Notice of Intent to Sole Source 111622.pdf

Notice of Intent to Sole Source

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. Reference#: N6264523R0012. Naval Medical Readiness Logistics Command – Detachment (NMRLC-DET) intends to award a firm fixed price contract under the authority of FAR 13.106- 1(b)(1)(i), only one source being available to meet the Government’s needs, to:

Eurofins DiscoverX Corporation 42501 Albrae ST Fremont, CA 94538-3394

The North American Industry Classification System (NAICS) code for this requirement is 541380, Testing Laboratories; the business size standard is 16.5 (millions of dollars).

The objective of this sole source award is to procure Bioassay testing services to include multiple classes of relevant operational medications (Tier 1 Epinephrine. Atropine, Norepinephrine, and Vasopressin) (Tier 2 Lidocaine, Dexetomidine, Rocuronium and entrapenem).

Eurofins DiscoverX Corporation is the only vendor capable of meeting all of the Government’s requirements.

Medications will be tested for exposure: Epinephrine, Norepinephrine, Phenylephrine, Vasopressin. Testing intervals: Day 5, 10, 15, 20, 25, 30. 2 samples per test. Control sample with 0 exposure. Each medication requires 2 samples to be tested at each of the 6 time intervals. Each sample also requires a technical replicate to ensure accurate results. The medication samples will be sent all packaged to gather via next day mail on the following post day 30 temperature exposure. Turn-around time is 15 business days from the study start date (following assay qualification data review and receipt of authorization from Client to proceed). Vendor must meet all requirements provided in the statement of work attached.

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide all required bioassay service testing as validated by Eurofins DiscoverX Corporation. Capability statements shall not exceed 6 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

Capability statements are due by 9:00 am eastern time, Friday 30 November 2022. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address:

heather.y.clipson.civ@health.mil . The email subject line shall state, “Naval Medical Readiness Logistics Command

- Detachment, Special Notice Number N6264523R0012.”

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED

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STATEMENT OF WORK

Project: Drug Activity Testing

1.0 INTRODUCTION

1.1 Serial drug activity testing post exposure to extreme environments is required to meet the mission of a research study.

1.2 Multiple classes of relevant operational medications were selected. Bio-assays to test the activity of these medications were also selected.

1.3 The contractor shall provide, in accordance with this statement of work, all results for target based efficacy testing for samples sent from the Naval Medical Center San Diego.

1.4 The contractor shall provide a study report in PDF form, a results file, as well as an IC/EC50 calculation if 10 concentrations are selected.

1.5 During the term of this contract, the contractor shall meet the 15 business day turn-around time from receipt of compounds and paperwork.

2.0 SCOPE

2.1 The contractor shall provide services, for samples that were collected, at intervals of day 0, 5, 10, 15, 20, 25, and 30.

2.2 The contractor shall provide testing and results for two samples per test for a total of 48 samples.

2.3 The contractor will adhere to industry best practices for data quality and integrity.

3.0 DUTIES

3.1 The contractor shall provide fully trained staff to complete all testing and reports.

3.2 Storage conditions for all samples shall be reported to the Naval Medical Center.

3.3 The contractor shall keep all data and results confidential.

3.4 The contractor must have personnel, organization, and administrative control necessary to ensure that the services performed under this contract are satisfactory and fully satisfy the Naval Medical Center requirements.

4.0 PROCESS

4.1 The Naval Medical Center will contact the contractor at the start of the study to schedule sample processing.

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4.2 Contractor will provide notice to the Naval Medical Center when samples are received.

4.3 Testing for each sample shall be done at the specified intervals.

4.4 All data shall be reported to the Naval Medical Center within 15 business days.

5.0 QUALIFICATIONS

5.1 Capability to perform target based efficacy studies on the following medications:

Epinephrine, Norepinephrine, Phenylephrine, and Vasopressin.

5.2 Approved laboratory space, reagents, access to technology, qualified lab technicians, and administrative personnel.

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