B01-Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Date: 9 February 2022

Contracting Office Address – US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

Subject: Notice of Intent to Sole Source –

CLINICAL OBSERVATIONAL STUDY OF BACTERIOPHAGE THERAPY IN SKIN AND SOFT TISSUE INFECTIONS IN

TBILISI, GEORGIA

Solicitation Number: W81XWH22Q0022

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1 with Eliava Phage Therapy Center

The Medical Research Development Command (MRDC) strategic research and development plan identifies treatments for combat wound infections and sepsis as a primary gap (Gap #203617) in military medical readiness. Conventional antibiotic therapeutics for wounds are increasingly failing to resolve infections due to widespread multidrug resistant (MDR) bacteria that have acquired resistance to most, and in some cases all, classes of antibiotics. Bacteriophages are viruses with naturally occurring antimicrobial activity that have been widely and historically used to combat bacterial infection in humans. The specific requirement for studies that seek to develop wound infection MDR bacteriophages biologics is an integral and explicit part of MIDRP’s investment strategy.

Contractor shall provide the following services: study personnel will meet WRAIR’s regulatory (federal-wide assurance) requirements, e.g., CITI-trained and credentialed by WRAIR as investigators on the study protocol;

Contractor will provide frequent updates on patient enrollments, blood draws, lab results, problems/protocol deviations/subject withdrawals, and sample transfer coordination to USA Medical Research Directorate – Georgia (MRD- G)USAMRD-G; all investigators will obtain protocol-specific training for on the clinical and regulatory aspects of the protocol (e.g., the study questionnaire, inclusion/exclusion criteria, study risks/benefits, enrollment processes, and informed consent/assent documents); all investigators will have familiarity with the protocol contents, to include appendix material, questionnaires, and other protocol-specific documentation, and will be responsible for complying with the specified tasks wherein those tasks;

Contractor will conduct testing in accordance with the protocol requirements and their own institutional SOPs; will log and track samples, e.g. blood and bacterial isolates; samples will be transferred between contractor and MRD-G; will capture a complete data set as defined in the protocol for each study participant.

SCOPE OF OBJECTIVE

Primary Requirements:

• Study personnel will meet WRAIR’s regulatory (federal-wide assurance) requirements, e.g., CITI-trained and credentialed by WRAIR as investigators on the study protocol.

• Investigators will provide frequent and bidirectional updates on patient enrollments, blood draws, lab results, problems/protocol deviations/subject withdrawals, and sample transfer coordination.

• All investigators will have protocol-specific training for on the clinical and regulatory aspects of the protocol (e.g., the study questionnaire, inclusion/exclusion criteria, study risks/benefits, enrollment processes, and informed consent/assent documents).

• All investigators will have familiarity with the protocol contents, to include appendix material, questionnaires, and other protocol-specific documentation, and will be responsible for complying with the specified tasks wherein those tasks.

• Laboratorians will conduct testing in accordance with the protocol requirements and their own institutional SOPs.

• Samples, e.g. blood and bacterial isolates, will be logged and tracked.

• Samples will be transferred between contractor and MRD-G.

• A complete data set as defined in the protocol will be captured for each study participant.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible, interested parties may identify their interest by submitting capability information, in writing, by 2:00 p.m. est. 23 February 2022 to Mr.

Nathaniel Reus at Nathaniel.a.reus.civ@mail.mil. Supporting evidence must be furnished in sufficient detail to demonstrate the firm’s ability to provide the stated capability.

Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, USAMRAA will proceed with the sole source contract.

mailto:Nathaniel.a.reus.civ@mail.mil