Development of Medical Countermeasures to Mitigate or Treat the Gastrointestinal Acute Radiation Syndrome after a Nuclear or Radiation Incident

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Allergy, Immunology and Transplantation has been charged by the DHHS with developing products for treatment of radiation exposures resulting from a nuclear and radiological attacks to the stage where products are eligible for advanced product development by the Biomedical Advanced Research and Development Authority or acquisition under the Project BioShield Act of 2004. The National Institute of Allergy and Infectious Diseases intends to solicit proposals for contracts entitled "Development of Medical Countermeasures to Mitigate or Treat the Gastrointestinal Acute Radiation Syndrome after a Nuclear or Radiation Incident" to advance the development of candidate medical countermeasures (MCMs) for gastrointestinal acute radiation syndrome (GI-ARS). NIAID anticipates that research and development studies supported by this BAA will advance candidate MCMs toward eventual FDA approval or licensure for GI-ARS. For this Broad Agency Announcement, it is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs or biologics that are already licensed or approved for other indications), so the offeror is expected to provide a Statement of Work based on the stage of the candidate and the work that needs to be performed to advance the MCM. The proposals will be evaluated on the underlying data supporting the GI-ARS indication, and the comprehensiveness, soundness, adequacy and suitability of the proposed scientific approach and methodology used to support the advancement of the candidate MCM for the mitigation or treatment of ARS towards FDA approval or licensure under the FDA Animal Rule. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, (GLP, cGMP compliance) and project management. It is anticipated that 2-4 cost reimbursement, completion type contracts will be awarded for a 3-year period of performance beginning on or about 7/15/13. The NIAID estimates that the average annual total cost (direct and indirect costs combined) will be $1-2 million per contract award per year; however, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The period of performance proposed by an offeror should not exceed 3 years. Any responsible sources may submit a proposal which will be considered by the Agency. This BAA will be available electronically on or about 8/17/12, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.