Request for Information Regarding Development and Operation of a Transplantation Sentinel Network, 48088-48089 [E9-22658]
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Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices
• How is adverse event information
from these sources being received,
reviewed, and processed?
• What challenges are presented in
handling adverse event information
from these sources?
• What uncertainties are there
regarding what should be reported from
these sources to meet FDA adverse
event reporting obligations?
mstockstill on DSKH9S0YB1PROD with NOTICES
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner is announcing that
the public hearing will be held in
accordance with part 15 (21 CFR part
15). The hearing will be conducted by
a presiding officer, accompanied by
FDA senior management from the Office
of the Commissioner and the Center for
Drug Evaluation and Research.
Under § 15.30, the hearing is informal,
and the rules of evidence do not apply.
No participant may interrupt the
presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (part 10 (21 CFR part 10),
subpart C). Under § 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b). To the extent that the
conditions for the hearing, as described
in this document, conflict with any
provisions set out in part 15, this
document acts as a waiver of those
provisions as specified in § 15.30(h).
V. Comments
Regardless of attendance at the public
hearing, interested persons may submit
written or electronic comments to the
Division of Dockets Management (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments should be identified
with the docket number found in
brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VI. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
VerDate Nov<24>2008
17:24 Sep 18, 2009
Jkt 217001
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Dated: September 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–22618 Filed 9–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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://wwwdev.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, Email 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.
E:\FR\FM\21SEN1.SGM
21SEN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices
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
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.
VerDate Nov<24>2008
17:24 Sep 18, 2009
Jkt 217001
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.
Dated: September 14, 2009.
Tanja Popovic,
Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–22658 Filed 9–18–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 74 FR 37718–37723
dated July 29, 2009).
This notice reflects organizational
changes in the Health Resources and
Services Administration. This notice
renames the Office of Performance
Review (RE) to the Office of Regional
Operations (ORO) (RE), and changes the
mission and functions of the office.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
48089
Chapter RE—Office of Regional
Operations (RE)
Section RE–00, Mission
Delete in its entirety and replace with
the following:
The mission of ORO is to improve
health care systems and America’s
health care safety net, increase access to
quality care, reduce disparities, and
advance public health by providing
leadership in support of the HHS and
HRSA missions, goals and strategic
priorities in each region.
Section RE–10, Organization
Delete in its entirety and replace with
the following:
The Office of Regional Operations
(RE) is headed by the Associate
Administrator who reports directly to
the Administrator, Health Resources
and Services Administration. The Office
of Regional Operations includes the
following components:
1. Office of the Associate
Administrator (RE);
2. Boston Regional Division (RF12)
serves Connecticut, Maine,
Massachusetts, New Hampshire, Rhode
Island and Vermont;
3. New York Regional Division (RF13)
serves New Jersey, New York, Puerto
Rico and the United States Virgin
Islands;
4. Philadelphia Regional Division
(RF11) serves Delaware, Maryland,
Pennsylvania, Virginia, West Virginia
and the District of Columbia;
5. Atlanta Regional Division (RF21)
serves Alabama, Florida, Georgia,
Kentucky, Mississippi, North Carolina,
South Carolina and Tennessee;
6. Chicago Regional Division (RF31)
serves Illinois, Indiana, Michigan,
Minnesota, Ohio and Wisconsin;
7. Dallas Regional Division (RF41)
serves Arkansas, Louisiana, New
Mexico, Oklahoma and Texas;
8. Kansas City Regional Division
(RF32) serves Iowa, Kansas, Missouri
and Nebraska;
9. Denver Regional Division (RF42)
serves Colorado, Montana, North
Dakota, South Dakota, Utah and
Wyoming;
10. San Francisco Regional Division
(RF51) serves Arizona, California,
Hawaii, Nevada, American Samoa,
Commonwealth of the Northern Mariana
Islands, Federated States of Micronesia,
Guam, Republic of the Marshall Islands
and the Republic of Palau; and
11. Seattle Regional Division (RF52)
serves Alaska, Idaho, Oregon and
Washington.
Section RE–20, Functions
Delete in its entirety and replace with
the following:
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48088-48089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22658]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
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://wwwdev.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.
[[Page 48089]]
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 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.
Dated: September 14, 2009.
Tanja Popovic,
Chief Science Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-22658 Filed 9-18-09; 8:45 am]
BILLING CODE P
