DESCRIPTION OF REQUIREMENT:
Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) intends to award a sole source contract to University of Trieste, they are the only university that can provide access to the toxicology data. FDA has a need to assess the toxicity of the novel lipophilic shellfish toxin Azaspiracid 59 (AZA59) in order to establish a toxicity equivalency factor (TEF) to be used by FDA to set the guidance level for this toxin in commercial shellfish under the National Shellfish Sanitation Program.
The applicable North American Industry Classification System (NAICS) code for this acquisition is 541712(4)" Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) 11."
The Government intends to solicit and negotiate directly with University of Georgia and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations; however, if any interested party believes they can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities must be submitted in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. All interested parties must express their interest and capabilities in writing via email to [email protected] within fifteen (15) days after the date of publication of this notice. No faxed documents will be accepted. If no responsive statements are received within fifteen (15) days, an award will subsequently be made to University of Trieste
This is a Federal contract opportunity; FDA-NOI-1216601 for services at Food and Drug Administration Office of Acquisitions and Grants Services - Rockville, MD. Response Due NLT 10:00 AM EST August 12, 2019.
Solicitation Number FDA-NOI-1216601
Set-Aside No Set-Aside Used
Contact(s) Telisha Wilson
Agency Department of Health and Human Services
Office Food and Drug Administration
Location Office of Acquisitions and Grants Services