AMENDMENT_0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this Amendment is provide the questions received and the related responses. Attachments A , B & C have also been revised.

Proposal due date is extended to April 25th, 2017 at 4pm EST.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 59

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 31-Mar-2017

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W911QY-17-R-0029

X 9B. DATED (SEE ITEM 11)

15-Mar-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

31-Mar-2017

CODE

W6QK ACC-APG NATICK

110 THOMAS JOHNSON DR SUITE #240

FREDERICK MD 21702

W911QY 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W911QY-17-R-0029

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Title: Basic and Applied Research Support

Requiring Activity Name: The Center for Military Psychiatry and Neuroscience (CMPNS)

Research, Walter Reed Army Institute of Research (WRAIR)

1.0 SCOPE

Walter Reed Army Institute of Research (WRAIR), in support of its biomedical research mission, has a requirement to support the Center for Military Psychiatry and Neurosciences

(CMPNS) mission to conduct basic and applied research to develop evidence-based strategies to diagnose, prevent, and mitigate the effects of psychological demands, continuous operations, and brain trauma on the health and well-being of Service Members. This single award contract shall support the Center's mission to the US Army Medical Research Detachment - West (USAMRD-

W); Military Psychiatry Branch; Blast Induced Neurotrauma Branch (BINT); Behavioral

Biology Branch; and the Research Transition Office (RTO). Specifically, this award shall provide scientific and technical development support, program management and operational support, laboratory management support, clinical research coordination support, protocol review support, physiological support, psychological support, veterinarian and animal care support, statistical support, Polysomnographic support, clinical monitoring support and administrative support to the Center's mission at the WRAIR as well as detachments.

WRAIR's research efforts must be world class quality and adaptive to changes in the Nation's requirements for support of military services. Tasks under this contract may entail brain and spinal cord injury and neuroprotection research; basic and exploratory science; translational research; product research and development; overpressure field studies and sleep studies; animal behavior research; applied psychological research; penetrating ballistic-like brain injury (PBBI) research support; projectile concussive impact (PCI) brain injury research support; polytrauma research support; traumatic brain injury (TBI) neuroprotection and neurorestoration research support; experimental sleep and performance studies; experimental human stress studies;

psychophysiology relationship investigations; and supporting existing research to update the soldier and spouse resilience training programs.

These tasks may require, but not limited to, the expertise of the below functions.

Scientific Support:

o Brain and Spinal Cord Trauma Research Support Services, o Research Associate Support Services, o Overpressure Field Study Research Support Services, o Laboratory Technical Support Services, o Animal Behavior Research Support, and o Statistical Support Services.

Clinical Research Support:

o Experimental Sleep and Performance Study Research Support Services, o Clinical Research Coordination Support Services, o Experimental Human Stress Study Support Services, o Psychophysiology Relationship Investigation Support Services, o Polysomnographic Support Services, o Experimental Human Stress Study Support Services, and o Clinical Monitoring Support.

Operational Support:

o Program and Operational Management, o Protocol Review Support, o Review and Update Resilience Training Programs, and o Administrative and Clerical Support Services.

This Performance Work Statement (PWS) defines the procurement of the technical expertise and support services necessary to provide research-based solutions and investigate medical solutions using basic preclinical and clinical research. The basic research will include, but is not limited to, conducting animal behavioral sessions, performing blast overpressure studies, and performing traumatic brain injury and neuroprotection research. The clinical research will include, but is not limited to, providing mental health research support, performing sleep studies (both clinical monitoring and field research), and supporting existing research to update the soldier and spouse resilience training programs. Subcontractor support may be required to complete specific scopes of work in support of individual tasks (i.e. statistical support, data management services, administrative, etc.).

2.0 BACKGROUND

2.1 Missions

2.1.1 WRAIR

WRAIR's mission is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the warfighter. WRAIR's focus on research for the Soldiers affects all aspects of its operations as military medical research priorities differ from those of the civilian sector. WRAIR scientists have a unique understanding of military operations and environments, including the stresses and exposures troops encounter and the performance requirements of a deployed military force. Despite WRAIR's focus on the military, its research has also been utilized to solve nonmilitary medical problems around the world. Its history is filled with the lifesaving or life-enhancing discoveries of distinguished scientists.

2.1.2 CMPNS

CMPNS’s mission is to conduct behavioral health research to: characterize behavioral health threats to the Force; identify moderators or risk, resilience, and readiness; develop and validate interventions; and deliver knowledge and information products for evidence-based best practices and policy recommendations.

2.1.3 Military Psychiatry

Military Psychiatry’s mission is to conduct requirements-driven basic and applied research to promote the psychological resilience, neurological functioning, and operational readiness of service members.

2.1.4 Behavioral Biology

The Behavioral Biology Branch’s mission is the exploration and development of strategies and technologies for monitoring, preventing, and/or reversing the decrementing effects of sleep loss, traumatic stress, brain trauma, and fatigue on cognitive performance to enhance Warfighter health and operational performance.

2.1.5 BINT

The BINT’s mission is in the laboratory is to use models to validate and characterize scaled experimental blast exposure conditions and assess outcomes relevant to blast-injured

Warfighters to define the biomechanical and neurobiological underpinnings of blast TBI and establish effective countermeasures. BINT’s mission in the field: is to characterize individual operator blast exposures in a variety of training environments to identify the effects of blast overpressure exposures on cognitive performance, brain and blood biomarkers, and symptom reporting.

2.1.6 RTO

The RTO’s mission is to transition research findings into information and training products as well as to disseminate Initial Military Training (IMT) and Professional Military Education

(PME) system and unit-level and deployment cycle training.

2.2 Goals

The main goal of the CMPNS is to understand, prevent, and treat the myriad and generally poorly understood threats to soldier health and performance that primarily act neurocognitively.

More specifically, CMPNS aims to conduct basic and applied research that promotes psychological resilience, neurological functioning, and operational readiness as well as develop evidence-based strategies to diagnose, prevent, and mitigate the effects of psychological demands, continuous operations, and brain trauma on the health and well-being of soldiers.

The Contractor shall provide services in support of the CMPNS and shall be project specific.

The Contractor shall conduct animal behavioral testing procedures which may include elevated plus maze, acoustic startle, operant conditioning, conditioned suppression, conditioned freezing, auditory and visual discrimination, radial arm maze, motor activity, open field exploration, Morris water maze, predator exposure, underwater trauma, novel object recognition and others.

The Contractor shall conduct animal blast overpressure, TBI and neuroprotection studies aimed at furthering knowledge of the pathophysiology TBI, focusing on novel strategies to diagnose

(i.e. biomarkers) and/or treat TBI occurring in military centric environments, with the goal of leading to clinical products using a bench to bedside strategy. The Contractor also shall communicate and cooperate with Veterinary and animal care support staff to maintain and verify appropriate levels of animal care for all research animals. The Contractor shall conduct clinical research studies which may involve data collection using survey, personal interviews, and neuro-physiological monitoring.

3.0 OBJECTIVES

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. One of its core missions is to advance military medical science to benefit the Warfighter. Research and development of solutions also address capability gaps that exist at all levels of care, particularly in the pre-hospital setting and scenarios in which the casualty cannot be transported through traditional levels of care (i.e., prolonged field care). Research is performed with an awareness of the potential to develop knowledge and materiel which may support selective and periodic resupply of certain prolonged field care scenarios (i.e. augmented prolonged field care).

The Contractor shall provide scientific support, clinical research support, study execution, and operational (management and ancillary) support as a service to CMPNS. Basic studies may include animal research. Clinical studies may be Phase 1, 2, 3, or 4 [as defined by the Food and

Drug Administration (FDA)] or combinations of these phases. Tasks under this vehicle may entail surveillance and sample collection; basic and exploratory science; translational research;

and product research and development support to CMPNS.

Scientific support services may include the following components:

Planning and pre-study activities:

o Protocol development support services, including the development of animal protocols and protocol-related documents; and o Establishment of sub-contracts necessary to execute the study; and o Development and implementation of training programs for onsite personnel.

Research protocol execution:

o Plan, organize, and execute CMPNS approved activities related to all aspects of the protocol(s);

o Receipt, assessment and maintenance of research documentation;

o Small animal handling;

o Performing complex assessments;

o Utilizing standard laboratory and molecular biology techniques;

o Scientific writing including but not limited to study reports; and o Training of onsite staff.

Data management and Biostatistics including but not limited to:

o Perform Advanced Biostatistics;

o Design and execution of a statistical analysis plan; and o Real time data-access.

Clinical research services may include the following components:

Planning and pre-study activities:

o Protocol development support services, including the development of clinical protocols and protocol-related documents;

o Assist Study Sponsor in final study protocol and investigator brochure development;

o Regulatory and other document preparation, editing, formatting, submission and approval(s);

o Establishment of sub-contracts necessary to execute the study; and o Development and implementation of training programs for clinical site personnel regarding the conduct of clinical trials including Quality Management.

Safety monitoring:

o Provision of 24 hour medical monitoring; and o Develop and institute plans for safety assessment and monitoring activity including identification, reporting and tracking systems for Adverse Effects

(AE), Serious Adverse Effect (SAE), as well as an effective medical monitoring action plan which includes stopping rules and communications of adverse events to all clinical sites.

Document creation and management:

o Receipt, assessment and maintenance of essential site regulatory documentation;

o Creation and maintenance of clinical trial master file(s);

o Provide clinical site regulatory support including preparing, submitting and maintaining regulatory documents;

o Assistance in the preparation of study-related materials and instructions;

o Medical writing including but not limited to final clinical study reports; and o Assist in obtaining necessary regulatory documents and approvals, developing

Case Report Forms (CRF), investigational drug brochures and clinical trial master file(s).

Clinical trial execution:

o Plan, organize, and execute CMPNS approved activities related to all aspects of the protocol(s) to include, but not limited to the development of subject recruitment plans, subject retention strategies and monitoring enrollment;

o Development and implementation of clinical site quality location, monitoring, and management programs;

o Site essential document management activities;

o Enrollment, site visits, SAEs; and o Training of clinical site staff and assessment of clinical site capabilities for data collection and management.

Identification and contractual agreements with clinical research vendors to support studies as needed, including but not limited to:

o Clinical laboratories;

o Remote data entry;

o Database Management;

o Biostatistics;

o Investigational product packaging, labeling and shipping; and o Interactive voice response systems for subject randomization and tracking.

Data management and Biostatistics including but not limited to:

o CRF design and database development/implementation;

o Establishment and maintenance of a centralized data reporting system to track the performance of all clinical support service activities, e.g. clinical specimen tracking system, radiological diagnostic data system;

o Design and execution of a statistical analysis plan;

o Real time data-access; and o Database off-site backup and retention post-trial completion.

Quality metrics:

o Implementation of an effective internal Quality Assurance (QA) and Quality

Control (QC) plan for the Offeror’s coordinating and documented preparation activities;

o Development and implementation of a Quality Assurance and Quality Control plan to ensure clinical sites comply with domestic and country-specific regulations governing research with human subjects;

o An established internal system to measure, monitor and improve the level of performance of the personnel responsible for direct management of the sites [e.g.

Clinical Research Associate (CRA) monitoring activities, Clinical Trial

Agreement (CTA) essential records management];

o Clinical monitoring support.

4.0 GENERAL INFORMATION

4.1 Primary Customer

This contract vehicle is restricted to the use of WRAIR and CMPNS components.

4.2 Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by FAR 37.

4.2.1 Inherently Government Functions

This PWS has been reviewed and contains no services that are identified as inherently governmental functions.

4.2.2 Functions Closely Associated with Inherently Governmental Functions.

This PWS has been reviewed and contains no services that are identified as closely associated inherently governmental functions.

4.3 Organizational Conflict of Interest (OCI)

WRAIR has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart

9.5. These categories apply to all enterprise laboratories: USAMRD-W, Military Psychiatry, BINT, Behavioral Biology, and RTO.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an CCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in

WRAIR requirements and in identifying and, where possible, avoiding or mitigating against

OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., Natick

Acquisition Activity, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ

Contracts, competitively negotiated awards under FAR Part 15, etc.).

4.3.1 OCI Categories

4.3.1.1 Global Support

Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the Contractor in a position to influence the award decision on a contract in which they are participating. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

4.3.1.2 Isolated Support

Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

4.4 Contracting Officer’s Representative (COR)

The COR or CORs will be identified by separate letter for the base award and/or per option periods. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

Assure that the Contractor performs the technical requirements of the contract

Perform inspections necessary in accordance with PWS

Maintain written and oral communications with the Contractor concerning technical aspects of the contract

Issue written interpretations of technical requirements, including Government drawings, designs, specifications

Monitor Contractor's performance and notify both the Contracting Officer and Contractor of any deficiencies

Coordinate availability of government furnished property, and

Provide site entry of Contractor personnel

A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

5.0 STATEMENT OF WORK

5.1 Performance Requirements

The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below at a standard enabling the CMPNS and its detachments, to achieve the cost, schedule, and performance goals of its research and development activities (inclusive of preparations for post Milestone-C requirements of the acquisition process), and to the level of quality necessary to comply with programmatic requirements, DoD and Army regulations, ISO standards, and FDA and EPA regulations (to include both human subject protection and animal care and use regulations); including submissions to federal regulatory agencies. Federal regulations governing cGCP are found in 21

CFR 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 45 CFR 46. Those governing cGLP are found in 21 CFR 11 and 58. The International Convention on Harmonization

Guidelines for Good Clinical Practice is the standard governing the conduct of research trials.

References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview.

5.2 Task Management Plan – Deliverable 1

The Contractor shall provide a Management Plan (Deliverable 1) that includes detailed staffing plans and the Offeror’s approach to controlling, coordinating, and directing performance, as well as organizing and managing resources in order to achieve technical/scientific requirements. The

Management Plan shall explain the Offeror’s approach to recruiting, selecting, hiring, and https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview managing employees in multiple duty locations. The Management Plan shall detail the Offeror’s approach to selecting, directing, and managing subcontractors, if applicable. The Management

Plan shall describe how the Offeror will communicate with subcontractors and ensure that performance is at the level required to ensure timely and effective contract execution. The

Management Plan shall initially be submitted with the Offeror’s proposal and will be updated after contract award.

5.3 Required Reports

5.3.1 Monthly Progress Report (MPR) – Deliverable 2

The Contractor shall ensure that an MPR (Deliverable 2) is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this contract. Serious problems/ issues should be brought to the attention of the COR immediately.

The MPR shall include the labor hours expended, by labor category, for each task and sub-task.

5.3.2 Subcontractor Expenditures Report – Deliverable 3

If Subcontractors are used, the Contractor shall prepare and deliver a Subcontract Expenditures

Report (Deliverable 3) that discloses actual subcontract expenditures by company name, business size standard (i.e. Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (i.e. Indian Incentive Program, Historically Black Colleges and

Universities and Minority Institutions, etc.).

5.4 Transition Support

5.4.1 Incoming Transition Plan – Deliverable 4

In accordance with the solicitation, the Contractor shall provide a plan for 30 days incoming transition from previous contract to incoming contract. The Contractor shall coordinate with the

Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall collaborate with the Government to develop and deliver an

Incoming Transition Plan (Deliverable 4). The Government will designate a transition period for the incoming Contractor to coordinate and work with the incumbent Contractor. This transition plan shall include, but is not limited to:

Coordination with Government representatives;

Review, evaluation and transition of current support services;

Transition of historic data to new Contractor system;

Government-approved training and certification process;

Transfer of hardware warranties and software licenses (if applicable);

Transfer of all necessary business and/or technical documentation;

Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes;

Distribution of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment (if applicable);

Transfer of Government Furnished Equipment (GFE) and Government Furnished

Information (GFI), and GFE inventory management assistance;

Applicable WRAIR briefing and personnel in-processing procedures;

Coordinate with the Government to account for government keys, ID/access cards, and security codes.

5.4.2 Ongoing Transition Plan – Deliverable 5

In accordance with the solicitation, the Contractor shall provide a plan for ongoing transitions within the contract to subcontractors. The Contractor shall collaborate with the Government to develop and deliver an Ongoing Transition Plan (Deliverable 5). This transition plan shall include, but is not limited to:

Review and evaluation of current support services;

Addition of newly created historic data to new Contractor system.

5.4.3 Outgoing Transition Plan – Deliverable 6

In accordance with the solicitation, the Contractor shall provide a plan (Deliverable 6) 15 days outgoing transition for transitioning work from an active task order to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract and/or orders issued under this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required metrics and statistics. This transition plan shall include, but is not limited to:

Review, evaluation and transition of current support services;

Transition of historic data to new Contractor system;

Government-approved training and certification process;

Transfer of hardware warranties and software licenses (if applicable);

Transfer of all necessary business and/or technical documentation;

Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches (if applicable);

Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes;

Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment;

Transfer of GFE and GFI, and GFE inventory management assistance;

Applicable CMPNS debriefing and personnel out-processing procedures;

Turn-in of all government keys, ID/access cards, and security codes.

5.4.4 Kickoff Meeting.

Contractor shall attend a kickoff meeting with the Government Program Manager/COR at the

WRAIR and/or via telecom within seven (7) business days of contract award. The Contractor shall provide concurrence with the date, time, and location for the meeting prior to the scheduled meeting.

5.5 Program Management Plan – Deliverable 7

The Contractor shall develop a Program Management Plan (Deliverable 7) that shall require

Government approval. This plan shall be applied by the Contractor to manage, track and evaluate the Contract performance. The Program Management Plan shall consist of control policies and procedures in accordance with standard industry practices for project administration, execution and tracking.

The Program Management Plan shall include the following:

Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities;

An Integrated Master Management Plan (IMMP) describing the Contractor’s overall management approaches, policies and procedures including suggested project metrics;

and

A detailed staffing plan.

The Program Management Plan shall be due thirty (30) calendar days after the award of the order.

5.6 Quality Control Plan – Deliverable 8

The Contractor shall prepare and adhere to a Quality Control Plan (QCP). The QCP will initially be submitted with the vendor’s quote and shall be updated following award (Deliverable 8). The

QCP shall document how the Contractor will meet and comply with the quality standards established in this statement of work. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this solicitation.

5.7 Contingency Operations Plan – Deliverable 9

The Contractor shall develop and submit a Contingency Operations Plan to the Government.

The Contingency Operations Plan shall be due sixty (60) calendar days after the award of the order, and will be updated on a semi-annual basis (Deliverable 9). The Contingency Operations

Plan shall document Contractor plans and procedures to maintain WRAIR support during an emergency to include situations when WRAIR facilities are not unavailable for use. The

Contingency Operations Plan shall include the following:

A description of the Contractor’s contingency management procedures and policy;

A description of how the Contractor will account for their employees during a contingency situation;

Planned temporary work locations and/or alternate facilities;

Planned off site clinical trials support capabilities and timeline (to include proposed location, facility size, equipment, cost, exit strategy, and if government funded-contractor operated or wholly contractor owned);

How the Contractor will communicate with WRAIR during a contingency situation;

A list of primary and alternate Contractor points of contact, each with primary and alternate:

o Telephone numbers, o E-mail addresses;

Procedures for protecting Government furnished equipment (if any);

Procedures for safeguarding sensitive and/or classified Government information (if applicable).

5.8 Operations During Contingency Situations

Individual contingency operation plans shall be activated immediately after determining that a contingency situation has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the contingency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR shall immediately make contact with the Contractor Task Manager to ascertain the status of any Contractor personnel who were located in affected Government controlled space. When any disruption of normal, daily operations occur, the Contractor Task

Manager shall promptly open an effective means of communication and verify:

Key points of contact (Government and Contractor);

Temporary work locations (alternate office spaces, telework, virtual offices, alternate clinical trial location);

Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier);

Essential work products expected to continue production by priority.

The Contractor Task Manager, in coordination with the COR, must make use of the resources and tools available to continue WRAIR contracted functions to the maximum extent possible under contingency situation circumstances. The Contractor must obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge accurately and in accordance with the terms of this contract.

6.0 MAJOR TASK AREA: TECHNICAL SUPPORT REQUIREMENTS

The following Functional Areas identify the range of services that are anticipated in this award.

6.1 Experimental Sleep Study Support

The Contractor shall provide scientific expertise in psychophysiology, actigraphy, cognitive performance testing, personality testing, psychological stress, Post Traumatic Stress Syndrome

(PTSD), Mild Traumatic Brain Injury (mTBI), pain, neurophysiology, statistics, and functional brain imaging. The Contractor shall perform human research studies (field and laboratory) to include writing protocols, executing protocols, analyzing data, and writing manuscripts.

Documents and management processes must comply with all regulatory requirements, both

Federal and DoD. Prepared documents must be appropriate for the purpose, accurate in content, and timely in submission. Contractor personnel providing technical services will be qualified by appropriate education, recent and relevant experience, and certification for the designated services.

6.2 Overpressure Field Study Support

The Contractor shall work closely with technical staff in the day to day program and operations and oversee requirements of CMPNS for the conduction of theoretical and applied research in blast, resilience, sleep deprivation, neurocognitive performance, and psychopharmacology. The

Contractor shall perform research studies (field and laboratory) to include writing protocols, executing protocols, analyzing data, and writing manuscripts. Contractor personnel providing technical services will be qualified by appropriate education, recent and relevant experience, and certification for the designated services. Prepared documents must be appropriate for the purpose, accurate in content, and timely in submission. Additionally, the Contractor shall perform the required human resource support services for volunteer recruitment and screening.

6.3 Behavioral Biology Research Support [Sleep Laboratory and Performance

Assessment and Chemical Evaluation (PACE) Laboratory]

The Contractor shall conduct all aspects of scientific research experiments according to individual reviewed protocols. The Contractor shall communicate and correspond with lead investigator(s) regarding experimental procedures, study progress, concerns about the study, and changes in procedure on a regular and ongoing basis. The Contractor shall perform routine and specialized behavior tests and procedures on animals and humans. Contractor personnel providing technical services will be qualified by appropriate education, recent and relevant experience, and certification for the designated services. The Contractor shall have the knowledge, skills and abilities in multiple Behavioral Biology research domains, including but not limited to sleep, PTSD, personality, combat stress, psychological resilience, psychological distress, physical pain and TBI, to advise and guide leadership and branch chiefs in the development of strategic research efforts and program.

6.4 RTO

The Contractor shall provide support to update Military Resilience Training (MRT) program materials currently managed within the RTO. The Contractor shall provide assessment of current MRT education and training needs, develop, and deliver updated materials. The

Contractor shall design and produce training and marketing materials for the MRT program including videos, student and instructor booklets, posters, brochures, and website(s). The

Contractor shall conduct and modify the training as needed until the skills are being successfully taught. The Contractor shall coordinate with key stakeholders such as Comprehensive Soldier

Fitness (CSF), Training and Doctrine Command (TRADOC), Forces Command (FORSCOM), and Brigade Combat Team leadership to ensure support for the program.

6.5 US Army Medical Research Detachment - West

This scope period of performance begins in Option Year 1. There is no requirement for this work during the base year of the contract. The Contractor shall provide Mental Health Research

(MHR) support conducted within the US Army Medical Research Unit-West, Joint Base Lewis-

McChord (JBLM). The Contractor shall conduct all aspects of scientific research experiments according to individual reviewed protocols. The Contractor shall perform routine and specialized behavior tests and procedures on humans. Contractor personnel providing technical services will be qualified by appropriate education, recent and relevant experience, and certification for the designated services. The Contractor shall have the knowledge, skills and abilities in multiple Behavioral Biology research domains, including but not limited to sleep, PTSD, personality, combat stress, psychological resilience, psychological distress, physical pain and TBI, to advise, guide, design, and implement studies examining how physiological, psychological, workload, and combat factors impact the readiness of US Service Members and military units.

6.6 Blast Induced Neurotrauma

The Contractor shall conduct all aspects of scientific research experiments according to individual reviewed protocols. The Contractor shall perform research studies to include writing protocols, executing protocols, analyzing data, and writing manuscripts. The Contractor shall communicate and correspond with lead investigator(s) regarding experimental procedures, study progress, concerns about the study, and changes in procedure on a regular and ongoing basis.

The Contractor shall perform routine and specialized behavior tests and procedures on animals and humans. Contractor personnel providing technical services will be qualified by appropriate education, recent and relevant experience, and certification for the designated services. The

Contractor shall have the knowledge, skills and abilities in multiple Behavioral Biology research domains, including but not limited to TBI, cellular biology, biomarkers, neuropathology, PTSD, personality, combat stress, psychological resilience, psychological distress, and physical pain, to advise and guide leadership and branch chiefs in the development of strategic research efforts and program.

7.0 SPECIFIC TASKS

7.1 Task Requirements

The Contractor shall perform the following tasks in support of Military Psychiatry Branch, Blast

Induced Neurotrauma Branch, Behavioral Biology Branch (Sleep Laboratory and Performance

Assessment and Chemical Evaluation (PACE) Laboratory), US Army Medical Research

Detachment - West (USAMRD-W), and the Research Transition Office. Joint Base Lewis-

McChord.

7.1.1 Performance Assessment and Chemical Evaluation (PACE) Laboratory Support

7.1.1.1 The Contractor shall generate, organize, copy, store, and archive day-to-day data files and summary files for the studies.

7.1.1.2 The Contractor shall communicate and otherwise correspond with the lead investigator regarding experimental procedures, changes in procedures, and study progress on a weekly frequency or as requested.

7.1.1.3 The Contractor shall independently report and solve study problems (when feasible) that arise (e.g., equipment malfunctions), conferring with the lead investigator and/or COR when necessary.

7.1.1.4 The Contractor shall prepare summary data files and data tables from study results as requested by COR or lead investigator.

7.1.1.5 The Contractor shall maintain orderly storage of purchased supplies and materials necessary to conduct experiments and maintain the laboratories.

7.1.1.6 The Contractor shall follow all SOPs for laboratory cleaning and maintenance daily, during work days.

7.1.1.7 The Contractor shall be physically able to handle laboratory equipment, chemicals and/or hazardous biological material. The Contractor may be exposed to blood borne pathogens, chemical fumes, and other hazardous agents.

7.1.1.8 The Contractor shall possess a minimal proficiency in common productivity software programs including Word, Excel, SigmaPlot and others, and have an understanding of basic descriptive statistics.

7.1.1.9 The Contractor shall have the ability to engage in and oversee multiple tasks simultaneously.

7.1.1.10 The Contractor shall have the ability to develop and demonstrate excellent and professional rapport with research assistants and other Institute personnel.

7.1.1.11 The Contractor shall assist in the preparation of scientific and technical manuscripts for publication in peer reviewed academic journals. The Contractor shall perform literature searches and literature reviews as part of protocol development and manuscript-writing process. The

Contractor shall be comfortable with written English and capable of writing in scientific prose.

7.1.1.12 The Contractor shall assist in the preparation of any progress reports and/or final reports submitted to the entities who are serving as the research sponsors.

7.1.1.13 The Contractor shall order and maintain inventories of laboratory supplies.

7.1.1.14 The Contractor shall serve as a technical resource to the research team to include being a subject matter expert for the Government and training other members of the research team, as appropriate.

7.1.1.15 The Contractor shall follow established procedures for collection and/or processing and analyses of blood, urine, saliva, etc., as needed in research protocols.

7.1.1.16 The Contractor shall prepare and maintain administrative paperwork (i.e. Laboratory

Notebooks, Research Protocols, Quarterly reports for sponsor, IRB, and inventory).

7.1.1.17 The Contractor shall collect and analyze data and present preliminary findings at military, national, and international scientific conferences. The Contractor shall be skilled in presentation techniques including design, construction and public speaking skills.

7.1.1.18 The Contractor shall serve as author or coauthor on manuscripts resulting from data collection efforts, incorporating computer generated displays into a written document. The

Contractor shall formulate and organize ideas into coherent manuscript design. The Contractor shall assist other researchers in scientific investigations through discussion, site visits, and collaborative efforts and participate in branch and research team meetings and conferences.

7.1.1.19 The Contractor shall assist in the preparation of scientific and technical manuscripts for publication in peer reviewed academic journals. The Contractor shall perform literature searches and literature reviews as part of protocol development and manuscript-writing process. The

Contractor shall be comfortable with written English and capable of writing in scientific prose.

7.1.1.20 The Contractor shall collect, process and prepare data for computer entry as well as create computer database files for the purpose of analyses and archiving. The Contractor shall also advise on the use of appropriate statistical and other analyses on collected data, perform standard and advanced statistics, using computer-based programs such as SPSS, SAS, etc. The

Contractor shall be familiar with standard Microsoft programs such as Excel, Word, and

PowerPoint. The Contractor shall be familiar with statistics and statistical packages for the purpose of data analyses and database management. The Contractor shall have an understanding of relevant databases and accompanying analyses.

7.1.1.21 The Contractor shall be able to work independently and with minimal supervision. The

Contractor shall also be able to function effectively as a leader of an interdisciplinary team composed of researchers from a variety of backgrounds/institutions including WRAIR, MRMC, NIH, various universities, etc.

7.1.1.22 The Contractor shall help secure intellectual property through the timely submission of invention disclosures.

7.1.1.23 The Contractor shall train, mentor, and lead Contractor and other junior research staff under this contract.

7.1.1.24 The Contractor shall comply with occupational health and safety standards and other applicable regulations and guidelines, which may include medical surveillance.

7.1.1.25 The Contractor shall provide scientific and technical support for the development, validation, and application of animal models (i.e. rodent, ferret, swine, non-human primate).

7.2 Experimental Sleep Study Support

The Contractor shall perform the following tasks to support and or conduct protocols utilizing the Sleep Laboratory to investigate stress, PTSD, TBI, Mental Health Research, neurotrauma, as well as the effects of blast, resilience, sleep deprivation, and pharmacological agents.

7.2.1 The Contractor shall develop and maintain Standard Operating Procedures for data collection, and ensure that all study data are collected, recorded, documented, and archived in compliance with Good Clinical Practices and pertinent government rules, regulations, and policies.

7.2.2 The Contractor shall administer psychological and performance measures to subjects as specified in protocols.

7.2.3 The Contractor shall maintain an appropriate, professional demeanor in all interactions with human research participants and research collaborators.

7.2.4 The Contractor shall oversee recruitment and screening of volunteers for human research protocols.

7.2.5 The Contractor shall administer neurocognitive tasks, symptom questionnaires, informed consent, and other related paperwork.

7.2.6 The Contractor shall collect physiological data (e.g., metabolic rate) and aid in their compilation/entry for later analyses.

7.2.7 The Contractor shall provide technical support in actigraph utilization for all research studies (field and laboratory) to include maintenance, testing, trouble-shooting, and repair of actigraphs.

7.2.8 The Contractor shall be able to train, lead, and/or coordinate technical staff members in all areas of polysomnography, performance testing, and actigraphy, and additional functions to include (but not limited to) PC-based initialization of devices with appropriate parameters and power sources; data acquisition; and data processing.

7.2.9 The Contractor shall assist in Subject recruitment physicals, including administration of standardized psychological evaluations.

7.2.10 The Contractor will be responsible for a number of sleep studies to include, pre-site visit preparations, as well as site visit responsibilities and travel/overnight stays for up to four (4) studies.

7.2.11 The Contractor shall conduct site visits as dictated by the monitoring plan, focusing on:

subject entry criteria, informed consent process, and verification of data accuracy and protocol/study compliance.

7.2.12 The Contractor shall communicate with site Investigator/coordinator any issues, including adverse effects, that require follow-up, action(s) to be taken, and expected timelines for completion for all action items.

7.2.13 The Contractor shall review and score polysomnograms, have ability to identify normal/abnormal patterns, artifacts, and sleep/wake stages, and generate reports that accurately summarize subjects…