[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22900-22902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9966]


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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.

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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 [email protected] 
(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'' http://www.hhs.gov/ash/bloodsafety/biovigilance/index.html), 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;

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     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

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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