Office of Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

The Office of Acquisitions Management, Contracts, and Grants (AMCG) on behalf of the Office of Biomedical Advanced Research and Development Authority (BARDA) solicits proposals for the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population. BARDA anticipates that Research and Development (R&D) activities awarded under this BAA will serve to advance candidate medical countermeasures towards licensure or approval by the U.S. Food and Drug Administration (FDA). This BAA will also serve to advance the knowledge and scientific understanding of candidates' platform technologies, modeling and forecasting, and visual analytics.BARDA encourages the advanced research, development, and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of CBRN agents, emerging infectious diseases, and pandemic influenza. These efforts are in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the 2016 PHEMCE Implementation Plan for CBRN Threats. The Implementation Plan is located on the ASPR website: https://www.phe.gov/Preparedness/mcm/phemce/Documents/2016-phemce-sip.pdf.The Pandemic and All Hazard Preparedness Act Pub. L. No. 109-417, 42 U.S.C. 241 et seq. (PAHPA: http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf) and The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No. 113-5, (PAHPRA: http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf) authorizes BARDA to (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development.Areas of Interest: The purpose of this Broad Agency Announcement (BAA) is to solicit proposals that focus on one or more of the following areas of interest as listed here and further described in Part I.Research and Development Areas of Interest:1. CBRN Vaccines2. Antitoxins and Therapeutic Proteins3. Antibacterials4. Radiological/Nuclear Threat Medical Countermeasures5. Chemical Threat Medical Countermeasures6. Burn Medical Countermeasures7. Diagnostics8. Influenza and Emerging Infectious Diseases (IEID) Vaccines9. Influenza and Emerging Infectious Diseases (IEID) Therapeutics 10. Respiratory Protective Devices11. Ventilators12. MCM Production Platform Systems13. Modeling as an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats14. Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN ThreatsThe Government intends to have a full & open competition for this requirement in the form of a BAA. The Government expects to make one or more awards, subject to the availability of funds.Anticipated funding for the program is subject to congressional appropriations. The program funding is subject to change due to government discretion and funding availability.