N62645-18-R-0046.docx

N6264518R0046

Section B - Supplies or Services and Prices

Lot

NAMRU-2 Research Support Services

FFP

Firm Fixed Price Task Orders The NTE amount on this CLIN is the maximum quantity that can be ordered against this CLIN.

FOB: Destination

MILSTRIP: ADVFY18RD00016

PURCHASE REQUEST NUMBER: ADVFY18RD00016

PSC CD: AN42

NET AMT

NAMRU-2 Research Support Services

COST

Firm Fixed Price Task Orders- ODC and Travel No profit can be added to ODCs or travel on FFP task orders.

The NTE amount on this CLIN is the maximum quantity that can be ordered against this CLIN.

FOB: Destination

MILSTRIP: ADVFY18RD00016

ESTIMATED COST

NAMRU-2 Research Support Services

CPFF

Cost Plus Fixed Fee Task Orders The NTE amount on this CLIN is the maximum quantity that can be ordered against this CLIN.

FOB: Destination

MILSTRIP: ADVFY18RD00016

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Section C - Descriptions and Specifications

PWS

SOUTHEAST ASIA BIOSURVEILLANCE & EPIDEMIOLOGY RESEARCH (SABER) II

C.1 Background & Assumptions / Constraints

Contemporary pandemics and outbreaks of disease, such as the recent Ebola outbreak and emergence of the Middle East Respiratory Syndrome (MERS) and Zika virus, serve as poignant reminders of our global vulnerability to emergent human health threats. Current global disease control focuses almost exclusively on responding to pandemics after they have emerged, highlighting our current inability to predict or prevent such events. Nevertheless, dramatic failures in pandemic control such as the ongoing lack of success in HIV vaccine development more than a generation into the pandemic, have shown that this wait-and-respond approach is not sufficient. The development of systems to prevent pandemics before they are established should be considered imperative to human health. The early detection of emergent threats to human health is all the more important given the speed with which disease causing agents are now capable of being distributed around the globe through air travel and global trade. Because the success of a pathogen depends on its ability to spread from human-to-human and on the number of susceptible individuals, our ability to cross continents in a single day poses a unique new challenge to emerging infectious disease control. In today’s world of global interconnectedness, a pathogen that may have remained a regional phenomenon in an era before globalization now has few barriers to rapid global distribution. Despite this, our current disease surveillance systems and our ability to identify and respond to emergent diseases early are inadequate. Developing more robust surveillance programs to identify pathogens early and to respond to their emergence appropriately is crucial to a coherent strategy for combating future threats infectious disease threats to human health.

The Naval Medical Research Unit 2 (NAMRU-2), based in Singapore, is at the forefront of the U.S. Department of Defense (DoD)’s disease surveillance efforts in the US Pacific Command (PACOM) Area of Responsibility (AOR). Within the context of its ongoing disease surveillance activities, the NAMRU-2 is well-positioned to evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and to develop local expertise (training to detect and respond to emergent disease threats). In consonance with its mission, the NAMRU-2 requires contractor services to support the ongoing development, performance and management of research across the Southeast Asia (SEA) region and in collaboration with host-country partners.

- For task orders that are considered severable services, the task order will be performance based and will include a Performance Work Statement (PWS) that identifies the tasks to be performed and a Quality Assurance Surveillance Plan (QASP) that establishes performance metrics for these tasks. It is anticipated that the majority of task orders that provide severable services will be Frim Fixed Price (FFP).

- For task orders that are considered non-servable services, the task order will not be performance based and will not include a PWS or a QASP. It is anticipated that the majority of the non-severable task orders will be incrementally-funded Cost Plus Fixed-Fee (CPFF). A CPFF arrangement addresses research and development because of the unpredictability of the level of support.

- This effort is not considered a new requirement (legacy contract W911QY-16-D-00058) and therefore the right of first refusal concerning incumbent employees with the successful offeror is relevant.

- Human use research is expected under the task orders that will be issued under this base Indefinite Delivery Indefinite Quantitate (IDIQ) contract. Research with human subjects may not begin until the contractor (and all subcontractors) obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A Human Research Protection Officer (HRPO) review must be in place before any human use research can be supported.

-Travel is expected in support of the research efforts at NAMRU-2. The number of Contractor personnel required will be determined at the discretion of COR. All travel must be approved by the COR in writing via e-mail prior to incurring costs. Travel costs may include medical evacuation (MEDEVAC) and repatriation insurance. All travel shall be conducted in accordance with NAMRU-2 procedures and the DoD with Joint Travel Regulations (JTR) and US Department of State (DoS) regulations.

An estimated travel amount will be delineated at the task order level. The estimated travel amount (provided at the task order level) is an estimated amount and is before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

- Other Direct Costs (ODC) are expected in support of the research efforts at NAMRU-2. All ODC costs must be approved by the COR in writing via e-mail prior to incurring costs. ODCs will be specified at the task order level, but will typically include (but are not limited to) contractor-procured supplies, equipment, disposable and non-disposable items, IT support and equipment.

An estimated ODC amount will be delineated at the task order level. The estimated ODC amount (provided at the task order level) is an estimated amount and is before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

- Task orders issued under this base IDIQ contract require indemnification and medical liability insurance. The Federal Tort Claims act does not apply.

- All services provided under this base IDIQ contract are non- personal in nature.

- There are no known Organizational Conflicts of Interest (OCI) within this effort.

- Performance is primarily at Government sites in South East Asia, but some offsite performance may be required due to space constraints or the requirements of the research being conducted. The specific place of performance will be specified at the task order level.

C.2. General Requirements

The contractor shall provide all personnel, equipment, supplies, facilities (if required by space constraints), transportation, tools, materials, supervision, and other items and non-personal services necessary to perform under this contract, as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property (GFP) and services, if any (there is no GFP identified at this time; any GFP will be specifically identified at the task order level). Performance includes assisting with the following functions: management, oversight, establishing procedures for planning, allocating, and controlling resources for awarded task orders; scheduling, budgeting, and accumulating expenditures (hours and dollars); identifying expenditure and schedule problems; tracking order performance; and providing timely detailed performance status to the Government. Assisting with management includes administrative functions performed to oversee an infectious disease research program (e.g., biosurveillance, vector control, and vaccine efficacy programs) from initiation to completion, including but not limited to; report generation to the Government principal investigator(s) and funding sponsors; assisting with the initiation of new field sites; assisting with establishing agreements in-country; tracking technical progress and expenditures; travel management, and assisting with the general oversight of research program resources in-country. The contractor shall perform to the standards in this contract to accomplish the following general requirements:

C.2.1. Assist with administrative and logistical support of NAMRU-2. This support will include assisting with project management and financial management support, tracking programmatic milestones, assisting with the preparing of internal/external research and contract documents, assisting with material/supply procurement support, assisting with program logistics, assisting with the managing of regulatory requirements for human and animal research, and translation of project/protocol documents from English to local languages and vice versa. This support will also involve providing management between the US Government and potentially foreign personnel located at the client’s site or AOR.

C.2.2. Assisting with the design and conduct of protocols with NAMRU-2 and in-country partners to conduct epidemiology studies. This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NAMRU-2. Examples of current projects include population-based studies of acute febrile illness, multi-year prospective cohort studies to evaluate the risk potential of emerging viral pathogens, and retrospective and prospective epidemiological studies of emerging disease threats in the SEA region.

C.2.3. Design and conduct of protocols with NAMRU-2 and in-country partners to evaluate novel disease diagnostics and therapeutic interventions, as well as disease and vector control strategies. This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NAMRU-2. Examples of current projects include sensitivity and functionality testing of Role 0 and Role 1 portable diagnostic assays, vector mapping studies related to tick-borne and bat-borne pathogens in Laos, and spatial repellency studies involving mosquitoes in the Mekong Delta.

C.2.4. Design and conduct training with NAMRU-2 and in-country partners to develop regional expertise to detect and respond to emergent disease threats. This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NAMRU-2. Examples of current projects include the Biosecurity Engagement Program (BEP) in collaboration with the US DoS, laboratory capacity building and biosafety initiatives in Malaysia, and ongoing biosurveillance and emerging disease response activities in support of the Global Emerging Infection Surveillance (GEIS) network.

C.2.5. Serve as subject matter experts and liaisons to sub-contractors and host-country partners within the above associated mission areas.

C.2.6. Quality Control

The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program (QCP) is a procedure intended to ensure that the services provided comply with the requirements of the contract.

C.2.7. Quality Assurance

The Government shall evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government will do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

C.3. Local Staffing Sources

For this contract it is anticipated that a prime contractor will work in conjunction with local solution partners or subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving NAMRU-2 the most cost effective solution, while maintaining an acceptable level of technical performance. Any prime contractor working in-theater AOR must ensure compliance with, and be responsible for, all local tax and labor laws in the country of operation. This includes ensuring that any subcontractor(s) are also in compliance with local laws. Any prime contractor will also ensure compliance with the cognizant US command of the relevant regions and the US State Department, as there may be high risk when entering into the area.

C.4. Period of Performance

The ordering period for this contract shall be for 60 months starting on 12 August 2018 and ending on 11 August 2023.

C.5. Scientific/Technical Requirements

In addition to the US management provided under this contract, the purpose of this acquisition includes providing scientific/technical (including administrative support) services in support of medical research and development, whether that be directly provided by the prime contractor or indirectly provided by a host-country subcontractor, or a third party entity not under this contract, for NAMRU-2 that are not personal services, inherently governmental functions, or subject to OMB Circular A76. NAMRU-2 R&D activities are generally categorized under the following topic areas: (1) Disease Surveillance and Epidemiology, (2) Evaluation of Novel Diagnostics, Therapeutic Interventions, and Vector Control Strategies, (3) Disease Ecology, and (4) Capacity Development and Training. Support for these activities will include, but is not limited to: general project oversight; study protocol and document development; development and validation of training materials and standard operating procedures, management of the regulatory requirements pertaining to the conduct of ethical human and animal research (e.g. IRB submissions and approvals); non-Governmental procurement support ; logistical support for shipping and travel; field-site evaluation and selection; subject recruitment and follow-up; biological or environmental sample collection/accessioning/storage; laboratory characterization of collected samples; data management and analysis; translation services to and from English; report generation; and manuscript preparation. A close working relationship, via sub-contract, agreement or other appropriate vehicle may also be required with numerous entities including, but not limited to, regional academic institutions and local health care facilities, as well as with foreign governmental institutions such as Ministries of Health, Ministries of Defense, Environmental and Wildlife Ministries. Additional details for each of the study categories are provided below:

C.5.1. Disease Surveillance and Epidemiology

Support is required on a variety of disease surveillance and related epidemiology activities; including but not limited to retrospective and prospective epidemiology studies, active disease surveillance studies, as well as cohort and cross-sectional studies.

C.5.2. Evaluation of Novel Diagnostics, Therapeutic Interventions, and Vector Control Strategies

Support is required for studies aimed at evaluating the performance of (yet to be determined) novel disease diagnostics, therapeutic interventions, and disease vector control strategies. Focus will be on advanced development and evaluation of commercially available products for the benefit of public health and military force health protection.

C.5.3. Disease Ecology

Support is required for studies aimed at elucidating the ecological relationships between disease pathogens and the environment. The principal goal of these studies is to understand the environmental conditions that are permissive to pathogen emergence and the characterization of the necessary and/or sufficient factors that increase the risk of transmission. Identification of such risk factors may point to potential mitigation strategies for disease control and identification of hazards for deploying forces.

C.5.4. Capacity Development and Training

Support is required for the development of regional capacity to detect and safely respond to emergent disease threats. It is envisioned that capacity development will take the form of targeted and distinct training topics. Examples of such training include but are not limited to Biosafety/Biosecurity Training, Field Diagnostics Training, and Epidemiological Investigation Training.

C.6. Data Deliverables

C.6.1. Contractor Progress, Status, and Management Report. The Contractor shall provide monthly/quarterly status reports for each individual task order in Contractor format by the 10th working day of each month/quarter to the COR and Contracting Officer (KO). This status report shall include, at a minimum, an executive summary roll-up of all contract efforts to include initiatives and efforts to date, planned tasks and travel for the next reporting period, projected overtime if approved by the KO, and concerns or issues related to performance as they relate to the PWS for this task.

C.6.2. Technical Report – Study/Services. The contractor shall provide a final technical report no later than thirty days after expiration of the task order. This final report shall include, at a minimum, a comprehensive summary of technical accomplishments and issues, if any, made during the course of the task order performance. To be applied at the task order level – not required for the base contract.

C.6.3. Lab/Data/Surveillance Reports. The contractor shall provide periodic technical data reports related to specific studies in which data output is required to be generated, such as the results of disease surveillance findings for a period of time. IRB/Human Research Protection Program (HRPP) documentation, such as approved protocols, approved informed consent forms, and assurance documentation is considered a data item under a task order (when required to furnish). To be applied at the task order level – not required for the base contract.

C.7. Security Requirements

C.7.1. DD254

Specific task orders issued under this contract may require personnel to have access to classified information. This contract will therefore include a DD254 at the SECRET level. Specifics regarding security classification will be handled at the task order level. The basis for need will be for the purpose of attending Department of State (DoS) or US Embassy-based meetings containing DoS/DoD sensitive information. Contractor employees, regardless of security classification requirement, are expected to comply with any onboarding procedures required by NAMRU-2and/or the US Embassy, Singapore.

C.8. QASP

TASK/

DELIVERABLE

PERFORMANCE

STANDARD

PERFORMANCE

INDICATOR/

ACCEPTABLE

LEVEL OF

PERFORMANCE

METHOD OF

SURVEILLANCE

PERFORMANCE RATING

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful and informative data and information.

Contractor's technical performance meets all contract requirements. Problems that are encountered are minor in nature, as follows: does not cause a delay in schedule; does not cause costs to increase; involves minimal effort to fix; and does not affect overall contractor performance.

All matters resolved in a satisfactory and timely manner.

Random inspection

Are study reports complete and are they compliant with various government regulations?

Assignment of performance rating and criteria:

Excellent Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner.

Unacceptable Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that were encountered were minor in nature, as follows: does not cause a delay in schedule; does not cause costs to increase; involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Inspection

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all contract timeliness requirements. Problems that are encountered are minor and resolved in a highly effective manner, having no impact on schedule, cost, and overall contractor performance.

Acceptable Performance meets most timeliness requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable Performance fails to meet many timeliness requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information Contractor's technical performance meets all contract requirements.

Problems encountered were minor in nature, as follows: does not cause a delay in schedule; does not cause increase costs;

involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Sampling and feedback from client

Is the contractor committed to high customer satisfaction? How proactive is the contractor? Is the contractor providing positive value to the government?

Assignment of performance rating and criteria:

Excellent Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, as follows: does not cause a delay in schedule; does not cause increased costs;

involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Sampling

What is the government’s overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

SUPTXT204-9400(1-17)

Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information

Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 – “DoD Implementation of Homeland Security Presidential Directive – 12 (HSPD-12)” dated November 26, 2008 (or its subsequent DoD instruction) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

APPLICABILITY

This text applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information, provide support associated with fiduciary duties, or perform duties that have been identified as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy Command under this contract is required to obtain a Department of Defense Common Access Card (DoD CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

ACCESS TO FEDERAL FACILITIES

Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Command’s Security Manager upon arrival to the Command and shall out-process prior to their departure at the completion of the individual’s performance under the contract.

ACCESS TO DOD IT SYSTEMS

In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI). All contractor employees under this contract who require access to Privacy Act protected information are therefore categorized no lower than IT-II. IT Levels are determined by the requiring activity’s Command Information Assurance Manager.

Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation , which is a higher level investigation than the National Agency Check with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance Technical Level 1, and must be trained and certified on the Operating System or Computing Environment they are required to maintain.

Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee’s duties, such employees shall in-process with the Navy Command’s Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-N; therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the “supervisor”.

The SAAR-N shall be forwarded to the Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

INTERIM ACCESS

The Command's Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR’S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor’s Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity’s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor’s Security Representative. The Contractor’s Security Representative shall be the primary point of contact on any security matter. The Contractor’s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES

Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Contractor employees under this contract are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified as National Security Positions. At a minimum, each contractor employee must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive or IT-II position. The investigation consists of a standard NAC and a FBI fingerprint check plus law enforcement checks and credit check. Each contractor employee filling a non-critical sensitive or IT-II position is required to complete:

Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than 10 years) throughout the contract performance period. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the Command’s Security Manager upon arrival to the command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Employees requiring IT access shall also check-in and check-out with the Navy Command’s Information Assurance Manager. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date.

The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Command Security Manager. The Command’s Security Manager will review the submitted documentation for completeness prior to submitting it to the Office of Personnel Management (OPM); Potential suitability or security issues identified may render the contractor employee ineligible for the assignment. An unfavorable determination is final (subject to SF-86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. The Command’s Security Manager will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DoD Central Adjudication Facility (CAF) for a determination.

If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor’s Security Representative. Although the contractor will take JPAS “Owning” role over the contractor employee, the Command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee’s performance under the contract.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO OR PERFORMING NON-SENSITIVE DUTIES

Contractor employee whose work is unclassified and non-sensitive (e.g., performing certain duties such as lawn maintenance, vendor services, etc. ...) and who require physical access to publicly accessible areas to perform those duties shall meet the following minimum requirements:

To be considered for a favorable trustworthiness determination, the Contractor’s Security Representative must submit for all employees each of the following:

The contractor shall ensure each individual employee has a current favorably completed National Agency Check with Written Inquiries (NACI) or T1 equivalent investigation, or ensure successful FBI fingerprint results have been gained and investigation has been processed with OPM

Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

* Consult with your Command Security Manager and Information Assurance Manager for local policy when IT-III (non-sensitive) access is required for non-US citizens outside the United States.

Section E - Inspection and Acceptance

COR

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) For the purpose of this clause, the Contracting Officer’s Representative (COR) is the duly authorized representative of the Contracting Officer.

(b) The COR for this contract will be appointed at the time the base contract is awarded.

(c) The COR will perform inspection and acceptance of services to be provided. Inspection and acceptance will be performed at the locations listed in the contract or task orders.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

11-AUG-2023

PSC 470 BOX 4200

FPO AP 96534

FOB: Destination N62814

11-AUG-2023

N62814

11-AUG-2023

N62814

Section G - Contract Administration Data

ADMINISTRATION CONTACTS

Contract Specialist: To Be Determined Phone Number:

Email:

Contracting Officer’s Representative: To Be Determined Phone Number:

Email:

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

See Individual Task Order

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

N/A

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table* Field Name in WAWF Data to be entered in WAWF

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

WAWF Acceptor/COR Email Address: TBD

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

SPECIAL CONTRACT REQUIREMENTS

INVENTION DISCLOSURES AND REPORTS

(a) In accordance with the requirements of the Patent Rights clause (FAR 52.227-13) of this contract, the contractor shall submit “Report of Inventions and Subcontracts” (DD Form 882) along with written disclosure of inventions to the designated Contract Administrator.

(b) The Contract Administrator will forward such reports and disclosures directly to the appropriate Patent Counsel, designated below, for review and recommendations, after which the reports will be returned to the Contract Administrator.

Address of Patent Counsel:

Office of Legal and Technology Services Naval Medical Research Center (Code 1URO) 503 Robert Grant Avenue, Suite 1W/15 Silver Spring, MD 20910

(c) The above designated Patent Counsel will represent the Procurement Contracting Officer with regard to invention reporting matters arising under this contract.

(d) A copy of each report and disclosure shall be forwarded to the Procuring Contracting Officer.

(e) The contractor shall furnish the Contracting Officer a final report within three (3) months after completion of the contracted work listing all subject inventions or certifying that there were no such inventions, and listing all subcontracts at any tier containing a patent rights clause or certifying that there were no such subcontracts.

PATIENT CARE AND MEDICAL LIABILITY INSURANCE

The character of services for health care workers that are providing patient care in clinical or administrative tasks under this contract will be categorized as non-personal services as provided for by Federal Acquisition Regulation (FAR) Subpart 37.4. Patient care will be incidental to research activities or projects supported under this contract. Alleged acts of medical malpractice by non-personal health care workers are not covered under the Federal Tort Claims Act and the contractor shall indemnify the Government against legal action alleging malpractice by such workers by way of indemnification and medical liability insurance provided by the contractor. Insurance as prescribed by FAR clause 52.237-7 shall be required for those medical personnel such as physicians or nurses providing patient care in clinical or administrative tasks consistent with standard coverage prevailing within the local community as to the specific medical specialty.

NOTICE REGARDING THE DISSEMINATION OF EXPORT-CONTROLLED TECHNICAL DATA

(a) Export of information contained herein, which includes release to foreign nationals within the United States, without first obtaining approval or license from the Department of State for items controlled by the International Traffic in Arms Regulations (ITARS), or the Department of Commerce for items controlled by the Export Administration Regulations (EAR), may constitute a violation of law.

(b) For violation of export laws, the contractor, its employees, officials or agents are subject to:

(c) The Government shall not be liable for any unauthorized use or release of export-controlled information, technical data or specifications in this contract.

(d) The contractor shall include the provisions or paragraphs (a) through (c) above in any subcontracts awarded under this contract.

PERFORMANCE BY FOREIGN NATIONALS OR FOREIGN OWNERSHIP, CONTROL OR INFLUENCE (FOCI) ORGANIZATIONS

In accordance with 8 U.S.C.1324a, it is unlawful to hire for employment in the U.S. an individual without verifying that individual’s employment authorization. 8 CFR 274a.2 VERIFICATION OF EMPLOYMENT ELIGIBILITY identifies the official documents that establish employment eligibility.

Prior to performance of work by a foreign national as a result of this contract, the employer shall provide the Contracting Officer the name of the foreign national and identify the type of form(s) produced for verification of employment status.

Should the foreign national’s performance require access to DoD facilities, the employer shall coordinate with the sponsor providing access, in order to submit the following:

1. Individual’s Name

1. Date/place of birth

1. Citizenship

1. Date and Location of the Visit

1. Purpose of the Visit

1. Passport Number

1. Employer’s Verification of Work Authorization

This information shall be forwarded to the Contracting Officer at least thirty days prior to the visit taking place. Failure to provide this information within this time frame may prevent the individual(s) from entry into the DoD facilities.

The offeror shall disclose if the company (or individual) is a FOCI organization. A FOCI organization includes sole proprietorships, partnerships, and corporations, and the divisions and subsidiaries of the corporation where: (a) 51% or more of the controlling (voting) stock is foreign-owned; or (b) parent organization is incorporated or otherwise charted in a country foreign to the U.S.; and (c) the organization is not performing a state function (any organization performing a state function falls under IPO authority). A division or subsidiary of an organization having a location in the U.S. is still considered a FOCI organization if the parent corporation is a FOCI organization. A university, college, or not-for-profit organization that is chartered, incorporated, or otherwise called into being in a country foreign to the U.S. and not performing a state function is a FOCI organization. A FOCI person is a non-U.S. citizen.