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Q -- Naval Medical Research RESUS Program Study

Notice Date
Notice Type
Solicitation Notice
622110 — General Medical and Surgical Hospitals
Contracting Office
Department of the Navy, Naval Supply Systems Command, FISC NORFOLK DETACHMENT PHILADELPHIA, 700 Robbins Avenue, Building 2B, Philadelphia, PA, 19111-5083
ZIP Code
Solicitation Number
Response Due
Archive Date
FISC Norfolk Philadelphia Division intends to solicit on a sole source pursuant to FAR 6-302-1 using commercial items acquisition procedures as defined under FAR part 12, and using Simplified Acquisition Procedures per FAR part 13.5 for medical research in support of an Investigational New Drug for the treatment of pre-hospitalize patients with severe hemorrhagic shock. The estimated total study population is 1,000 patients which will be spread un-equally among qualified Medical Research Facilities. The Medical Research Facilities identified below have all met an extensive criteria that includes an affiliation with a hospital or Medical University, are considered by the American College of Surgeons Trauma Program, and the American Trauma Society?s Trauma Information Exchange Program as a level one trauma center, have a laboratory facility that passes the required certifications and are located in states that allow for an Exception from Informed Consent (EIC) trials, and are supported by EMS infrastructure that is considered appropriate for this type of study. Medical research facilities that are supported by too many EMS services (which will create problems for distributing enough of the Investigational New Drug to all EMS providers)or with a arrival time that is too short to allow adequate time for the Investigational New Drug to work will not be eligible to participate in this study opportunity. In addition, the Medical Research Facility must not be participating in a study that is similar or competing to this study of the Investigational New Drug. The following Medical Research Facilities have expressed an interest in participating in this study and have been preliminarily approved to do so: Washington Hospital Center University of CA. Irvine University of Maryland Med Syst. UCLA Medical Center UPMC-Presbyterian Hosp. Wake Forest University Allegheny University Hosp Baystate Medical Center Mercy Hospital of Pittsburgh Alfred Hospital Geisinger Medical Center Royal Melbourne Hosp (A) Parkland Memorial Hospital University of Vermont Johannesburg Hospital (SA) University of Rochester Miplark Hospital (SA) University of South Carolina University of Southern Ca. University of Connecticut University of Iowa Palmetto Hospital, Columbia SC Via Crhist Regional Med Center Yale University Hospital Spectrum Medical Center, The estimated start date for portions of this study to begin is 15 September 05. Firm fixed price contracts are the anticipated result of this negotiation effort. The duration of this study is expected to last for a two year period but will if necessary be extended to accommodate. The NACIS code for this effort is 622110. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only those sources listed above, under the authority of the Clinger Cohen act, interested medical research facilities may identify their interest and capability to respond to the requirement by email to Joseph.Tierney@Navy.Mil.
Place of Performance
Address: Various
SN00857205-W 20050730/050728212852 (fbodaily.com)
FedBizOpps.gov Link to This Notice
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