Attachment_6,_TO_0002_SOO_-_Human_Performance_Sensor_Development_and_Testing.pdf

STATEMENT OF OBJECTIVES

HUMAN PERFORMANCE SENSOR DEVELOPMENT AND TESTING

TASK ORDER 0002

1.0 BACKGROUND

A need exists for persistent assessment of health and performance of the warfighter.

This can be accomplished by means of biometrics and biomarkers that can provide continuous and non-invasive physiological monitoring. Biometrics are vital signs such as heart rate, electrocardiogram (ECG) waveform, respiration rate, blood pressure, blood oximetry.

Biomarkers are molecular targets present in biofluids (i.e., blood, saliva, urine, breath condensate and sweat and air samples (i.e., exhaled breath, body odor, and headspace gas) that can provide a more precise assessment of a multitude of physiological conditions.

2.0 OBJECTIVES

The objective is to research and develop biometric and biomarker technologies, such as physiological and performance monitoring using rapid to real-time biomarker analysis, for a variety of Air Force applications that include, but are not limited to, noninvasive Wearable/Wireless/Disposable (WWD) devices.

3.0 SCOPE

The Contractor will provide basic, applied and advanced technology development research, development and demonstration for understanding human performance sensor development and testing. Research performed in the following technical areas: Real-Time Molecular Sensors and Sensor Development & Testing. The overall goals and requirements are to research and develop in advanced development of biometric (vital sign) monitoring devices, platforms for point-of-use assays to quantify biofluid biomarkers, wearable technologies for semi-continuous biomarker monitoring in biofluids, wearable sensor technologies for continuous gas-phase biomarker monitoring, biosensor platforms. In addition to investigate force health protection and environmental medicine technology, biometrics and biomarkers for sensor design, human operational performance enhancement technology.

4.0 TASKS/TECHNICAL REQUIREMENTS

4.1 BIOMETRIC VITAL SIGN DEVICE DEVELOPMENT: The focus is to research and develop sensor performance, features or durability toward Air Force applications. Additional research will be performed between Contractor personnel and collaborators to transform such technologies to meet Air Force requirements when necessary. The Contractor will coordinate with the Air Force sponsor to ensure the AF goals are met.

4.2 WEARABLE BIOFLUID AND GAS-PHASE BIOMARKER MONITORING: The focus is to identify appropriate wearable biomarker monitoring technology, verify and validate the claimed attributes of such technologies, and advance the technologies into truly wearable devices that monitor gas-phase biomarkers of interest with temporal relevance. Teaming with collaborators may include but not limited to sampling, transportation, selective and semi-selective pre-processing, sensor development, sensor integration, flexible electronics, communications, and Android and/or personal computer (PC) software development.

4.3 BIOSENSOR PLATFORM DEVELOPMENT: The focus is to develop biosensor platforms, such as riboswitch-integrated cell-based sensors or synthetic biological circuits, to monitor human performance biomarkers. The biosensor signal output will include colorimetric, electronic, and/or optical signals, which could be incorporated into various device form factors including point of care, benchtop, and/or wearable/wireless. Collaboration with Air Force sponsors to meet the AF goals.

4.4 FORCE HEALTH PROTECTION AND ENVIRONMENTAL MEDICINE: The focus is to identify and characterize specific risk profiles/threats associated with Special Operation Forces (SOF) unique mission sets. In addition to research, apply and develop novel approaches to counter fatigue in extreme environments. Lastly, to research, apply and develop novel approaches to diagnose, treat and protect humans during exposure to chemical, biological, radiological, nuclear and high yield explosives in near real-time.

4.5 HUMAN OPERATIONAL PERFORMANCE: The focus is to research and apply current approaches, and/or develop novel approaches, to achieve the restorative effects of sleep through methods requiring less time or enabling the SOF operator to quickly reach the stages of sleep where highest restoration effects occur. In addition to developing technologies to maximize the physiological performance of the operators, which will include greater mental acuity, increased endurance, enhanced senses, and tolerance to environmental extremes in order to maintain operational posture/ability in high stress scenarios without noticeable augmentation and without hampering personnel mobility.

Also, research, apply and/or develop salivary diagnostic devices to provide genetic prediction of injury, response to training, and response to performance enhancement interventions and methods to accurately measure nutritional status in SOF operators. Lastly, research, apply and/or develop novel approaches that provide rapid and sustainable human performance in austere environments and/or for the SOF training calendar.

5.0 OTHER REQUIREMENTS

5.1 MANAGEMENT OF EFFORT: The contractor shall manage technical schedule and cost satisfaction of the task order; plan, prepare, conduct and document reviews; track CDRL satisfaction; and interface with the customer to assess performance satisfaction and re-plan the project as needed. Contractor shall comply with all applicable human use and animal use regulations.

5.2 CONTRACT HOLIDAYS: The prices/costs in Section B of the contract include holiday observances; accordingly, the Government shall not be billed for such holidays, except when services are required by the Government and are actually performed on a holiday.

The following days are contract holidays: New Year’s Day, Martin Luther King Jr. Day, Presidents Day, Memorial Day,4th of July, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

5.3 PROTECTION OF HUMAN SUBJECTS: The Contractor shall perform research using subjects in various laboratory experiments. The Contractor shall provide screening, scheduling, and training of subjects in order to accomplish this task order research, and will provide technical information required by the USAF IRB to approve the study design. The Contractor shall comply with the provisions of the following directives/regulations:

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

(ii) Department of Health and Human Services Regulations, 45 CFR 46, “Protection of Human Subjects,” 14 July 2009;

(iii) DoD Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research,” 8 Nov 2011;

(iv) Air Force Instruction (AFI) 40-402, “Protection of Human Subjects and Adherence to Ethical Standards in Air Force Supported Research,” 10 Sep 2014.;” and

(v) AFRL Instruction 40-402 “Protection of Human Subjects in Research,” 9 Jul 2014.

Human testing shall not commence until approval from the Air Force Internal Review Board (IRB) has been obtained. If an exemption to the above is granted by the IRB, the provisions above are no longer applicable.

5.4 WORKING WITH HAZARDOUS MATERIALS: The Contractor shall adhere to all safety requirements regarding working with hazardous materials, including the Chemical Hygiene Plan and/or Material Information Sheets. The Contractor shall execute hazardous materials responsibilities in accordance with all applicable federal and military procurement policies and requirements, to include, but not limited to AFI 32-7086 “Hazardous Materials Management”, AFI 32-7086 WPAFB Supplement, and the Wright-Patterson AFB (WPAFB) Installation HAZMAT Management Program (IHMP) Plan. This documents will be provided by the Program Manager upon award.

5.5 OPERATIONS SECURITY: The Contractor shall provide Operations Security (OPSEC) protection for all sensitive/critical information as defined by AFI 10-701 (Operations Security), the 711 HPW OPSEC Plan, and critical information list. The Contractor shall participate in the 711 HPW sustained OPSEC awareness training or include OPSEC training as part of their ongoing security program. The 711 HPW OPSEC Coordinator shall evaluate the OPSEC posture of Air Force contract activities and operations.

5.6 INFORMATION SECURITY AND FORCE PROTECTION: The Contractor shall provide information security and force protection training as defined by AFI 16-1404 (Air Force Information Security Program) and AFI 10-245 (Antiterrorism (AT)). The Contractor shall participate in the 711 HPW sustained information security and force protection/antiterrorism training or include this training as part of their on-going security program. The 711 HPW Security Managers will evaluate the training posture of Air Force contract activities and operations. This requirement is set forth in AFI 16-1404, AFI 10-245 and applicable Air Force Materiel Command (AFMC) and local supplements.

5.7 USE OF LIVE ANIMALS SUBJECTS: The Contractor shall comply, as appropriate, with the provisions of the following directives/regulations: (i) Air Force Manual 40-401(I), "The Care and Use of Laboratory Animals in DoD Programs", (July 2006); (ii) DoD Directive 3216.1, "Use of Laboratory Animals in DoD Programs" (13 September 2010).

The use of live animals shall not commence until:

a. The Air Force Institutional Animal Care and Use Committee (IACUC) has approved the animal protocol.

b. The appropriate DoD/service veterinarian has reviewed and approved the animal protocol.

c. The appropriate DoD/service veterinarian has conducted, if necessary, a site visit to the Contractor's facilities.

5.8 SECURITY REQUIREMENTS: This effort is unclassified.

5.9 PERIOD OF PERFORMANCE: 39 months total; 36 months of technical effort and 3 months for final reporting.

5.10 DELIVERABLES:

5.10.1 CDRLs:

5.10.2 SOFTWARE: Software deliverables include specialized data software, modeling software, algorithms, and source code.

CDRL # CDRL NAME FREQUENCY

A001 Scientific and Technical Reports – Final Report ONE/R A002 Funds and Man-Hour Expenditure Report MTHLY A003 Contract Funds Status Report QRTLY A004 Status Report MTHLY A005 Presentation Material ASREQ

5.10.3 HARDWARE: Hardware deliverables include sensor prototypes.