N62645-16-R-0038.doc

Section B - Supplies or Services and Prices

Base Period: Medical Modeling

CPFF

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Base Period: ODCs

COST

ESTIMATED COST

Base Period: Travel

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

ESTIMATED COST

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

CAPABILITY-BASED MEDICAL MODELING AND SIMULATION FOR NHRC

1.0 BACKGROUND

Naval Health Research Center (NHRC) Medical Modeling and Simulation Department performs medical modeling and simulation research for DoD activities. The Joint Medical Planning Tool (JMPT) is a software program for DoD medical planners that estimates medical resource requirements using data from the Expeditionary Medical Encounter Database (EMED) and Expeditionary Medical Knowledge Warehouse (EMedKW) to develop course of action operational risk assessments. JMPT performs overall medical systems analysis and operations research studies for a variety of scenarios. This work assumes a systems view of the tactical medical treatment facility (MTF) network within the theater of operation where the MTFs are integrated with transportation assets and compete for medical/logistics resources (staff, equipment, transporters) as human casualties flow through the system. JMPT supports analysis of casualty mortality relative to time and space on the battlefield and the capabilities of medical and evacuation assets. Casualty data from the EMED is used along with subject matter expert input to model the likelihood of dying from injuries because of delay in treatment.

Users enter various factors, such as personnel resources, number and types of treatment sites, treatment capability, distribution of casualties and arrival rate, and transport quantity, and home locations. JMPT provides a graphic representation of the assets used, the location of these assets, the number of patients treated at each treatment facility, and how often the patients use them. It reports overall patient arrivals, patient disposition, and resource utilization. JMPT provides a decision aid for medical planners to conduct course of action risk assessments. JMPT has undergone formal DoD verification and validation testing and has been accredited by the OASD (DHA) for use as a DoD medical planning modeling and simulation tool for all service branches.

2.0 SCOPE OF WORK

This acquisition will enhance the current capabilities of the JMPT to better assist military medical planners and logisticians in assessing the adequacy of medical support when synchronized with military operations and in evaluating the medical support mission as well as providing support medical course of action analysis and studies across the Range of Military Operations (ROMO). National and Defense Planning Scenarios may be represented in the tool to address a variety of operational concepts. The contractor shall design and develop IT applications in accordance with the specifications for enhancing JMPT and for establishing a common user database where data elements can be updated or added and are available for use in the suite of NHRC tools. This effort includes defining and expanding the medical capabilities, determining the data elements and data relationships for forward resuscitative care and theater hospitalization required to conduct risk assessment, configure medical capabilities, evaluate emerging requirements, conduct mission rehearsal and deliver training, and provide help-desk services. The tasks also include developing a methodology and implementing a died of wounds (DOW) due to delay of treatment algorithms. Experience developing DOW algorithms is a requirement.

Medical planners may use various programs that produce input used in the JMPT. Examples of these programs include the Casualty Rate Estimation Tool (CREstT) for shipboard, fixed base and ground casualty estimation, the Patient Condition Occurrence Frequency Tool (PCOF), the Expeditionary Medical Requirements Estimator (EMRE), and the Estimating Supplies Program (ESP). Given the likely medical planner use of these programs, development and maintenance-related knowledge and experience with each of these tools is a minimum requirement of this solicitation.

3.0 SPECIFIC REQUIREMENTS

Activities to accomplish the aforementioned requirement to completion include:

3.1 Develop, maintain and enhance the Expeditionary Medical Knowledge Warehouse (EMedKW) - Manage medical modeling and simulation data sets, monitor for data integrity, and perform statistical analysis of these data sets. The contractor shall develop the data dictionaries and data specification documents. The data elements in the warehouse will be accessible by a variety of program applications, such as casualty rate estimation, medical logistics, the Estimating Supplies Program (ESP), and other medical planning software. The contractor will design, develop and build enhanced operational capability for the EMedKW. The contractor will further assist in the configuration control management of EMedKW. The contractor will demonstrate an existing, intimate knowledge and understanding of all content, structure, and relationships among fields and files within EMedKW and the software, programs, models and simulations it supports.

3.2 Maintain and enhance JMPT and other NHRC M&S tool functionality. This includes convening a Change Control Board (CCB) and maintaining an on-going database of desired enhancements as defined by the Government project sponsors and principal investigators. Enhancements will include integrating JMPT into Navy wargaming environments (e.g. Navy Continuous Training Environment (NCTE)) and with other DoD models and development of collaboration tools. This would allow several people to exchange data, share scenarios and reports. Identify operationally relevant reporting metrics (e.g., ANNEX Q) and implement enhancements to the JMPT and other M&S tool reporting features. Provide additional user feedback during JMPT scenario development and add more validation checks (e.g., validate military treatment facility (MTF) data to detect data errors before simulation is run).

3.3 Design, develop, document and test new functionality to design optimum MTFs. This work will likely require collaborative effort between military research and development, academic and industry partners.

3.4 Design, develop, document and integrate modeling for chemical, biological, radiological, and nuclear casualties within existing tools.

3.5 Configure JMPT to run large, data intensive scenarios efficiently and without failure on PCs. Develop necessary documentation as described in MIL-STD 3022 (26 Jan 2008) to support the continued accreditation of JMPT. Additional authorizations include NMCI and OneNet certification while complying with Defense Risk Management Framework (RMF) protocols. The contractor must demonstrate at least 5 years knowledge and working experience of JMPT functionality, modeling assumptions, and development environment. In addition, the contractor must demonstrate direct experience integrating and federating JMPT into other operating environments (i.e., Human Injury and Treatment Endgame Framework) and with other M&S tools.

3.6 Develop necessary documentation as described in MIL-STD 3022 (26 Jan 2008) to support the accreditation of modeling and simulation tools including CRestT, PCOF, ESP, EMRE and other M&S tools developed under this PWS. Additional authorizations include, but are not limited to NMCI and OneNet certification while complying with RMF protocols.

3.7 Support for studies, analyses and reporting. JMPT and the other M&S tools in this PWS can be used to determine the medical requirements for theater hospitals and for new military concepts of operation. Provide support for future operations in complex and distributed environments including new and evolving concepts of operation within the Range of Military Operations (ROMO). JMPT can be used to evaluate Forward Resuscitative capabilities across the ROMO, to include Humanitarian Assistance missions. Additional studies for other agencies may be performed including Department of Homeland Defense, State, Health and Human services as well as regional government agencies and private sector organizations. All tasks may be conducted using the input and expertise of the Subject Matter Expert panels. Support analytic efforts using the suite of planning and assessment tools described above. The contractor must demonstrate proficiency in use of JMPT, PCOF, CREstT, ESP and EMRE, and must show analysis conducted utilizing these tools. The contractor must demonstrate at least 5 years knowledge and work experience using planning tools in a military expeditionary medical M&S environment.

3.8 Design, develop, implement, and test JMPT and other NHRC M&S tool functionality- Add client/server capability and collaboration tools that would allow several people to work on scenarios and share their scenarios, common data, and reports. Enhance user-defined reports features, allowing users to create charts from custom queries, and data manipulation without the need for complex queries. Deliverables include reports and or conference presentations (for example, the Military Operations Research Society Symposium) that describe the additional JMPT and other NHRC M&S tool functionality.

3.9 Develop software architecture and framework. Integrate the medical treatment modules into the larger campaign models including weapons effects and threat vulnerability models. Develop database structures, monitor and maintain data integrity, maintain database, integrated injury generation model, and develop understanding of afloat and ashore, ship and vehicle vulnerabilities to address patient injury and treatment. Develop multiple injury scoring methodologies (e.g. , the Military Combat Injury scoring system (MCIS) and the Military Functional Incapacity Scale (MFIS)) and integrate them into the casualty generation and care providing components of JMPT.

3.10 Development and transition of a Medical Network Optimization tool prototype to estimate throughput from point of injury to evacuation from theater.

3.11 Develop training materials and establish a broader JMPT community of users. Develop training to introduce the medical planner to conduct risk assessments using JMPT. Provide initial entry level medical planners the ability to visualize theater support requirements and to learn how to create medical estimates and supportability within a defined theater of operations. Training sessions in both classified and unclassified environments, will be needed both through DCO and other virtual modalities as well as direct travel to various sites globally. Develop and manage Help Desk support activities and provide monthly metrics defined by government sponsor and PI on Help Desk related functions. Develop Microsoft Windows and Microsoft Office Suite compatible tutorials on JMPT and other NHRC M&S tool functionality and use. Support collaborative efforts with other organizations (as needed).

3.12 Incorporate simulated time of death into casualty flow using survival function modeling in JMPT. The subjective results derived from the SME panel are useful as an initial capability but need to be extended and tested with empirical data. This task includes the development and demonstration of an automated capability for quickly collecting/analyzing data from the EMED to support the DOW and injury severity scoring research efforts and future DOW and injury severity scoring research efforts. The contractor must demonstrate prior experience developing mortality based outcome algorithms.

3.13 Develop, implement, document and maintain resource utilization estimation methodologies. Deliver a comprehensive logistics utilization simulation environment for testing healthcare planning assumptions at the organizational level. Healthcare delivery performance, resource requirements, and fiscal implications will be projected under a variety of risk profiles across the range of military and civilian operations.

3.14 For all products, models, and simulations develop security protocols for networking, Validation and Verification (V&V), and DMDS and NMCI certification while complying with RMF protocols.

3.15 Provide subcontractor management support as needed.

3.16 Furnish and deliver documentation of the software, technical data, and data that is developed, created, drafted, modified, and/or changed under this contract to the Government.

4.0 ESTIMATED STAFFING

The period of performance shall be for one base period of 12 months, followed by four, 12-month option years, for a potential total of approximately 60 months. The expectation is that this is approximately a 31,680 hour (or less) effort for the base period of performance. An estimate of the type of direct labor and FTEs required to accomplish the aforementioned research include:

This is the Government’s estimation of the staffing needed to accomplish this effort. The offeror may have an alternative approach to staffing during the proposal phase. However, any deviation from the staffing estimated could be perceived as noncompliance if not sufficiently supported by the offeror and acknowledged by the evaluator/client. Therefore, if an alternative is being proposed, it is required that the offeror first address the base requirement as a minimum and then augment such with an alternative if the offeror is proposing an alternative.

Resumes shall be provided for all positions to demonstrate sufficiently enough to the evaluator or client that the person proposed has the knowledge and experience relevant to accomplish the aforementioned tasks.

5.0 TRAVEL AND OTHER DIRECT COSTS

5.1 Travel: There may be travel (CONUS and OCONUS) required to perform this PWS. Travel destinations are not definitive at this time and will be defined on an as needed basis in writing (e.g., email) by the COR. For proposal purposes, the offeror shall use a figure of NTE $35,000 per year for the base and 4 option periods (before contractor burdens). Travel approval must be processed in accordance with client-command procedures (e.g., TAD request), in accordance with Joint Travel Regulations, documented and submitted with the Monthly Status Report, and correlated with a corresponding line item in the invoice for payment. The number of Contractor personnel required will be determined at the discretion of the technical point of contact. There may be circumstances requiring contract personnel to drive or ride in a Government vehicle in the performance of conducting various research study requirements, including (but not limited to) travel to off-site commands for meetings, relocation of research equipment or transportation of research subjects, but not including any personal services. Should such a situation arise, the contractor must first be in compliance with local base/command regulations. Travel claims for all on-site Contractor personnel shall be in accordance with the Joint Travel Regulations (JTR). All travel will need to be approved by the technical point of contact and COR in writing via e-mail. Travel into any of the OCONUS or FOREIGN areas must be processed in accordance with standing DoD Directives and Command area of responsibility procedures.

5.2 Other Direct Costs (ODC): There may be ODCs required to perform this requirement and will be defined on an as needed basis in writing (e.g., e-mail) by the technical point of contact for this task order. All ODCs will need to be approved by the technical point of contact and COR in writing (e.g., email) if within scope and budget. The ODCs anticipated over the period of performance are as follows (but subject to change):

· Software and supplies: For proposal purposes, the offeror shall use a figure of NTE $7,000 per year for the base and 4 option periods (before contractor burdens).

· Computers: For proposal purposes, the offeror shall use a figure of NTE $45,000 for the base year (before contractor burdens).

6.0 ASSUMPTIONS AND CONSTRAINTS

6.1 The expectation is that this will be an incrementally-funded Cost-Plus Fixed-Fee type contract because the service is directed toward objectives for which the work cannot be precisely described in advance. This requirement addresses an indeterminate amount of data to be processed and analyzed. This effort requires data sets from various programs to produce input values that will be used by the Joint Medical Analysis Tool (JMPT). There is an uncertainty pertaining to the amount of and frequency with which data will be obtained from these programs to fully complete the requirement. The Offeror shall already be approved for performance on a Cost-Plus-Fixed-Fee contract and a security clearance level of SECRET (requiring a DD254).

6.2 This effort does not require on-site contractor personnel at the Naval Health Research Center. All positions will be located at the contractor’s facility. Access to SIPRNet at the contractor’s facility may be required to perform this requirement. The contractor shall have a history of access to SIPRNet at their facility. Additionally, the contractor must have the ability to establish and maintain a classified analysis environment to perform the scope of work required for this effort.

6.3 This effort is not considered a new requirement (legacy contract: W911QY-11-D-0058 0003) and therefore the employer-employee right of first refusal concerning incumbent employees with the successful offer is relevant to this contract.

6.4 Resumes shall be provided for the aforementioned positions, if proposed (see section 4.0). Proposed contractor personnel must have existing favorable adjudication and have or be able to receive a Common Access Card (CAC) on the first day of performance.

6.5 The period of performance shall be for a base period of 12 months, followed by four, 12 month option periods, for a total of 60 months. The expectation is that this is approximately a 31,680 hour (or less) direct labor effort for each 12 month period of performance. In addition, there is anticipated travel which is estimated at $175,000 (Not to exceed $35,000 per year) and other direct costs (ODCs) estimated at $80,000 (Not to exceed $52,000 for the base period and not to exceed $7,000 for each option period) before contractor burdens for the 60 month period of performance.

6.6 Contractor procured equipment under this contract is considered a deliverable end item and ownership title is retained by the Government unless otherwise defined within the contractor’s proposal and approved by the NHRC technical project manager (FAR Subpart 45.4 applies).

7.0 METHODS OF QUALITY ASSURANCE SURVEILLANCE

The Quality Assurance Surveillance Plan for this requirement is contained in Attachment 2.

Section D - Packaging and Marking

DELIVERABLES

All deliverables required under this contract shall be packaged, marked and shipped in accordance with best commercial practice. At a minimum, all deliverables shall be marked with the contract number and contractor name.

Section E - Inspection and Acceptance

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 time of award.

(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.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

30-AUG-2017

140 SYLVESTER ROAD

SAN DIEGO CA 92106-3521

619-553-0628

N63116

30-AUG-2017

N63116

30-AUG-2017

N63116

30-AUG-2018

N63116

30-AUG-2018

N63116

30-AUG-2018

N63116

30-AUG-2019

N63116

30-AUG-2019

N63116

30-AUG-2019

N63116

30-AUG-2020

N63116

30-AUG-2020

N63116

30-AUG-2020

N63116

30-AUG-2021

N63116

30-AUG-2021

N63116

30-AUG-2021

N63116

Section G - Contract Administration Data

CONTRACT POCS

CONTRACT ADMINISTRATION CONTACT

Contract Specialist: TBD

Phone Number: TBD

Email: TBD

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

Name: TBD

Phone Number: TBD

Email: TBD

CLAUSES INCORPORATED BY REFERENCE

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).

Cost Voucher

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

(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

Pay Official DoDAAC

Issue By DoDAAC

Admin DoDAAC

Inspect By DoDAAC

Ship To Code

Ship From Code

Mark For Code

Service Approver (DoDAAC)

Service Acceptor (DoDAAC)

Accept at Other DoDAAC

LPO DoDAAC

DCAA Auditor DoDAAC

Other DoDAAC(s)

(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.

(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.

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

(End of clause)

Section H - Special Contract Requirements

SPECIAL REQUIREMENTS

INVENTION DISCLOSURES AND REPORTS

(a) In accordance with the requirements of the Patent Rights clause 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.

Name and address of Patent Counsel:

{Insert Office Name & Address}

{Example for NMRC}

Office of Legal and Technology Services

Naval Medical Research Center (Code 1URO)

503 Robert Grant Avenue, Suite 1W/15

Silver Spring, MD 20910

Phone: 301-319-7503/7429

(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.

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:

(1) Imprisonment and/or imposition of criminal fines; and

(2) Suspension or debarment from future Government contracting actions.

(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

2. Date/place of birth

3. Citizenship

4. Date and Location of the Visit

5. Purpose of the Visit

6. Passport Number

7. 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. Resident aliens are considered FOCI persons for licensing and technology transfer purposes. Approval by the U.S. Trade Representative may be required prior to executing a contract with a FOCI organization or person.

PRIVACY ACT AND HIPAA

The contractor shall ensure that all Protected Health Information (PHI) is protected in accordance with the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated safeguards to ensure confidentiality of health information. All contractor personnel are required to complete HIPAA training within one (1) year prior to the provision of services under this contract. Contractor personnel must complete HIPAA refresher training annually.

ENVIRONMENTAL STANDARDS

Note: This requirement applies to work performed at the contractor’s or subcontractor’s facility.

By accepting funds under this contract, the contractor assures that it will:

Comply with all applicable standards, orders, or regulations issued pursuant to the Clean Air Act (42 U.S.C. 7401, et seq.) and Federal Water Pollution Control Act (33 U.S.C. 1251, et.seq.), as implemented by Executive Order 11738 [3 CFR, 1971-1975 comp., p. 799] and Environmental Protection Agency (EPA) rules at 40 CFR Part 15. In accordance with the EPA rules, the contractor further agrees that it will:

Avoid use of any facility with a current compliance status of (1) violation, (2) non-compliance, (3) significant non-compliance, or (4) high priority violation in the EPA’s Enforcement and Compliance History Online (ECHO) website (http://echo.epa.gov/) in performing any contract that is nonexempt under 40 CFR 15.5 (contracts of less than $100,000, and certain other contracts, exempt from the EPA regulations), as long as the facility remains in one of the listed current compliance statuses.

Notify the awarding agency if it intends to use a facility in performing this contract that is in one of the listed EPA current compliance statuses or that the contractor knows has been recommended to be placed in one of the listed current compliance statuses.

Identify to the awarding agency any impact this contract may have on:

The quality of the human environment, and provide help the agency may need to comply with the National Environmental Policy Act (NEPA, at 42 U.S.C. 4321, et seq.) and to prepare Environmental Impact Statements or other required environmental documentation. In such cases, the contractor agrees to take no action that will have an adverse environmental impact (e.g., physical disturbance of a site such as breaking of ground) until the agency provides written notification of compliance with the environmental impact analysis process.

Coastal barriers, and provide help the agency may need to comply with the Coastal Barriers Resource Act (16 U.S.C. 3501, et seq.), concerning preservation of barrier resources.

Any existing or proposed component of the National Wild and Scenic Rivers system, and provide help the agency may need to comply with the Wild and Scenic Rivers Act of 1968 (16 U.S.C. 1271, et seq.).

AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor’s facilities or in any other manner communicates with contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

REVIEW OF PRESS RELEASES

The contractor agrees to accurately and factually represent the work conducted under the contract in all press releases. Misrepresenting contract results or releasing information that is injurious to the integrity of the Government may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer has received an advance copy of any press release related to the contract for review and comments at least five (5) working days prior to proposed issuance. After receipt of the Government’s comments, the contractor shall provide a copy to the Contracting Officer prior to issuance of the press release.

CONTRACTOR'S PROPOSAL

Performance of this contract by the contractor shall be conducted and performed in accordance with detailed obligations to which the contractor committed itself in Proposal dated (To be filled in at contract award) in response to NMLC Solicitation No. (To be filled in at contract award).

RESEARCH CONDUCT

Research provided under this contract must be conducted in accordance with all state, federal, Department of Defense, Department of the Navy, and command laws, regulations, policies, and procedures that govern the conduct of regulated research. Bureau of Medicine and Surgery (BUMED) Instruction 6500.3 (Series) “Research Integrity, Responsible Conduct of Research Education, and Research Misconduct” applies to research sponsored or funded by Navy Medicine. Federal regulations governing current Good Clinical Practice (cGCP) are found in 21CFR 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects protection are found in 45CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice are also standards governing the conduct of research trials. Reference for military regulations and policy governing regulated research may be found at http://www.med.navy.mil/sites/sample/bumed/humanresearch/Pages/ReferenceMaterial.aspx.

This is a non-personal services contract for research and development. The Federal Tort Claims Act does not apply.

REIMBURSEMENT OF TRAVEL, PER DIEM, AND SPECIAL MATERIAL COSTS

(a) Area of Travel. Performance under this contract may require travel by contractor personnel. If travel, domestic or overseas, is required, the contractor is responsible for making all necessary arrangements for its personnel. These include but are not limited to: medical examinations, immunizations, passports/visas/etc., and security clearances.

(b) Travel Policy. The Government will reimburse the contractor for allowable travel costs incurred by the contractor in performance of the contract in accordance with FAR 31.205-46. Travel required for tasks assigned under this contract shall be governed in accordance with: Federal Travel Regulations, prescribed by the General Services Administration for travel in the conterminous 48 United States, (hereinafter the FTR); Joint Travel Regulation, Volume 2, DoD Civilian Personnel, Appendix A, prescribed by the Department of Defense, for travel in Alaska, Hawaii, The Commonwealth of Puerto Rico, and territories and possessions of the United States (hereinafter JTR); and Standardized Regulations (Government Civilians, Foreign Areas), Section 925, "Maximum Travel Per Diem Allowances for Foreign Areas," prescribed by the Department of State, for travel in areas not covered in the FTR or JTR (hereinafter the SR).

(c) Travel. Travel and subsistence are authorized for travel beyond a fifty-mile radius of the contractor’s office whenever a task assignment requires work to be accomplished at a temporary alternate worksite. No travel or subsistence shall be charged for work performed within a fifty-mile radius of the contractor’s office. The contractor shall not be paid for travel or subsistence for contractor personnel who reside in the metropolitan area in which the tasks are being performed. Travel performed for personal convenience, in conjunction with personal recreation, or daily travel to and from work at the contractor’s facility will not be reimbursed.

(1) For travel costs other than described in paragraph (c) above, the contractor shall be paid on the basis of actual amount paid to the extent that such travel is necessary for the performance of services under the contract and is authorized by the Contracting Officer and the COR in writing.

(2) When transportation by privately owned conveyance is authorized, the contractor shall be paid on a mileage basis not to exceed the applicable Government transportation rate as contained in the FTR, JTR or SR. Authorization for the use of privately owned conveyance shall be indicated in the basic contract. Distances traveled between points shall be shown on invoices as listed in standard highway mileage guides. Reimbursement will not exceed the mileage shown in the standard highway mileage guides.

(3) The contractor agrees, in the performance of necessary travel, to use the lowest cost mode commensurate with the requirements of the mission as set forth in the basic contract and in accordance with good traffic management principles. When it is necessary to use air or rail travel, the contractor agrees to use coach, tourist class, or similar accommodations to the extent consistent with the successful and economical accomplishment of the mission for which the travel is being performed.

(4) The contractor’s invoices shall include receipts or other evidence substantiating actual costs incurred for authorized travel. In no event will such payments exceed the rates of common carriers.

(d) Vehicle and/or Truck Rentals. The contractor shall be reimbursed for actual rental/lease of special vehicles and/or trucks (i.e., of a type not normally used by the contractor in the conduct of its business) only if authorized in the basic contract or upon approval by the COR. Reimbursement of such rental shall be made based on actual amounts paid by the contractor. Use of rental/lease costs of vehicles and/or trucks that are of a type normally used by the contractor in the conduct of its business are not subject to reimbursement.

(e) Car Rental. The contractor shall be reimbursed for car rental, exclusive of mileage charges, as authorized in the basic contract or upon approval by the COR, when the services are required to be performed beyond the normal commuting distance from the contractor’s facilities. Car rental for a team on Temporary Duty (TDY) at one site will be allowed for a minimum of four (4) persons per car, provided that such number or greater comprise the TDY team.

(f) Per Diem. The contractor shall not be paid for per diem for contractor personnel who reside in the metropolitan areas in which the tasks are being performed. Per Diem shall not be paid on services performed within a fifty-mile radius of the contractor’s home office or the contractor’s local office. Per Diem is authorized for contractor personnel beyond a fifty-mile radius of the contractor’s home or local offices whenever a task assigned requires work to be done at a temporary alternate worksite. Per Diem shall be paid to the contractor only to the extent that overnight stay is necessary and authorized under this contract. The authorized per diem rate shall be the same as the prevailing per diem in the worksite locality. These rates will be based on rates contained in the FTR, JTR or SR. The applicable rate is authorized at a flat seventy-five (75%) percent on the day of departure from contractor’s home or local office, and on the day of return. Reimbursement to the contractor for per diem shall be limited to actual payments to per diem defined herein. The contractor shall provide actual payments of per diem defined herein. The contractor shall provide supporting documentation (e.g., signed travel expense reports) for per diem expenses as evidence of actual payment.

(g) Shipboard Stays. Whenever work assignments require temporary duty aboard a Government ship, the contractor will be reimbursed at the per diem rates identified in paragraph C8101.2C or C81181.3B(6) of the Department of Defense Joint Travel Regulations, Volume II.

(h) Special Material. “Special material” includes only the costs of material, supplies, or services which is peculiar to the ordered services and which is not suitable for use in the course of the contractor’s normal business. It shall be furnished pursuant to specific authorization approved by the COR. The contractor will be required to support all material costs claimed by its costs less any applicable discounts. “Special materials” include, but are not limited to, graphic reproduction expenses, or technical illustrative or design requirements needing special processing.

The Contractor shall ensure that the requested travel costs will not exceed what the Government has pre-authorized. Contractor personnel must follow established Government travel requirements, complete all forms, and obtain the required signatures prior to any travel. The Contractor may be required to coordinate with other DOD and industry for travel. Trip reports will be required at the direction of the Government.

The Contractor may be required to attend various meetings and reviews or to participate in Government projects. Travel may be CONUS as well as OCONUS. Reimbursements for travel will be in accordance with JTR and will in no case exceed those travel costs allowed by the JTR unless approved by the Government. No surcharges shall be authorized for travel costs other than the Contractor’s G&A rate approved by the Defense Contract Audit Agency (DCAA). No fee or profit shall be applied to travel costs.

Any OCONUS/FOREIGN travel by contractor personnel shall be in accordance with procedures for entering into the Area of Responsibility (e.g., CENTCOM). Refer to the Foreign Clearance Guide at https://www.fcg.pentagon.mil.

NONDISPLACEMENT OF QUALIFIED WORKERS

The requirements of FAR clause 52.222-17 (Nondisplacement of Qualified Workers) apply to this contract. The incumbent contractor is: Teledyne Brown Engineering

LIMITATION OF LIABILITY - INCREMENTAL FUNDING (NAVSUP 5252.232-9400) (JAN 1992)

This contract is incrementally funded and the amount currently available for payment hereunder is limited to (insert amount) inclusive of fee. It is estimated that these funds will cover the cost of performance through (insert date). Subject to the provisions of the clause entitled "Limitation of Funds" FAR 52.232-22 of the General Provisions of this contract, no legal liability on the part of the Government for payment in excess of (insert amount) shall arise unless additional funds are made available and are incorporated as a modification to this contract.

STANDARD FORMAT REQUIREMENTS FOR SCIENTIFIC AND TECHNICAL REPORTS

The contractor shall comply with the requirements of SECNAVINST 3900.29E “Standard Format Requirements for Scientific and Technical Reports” in preparing scientific and technical reports delivered under the contract.

CONTRACTOR PERSONNEL IDENTIFICATION

Contractor employees shall identify themselves as contractor personnel by introducing themselves or being introduced as contractor personnel and displaying distinguishing badges or other visible identification for meetings with Government personnel. Contractor personnel shall also appropriately identify themselves as contractor employees in telephone conversations and in formal and informal written correspondence. When working at Government facilities, distinguishing badges or other visible identification shall be displayed by contractor personnel.

Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in written or verbal communications associated with the contract under which they provide services.

STANDARDS OF CONDUCT

Contractor employees providing support to the Government shall conduct themselves in a professional, businesslike manner adhering to high ethical standards. Contractor employees must follow the Standards of Ethical Conduct for Employees of the Executive Branch (Codified in 5 C.F.R. Part 2635 and as amended at 76 FR 38547) and local command policy in addition to the standards of conduct policies of the contractor. The Government will not tolerate unethical behavior and behavior that reflects poorly upon the Government, its mission, and its operations. If a contractor employee is uncertain whether contemplated acts or conduct may violate the Standards of Ethical Conduct for Employees of the Executive Branch or local command policy, the contractor employee must contact the Contracting Officer Representative (COR) before engaging in such acts or conduct. CORs will seek advice on ethics issues from their ethics counselor.

NON-DISCLOSURE OF INFORMATION AGREEMENT

The contractor shall ensure that its employees complete the [Confidentiality Agreement or Non-Disclosure Agreement] included below prior to the performance of work under this [contract or task order]. Completed agreements shall be submitted to the Contracting Officer’s Representative (COR) with a copy to the Contracting Officer. The agreements will be retained in the Government’s [contract or task order] file and will be subject to periodic review.

Confidentiality Agreement (Non-Federal Employee)

Contract Number: N62645-xx-x-xxxx

Task Order Number (if applicable): xxxx

As a non-federal employee with access to procurement and command sensitive information in my performance under subject award number issued by the Naval Medical Logistics Command (NMLC) Contracting Office, I acknowledge that my conduct is governed by the Procurement Integrity Regulations found at 48 CFR or FAR Part 3.104. I also recognize that any Contractor Bid or Proposal Information and Source Selection Information, relative to my performance under this award, may be subject to further restrictions under the Trade Secrets Act, 18 U.S.C. 1832, 18 U.S.C.1905 and the Privacy Act, 5 U.S.C. 552a.

By executing this Confidentiality Agreement I agree not to disclose any procurement or command sensitive information, outside the federal government. I further agree that I will only disclose, within the federal government, any procurement or command sensitive information, to persons authorized to receive such information, in accordance…