Chemical Biological Defense Acquisition Initiatives Forum

1
Chemical Biological Defense Acquisition
Initiatives Forum
UNCLASSIFIED

• 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
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Updates

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

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Congressional Outlook

• FY 08 Presidents Budget Submission
• Budget Drivers
• War Costs / OM Bills
• Supplementals
• Tri-Care for Life
• Congressional Budget Adds to CBDP
• FY03 400M FY07 44M

4
Lean Six Sigma

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

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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.m
il/pm/ EVM Community of Practice
https//acc.dau.mil/evm
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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

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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) RD 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

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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

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

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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

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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
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Using Experimentation to Define
Requirements/Concepts of Use
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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

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Net-Centric
JCID On A Chip
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Near Term Industry JPEO Opportunities
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Near Term Industry JPEO Opportunities (Contd)
Near Term Industry JPEO Opportunities (Contd)
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JPEO Medical Program Business Opportunities
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Chemical Biological Information Systems Conference

• When January 8 11, 2007
• Where Austin, TX, Renaissance Austin Hotel

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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

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(No Transcript)
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BACKUPS
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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

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Earned Value Management Requirements (Contd)

• 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
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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

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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

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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.

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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