Special Studies and Analysis

This is a combined synopsis/solicitation Notice of Intent for commercial items prepared in accordance with the format of FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are not being requested, and a written solicitation will not be issued for the solicitation number NOI10139 a Notice of Intent. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC2005-42, dated June 16, 2010. This acquisition will be processed under Simplified Acquisition Procedures (SAP) and is not a small business set-aside. The associated North American Industry Classification System (NAICS) Code is 541712, which has a size standard of 500. The National Institute of Allergy and Infectious Diseases (NIAID) intends to obtain knowledge about the neuropathogenesis of the West Nile virus infection from a non human primate model and pre-clinical data on the safety of new WN/DEN4-30 vaccine products on a sole source basis from Charles River, Pathology Associates (PAI). This consistency is essential for analysis that is proprietary experimental design and is the only provider fulfilling our requirements for expertise, quality control, and timeline thereby making PAI a sole source provider for our vaccine safety studies. The PAI will conduct the following services: 1) up to six (6) preliminary staining runs to verify staining procedures and conditions detailed in the staining protocols provided by NIH, and NIH will provide all antibodies as well as positive and/or negative control materials to be used with the study; 2) 1860 slides will be processed in accordance with the provided NIH staining protocols, and appropriate positive and negative controls (as provided by Sponsor) will be included in each staining run conducted; 3) All stained slides will be quality controlled by an experienced pathologist (board-eligible or board-certified veterinary pathologist or PhD level pathologist with extensive experience in immunohistochemistry); 4) This will not be an non-GLP study and, as such, will not be monitored or audited by PAI's Quality Assurance Unit; and 5) Upon completion of the staining, all study materials (residual wet tissue, blocks, stained slides, residual antibodies, residual positive and negative control materials and raw data) will be returned to the Sponsor. The following factors shall be used to evaluate offers: 1) price, 2) capability to meet required specifications, and 3) delivery. Place of delivery Bethesda, Maryland, 20892. Delivery shall be 3 months after receipt of order. The FOB point shall be Destination. This will be a firm-fixed price contract. The following Federal Acquisition Regulations provisions and clauses apply to the acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items; FAR 52.212-2 Evaluation - Commercial Items; Far 52.212-3 Offeror Representation and Certifications Commercial Items; Far 52.212-4 Contract Terms and Conditions Commercial Items; Far 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items; and FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003); FAR 45.103 Responsibility and Liability for Government Property. A completed copy of provisions at FAR 52.212-3 Offerors Representation and Certifications Commercial Items must be included which can be found at Online Representations and Certifications Application (ORCA) https://orca.bpn.gov. By submission of an offer, the Offeror acknowledges the requirement that a prospective awardee shall be registered in the CCR database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The CCR website is http://www/ccr.gov. Copies of the aforementioned clauses are available upon request by telephone to Lawrence Bland at (301) 402-2282. All responsible sources may submit offers that will be considered by this agency. Offers must be submitted no later than 5:00 p.m. Eastern Daylight Savings Time (EDST), July 26, 2010. For delivery through the U.S. Postal Service, the address is NIH/NIAID/AMOB, 10401 Fernwood Road, Room 2NE38C, and Bethesda, MD, 20892-4811. Electronic and fax copies are not accepted. Requests for information concerning this requirement are to be addressed to Lawrence Bland at 301-402-2282. Collect calls will not be accepted.