Inactive

NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: NIMH21003646 2. TITLE: Generation of Neural Progenitor Cells (NPCs) from Human Induced Pluripotent Stem Cells (iPSCs) individuals with Varying S... NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: NIMH21003646 2. TITLE: Generation of Neural Progenitor Cells (NPCs) from Human Induced Pluripotent Stem Cells (iPSCs) individuals with Varying Sex Chromosome Counts 3. CLASSIFICATION CODE: Q -- Medical services 4. NAICS CODE: 541714 – RESEARCH AND DEVELOPMENT IN BIOTECHNOLOGY (EXCEPT NANOBIOTECHNOLOGY) 5. RESPONSE DATE: June 23, 2021 at 12:00 PM EST 6. PRIMARY POINT OF CONTACT: Thien Nguyen Thien.Nguyen2@nih.gov Phone: 301-827-0914 7. DESCRIPTION: 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). The National Institute of Mental Health (NIMH) intends to negotiate on a sole source bases with New York Stem Cell Foundation Inc, 619 W 54th ST FL 3, New York, NY 10019-3545 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) with a Size Standard of 1000 employees. 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 (FAC) 20019-01 dated December 1, 2018. PURPOSE AND OBJECTIVES: 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). We are 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, we need to rely on new and specialized techniques for differentiation of neural cells from human induced pluripotent stem cells (iPSCs). We have iPSCs derived from several female 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 derive NPCs from male SCA study participants. 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 16 individuals from this series. We would receive 32 lines from these 16 individuals (2 lines per person). The contract would also allow for use of a process called “monoclonalization” to support successful line development for the subset of 20 lines 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. DESCRIPTION OF REQUIREMENT The specific requirements include: • expansion and quality control of provided iPSCs for 16 individuals. o 2 iPSC lines per individual. Quality Control (QC) to include sterility, mycoplasma, karyotyping, identity testing, pluripotency expression profiling, and differentiation capacity. • Differentiation of the resulting 32 iPSC lines 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. We have already expanded iPSCs and generated NPCs on females with varying X-chromosome count (X, XX, XXX, XXXX) through a prior contract with NYSCF. We now need to complete the same process for males with varying sex chromosomes (XY, XXY, XYY, XXYY). We will be comparing male and female groups, and therefore need them to have been processed through exactly the same method. Since prior samples were processed with a highly specialized workflow that is specific to NYSCF and cannot be setup by another vendor without substantial investment and time loss. Consistency in workflow is essential for data validity. Other vendors may provide similar workflows, but subtle, not yet fully characterized differences in processing methods have been shown to cause iPSCs and NPCs generated to later yield dramatically different research results. This would in effect, risk rendering our samples, data and results generated virtually useless, thus setting our research back years. In other words, 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’ lines we need generated and the female’s lines already generated by NYSCF. Thus, this is considered a follow-on acquisition with NYSCF. Using a different vendor would cause irreparable harm to our ongoing experiments and research. We require the same vendor and processes in order to compare the data that has been collected thus far in our previous contract with The New York Stem Cell Foundation. 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. Specifically, Yair Bar-Haim is the only vendor in the marketplace that can provide the services required by NIMH. The intended source is: New York Stem Cell Inc 619 W 54th ST FL 3 New York, NY 10019-3545 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. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH21003646. Responses must be submitted electronically to Thien Nguyen, Contract Specialist, at thien.nguyen2@nih.gov. and Valerie Whipple, Contracting Officer, at valerie.whipple@nih.gov. U.S. Mail and fax responses will not be accepted.