Joint Program Executive Office for Chemical and Biological ...

Joint Program Executive Office for Chemical and Biological Defense

061215_CBDAIF_Briefing 1

STEPHEN V. REEVESMajor General, USA

Joint Program Executive Officerfor Chemical and Biological Defense

(703) 681-9600

Chemical Biological Defense Acquisition Initiatives Forum

December 15, 2006

Distribution Statement A: Approved for Public Release

UNCLASSIFIED


2061215_CBDAIF_Briefing UNCLASSIFIED

Updates

• Congressional Outlook – FY08 Budget

• Lean Six Sigma

• EVMS Policy

• BARDA

• Industry Security Clearances

• Biosurety Regulations

• Experimentation in Requirements Definition

• Contracting Opportunities

• Upcoming Events



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



Lean Six Sigma

• Key Element of DoD Business Transformation

• Applies Quantitative Methods to Process Improvement

• Lean Six Sigma Technique Deployed Through-out Services



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

References:OSD EVM Web Site: http://www.acq.osd.mil/pm/

EVM Community of Practice: https://acc.dau.mil/evm



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



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



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



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



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



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



Using Experimentation to Define Requirements/Concepts of Use



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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Opportunities Description Dates

Joint Service Light NBC Reconnaissance Vehicle

•Production RFP 2QFY07

Joint Chemical Agent Detector

• FY08 SBIR 1QFY08

Joint Biological Tactical Detection System

•RFP - Technology Demonstration of Tactical Bio System Capability

4QFY08

Joint Biological Standoff Detection System

•Technology Readiness Assessment FY08

Joint Expeditionary Collective Protection System (JECP)

• Initial Increment - RFP for Prime Contractor

1QFY07

SPAWAR Knowledge Superiority

•BAA N00039-05-X-0011 Continual

JWARN Component Interface Device

•Production FY08

Near Term Industry JPEO Opportunities



Near Term Industry JPEO Opportunities (Cont’d)


Joint Modular Decon System

•Capability for Platform Interior and Sensitive Item Decontamination

2QFY07

Joint Service Tactical Decon System – Large Scale

•RFP Release for R&D/Test Quantities FY08

Joint Platform Decon System

•Expected RFP Release for Increment 1 R&D/Test Quantities

FY08

Joint Chemical Ensemble •RDT&E - Next Generation Protective Ensemble

FY08

Installation Protection Plan Recompete

•Draft SOW Available for Comment at:http://www.jpeocbd.osd.mil/page_manager.asp?pg=3

TBD

Near Term Industry JPEO Opportunities (Cont’d)



JPEO Medical Program Business Opportunities


MITS

Medical Radiation Countermeasures RFP for Prime Contractor 1QFY07

JVAP – Subcontract Through DVC

Venezuelan Equine Encephalitis (VEE) Vaccine NIAID-funded Phase 2 Clinical Trial 4QFY07

Recombinant Botulinum (rBot) A/B Vaccine

Clinical Site Management for rBot Vaccine Phase 1B Clinical Trial 1QFY07



Chemical Biological Information Systems Conference

• When: January 8 – 11, 2007

• Where: Austin, TX, Renaissance Austin Hotel



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





BACKUPS



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



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




• 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




• 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




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.



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

Joint Program Executive Office for Chemical and Biological ...

Documents

bioshield barda barda

synchronization barda

security countermeasures

dod instruction

dhhs bioshield

development centers

safeguarding biological

evms references