Radiation/Nuclear Medical Countermeasure Product Development Support Services

Type of Requirement: Re-competition (Contract No.: HHSN266200500043C) Place of Performance: Place of performance is unknown at this time. Recompetition: University of Maryland School of Medicine, PI: Dr. Thomas MacVittie, 10 South Pine Street, MSTF 6-04, Baltimore, MD 21201 Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612 Duration of contract: (5) Years If Options will be included, describe Options: None Anticipated award date: September 28, 2010 Presolicitation Notice Information 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 a contract entitled "Radiation/Nuclear Medical Countermeasure Product Development Support Services" to advance the development of candidate MCMs. NIAID anticipates that research and development studies supported by this RFP will advance candidate MCMs toward eventual FDA approval or licensure for ARS/DEARE and radionuclide contamination. 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). The Contractor will collaborate with NIAID and, under the direction of NIAID, with organizations that have developed MCMs and with other federal authorities, including the FDA. The proposals will be evaluated on the comprehensiveness, soundness, adequacy and suitability of the proposed scientific approach and methodology used to support the advancement of candidate MCMs for the mitigation or treatment of ARS/DEARES and internal radionuclide contamination towards FDA approval or licensure under the Animal Efficacy Rule and the organizational capabilities, experience and understanding of the development of MCMs against radiological and nuclear agents. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, GLP, cGMP and GCP compliance and project management. It is anticipated that one cost reimbursement, completion type contract will be awarded for a 5-year period of performance beginning on or about September 28, 2010. The Contract will focus in GLP and non-GLP animal efficacy studies to advance the development of radiation/nuclear medical countermeasures (MCMs) suitable for use in a mass casualty incident for 1) the mitigation or treatment of the acute radiation syndromes (ARS) and delayed effects of acute radiation exposure (DEARES); and 2) the decorporation of internalized radionuclides. The contract would also provide support services for chemistry, manufacturing and controls, non-clinical safety and pharmacology studies in support of IND/NDA/BLA submissions, and phase I clinical safety studies. The estimated FTEs would be approximately 20.3 per year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 10/06/09, 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.