Draft Final PWS BioScience SR 25 january.pdf

Performance Work Statement For the “Chemical, Biological Defense and Biomanufacturing Research” Effort

C.1.0 Scope. The U.S. Army Combat Capabilities Development Command, Chemical Biological Center, Biosciences Division (DEVCOM CBC BSD) has been tasked to support National Chemical, biological, radiological and nuclear (CBRN) defense programs aimed at defeating chemical and biological threats by providing laboratory technical experience and expertise, technical laboratory work, programmatic support for applied and basic research and administrative support. This effort will encompass the detection, identification, growth, purification, analysis and detoxification of known and new biological pathogens, naturally occurring and synthetic toxins, biologically active compounds, biomanufacturing of biological and chemical products and organophosphorus chemical warfare nerve agents that have high potential for use as warfare and terror.

C.1.1 Background. DEVCOM CBC BSD at Aberdeen Proving Ground Edgewood Area (APG EA) is responsible for basic research, advanced development, testing, and evaluation of technology in microbiological, biochemical, chemical and analytical fields of science, which support a broad range of research studies that include chemical and biological detection technology and sensors, immunosensor assay development, validation, production of biological reference material and biological reagents, production of tri-service biomaterials and commodity chemicals with downstream processing and data management. Furthermore, the DEVCOM CBC BSD maintains a formal Quality Management System to support its International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) certification for quality analytical and operational processes.

The DEVCOM CBC BSD will support the current capability primarily through the conduct of chemical and biological surety and non-surety laboratory expertise. The majority of the effort shall be performed in the laboratories at DEVCOM CBC BSD. In accordance with these assignments, the DEV COM CBC BSD provides the following:

a. Research and Development programs in the areas of biomanufacturing, microbiological, biochemical, chemical and computational fields, which support a diverse base of research topics, to include pathogen studies, decontamination, toxic small molecules, threat characterization, sensor and assay development/evaluation and the production of biologically derived materials to include both biological material and chemical commodities.

C.1.2 Objective. The objective of this contract is to obtain qualified non-surety and surety laboratory, technical, programmatic, and administrative services in support of the DEVCOM CBC BSD mission relating to CBRN detection, decontamination, threat characterization, biomanufacturing, and other basic and applied research and development efforts to meet DEVCOM CDC’s customer requirements.

C.2.0 Applicable Documents.

C.2.1 QMS-QA-01 R2 DB Laboratory Quality Assurance Plan, current version (Available upon award)

C.2.2 Biosciences SOPS, IOPS, test plans, CBC Biosafety manual, current version etc. (Available upon award)

C.2.3 SOP Guidebook, Preparation of Standing Operating Procedures, current version

C.2.4 AR 50-6, Chemical Surety, current version.

https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN3125_AR50-6_WEB_FINAL.pdf

C.2.5 AR 190-59, Chemical Agent Security Program, current version https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/r190_59.pdf

C.2.6 AR 385-10, The Army Safety Program, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN16777_ARN16343_AR385_10_FINAL.pdf

DRAFT

https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN3125_AR50-6_WEB_FINAL.pdf https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/r190_59.pdf https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN16777_ARN16343_AR385_10_FINAL.pdf

C.2.7 AR 25-2 Army Regulation (AR 25-2 “Army Cybersecurity”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN17503_AR25_2_Admin_FINAL.pdf

C.2.8 AR 2014-5

C.2.9 AR 381-12 C.2.17 Army Regulation (AR 381-12 “Threat Awareness and Reporting Program”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/AR%20381-12%20FINAL%20WEB.pdf

C.2.10 AR 190-17

C.2.11 AR 50-1

C.2.12 AR 190-59

C.2.13 AR 11-34

C.2.14 530-1 C.2.18 Army Regulation (AR 530-1 “Operations Security”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r530_1.pdf

C.2.15 AR 190-13

C.2.16 DA Pam 40-8, Occupational Health Guidelines for the Evaluation and Control of Occupational Exposure to Nerve Agents GA, GB, GD, and VX, current version

C.2.17 DA Pam 40-173, Occupational Health Guidelines for the Evaluation and Control of Occupational Exposure to Mustard Agents H, HD, and HT, current version

C.2.18 DA Pam 385-61, Toxic Chemical Agent Safety Standards, current version

C.2.19 DODI 5220.22M (National Industry Security Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/522022M.pdf

C.20 DA PAM 385-10

C.21 DA PAM 385-69

C.22 29 CFR 1910.134

C.23 Radiation Safety Program for DEVCOM CBC

C.2.20 DOD 8570.01 (Certification Requirements)

C.2.21 DOD 8570.01M (Information Assurance Workforce Improvement Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf

C.3.0 Requirements. The Contractor, as an independent entity and not as an agent of the Government, shall provide the necessary resources (except those specifically designated as Government-furnished) to accomplish tasks of the type set forth below. The anticipated work requires specialized facilities, equipment and procedures, and Contractor personnel will be required to perform work on site at DEVCOM CBC, Aberdeen Proving Ground, contractor facilities, or other anticipated Government approved cites. The Contractor must have an active Personnel Reliability Program with DEVCOM CBC and provide a fully qualified Personnel Reliability Program (PRP) staff with requisite experience on day one of contract award to perform the task under the paragraph C.3.3 in this PWS.

C.3.1 The contractor shall conduct a Start of Work Meeting within 14 calendar days after contract award.

DRAFT

https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN17503_AR25_2_Admin_FINAL.pdf https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/AR%20381-12%20FINAL%20WEB.pdf https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r530_1.pdf https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/522022M.pdf https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf

C.3.1.1 The start of work meeting shall include a verbal “walk-through” of this Performance Work Statement (PWS) to summarize its understanding of the specific tasks to be completed, ask and answer questions, and serve as a venue for all parties to make introductions.

C.3.1.2 The contractor shall provide start of work meeting minutes to the Government No later than (NLT) forty eight (48) hours after the scheduled start of work meeting in accordance with (IAW) Exhibit Line Item Number

(ELIN) A001.

C.3.2 The contractor shall provide hands on support for biomanufacturing efforts at DEVCOM CBC. The Contractor shall conduct hands on bioproduction, technical interpretations and laboratory test support to the Government on matters dealing with the use and development of laboratory testing approaches and methodologies, laboratory instrumentation, analyses and proper waste disposal procedures cited in Standard Operating Procedures (SOPs).

C.3.2.1 The contractor shall design and optimize processes for the scale-up production of materials that can be synthesized and produced in gram to kilogram quantities using batch fermentation of genetically engineered cell lines.

C.3.2.2 The contractor shall design and optimize downstream production processes to separate, purify and preserve materials produced.

C.3.2.3 The contractor shall use material handling equipment (e.g., pallet jack, fork lift, compressed gas cylinder cart) as needed to move, position, or set-up equipment or supplies required for testing. As needed, the contractor will ensure personnel have training prior to operating government materials handling equipment.

C.3.2.4 The contractor shall provide technical expertise, prepare Internal Operating Procedures (IOPs), update laboratory notebooks based on process development procedures and conduct hands on analyses for Government customer programs using, but not limited to, the following instrumentation and equipment:

• 5-1500 L Fermenters

• Alfa Laval Centrifuge

• Continuous Flow Centrifuge

• Distillation Column

• Filter Press

• Ion Exchange Chromatography

• KARR or Scheible Column

• Lyophilizer

• Millipore Ultrafiltration Unit

• Spray Dryer

• Tangential Flow Filtration Unit

• Rotary Evaporator

• Thin Layer Chromatography Tanks

• Miller

• Tube Furnace

C.3.2.5 The contractor shall provide administrative support to the Contracting Officer’s Representative (COR) to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.2.6 The contractor shall participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.3 TASK 1: The contractor shall provide hands-on chemical surety and non-surety biological expertise, technical interpretations and laboratory test support to the Government on matters dealing with the use and development of laboratory testing approaches and methodologies, laboratory instrumentation, analyses and proper waste disposal procedures.

C.3.3.1 On day one of contract award, the contractor shall have an active PRP program with DEVCOM CBC in accordance with AR50-6, and provide personnel certified in the PRP. New personnel must be capable of being made PRP certified within two months of contract award.

C.3.3.2 The contractor shall review the technical literature and provide comments to the Government on matters concerning the development or modification of test methodologies and operational procedures pertinent to the evaluation, production, and characterization of small molecule and peptide toxins.

C.3.3.3 The contractor shall develop, test, optimize, improve, and evaluate various immunochemical and nucleic acid-based assay technologies - both for specific sensors and for new assay concepts (e.g. new reagent types, new maintenance purchased for assay methods), for bacteria, viruses, toxins, and proteins.

C.3.3.4 The contractor shall conduct hands on chemical and biological surety laboratory testing, analyses of chemical and biological surety agent materials, emerging threat compounds, experimental agents, and toxic industrial chemicals (TICs) or other unique compounds of military relevance and materials and must stay current in the Personnel Reliability Program (PRP).

C.3.3.5 The contractor shall comply with applicable documents listed in paragraph 2.0 and all local policies for operations involving chemical and biological agents or other chemicals which fall into the same range of toxicity as chemical agents (such as agent degradation products or precursors) when using chemical agents on-site at the Edgewood Area of Aberdeen Proving Ground.

C.3.3.6 The contractor shall meet all requirements for a respirator medical clearance and proper mask fit as part of being Chemical Personnel Reliability Program (CPRP) capable. Individuals failing to meet all medical and fit requirements will be prohibited from performing operations in a chemical agent or hazardous work environment that requires respiratory protection.

C.3.3.7 The contractor shall examine prior to use and make use of proper personal protection equipment (PPE) as needed per SOP testing.

C.3.3.8 The contractor shall participate in test report preparation, peer reviewed journal articles and technical report writing support to include statistical test design, data analysis, experimental procedures, evaluations, interpretations and conclusions to capture lessons learned to provide improvement and expansion of capabilities to complete customer programs. This effort shall include literature searches, networking with government agencies, academia, and commercial clients.

C.3.3.9 The contractor shall provide technical expertise and conduct hands on analyses for Government customer programs using, but not limited to, the following analytical instrumentation and equipment:

• Real Time PCR instrumentation to include

• SeqStudio Genetic Analyzer

• Oligosynthesizer

• Liberty Blue, Automated Peptide Synthesizer

• Ultraviolet Spectrometer (UV VIS)

• Agilent LC/MSD and Associated Accessories

C.3.3.10 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.3.11 Equipment and supplies. The contractor shall provide equipment and supplies as necessary, with government concurrence.

C.3.3.12 The contractor shall provide administrative support to the Contracting Officer’s Representative (COR) to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.3.13 The contractor shall drive or ride in government vehicles as needed to participate in the transport of test equipment or test materials between buildings. As needed, the contractor will ensure personnel have training prior to operating government vehicles.

C.3.4 TASK 2: The contractor shall provide a subject matter expert (SME) in the development processes for fermentation, downstream processing, and characterization of microbial products, including specialty chemicals, biological polymers, proteins, and phage-based products.

C.3.4.1 The contractor shall design and implement processes for the production of military-relevant products using DEVCOM CBC fermentation and down-stream processing equipment under overall guidance of the Biomanufacturing program manager. The contractor shall provide technical expertise to ongoing biomanufacturing operations, and shall work with the Program Manger and other DEVCOM CBC personnel to ensure timely execution of projects within budget.

C.3.4.2 The contractor shall write project proposals, test plans, SOWs, production documentation, SOPs, IOPs, technical reports, research publications, and other documents as needed to support incoming projects.

C.3.4.3 The contractor shall make recommendations to DEVCOM CBC for additional downstream processing capabilities as needed for new production methods and will assist DEVCOM staff in the identification, evaluation, acquisition, and implementation of new equipment and procedures.

C.3.4.4 The contractor shall communicate the progress of research and development efforts clearly and succinctly with DEVCOM personnel, customers, external program managers and stakeholders, as needed.

C.3.4.5 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.4.6 The contractor shall participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.5 TASK 3: The contractor shall provide support to the biomanufacturing effort.

C.3.5.1 The contractor shall operate the fermentation, downstream processing equipment, and/or analytical equipment in accordance with established IOP’s, SOP’s, and with project-specific production and test plans.

C.3.5.2 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP’s, SOP’s, production and test plans, and data management procedures.

C.3.5.3 The contractor shall communicate project progress, results, and issues in accordance with ELIN A002.

C.3.5.4 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.5.5 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.5.6 The contractor shall participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.6 TASK 4: The contractor shall provide information technology services, to include support to dedicated software and hardware for biomanufacturing operations, data and information collection, management, analysis, and communication.

C.3.6.1 The contractor shall develop tools to analyze and manage fermentation/production data, metabolomics data, microbiological data, and/or synthetic biology data. The contractor shall develop software pipelines by utilizing combinations of Government off the shelf (GOTS), and Commercial off the shelf (COTS) tools that are adaptable in accordance with contract security requirements. The contractor shall be familiar with current cloud-based laboratory data management and analysis packages and shall make recommendations to DEVCOM CBC principal investigators on systems that would be suitable to the needs of the facility.

C.3.6.2 The contractor shall be familiar with Laboratory Information Management Systems (LIMS) and modern cloud-based notebook and data management solutions, particularly regarding fermentation and downstream processing, product yield and purity analysis, metabolomic characterization of fermentation broth, and strain characterization.

C.3.6.3 The contractor shall be familiar with Agile Development concepts and develop solutions through collaborative effort with CBC Principal Investigators. The contractor shall apply principles of software engineering to the design, maintenance, testing and evaluation of software.

C.3.6.4 The contractor shall build, maintain, and upgrade hardware and software to accomplish data management requirements. The contractor shall provide support during test and evaluation events involving software, software interfaces, hardware, or integration requirements.

C.3.6.5 The contractor shall work closely with other CBC bioinformatics personnel and principal investigators to maximize use of existing hardware infrastructure in the Branch and throughout DEVCOM CBC.

C.3.6.6 The Contractor shall assist the Government by learning coding software should it be deemed necessary to the success of the project.

C.3.6.7 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.6.8 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.7 TASK 5: The contractor shall assist the Government with the study of cell processes and shall have an understanding of gene sequencing, cell signaling, and gene expression. The contractor shall participate in laboratory procedures following protocols including DNA sequencing, cloning and extraction, RNA purification, gel electrophoresis and/or protein expression and purification protocols.

C.3.7.1 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP, SOP’s, production and test plans and data management procedures.

C.3.7.2 The contractor shall communicate project progress, results, and issues in a timely manner to principal investigators.

C.3.7.3 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.7.4 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.7.5 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.8 TASK 6: The contractor shall assist the Government to grow and study a number of viruses or bacteria at BSL 1, 2, and/or 3. The contractor is responsible for investigating the growth, structure, development and other characteristics of microscopic organisms. Contractor may participate in characterization, detection, identification and decontamination studies using a wide range of analytical and scientific techniques.

C.3.8.1 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP’s, SOP’s, production and test plans, and data management procedures.

C.3.8.2 The contractor shall communicate project progress, results, and issues in a timely manner to principal investigators.

C.3.8.3 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.8.4 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.8.5 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.9 TASK 7: The contractor shall provide expertise in downstream processing for Biomanufacturing and facilities design for Biomanufacturing.

C.3.9.1 The contractor shall have experience with downstream purification from the standpoint of purity, yield and efficiency and is responsible for the general strategies employed to achieve these goals.

C.3.9.2 The contractor shall define the specific methods and in-process tools and materials used in the downstream process to include filtration and centrifugation, chromatography, ultrafiltration and final polishing chromatography steps.

C.3.9.3 The contractor shall participate in the ongoing operation and maintenance of the downstream unit operations within a facility.

C.3.9.4 The contractor shall participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.10 TASK 8: The contractor shall provide administrative/Program/Project support.

C.3.10.1 The contractor shall perform a variety of administrative tasks and responsibilities as detailed below, to ensure continuity and efficiency of the administrative office operations and procedures.

C.3.10.2 The contractor shall answer phones, prepare correspondence and reports that are required to maintain client relations.

C.3.10.3 The contractor shall collect and maintain time sheets from personnel to provide for Government use in time keeping duties.

C.3.10.4 The contractor shall maintain a supply room to ensure that routine supplies are on hand for support of operations. The Government will select the vendors and input the purchase requests to support the contractor in the maintenance of the supply room.

C.3.10.5 The contractor shall inspect all incoming supplies for conformance to the purchase request and report any deficiencies to the appropriate Branch member.

C.3.10.6 The contractor shall have experience in budgeting, procurement, purchasing supplies and services, and constructing financial reports through the General Fund Enterprise Business Systems (GFEBs).

C.3.10.7 The contractor shall be responsible for entering data in the Army’s Automated Time Attendance and Production System (ATAAPS), the Defense Travel System (DTS) and other government portals that are deemed necessary for efficient management of project, personnel and financial tasks.

C.3.10.8 The contractor shall provide management, personnel, training, contract and procurement records in accordance with Department of Defense (DoD), Defense Finance and Accounting Service (DFAS) and Office of Personnel Management (OPM) requirements.

C. 3.10.9 The contractor shall provide the government with financial data to be used for transfers of funding, to include Military Interdepartmental Purchase Requests (MIPR), Internal Funds Transfers, Purchase Orders, and Purchase Requests.

C.3.10.10 The contractor shall be familiar with the Chemical and Biological Center SharePoint system and maintain non-conflicting calendar schedules for the daily activities of the managers and the shared conference rooms. The contractor shall perform these duties on-site at Aberdeen Proving Ground.

C.3.11 Environmental

C.3.11.1 Compliance with Environmental Laws and Regulations. Contractor shall comply with all applicable federal, state, and local environmental laws, statutes, regulations, executive orders, permits, Army regulations (with supplements), as well as Major Subordinate Command (MSC) and installation regulations and policies. Contractor shall immediately report any conflicts between applicable federal, state, local environmental laws, statutes, executive orders, and provisions of Army Regulation 200-1, and any specifications within this contract to the Contracting Officer Representative (COR) as well as the Director of Engineering & Public Works.

C.3.11.2 Reporting Noncompliance. Contractor shall immediately report any nonconformance and/or noncompliance with applicable Federal, State or Local environmental laws, Army and installation environmental regulations or policies to the COR and Director of Engineering & Public Works.

C.4.0 Administration.

C.4.1 On-Site Workers: The Government will coordinate with the contractor’s program manager for assignment of work tasks to on-site contractor personnel. The contractor support personnel working on-site shall:

C.4.1.1 Implicitly consent to Government searches, monitoring and surveillance, including audio and video recording of actions and conversations while entering and working on the Government facility.

DRAFT

Ramos, Sheila CIV This was revised a bit. Is this acceptable?

C.4.1.2 Wear a Common Access Card (CAC) or a DA Form 1602, Contractor Identification Card, attached above the waist or on a lanyard around the neck at all times while in any DEVCOM CBC owned or controlled building or facility.

C.4.1.3 Label workstations and offices with employee and company name.

C.4.1.4 Identify themselves as a contractor when answering government telephones.

C.4.1.5 Have an auto-generated caveat in the name field on all emails that distinctly identifies the employee as a contractor.

C.4.1.6 Not sign memoranda or any other documents which will imply that they are making a decision on behalf of the Government.

C.4.1.7 Not attend meetings as the sole representative of DEVCOM CBC with the Department of the Army (DA), Department of Defense (DOD), or other Governmental agencies.

C.4.1.8 Identify themselves as a contractor employee at the start of any meetings.

C.4.2 DoD Computer Network Access. All Contractor employees, subcontractors, and suppliers at the applicable installation or facility shall comply with governing policies for gaining network access and for securing and using email accounts. All Contractor employees, subcontractors, and suppliers shall comply with DOD and agency-specific regulations and policies pertaining to Government-owned websites and databases. The contractor shall coordinate with the Government to obtain approval from the agencies’ security and public affairs officials.

C.4.3 Security. This contract requires access to classified materials. The highest clearance required shall be SECRET. The DD Form 254 for this contract governs access and use of classified materials. The contractor and subcontractor personnel shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified "Confidential," "Secret," and requires contractors to comply with the Security Agreement (DD Form 441) and the most recent version of the National Industrial Security Program Operating Manual (DoD 5220.22-M). The DD Form 254 for this task governs access and use of classified information.

C.4.3.1 AT Level I training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil.

C.4.3.2 iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the CO. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

C.4.3.3 Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to government information systems. All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DoD Information Assurance Awareness prior to access to the IS and then annually thereafter.

C.4.3.4 For contracts that require a formal OPSEC program. The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan with 90 calendar days of contract award, to be reviewed and approved by the responsible government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

C.4.3.5 For contracts that require OPSEC training. Per AR 530-1, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained with 30 calendar days of their reporting for duty and annually thereafter.

C.4.3.6 For information assurance (IA)/information technology (IT) training. All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoD 8570.01, DoD 8570.01-M and AR 25-2 which must be completed upon contract awards.

C.4.3.8 For contracts that require handling or access to classified information. Contractor shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified "Confidential," "Secret," or "Top Secret" and requires contractors to comply with: (1) The Security Agreement (DD Form 441), including the National Industrial Security Program Operating Manual (DoD 5220.22-M) and, (2) any revisions to DoD 5220.22- M, notice of which has been furnished to the contractor.

C.4.3.9 Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. Contractor and all associated subcontractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes must be completed upon contract award.

C.4.3.10 For contractors requiring a Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated national Agency Check with Inquiries (NACI) or an equipment or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, do a DoD network using DoD-approved remote access procedures; or, (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

C.4.3.11 For contractors that do not require a CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and processes using the National Crime Information Center Interstate Identification Inex (NCICIII) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

C.4.3.12 Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12, Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

C.4.4 The contractor shall return all items provided at Government on-site facilities, to include notes, reports, computer software, and files to the Government upon request or at the end of this contract.

C.4.5. Accounting for Contract Services Requirement. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.sam.gov. For instructions, please select “Help” from the main navigation menu, then select “User Guides”, and then select “Quick Start Guide for Service Contract Reporting” to create the required report.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year, which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2021. If further assistance is required, contractors may direct questions to the Federal Service Desk located at www.fsd.gov.

C.4.5.2 The reporting period shall be the period of performance ending 30 September of the government fiscal year and must be reported by 31 October of each calendar year.

C.5.0 Deliverables. The following items shall be delivered by the contractor. All data shall be delivered in accordance with the attached DD Form(s) 1423. The contractor may obtain a copy of Data Item Descriptions listed in block 4 from: http://assist1.daps.dla.mil/quicksearch/.

C.5.1 ELINA001; Start of Work Meeting Minutes. The contractor shall deliver minutes from the start of work meeting.

C.5.2 ELINA002; Contractor’s Progress, Status, and Management Report. The contractor shall prepare monthly progress reports

C.5.3 ELIN A003; Annual Report. The contractor shall prepare and provide an annual report at the end of each period of performance (base year, option year 1, option year 2).

C.5.4 ELIN A004; Final Comprehensive Report. The contract shall prepare and provide a final comprehensive report at the end of the total effort.

C.6.0 Security/Surety Clearance. Efforts performed under this contract shall require access to documentation up to the SECRET level. Failure to obtain or maintain these clearances shall be considered grounds for termination.

Access to some of the data and field test sites will require a SECRET level security clearance.

C.6.1 The contractor must provide personnel with SECRET level clearances on day one of contract award. New personnel must be capable of obtaining an interim SECRET level clearance within two months of contract award.

C.7.0 Place of Performance. This effort will take place at U.S. Army laboratory facilities located at the Aberdeen Proving Ground, Edgewood Area (APGEA). The Government will provide basic utilities (electric, water, gas, vacuum, communication) to support work on the contract. The contractor shall have a Government desk area and computer access, be required to facilitate and attend meetings in government conference rooms, and conduct laboratory evaluations in government lab rooms. The contractor will use Government facilities for surety evaluations.

C.8.0 Government Furnished Property/Equipment (GFP/GFE): None

C.9.0 Safety/Hazards Information. This contract requires the contractor to perform surety operations with the chemical agents GA, GB, GD, GF, VX, L, HD, HN1, HN3, HL, AC, CK, EA Compounds, stimulants, non-agent compounds, TICs, BSL2 and BSL3 agents and various solvents in accordance with Biosciences Standing Operating Procedures (SOPs), written procedures, DEV COM CBC requirements, local guidelines and material safety data sheets. The contractor shall also handle chemical agent contaminated items in accordance with DB SOPs, DB written procedures, CBC requirements, and local guidelines to minimize hazards. The contractor shall follow the requirements of the SOP and local guidelines to minimize hazards and shall comply with the applicable SOPs. The contractor shall follow the SOP that pertains to the agent and operation per evaluation.

C.9.1 CHEMICAL: When using Chemical agents on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor shall comply with the current versions of: AR 385-10 (The Army Safety Program); DA PAM 385-61 (Toxic Chemical Agent Safety Standards); DA PAM 385-10 (Army Safety Program); AR 190-59 (Chemical Agent Security Program); Interim Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Nerve Agents GB, GA, GD, GF, VX, and Mustard Agents H, HD, and HT; AR 50-6 (Chemical Surety); and all local policies and procedures (available upon request) for operations involving military unique chemical agents or other chemicals which fall into the same range of toxicity as chemical agents (such as agent degradation products and/or precursors). Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.2 BIOLOGICAL AND TOXINS: When using biological select agents and toxins on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor shall comply with the current versions of: AR 50-1 (Biological Surety); AR 385-10 (The Army Safety Program); DA PAM 385-10 (Army Safety Program); DA PAM 385-69 (Safety Standards for Microbiological and Biomedical Laboratories); AR 190-17 (Biological Select Agents and Toxins Security Program); 7 C.F.R. 331 (Possession, Use, and Transfer of Select Agents and Toxins); 9 C.F.R. 121 (Possession, Use and Transfer of Biological Agents and Toxins), and 42 C.F.R. 73 (Select Agents and Toxins).

Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. In addition, the contractor shall comply with all local biological safety, security, or surety policies and procedures (available upon request). The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.2.1 The contractor shall comply with the current versions of: AR 385-10 (The Army Safety Program; DA PAM 385-10 (Army Safety Program); and DA PAM 385-69 (Safety Standards for Microbiological and Biomedical Laboratories) when working with infectious agents and toxins. Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. In addition, the contractor shall comply with all local policies and procedures concerning infectious agents and toxins (available upon request). The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.3 RAD/ LASER: The contractor shall comply with the current versions of the CBC Radiation Safety Program for all operations involving lasers or non-ionizing radiation.

C.9.3.1 Onsite contractors shall not bring or use radioactive material or equipment which generates ionizing radiation unless approved by the CCDC CBC Radiation Safety Officer ((410) 436-4411).

C.9.4 GENERAL: When working on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor will operate under an approved Standard Operating Procedure (SOP) for all hazardous operations to include, but not limited to: toxic chemicals, microbiologicals (pathogenic and non-pathogenic), toxins, radioactive materials, explosives/pyrotechnics, lasers, x-rays devices or any other substance or equipment which is hazardous. It the contractor must prepare an SOP, it shall do so IAW the latest version of Preparation of Standing Operating Procedure (SOP). The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.4.1 When working on-site at the Edgewood Area of Aberdeen Proving Ground, the Government will conduct, and contractor personnel are subject to, respirator fit testing IAW the current versions of 29 CFR 1910.134 and AR 11-34 (The Army Respiratory Protection Program). The contractor shall meet all requirements for a respirator medical clearance and proper fit prior to contract start of work. Individuals failing to meet all medical and fit requirements will be prohibited from performing operations in a chemical agent and/or hazardous work environment that requires respiratory protection.

C.10.0 Travel Requirements. There is limited travel requirements associated with this effort, to include possible attendance at off-site meetings, conferences, or required trainings and in accordance with the Joint Travel Regulations (JTR). Travel locations for this effort are listed in the table below and are estimated based on program history; however, exact locations and trips are dependent upon anticipated requirements.

Trip Destination # of Trips # of Days # of People CONUS (To be Determined) 4 Per Year 5 1 to 8

C.11.0 Period of Performance. All work, including acceptance of all deliverables by the Government, shall be completed over one 12 month base period and two 12 month option periods.

C.12.0 Government Contract Manager.

C.13.0 Government Contracting Officer’s Representative (COR).