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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Pre-Solicitation memorandum

For: MICRO CT SCANNER SYSTEM WITH ACCESSORIES FOR mission critical COVID19 vaccine and therapeutics development NAICS CODE: 334516 / 1000– Analytical Laboratory Instrument Manufacturing.

Delivery order / code 6640 date: July 20, 2020

I. Background: NIAID has a longstanding commitment to coronavirus research, including extensive efforts to combat diseases such as severe acute respiratory syndrome (SARS). This research as improved our understanding of coronaviruses and provides a strong foundation for our efforts to learn more about SARS-CoV-2, the novel coronavirus that causes COVID-19. NIAID has quickly responded to the newly emerging SARS-2 outbreak and started the development of urgently needed medical countermeasures (MCMs). Given the widespread circulation of SARS-2, and an increasing number of cases in the USA, it is crucial that essential reagents and platforms critical for the development of MCMs are directly available. To that end, The Laboratory of Virology has researched animal models of COVID-19 disease, including non-human primates and rodents, using these models for vaccine and therapeutic testing. However, the cost of non-human primates and other space and ethical concerns makes it unlikely that these animals could be used for high-throughput testing. Rodents are the preferred initial choice for screening, but the disease read-outs in mice and hamsters are largely based on weight, visual scores and findings after euthanasia. A CT scan is ideal for tracking disease within the animal, especially a respiratory disease such as COVID-19

A. Project Description The MOLECUBES X-CUBE Micro CT scanner will be used to better understand the disease course of rodents (mice, hamsters and possibly guinea pigs) infected with SARS-CoV-2 virus. As animals develop COVID-19 disease, the CT allows for an in-depth, internal look at the respiratory tract and changes throughout the disease course. As this disease is not lethal in 100% of tested rodents, the scans are a significant output to gauge disease severity and trends. As animals are vaccinated or treated with therapeutics, the CT scans will allow researchers to clearly quantify changes in the disease course without requiring euthanasia of the animals to test internal organs for viral load. These scans will be much more valuable in utilizing the rodent models for COVID-19 for vaccine/therapeutic screening than the highly variable outputs of virus shedding and weight gain or loss. Delay in this procurement will undoubtably delay an approved vaccine and therefore cause loss of human life. The study start date is set for as soon as this equipment arrives.

The newly emerged SARS-COV2 virus currently causing a pandemic has had a major impact on morbidity and mortality worldwide, as well as having a devastating global economic and societal impact. The overall impact cannot be quantified, some of which is due to the worldwide public health response and not the virus itself. Decisions are being made without any data and it is critical to gain a rapid understanding of the exposures and immunity in the general population. The mission is to create and develop potentially lifesaving vaccines for COVD-19, HIV, Ebola, Zika, and other known pathogens and get these potentially lifesaving products into the clinic. This equipment is needed in the efforts to develop work on vaccine for the COVID-19.

This request is for a time-sensitive, urgent response to the COVID-19 pandemic. This is considered an unusual and compelling request to address NIH's response to the spread of the disease. This requirement qualifies as an exception from Full and Open Competition under FAR 6.302-5(2) (i). & 6.302-2 – Unusual and Compelling Urgency.

II. Period of Performance/Delivery Date: To be delivered as soon as possible.

III. Considerations

· Mandatory and Preferred sources such as Ability One, HHS Internal contracts and FSS contract mechanisms

· NIH Policy Manual 6307-3 (Clearance, justifications and/or approvals) - IT clearance is required for this requirement and is attached to the Ambis requisition.

· FAR 39.2, 508 Compliance – This requirement is NOT for commercial software or IT products, so IT clearance is not required.

· Other special considerations, including green purchasing (FAR 23), licensing agreements, data rights, information security, and Individual Privacy Protection – No additional considerations

· The Buy American Act (BAA) – Buy American Act applies, if this is an open market acquisition.

· Brand name or equal JUSTIFICATION (JOFOC): This is a consideration that will be included in market research and analysis.

I. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ An urgent and compelling need exists, and following the procedures would result in

II. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s): LabLogic Systems, Inc., 1911 N US Highway 301, Tampa, FL 33619

B. Describe why only the requested supply/service will meet the government’s needs.

Despite being considered a BLS3 pathogen, much of our SARS-CoV-2 work is carried out in the BSL4 laboratory. This allows us to, among other things, directly compare SARS-CoV-2 research with SARS1, which is a select agent. This machine will be used in the BSL4 laboratory, a highly specialized space that requires a particular set of concerns to be addressed before purchase. While other CT Scanners are available for veterinary work, this one is designed to handle research rodents rather than companion animals, and is considerably less expensive than a CT that could scan larger animals. Size is a distinct issue in the BSL4, where space is at a premium, and this machine has a small footprint. As electronics in the BSL4 must meet IT, Security and Biosafety requirements, it is noted that LabLogics works with a number of federal laboratories and is compliant in terms of IT security. Additionally, removal of equipment from BSL4 space for calibration or repair requires a complicated procedure of decontamination which may render electronics useless—this machine 1) does not require calibration when moved, reducing the numbers of times that an outside agent might be called in to work on it and 2) can be put through the rigorous annual shutdown decontamination procedures for annual maintenance with no harm to the equipment.

C. Describe why only the proposed contractor is capable of providing the requested supply/service.

Other veterinary CT scanners are larger and more expensive, both prohibitive to BSL4 work. The Molecubes scanner purchased through LabLogics meets all the requirements for equipment entering the BSL4. This machine will be used entirely for COVID research in the foreseeable future, and time is of the essence to receive and being using the machine to further characterize the disease course in rodents and begin an in-depth look at the effects of therapeutics on the virus and disease.

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