HT942525R0005 _PWS_Draft.pdf

PERFORMANCE WORK STATEMENT

Scientific and Technical Research Support Services II U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

Last Revised: September 2024

SECTION 1 PURPOSE

1.1. Introduction

The purpose of this procurement is to ensure the U.S. Army Medical Research Institute of Infectious Diseases’ (USAMRIID) Foundational Sciences Directorate, Core Support Directorate, and the offices of the Commander’s Special Staff are provided the necessary scientific and technical Contractor support required to accomplish their missions.

1.2. Mission

USAMRIID, located at Fort Detrick, Maryland, works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, Department of Defense (DoD), the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health. This includes conducting Research, Development, Testing, & Evaluation (RDTE) of medical countermeasure against biological threats and the safety, quality assurance, project management, and core support required for these research activities.

The specific mission of each organizational unit relevant to this performance work statement (PWS) is described below:

Foundational Sciences Directorate:

Bacteriology Division Directs and manages basic and applied research programs for the prevention and treatment of militarily important bacterial threat agents and their associated toxins. This is accomplished by studying the genetics, physiology, pathogenesis, and immunology of the relevant bacterial threat agents and host systems. Supplies subject matter experts in bacterial diseases to DoD and other government agencies and provides technical support for preclinical and clinical trials. Investigators collaborate inside and outside the Institute to evaluate novel vaccine platforms, assist with selection of diagnostic targets, and develop new animal models.

Molecular Biology Division (MBD) The MBD supports the mission to prepare for and combat biological threats and weapons of mass destruction. The MBD also develops reliable, accurate and rapid high-throughput sequencing (HTS) and protein profiling capabilities to support the Defense Threat Reduction Agency/Joint Science and Technology Office (DTRA/JTSO) initiative to identify unknown and emerging pathogens; to perform whole genome sequencing; and to characterize host-pathogen interactions. The Division identifies, evaluates, and improves medical countermeasures against biological threat agents; employs the DoD recommended technology readiness levels roadmap for countermeasure development;

provides strategic evaluation of the status of pathogen-specific countermeasures and assessment of activities leading to their ethical use (e.g., Food and Drug Administration (FDA) approval); and, facilitates evaluation of expanding indications and combination with existing countermeasures.

The MBD conducts research to fully understand the interactions at the host-pathogen interface and to use systems--based technologies to discover new biological pathways and underlying mechanisms of disease in order to identify, evaluate, and improve Medical Countermeasures (MCM) against biological threat agents. The basic research effort elucidates molecular mechanisms, mechanisms of action, molecular structures and targets and reveals how pathogens and their virulence factors manipulate host mechanisms. Included in the basic research effort are studies for the identification of viral, bacterial and toxin components that can serve as targets for drug and immunotherapy development to treat and prevent pathology associated with exposure to biological threat agents.

Virology Division Conducts basic and applied research in molecular virology, biochemistry, cell biology, immunology, arbovirology, viral virulence factor determinations, and viral strain diversity characterizations along with the associated effects on pathogenicity. Studies the natural history of human and animal disease along with disease pathogenesis in animal models to support FDA "animal efficacy rule" licensure requirements, participate in the early development of MCM vaccine, drug, and biologicals, and develops novel viral vaccine vectors and molecular vaccine delivery methods.

Emphasizes discovery of broad spectrum antiviral threat MCM technologies for the DoD and the nation.

Diagnostics Systems Division (DSD) Manages and directs research on the laboratory diagnosis of biological defense and infectious disease agents capable of affecting the operational readiness of U.S. forces worldwide. Evaluates new diagnostic technologies, develops pilot assays, produces diagnostic reagents, and evaluates candidate assays in the field or clinical environment.

Develops assays in support of studies of vaccine and therapeutic candidates. Provides direct operational diagnostic and analytic services to a variety of customers within and outside of USAMRIID, including the DoD medical community, researchers and Warfighters. Operates and leads USAMRIID's National Level Center for Disease Control (CDC) Laboratory Response Network (LRN) capability by providing accredited laboratory services in initial clinical and environmental detection, identification, and characterization of biological threat agents, including emerging diseases. As appropriate, operates under a variety of Quality Assessment standards and accreditations, including but not limited to International Organization for Standardization (ISO), Good Laboratory Practice (GLP), and Clinical Laboratory Improvement Program/Clinical Laboratory Improvement Amendments (CLIP/CLIA).

Provides evaluation, verification and validation of biological agent identification methods, advanced development diagnostics and analytical platforms, evaluates protocols, reagents, and technologies for the rapid identification of biological agents for transition to military-unique laboratory environments. Manages reference material production, characterization, and maintenance through various accredited and non-accredited reagent and organism/agent repositories.

Core Support Directorate:

Division of Medicine (DoM) The mission of the DoM is to support the biodefense (BD) research mission of USAMRIID by providing on and off-site clinical research of Infectious Diseases (ID) of military significance and training and education on the Biodefense part of Chemical, Biological, Radiological, and Nuclear (CBRN) at USAMRIID and with other DoD partners.

Aerobiology, Animal Clinical Pathology and Telemetry Support Services (AAT) AAT is a subordinate capability within the USAMRIID Core Support Directorate providing Aerobiology, Animal Clinical Pathology and Telemetry support services. This team’s directive is to support the BD research mission of USAMRIID by providing aerosol consultation and services, blood analysis/clinical pathology services, telemetry research services and laboratory technician support to internal and external investigators supporting all levels of biocontainment for non-GLP and GLP non-clinical research studies. AAT personnel also responsible for clinical sample testing of the USAMRIID’s non-human primate (NHP) colony.

Pathology Division The mission of the Pathology Division is to support the BD research mission of USAMRIID by offering comprehensive necropsy, histopathology, clinical pathology, ultrastructural pathology, and molecular pathology services, consultation, other support to its investigators supporting all levels of biocontainment.

Regulated Research Administration Division The Regulated Research Administration Division (RRAD) is an institutional asset that assures the successful conduct of Good Laboratory Practice (GLP) studies and non-GLP Enhanced Quality studies by coordinating with Testing Facility Management (TFM), the Research Project Office (RPO), study director (SD)/principal investigator (PI), and others to determine the appropriate resources needed to meet sponsor requirements or therapeutic and vaccine studies aimed at protecting the Warfighter against emerging biological threats. RRAD provides institutional research support for quality review, biostatistics, data management, validation, and technical writing.

Commander’s Special Staff:

Risk Management Division/Transition Office The Risk Management Division is responsible for ensuring that personnel working or supporting laboratory operations receive training, education and personal protective equipment necessary to conduct their duties safely and effectively.

The Transition Office is responsible for the planning, coordinating, and execution of equipment, personnel and operations to Building 8100 while maintaining USAMRIID mission requirements.

1.3. Background

The USAMRIID technical staff is organized into several major divisions, which are responsible for conducting research relevant to the Institute’s mission. The staff are comprised of civilian, military, and Contractor personnel who work together to conduct research. The staff is comprised of doctoral level investigators as well as technicians.

These organizational units may execute individual research projects as well as provide core shared technical services utilized by other science divisions within USAMRIID. Research projects may range from small discovery-based, individual investigator-initiated efforts to large multi-investigator, task-directed programs to develop a medical countermeasure (i.e. vaccines, therapeutics, and diagnostics). USAMRIID is also responsible for conducting developmental testing & evaluation of medical countermeasures (MCMTE) in support of FDA licensure. These studies are typically cost and schedule-sensitive efforts, requiring documentation practices consistent with FDA GLP and Good Clinical Practice (GCP).

Specific details related to each major organizational unit related to this PWS are described below.

Bacteriology Division USAMRIID’s core competencies are enhanced by the Bacteriology Division’s immunological and therapeutic countermeasure development and its expert capabilities in the characterization of bacterial pathogenesis. Division members are active in training efforts within the DoD and overseas. The Bacteriology Division strives to be a team-oriented and dynamic scientific body that accomplishes mission-related milestones within the Nation’s preeminent research laboratory and in collaboration with external agencies. The division is the DoD resource for subject matter expertise in bacterial pathogens and the countermeasures to those threats. The division has several mission areas:

bacterial pathogenesis, immunology, vaccines, and therapeutics.

The division will seek funding for BD research from a variety of customers, including federal agencies and partners in industry. Bacteriology will actively develop collaborations within the institute to promote efficiency in research and to improve resource utilization. The division will also seek collaborations with external customers who complement our skill sets. In sharing of Scientific Information, where Operations Security (OPSEC) permits, Bacteriology will publish research in the open literature. Research reports will be archived to ensure that the information is available in the long term. Researchers will represent the institute and DoD at national and international scientific meetings to promote the essential peer review of their work. The Bacteriology Division provides the highest quality services with the goal of meeting our objectives to each of its customers. The division will respond rapidly to the needs of the DoD and other federal agencies, providing research support and subject matter expertise for bacterial pathogens and will actively seek funding for division research efforts.

MBD

The MBD is comprised of three branches: Therapeutic Discovery (TD), Synthetic Biology & Biosurveillance, and Systems Biology (The Center for Genome Sciences (CGS)).

The goal of the TD Branch is to support the National BD Strategy to provide medical countermeasures including antiviral, antibacterial, and antitoxin pharmaceutical products to enhance preparedness to reduce the impact of bioincidents. To support the USAMRIID mission to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Therapeutic Discovery Branch is equipped to discover novel therapeutics that may be used alone or in combination to treat individual and a broad spectrum of biological threat agents. Candidate countermeasures are carefully evaluated for feasibility of use and safety. Subject matter experts in the division analyze data, mechanism of action, pharmacokinetics, pharmacodynamics, medicinal chemistry, and strategic use of countermeasures. The Therapeutic Discovery Branch is highly interactive with divisions within USAMRIID in the foundational, translational, and core directorates acting as a team to exploit molecular targets in pathogen and host for optimal guidance in countermeasures development.

The goal of the Synthetic Biology & Biosurveillance and CGS branches is to provide the scientific expertise and technology platforms to provide cutting-edge next-generation sequencing, protein identification and characterization, and analysis of Biological Select Agents and Toxins (BSAT) and other samples in support of the USAMRIID mission. The CGS also develops reliable, accurate and rapid HTS and protein profiling capabilities to support the DTRA/JSTO initiative to identify unknown and emerging pathogens; to perform whole genome sequencing; and to characterize host-pathogen interactions. It also provides the development and application of liquid chromatography / mass spectrometry workflows to investigate the proteomic and metabolomic host response to infection with biothreat pathogens, and the investigation of viral, bacterial, and host cellular protein interactions for vaccine design and the discovery of novel therapeutic targets. The CGS has six core mission research areas:

pathogen discovery, system biology, functional genomics, immunomics, proteomics and bacterial comparative genomics.

DTRA/JSTO is the primary funding organization supporting MBD. The number of research studies completed per year within MBD is highly dependent on available funding and current mission requirements.

Virology Division The Virology Division supports USAMRIID’s mission to protect the war-fighter from biological threats and to be prepared to investigate disease outbreaks. Virology Divisions must be prepared to test and evaluate medical countermeasures and rapidly identify biological agents. Virology Division consists of subject matter experts in viral pathogenesis advance development and clinical trials. Viral Biology research provides data and analysis of the structure and function of genes of viruses, defines biochemical properties of viruses, identifies cell receptors, investigates transcription and translation mechanism, identifies potential molecular targets for disruption of viral replication, and defines the genetic and molecular basis for those interactions. Viral Immunology research characterizes the immune response to threat agents, protective mechanisms leading to the selection of candidate vaccines, and surrogate markers of protection to viral agents; and develops and evaluates selected vaccine strategies to improve host responses. Animal modeling is provided to develop, characterize and evaluate viral agents for different BSAT viral agents. The established animal models are crucial for comparing medical countermeasures, future licensures, and GLP studies. Telemetry is incorporated into animal model development and provides the researchers with comprehensive physiological data. Cell Biology is conducted to elucidate host-agent interactions that determine outcomes of infection; identify target cells, viral cell receptors and cell to cell interactions; and define the genetic and molecular basis of those interactions. Viral Molecular Biology provides the genetic structure and function of viruses, defines biochemical properties of viruses, investigates transcription and translates mechanisms, develops vaccines and identifies potential molecular targets for disruption of viral replication. Entomology and Vector Assessment identifies the potential vectors of viral agents, develops laboratory and field capable rapid diagnostics to identify pathogens conducts biosurveillance, investigates outbreaks of severe disease, and conducts field studies to determine risk factors for various arthropod-borne diseases.

Diagnostic Systems Division The Diagnostic Systems Division (DSD) provides reference diagnostic and disease assessment consultation within the medical community in support of DoD operational requirements. DSD supports analytical studies for advanced development and FDA clearance of diagnostic assays as well as pre-clinical studies of vaccine and therapeutic candidates. The division is functionally organized into four departments: Developmental Diagnostics, Applied Diagnostics, Operational Diagnostics, and Regulated Products.

The Developmental Diagnostics Branch’s mission focuses on development of diagnostic platforms, protocols, and reagents for maturation of molecular and immunodiagnostic capabilities, with particular emphasis on technologies for rapid detection and diagnosis of biological threats to protect US Forces. Core programs within the group span a variety of research areas and include: sample preparation, assay development, biomarker discovery, genomics and threat characterization. Disciplines utilized in these efforts include molecular biology, microbiology, biochemistry and genomics. Overall, this branch seeks to positively impact Warfighter health and protection through enhancing current fielded molecular diagnostic capabilities.

The Applied Diagnostics Branch’s mission is to transition assays developed in the developmental diagnostics branch to both benchtop and field-forward platforms to test and evaluate their use for biothreat detection and diagnosis for the Warfighter and the Nation. Additionally, this branch interacts with PIs in the institute to support animal study needs for PCR, antigen, antibody, and biomarker testing. Serosurveillance and vector testing with overseas partners funded by GEIS, DTRA-BTRP, and other organizations as well as training programs to support capacity building falls under this branch. The branch also serves as a RUO confirmatory diagnostic laboratory for arthropod-borne and hemorrhagic fever viruses for DoD Contiguous United States (CONUS) and Outside Contiguous United States (OCONUS) facilities.

The Operational Diagnostics Branch’s mission to utilize assays in a fielded context including real-time PCR under validated and non-validated conditions. We maintain a CLIA accredited Clinical Diagnostic Laboratory (COLA), which includes the Special Pathogens Laboratory and LRN for clinical and environmental analysis and confirmatory diagnostics. The LRN/SPL lab is the only National Level LRN laboratory in the DoD operating in Biosafety Level (BSL) 2 through BSL-4. The SPL is also an active participant in the Food Emergency Response Network (FERN), linking USAMRIID’s LRN/SPL with Public Health and United States Department of Agriculture (USDA) labs.

DSD’s Department of Regulated Products provides standardized high quality reference material and reagent support to USAMRIID researchers and a variety of external customers and partners, to include study stakeholders, DoD Military Branches, National Guard Bureau, Federal Government Agencies, Combatant Commands, DoD Beneficiaries and direct support to the Warfighter. The department includes the Biodefense Reference Materials Repository (BRMR), an ISO accredited bacterial, viral, and reagent repository, which supports researchers with highly characterized challenge stocks and reagents to support Animal Rule and FDA studies.

DoM DoM conducts a variety of educational programs on BD through the Training and Education (T & E) Department to include some on-line content and runs the Laboratory Transition Training/Field Identification of Biological Warfare Agents (FIBWA) training center, which is located on Fort Detrick’s Area B. This training center offers a suite of curriculums to train, and competency assess end users to establish and operate Chemical, Biological, Radiological, and Nuclear (CBRN) laboratories in austere or challenging environments. It provides the Technical and SME support necessary to ensure transitioning and state of the art technologies for CBRN laboratory managers and technicians through classroom, lab based and field exercises. The training center also supports USAMRIID through the facilitation of training space as well as some standardized and lab tailored hands-on training. Clinical trials of various countermeasures are conducted by the Military Vaccine Clinical Research Center (MVCRC) under the Department of Clinical Research (DCR), in collaboration with outside centers to include military treatment facilities such as Ft. Bragg, Republic of Korea, Hawaii and elsewhere, in support of the Defense Health Agency- Immunization Health Division (DHA-IHD) formally, Military Vaccine Program (MILVAX).

AAT

The USAMRIID Aerobiology capability is one of the only medical BD research capabilities in the country focused on high containment (BSL-3 and BSL-4) infectious disease aerobiology. AAT conducts and supports research on aerosol science, inhalation disease pathogenesis, and evaluation of medical countermeasures for diseases caused by aerosolized biological threat agents. Animal clinical pathology is responsible for the evaluation and reporting of clinical pathology data from non-clinical research studies and the USAMRIID NHP colony. AAT’s telemetry capability provides specialized services to support all large animal telemetry studies performed at USAMRIID, offering reliable and cost-effective support while handling all the aspects of collecting and analyzing physiological telemetry data from implanted animals. With few exceptions, all AAT equipment, instrumentation, and associated software are maintained in a validated state to meet GLP study requirements.

AAT is a highly dynamic work/laboratory environment that demands performance of high quality results-based research, data integrity, regulatory compliance, and overall ability to work together with a diverse group of professionals from a variety of basic and applied scientific disciplines. Team members provide expertise ranging from engineering, aerosol technology, animal plethysmography, animal research, in vitro assays, evaluation and reporting of clinical pathology data, and telemetry study data analysis.

Pathology Division The Pathology Division is the largest research pathology program in the DoD and the only one focused on high containment (BSL-3 and BSL-4) infectious disease pathobiology. The Pathology Division conducts and supports basic research on disease pathogenesis, as well as advanced development and evaluation of medical countermeasures for diseases caused by biological threat agents. The Pathology Division is a highly dynamic work/laboratory environment that demands performance of high quality results-based research, academic scholarship, and overall ability to work together with a diverse group of investigators and technicians from a variety of basic and applied scientific disciplines.

The Pathology Division is divided into three Departments. The Laboratory Department provides high quality necropsy, histopathology, and special staining services to each of its customers in a timely manner at a competitive price compared to industry and governmental agencies. The Ultrastructural Pathology Department develops and applies novel, cutting-edge electron microscopy techniques and manages all electron microscopy assets in support of the USAMRIID mission. The Molecular Pathology Department develops and applies various molecular techniques to the study of biological threat agents and conducts independent research as well as provides services to Institute investigators.

Regulated Research Administration Division Technical writing support within the Core Support Directorate provides nonclinical study support to research scientists, study teams, project managers and regulatory affairs personnel across the Institute. Technical writing support assists the USAMRIID Public Affairs Office (PAO) with review of technical documents and writing, editing, and formatting of communications products as needed.

Risk Management Division /Transition Office The Risk Management Division is responsible for ensuring that personnel working or supporting laboratory operations receive training, education and personal protective equipment necessary to conduct their duties safely and effectively.

The Transition Office is responsible for the planning, coordinating, and execution of equipment, personnel and operations to Building 8100 while maintaining USAMRIID mission requirements.

1.4. Scope

This section describes the scope of activities the Contractor is expected to provide under this PWS for each organizational unit. As the mission changes scope may increase or decrease in magnitude.

Bacteriology Division The Bacteriology Division leads approved, mission-related research on bacterial threats at the BSL-2 and BSL-3 levels and includes the core of bacterial threats Subject Matter Experts for the DoD. The research focuses on current and emerging bacterial threats by leveraging our expertise in bacterial pathogenesis, immunology, vaccines, and therapeutics. The Contractor will provide Bacteriology Division with the scientific, technical, and project management support required to execute its research mission.

MBD

The Contractor shall provide the MBD with the scientific, technical, and project management support necessary to execute all aspects of its mission that relies on Next-generation sequencing, protein analysis, and target molecule characterization within the above stated functional capabilities.

The Contractor shall provide several levels of scientific and technical support to cover the MBD functional capabilities. For the Synthetic Biology & Biosurveillance branch these include pathogen discovery and stock characterization, pathogen population genetics, pathogen genome reconstruction, comparative genomics and technology development and integration. For the Systems Biology branch these include host-immune response characterization, host genes expression, epitope mapping, quantitative proteomics, structural biology, metabolomics, small molecule quantitation in biofluids, mass spectrometry tissue imaging, high resolution accurate mass determination, and protein characterization to include post-translational modification analysis. Scientific Support shall include tasks to establish research protocols supporting both CGS branches functional capabilities, to provide research governance of data integrity and good research conduct. In addition, Scientific Support shall provide high-level bioinformatics expertise for integration and analysis of ~4 Terabytes of data produced monthly. Technical support shall include laboratory procedures supporting sample processing with management of Standard Operating Procedures (SOPs) and maintaining compliance with USAMRIID Safety regulations.

The Contractor shall provide the scientific and technical support necessary to execute the Therapeutic Discovery Branch and USAMRIID’s current missions as mission scope may increase or decrease. Contractors shall serve as Lead Investigators, staff scientists, and technicians within the Division, providing personnel with qualifications to support all mission requirements. Therapeutic Discovery Branch conducts research in BSL-2, BSL-3 and BSL-4 laboratories and works with a variety of viral and bacterial agents so there is a significant need for personnel enrolled in the Army’s Biosurety Personnel Reliability Program (BPRP). Project Managers shall provide support to all phases of RDTE projects. Working independently, with Principal Investigators (PIs) and/or in project teams, and using established project management best practices, strong organizational skills, and USAMRIID processes, systems, and tools, they assist in ensuring that projects are well planned and deliverables are provided on schedule and at cost. They shall monitor and report on execution of the project from a cost, schedule, and performance basis.

Contractors shall work well in teams as Therapeutic Discovery Branch involves collaboration with every division at USAMRIID including Business Innovation and Programs.

Virology Division The Contractor shall provide the scientific, technical, and project management support necessary to execute all of Virology’s and USAMRIID’s current missions, as the mission changes scope may increase or decrease in magnitude. Contractors shall serve as Lead Investigators, staff and research scientists, and technicians within the Division, providing personnel with qualifications to support all mission requirements. Virology conducts research in BSL-2, BSL-3 and BSL-4 laboratories and works with a variety of viral threat agents. Virology has a significant need for personnel enrolled in the Army’s Personnel Reliability Program.

Virology task requirements include scientific and technical support to conduct viral pathogenesis research, viral biology research, viral immunology research, animal modeling, cell biology, viral molecular biology, entomology, and vector assessment. Project Managers shall provide support to all phases of RDTE projects. Working independently, with Principal Investigators (PIs) and/or in project teams, and using established project management best practices, strong organizational skills, and USAMRIID processes, systems, and tools, they assist in ensuring that projects are well planned and deliverables are provided on schedule and at cost. They shall monitor and report on execution of the project from a cost, schedule, and performance basis.

Diagnostic Systems Division The Contractor shall provide the scientific, technical, and project management support necessary to execute all aspects of the DSD’s and USAMRIID’s current missions, as the mission changes scope may increase or decrease in magnitude. This includes acting as Lead Investigators, staff scientists and technicians within the Division, providing personnel with qualifications to operate within BSL-2, BSL-3 and BSL-4, providing research support to execute all research activities as outlined in section 1.1 and 1.2, maintaining laboratory equipment and supplies, and providing personnel with qualification to meet regulatory and accredited activities under applicable parts of the Code of Federal Regulations (CFR); 21 CFR (GLP/CGMP), 42 CFR (CLIP/CLIA), ISO standards and accreditation agency guidelines as applicable. DSD operates and has funded activities at BSL-2, BSL-3 and BSL-4 and works with a wide variety of threat agents to include viruses, bacteria and toxins. Personnel will be expected to support and execute research, repository, reagent production, verification/validation and diagnostic and service support in BSL- 2, BSL-3 and BSL-4 laboratories. As such, DSD has a significant need for personnel enrolled in the Army’s Personnel Reliability Program. The number of scientific programs per year within DSD is highly dependent on available funding and current mission requirements, but historically 20-30 projects receive funding per year. The Contractor will provide the necessary project management support to monitor and ensure execution of all phases of RDTE projects. Working independently, with Principal Investigators (PIs) and/or in project teams, and using established project management best practices, strong organizational skills, and USAMRIID processes, systems, and tools, they assist in ensuring that projects are well planned and deliverables are provided on schedule and at cost.

They shall monitor and report on execution of the project from a cost, schedule, and performance basis.

The Key Tasks for this requirement include scientific support to conduct immunodiagnostic research, molecular diagnostic research and advanced development of diagnostics to support regulatory approval.

DoM The Contractor shall provide clinical, administrative, and project management support for the DoM clinical research programs associated with biological warfare defense (e.g., DCR). The Contractor is responsible for overall administration of the medical and non-medical operations and shall be required to provide administrative and technical guidance with medical background and matters pertaining to the individual branches as described within the DoM.

The DoM conducts on-site Clinical Trials and clinical research in the field on BD and Infectious Diseases (ID) of military significance.

The DCR is a state-of-the-art program staffed and resourced at the USAMRIID to conduct intramural and extramural clinical research with a focus on issues pertaining to human vaccines against biological weapons. The program goals are to conceive, develop, and execute clinical and laboratory research in support of the DCR and its mission to optimize and coordinate vaccine prophylaxis (and, as appropriate, therapy) against specified natural and/or artificially acquired disease threats to the Armed Forces of the United States. Issues and questions regarding vaccine safety, immunogenicity, effectiveness, and utility, as identified by operation forces, policy makers, and the scientific community, will be translated into study protocols and addressed rigorously and IAW the highest scientific and ethical standards particularly with regard to the protection of human volunteer study subjects.

The MVCRC objectives are developed through coordinated communication among the DHA-IHD, Headquarters at USAMRIID, and the Director of the DCR office. A continually reviewed and updated prioritized project list created through this process is used to develop resource needs, budgets, and personnel requirements. Direction and oversight of the DCR USAMRIID office is provided by a senior physician at USAMRIID. Program resources derive from the DHA-IHD with infrastructure support provided by USAMRIID. Contract clinical and laboratory staff work in conjunction with the DCR Director to project and identify resource needs, develop and coordinate study protocols, execute approved research projects, and coordinate volunteer compensation on a schedule determined by the Director. The Contractor shall provide the scientific and technical support necessary to execute all appropriate aspects of the research.

The DoM Training and Education department teaches the Medical Management of Chemical and Biological Casualties Course (MCBC) course four times annually, which provides a one-week state-of-the-art-training platform to physicians, nurses, and other medical personnel of the four services. Up to 600 personnel per year receive MCBC training. Additionally, condensed versions (“the Road Course”) of the MCBC course are offered as requested in Korea, Germany, the United States Central Command’s (CENTCOM) area of responsibility (AOR), the annual Association of Military Surgeons of the United States (AMSUS) convention, and in other venues. The DoM team also participate as guest lecturers in the Field Management of Chemical and Biological Casualties (FCBC) Course given five times per year at Aberdeen Proving Grounds, MD. Additionally, the DoM team also participate as guest lecturers in the Hospital Management of Chemical, Biological, Radiological, Nuclear, and Explosive Incidents (HM- CBRNE) Course given two times per year at Aberdeen Proving Grounds, MD. DoM also provides recognized, on-going FIBWA training programs requiring highly skilled instructor(s) with excellent interpersonal and organizational skills.

Physicians and other personnel can respond on very short notice and provide expert consultation to DoD assets throughout the world. DCR Medicine personnel provide support to deployed forces, the Domestic and Foreign Emergency Support Teams, the Chem/Bio Rapid Response Team, and other contingency support teams. The Division maintains close ties with the Special Operations community and provides consultation and liaison services.

The Department maintains close ties with the Intelligence community, similarly, providing consultation and liaison support. DoM supports the warfighter through biological warfare agents research and education to develop resilience and ability to mitigate and reconstitute Army capabilities improving readiness.

AAT

The Contractor shall provide the scientific and technical support necessary to execute all aspects of USAMRIID’s current AAT-associated missions. As the mission changes, the scope may increase or decrease in magnitude. This includes providing GLP expertise to support the validation of all aerosol equipment, providing research technical support to execute research studies, maintaining all laboratory equipment, providing support to internal and external research efforts by delivering standardized and well defined aerosols in support of the USAMRIID mission (approximately 200 aerosols per year) in addition to implementing new aerosol technology, as identified by AAT leadership. Research equipment includes Class III safety cabinets (9 hoodlines and 8 transport boxes), each hoodline equipped with an aerosol exposure system (approximately 10 components each), and approximately 500 miscellaneous tools and equipment. The number of research studies supported per year is highly dependent on available funding and the current mission requirements, but historically 15-20 projects requiring AAT protocol support receive funding per year. Telemetry technical support is required to support approximately 20 studies per year. This includes providing telemetry research support for all USAMRIID investigators in addition to maintaining and supporting telemetry equipment in a validated state to support GLP animal studies in all levels of containment.

The Key Tasks for this requirement include providing aerosol research support, technical support for aerosol technology development and evaluation, AAT equipment maintenance and validation for GLP compliance, technical support for animal research protocols, clinical pathology sample evaluation and reporting of data, organizing study rooms with necessary telemetry equipment, maintaining a current inventory of telemetry implants, and configuring telemetry hardware and software for data acquisition under the direction of AAT leadership. Majority of tasks are performed in BSL-2 through BSL-4 containment levels. AAT has a significant need for personnel enrolled in the Army’s Personnel Reliability Program and the Controlled Substance Personnel Reliability Program.

Pathology Division The Contractor shall provide the scientific and technical support necessary to execute all aspects of the Pathology Division’s and USAMRIID’s current missions. As the mission changes, scope may increase or decrease in magnitude. Scientific and technical support may include acting as Lead Investigators within the Division, providing GLP expertise, providing research support to execute all animal research studies (including well-documented and GLP studies), maintaining all laboratory equipment, and developing new ultrastructural and molecular pathology techniques. The number of research studies supported by the Pathology Division is highly dependent on available funding and the current mission requirements; therefore scope and magnitude may vary over time. Research equipment includes items such as light microscopes, transmission electron microscopes, scanning electron microscope, laser capture micro dissection scope, confocal microscope, digital slide scanner, services and various histology laboratory equipment such as fume hoods, tissue processors, tissue embedding equipment, microtomes, automatic slide stainers, and automatic slide cover-slippers.

The Key Tasks for this requirement include the support of research and development of animal models, disease pathogenesis, medical countermeasure safety and efficacy non-clinical studies, histology, ultrastructural, and molecular pathology equipment maintenance and validation for GLP compliance, ultrastructural and molecular pathology technique development and evaluation. Some positions will require necropsy support in BSL-2 through BSL-4 containment levels.

Regulated Research Administration Division The Contractor shall serve as an Institute resource by providing technical writing expertise and support. A scientific background supplemented with a knowledge base to include protocols, protocol amendments, nonclinical study reports, FDA animal rule and FDA/GLP regulations is required. Strong intrapersonal and organization skills are critical for success.

Risk Management Division /Transition Office The Contractor shall provide project management support to assist the Director of Transition, Biosafety Officer, Health Facilities Planning Agency, and IO&T Contractor in transition planning and transition execution to Building 8100. The Contractor will provide technical and program management suite supervision support for BSL-2, BSL-3 and BSL-4 containment suites in Buildings 1301, 1408, 1412, 1425, 1443, 1444 and 8100. Enrollment in the Army’s Personnel Reliability Program (PRP) is required. Strong organizational and interpersonal skills, a thorough understanding of USAMRIID’s research and biocontainment needs and knowledge of current biocontainment regulations are critical for success.

SECTION 2 GENERAL REQUIREMENT

2.1. Place of Performance

Primary On-Site Government Locations:

USAMRIID, 1425 Porter Street, Fort Detrick, MD 21702-5011 in Buildings 1425 and 1412 FIBWA Training Center, Area B, Fort Detrick, MD 21702-5011 1301 Ditto Avenue, Fort Detrick, MD 21702-5011

2.2. Duty Hours

USAMRIID’s core hours of operation are generally Monday through Friday, 0900 to 1500, daily except for U.S.

Federal holidays. Workers typically work eight hours per day, 40 hours per week. All employees are expected to be available during core hours. Based on mission needs, extended work hours may be required/needed, which can include early or extended work week and weekend hours outside and/or in addition to the typical 40 hours per week.

Based on mission needs, Federal holiday hours may be required/needed.

2.2.1. Cell Culture Staff Support (PWS Section 3.3.6). To ensure product quality, timelines of cell lines and overall section operations, Cell Culture Support staff shall start work by 0700 on normal duty days.

2.2.2. When duties are required to be performed outside the scope of the typical workday, workers shall be eligible for flextime. Prior approval shall be coordinated, at least weekly, through the Contractor supervisor/Program Manager and the Contracting Officer’s Representative (COR) or designated representative. Flextime must be approved by the Contractor who will coordinate with the COR to ensure appropriate Contractor coverage so that flextime is not detrimental to completion of the mission.

2.2.3. The Contractor shall not routinely perform services on days designated as a U.S. Federal holidays by Federal Statute, Executive Order, Presidential Proclamation or Notice form the Installation Commander. U.S. Federal holidays are an exception to the regular duty hours. Any of the holidays, listed below, falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of the U.S. federal holidays that services shall not be performed:

New Years’ Day, 1 January Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, last Monday in May Juneteenth National Independence Day, 19 June Independence Day, 4 July Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, 11 November Thanksgiving Day, 4th Thursday in November Christmas Day, 25 December

2.2.4. Telecommuting. In accordance with Federal Acquisition Regulation (FAR) Part 7.108, telecommuting is permitted; however, not all labor categories support telecommuting. Telecommuting is situational and requires the approval of the Contractor supervisor/Program Manager who will coordinate the telework schedule with the COR and designated TPOC to ensure appropriate Contractor coverage. A proposed list of tasks to be completed while teleworking will be provided to the Contractor PM, COR, and TPOC with each telework request for review. A summary of completed telework activities will be provided to the COR and TPOC within 24 hours for all telecommuting unless otherwise coordinated and agreed between the COR and Contractor Program Manager.

2.2.5. Operation During Emergency Situations.

2.2.5.1. Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within 12 hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Program Manager to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including base closures, the Contractor Program Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Program Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer (KO) prior to incurring costs over and above those allowed for under the terms of the contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately IAW the terms of the contract.

2.2.5.2. Contractor shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Installation Commander for any other reason. During these periods of closure, the contractor employees that are not designated as essential IAW this requirement shall not report for work nor shall they be compensated for those days, unless there is an approved telework agreement. If there is an approved Telework Agreement in place, then the Contractor should work on the days the installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Installation Commander for any other reason. The Contractor POC will provide to the COR a Telework Report for the completed telework period describing specific tasks accomplished. Telework Reports shall be submitted at the end of each telework day to the COR and TPOC or as otherwise coordinated and agreed between the COR and Contractor Program Manager.

2.2.5.3. Mission Essential Schedule – Emergency Situations. In response to emergency situations, such as but not limited to COVID-19 (Coronavirus), a living schedule could be adopted to limit exposure amongst the workers. The schedule will be coordinated by the COR and the Contractor Program Manager and provided to the KO. The schedule may be revised based on the uniqueness of the circumstance to meet the mission.

2.3. Non-Personal Services

2.3.1. This PWS identifies services that are strictly non-personal in nature, as defined by FAR Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the KO immediately.

2.3.2. Severable / Non-Severable Services. This PWS identifies services that are severable in nature.

2.3.3. Inherently Governmental Functions. This PWS has been reviewed and contains no services that are inherently governmental functions, as defined in FAR Part 2.1.

2.3.4. Acquisition Functions Closely Associated with Inherently Governmental Functions. This PWS has been reviewed and contains no acquisition functions closely associated with inherently governmental functions.

2.3.5. Nomenclature for Verification of Risk and Access. Due to the sensitive nature, potential risks, and information system security requirements of the PWS tasks, the COR or Technical Points of Contact (TPOC) may be required to review, complete, and verify through signature, on internal and external government forms as a “Supervisor”.