Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development

BARDA - Strategic Science and Technology Division Broad Agency Announcement Synopsis Notice Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development The Office of Acquisition Management Contracts & Grants (AMCG) with the office of Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA/AMCG's mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN), as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. Preparedness mission and priorities are articulated in the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan for CBRN Threats and the National Strategy for Pandemic Influenza. The implementation plans are located on the Assistant Secretary for Preparedness and Response (ASPR) website http://www.phe.gov/preparedness/pages/default.aspx and the National Strategy for Pandemic Influenza on the website http://www.pandemicflu.gov. The Pandemic and All Hazard Preparedness Act (PAHPA) directs BARDA to promote (i) innovations in technologies that may assist countermeasure and product advanced research and development, (ii) research on and development of research tools and other devices and technologies, and (iii) research to promote strategic initiatives. Through this Broad Agency Announcement (BAA), BARDA seeks to advance the technological and scientific advancements of medical countermeasures for biodefense and emerging infectious disease threats, including pandemic influenza. The PAHPA is located on the ASPR website http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx. This BAA is a continuation of a previous BAA (BARDA-BAA-09-100-SOL-0010) and is similarly designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SST) of BARDA/AMCG and will be open to all responsible Offerors. The Government's intent is to solicit potential advancements in science and technology in the following BARDA SST Areas of Interest: 1. Technologies to accelerate evaluation of vaccines and therapeutics. 2. Formulation chemistry, protein stabilization, and vaccine delivery technologies. 3. Innovative methods in bioprocess development and manufacturing. 4. Methods and technologies to advance development of tests for rapid diagnosis of human injury and infection. The BARDA SST Areas of Interest are designed to target platform technologies focused on (1) product improvements to enhance the safety, efficacy, and ease of use of MCM, (2) reducing time and cost of MCM development, evaluation, and manufacturing, and (3) development of innovative diagnostic platforms for the rapid diagnosis of priority pathogens. The specific application of the technologies will focus on biodefense, pandemic influenza, and other emerging infectious diseases (EID). BARDA is open to evaluation of technologies at multiple stages of product development. BARDA anticipates that demonstrating utility of these novel platform technologies will generate validated data suitable for comparability analysis with candidate products and have direct application to commercial-scale manufacturing or testing processes. The development activities are to be fully integrated with regulatory activities associated with product development efforts. BARDA anticipates awarding multiple contracts, grants, cooperative agreements, and/or other transactions for research and development efforts from this BAA that have sufficient potential for success, are of interest to the Government, and support one or more of the listed BARDA SST Areas of Interest. Please contact the Contracting Officer for additional information. Point of Contact(s): Carolyn Keeseman, Contracting Officer Phone: 202-260-0950 Fax: 202-205-0613 Email: Carolyn.Keeseman@hhs.gov Elizabeth Elmazahi, Contract Specialist (Alternate) Phone: 202-205-8926 Fax: 202-205-6061 Email: Elizabeth.Elmazahi@hhs.gov Contracting Office Address: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Acquisitions Management, Contracts, and Grants, 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, USA 2/28/2011 Amended the POC and POC Alternate Individuals to Carolyn Keeseman, Contracting Officer and Elizabeth Elmazahi with respective contact information.