Mini Fragment Instrument and Impant Set

This is a synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. The Request for Quote number is N62645-09-T-0221. Quotes are due not later than 4:00 P.M. EST on 25 AUGUST, 2009. Provisions and clauses in effect through Federal Acquisition Circular 2005-18 are incorporated. NAICS 339112. Small Business size standard is 500 employees. The Naval Medical Logistics Command (NMLC) intends to negotiate on a Brand Name Only basis to procure a Mini Fragment Instrument and Implant Set, manufactured by Synthes, 1032 Wrights Lane E., West Chester PA In compliance with the Deployable Medical System (DEPMEDS) program and the Command's initiative to enhance Integrated Logistic Support (ILS) for Fleet Hospital applications, the only technically acceptable item that has (ILS) support is the Mini Fragment Instrument and Implant Set manufactured by Synthes. The Mini Fragment Instrument and Implant Set made by Synthes has been standardized for all of the fleet hospitals. The installed base is currently in more than half of the fleet hospitals. Brand name only is specified because the Government would incur a substantial duplication of cost, to consider other than the Synthes Mini Fragment Instrument and Implant Set, which is not expected to be recovered through competition. These items were standardized to maintain interoperability between all of the fleet hospitals. The choice of any other manufacturer would result in a breakdown of that interoperability between fleet hospitals and reduce the lifesaving capability of each of the fleet hospitals. Any vendors who can provide the brand name only equipment are encouraged to submit a quote. The Government contemplates award of a firm fixed price contract. This acquisition is being conducted under the FAR 13.5 test procedures for commercial items. Regulatory Requirements: The Mini Fragment Instrument and Implant Set and all of its components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States EVALUATION FACTORS FOR AWARD: The lowest price technically acceptable offeror for this brand name only requirement will represent best value to the Government. The government anticipates award of a Firm Fixed Price Contract. BUSINESS QUOTE INSTRUCTIONS: Offerors shall price each CLIN and shall submit firm-fixed pricing for all CLINS, otherwise your quote will be determined to be substantially incomplete and not warrant any further consideration. If no separate price for a CLIN this must be stated. Brand name only. No substitutions will be allowed. Shipping shall be FOB Destination. Business quotes will be evaluated for Completeness (all CLINS are priced) and Reasonableness (the degree to which the proposed prices compare to prices that are reasonable, prudent person would expect to incur for the same or similar equipment and commensurate with the Governments need). The government anticipates award of a Firm Fixed Price contract. Include commercial price lists and if applicable, any FSS schedule numbers and pricing, and any applicable discounts to the Government. ITEMS BEING PURCHASED IN THIS ACQUISITION: Synthes Mini-Fragment Instrument & Implant Set P/N 105.48J QTY 7 In order to be determined responsible, companies shall be registered in CCR, provide DUNS number, Cage Code, and TIN. Companies shall also comply with DFARS 252.232-7003, ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (JAN 2004). PROVISIONS at FAR 52.212-1, Instructions to Offerors---Commercial Items, apply to this acquisition with the exception of (d), (h), and (i) of the clause, which are RESERVED. Offeror shall include a completed copy of provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with their proposal. Offeror shall include a completed copy of provision at DFARS 252.212-7000, Offeror Representations and Certification-Commercial Items. Addenda to this provision includes DFARS 252.225-7000, Buy American Act-Balance of Payments Program Certificate; 252.225-7006, Buy American Act-Trade Agreements-Balance of Payments Program Certificate; and 252.225-7035, Buy American Act--North American Free Trade Agreement Implementation Act--Balance of Payments Program Certificate. FAR 52.212-4, Contract Terms and Conditions---Commercial Items, applies to this acquisition. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. In compliance with said clause, the following FAR clauses apply: 52.203-6, Restrictions on Subcontractor Sales to the Government, with Alternate I; 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36, Affirmative Action for Handicapped Workers; 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era. DFARS 252.212-7001, Contract Terms and Conditions Required to Implement Statutes or Executive Orders---Commercial Items, applies to this acquisition. In compliance with said clause, following additional DFARS clauses apply: 252.205-7000, Provision of Information to Cooperative Agreement Holders; 252.219-7005, Incentive for Subcontracting with Small Business, Small disadvantaged Businesses, Historically Black Colleges and Universities and Minority Institutions, Alternate I; 252.225-7001, Buy American Act and Balance of Payment Program; 252.225-7007, Trade Agreements; 252.225-7012, Preference for Certain Domestic Commodities; 252.225-7036, North American Free Trade Agreement Implementation Act; 252.247-7024, Notification of Transportation of Supplies by Sea. FAR clauses 52.202-1, Definitions; 52.211-6 Proposals shall be submitted by email only to Amanda Heller at: Amanda.Heller@med.navy.mil. Proposals are due by NLT 4:00 p.m. EST on 25 AUGUST 2009. All questions shall be addressed to Amanda Heller by email only, NLT 4:00 P.M. EST on 24 AUGUST 2009. No phone calls will be accepted.