Toxicity testing on a new PET ligand (Sources Sought)
ID: NIH-CC-OPC-25-002889Type: Sources Sought
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/c0805d19ede04b71a9d11c190e7ba5e8/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified contractors to conduct a toxicity study on a new PET ligand, Fluorine-18-Fluorocellobiose, as part of the Investigational New Drug (IND) application process. The project entails performing a single-dose toxicity study on Sprague Dawley rats, adhering to FDA's Good Laboratory Practice (GLP) standards, with the aim of assessing toxicity endpoints and developing analytical methods for drug level evaluation. This initiative underscores NIH's commitment to advancing biomedical research while ensuring compliance with regulatory requirements in drug development. Interested parties must submit their responses, including company information and capability statements, to Grace Wong-Darko at Grace.Wong-Darko@nih.gov by 1:00 PM EST on January 31, 2025.

    Point(s) of Contact
    Grace Wong-Darko
    Grace.Wong-Darko@nih.gov
    Files
    Title
    Posted
    STATEMENT-OF-WORK-fluorocellobiose.pdf
    The National Institutes of Health (NIH) is issuing a Request for Proposal (RFP) for toxicity testing of a new PET ligand, Fluorine-18-Fluorocellobiose, necessary for an Investigational New Drug (IND) application. The project involves conducting a single-dose toxicity study on Sprague Dawley rats, adhering to FDA's Good Laboratory Practice (GLP) standards. The contractor will develop and validate analytical methods to assess drug levels and perform evaluations on toxicity endpoints, including maximum tolerated doses and organ effects. Key deliverables include comprehensive reports and FDA submission-ready files. The projected timeline for the study is up to 12 months, with the NIH Clinical Center offering support in terms of feedback on final datasets. No government property will be provided, nor are there specific security requirements for this project. This initiative signifies NIH’s commitment to advancing biomedical research while ensuring regulatory compliance in drug development.
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    Toxicity testing on a new PET ligand (Sources Sought)
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