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 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 ENTRECHEM SL for the acquisition of Enantiomers of trans-N-Boc-1,2- Tetrahydro-3,4-furandiamine.  

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 325180 with a Size Standard of 1,000.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2020-07 effective August 31, 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 ($250,000).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.  Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. 

BACKGROUND
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. 

The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. 

NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities.  The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts.
 
PURPOSE AND OBJECTIVES
Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) 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 Appella lab has shown that the incorporation of trans-cyclopentanediamine into PNA backbones improves binding to target nucleic acid sequences. Our research on thyclotide development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals in this order. 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.

The objective of the research is to advance the testing of thyclotides as probes to signal the presence of infection or disease. To properly make thyclotide oligomers, the lab must have the correct building blocks that will be made from the materials to be purchased in this contract. The company must provide 100g each of (1S,2S)-trans-N-Boc- Tetrahydro-3,4-furandiamine and (1R,2R)-trans-N-Boc- Tetrahydro-3,4-furandiamine. These materials will be converted into the monomers needed to make thyclotide 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.  

The unique molecules in this order are (1S,2S)-trans-N-Boc--Tetrahydro-3,4-furandiamine and (1R,2R)-trans-N-Boc- Tetrahydro-3,4-furandiamine which are provided in greater than 99% enantiomeric excess. These starting materials are needed to make an experimental class of molecules called thyclotides, which were invented in the Appella lab of NIDDK. Thyclotides have the potential to become components of diagnostic kits to signal the presence of disease. Reliable diagnostic tests can be of great benefit to human health and thus to NIDDK’s overarching mission. The development of thyclotides as components of diagnostic kits cannot proceed without the chemicals in this order and in the stated enantiopurity.

This Sources Sought is for an organization or institution to provide the NIDDK with the chemicals identified above.  The purchase of these chemicals is necessary to maintain the high quality of our research.  

All qualified small businesses, whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; interested in submitting a corporate capability statement should demonstrate their capability to provide equipment that meets the characteristics below.

Specifically, the NIDDK requires the following:

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS:

Task Area 1 – Synthesize 100g each of (1S,2S)-trans-N-Boc-cyclopentanediamine and (1R,2R)-trans-N-Boc- Tetrahydro-3,4-furandiamine with purity equal or greater than 98% by NMR, and with enantiopurity greater than 99%ee. Any single contaminant to be less than 1.0% by weight.
    
Task Area 2 – Deliver 100g each of (1S,2S)-trans-N-Boc- Tetrahydro-3,4-furandiamine and (1R,2R)-trans-N-Boc- Tetrahydro-3,4-furandiamine in a glass or plastic canister inside a protected shipping box or package to NIDDK investigator on NIH campus, Building 8, Room 404.

Task Area 3 – Deliver each Certificate of Analysis to NIDDK Investigator.

Task Area 4 – Deliver written details of synthesis as conducted including throughput, to make the compound, to NIDDK investigator.

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 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 MEDSTAR RESEARCH INSTITUTE INC to be the only reasonably available source to provide the services to study if evidence that beet root juice supplementation can improve nitric oxide delivery into the human eye the NIDDK requires.  

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 company, ENTRECHEM SL, is an established chemical company with specific expertise to make the molecules in this purchase.  ENTRECHEM SL has proprietary technology to make these desired molecules.  This is a highly specific research-based purchase to acquire materials that are not commonly produced. These are synthetic materials that do not occur naturally and must be made using custom protocols. There is no other vendor that can provide the same materials in the quantity and enantiopurity that we require.

PERIOD OF PERFORMANCE

Description of the supplies or services to be purchased:
Synthesis of Enantiomers of trans-N-Boc-1,2- Tetrahydro-3,4-furandiamine     100 g of each molecule     90 days from award
Data Analysis & Report    COA    100 days from award
Written details of the synthesis as conducted including yields        100 days from award

Place of Performance
National Institutes of Health 
National Institute of Digestive, Diabetes & Kidney Diseases 
8 Center Drive
Bethesda MD 20814
 

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 responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Tuesday, September 15, 2020 to the Contract Specialist, Amber Harris, at [email protected] .

Assessment of Capability
Lowest Price Technically Acceptable