W911QY-17-R-0029.pdf

CODE

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PAGE(S)

until local t ime

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A X B X C X D

EX

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G F 88 - 93

94 - 101 X H 102 - 106

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 106

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W911QY 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 12

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

13 - 65

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

68 - 70 X K REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 71 - 73 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 74 - 75 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIO NS AND INSTRUCTIO NS

PART III - LIST O F DO CUMENTS, EXHIBITS AND O THER ATTACHMENTS

76 - 86

PART II - CO NTRACT CLAUSES

W6QK ACC-APG NATICK

110 THOMAS JOHNSON DR SUITE #240

FREDERICK MD 21702

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

15 Mar 2017

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W911QY-17-R-0029

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Lot Incoming Transition Period

FFP

The contractor shall supply all services necessary to perform the Incoming transition period (30 days) in accordance with the performance work statement and deliverable #4.

FOB: Destination

NET AMT

0002 12 Months Base Year

FFP

Provide all labor necessary to provide the Services and Deliverables in accordance with the Performance Work Statement.

0003 Each Travel

COST

Travel is anticipated during the performance of this requirement. These costs cannot be accurately forecast at this time and are therefore awarded on a cost reimbursable basis and may be partially funded as indicated on the award document. Travel costs are limited to the constraints of FAR 31.205-46 and the Joint Travel Regulations.

All requests for travel must be submitted to the Contracting Officers Representative for approval at least 5 days prior to incurring costs. Travel will be reimbursed to the extent allowable pursuant to the Federal Travel Regulations

(FTR).

Contractor shall seek the lowest fare available to meet the revised schedule.

Contractor shall document the change in their submission for reimbursement. The contractor shall use only the minimum quantity and cost of travel required to accomplish the task. Travel shall be scheduled during normal duty hours whenever possible. Airfare will be reimbursed for actual common carrier fares which are obtained by the most reasonable and economical means.

ESTIMATED COST

0004 Each ODCs

COST

Materials/Other Direct Costs (ODC's): Materials/Supplies/Spares may be purchased on a cost reimbursement basis. The contractor may be required to procure necessary supplies and equipment, and incur other incidental costs necessary to complete the mission. All incidental procurement shall be reimbursed on an actual cost basis and approved by the Contracting Officers Representative prior to the procurement. Other than Cost & Pricing Data shall be submitted to support reimbursement invoicing for ODC’s.

CMR Reporting

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than OCtober 31 of each calendar year, beginning with 2017.

Contractors may direct questions to the help desk at the reporting website.

0006 12 Months OPTION Option Year 1

FFP

Provide all labor necessary to provide the Services and Deliverables in accordance

0007 Each OPTION Travel Option Year 1

COST

Travel is anticipated during the performance of this requirement. These costs cannot be accurately forecast at this time and are therefore awarded on a cost reimbursable basis and may be partially funded as indicated on the award document. Travel costs are limited to the constraints of FAR 31.205-46 and the Joint Travel Regulations.

All requests for travel must be submitted to the Contracting Officers Representative for approval at least 5 days prior to incurring costs. Travel will be reimbursed to the extent allowable pursuant to the Federal Travel Regulations

(FTR).

Contractor shall seek the lowest fare available to meet the revised schedule.

Contractor shall document the change in their submission for reimbursement. The contractor shall use only the minimum quantity and cost of travel required to accomplish the task. Travel shall be scheduled during normal duty hours whenever possible. Airfare will be reimbursed for actual common carrier fares

0008 Each OPTION ODCs Option Year 1

COST

Materials/Other Direct Costs (ODC's): Materials/Supplies/Spares may be purchased on a cost reimbursement basis. The contractor may be required to procure necessary supplies and equipment, and incur other incidental costs necessary to complete the mission. All incidental procurement shall be reimbursed on an actual cost basis and approved by the Contracting Officers Representative prior to the procurement. Other than Cost & Pricing Data shall be submitted to

OPTION CMR Reporting Option Year 1

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than OCtober 31 of each calendar year, beginning with 2017.

0010 12 Months OPTION Option Year 2

FFP

Provide all labor necessary to provide the Services and Deliverables in accordance

0011 Each OPTION Travel Option Year 2

COST

Travel is anticipated during the performance of this requirement. These costs cannot be accurately forecast at this time and are therefore awarded on a cost reimbursable basis and may be partially funded as indicated on the award document. Travel costs are limited to the constraints of FAR 31.205-46 and the Joint Travel Regulations.

All requests for travel must be submitted to the Contracting Officers Representative for approval at least 5 days prior to incurring costs. Travel will be reimbursed to the extent allowable pursuant to the Federal Travel Regulations

(FTR).

Contractor shall seek the lowest fare available to meet the revised schedule.

Contractor shall document the change in their submission for reimbursement. The contractor shall use only the minimum quantity and cost of travel required to accomplish the task. Travel shall be scheduled during normal duty hours whenever possible. Airfare will be reimbursed for actual common carrier fares

0012 Each OPTION ODCs Option Year 2

COST

Materials/Other Direct Costs (ODC's): Materials/Supplies/Spares may be purchased on a cost reimbursement basis. The contractor may be required to procure necessary supplies and equipment, and incur other incidental costs necessary to complete the mission. All incidental procurement shall be reimbursed on an actual cost basis and approved by the Contracting Officers Representative prior to the procurement. Other than Cost & Pricing Data shall be submitted to

OPTION CMR Reporting Option Year 2

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than OCtober 31 of each calendar year, beginning with 2017.

0014 12 Months OPTION Option Year 3

FFP

Provide all labor necessary to provide the Services and Deliverables in accordance

0015 Each OPTION Travel Option Year 3

COST

Travel is anticipated during the performance of this requirement. These costs cannot be accurately forecast at this time and are therefore awarded on a cost reimbursable basis and may be partially funded as indicated on the award document. Travel costs are limited to the constraints of FAR 31.205-46 and the Joint Travel Regulations.

All requests for travel must be submitted to the Contracting Officers Representative for approval at least 5 days prior to incurring costs. Travel will be reimbursed to the extent allowable pursuant to the Federal Travel Regulations

(FTR).

Contractor shall seek the lowest fare available to meet the revised schedule.

Contractor shall document the change in their submission for reimbursement. The contractor shall use only the minimum quantity and cost of travel required to accomplish the task. Travel shall be scheduled during normal duty hours whenever possible. Airfare will be reimbursed for actual common carrier fares

0016 Each OPTION ODCs Option Year 3

COST

Materials/Other Direct Costs (ODC's): Materials/Supplies/Spares may be purchased on a cost reimbursement basis. The contractor may be required to procure necessary supplies and equipment, and incur other incidental costs necessary to complete the mission. All incidental procurement shall be reimbursed on an actual cost basis and approved by the Contracting Officers Representative prior to the procurement. Other than Cost & Pricing Data shall be submitted to

OPTION CMR Reporting Option Year 3

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than OCtober 31 of each calendar year, beginning with 2017.

0018 12 Months OPTION Option Year 4

FFP

Provide all labor necessary to provide the Services and Deliverables in accordance

0019 Each OPTION Travel Option Year 4

COST

Travel is anticipated during the performance of this requirement. These costs cannot be accurately forecast at this time and are therefore awarded on a cost reimbursable basis and may be partially funded as indicated on the award document. Travel costs are limited to the constraints of FAR 31.205-46 and the Joint Travel Regulations.

All requests for travel must be submitted to the Contracting Officers Representative for approval at least 5 days prior to incurring costs. Travel will be reimbursed to the extent allowable pursuant to the Federal Travel Regulations

(FTR).

Contractor shall seek the lowest fare available to meet the revised schedule.

Contractor shall document the change in their submission for reimbursement. The contractor shall use only the minimum quantity and cost of travel required to accomplish the task. Travel shall be scheduled during normal duty hours whenever possible. Airfare will be reimbursed for actual common carrier fares

0020 Each OPTION ODCs Option Year 4

COST

Materials/Other Direct Costs (ODC's): Materials/Supplies/Spares may be purchased on a cost reimbursement basis. The contractor may be required to procure necessary supplies and equipment, and incur other incidental costs necessary to complete the mission. All incidental procurement shall be reimbursed on an actual cost basis and approved by the Contracting Officers Representative prior to the procurement. Other than Cost & Pricing Data shall be submitted to

OPTION CMR Reporting option Year 4

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than OCtober 31 of each calendar year, beginning with 2017.

0022 1 Lot OPTION Outgoing Transition Period

FFP

The contractor shall supply all services necessary to perform the Outgoing transition period (15 days) in accordance with the performance work statement and Deliverable #6.

Section C - Descriptions and Specifications

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; and 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].

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., USAMRAA, 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 PERFORMANCE WORK STATEMENT

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 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

https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview

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 the active contract 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 performance work statement. 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 Syndrom (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.