NOI to Sole Source - Regulated Activities Support Services in Support of USAMRIID (Bridge to W81XWH18F0209)

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a bridge, via a sole source contract, to Laulima Government Solutions, LLC, 12565 Research Pkwy Ste 300, Orlando, FL 32826, under the authority of FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. This requirement is for Regulated Activities support services for the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The regulated activities support services include:Providing professional-level human subjects protection and administrative support to the OHRO associated with developing, implementing, and administering the USAMRIID HRPP.Providing technical support to the QARCO in the areas of FDA and ISO-regulated quality assurance, quality review, GLP training and document control to support the USAMRIID.Providing professional-level animal welfare oversight and administrative support for the USAMRIID animal care and use

program, the OAWC, and the scientific research staff.Providing research technical support to Biostatistics in the areas of clinical and non-clinical development including, disease models, countermeasure efficiency, GCP studies, GLP studies, and technology development and integration.Providing equipment and software validation support for Regulatory Validation to support USAMRIID’s FDA-regulated scientific community.Providing research support for Select Agent Management in the area of biological select agent and toxin (BSAT) management in accordance with all governing regulations.Providing equipment lifecycle support, hand-receipt management/accountability and collection, identification, and turn-in of hazardous materials within Logistics.  The estimated period of performance of the requirement, including option periods, is 12 months (01 January 2022 – 31 December 2022). The short-fused, short-timeframe requirement is intended to bridge services in anticipation of award of the Defense Health Agency (DHA) OMNIBUS IV Multiple Award Indefinite Delivery Indefinite Quantity (MA-IDIQ) contracts. The award of a sole source, bridge contract will help establish a stop-gap measure to provide the services required to meet the existing mission of USAMRIID.Laulima Government Solutions, LLC is the only source able to meet the Government requirements. The contract employees providing the services are required to be enrolled in the Army’s Biological Personnel Reliability Program (BPRP). Historically the process to enroll a new individual into the Army BPRP has taken at least 12 months to complete the process. The services require BPRP, which is highly specialized and unique. Laulima Government Solutions, LLC already has BPRP certified personnel in place capable of providing regulated activities support services during the 12-month requirement; thus, avoiding a lapse in service. Given USAMRIID is the DoD’s lead laboratory for medical biological defense research, any lapse in service could result in USAMRIID not meeting its mission. At this juncture, no other contractor could replace Laulima Government Solutions, LLC and successfully recruit, submit employee packages, obtain BPRP certification, complete orientation and have their employees in place in order to avoid a lapse in service. Acquiring the services from another contractor would adversely impact the Office of the Commander and USAMRIID Directorates and they would lose functionality and critical quality assurance, administrative, scientific and technical support services required to support the biodefense research being performed within USAMRIID and would not be able to meet mission requirements.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 five (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 Eastern Time, 17 November 2021. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following address: jayme.l.fletcher2.civ@mail.mil.