N62645-15-R-1004_EKO.doc

Section B - Supplies or Services and Prices

Lot

BASE PERIOD- MEDICAL MODELING

CPFF

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

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Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

OPERATIONAL MEDICINE RESEARCH MODELING SUPPORT SERVICES

FOR THE NAVAL HEALTH RESEARCH CENTER

1.0 BACKGROUND

The Naval Health Research Center (NHRC) performs medical modeling and simulation research for Department of Defense (DoD), homeland defense, humanitarian assistance, peace-keeping and disaster relief activities including casualty projection, medical planning factor development, identification of weapons effects both ground and shipboard-based, projection of resource requirements, database development and maintenance, and quality of life outcome studies.

2.0 SCOPE OF WORK

This acquisition will provide contractor support services for research modeling such as casualty projection in support of operational medicine. It is heavily data driven and depends upon the collection, characterization, analysis, and reporting of data from multiple sources, including both in-house sources such as the Expeditionary Medical Encounter database (EMED) and external sources such as the Military Health System (MHS), the VA, civilian/homeland defense data, tactical data, operational data, and personnel data.

3.0 SPECIFIC REQUIREMENTS

The Modeling and Simulation (M&S) department (Department 161) at NHRC conducts analysis and develops models to provide medical decision support to operational commanders, medical logisticians, and field medical personnel as they see to determine the resources required to support combat and peacetime deployments. M&S works with medical planners providers and logisticians to develop projects that assist in field medical services planning, systems analysis, operational risk assessment, wargaming, and to determine the best course of action for treating a particular patient stream using the available resources.

Activities to accomplish the aforementioned requirement include:

3.1 Manage both in-house and external medical modeling and simulation data sets, monitor for data integrity, and perform statistical analysis of these data sets. The contractor shall draft NHRC technical reports, informational/marketing material, and articles for peer-reviewed journals based on the results of the analyses of these data sets. The performer must demonstrate experience and knowledge developing operationally-relevant research ideas, operationally-relevant research designs, and be capable of interpreting research results in terms of operationally-relevant concepts, products and recommendations.

3.2 Support for studies, analyses and reporting. Assemble, examine, and abstract relevant clinical data from service member medical records, theater medical data, event data, and large DoD/VA databases from both in-house and remote locations such as DoD/VA Medical Treatment Facilities (MTFs) and enter data into the EMED or other DoD, homeland defense, humanitarian assistance, disaster relief and Dept 161 databases. This task requires clinical experience and knowledge in military, humanitarian/disaster response, and homeland defense clinical environments.

3.3 Develop database structures, monitor data integrity, perform data quality assurance, maintain databases, and write data queries to extract data from both in-house and large, external DoD, homeland defense, humanitarian assistance, and disaster relief databases. Experience working with large military, VA, humanitarian/disaster response, and homeland defense data sets is desired.

3.4 Develop injury/ICD-9/ICD-10 (International Classification of Diseases 9th/10th edition/revision) profiles for various operational scenarios and model weapons effects and medical resource requirements.

3.5 Develop clinical ICD-9/ICD-10 based treatment profiles for operational scenarios and model weapons effects and medical resource requirements.

3.6 Assign medical supplies to ICD-9/ICD-10 treatment profiles for various operational scenarios and model weapons effects and medical resource requirements. Knowledge of and experience using Navy, Marine Corps, Army or Air Force supply assemblages is required.

3.7 Develop data sets and methodologies to project casualty rate estimations using both current methodologies as well as demonstrating knowledge and experience developing new methodologies. Identify medical planning factors and model their effect on DoD operational scenarios, humanitarian assistance, homeland defense and disaster relief missions.

3.8 Code data abstracted from member medical records using the following taxonomies: International Classifications of Diseases, Abbreviated Injury Scale, Injury Severity Score, and DSM-IV (Diagnostics and Statistical Manual of Mental Disorders 4th edition) Axis Codes. Specific knowledge and experience using the Military Abbreviated Injury Scale-2008 required.

3.9 Develop, manage, and execute longitudinal, large cohort studies of casualty experiences, clinical, rehabilitative, long term, and quality of life outcomes. This includes senior epidemiological scientist, study manager/analyst/writer, interviewers, development and maintenance of subject identification and tracking methodologies, website design, advanced scientific analysis techniques, drafting of scientific papers and publishing of scientific papers in peer review publications.

3.10 Examine, interpret, and prepare reports on various aspects of casualty clinical records, including subject areas of general surgery, orthopedic surgery, neurology, pathology, and radiology. The contractor shall examine and interpret casualty clinical records; code injury data into diagnostic and severity categories; analyze both in-house and external DoD data; and write reports describing findings in scientific peer review publications.

3.11 Possess detailed knowledge and experience using large DoD/VA clinical, operational and personnel data bases for performing epidemiological research. Demonstrated experience using SAS and SPSS to perform advanced statistical analyses on large DoD/VA data sets. These data sets include the Theater Medical Data Store (TMDS), Military Health System Data Repository (MDR), Clinical Data Repository (CDR), Armed Forces Health Longitudinal Technology Application (AHLTA), and Armed Forces Health Longitudinal Technology Application-Theater (AHLTA-T), Veteran Affairs (VA), Expeditionary Medical Knowledge Warehouse (EMedKW), and the Expeditionary Medical Encounter Database (EMED).

3.12 Provide information technology to support: in-house and external database infrastructure development, maintenance, and querying of the EMED.

3.13 Provide technical support to other commands to install, instruct, and oversee NHRC developed software and applications to facilitate expansion of functional capabilities into the training and exercise support domains, including federating NHRC medical models into larger DoD war-gaming simulations. Provide liaison capability between NHRC and operational commands. Provide on-site support of Department 161 activities at commands outside NHRC.

3.14 Provide programming support for integrating NHRC modeling and simulation tools into both service-specific and DoD simulation tools and suites.

3.15 Oversee, manage and develop plans to modernize NHRC developed software and applications, including casualty forecasting and injury projection. Knowledge and experience using EMedKW, Enterprise Estimating Supplies Program (ESP), ReSupply Validation Program (RSVP), Joint Medical Planning Tool (JMPT) and Medical Planners Toolkit (MPTk) clinical modeling tools is required.

3.16 Assist in the design and development of new tools and applications in support of DoD,VA, homeland defense, humanitarian assistance, and disaster relief modeling and simulation.

3.17 Conduct epidemiology support to ongoing and future projects by developing testable research hypotheses, reporting data trends and data management of longitudinal data sets using TMDS, MDR, CDR, AHLTA, Pharmacy Data Transaction Service (PDTS), AHLTA-T, EMED, MPTk, and JMPT.

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

3.19 Monitor theater medical data collection activities and provide theater data collection support and training.

3.20 Develop procedures, identify data sets, and perform studies and analyses using clinical and tactical event data in both classified and unclassified environments.

3.21 Performer must have current/active Data Use Agreement (DUA) in place with OSD (Defense Health Agency- DHA) granting access to medical and personnel records resident in the Military Health System (MHS) including the TMDS, the MDR, Defense Occupational and Environmental Health Readiness System (DOEHRS) Hearing Conservation (HC) and pre/post deployment health assessments/reassessments. A current DUA must also include full access to protected health information. This is a minimum requirement for the contract as failure to have a current/active DUA with OSD (TMA) at time of award would result in a work stoppage in NHRC department 161 and a failure for the client to meet funding sponsor requirements for product delivery.

3.22 Demonstrated experience working within a US military-oriented environment required for all positions.

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 66,000 hour (or less) effort for the base period of performance. An estimate of the type of direct labor required to accomplish the aforementioned research include:

*Considered key personnel in performance of the contract

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 key personnel positions. Key personnel shall 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

Travel: There may be travel (CONUS and OCONUS) required to perform this PWS. 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. For all trips, the point of departure is San Diego, CA, unless otherwise directed by the technical point of contact. 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. Travel destinations may include but are not limited to:

Total (NTE): $125K per year

Other Direct Costs (ODCs): There may be ODCs (includes items incidental in performance such as costs associated with executing research studies.) required to perform this PWS (NTE $200,000 per year before contractor burdens), and will be defined on an as needed basis in writing (e.g., e-mail) by the technical point of contact for this contract.

6.0 CONSULTANTS

There may be consultants (NTE $670,000 per year before contractor burdens) required to perform this PWS. The Government estimates this would equate to 6700 hours (or less) per each period of performance (base and options). In order to further research goals, consultants would provide the following capabilities:

a. Project management

b. Advisement

c. Data Analysis

d. Manuscript writing

e. IT/database support

7.0 ASSUMPTIONS AND CONSTRAINTS

7.1 The expectation is that this will be an incrementally-funded Cost-Plus Fixed-Fee 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. 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).

7.2 This effort is considered non-severable because it represents a single undertaking which, if severed mid-performance, would be deleterious to the desired outcome of the program. Specifically, there are models being developed / maintained in support of operational requirements that cannot be terminated before completion / exercised.

7.3 Health Insurance Portability and Accountability Act (HIPAA) of 1996 related guidance and requirements in accordance with BUMEDINST 7050.1B – Agreements with non-DoD entities: NHRC is a DoD activity and as such is a Covered Entity as defined by the aforementioned BUMED instruction. However, in performance of its mission, NHRC does contract out to non-DoD entities such that these non-DoD entities may have access to information covered under the HIPAA of 1996. In this circumstance, NHRC 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). The Offeror will be required to sign a BAA and is contained in Attachment 1.

7.4 There is human research involved with this effort requiring human-subject research assurance certification by the contractor performer. Specifically, a Federalwide Assurance (FWA) and MPA DoD-Addendum to the FWA.

7.5 This effort represents a mix of on-site and off-site contractor personnel. Those personnel performing on-site shall be processed in accordance with on-site base/command procedures (e.g. CAC cards, personnel physicals, etc.). Contractor personnel shall be required to wear a contractor identification badge while on Government property. On-site contractor personnel are expected to conform to client-agency, normal business hours, which is an Alternative Work Schedule with nine-hour days and alternate Fridays off, with the exception of Federal holidays. On-site work will be performed at NHRC in San Diego, CA.

7.6 This effort is not considered a new requirement (legacy contract: N62645-12-C-4076) and therefore the employer-employee right of first refusal concerning incumbent employees with the successful offer is relevant to this contract.

7.7 Resumes shall be provided for the aforementioned positions if proposed, as they are considered key personnel. However, after award, resumes shall be provided for all positions prior to hire. The Contracting Officer’s Representative (COR) reserves the right to review the qualifications of all personnel performing or to be performing on this contract (see Section 4.0).

7.8 The period of performance shall be for a base period of 12 months, followed by four, 12 month option periods, for a total of approximately 60 months. The expectation is that this is approximately a 66,000-hour (or less) direct labor effort for each 12 month period of performance. In addition, there is an anticipated 6,700 hours (or less) of consultant efforts (NTE $670,000) for each 12 month period of performance. Other Direct Costs are estimated at $200,000 and travel at $125,000 per year (before contractor burdens) with a 3% escalation applied annually to direct labor before indirect costs are applied.

8.0 PERFORMANCE STANDARD

Tasks will be evaluated for completeness, timeliness, utility, and accuracy. Positive and negative performance will be documented in the Contractor Performance Assessment Report System (CPARS).

8.1 Performance: The Contracting Officer’s Representative (COR) will measure the contractor’s performance by assessing the quality of the services delivered by the contractor as evaluated by the NHRC staff. Examples of services to be provided include research, studies, and reports provided in accordance with the tasks in the performance work statement. The quality standards are defined as follows:

· Successful services are defined as those that conform to the task description provided in the Performance Work Statement (PWS) with little or no rework required of the contractor by the Government.

· Unsuccessful services are defined as those that do not conform to the task description provided in the PWS, thereby requiring significant rework by the contractor at the direction of the Government.

8.2 Schedule: The Contracting Officer’s Representative (COR) will determine whether the contractor has met the schedule using the due dates for receipt of deliverables. The quality standards are defined as follows:

· Successful delivery is defined as delivery of data and accomplishment of the metrics at least 95% of the time.

· Unsuccessful delivery is defined as delivery of data and accomplishment of the metrics less than 95% of the time.

8.3 Cost: The COR will review monthly cost vouchers to monitor the contractor’s expenditures in comparison to the contractor’s proposed budget (submitted under the Monthly Progress Reports) throughout the contract performance. The quality standards are defined as follows:

· Successful cost control is defined as performance of the tasks within the amount of funds allotted. If the contractor’s actual expenditures on a monthly basis exceed the budgeted amount for expenditures, the contractor must provide an explanation as to why this occurred and what changes have been made to ensure completion of the work within the ceiling in order to still receive a successful assessment of performance.

· Unsuccessful cost control is defined as exceeding the funding allotted for the tasks or exceeding the original ceiling of the contract for reasons not attributable to the Government. Furthermore, if the Government is not notified of why budgetary overruns have occurred on a monthly basis and what steps the contractor is taking to ensure completion of the work within the ceiling, the contractor will receive an unsuccessful assessment of performance.

9.0 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

16-SEP-2016

140 SYLVESTER ROAD

SAN DIEGO CA 92106-3521

N63116

16-SEP-2017

N63116

16-SEP-2018

N63116

16-SEP-2019

N63116

16-SEP-2020

N63116

CLAUSES INCORPORATED BY REFERENCE

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.

N63116

(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 CONTRACT CLAUSES

H.1. 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.

H.2. RESERVED.

H.3. 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.

H.4. 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. 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 FOCI if the parent corporation is a FOCI. 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 FOCI. A FOCI person is a non-U.S. citizen. Resident aliens are considered FOCI for licensing and technology transfer purposes. Approval by the U.S. Trade Representative may be required prior to executing a contract with a FOCI.

H.5. PROTECTION OF HUMAN SUBJECTS:

(a) The performance of research involving human subjects shall be conducted in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.235-7004 “Protection of Human Subjects,” 32 CFR 219 “The Common Rule,” 10 USC 980 “Limitation on Use of Humans as Experimental Subjects,” Department of Defense (DoD) Instruction 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” and Secretary of the Navy Instruction 3900.39 (series) “Human Research Protection Program,” as well as other applicable federal and state law and regulations, and Department of the Navy guidance. The Contractor must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations, recruitment of military research subjects, and informed consent and surrogate consent and chemical and biological agent research. Food and Drug Administration regulation and policies may also apply. The Contractor shall rely on the local command’s designated Institutional Review Board (IRB) as the IRB of record for the research to be supported under the contract. The Contractor shall also comply with all research training requirements directed by the local command.

(b) The Contractor shall hold an active (i.e., not expired) Federalwide Assurance (FWA) appropriate for research to be supported under the contract. The FWA shall remain active for the duration of the contract. The FWA is issued by the Department of Health and Human Services.

(c) The Contractor shall hold an active (i.e., not expired) DoD-Navy Addendum to the FWA or other Military Service equivalent (e.g., DoD-Air Force Addendum) appropriate for research to be supported under the contract. The DoD-Navy Addendum to the FWA shall remain active for the duration of the contract. The DoD-Navy Addendum is issued by the Department of Navy Human Research Protection Program (DON HRPP).

(d) The following requirements must be completed prior to the Contractor’s performance of research involving human subjects or expenditure of funding on such effort, whichever occurs first:

(1) The Contractor shall enter into a DoD Institutional Agreement for Institutional Review Board (IRB) Review (IAIR) with the local command. The IAIR will apply to all human subject research supported under the contract. The IAIR shall be executed by the parties no later than 30 days after the effective date of the contract, or before commencement of performance of research involving human subjects or expenditure of funding, whichever occurs first.

(2) Contractor personnel providing support under the contract shall complete initial and ongoing research ethics and human subject protections training appropriate to each individual’s level of involvement, duties, and responsibilities. Specific training requirements will be directed by the local command.

(3) The Contractor shall obtain written notice from the local command that: (i) Contractor personnel identified as supporting human subject research under the contract have been added to the applicable research protocol; (ii) performance of the protocol has been approved by the Command’s Institutional Official and that performance may begin; (iii) a determination that the protocol meets exemption criteria including the exemption category or classification of research risk (e.g., minimal risk); (iv) confirmation of continuing acceptability of the Contractor’s assurances; and (v) Human Research Protection Official (HRPO) review of the protocol in accordance with DFARS clause 252.235-7004 has been completed. Contractor personnel shall not commence performance of research involving human subjects until stated notice is received.

(4) The Contractor shall notify the local command of personnel changes under the contract. New personnel that will perform research involving human subjects will be required to complete applicable training and will be added to the applicable research protocol(s) as discussed above.

(e) The Contractor shall support administrative efforts by the local command to ensure compliance with the terms of this requirement. This support includes identifying Contractor personnel that may support human subject research under the contract and maintaining records of training and other documentation to demonstrate compliance with human research protection requirements under the contract. The Contractor shall also assist with the continuing review of the human subject research that is supported under the contract.

(f) Failure of the Contractor to comply with the terms of this requirement will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

(g) The terms of this requirement are applicable to and shall be included in all subcontracts that may include the support of human subject research.

H.6. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES

Any contractor performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules agrees by acceptance of this contract to comply with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules", of July 5, 1994 (59 FR 34496), amended August 5, 1994 (59 FR 40170), amended April 27, 1995 (60 FR 20726), and such later revision of those guidelines as may be published in the Federal Register.

H.7. 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.

H.8. 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.).

H.9. 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.

H.10. 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.

H.11. 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).

H.12. 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.

H.13. 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:

Safety Officer/Industrial Hygiene Officer

Naval Medical Research Center

503 Robert Grant Avenue, Silver Spring, MD 20910-7500 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.

H.14. 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.

H.15. 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. 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…