Research

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541711, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for 100% Small Business Set Aside competition for a firm fixed-price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Background: The Center for Biologics Evaluation and Research (CBER) is seeking a contractor to produce 40 German cockroach-specific scFvs (single-chain fragment variable; a type of antibody), 40 Neurospora crassa-specific scFvs, 40 Agarigus bisporus-specific scFvs, and 40 Nicotiana benthamiana/excelsiana-specific scFvs. These four allergens will be provided to the contractor. This work will be done as part of the development of the multiplex allergen extract potency assay (MAEPA). The purpose of MAEPA is to assess the overall potency of complex allergen mixtures. CBER is currently in the process of developing and optimizing MAEPA for less complex allergen mixtures and are ready to move into more complex mixtures such as the cockroach allergen extract. The development of this assay will be an important step towards analyzing the allergenicity of cockroach extract as well as many other extracts currently on the market that do not have a standard of potency. We are also working to evaluate potential allergens that may exist and co-purify with vaccines produced in novel expression systems. A human scFv library used to screen these extracts will be expected to enable us to find allergens relevant to humans. I. Scope of Work A. TASKS – The contractor shall perform the following services for each of the four allergens (allergens to be provided to contractor) 1. Phage display screening (4 cycles) of human recombinant library (scFv) 2. Characterization of 40 selected binders by ELISA (enzyme linked immunosorbent assay) of expressed antibody and sequence of encoding DNA (deoxyribonucleic acid) 3. Production of plasmids encoding 25 selected unique binders. B. DELIVERABLES for each of the four allergens (allergens to be provided to contractor) I. ELISA results from biopanning cycle 4 submitted in Excel spreadsheet. DUE: 1 October 2009 II. ELISA of each of the 40 positive clones DUE: 1 December 2009 III. DNA sequence of all ELISA-positive clones DUE: 1 December 2009 III. Plasmids of each of the 25 positive and unique clones (may be in bacterial stocks) DUE: 1 December 2009 IV. Written report of the study in Word format DUE: 1 December 2009 EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," (2) Past performance and 3) Price-- price warranty to include two (2) option years. Technical Capability and past performance when combined are significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: [email protected], no later than 4:30pm, EST on or before August 12, 2009. QUOTATIONS DUE: All quotations must be received by email to: [email protected], no later than 4:30pm, EST on or before August 17, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.