Chemical Biological Defense Acquisition Initiatives Forum December 15, 2006 STEPHEN V. REEVES Major General, USA Joint Pro...
Updates <ul><li>Congressional Outlook – FY08 Budget </li></ul><ul><li>Lean Six Sigma </li></ul><ul><li>EVMS Policy </li></...
Congressional Outlook <ul><li>FY 08 President’s Budget Submission </li></ul><ul><li>Budget Drivers </li></ul><ul><ul><li>W...
Lean Six Sigma <ul><li>Key Element of DoD Business Transformation </li></ul><ul><li>Applies Quantitative Methods to Proces...
Earned Value Management Thresholds <ul><li>DoD Revised Earned Value Management System (EVMS) Contract Thresholds in March ...
Biomedical Advanced Research and Development Authority (BARDA)  <ul><li>Biodefense and Pandemic Vaccine and Drug Developme...
BARDA and BioShield  <ul><li>BARDA </li></ul><ul><li>BARDA Focuses Solely to Promote Advanced Research & Development of Bi...
CBDP and BARDA <ul><li>BARDA Provides an Opportunity to Leverage and Synchronize Medical Countermeasure Investments </li><...
GAO Report on Security Clearances <ul><li>Industry Personnel Hold 34% of 2.5 Million DoD Clearances </li></ul><ul><li>Offi...
Speeding Clearances - Reducing Backlog <ul><li>All Investigations Placed Under OPM  </li></ul><ul><li>OPM Added More Inves...
Biosurety Regulations Update <ul><li>DoD Directive 5210.88 Safeguarding Biological Select Agents and Toxins. February 2004...
Using Experimentation to Define Requirements/Concepts of Use
Joint CBRN Dismountable Reconnaissance System Limited Objective Experiment (JCDRS LOE) Phase III Modular Concept <ul><li>D...
JCID On A Chip Net-Centric
Near Term Industry JPEO Opportunities FY08 <ul><li>Production </li></ul>JWARN Component Interface Device FY08 <ul><li>Tech...
Near Term Industry JPEO Opportunities  (Cont’d) Near Term Industry JPEO Opportunities  (Cont’d) TBD <ul><li>Draft SOW Avai...
JPEO Medical Program Business Opportunities 1QFY07 Clinical Site Management for rBot Vaccine Phase 1B Clinical Trial Recom...
Chemical Biological Information Systems Conference <ul><li>When:  January 8 – 11, 2007 </li></ul><ul><li>Where:  Austin, T...
Advanced Planning Briefing for Industry <ul><li>When:  April 4 – 5, 2007 </li></ul><ul><li>Where:  Washington DC Conventio...
 
BACKUPS
Earned Value Management Requirements <ul><li>Cost or Incentive Type Contract Greater Than $50M </li></ul><ul><ul><li>Compl...
Earned Value Management Requirements  (Cont’d) <ul><li>Cost or Incentive Type Contract Less Than $20M </li></ul><ul><ul><l...
Biomedical Advanced Research and Development Authority (BARDA)  <ul><li>Through BARDA, DHHS will Coordinate and Oversee th...
Biomedical Advanced Research and Development Authority (BARDA) <ul><li>Rationale: </li></ul><ul><ul><li>The Lack of Commer...
Biomedical Advanced Research and Development Authority (BARDA) <ul><li>BARDA Requires DHHS to: </li></ul><ul><li>Develop a...
Installation Protection Program (IPP) <ul><li>Industry is Invited to Comment on a Draft IPP Statement of Work (SOW) </li><...
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  • FY06 CBDIF is executed based on Congressional language to resolve issues in CB defense. In FY06, language was directed to Basic Research, Applied Research, and Advanced Technology Development (BA 6.1, 6.2, 6.3) 6.1 Surface Adhesion/Surface Chemistry Mechanisms Fundamental questions surround the understanding of the mechanisms responsible for surface adhesion and surface chemistry interactions between microorganisms and biomolecules that are associated with biological defense and threat agents. Ultimately, these adhesion characteristics are necessary to understand so that biomaterials can be physically removed from surfaces for the following applications: detection (agent recovery); decontamination techniques (physical wipes); protection (enhanced activity protective fabrics); or modeling and simulation (predict interactions with potential future sensing elements). Medical Therapeutics Models for Basic Research Develop improved in vitro and in vivo models for basic research studies of the physiological effects of exposure to known and emerging chemical and biological threat agents. 6.2/6.3 Feasibility of High Accuracy Large Fragment Nucleic Acid Amp1ification. Today, whole genomic sequencing requires a full laboratory facility, large amounts of resources/con sum abIes and more than 48 hours to perform. The overall objective for this topic is to perform whole genomic sequencing from an intact organism in less than half a day in a fully automated system using no more consumables than a typical commercially available PCR system. amplification Detection/Identification of Aerosols that Do Not Fluoresce. The majority of technologies currently used for aerosol detection is based on UV laser induced fluorescence of the aerosol which limits the compounds of interest to those that fluoresces upon excitation by a UV source. There are materials of interest that produce no fluorescent signatures but do have Raman signatures. Raman technology has the potential to detect/identify these materials of interest but generally lack the required sensitivity to meet our needs.. Individual Protection: Non-sorbent or regenerative based air purification technologies for application in CBRN protective masks. Collective Protection: Revolutionary concepts for ingress/egress to the Toxic Free Area (TF A) currently achieved by airlock systems.. Enzyme Based Decontamination Systems The development of a broad spectrum chemical and biological agent decontamination solution for use in both tactical and installation decontamination. Modeling of Human Factors in C41 Systems. Develop a model of human performance and human interfaces to allow the simulation of human reports and actions during operation of networked systems. Medical Drug Delivery Systems - Electroporation Mediated Delivery of Genetic Vaccines and Therapeutic Countermeasures. Develop and/or utilize an existing system for the delivery of plasmid DNA by in vivo electroporation.. Medical Therapeutics/Development of Vehicles to Deliver siRNA Therapeutics. Develop novel, efficient and stable vehicles to deliver novel short interfering RNA (siRNA) constructs within cells for pathogens of military relevance. Medical Therapeutics/Research and Development of System Biology Platforms Identify system biology platforms to study comparative and correlative genomics, proteomics and metabolomics of host response of pathogens of military relevance.. Medical Diagnostics/ Environmental Sample Concentration. Develop improved concentration technologies focusing on sample concentration prior to sample extraction and micro fluidic sample pre-processing. Dual application methods are required for both environmental and clinical sample matrices. The improved methodologies should be able to be performed manually in addition to being performed via an automated sample processor. Medical Diagnostics/Is Toxin Identification a Valuable Diagnostic Tool?
  • FY06 CBDIF is executed based on Congressional language to resolve issues in CB defense. In FY06, language was directed to Basic Research, Applied Research, and Advanced Technology Development (BA 6.1, 6.2, 6.3) 6.1 Surface Adhesion/Surface Chemistry Mechanisms Fundamental questions surround the understanding of the mechanisms responsible for surface adhesion and surface chemistry interactions between microorganisms and biomolecules that are associated with biological defense and threat agents. Ultimately, these adhesion characteristics are necessary to understand so that biomaterials can be physically removed from surfaces for the following applications: detection (agent recovery); decontamination techniques (physical wipes); protection (enhanced activity protective fabrics); or modeling and simulation (predict interactions with potential future sensing elements). Medical Therapeutics Models for Basic Research Develop improved in vitro and in vivo models for basic research studies of the physiological effects of exposure to known and emerging chemical and biological threat agents. 6.2/6.3 Feasibility of High Accuracy Large Fragment Nucleic Acid Amp1ification. Today, whole genomic sequencing requires a full laboratory facility, large amounts of resources/con sum abIes and more than 48 hours to perform. The overall objective for this topic is to perform whole genomic sequencing from an intact organism in less than half a day in a fully automated system using no more consumables than a typical commercially available PCR system. amplification Detection/Identification of Aerosols that Do Not Fluoresce. The majority of technologies currently used for aerosol detection is based on UV laser induced fluorescence of the aerosol which limits the compounds of interest to those that fluoresces upon excitation by a UV source. There are materials of interest that produce no fluorescent signatures but do have Raman signatures. Raman technology has the potential to detect/identify these materials of interest but generally lack the required sensitivity to meet our needs.. Individual Protection: Non-sorbent or regenerative based air purification technologies for application in CBRN protective masks. Collective Protection: Revolutionary concepts for ingress/egress to the Toxic Free Area (TF A) currently achieved by airlock systems.. Enzyme Based Decontamination Systems The development of a broad spectrum chemical and biological agent decontamination solution for use in both tactical and installation decontamination. Modeling of Human Factors in C41 Systems. Develop a model of human performance and human interfaces to allow the simulation of human reports and actions during operation of networked systems. Medical Drug Delivery Systems - Electroporation Mediated Delivery of Genetic Vaccines and Therapeutic Countermeasures. Develop and/or utilize an existing system for the delivery of plasmid DNA by in vivo electroporation.. Medical Therapeutics/Development of Vehicles to Deliver siRNA Therapeutics. Develop novel, efficient and stable vehicles to deliver novel short interfering RNA (siRNA) constructs within cells for pathogens of military relevance. Medical Therapeutics/Research and Development of System Biology Platforms Identify system biology platforms to study comparative and correlative genomics, proteomics and metabolomics of host response of pathogens of military relevance.. Medical Diagnostics/ Environmental Sample Concentration. Develop improved concentration technologies focusing on sample concentration prior to sample extraction and micro fluidic sample pre-processing. Dual application methods are required for both environmental and clinical sample matrices. The improved methodologies should be able to be performed manually in addition to being performed via an automated sample processor. Medical Diagnostics/Is Toxin Identification a Valuable Diagnostic Tool?
  • FY06 CBDIF is executed based on Congressional language to resolve issues in CB defense. In FY06, language was directed to Basic Research, Applied Research, and Advanced Technology Development (BA 6.1, 6.2, 6.3) 6.1 Surface Adhesion/Surface Chemistry Mechanisms Fundamental questions surround the understanding of the mechanisms responsible for surface adhesion and surface chemistry interactions between microorganisms and biomolecules that are associated with biological defense and threat agents. Ultimately, these adhesion characteristics are necessary to understand so that biomaterials can be physically removed from surfaces for the following applications: detection (agent recovery); decontamination techniques (physical wipes); protection (enhanced activity protective fabrics); or modeling and simulation (predict interactions with potential future sensing elements). Medical Therapeutics Models for Basic Research Develop improved in vitro and in vivo models for basic research studies of the physiological effects of exposure to known and emerging chemical and biological threat agents. 6.2/6.3 Feasibility of High Accuracy Large Fragment Nucleic Acid Amp1ification. Today, whole genomic sequencing requires a full laboratory facility, large amounts of resources/con sum abIes and more than 48 hours to perform. The overall objective for this topic is to perform whole genomic sequencing from an intact organism in less than half a day in a fully automated system using no more consumables than a typical commercially available PCR system. amplification Detection/Identification of Aerosols that Do Not Fluoresce. The majority of technologies currently used for aerosol detection is based on UV laser induced fluorescence of the aerosol which limits the compounds of interest to those that fluoresces upon excitation by a UV source. There are materials of interest that produce no fluorescent signatures but do have Raman signatures. Raman technology has the potential to detect/identify these materials of interest but generally lack the required sensitivity to meet our needs.. Individual Protection: Non-sorbent or regenerative based air purification technologies for application in CBRN protective masks. Collective Protection: Revolutionary concepts for ingress/egress to the Toxic Free Area (TF A) currently achieved by airlock systems.. Enzyme Based Decontamination Systems The development of a broad spectrum chemical and biological agent decontamination solution for use in both tactical and installation decontamination. Modeling of Human Factors in C41 Systems. Develop a model of human performance and human interfaces to allow the simulation of human reports and actions during operation of networked systems. Medical Drug Delivery Systems - Electroporation Mediated Delivery of Genetic Vaccines and Therapeutic Countermeasures. Develop and/or utilize an existing system for the delivery of plasmid DNA by in vivo electroporation.. Medical Therapeutics/Development of Vehicles to Deliver siRNA Therapeutics. Develop novel, efficient and stable vehicles to deliver novel short interfering RNA (siRNA) constructs within cells for pathogens of military relevance. Medical Therapeutics/Research and Development of System Biology Platforms Identify system biology platforms to study comparative and correlative genomics, proteomics and metabolomics of host response of pathogens of military relevance.. Medical Diagnostics/ Environmental Sample Concentration. Develop improved concentration technologies focusing on sample concentration prior to sample extraction and micro fluidic sample pre-processing. Dual application methods are required for both environmental and clinical sample matrices. The improved methodologies should be able to be performed manually in addition to being performed via an automated sample processor. Medical Diagnostics/Is Toxin Identification a Valuable Diagnostic Tool?
  • Joint Program Executive Office for Chemical and Biological ...

    1. 1. Chemical Biological Defense Acquisition Initiatives Forum December 15, 2006 STEPHEN V. REEVES Major General, USA Joint Program Executive Officer for Chemical and Biological Defense (703) 681-9600 Distribution Statement A: Approved for Public Release UNCLASSIFIED
    2. 2. Updates <ul><li>Congressional Outlook – FY08 Budget </li></ul><ul><li>Lean Six Sigma </li></ul><ul><li>EVMS Policy </li></ul><ul><li>BARDA </li></ul><ul><li>Industry Security Clearances </li></ul><ul><li>Biosurety Regulations </li></ul><ul><li>Experimentation in Requirements Definition </li></ul><ul><li>Contracting Opportunities </li></ul><ul><li>Upcoming Events </li></ul>
    3. 3. Congressional Outlook <ul><li>FY 08 President’s Budget Submission </li></ul><ul><li>Budget Drivers </li></ul><ul><ul><li>War Costs / O&M Bills </li></ul></ul><ul><ul><li>Supplementals </li></ul></ul><ul><ul><li>Tri-Care for Life </li></ul></ul><ul><li>Congressional Budget Adds to CBDP </li></ul><ul><ul><li>FY03 + 400M FY07 – 44M </li></ul></ul>
    4. 4. Lean Six Sigma <ul><li>Key Element of DoD Business Transformation </li></ul><ul><li>Applies Quantitative Methods to Process Improvement </li></ul><ul><li>Lean Six Sigma Technique Deployed Through-out Services </li></ul>
    5. 5. Earned Value Management Thresholds <ul><li>DoD Revised Earned Value Management System (EVMS) Contract Thresholds in March 2005 </li></ul><ul><ul><li>A Validated EVMS is Required for Contracts Over $50M </li></ul></ul><ul><ul><li>A Tailored EVMS is Required for Contracts From $20M - $50M </li></ul></ul><ul><ul><li>EVMS is Optional for Contracts Less Than $20M – Project Manager Decides Based on Business Case Analysis </li></ul></ul><ul><li>EVMS is Based on Industry Standard ANSI/EIA 748 </li></ul><ul><li>Work Breakdown Structure, Contract Performance Reporting and Integrated Master Schedule Also Required with EVMS </li></ul>References: OSD EVM Web Site: http://www.acq.osd.mil/pm/ EVM Community of Practice: https://acc.dau.mil/evm
    6. 6. Biomedical Advanced Research and Development Authority (BARDA) <ul><li>Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (HR 5533) </li></ul><ul><ul><li>Establishes the Biomedical Advanced Research and Development Authority (BARDA) within DHHS </li></ul></ul><ul><ul><li>Designates BARDA as the Single Federal Authority with the Core Mission of Heading Off a Public Health Catastrophe (Epidemic, Pandemic or Bioterrorism) Through Coordinated Research and Development Activities for Countermeasures to Bioterrorism and Pandemic Influenza </li></ul></ul><ul><ul><li>Authorizes One or More Federally-funded Research and Development Centers, or University-Affiliated Research Centers </li></ul></ul><ul><ul><li>Status: Pending Joint House and Senate Conference </li></ul></ul>
    7. 7. BARDA and BioShield <ul><li>BARDA </li></ul><ul><li>BARDA Focuses Solely to Promote Advanced Research & Development of Bioterrorism/ Pandemic Countermeasures </li></ul><ul><li>BARDA Overseen by DHHS </li></ul><ul><li>BioShield </li></ul><ul><li>H.R. 5533 Clarifies Project BioShield as a Program that Provides Incentives to Companies to Manufacture Vaccines and Drugs </li></ul><ul><li>BioShield Covers Certain Products (e.g., qualified and security countermeasures) that Address Public Health Threats Caused by Acts of Terrorism. </li></ul><ul><li>Project BioShield Expedites National Institutes of Health (NIH) R&D Efforts </li></ul><ul><ul><li>Allows FDA to Make Countermeasures Available During an Emergency </li></ul></ul><ul><ul><li>Allows the Federal Government to Procure and Maintain Medical Countermeasure Supplies (DHS, $5.6B over 10 yrs) </li></ul></ul><ul><ul><li>Overseen by DHS and DHHS </li></ul></ul>
    8. 8. CBDP and BARDA <ul><li>BARDA Provides an Opportunity to Leverage and Synchronize Medical Countermeasure Investments </li></ul><ul><li>CBDP Should Coordinate with DHHS in the Development of the DHHS Strategic Plan for Consideration of DoD Opportunity Savings and Synchronization </li></ul><ul><li>BARDA May Be Used to Leverage TMTI Countermeasure Investments, Especially FDA Approaches </li></ul>
    9. 9. GAO Report on Security Clearances <ul><li>Industry Personnel Hold 34% of 2.5 Million DoD Clearances </li></ul><ul><li>Office of Personnel Management Investigates </li></ul><ul><li>GAO Found for Top Secret Clearances: </li></ul><ul><ul><li>446 Days Required for Initial Clearance </li></ul></ul><ul><ul><li>545 Days Required for Clearance Update </li></ul></ul><ul><li>GAO Recommended: </li></ul><ul><ul><li>More Accurate Measurement of Process Time </li></ul></ul><ul><ul><li>Use of Information Technology Solutions </li></ul></ul><ul><ul><li>Update the Plan to Improve the Process </li></ul></ul><ul><ul><li>Metrics to Monitor Effectiveness of New Procedures </li></ul></ul>
    10. 10. Speeding Clearances - Reducing Backlog <ul><li>All Investigations Placed Under OPM </li></ul><ul><li>OPM Added More Investigators </li></ul><ul><li>Closer OPM Coordination with Records Agencies </li></ul><ul><li>Resumed Industry Submissions July 2006 </li></ul><ul><li>DoD Increasing Electronic Submissions (eQIP) </li></ul><ul><li>Additional DoD Positions Added to Reduce Adjudication Time </li></ul><ul><li>Additional Defense Security Service Funding </li></ul>
    11. 11. Biosurety Regulations Update <ul><li>DoD Directive 5210.88 Safeguarding Biological Select Agents and Toxins. February 2004 </li></ul><ul><li>DoD Instruction 5210.89 Minimum Security Standards for Safeguarding Biological Select agent and Toxins. April 2006 </li></ul><ul><li>Army Regulation 190-17, Biological Select Agents and Toxins Security Program. October 2006 </li></ul><ul><li>Draft Army Regulation 50-X Biological Surety. Coordinating with OSD to Minimize Disparities with DoD Directive. (Pending Legal Review) </li></ul>Guidance and Information for Industry at: http:// www.dss.mil/index.htm
    12. 12. Using Experimentation to Define Requirements/Concepts of Use
    13. 13. Joint CBRN Dismountable Reconnaissance System Limited Objective Experiment (JCDRS LOE) Phase III Modular Concept <ul><li>Definition </li></ul><ul><li>Employment of Mature, Enabling Technologies (Plug-n-Play, Interface Standards, Wireless, GPS, …) to Provide Net-centric and Modular Capability </li></ul><ul><li>Integrated Components Designed for Mounted and Dismounted Operation </li></ul><ul><li>Standardization of Data Formats, Communications Protocols, and Sensor/Hardware Packaging </li></ul><ul><li>Benefits </li></ul><ul><li>Easier CBRN Integration into Platforms </li></ul><ul><li>Tailorable CBRN Defense Capability </li></ul><ul><li>Increased Standardization of CBRN Equipment </li></ul><ul><li>Easily Upgraded Systems </li></ul><ul><li>Net-Centric Architecture: Easily Accessed Data, Shared Awareness, Increased Speed of Command, and Remote Access to Systems </li></ul>
    14. 14. JCID On A Chip Net-Centric
    15. 15. Near Term Industry JPEO Opportunities FY08 <ul><li>Production </li></ul>JWARN Component Interface Device FY08 <ul><li>Technology Readiness Assessment </li></ul>Joint Biological Standoff Detection System 1QFY07 <ul><li>Initial Increment - RFP for Prime Contractor </li></ul>Joint Expeditionary Collective Protection System (JECP) Continual <ul><li>BAA N00039-05-X-0011 </li></ul>SPAWAR Knowledge Superiority 4QFY08 <ul><li>RFP - Technology Demonstration of Tactical Bio System Capability </li></ul>Joint Biological Tactical Detection System 1QFY08 <ul><li>FY08 SBIR </li></ul>Joint Chemical Agent Detector 2QFY07 <ul><li>Production RFP </li></ul>Joint Service Light NBC Reconnaissance Vehicle Dates Description Opportunities
    16. 16. Near Term Industry JPEO Opportunities (Cont’d) Near Term Industry JPEO Opportunities (Cont’d) TBD <ul><li>Draft SOW Available for Comment at: http:// www.jpeocbd.osd.mil/page_manager.asp?pg =3 </li></ul>Installation Protection Plan Recompete FY08 <ul><li>RDT&E - Next Generation Protective Ensemble </li></ul>Joint Chemical Ensemble FY08 <ul><li>Expected RFP Release for Increment 1 R&D/Test Quantities </li></ul>Joint Platform Decon System FY08 <ul><li>RFP Release for R&D/Test Quantities </li></ul>Joint Service Tactical Decon System – Large Scale 2QFY07 <ul><li>Capability for Platform Interior and Sensitive Item Decontamination </li></ul>Joint Modular Decon System Dates Description Opportunities
    17. 17. JPEO Medical Program Business Opportunities 1QFY07 Clinical Site Management for rBot Vaccine Phase 1B Clinical Trial Recombinant Botulinum (rBot) A/B Vaccine JVAP – Subcontract Through DVC 4QFY07 NIAID-funded Phase 2 Clinical Trial Venezuelan Equine Encephalitis (VEE) Vaccine 1QFY07 RFP for Prime Contractor Medical Radiation Countermeasures MITS Dates Description Opportunities
    18. 18. Chemical Biological Information Systems Conference <ul><li>When: January 8 – 11, 2007 </li></ul><ul><li>Where: Austin, TX, Renaissance Austin Hotel </li></ul>
    19. 19. Advanced Planning Briefing for Industry <ul><li>When: April 4 – 5, 2007 </li></ul><ul><li>Where: Washington DC Convention Center </li></ul><ul><li>Format: </li></ul><ul><ul><li>Day 1 </li></ul></ul><ul><ul><ul><li>JPM/CAPO Joint Brief </li></ul></ul></ul><ul><ul><li>Day 2 </li></ul></ul><ul><ul><ul><li>JPM/ CAPO “1 on 1” with Industry </li></ul></ul></ul>
    20. 21. BACKUPS
    21. 22. Earned Value Management Requirements <ul><li>Cost or Incentive Type Contract Greater Than $50M </li></ul><ul><ul><li>Compliance with Industry EVM Standard - ANSI/EIA 748 </li></ul></ul><ul><ul><li>Formal EVMS Validation by DCMA </li></ul></ul><ul><ul><li>Cost Performance Report </li></ul></ul><ul><ul><li>Integrated Master Schedule </li></ul></ul><ul><ul><li>Integrated Baseline Review </li></ul></ul><ul><ul><li>Ongoing Surveillance by DCMA </li></ul></ul><ul><li>Cost or Incentive Type Contract Greater Than $20M and Less Than $50M </li></ul><ul><ul><li>Compliance with Industry EVM Standard </li></ul></ul><ul><ul><li>No Formal EVMS Validation </li></ul></ul><ul><ul><li>Cost Performance Report </li></ul></ul><ul><ul><li>Tailored Integrated Master Schedule </li></ul></ul><ul><ul><li>Integrated Baseline Review </li></ul></ul><ul><ul><li>Ongoing Surveillance by DCMA </li></ul></ul>
    22. 23. Earned Value Management Requirements (Cont’d) <ul><li>Cost or Incentive Type Contract Less Than $20M </li></ul><ul><ul><li>EVMS is Optional </li></ul></ul><ul><ul><li>Business Case Required to Justify EVM </li></ul></ul>Applying EVM to FFP Contracts is Strongly Discouraged
    23. 24. Biomedical Advanced Research and Development Authority (BARDA) <ul><li>Through BARDA, DHHS will Coordinate and Oversee the Acceleration of Medical Countermeasure and Advanced Research and Development by: </li></ul><ul><ul><li>Facilitating Collaboration Among DHHS, Other Federal Agencies, Relevant Industries, and Academia </li></ul></ul><ul><ul><li>Facilitating Contacts and Coordinating Efforts to Improve Process and Requirements Under the Federal Food, Drug, and Cosmetic Act </li></ul></ul><ul><ul><li>Promoting Innovation to Reduce the Time and Cost of Countermeasure and Product Advanced Research and Development </li></ul></ul>
    24. 25. Biomedical Advanced Research and Development Authority (BARDA) <ul><li>Rationale: </li></ul><ul><ul><li>The Lack of Commercial Demand for Certain Medical Countermeasures has Discouraged Development and Created a Funding Gap Between Early Research and Transition Investment to Licensure </li></ul></ul><ul><ul><li>BARDA Intends to Bridge That Gap By: </li></ul></ul><ul><ul><ul><li>Providing Interim Funding at Key Development Milestones </li></ul></ul></ul><ul><ul><ul><li>Offer Grants, Awards Through Other Transaction Authority, and Prizes to Industry to Provide Incentives to Develop Certain Countermeasures Deemed Priorities </li></ul></ul></ul><ul><ul><ul><li>Encourage Companies to Pursue Medicines Showing Promise in Early Research </li></ul></ul></ul>
    25. 26. Biomedical Advanced Research and Development Authority (BARDA) <ul><li>BARDA Requires DHHS to: </li></ul><ul><li>Develop a Strategic Plan to Identify Biological and Infectious Disease Threats </li></ul><ul><li>Evaluate Research and Development Opportunities </li></ul><ul><li>Conduct Annual Outreach and Working Groups </li></ul><ul><li>Funding </li></ul><ul><ul><li>Authorizes the appropriation of $160 million for each of fiscal years 2007 and 2008 for activities related to the operation of BARDA. </li></ul></ul><ul><ul><li>The bill also would authorize the appropriation of $1 million for each of fiscal years 2007 and 2008 for the National Biodefense Science Board. </li></ul></ul><ul><ul><li>Congressional Budget Office (CBO) estimates that $1 million a year would be necessary for FDA to implement activities outlined in the bill. </li></ul></ul><ul><ul><li>Assuming appropriation of the authorized and necessary amounts, CBO estimates that implementing H.R. 5533 would cost $33 million in 2007 and $319 million over the 2007-2011 period. </li></ul></ul>
    26. 27. Installation Protection Program (IPP) <ul><li>Industry is Invited to Comment on a Draft IPP Statement of Work (SOW) </li></ul><ul><li>This Provides JPM Guardian Information to Improve the SOW for any Upcoming Procurements </li></ul><ul><li>The SOW is Available at: </li></ul>http:// www.jpeocbd.osd.mil

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