Attachment_3_-_BAA-FA8650-19-S-6055_DD_254_(FOUO).pdf

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ADDENDUM TO DD FORM 254 (Block 10e (1)) SENSITIVE

COMPARTMENTED INFORMATION

(SCI) CLAUSES

Dec 2018

Contract #: Supporting SSO:

Company: Office Symbol:

Expiration Date: Address:

SCI COR/CM: Phone:

Office Symbol

Phone Number

1. Reference Block 14: This contract requires access to Sensitive Compartmented Information (SCI).

The following references (use current versions) are offered to provide the necessary guidance for physical, personnel, information, and information systems security measures and is part of the SCI security specifications for the contract:

National Security Act of 1947, as amended; Executive Order (EO) 12333, as amended; EO 13526;

EO 13549; EO 12829; EO 12968, as amended; 32 CFR Part 2001; 32 CFR Part 2003, 32 CFR Part 2004; and other applicable provisions of law; DoD Manual 5105.21, Volumes 1 -3; AFMAN 14- 304; AFMAN 14-401; 5220.22-M (NISPOM and Supplement); ICD 701, ICD 702, ICD 703, ICD 704/ICPGs 704.1. ICPG 704.2, ICPG 704.3, ICPG 704.4, ICD 710, DCID 6-06, as amended; ICD 705, ICS 705-1; ICD 503 and related NIST/CNSSI guidance for Risk Management Framework, and the ICD 503 Practitioner Manual; (this defines the RMF, Reciprocity, Roles & Responsibilities and each of the 6 steps of RMF), CNSS policies and instructions, as applicable; and the current AFMC SCI Management Guidance.

2. SCI will not be released to contractor employees without the specific release approval by the originator of the material as outlined in the governing directives and based on prior approval and certification of “need-to-know” by the SCI Contracting Officer’s Representative (COR) or Contract Monitor (CM), identified above.

3. Names of contractor personnel requiring access to SCI and justification for SCI positions will be submitted for coordination and action to the supporting SSO (above) after the COR/CM approval/concurrence. Upon receipt of written approval from the COR/CM, , the Facility Security Officer (FSO) and/or Contractor Special Security Officer (CSSO) may submit the necessary forms to Defense Security Service (DSS) for a Tier 5 investigation for those personnel nominated for SCI access in accordance with the National Industrial Security Program Operating Manual (NISPOM).

The CSSO and/or Special Security Representative (SSR) will monitor JPAS for status changes affecting adjudication and eligibility for personnel under their cognizance and notify the SSO when changes are noted.

4. This contract will require ______ SCI positions in order to fulfill contractual obligations incurred.

SCI access is subject to U.S. Government review and approval as outlined in the aforementioned SCI security guidance. Upon completion or cancellation of the contract, the SSO/CSSO will debrief all personnel not required for contract closeout and those positions will be disestablished.

5. The SSO/CSSO must restrict access to only those individuals who possess the necessary security clearance and who are actually providing services under the contract. Further dissemination to other contractors, sub-contractors, other government agencies, private individuals or organizations is prohibited unless authorized in writing by the releasing agency

6. SCI materials furnished in support of this contract remain the property of the DoD department or command that released it. Upon completion or cancellation of the contract, all SCI materials furnished will be returned to the direct custody of the originator of the materials or the COR.

7. Classified foreign intelligence materials must not be released to foreign nationals or immigrant aliens whether or not they are also consultants, US contractors, or employees of the contractor, regardless of the level of their security clearance, except with advanced written permission from the originator.

8. The CSSO must not reproduce classified foreign intelligence without advance approval of the releasing agency. If permission is granted, each copy will be controlled in the same manner as the original. The CSSO must not destroy any classified foreign intelligence without advance approval of the releasing agency.

9. Contractor personnel must maintain accountability for all intelligence (to include foreign intelligence) materials released to their custody.

10. Inquiries pertaining to classification guidance on SCI will be directed to the COR listed in para 2 above. SCI security management issues shall be directed to the supporting SSO, identified at the top of this document.

11. ________ An SCI Facility (SCIF) meeting the physical security requirements outlined in ICD 705 is required for this contracting effort. All SCI used for this contract shall be stored, handled, and maintained in an accredited SCIF, be it the local contractor SCIF or similarly SCI- accredited facilities used by the contractor. All places of performance will be identified in the DD 254 (Version dated April 2018) item 8 and locations in which SCI will be generated are listed below. If SCI access is for meeting, conferences, demonstrations, etc. ONLY check here:

a. Office Symbol and/or Company Name; Street Address, Bldg#, City State & Zip Code; SCIF ID Number(s); Name/Telephone Number of SSR or CSSO

**NOTE: CUA/JUA REQUIRED IF NON AFMC SCIF**

**DOCUMENT BECOMES U//FOUO WHEN BELOW SECTION IS FILLED IN. MARK DOCUMENT

ACCORDINGLY**

12. For contract work within an approved contractor facility, all SCI information systems will be accredited and authorized following the Risk Management Framework (RMF), IAW ICD 503 and the ICD 503 Practitioners Manual. All SCI systems will be accredited through the Designated Authorizing Official using the XACTA system. These are processed through the Command CISO at HQ AFMC/A2S to the 25th AF/A6S (AF Intelligence Community - AO). Other applicable policy as directed by DIA, ODNI, or HQ AFMC shall apply. This includes all electronic connectivity and electronic methods for storing and communicating within and outside the SCIF.

13. Other networks processing corporate unclassified, SIPRNET, or other collateral information will follow the cognizant authority policy requirements. Prior authorization by a cognizant authority must be obtained prior to operation. Non-AF SCI systems must be accredited by the designated authority and may require a CUA/JUA for operation in DIA facilities.

14. Reference Block 15: This contract requires access to SCI. If the contractor has established a SCIF, DIA and its designees are responsible for all inspections of the contractor SCIF and SCI security management for ensuring compliance related to SCI security regulations and policies. The supporting SSO maintains security cognizance for all SCI requirements on this contract. Inspections of the SCIF(s) will be conducted by the Intelligence Community accrediting agency who approved the SCIF or their delegated official. The Defense Security Service (DSS) is relieved of security oversight for SCI performance.

15. Visits. The contractor will submit the written request for SCI visit certifications through the

COR/CM for approval of the visit. The certification must arrive at their servicing SSO at least three working days prior to the visit.

16. This contract requires that the contractor requires courier authorization in order to transport classified materials between work locations. This authorization is based on duty location and distance and will be processed IAWDODM 5105.21 V1. Check here:

SCI requirements reviewed and approved by: Phone:

(SSO WPAFB)

Continuation Block

This contract will require: 2 required for this contracting effort All SCI used for this contract shall be stored handled and: U//FOUO

Text1: 711 HPW/RHD, 4141 Petroleum Drive, JBSA Fort Sam Houston 78234; SCIF ID: AF-08-066; SSR: Mr. Rodney T. McLeod, 711 HPW/OMT, (210) 539-7001, rodney.mcleod.4@us.af.mil

Text2:

Text6: TBD - solicitation phase

Text8: Leland Johnson

Text9: 711 HPW/RHDR

Text10: 210-539-7950

Check Box15: Off

Check Box16: Off

Text17: Tiffany Trivett

Text18: 713-3494

2019-02-14T10:04:58-0500

TRIVETT.TIFFANY.NICHOLE.1256000780

Text20: FOUO

Text21: FOUO

Text22: FOUO

Text7: TBD

Text13: 2450 D. Street, WPAFB OH 45433

Text14: 713-3482

Text23: FA8650-13-S-6368

Text24: FA8650-13-S-6368

Text12: 21 IS/INS

Text11: WPAFB

Text5: FA8650-13-S-6368

Section J, Attachment 1

STATEMENT OF OBJECTIVE

Bioeffects Research of Directed Energy Exposures

2 February 2019

I. Statement of Objective TITLE: Bioeffects Research of Directed Energy Exposures This task order effort will be performed on base at JBSA-Ft Sam Houston TX.

Period of Performance: 75 months, 72 months technical effort plus 3 months for Final Technical Report SECURITY CLASSIFICATION LEVEL: Top Secret/SCI/SAP/SAR

1. Background, Scope, Goals, Objectives, and Needs.

a. Background.

The Bioeffects Research of Directed Energy Exposures (BRDEE) contract supports the US Air Force, one of the largest developers and users of radio frequency (RF) and high power microwave (HPM) emitting devices in the world, which has been at the forefront of research on the biological effects of RF/HPM radiation for more than 30 years. The use of Directed Energy (DE) extends to military and commercial applications. While the targeted customers for this effort are primarily concerned with the use and application of RF/HPM radiation technologies, the joint services and others like the Department of Homeland Security along with commercial customers will likely benefit from the research conducted and discoveries made under this program.

Specifically, the BRDEE contract aids in the mission accomplishment of the Radio Frequency Bioeffects Branch (711 HPW/RHDR) part of the Bioeffects Division (711 HPW/RHD) to protect Air Force personnel from RF/HPM radiation hazards, while minimizing negative operational impact. This will be conducted as part of an extensive research program in the bioeffects and dosimetry of RF/HPM radiation.

Research results will be transitioned and transferred to national and international health and safety standards, which will be used by the Air Force Surgeon General for Occupational Health and Environmental Safety, as well as for data to support the rapid development and deployment of DE technologies. The advent of HPM and ultra-wide band for directed energy weapons (DEW) make this effort supporting 711 HPW/RHDR’s products and services ever more essential to national security.

This research effort is composed of many individual projects. On average we perform 5 small scale (3-6 months) and 2-3 large scale (12 month) projects per year.

b. Goals.

The goal of the Air Force Research Laboratory (AFRL) and this contract is to provide the USAF with the world's best RF/HPM radiation bioeffects research, model-driven science-based exposure standards and, applied knowledge allowing maximum safe exploitation of DE for the national defense. Using joint-service cooperation, this contract will help bring broad expertise, advocacy, and involvement in RF/HPM technologies.

c. Scope.

The Contractor shall conduct research on Directed Energy (DE) systems to assist in transitioning DoD technologies. Research efforts shall include the following technical areas: Biological Sciences; RF Directed Energy Bioeffects Applications; and RF/HPM Modeling, Simulation, & Analysis. On-site government facilities at Tri- Service Research Laboratory, Joint Base San Antonio (JBSA), Fort Sam Houston, TX may be used. Radio Frequency radiation technologies are ever increasing in use and power by the USAF and DoD. To address risks to airmen, the contractor shall expand methods to: minimize injury; establish occupational safety standards and tactics; define specifications for countermeasures; enhance safety; develop procedures for injury assessment; conduct research to determine appropriate technologies for non-lethal weapons (NLW) and scalable effects weapons (SEW) applications. The Contractor shall advance the state of the art in modeling, simulation, and analysis tools to include: the development of safety analysis tools capable of predicting DE hazards, use and further refine computational physics models that integrate existing thermodynamics and electrodynamics methods to investigate the propagation and interaction of DE to predict exposure thresholds, and develop models of behavioral response to DE systems in relevant software architectures.

d. Objectives.

This effort includes conducting research to identify the benefits, risks, and capabilities for a wide range of military RF/HPM radiation systems. This includes prediction and mitigation of the bio-effects of DE on personnel and mission performance and exploitation of the bio-effects of DE for DEW applications. Three technology areas; Biological Sciences, RF Directed Energy Bioeffects Applications, and RF/HPM Modeling and Simulation; and integrate both amongst themselves and with government researchers.

i. Biological Science: The biological sciences conduct proteomic, genomic, and metabolomic studies that identify critical biochemical or molecular changes following exposure to DE prior to or during mission operations that assists in the prediction of health degradation. The goal is to investigate basic mechanism(s) of interactions between biology and RF radiation (DC-THz); and to uncover previously unknown bioeffects of RF exposure that may provide a defensive or offensive capability to the Air Force. Conduct and design laboratory and field research and testing of the bioeffects of RF and DEW systems hardware and software Research Descriptions.

(1) Genomics. Analysis of cellular deoxyribonucleic acid (DNA), gene expression, and epigenetic regulation.

(a) Extraction and purification of cellular ribonucleic acid (RNA).

(b) Quantitation of total RNA by spectrophotometry.

(c) Quality control of total RNA by denaturing agarose gel electrophoresis.

(d) Analysis of data from gene expression arrays (Affymetrix).

(e) Evaluation of protein functions in signal transduction pathways.

(f) Quantitative real-time reverse-transcription polymerase chain reaction

(Roche, ABI), data analysis, and statistics.

(2) Proteomics. Analysis of protein profiles, levels, and modifications.

(a) Protein/peptide purification by high performance liquid chromatography (Waters).

(b) Extraction and purification of proteins from cell lysates.

(c) Quantitation of proteins by colorimetric assay and spectrophotometry.

(d) One-dimensional (1D) analysis of proteins by denaturing polyacrylamide gel electrophoresis (PAGE).

(i) Two-dimensional (2D) analysis of proteins by PAGE.

(ii) Immunoblot following 1D- or 2D-PAGE.

(iii) Staining of PAGE gels (fluorescent dye, silver stain) and scanning.

(iv) Computer-assisted quantitative comparison of 2D gels.

(v) Peptide preparation of protein extracts for mass spectrometry.

(vi) Mass spectrometry using protein separation by capillary column, nanospray (NSI)- or matrix assisted laser desorption (MALDI) ionization methods, and time-of-flight (TOF) mass analysis.

(vii) Computer-assisted mass spectrometric data analysis.

(3) Metabolomics. Analysis of small molecule metabolites.

(a) Analysis of metabolomic byproducts as indication of activity in cells

(4) Immunology. Analysis of immune cell functions, cytokine expression, innate and adaptive responses, cellular and humoral immunity.

(a) Immune cell culture and activation.

(b) Immune cell proteomics.

(c) Enzyme-linked immunosorbent assays.

(d) Fluorescent immunoassays.

(5) Cell culture. In vitro culturing of mammalian cells.

(a) Culturing of immune cells, fibroblasts, and keratinocytes.

(b) Cryo-preservation of cells.

(c) In situ assays for apoptosis, cell proliferation, and vital staining.

(d) Cellular transfection/genomic modification of cell cultures

(6) Animal subject research. Laboratory animal models are used for bioeffects research. Virtually all tissue types, body fluids, and breath are analyzed. All animal research is performed under approved protocols in accordance with federal and institutional requirements and is supervised by the veterinary branch 711 HPW/RHDV.

(a) Short-term husbandry, dietary planning and care.

(b) Experimental handling, including anesthesia and microwave exposure.

(c) Biopsy/necropsy, sample collection and preservation from all tissue types.

(d) Maintaining a breeding colony for transgenic rodent species

(7) Human subject research. Bioeffects are also determined with human research subjects. This type of research is performed under approved protocols in strict accordance with federal, military, and institutional requirements.

(a) Saliva collection by anonymous donation (designated "Exempt From Review" by the Institutional Review Board).

(b) Saliva proteomics and small molecule analysis.

(c) Blood biomarker analysis

(d) Sweat Analysis

(e) Body-worn biometrics/wearables

(8) Pathology. In collaboration with the veterinary branch 711 HPW/RHDV, the biological effects of microwave exposure are studied microscopically at the cellular and tissue levels.

(a) Histology with tissue sectioning and staining.

(b) Immunohistochemistry and immunofluorescence with tissue sections.

(c) Quantitative scoring of histological phenotypes.

(9) Bioinformatics. Overlapping with efforts in genomics, proteomics, and metabolomics, molecular bioeffects researchers also use bioinformatic methods.

(a) Computer-based data management.

(b) Sample statistics and probability testing.

(c) Analysis of Affymetrix gene chip data.

(d) Predictive modeling of cellular signal transduction, assessment of impact of bioeffects on body systems, and associating molecular function with physiological response and disease.

(e) Microwave exposure, biological modeling and simulations. At present, the prediction of biological effects of directed energy applications is limited by the relatively macroscopic nature of models. Recent advances in micro-dosimetry and the capacity to apply genomic and proteomic methods to single cell entities, now permit the development of more sophisticated model systems.

(f) Analysis of infrared and conventional thermometry data.

(g) Efforts to model microwave exposure at the tissue, cellular, and sub-cellular levels.

(10) Microscopy

(a) Use of fluorescent microscopy system

(b) Use of confocal fluorescent and nonlinear optical microscopy system

(c) Use of conventional microscopy system with cells and tissues

(d) Using TIRF microscope for imaging molecular response to RF

(e) Using custom-engineered microscopy systems at the molecular to tissue levels.

(11) Electrophysiology

(a) Application of fundamental cellular electrophysiology during RF exposures

(b) Analysis of ion channel activity during RF exposure

(c) Analysis of electrophysiological data obtained via patch clamp

(d) Tissue and organ level electrophysiology

(12) Animal Imaging

(a) IVIS imaging of small animal response to RF via luciferase and fluorescent imaging techniques

(b) MRI imaging of animal subjects

(c) CT scanning of animal subjects

(13) Behavioral analysis of animal physiological response to RF Experimental Dosimetry

(a) Advanced measurement of thermal and acoustic sources

(b) In Vivo measurement of heat/acoustic deposition

(c) Animal behavioral testing

(d) In vivo cell level dosimetry of RF exposures

ii. RF Directed Energy Bioeffects Applications: Conduct biological effects research to enable the development and deployment of future DE weapons and other emerging technologies that could be beneficial to the Air Force and the warfighter. To accomplish this goal, it is essential to discover and explore new technologies or new potential capabilities. Data obtained will be used to develop models and simulation tools. The research will also provide data to aid in the development of tactics, training, and procedures for the safe and optimal use of DE weapons. Research will provide data that evaluates and supports the DE system effectiveness, its policy acceptability, and optimal use. The research leads to a better understanding of the bioeffects of DE applications, as well as methods to counter the bioeffects produced by these technologies. This research is intended to characterize behavioral and physiological responses of individuals in response to high average power and high peak power directed energy systems.

Research Descriptions.

This effort shall include an integrated contractor and government teaming arrangement to accomplish various research studies, e.g., developing test plans and protocols, conducting tests, performing data collection and analysis, writing reports and research papers, developing integrated databases and developing models; procure subjects to participate in human research studies; and provide materials, equipment, and supplies to operate, modify, maintain, and develop specialized research capabilities. In addition, provide substantial value to the Air Force and scientific community by evaluating bioeffects of DE exposure. It is important to address the physical and cognitive health and safety concerns of DE systems. Data obtained from RF/HPM radiation bioeffects research is designed in this technical area to support national and international health and safety standards.

Tasks shall include, but not be limited to the following:

(1) Research Experimentation

(a) Perform laboratory and field testing on the bioeffects of DE systems;

conduct technology demonstrations, training, and evaluations of DE systems; provide scientific and technical expertise, directly related to research being conducted under this order.

(b) Develop and execute human use and animal research protocols required to investigate the biological research efforts to study the effects of DE systems. At the conclusion of the experiments, perform appropriate statistical analyses of the results and prepare a report suitable for publication in a peer-reviewed journal.

(c) The Contractor shall design experiments that shall maximize the potential to extrapolate results and data from animal subjects to humans.

(d) In coordination with the integrated team, the contractor shall develop test plans and experiments to expand the knowledge of bioeffects specific to this frequency and pulse width domain.

(e) Conduct research that increase the RF science community’s understanding of fundamental processes involved in RF exposure environments, including biological systems such as: cardiovascular, reproductive, immune, neurological, gastrointestinal, and endocrine.

(f) Support the research by developing and using RFR dosimetry, including mathematical models of animals and man, tissue dielectric values, and numerical methods (e.g., finite difference time domain)

(g) Perform laboratory research, using cells, isolated tissue preparations, and whole animals, and humans (e.g., use these preparations or subjects to determine rhabdomyolysis (breakdown of muscles, with release of substances into the circulation), acidosis, other blood changes such as hyperkalermia, and cardiac arrhythmias) and use appropriate histological methods to estimate the degree of damage.

(2) Health and Safety

(a) Integrate disciplines of physics, electronics, neuroscience, behavioral science, physiology, toxicology, and pharmacology to obtain findings.

Transition findings to support health and safety standards.

(b) Conduct research relating to standardization activity in the Transmitted Electromagnetic Radiation Protection Working Group (TERP). Standard procedures should ensure environmental safety and occupational health.

(c) Interface with Federal, DoD, national and international organizations;

participate in non-governmental standards organizations; coordinate standards interpretations and technical aspects of radio frequency activities supporting personnel health and safety; provide research to assist in preparing DoD draft positions on standards.

(d) Analyze bioeffects of direct-contact systems. Effects of rapid-rise-time, short-duration, high-voltage, low-current impulses on biochemical or physiological responses should be studied, as well as the efficacy and safety of devices.

(3) Measurements and execution

(a) Investigate state-of the-art high power microwave source for use in extending current RF bioeffects research capabilities.

(b) At the request of and close coordination with the government, develop test plans in compliance with Air Force policies to enable execution of demonstrations, training, and evaluation of DE weapons research being conducted.

(c) Provide screening, scheduling, and training of subjects in support of DE research. Provide opportunity for persons to serve as research subjects in various simulations and laboratory experiments.

(d) The Contractor shall operate and maintain numerous RF/HPM systems and support equipment that cover a wide range of frequencies from DC thru THz necessary for research applications.

(e) Perform routine scheduled maintenance of the research facilities, systems, and ancillary equipment. Also, maintain and calibrate associated instrumentation/equipment; and provide hardware and software modifications and upgrades to meet research objectives and goals.

(f) The contractor shall design, operate, and troubleshoot RF dosimetry systems. This includes but not limited to development of passive dosimetry of thermal and secondary effects (thermoelastic) of RF exposure require passive sensing mechanisms capable of withstanding high power RF insults.

(g) The contractor shall design and construct custom test fixtures and apparatuses that are non-interfering for use in RF fields.

iii. RF/HPM Modeling and Simulation: Conduct mathematical, statistical, and theoretical analyses necessary for the development of modeling and simulation products. These models will lead to capabilities that include predictive and decision-making software that allow futuristic views of the bioeffects from exposure to RF/HPM radiation.

Develop multi-physics and multi-resolution models of the biological effects of high average power (HAP) and high peak power (HPP) RF energy. These approaches should include, but are not limited to, molecular dynamics models, thermo-elastic expansion effect models, models of RF induced mechanical stress, and thermoregulatory response models. The spatial scale may range from the molecular and cellular levels, up to the tissue and whole organism levels.

Develop algorithms and models that predict the biological effects of exposure to RF/HPM energy. The development and execution of modeling and simulation of electrical current, DE weapons, and radar and communication effects aids in the understanding of effects on and within biological systems.

Create software that implements these models for use in guiding in-house research and for supporting safety reviews and establishing exposure guidelines for DE systems. Utilize models to estimate bioeffect thresholds for RF/HPM energy, and to study the trade-space of system effectiveness versus biological response or effect.

This Modeling and Simulation of RF Bioeffects effort shall develop models to predict the biological response of tissue to DE exposure, create software that implements these models, and utilize these models and software to estimate bioeffects.

Research Description.

Perform the following tasks related to the development and use of M&S approaches to predict the biological responses to DE exposure:

(1) Develop algorithms and models that predict the dosimetry within tissues, organs, or whole organisms resulting from exposure to RF, microwave, millimeter wave and terahertz energy. These algorithms and models may include analytical, heuristic, statistical or numerical approaches for predicting the amount and location of electromagnetic absorption within biological media.

(2) Develop models to predict the thermal response of tissue resulting from exposure to RF, microwave, millimeter wave and terahertz energy.

(3) Develop models to estimate the thermally induced bioeffects thresholds from exposure to RF, microwave, millimeter wave and terahertz energy.

(4) Develop and implement within software both numerical and analytical solutions to the Bio-Heat Equation. Where appropriate, couple these solutions to models of adverse thermal effect (e.g. Rate-process damage models).

(5) Utilize M&S software to investigate the appropriateness of existing RF exposure standards, and to recommend suitable threshold levels for military engagements.

(6) Create real-time distillations of numerical modeling approaches for integration within DoD/AF/AFRL engagement- and mission-level simulation packages.

(7) Stay apprised of branch and peer-reviewed research on the bioeffects of High Peak Power (HPP) electromagnetic exposures. For HPP exposures that lead to biological effects, the contractor shall develop predictive models of these bioeffects.

(8) Develop models to predict the energy levels vs. range for DE systems, and to compare these energy levels against RF exposure guidelines and bioeffect thresholds.

(9) Develop algorithms and models that predict the biological effects of novel DE exposure scenarios as such DE systems and capabilities are created.

(10) Develop research software that implements dosimetry, thermal response, propagation characteristics and bioeffects models to support branch projects and goals. This software shall be developed using C/C++ programming language, or a similar software language as deemed appropriate by the government M&S technical lead. Where necessary, the contractor shall extend the research software for use on a computer cluster using parallel processing approaches or for use on a Graphics Processing Unit (GPU) using either CUDA or OpenCL GPU language.

(11) Develop Graphical User Interface (GUI) based transition level software for the purpose of DE system analysis and mission decision support. The software shall be cross-platform compatible for both Windows and Linux computers.

(12) Support for the procurement, setup and maintenance of dedicated High Performance Computing (HPC) hardware.

(13) Provide validation studies for the developed modeling tools. These studies might include comparisons against RHDR laboratory research data, comparisons against peer-reviewed publications, or comparisons against other modeling and simulation approaches.

iv. Research Planning. To pursue relevant research objectives within mission requirements, the contractor shall designate a lead scientist to act as the intellectual center. The subtask leader shall coordinate and perform research within a specific subtask and work with a subset of team members having the appropriate expertise.

(1) Prior to the initiation of research, the subtask leader shall develop and deliver a subtask outline.

(2) The subtask outline shall exhibit the following structure, which essentially follows that of a scientific publication:

(a) Introduction - Literature review, rationale, and hypothesis.

(b) Materials and methods - A description of the major procedures and requirements.

(c) Results - The number and scope of experiments and anticipated outcomes.

(d) Discussion - Meaning and context of expected results.

(e) Bibliography - References for publications relevant for subtask research.

(f) Estimated manpower involvement and costs.

(g) Estimated material costs.

(h) Estimated schedule of performance.

v. Experimentation. To obtain the highest quality of data from research, each scientist is expected to do the following:

(1) Develop/adapt protocols from published sources, manufacturer brochures, and laboratory manuals.

(2) Approach pilot studies and large experiments with the same attention to detail, to assure that the experimental outcome, while not being predictable, will nevertheless be fully traceable to specific starting materials and a reproducible method of investigation.

(3) Perform experiments in a consistent manner, including appropriate controls and independent repetitions of assays to obtain statistically significant insights.

(4) Follow science documentation procedures as specified by government managers.

vi. Research Communications. Scientists involved at any level in molecular bioeffects research are expected to:

(1) Prepare abstracts, posters, platform talks for and present at scientific conferences.

(2) Prepare Technical Reports according to Air Force Science and Technology

Information Office (STINFO) requirements, documenting laboratory-specific research methods, procedures, or protocols.

(3) Publishing experimental results is an integral part of scientific investigation.

The results and conclusions of each subtask-specific research will be published within the period of subtask performance. All team members are expected to contribute their expertise and partake in the preparation of manuscripts; subtask leaders shall:

(4) Coordinate the synthesis of collected accomplishments, results, insights, and assessments of subtask research as framework for a manuscript.

(5) Prepare Technical Reports according to STINFO requirements to document the completion of subtask research in case classified data is involved.

(6) Prepare manuscripts for peer-review and publication according to the Instructions for Authors of an appropriate scientific journal, documenting the completion of a subtask which contains unclassified data.

(7) Coordinate drafting/revising and complete editing of reports/manuscripts within the IRT until they are ready for submission to STINFO or a scientific journal.

vii. Program Administration. The contractor shall be responsible for scheduling activities and milestones, describing resource status, outlining contractor activity and progress toward accomplishing objectives and making recommendations to research objectives, and program planning based on the research results, describing in detail the overall results of the effort, and documenting results in technical papers. The contractor shall designate a lead manager to be responsible for all contributions to the effort.

e. Needs.

This effort will provide the means to protect personnel from RF radiation exposure hazards, and assess weapons application of RF/HPM radiation, by meeting the military needs to push the state-of-the art in science. The contract effort will do so by evaluating the bioeffects of DE systems. All this will be accomplished while addressing the health and safety concerns of the Air Force. These outcomes will help to enable the maximum safe exploitation of the RF/HPM electromagnetic spectrum for national defense.

2. Deliverable Items.

A001 DI-MISC-80711A/T Scientific and Technical Reports (AKA – Final Report) A002 DI-FNCL-80331/T Funds and Man-Hour Expenditure Report A003 DI-MGMT-81468/T Contract Funds Status Report (AKA – Quarterly PMR) A004 DI-MGMT-80368/T Status Report (AKA – Monthly Performance Report)

A005 DI-ADMN-81373/T Presentation Material (AKA – Abstract/Presentation Material) A006 DI-IPSC-81443A/T Software User Manual (AKA –Contractor developed software) A007 DI-MISC-80508A/T Technical Report-Study/Services (AKA – Reports/Protocols) A008 DI-TMSS-80527A/T Commercial Off-The-Shelf Manual A009 DI-MISC-80711A/T Scientific and Technical Reports (AKA: Work Plans)

3. Requirements and Other Information.

a. Human Use Research Protocols; Development and Approval:

The Contractor shall prepare research protocols for all human use experiments.

These protocols shall be prepared well in advance of need to allow time for approval by the Air Force Institutional Review Board (IRB). The use of human subjects in Air Force-funded research is subject to rigorous standards and regulations. All such work shall be conducted in accordance with the directives and instructions listed below.

i. Department of Defense, Title 32, Code of Federal Regulations, Part 219 (32 CFR

219),”Protection of Human Subjects” July 2004;

ii. DHHS Regulations, Title 45, Code of Federal Regulations, Part 46 (45 CFR 46)

“Protection of Human Subjects,” October 2004;

iii. DoD Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical

Standards in DoD Supported Research,” 25 March 2002;

iv. 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).

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

Human testing shall not commence until approval from the Air Force IRB has been obtained.

b. Animal Use Research Protocols; Development and Approval:

The Contractor shall prepare research protocols for all animal use experiments.

These protocols shall be prepared well in advance of need to allow time for approval by the Air Force the Institutional Animal Care and Use Committee (IACUC). The use of animal subjects in Air Force-funded research is subject to rigorous standards and regulations. The contractor shall comply, as appropriate, in accordance with the directives and instructions listed below.

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

ii. Federal Animal Welfare Act. Public Law 89-544, 1966 as amended, and it’s implementing regulations;

iii. Guide for the Care and Use of Laboratory Animals. National Research Council, published by the Academy Press, revised 1996, or succeeding editions;

iv. DoD Directive 3216.1, Use of Laboratory Animals in DoD Programs, dated 17 April 1995;

v. AFJI 40-401, dated June 84, The Use of Animals in DoD Programs;

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

1984;

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

Moreover, the contractor shall maintain records associated with animal subjects research as required by the approved protocol.

Animal testing shall not commence until approval from the Air Force Institutional Animal Care and Use Committee has been obtained.

c. Standards: The Contractor shall support the development of 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 support USAF RF safety training and lecture activities through the procurement and development of training materials such as safety standards and briefings.

d. 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 require local access to the Department of Defense computer networks and systems and shall be issued a Common Access Card (CAC).

e. 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, and Export Control training.

f. Security: All Contractor personnel shall wear appropriate badges while in Government facilities to identify themselves as Contractors and provide name, company affiliation, and security clearance.

g. Associate Contractor Agreements:

i. 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.

ii. ACAs shall include the following general information:

(1) Identify the associate contractors and their relationships.

(2) Identify the program involved and the relevant Government contracts of the associate contractors.

(3) Describe the associate contractor interfaces by general subject matter.

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

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

(6) Identify potential conflicts between relevant Government contracts and the

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

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

iv. 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.

v. 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.

DRAFT

SAMPLE

PREVIOUS EDITION IS OBSOLETE.

Page of AEM LiveCycle Designer

DD FORM 254, APR 2018

NEEDS DD67

DEPARTMENT OF DEFENSE

CONTRACT SECURITY CLASSIFICATION SPECIFICATION

(The requirements of the National Industrial Security Program (NISP) apply to all security aspects of this effort involving classified information.)

OMB No. 0704-0567 OMB approval expires:

October 31, 2020 The public reporting burden for this collection of information, 0704-0567, is estimated to average 70 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to the Department of Defense, Washington Headquarters Services, at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number.

RETURN COMPLETED FORM AS DIRECTED IN THE INSTRUCTIONS.

1. CLEARANCE AND SAFEGUARDING

2. THIS SPECIFICATION IS FOR: (X and complete as applicable.)

3. THIS SPECIFICATION IS: (X and complete as applicable.)

a. ORIGINAL (Complete date in all cases.)

b. REVISED (Supersedes all previous specifications.)

4. IS THIS A FOLLOW-ON CONTRACT?

If yes, complete the following:

Classified material received or generated under

5. IS THIS A FINAL DD FORM 254?

If yes, complete the following:

6. CONTRACTOR (Include Commercial and Government Entity (CAGE) Code)

7. SUBCONTRACTOR(S) (Click button if you choose to add or list the subcontractors -- but will still require a separate DD Form 254 issued by a prime contractor to each subcontractor)

8. ACTUAL PERFORMANCE (Click button to add more locations.)

10. CONTRACTOR WILL REQUIRE ACCESS TO: (X all that apply. Provide details in Blocks 13 or 14 as set forth in the instructions.)

e. NATIONAL INTELLIGENCE INFORMATION:

11. IN PERFORMING THIS CONTRACT, THE CONTRACTOR WILL: (X all that apply. See instructions. Provide details in Blocks 13 or 14 as set forth in the instructions.)

12. PUBLIC RELEASE

Any information (classified or unclassified) pertaining to this contract shall not be released for public dissemination except as provided by the National Industrial Security Program Operating Manual (NISPOM) or unless it has been approved for public release by appropriate U.S. Government authority. Proposed public releases shall be submitted for review and approval prior to release to the appropriate government approval authority identified here with at least office and phone contact information and if available, an e-mail address. (See instructions)

13. SECURITY GUIDANCE

The security classification guidance for classified information needed for this effort is identified below. If any difficulty is encountered in applying this guidance or if any other contributing factor indicates a need for changes in this guidance, the contractor is authorized and encouraged to provide recommended changes; to challenge the guidance or the classification assigned to any information or material furnished or generated under this contract; and to submit any questions for interpretation of this guidance to the official identified below. Pending final decision, the information involved shall be handled and protected at the highest level of classification assigned or recommended.

(Fill in as appropriate for the classified effort. Attach, or forward under separate correspondence, any documents/guides/extracts referenced herein. The field will expand as text is added. When removing any expanded text area, use delete key or backspace key, then click out of the text field for it to shrink after the text has been deleted. Also allows for up to 6 internal reviewers to digitally sign. See instructions for additional guidance or use of the fillable PDF.)

14. ADDITIONAL SECURITY REQUIREMENTS

Requirements, in addition to NISPOM requirements for classified information, are established for this contract.

If Yes, identify the pertinent contractual clauses in the contract document itself, or provide an appropriate statement which identifies the additional requirements. Provide a copy of the requirements to the CSO. The field will expand as text is added or you can also use item 13. When removing any expanded text area, use delete key or backspace key, then click out of the text field for it to shrink after the text has been deleted. (See instructions for additional guidance or use of the fillable PDF.)

15. INSPECTIONS

Elements of this contract are outside the inspection responsibility of the CSO.

If Yes, explain and identify specific areas and government activity responsible for inspections. The field will expand as text is added or you can also use item 13. When removing any expanded text area, use delete key or backspace key, then click out of the text field for it to shrink after the text has been deleted. (See instructions for additional guidance or use of the fillable PDF.)

16. GOVERNMENT CONTRACTING ACTIVITY (GCA) AND POINT OF CONTACT (POC)

17. CERTIFICATION AND SIGNATURES

Security requirements stated herein are complete and adequate for safeguarding the classified information to be released or generated under this classified effort. All questions shall be referred to the official named below. Upon digitally signing Item 17h, no changes can be made as the form will be locked.

18. REQUIRED DISTRIBUTION BY THE CERTIFYING OFFICIAL

9.0.0.2.20120627.2.874785 DD 254, DoD Contract Security Classification Specification List of Attachments [2] (All Files Must be Attached Prior to Signing, i.e., for any digital signature on the form) Basic SOO - V8.pdf SCI ADDENDUM TO DD FORM 254-FA8650-19-S-6055.pdf

1777 NE Loop 410, Ste. 801 San Antonio, TX 78217

(210) 810-4495 dss.sanantoniofieldoffice@mail.mil

(See also Blk 13.)

Ref Blk 8a: Actual performance at 711 HPW/RHD, 4141 Petroleum Dr, JBSA Fort Sam Houston, TX 78235 and elsewhere as directed by the Program Manager including military installations and approved contractor-operated facilities.

Ref Blk l0e(l): SCI security requirements apply, see 21…