Chemical Biological Defense Acquisition Initiatives Forum

1. UNCLASSIFIED 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 061215_CBDAIF_Briefing

2. Updates • Congressional Outlook – FY08 Budget • Lean Six Sigma • EVMS Policy • BARDA • Industry Security Clearances • Biosurety Regulations • Experimentation in Requirements Definition • Contracting Opportunities • Upcoming Events 061215_CBDAIF_Briefing

3. Congressional Outlook • FY 08 President’s Budget Submission • Budget Drivers • War Costs / O&M Bills • Supplementals • Tri-Care for Life • Congressional Budget Adds to CBDP FY03 + 400M FY07 – 44M 061215_CBDAIF_Briefing

4. Lean Six Sigma • Key Element of DoD Business Transformation • Applies Quantitative Methods to Process Improvement • Lean Six Sigma Technique Deployed Through-out Services 061215_CBDAIF_Briefing

5. Earned Value Management Thresholds • DoD Revised Earned Value Management System (EVMS) Contract Thresholds in March 2005 • A Validated EVMS is Required for Contracts Over $50M • A Tailored EVMS is Required for Contracts From $20M - $50M • EVMS is Optional for Contracts Less Than $20M – Project Manager Decides Based on Business Case Analysis • EVMS is Based on Industry Standard ANSI/EIA 748 • Work Breakdown Structure, Contract Performance Reporting and Integrated Master Schedule Also Required with EVMS References: OSD EVM Web Site: http://www.acq.osd.mil/pm/ EVM Community of Practice: https://acc.dau.mil/evm 061215_CBDAIF_Briefing

6. Biomedical Advanced Research and Development Authority (BARDA) • Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (HR 5533) • Establishes the Biomedical Advanced Research and Development Authority (BARDA) within DHHS • 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 • Authorizes One or More Federally-funded Research and Development Centers, or University-Affiliated Research Centers • Status: Pending Joint House and Senate Conference 061215_CBDAIF_Briefing

7. BARDA and BioShield BARDA • BARDA Focuses Solely to Promote Advanced Research & Development of Bioterrorism/ Pandemic Countermeasures • BARDA Overseen by DHHS BioShield • H.R. 5533 Clarifies Project BioShield as a Program that Provides Incentives to Companies to Manufacture Vaccines and Drugs • BioShield Covers Certain Products (e.g., qualified and security countermeasures) that Address Public Health Threats Caused by Acts of Terrorism. • Project BioShield Expedites National Institutes of Health (NIH) R&D Efforts • Allows FDA to Make Countermeasures Available During an Emergency • Allows the Federal Government to Procure and Maintain Medical Countermeasure Supplies (DHS, $5.6B over 10 yrs) • Overseen by DHS and DHHS 061215_CBDAIF_Briefing

8. CBDP and BARDA • BARDA Provides an Opportunity to Leverage and Synchronize Medical Countermeasure Investments • CBDP Should Coordinate with DHHS in the Development of the DHHS Strategic Plan for Consideration of DoD Opportunity Savings and Synchronization • BARDA May Be Used to Leverage TMTI Countermeasure Investments, Especially FDA Approaches 061215_CBDAIF_Briefing

9. GAO Report on Security Clearances • Industry Personnel Hold 34% of 2.5 Million DoD Clearances • Office of Personnel Management Investigates • GAO Found for Top Secret Clearances: • 446 Days Required for Initial Clearance • 545 Days Required for Clearance Update • GAO Recommended: • More Accurate Measurement of Process Time • Use of Information Technology Solutions • Update the Plan to Improve the Process • Metrics to Monitor Effectiveness of New Procedures 061215_CBDAIF_Briefing

10. Speeding Clearances - Reducing Backlog • All Investigations Placed Under OPM • OPM Added More Investigators • Closer OPM Coordination with Records Agencies • Resumed Industry Submissions July 2006 • DoD Increasing Electronic Submissions (eQIP) • Additional DoD Positions Added to Reduce Adjudication Time • Additional Defense Security Service Funding 061215_CBDAIF_Briefing

11. Biosurety Regulations Update • DoD Directive 5210.88 Safeguarding Biological Select Agents and Toxins. February 2004 • DoD Instruction 5210.89 Minimum Security Standards for Safeguarding Biological Select agent and Toxins. April 2006 • Army Regulation 190-17, Biological Select Agents and Toxins Security Program. October 2006 • Draft Army Regulation 50-X Biological Surety. Coordinating with OSD to Minimize Disparities with DoD Directive. (Pending Legal Review) Guidance and Information for Industry at: http://www.dss.mil/index.htm 061215_CBDAIF_Briefing

12. Using Experimentation to Define Requirements/Concepts of Use 061215_CBDAIF_Briefing

13. Joint CBRN Dismountable Reconnaissance System Limited Objective Experiment (JCDRS LOE) Phase III Modular Concept Definition • Employment of Mature, Enabling Technologies (Plug-n-Play, Interface Standards, Wireless, GPS, …) to Provide Net-centric and Modular Capability • Integrated Components Designed for Mounted and Dismounted Operation • Standardization of Data Formats, Communications Protocols, and Sensor/Hardware Packaging Benefits • Easier CBRN Integration into Platforms • Tailorable CBRN Defense Capability • Increased Standardization of CBRN Equipment • Easily Upgraded Systems • Net-Centric Architecture: Easily Accessed Data, Shared Awareness, Increased Speed of Command, and Remote Access to Systems 061215_CBDAIF_Briefing

14. Net-Centric JCID On A Chip 061215_CBDAIF_Briefing

15. Near Term Industry JPEO Opportunities 061215_CBDAIF_Briefing

16. Near Term Industry JPEO Opportunities (Cont’d) Near Term Industry JPEO Opportunities (Cont’d) 061215_CBDAIF_Briefing

17. JPEO Medical Program Business Opportunities 061215_CBDAIF_Briefing

18. Chemical Biological Information Systems Conference • When: January 8 – 11, 2007 • Where: Austin, TX, Renaissance Austin Hotel 061215_CBDAIF_Briefing

19. Advanced Planning Briefing for Industry • When: April 4 – 5, 2007 • Where: Washington DC Convention Center • Format: • Day 1 • JPM/CAPO Joint Brief • Day 2 • JPM/ CAPO “1 on 1” with Industry 061215_CBDAIF_Briefing

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21. BACKUPS 061215_CBDAIF_Briefing

22. Earned Value Management Requirements • Cost or Incentive Type Contract Greater Than $50M • Compliance with Industry EVM Standard - ANSI/EIA 748 • Formal EVMS Validation by DCMA • Cost Performance Report • Integrated Master Schedule • Integrated Baseline Review • Ongoing Surveillance by DCMA • Cost or Incentive Type Contract Greater Than $20M and Less Than $50M • Compliance with Industry EVM Standard • No Formal EVMS Validation • Cost Performance Report • Tailored Integrated Master Schedule • Integrated Baseline Review • Ongoing Surveillance by DCMA 061215_CBDAIF_Briefing

23. Earned Value Management Requirements (Cont’d) • Cost or Incentive Type Contract Less Than $20M • EVMS is Optional • Business Case Required to Justify EVM Applying EVM to FFP Contracts is Strongly Discouraged 061215_CBDAIF_Briefing

24. Biomedical Advanced Research and Development Authority (BARDA) • Through BARDA, DHHS will Coordinate and Oversee the Acceleration of Medical Countermeasure and Advanced Research and Development by: • Facilitating Collaboration Among DHHS, Other Federal Agencies, Relevant Industries, and Academia • Facilitating Contacts and Coordinating Efforts to Improve Process and Requirements Under the Federal Food, Drug, and Cosmetic Act • Promoting Innovation to Reduce the Time and Cost of Countermeasure and Product Advanced Research and Development 061215_CBDAIF_Briefing

25. Biomedical Advanced Research and Development Authority (BARDA) • Rationale: • 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 • BARDA Intends to Bridge That Gap By: • Providing Interim Funding at Key Development Milestones • Offer Grants, Awards Through Other Transaction Authority, and Prizes to Industry to Provide Incentives to Develop Certain Countermeasures Deemed Priorities • Encourage Companies to Pursue Medicines Showing Promise in Early Research 061215_CBDAIF_Briefing

26. Biomedical Advanced Research and Development Authority (BARDA) BARDA Requires DHHS to: • Develop a Strategic Plan to Identify Biological and Infectious Disease Threats • Evaluate Research and Development Opportunities • Conduct Annual Outreach and Working Groups • Funding • Authorizes the appropriation of $160 million for each of fiscal years 2007 and 2008 for activities related to the operation of BARDA. • The bill also would authorize the appropriation of $1 million for each of fiscal years 2007 and 2008 for the National Biodefense Science Board. • Congressional Budget Office (CBO) estimates that $1 million a year would be necessary for FDA to implement activities outlined in the bill. • 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. 061215_CBDAIF_Briefing

27. Installation Protection Program (IPP) • Industry is Invited to Comment on a Draft IPP Statement of Work (SOW) • This Provides JPM Guardian Information to Improve the SOW for any Upcoming Procurements • The SOW is Available at: http://www.jpeocbd.osd.mil 061215_CBDAIF_Briefing