Intent to Sole Source FDA-75F40126Q00384.pdf
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- Solicitation number
- FDA-75F40126Q00384
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Intent to Sole Source Notice
This is an Intent to Sole Source notice for AEMS Think Trends Licenses (FDA-75F40126Q00384) issued by the U.S. Food and Drug Administration. The FDA intends to award a firm fixed-price sole source contract to ThinkTrends, LLC, located at 171 Elden Street, Suite 3C1, Herndon, Virginia 20170, under FAR 6.302-1 authority. The contract period of performance is one year. The classification code is DA10 – IT and Telecom - Business Application/Application Development Software as a Service, with NAICS code 541519 – Other Computer Related Services.
The FDA Centers and Offices require Think Trends Software Licenses to reduce manual case-processing burden, improve extraction accuracy, accelerate regulatory review workflows, and support Center-specific adverse event reporting requirements through configurable AI agents, human-in-the-loop validation, auditability, and secure deployment within FDA-approved environments. The government asserts that the proposed source possesses the sole unique technical and other resources required for this acquisition. Interested parties who believe they can meet the requirement may submit a capability statement to Terina Hicks at terina.hicks@fda.hhs.gov by September 9, 2026, at 1:00 PM Eastern Standard Time. If no responsive statements are received by the closing date and time, an award will be made to ThinkTrends, LLC. No telephonic inquiries are accepted.
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Intent to Sole Source
AEMS Think Trends Licenses (Brand Name)
FDA-75F40126Q00384
Date Posted: August 26, 2026
Response Date: September 9, 2026, 1:00 PM EST
Classification Code: DA10 – IT and Telecom - Business Application/Application Development
Software as A Service
NAICS Code: 541519 – Other Computer Related Services
The United States (US) Food and Drug Administration (FDA) intends to award a sole source, firm fixed-price contract to ThinkTrends, LLC, 171 Elden Street, Suite 3C1, Herndon, Virginia 20170, on a sole source base, under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services
Will Satisfy Agency Requirements.
The FDA Centers and Offices requires Think Trends Software Licenses to reduce manual case-processing burden, improve extraction accuracy, accelerate regulatory review workflows, and support Center-specific adverse event reporting requirements through configurable AI agents, human-in-the-loop validation, auditability, and secure deployment within FDA-approved environments. The proposed source has the sole unique technical and other resources required for this acquisition. This will be a one-year period of performance.
This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 6.302-1.
This notice of intent is not a request for competitive proposals. Interested parties that believes it can meet the requirement, may submit a capability statement to Terina Hicks at terina.hicks@fda.hhs.gov by
September 9, 2026, at 1:00 pm Eastern Standard Time (EST). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to ThinkTrends, LLC. No telephonic inquiries.
mailto:terina.hicks@fda.hhs.gov
File details come from the government source that posted it. Updated .