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###### Department of Health and Human Services

# 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”                     *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;       ( print 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:

○ Scope, key priorities, goals, or initiatives for the PPP in the first five years;

○ Key PPP challenges and critical success factors.
    - Structural issues, such as:

○ Governance structure, operating and voting rules, and decision-making processes for the PPP;

○ 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:

○ Identification of potential partners;

○ Management approaches for optimizing public and private-sector involvement.
    - PPP scope and activities:

○ Project and research selection strategies in evaluation of the suitability of projects, partners, and overall internal decision-making structure;

○ Standards and measurements (definition, development, implementation)

○ Data collection through surveillance;

○ Analysis of data;

○ Public policy influence and development;

○ International biovigilance.
    - PPP Management issues, such as:

○ Expertise and experience in managing a PPP, particularly in the biological sciences and public health domains;

                    ○ 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                           ( print page 22902)                        projects;                

○ Fund-raising experience;

○ 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