THIS IS A FORMAL SYNOPSIS OF A PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. THIS COMPETITIVE ACTION IS BEING PROCURED UNDER FULL AND OPEN COMPETITION. The Department of Health and Human Services (HHS) intends to issue a Request for Proposal (RFP) for the acquisition of ancillary materials (needles, syringes, and combination units, isopropyl alcohol prep pads) from medical/surgical device manufacturers to meet the vaccine administration needs of the American public during a pandemic influenza event. To ensure coverage, manufacturers are expected to acquire, maintain and rotate inventories of integrated needle and syringe units of various types for pandemic preparedness. The management of these materials will be coordinated and integrated by HHS/ASPR/BARDA to provide long-term solutions that address and satisfy the vaccine administration requirements during pandemic influenza events and account for recent technology advances in vaccine manufacturing where the ability to produce influenza vaccines may outstrip the capability of medical/surgical manufacturers to maintain pace with sufficient needle/syringe units. The requirements for this RFP are as follows: 1. Manufacture and make available for purchase up to 512 million FDA approved integrated needle and syringe combination units. 2. Manufacture and make available for purchase up to 50 million FDA approved Needle/Syringe combination unit, 5ml or 6ml syringe, 20Gx1.5" needle, safety engineered. 3. Manufacture and make available for purchase up to 88 million FDA approved needles, safety engineered, of the following sizes: 23Gx1", 25Gx1", 25Gx5/8". 4. Manufacture and make available for purchase up to 88 million FDA approved 3ml Syringes, luer lock, safety engineered. 5. Manufacture and make available for purchase up to 600 million Isopropyl Alcohol Impregnated Prep Pads, sterile, individually sealed, small. Note: Manufacturers who do not manufacture this product do not need to respond to this CLIN. 6. Manufacture and make available for purchase up to 300 million FDA approved integrated needle and syringe combination units (conventional) 7. Provide a manufacturing/production schedule representative of the surge capacity that can be made available to the USG for pandemic planning purposes. 8. Upon request, provide a delivery schedule of the products that will be made available to the USG for pandemic Influenza response. 9. Store, rotate, replenish and manage USG purchased products as vendor management inventory. 10. Package, handle, and ship USG purchased products from contractor owned/contractor operated distribution facilities to USG designated domestic receiving locations. Receiving locations and Points of Contact information will be provided in task orders. For planning purposes, the USG may elect to identify up to ten (10) receiving locations in the following continental geographic regions; three (3) in the Northeast, two (2) in the South Central Midwest, two (2) in the North Central Midwest, and three (3) in the west region. The contractor shall include all costs and expenses for transit, delivery and insurance of USG product. 11. Exchange USG purchased products for similar products where market demands indicate a change in user preference for other drug device products. 12. Dispose of expired, adulterated or damaged USG products as directed by the USG. The contractor shall dispose of product following any federal, state, local regulation for the appropriate waste category and provide documentation on the completed disposal activity. 13. Reporting and Inventory Requirements. Mandatory Criteria: The mandatory eligibility criteria must be met at time of proposal submission. To enter into consideration for the technical evaluation phase of the review process, the Contractor(s) is required to satisfy the following mandatory criteria for eligibility: - Documentation of FDA clearance for items 1-6 referenced in the requirement. - Documentation of meeting Quality Systems Regulation (21 CFR Part 820), e.g., Certificates of Analysis, Certificates of Conformance, Certificates of Sterility (where applicable). - Confirmation of Contractor's Manufacturing Site registration with the FDA. - Evidence to support weekly production of 250,000 needle / syringes units or more. - Evidence to support a 50%-100% surge in production capacity within three months of notification Technical Criteria: - Evaluation Criteria 1, Technical Approach: - Technical completeness and feasibility of the proposed plan to manufacture and make ancillary materials available at commercial scale for CLINs 0001 to 0006. - Technical completeness and feasibility of the proposed plan which addresses vendor management, i.e., storage, rotating of inventory, and replenishment of USG products during seasonal influenza campaigns. - Technical completeness and feasibility of the proposed plan to package, handle and ship ancillary products throughout the continental United States in pre-pandemic and pandemic (surge) phases. - Evaluation Criteria 2, Management Approach: - Adequacy of the contractor's plan to organize and manage work efforts across multiple product lines in support of a pandemic response. - Adequacy and appropriateness of experience, education, and training of corporate management, program manager(s), and other personnel assigned to the contract for the Statement of Work - Adequacy of the Risk Mitigation Plan to address the following supply chain risks. - Shortages in raw materials due to surge requirements. - Production line problems that may impact the delivery of product in a timely manner. - Quality control issues that may surface in production line operations when required to operating at maximum capacity. Issuance of this Pre-solicitation Notice does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Presolicitation Notice does not commit the Government to contract for any supply or service whatsoever. A Request for Proposals (RFP) will be available electronically through the FedBizOpps on or about May 17, 2013, with proposals being due on or about June 18, 2013. Any responsible Offeror may submit a proposal that will be considered by the U.S. Government. It is the Offeror's responsibility to monitor this internet site (www.fbo.gov ) for the release of the 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 around July 2013. Contract(s) awarded under this solicitation will be Indefinite-Delivery, Indefinite-Quantity with a base period of 12 months and three 12-month option periods. Please note that all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov and have their records updated in both the Central Contractor Registry (CCR) and the Online Representations and Certifications Application (ORCA).
