This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform the potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Background: The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), Therapeutic Development Branch (TDB) partners with researchers across NIH to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand new formulation laboratory dedicated to preclinical research will be opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized Instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. Purpose and Objectives: The purpose of this to purchase a Horiba LA-960S2 Laser Diffraction Particle Size Analyzer with Solvent Resistant Pump System and a Horiba SZ-100Z2 Dynamic Light Scattering Particle Size Analyzer with Zeta Potential Analyzer, accessories, and services for the Formulation Laboratory. Project requirements: Generic Product: Laser diffraction particle size analyzer Dynamic Light Scattering Particle Size Analyzer Brand Name or Equivalent: (1) Specify trade name; Horiba (2) Specify product’s brand name; Partica LA-960S2 and SZ-100Z2 (3) Specify manufacturer's name; Horiba Instruments Inc. (4) Specify model, type, catalog, and/or part number(s)> Horiba Partica LA-960S2 Laser Diffraction Particle Size Analyzer With Solvent Resistant Pump System Horiba SZ-100Z2 Dynamic Light Scattering Particle Size Analyzer with Zeta Potential Analyzer Salient Characteristics: Horiba Partica LA-960S2 Laser Diffraction Particle Size Analyzer With Solvent Resistant Pump System 3200773310 - LA-960S2 Laser Diffraction Particle Size Analyzer With Solvent Resistant Pump System Flow Cell Drain Tubing Fill tubing Applicators Instrument control software 5505258009 - Instrument Control Computer System Dell or HP brand Personal Computer Monitor 5500526306 - 1 um PSL Standard 5500007203 - PowderJet Dry Feeder System Feeder Vacuum Compressor 3200022742 - Fraction Cell Holder For LA-950 & LA-960 3014043315 - Fraction Cell, 10ml 5200837494 – Imaging Unit Accessory Measurable range for image analysis: 9-1000 um Resolution: 0.73 um Speed: Greater or equal to 4 fps 3200748699 - LY-9609 High Concentration Cell Set 5500525589 – 100 um PSL Standard for LA-950 & LA-960 50000055 - Installation and Training On-Site for hardware, software and accessories 5500602716 - Wooden Shipping Crate 5500602713 - Wooden Shipping Crate with Foam 50000082 - Second Year System Warranty Horiba SZ-100Z2 Dynamic Light Scattering Particle Size Analyzer with Zeta Potential Analyzer 3200771547 - SZ-100Z2 Dynamic Light Scattering Particle Size Analyzer with Zeta Potential Analyzer Sizing Cells Zeta Cells 5500526258 - 100 nm PSL Standard 50000055 - Installation and Training On-Site for hardware, software and accessories 5500602713 - Wooden Shipping Crate for SZ-100Z2 50000082 - Second Year System Warranty Anticipated period of performance: Delivery is to be six months after receipt of the award (ARO). Additionally, a one year factory warranty. In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Buy American Clauses: FAR 52.225-2, Buy American Certificate (Feb 2021) FAR 52.225-6, Trade Agreements Certificate (Feb 2021 Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. 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 an 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. 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 Morgen Slager, Contract Specialist, at e-mail address
[email protected]. The response must be received on or before May 9, 2023, at 2:00 pm, Eastern Standard 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 www.sam.gov. 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).”