Inactive

Federal Business Opportunities (FBO) SOURCES SOUGHT NOTICE Solicitation Number: 75N95021Q00299 Title: X-ray crystallography (XRC) Structure Studies for the National Center for Translational Sciences (... Federal Business Opportunities (FBO) SOURCES SOUGHT NOTICE Solicitation Number: 75N95021Q00299 Title: X-ray crystallography (XRC) Structure Studies for the National Center for Translational Sciences (NCATS) Classification Code: Q301 – MEDICAL- LABORATORY TESTING NAICS Code: 541380 – Testing Laboratories Dollars or Number of Employees: $22 million Description: The purpose of this requisition is NCATS needs co-crystal structures of compounds from two projects in complex with their protein targets to assist in structure-guided drug design. Background: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Within NCATS is the Division of Preclinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum. Specifically, this division: • Plans, conducts and collaborates on research to develop new methods and technologies to enhance preclinical processes. • Plans, conducts and collaborates on research to evaluate existing and developing approaches, technologies, and processes in the preclinical spectrum. • Supports training programs relevant to preclinical phases of translational science. • Allocates DPI resources to preclinical extramural and intramural investigators. • Collaborates with other NIH Institutes and Centers and the scientists they support. • Consults with stakeholders, including patients, industry and regulators. Purpose and Objectives: Within DPI’s ongoing research, NCATS researchers plan to structure guided drug design forms for a central strategy in optimizing compounds in medicinal chemistry campaigns in target-based drug discovery. NCATS is currently optimizing compounds against the beta glucuronidase GUS H11G11 that cleaves glucuronide -drug addicts in the gut releasing toxic anticancer drugs in the gut leading to gastrointestinal (GI) toxicity. NCATS would like to produce/purify GUS H11G11 and attempt to get go crystal structures of our small molecules docked inside the protein. NCATS researchers are also optimizing compounds against the methyl transferase GNMT. NCATS would like to produce the respective protein and attempt to get co crystal structures of our small molecules docked inside the protein. As a result, the examination of the structure will aid structure guided drug design. Project requirements: The Contractor shall Crystallize and determine the X-ray crystal structures of three proteins of interest H11G11 BG in complex with provided ligands and GNMT in complex with provided ligands. Phase 1: Protein Supply Phase 2: Co-crystallization screening and optimization Time estimate: approximately 4 to 6 weeks per protein - Based on a review of the available information, each protein will be complexed with the NCAT compound(s). Based on the binding interaction data, experimental conditions will be designed for the production of the complex on the milligram scale for use in the crystallographic studies. - The protein-ligand complex(es) will be screened for crystallization with sparse-matrix and systematic grid screening approaches. - Conditions that initially produce microcrystals will be identified. - Selected conditions will be optimized to improve the crystal size and quality. Phase 3: Crystal harvest, synchrotron X-ray evaluation and X-ray structure determination Time estimate: synchrotron shipments occur approximately every two weeks, if suitable X-ray data is obtained, the structure will be delivered after approximately two additional weeks. Crystal Harvest: - Crystals of suitable size will be harvested, transferred into suitable cryoprotection solutions, and frozen for transport to a synchrotron X-ray facility. - For each targeted structure, multiple crystals will be screened for X-ray data quality. - If the X-ray diffraction is of sufficient quality (resolution and diffraction lattice properties) then complete X-ray data sets will be obtained for the best crystals. Initial data processing: - Complete data sets will be indexed and scaled, followed by space group evaluation, molecular replacement, and generation of initial electron density maps. - Processed data sets will be evaluated according to statistical values and interpretation of the initial electron density map; contractor will proceed if within standards. If the electron density for the ligand is not observed, a scientific review will determine how to proceed and whether alternatives will be considered. Refinement, model building, analysis, and reporting: - If the processed data and electron density maps are of sufficient quality and resolution, and the bound ligand is observed, then multiple rounds of refinement and model building will be performed to obtain a final model. - The resultant model will be analyzed, and both the structure and results presented to Client in a summary document, along with structure files (.pdb, .mtz). - A meeting will be scheduled to present the results and provide comments regarding the crystallography. Contractor will execute the research project with due diligence to meet the project deliverables in a timely manner. On a regular basis, the lead scientist at Contractor’s facility will report on the status of the ongoing work via phone, e-mail, personal meetings, or presentations. The project will be divided into a series of phases, and contractor and NCATS will maintain iterative and collaborative communication, with decisions made jointly between the two companies at defined points. Contractor will progress to the next phase based upon such approvals/decisions. Anticipated period of performance: Anticipated to 12 months from ARO Other important considerations: 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 work mentioned above. Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) current in-house capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and other management capability; and (e) examples of prior completed Government contracts, references, and other related information. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Nick Niefeld, Contract Specialist at e-mail address nick.niefeld@nih.gov. The response must be received on or before August 17, 2021, at 9 am Eastern Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

Inactive

NOTICE OF INTENT TO SOLE SOURCE SOLICITATION NUMBER: 75N95021Q00299 TITLE: Fluidigm Helios Preventative Maintenance for the Stem Cell Translation Laboratory (SCTL) within NCATS Product Service Code: J... NOTICE OF INTENT TO SOLE SOURCE SOLICITATION NUMBER: 75N95021Q00299 TITLE: Fluidigm Helios Preventative Maintenance for the Stem Cell Translation Laboratory (SCTL) within NCATS Product Service Code: J066 – Maintenance/Repair/Rebuild of Equipment-Instrument and Laboratory Equipment NAICS: 811219 – Other Electronic and Precision Equipment Repair and Maintenance SIZE STANDARD: $22 million SET-ASIDE: This acquisition is not set aside for small businesses. RESPONSE DUE: July 28, 2021 at 9:00 A.M ET. PRIMARY POINT OF CONTACT: Nicholas Niefeld Email: nick.niefeld@nih.gov Phone: 301-827-2094 DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF INTENT (NON-COMPETITIVE) TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. To establish and move stem cell technologies forward through a more centralized effort, NIH has launched the Stem Cell Translation Laboratory (SCTL) within the NCATS. SCTL goal is to bring iPSC technology closer to clinical application, drug discovery and regenerative medicine. Ongoing research projects in SCTL focus on understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells. As such, discovering probe molecules that could serve as starting points for therapeutics in rare cancers is of great interest within NCATS. NCATS has several projects that address many aspects of oncology mechanisms and approaches to discovering novel, effective small molecules. The services requested here are fee for service testing that will provide insight on efficacy across many cancers and will help progress and provide critical scientific guidance on projects that NCATS has been working on for many years. The Stem Cell Translation Laboratory (SCTL) within the NCATS has a request for a preventative maintenance to service the Fluidigm Helios system and ensure that it is consistently operational. Because this system is essential to SCTL’s operations and ongoing research projects, it is necessary that it is operating correctly with as little down time as possible. Qualified spare parts and accessory items must be compatible with this existing equipment and requires the original equipment manufacturer (OEM) certified technicians to service the instrument. 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) (1) Soliciting from a single source provides that “[f]or purchases not exceeding the simplified acquisition threshold. (i) 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 award will include all applicable provisions and clauses in effect through Federal Acquisition Circular (FAC) 2021-06, dated July 12, 2021. DESCRIPTION OF REQUIREMENT This requirement is for a preventative maintenance agreement for the Fluidigm Helios instruments comprised of various parts listed under the Specific Requirements of the Statement of Work below in fully functioning order via preventive maintenance. Because Fluidigm is the original equipment manufacturer (OEM), is the only source of spare or replacement parts and software for these instruments, this requirement is a sole source requirement. 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 Statement of Work below: 1. Preventative maintenance for the following products: Biomark s/n 90391 C1 System s/n 110552 Helios s/n D16-0196 Hyperion Tissue Imager s/n E18-0056 2. Specific Requirements: 104304 Helios Preventative Maintenance: 1 on-site preventative maintenance visit Detector coverage not included Travel charges not included 108605 Hyperion Tissue Imager Preventive Maintenance: 1 on-site preventative maintenance visit. Laser coverage not included SVC-TRV1 Travel Zone 1: Technical Support Zone 1-100 Travel Rate 3. All parts and accessories used must be Fluidigm Original Equipment Manufacturer (OEM) parts or accessories. This is necessary to ensure continuance of equipment warranty and standardization of research data. 4. All PM work must be completed by an Fluidigm factory trained engineer. This is necessary to ensure continuance of equipment warranty and standardization of research data. 5. All charges to ship replacement or repaired equipment to the customer, or charges for the return of equipment must be covered. 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, Fluidigm, is the only service provider in the marketplace that can provide the above described services. The essential characteristics of the four (4) Fluidigm instruments, Biomark (s/n 90391), C1 System (s/n 110552), Helios (s/n D16-0196), and Hyperion Tissue Imager (s/n E18-0056) that limit the availability to a sole source are Fluidigm is the sole contractor qualified to provide OEM parts, services and technicians for the four instruments mentioned above as indicated in a sole source letter received from Fluidigm. The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. The current equipment are four (4) Fluidigm instruments, Biomark s/n 90391, C1 System s/n 110552, Helios s/n D16-0196, and Hyperion Tissue Imager s/n E18-0056, and the new item/service must coordinate, connect, or interface with the existing system by Fluidigm is the sole contractor qualified to provide OEM parts, services and technicians for the four instruments mentioned above. In accordance with FAR part 10, extensive market research was conducted to reach this determination. The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. The current equipment was obtained from Fluidigm., and has been maintained by Fluidigm., since acquisition. The new item/service must coordinate, connect, or interface with the existing system by replacing defective components exactly when required. Since Fluidigm., is the manufacturer of its Fluidigm instruments, Biomark s/n 90391, C1 System s/n 110552, Helios s/n D16-0196, and Hyperion Tissue Imager s/n E18-0056 and does not permit maintenance services of the above instruments to be performed by third parties, only the original manufacturer can meet this requirement. The intended source is: Fluidigm 2 Tower Place, Suite 2000 South San Francisco, CA 94080 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and submit a capability statement in response to this notice. The purpose of this requirement is to Fluidigm Helios Preventative Maintenance for the Stem Cell Translation Laboratory (SCTL) within NCATS. The contractor must be an Original Equipment Manufacturer (OEM) Authorized Service Provider of Fluidigm Instruments, and all maintenance must be performed by OEM certified technicians using genuine OEM parts. 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 “75N95021Q00299. Responses must be submitted electronically to Nick Niefeld at nick.niefeld@nih.gov. Fax responses will not be accepted.