SSNT.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

NTELX Perpetual License, Software Maintenance & Support

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Office of Regulatory Affairs (ORA), to require a contract for NTELX Perpetual License, Maintenance and Support for NTELX software. This contract is to provide continuous support for ORA applications used by ORA staff for mission critical operations.

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The current FDA import examination program attempts to focus its limited resources for physical examination of high-risk shipments. With the passing of the Bioterrorism Act of 2002, the FDA has been tasked with inspecting shipments not only from a food safety perspective, but a security perspective as well.

This new responsibility, in conjunction with an ever- increasing volume of imports, has overtaxed the legacy import screening technology beyond its design limits. By incorporating new risk-assessment tools that narrow the focus of inspections to imports that have a higher likelihood of being in violation of FDA regulations, the FDA can optimize the deployment of its inspection, testing and analytical resources even with the expanded shipment volumes and broader legislative mandates. This approach will also minimize delays to legitimate trade.

The Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) is written in very specific software and there is no other product that can perform the functions of the PREDICT rules engine. The rules engine applies risk-based targeting rules to the 50 million import entry lines for which FDA must make admissibility decisions each year on regulated products. The risk scoring supports FDA’s mission by helping to identify regulated products that may be more violative, thus improving FDA’s ability to protect public health.

PREDICT uses the NTEL-X software modules: FDanalyzer + FDfusion, FDmonitor, and FDauditor (“NTEL-X software”). These are COTS products. NTEL-X software allows FDA to input and extract information into a proprietary relational database that provides the baseline architecture for the capture, aggregation, and representation of data pertaining to entry lines that will be profiled to encompass all FDA-regulated products and all ports of entry.

The PREDICT application (built on the NTELX software) has been considered in production since January 1, 2010.

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Description of software modules and benefits:

Module Description Benefit to FDA

FDanalyzer

Powerful risk assessment, data analysis, rule management and rule deployment application.

Presents the risk analysis results to users in a variety of interactive formats and allows the users to manage their risk management inbox, take action on cases and provide implicit and explicit feedback on the functioning of the rules.

Principal interface of the PREDICT application— provides the ability to enter and manage the rules used to screen Entry Lines and provides results of the line-level analyses.

Module Description Benefit to FDA

FDfusion™ Execution engine that uses a sophisticated in-memory rules engine and the power of the Rete algorithm to efficiently match rules against target items.

Configurable deployment architecture allows distribution of engines on multiple CPUs.

Processing backbone of PREDICT— executes rules against individual entry lines and calculates risk score as well as identifies any detention flags.

FDmonitor™ Provides business process monitoring using interactive dashboards, and business process automation using business processes and control agents. Enables monitoring of multiple databases, file systems, and remote servers and triggers necessary actions and user alerts.

Allows definition of key performance indicators and display real- time results in rich dashboards.

Provides live interfaces with external databases for entry-line screening, allows for automation of review processes, and supports development and management of performance measures.

FDauditor™ Simplifies the addition of change tracking of business data to Java applications. This self-contained solution enables critical auditing functionality without adding additional complexity to business logic and without polluting the production database.

Provides ability to manage and track changes to screening rules and to the PREDICT application.

Scope Software Maintenance Support and Upgrades. The Software Maintenance Support includes:

• Level 1 support which is “technical” telephone consultation and error correction services as well as upgrades in the form of enhancements. Services shall be provided during normal business hours, 9:00 – 17:00 Eastern Standard Time (EST). However, given the criticality of this software to FDA’s mission, support outside of normal business hours may be required if operations of the ORA applications is impacted.

• Software maintenance updates are defined as new builds for the current version of the Software that results in a patch, bug fix, updated documentation, and improved performance. Software bugs resulting from any upgrades that impact operations of the ORA applications that utilize this software shall be resolved, and an updated version of the code shall be provided within 1 business day.

• Software upgrades are defined as new releases of all or the component modules which comprise the Software that substantially enhances the functionality of the product and/or results in a change to the release number of the product included in the suite (e.g. the FDanalyzer module licensed has a major releases 4.0 release.)

• The vendor will be responsible for providing online or telephone support as needed to PREDICT & Prior Notice application teams in instances where questions or issues with the NTELX tools or integrations arise. In addition, the vendor shall provide support for any potential future upgrades to the NTELX software.

Period of Performance Base Year: 3/01/2025 - 2/28/2026 Option 1: 3/01/2026 - 2/28/2027 Option 2: 3/01/2027 - 2/29/2028 Option 3: 3/01/2028 - 2/28/2029 Option 4: 3/01/2029 - 2/28/2030

FOB Point Destination

• All items shall include shipping, handling and in-side delivery to the destination identified herein.

Delivery/installation completed within 30 days after receipt of order.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, UEI number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);

• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, descriptive material, literature, brochures, and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include UEI number and size status) if not the respondent.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

• If a large business, identify the subcontracting opportunities that would exist for small business concerns;

• Standard commercial warranty and payment terms; and

• Though this is not a request for quote, informational pricing is encouraged.

• The government is not responsible for locating or securing any information, not identified in the response.

• The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

• Interested Parties shall respond with capability statements via email to robert.waite@fda.hhs.gov on or before 11/14/2024, by 1:00 pm Eastern Time (ET).

mailto:robert.waite@fda.hhs.gov

Notice of Intent Responses to this source sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on Sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

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