THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE, 100% SMALL BUSINESS SET-ASIDE, OR UNDER FULL AND OPEN COMPETION . ALL ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. 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 (DAIT) and The Biomedical Advanced Research and Development Authority (BARDA) have a requirement to develop medical therapies and diagnostics to counter radiological and nuclear threats. Radiation injury can be caused by external or internal exposure, and the effects of radiation on the body may appear within minutes or develop many years after exposure. Internal exposure occurs when radionuclides are internalized by inhalation, ingestion, or through contaminated wounds and distributed to sensitive tissues. The primary treatment to minimize internal exposure is the elimination of internal radionuclides through the administration of chelating, decorporating, or blocking agents. Pentetate (diethylenetriaminepentaacetate) calcium trisodium (Ca-DTPA) and pentetate (diethylenetriaminepentaacetate) zinc trisodium (Zn-DTPA) have been shown to be effective in treating internal contamination with radionuclides such as plutonium, americium, or curium. DTPA increases the rates of elimination of these substances from the body through the exchange of calcium or zinc ions with the transuranium element. The transuranium-DTPA complex is stable and is excreted in urine. The calcium salt is 10X more effective than the zinc salt of DTPA in the first 24 hours following internal contamination, but after 24 hours, the salts are similarly effective. DTPA has been available for distribution from the Radiation Emergency Assistance Center/Training Site under an IND and formulations of Ca-DTPA and Zn-DTPA suitable for intravenous administration, or inhalation via nebulizer, were approved by the FDA in August 2004. Oral formulations of DTPA would be more easily administered than the injectable formulations, making DTPA easier to use in a mass casualty situation; however, DTPA is poorly absorbed when administered by these routes. The NIAID is interested in furthering the development of alternative formulations of DTPA that have enhanced oral bioavailability, and the capability to decorporate systemic transuranic compounds. The Offeror will have a lead native DTPA (Ca and/or Zn) nanoparticle formulation that has been shown to have enhanced DTPA oral bioavailability compared to the licensed formulation, and has been shown to decorporate a systemic transuranic compound in animals. The Offeror will provide the following by itself or through subcontract: assays in place to measure DTPA levels in biological fluids, pharmacology and toxicology capabilities to evaluate DTPA and transuranic radionuclide pharmacokinetics and safety of the formulated product, efficacy evaluation animal models, and radionuclide exposure facilities. Adherence to the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) is a term and condition of all PHS grant or contract awards that includes use of live, invertebrate animals. Both OLAW and AAALAC accreditations demonstrate compliance with PHS Policy. The USDA regulates institutions performing research on warm-blooded species other than rodents and birds and must comply with the Animal Welfare Act and Regulations. Any research facility using radioactive materials in scientific research studies must comply with appropriate federal and state licensing requirements. Organizations that have a lead DTPA oral formulation candidate and current capabilities in the following areas are invited to submit a capability statement to the NIAID. Requirements include: Oral bioavailability and radionuclide (transuranic) decorporation data of a lead nanoparticle candidate Radionuclide resources including a range of pertinent radionuclides (transuranics) Facilities for storage and disposal of radionuclides and contaminated waste Animal facilities for rodents and for housing and care of radionuclide contaminated animals Laboratories for all analyses and radionuclide measurements Instrumentation and equipment for laboratory, animal tissue, and radionuclide measurements Laboratories for radionuclide administration by injection Licenses and accreditations Staff trained and experienced in projected studies. Capability statements submitted as a result of this announcement should demonstrate the Offerors? qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: cGMP synthesis and product manufacturing capabilities, including stability studies Efficacy evaluation of radionuclide decorporation agents in animal models predictive of human responses Optimization studies for candidate decorporation agents (dose, schedule of administration) Radionuclide pharmacokinetic and biodistribution studies following intravenous administration Safety pharmacology studies in animal models Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. All capable organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Please limit responses to 5 pages. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer no later than 4:00 P.M., local time on March 21, 2008. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked (see Government-Wide Numbered Note 25).

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