Notice of Intent to Sole Source to MICRON BIOMEDICAL, INC.

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to MICRON BIOMEDICAL, INC., 311 Ferst Drive NW, Suite L1309 Atlanta, GA 30332 for a robust manufacturing process will be implemented to produce MN patches that are suitable for a future pre-clinical trial. As such, appropriate controls will be implemented to meet and/or exceed the requirements described in FDA’s Guidance for Industry: Good Laboratory Practice and cGMP for Phase 1 Investigational Drugs. Controls will be developed and implemented for the process, personnel, equipment, facilities, environment, materials/components, packaging/labeling, records, and testing. Also, because rotavirus 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 high quality MN patch vaccines. The MN patch vaccine 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. At this time, there are no other known sources. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. All quotations/responses received by the deadline specified in this notice, in accordance with FAR 5.203, will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the contract specialist at [email protected] by 3:00 PM EST September 18, 2023.