NOI.pdf

PRESOLICITATION NOTICE: INTENT TO AWARD A SOLE-SOURCE CONTRACT

INTENDED SOURCE: Eurofins Panlabs Inc. – 6 Research Park Drive, Saint Charles, MS 63304-5685

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) intends to award a sole source contract Eurofins Panlabs, Inc., 6 Research Park Drive, Saint Charles, Missouri 63304.

FDA has a need to obtain in vitro safety data on chemical compounds of concern to CFSAN screened against biological targets. This data will allow CFSAN/OARSA/DOT to predict the safety of these chemicals, which is vital for carrying out the regulatory mission of CFSAN to protect public health. Eurofins Panlabs Inc. is the only company that can fufil this requirement because of the work that has already been done. Using another company would interrupt the integrity of the study.

The applicable North American Industry Classification System (NAICS) code for this acquisition is 334516 "Analytical Laboratory Instrument Manufacturing.”

MINIMUM REQUIREMENTS:

1. The contractor shall receive five (5) chemical compounds for screening on biological targets:

cannabichromene (CBC), cannabigerol (CBG), cannabinol (CBN), cannabidivarin (CBDV), (−)-trans-Δ9-THC (THC), and cannabidiol (CBD).

2. The contractor shall perform the biological target assays according to the table below:

Number of wells per chemical

Biological target assay CBC CBD CBDV CBG CBN THC

CB1 Human Cannabinoid GPCR Binding 14

12 12 12 12

CB2 Human Cannabinoid GPCR Binding 14

RARalpha Human Retinoic Acid NHR Binding 12

12 12 12 hERG Human Potassium Ion Channel Binding 14 12 12 12 12

AR Human Androgen NHR Binding 12

PPARgamma Human NHR Binding 2

2 2 2 alpha2A Human Adrenoceptor GPCR Binding 12

DAT Human Dopamine Transporter Binding 12

NET Human Norepinephrine Transporter Binding 12

5-HT2B Human Serotonin GPCR Binding 14

5-HT2A Human Serotonin GPCR Binding 12 beta2 Human Adrenoceptor GPCR Binding 12 beta1 Human Adrenoceptor GPCR Binding 12

D1 Human Dopamine GPCR Binding 12

PR Human Progesterone NHR Binding 14

2 = test 10 µM in duplicate 12 = test 3.16, 10, 31.62, 100, 316.28, and 1000 nM (each in duplicate) 14 = test 3.16, 10, 31.62, 100, 316.28, 1000, and 3163 nM (each in duplicate)

3. The contractor shall determine binding or inhibition (% relative to control) for each measurement. The Contractor shall provide the data in an electronic format (e.g., HTML, Excel, Word, or PDF document) to the Technical Point of Contact (TPOC) not later than one month after completing the screening.

4. The contractor shall include in the data all experimental protocols for each target assay including the identity of all reagents, buffers, concentrations, temperatures, incubation times, equipment, consumables, etc.

The Government intends to solicit and negotiate directly with Eurofins Panlabs Inc.. and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations; however, if any interested party believes they can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities must be submitted in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government.

All interested parties must express their interest and capabilities in writing via email to Telisha.Wilson@fda.hhs.gov within seven (7) calendar days after the date of publication of this notice. No faxed documents will be accepted. If no responsive statements are received within fifteen (15) calendar days, an award will subsequently be made to Eurofins Panlabs Inc.

This is a Federal contract opportunity; FDA-NOI-1255615 for services at Food and Drug Administration Office of Acquisitions and Grants Services.

MINIMUM REQUIREMENTS: