INSTEM SOFTWARE MODULES—SEND SUBMIT AND PROVANTIS

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1 (b)(2) Soliciting from a single source. For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The Government intends to award the contract Instem LSS (North America) Limited 161 Washington ST, STE 1550, Conshohocken, Pennsylvania 19428.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 518210 with a Size Standard of $40 Million.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) (2) Soliciting from a single source provides that: For purchases exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available

(e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2025-05 dated August 7, 2025.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

NIDA requires Instem software programs (SEND Submit and Provantis) to be implemented at National Center for Advancing Translational Sciences (NCATS). These software modules are needed to generate Food Drug Administration (FDA) compliant SEND files (XPT Format) for Investigational New Drug Application (IND) enabling toxicology studies.

1. Background Information and Project details:
   1. Project Request ID: PIO0001240
   2. Project Title: In-house SEND dataset creation for non-clinical toxicology
   3. This project will commence after the implementation of the software at NCATS.
2. Generic Name of Product:
   1. SEND Submit module
   2. Provantis module
3. Purchase Description and Salient Characteristics:
   1. SEND Creation Software and Provantis software of Instem
   2. SubmitTM and Provantis®
4. Quantity:
   1. SEND SubmitTM: 1 license for 3 users
   2. Provantis: 1 license for approximately 100 users
   3. Implementation of Provantis: 1 time setup
5. Delivery Date or Period of Performance:
   1. Delivery date: 40-60 days
   2. Period of performance: The estimated period of performance is September 29, 2025 through September 28, 2026.
6. Special Instructions:  Deliver license keys to Pramod Terse at tersep@mail.nih.gov and   NCATSHelpDeskSupport@mail.nih.gov .

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Instem is the only entity that can supply these proprietary modules.

The purpose of this acquisition is to obtain two cloud-based, web-accessible modules from Instem software (Send and Provantis) (https://www.instem.com/) to enhance the Division of Preclinical Innovation (DPI) Toxicologists’ ability to create, review, and manage SEND (Standard for Exchange of Nonclinical Data) datasets internally. The SEND is a required format for submitting nonclinical study to the FDA. Another key objective is to accelerate the IND submission process by enabling in-house teams to generate SEND datasets in under a week, compared to the 4–6-week timelines at CROs. Additionally, the acquisition will provide critical internal review capabilities through the SENDView tool, ensuring data quality and regulatory compliance. The modules will also support educational and training goals by allowing staff and students to compare toxicity data across studies, fostering deeper insights into on- and off-target effects and species-specific responses.

DPI Toxicologists aims to acquire two cloud-based, web-accessible modules through Instem software to improve efficiency and reduce costs associated with the creation and review of SEND (Standard for Exchange of Nonclinical Data) datasets. The SEND is a required format for submitting nonclinical study to the FDA. By generating these datasets in-house, DPI can significantly reduce reliance on costly CRO services. The software also includes the SENDView tool, enhancing DPI’s ability to internally review and ensure the quality and compliance of datasets, a capability currently lacking. Additionally, it provides valuable educational opportunities by allowing staff and students to explore and compare toxicity data across studies, supporting the identification of on- and off-target effects and species-specific responses. These are two cloud-based, web-accessible modules through Instem software to improve efficiency and reduce costs associated with the creation and review of SEND (Standard for Exchange of Nonclinical Data) datasets.

The intended source is:

Instem LSS (North America) Limited

161 Washington ST, STE 1550

Conshohocken, Pennsylvania 19428

Closing Statement: THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95025Q00270. Responses must be submitted electronically to Josh Lazarus, Contracting Officer, at Josh.Lazarus@nih.gov or Llakim Dubroff, Contract Specialist, at Llakim.Dubroff@nih.gov U.S. Mail and Fax responses will not be accepted.