Cryopreserved Platelet (CPP) Development for U. S. Food and Drug Administration Licensure

This is a pre-solicitation notice for a requirement that will be posted as a Request for Proposal at a future date.

The U.S. Army Medical Materiel Development Activity (USAMMDA) is seeking a contractor that is experienced in designing, managing, and carrying out the performance of Phase 2 and Phase 3 clinical trials in accordance with Good Clinical Practices (CGP) guidelines. The result of this effort will be a single award Research and Development (R & D) contract for the purpose of conducting all activities necessary to successfully develop a Food and Drug Administration (FDA) licensed dimethyl sulfoxide (DMSO) Cryopreserved Platelet (CPP) product for the U.S. Military. The U.S. Army Office of the Surgeon General is currently the regulatory sponsor of record for CPP, but will transfer regulatory sponsorship to the successful offeror upon contract award. Investigational work conducted under this contract will be used to support Food and Drug Administration (FDA) approval of CPP.

This award will be for performance of non-personal external services and will identify services that are non-severable in nature.

The request for proposal related to this requirement will be solicited as a total small business set-aside.

No contracts will be awarded based on this pre-solicitation notice. No pre-solicitation questions will be answered and proposals are not requested at this time. A company/business statement of capabilities will be accepted. The solicitation/request for proposal that will cover all the contract requirements will be posted at a later date, expected to be released in May 2019.

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