United States Special Operations Command, Directorate of Procurement (SOAL-KB), 2418 Florida Keys Ave., MacDill AFB, FL 33621-5316

A -- BAA; PRE-PROPOSALS FOR BASIC AND APPLIIED BIOMEDICAL RESEARCH RELEVANT TO SOF SOL USZA22-0-R-0001 DUE 113099 POC David Saren, sarend@socom.mil OR Susan Keeler, keelers@socom.mil (813) 828-7411 WEB: Full Text, soal.socom.mil. E-MAIL: Susan M. Keeler, Contracting Officer, keelers@socom.mil. The US Special Operations Command is soliciting pre-proposals directed at basic and applied biomedical research focusing on Special Operations Forces (SOF)-relevant aspects of medical care, particularly related to: combat casualty management; medical aspects of mission planning, biomedical training, environmental protection, vibration/shock injury, nutrition, hydration, diving procedures equipment and injuries, exercise and mission related physiology, field diagnostic and care equipment; and medical information management systems. This notice constitutes a Broad Agency Announcement (BAA) as contemplated in FAR6.102(d)(2). The following general aspects/topic areas of basic and applied biomedical research are of interest: 2.1 Casualty Management 2.1.1 Hespan/crystalloid comparative study in delayed surgery (animal studies). 2.1.2 Hypotensive resuscitation study (human studies). 2.1.3 Pharmacologic treatment of Decompression Sickness (DCS) and Arterial Gas Embolism (AGE) (animal studies). 2.1.4 Pharmacologic treatment of DCS and AGE (human trials). 2.1.5 Card diagnostics in SOF. 2.2 Medical Aspects of Mission Planning 2.2.1 Medical aspects of Foreign Internal Defense missions. 2.2.2 Medical aspects of Humanitarian/Civic Action missions. 2.3 Biomedical Training 2.3.1 SOF corpsman/medic skills utilization studies. 2.3.2 Medical simulations in SOF medical training. 2.3.3 SOF video-based interactive tactical combat casualty care training. 2.4 Thermal Protection 2.4.1 Thermal protection in dive/overland transition operations. 2.4.2 Cold acclimatization schedules. 2.5 Nutrition/Hydration 2.5.1 Carbohydrate loading and SEAL Delivery Vehicle (SDV) performance in cold water. 2.6 Exercise and Mission-Related Physiology 2.6.1 Health surveillance for SOF personnel. 2.6.2 Pain suppression modalities in Special Operations. 2.6.3 Human performance enhancements; evaluation of alertness enhancing agents (e.g. tyrosine and modafinal) and situational awareness training. 2.6.4 Optimal fluid loads and DDAVP in extreme environments. From the above, several specific areas have been selected for funding consideration for funds becoming available during Fiscal Year 2000 (i.e., becoming available 1 October 1999). These areas and their associated research tasks and deliverables are as follows: 3.1.1 Casualty Evacuation (CASEVAC) Delays and Outcomes. Tactical combat casualty care in Special Operations entails many differences from civilian trauma care. One of these differences is that in certain casualty scenarios, immediate CASEVAC of the casualty may result in failure to complete the mission or an increased hazard to the entire patrol. In these scenarios, mission commanders must weigh the benefit of immediate evacuation to the casualty against the other factors mentioned. One element of information that is critically important to making this decision is the effect of the delay on the expected outcome for the casualty. If the delay entails only a minimal decrease in the casualty's expectation of a favorable outcome, then the commander might be more inclined to complete the mission before evacuating the casualty. The effects of delays in evacuation on casualty outcome have not been systematically evaluated. The following are specific research areas and deliverables of interest: 3.1.1.1. For the injuries and clinical indicators shown below, research into the impact of delays in evacuation on casualty outcome. Assuming that Care under Fire and Tactical Field Care are provided according to current guidelines. Adding any additional injuries and/or clinical indicators deemed appropriate. 3.1.1.2. Developing an unrestricted access computer-based database with expected survival at 1, 4, 12, and 24 hours for abdominal, chest, head, extremity, neck, maxillofacial, traumatic amputation, burn, blast, crush, and torso injuries. 3.1.1.3. Reports suitable for publication in the peer-reviewed literature addressing the above issues and including graphical database outputs, and the database itself. 3.1.2 Combat Casualty Care Equipment Review and Enhancement. Special Operations medical personnel are trained to perform complicated life saving procedures in austere, remote locations and perform wound management for extended periods of time. SOF medics are trained to the skill levels of their civilian counterpart, Emergency Medical Technician-Paramedic. Initial medical skills are taught at the Joint Special Operations Medical Training Center (JSOMTC). SOF medical personnel are equipped with a Medical Equipment Set (MES). Many items of equipment have become outdated through changes either in technology, treatment procedures, or doctrine. Delays in modernization of the authorized tables of allowance sometimes force users to local purchase items. The result of this leads to procuring and deploying with nonstandard items; no formal training and no structured logistics for restocking needed items. The following are specific research areas and deliverables of interest: 3.1.2.1. Market investigation s/surveys to ascertain which items of equipment that have been designated by the Component Surgeon's and the Dean, JSOMTC as replacement for MES components. 3.1.2.2. Preliminary analysis of commercial Off the Shelf (COTS), FDA approved items and assisting in technical/field evaluation and training as required. 3.1.2.3. Technical and user evaluation reports. 3.1.3 Health Surveillance in Deployed SOF Personnel. There is a need for health surveillance and record-keeping for SOF. This requirement is exceedingly difficult to fill for deployed SOF personnel for the following reasons: 1) information security and 2) limited resources (e.g., personnel, time, equipment, access to laboratories). Yet SOF may have a greater need for health surveillance than conventional military forces because of potential exposure to hazardous environments without an organic medical monitoring infrastructure, and small unit sizes that impede the observation of early indicators of problems. A health surveillance system is required for joint SOF personnel that encompasses "front-line" to garrison, and "cradle-to-grave" data collection and storage to support analysis and linkage to appropriate Government information management centers and authorized healthcare providers without risking Patient Confidentiality. The system must be capable of handling secure data, in a user friendly manner, without requiring inordinate expenditure of resources and be operable within the constraints of small unit operations. Design must consider all facets of the system such that it can be implemented incrementally and essentially become a turn-key operation. Specific areas of research interest and report include new applications of existing capabilities or new capabilities for: 3.1.3.1. Survey instruments designed to capture subjective health data and allow input by medics and, possibly, by trained non-medics. 3.1.3.2. Means to convey data from deployment sites to data collection point (e.g. computer modem/software utilizing existing/planned communication pathways) in a timely manner. Considerations include compatibility with SOF operations and data security. 3.1.3.3. Means for timely data accumulation, analysis, and dissemination of information (e.g., data and findings). Considerations include infrastructure, connectivity, and security. 3.1.3.4. Means for for interfacing SOF health surveillance data with larger conventional forces surveillance data sets. 3.1.3.5. Means for healthcare workers to access SOF health surveillance data. It is not the intent of this solicitation to fund the FDA approval of devices or drugs, although cooperative research and development that promotes or accelerates FDA approval of such items if they were of high value to SOF would be considered. Furthermore, it is not the intent of this solicitation to establish new facilities, rather, institutions having demonstrated research capability and the necessary facilities are invited to submit a project pre-proposal not exceeding three pages of text that describes: 4.1 The research objective, 4.2 The research approach, 4.3 Related work by the proposer, 4.4 Anticipated contributions to the USSOCOM program, and 4.5 An estimate of overall costs (including indirect) for up to a three year effort. 4.6 A curriculum vitae of the principal investigator(s) should be appended together with any supporting information, such as reprints or preprints, that will assist in the evaluation of the pre-proposal. Pre-proposals, and any follow-up full proposal submission, will be evaluated on the following criteria: 5.1 Scientific and technical merits of the research, 5.2 Qualifications and experience of the principal investigator(s), and availability of facilities to support the research. 5.3 Relevance of the proposed research to USSOCOM program priorities, 5.4 Realism of proposed costs, and availability of funds. There will be no other requests for proposals or other formal solicitations regarding this announcement. Formal full proposals for competitive review will be requested based on those pre-proposal submissions judged most likely to meet program objectives. Proposal deadline date and format instruction will be provided at that time. The initial deadline for pre-proposals is 30 November 1999. Pre-proposals may be submitted after that date and until 30 November 2000 for consideration in subsequent funding cycles. Pre-proposals should be sent to: US Special Operations Command ATTN: SOAL-T (David Saren-Program Manager Special Operations Medical Technology Development Program) 7701 Tampa Point Boulevard MacDill AFB, FL, 33621-5323 Or by e-mail to: Mr. Saren at sarend@ socom.mil. Any additional questions relating to this BAA should be directed to: US Special Operations Command ATTN: SOAL-KB (Ms. Susan Keeler), 7701 Tampa Point Blvd, MacDill AFB, FL 33621-5323, or via e-mail at keelers@socom.mil,or telephonically (813) 828-7411. Posted 11/15/99 (W-SN400695). (0319)

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