Request for Information (RFI) To Identify and Obtain Relevant Information From Public or Private Entities With an Interest in Biovigilance, 22900-22902 [2011-9966]
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Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices
was posted on the ONC Web site on
March 25, 2011 and originally open for
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22 at 11:59 p.m. (Eastern). This notice
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Dated: April 19, 2011.
Erin Poetter,
Office of Policy and Planning, Office of the
National Coordinator for Health Information
Technology.
[FR Doc. 2011–9941 Filed 4–22–11; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
AGENCY:
Notice.
HHS gives notice as required
by 42 CFR 83.12(e) of a decision to
evaluate a petition to designate a class
of employees from Ames Laboratory in
Ames, Iowa, to be included in the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000. The
initial proposed definition for the class
being evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Ames Laboratory.
Location: Ames, Iowa.
Job Titles and/or Job Duties: All
Department of Energy (DOE) employees,
its predecessor agencies, and its
contractors and subcontractors who
worked in any area of the DOE facility.
Period of Employment: January 1,
1942 through December 31, 1970.
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SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 877–
222–7570. Information requests can also
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John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–9928 Filed 4–22–11; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information (RFI) To
Identify and Obtain Relevant
Information From Public or Private
Entities With an Interest in
Biovigilance
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
This Request for Information
(RFI) seeks to identify and obtain
relevant information regarding the
possible development of a publicprivate partnership (PPP) designed to
facilitate the identification of risks and
strategies to assure safety of the U.S.
supply of blood and blood components,
tissues, cells, and organs. This RFI is
intended to inform the Department of
Health and Human Services (HHS)
regarding stakeholders, mechanisms,
and approaches on issues related to
developing and managing a PPP and
scope of PPP activities. Replies are
invited from (1) public or private
entities with an interest in biovigilance,
and (2) entities with experience and
capabilities managing public-private
partnerships (PPPs) in the biological
sciences and public health domains.
This RFI is for information and planning
purposes only and is not a solicitation
for applications or an obligation on the
part of the U.S. Government to provide
support for any ideas identified in
response to it. Please note that the U.S.
Government will not pay for the
preparation of any information
submitted or for its use of that
information.
All responses must be received
no later than 4 p.m. EDT on June 9, 2011
at the address listed below.
ADDRESSES: All responses should be
e-mailed to Biovigilance@hhs.gov
(attention Dr. Jerry Holmberg). Please
limit responses to 10 pages. Include in
the subject line, the following
information:
• Name of the institution or site.
• Respondent, title, and full contact
information.
DATES:
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Dr.
Jerry Holmberg, Senior Advisor for
Blood Safety, Office of the Assistant
Secretary for Health, Office of the
Secretary, U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Tower Building, Suite 250,
Rockville, MD 20852.
SUPPLEMENTARY INFORMATION: In 2009,
the Advisory Committee on Blood
Safety and Availability (ACBSA) within
the Department of Health and Human
Services (HHS), Office of the Assistant
Secretary of Health, reviewed and
discussed a report on the current state
of biovigilance. In that report
(‘‘Biovigilance: Efforts to Bridge a
Critical Gap in Patient Safety and Donor
Health’’ https://www.hhs.gov/ash/
bloodsafety/biovigilance/),
biovigilance was defined as ‘‘a
comprehensive and integrated national
patient safety program to collect,
analyze, and report on the outcomes of
collection and transfusion and/or
transplantation of blood components
and derivatives, tissues, cells, and
organs. This definition does not include
vaccines, allergenic products, and most
recombinant human proteins.’’ Safety
surveillance for plasma derivatives,
while a logical part of biovigilance,
already falls under FDA mandated drug
adverse event reporting and is not
addressed in the current HHS initiative.
Among the recommendations in that
report was for HHS to develop an HHS
action plan to support a national
biovigilance program, integration of
systems within government and private
sectors, and steps to enhance
mechanisms for surveillance.
HHS is continuing its efforts to
develop an action plan to support a
national biovigilance program for blood
and blood components, tissues, cells,
and organs. As part of these efforts, HHS
is exploring the feasibility of a PPP.
HHS believes that a PPP potentially
could serve as an appropriate
mechanism for achieving the broad
goals and mission of biovigilance. A
PPP might provide the American public
with a mechanism for leveraging and
maximizing resources, for collaborating
on research and problem solving, for
creating new opportunities, and for
advancing the Department’s public
health mission as it relates to challenges
associated with disease prevention
(including emerging infectious diseases
or EIDs), adverse events, and process
improvements.
Biovigilance is an area of growing
importance, with a potential role in any
of the following areas:
• Identifying strategies for protecting
recipients and living donor health;
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
Decision To Evaluate a Petition To
Designate a Class of Employees From
Ames Laboratory in Ames, IA, To Be
Included in the Special Exposure
Cohort
ACTION:
be submitted by e-mail to
DCAS@CDC.GOV.
E:\FR\FM\25APN1.SGM
25APN1
jdjones on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices
• Identifying processes that reduce
medical errors and improve donor/
patient outcomes in blood transfusions,
and tissue and organ transplantations;
• Reporting and analyzing adverse
events, including medical ‘‘near misses’’
and patient adverse reactions;
• Identifying emerging infectious
disease prevalence and incidence in
donors and recipients, both quickly and
effectively;
• Informing public health and
regulatory policy, and reimbursement
decisions; and,
• Contributing to and collaborating
on research studies, including research
that provides a basic understanding of
recipient outcomes so as to inform
future surveillance activities.
Specific areas and activities in which
a biovigilance PPP is likely to be
involved may include:
• Safety and surveillance—
Identifying areas where greater safety
and surveillance measures are needed.
• Process improvement—Proposing
new processes or process enhancements
to improve blood and blood component,
tissue, cell, and organ safety for donors
and recipients.
• Standards and measurements—
Identifying areas where standards are
lacking or need additional development;
proposing definitions for standards;
defining measurement approaches or
best practices for collecting
measurement data.
• Research and analysis—Identifying
research needs; proposing and
conducting short and long-term research
studies; identifying knowledge gaps that
prevent effective surveillance or
reporting; proposing strategies for
closing these gaps.
• Data repositories, infrastructure and
policies—Identifying requirements for
new data repositories and related
infrastructure; developing policies for
data sharing, access, privacy and
confidentiality; establishing and
operating such data repositories and
related infrastructure (or contractually
arranging for the operation).
• Baseline data, data quality,
measurement, and collection—
Establishing baseline data and
associated quality standards for
measurement and collection of that
data.
• Goal setting—Establishing targets or
goals for improved outcomes.
• Reporting—Issuing regular and
periodic reports on progress, trends,
adverse outcomes, and corrective
actions to improve patient safety and
donor health.
• Innovation in technologies and
post-marking surveillance of new
technologies.
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Interested stakeholders in
biovigilance may include any of the
following, and/or others:
• Foundations and non-profit entities
with an interest or responsibilities in
biovigilance, in particular those with a
public advocacy mission related to
supply, access, safety, use, or payment
of blood, tissues, cells and organs and/
or those with expertise in PPPs;
• Recipients of blood or blood
components, tissues, cells, or organs;
• Donors, potential donors, and donor
families;
• Healthcare facilities, including
transfusion services and transplant
centers;
• Pharmaceutical, diagnostic, and
other related biotechnology companies
offering products, services, medical
equipment, or technology;
• Organizations engaged in collecting,
recovery banking, preserving,
distributing or processing blood, organs,
or tissues, or cells;
• Insurance companies, self-insured
entities, and other payers;
• IT and database companies;
• Professional, research, and
academic organizations;
• Other U.S. Federal, State, or local
government groups with an interest or
responsibilities in biovigilance; and,
• Managing partners or consultancy
firms.
Information Requested
The Assistant Secretary for Health has
charged a biovigilance working group,
with membership from the HHS
Operating Divisions, to define the
foundational elements and operating
framework for a National Biovigilance
Program within HHS and for a PPP. This
framework for a National Biovigilance
Program will propose a set of high-level
strategic goals, priorities, and key
initiatives for the next five years. In
developing the framework, HHS will
take into account the feasibility, as well
as foundational elements and basic
operating framework for a PPP.
HHS is interested in exploring a
biovigilance PPP that could achieve its
mission through collaboration among
public sector entities (e.g., government
agencies and institutions) and private
sector entities. Private sector entities
include, but are not limited to academia;
non-governmental organizations
(NGOs); philanthropic institutions;
patient groups; blood bank operators;
blood, tissue, cell, and organ
establishments or manufacturers,
transplant centers, and professional
societies; and other members of the
blood, tissue, cells, and organ
communities. Under such a partnership,
all partners might engage in the
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22901
development of an operating structure
and policies that will meet the broad
goals of biovigilance as well as serving
the needs and interests of the partners.
Due to the expanding role of blood
transfusion, and tissue, cell and organ
transplantation in the healthcare sector,
sustained involvement among partners
might be needed for the foreseeable
future.
This RFI is being issued to notify the
public that HHS is exploring the
feasibility of a PPP as an approach for
achieving the broad goals of
biovigilance. This RFI, moreover, is
being issued to encourage all interested
parties to comment on any aspect of a
PPP. This may include any of the
following:
• General or organizational issues:
Æ Scope, key priorities, goals, or
initiatives for the PPP in the first
five years;
Æ Key PPP challenges and critical
success factors.
• Structural issues, such as:
Æ Governance structure, operating
and voting rules, and decisionmaking processes for the PPP;
Æ Funding mechanisms and models
for both the start-up period (during
the initial 6–18 months) and the
long term, to support sustained
funding for an ongoing
collaboration.
• Partner issues, including:
Æ Identification of potential partners;
Æ Management approaches for
optimizing public and privatesector involvement.
• PPP scope and activities:
Æ Project and research selection
strategies in evaluation of the
suitability of projects, partners, and
overall internal decision-making
structure;
Æ Standards and measurements
(definition, development,
implementation)
Æ Data collection through
surveillance;
Æ Analysis of data;
Æ Public policy influence and
development;
Æ International biovigilance.
• PPP Management issues, such as:
Æ Expertise and experience in
managing a PPP, particularly in the
biological sciences and public
health domains;
Æ Expertise and input on applicable
research agendas. This could
include how the PPP functions with
regard to direct solicitation of
research applications, how funding
decisions are made, and the
performance of administrative or
oversight functions for such
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Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices
projects;
Æ Fund-raising experience;
Æ Fiscal management experience,
including management of the flow
of funds among the partners.
This RFI is for information and
planning purposes only and should not
be construed as a solicitation or as an
obligation on the part of HHS. HHS does
not intend to award a grant or contract
to pay for the preparation of any
information submitted or for the use of
such information by HHS.
Acknowledgment of receipt of responses
may not be made, nor will respondents
be notified of the evaluation by HHS of
the information received. No basis for
claims against HHS shall arise as a
result of a response to this request for
information or to the use of such
information by HHS as either part of our
evaluation process or in developing
specifications for any subsequent
announcement. Any proprietary
information submitted should be clearly
marked for confidentiality.
Dated: April 20, 2011.
James J. Berger,
Associate Public Health Advisor for Blood,
Organ, and Tissue Safety.
[FR Doc. 2011–9966 Filed 4–22–11; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–11–0020]
Agency Forms Undergoing Paperwork
Reduction Act Review
jdjones on DSKHWCL6B1PROD with NOTICES
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Coal Workers’ Health Surveillance
Program (CWHSP)—OMB 0920–0020–
Reinstatement With Change—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
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Background and Brief Description
This submission will incorporate the
National Coal Workers’ X-Ray
Surveillance Program 42 CFR 37 (0920–
0020) and National Coal Workers’
Autopsy Study 42 CFR part 37.204
(0920–0021) into one complete package
which will be called the Coal Workers’
Health Surveillance Program (CWHSP).
Upon OMB approval, 0920–0021 will be
discontinued. CWHSP is a
congressionally-mandated medical
examination program for monitoring the
health of underground coal miners,
established under the Federal Coal Mine
Health and Safety Act of 1969, as
amended in 1977 and 2006, PL–91–173
(the Act). The Act provides the
regulatory authority for the
administration of the CWHSP. This
Program, which includes both a health
surveillance and an autopsy component,
has been useful in providing tools for
protecting the health of miners (whose
participation is entirely voluntary), and
also in documenting trends and patterns
in the prevalence of coal workers’
pneumoconiosis (‘black lung’ disease)
among miners employed in U.S. coal
mines. During the early 1970s, one out
of every three miners examined through
the CWHSP who had worked at least 25
years underground had evidence of
pneumoconiosis on their chest x-ray. An
analysis among over 25,000 miners who
participated in the x-ray Programs from
1996 to 2002 indicated that the
proportion of affected individuals had
decreased to about one in 20. However,
recent surveillance analyses and
research studies have confirmed that the
prevalence of ‘black lung’ disease is
increasing, there is regional clustering of
rapidly progressive pneumoconiosis
cases, and coal miners have a higher
risk of disease if they perform certain
jobs, work in smaller mines, or are from
certain geographic areas. Importantly,
young coal miners are developing the
disabling and lethal forms of ‘black
lung’.
Demographic and logistical
information is gathered from coal mine
operators and participating x-ray
facilities. Participating miners also
provide health and work histories, and
participating physicians report
radiographic findings. The Centers for
Disease Control and Prevention’s
National Institute for Occupational
Safety and Health, Division of
Respiratory Disease Studies, 1095
Willowdale Road, Morgantown, WV
26505, also called the Appalachian
Laboratory for Occupational Safety and
Health (ALOSH), is charged with
administration of this Program.
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From October 1, 1999 through
September 30, 2002, the Mine Safety
and Health Administration (MSHA), in
consultation with NIOSH, conducted a
pilot health surveillance program for
both underground and surface miners
(The Miners’ Choice Program). The
Miners’ Choice Program has been
continued as an extension of the
CWHSP (currently called the Enhanced
Coal Workers’ Health Surveillance
Program—ECWHSP). This extension of
the CWHSP currently operates utilizing
a mobile examination unit which travels
to mining regions to provide locally
accessible and more comprehensive
health surveillance, including chest
radiography, spirometry, and blood
pressure screening.
Under the Act, the provision of
periodic chest x-ray examinations is
specifically mandated, and the x-rays
are to be supplemented by such other
tests as the Secretary deems necessary.
In addition to radiographically-apparent
pneumoconiosis, miners are at risk for
the development of chronic obstructive
pulmonary disease (COPD). Chest
radiographs alone cannot provide a
measure of airflow obstruction and
therefore often miss important lung
disease. For this reason, spirometry, a
simple breathing test, is an additional
component that is particularly useful for
the health assessment of miners.
Periodic medical history and spirometry
tests have been recommended by
NIOSH for both surface and
underground coal miners since 1995, to
facilitate preventive actions, increase
miners’ participation in programs for
early detection of disease, and improve
the derivation of representative
estimates of the burden, distribution,
and determinants of occupational lung
disease in relation to coal mining in the
U.S. Finally, unrecognized hypertension
has previously been observed among
many miners, and the ECWHSP offers
blood pressure screening as a safe,
simple, and inexpensive test, which can
help target initiation of proven health
conserving medications.
The National Coal Workers’ Autopsy
Study (NCWAS) provides standardized
lung specimens for ongoing scientific
research as well as information to the
next-of-kin regarding the presence and
extent of coal workers’ pneumoconiosis
(black lung) in the lungs of the deceased
miner. The Consent Release and History
Form is primarily used to obtain written
authorization from the next-of-kin to
perform an autopsy on the deceased
miner. Because a basic reason for the
post-mortem examination is research
(both epidemiological and clinical), a
minimum of essential information is
collected regarding the deceased miner,
E:\FR\FM\25APN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22900-22902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9966]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information (RFI) To Identify and Obtain Relevant
Information From Public or Private Entities With an Interest in
Biovigilance
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This Request for Information (RFI) seeks to identify and
obtain relevant information regarding the possible development of a
public-private partnership (PPP) designed to facilitate the
identification of risks and strategies to assure safety of the U.S.
supply of blood and blood components, tissues, cells, and organs. This
RFI is intended to inform the Department of Health and Human Services
(HHS) regarding stakeholders, mechanisms, and approaches on issues
related to developing and managing a PPP and scope of PPP activities.
Replies are invited from (1) public or private entities with an
interest in biovigilance, and (2) entities with experience and
capabilities managing public-private partnerships (PPPs) in the
biological sciences and public health domains. This RFI is for
information and planning purposes only and is not a solicitation for
applications or an obligation on the part of the U.S. Government to
provide support for any ideas identified in response to it. Please note
that the U.S. Government will not pay for the preparation of any
information submitted or for its use of that information.
DATES: All responses must be received no later than 4 p.m. EDT on June
9, 2011 at the address listed below.
ADDRESSES: All responses should be e-mailed to Biovigilance@hhs.gov
(attention Dr. Jerry Holmberg). Please limit responses to 10 pages.
Include in the subject line, the following information:
Name of the institution or site.
Respondent, title, and full contact information.
FOR FURTHER INFORMATION CONTACT: Dr. Jerry Holmberg, Senior Advisor for
Blood Safety, Office of the Assistant Secretary for Health, Office of
the Secretary, U.S. Department of Health and Human Services, 1101
Wootton Parkway, Tower Building, Suite 250, Rockville, MD 20852.
SUPPLEMENTARY INFORMATION: In 2009, the Advisory Committee on Blood
Safety and Availability (ACBSA) within the Department of Health and
Human Services (HHS), Office of the Assistant Secretary of Health,
reviewed and discussed a report on the current state of biovigilance.
In that report (``Biovigilance: Efforts to Bridge a Critical Gap in
Patient Safety and Donor Health'' https://www.hhs.gov/ash/bloodsafety/biovigilance/), biovigilance was defined as ``a comprehensive
and integrated national patient safety program to collect, analyze, and
report on the outcomes of collection and transfusion and/or
transplantation of blood components and derivatives, tissues, cells,
and organs. This definition does not include vaccines, allergenic
products, and most recombinant human proteins.'' Safety surveillance
for plasma derivatives, while a logical part of biovigilance, already
falls under FDA mandated drug adverse event reporting and is not
addressed in the current HHS initiative. Among the recommendations in
that report was for HHS to develop an HHS action plan to support a
national biovigilance program, integration of systems within government
and private sectors, and steps to enhance mechanisms for surveillance.
HHS is continuing its efforts to develop an action plan to support
a national biovigilance program for blood and blood components,
tissues, cells, and organs. As part of these efforts, HHS is exploring
the feasibility of a PPP. HHS believes that a PPP potentially could
serve as an appropriate mechanism for achieving the broad goals and
mission of biovigilance. A PPP might provide the American public with a
mechanism for leveraging and maximizing resources, for collaborating on
research and problem solving, for creating new opportunities, and for
advancing the Department's public health mission as it relates to
challenges associated with disease prevention (including emerging
infectious diseases or EIDs), adverse events, and process improvements.
Biovigilance is an area of growing importance, with a potential
role in any of the following areas:
Identifying strategies for protecting recipients and
living donor health;
[[Page 22901]]
Identifying processes that reduce medical errors and
improve donor/patient outcomes in blood transfusions, and tissue and
organ transplantations;
Reporting and analyzing adverse events, including medical
``near misses'' and patient adverse reactions;
Identifying emerging infectious disease prevalence and
incidence in donors and recipients, both quickly and effectively;
Informing public health and regulatory policy, and
reimbursement decisions; and,
Contributing to and collaborating on research studies,
including research that provides a basic understanding of recipient
outcomes so as to inform future surveillance activities.
Specific areas and activities in which a biovigilance PPP is likely
to be involved may include:
Safety and surveillance--Identifying areas where greater
safety and surveillance measures are needed.
Process improvement--Proposing new processes or process
enhancements to improve blood and blood component, tissue, cell, and
organ safety for donors and recipients.
Standards and measurements--Identifying areas where
standards are lacking or need additional development; proposing
definitions for standards; defining measurement approaches or best
practices for collecting measurement data.
Research and analysis--Identifying research needs;
proposing and conducting short and long-term research studies;
identifying knowledge gaps that prevent effective surveillance or
reporting; proposing strategies for closing these gaps.
Data repositories, infrastructure and policies--
Identifying requirements for new data repositories and related
infrastructure; developing policies for data sharing, access, privacy
and confidentiality; establishing and operating such data repositories
and related infrastructure (or contractually arranging for the
operation).
Baseline data, data quality, measurement, and collection--
Establishing baseline data and associated quality standards for
measurement and collection of that data.
Goal setting--Establishing targets or goals for improved
outcomes.
Reporting--Issuing regular and periodic reports on
progress, trends, adverse outcomes, and corrective actions to improve
patient safety and donor health.
Innovation in technologies and post-marking surveillance
of new technologies.
Interested stakeholders in biovigilance may include any of the
following, and/or others:
Foundations and non-profit entities with an interest or
responsibilities in biovigilance, in particular those with a public
advocacy mission related to supply, access, safety, use, or payment of
blood, tissues, cells and organs and/or those with expertise in PPPs;
Recipients of blood or blood components, tissues, cells,
or organs;
Donors, potential donors, and donor families;
Healthcare facilities, including transfusion services and
transplant centers;
Pharmaceutical, diagnostic, and other related
biotechnology companies offering products, services, medical equipment,
or technology;
Organizations engaged in collecting, recovery banking,
preserving, distributing or processing blood, organs, or tissues, or
cells;
Insurance companies, self-insured entities, and other
payers;
IT and database companies;
Professional, research, and academic organizations;
Other U.S. Federal, State, or local government groups with
an interest or responsibilities in biovigilance; and,
Managing partners or consultancy firms.
Information Requested
The Assistant Secretary for Health has charged a biovigilance
working group, with membership from the HHS Operating Divisions, to
define the foundational elements and operating framework for a National
Biovigilance Program within HHS and for a PPP. This framework for a
National Biovigilance Program will propose a set of high-level
strategic goals, priorities, and key initiatives for the next five
years. In developing the framework, HHS will take into account the
feasibility, as well as foundational elements and basic operating
framework for a PPP.
HHS is interested in exploring a biovigilance PPP that could
achieve its mission through collaboration among public sector entities
(e.g., government agencies and institutions) and private sector
entities. Private sector entities include, but are not limited to
academia; non-governmental organizations (NGOs); philanthropic
institutions; patient groups; blood bank operators; blood, tissue,
cell, and organ establishments or manufacturers, transplant centers,
and professional societies; and other members of the blood, tissue,
cells, and organ communities. Under such a partnership, all partners
might engage in the development of an operating structure and policies
that will meet the broad goals of biovigilance as well as serving the
needs and interests of the partners. Due to the expanding role of blood
transfusion, and tissue, cell and organ transplantation in the
healthcare sector, sustained involvement among partners might be needed
for the foreseeable future.
This RFI is being issued to notify the public that HHS is exploring
the feasibility of a PPP as an approach for achieving the broad goals
of biovigilance. This RFI, moreover, is being issued to encourage all
interested parties to comment on any aspect of a PPP. This may include
any of the following:
General or organizational issues:
[cir] Scope, key priorities, goals, or initiatives for the PPP in
the first five years;
[cir] Key PPP challenges and critical success factors.
Structural issues, such as:
[cir] Governance structure, operating and voting rules, and
decision-making processes for the PPP;
[cir] Funding mechanisms and models for both the start-up period
(during the initial 6-18 months) and the long term, to support
sustained funding for an ongoing collaboration.
Partner issues, including:
[cir] Identification of potential partners;
[cir] Management approaches for optimizing public and private-
sector involvement.
PPP scope and activities:
[cir] Project and research selection strategies in evaluation of
the suitability of projects, partners, and overall internal decision-
making structure;
[cir] Standards and measurements (definition, development,
implementation)
[cir] Data collection through surveillance;
[cir] Analysis of data;
[cir] Public policy influence and development;
[cir] International biovigilance.
PPP Management issues, such as:
[cir] Expertise and experience in managing a PPP, particularly in
the biological sciences and public health domains;
[cir] Expertise and input on applicable research agendas. This
could include how the PPP functions with regard to direct solicitation
of research applications, how funding decisions are made, and the
performance of administrative or oversight functions for such
[[Page 22902]]
projects;
[cir] Fund-raising experience;
[cir] Fiscal management experience, including management of the
flow of funds among the partners.
This RFI is for information and planning purposes only and should
not be construed as a solicitation or as an obligation on the part of
HHS. HHS does not intend to award a grant or contract to pay for the
preparation of any information submitted or for the use of such
information by HHS. Acknowledgment of receipt of responses may not be
made, nor will respondents be notified of the evaluation by HHS of the
information received. No basis for claims against HHS shall arise as a
result of a response to this request for information or to the use of
such information by HHS as either part of our evaluation process or in
developing specifications for any subsequent announcement. Any
proprietary information submitted should be clearly marked for
confidentiality.
Dated: April 20, 2011.
James J. Berger,
Associate Public Health Advisor for Blood, Organ, and Tissue Safety.
[FR Doc. 2011-9966 Filed 4-22-11; 8:45 am]
BILLING CODE 4150-41-P
