J-6_SAMPLE_TO_4_Pool_3_3Oct17.docx

IAC MAC

Pool 3

Sample Task Order #4

Performance Work Statement (PWS)

Chemical-Biological-Radiological-Nuclear (CBRN) Detection, Decontamination, Medical Counter-Measures, and RMQSI of CBRN Closed Armor Protective Systems

[Focus Areas: Chemical Biological Radiological Nuclear (CBRN) - Labs; Survivability & Vulnerability; Modeling & Simulation; Reliability, Maintainability, Quality, Supportability, and Interoperability (RMQSI); and Weapons Systems]

September 9, 2017

TABLE OF CONTENTS

GENERAL

This document describes the performance objectives for a Task Order (TO) for a FICTIONAL CBRN requirement. This document will be the basis of a potential offeror’s study approach and cost information in support of the Information Analysis Center (IAC) Multiple Award Contract (MAC) proposal preparation for the Full and Open (Pool 3). The Section Three (3) and Four (4) of the PWS, includes a set of requirements including specific tasks and deliverables for this Sample Task Order.

All contents provided as a part of this PWS are fictional and no actual IAC involvement is to be pursued, neither any discussions nor details on specific requirements or deliverables will be provided. This document has been tailored to be at the UNCLASSIFIED//FOUO level and apply to this fictional Sample Task Order #4 only.

BACKGROUND

The Chemical-Biological-Radiological-Nuclear Program Management Office (CBRN PMO) develops equipment and techniques that improve survivability of individuals, facilities, and materiel by protecting them from the effects of Chemical-Biological (CB) threats through protective clothing, monitors, and filtration systems. CBRN PMO also integrates CBRN technologies into other developmental systems, for example by installing sensors and protective equipment into tactical vehicles, aircraft and ships. CBRN PMO is responsible for research, development, acquisition, fielding, and life-cycle support of CBRN defense and detection equipment, the development of suitable and effective medical counter-measures to weaponized agents, and the employment and development of reliability analysis methodologies for CBRN protective systems.

OBJECTIVE AND SCOPE

2.1 Objective

The primary purpose of this TO is to study, analyze, provide advice, research, and develop deliverables to advance IACMAC related scientific and technical information (STI) through the application of knowledge and resources in achieving the requiring activity's mission requirements defined herein.

The objective of this TAT is to provide Research, Development, Testing, and Evaluation support for CBRN defense and detection equipment technologies and medical counter-measures that protect and preserve forces against current and emerging threats and reliability models for protective systems. Further, the objective of this TAT is to research the development of vaccines, treatments, and pharmaceuticals against CB threat agents, and develop robust and variable reliability assessment models for closed armor protective systems. The Contractor shall:

· Conduct research, assessment, and analysis of Chemical-Biological (CB) detection equipment performance designed and developed for use by the warfighter, as well as decontamination processes and methodologies, and make recommendations from the assessments and analysis

· Conduct Survivability and Vulnerability studies through the use of Modeling and Simulation (M&S) on troop safety when in the presence of chemical and biological agents

2.2 Scope

2.2.1 IAC MAC Basic PWS references. The work under this TO is within the scope of the IAC MAC Basic Performance Work Statement for CBRN Laboratories (1.4.2.4.9), Survivability and Vulnerability (1.4.2.2.1), Modeling and Simulation (1.4.2.3.3), RMQSI (1.4.2.2.2) and Weapons Systems (1.4.2.2.9).

TASKS

The Contracting Officer (CO) is the only person authorized to direct the contractor or take any actions that would change the TO or commit the Government in any way.

Any and all source code, models, prototypes, programming, language, licensure, enterprise-wide rights, software, Contract Data Requirement Lists (CDRLs), manuals, training documents, and other similar products and related data developed, modified, or created under this shall be exclusively at the United States (U.S.) Government's expense. Per DFARS 252.227-7014(b) (1), all of these items must be delivered to the U.S. Government with unlimited rights. As such, the Government may use, modify, reproduce, release, perform, display, or disclose the source code in whole or in part, in any manner and for any purpose whatsoever, and it may authorize others to do so.

Each subtask that requires the analysis and recommendations for the Government shall include the development and delivery of reports describing results of Assessment and Recommendations.

Some of the tasks in Section 3 requires testing capability at federally accredited laboratory facilities which requires 100% operational capability at the beginning of the Period of Performance (PoP) to ensure program continuity.

(Task 1) – Program Management

3.1.1 Post Award Orientation. The Post-Award Orientation shall be held within seven (7) calendar days of the start of performance. Schedule and conduct this meeting, in coordination with the ACOR, Contracting Office Representative (COR), and CO. The purpose of the Post-Award Orientation is to: 1) discuss any unique characteristics of the requirement(s); 2) identify stakeholders' roles and responsibilities; 3) review the 30-day transition-in to full performance and 4) establish a common understanding of cost, schedule, and performance expectations (Deliverable 1A: Post Award Brief Slides and Minutes with Attendees List).

3.1.2 Program Management Plan. Provide a Program Management Plan (PMP) within fifteen (15) days after contract award. The Program Management Plan shall provide a resource-loaded schedule that outlines the steps that will be taken, the timeline to completion, and any associated risks with execution of the order. If/when a project tasking is submitted to the contractor, the PMP will be updated within 15 days of each new project tasking. The update shall specify estimated project start and stop dates as well as a risk mitigation plan and an expenditure plan aligned to key milestones within the project, to include any anticipated Other Direct Costs (ODCs). The update should highlight any interdependencies within the tasks and/or the project(s) schedules. Upon acceptance and approval by the Government, the contractor shall meet the cost, schedule and forecasted delivery date of all deliverables by taking all reasonable measures to fulfill the requirement (Deliverable 1B: Program Management Plan (PMP)) and shall report monthly status updates (Deliverable 1C: Monthly Status Report (MSR)).

3.1.3 Monthly Status Report. Submit a Monthly Status Report. The MSR shall provide detailed status for the project(s) within the PMP as well as capture an overall status of the order. The MSR reports cost, schedule, and performance against PMP requirements and identifies status of funding, planned versus actual expenditures per project, status of known risks, risk mitigation efforts, deliverables funded and date they were funded, technical progress made and schedule status per deliverable, the titles, dates and number(s) of deliverables completed, and the deliverables scheduled to be delivered during the upcoming month. Specific MSR format, and additional content not specified in this section, shall be mutually agreed upon by the contractor and ACOR; this should be established no later than the Post-Award Orientation. If the MSR shows that the project is not meeting the performance thresholds set forth in the Service Summary found in Section 8.0, the contractor shall provide the rationale and circumstances preventing the threshold from being met, and provide an update to the PMP, to the satisfaction, acceptance and approval of the ACOR (Deliverable 1C: Monthly Status Report).

3.1.4 Final Technical Report. Prior to expiration of the order, submit a Final Technical Report (FTR) as detailed in section 4.0. The FTR shall include TAT-specific background information, objectives, assumptions, specific data collected, conclusions, analyses conducted, and recommendations. Each report shall be delivered to the ACOR and COR (Deliverable 1D: Final Technical Report (FTR)).

Task 1 – Deliverables Table

Slides and Minutes with Attendees List

Award Orientation

(PAO)

(CDRL A008) Slides, as a minimum, should identify the key stakeholders and highlight their roles and responsibilities, summarize the tasks and associated deliverables (with specific focus of building on the BCO knowledge base and producing STI for future reuse), and monthly status reporting (cost, schedule, performance). Minutes (with a list of attendees) should capture the substance of the meeting. Provide draft of slides three days prior to PAO. Slides and Minutes should be provided to all attendees, including ACOR, COR and CO.

Management Plan

(PMP)

updated within 15 days of each new project tasking (CDRL A009) PMP shall include a schedule that outlines the steps to take and a timeline to completion of the program and all projects as well as any interdependencies amongst the projects’ schedules. The schedule shall specify estimated project start and stop dates as well as a risk mitigation plan and expenditure plan aligned to key milestones within the project, to include any anticipated Other Direct Costs (ODCs).

Report (MSR)

Receipt of Order (ARO), Monthly, thereafter. Final MSR due with

FTR.

(CDRL A010) Includes actual versus planned task expenditures, technical progress made, schedule status, travel conducted, meetings attended, issues, and recommendations. The MSR reports cost, schedule, risks, and performance against PMP and PWS requirements. Identifies funding compared to ceiling, planned versus actual expenditures, status of known risks, risk mitigation efforts, deliverables funded and date they were funded, technical progress made and schedule status per deliverable, deliverable titles and numbers completed within the previous month, and the deliverables scheduled to be delivered during the upcoming month. Reports all Military Interdepartmental Purchase Request (MIPRs) received and details the funding source of each MIPR Specific MSR format and content shall be mutually agreed upon by the contractor and ACOR, per the guidance contained herein. Establishes a baseline schedule for and steps to completion for each requirement. Upon acceptance and approval by the Government, the Contractor shall meet the schedule and forecasted delivery date of all deliverables by taking all reasonable measures to fulfil the requirement.

The MSR content should be established no later than the postaward conference. The MSR shall be in PDF format, e-mailed to the ACOR, COR, and CO.

Report (FTR)

if sensitive internal information is contained in the FTR, every attempt shall be made to produce a sanitized (redacted) version of the FTR for distribution within DoD (Distribution D) and inclusion in the DTIC database. For classified reports to be included in DTIC classified databases, an unclassified SF298 will be produced and signed by the Government ACOR; this document shall serve as the basis for creating unclassified metadata, which the BCO will add to the DTIC unclassified database, in accordance with established policy and procedures.

3.2 (Task 2) – Laboratory Test and Evaluation of Chemical and Biological (CB) Detection Equipment and Decontamination Processes, Materiel, and Equipment The Contractor shall ensure immediate availability of appropriately accredited laboratory facilities at the beginning of the TO PoP to perform tasks listed below in Section 3.1 at 100% capability.

The contractor shall provide the ability, by having all relevant licenses, permits, and facilities, to handle chemical and biological agents or toxins and to test their impact on various equipment in realistic conditions. This may include manipulation and application of actual agents and assessing interactions with garments, equipment, and live animals. Test chemicals shall include simulants, stimulants, Toxic Industrial Chemicals (TICs), explosives, Non-Traditional Agents (NTAs), Chemical Warfare Agents (CWA), and Biological Warfare Agents (BWA).

The contractor shall provide technical expertise to advance CB detection equipment and sub-component development to verify calibration and advance the science and maturation of emerging and innovative technologies for CB detection equipment applications. Technology development shall focus on the following capabilities: detection of a full spectrum of CB warfare agents and other emerging threats to include liquids, gases, aerosols and solids.

3.2.1 CB Detection Equipment Development and Assessment

The Contractor shall conduct research of existing and emerging CB detection equipment testing methodologies and identify the most opportune strategies, plans, and methodologies for CB detection equipment testing with TICs, explosives, CWAs, BWAs, and NTAs. Perform testing of CB detection equipment under varied conditions (e.g., temperature, humidity, mode of sampling, potential interferences (natural and man-made), duration of exposure, etc.) to evaluate the effectiveness, performance, and limits of chemical detectors, sensors, small decontamination devices, and other decontamination equipment and sub-components. The Contractor shall perform Detection Studies; Performance, Environmental, and Interferent Effects Studies; and Mechanical and Extreme Environment Testing (Deliverable 2A: Test Plans; Deliverable 2B: Advanced Technologies and Methodologies for the Assessment of Detection Equipment).

3.2.2.2 Perform the following testing of CB decontaminants under varied conditions:

· Chemical Kinetics/By-Product Analysis;

· Storage Studies;

· Hazard Mitigation Efficacy Testing – Coupon;

· Decontamination Conduct of Operations (CONOPS) Evaluation;

· Hazard Mitigation Efficacy Testing – Panel/Component;

· Decontamination Verification Testing; and

· Individual Protection Equipment (IPE) Compatibility Testing.

(Deliverable 4F: Emerging Results Briefings for the Assessment of Decontamination Processes; Deliverable 4G: Test Reports for the Assessment of Decontamination Processes).

3.2.2.3 Conduct physical and chemical Test and Evaluation (T&E) for both developmental and/or commercial fibers, textiles swatches, films and coatings. Conduct swatch testing to assess novel materials and components for protection (e.g., boots, garments, gloves, etc.) against live chemical and biological agents in liquid, aerosol, vapor or solid form. Agents tested may include sulfur mustard (HD); soman (GD); methylphosphonothioic acid (VX); chemical agent simulants; TICSs; non-traditional and emerging threat agents; biological warfare agents and simulants; and aerosols. Identify effects of battlefield contaminants for protective materials, garments, components and systems when in operational environments. Assess smart material performance in the presence of live agents (Deliverable 4F: Fiber/Swatch Test Reports).

Task 2 Deliverables Table

(CDRL A007) Plan addresses test design, Internal Review Board processes/approvals, test item control and handling, describe data that will be collected and discuss planned analysis of data that will be collected.

2B

2E

3.3 (Task 3) – Test and Evaluation of Medical Countermeasure to Chemical and Biological (CB) Threats The Contractor shall ensure immediate availability of appropriately accredited laboratory facilities at the beginning of the TO PoP to perform tasks listed below in Section 3.1 at 100% capability. The Contractor shall provide all relevant licenses, permits, and facilities, to handle chemical and biological agents or toxins and to test medical countermeasures in realistic conditions. This may include manipulation and application of actual agents and testing on live animals.

The contractor shall provide technical expertise to advance the science and maturation of emerging and innovative medical countermeasures against CB threats. For cost estimation purposes, the Contractor shall plan to review, develop, and execute FDA-regulated clinical safety studies and nonclinical efficacy studies of a candidate vaccine against Anthrax. The Contractor shall:

3.3.1 Conduct Non-Clinical Safety Studies.

The Contractor shall perform the toxicity studies of varying length, with toxicology end points including in-life findings and pathology. The Contractor shall perform Pre-Clinical Toxicity testing of the vaccine products include acute toxicity. The Contractor shall collect information about toxicity (chronic toxicity, carcinogenicity, reproductive toxicity, and teratogenicity), reversibility of toxicity, cause of death, mechanism of action, target organs, determination of maximum tolerated dose, recovery from treatment-related effects, and changes in kinetic parameters between single and multiple exposures. The Contractor shall provide study reports, and submit the e-data set associated for this animal study in the Standard for Exchange of Nonclinical Data (SEND) format. All tasks shall be performed using methods compliant to Good Manufacturing Practice (GMP) (Deliverable 3A: Non-Clinical GLP Safety Study Protocol; Deliverable 3B: Non-Clinical Safety Study Report (Draft and Final); Deliverable 3C: Non-Clinical Safety Study in SEND files).

3.3.2 Conduct Phase 1 Clinical Human Safety Studies.

The Contractor shall manage the Phase I clinical trials. The Contractor shall be responsible for the overall program management of the clinical study. The Contractor shall support activities related to the submission of an Investigational New Drug (IND) application in eCTD format, development of a clinical protocol and informed consent form, submission of the protocol and informed consent to the Institutional Review Boards (IRB), analytical methods evaluation and validation, management of day to day study operations, clinical study data management, statistical planning and analysis, and final report. The Contractor shall provide a draft and final Phase 1 Clinical Trial Report (Deliverable 3C: Non-Clinical Safety Study files; Deliverable 3D: Phase 1 Clinical Study Protocol; Deliverable 3E: Clinical Study Report(s) (Draft and Final)).

3.3.3 Develop In Vitro Assays For Multiple Species.

The Contractor shall develop, qualify, and/or validate in vitro methods to determine the immunogenicity of the vaccine. To support these efforts, the Contractor shall produce critical reagents, conduct suitability testing and stability testing. The Contractor shall provide draft and final reports for each assay developed. These efforts may or may not require GLP compliance. The Contractor shall collect study data and perform statistical planning and analysis (Deliverable 3F: Development Report(s) [Draft and Final]; Deliverable 3G: Qualification Reports [Draft and Final]).

3.3.4 Produce Well-Characterized Challenge Material.

The Contractor shall produce well-characterized challenge material suitable for use for in vivo challenge studies in animal models, to include selecting the threat agent strain(s) to be used as standards. The Contractor shall identify the strains and define the procedures to produce and characterize research quantities. The Contractor shall collect study data and perform statistical planning and analysis. These efforts may or may not require Good Laboratory Practice (GLP) compliance (Deliverable 3H: Challenge Material Report [Draft and Final])

3.3.5 Develop Well-Characterized Animal Models.

The Contractor shall provide or develop well characterized animal models using validated procedures to be used in subsequent testing of candidate vaccine. The Contractor shall develop Animal models including small and large animal species, and involve various routes exposure to Anthrax (e.g., oral. parenteral, inhalation, dermal) as well as telemetry monitoring of endpoints or biomarker analyses. In developing animal model, the Contractor shall study Disease mechanism of action or the mechanism of the Anthrax toxicity. The Contractor shall involve a range of animals including nonhuman primates, guinea pigs, rats, and mice consistent with FDA guidance. These efforts may or may not require GLP compliance (Deliverable 3I: Animal Model Study Protocols [Draft and Final]; Deliverable 3J: Animal Model Study Report [Draft and Final]).

Task 3 Deliverables Table

3.4 (Task 4) – Strategic Scientific, Programmatic, and Technical Analysis of CBRN Warfare Protection System The reliability and survivability of CBRN warfare protection systems are paramount. The Contractor shall conduct a survivability analysis of CBRN protection, detection, and decontamination across the full range of CBRN system requirements for Weapons systems, to include functional configuration of armored systems. The functional configuration of armored systems are placed into two operational categories: open and closed. In open armored systems, combat tasks are performed with the crew and equipment exposed directly to the combat environment. In closed armored systems, combat tasks are performed in a crew compartment and the crew and equipment are protected from direct exposure to the threat environment by the use of filtered air to overpressure the entire crew compartment.

The Contractor shall conduct strategic scientific, programmatic and technical analysis of CBRN Warfare Protection Systems to support development of advanced CBRN technology capabilities and future RDT&E initiatives. The contractor shall support development of conclusions and recommendations on future technology development and performance standards required to improve warfighter and CBRNE systems protection and survivability. The Contractor Shall:

3.4.1 Conduct Survivability Studies of CBRN Protection of Weapon Systems The Contractor shall conduct survivability and vulnerability studies and provide technical reports detailing analysis and evaluation of the survivability of the M1/A1/A2 Abrams Main Battle Tank, equipped with CBRN warfare protection in the form of an overpressure clean-air conditioning air system, a radiological warning system, and a chemical agent detector. The overpressure system (200 SCFM – Clean Cooled Air) provides for a safe area which as far as possible is sealed from possible contaminated air and an air filtration system which will filter out all possible toxins. Air pumps force clean air through the filters in to the safe area, creating a pressure differential that ensures air flows will always be from the safe area to outside, preventing the entry of toxins. Two elements of this overpressure system are susceptible to failure: air pumps and filters.

3.4.2 Conduct RMQSI Analysis & Reliability Model Development

The Contractor shall conduct RMQSI analysis based on laboratory experiments with active chemical toxins, which identifies the mean time between operational mission failure of individual components of the overpressure system and the overpressure system as a whole, and develop a reliability model. The model shall be robust with respect to variability, allowing the manipulation of a wide variety of anticipated environmental conditions, e.g., wind speed, humidity, presence of air particulates, temperature, etc. (Deliverable 4A: RMQSI Model and supporting data).

3.4.3 Conduct CBRN Threat and Response Analysis

The Contractor shall ensures CBRN PMO sustains and grows core competencies required to counter enduring and emerging chemical and CB threats, from characterizing the problem, to scenario building, modeling and simulation, equipment testing, molecular building, and synthesis and analysis. The Contractor shall support the development of recommendations on capability development and performance standards required to improve CBRN systems protection and survivability. The Contractor shall conduct scientific, programmatic and technical analysis such as (Deliverable 4B: CBRN Threat and Analysis Report):

· Completing Analysis of Alternatives by performing real-time trade-off analysis to determine the optimal technical solution based on cost constraints and project requirements

· Completing Wargaming Modeling & Simulation by providing real-time player feedback and analysis of decisions and strategies employed in a simulated environment

Task 4 Deliverables Table

ADMINISTRATIVE REQUIREMENTS

Security The work on this TAT is anticipated to have a classification level up to TOP SECRET. The proposed Contractor shall ensure all personnel (including administrative and subcontractor personnel) specified as requiring access to classified facilities, systems, and information with TOP SECRET classification, have a TOP SECRET security clearance.

Offeror shall consider for this fictional task that contractor personnel to perform tasks described in Section 3.0 of this PWS need to possess current DoD Top Secret clearances.

Software The Contractor shall possess and utilize approved software that are compatible with the ones used by the Government, which consists of latest versions of Microsoft Office Professional (Word, PowerPoint, Excel and Access), Microsoft Project Standard, and Adobe Acrobat Reader. An appropriate industry standard software of the Contractor’s choice, shall be used to develop/produce all required system / software architecture views. A software license for required software shall be provided by the government for the period of the study.

Travel The Contractor travel shall be authorized in writing by the COR, to support customer requirements including but not limited to interviews, User Conference, Government Program Reviews, Government team meeting, or other technical meetings or conferences as required. The Contractor reimbursement for travel expenses shall be billed without fee and at the rates provided in the Joint Travel Regulations (JTR). The Contractor travel shall not exceed $64,000 per year ($320,000 over the entire PoP).

All potential Offerors shall use the minimum Government estimate for Other Direct Costs (ODCs) provided in the table below. The Government ODC estimates are inclusive of any subcontractor travel costs, material, and supplies but do not include any material handling fee or General and Administrative (G&A) costs. Contractors may propose additional ODCs but they must be clearly identified, fully justified, and will be evaluated as part of the overall price of the proposal.

Government ODC Estimate

Period of Performance Period of Performance will be 60 months. The period of performance will be 1 January 2018 to 31 December 2022.

5.5 Place of Performance

The place of performance will be the contractor’s lab facility (80%) and the CBRN PMO office in Arlington, VA (20%).

GOVERNMENT FURNISHED INFORMATION (GFI) AND EQUIPMENT (GFE)

The Government will make available the GFI reference material and GFE required to perform tasks described in the PWS.

SERVICE SUMMARY

TO

PERFORMANCE OBJECTIVE

TO

PWS REFERENCE

TO

PERFORMANCE STANDARD/THRESHOLD

Threshold: Completed on time and updated to reflect changes as they occur 100% of the time. A corrected PMP will be submitted within 5 business days of identification of an error.

Threshold: 100% compliance with PWS and CDRL requirements. The Government shall receive no more than three Corrective Action Reports (CARs) or similar deficiency reports during the contractor’s performance of the entire task order. Provide a get well plan within 5 business days of identification of deficiency.

Threshold: 100% compliance with CDRL requirements. The contractor shall submit all Deliverables/CDRLs as instructed per the established schedule (due date) with no need for substantive changes. Provide a revised deliverable within 5 business days of identification of deficiency.

Threshold: The Government shall perform random service sampling (reviews) to gauge the contractor’s customer service responsiveness and professionalism. The Government shall receive no more than three complaints or negative reviews denoting a customer service/business acumen deficiency during the contractor’s performance of the entire task order. Provide a get well plan within 5 business days of identification of deficiency.