DRAFT SOW-Live Animal Blast Overpressure Study.pdf

DRAFT

STATEMENT OF WORK (SOW)

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE (PoP)

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. CONTRACT MANAGEMENT

9. COMPLIANCE DOCUMENTS

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

11. ATTACHMENTS

STATEMENT OF WORK (SOW)

Title: Live Animal Blast Overpressure Study

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Center for Military Psychiatry and Neuroscience (CMPN), Blast Induced Neurotrauma Branch (BINB)

1. INTRODUCTION

Since 1893, the WRAIR has been a leader in solving the most significant threats to Soldier readiness and lethality such as disease and battle injury. WRAIR’s broad research capabilities afford Soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR’s research is focused on Soldier health, its products have important civilian applications responsible for saving countless lives around the world. WRAIR provides unique research capabilities and innovative medical solutions to a range of Force Health Protection (FHP) and readiness challenges currently facing United States (U.S.)

Service members, as well as threats anticipated during future operations.

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) requirements and to deliver life-saving products including knowledge, technology, and medical material that sustain the combat effectiveness of the Warfighter. The WRAIR headquarters is dedicated to Senator Daniel E. Inouye and is located in Silver Spring, Maryland. Additionally, WRAIR maintains a network of laboratories on four continents to identify, study, and overcome diseases where they are found with Research and Development (R&D) activities that reach around the world to include Georgia, Thailand, and Kenya.

WRAIR’s vision is to be the premier DoD biomedical research organization that executes constantly relevant, integrated basic research and advanced technology that protects, projects, and sustains the warfighter today, invents global medical solutions for the future, and keeps the warfighter on point for the Nation. WRAIR conducts basic and applied research that promotes psychological resilience, enhances neurological functioning, and improves operational readiness among U.S. Service members. By using a continuum of research from basic science to applied field studies, WRAIR creates innovative solutions to enhance Service members’ resilience and recovery. WRAIR researchers are recognized leaders in operational medical research for the military in a number of fields, including brain trauma, blast exposure, deployment stressors, and sleep management.

2. PURPOSE AND BACKGROUND

WRAIR’s CMPN is the premier DoD research organization for brain health, behavioral health, and performance. The mission of CMPN is to discover, design, develop, and deliver evidence based solutions to protect brain health, optimize psychological health, and ensure peak readiness and performance. CMPN capabilities include blast induced neurotrauma and neuroprotection, sleep optimization and fatigue mitigation, resiliency training, team performance and mental fitness, military psychiatry, and systems biology (multi-omics).

The BINB is aligned under the CMPN and consists of a team of research scientists and support staff focused on creating evidence-based knowledge products and interventions to mitigate blast induced injuries and optimize Soldier health and readiness. BINB researchers investigate the mechanism of closed-head injury and the cumulative effects of repeated blast exposure and its relationship to neurodegenerative phenomena.

Using laboratory experiments, mathematical modeling techniques, and data captured in the field, BINB scientists work to develop standardized models of blast injury to improve coordination of research across diverse laboratories, produce high-fidelity simulations of head injury, study whether cellular and organ-level processes in head trauma are a unique form of injury, and innovate new forms of Personal Protective Equipment (PPE), such as improved helmet designs and bomb suits. Cumulatively, these efforts produce safer operating conditions for Soldiers.

The research mission of BINB is to investigate blast and other tactical exposures; define the biomechanical and neurobiological underpinnings of blast induced impairments and injuries; and identify risks, countermeasures, and mitigation strategies to enhance Warfighter readiness, health, and performance. Although primarily focused on the brain, since blast and non-kinetic injuries result in a whole-body insult, these objectives currently extend to systemic organs, pulmonary, and immunological consequences of blast exposure, including the cumulative effects of low-level repeated exposures. BINB is uniquely qualified to approach these objectives jointly in the laboratory and in the field. In the laboratory, high fidelity scaled experimental blast exposure conditions are applied to refine ecologically valid animal models of blast and non-kinetic energy induced traumatic brain injury and neurosensory impairment that closely recreate features of human injuries which, in combination with biosimulants, can be used to judiciously investigate blast injury to brain and other organs, define injury criteria, identify countermeasures, and develop predictive risk algorithms. In the field, exposures of personnel to overpressure and associated insults in a variety of training environments are carefully monitored and characterized to identify the effects of these conditions on cognitive performance, sensory function, blood-borne neurotrauma biomarkers, and symptom reporting. The breadth of these capabilities extends from basic blast physics to human performance assessments.

The centerpieces of blast research in the laboratory are two state-of-the-art advanced blast simulators and a non-kinetic energy Gigahertz Transverse Electro Magnetic (GTEM) cell which fully recreate flow conditions associated with free field blast and non-kinetic conditions, respectively, and are free of artefacts confounding traditional laboratory simulations to date. This critical competency is complemented by similarly advanced neurobehavioral and neurosensory assessment capabilities, chemical analytical instrumentation, and cellular and molecular biology resources. The excellence of the field work is based upon the trust and relationships forged with field units and the recognition by their leadership of the value of this research to the performance and well-being of their troops.

Finally, the greatest asset determining the excellence of research in BINB and its positive impact on health readiness and the combat effectiveness of the Warfighter is the dedicated excellence of the scientific and support staff.

3. SCOPE

The purpose of this requirement is to obtain blast injury data from a blast overpressure study on live sheep and swine in collaboration with a Government Principal Investigator (PI). This data shall be used by the Government to assess the lethality and injury risk of blast exposure and to develop injury risk metrics suitable for assessing the effectiveness of PPE (e.g., bomb suits, helmets, etc.) as countermeasures to primary blast.

The contractor shall provide the specialized facilities, equipment, animals, supplies, and labor to execute a blast overpressure study on live sheep and swine in collaboration with a Government PI to collect injury data for each incident blast overpressure level. This action requires specialized blasting facilities at pressures up to 45 pounds per square inch (psi) along with regulatory approved animal housing facilities and care. The contractor shall provide raw data to the Government; however, no analysis of data is required from the contractor.

4. PERIOD OF PERFORMANCE (PoP)

The initial blast overpressure study shall include blast exposure testing on a total of 110 animals over a 24-month base period (55 animals/year). The Government may extend the initial study by exercising up to six additional six-month options, each providing injury data for eight additional swine or ten additional sheep. The total PoP, inclusive of all option periods, is five years. The anticipated PoP for this contract is as follows:

Base Period – 24 months 01 December 2024 – 30 November 2026 Optional Period 1 – 6 months 01 December 2026 – 31 May 2027 Optional Period 2 – 6 months 01 June 2027 – 30 November 2027 Optional Period 3 – 6 months 01 December 2027 – 31 May 2028 Optional Period 4 – 6 months 01 June 2028 – 30 November 2028 Optional Period 5 – 6 months 01 December 2028– 31 May 2029 Optional Period 6 – 6 months 01 June 2029 – 30 November 2029

5. WORK SCHEDULE AND LOCATION

5.1. Primary Place of Performance: The work to be performed under this contract shall be performed off-site at contractor facilities that may be located anywhere in the Continental United States (CONUS). The contractor’s facilities may require 24-hour monitoring (video and audio) of animals at times.

5.2. Contractor Facility Capabilities: The contractor shall provide specialized experimental blasting facilities along with regulatory approved animal housing facilities and care to complete the tasks required under this SOW.

5.2.1 Blast Facilities: The contractor’s specialized blasting facilities shall be capable of generating blast overpressures up to 45 psi with a detonable gas driven blast simulator and be sound proofed to meet local sound ordinances. The simulator shall be of sufficient size (at least 4 feet x 3 feet test section) to handle large animals (i.e., swine and sheep) needed for this study and have observation ports that provide high speed video.

5.2.2 Vivarium and Surgery Facilities: Availability of a vivarium and surgery located near the blast simulator is required to allow for quick turnaround of animal studies. The contractor shall have access to necropsy facilities to conduct tissue collection for at least two animals at a time.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives: The contractor shall provide the specialized experimental blasting facilities, equipment, animals, supplies, and labor to execute a blast overpressure study on live sheep and swine in collaboration with a Government PI to collect injury data for each incident blast overpressure level. The contractor shall provide raw data to the Government; however, no analysis of data is required from the contractor.

6.2. Tasks:

6.2.1 Procure, house, and care for live sheep and swine required for blast simulation testing.

6.2.1.1 Animal housing facilities shall be in regulatory compliance with WRAIR Veterinary Services Program (VSP) and Institutional Animal Care and Use Committee (IACUC) policies.

6.2.1.2 Provide housing and animal care for approximately 110 animals throughout the initial 24-month base period of the study. Half of the specimen (55 animals) shall be tested in the first 12 months with the remaining specimens tested in the second 12 months. If the Government elects to extend the study after the initial 24 months, housing and animal care shall be provided for additional animals (eight swine or ten sheep) in optional six-month increments.

6.2.2 Provide blast facilities that can generate up to 45 psi in incident pressure that is controlled and repeatable for high throughput preclinical research. Provide post-blast exposure monitoring facilities with six-hour and 24-hour monitoring. Availability of an onsite vivarium and surgery located near the blast simulator is also required to allow for quick turnaround of animal studies. The contractor shall have access to necropsy facilities to conduct tissue collection for at least two animals at a time.

6.2.3 Fabricate animal holders for experimentation in the blast chamber (A.001).

6.2.4 Execute experiments in compliance with the approved protocols at WRAIR to collect relevant blast overpressure and biomechanical data. All protocols will be approved by the Government PI’s animal committee with contractor personnel designated as part of those protocols where applicable. Assist the Government PI with test instrumentation as required (A.002 and A.003).

6.2.4.1 Experiments shall consist of blast simulation testing on large animals for biomedical research studies. Perform blast exposure on live animals using a detonable gas driven blast simulator of sufficient size (at least 4 feet x 3 feet test section) to handle the large animals with observation ports that provide high speed video. The initial 24-month base period of the study shall include blast exposure of 50 swine and 60 sheep (55 animals tested/year) with one blast exposure per specimen and an average of two specimens tested per day anticipated.

6.2.4.2 Collect the desired injury data for each incident blast overpressure level. Provide exposure data (raw files) along with raw pencil and wall sensor probes used in blast experimental processes. Data shall be delivered on a monthly basis to include pressure readings, probe readings, and animal stats throughout the monitoring period. Assist with post-mortem tissue collection and animal disposal (A.003).

6.2.5 Provide a Program Management Plan (PMP) that documents a resource-loaded baseline that outlines the steps that will be taken, provides the timeline to completion (estimated project start and stop dates), provides an expenditure plan aligned to key milestones within the project (to include any anticipated Other Direct Costs (ODCs)), identifies and quantifies the deliverables associated with each project, and identifies any associated risks and appropriate mitigation needed for execution of the contract. The completion timeline(s) of any given project shall not extend beyond the overall PoP of the contract. The contractor shall provide the initial PMP within 30 days after contract award and provide an updated PMP quarterly. Upon acceptance and approval by the Government, the contractor shall meet the cost, schedule, and forecasted delivery date of deliverables by taking all reasonable measures to fulfill the requirement (A.004).

6.3. Optional Support: The Government may elect to extend the study to test additional animals in a manner consistent with the requirements outlined above. If additional blast simulation testing is determined necessary, the Government can exercise an optional Contract Line Item Number (CLIN) to obtain data on additional animals. Up to six additional six-month options may be exercised with each six-month increment providing injury data for eight additional swine or ten additional sheep tested.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the table below.

DELIVERABLES TABLE

SOW

Ref.

Number Title/Description Due

6.2.3 A.001 Animal Holders Due within 60 days of contract award

6.2.4 A.002 Protocol Documentation As needed

6.2.4 and 6.2.4.2

A.003 Raw Injury Data Due monthly

6.2.5 A.004 PMP Due 30 days after contract award;

updated quarterly

9.1.3.1.1 and

9.1.3.1.2

A.005 Animal Usage Information (ACURO) Annually

7.1. Inspection and Acceptance

The Contracting Officer’s Representative (COR) is delegated with oversight of specific technical and functional responsiblities to include inspection and acceptance of all products, incoming shipments, documents, deliverables, and services.

Certification by the Government of satisfactory performance provided is contingent upon the contractor adhering to the performance standards contained in the SOW and all terms and conditions of this order, including all modifications.

7.2. Contracting Officer’s Representative (COR) Information

To be Determined

8. CONTRACT MANAGEMENT

8.1. Government Management

The COR for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

8.2. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

9. COMPLIANCE DOCUMENTS

9.1. General Compliance

9.1.1 Federal Law

The products and services provided under this contract must be provided in accordance with all Federal, DoD, Defense Health Agency (DHA), and United States Army Medical Research and Development Command (USAMRDC) laws, as well as command laws, regulations, policies, and procedures that govern the conduct of regulated research.

9.1.2 Department of Defense (DoD) Compliance Documents

A complete list of DoD compliance documents providing specifications, standards, or guidelines can be found at https://www.defense.gov/Resources/Forms-Directives-Instructions/. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this SOW and under this contract.

9.1.3 Animal Welfare Compliance

9.1.3.1 Animal Care and Use Review Office (ACURO) Requirements:

9.1.3.1.1 All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO) Animal Care and Use Review Office (ACURO), in addition to the local IACUC of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled, “Research Involving Animals.” The ACURO regulatory review and approval process for animal studies can take several (between two and three) months (A.005).

9.1.3.1.2 Notwithstanding any other terms and conditions contained in this contract or incorporated by reference herein, awardees (and lower tier subawards) are expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of the ACURO. Written authorization to begin research under the applicable protocol(s) proposed will be issued in the form of an approval letter from the USAMRDC ACURO. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, the contractor must maintain, and upon request from ACURO, submit animal usage information. Non-compliance with any of these terms and conditions may result in withholding of funds and/or the termination of the contract (A.005).

9.1.3.2 The contractor shall maintain compliance with Defense Federal Acquisition Regulation (DFARS) 252-235-7002, Animal Welfare.

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

10.1. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official the invoice and receiving report for payment. Invoices submitted for payment which do not contain CLIN and Accounting Classification Reference Number (ACRN) information will be rejected. The WAWF – Receipt and Acceptance application is the required method of submission.

10.2. Anti-Terrorism (AT) and Operational Security (OPSEC) - RESERVED

10.3. Compliance with Relevant DoD, Service, and Institutional Policy Regulations - RESERVED

10.4. Personally Identifiable Information (PII) and Protected Health Information (PHI) - RESERVED

11. ATTACHMENTS

Attachment 1 - Acronyms List

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

ACRN Accounting Classification Reference Number

ACURO Animal Care and Use Review Office

AT Antiterrorism

BINB Blast Induced Neurotrauma Branch

CLIN Contract Line Item Number

CONUS Continental United States

COR Contracting Officer’s Representative

CMPN Center for Military Psychiatry and Neuroscience

DFARS Defense Federal Acquisition Regulation

DHA Defense Health Agency

DoD Department of Defense

FHP Force Health Protection

GTEM Gigahertz Transverse Electro Magnetic

IACUC Institutional Animal Care and Use Committee

KO Contracting Officer

ODC Other Direct Cost

OHARO Office of Human and Animal Research Oversight

OPSEC Operational Security

PHI Protected Health Information

PI Principal Investigator

PII Personally Identifiable Information

PMP Program Management Plan

PoP Period of Performance

PPE Personal Protective Equipment psi Pounds per square inch

R&D Research and Development

SOW Statement of Work

U.S. United States

USAMRDC United States Army Medical Research and Development Command

VSP Veterinary Services Program

WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research