JOFOC Brand Name Portable Laser Speckle PDF REDACT.pdf

Justification for Other than Full and Open Competition:

Brand-Name at or Below the Simplified Acquisition Threshold

Project Title: Human Skin Immune Response to Tick Bites

I . Identification of the agency and contracting activity DHHS, NIH, NIAID, __Laboratory of Malaria and Vector Research (LMVR), Vector Molecular Biology Section

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action: (check the appropriate box)

☒ New requirement ☐ Follow-on

• Name of the previous contractor(s): ________________________________

• Sequence number, if available: ____________________________________

• Was the initial and any subsequent awards competed? ☐ Yes ☐ No

B. AMBIS Sequence number for this requirement: __ ________________ C. Total estimated dollar value of the requirement (including options, if applicable): _

D. Period of performance, inclusive of options: from E. Project Background

a) One of the main goals of the LMVR Vector Biology Section is to study the skin immune responses to the bites of vectors of disease that includes, mosquitoes, sand flies and ticks.

We are translating our research findings to the clinic and we need a quantifiable method to measure the redness of a skin immune response in humans to tick bites for an ongoing clinical trial at the NIH Clinical Center. Laser Speckle Contrast Imaging (LSCI) is a simple yet powerful technique that is used for full-field imaging of blood flow. Laser Speckle imaging, a non-invasive approach has been already used in clinical setting to image blood flow in the retina, skin, and the brain. A paper just published in Cell Reports by Calvo’s and Ackerman’s lab from LMVR (Cell Rep 2022;39(2):110648. doi: 10.1016) and our current work with guinea pigs and ticks show that Laser Speckle imaging can provide an accurate measurement of skin blood flow and skin immune responses to mosquitoes and tick bites.

We are in need of a portable laser speckle instrument to perform our studies at the NIH Clinical Center because the current instrument in our facility is large and static and and does not reach the areas in the thorax of the human subjects where the ticks are placed. The portability of this type of instrument will allow the mesurements of the body site where ticks are placed in the participant volunteers of our study and it will allow other investigators at NIAID to use it for studies in disease endemic areas for humans exposed to other insects such as sand flies and mosquitoes.

b) There is only one company that has available a portable laser speckler instrument. The portable instrument, the Full Field Laser Perfusion Imager or laser speckle imager (FLP2) is from the company Moor Instrument, Ltd that is located in Wilmington, DE.

The Full Field Laser Perfusion Imager, comprisises a 785nm imaging camera with inbuilt video camera (motorised zoom and auto focus with manual over-ride), lens cover, power supply and mains lead, USB lead for PC connection. The portability of the instrument is enhanced by a high performance i7 based laptop for use with FLPI2. This instrument has all the required features we require to measure the human skin responses at the tick bite site. Therefore, the FLP2 Laser Perfusion

Imager analyzer is the appropriate instrument for our human studies at the NIH clinical center and is necessary for us to collect our data from many human subjects in our ongoing and approved human clinical protocol.

F. Description of the supplies/services to be purchased

• Complete common generic identification of the item required.

Portable Laser Perfusion Imager analyzer

• Applicable model, make, or catalog number for each brand name product referenced and identity of the commercial catalog in which it appears.

MOORFLPI2 (Moor Instruments Ltd) https://www.moor.co.uk/en-us/products/imaging/laser-speckle-contrast-imager/

• Name of manufacturer, producer, or distributor of each brand name product referenced (and address if not well known).

Moor Instruments Ltd 501 Silverside Road, Wilmington, DE 19809 Tel: 302-798-7470

• Any other information necessary to describe the item required.

• Portable

• 785nm imaging camera with inbuilt video camera

• Motorised zoom and auto focus with manual over-ride

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

☒ 41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source / Brand Name

☐ F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition / Brand Name

Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute / Brand Name

IV. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

• Name and address of the proposed contractor(s)

Moor Instruments Ltd 501 Silverside Road, Wilmington, DE 19809 Tel: 302-798-7470

• Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

This vendor (Moor Instruments Ltd) was selected because it is the only company that offers a portable

Laser Perfusion Imager analyzer that weill measure the skin response to tick bites in human subjects at the NIH Clinical Center. They are a reliable manufacturer and vendor of Laser Perfusion Imager systems. They currently supply and maintain hematology analyzers for human samples in the NIH Clinical Center Department of Laboratory Medicine.

There is no competing system in the market that has the portability that this instrument offers. The MOORFLPI2 Full Field Laser Perfusion Imager system is the only commercially available system that offers the specific parameters needed for our experiments. We require a portable instrument that can be displaced from different rooms and imporatantly that can reach the area on the human subjects, including the thorax, where ticks are placed for these studies. Without this system, we will be unable to measure in real time and in a non-invasive manner the skin response at the tick bite site in our clinical human study.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable

Price reasonableness determination will be included in the acquisition file.

VI. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date