Inactive

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This annou... (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is HHS-NIH-NIDA-NCATS-CSS-20-004597 and the solicitation is issued as a Request for Quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold. The solicitation is issued as non-competitive. (iii) This solicitation incorporates the provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-07, effective July 2, 2020. (iv) The associated North American Industry Classification System (NAICS) code: 541715—Research and Development in the Physical, Engineering, and Life Sciences (Except Nanotechnology and Biotechnology). Size Standard; 1,000 Employees. (v) Evaluation of Mature and Functional Hepatocyte Organoids Derived from Induced Pluripotent Stem Cell (vi) Project Requirements. The Tox21 group of National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) requires a service named “Evaluation of mature and functional Hepatocyte Organoids derived from induced pluripotent stem cell” from 3Dnamics Inc. The service will be used to study liver toxicity caused by a group of compounds that identified from Tox21 mitochondrial 10K screening project, which is one of the key projects in the Tox21 program. The purpose of the work requirement is to support the evaluation of chemical effect on the pathophysiology level that are involved in mitochondrial toxicity. This project is one of the cross-partner projects in the Tox21 collaboration between NCATS and NTP/EPA/FDA. The mission of the Tox21 group of NCATS at the National Institutes of Health (NIH) is to develop better toxicity assessment methods to quickly and efficiently test chemicals for their potential disrupt processes in the human body that may lead to negative health effects. Mitochondria play a central role in cellular metabolism including heme, fatty acid, and steroid synthesis; metabolic cell signaling; oxidative phosphorylation; Ca2+ homeostasis; and apoptosis. Mitochondrial toxicity is one of major mechanisms of chemicals in organ toxicity, including the heart, nerves, muscles, pancreas, kidneys, and liver. As a participant of Tox21 program, we have screened the Tox21 10k compound library in a cell-based mitochondrial membrane potential (MMP) assay and identified a group of novel compounds that significantly decreased MMP. To further in-depth investigation these chemicals, the iPSC-derived liver organoids will mimic liver development, expressed key functional hallmarks of the liver such as expression of metabolic enzymes cytochrome and sulfotransferases. Having an in vitro model that can mimic the physiology and functions of a human liver is immensely invaluable to developing assays for drug metabolism and toxicology, screening for potential antiviral agents, predicting in vivo drug metabolism, and creating cell-based therapies to treat liver diseases. While there are numerous protocols that can differentiate induced pluripotent stem cells (iPSCs) into hepatocytes, they are inconsistent and not amenable to drug testing. These issues are mainly due to our lack of understanding of human liver development, and that most of the protocols were developed using a monolayer culture system that is insufficient to replicate the cell-cell interactions and complex signaling in three dimensional tissues. Liver organoids differentiated from pluripotent stem cells may overcome these issues and provide a more accurate and predictive liver model for drug development. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the specific requirements below. Scope of Work. The contractor shall evaluate mature and functional Hepatocyte Organoids derived from induced pluripotent stem cells using differentiation protocols developed by 3Dnamics, 1812 Ashland Avenue, Baltimore, MD 21205. Specifically, the contractor shall: (1) upon receipt, inspect vials and make certain cells arrive in proper conditions and will take necessary steps for proper storage of cells until project start date; (2) expand wildtype iPSC lines into liver organoids; (3) differentiate iPSC into liver organoids; (4) characterize and quality assessment of liver organoids; (5) generate multiple batches of liver organoids (1000+) for additional assays and drug screening at different time points and stages; and (6) ship the hepatocyte organoids to the government via FedEx overnight shipping on dry ice or in person. Government Responsibilities. The Government will; (1) provide to the contractor the frozen iPSC lines and some of the reagents; (2) prepare and package the cells; and (3) notify the contractor when cells are shipped. Project Timeline. Two (2) Weeks (from state date): Expansion of wildtype iPSC lines. Four (4) to Six (6) Weeks: Differentiation of iPSC into liver organoids Four (4) to Six (6) Weeks: Characterization and quality assessment of liver organoids Six (6) to Thirty (30) Weeks: Generation multiple batches of liver organoids (1000+) for additional assays and drug screening at different time points and stages. Deliverables: 1. Characterization (immunostaining, functional analysis, etc.) of organoids at different stages (7-, 14-, and 21-day or longer if necessary); and 2. Multiple batches of hepatocyte organoids at different time points and/or stages of maturation. Reporting Requirements. 1. Complete data package including spreadsheet of raw data (viability counts, immunocytochemistry quantification, etc.); and 2. Complete data work-up and full report for four patient lines and two WTs. Data Rights. All data used and analyzed is sole property of the government. Contractor has no right to any analyzed iPSCs lines provided by Tox21 group and must keep them confidential. Anticipated period of performance / delivery date: The Government anticipates a period of performance of 12-months (September 2020 through August 2021). (vii) Government's Anticipated Delivery/Period of Performance : 12-month Period after receipt of order (ARO), September 2020 through August 2021. Delivery Point: FOB Destination. Delivery Location: The National Center for Advancing Translational Sciences (NCATS), Rockville, Maryland 20850. The successful offeror shall coordinate delivery arrangements with the customer prior to shipment. The Loading Dock hours are as follows: 8:00 am to 4:30 pm Eastern Time, Monday through Friday except on Federal holidays. All products delivered must contain a Packing Slip (with serial numbers as applicable). (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The factors used to evaluate offers are the unique technical and performance capabilities of product and cost. Technical and past performance, when combined, are significantly more important than cost or price. (x) Offerors are advised to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, with its offer. (xi) FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. (xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) Defense Priorities and Allocations System (DPAS) and assigned rating, is not applicable to this solicitation. (xv) All quotations or offers are due 12:00 Noon, Eastern Time, on August 24, 2020, and must reference the solicitation number noted herein. Quotations or offers must be submitted electronically to the contact person identified herein at debra.hawkins@nih.gov. Fax responses will not be accepted. (xvi) For information regarding this solicitation contact: Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at debra.hawkins@nih.gov.