A--Medical Radiation Countermeasure (MRC)

he U.S. Army Space and Missile Defense Command (USASMDC) is providing notice that a Request for Proposal (RFP), W9113M-07-R-0002, for the Advanced Development of Medical Radiation Countermeasures (MRC) will be issued on or about 10 January 2007 with an anticipated contract award on or about 20 July 2007. This requirement is being set aside 100% for small businesses. In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the Central Contractor Registration (CCR) data base. CCR registration can be accomplished at the following website: http://www.ccr.gov. The North American Industry Classification System (NAICS) code for this procurement is 541710 with a size standard of 500 employees. The Government does not intend t o use FAR Part 12 for this acquisition. The MRC shall be a drug or biologic that can be expeditiously developed, and when used after exposure to doses of ionizing radiation sufficient to cause the gastrointestinal (GI) syndrome of acute radiation syndrome , will either prevent/reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation/restoration of the anatomic integrity and normal physiologic functioning of the GI tract resulting in increased survi val, reduced incapacitation, and sustained operational effectiveness. The MRC should be delivered by minimally invasive means and in as few doses as possible. The MRC should have minimal logistics requirements, preferably not requiring refrigeration. Dev elopment and delivery of the MRC product shall require a Contractor to coordinate and manage the activities associated with advanced development of the product. The Contractor will be responsible for conducting the various activities associated with drug/b iologic development in manners that are consistent with eventual approval or licensure by the Food and Drug Administration (FDA). Associated activities will include, but are not limited to: manufacturing process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant small-scale manufacturing and testing of the radiation countermeasure product, Good Laboratory Practices (GLP)-compliant acute toxicology testing in animals, filing of an Investigational New Drug (IND) application, and conducting a Phase I clinical trial in accordance with FDA regulations and guidelines. After successful completion of the Phase I clinical study and Government review, the Contractor shall conduct necessary follow-on advanced developed activities leadi ng to FDA approval of the developmental end item. Production quantities will also be required. Proposals will be evaluated based on Factors, Subfactors, and Elements representing the Best Value to the Government. Delivery schedules will be proposed by the offerors and will be used as one of the evaluation criteria associated with a Best Value evaluation. Proposed delivery schedule calling for delivery of the approved FDA product within 5 to 8 years after contract award is anticipated, but all proposed d elivery schedules will be evaluated. All interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released on or about 10 January 2007 at the SMDC website hyperlink: http://www.smdc.army.mil/contracts/c ontracts.html. No paper copies of the RFP will be provided and no mailing list will be maintained because the acquisition will be posted on the above website. Questions or correspondence should be directed by e-mail to contact@example.gov and please reference the RFP number W9113M-07-R-0002.