Digital Surveillance & Intelligence Subscription Services
This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13.
The solicitation number is 75F4012Q00448. This solicitation is issued as a Request for Quote (RFQ).
The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2025-03, effective January 2025. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website: https://www.acquisition.gov/browse/index/far
This requirement is being competed as a Total Small Business Set-Aside.
The purpose of this solicitation is to acquire a commercially available license subscription to an integrated digital intelligence and surveillance platform with service support. The subscription shall provide access to API's, dashboards, and data feeds that enable FDA to monitor, analyze, and respond to public health risks across digital channels.
This acquisition will allow FDA to transition from manual, fragmented monitoring processes to proactive, automated surveillance capabilities, ensuring timely detection of emerging risks and consistent compliance oversight. The platform must support five critical use cases:
- Social Listening for Drug Safety Surveillance
- Due Diligence for Bioterrorism Investigations
- Early Warning for Outbreaks and Supply Chain Disruptions
- Illegal Drugs and Supplements Surveillance
- Pharmaceutical Advertising Monitoring
Functional Requirements (Use Case Modules)
- Social Listening Module: Must capture, aggregate, and analyze online discussions across social media, forums, and review sites; identify mentions of specific drugs and potential adverse events; and generate reports and visual dashboards.
- Due Diligence Module: Must provide entity screening, risk profiling, and relationship mapping for companies or individuals associated with bioterrorism investigations and import holds.
- Early Warning Module: Must continuously monitor online sources (health blogs, news outlets, supply chain alerts) to detect signals of outbreaks or disruptions, using anomaly detection and NLP methods.
- Illegal Drugs & Supplements Module: Must detect unlawful drugs and fraudulent dietary supplements marketed online, issue automated violation reports, and support FDA enforcement workflows.
- Advertising Monitoring Module: Must capture, catalog, and evaluate online pharmaceutical advertisements; assess compliance with FDA regulations (e.g., Form 2253, 21 CFR Parts 202 and 314); and generate compliance trend analyses.
Salient Characteristics:
- Ability to operate through an ensemble of highly specialized deep neural architectures engineered for distinct cognitive domains that collectively mirror human analytical capabilities.
- Ability to enable constant inter-model communication where neural architectures share insights and build consensus interpretations similar to collaborative processing between different cortical regions in human cognition.
- Ability to process audio and visual content from global news feeds, social media streams, and public broadcasts while interpreting contextual cues, crowd behaviors, and environmental indicators.
- Ability to continuously map complex relationships across seemingly unrelated data points, connecting pharmaceutical supply chain disruptions to emerging symptom clusters or linking social media sentiment shifts to behavioral changes.
- Ability to parse communications across multiple languages and cultural contexts while tracking how information and behaviors propagate through different community structures.
- Ability to process structured and unstructured datasets (from structured epidemiological databases to social conversations, darknet forum discussions.)
- Ability to map the social and digital geography of information flow across different communities and networks.
- Ability to predict where health threats are likely to emerge next and which populations are most vulnerable, enabling proactive rather than reactive public health responses.
- Ability to enable each user to individually train the system's neural networks to identify signals, patterns, and trends specific to their unique operational requirements and domain expertise through private customer instances.
- Ability to allow users to fine-tune models by providing labeled examples of what constitutes meaningful signal within their specific context, whether identifying pharmaceutical adverse events, infectious disease patterns, or dangerous health trends.
- Ability to learn each user's analytical priorities and prioritize different types of information based on historical decisions and feedback.
- Ability to continuously refine understanding of what constitutes actionable intelligence for particular users as they interact with findings, mark alerts as high-priority, dismiss false positives, or request deeper analysis.
- Ability to continually adapt its processing network to move with the speed of data as applications and platforms shift in usage patterns.
- Ability to move at digital velocity while maintaining analytical depth, identifying where critical health information is being generated, shared, and consumed across different population segments.
- Ability to surface the most relevant signals from vast global data while filtering out noise that might overwhelm human decision-makers.
- Ability to understand nuanced context that makes certain signals relevant to specific users, creating personalized AI analysts increasingly attuned to each user's analytical needs.
- Ability to provide secure web-based dashboards and role-based user licenses for FDA staff.
- Ability to offer data export in FDA-approved formats (CSV, JSON, XML, PDF/A).
- Ability to maintain 95% system uptime and real-time or near real-time data ingestion.
- Ability to provide complete audit logs of system usage, data sources, and alerts for traceability.
- Ablity to scale to support additional FDA users, higher data volumes, or expanded modules.
Background
The Food and Drug Administration (FDA) is seeking to enhance its capabilities in monitoring public health threats and ensuring regulatory compliance in the digital environment. Traditional reporting systems have proven inadequate, capturing only a fraction of real-world signals and leaving gaps in adverse event detection and regulatory oversight.
The increasing digital nature of pharmaceutical promotion, online marketplaces, and global supply chains necessitates continuous, automated monitoring. To address these challenges, the FDA requires a subscription to an integrated digital intelligence platform that supports five critical use cases: social listening for drug safety surveillance, due diligence for bioterrorism investigations, early warning for outbreaks and supply chain disruptions, surveillance of illegal drugs and supplements, and monitoring of online pharmaceutical advertising.
This acquisition aims to transition from fragmented manual processes to proactive automated surveillance, ensuring timely risk detection and compliance oversight while adhering to FDA’s cybersecurity, privacy, and regulatory requirements.
Work Details
The contractor shall provide subscription access to a commercially available digital intelligence platform that includes user licenses, APIs, dashboard access, regular data updates, and service support such as training, bug fixes, and system enhancements. The platform must support the following use cases:
1) Social Listening Module - capture and analyze online discussions about specific drugs;
2) Due Diligence Module - provide entity screening for bioterrorism investigations;
3) Early Warning Module - monitor online sources for signals of outbreaks;
4) Illegal Drugs & Supplements Module - detect unlawful drugs marketed online;
5) Advertising Monitoring Module - evaluate compliance of pharmaceutical advertisements with FDA regulations.
Additionally, the platform must have capabilities such as processing audio/visual content from various sources, mapping complex relationships across data points, adapting to user-specific analytical needs, providing secure dashboards for FDA staff, maintaining high system uptime, offering data export in FDA-approved formats, and ensuring comprehensive audit logs.
