Medical Systems - Adv Dev
Abstract
This Program Element (PE) funds development of medical materiel within the early system integration portion of the System Development and Demonstration phase of the acquisition life cycle using 6.4 (Advanced Component Development and Prototype) funding. Program efforts support transition of promising Science and Technology candidate medical technologies (drugs, vaccines, medical devices, diagnostics, and mechanisms for detection and control of disease carrying insects) to larger scale testing in humans for safety and effectiveness. Programs are aligned to meet future force requirements identified within concept documents and organizational structures. This Program Element also provides funding for Food and Drug Administration (FDA) regulated human clinical trials to gain additional information about safety and effectiveness on the path to licensure for use in humans. The Projects supported by this PE are: Project 808 funds development of candidate medical countermeasures for infectious diseases of military relevance. Efforts include vaccines, drugs, diagnostic kits/devices, and insect control measures. These funds support human clinical efficacy trials of the drug/vaccine in a larger group that are designed to assess performance and to continue safety assessments in a larger group of volunteers. Products from this Project will transition to PE 0604807A/Project 849. Project 811 funds the development of military relevant human immunodeficiency virus (HIV) medical countermeasures. It provides funding for planning and conducting of human clinical trials in a group of healthy volunteers to assess the drug/vaccine for safety, tolerability, how the drug/vaccine is distributed, metabolized, and excreted from the body, and investigate the appropriate dose for therapeutic use. Products from this Project will transition to PE 0604807A/Project 812. Project 836 funds the demonstration and validation of medical products for enhanced combat casualty care and follow-on care, including rehabilitation. This project also funds the human clinical trials that test the safety and effectiveness of biologics, devices and demonstration. Clinical trials are conducted in accordance with United States (U.S.) FDA regulations. Products from this project will transition to PE 0604807A/Project 832. Project VS7 funds program upgrades, retrofits, trains, and sustains the fleet of Medical Evacuation legacy helicopters that continue to play a major role in Iraq and Afghanistan. The approved force design increased the number of air frames in the force from 12 to 15 aircraft for 37 medical evacuation (MEDEVAC) companies. All products from this Project will transition to PE 0604807A/Project VS8. These Projects are managed by U.S. Army Medical Materiel Development Activity (USAMMDA) and U.S. Army Medical Materiel Agency (USAMMA) of the U.S. Army Medical Research and Materiel Command. Project FF4 funded Secretary of Defense approved counterdrug advanced development efforts used in a major re-design of the Forensic Toxicology Drug Testing Laboratory (FTDTL) information management system used to test urine samples for the presence of illegal drugs. The Drug Testing Program - Client Collection System (DTP-CSS) is comprised of several variations of a desktop application used to select service members for random drug testing, prepare labels for urine specimen bottles, and print corresponding chain-of-custody documents. This Project will standardize DTP-CSS across all services and migrate it to a Web-based system.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2018
- Source ID
- 0603807A_4_2040_PB_2018
- Change Summary Explanation
- Two program changes account for the difference in FY16 between previous and current President's Budgets: First, a $4.4 million increase in Fiscal Year (FY) 16 is due to an Office of the Secretary of Defense (OSD)-directed funding of Project FF4: Counterdrug, DDR, System Development & Demonstration. These funds are to be used for development by United States Army Medical Command (USAMEDCOM) of a standard Department of Defense (DoD) tracking system of lab samples collected at military units and tested for illegal drugs. Second, a $4.5 million adjustment in FY16 is due to a reprogramming of this amount from PE 0604807A/Project 812 Military HIV Vaccine & Drug Development to PE 0603807A/Project 811, Military HIV Vaccine & Drug Development. In FY18 the budget year adjustment of $4.83M was primarily due to an adjustment of $4.42M from PE 0604807A/Project 812 Military HIV Vaccine & Drug Development to PE 0603807A/Project 811, Military HIV Vaccine & Drug Development and minor adjustments in the other project lines.
- Service Agency Name
- Army
Entities
Organizations
- United States Army
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