Volume 5B - Army Financial Management - U.S. Army

UNCLASSIFIEDExhibit R-2A, RDT&E Project Justification: PB 2012 Army DATE: February 2011APPROPRIATION/BUDGET ACTIVITY2040: Research, Development, Test & Evaluation, ArmyBA 5: Development & Demonstration (SDD)COST ($ in Millions)FY 2010 FY 2011FY 2012BaseR-1 ITEM NOMENCLATUREPE 0604807A: Medical Materiel/MedicalBiological Defense Equipment - Eng DevFY 2012OCOPROJECT849: INFEC DIS DRUG/VACC EDFY 2012Total FY 2013 FY 2014 FY 2015 FY 2016Cost ToComplete Total Cost849: INFEC DIS DRUG/VACC ED 13.193 12.227 8.487 - 8.487 13.631 14.728 15.131 15.178 Continuing ContinuingQuantity of RDT&E ArticlesA. Mission Description and Budget Item JustificationThis project funds development of candidate medical countermeasures for militarily relevant infectious diseases. These products fall within four major areas: vaccines,drugs, diagnostic kits/devices, and insect control measures to limit exposure and disease transmission. It funds research that supports conclusive human clinicaltrials for large-scale human efficacy testing, expanded human safety clinical trials, long-term animal studies, and related manufacturing tests. This work, which isjointly performed by military laboratories, civilian contracted pharmaceutical firms and foreign research partners, is directed toward the prevention of disease, earlydiagnosis, and speeding recovery once diagnosed. Medical products approved for human use must successfully complete a series of clinical trials that are requiredand regulated by the U.S. Food and Drug Administration (FDA). FDA approval is a mandatory obligation for all military products placed into the hands of medicalproviders or service members for human use. Development priority is based upon four major factors: (1) the extent of the disease within the Combatant Commands'theater of operations, (2) the clinical severity of the disease, (3) the technical maturity of the proposed solution, and (4) the affordability of the solution (development,production, and sustainment). Malaria, dysentery, hepatitis, and dengue diseases (a severe debilitating disease transmitted by mosquitoes), which are found in AfricaCommand, Central Command, European Command, Southern Command, and Pacific Command areas are at the top of the infectious diseases requirements list.B. Accomplishments/Planned Programs ($ in Millions, Article Quantities in Each) FY 2010 FY 2011 FY 2012Title: FY 10 Malaria Drug/ Vaccine Engineering DevelopmentDescription: This project funds in FY 10 development of candidate medical countermeasures for militarily relevant infectiousdiseases.Articles:FY 2010 Accomplishments:Conducted clinical trials, developmental testing, and reviews of malarial/antimalarial vaccines, drugs, diagnostics and insectrepellents. For Tafenoquine, conducted data analysis and prepared a final report on the small human challenge clinical trial, andbegan pre-trial activities for a large-scale safety/efficacy human clinical trial (treatment indication) in a malaria endemic country.6.01804.5680-FY 2011 Plans:Will conduct clinical trials, developmental testing, and reviews of malarial/antimalarial vaccines, drugs, diagnostics and insectrepellents. For Tafenoquine, will complete pre-trial activities for a large-scale safety/efficacy human clinical trial (treatmentindication) in a malaria endemic country.Title: FY 10 Infectious Disease Drug and Vaccine Engineering DevelopmentArticles:7.17507.65908.487UNCLASSIFIEDArmy Page 17 of 27 R-1 Line Item #111Volume 5B - 210