R&D FOR SATISFACTORY METHOD OF PEDIATRIC PRUSSIAN BLUE (Radiogardase)

BARDA - Chemical, Biological, Radiological and Nuclear Medical Countermeasures Division Sole Source Synopsis Radiogardase 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 (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's mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN), in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the PHEMCE Implementation Plan for CBRN Threats and the National Strategy for Pandemic Influenza. The Implementation Plan for CBRN agents is located on the Assistant Secretary for Preparedness and Response (ASPR) website http://www.hhs.gov/aspr/barda/phemc/index.html and the National Strategy for Pandemic Influenza on the website http://www.pandemicflu.gov. The Government intends to award a sole source contract under the authority of FAR Part 6.302-1 to the Heyltex Corporation for the performance of research and development (R&D) to develop a satisfactory method of administering Radiogardase (Prussian blue) to pediatric subjects (age 0-2) and acquire FDA approval for language in the Radiogardase package insert that provides for the safe and effective use of the current formulation administered to members of the pediatric population (age 0-2 years) to reduce or eliminate internalized radioactive cesium (e.g., Cs-137) due to ingestion, inhalation, or other routes of exposure. Radiogardase is an FDA-approved product produced and distributed by the Heyltex Corporation with market exclusivity rights issued under the Orphan Drug Rule. The HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has a requirement to treat adults and children, including the 0-2 years of age range, who have internal contamination (ingested, inhaled, or otherwise) with radioactive cesium (e.g., Cs-137). The US Government currently has a surplus of Prussian blue, the FDA-approved treatment for Cs-137 decorporation in people greater than 2 years of age. The product in its current capsular form, however, is not FDA-approved for use in the age 0-2 years population. The work required is to obtain FDA approval for language in the Radiogardase (Prussian blue) package insert that provides for the safe and effective use of the current formulation of Radiogardase (FDA-approved for use in subjects of other ages), when administered to members of the pediatric population of age 0-2 years. Potential offerors who believe they may be capable of offering the requested services and would like to be considered as an alternative source are required to contact the Contracting Specialist by the published response time. State the Offeror's name, point of contact and a brief description of the services that may be provided that will accomplish the stated requirement so that the Government may make a determination of the feasibility of allowing open competition. Please contact the Contracting Officer/Specialist for additional information. Point of Contact(s): Michael Younkins, Contracting Officer Phone: 202-205-4709 Fax: 202-205-6061 Email: Michael.Younkins@hhs.gov Wayne Medina Phone: 202-205-2763 Fax: 202-205-6061 Email: Wayne.Medina@hhs.gov Contracting Office Address: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response (OS/ASPR), Acquisition Management, Contracts and Grants (AMCG), 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, USA