AMENDMENT 001: To delay the dates tentatively scheduled in the Pre-solicitation Notice. Please see attached Amendment 001. AMENDMENT 002: To revise the schedule pertaining to this Solicitation. The corrections have been made in the body of this Notice, and Amendment 002 is attached. AMENDMENT 003: To provide information regarding the Pre-proposal Conference. The Department of Health and Human Services (HHS) has the responsibility of maintaining a definitive supply of medical countermeasures - or the forward deployment of same - for use in national medical emergencies declared by the Secretary of HHS. HHS has a requirement to acquire, hold, and distribute medical countermeasures that will mitigate injuries caused by exposure to chemical threat agents, biological threat agents, and physical radiologic and nuclear exposures. In the case of exposure to radiologic or nuclear ionizing energy, the integrity and homeostasis of neutrophil number and function (i.e., neutropenia) is an early pathology that must be clinically addressed due to increased risk of infection and sepsis. The most common clinical treatment to address neutropenia is the use of Colony Stimulating Factor (CSF) as either Granulocyte (G) or Granulocyte-Macrophage (GM), also known as G-CSF or GM-CSF. HHS through the Office of the Assistant Secretary of Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA) contemplates single or multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contract(s) to support the acquisition of: 1) Product: a recombinant human Colony Stimulating Factor (CSF) as either Granulocyte (G) or Granulocyte-Macrophage (GM), also known as G-CSF or GM-CSF, for use in the treatment of neutropenia arising as a primary pathology from hematopoietic progenitor cell injury caused by a radiation or nuclear incident. The USG intends to purchase up to 2.79 million doses; 2) Services: a vendor-managed inventory (VMI, or as otherwise proposed by the offeror) with rotation of stock to control product expiry. The offeror shall provide and implement an inventory management plan that shall also include a plan for "at need" delivery of product should the USG have an immediate need for product in a declared emergency. 3) Advanced Development: It is the goal of the forthcoming RFP to obtain licensed products which have the indication of treatment of neutropenia (regardless of cause). No product currently holds a license for the indication of neutropenia arising from exposure to ionizing radiation alone. Thus, the USG intends to fund the advanced development of G- and GM-CSF products for this new indication. Prior to the submission of the proposal, the Offeror must have regulatory consult on the appropriate path for approval of their respective therapeutic for use in the treatment of neutropenia arising from exposure to ionizing radiation. It is the goal of BARDA to acquire one or more Colony Stimulating Factors (G- or GM-CSF) for mitigation of neutropenia arising from exposure to ionizing radiation. The optional cost reimbursement advanced development CLIN will provide BARDA with a compendium of studies that will support the use of the product in a declared emergency (a CDC and FDA agreement) and aid in taking the product to license or approval. The Awardee(s) selected for this contract will be providing either the designated product, the vendor-managed inventory (VMI), or both. The successful Offeror(s) will provide product and service, or assure coordination with the product contractor (sponsor) or provider of the VMI (as appropriate) in providing product holding with stock rotation. Offerors shall propose a product delivery or availability schedule that may be subject to negotiation. The schedule for delivery or manner of product availability will be incorporated into the final contract upon award. The government may also assist qualified offeror(s) in the Advanced Development of their product under an optional Contract Line Item Number (CLIN) to provide funding toward a second licensed indication for treating neutropenia arising from exposure to ionizing radiation. Offerors may submit proposals for acquisition of product only or acquisition of product with advanced development. The anticipated period of performance will be for base period of up to five years or 60 months. Additional details and requirements will be described in the solicitation. A Request for Proposal (RFP) will be available electronically through the FedBizOpps on August 10, 2012, with proposals being due on October 10, 2012. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. It is the offeror's responsibility to monitor this internet site (www.fbo.gov ) for the release of this solicitation as well as any amendments. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses should be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, fax number, and email address, and should be submitted to the Point of Contact(s) identified in this notice. Multiple awards may result from this solicitation with an estimated award date of April 2013.
