N6264518R0066_Amendment_1.docx

N6264518R0066

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

PERFORMANCE WORK STATEMENT

Naval Health Research Center San Diego Enhancement of Tactical Planning Tools to Optimize Operational Risk Assessment & Course of Action Analyses

Administrative Requirements

1. Period of Performance (PoP): One 12-month base period and one 12-month option period.

1. Contract Type: The expectation is that this will be a |_| Firm-Fixed-Price or |X| Cost-Plus-Fixed-Fee contract.

1. Right of First Refusal: This effort |_| is or |X| is not considered a new requirement (legacy contract W911QY-11-D-0058-0004) and therefore the right of first refusal concerning incumbent employees with the successful offeror |X| is or |_| is not relevant.

1. Severability: This effort is considered to be |X| severable or |_| non-severable (entire).

1. Security Clearance: Performance of this requirement |_| does not require access and does not authorize access to classified information or |X| does require access and does authorize access to classified information up to and including the SECRET level and will have a DD254 (including access to SIPRNET). Offerors are expected to demonstrate in the proposal possession of an active facility security clearance at the company level, including the name, phone number, and e-mail address of the company’s Facility Security Officer; and the name, phone number, and e-mail address of their cognizant DSS agent. Offeror must have a recent history of access to SIPRNET. Before extending an offer to the proposed candidates and processing personnel on this requirement for adjudication, first receive acknowledgement from the COR on acceptance of their resumes and information from the Government’s cognizant security representative concerning instructions for processing personnel clearances or government background checks.

1. Government Furnished Facilities (on-site) and Government Furnished Information:

5. This effort |X| does not or |_| does require on-site contractor personnel. This effort |_| does not |X|does represent a mix of on-site and off-site contractor personnel. The majority of the positions will be located at the contractor’s facility. Contractor personnel and its subcontractors must comply and meet the requirements under Directive-Type memorandum (DTM 08-003, Homeland Security Presidential Directive-12 (HSPD-12) and Federal Information Standards prior to issuance of Personal Identity Verification (PIV) credential or Common Access Card. The applicable SF form can be sent either by the contractor or the client’s security office, depending upon the direction of the client’s security office, prior to contractor personnel arriving at agency to begin work. SF and FD 258 shall be sent by way of FEDEX (or comparable carrier) to Naval Health Research Center (Attention: Security Manager), 140 Sylvester Road, San Diego, CA 92106 (phone 619-767-4256). This effort |_| does not |X| does require proposed contractor personnel to have a favorable adjudication of the results of the background investigation. Those personnel performing on-site shall be processed in accordance with on-site base/command procedures (e.g., SF 86, CAC cards, personnel physicals, etc.), particularly: Common Access Cards (CAC). Proposed contractors must have existing favorable adjudication and be able to receive a CAC on the first day of contract award. Contractor personnel must comply with all the onsite security requirements of the host command.

5. Health Insurance Portability and Accountability Act (HIPAA) of 1996 related guidance and requirements in accordance with BUMEDINST 7050.1B – Agreements with non-DoD entities: DoD commands are a Covered Entity as defined by the aforementioned BUMED instruction. However, in performance of its mission, the DoD command may and does contract out to non-DoD entities such that these non-DoD entities may have access to information covered under the HIPAA of 1996. When doing so, the DoD command must execute documentation in accordance with this instruction as it pertains to non-DoD entities by executing with the non-DoD entity a Business Associate Agreement (BAA, not to be confused with a Broad Agency Announcement). This effort |X| does not |_| does require a BAA and if so then the BAA is attached (see Section H). This effort |X| does not |_| does require a Data Use Agreement or Data Sharing Agreement.

5. Government Furnished Equipment / Property: There is no GFE/P identified at this time that is unique to this effort. It should be noted that all contractor procured equipment under this effort (either for FFP or CPFF) is considered as a deliverable end item and ownership title is retained by the Government unless otherwise defined within the contractor’s proposal and approved by the Government POC (FAR Subpart 45.4 applies).

1. Personal Services: This requirement |X| does not or |_| does include personal services. This effort |X| does not or |_| does include Health Care Workers. This requirement |X| does not or |_| does include clinical positions.

1. Indemnification of the Government by the Contractor and Requirement for Medical Liability Insurance: This effort |X| does not or |_| does require indemnification and medical liability insurance.

1. Human Research: There |X| is not |_| is human research involved with the client’s effort. This effort is for |X| intramural (DoD) |_| extramural (non-DoD) research

1. Animal Use: There |X| is not |_| is animal use involved with this effort.

1. Organizational Conflicts of Interest (OCI): There |X| is not or |_| is an identified potential or perceived OCI within this task order. If there is an identified potential or perceived OCI, then the technical proposal shall include as an attachment an OCI Mitigation Plan for review/approval by the client / Contracting Officer.

1. Other Contract Requirements:

11. This PWS has been reviewed and contains no services that are inherently Government functions.

11. Performance of this PWS may include access or exposure to private information subject to compliance to FAR Subparts 52.224-1 and 52.224-2.

11. Performance of this PWS may include dissemination of information / publishing subject to compliance with the Government’s requirements.

11. This PWS may include data that is subject to data right restrictions by the Government.

11. One FTE = 1920 hours (2080 hours – 80 holidays – 80 hours PTO); PTO amount may vary from company to company. Offeror’s shall propose based on their accounting system, their benefit plan and explain the calculations in their proposal.

11. A TAD form must be completed by the contractor and submitted to the Principal Investigator/Project Officer for review. After such review and if there are sufficient provisions already in the contract, the COR will notify the contractor that travel is approved. If there are not sufficient provisions in the contract then the COR will ask the Contracting Officer fa modification. This process must be adhered to before contractor personnel go on travel.

11. All travel in support of Navy Medicine must be deemed mission critical and written approval from the proper chain of command must be obtained before the travel takes place. Contractors must adhere to the travel approval process in accordance with the cognizent command’s travel policy and BUMED Memorandum “Travel Approval in Navy Medicine” issued on 10/7/13.

11. Comply with Contractor Manpower Reporting requirements.

11. For efforts requiring Reporting of Inventions or patent related matters, including during closeout of contracts, and for those that are for an NMRC enterprise command, such forms shall be processed via NMRC legal, which is currently staffed by Dr. Albert Churilla. The processing of DD 882s is not restricted to the period of closure of this contract. That is, as the technology/science develops, a DD 882 shall be filed when potential title to intellectual property is first identified.

ADDENDUM

ENHANCEMENT OF TACTICAL TOOLS TO OPTIMIZE OPERATIONAL RISK ASSESSMENT & COURSE OF ACTION ANALYSES

1. GLOBAL REQUIREMENT

1.1. Background: Providing life-saving care in-theater and maintaining the health and readiness of our warfighters across a range of operations require the right equipment, supplies, and personnel to deliver the high level of care whenever and wherever it is needed. In the past, military medical planners and logisticians have lacked a science-based standardized methodology for predicting the likelihood of injuries and illnesses, estimating casualties and patient streams, and estimating the requirements for in-theater hospitals to provide proper care for those patients. This gap undermines effective planning for operational medical support. To bridge this gap, Naval Health Research Center (NHRC) developed the Joint Medical Planning Tool (JMPT) and the Medical Planner’s Toolkit (MPTk) to fill this gap.

1.2. Scope: The Modeling and Simulation (M&S) Department at Naval Health Research Center (NHRC) utilizes the JMPT and MPTk tools to perform medical M&S research for the Department of Defense (DoD) and other governmental activities. JMPT is an operational risk assessment software program for medical planners* that estimates medical resource requirements using data from the Expeditionary Medical Knowledge Warehouse (EMedKW), the Medical Planners Tool Kit (MPTk), and the Enterprise Estimating Supplies Program (EESP). JMPT can perform 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 where the MTFs are integrated with transportation assets and compete for medical/logistics resources (staff, equipment, consumables, transporters), as 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 Tri-Service Expeditionary Medical Encounter Database has been 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 of treatment sites, treatment capability, distribution of casualties and arrival rate, and vehicle quantity, speed, and home locations. JMPT will then output graphic representations of the assets used, the location of these assets, the number of patients treated at each 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 risk assessments and broad operations research studies to improve medical systems primarily at the theater level. In addition to combat operations, JMPT is also useful for understanding medical resource requirements for international and domestic humanitarian assistance and disaster relief scenarios.

*Examples of medical planners include Joint Staff, Office of the Assistant Secretary of Defense (OASD), Defense Health Agency (DHA), Marine Expeditionary Force (MEF), Marine Corps Combat Development Command (MCCDC), U.S. Fleet Forces Command (USFFC), and Navy Warfare Development Command (NWDC).

2. SPECIFIC REQUIREMENTS

The objective of this acquisition is to continue to develop, implement, use, and enhance JMPT, MPTk, ESP and other military M&S tools to design medical course of action analyses and studies in a distributed web-based environment for the entire range of operations. National and Defense Planning Scenarios may be represented in the tool to address a variety of operational concepts. The contractor shall develop the specifications for enhancing JMPT and for establishing and enhancing a common user database where data elements can be updated, added, and available for use in a variety of medical planning and logistical tools. This 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 both CONUS and OCONUS. The tasks also include developing a methodology and implementing the died of wounds (DOW) due to delay of treatment algorithm.

The contractor shall perform the following tasks:

1. Develop, implement, use and enhance 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 will maintain the data dictionaries and data specification documents. The data elements in the warehouse will be accessible by a variety of program applications including casualty rate estimation, medical logistics, military operations risk assessment, forecasting and other medical planning software.

1. Develop, implement, use and enhance the Enterprise Estimating Supplies Program (EESP). The contractor will maintain the data dictionaries, data specification documents and the web-based interface.

1. Develop, implement, use and enhance JMPT and MPTk functionality. This includes governing a Configuration Control Board (CCB) and maintaining an on-going database of desired enhancements. Enhancements will include integrating JMPT and the ONR HIT model into Navy war-gaming environments (e.g. Navy Common Training Environment) and other planning and execution tools. These tools will be designed and accredited to function in both a local environment and across the Internet. This would allow several people to exchange data, and share scenarios and reports. Identify operationally relevant reporting metrics (e.g., ANNEX Q) and implement enhancements to the reporting feature of the tools. Develop necessary documentation as described in MIL-STD 3022 (05 APR 2012) to support the continued accreditation of suites of planning tools. Additional authorizations include DADMS (Department of Navy Application & Database Management System) and NMCI (Navy Marine Corps Intranet) certification while complying with RMF (Risk Management Framework for DoD Information Technology) protocols.

1. Conduct studies, analyses, and reporting of military expeditionary medicine within the planning tool operating environments. Recommend and implement planning tool enhancements necessary to modify JMPT functionality, data structures, user interfaces, output report content and format. Provide analytic and programming support for future operations in complex and distributed combat and Humanitarian Assistant/Disaster Response (HA/DR) environments anticipated for each of the individual services, COCOMS, at the joint OASD (HA) and Joint Staff level and other government departments such as State, Homeland Security and Health and Human Services. Present papers at professional conferences and support collaborative efforts with other organizations as needed.

1. Develop necessary 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 data integrity, maintain database, integrate a supply generation model, and develop understanding of afloat and ashore, ship and vehicle vulnerabilities to address patient injury and treatment. Develop automated mechanisms for determining Injury/ICD-9/Injury Severity Score profiles for various operational scenarios from ship and ground vehicle structural model output and model weapons effects and medical resource requirements. Design, implement, integrate and test an empirically based enhancements to the casualty outcome module (died of wounds algorithm) of JMPT and other planning tools as required.

1. Theater medical network optimization technologies. Conduct directed research to examine, evaluate, design and implement methods and technologies to optimize MTF and theater medical network design.

1. Design and implement modular expeditionary medical facilities into JMPT. This task will include data, schema and software development.

1. Develop training, outreach materials, and conduct training for the medical planner community of interest. Provide demonstrations and medical planning tool training at both performers’ facilities and at DoD customer sites in CONUS/OCONUS. Develop and conduct training at the introductory and power-user levels to maximize medical planner ability to conduct risk assessments effectively and medical course of action analyses. Provide entry-level medical planners the ability to visualize the theater support requirements and to learn how to create medical estimates and supportability within a defined theater of operations.

1. Provide technical support including planning and course of analysis software to the global community of users. Establish and maintain a help desk support system. The system must provide monthly metrics that allow tracking of user incidents and resolutions. Implement and maintain an access-controlled software distribution system.

1. Provide technical writing, editorial and clerical support for the aforementioned projects to include editing, word processing, and project maintenance requirements and budgeting elements.

1. Upon completion of the required tasking the contractor shall create a final report detailing the development, implementation, and use of all systems/tools. Additionally, the contractor shall provide the Government with all software, and developed training and outreach materials for successful transfer to Government Personnel.

3. ESTIMATED STAFFING

The base period of performance shall be for 12-months. The option period of performance will be for 12-months. The Government’s estimated level of effort for each 12-month period of performance to accomplish the aforementioned requirement includes:

Full-Time Individuals

Estimated Hours

*Denotes key designated personnel for this requirement ** The offeror shall propose the number of hours in accordance with their management/technical approach, their holiday and paid time off (PTO) benefits, etc. The number of hours stated in the above table is based on the Government’s estimate of hours per FTE per 12 months (1,920).

3.1 Resumes are required for key designated personnel*; resumes provided shall demonstrate sufficiently enough to the evaluator that the person proposed has the knowledge and experience relevant to accomplish the aforementioned tasks.

3.2 Staffing Qualifications

The Government’s estimate of the level of effort required to accomplish the aforementioned requirement includes:

3.3 Senior Engineer: Develop designs, plans, and specifications for a wide variety of projects. Administer or supervise research or other professional and scientific work involving the application of engineering fundamentals by other contractor personnel. Are responsible for the development of preliminary and conceptual design processes as well as the detailed design of facilities, systems, structures, or equipment, and provide expert technical advice and direction to contractor professionals. Should have experience in one or more of the following disciplines: Aerospace, Mechanical, Structural, Electrical, Civil and Logistics. Should have a Master’s degree in a relevant field or equivalent experience with 4+ years of knowledge and work experience in a relevant field.

3.4 Principal Engineer: Advise on, or perform research or other professional and scientific work involving the application of engineering fundamentals. Must have professional knowledge of the concepts and principles of general engineering to resolve problems, extend and modify techniques, and/or apply new, innovative, or experimental general engineering theories; knowledge of advanced mathematical techniques; and the ability to analyze and evaluate scientific engineering problems. Should have experience in one or more of the following disciplines: Aerospace, Mechanical, Structural, Electrical, Civil and Logistics.

3.5 Management Analyst: Performs research, codes and participates in testing. May also be required to assist in user training throughout various phases of the development cycle. Additionally, ensures that all development practices are in compliance with his employer's best practices policies and procedures. Tracking and maintaining all records and metric, reports the project's progress to the contractor’s program manager or cognizant Government employees. Should have experience in one or more of the following disciplines: Software Development, IT Administration and Database Administration.

3.6 Senior Systems Analyst/ Program Manager: Under indirect supervision, oversees the operational planning, establishment, execution, and evaluation of a multifaceted program/project typically consisting of a set of closely related subprograms or associated activities. Oversees fiscal, operational, administrative, and human resources management of the program; seeks and develops outside funding sources, serves as principal point of representation and liaison with external constituencies on operational matters, and provides day-to-day technical/professional guidance and leadership as appropriate to the area of expertise. Should have a Master’s degree in a relevant field or equivalent experience with 4+ years of knowledge and work experience in a relevant field.

3.7 Programmer/Analyst: Performs research, codes and participates in testing. May also be required to assist in user training throughout various phases of the development cycle. Additionally, ensures that all development practices are in compliance with employer's best practices policies and procedures. Tracking and maintaining all records and metric, reports the project's progress to the contractor’s program manager or cognizant Government employees. Should have experience in one or more of the following disciplines: Software Development, IT Administration and Database Administration.

3.8 Senior Programmer Analyst: Overseeing the development team, they manage the full life cycle of the process, monitoring research, reviewing codes and supervising any testing. May also be required to administer training throughout various phases of the development cycle. Additionally, ensures that all development practices are in compliance with their employer's best practices policies and procedures. Tracking and maintaining all records and metric, they report the project's progress to the contractor’s program manager or cognizant Government employees. Should have experience in one or more of the following disciplines: Software Development, IT Administration and Database Administration. Should have a Master’s degree in a relevant field or equivalent experience with 4+ years of knowledge and work experience in a relevant field.

3.9 Principal Programmer Analyst: Performs research, codes and participates in testing. May also be required to assist in user training throughout various phases of the development cycle. Additionally, ensures that all development practices are in compliance with their employer's best practices policies and procedures. Tracking and maintaining all records and metric, reports the project's progress to the contractor’s program manager or cognizant Government employees. Should have experience in one or more of the following disciplines: Software Development, IT Administration and Database Administration. Must demonstrate:

1. An existing intimate knowledge and understanding of all content, structure and relationships among fields and files within EMEDKW and EESP or similar types of programs. .

1. At least 5 years knowledge and working experience of JMPT and MPTk functionality, modeling assumptions, and development environment or similar knowledge/ experience. In addition, performer must demonstrate direct experience integrating and federating JMPT, HIT and other planning and execution tools into other operating environments (e.g., wargaming simulations) and with other M&S tools or similar experience.

1. At least 5 years knowledge and work experience developing and using planning tools in a military expeditionary medical M&S environment or similar knowledge/ experience.

1. Prior experience developing mortality based outcome algorithms or similar experience.

4. TRAVEL AND OTHER DIRECT COSTS

4.1 Travel destinations are not definitive at this time and will be defined on an as needed basis in writing (e.g., email) by the technical point of contact. In accordance with Section 2.3.4 below, all travel and ODC costs must be approved by the technical point of contact and the COR, in writing, prior to travel and prior to the incurrence of any costs associated with this Section. Travel to Navy medical treatment facilities, and USMC bases (including travel outside the continental United States (OCONUS and FOREIGN) are the most typical travel destinations, which may include but are not limited to (for the duration of the contract – base and option period):

4.2 Other Direct Costs (ODC): There may be ODCs required to perform this requirement (NTE $450,000 for each 12-month period of performance, before contractor indirect rate burdens) 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. Otherwise, a modification to the contract will be required. The ODCs anticipated over the period of performance are as follows (but subject to change): 4 consultants (3 Programmer/Analysts and 1 Senior Systems Analyst) to provide analysis support for the enhancement of JMPT, MPTk and EMedKW functionality.

4.3 All travel and ODC costs are estimated amounts excluding Contractor burdens. Contractor burdens must be applied in accordance with the Offerors accounting system and Forward Pricing Rate Agreement(s) (if applicable) and shall be reimbursed, to include applicable burdens, in accordance with Section H. Reimbursement of Travel, Per Diem.

4.4 All travel and ODC costs must be approved by the technical point of contact and the COR, in writing, prior to travel and prior to the incurrence of any costs associated with this contract.

4.5 FOR PROPOSAL PURPOSES: For the base 12–month PoP and the option 12-month PoP, offerors shall include in their proposal the Government’s estimate of not-to-exceed (NTE) $350,000 for travel and NTE $450,000 for ODCs, before contractor burdens.

5. QUALITY ASSURANCE SURVEILLANCE PLAN / DELIVERABLES

Objective. This Quality Assurance Surveillance Plan (QASP) serves as the principal basis for assessing overall performance quality by the contractor. This document will be used by the Government to assess the effectiveness of the contractor’s performance, including on a risk rated basis. This QASP provides the methodology by which the contractor's performance will be monitored to determine compliance with established performance objectives and to establish performance benchmarks that ensure a quantifiable basis for measuring effectiveness. The plan is designed so that surveillance is limited to that which is necessary to verify the contractor is performing satisfactorily and relates directly to performance objectives of the performance objectives delineated in the PWS.

5.1 Performance Objectives Summary Matrix:

TASK/

DELIVERABLE

ACCEPTABLE LEVEL OF PERFORMANCE (ALP)

METHOD OF SURVEILLANCE

AND RISK RELATED SCHEDULE

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, and are 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 shall be resolved in a satisfactory and timely manner.

Random Inspection (becomes more frequent if higher risk)

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

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements not met.

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

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, and are 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 shall be resolved in a satisfactory and timely manner.

Random Inspection (becomes more frequent if higher risk)

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements not met. Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

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, and are 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 shall be resolved in a satisfactory and timely manner.

Random Sampling (becomes more frequent if higher risk)

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

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements not met. Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

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, and are 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 shall be resolved in a satisfactory and timely manner.

Random Sampling (becomes more frequent if higher risk)

What is the governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements not met. Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

6. DELIVERABLES SCHEDULE / INVOICES: Progress updates will be required in the form of quarterly reporting and annual reporting as outlined below. Reporting Requirements: All reports must include the following information on the front of each submission: (1) Contract Number; (2) Contract Description of Services and any Significant Events; (3) Description of any significant problems or potential problems, and proposed resolution or risk mitigation strategies; (4) Explanation of any other unique services provided.

7. QUARTERLY STATUS REPORT: The Contractor shall submit to the COR a quarterly status report beginning with 90 days after award of the contract until completion of the period of performance. The Contractor shall outline progress made under the contract within the 90-day period, as well as highlight achievements and problem areas that affect the performance and progress of the effort. These reports shall contain, at a minimum, discussion of any significant issues, copies of any abstracts or reports sent out for presentations or publications, and a short report/status of each task.

8. INVOICES: All monthly invoices must be submitted to the Technical Point of Contact and COR. In addition, Status Reports are to be submitted on a quarterly basis accompanying the monthly invoice. Upon approval of invoice and receipt of signed DD250, the Contractor must upload it electronically through Wide Area Work Flow (WAWF). The Contractor shall submit invoices/cost vouchers for payment per terms of the contract; the Government shall process invoices/cost vouchers for payment per terms of the contract; and for each invoice/cost voucher submitted, the Contractor shall email WAWF automated invoice notice to the Government point(s) of contact outlined in the contract.

9. REPORT & FINAL REPORT: A report will be required at the end of the first 12-month PoP summarizing and/or stating completed research projects with their associated efforts on data collections, data analysis, summary reports, briefing, presentations, and publications. The final report include the option period 12-month report and will also address the current state of the environment, as it relates to medical M&S, the associated toolset (MPTk and JMPT), and potential courses of action to address shortcomings or preemptive issues facing these MPTk and JMPT.

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:

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:

(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.

COMMAND/ACTIVITY TRAINING

Contractor personnel shall complete initial and annual training as required by the Command or Activity. This includes but is not limited to orientation training for new personnel, information awareness training, records management training, occupational health and safety training, and Health Insurance Portability and Accountability Act (HIPAA) training. This training shall occur during normal working hours.

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 TBD in response to NMLC Solicitation No. N6264518R0066.

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/bumed/humanresearch/Pages/default.aspx.

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

ENVIRONMENTAL AND ENERGY CONSERVATION OBJECTIVES

If performance of any work under this contract is required at a Government facility, the Contractor shall contact the appropriate office and code with cognizance over safety and environmental requirement prior to performance of ANY work under this contract. The office having overall governance concerning safety is as follows:

Naval Health Research Center 140 Sylvester Road San Diego, CA 92106

Contractors are responsible for following all safety and health related State and Federal statutes and corresponding State, Federal and/or Department of Defense regulations protecting the environment, contractor employees, and persons who live and work in and around contractor and/or federal facilities.

STANDARD LIABILITY INSURANCE

The following types of insurance are required in accordance with the clause entitled, FAR 52.228-7, Insurance--Liability To Third Persons and shall be maintained in the minimum amounts shown:

(a) Comprehensive General Liability: $ N/A per person and $500,000 per accident for bodily injury.

(b) Automobile Insurance: $200,000 per person and $500,000 per accident for bodily injury and $20,000 per accident for property damage.

(c) Standard Workman’s Compensation and Employer’s Liability Insurance (or, where maritime employment is involved, Longshoremen’s and Harbor Worker’s Compensation Insurance) in the minimum amount of $100,000.

(d) Aircraft public and passenger liability: $N/A per person and $ N/A per occurrence for bodily injury, other than passenger liability; $ N/A per occurrence for property damage. Passenger bodily injury liability limits of $N/A per passenger, multiplied by the number of seats or number of passengers, whichever is greater.

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 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.