N62645-16-R-0006.doc

Section B - Supplies or Services and Prices

Lot

Base: Research Support Services

CPFF

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Lot

Lot

Lot

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Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

NAVAL MEDICAL RESEARCH UNIT DAYTON

RESEARCH SUPPORT SERVICES

1.0 INTRODUCTION AND BACKGROUND:

1.1 The Naval Medical Research Unit Dayton (NAMRU-D) mission is to maximize warfighter performance and survivability through world-class aeromedical and environmental health research by delivering solutions to the field, the Fleet, and for the future.

1.2 The effort required under this PWS is to provide non-personal research support services to NAMRU-D, Wright-Patterson Air Force Base (WPAFB), Ohio.

1.3 NAMRU-D has determined this contract is not being used to procure personal services as defined by Subpart 37.1 of the Federal Acquisition Regulations (FAR). The Contracting Officer’s Representative (COR) has been trained on the avoidance of personal services and those actions that represent personal services. To counter the circumstances that infer personal services and to preserve the non-personal nature of this contract, the Contractor shall:

· Provide for direct onsite supervision of all contract employees assigned to the task.

· Refrain from discussing issues such as skill levels, salaries, cost and funding data, or administrative and personnel/human resourcing matters affecting contractor staff with government personnel.

· Assign a client site task leader or leaders who will maintain the supervisory function over all assigned contractor employees. These functions include but are not necessarily limited to setting work schedules, approving time recording, approving absence requests, writing and conducting performance reviews, administering employee awards and corrective measures, terminating employees, and any other relevant personnel administrative functions. The contractor shall not permit any government employee to perform any of these functions and will promptly inform the COR if any government employee attempts to do so.

2.0 SCOPE OF WORK:

2.1 Research performed under this contract is broad in scope, and encompasses a range of disciplines. The contractor will support research for two NAMRU-D Directorates: Aeromedical and Environmental Health.

2.2 Aeromedical Research Support

2.2.1 The contractor shall support research studies and analyses to understand the human cognitive, and physiological factors associated with military operations in the aviation, underwater, and special warfare environments especially as they relate to motion sickness (e.g., sea-sickness, air-sickness, simulator-sickness and space-sickness), aeromedical standards, hypoxia, fatigue assessment, aviation safety, and neurocognitive/neurophysiological effects. The contractor will support aeromedical research on conditions affecting the health, safety, or performance of pilots and aircrew including the effects of acceleration, altitude, high workload, fatigue, medication, physiological status, or other military operational factors. Research activities will involve human use research both in the laboratory and in the field.

2.2.2 These research efforts will require the collection and analysis of data, computer programming, statistical analysis, design and construction of research equipment and support systems, and scientific reporting. As an integral portion of these research activities, the contractor shall be expected to support and perform daily routine set-up and maintenance of critical human devices to include the preparation of devices for specific research protocols, operation of devices during testing and data collection, routine preventive maintenance of devices, and data collection and recording from research conducted on the devices. These devices include the Reduced Oxygen Breathing Device (ROBD), Disorientation Research Device (DRD), the Visual Vestibular Sphere Device (VVSD), the Vertical Linear Accelerator (VLA), as well as other aircraft motion and orientation simulators, and various physiological and medical monitoring types of equipment.

2.3 Environmental Health Support

2.3.1 The contractor will support cell-based and animal research studies on environmental and occupational exposures, particularly in deployed environments, in order to identify toxic effects before health and operational performance is compromised in the warfighter. Cell-based studies include the use of in-vitro models, bacterial systems and molecular assays to address toxic effects and mechanisms. Animal studies may include, but are not limited to exposures via gavage, in drinking water, in feed, intravenously, intraperitoneal, intratracheal, whole body inhalation, and nose-only inhalation.

2.3.2 These research efforts will require the collection and analysis of data, computer programming, statistical analysis, and scientific reporting. As an integral portion of these research activities, the contractor shall be expected to support and perform daily routine set-up and maintenance of critical devices at NAMRU-D, to include the preparation of devices for specific research protocols, operation of devices during testing and data collection, routine preventive maintenance of devices, data collection and recording from research conducted on the devices. These devices include, but are not limited to, various behavioral, physiologic and medical monitoring equipment, in vivo inhalation exposure systems, in vitro cell culture systems, analytical equipment for monitoring chemicals in animal tissues, and various exposure media (e.g., air, water, feed).

2.4 General Research Support

2.4.1 The contractor shall provide administrative, graphic, logistic, statistical, and technical support to complete research and development activities. Examples of technical support include, but are not limited to: interrogatories; medical and scientific editing of research proposals, human use protocols, animal use protocols, and technical and scientific reports; workshop and conference administrative, scientific, and technical support and management; coordination of technical review meetings and the preparation and presentation of point papers, technical reports, and other briefings resulting from these meetings; preparation and support of technical summaries and publications resulting from research activities; support in development of Institutional Review Board (IRB) protocols for human use research; preparation and support of Institutional Animal Care and Use Committee (IACUC) protocols for animal research; presentation of research findings at scientific meetings and professional conferences; writing, reviewing, editing, and submitting peer-reviewed articles and technical reports.

2.4.2 The contractor shall support studies conducted at the NAMRU-D facilities, other commands, installations, and locations. This requirement includes coordination of such with other Navy commands when necessary. Work also includes assisting in preparation of intramural and extramural grant applications for studies. The contractor shall support coordination with other Navy commands and outside organizations when necessary to complete the various research programs in place. Preparation of survey materials and psychological assessment materials shall also be required.

2.5 Research Logistical Support

2.5.1 The contractor shall procure and distribute research project supplies and equipment based on Government-provided specs and using competitive acquisition procedures. All purchases shall be tracked and documented according to Government standards and copies of purchasing approvals, packing slips, and receipts shall be provided to the NAMRU-D Equipment Manager. All items purchased will be the property of the Government.

2.6 Qualifications of the Contractor:

2.6.1 The contractor must have access to fully qualified individuals that have an understanding of the Navy Medicine Research vision, mission, programs, personnel, and facilities. In-depth knowledge of Department of Defense and Federal research and administrative policy is required.

2.6.2 Knowledge and experience working within the Department of Navy, Bureau of Medicine and Surgery (BUMED) Research and Development (R&D) requirement processes, including detailed knowledge of BUMED R&D policies and procedures.

2.6.3 Technical writing expertise and expertise in development of briefings materials and presentation of briefings.

2.6.4 Experience evaluating the latest applicable reports from the worldwide medical and research communities.

2.6.5 Contractor personnel shall be fluent in the English language as exemplified in their written and verbal skills.

2.6.6 The contractor shall be familiar with the intramural and extramural grant application and management process to include but not limited to grants managed through grants.gov and the Congressionally Directed Medical Research Programs (CDMRP). When necessary, the contractor shall have the ability to act on behalf of their employees as the Applicant Organization.

3.0 ASSUMPTIONS AND CONSTRAINTS:

3.1 The expectation is that this will be an incrementally-funded Cost plus fixed fee contract. Contractors submitting proposals shall already be approved for performance on a Cost plus fixed fee contract and a security clearance level of Secret.

3.2 This effort is not considered a new requirement and therefore the employer-employee right of first refusal concerning incumbent employees with the successful offer is relevant to this contract. This is a follow on to a contract performed by CAMRIS International (Refer to FAR 52.222-17).

3.2.1 An estimate of the type of direct labor required to accomplish the aforementioned research include one Engineer 1, one Engineer 2, four Life Scientist 1, five Life Scientist 2, two Program Manager 1, four Research Assistant 2, one Research Assistant 3, three Scientist 1, and one Software Engineer 3.

3.2.1.1. 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.

3.3 For bidding purposes, the expectation is that this is a 44,620-hour effort over a period of one year, with the possibility of extensions out to 60 months. Travel is estimated at $45,000 per year (before contractor burdens) with a 3% escalation applied annually.

4.0 CONTRACT DELIVERABLES:

4.1 Monthly Activity Report which provides breakdown of the total hours charged by each contractor assigned to the project and a listing of all charges billed to the contract. This deliverable is due to the COR no later than close of business on the day the monthly invoices are submitted through Wide Area Workflow.

4.2 Annual Activity Report which will include, at a minimum, any notable contractor performance, the total hours for the year charged by each contractor employee on the project, and a summary of all charges billed to the contract for the year. This deliverable is due to the COR no later than 14 days after the end of the Period of Perfor..mance.

5.0 WORK LOCATION AND SCHEDULE:

5.1 The majority of the effort under this contract will be performed on a WPAFB, a government installation. Contractor personnel must be eligible for issuance of a DoD Common Access Card (CAC) in order to gain access to the installation and computer network.

5.2 The normal work week for NAMRU-D is Monday through Friday with flexible working hours from 0600 to 1800. All Federal holidays are observed as scheduled.

6.0 GOVERNMENT-FURNISHED PROPERTY/MATERIAL:

6.1 NAMRU-D shall provide office space, computers, and necessary office supplies and materials to perform tasks on a daily basis.

7.0 TRAVEL:

7.1 All anticipated travel shall leave from Dayton, Ohio. Travel approval must be processed in accordance with client-command procedures, 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. All travel will need to be approved by the technical point of contact and COR in writing via e-mail. Annual estimated travel includes the following types of trips:

· 1 trip, 2 people, 5 days/trip to the Society of Toxicology Annual Meeting

· 1 trip, 1 person, 5 days/trip to the Military Health System Research Symposium

· 1 trip, 2 people, 5 days/trip to the Society of Neuroscience Annual Meeting

· 1 trip, 5 people, 5 days/trip to the Aerospace Medical Association Annual Meeting

The actual locations for each of these travel destinations changes each year.

8.0 PERFORMANCE STANDARD:

8.1 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).

8.2 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 NAMRU-D staff. Examples of services to be provided include research, studies, and reports provided in accordance with the tasks in the work statement. The quality standards are defined as follows:

· Successful services are defined as those that conform to the task description provided in the PWS and in accordance with applicable DoD and Navy Instructions 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 more than minimal rework by the contractor at the direction of the Government.

8.3 Schedule: The 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 on-time delivery at least 90% of the time.

· Unsuccessful delivery is defined as on-time delivery less than 90% of the time.

8.4 Cost: The COR will review monthly cost vouchers to monitor the contractor’s expenditures in comparison to the contractor’s proposed budget (submitted in the Monthly Activity 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

07-MAR-2017

2568 5TH STREET/BLDG 851

WRIGHT PATTERSON AFB OH 45433

937-938-3866

N41817

07-MAR-2018

N41817

07-MAR-2019

N41817

07-MAR-2020

N41817

07-MAR-2021

N41817

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.

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

Routing Data Table*

Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC

Issue By DoDAAC

Admin DoDAAC

Inspect By DoDAAC

Ship To Code

Ship From Code

Mark For Code

Service Approver (DoDAAC)

Service Acceptor (DoDAAC)

Accept at Other DoDAAC

LPO DoDAAC

DCAA Auditor DoDAAC

Other DoDAAC(s)

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

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

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

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

(End of clause)

Section H - Special Contract Requirements

SPECIAL REQUIREMENTS

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 cerifying that there were no such subcontracts.

H.2. 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.3. PERFORMANCE BY FOREIGN NATIONALS OR FOREIGN OWNERSHIP, CONTROL OR INFLUENCE (FOCI) ORGANIZATIONS

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

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

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

1. Individual’s Name

2. Date/place of birth

3. Citizenship

4. Date and Location of the Visit

5. Purpose of the Visit

6. Passport Number

7. Employer’s Verification of Work Authorization

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

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

H.4. 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 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.

(d) 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.

(e) 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.

(f) 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.5. PROTECTION AND USE OF ANIMALS (R&D Support Services)

(a) All activities involving animal subjects shall be conducted in accordance with DoD Instruction 3216.01 “Use of Animals in DoD Programs”, Secretary of the Navy Instruction (SECNAVINST) 3900.38 (Series) “The Care and Use of Laboratory Animals in DOD Programs”, 9 CFR (parts 1- 4) “Animal Welfare Regulations”, National Academy of Sciences Publication “Guide for the Care & Use of Laboratory Animals”, as amended, and the Department of Agriculture rules implementing the Animal Welfare Act as amended (7 U.S.C. 2131-2159), as amended, as well as other applicable federal and state law and regulation and DoD guidance. The contractor shall also comply with all training requirements directed by the Command's Institutional Animal Care and Use Committee (IACUC) and associated department of the Navy policies and procedures.

(b) Research under this contract involving the use of animals is based upon required institutional approvals being obtained by the Department of the Navy. Deviation from the approved research involving the use of animals is not allowed.

(c) The Department of the Navy reserves the right to conduct a post award site visit to any contractor or subcontractor facility where animal work will take place.

(d) Non-compliance with any provision of this term and condition or with the incorporated regulations and policy, will result in the issuance of a stop-work request 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.

H.6. 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.7. 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.8. 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.9. 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. N62645-16-R-0006.

H.10. 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/Pages/default.aspx This is a non-personal services contract for research and development. The Federal Tort Claims Act does not apply.

H.11. 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. Please contact the Contracting Officer Representative (COR) under this contract for contact information for the office having overall governance concerning safety.

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.12. 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.

H.13. 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 WPAFB 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 WPAFB. 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 the WPAFB 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 WPAFB. Per Diem is authorized for contractor personnel beyond a fifty-mile radius of the WPAFB 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 the WPAFB, and on the day of return. Reimbursement to the contractor for per diem shall be limited to actual payments to per diem defined herein. The contractor shall provide actual payments of per diem defined herein. The contractor shall provide supporting documentation (e.g., signed travel expense reports) for per diem expenses as evidence of actual payment.

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

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

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

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

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

H.14. ORGANIZATIONAL CONFLICT OF INTEREST (JAN 1992) (NAVSUP)

This clause provides examples of certain organizational conflicts of interest which are prescribed by Federal Acquisition Regulation Subpart 9.5. The two (2) underlying principles which this clause seeks to avoid are preventing the existence of conflicting roles that might bias a contractor's judgment and preventing unfair competitive advantage. The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

If, under this contract, the contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the contractor will prepare and furnish complete specifications covering nondevelopmental items, to be used in a competitive acquisition, the contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to contractors who furnish specifications or data at Government request or to situations in which contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the contractor shall not supply the system, its major components, or the service unless the contractor is the sole source, the contractor has participated in the development and design work, or more than one contractor has been involved in preparing the work statement.

The term of this prohibition shall endure until the end of the contract.

If, under this contract, the contractor will provide technical evaluation of products or advisory and assistance services, the contractor shall not provide such services if the services relate to the contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer. Any OCI Mitigation Plan between the contractor and the Government does not give authorization for a contractor being in possession of another company’s proprietary or sensitive information.

H.15. STATION/BASE REGULATIONS

The contractor and its employees and subcontractors shall become familiar with and obey station/base regulations, including fire, traffic, and security regulations.