Notice of Intent to Award a Contract Modification to USC

The Food and Drug Administration intends to modify contract HHSF223201400115C, "Rapid Assessment of Acute Illness and Injury to Enhance the U.S. Response to Public Health Emergencies" in the amount of $394,000. The contract modification will be awarded to: University of Southern California 3720 S. Flower Street Los Angeles, CA 90089 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. USC is currently conducting the study on Rapid Assessment of Acute Illness and Injury to Enhance the U.S. Response to Public Health Emergencies under FDA contract HHSF223201400115C. Under this contract, USC has developed unique capabilities that are vital to this contract. Therefore, only USC has the ability to collect the additional data required for the analysis. FDA subject matter experts determined that the current study needed to be modified to add value to the framework protocol under development by USC regarding emerging infectious diseases. Under the current contract USC has developed vital capabilities and unique knowledge regarding the centralized ethics review and data use agreements to facilitate FDA's mission priorities during a public health emergency. The added work proposed in the contract modification is a natural extension of the research studies already under contract and USC is the only organization that can complete the proposed work within the timeframe required. USC will aid in the development of single treatment protocol to study three Phase 4 anthrax therapeutics. USC will also aid in the development of a Randomized Controlled Trial (RCT) treatment protocol for antigenically distinct or emerging influenza strains (e.g., H7N9) that study antiviral therapeutic agent(s) identified by FDA and/or BARDA. These MCMs may be novel antiviral or monoclonal antibody in nature. The protocol may include more than one (investigational or approved) anti-influenza MCM, be adaptive in nature to allow rapid addition of new MCMs, and may ultimately be used as a template or framework protocol for other emerging infectious diseases. USC will analyze the additional data and provide the FDA with the added value for the study. The NAICS code for this action is 541712. This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements. This is a notice of intent to issue an award on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item to: Lisa Yaw Contracts Specialist Lisa.Yaw@fda.hhs.gov 240-402-4018 A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about July 21, 2017.