Notice of Intent to Sole Source - Arakoda (Tafenoquine) Commercial Packaging and Validation Anti-malarial Drug

Notice of Intent to Sole Source The United States Army Medical Research Acquisition Activity (USAMRAA), on behalf of the United States Army Medical Materiel Development Activity (USAMMDA) is issuing this notice of intent to award a new contract on a sole source basis. This is not a request for proposals. This notice does not represent a commitment by the Government to pay for costs incurred from the preparation and/or submission of data in response to this notice.

The Government intends to award a sole source contract, in accordance with FAR 6.302-1(a)(2), to 60 Degrees Pharmaceuticals, Incorporated (60P), 1025 Connecticut Ave, STE 1000, Washington, D.C. 20036-5417. This is a new contract for commercial packaging and validation for the Arakoda (Tafenoquine) anti-malarial prophylactic drug. 60P will conduct packaging validation studies to transition from discontinued blister packs to bottles and validate new blister packaging.

The current packing configuration will be discontinued and 60P will work with a manufacturer to upgrade the packaging and conduct validation studies for the U.S. Food and Drug Administration (FDA) approval. This contract will be issued on a sole source basis as the Government’s market research indicates that 60P is the only source capable of providing the requested Research and Development services.

The North American Industry Classification System (NAICS) code for this requirement is 325412 (Pharmaceutical Preparation Manufacturing) and the small business size standard is 1,300 Employees. Any sources that believe they are eligible and capable of providing these services must respond in writing. Responses must be supported with clear and convincing evidence articulating the ability to provide the items outlined above. A request for documentation will not be considered an affirmative response.

Information received will be considered solely for the purposes 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 fifteen (15) days after the publication of this notice, the contract will be awarded without further remark. This notice is provided solely as information to the marketplace.

CONTACT INFORMATION: Questions may be submitted to Mr. Christopher M. Sult at Christopher.m.sult.civ@health.mil no later than 4:00PM EST on Wednesday, 10 May 2024.