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. The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), Laboratory of Cellular and Developmental Biology intends to award a purchase order without providing for full and open competition for Fmoc PNA monomers and Bhoc Nucleobase Acids from Polyorg, Inc., 10 Powers Street, Leominster, MA 01453. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325414 with a Size Standard 1,250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2020-07 effective 07-02-2020. 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 ($150,000) and FAR Subpart 12- Acquisition of Commercial Items. 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). Place of Performance National Institutes of Health National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK)/DKUHD 9000 Rockville Pike Bethesda, MD 20892, United States Description of the Requirement: Chemists in the NIH/NIDDK have designed and synthesized a series of new molecules called thyclotides. 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 thyclotides and study their binding to nucleic acid sequences, it is essential to have the correct starting materials. The NIDDK lab has shown that the incorporation of trans-cyclopentanediamine into PNA backbones improves binding to target nucleic acid sequences. Research on thyclotide development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals in this order. Thyclotides are made in combination with aegPNAs, the monomers of which are part of this purchase. Thyclotides need the nucleobase attached, and the Bhoc nucleobase acids are also part of this purchase. These are the essential starting materials we must have for our research to continue. Substantial in vitro work has been done to select thyclotides to move forward as probes for diseases, which has incurred substantial investment. Fmoc-A-(Bhoc)-aeg-OH, 98+% Catalog#: 16-0601 Quantity: 20 g Fmoc-C-(Bhoc)-aeg-OH, 98+% Catalog#: 16-0603 Quantity: 20 gm Fmoc-G-(Bhoc)-aeg-OH, 98+% Catalog#: 16-0607 Quantity: 20 gm Fmoc-T-aeg-OH, 98+% Catalog#: 16-0620 Quantity: 20 gm A-(Bhoc)-acetic acid Catalog#: 01-0211 Quantity: 60 gm C-(Bhoc)-acetic acid Catalog#: 03-0211 Quantity: 60 gm G-(Bhoc)-acetic acid Catalog#: 07-0211 Quantity: 60 gm CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon previous the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined Polyorg the sole source provider of the materials needed to continue research. The NIDDK is unable to scale up synthesis beyond specific scales and is also unable to make the starting material desired in this purchase. The cyPNA molecules must be produced using the starting materials in this purchase. The incumbent company, Polyorg, is a highly specialized chemical company with specific proprietary technology to make the required starting materials. 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 company Polyorg. There are no other sources that can provide the material we need in the quantity and enantiopurity that is required. 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: unit price, list price, shipping and handling costs, the delivery period after contract award, 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 11:00 am Eastern Standard Time, on August 4, 2020 to Verne Griffin,
[email protected] and shall reference solicitation number NICHD-20-162. Assessment of Capability Award will be made to the contractor who provides the most advantageous quote to the government. Technical factors and price considered. In order to be considered technically acceptable the offeror must provide the services listed under “Description of the Requirement”.