Regulatory Support for FDA Pre-IND Meeting: QGRFT for the Prevention of SARS-CoV-2 Infection

Amendment 1 is issued on June 15, 2020 and amends the following:
1. The Statement of Work is amended to include the estimated number of hours for this requirement.
2. The Request for Quotations is amended to include a suggested format for price information.
The revised Statement of Work and Request for Quotations are attached and replace the original versions.
 

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) requires regulatory and operational support for a pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA). This pre-IND application meeting is for the preclinical development of Q-Griffithsin (QGRFT), which may have therapeutic value as a preventative against SARS-CoV-2, the causative agent of the current COVID-19 pandemic. QGRFT data is proprietary to NCATS’ collaborators at the University of Louisville Research Foundation (ULRF) and the contractor must work collaboratively with ULRF and NCATS throughout the entire period of performance.

Due to the urgency of supporting the development of treatment for COVID-19, the awardee must be capable of beginning work with QGRFT immediately upon contract execution.

See attached Request for Quotations, Statement of Work, and related attachments for complete requirement details.