine use has been added for the
purpose of sharing with the media
where appropriate. This updated system
will be included in the Department of
Homeland Security’s inventory of
record systems.
DATES: Written comments must be
submitted on or before October 29,
2009.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
ADDRESSES: You may submit comments,
identified by Docket Number DHS–
2009–0038 by one of the following
methods:
• Federal e-Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 703–483–2999.
• Mail: Mary Ellen Callahan, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528.
• Instructions: All submissions
received must include the agency name
and docket number for this rulemaking.
All comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
• Docket: For access to the docket to
read background documents or
comments received go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
general questions and for privacy issues
please contact: Mary Ellen Callahan
(703–235–0780), Chief Privacy Officer,
Privacy Office, U.S. Department of
Homeland Security, Washington, DC
20528.
SUPPLEMENTARY INFORMATION:
I. Background
As part of its efforts to maintain its
Privacy Act record systems, the
Department of Homeland Security
(DHS) is updating and reissuing a
Department-wide system of records
under the Privacy Act (5 U.S.C. 552a)
for DHS/ALL–004 General Information
Technology Access Account Records
System of Records (73 FR 28139, May
15, 2008). This will ensure that all
components of DHS follow the same
privacy rules for collecting and
handling information technology access
account records. The collection and
maintenance of this information will
assist DHS in managing the
Department’s information technology
access account records.
This system of records is part of DHS’
ongoing record integration and
management efforts. This system
consists of information collected in
order to provide authorized individuals
with access to DHS information
technology resources. This information
includes user name, business affiliation,
account information and passwords.
In accordance with the Privacy Act of
1974, DHS is giving notice that it
proposes to update and reissue a DHS
system of records notice titled, DHS/
ALL–004 General Information
Technology Access Account Records
System of Records. As a result of the
biennial review of this system, the
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 74, Number 187 (Tuesday, September 29, 2009)]
[Notices]
[Pages 49881-49882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23427]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.cdc.gov/ncidod/dhqp/pdf/ttsn/RFI_TSN_FedRegDoc_9909.pdf. Electronic
responses are preferred and should be sent to TransplantRFI@cdc.gov.
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:
gqi4@cdc.gov.
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]
BILLING CODE P
