A--This request for information is seeking entities interested in the development of a FDA licensed freeze-dried plasma (FDP) product for use in battlefield treatment of severe hemorrhage.

1.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission is to develop and manage medical materiel to protect and sustain the Warfighter, this request for information is seeking entities interested in the development of a FDA licensed freeze-dried plasma (FDP) product suitable for use in battlefield treatment of severe hemorrhage. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 DESCRIPTION: This request for information is seeking entities interested in the development of a FDA licensed freeze-dried plasma (FDP) product for use in battlefield treatment of severe hemorrhage. Specifically sought is a company with a freeze dried plasma product candidate interested in obtaining US FDA licensure or a commercial manufacturing organization with lyophilization capability interested in providing freeze dried plasma to the US Government under a potential U.S. Army Office of The Surgeon General sponsored Investigational New Drug (IND) application. Table 1 (ATTACHMENT A) provides the essential FDP Performance Attributes sought by the USAMMDA. 4.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a responce must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to accomplish licensure of a FDP product or provide FDP product for a US Government sponsored IND. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. 5.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Ms. Shannyn Scassero at contact@example.gov no later than the close of business 26 AUG 13. Telephonic communication will not be considered as submission or receive response. 6.0 QUESTIONS AND ANSWERS 6.1 Is there a standard format for the 2-3 page synopsis? There is no set format for the 2-3 page synopsis. 6.2 In the table for performance attributes, what is the definition of the Operational Temperature? If the storage temperature is 2-8C, is the operational temperature related to excursions outside this range? The expected operational temperature where plasma may be transfused will range depending on the worldwide location of deployed forces. Immediate life saving transfusions may not occur in a medical facility. The threshold requirement for operational temperature in the FDP Capability Development Document is 0-40 degrees Celsius.