Att 7 - Statement of Objectives.pdf

Draft 30 Oct 2024

STATEMENT OF OBJECTIVES

Bioeffects Research of Directed Energy Exposures (BRDEE)

Background, Goal, Scope, Objectives

1. Background. The Air Force Research Laboratory’s (AFRL) Radio Frequency Bioeffects Branch (RHDR) is a key component of the Bioeffects Division (RHD) under the Human Effectiveness Directorate (RH) within the 711th Human Performance Wing (711 HPW). The branch comprises a diverse group of military, civilian, and contractor scientists and engineers whose mission is to understand the short and long-term biological effects associated with Directed Energy (DE) technologies. Research activities primarily focus on technologies spanning radio through terahertz frequencies of the electromagnetic spectrum, however, other forms of DE exposures (e.g., acoustics, ultrasound, particle beam, etc.) may be investigated as required by United States Air Force (USAF) and Department of Defense (DoD) demands.

2. Goal. The Bioeffects Research of Directed Energy Exposures (BRDEE) program conducts research studies with DE-based devices and systems to deliver accurate, evidence-based information to DoD and industry stakeholders, national and international health and safety standards committees, and the public. The goal is to enable optimal use and maximum safe exploitation of the electromagnetic spectrum for national defense by protecting personnel and communities and evaluating the applications of DE systems.

3. Scope. This Statement of Objectives (SOO) describes the work that shall be performed by the Contractor to support 711 HPW/RHDR in a full range of research and experimentation efforts as described in the Continuing Human Enabling, Enhancing, Restoring, and Sustaining (CHEERS) Multiple Authority Announcement (MAA) (# FA2384-24-S-2233) SOO (attachment

2) RHD Technical Requirements (section 3.2). Research activities under this program are anticipated to follow the RH organizational construct as described in CHEERS, i.e., research will be categorized based on the technology readiness level (TRL). The Contractor should expect to perform basic to early applied research and advanced technology development and transition. The basic to early applied research will align with the Bioeffects Core Technical Competency (CTC1) and fall under the DE Bioeffects modeling, simulation, and analysis core research area (CRA1) and/or the DE Bioeffects and mechanisms core research area (CRA2).

The advanced technology development and transition activities will align with the Bioeffects Product Line (PL). For further details on CHEERS and/or the RH organizational construct, please review the CHEERS MAA notice and CHEERS MAA Technical Requirements SOO on SAM.gov.

BRDEE technical objectives are categorized under three main functional areas for which technical expertise will be required:

1) DE bioeffects modeling, simulation, and analysis

2) DE bioeffects experimentation

3) Engineering for DE bioeffects applications

Within these functional areas, the Contractor shall characterize the fundamental bioeffects associated with DE technologies, optimize/assess the safety and effectiveness of DE systems, develop and assess dosimetry tools, provide modeling and simulation support to laboratory experiments and DE applications, design and characterize protective devices, investigate DE countermeasures, and provide science-based information to the DoD to support national & international safety standards.

4. Objectives. The three functional areas and their respective technical objectives are intended to steer the research and development efforts of this program. Furthermore, they are designed to address critical research challenges, advance technological capabilities, and achieve measurable outcomes that support the overarching mission of RHDR. It is expected that across the three functional areas, research efforts will span from the lowest level of biological interaction, i.e., molecular, through the highest level of interaction, i.e., whole organisms. A non-exclusive list of knowledge, skills, and abilities to successfully execute RHDR’s mission can be found at the end of this section in Table 1.

Functional Area 1: DE Bioeffects Modeling, Simulation, and Analysis (MS&A).

Enhance existing and develop new MS&A tools and software products related to the biophysics of DE exposures.

The Contractor shall develop and enhance MS&A tools to conduct mathematical, statistical, and theoretical analyses to fully characterize dose-response relationships between DE exposures and associated bioeffects and establish the theoretical bases for such effects.

Software development will include the design and improvement of multi-physics models relevant to the bioeffects of DE exposures across a broad parameter space to include Radio Frequency (RF) high average power (HAP), high peak power (HPP), continuous wave (CW), and modulated (e.g., amplitude, frequency, and pulse) fields. Models should include the propagation of RF in free space and through biological materials. These approaches should include, but are not limited to, models and solution techniques to predict electromagnetic wave propagation, molecular dynamics (MD) models, thermal and thermoregulatory models, multi-physics models (e.g., thermoacoustics), and multi-scale models (e.g., whole-body distributions of electric fields coupled to nerve activation models). Software tools created in this program may be utilized to parametrize in-house experiments, support the RF standards community with evidence-based energy absorption and thermal predictions, aid in computational dosimetry, enable DoD-directed health and safety reviews of DE technologies, establish exposure guidelines for novel DE systems, and analyze the trade-space of system effectiveness versus biological effect. Technical Objectives are listed below:

A. Computational Dosimetry: Develop algorithms and models that predict the dosimetry from exposure to DE systems. These algorithms and models may include analytical, heuristic, statistical, or numerical approaches for predicting the amount and location of electromagnetic absorption within biological materials or surrogates.

B. Thermal Models: Develop models to predict the thermal response of biological material resulting from exposure to DE systems.

C. Bio-heat Equation Solutions: Develop and implement software that utilizes numerical and analytical solutions to the Bio-heat Equation, including physiological responses to heat (e.g., thermoregulation). As appropriate, couple these solutions to models of adverse thermal effect (e.g., rate-process damage models).

D. Continuous Review of Safety Standards: Utilize MS&A software to investigate the appropriateness of existing DE exposure standards and recommend evidence-based threshold levels for analysis of military engagements.

E. Real-Time MS&A Tools: Create real-time distillations of numerical modeling approaches for integration within DoD, USAF, and AFRL engagement and mission-level simulation packages.

F. Bioeffects Predictive Models: Develop predictive models for established DE-induced bioeffects and techniques for leveraging those models within probabilistic assessment scenarios.

G. Field Mapping Models: Develop simulation models to predict the energy levels vs.

range for DE systems and compare these energy levels against DE exposure guidelines and bioeffects thresholds. Simulate field distributions in support of laboratory experimentation, to include effects of experimental equipment and apparatus (e.g., petri dish for in vitro studies) on field homogeneity and intensity.

H. Novel DE Systems Models: Develop and use models that predict the bioeffects of novel

DE exposure scenarios such as emerging DE systems and capabilities.

I. Novel Physics-Level Models: Develop and use physics-level modeling to capture higher-order effects excluded from existing tools and to describe other DE exposure modalities (e.g., particle-beam, acoustics, etc.).

J. Software Tools: Develop multi-physics research software that implements dosimetry, thermal response, and propagation characteristics and bioeffects models to support program goals. Software shall be cross-platform compatible for both Windows and Linux computers. Implement Graphical User Interface (GUI) based transition level software for DE system analysis and mission decision support.

K. High-performance Computing (HPC) Support: Provide support for the procurement, setup and maintenance of dedicated HPC hardware.

L. Empirical Studies Support: Consult on the design and parameterization of empirical research.

Functional Area 2: DE Bioeffects Experimentation. Plan and execute high-quality empirical research on the bioeffects of DE exposures.

The Contractor shall conduct laboratory and/or field studies to identify the short and long-term bioeffects associated with DE exposures, investigate basic mechanism(s)-of-interaction between biology and DE exposures, and characterize the range of bioeffects to inform capability development for the USAF. Research areas include discovery science for understanding mechanisms, investigation of neurobiological and behavioral responses, hardening of biological targets, biomarker discovery to include all types of omics data, membrane and ion channel response, supra-threshold response to include probability and severity of effects, and human factors in technologies for protection. Collaborative research with medical partners may also be anticipated, with potential focus on diagnostic/triage technologies and medical treatment strategies. Technical Objectives are listed below:

A. In vitro Characterization: Investigate the effects of DE exposure on various biological events and functions, including, but not limited to cell viability and cell metabolism/bioenergetics, cell membrane permeability and fluidity, enzyme activity, channel activity and electrophysiology, intracellular signaling, and changes in epigenetic patterns and in transcriptional/protein expression. Characterize the relationship between exposure doses and biological responses (dose-responses) across a variety of biological assays.

B. In vivo Characterization: Investigate effects at a whole organism level to determine the relationship between various exposure doses/conditions and the biochemical, behavioral, and physiological responses of animal subjects during and following DE exposures.

C. Mechanism Validation Studies: Design and conduct experiments to test the validity of proposed mechanistic theories relevant to DE bioeffects.

D. Effects Thresholds: Compare the bioeffects of various frequencies, intensities, and modes (e.g., continuous vs. modulated) to determine their relative effect thresholds.

E. Translatable Models: Develop, identify and utilize cellular and animal models that are translatable to DE effects in humans, with an emphasis on models that enable high throughput analysis, strongly powered statistical studies, and exposure conditions ranging from acute (seconds to minutes) to chronic (days, weeks, and months).

F. Volunteer Human Subject Research: Conduct human-related research activities that investigate impacts of DE exposure on human effectiveness, cognitive performance, perception thresholds, and physiological and psychological responses at safe exposure levels.

Functional Area 3: Engineering for DE Bioeffects Applications. Support bioeffects research to enable the development and deployment of future DE systems and other emerging technologies that could be beneficial to the USAF and the warfighter.

The Contractor shall develop novel tools, software, hardware and techniques to better characterize DE interactions with biology and adverse effect thresholds, capture and analyze laboratory data to inform software approaches enabling simulation of dynamic scenarios, design analysis techniques to quantify the dosimetry in real-time during DE exposures, and estimate the uncertainty associated with those exposures. Technical Objectives are listed below:

A. Equipment: Maintain and operate DE sources and associated equipment as required for planned experimentation. Assist in the procurement of commercial and custom DE sources as required by government identified research needs by coordination with government technical leads on system characteristics and requirements.

B. Exposure Control: Design hardware and software solutions to conduct and control exposures for bioeffects experiments.

C. Dosimetry: Utilize existing hardware and software measurement tools to measure and document dose for bioeffects experiments. Spatially map the electric field strength and power density of exposures. Develop novel techniques and tools to characterize patterns of exposure and field levels for exposure conditions with characteristics that are outside the measurement capabilities of standard commercial sensors. Investigate the use of biological materials as in vivo and in vitro dosimeters.

D. Calorimetry & Thermometry: Use existing hardware and software tools to measure thermal energy and recommend new tools as required by research objectives.

Calorimeters can be used to estimate the average temperature (or energy absorption) of biological systems due to exposure. Infrared cameras can be used to measure surface temperature and fiber optic temperature probes can be used to measure the temperature at specific locations in biology pre, during, and post exposure.

E. Uncertainty Quantification: Establish robust and repeatable approaches to assess the uncertainty of dosimetry during experimentation.

F. Documentation: Create software solutions to capture, store, and analyze the measured dose in real-time during experimentation.

G. Hardware Support: Design and fabricate hardware for experimental setups to support empirical research efforts (e.g., custom printed probe holders to ensure accurate and repeatable placement of sensors in free space or within phantoms & biological systems), create physical phantoms from tissue-equivalent materials for characterization of dose and measurement of physical responses. Procure hardware for research support activities when commercial solutions are available and appropriate.

Table 1: Knowledge, Skills, and Abilities by Functional Area.

Functional Area 1: DE Bioeffects Modeling, Simulation & Analysis (MS&A)

Knowledge Skills & Abilities

Programming Languages

Bash, C, C++, FORTRAN, JAVA, MATLAB, Python, SQL

Numerical Analysis

Finite Difference Methods, Finite Element Method, Finite Integration Techniques, Boundary Element Methods, Fourier Analysis, Stochastic Methods

Software Development

Agile/DevOps/Waterfall, Model-Based System Engineering, Unit Testing, Version control systems

Data Visualization & Processing

ImageJ, Matplotlib, ParaView, Excel, Computer Aided Design (CAD) software, Machine Learning, Computer Vision

High Performance Computing

Administration, Data Archiving, GPU, Parallel Processing, Workflow Management

Statistical Analysis Exploratory data analysis, Statistical Modeling and Inference using R, Python, or other preferred statistical software

Analytical Methods Calculus, Linear Algebra, Differential Equations

Functional Area 2: DE Bioeffects Experimentation

Knowledge Skills & Abilities

Cell Culture

The preparation, propagation & maintenance of primary, immortalized, stem, self-propagating eukaryotic/prokaryotic cell lines/strains under various culture environments Ex.) 2D cell culture, 3D organoids, 3D tissue scaffolds, 3D chip technology, & bioprinting; Cell media fabrication, and cell-based assays & testing Ex.) Osmolarity, pH.

Conductivity; Cryo-preservation of cell stocks; immunological and biochemical assays & staining Ex.) Analysis of cell health/viability, proliferation, apoptosis, cell cycle & other biochemical and cell-based assays

Genomics/ Transcriptomics

Analysis of the complete set of an organism's genetic material with a focus on the structure, function, mapping, & editing of the genome to include its deoxyribonucleic acid (DNA) & ribonucleic acid (RNA);

DNA/RNA extraction, purification, & quantification methods Ex.)

Commercial extraction/purification kits, NanoDrop spectrophotometry, gel electrophoresis; DNA/RNA analysis methods Ex.) Non-radioactive southern & northern blotting, quantitative real-time polymerase chain reaction (QRT-PCR); Recombinant DNA methods Ex.) Polymerase chain reaction (PCR), Restriction enzymes, bacterial & viral cloning;

Epigenetic regulation methods Ex.) DNA methylation, histone modification, chromatin compaction, & nuclear organization;

Sequencing Ex.) Microarray platforms for whole genome sequencing & whole exome sequencing; Microarray analysis; RNA interference

Proteomics

Analysis of an organism's complete protein profile with a focus on the structure, function, & expression. Protein extraction, purification, & quantification methods Ex.) Commercial extraction/purification kits, NanoDrop spectrophotometry, gel electrophoresis, high-performance liquid chromatography (HPLC), Enzyme-linked immunosorbent assay (ELISA), non-radioactive western blot; Protein structure methods to include protein-protein, protein-DNA, & protein-RNA interactions Ex.)

Nuclear magnetic resonance (NMR); Protein function methods to include interactions that are involved in specific biological pathways/processes Ex.) Microarray analysis, RNS interference, & yeast two-hybrid system; Protein Expression to include qualitative & quantitative methods Ex.) 1D & 2D polyacrylamide gel electrophoresis (PAGE), immunoblotting & staining, Chromatography, Mass spectrometry using protein separation by capillary column, nanospray (NSI) or matrix-assisted laser desorption (MALDI) ionization methods, & time-of-flight (TOF) mass analysis; Computer-assisted quantitative comparison of 2D gels; Computer-assisted mass spectrometric data analysis

Metabolomics

Analysis of biochemical processes investigating small molecule metabolites as an indication of activity in cells. Metabolomics analysis methods Ex). Nuclear magnetic resonance (NMR), Mass spectrometry, high-performance liquid chromatography

Immunology & Immunoassays

Analysis of immune cell functions, cytokine expression, innate & adaptive responses, & cellular/humoral immunity. Ex.) Cell activation;

Fluorescent immunoassays; Enzyme-linked immunosorbent assays (ELISA); Immunocytochemistry; Fluorescent immunolabeling, Immunoprecipitation; Flow immunoassay

Histochemistry

Analysis of tissue & organs to visualize changes at the microscopic level. Ex.) Tissue sectioning & staining; Immunohistochemistry & immunofluorescence with tissue sections; Quantitative scoring of histological phenotypes

Microscopy

Use of basic microscopy systems to observe/image cells & tissues Ex) Brightfield, phase contrast & dark field; Use of advanced microscopy systems to observe/image molecular responses in real-time Ex) Fluorescent, 1-photon confocal, 2-photon confocal, total internal reflection fluorescence (TIRF) & non-linear optical systems; Use of custom-engineered microscopy systems to observe/image cells & tissues; Use of microscopy associated software to process and analyze micrographs Ex.) Zen Blue, Zen Black, Image J, FIJI

Electrophysiology

Analysis of the electrical activity and electrical properties of cells & tissues. Analysis of ions movement across the cell membrane and ion channel activity Ex.) Measurements of voltages or electrical currents with Patch-clamp

Radiography/Small Animal Imaging

Use of advanced radiographic imaging techniques to generate high resolution images. Ex.) MRI; microCT; Bioluminescent/Fluorescent whole animal (IVIS). Interpretation/reading of scans for quantitative & qualitative analysis.

Bioinformatics

Use of computer technology to collect, store, analyze, & share biological data. Computer-based data management; Statistics and probability testing; Sequencing Ex.) NCBI BLAST, Ingenuity Pathway Analysis and other open-source and commercial web-based bioinformatics tools

Animal Subject Research

Animal protocol development, Animal care & welfare Ex.) Short & long-term husbandry, dietary planning; Experimental handling Ex.)

Anesthesia, DE exposures, analysis of tissue, bodily fluids, & breath;

Surgical procedures; Optogenetics; Imaging techniques;

Electrophysiology; Biopsy/necropsy sample collection & preservation;

Maintenance of a breeding colony for transgenic rodent species;

Longitudinal colony maintenance Ex.) Animal behavioral studies to include natural & trained behaviors, learning, memory, cognitive behavioral assays, vocal & hearing assessments, active & passive avoidance, operant conditioning

Human Subject Research

Human use protocol development, Measurement of biological effects spanning cognitive performance, perception thresholds, & physiological responses Ex.) Biomarkers, electroencephalogram

Functional Area 3: Engineering for DE Bioeffects Applications

Knowledge Skills & Abilities

DE Equipment Electric & magnetic field probes, power density probes, power meters, infrared cameras, fiber optic electromagnetic field sensors, & calorimetry

Laboratory Control

LabView, MATLAB/Simulink, Python, DASYLab, Validation and calibration procedures, DE safety & regulatory knowledge

Electronics Equipment

Oscilloscopes, network analyzers, waveform generators, amplifiers

Fabrication CAD and prototyping, 3D printing, Machining, Additive Manufacturing, Soldering

Requirements and Other Information

1. Human Use Research Protocols Development & Approval. USAF human use research involves the study of human subjects to advance the understanding of factors that impact the performance, health, and safety of USAF personnel. This research is essential for developing technologies, protocols, and interventions that enhance operational effectiveness and safeguard the well-being of airmen. It demands a high level of expertise to ensure ethical conduct, scientific integrity, and the protection of participants. The use of human subjects in Air Force-funded research is subject to participant rights, ensuring informed consent, and adhering to rigorous regulatory and ethical standards. Hence, the Contractor shall assist in the preparation of research protocols for all human use experiments which shall be prepared well in advance of need, to allow time for review/approval by the 711 HPW Institutional Review Board (IRB). The Contractor shall maintain records associated with human subject research as required by the approved protocol. All such work shall be conducted per the directives and instructions listed below:

A. Department of Defense, Title 32, Code of Federal Regulations, Part 219 (32 CFR 219), ”Protection of Human Subjects” July 2004

B. DHHS Regulations, Title 45, Code of Federal Regulations, Part 46 (45 CFR 46) “Protection of Human Subjects,” October 2004

C. DoD Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research,” 25 March 2002

D. Air Force Instruction 40-402, “Protection of Human Subjects in Biomedical and Behavioral Research, (Sep 2000);” and (v) AFRL Instruction 40-402, “Using Human Subjects in Research, Development, Test, and Evaluation” (Feb 1999)

E. AFRL Instruction 40-402, “Using Human Subjects in Research, Development, Test and Evaluation” (Feb 1999)

Human testing shall not commence until approval by the 711 HPW IRB has been obtained.

2. Animal Use Research Protocols Development & Approval. USAF animal use research plays a critical role in advancing the safety, health, and operational effectiveness of USAF personnel by providing valuable insights that cannot be obtained through other means. It requires specialized skills and expertise to ensure ethical, accurate, and scientifically valid outcomes. The use of animal subjects in USAF-funded research is subject to humane practices, rigorous methodology, adherence to regulatory standards, and follows the reduce, refine, and replace philosophy. Hence, the Contractor shall assist in the preparation of animal use research protocols which shall be prepared well in advance of need, to allow time for review/approval by the Tri-Service Research Laboratory Institutional Animal Care and Use Committee (IACUC). The Contractor shall maintain records associated with animal subject research as required by the approved protocol. All such work shall be conducted per the directives and instructions listed below:

A. PHS Policy on Humane Care and Use of Laboratory Animals (10/00)

B. Federal Animal Welfare Act. Public Law 89-544, 1966 as amended, and its implementing regulations

C. Guide for the Care and Use of Laboratory Animals. National Research Council, published by the Academy Press, revised 2011, or succeeding editions

D. DoD Directive 3216.01, Use of Laboratory Animals in DoD Programs, dated 20 March

E. DHA-MSR 6025.02/AR 40–33/SECNAVINST 3900.38C/AFMAN 40-401(I), The Care and Use of Animals in DoD Research, Development, Test, and Evaluation (RDT&E) or Training Programs, 01 September 2022

F. AFR 169-2, Use of Animals in DoD Programs, and AFRL Sup 1, dated 1 June 1984

G. Branch Operating Instruction 61-29, Herpes B-virus (Herpes simian) Guidelines

Animal testing shall not commence until approval by the Tri-Service Research Laboratory (TSRL) IACUC has been obtained.

3. 711 HPW Biosafety Program: All research under this program shall conform to the applicable biosafety policies, regulations and guidelines and follow the 711 HPW Operating Instruction

90-800 which establishes the biosafety requirements to use, handle, transport, transfer, store, or dispose of infectious agents and toxins (IAT), recombinant and synthetic nucleic acids, blood, and other potentially infectious materials (OPIM) and establishes the Institutional

Biosafety Committee (IBC) as the reviewing and oversight body of the biosafety program. The

Contractor shall assist in the preparation of IBC research protocols which shall be prepared well in advance of need, to allow time for review/approval by the 711 HPW IBC. All such work shall be conducted per the directives and instructions listed below:

A. US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, dated 24 September 2015

B. 711 HPW OI 90-800, 711 HPW Biosafety Program, dated 15 March 2022

C. 711 HPW PAM 90-800, Biosafety Manual, dated 15 November 2022

D. DoD Manual 6055.18, Safety Standards for Microbiological and Biomedical Laboratories, dated 11 August 2020

E. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), dated April 2024

F. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, 6th edition, Revised June 2020

G. NSF/ANSI 49-2018, Biosafety Cabinetry: Design, Construction, Performance and Field Certification, Dated 05 March 2018

H. USDA, Containment Guidelines for Nonindigenous, Phytophagous Arthropods and Their Parasitoids and Predators, Dated 2002

Research activities under the purview of the Biosafety Program and IBC shall not commence until approval by the 711 HPW IBC has been obtained.

4. Standards: The Contractor shall contribute to developing safety standards as a participant in national and international technical working groups. The work shall include the development of safety analysis and measurement procedures. Safety standard documents shall be reviewed for accuracy. Example analyses shall be developed for inclusion in standards. Peer-reviewed papers summarizing new methods and research findings shall be authored for publication in support of new safety standard issues. The Contractor shall also contribute to DE safety training and lecture activities through the procurement and development of training materials such as safety standards and briefings.

5. Base Support: The Government may provide laboratory space and all necessary equipment for completion of the technical effort. Desk space to accommodate personnel shall be provided to complete necessary planning and analysis and writing of technical reports to fulfill objectives of the effort. The Government, as a part of its Base support, shall include office workspace equipped with appropriate computer system(s) and software, facsimile machine, and telephone equipment. The Contractor shall obtain a Common Access Card (CAC) to access to the Department of Defense computer networks and systems.

6. Training: The Contractor shall ensure all employees complete Environmental Health and Safety and Security training; as well as other special training to include Hazardous Materials controls, Laser Safety training, Organizational Conflict of Interest (OCI) training, CITI training for Protection of Human Subjects, Export Control, and 711 HPW Biosafety Program training.

7. Deliverables: For each functional area, the Contractor shall be responsible for generating deliverables as defined in the overall contract data requirements list (CDRL) and specific data item descriptions; examples of deliverables include but are not limited to journal publications, technical reports, oral presentations, posters, software, and hardware. These deliverables may be developed for a broad and varied audience, including stakeholders in the DoD, source developers, safety standard committees, industry, and academia.

A. Data: It shall be the responsibility of the Contractor through the Program Manager and Subtask Leader to meet all reporting and documentation requirements of the BRDEE contract. Reporting shall, at a minimum, include delivery of a monthly status report, and a monthly financial report highlighting financial activity to the subtask level. Quarterly summary data shall also be provided via a quarterly status report summarizing technical activity and via a quarterly Contract Funds Status Report. In addition, there are a number of data items that shall be required on an “as required” basis such as Scientific and Technical Reports, to document a final report; and Technical Report-Study/Services to document research results on subtask (projects) in either AFRL Technical Report or

Scientific Journal Article format; and to document hardware and/or software developed as part of this research. Slides for the annual Program Management Review on the overall contract shall be delivered per presentation material.

B. Hardware: Hardware that has been developed as a part of this program shall be delivered to the Government at the end of the contract period, or earlier if desired by the Government. The Contractor shall prepare such hardware items for delivery to the Government and shall prepare the appropriate data as specified in the contract CDRL.

C. Software: The Contractor shall deliver executable software and source code developed under this contract along with approved documentation at the end of the contract period, or earlier if desired by the Government. The Contractor shall prepare such software items for delivery to the Government and shall prepare the appropriate data as specified in the contract CDRL.

8. Security

A. Individual Clearances. Upon receipt of a final DD Form 254, the Contractor shall obtain a U.S. security clearance at the minimum level of Secret for all contractor personnel required to have access to classified information and/or require IT-II or IT-I level access.

Onsite contractor personnel should have an active clearance prior to reporting for duty in support of any contract. Interim clearances for newly hired personnel shall be processed as expeditiously as possible since some contractor personnel will be required to utilize the SIPRNET to process classified materials; however, this will be on a case-by-case basis.

Such clearance must be obtained through the Defense Investigative Services. As required, for the performance of the contract the Contractor shall ensure those contractors requiring access to TS/SCI, and/or the individual contractor requires access to JWICS, have the required, favorably adjudicated TS investigation and have been granted TS eligibility. Host unit will be responsible for submission of upgrade to SCI eligibility, if required. The Contractor shall ensure that employees meet the personnel security clearance requirements of the National Industrial Security Program (NISPOM), Chapter 2, Section 2. The Contractor shall provide current listing of employees prior to the start of the contract and immediately upon any updates to an employee's status or information change. The list shall include employee's name, social security number, and level of security clearance for all contractors performing work at 711 HPW/RHD, Fort Sam Houston, TX. The Contractors Facility Security Officer (FSO) shall validate the list and provide to the Sponsoring Agency's Unit Security Manger via a Visit Request submitted in DISS. The 711 HPW, Fort Sam Houston SMO Code is: JBSA-FSHPW.

B. Information Security and Force Protection. The contractor shall comply with the Information Security and Force Protection requirements as defined by DoDM 5200.01 Vol 1-3 (DoD Information Security), AFMAN16-1404 (Information Security Program Management), and DoDI 2000.16 V-1, AFI 10-245-O (AT Program Implementation).

Contractors performing work at 711 HPW/RHD, Fort Sam Houston, TX shall participate in the 711 HPW sustained Information Security and Force Protection/Anti-terrorism training program as provided/required by the 711 HPW/RHD Security Managers and Unit Antiterrorism Representative (UATR). The 711 HPW/RHD Training Manager will evaluate the training posture of USAF contract activities and operations. Participation in the unit’s Information Security program will include compliance with the unit’s established in and out processing requirements. This requirement is set forth in the guidance above and applicable Air Force Materiel Command (AFMC), AFRL, and local supplements.

C. Operations Security (OPSEC). The contractor shall provide OPSEC protection for all sensitive/critical information as defined by AFI 10-701 (Operations Security), the TSRL OPSEC Plan, and critical information list. The contractor shall participate in the 711 HPW/RHD sustained OPSEC awareness training program as part of their on-going security education and training. The 711 HPW/RHD OPSEC coordinator will evaluate the OPSEC posture of USAF contract activities and operations.

D. Access Credentials. Contractors performing work at 711 HPW/RHD, Fort Sam Houston, TX will be issued facility access credentials upon in-processing. Contractors are required to display the access credentials when inside of the facility and immediately remove the credential upon departure from the facility. The contractors will be provided a unique PIN which is not to be shared with any other individual. Contractors are required to notify the 711 HPW/RHD Security Managers immediately in the event the access credential is lost or stolen. The Contractor shall obtain the pass and identification items required for contract performance. The Contractor shall obtain base identification badges from the appropriate security office for each Contractor employee. The Contractor shall obtain all other required access badges, such as computer facilities access badges, computer access ID numbers and passwords from the Government.

E. Physical Security. Contractors performing work at 711 HPW/RHD, Fort Sam Houston, TX shall be responsible for safeguarding all government equipment, information, and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured. When authorized in writing by the unit of assignment unit commander, contractors may be authorized to open/close the facility. Specific facility opening/closing training will be provided by 711 HPW/RHD Security Managers. The Contractor shall comply with established security procedures. Security support requiring joint USAF and Contractor coordination includes, but is not limited to, packaging classified information, mailing and receiving classified materials, implementing emergency procedures for protection of classified information, security checks, and internal security controls for protection of classified material and high value pilferable property.

F. Contractor-Supplied Personal Electronic Devices (PED). Only validated contractor-supplied PEDs, which serve a justified mission requirement in support of this contract, will be considered and authorized by the appropriate Information Protection Office and/or Security Manager. All required contractor-supplied PEDs will be listed in the Statement of Work and identified in the Department of Defense Form 254, Department of Defense Contract Security Classification Specification, in Block 13. Device listing must include type, model, serial number, and justification for usage. Contractors utilizing contractor-supplied PEDs will be required to adhere to established usage policies and procedures to include being issued a property pass to carry contractor-supplied PEDs in and out of facilities in support of a USAF contract. Exception: Individuals issued a contractor-supplied fitness device must contact TSRL Security Managers prior to introducing the device into the secure areas of the facility.

G. Security Agreement for Integrated Visitor Groups. The contractor shall provide acknowledgement of receipt for a local specific Contractor Security Agreement to protect classified information involved in performance under this contract. The agreement will outline responsibilities to include the following areas: Contractor security supervision;

standard practice procedures; access, accountability, storage, and transmission of classified material; marking requirements; security education; personnel security clearances; reports; security checks; security guidance; emergency protection; protection of government resources; DD Form 254’s; periodic security reviews; and other responsibilities, as required.

H. TEMPEST/INFOSEC/COMPUSEC. The Contractor shall implement TEMPEST, Communications Security, Information Security (INFOSEC), and Computer Security (COMPUSEC), measures IAW Government, host base, and assigned unit policies as required, to include participation in any/all training requirements for the above disciplines.

The Contractor shall safeguard Government property and controlled forms provided for contractor use. At the end of each work period and when authorized, the Contractor shall secure Government facilities, equipment, and materials.

I. Base Traffic Regulations. The Contractor shall comply with base regulations pertaining to the possession of weapons, firearms and ammunition, speed limits and use of cell phones while on the installation.

9. Associate Contractor Agreements:

A. The Contractor shall enter into Associate Contractor Agreements (ACA) for any portion of the contract requiring joint participation in the accomplishment of the Government’s requirement. The agreements shall include the basis for sharing information, data, technical knowledge, expertise, and/or resources essential to the integration of the Radio Frequency Bioeffects and Safety, which shall ensure the greatest degree of cooperation for the development of the program to meet the terms of the contract.

B. ACAs shall include the following general information:

(a) Identify the associate Contractors and their relationships.

(b) Identify the program involved and the relevant Government contracts of the associate Contractors.

(c) Describe the associate Contractor interfaces by general subject matter.

(d) Specify the categories of information to be exchanged or support to be provided.

(e) Include the expiration date (or event) of the ACA.

(f) Identify potential conflicts between relevant Government contracts and the ACA;

include agreements on protection of proprietary data and restrictions on employees.

C. A copy of such agreement shall be provided to the Contracting Officer for review before execution of the document by the cooperating Contractors.

D. The Contractor is not relieved of any contract requirements or entitled to any adjustments to the contract terms because of a failure to resolve a disagreement with an associate Contractor.

E. Liability for the improper disclosure of any proprietary data contained in or referenced by any agreement shall rest with the parties to the agreement, and not the Government.

F. All costs associated with the agreements are included in the negotiated cost of this contract. Agreements may be amended as required by the Government during the performance of this contract.