ANSI - American National Standards Institute
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HHS Issues Request for Information on Public-Private Partnership for Biovigilance


New York, Jun 15, 2011

The U.S. Department of Health and Human Services (HHS) has issued a request for information as it considers the potential development of a public-private partnership on biovigilance that would assure the safety of the U.S. supply of blood and blood components, tissues, cells, and organs. As the coordinator of the U.S. standards and conformance system, the American National Standards Institute (ANSI) encourages members and all affected stakeholders to provide relevant input on this key area of activity for public health and safety. Responses may be submitted to HHS through June 30, 2011.

According to HHS, biovigilance is an area of growing importance, and has been 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.

Specific areas and activities in which a public-private partnership in biovigilance is likely to be involved may include:

  • 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.

  • 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.

  • 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. <

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Responses received will inform HHS regarding stakeholders, mechanisms, and approaches on issues related to developing and managing a public-private partnership and the scope of the partnership’s activities. Replies are invited from public or private entities with an interest in biovigilance, and entities with experience and capabilities managing public-private partnerships in the biological sciences and public health domains.

Comments may be submitted to biovigilance@hhs.gov through June 30, 2011.

For further details, read the April 25 or June 10 Federal Register notices.

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