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federal_register: E6-15325

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E6-15325 International Development of H5N1 Influenza Vaccines; Funding Opportunity Notice The objective of this project is to mitigate any potential global shortage of influenza vaccines and the manufacturing of this vaccine in the event of an influenza pandemic. The Office of Public Health Emergency Preparedness (OPHEP) requires the World Health Organization (WHO) to perform activities related to pandemic influenza preparedness and planning, particularly in the international development of H5N1 human vaccines (and other pandemic influenza vaccine candidates) and influenza vaccine manufacturing infrastructure building in countries where resources for vaccine acquisition and manufacturing may be limited. The specific countries in which the WHO Secretariat will carry out these activities are Argentina, Brazil, India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. Activities include pre-clinical safety and immunogenicity testing, toxicology testing, clinical vaccine lot manufacturing, scale-up and process development, analytical lot release assay development and validation, and clinical immunogencity assay development and validation. 2006-09-15 2006 9 https://www.federalregister.gov/documents/2006/09/15/E6-15325/international-development-of-h5n1-influenza-vaccines-funding-opportunity https://www.govinfo.gov/content/pkg/FR-2006-09-15/pdf/E6-15325.pdf Health and Human Services Department 221 The objective of this project is to mitigate any potential global shortage of influenza vaccines and the manufacturing of this vaccine in the event of an influenza pandemic. The Office of Public Health Emergency Preparedness (OPHEP) requires the World...  

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