FA8650-19-S-6005-Atch5.pdf

STATEMENT OF OBJECTIVES

OPTICAL RADIATION BIOEFFECTS AND SAFETY (ORBS) RESEARCH

(October 2018)

1.0 Scope: This SOO defines the work that shall be performed by the Contractor to support the 711 HPW/RHDO in a full range of research activities as described in BAA FA8650-19-S-6005: Optical Radiation Bioeffects and Safety. The Contractor shall conduct research on Directed Energy (DE) and Kinetic Energy (KE) systems to assist in transitioning DoD technologies. Research efforts shall include the following technical areas: Novel Laser Bioeffects, Nuclear Flash and Laser Eye Protection (LEP), and Modeling, Simulation, & Analysis. On-site government facilities at Tri-Service Research Laboratory, Joint Base San Antonio (JBSA), Fort Sam Houston, TX may be used, although work off-site may be required.

Optical radiation technologies (laser and broadband) are increasing in use by the USAF and DoD. Lasers are essential for range finding, precision delivery of munitions, target illumination when combined with night-vision goggle use, and are being developed for advanced applications such as missile defeat. Lasers can pose threats to missions or can enhance capabilities for security forces and special operations by visual jamming. To address risks to aircrews, the Contractor shall expand methods to: minimize injury to aircrews; establish occupational safety standards and flight tactics; define specifications for countermeasures; transition LEP; enhance safety at ranges; develop procedures for laser injury assessment; conduct research to determine appropriate technologies for non-lethal weapons (NLW) and scalable effects weapons (SEW) applications. USAF and joint service payoffs include validation of effectiveness of non-lethal optical technologies, safe use of ranges, compliance with SECDEF policy on laser weapons, data for Electronic Information Security processes, mission planning for laser threats, and LEP acceptable for combat operations. 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 and KE hazards, use and further refine computational physics models that integrate existing thermodynamics and electrodynamics methods to investigate the propagation and interaction of DE and KE to predict exposure thresholds, and develop models of behavioral response to DE and KE systems in relevant software architectures.

1.1 Introduction: The Contractor conducts a broad range of research and experimentation in three broad research areas: (a) Novel Laser Bioeffects, (b) Nuclear Flash and Laser Eye Protection, and (c) Modeling, Simulation, & Analysis. Offerors may propose on all of, any of, or a niche within these three broad research areas. In any of the instances where the research/experimentation described references any of various international agreements or entities, applicable export control statutes, to include requirements for licenses, apply.

1.1.1 Novel Laser Bioeffects:

1.1.1.1 Overview: The Contractor shall conduct Laser Bioeffects research and modeling to determine laser exposure thresholds, damage mechanisms, and laser-tissue interactions for given optical parameters; and shall determine the effectiveness of using optical exposures to produce any militarily relevant response in humans. The Contractor shall validate and recommend health and safety standard values for national and international implementation; and work with other government, contracted, academic, and civilian researchers to promote and expand biophotonics research and technology applications. In addition, the Contractor shall perform Vision Science research to assess the mission impact of bright light to humans; and develop advanced protection technologies, low-vision models and simulations, threat analysis systems, and special test equipment that measure advanced optical technologies and their countermeasures. The Contractor shall work with personnel in the intelligence, developmental, medical, training, and operational communities across DoD and other government agencies.

1.1.1.2 Technical Performance:

The Contractor’s technical performance shall include at a minimum the activities listed below:

a. Determine experimental laser exposure damage thresholds, damage mechanisms, and other laser-tissue interactions for given optical parameters,

b. Validate and recommend health and safety standard values for national and international consensus standard implementation,

c. Determine the effectiveness in using optical exposures to produce any militarily relevant response in humans,

d. Work with other government, contracted, academic, and civilian researchers to promote and expand biophotonics research and technology applications,

e. Develop experimental plans, test plans, operate and maintain numerous laser systems (including advanced continuous wave through pulsed femtosecond laser systems) and related test equipment,

f. Develop tissue and animal-use protocols following the process of reduction, refinement, and replacement,

g. Develop database(s) of laser exposure effects from scientific literature,

h. Develop advanced theoretical and computational models describing fundamental interactions of laser-tissue interactions to include propagation, thermal response, and damage mechanisms,

i. Perform research investigating fundamental visual mechanisms such as color vision, visual acuity, photostress recovery, and visual perception,

j. Conduct laboratory experiments and field studies that include applications of optical non-lethal weapons, examining overall effectiveness and safety,

k. Draft human use protocols investigating impact of lasers on human effectiveness, task performance, and personnel susceptibility and vulnerability to single and combined laser sources and threats,

l. Develop optical models predicting personnel susceptibility to optical glare sources,

m. Design, develop, and evaluate hardware to exploit personnel susceptibilities based on bioeffects modeling.

1.1.1.3 Conduct of Technical Effort:

1.1.1.3.1 Research and Development: The Contractor shall operate and maintain the laser systems required to accomplish the research objectives. The Contractor shall operate and maintain numerous laser systems to include: an existing wavelength-tunable high pulse power titanium-Sapphire laser, femtosecond laser systems, multiple high-energy continuous wave lasers, and tunable nanosecond optical parametric oscillators, etc. In coordination with the Integrated Product Team, the Contractor shall develop test plans and experiments using these lasers, to expand the knowledge of bioeffects specific to this frequency and pulse width domain. The Contractor shall assist in the development of Animal Use Protocols as required to support bioeffects research efforts involving tissue and animals. Requirements specific to animal use in research and in protocol development is discussed in paragraph 3.3.2 below. The Contractor shall develop a master database listing each animal used, including all related and relevant information derived from the experiment. The Contractor shall design experiments that shall maximize the potential to extrapolate results and data from animal subjects to humans. The Contractor shall develop advanced theoretical and computational models describing fundamental laser-tissue interactions to include propagation, thermal response, and damage mechanisms.

1.1.1.3.2 Laser Exposure Studies: The Contractor shall plan and conduct experiments to determine probabilities of ocular or skin damage and damage mechanisms from both acute and long-term chronic exposure to ultraviolet, visible, and infrared lasers. The experiments shall include both animal and human in-vivo, in-vitro and ex-vivo studies and the supporting computer modeling. The assessment shall include using advanced imaging techniques to determine mission impact through post-event evaluation of human subjects in support of RHDO and customer funded goals.

1.1.1.3.3 Human Susceptibility: The Contractor shall design experiments and develop experimental protocols (animal and human) to investigate the scope of militarily relevant responses to optical radiation. This research shall lead to assessment of the operational utility of laser weapons and devices in military scenarios. This research shall support operational assessments of laser weapon effectiveness. Software models and simulations shall be developed, tested, and validated as appropriate by the Contractor to address specific RHDO or outside customer needs.

1.1.1.3.4 Safety Standards: The Contractor shall incorporate the findings from advanced laser-tissue interaction research, including damage thresholds and mechanisms, into recommendations for health and safety standards. These data and findings should be validated and prepared for implementation in national and international safety standards.

1.1.1.3.5 Biophotonics Research: The Contractor shall develop a plan for advancing the state-of-the-art research and development in biophotonics and its technology applications. The Contractor shall engage and work with researchers in academia, in Government, and in corporate or other civilian entities to promote and expand this area of research.

1.1.1.3.6 Export of Technical Data (UK): The Contractor shall have technical interactions with, and disclose technical data to, UK MoD personnel in the US and in the UK in order to complete the required tasks. This includes tasks pursuant to multiple AF US-UK International Agreements. Also, the Contractor shall make trips to the UK and perform research activities in support of US and host-nation national defense priorities to include exchange of technical data with non-US citizens.

1.1.1.3.7 Export of Technical Data (CANADA): The Contractor shall have technical interactions with, and disclose technical data to, Department of National Defense of Canada personnel in the USA and Canada in order to complete the required tasks. This includes tasks pursuant to the Master Data Exchange Arrangement between the United States Department of Defense (US DoD) and the Department of National Defense of Canada (CA DND), signed 10 April 1984; and specifically Data Exchange Annex updated to include work in laser bioeffects and laser protection.

Also, the Contractor shall make trips to Canada and perform research activities in support of US and host-nation national defense priorities to include exchange of technical data with non-US citizens.

1.1.1.3.8 Export of Technical Data (INDIA): The Contractor shall have technical interactions with, and disclose technical data to personnel from the Defence Institute of Physiology and Applied Science in New Delhi, India and their assigned representatives in the USA and India in order to complete the required tasks. This includes tasks pursuant to the Project Agreement entitled “Bioeffects of Laser and High-Power Microwave Sources” between the United States Department of Defense and the Defence Institute of Physiology and Allied Sciences signed on April 11, 2017.

Also, the Contractor shall make trips to India and perform research activities in support of US and host-nation national defense priorities to include exchange of technical data with non-US citizens.

1.1.1.3.9 Cell Culture Bioeffects and International Basic Research Collaborations: The Contractor shall support international basic research collaborations in the area of cell culture laser (optical radiation) bioeffects with non-US universities, and other non-US entities identified by RHDO and other government research organizations such as the Air Force Office of Scientific Research (AFOSR). The research and collaboration shall cover only open source, non-military application based laser safety research, investigating basic damage thresholds and mechanisms in cultured cell models using lasers of various wavelengths, exposure durations, and power levels. Specific collaborators shall include the researchers at Luebeck University and the Medical Laser Center Luebeck GmbH, in Luebeck, Germany. Other non-US organizations shall be added as appropriate when identified later in the program. Also, the Contractor shall make international trips to support these efforts; no-export controlled technical data shall be provided.

1.1.2 Nuclear Flash and Laser Eye Protection:

1.1.2.1 Overview: The Contractor shall design, develop, and test LEP to counter emerging directed energy weapons with developing technologies for agile wavelength threats. The Contractor shall employ techniques including rapid-prototyping and computer modeling of current protective systems, multiple aircrew helmets, oxygen masks, head forms and more; and shall create databases including life support equipment in order to determine parameters for future designs of laser/broadband. The Contractor shall develop a vulnerability model using computer modeling techniques, enabling future validation of newly designed protective systems. The Contractor shall perform field studies to validate laboratory data in order to provide high-quality protective equipment to the war-fighter. The contractor support shall include research and design of demonstration eyewear, tests of eyewear optical quality and physical properties, and laboratory psychophysical vision tests with human subjects to assess the human performance impacts of these eyewear. The Contractor shall perform simulator, ground, and flight tests of the laser eye protection devices, investigate vision enhancement eyewear, and develop new methods to assess operational effectiveness, develop 3D eyewear models, new eyewear designs, and perform on-site prototyping of LEP devices.

1.1.2.2 Technical Performance:

The Contractor’s technical performance shall include at a minimum the activities listed below:

a. Research, characterize, and evaluate protection (including eye protection) to counter emerging directed energy weapons, laser systems with advanced technologies for agile laser wavelengths, and nuclear flash.

b. Develop techniques for rapid-prototyping and computer modeling of current protective systems, multiple aircrew helmets, oxygen masks, head forms and other life support equipment.

c. Creation of databases including life support equipment in order to determine parameters for future designs of nuclear flash and laser eye protection.

d. Develop a vulnerability model using computer modeling techniques; enabling future validation of newly designed protective systems.

e. Perform field studies to validate laboratory data in order to provide high-quality protective equipment to the war-fighter.

1.1.2.3 Conduct of Technical Effort:

1.1.2.3.1 Research and Development: The Contractor shall undertake a research program to develop and evaluate parameters for protection (including eye protection) to counter emerging directed energy weapons, laser systems with advanced technologies for agile laser wavelengths, and nuclear flash. Test methodologies and laboratory equipment shall be developed to evaluate the performance of developmental protection devices (primarily eye protection). The Contractor shall design laboratory experiments, including those requiring human use, to determine the visual effects of these developmental devices on human performance. Any experiments that require human protocols shall observe the requirements of AFI 40-402 and all other regulations and guidelines on the protection of human subjects. The Contractor shall conduct research leading to the capability of computer modeling and rapid prototyping of life-support equipment. Contractor modeling activities shall also be employed to develop vulnerability models capable of establishing the protection requirements and the performance impact of newly designed protective systems.

1.1.2.3.2 Field Studies: The Contractor shall conduct field evaluations and studies of eye protection devices to validate laboratory and computer model results. Performance evaluations shall be conducted on a non-interference basis under realistic operational conditions to include weapon system trainers, operational aircraft, and other battlefield training situations. The Contractor shall determine, through field experimentation, the human factors and systems compatibility issues between developmental eye protection systems and the aircraft and other operational systems in which the users must function. Human use experimental protocols shall be developed as necessary for the field testing.

1.1.2.3.3 Database Development and Modeling: The Contractor shall extend the scientific and engineering databases to enhance capabilities to measure and assess protective measures. These databases include optical properties and physical properties of the protective systems up to and including all necessary parametric data on life support protective equipment. This database also includes performance factors so that it can become a basis for detailed predictive models of human performance under various operational conditions, with and without the protective systems.

1.1.2.3.4 Export of Technical Data (UK): The Contractor shall be required to have technical interactions with, and disclose technical data to, UK MoD personnel in order to complete the required tasks. This includes tasks pursuant to the US-UK International Agreement (TRDP-MOU- PA), and in particularly, those tasks outlined in Section V titled, Sharing of Tasks. Also, the Contractor shall be required to make trips to the UK and perform research activities in support of US and host-nation national defense priorities to include exchange of technical data with non-US citizens.

1.1.2.3.5 Export of Technical Data (CANADA): The Contractor shall be required to have technical interactions with, and disclose technical data to, Department of National Defense of Canada personnel in the USA and Canada in order to complete the required tasks. This includes tasks pursuant to the Master Data Exchange Arrangement between the United States Department of Defense (US DoD) and the Department of National Defense of Canada (CA DND), signed 10 April 1984; and specifically Data Exchange Annex NO. DEAAF-CA-2013-7104. Also, the Contractor shall be required to make trips to Canada and perform research activities in support of US and host-nation national defense priorities to include exchange of technical data with non-US citizens.

1.1.3 Modeling, Simulation & Analysis:

1.1.3.1 Overview: The Contractor shall advance the state of the art in modeling, simulation, and analysis tools. This shall include the development of safety analysis tools which are capable of predicting DE and KE hazards in multiple simulation environments. This development shall include deterministic high-energy laser (HEL) range safety, based on the ANSI Z136 standard, as well as probabilistic risk methods delineating severity and probability of hazard. The Contractor shall also perform research on the propagation and interaction of DE and KE to predict exposure thresholds through computational physics models that integrate existing thermodynamics and electrodynamics methods. The Contractor shall also develop models of behavioral response to DE and KE systems in relevant software architectures.

The Contractor shall develop and deliver a software development plan for mature software models prior to implementation. This plan should include traceability of system goals, key functional features, critical stakeholders, system architecture design, and a test plan for verifying correctness of functional capabilities, to include potential verification and validation of the software. The architecture must be at a level of detail sufficient to show functional flow and identify data interface requirements between system functional components. This plan must enable planning for future modification of the system and include justification for design decisions.

Each of the above modeling, simulation, and analysis tools may fall into one or more of the three modeling levels, Physics, Engineering, and Mission. These categories define a specific scope of fidelity and intended use of the system, as detailed below.

1.1.3.1.1 Physics-Level Modeling: Physics-level modeling includes the development of first principle theories, and computational approaches which describe laser-tissue interactions, laser-material interactions, molecular dynamics, cell membrane dynamics, and the evaluation of physiological response factors. It includes prototyping through common numerical analysis tools and implementations in both higher-level languages and languages optimized for high-performance computing (HPC) architectures. These high-fidelity numerical models integrate the latest data available on dynamic tissue properties and interaction modes to produce a multi-physics level model of tissue response to DE or KE exposure. These numerical models can be computationally expensive and typically run on a HPC system, using automation and experimental design tools for large numbers of parametric runs and optimization of specific outcomes. Analysis is a component of this modeling, requiring the creation of customized data analysis and synthesis for outputs from very large data sets.

1.1.3.1.2 Engineering-Level Integration of Models: Engineering-level models include the encapsulation of near-real-time algorithms in standard C++ and other common production code languages. This shall include the translation of codes from a variety of individual prototypes into standard production code languages. The activities require the skills for integration of models from a variety of environments (Linux, MS Windows, etc.) and the ability to re-write complex mathematical representations in standard production languages. Specific engineering-level modeling efforts include research and characterization of HEL effectiveness by developing new laser safety procedures and safety analysis tools to predict and analyze hazardous zones for HEL and (potentially) kinetic systems. The engineering-level simulation codes also include the implementation of radiometric principals from light propagation and scatter, to estimates of dosimetry. These types of models include range safety tools and engagement analysis tools (e.g.

IWEA), and are run as desktop applications.

1.1.3.1.3 Mission-Level Models: Mission-level modeling includes integrating component-level engineering level models into various simulation architectures (e.g. AFSIM, Endgame Framework, DIS environments, etc.) for mission-level assessment of the effects of lasers and broad-band light on the battlefield. These architectures focus on many-versus-many engagement scenarios. This type of modeling may include DE/KE hazard model integration into operator-in-the-loop battle management systems. These types of tools may be desktop applications, or applications that run in a distributed environment.

1.1.3.1.4 Analysis Efforts Making Use of Modeling Tools: On-going analysis efforts making use of modeling, simulation, and analysis tools in one or more of the three modeling levels include:

1.1.3.1.4.1 Optical Radiation Safety: The Contractor shall provide analysis in coordination with the 711 HPW/RHDO Optical Radiation Safety team to certify the safe use of optical systems on test and training ranges throughout the Air Force. The Contractor shall develop, mature, validate, and apply modeling software and analysis to perform laser hazard evaluations that are used by policy-making bodies to formulate safety recommendations based on current ANSI standards (ANSI Z 136.1), AF regulations (AFI 48-139), and ACGIH policy, and shall develop and maintain the research information database, analyze the contents of the database, and develop methods of improving the efficiency of responding to information requests.

1.1.3.1.4.2 NLW/SEW Evaluations. The Contractor shall conduct research to determine appropriate technologies for NLW and SEW applications. The Contractor shall conduct and document efforts involving human effects analyses on candidate NLW and SEW systems, and risk assessments on candidate systems. The Contractors shall develop and or modify models to characterize the physiological and psychological effects of NLW and SEW payloads, and support field test planning and data interpretation for NLW and SEW systems.

1.1.3.2 Technical Performance:

The Contractor’s technical performance shall include at a minimum the activities listed below:

a. Conduct research in the verification, validation, or accreditation of modeling and simulation which assesses safety of military lasers and their use,

b. Conduct research in the development of new laser safety procedures and safety analysis tools to predict and analyze hazardous and injurious zones for high-energy laser systems,

c. Develop and validate a HEL range safety software tool based on the ANSI Z136 standard, probabilistic risk methodologies, and dose-response models of injuries, to be used by range safety officers as well as mission planners for HEL development, test, and training programs,

d. Conduct research in the instrumentation of outdoor range tests for the purpose of assessing collateral hazards associated with the use of these HEL Initiative Systems. Develop test plans and safety plans for tests,

e. Develop and validate probabilistic models of radiometric distributions, exposure, and potential injury from laser exposures,

f. Predict exposure thresholds through computational physics models that integrate existing thermo, acoustic, fluid, and electrodynamics methods,

g. Develop first principle theories and computational models which describe laser-tissue interactions and mechanisms of damage,

h. Simulate experimental findings using theoretical models in order to demonstrate biophysical understanding,

i. Integrate incremental updates to existing code when applicable,

j. Create core components of analysis tools using parallel environment for codes, languages should include MATLAB, FORTRAN, C, C++, and Python in a Linux High-Performance Computing environment,

k. Transition through integration of new analysis models and tools to customer platforms such as AFSIM and Endgame Framework,

l. Validate standards through biological response provided through experimentation and simulations using parametric analysis,

m. Integration of first-principle models through construction of empirical representations,

n. Build analysis tools based upon laser-bioeffect simulations,

o. Develop software products which assess laser and optical radiation hazards,

p. Provide research insight into High Energy Laser technology from the standpoint of measures of suitability from the perspective of potential collateral damage,

q. Maintain and administer in-house high-performance computing resources running the Linux operating system used for this effort.

1.1.3.3 Conduct of Technical Effort:

1.1.3.3.1 Research and Development – Laboratory and Field Studies: The Contractor shall operate and maintain the laser systems required to accomplish the research objectives. In coordination with the IRT, the Contractor shall develop test plans and experiments to expand the knowledge of HEL bioeffects and material property changes due to HEL exposure. The Contractor shall assist in the development of Human and/or Animal Use Protocols as required to support bioeffects research efforts involving tissue and animals. Requirements specific to human and animal use in research and in protocol development are discussed in paragraph 3.3 below. The Contractor shall use experimental material property laboratory test results to develop new laser safety procedures and safety analysis tools to predict and analyze hazardous and injurious zones for high-energy laser systems, including continuing the development and validation of a HEL range safety software tool based on the ANSI Z136 standard, risk-based models of exposure, and injury dose-response approaches, to be used by range safety officers as well as mission planners for HEL development, test, and training programs. The contractor shall also provide research and analysis which inform policy decisions with laser safety and laser hazard analysis, to include providing support in the instrumentation of outdoor range tests.

1.1.3.3.2 Research and Development – Modeling of Optical Radiation Propagation and Interaction: The contractor shall develop first principle theories and computational models from laboratory and field tests which describe laser-tissue interactions, and simulate experimental findings using theoretical models in order to demonstrate biophysical understanding, and integrate incremental updates to existing code when applicable. The Contractor shall automate the use of these analytical models to create, validate, and run physics models and simulations to predict exposure thresholds that integrate existing thermodynamics, hydrodynamics, and electrodynamics methods. The Contractor shall transition new analysis tools and software that are developed and validated to customer platforms when possible. The core components of analysis tools shall be created using standard C++ conventions.

1.1.3.3.3 Assessments for Procurement: The Contractor shall conduct analysis to inform policy decisions involving procurement of HEL systems. The Contractor shall provide the staffing capability to work with range officials in the instrumentation of outdoor test ranges for the purpose of characterizing and estimating collateral hazards associated with HEL systems. The Contractor shall assist with test planning and safety plans and shall identify specific instruments needed to record incident laser radiation from direct and reflected modes.

1.1.3.3.4: Export of Technical Data (CANADA): The Contractor shall have technical interactions with, and disclose technical data to, Department of National Defense of Canada personnel in order to complete the required tasks. This includes tasks pursuant to the Master Data Exchange Arrangement between the United States Department of Defense (US DoD) and the Department of National Defense of Canada (CA DND), signed 10 April 1984; and specifically Data Exchange Annex NO. DEA-AF-CA-2013-7104. Also, the Contractor shall be required to make trips to Canada and perform research activities in support of US and host-nation national defense priorities to include exchange of technical data with non-US citizens.

2.0 References and Applicable Documents:

All documents are available for public release. Most are freely available at various web sites (e.g., static.e-publishing.af.mil, olaw.nih.gov, dtic.mil) or are available for purchase.

2.1 “PHS Policy on Humane Care and Use of Laboratory Animal”, 2015 Reprint;

2.2 “Federal Animal Welfare Act”, Public Law 89-544, 1966 as amended, and its implementing regulations;

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

2.4 DoDI 3216.01, “Use of Animals in DoD Programs”, October 2017;

2.5 AFMAN 40-401, “The Care and Use of Laboratory Animals in DoD Programs”, February 2005;

2.6 AFI 48-123, "Medical Examination and Standards”, November 2013;

2.7 AFI 48-139, "Laser and Optical Radiation Protection Program”, September 2014;

2.8 ANSI Zl36.1, “Safe Use of Lasers, Laser Institute of America”, 2014;

2.9 R.P. Green et al, "Medical Management of Combat Laser Eye Injuries";

2.10 DoD, Title 32, Code of Federal Regulations, Part 219 (32 CFR 219),”Protection of Human Subjects”, July 2006;

2.11 DHHS Regulations, Title 45, Code of Federal Regulations, Part 46 (45 CFR 46) “Protection of Human Subjects”, July 2009;

2.12 DoD Instruction 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research”, November 2011;

2.13 AFI 40-402, "Protection of Human Subjects and Adherence to Ethical Standards in Air Force Supported Research”, September 2014;

2.14 ANSI Z80.3, “Non-Prescription Sunglasses and Fashion Eyewear”, 2001;

2.15 AFI 48-123, “Medical Examinations and Medical Standards”, May 2001;

2.16 AFOSH 161-10, “Health Hazards Control for Laser Radiation”, February 1984;

2.17 ANSI Z136.4, “American National Recommended Practice for Laser Safety Measurements for Hazard Evaluations”, 2004;

2.18 ANSI Z136.6, “American National Standard for Safe Use of Lasers Outdoors”, 2015;

2.19 21 CFR Part 1040, “Performance Standards for Light Emitting Products”;

2.20 OSHA Publication B 8.1-7 "Guidelines for Laser Safety and Hazard Assessments";

2.21 FAA Order 7400.2E, Part 6, Chapter 28, “Outdoor Laser Operations”;

2.22 NATO STANAG 3606, “Evaluation and Control of Laser Hazards on Military Ranges”, October 2016;

2.23 MIL-HDBK-828A, “Laser Safety on Ranges and in Other Outdoor Areas”, December 1996;

2.24 MIL-STD-1425A, “Safety Design Requirements for Military Lasers and Associated Support Equipment”, August 1991;

2.25 DODI 6055.11, “Protection of DoD Personnel from Exposure to Radiofrequency Radiation and Military Exempt Lasers”, February 1995;

2.26 DOD RCC Document 316-98, “Laser Range Safety”;

2.27 AFI 13-212 V1, “Range Planning and Operations”, April 2015;

2.28 AFI 13-212 V2, “Range Construction and Maintenance”, April 2015;

2.29 AFI 13-212 V3, “Safe-Range Program Methodology”, April 2015;

2.30 USAFOEHL Report AL-TR-1991-0112, “Base-Level Management of Laser Radiation Protection Program”;

2.31 USAFOEHL Report 87-091 RCO III GLA, “Laser Range Evaluation Guide for Bioenvironmental Engineers”;

2.32 ANSI Z80-1, “Prescription Ophthalmic Lenses”, 2005;

2.33 ANSI Z87.1, “Occupational and Educational Personnel Eye and Face Protection Devices”, 2003.

3.0 Requirements:

3.0.1 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” (Oct 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);

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

3.0.2 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. All such work shall be conducted 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.

3.0.3 Approval for Animal and Human Testing. The contractor shall ensure no animal or human testing shall commence prior to gaining approval of the relevant Air Force protocol.

3.0.4 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 laser safety training and lecture activities through the procurement and development of training materials such as safety standards and briefings.

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

3.0.6 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, and Export Control training.

3.0.7 Deliverables:

3.0.7.1 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 Optical Radiation Bioeffects and Safety contract. Specific requirements shall be detailed in the overall Contract CDRL and specific Data Item Descriptions. 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 of Scientific Journal Article format; and to document hardware and/or software developed as a part of this research. Also, slides for the annual Program Management Review on the overall contract shall be delivered per Presentation Material.

3.0.7.2 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.

3.0.7.3 Software: The Contractor shall deliver executable software developed under this contract along with approved documentation at the end of the contract period, or earlier if desired by the Government.

3.0.8 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.

3.0.9 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 Optical Radiation Bioeffects and Safety, which shall ensure the greatest degree of cooperation for the development of the program to meet the terms of the contract. Associate contractors are listed in (h) below.

(b) 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.

(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.