Low Volume Isothermal Titration Calorimeter
ID: 75F40124Q00313Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Original Source

https://sam.gov/opp/a48bcd09cb3140d0823fd80d129f3c08/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for the procurement of a Low Volume Isothermal Titration Calorimeter to support its Division of Pharmaceutical Quality Research. The calorimeter must meet specific technical requirements, including automated titrant delivery, temperature stability, low noise levels, and efficient data acquisition capabilities, which are crucial for analyzing complex drug formulations. This procurement is vital for enhancing the FDA's regulatory reviews and guidance development related to drug product components. Interested vendors must submit their proposals, including technical and price volumes, by September 12, 2024, with questions due by September 6, 2024. For further inquiries, contact Iris Johnson at Iris.Johnson1@fda.hhs.gov or Sheneil Green at Sheneil.Green@fda.hhs.gov.

    Files
    Title
    Posted
    Solicitation_75F40124Q00313_CDER-2024-123052_CO approved.pdf
    The document is a Request for Quotation (RFQ) issued by the FDA for the procurement of a low-volume isothermal titration calorimeter. This solicitation, identified by number 75F40124Q000313, aims to support the FDA's Division of Pharmaceutical Quality Research in analyzing complex drug formulations. The calorimeter must meet specific technical specifications, including automated titrant delivery, temperature stability, low noise levels, and expeditious data acquisition capabilities. Quoters must submit their proposals, inclusive of technical and price volumes, by September 12, 2024, with a clear separation of pricing information from technical specifications. The selection will be based on a Lowest Price Technically Acceptable (LPTA) evaluation process, promoting full and open competition among eligible businesses, defined as those under NAICS code 334516. Questions regarding the procurement must be directed to the Contract Specialist by the stipulated deadline. The RFQ outlines explicit requirements for submission and clarifies the contracting clauses applicable to the award, ensuring compliance with federal regulations. This procurement aims to refine understanding of drug product components, ultimately bolstering FDA regulatory reviews and guidance development.
    Lifecycle
    Title
    Type
    Low Volume Isothermal Titration Calorimeter
    Currently viewing
    Combined Synopsis/Solicitation
    Similar Opportunities
    Isolator
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking proposals for the acquisition of an isolator to support sterility testing at its New York Laboratory Medical Products (NYLMP). The isolator must meet specific technical specifications, including a modular design, built-in bio-decontamination features, and necessary technical integrations to comply with FDA standards, addressing the increased demand on existing resources. This procurement is crucial for enhancing analytical capabilities, improving workflow, and ensuring adherence to quality standards in laboratory operations. Proposals are due electronically by September 17, 2024, at 10:00 a.m. (EST), and interested parties should contact Nina Montgomery at nina.montgomery@fda.hhs.gov for further information.
    Mass Spectrometry Bench
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking quotes for a Mass Spectrometry Bench with Integrated Pump Enclosure to enhance laboratory conditions at the San Juan Medical Products Laboratory in Puerto Rico. The procurement aims to replace outdated equipment with a new bench that includes features such as a noise enclosure for the vacuum pump, a chemical-resistant countertop, drawer storage, and integrated cable management, thereby improving productivity and ergonomics in the workspace. This initiative is critical for upgrading laboratory facilities to meet modern operational standards, with a firm fixed-price contract expected to be awarded within 60 days of the solicitation. Interested vendors must submit their quotes by September 19, 2024, at 11:00 AM EST, and can direct inquiries to Warren Jackson at warren.jackson@fda.hhs.gov.
    Mass Spectrometry Bench
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is soliciting quotes for a Mass Spectrometry Bench with Integrated Pump Enclosure to enhance operations at the San Juan Medical Products Laboratory in Puerto Rico. The procurement aims to replace outdated equipment with a newly manufactured, firm fixed-price item that includes specific features such as a 78.5" x 34.5" counter, noise enclosures, sliding platforms, and various storage options to improve laboratory ergonomics and maintenance efficiency. This equipment is crucial for optimizing laboratory functionality and reducing noise levels during operations. Interested vendors must submit their quotes by September 19, 2024, at 11:00 AM EST, and can direct inquiries to Warren Jackson at warren.jackson@fda.hhs.gov.
    Two Microcalorimeter Instruments
    Active
    Agriculture, Department Of
    The Department of Agriculture, specifically the Agricultural Research Service (ARS), is seeking a contractor to provide two microcalorimeter instruments for the Environmental and Microbial Food Safety Unit located in Beltsville, Maryland. The required equipment will monitor real-time metabolic activity and biofilm formation in living organisms, analyzing small sample volumes from various sources, including environmental and food samples. This procurement is crucial for advancing food safety and microbial research through precise measurement technologies, with a focus on maintaining specific temperature parameters and providing comprehensive training for laboratory personnel. Proposals are due by September 17, 2024, at 9 AM EST, and interested parties should contact Dilynn Rogers at dilynn.rogers@usda.gov for further inquiries.
    Irvine Vacuum Pump Replacement
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for the replacement of an obsolete vacuum pump system at its Los Angeles District Office and Pacific Southwest Food and Feed Laboratory in Irvine, California. The project requires the installation of a new vacuum pump system that adheres to NIH Design Requirements and includes N+1 system redundancy to mitigate risks associated with the current system's obsolescence. This procurement is critical for maintaining operational efficiency and safety in laboratory environments, ensuring that the FDA can continue its vital work in food and drug safety. Interested contractors must attend a mandatory site visit on September 5, 2024, submit questions by September 9, 2024, and deliver proposals by September 18, 2024, with all submissions directed to Sheneil Green at Sheneil.Green@fda.hhs.gov. The contract will be awarded based on a firm fixed price, and compliance with federal regulations is required throughout the process.
    CDER Division of Applied Regulatory Science’s (DARS) Purchase of Cryopreservation System
    Active
    Health And Human Services, Department Of
    The U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking quotes for the procurement of a high-performance cryopreservation system to enhance the cryogenic storage capacity for biological materials used in drug metabolism and toxicology studies. The primary objective is to purchase an MVE HECO Vapor Series P-190 cryopreservation system that maintains stable -190°C temperatures and low nitrogen consumption, thereby complementing existing MVE freezers and ensuring consistent storage conditions across studies. This procurement is critical for maintaining the integrity of samples collected in the FDA's Division of Applied Regulatory Science (DARS) and is set aside exclusively for small businesses, with a firm-fixed-price contract expected to be awarded. Interested vendors should direct inquiries to Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov, with delivery anticipated within 90 days of contract award.
    Software License and Device Warranty for Two Nanopore GridION Instruments
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking to procure a Software License and Device Warranty for two Nanopore GridION instruments, which are critical for the FDA's Next Generation Sequencing (NGS) initiatives focused on genomic data collection and analysis. The procurement aims to ensure optimal performance of these instruments through software and hardware updates, remote troubleshooting, and a return and replace policy for faulty devices, with a total cost of $25,000 for a one-year warranty and license renewal. This acquisition underscores the FDA's commitment to enhancing pathogen identification capabilities through advanced genomic technology, with the performance period set from September 28, 2024, to September 27, 2025, and the possibility of extending for three additional years, subject to funding. Interested vendors should submit their quotes electronically to Raphael Hall at raphael.hall@fda.hhs.gov by September 19, 2024, at 11:59 PM Eastern Standard Time.
    Facility Management System (FMS) Administration and Data Management
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified vendors for the administration and data management of its Facility Management System (FMS), utilizing the ARCHIBUS software. The contractor will be responsible for providing ongoing FMS support, ensuring compliance with federal reporting requirements, maintaining data integrity, and offering user training and technical assistance. This initiative is crucial for managing the FDA's facilities efficiently in response to increasing service demands and regulatory requirements, with the contract anticipated to span from March 24, 2025, to March 23, 2030. Interested parties must submit their responses, including a Vendor Feedback Form, to Nicholas Bisher and Kimberly Pennix by September 23, 2024, at 2:00 PM EST, as this is a Sources Sought Notice and not a solicitation for proposals.
    ThermoFisher branded Invitrogen ProcartaPlex immunoassay kits (Brand Name restriction)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking quotes for ThermoFisher branded Invitrogen ProcartaPlex immunoassay kits as part of a combined synopsis/solicitation. The procurement aims to acquire specific immunoassay kits necessary for testing human cytokine and chemokine levels in serum and saliva samples from individuals with alcohol use disorder, which is critical for ongoing research into the effects of alcohol consumption on health. The required kits must be capable of detecting and quantifying a panel of 80 targets simultaneously and are essential for ensuring continuity and comparability across various studies conducted by the NIH Clinical Center. Interested vendors must submit their offers by September 17, 2024, to Lu Chang at lu-chang.lu@nih.gov, including pricing and delivery timelines, as late submissions will not be considered.
    Preventive Maintenance and Repair Services for a Sciex Triple Quad 5500+ QTRAP HPLC/MS/MS system and Agilent 1260 HPLC system
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking qualified vendors to provide preventive maintenance and repair services for a Sciex Triple Quad 5500+ QTRAP HPLC/MS/MS system and an Agilent 1260 HPLC system at the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas. The procurement includes one scheduled on-site preventive maintenance visit per year and unlimited on-site corrective maintenance within specified timeframes, ensuring that the equipment remains operational to support critical analytical chemistry projects. Interested small business sources are encouraged to submit capability statements by September 18, 2024, to Warren Dutter at warren.dutter@fda.hhs.gov, as this opportunity is part of a market survey and not a solicitation for proposals.