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The Centers for Disease Control and Prevention, NCIRD/DVD/VGB, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Mi... The Centers for Disease Control and Prevention, NCIRD/DVD/VGB, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Micro Biomedical, 57514th Street NE #100, Atlanta, Ga 30318 to manufacture cGMP microneedle (MN) patch to deliver IRV for use in animal toxicology and a Phase 1 clinical trial in humans. A cGMP manufacturing process will be implemented to produce MN patches that are suitable for a future Phase 1 clinical trial. As such, appropriate controls will be implemented to meet and/or exceed the requirements described in FDA’s Guidance for Industry: cGMP for Phase 1 Investigational Drugs (2008). Controls will be developed and implemented for the process, personnel, equipment, facilities, environment, materials/components, packaging/labeling, records, and testing. Also, because IRV antigens are sensitive to heat and other sterilization methods, terminal sterilization is not an option. Therefore, the MN patches will be manufactured under controlled bioburden conditions. Through contamination control methodologies along with aseptic techniques Micron will conduct production runs of a high quality, cGMP batch of IRV MN patches. The IRV formulation will be optimized for stability and potency, and a scalable manufacturing process will be developed that is compatible with aseptic processing within a cGMP environment. The specific deliverables will be to: qualify all test methods to support the release and stability studies of IRV MN patch, optimize a cGMP IRV MN patch manufacturing process, and manufacture cGMP IRV MN patch suitable for pre-clinical toxicology study. Micron Biomedical is the only vendor in the US that has this highly specialized microneedle manufacturing facility for human vaccines. CDC will be using Micron Biomedical's proprietary research data to complete our GMP manufacturing, which cannot be provided by any other source. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement which shall be considered by the agency. Please forward the capability statement information to Maria Shamburger, Contracting Officer, Reference 2020-44118, Centers for Disease Control, Office of Acquisition Services, ATTN: Maria Shamburger, heg9@cdc.gov. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov.