Medevac Companies To Better Meet Operation Needs Unclassified-Books Pdf

MEDEVAC companies to better meet operation needs UNCLASSIFIED
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UNCLASSIFIED, Exhibit R 2 RDT E Budget Item Justification PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name. 2040 Research Development Test Evaluation Army BA 5 System PE 0604807A Medical Materiel Medical Biological Defense Equipment Eng Dev. Development Demonstration SDD, This program is managed by U S Army Medical Materiel Development Activity USAMMDA and U S Army Medical Materiel Agency USAMMA of the US Army. Medical Research and Materiel Command, B Program Change Summary in Millions FY 2014 FY 2015 FY 2016 Base FY 2016 OCO FY 2016 Total. Previous President s Budget 39 447 30 397 48 304 48 304. Current President s Budget 33 890 30 384 45 412 45 412. Total Adjustments 5 557 0 013 2 892 2 892,Congressional General Reductions 0 013. Congressional Directed Reductions,Congressional Rescissions.
Congressional Adds,Congressional Directed Transfers. Reprogrammings 4 292,SBIR STTR Transfer 1 265,Adjustments to Budget Years 2 892 2 892. PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED. Army Page 2 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 2A RDT E Project Justification PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 812 Mil HIV Vac Drug Dev. Biological Defense Equipment Eng Dev,Prior FY 2016 FY 2016 FY 2016 Cost To Total. COST in Millions, Years FY 2014 FY 2015 Base OCO Total FY 2017 FY 2018 FY 2019 FY 2020 Complete Cost.
812 Mil HIV Vac Drug Dev 3 770 1 499 5 031 5 031 4 812 5 475 5 588 5 751 Continuing Continuing. Quantity of RDT E Articles, A Mission Description and Budget Item Justification. This project funds militarily relevant human immunodeficiency virus HIV medical countermeasures These funds provide for engineering and manufacturing. development of candidate vaccines and drugs to permit large scale field testing Development is focused on militarily unique needs effecting manning mobilization and. deployment, The major contractor is The Henry M Jackson Foundation for the Advancement of Military Medicine Rockville MD Research efforts are coordinated with the National. Institutes of Health, B Accomplishments Planned Programs in Millions FY 2014 FY 2015 FY 2016. Title Military HIV Vaccine and Drug Development 3 770 1 499 5 031. Description This project provides funds for engineering and manufacturing development of candidate vaccines and drugs to. permit large scale field testing of vaccines for medical countermeasures to HIV. FY 2014 Accomplishments, Continued to refine vaccine administration schedule as well as clinical trial design based on data from previous clinical trials. Adjusted plan for Regional well controlled clinical trial large enough to demonstrate vaccine efficacy which initiated mid 2013. future Prime Boost Regional Phase 3 Study to Confirm Safety and Effectiveness in a Diverse Population planned to begin in early. FY 2015 Plans, Continue to refine vaccine administration schedule as well as clinical trial design based on data from previous clinical trials.
Continue to adjust plan for Regional well controlled clinical trial large enough to demonstrate vaccine efficacy which initiated. FY 2016 Plans, Will begin early testing of new Envelope glycoprotein 120 bivalent products in prime boost formal will allow for efficacy site. preparation and potential trial start in Q1 of FY17 Will begin final site selection and ramp up of efficacy trial activities. Accomplishments Planned Programs Subtotals 3 770 1 499 5 031. PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED. Army Page 3 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 2A RDT E Project Justification PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 812 Mil HIV Vac Drug Dev. Biological Defense Equipment Eng Dev,C Other Program Funding Summary in Millions. D Acquisition Strategy, Test and evaluate commercially developed vaccine candidates in government managed trials. E Performance Metrics, PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED.
Army Page 4 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 3 RDT E Project Cost Analysis PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 812 Mil HIV Vac Drug Dev. Biological Defense Equipment Eng Dev,FY 2016 FY 2016 FY 2016. Management Services in Millions FY 2014 FY 2015 Base OCO Total. Contract Target, Method Performing Prior Award Award Award Award Cost To Total Value of. Cost Category Item Type Activity Location Years Cost Date Cost Date Cost Date Cost Date Cost Complete Cost Contract. Medical Product, Development Management Various Various Various 1 638 0 823 0 173 1 018 1 018 Continuing Continuing. Services Cost,Subtotal 1 638 0 823 0 173 1 018 1 018.
FY 2016 FY 2016 FY 2016, Product Development in Millions FY 2014 FY 2015 Base OCO Total. Contract Target, Method Performing Prior Award Award Award Award Cost To Total Value of. Cost Category Item Type Activity Location Years Cost Date Cost Date Cost Date Cost Date Cost Complete Cost Contract. Medical Product Henry M Jackson, Various 32 326 0 951 0 325 2 000 2 000 Continuing Continuing Continuing. Development Cost Foundation Various,Subtotal 32 326 0 951 0 325 2 000 2 000. FY 2016 FY 2016 FY 2016, Support in Millions FY 2014 FY 2015 Base OCO Total.
Contract Target, Method Performing Prior Award Award Award Award Cost To Total Value of. Cost Category Item Type Activity Location Years Cost Date Cost Date Cost Date Cost Date Cost Complete Cost Contract. Medical Product, Various Various Various 0 657 0 748 0 301 0 963 0 963 Continuing Continuing. Development Support Cost,Subtotal 0 657 0 748 0 301 0 963 0 963. FY 2016 FY 2016 FY 2016, Test and Evaluation in Millions FY 2014 FY 2015 Base OCO Total. Contract Target, Method Performing Prior Award Award Award Award Cost To Total Value of.
Cost Category Item Type Activity Location Years Cost Date Cost Date Cost Date Cost Date Cost Complete Cost Contract. Medical Product Henry M Jackson, Various 25 147 1 248 0 700 1 050 1 050 Continuing Continuing Continuing. Development T E Cost Foundation Various,Subtotal 25 147 1 248 0 700 1 050 1 050. PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED. Army Page 5 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 3 RDT E Project Cost Analysis PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 812 Mil HIV Vac Drug Dev. Biological Defense Equipment Eng Dev, Prior FY 2016 FY 2016 FY 2016 Cost To Total Value of. Years FY 2014 FY 2015 Base OCO Total Complete Cost Contract. Project Cost Totals 59 768 3 770 1 499 5 031 5 031. PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED. Army Page 6 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 4 RDT E Schedule Profile PB 2016 Army Date February 2015.
Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 812 Mil HIV Vac Drug Dev. Biological Defense Equipment Eng Dev, PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED. Army Page 7 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 4A RDT E Schedule Details PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 812 Mil HIV Vac Drug Dev. Biological Defense Equipment Eng Dev,Schedule Details. Events Quarter Year Quarter Year, Protein Production of new B E Protein 3 2015 3 2016. Phase I Study small population of healthy volunteers B E Protein 3 2016 3 2017. Phase II prime boost regional study to confirm safety and evaluate effectiveness 3 2017 4 2018. Phase III prime boost regional vaccine in a large well controlled population to 1 2019 4 2021. PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED. Army Page 8 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 2A RDT E Project Justification PB 2016 Army Date February 2015.
Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 832 Field Medical Systems Engineering. Biological Defense Equipment Eng Dev Development,Prior FY 2016 FY 2016 FY 2016 Cost To Total. COST in Millions, Years FY 2014 FY 2015 Base OCO Total FY 2017 FY 2018 FY 2019 FY 2020 Complete Cost. 832 Field Medical Systems 18 081 18 197 25 029 25 029 24 610 25 212 32 495 35 030 Continuing Continuing. Engineering Development,Quantity of RDT E Articles. A Mission Description and Budget Item Justification. This project funds the engineering and manufacturing development of medical products for enhanced combat casualty care and follow on care including rehabilitation. This project funds pivotal conclusive human clinical trials or mechanical engineering evaluations for effectiveness of devices or biologics products derived from. living organisms to fulfill unique military requirements Mature commercial off the shelf COTS medical products are also evaluated for military use Consideration is. also given to reducing the medical sustainment footprint through smaller weight and cube volume or equipment independence from supporting materiel This work is. frequently completed through a laboratory contractor team with the contractor obtaining the U S Food and Drug Administration FDA licensure for sale of the product. Major contractors intra governmental agencies include IGR Enterprises Inc Army Medical Department Board Test Center Se Qual Technologies Inc Enginivity. Inc Ultrasound Diagnostics Inc HemCon Medical Technologies Cerdak Ltd Hemerus Medical LLC Fast Track Drugs Biologics LLC Integrated Medical. Systems Inc the National Institutes of Health National Heart Lung and Blood Institute NHLBI and the U S Army Aeromedical Research Laboratory Walter Reed Army. Institute of Research WRAIR and Institute of Surgical Research ISR for user evaluation Other military agencies include Program Executive Office PEO Soldier. PEO Combat Service Support CSS and Naval Undersea Warfare Center. B Accomplishments Planned Programs in Millions FY 2014 FY 2015 FY 2016. Title Field Medical Systems Engineering Development PM Medical Devices 0 943 2 984 3 260. Description This project funds the engineering and manufacturing development of medical products for enhanced combat. casualty care managed by PM Medical Devices,FY 2014 Accomplishments. Oxygen Generator 15 LPM System Army efforts are airworthiness certification for MEDEVAC aircraft and other Army unique. requirements Air Force has funding to complete the project for their needs Replacement for the M 138 Steam Sterilizer. Continued planned testing of devices designed and developed in previous years Medical Equipment Sets Development. Continued development and testing to ensure the most current and cost effective devices are being utilized Equipment was. selected for modernization based on its own life cycle plan as part of a Sets Kits and Outfits SKO Modernization also occurred. when products are discontinued new models were available and new technology was introduced to meet current standard of. patient care TBI Diagnostic Assay System Increment II Point of Care Device Candidate product entered pivotal clinical trial and. prepared to obtain FDA approval once transition from project 836 was completed. FY 2015 Plans, PE 0604807A Medical Materiel Medical Biological Defe UNCLASSIFIED.
Army Page 9 of 33 R 1 Line 101,UNCLASSIFIED, Exhibit R 2A RDT E Project Justification PB 2016 Army Date February 2015. Appropriation Budget Activity R 1 Program Element Number Name Project Number Name. 2040 5 PE 0604807A Medical Materiel Medical 832 Field Medical Systems Engineering. Biological Defense Equipment Eng Dev Development, B Accomplishments Planned Programs in Millions FY 2014 FY 2015 FY 2016. Oxygen Generator 15 LPM System An MOA was developed in FY13 between USAMMA and the USAF to address this joint. requirement At this time no Army funds are projected for this project Anticipate DHP RDT E funds to be used in support of. the joint requirement Replacement for the M 138 Steam Sterilizer In FY13 the sterilizer project had undergone a major shift. in contract strategy Funds will be used to allow a manufacturer to fully develop and achieve FDA approval by the end of FY15. At the end of the contract period it is fully anticipated that the Army will have a new sterilizer available for fielding Moved this. project through the DOD Acquisition process to accommodate the modernization effort Medical Equipment Sets Development. Continue development and testing to ensure the most current and cost effective devices are being utilized Equipment is selected. for modernization based on its own life cycle plan as part of a Sets Kits and Outfits SKO Modernization also occurs when. products are discontinued new models are available and new technology introduced to meet the current standard of patient. care TBI Diagnostic Assay System Increment II Point of Care Device The focus of this effort is to use the current Biomarker. technology developed by Banyan and cross level all known technologies to Abbott Diagnostics Contracting efforts are in . drugs diagnostic kits devices and insect control measures to limit exposure and disease transmission FDA approval is a mandatory obligation for all military products FDA approval is a mandatory

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