INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND- NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to CHEMISTRY RESEARCH SOLUTION LLC for the synthesis, analysis and delivery of 4 g of each Fmoc-Cyclopentane PNA (cyPNA) monomers. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard $15,000,000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-98 This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE 90 days from award of Contract ? Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 8 Center Drive Bethesda MD 20892 DESCRIPTION OF REQUIREMENT Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) have designed and synthesized a series of new molecules called cyclopentane peptide nucleic acids (cyPNAs). Some of these molecules are potential components for diagnostic kits to be used for the rapid detection of nucleic acids associated with diseases. The development of new diagnostic kits to signal the early stages of infections or cancers could be of great benefit to human health and thus to NIDDK's mission. In order to make cyPNAs and study their binding to nucleic acid sequences, it is essential to have the correct starting materials. The Appella lab has shown that the incorporation of trans-cyclopentanediamine into PNA backbones improves binding to target nucleic acid sequences. Our research on cyPNA development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals to be custom synthesized in this order. Substantial in vitro work has been done to select cyPNAs to move forward as probes for diseases, which has incurred substantial investment. The company, Abzena, is a full-service contract research organization (CRO) fully familiar with the technical documentation required by the Food and Drug Administration (FDA). Abzena was originally recommended by the chemists at NCATS who work on the drug development program for orphan diseases. This is a highly specific research-based contract to make materials that are not commonly produced. These are synthetic materials that do not occur naturally and must be made using custom protocols developed by the NIDDK chemists. We have tried other sources and encountered technical difficulties, therefore a highly recommend and experienced contractor is essential. The objective of the research is to advance the testing of cyPNA as probes to signal the presence of infection or disease. To properly make cyPNA oligomers, the lab must have the correct building blocks that will be made in the proposed contract. Using the procedures provided by the NIDDK chemists, the company must scale up the production of the cyPNA monomer building blocks and deliver 4 g of each monomer to the NIDDK lab. Monomers received will be used to make cyPNA probes to target specific nucleic acids sequences associated with infection or disease. Results from each set of tests done are added to the file that will eventually be submitted for FDA approval as a new diagnostic test. The continuity of the project is enhanced by the use of as few CRO's as possible and only ones technically qualified to meet the specific needs of the research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Monday, August 6, 2018 to the Contract Specialist, Amber Harris, at
contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable
