The Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority’s (BARDA), has a requirement for Advanced Scientific Professional Staffing Support.

ASPR/BARDA’s mission is to support research and development efforts to provide medical countermeasures (MCM) that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.

BARDA was established by the Pandemic and All-Hazards Preparedness Act (PAHPA; PL 109- 417), which was signed into law on December 19, 2006. Title IV of PAHPA established BARDA within HHS to coordinate the acceleration of medical countermeasure advanced research and development by collaborating with medical countermeasures developers and manufacturers, supporting advanced research and development, facilitating advice from the HHS Food and Drug Administration (FDA) and other regulatory bodies, and by supporting innovation in technologies and strategic initiatives (PAHPA, Title IV, Sec. 319L (4)).

BARDA uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures including vaccines, therapeutics, diagnostics, and non- pharmaceutical products. This approach includes coordination and co-management of medical countermeasure programs across HHS agencies and other United States Government (USG) agencies and with industry stakeholders through public – private partnerships. Additionally, the pandemic influenza program establishes national networks and Centers to provide and sustain domestic manufacturing infrastructure of these medical countermeasures. Since pandemics by their very nature as global epidemics are not just a domestic concern, BARDA supports USG global leadership and obligations through pandemic influenza programs that support the building of influenza vaccine manufacturing capacity in developing countries with direct funding and technical expertise.

In the CBRN program, BARDA manages extramural programs that support advanced research and development and stockpiling acquisition of CBRN MCMs under Project BioShield including vaccines, antivirals and antibiotics, therapeutic antibodies, therapeutic proteins, peptides, small molecules, and diagnostics. The CBRN MCM portfolio includes candidates and products for smallpox, hemorrhagic fever viruses, anthrax, botulism, plague, tularemia, radiological and nuclear agents, nerve agents, and other bio-threats. Additionally, the CBRN division conducts intramural studies with The National Institutes of Health (NIH), Centers of Disease Control and Prevention (CDC), and industry partners to develop animal models that improve product formulations and analytical testing.

BARDA’s Emerging Infectious Diseases program is currently developing a formal methodology to assess which emerging or re-emerging diseases, including exploring products that may require Environmental Protection Agency (EPA) registration status, should be incorporated into the BARDA portfolio. We will next assess MCM needs and gaps through interagency teams, “Blue Ribbon” expert panels, public outreach, and mathematical modeling to support the development of priorities.

• Advanced Scientific Professional Staffing Support