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INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). National Institute of Men... INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). National Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with New York Stem Cell Foundation Research Institute (NYSCF), 619 W. 54th Street, Floor 3, New York, NY 10019-3545, USA NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541714 – Research and Development in Biotechnology (except Nanobiotechnology). REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases NOT exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-04 dated January 30, 2022. STATEMENT OF NEED AND PURPOSE: The NIMH Section on Developmental Neurogenomics has invested significant Division of Intramural Research Programs’ resources in recruitment and characterization of rare patient groups with varying sex chromosome count (along with matched controls). NIMH is studying how sex chromosome aneuploidy (SCA) impacts brain structure amf function at multiple scales – from behavior to brain imaging to cellular features. To understand the impact of SCA on human brain cells, NIMH needed to rely on new and specialized techniques for differentiation of neural cells from human induced pluripotent stem cells (iPSCs). NIMH has iPSCs derived from several participants from our SCA study and have already begun to convert these to neuronal progenitor cells (NPCs) through a prior contract with New York Stem Cell Foundation (NYSCF). We now need to expand the sample size of each patient group for analysis at iPSC and NPC stage to maximize statistical power. BACKGROUND INFORMATION AND OBJECTIVE: The objective of this contract is to complete a full series of SCA NPCs spanning groups with many different combinations of X- and Y-chromosomes: X, XX, XXX, XXXX, XY, XYY, XXY, and XXYY. The contract would generate NPCs from a total of 20 individuals from this series (i.e. 20 lines). NIMHwould receive 40 clones from these 20 lines (2 clones per line). The contract would also allow for use of a process called “monoclonalization” to support successful line development for the subset of 20 clones estimated to need this. The invaluable tissues generated by this contract will enable us to measure – for the first time – how a wide range of sex chromosome dosage variation shapes cellular functioning in human brain tissue. These insights in turn will bring us closer to identifying molecular pathways that underpin medical disorders like sex chromosome aneuploidies, as well as sex-chromosome based differences between males and females in the general population. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION DETERMINATION NIH has already expanded iPSCs and generated NPCs on females with varying X-chromosome count (X, XX, XXX, XXXX) through a prior contract with NYSCF. NIMH also completed the same process for males with varying sex chromosomes (XY, XXY, XYY, XXYY) through another contract with NYSCF. The goal of this contract with NYSCF is to complete the full series of SCA NPCs spanning groups with many different combinations of X- and Y- chromosomes: X, XX, XXX, XXXX, XY, XYY, XXY, and XXYY. Therefore, NIMH needs the full series to be processed through the exact the same method. The process implemented by NYSCF is highly specific, multistage, and extends over several months – there is no way of replicating the process through another provider for comparability between the new males’ and females’ lines that have already been generated by NYSCF and the requested full series of SCA NPCs spanning groups with many different X- and Y- chromosomes. Thus, this is considered a follow-on acquisition to contract numbers 75N95020C00034 and 75N95021P00336 with NYSCF. Using a different vendor would cause irreparable harm to NIMH’s ongoing experiments and research because (i) loss of standardization in tissue culture protocols will introduce biases that prevent detection of interpretable differences between karyotype groups, and (ii) the central goal of this research is to detect differences between karyotype groups. NIMH requires the same vendor and processes in order to compare the data that has been collected thus far in previous contracts with The New York Stem Cell Foundation. In order to maximize statistical power, the expansion of the sample size of each patient group for analysis at iPSC and NPC stage is available from only one source, and competition is precluded. There are no substitutes available. PURCHASE DESCRIPTION: The specific requirements include: expansion and quality control of provided iPSCs for 20 individuals. 2 iPSC clones per individual line. Quality Control (QC) to include sterility, mycoplasma, karyotyping, identity testing, pluripotency expression profiling, and differentiation capacity. Differentiation of the resulting 20 iPSC clones into neuronal progenitor cells (NPCs), and verification of NPC status using standard immunofluorescence methods for presence of cell-type markers including, but not limited to, MAP2+ and nestin+. LEVEL OF EFFORT: iPSC expansion and QC: 60 labor hours per clone, 7 months to complete the process per clone. NPC generation and characterization: 40 labor hours per clone, 3 months to complete per line. GOVERNMENT RESPONSIBILITIES: Providing frozen vials containing iPSC clones, as well as associated coded IDs. No personally identifiable information (PII) will be available to the contractor. All work will be performed at the contractor’s facility. Reviewing and approving quality control and characterization reports as well as the final products (expanded iPSCs and NPCs) generated under the contract. DELIVERY OR DELIVERABLES: For each clone submitted to Contractor, Contractor will generate quality control data as specified under specific requirements and provide a written/electronic report to the Principal Investigator within 7 months of sample receipt. Within 21 days of providing the expanded iPSC quality control report, Contractor will ship at least 6 vials of each expanded iPSC clone. Clones will be frozen, packed on dry ice, and delivered safely to the Principal Investigator. Principal Investigator will review quality control report pertaining to characterization of iPSCs within 14 calendar days from date of receipt and notify Contractor which clones are authorized to be carried forward for NPC differentiation. Within 2 months of this notification, Contractor will use published protocols to generate neural progenitor cells (NPCs) that display >80% positivity for both MAP2+ and Nestin+. A report of the immunostaining results will be provided electronically upon request. Within 21 days of providing this report, Contractor will ship multiple vials of each NPC clone (totaling approximately 10 million cells). Clones will be frozen, packed on dry ice, and delivered safely to the Principal Investigator. Contractor will retain detailed records of all work for a period not less than 2 years after completion of the project and provide these reports to Principal Investigator upon request. The data and deliverables may be staggered in time as contractor completes various stages of the project. Given the evolving COVID-19 situation, both government and contractor resources may need to be reviewed and revised to determine feasible delivery dates. REPORTING REQUIREMENTS The contractor is required to provide, minimally, monthly written progress reports. The reports will cover accomplishments, any problems encountered and/or resolved. The progress reports should be emailed to the Principal Investigator or designee. KEY PERSONNEL Several experienced biological laboratory technicians as well as one or more senior scientific researchers will be essential to successful performance by the contractor. DELIVERY 60 days after contract award