BARDA Nonclinical Development Biological Network   9

The 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, provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

Together with our industry partners, BARDA promotes the advanced development of medical countermeasures (MCM) to protect Americans and respond to 21st century health security threats.

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) MCM Review (2010) recommended that PHEMCE partners provide not only financial help to medical countermeasure developers but also technical and regulatory assistance. BARDA's Strategic Plan (2011) set a goal to provide assistance to developers through core assistance programs in critical areas including nonclinical and clinical services to obtain safety and efficacy data supporting MCM development.

To meet the demands for MCM development and support an ever-increasing need for nonclinical services including those required to address 21st Century Threats and BARDA's innovation activities, this solicitation seeks to establish a Nonclinical Services Network of laboratories providing expertise, capacity, and program management across three capability areas:

Capability Area 1: Animal Model Development and MCM Testing (Biological Agents)

Capability Area 2: Analytical Method Development, Qualification, Validation, and Testing

Capability Area 3: Safety and Toxicity Testing

BARDA anticipates awarding multiple IDIQ contracts that provide a guaranteed minimum award to the organizations or consortiums that meet the overall qualifications needed to fulfill the technical requirements of this solicitation for each capability area. Sample Task Orders are provided in the RFP solely to evaluate Offerors' responses and capabilities. Responses for Task Order Requests (RTORs) for specific tasks will be issued after award of the Parent Contract. This IDIQ will be administered and used to support BARDA initiatives as necessary to help accomplish its mission.