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
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    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.
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    Low Volume Isothermal Titration Calorimeter
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    Combined Synopsis/Solicitation
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