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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 Nat... 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 PRECIGEN BIOINFORMATICS GERMANY GMBH for the purchase of a Genomatix Genome Analyzer and associated maintenance agreement for access to cloud-based instance. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 511210 with a Size Standard of $41.5. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-06 Effective July 12, 2021. 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 Base Year: 9/01/2021 -8/31/2022 Option 1*: 9/01/2022 -8/31/2023 Option 2*: 9/01/2023 -8/31/2024 Option 3*: 9/01/2024 -8/31/2025 Option 4*: 9/01/2025 -8/31/2026 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 8 Center Drive Bethesda MD 20892 ? DESCRIPTION OF REQUIREMENT 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 The National Institutes of Health (NIH)’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement for the Genomatix Genome Analyzer (GGA)- an integrated bioinformatics/biological content platform for the analysis of gene lists, microarray, and NGS data for a base plus four option years. The research projects that are submitted from PIs from NIDDK and beyond, which include about at least 100-300 projects, including microarray, mostly NGS projects, and some downstream bioinformatics data analysis per years.. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS Specifically, the NIDDK requires the following: • ElDorado: Extendend genome annotation for 33 organisms, including extensive proprietary regulatory annotation. • Gene2Promoter: Retrieve and analyze up to 1,000 promoters. • Genomatix Pathway System: Canonical Pathway database with dynamic unsupervised real time pathway construction, modeling and analysis mining. Integrates knowledge (literature) mining with molecular level sequence information and experimental data. • GEMS Launcher: Software Tool Kit containing regulatory sequence analysis and modeling software packages. • MatInspector: The de facto standard for transcription factor binding site search and analysis. • PromoterInspector: Highly specific proprietary algorithm for the prediction of mammalian promoters. • RegionMiner: Toolkit with multiple applications/workflows for the high throughput analysis of NGS data. All above functions will greatly help NIDDK for the downstream unique data analysis. 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 PRECIGEN BIOINFORMATICS GERMANY GMBH to be the only reasonable available source to provide a Genomatix Genome Analyzer and associated maintenance agreement for access to cloud-based instance. This acquisition was pursued on a sole source basis centered on the following: Genomatix Genome Analyzer (GGA)- is an integrated bioinformatics/biological content platform for the analysis of gene lists, microarray, and NGS data. • The extensive amount of proprietary genome annotation is only available from Genomatix (e.g. S/MARs, Promoters, SNPs, protein/protein interactions, gene/transcription factor interactions, etc.), and also includes a proprietary, extensive, and unique promoter database. Both are basic requirements for a molecular level understanding of any form of biological process. Additionally, ENCODE validated data content has been included where appropriate to provide an additional level of confidence to the software’s outcomes. • Pathway analysis capabilities (Genomatix Pathway System) integrated with simultaneous DNA regulatory sequence information for understanding bait/prey relationships. This integration of literature mining (co-citation), extensive tissue, disease, biological process, and GO filtering, and molecular level knowledge is required for bridging the gap between experimental data and an understanding of the regulatory factors involved in the system of study is unique to Genomatix. The dynamic unsupervised network building available in the Genomatix Pathway System allows for context specific pathway analysis under different biological conditions without limit as to the size/extent of the network, another unique Genomatix feature needed for any complete analysis. • Genomatix is the only source for comparative genomics promoter sequences, generated by a patent-pending CompGen software algorithm. Knowledge of Promoter sequences can be effectively used to understand the regulatory relationships between regulatory molecules. Genomatix is unique in both the extensive nature of its promoter library (in multiple species, allowing orthologous comparisons) and the integrated set of tools provided to search for common regulatory motifs. • The world’s largest database of high specificity transcription factor binding site matrices as referenced in: Cartharius, K., Frech, K., Grote, K., Klocke, B., Haltmeier, M., Klingenhoff, A., Frisch, M., Bayerlein, M., Werner, T. (2005) MatInspector and beyond: promoter analysis based on transcription factor binding sites. Bioinformatics, April 28, 2005 https://academic.oup.com/bioinformatics/article/21/13/2933/197757 This database is crucial for an accurate and in-depth understanding of common regulatory mechanisms. • Fully automated workflows for ChIP-Seq and RNA-Seq expression analyses of NGS experiments that are completely integrated with the platform’s database content and multiple downstream analysis applications (some of which are described above). Therefore, the procurement of a Genomatix Genome Analyzer and associated maintenance agreement for access to cloud-based instance is necessary for continued analysis support. Failure to procure these deliverables from PRECIGEN BIOINFORMATICS GERMANY GMBH would result in a significant loss of 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 Wednesday, July 28, 2021 to the Contracting Officer, Amber Harris, at amber.harris@nih.gov. Assessment of Capability Lowest Price Technically Acceptable