Notice of Intent to Sole Source Short Chain Fatty Acid Pills

Notice ID:

W81XWH22Q0016

Department/Ind. Agency:

DEPT OF DEFENSE

Sub-tier:

DEPT OF DEFENSE

Sub Command:

W4PZ USA MED RSCH ACQUIS ACT

Office:

W4PZ USA MED RSCH ACQUIS ACT

All Dates/Times are:

(utc-05:00) eastern standard time, new york, usa

Updated Published Date:

(utc-05:00) eastern standard time, new york, usa

Original Published Date:

0000-00-00 00:00:00

Original Response Date:

dec 21, 2021 08:00 am est

Inactive Policy:

15 days after response date

Original Inactive Date:

jan 05, 2022

Initiative:

• None***--***

Product Service Code:

6505 - drugs and biologicals

NAICS Code:

325412 - pharmaceutical preparation manufacturing

Original Set Aside:

This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Research Institute of Environmental Medicine (USAMRIEM) to procure short chain fatty acid pills without competition as prescribed in FAR 13.106-1(b)(1). Specifically, the Government will procure this from Eurofins CDMO. Eurofins CDMO is the only source who can provide the required supplies. They are the only company that has the unique expertise and have demonstrated the capability to manufacture the required supplies to the required specifications. The supplies required are capsules specifically designed to release a dietary supplement into a specific region of the gastrointestinal tract. To ensure supplement delivery is targeted to the appropriate region of the gastrointestinal tract the capsules must be coated with a special coating at a specific thickness and must include a specific combination of certain inert ingredients. USARIEM scientists will use the supplies in a human subjects research study that is attempting to show proof of principle that the compounds in the supplement can improve physical performance. The compounds being used are produced by healthy gut bacteria that live in the human large intestine. USARIEM scientists are attempting to demonstrate that these gut bacteria-derived compounds can benefit performance. However, the only way to achieve that aim is to deliver a controlled amount of the compounds to the region of the gastrointestinal tract (i.e. the large intestine) in which they are produced by gut bacteria. This necessitates engaging Eurofins CDMO as they are the only company to previously conducted research & development activities to establish the correct coating and thickness required to deliver the compounds to the large intestine, to identify the appropriate inert ingredients and their amounts, and to demonstrate the necessary performance of the final product. No other company has undertaken this research & development process or demonstrated the capability to manufacture the required supplies to the required specifications. As such, no other company is prepared to manufacture the required supplies to the required specifications. In addition to the unique expertise described above, the Eurofins CDMO maintains several additional unique capabilities necessary to meet this requirement. These include a fully certified, licensed and inspected Good Manufacturing Practice (GMP) facility, and capability to manufacture non-sterile Drug Products including encapsulation. This announcement fulfills the synopsis requirements under FAR 5.102 (a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source requirement. All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@mail.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 8:00 AM ET, 21 Dec 2021.

BLDG 820 PBO 820 CHANDLER STREET

FORT DETRICK , MD 21702-5014

USA

Primary Point of Contacts:

James Cheng