Notice of Intent to Sole Source

The Naval Medical Readiness Logistics Command (NMRLC) intends to award a sole source contract under the authority of FAR13.106-1(b)(1) to IDT Biologika Corporation, 1405 Research BLVD STE 100, Rockville, MD for the delivery of the described requirement in support of Naval Medical Research Center (NMRC), Silver Spring, MD, 503 Robert Grant Avenue, Silver Spring, MD 20910. The requirement is for research support for (NMRC).

NMRC has a requirement to support ongoing research efforts to manufacture psoralen-inactivated dengue Virus 1 (DENV PsIV) vaccine under Good manufacturing Practice (GMP) conditions for conducting a phase 1 clinical trial in humans to evaluate its safety. Since the vaccine will be administered to humans, FDA requires that the product be manufactured and vialed under GMP conditions.

NMRC is currently engaged in preparation and testing of a psoralen inactivated Dengue vaccine. Promising results in the areas of Dengue virus growth, inactivation, purification and immunogenicity studies in rodents and non-human primates has warranted a Phase-1 clinical trial to demonstrate the safety of the product in humans. the contractor is a CDMO that has the capability to assist NMRC in this effort. the contractor has GMP facilities to accommodate virus growth and inactivation and has streamlined processes for purification process development, cGMP manufacture, aseptic fill/finish and required safety/stability testing for filing an IND with the FDA. Through this contract IDT will provide cGMP grade psoralen-inactivated Dengue vaccines (Dengue PsIV) to support a Phase I clinical trial to evaluate the safety and immunogenicity of DENV PsIV in humans. The contractor will also provide the Certificate of Analysis (CoA) for each batch of the Dengue PsIV as well as the batch analyses reports.

The proposed period of performance for this requirement is 24 months.

NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences. The small business size standard, for NAICS Code 541715, is 1,000 employees.

If capable sources are not identified through this notice, then NMRLC intends to award a sole source contract under the authority of FAR 13.106-1(b)(1) to IDT Biologika Corporation.

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 perform the required work. Capability statements shall not exceed 5 (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 contract.

Capability statements are due by 10:00 AM Local Time, 6 April 2023 (15 days). Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: lendorph.e.ramos.civ@health.mil and CC ronald.d.govans2.civ@health.mil .