Toxicity testing on a new PET ligand for the NIH
ID: RFQ-CC-25-002889Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Testing Laboratories and Services (541380)

PSC

MEDICAL- LABORATORY TESTING (Q301)

Original Source

https://sam.gov/opp/1e16b1c3d52a43edbc2df8b066ae0938/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for a toxicity testing service on a new PET ligand, Fluorine-18-Fluorocellobiose, as part of the requirements for an Investigational New Drug (IND) application to the FDA. The project entails conducting a single-dose toxicity study in Sprague Dawley rats to assess potential toxic effects, establish the maximum tolerated dose (MTD), and determine the no observable adverse effect level (NOAEL), all under Good Laboratory Practice (GLP) conditions. This initiative is crucial for advancing biomedical research and improving imaging techniques in the diagnosis and treatment of infectious diseases. Interested parties must submit their proposals by April 4, 2025, with the contract period expected to last for one year, and inquiries can be directed to Lu Chang at lu-chang.lu@nih.gov.

    Point(s) of Contact
    Lu Chang
    lu-chang.lu@nih.gov
    Files
    Title
    Posted
    STATEMENT-OF-WORK-fluorocellobiose 12 28 2024.docx
    The National Institutes of Health (NIH) seeks to contract a service for toxicity testing of a new PET ligand, Fluorine-18-Fluorocellobiose, required for an Investigational New Drug (IND) application to the FDA. The project involves a single-dose toxicity study in Sprague Dawley rats to determine the ligand's potential toxic effects and to establish maximum tolerated dose (MTD) and no observable adverse effect level (NOAEL). Testing will be conducted under Good Laboratory Practice (GLP) conditions, encompassing clinical observations, pathology evaluations, and detailed reporting of findings. Deliverables include comprehensive reports and datasets necessary for FDA submission, with a completion timeframe of up to 12 months post-authorization and receipt of study materials. There will be no government-furnished property needed, nor specific security requirements associated with the contract. This initiative underlines NIH's role in advancing biomedical research, particularly in the field of infectious diseases through improved imaging techniques. Efforts aim to validate the proposed human doses for the ligand, which could enhance diagnosis and treatment in related clinical applications.
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    Toxicity testing on a new PET ligand for the NIH
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    Combined Synopsis/Solicitation
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