pre-sol_notice.docx

Pre-Solicitation Notice

RADx Tech Accurate, Sensitive and Affordable POC Device

Presolicitation No. 75N92020C00015

Introduction The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), intends to negotiate and award a contract extension/modification without providing for full and open competition to the MicroGem US Inc (MicroGEM) under Contract 75N92020C00015 entitled “Accurate, Sensitive and Affordable POC Device” using the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart FAR 6.302-3—Industrial mobilization; engineering, developmental, or research capability; or expert services.

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

North American Industry Classification System (NAICS) Code This procurement is classified under NAICS code 334516 Analytical Laboratory Instrument Manufacturing with a size standard of 1,000 employees.

Background Rapid Acceleration of Diagnostics (RADx), is a fast-track technology development program that leverages the NIH Point-of-Care Technology Research Network (POCTRN). RADx supports novel solutions that build the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches. Rapid Acceleration of Diagnostics Tech (RADx Tech) fast track program which supports the development and commercialization of innovative technologies to significantly increase the U.S. testing capacity for SARS-CoV-2, the virus that causes COVID-19. MicroGEM’s contract was awarded under Rapid Acceleration of Diagnostics Tech (RADx-Tech) to produce a point-of-need, portable point-of-care device for the detection of SARS-CoV-2 for rapid acceleration of testing.

The timeline of the RADx program goals has shifted over recent weeks. This is in large part due a convergence of factors: the nation not meeting the vaccination goals in numbers necessary to help curb the pandemic; a portion of the population (i.e., children) still unable to be vaccinated; the reopening of public places across the country; and the increased spread of the SARS-CoV-2 Delta variant. This has led to a crisis in the unvaccinated community, and a rapid rise in demand for COVID-19 testing in recent weeks, from a previously reduced stable state of testing. Recently, the Secretary, HHS renewed the determination that a Public Health Emergency exists (signed July 29, 2021; link: https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx). In order to effectively respond to these events, the RADx program leadership has made a decision to shift focus, from a planned ramp-down of RADx projects, to a need to maintain the testing and production capabilities offered by the RADx vendors in order to respond to this national emergency.

The scope of work performed under MicroGEM’s Contract 75N92020C00015 incorporates technology leveraging core competency in enzymatic sample preparation for nucleic acid isolation to create a non-invasive, portable, saliva-based, high-performing RT-PCR point-of-care test and device for SARS-CoV-2 that provides rapid results in 25 minutes.

MicroGEM’s contract was awarded under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-2, Unusual and compelling urgency under the Department of Health and Human Services (HHS) class Justification & Approval (J&A) to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-19). The class J&A was issued in response to the Presidential Emergency Proclamation signed on March 13, 2020 for the COVID-19 pandemic. See https://intranet.hhs.gov/sites/default/files/s3fs-public/s3fs-public/2020-03/class- justification-open-competition-covid-19-response.pdf.

Description of Requirment Under the current contract MicroGEM has ramped up production to capacity to process 160,000 cartridges/1,000 devices per day. The purpose of this modification is to extend the contract for 3 months at no additional cost to the Government in order to allow for ongoing evaluation of emerging variants and to ensure MicroGEM’s production capacity meets surge in testing needs.

Period of Performance The period of performance is being extended by 3 months, from August 26, 2020 – August 25, 2021 to August 26, 2020 – November 25, 2021.

In light of the aforementioned facts, the U.S. Government intends to award this new requirement via a contract modification to MicroGEM’s Contract 75N92020C00015 to ensure it sustains the capacity to produce 160,000 cartridges/1,000 devices per day.

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 and include the following: 1) the Dun & Bradstreet Number (DUNS), 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) ability to perform and experience in performing the requirements described above;

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

This is notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.2 requiring dissemination of information of proposed contract actions. This is a notice of intent to award a sole-source contract modification and is not a request for competitive proposals. The statutory authority for this sole-source procurement is under the authority of the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart FAR 6.302-3—Industrial mobilization; engineering, developmental, or research capability; or expert services. The Government is not committed to award a contract pursuant to this announcement.

This notice of intent is not a request for competitive proposals. Any Interested party that believes it can meet the requirement, may submit a capability statement through FedConnect before 3:00 PM ET on Monday, August 23, 2021. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

Point of Contact:

Tara Knox, Contracting Officer, Office of Acquisitions, NHLBI, Email: tara.knox@nih.gov

Information Submission Instructions Interested parties shall submit capability statements via the FedConnect web portal (www.fedconnect.net) and reference Pre-solicitation Number 75N92020C00015. The due date for receipt of statements is Monday, August 23, 2021 by 3:00 PM Eastern Time. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf .

For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. Please use the Contracting Officer contact information provided, should you require a waiver to not use FedConnect for submitting your capability statement.

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 in Federal Business Opportunities. 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).