Draft Performance Work Statement.docx

UNCLASSIFIED/CUI

Performance Work Statement (PWS)

MIP-based sensor for detection of Norfentanylnorfentanyl, norcarfenanil, and remifentanil acid (Phases 2-4)

Vision Statement The USAMRICD would like to continue and expand development, optimization, and refinement the molecularly imprinted polymer (MIPs) –based sensors for the detection of norfentanyl, norcarfenanil, and remifentanil acid in biological samples (i.e., blood, urine, plasma). This effort will support the United States Army Medical Research Institute of Chemical Defense (USAMRICD) and provide critical resources that are necessary to allow the USAMRICD to continue to be a recognized leader in the development of chemical warfare agent countermeasures.

MIP - Diagnostics will provide support in the development of a novel sensor based on molecularly imprinted polymers (MIPs) for detection of Norfentanyl in biological samples (i.e., blood, urine, plasma). This effort will support the United States Army Medical Research Institute of Chemical Defense (USAMRICD) and provide the required staffing resources as necessary to allow the USAMRICD to continue to be a recognized leader in the development of chemical warfare countermeasures.

1. Introduction

The USAMRICD is a world leader in the discovery and development of medical products and knowledge solutions against chemical threats through research, education and training, and consultation. It is through successful partnerships with outside agencies that USAMRICD is able to maintain a high level of excellence.

1.1. Mission

The USAMRICD’s mission is to discover and develop medical products and knowledge solutions against chemical and biochemical threats through research, education and training, and consultation. After a preliminary assessment of the technical requirements discussed with USAMRICD, we have devised a development program to generate the required MIP-based sensors.

The USAMRICD has developed the ChemDx test system, currently in Advanced Development, for the detection of exposure to chemical warfare nerve agents far-forward on the austere battlefield. There has been a demand signal from our funding agency and the Warfighter to expand the capability of the ChemDx test system to access exposure to other chemical threats. Exposure to synthetic opioids is considered a high priority threat. Thus, the USAMRICD has previously engaged in conducting feasibility and early development of opioid metabolite sensors that could potentially integrate into the ChemDx platform.

Given that the O2 nanoMIPs developed in the previous project met the agreed upon design goals in terms of affinity (by SPR) and were successfully integrated in a prototype sensor, we recommend using the O2C and O2D nanoMIPs as starting material for the sensor development scoped out in this proposal.

ln order to de-risk the project, MIP Diagnostics proposes a staged approach, with an initial study on different chemistries and/or linkers used to anchor the nanoMIPs to the electrode surface. The following stage entails a further refinement of the amount of tag incorporated into O2C and O2D nanoMIPs. The performance of the developed sensor prototype will be evaluated by impedance analysis (as performed in the first project) in either artificial urine or spiked real urine.

1.2. Background

In FY20, the USAMRICD engaged in developing a MIP-based sensor targeted for detection of norfentanyl in a solvent system (i.e., water, buffer). The agreed-upon design goals in terms of affinity and selectivity were met in this effort. In FY21/22 the USAMRICD requires continuation and expanded development, optimization, and refinement of the molecularly imprinted polymer (MIPs) –based sensors for the detection of norfentanyl, norcarfenanil, and remifentanil acid in biological samples (i.e., blood, urine, plasma). Actual sensor prototypes will be procured from the contractor as part of the contractual agreement for confirmatory testing.

The effort described herein will allow continued development, optimization, and refinement of the previous candidate MIP sensor for norfentanyl in contract year 1. The second contract year will expand the MIP sensors to allow detection of norcarfentanil and remifentanil acid followed by optimization and refinement based on the developments learned in contract year 1.

will provide technical support in order to best ensure that the produced nanoMIPs, once transferred to USAMRICD are handled effectively and in accordance with the results obtained from our own testing. We will therefore provide such advice as is reasonably required by e-mail, telephone and/or webinar. Members of USAMRICD technical staff, or their consultant, will be welcome to attend MIP Diagnostic’s labs in order to familiarize themselves with the technology.

1.3. Scope

Contract Year 1 (8 weeks)

1.3.1 WP1 Selectivity assessment on O2C or O2D nanoof norfentanyl-MIPs in artificial urine or phosphate buffered saline (PBS)

The selectivity of either O2C or O2D nanoMIPs developed in the previous project will be assessed by impedance analysis. The aforementioned nanoMIPs will be immobilized onto screen-printed electrodes (as performed in the first project) and tested against up to 3 potential sample interferents (albumin/urea/paracetamol), in artificial urine or PBS.

N.B. Depending on the nature of the interferent molecule, a certain level of cross-reactivity may occur (e.g. Norfentanyl vs fentanyl). MIP Diagnostics will be able to test only drugs/compounds that are not currently controlled under the misuse of drugs legislation (under both the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001).

Deliverable: data and methodology on the selectivity of nonfentanyl MIP-modified screen-printed electrodes, confirming the sensor prototype is capable of selectively recognizing nNorfentanyl in artificial urine or PBS. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

Risk mitigationTimeline: previous selectivity tests on O2C and O2D nanoMIPs against vancomycin, urea and creatinine in SPR have already been performed successfully.1 week

1.3.2. WP2: Optimization of nanoMIP immobilization

The nanoMIPs that showed selectivity over interferents in WP1 will be selected as candidate for immobilization tests. In particular, at least 3 of the following 4 methods will be attempted.:

1. Ferrocene dicarboxyaldehyde will be used as a linker between the cysteamine-modified chip and the nanoMIPs.

2. Tyramine/aniline (or a suitable analogue) will be electro polymerized on gold in the presence of the nanoMIPs in suspension, which will therefore be incorporated within the tyramine/aniline matrix.

3. Tyramine/aniline (or a suitable analogue) will be first electro polymerized on gold, and then the nanoMIPs will be linked via EDC/NHS chemistry or Ferrocene dicarboxyaldehyde.

4. Drop casting the nanoMIPs in the presence of PVA/nylon or a suitable analogue.

Deliverable: data and methodology on the best immobilization route, capable of delivering the best signal generation upon binding of nNorfentanyl in artificial urine or PBS. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

Risk mitigationTimeline: 3 weeksseveral immobilization routes are potentially available. The one developed in the previous project has already shown good performance.

1.3.3 WP3 Refinement of the amount of tag in norfentanyl-to O2C or O2D nanoMIPs constructs

The formulation of the selected nanoMIPss (out of WP1) will be subject to a further refinement, such that a number (at least 4) of different amounts/positions of the tag in the MIP matrix will be tested. Affinity analysis of the resulting MIPs will be accomplished in PBS, by immobilizing the nanoMIPs on the screen-printed electrode via the besta preferred immobilization route. selected in WP2.

Deliverable: Dodocument ed data and methodology. At least 3-4 different amounts of tags will be attempted. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

Risk mitigationTimeline: at least 3-4 different amounts of tags will be attempted. The one developed in the previous project has already proven to work.3 weeks (in parallel with 1.3.2)

1.3.4 WP4 Production of optimized norfentanyl-MIP-modified electrodes for USAMRICD testing

Once the best method for MIP immobilization has been identified (WP2) and the amount of tag in the nanoMIPs has been refined (WP3), this information will be combined and MIP Diagnostics will used to manufacture a number of MIP-modified electrodes sensors for in-house testing at USAMRICD.

Deliverable: 5 norfentanyl-MIP-modified electrodes available for evaluation (via impedance analysis) by USAMRICD. The contractor will This would be for in-house testing at USAMRICD in addition to any further development work at MIP Diagnostics, should that be deemed necessary. MIP Diagnostics will also provide a protocol to ensure the exact electrochemical methods and procedures for testing will be transferred to USAMRICD.

A final report will be provided summarizing work conducted per each contract year. covered in Phase 2. Interim work package updates shall be provided via email to the USAMRICD.

Timeline: 4 weeks

Contract Year 2 (15 weeks)

1.3.5 In silico modelling for norcarfentanil and remifentanil acid The norcarfentanil and remifentanil acid structures will be fully coded into software, such that monomers with affinity – low binding energy – for the metabolites can be selected. The modelling will then be refined further, to directly reduce interference from any key interferents identified by the USAMRICD, should that be required.

Deliverable: A set of monomers selective for norcarfentanil and remifentanil acid will be reported, and an assessment for subsequent imprinting performed (which may reflect the desired imprinting conditions, solvent compatibility etc.). Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

Timeline: 4 weeks

1.3.6 Sourcing of the analogues and linkers for imprinting and solid phase attachment and generate candidate MIPs for norcarfentanil and remifentanil acid

In order to imprint for norcarfentanil and remifentanil acid, a version with a suitable group for attachment to the glass-bead solid phase will required. An analogue and linker will be developed for each metabolite. Consecutive attachment to glass bead supports will follow.

Deliverable: The sourcing of a suitable molecule (or analogue) for imprinting, and a methodology for presenting norcarfentanil and remifentanil acid for imprinting in the correct orientation such that the molecule is not partially buried in the silane layer on the glass beads. Generate and test affinity of MIP candidates. Down-select to 1 or 2 lead candidates for sensor development. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

Timeline: 4 weeks (in parallel with 1.3.5)

1.3.7 Configuration, development, optimization, and refinement of electrochemical prototype sensors for norcarfentanil and remifentanil acid

Configure and develop prototype sensors for norcarfentanil and remifentanil acid. Up to 5 sensors will be produced for each metabolite. Contractor will initially test sensors prior to production under 1.3.8.

Deliverable: Reagents configured for electrochemical assay development, attached to screen-printed electrodes and proof of principle data confirming that a basic assay is feasible in a buffer matrix and, ideally, also in spiked urine. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

Timeline: 7 weeks

1.3.8 Production of MIP-modified electrodes specific for norcarfentanil and remifentanil acid for test at the USAMRICD

Utilize the optimization strategies in Contract Year 1 to develop and manufacture a number of MIP-modified sensors for testing at USAMRICD.

Deliverable: 5 MIP-modified electrodes, for each metabolite, available for evaluation (via impedance analysis) by USAMRICD. The contractor will provide a protocol to ensure the exact electrochemical methods and procedures for testing will be transferred to USAMRICD.

A final report will be provided summarizing work conducted per each contract year.

Timeline: 4 weeks

1.4. Organizational Conflicts of Interest (OCI) (See Attachment 1)

The FAR Part 9.5 provides guidance for Contracting Activities with regards to OCI. OCI is characterized by a) biased judgment on the part of the Contractor or b) unfair competitive advantage in procurement. The FAR encourages mitigation of a conflict if at all possible. The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered. The work to be performed under this requirement has a significant potential for OCI.

1.4.1 OCI Mitigation Strategy

Offerors are encouraged to present their best strategy for mitigation of any potential OCI under this requirement. Offerors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

1.4.2. Comparative OCI Analysis

At the contract level the Contractor shall perform a comparative analysis of the potential new work against all current and previous work performed in any category other than that of the new work being offered. The comparative analysis must be included in the proposal for each contract, and must include a statement certifying whether the Contractor believes that its performance of the proposed contract would create a real or apparent OCI. For this contract, the Contractor shall sign and submit the Organizational Conflict of Interest certification statement (Attachment 1). Failure to adhere to this OCI statement may constitute default on the part of the Contractor.

The Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to tasking any such party under this contract. The Contractor shall appropriately modify and include this Paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

The Contractor shall complete the OCI document (Attachment 1 of the Solicitation) and provide a copy with their proposal (Deliverable 1) if necessary, the Contractor shall submit their OCI Mitigation Plan (Deliverable 2) to the Contracting Officer and Contracting Officer’s Representative.

1. General Requirements:

a. Place of Performance. Work will be performed at Contractor MIP- Dx with confirmation of final product done conducted at the USAMRICD by our staff.

b. Period of Performance. The Period of Performance will start approximately 2 weeks after award: MIP DiagnosticsContractor shall provide technical support in order to best ensure that the produced nanoMIP-based sensorss, once transferred to USAMRICD, are handled effectively and in accordance with the results obtained from our own testing. We will thereforeContractor will provide such advice as is reasonably required by e-mail.

2.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by FAR Part 37 and to ensure there is not an appearance of such this contract will have an identified COR. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks.

2.1.2. Personnel Conduct. Non – Applicable.

2.2. Business Relations

2.2.1. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timelines, completeness, and quality of problem identification.

2.3. Contract Administration and Management

2.3.1. Contract Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. Contractor duties will be performed at the contactor’s corporate office.

2.3.1.1. Contract Management Activities.

a. Government Management of the Contract. The KO will officially designate a Contracting Officer’s Representative (COR) to oversee this Contract. The Government’s COR will have responsibility for:

(1) Ensuring that the Surveillance Plan is developed and executed by the COR and any other involved USAMRICD representative who may have responsibilities monitoring and managing the contract.

(2) Providing advice and assistance in resolving any performance issues that may arise during the life of the order.

(3) Initiating and coordinating global contract changes such as changes in the paying office.

(4) Conducting other activities as specified in their appointment memorandum.

(5) Elevating to the KO any problems that cannot be addressed by the COR.

(6) COR does not have the authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications.

(7) The COR DOES NOT have the authority to change the terms and conditions of the contract.

(8) Contractor Management of the Contract. The contractor shall designate a single program manager to oversee the contract. The Contractor’s designated program manager shall serve as the single point of contact for addressing contract issues, quality issues, and overall contractor performance. This may include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract or proposed changes or modifications to the contract. Contract management activities may include:

(9) Non-Disclosure Statement (Deliverable 3). The Contractor shall sign the Non-Disclosure Statement and ensure that all staff including all employees, subcontractors, and consultants assigned to or performing under the contract, execute, sign, and adhere to the terms of the Non-Disclosure Statement. The Contractor and Employee shall also execute a Non-Disclosure Agreement during in processing to the USAMRICD.

2.3.2. Contract Administration.

The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support the contract. The Contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement. The Contract Administration Team will consist of the following members:

2.3.2.1 The KO will have overall responsibility for administering the contract. The KO is the only person authorized to obligate the Government and make changes to the contract. The KO will manage contract administration and ensure COR responsibilities are being performed.

2.3.2.2. The COR will be appointed in writing and will be directly responsible to the KO. The COR serves as the Government’s point of contact for contract-level coordination of administration and technical performance matters. The COR will assist in resolving performance issues; initiate and coordinate contract-level changes; notify the KO of any disputes, performance issues, or contractual issues that cannot be resolved at the COR level; and conduct other activities as specified by appointment.

2.3.2.3. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contact for coordination for the contract; approve or disapprove contractor invoices; review and accept or reject all contractor technical deliverables; monitor funds obligated and disbursed; complete Contractor Manpower Reporting (CMR); conduct surveillance by uploading a monthly report in the Contracting Officer Representative Tracking (CORT) tool; and conduct other activities as may be specified by the COR appointment letter.

2.3.2.4. The Contractor’s Program Manager is the point of contact with the COR. This position is responsible for the overall management of the contract. Responsible for formulating and enforcing work standards, assigning contractor schedules, reviewing work quality.

2.3.3. Personnel Administration

2.3.3.1. The Contractor shall provide management and support as required. N/A

2.3.4. Subcontract Management

The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this contract and shall be responsible and accountable for subcontractor performance. The prime Contractor will manage work distribution to ensure there are no OCI considerations. A notification must be sent to the KO and COR within 30 days of the agreement between the prime and the subcontractor.

2.4. Location and Hours of Work

2.4.1. Location of Work

2.4.1.1. Primary Location. Offsite at Contractor’s place of work.

2.4.1.2. Other Locations. Not applicable

2.4.1.3. Telecommuting. Not applicable.

2.4.2. Hours of Work. Not applicable

2.4.2.4. Government-directed training. Contractors are expected to have the skills to perform their contractual duties. If they must train to maintain the required skills, it is not to be done on Government time. Change in technical requirements and Command determination for total team training are conditions that permit contractor training at Government time or expense.

2.4.2.5. The contractor employee is responsible for maintaining the work place and the equipment assigned to them by the Institute for the completion of assigned tasks in a safe, secure, and orderly manner.

2.5. Required Training Not applicable

1. Performance Requirements

Contract Year 1

3.1. Objective 1 – Assess selectivity of O2C and O2D nanonorfentanyl-MIPs in artificial urine or PBS; corresponds to Work Package 11.3.1 of scope

3.1.1 Key Task 1 – Impedance analysis of O2C and O2Dcandidate nanonorfentanyl-MIPs in the presence of potential interfering substances (i.e., albumin, urea, paracetamol) in artificial urine. Impedance data, interpretation, and methodology will be delivered to the USAMRICD as a data package for Objective 1. Determine which nanoMIP candidate has the best selectivity for inclusion in subsequent testing.

Objective 1 Performance Standard: Develop and provide a data package that reports impedance data, interpretation, and methodology to the USAMRICD at the completion of Objective 1.

Objective 1 Acceptable Quality Level: PowerPoint presentation slides show that provides impedance data, interpretation of results, and methodology utilized for the study.

Objective 1 Deliverable: Data package providing results and conclusion for 1.3.1 of testing.

3.2 Objective 2 – Evaluate norfentanyl-nanoMIP immobilization methodologies and test for best signal generation; corresponds to 1.3.2Work Package 2 of scope

3.2.1 Key Task 1 – Test at least 3 of the 4 distinct methodologies as presented below for immobilizing norfentanylanoMIPs to the surface of sensor electrodes.

3.2.1.1 Evaluate ferrocene dicarboxyaldehyde as a linker between the cysteamine-modified chip and the nanoMIPs

3.2.1.2 Evaluate tyramine/aniline (or a suitable analogue) to be electro polymerized on gold in the presence of the nanoMIPs in suspension, which will therefore be incorporated within the tyramine/aniline matrix.

3.2.1.3 Evaluate tyramine/aniline (or a suitable analogue) will be first electro polymerized on gold, and then the nanoMIPs will be linked via EDC/NHS chemistry or Ferrocene dicarboxyaldehyde.

3.2.1.4 Drop casting the nanoMIPs in the presence of PVA/nylon or a suitable analogue.

Objective 2 Performance Standard: A data package reporting impedance data and interpretation of data for each methodology tested to include the selection of the optimal methodology found in this evaluation

Objective 2 Acceptable Quality Level: PowerPoint presentation slides that provides impedance data, interpretation of results, and selection of the optimal methodology determined in this study.

Objective 2 Deliverable: Data package providing results and conclusion of testing to include down-selection of optimal methodology for 1.3.2

3.3 Objective 3 – Evaluate and refine the amount of tag incorporated into the O2C or O2Dcandidate norfentaylanoMIPs; corresponds to Work Package 31.3.3 of scope.

3.3.1 Key Task 1 – Evaluate up to at least 4 of tag amounts in combination with different tag positions with the nanoMIP candidate selected from Objective 1 (WP1)1.3.1 along with incorporation of the best immobilization methodology determined in Objective 2 (WP2)1.3.2.

Objective 3 Performance Standard: A data package reporting impedance data and interpretation of data for each combination tested to include the selection of the optimal combination found in this evaluation

Objective 3 Acceptable Quality Level: PowerPoint presentation slides that provide impedance data, interpretation of results, and selection of the optimal combination determined in this study.

Objective 3 Deliverable: Data package providing results and conclusion of testing to include down-selection of optimal combination.

3.4 Objective 4 – Produce optimized nanoMIP sensors based on results of Objectives 1-3 (WP 1-3) and send 5 sensors to the USAMRICD for further testing. Comment by Chandler, Jessica K Ms CIV US USA MEDCOM USAMRICD: Objectives 1-4 read for year 1. Im not seeing any objectives for Year 2. Please define this. From section 1.3 Scope, year 2 sections 1.3.5-8 are year 2, and I would expect Objectives for each of these Scopes.

3.4.1 Key Task 1 – Utilize the best method for MIP immobilization and tag combination from prior objectives to produce 5 optimized sensors for nor-fentanyl.

Objective 4 Performance Standard: Produce 5 optimized nor-fentanyl sensors. The contractor will provide a protocol to ensure the exact electrochemical methods and procedures for testing will be transferred to USAMRICD.

Objective 4 Acceptable Quality Level: 5 working sensors must be received at the USAMRICD..

Objective 4 Deliverable: All 5 optimized sensors must be received in good working order and show concentration dependent signal upon testing with various levels of nor-fentanyl. The contractor will provide a protocol to ensure the exact electrochemical methods and procedures for testing will be transferred to USAMRICD. A final report will be provided summarizing work conducted per each contract year.

Contract Year 2

3.5 Objective 5 – Conduct in silico modelling for norcarfentanil and remifentanil acid.

3.5.1 Key Task 1 – Utilize in silico modelling to predict monomers with low binding energy to norcarfentanil and remifentanil acid.

Objective 5 Performance Standard: Define a predicted set of monomers selective for binding to norcarfentanil and remifentanil acid to allow imprinting and MIP construction.

Objective 5 Acceptable Quality Level: Survey 350 or more monomers during in silico modelling.

Objective 5 Deliverable: A set of monomers selective for norcarfentanil and remifentanil acid will be reported, and an assessment for subsequent imprinting performed (which may reflect the desired imprinting conditions, solvent compatibility etc.). Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

3.6 Objective 6 – Sourcing of the analogues and linkers for imprinting and solid phase attachment followed by generation of norcarfentanil and remifentanil acid with high affinity

3.6.1 Key Task 1 – Develop suitable analog of norcarfentanil and remifentanil acid for attachment to glass beads. Generate MIP candidates for affinity testing.

Objective 6 Performance Standard: Develop analogs that can be covalently attached to glass beads with customized linker construct if needed. Generate MIP candidates to allow surface plasmon resonance (SPR) affinity testing.

Objective 6 Acceptable Quality Level: Analogs allow proper imprinting for MIP generation. Develop MIP candidates with nanomolar affinity for norcarfentanil and remifentanil acid as determined by SPR.

Objective 6 Deliverable: The sourcing of a suitable molecule (or analogue) for imprinting, and a methodology for presenting norcarfentanil and remifentanil acid for imprinting in the correct orientation such that the molecule is not partially buried in the silane layer on the glass beads. Generate and test affinity of MIP candidates. Down-select to 1 or 2 lead candidates for sensor development. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

3.7 Objective 7 – Configure, develop, optimize, and refine electrochemical prototype sensors for norcarfentanil and remifentanil acid

3.7.1 Key Task 1 – Configure and develop prototype sensors for norcarfentanil and remifentanil acid based on optimized strategies determined in Contract Year 1.

Objective 7 Performance Standard: Contractor will develop and test 5 MIP sensors.

Objective 7 Acceptable Quality Level: MIP-sensors will be able to detect norcarfentanil and remifentanil acid in a concentration dependent manner utilizing impedance.

Objective 7 Deliverable: Reagents configured for electrochemical assay development, attached to screen-printed electrodes and proof of principle data confirming that a basic assay is feasible in a buffer matrix and, ideally, also in spiked urine. Provide report to the USAMRICD at the conclusion of the task summarizing data and results.

3.8 Objective 8 – Production of MIP-modified electrodes specific for norcarfentanil and remifentanil acid for testing at the USAMRICD

3.8.1 Key Task 1 – Configure and develop prototype sensors for norcarfentanil and remifentanil acid based on optimized strategies determined in Contract Year 1.

Objective 8 Performance Standard: Contractor will develop and test 5 MIP sensors before sending to the USAMRICD for confirmatory testing.

Objective 8 Acceptable Quality Level: MIP-sensors will be able to detect norcarfentanil and remifentanil acid in a concentration dependent manner utilizing impedance.

Objective 8 Deliverable: 5 MIP-modified electrodes, for each metabolite, available for evaluation (via impedance analysis) by USAMRICD. The contractor will provide a protocol to ensure the exact electrochemical methods and procedures for testing will be transferred to USAMRICD.

A final report will be provided summarizing work conducted per each contract year.

3.5. Contractor Manpower Reporting: Non- Applicable

3.6. Contractor identification. Contractor personnel must clearly identify themselves as a contract employee. The name of their company must be part of their email address, all correspondence, and on all identification badges, desk plates, etc. Additionally, contractor personnel are required to identify themselves as contractor personnel when attending meetings, answering Government telephones, or working in situations where their status as contractor employees may not be obvious.

3.7. Sexual Assault and Sexual Harassment Reporting: Non Applicable

4.0. Security Requirements: Non Applicable

4.1.3. When Contractor employees are considered mission essential, all Contractor employees are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the KO via the COR.

4.2. Special Requirements: Not - applicable.

4.3. Government Furnished Facilities, Supplies, and Equipment. Not applicable.

4.4. Proprietary Information Assurance and Security.

4.4.1. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the KO grants a specific exception.

4.4.2. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.4.3. Government Data Rights. All products including files, software, and other information, which are created, produced, or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.5. Transition In/Out:

4.5.1. Transition is nNot applicable. to this requirement.

4.6. In and Out Processing :Processing: Not applicable.

4.7. Acronyms.

ALMS Army Learning Management System AT Antiterrorism ATAAPS Automated Time, Attendance, and Production System ATCTS Army Training Certification Tracking System CMR Contractor Manpower Reporting COR Contracting Officer Representative CPARS Contractor Performance Assessment Reporting System

DFARS Department of Defense Acquisition Regulation Supplement DoD Department of Defense DSS Defense Security Service DTS Defense Travel System EST Eastern Standard Time FAR Federal Acquisition Regulation FDA Food and Drug Administration FFP Firm-Fixed-Price FTE Full Time Equivalent GFP Government Furnished Property HIPPA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness IAW In Accordance With INFOSEC Information Security IT Information Technology KO Contracting Officer LAN Local Area Network NAC National Agency Check NLT No Later Than OCI Organizational Conflict of Interest OCONUS Outside Continental United States OPM U.S. Office of Personnel Management OPSEC Operations Security PRS Performance Requirements Summary POP Period of Performance PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan SCA Service Contract Act

4.8 Environmental Requirements

Non-applicable

4.8.1 Mandatory Requirements

Non-applicable

4.8.2 Non Mandatory Documents

Non-applicable

4.9 Applicable Directives

4.9.1 References

None

4.9.2 Compliances

5.0. Schedules/Deliverables.

The Contract Year 1 is project will be completed in 8 weeks to include making available all deliverables. The Contract Year 2 project will be completed in 15 weeks to include making available all deliverables. Objectives should be completed in chronological order or in parallel when appropriate. Deliverables for Objective 1-3 must be made available 1 week prior to production of optimized sensors under Objective 4. Comment by Chandler, Jessica K Ms CIV US USA MEDCOM USAMRICD: Identify year 1 versus Year2. Define when year 2 starts and for how long (12 months, 3 months?)

UNCLASSIFIED/CUI