Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH21003690 TITLE: Generation and Characterization of Human Induced Pluripotent Stem Cells (iPSCs), Neural Progenitor Cells (NPCs), and Stable Tra... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH21003690 TITLE: Generation and Characterization of Human Induced Pluripotent Stem Cells (iPSCs), Neural Progenitor Cells (NPCs), and Stable Transgenic iPSC Lines from Individuals with Mood and Anxiety Disorders. CLASSIFICATION CODE: Q -- Medical services NAICS CODE: 541714 – Research and Development in Biotechnology (except Nanobiotechnology) RESPONSE DATE: June 25, 2021 at 12:00 PM EST PRIMARY POINT OF CONTACT: Kristina Jenkins Kristina.Jenkins@nih.gov 301-402-7464 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 basis with The New York Stem Cell Foundation, 619 W. 54th St., New York, NY 10019 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 (FAC) 2021-05 dated March 10, 2021. JUSTIFICATION FOR SOLE SOURCE CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION DETERMINATION The National Institute of Mental Health (NIMH) have already expanded iPSCs and generated NPCs for multiple families with known chromosomal structural variants (SVs) involved in mood and anxiety disorders through a prior contract with NYSCF. NIMH has a need to add more replicates as well as additional SVs to continue our ongoing research projects. NIMH will compare subjects both within and between SV groups, and therefore need to minimize any potential vendor-to-vendor variability between these samples. Since prior samples were processed with a highly specialized workflow that is specific to NYSCF and cannot be set up 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 methods/processes implemented by NYSCF are highly specific, multistage, and extend over several months. There is no way of replicating the process through another provider for comparability between the new lines we need generated and the lines already generated by NYSCF without substantial investment and time loss. Therefore, NIMH has a need to keep every method and process as standardized and identical as possible to contract number 75N95020C00034 with NYSCF. 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. 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 in this notice. Responses must be submitted electronically to Kristina Jenkins, Contracting Officer, at kristina.jenkins@nih.gov. U.S. Mail and fax responses will not be accepted.