Scientific Support Services for Conversion of Fibroblasts to Induced Pluripotent Stem Cells

NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: HHS-NIH-NIDA-SSSA-NOI-2017-800 2. TITLE: Scientific Support Services for Conversion of Fibroblasts to Induced Pluripotent Stem Cells 3. CLASSIFICATION CODE: R -- Professional, administrative, and management support services 4. NAICS CODE: 541990 -- All Other Professional, Scientific, and Technical Services 5. RESPONSE DATE: September 19, 2017 at 11:00 am EST. 6. PRIMARY POINT OF CONTACT: Zenab Chowdhry zenab.chowdhry@nih.gov Phone: 301-827-6909 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 on Drug Abuse (NIDA), Station Support and Simplified Acquisitions (SSSA) Branch intends to solicit by a request for quotation from University of Oxford University Offices Wellington Square Oxford, Oxfordshire, OX1, 2JD United Kingdom for award on or around September 30, 2017. The purpose of this purchase order will be to provide the National Institute of Mental Health (NIMH) with scientific support services for the conversion of fibroblasts to Induced Pluripotent Stem Cells (iPSCs). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541990 -- All Other Professional, Scientific, and Technical Services This acquisition is NOT set aside for small businesses. 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) 2005-85 dated February 26, 2016. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The purpose of this potential requirement is to acquire scientific support services for the conversion of fibroblasts to Induced Pluripotent Stem Cells (iPSCs). The objective is to conduct an analysis of single-cell RNA sequencing analysis of gene-expression in iPSC-derived tissues from patients with sex chromosome aneuploidy, in comparison with the globally-unique set of StemBancc controls at University of Oxford. To complete this objective, NIMH must ensure our patient samples are specifically matched with these uniquely-derived control cells at Oxford, which have been reprogrammed, passaged, quality controlled, differentiated and sequenced according to a proprietary pipeline at Oxford University. The required stage of cellular phenotyping and RNAseq analysis must be done on patient and control cells which have all been through exactly the same reprogramming/differentiation pathway. PROJECT REQUIREMENTS: The Contractor: 1. Will convert fibroblast samples provided by the Government into induced pluripotent stem cell (iPSC) lines. Conversion shall be performed using the Sendai virus system; 2. Will identify pluripotency markers in iPSC lines using Pluritest and genome-wide SNP typing; 3. Shall confirm clearance of Sendai from the iPSCs using RT-qPCR; 4. Shall extract RNA from iPSCS and fibroblasts; and 5. Shall confirm iPSC lines test negative for mycoplasma using MycoAlert. 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, the University of Oxford is the only vendor in the marketplace that can provide the products required by NIMH. In particular, the NIMH DNU requires this specific protocol chain, and only this specific chain for 2 specific reasons: (i) the protocol chain is established to support differentiation of iPSC-derived neurons with our required cortical layer identity markings (Handel at al, Human Molecular Genetics 2016), and (ii) the protocol chain permits direct comparison with publically available data from StemBANCC tissues generated by identical protocols to enable the NIMH DNU to test specificity of SCA effects on genome function (Morrison et al, Stem Cell Rev, 2015). In accordance with FAR part 10, extensive market research was conducted to reach this determination. Specifically, a small business sources sought notice was posted to FedBizOpps referencing the above detailed requirements and no responses were received. Additionally, contacts with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. Finally, a review of the GSA Advantage, Dynamic Small Business Search, and previous government acquisitions returned no results that meet all of the requirements. Therefore, only the University of Oxford is capable of meeting the needs of this requirement. The intended source is: University of Oxford University Offices Wellington Square Oxford, Oxfordshire, OX1, 2JD United Kingdom 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, HHS-NIH-NIDA-SSSA-NOI-2017-800. Responses must be submitted electronically to Zenab Chowdhry, Contract Specialist, at zenab.chowdhry@nih.gov. U.S. Mail and Fax responses will not be accepted.