Pre-Sol_Notice_-_75N98026R00128_2.pdf

Corrective Action for Pre-Solicitation Notice

National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation Funnel Commercialization Center

Solicitation No. 75N98026R00128

INTRODUCTION:

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).

THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.

The National Institute of Biomedical, Imaging, and Bioengineering (NIBIB) intends to award a modification to Indefinite-Delivery/Indefinite-Quantity (IDIQ) Contract No. 75N92022D00013, facilitating the requirements of the Rapid Acceleration of Diagnostics (RADx-Tech) initiative, an innovation funnel aimed at increasing the speed of development, commercialization, and implementation of health technologies, without providing for full and open competition (including brand-name) to the National Collegiate Inventors & Innovators Alliance, Inc.

(VentureWell). The IDIQ ceiling value for Contract No. 75N92022D00013 will be increased through a modification action to accommodate and to continue core operational activities outlined in the Statement of Work (SOW). It is anticipated that the modification will be issued around September 2026.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE:

The intended procurement is classified under NAICS code 541618- Other Management Consulting Services

REGULATORY AUTHORITY:

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective March 13, 2026. This acquisition is conducted under the procedures as prescribed in FAR subpart 12—Acquisition of Commercial Items and FAR subpart 15—Contracting by Negotiation at an amount exceeding the simplified acquisition threshold (SAT).

STATUTORY AUTHORITY:

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1), as set forth in RFO – Federal Acquisition Regulation (FAR) 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

DESCRIPTION OF REQUIREMENT:

BACKGROUND AND PROGRAM OBJECTIVES

In response to the COVID-19 pandemic, the NIBIB created the Rapid Acceleration of Diagnostics (RADx-Tech) initiative, an innovation funnel aimed at increasing the speed of development, commercialization, and implementation of technologies for COVID-19 testing. The RADx-Tech innovation funnel was designed to compress the customary technology development timeline from years down to just months. This was accomplished by employing, in parallel, expert teams of contracted consultants to assist technology developers in addressing technical, regulatory, clinical, and commercialization projects. It is envisioned that further acceleration of healthcare innovations will enable greater preparedness for future pandemics, as well as provide significant advances to the current healthcare paradigm across a broad range of clinical indications beyond COVID-19. In an effort to leverage the RADx-Tech model for rapid acceleration of innovative technologies, the NIBIB requires highly specialized and uniquely experienced contracted personnel capable of providing critical project, program, and portfolio support.

The innovation funnel has been structured as a collaborative network of centers that each serve critical roles in accelerating technology development progress. The three centers – Coordination Center, Commercialization Center, and Validation Center – will be required to communicate and interact routinely within the various innovation funnel processes. The Coordination Center will be responsible for overall operational oversight and guidance, ensuring standard operating procedures and streamlined workflows for project review and management. The Commercialization Center will be responsible for identifying and selecting subject matter experts who will support the innovation funnel processes, such as project review, project management, and commercialization assistance. The Coordination Center and Commercialization Center partner closely to determine expertise gaps and fill needs as appropriate. The Validation Center will be responsible for providing technical and clinical validation services, verifying progress of prototype technologies against key performance and design metrics. The Validation Center will harmonize services with the workflows from the Coordination Center and the experts of the Commercialization Center. Working in concert, the three innovation funnel centers enable parallel efforts that greatly increase the efficiency of the funnel.

The objective of this requirement is to provide product commercialization expertise and resources to various NIH translational activities.

PROJECT REQUIREMENTS

Indefinite Delivery-Indefinite Quantity (IDIQ) contract 75N92022D00013 is for a single vendor that requires professional services support across a range of commercialization domains to NIH translational activities. To support rapid technology development, consultants with specialized domain expertise are needed to assess and mitigate risks at various stages. The vetting and management of professional service consultants and vendors is a critical component of the parallelization effort to speed innovation.

At present, the IDIQ provides vendor support for rapid technology development that requires consultants with specialized domain expertise are needed to assess and mitigate risks at various stages. The vetting and management of professional service consultants and vendors is a critical component of the parallelization effort to speed innovation. Responsibilities cover the recruitment of professional services consultants and professional services vendors, client services support for subcontracting and consultant services, and maintenance of an enterprise-level automated management software solution. Continued synchronization of all aspects of this IDIQ is important for successful completion of the program.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement, addressing each project requirement separately. The response should also include: 1) the total number of employees; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including computer equipment and software; 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and

5) any other information considered relevant to this program. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract modification action based upon responses to this notice is solely within the discretion of the Government. 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.

All responses must be received by the closing date on this notice and must reference the solicitation number. Responses may be submitted electronically in accordance with the instructions below.

“All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

Submission Instructions:

Interested parties shall submit capability statements via electronic mail and must reference the Notice number 75N98026R00128 in the subject line of the e-mail submission.

The due date for receipt of responses is 3:00 p.m. Eastern Standard Time (EST) on August 5, 2026. All responses must be received by the specified due date and time in order to be considered.

Capability responses shall be submitted electronically to the designated Contracting Officer and Contract Specialist as follows:

Melanie Suarez, Contracting Officer: melanie.suarez@nih.gov

Noelle Decenzo, Contract Specialist: noelle.decenzo@nih.gov

This notice does not obligate the Government to award a contract(s) or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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.