Released Amendment 1_N6264520R0020.docx

N6264520R0020

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

RESPONSES TO QUESTIONS

List of Questions/Comments Received for Solicitation N6264520R0020

1. Per C.3.3 of the Initial Task Order (ITO), what is the GOVT using for a one (1) man hour equivalent (e.g., 1880)?

Response: As stated in Section C.2.24 of the solicitation for the base contract, the Government estimates a full time equivalent (FTE) at 1920 hours (One FTE = 1920 hours (2080 hours – 80 hours holidays – 80 hours PTO)) for the purposes of the estimated level of effort that is provided at the task order level. This language has now been added to Section C.3.3. of the ITO as well.

2. Section C.2.20 references subcontracts and that the awardee must have the capacity to award subcontracts to meet R&D needs. It states that this could include renting space for sample storage, offices or a research facility -also support from a CRO, data analysis and management sub. Can the government please clarify what might be needed on the rental of space, etc.? Does this apply only for alternative study sites?

Response: The Warfighter Performance Department performs and executes on a diverse range of research projects, to include data collection in remote, sometimes austere, locations. Furthermore, the diversity and ever changing scope of research performed sometimes requires the flexibility to expand capabilities beyond those organic to the command. Therefore, it would be important for the potential contractor to have the logistic capacity to procure temporary facilities, equipment, and performers, in the local San Diego area, in CONUS, and OCONUS to meet this need. Language has been added to Section C.2.20 to state these locations.

3. A PM III is required for the base IDIQ contract. Can this same person fulfill one of the two (2) PM III positions required for the ITO since they are not FTEs?

Response: Yes, the same person can fulfill the PM III positions listed on the base IDIQ contract and ITO.

4. Regarding Key Personnel, in Section C.5.1 page 15, for base IDIQ contract the Government lists one Key Personnel position, Project Manager III. In the ITO PWS page 4, the Government lists two Project Manager III Key Personnel positions. Would the Government accept 2 resumes for Project Manager III Key Personnel position or does the Government require 3 Key Personnel resumes?

Response: Two resumes is sufficient for Project Manager III Key Personnel positions. Section C.5.1. has been updated to list the estimated amount of personnel per labor category. Language has been added to Section C.5.2. to note that both Project Manager III Key Personnel listed in the solicitation are accounted for in the ITO.

5. Will the government please confirm the labor categories and quantity of key personnel as there is a discrepancy between the Solicitation Section C.5 Table and the Attachment IV-ITO PWS Section C.3.3 direct labor mix? Table C.5 indicates an asterix only next to the C.5.3.22 Project Manager III position, while Table C.3.3 lists Project Manager III (Qty 2) and Data Informatics/Researcher (Qty 5) as key personnel for a total of 7 resumes.

Response: Seven resumes will be sufficient. Section C.5.1. has been updated to list the estimated amount of personnel per labor category. Language has been added to Section C.5.2. to note that both Project Manager III Key Personnel listed in the solicitation are accounted for in the ITO.

6. The awarded contractor must have an active Data Sharing Agreement (DSA) in place before commencement of services with the Office of the Secretary of Defense (OSD) (Defense Health Agency- DHA) granting access to medical and personnel records resident in the Military Health System (MHS) including the TMDS, the MDR, Defense Occupational and Environmental Health Readiness System (DOEHRS) Hearing Conservation (HC) and pre/post deployment health assessments/reassessments. A DSA must also include full access to protected health information. Obtaining an active DSA is a minimum requirement for the awarded contractor as failure to have a current DSA with OSD (Tricare Management Agency - TMA) before commencement of services would result in a work stoppage in NHRC department 161 and a failure for the Government to meet funding sponsor requirements for product delivery.

Under current DHA Privacy Office requirements, any new contract must have a new DSA. This would mean any contractor other than the incumbent could not technically meet this requirement as the DSA would not be registered under the new award. The DSA held by the incumbent however, can be extended 30 days after expiration. This represents a clear bias or unfair advantage towards the incumbent contractor.

Response: As identified in C.2.11. of the solicitation, this is a brand new requirement, and therefore, there is no incumbent contractor. Per C.4.3.21 of the solicitation, the Contractor shall possess an active Data Sharing Agreement (DSA) before commencement of services with Office of the Secretary of Defense (OSD) (i.e. Defense Health Agency- DHA). A DSA is not required to be in place at award of the base contract. Language in Section C.4.3.21 has been revised.

7. Since this is a Task Order IDIQ contract with unknown work requirements to be contracted via Task Orders over the 5-year contract period of performance, would the Government provide the number of hours per year per position (48 Positions) listed in Attachment III-Rates_Formulas Base Contract Hourly Rates Worksheet due to the lack of specifics?

Response: The table listed in Section C.5.1. has been updated to include the estimated number of personnel and estimated amount of hours under each labor category. Offerors shall use these amounts to determine their proposed costs for these labor categories.

8. Regarding Attachment III-Rates_Formulas, the Base Contract Hourly Rates Worksheet:

Question 8a: For each of the 48 positions listed, does the Government want Offerors to list the base salary for each year (unburdened)?

Response: For the prime contractor’s personnel, Offerors’ proposals shall indicate in the Base Contract Hourly Rates Worksheet of Attachment III- Rates & Formulas the unburdened hourly rates per labor category and FTE, when applicable, for each year. For the Offeror’s subcontracted personnel, Offerors’ proposals shall indicate, in Attachment III “Base Contract Hourly Rates”, the burdened hourly rates per labor category and FTE, if applicable, for each year. Offerors shall notate (e.g., by asterisk) which hourly rates are fully burdened. Offerors shall also comply with the requirements outlined in Section L.7.7.(5). Language has been added to both Section L.7.7.(5) and Attachment III to state this information.

Question 8b. On row 53, does the Government want Offerors to provide the escalation rate being used in each Option Year?

Response: A column has been added to enter in an escalation rate beside each labor category in Attachment III-Rates_Formulas (Base Contract Hourly Rates). Escalation rates can be either one set rate for all labor categories, or each labor category can have its own unique escalation rate.

Question 8c. On row 57, does the Government want Offerors to provide the yearly fixed fee as a %?

Response: This is up to the offeror on how they want to calculate the fixed fee. Technically, cost plus fixed fee means that the fixed fee is a flat amount. A percentage can be used to calculate the fixed fee, however, the contract will reflect the fixed fee as a flat amount. For example, if costs were $100 and an offeror used a 5% rate to calculate the fixed fee, the contract would reflect a fixed fee of $5.00, not 5%.

9. Regarding Attachment III-Rates_Formulas, the Base Contract Cost Format Worksheet and the Base Contract Hourly Rates Worksheet:

Question 9a. Will the Government be using the Total Cost-Plus-Fixed-Fee value on the Base Contract Cost Format Worksheet for evaluation purposes?

Response: Yes, the Total Cost-Plus-Fixed-Fee value on the Base Contract Cost Format Worksheet in Attachment III will be used in the price analysis for evaluation purposes. The individual costs that make up the Total Value (Direct Labor Rates, Indirect Labor Rates, etc.) will be used in the cost realism analysis (and potentially a cost analysis if only one offer is received and/or receives a “Pass” rating for the Mandatory Documentation) for evaluation purposes as well.

Question 9b. If yes to Question 9a, will the Government provide the hours to be used per year in the Base Contract Cost Format Worksheet for each of the 48 positions listed in the Base Contract Hourly Rates Worksheet? This will ensure all Offerors are provided an equal opportunity given the unknown task requirements on this new IDIQ and not give an unfair competitive advantage to any partial incumbent.

Response: The table listed in Section C.5.1. has been updated to include the estimated number of personnel and estimated amount of hours under each labor category. Offerors shall use these amounts to determine their proposed costs for these labor categories.

10. Section L.6.1.- Does the government want the PPIS forms submitted as a separate PDF attachment, or embedded in the main file as an Object? Or can we submit the Volumes I & II in PDF, which will help with the file size limit?

Response: The PPIS forms are to be submitted as a separate PDF attachment. The instructions in Attachment II: PPIS and Section L.7.3.1.(2) have been updated to reflect this clarification. The remainder of Volume I as well as Volume II is to still be submitted in either Microsoft Word or Microsoft Excel.

11. Section L.6.1- Can the government please confirm that they want an inch margin around the figures or is this in reference to the 1” margins for the document and whether there is a font requirement outside of size?

Response: Language has been revised in Section L.6.1. to state that all pages are to have 1” margins. In addition, language has been revised to state that all documentation, graphics, tables and reproductions shall be Times New Roman and no smaller than a font size of ten (10) and shall have a minimum of 1.0 line spacing. This allows all format requirements to be consistent regardless of information is in graphics, tables, and reproductions or not.

12. Section L.6.1 of the RFP does not require an evaluated technical approach specifically associated with the ITO. To better describe the approach, understanding and technical execution of the ITO, would the government consider adding an additional evaluated technical approach section to the requirement of not more than 10 pages?

Response: Please note that, as per Section M.3.2.6., the ITO will be evaluated within Evaluation Factor I: Management Approach/Risk. An additional evaluated technical approach section will not be added to this requirement.

13. Section L.7.2.1 of the RFP states deviations from the estimated staffing outlined in Section C shall be addressed. In order to better execute the described mission of the ITO, would the government allow alternate staff models to not only include changes to the ITO titles in the estimated labor mix in C.3.3 of the ITO as well as the addition of key personnel to further demonstrate an understanding of the mission and accomplish the requirements?

Response: Yes, in addition to allowing alternate staff models, the Government would allow an Offeror to propose additional key personnel if the Offeror thought necessary to implement as part of its alternate labor mix.

14. In Section L.7.7. VOLUME II, SUBPART II: Excel Spreadsheet/Cost Breakdown, Item 6, the Government states, “If subcontractors are unwilling to submit their direct labor rates to the prime contractor, they shall submit only the direct labor rates to the Government utilizing the same proposal submission instructions and due date and time located in this section.”

Questions 14a. If the subcontractors are unwilling to provide to the Prime, please clarify what the Government means by “direct labor rates”? Does the Government want subcontractors unburdened labor rates or their fully burdened labor rates including build-up?

Response: “Direct labor rates” means the labor that is considered a direct cost. For the prime contractor’s personnel, Offerors’ proposals shall indicate in the Base Contract Hourly Rates Worksheet of Attachment III- Rates & Formulas the unburdened hourly rates per labor category and FTE, when applicable, for each year. For the Offeror’s subcontracted personnel, Offerors’ proposals shall indicate, in Attachment III “Base Contract Hourly Rates”, the burdened hourly rates per labor category and FTE, if applicable, for each year. Offerors shall notate (e.g., by asterisk) which hourly rates are fully burdened. Offerors shall also comply with the requirements outlined in Section L.7.7.(5). Language has been added to both Section L.7.7.(5) and Attachment III to state this information.

For the Base Contract Cost Format Worksheet, the Offeror shall indicate the unburdened amounts, regardless if labor is for the prime contractor or subcontractor, with the handling burden listed separately.

Question 14b. Please confirm that subcontractors are not required to complete the complete Attachment III-Rates_Formulas Spreadsheet, including all worksheets.

Response: Per Section L.7.7.(6), “If subcontractors are unwilling to submit their direct labor rates to the prime contractor, they shall submit only the direct labor rates to the Government utilizing the same proposal submission instructions and due date and time located in this section.” If a subcontractor is unwilling to submit their direct labor rates to the prime contractor, the subcontractor must submit these rates to the Government utilizing the format in Attachment III: Rates & Formulas. With that said, subcontractors shall revise cost elements as applicable. Language has been added to Section L.7.7.(6) to state that the subcontractor must clearly state who their prime contractor will be in order for the Government to evaluate their rates with the appropriate proposal.

15. This section of the RFP seems to be missing a couple sub-sections – it goes from L.7.9. VOLUME II, SUBPART IV. ITO – EXCEL SPREADSHEET/COST BREAKDOWN. to L.10. PROPOSAL SUBMISSION. Can the government please verify that all sections are present or provide any sections that may be missing?

Response: No sections were missing, and the numbering has been corrected (Section L.10 is now L.8, Section L.11 is now L.9, and Section L.12 is now L.10).

16. The Government states in Section L.10 on page 114, that proposals are due Sunday, 3 May 2020 at 10:00 a.m. ET. Since the Government will need time to respond to questions and then Offerors will need to adjust their proposals based on the Government responses, would the Government please grant a one-week proposal extension to 11 May 2020 at 10:00 a.m. ET?

Response: Due to the amount of time taken to address questions, the proposal submission date has been extended from 10:00AM EST, 3 May 2020 to 10:00AM EST, 7 May 2020.

17. On 12 March 2020, Solicitation Number N6264520R0014 was issued on beta.sam.gov and appears to have overlapping medical modeling and simulation tasks to this current Solicitation. Would the Government confirm that the requirements included in the current solicitation are distinct?

Response: Solicitation Number N6264520R0020 is distinctly different from Solicitation Number N6264520R0014.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

SOW/PWS

STATEMENT OF WORK / PERFORMANCE WORK STATEMENT

RESEARCH SUPPORT SERVICES FOR THE OPERATIONAL READINESS DIRECTORATE AT THE NAVAL HEALTH RESEARCH CENTER

C.1. INTRODUCTION AND BACKGROUND:

C.1.1. This Statement of Work (SOW) / Performance Work Statement (PWS), located in Section C of the base contract, applies to all subsequent task orders issued under this base contract.

C.1.2. Naval Health Research Center (NHRC) is a Navy Medical Research and Development (R&D) Command charged with conducting medical research, development, testing, evaluation, and surveillance to enhance deployment readiness of Department of Defense (DOD) personnel worldwide.

C.1.3. The effort required under this SOW / PWS is to provide non-personal research support services to the NHRC. Performance will include intramural R&D support services for the NHRC Operational Readiness Directorate (ORD) and its departments, which includes the Warfighter Performance (WP) Department and Medical Modeling, Simulation and Mission Support (MMS) Department. This includes investigative studies that involve planning, coordinating, designing, and executing experimental protocols that meet with the overall mission of each department’s research objectives and/or overlapping efforts. The WP Department leverages science and technology to: maximize the operational performance and enhance warfighter resilience-both physiological and psychological; and to improve assessment, diagnosis, and advanced rehabilitation strategies to optimize warfighter reset to optimize mission readiness. The MMS Department performs medical modeling and simulation research for the DOD, homeland defense, humanitarian assistance, peace-keeping and disaster relief activities including casualty projection, medical planning factor development, identification of weapons effects both ground and shipboard-based, projection of resource requirements, database development and maintenance, and quality of life outcome studies.

Performance in support of the WP Department may include: research support services in support of NHRC intramural research devoted to the development of new strategies for enhancing human performance including load carriage impact on injury and performance; thermoregulation as it relates to prevention of heat illness and return to duty from a heat injury; exposure to cold temperature and cold water operations; operations performed at altitude; surveillance markers of wounded or injured warfighters relative to biomechanics and cognitive function; defining patterns of resiliency to physical and psychological injury; mitigating the impact of insufficient sleep and fatigue; enhancing training strategies to improve post deployment behavioral health outcomes; evaluation and development of health and wellness strategies; evaluation of wounded warrior care; and recommending return-to-duty criteria for wounded service members.

Performance in support of the MMS Department may include: research support services in support of NHRC intramural research devoted to the development and support services for research on casualty outcomes and modeling of casualty projections in support of operational medicine. It is heavily data driven and depends upon the collection, characterization, analysis, and reporting of data from multiple sources, including both in-house sources such as the Expeditionary Medical Encounter Database (EMED) and external DoD sources such as the Military Health System (MHS), the Department of Veterans Affairs (VA), civilian and homeland defense data, tactical data, operational data, and personnel data.

C.2. ASSUMPTIONS AND CONSTRAINTS

C.2.1. All task orders issued under this base Indefinite Delivery Indefinite Quantity (IDIQ) - contract will be Cost Plus Fixed-Fee (CPFF). All task orders issued under this contract will be for non-personal services.

C.2.2. For task orders that are considered severable services, the task order will be performance based and will include a PWS that identifies the tasks to be performed and a Quality Assurance Surveillance Plan (QASP) that establishes performance metrics for these tasks.

C.2.3. For task orders that are considered non-severable services, the task order will not be performance based and will not include a PWS or a QASP. Task orders for non-severable services will include a SOW.

C.2.4. Severable task orders will not have a Period of Performance (POP) of more than twelve (12) months (without exercising an option period). The POP for a non-severable task order will be dependent on the nature of the task. The POP for each task order will be delineated in the Task Order Proposal Requests (TOPR).

C.2.5. TOPRs will include the Government’s Estimated Level of Effort (LOE). The Government’s estimated LOE will include the estimated labor mix (typically comprised of labor categories from the base contract SOW/PWS) and the estimated LOE will include the number of Full Time Employees (FTE). If applicable, TOPRs will also include estimated Other Direct Costs (ODCs), Travel, and Subcontract amounts. The TOPR will also include the required assurances for human subject research (HSR), if applicable.

C.2.6. Contractor personnel are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. At a minimum, Contractor personnel must be US citizens and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive. Refer to SUPTXT204-9400 (9-18) herein. It is not anticipated that access to classified material will be required under this base contract or resulting task orders. As a result, notwithstanding the required background investigation, a facility level clearance (FCL) is not required.

C.2.7. No later than fifteen days after contract award, the Contractor’s Security Representative shall submit to the Command Security Manager, via the Contracting Officer’s Representative (COR), the necessary documents to obtain the appropriate Federal background investigation.

C.2.8. Orientation: Contractor personnel shall attend and complete Orientation at the first available opportunity. Contractor personnel shall attend orientation sessions as follows: Command Orientation is provided by the Command consisting of annual training requirements for topics such as but not limited to fire, safety, infection control, family advocacy, Chemical, Biological, Radiological, Nuclear, and Explosive Events (CBRNE) Basic Awareness, and various Navy required on-line trainings. On a case-by-case basis, the Government may waive orientation sessions if contract personnel are currently working or have previously worked at the Command. Contract personnel shall complete all command required training, which may include but not limited to Diversity, HIPAA, Healthstream, and Navy Knowledge Online courses. Contract personnel providing service under this contract or resultant task orders shall undergo an orientation and shall complete mandatory Navy and DoD on-line training as indicated above.

C.2.9. Occupational Health Requirements: The requirements on the HEALTH EXAMINATION AND IMMUNIZATION/SCREENING REQUIREMENT FORM and the Latex Allergy Screening Questionnaire are available at https://www.med.navy.mil/sites/nmlc/Public_Docs/Physical%20Exam%20and%20Immunization%20Form.pdf. Declinations shall only be permitted based on either the contract personnel’s religious convictions or medical contraindications (as documented by a qualified health care provider). All contract personnel shall comply with infection control guidelines to include the proper handling, storage, and disposal of infectious wastes and the use of universal precautions to prevent the spread of infections. The work environment inherently involves risks typically associated with the performance of job duties. The contract personnel may be exposed to contagious diseases, infections and flying debris, requiring the wearing of personal protection equipment such as scrub attire, gloves, masks, and eye protection.

C.2.10. Contractor personnel shall participate in executing the Emergency Preparedness Plan (drills and actual emergencies) as scheduled by the Command (typically semiannually). The Command maintains a recall list with personal contact information for all military, civil service, and contractor personnel which is required to prepare in advance for an actual emergency. Upon commencement of performance, the contractor shall provide the COR with a list of personal contact information for a designated contractor representative as well as all contractor staff performing services. Should an emergency occur that will affect the workers’ shifts, the designated contractor representative and contract personnel shall be contacted.

C.2.11. This effort is considered a new requirement; there is not a legacy contract and therefore the right of first refusal concerning incumbent personnel does not apply.

C.2.12. Intramural HSR is expected under the task orders that will be issued under this base IDIQ contract. An award containing research with human subjects will not be executed unless the Contractor (and all appropriate subcontractors) holds an active Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). A Human Research Protection Officer (HRPO) review must be in place before any funding can be placed on a task order which contains HSR (or on any Option CLIN where HSR is segregated from the remainder of the task order). The COR will be in charge of coordinating with the HRPO to make sure the necessary International Review Board (IRB) protocols are approved prior to the start of services involving HSR. An award of a task order or a modification exercising an option period that contains HSR will not be completed until the Contracting Officer is given the necessary signed HRPO paperwork. All completed HRPO documents will be filed in the physical contract file.

C.2.13. Intramural HSR can include interaction with study participants. When interaction with study participants is required, the Contractor shall possess medical liability and indemnity insurance. The Federal Tort Claims Act does not apply. The requirement for medical liability and indemnity insurance will be delineated at the task order level.

C.2.14. Travel is expected in support of the research efforts at NHRC. Travel approval must be processed in accordance with NHRC procedures, in accordance with Joint Travel Regulations, documented and submitted with monthly reports and correlated with a corresponding line item in the invoice for payment. The number of Contractor personnel required will be determined at the discretion of the COR. All travel must be approved by the COR in writing via e-mail prior to the Contractor incurring any costs.

C.2.15. The Government retains the right to direct the mode of travel including the availability and size of rental cars. It should be noted that vendors are not obligated to extend discounted Government rates to Contractors working on behalf of the Federal Government.

C.2.16. An estimated travel cost will be delineated at the task order level. The estimated travel cost shall not include fee or Contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

C.2.17. Please refer to Section H.14., “REIMBURSEMENT OF TRAVEL, PER DIEM, AND SPECIAL MATERIAL COSTS”, for further details.

C.2.18. Other Direct Costs (ODC) are expected in support of the research efforts at NHRC. ODCs may include equipment for field requirements, research supplies, services and other costs that will accomplish the mission objectives such as the Food and Drug Administration (FDA) and local regulatory authorities applications, study start-up planning, statistical analysis support, study site rentals, medical indemnity/liability insurance, internet services, cloud services, mobile data/communications equipment and services, shipping/transportation fees, transportation that directly supports clinical trials and other research field studies and research subject compensation. All ODC costs (to include gift cards to compensate study participants) must be approved/endorsed by the COR in writing via e-mail prior to the Contractor incurring any costs.

C.2.19. An estimated ODC amount will be delineated at the task order level. The ODC amount shall not include fee or Contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

C.2.20. Subcontracts: Subcontracts are expected in support of the research efforts at NHRC. The awardee must have the capacity to award subcontracts as needed to meet research and development needs. Subcontracts could include (but are not limited to): rent of space for sample storage, rent of office space or research facility with a security system (to execute clinical trials or field research activities, such as performing subject recruitment, initial evaluation, and follow up visits), support from clinical research organizations (CRO), data analysis and management, clinical monitoring and support of data quality assurance and regulatory filing and support. Some of these subcontracts may take place in the local San Diego area, other Continental United States (CONUS) areas, and/or outside the Continental United States (OCONUS) areas. All quality assurance duties are subject to Government approval.

C.2.21. An estimated subcontracts amount will be delineated at the task order level. The subcontracts amount shall not include fee or Contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

C.2.22. The identified potential or perceived Organizational Conflict of Interest (OCI) within this effort is that contractor personnel performing work under this requirement may also have access to include, but not limited to, budgetary information; research program design; sensitive, personal; personnel information; procurement information; support acquisition tasks; support development of research proposals; and support development of research protocols which may create a current or subsequent OCI as defined in FAR Subpart 9.5. As such, all offerors’ proposals shall include OCI Mitigation Plan for review/approval by the Command / Contracting Officer. Acceptance of a contract by the Contractor shall not create an OCI condition, either for legacy work being performed or future work to be bid or performed. The OCI Mitigation Plan shall include Non-disclosure Agreements (NDAs) signed by the personnel performing on this requirement and counter-signed by their management. The OCI Mitigation Plan and NDAs shall state: “This document does not authorize access to another company’s proprietary or sensitive information.” The mitigation plan shall address the possibility (of the offeror) of reviewing (1) its own research such that a bias in favor of itself may be perceived or (2) a competitor’s research such that a bias against the competitor may be perceived. (3) Contract personnel performing work under this requirement may also have access to include, but not limited to, budgetary information, research program design, sensitive, personal, and/or classified information, which may create a current or subsequent OCI as defined in FAR Subpart 9.5. Subject to Contracting Officer discretion, the Contracting Officer may deem an Offeror’s proposal invalid if the OCI has not been or cannot be adequately mitigated.

C.2.23. All financial, statistical, personnel, and technical data, which are furnished, produced, or otherwise available to the contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract. Such data shall not be released by the contractor without prior written consent of the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from studies covered by this contract, will be subject to review and approval by the COR before publication or dissemination. All inquiries from the media shall be forwarded to the Command Public Affairs Officer via the COR. All records produced in the performance of this contract are the property of, and subject to the exclusive control of, the Government. The contractor may retain a copy of all such records or evaluations, but may not provide further copies or disclose the information from such records or evaluations to third parties. All requests from other Commands, treatment facilities or other individuals for research data shall be handled in accordance with procedures specified by applicable Command instructions.

C.2.24. The Government estimates a full time equivalent (FTE) at 1920 hours (One FTE = 1920 hours (2080 hours – 80 hours holidays – 80 hours PTO)) for the purposes of the estimated level of effort that is provided at the task order level. The Government estimate is provided so that all offerors are aware of the Government’s estimated level of effort for each task order. Positions may be requested at less than a full time status.

C.2.25. Government Vehicle Use: There may be circumstances requiring contract personnel ride in a Government vehicle in the performance of conducting various research study requirements, including but not limited to travel to field or remote sites, relocation of research equipment, or transportation of research subjects. Government vehicle use will be on official business for non-personal service in accordance with NHRC’s instruction. If Contractor use of General Services Administration (GSA) Fleet vehicles is allowable under NHRC’s GSA lease agreement, vehicles are available for use and such use will result in a significant savings to the Government; the Government will consider allowing Contractor personnel to use GSA Fleet vehicles and related services in performance of the contract. Contractor use of GSA fleet vehicles will be delineated at the task order level (if applicable).

C.2.26. Work Location and Schedule: NHRC is headquartered in San Diego, California at 140 Sylvester Road, San Diego, CA 92106.

C.2.27. Other locations where research support services may be required at are:

Bridgeport, CA Camp Lejeune, NC Camp Pendleton, CA Pearl Harbor, HI Groton, CT Minneapolis, MN Baltimore, MD Norfolk, VA Quantico, VA Orlando, FL Washington, DC Bethesda, MD Boston, MA Arlington, VA St. Petersburg, FL Keyport, WA Twenty-Nine Palms Fort Bragg, NC Fort Lewis, WA La Posta, CA

The locations provided above are examples, and the exact locations will be delineated at the task order level.

C.2.28. The normal work schedule is outlined in Section H.5. Due to the nature of this support, work outside of core hours is authorized, on an as-needed basis, and at the discretion of the government. Work outside of normal hours (as listed in Section H.5) will be authorized/endorsed by the Contracting Officer.

C.2.29. Telework may be authorized at the task order level. Telework may be granted on a case-by-case basis and must be endorsed by the COR and approved by the Contracting Officer via a post award modification. If endorsed by the COR, telework is not permitted unless the task order is modified by the Contracting Officer to lift the restriction on teleworking. Applicable Government Furnished Property (GFP) information for telework shall be included in the task order SOW/PWS via a modification to the task order.

C.2.30. Government Furnished Property (GFP), Contractor Acquired Property, Publications and Forms: NHRC will provide, without cost, the facilities, computers, laboratory equipment, safety equipment, and necessary office supplies and materials required to perform the duties outlined under this requirement. GFP shall only be used in the performance of this order. The Government will provide routine scheduled maintenance and repair of Government-provided equipment according to NHRC Instructions. Upon contractor’s request, through the COR, the Government will provide repairs of government-provided equipment in accordance with command instructions. The Contractor will be responsible for implementing property management procedures for accountability and reporting of GFP issued to Contractor personnel, including subcontractor personnel. The Contractor is liable for loss of or damage to supplies and equipment if such loss or damage is due to negligence or willful misuse. The Contractor shall ensure efficient and economical use of supplies. At no time during the term of this contract shall the Contractor remove Government-furnished supplies or equipment from the Command facilities. GFP will be delineated at the task order level.

C.2.31. Contractor Furnished Items: The contractor must provide any ergonomic evaluations and supply furniture necessary for ergonomic support.

C.2.32. Publications and Forms: The Government will furnish all forms and publications required for the contract. The Contractor is required to comply with various instructions, directives and regulations covering routine administrative, safety and security matters in the same manner as other members of the staff. Such data shall not be released by the Contractor without prior written consent of the COR. Such compliance does not constitute a material expense to the contract.

C.2.33. Options on Task Orders: Task orders may contain option periods. The Contracting Officer may exercise options only after determining that (1) funds are available, (2) the requirement covered by the option fulfills an existing Government need and (3) successful performance of the Contractor in the preceding performance period.

C.3. MANAGEMENT

C.3.1. The Contractor shall provide direct on-site supervision of all Contractor personnel and provide direct on-site management functions for Contractor personnel such as timekeeping, leave, pay, benefits, performance reporting, and all related human resourcing, supervision, and management functions. The Contractor shall ensure all Contractor personnel are aware that all such functions are to be performed by the Contractor’s management and issues or problems related to these areas should not be discussed with Government employees. The Contractor will clearly communicate to Contractor personnel who their point of contact is for these matters.

C.3.2. The Government retains no direct control of the Contractor or its personnel and how they render services. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or personnel. The Contractor will assume all responsibility and liability for any and all personal injuries or death and/or property damage or losses suffered due to the negligence of the Contractor’s personnel in the performance of services under this contract. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government.

C.3.3. The Commanding Officer of NHRC maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and U.S. Navy Regulations.

C.4. SCOPE OF WORK

C.4.1. Performance in support of the WP Department. The Contractor shall provide R&D services for the Warfighter Performance Department at NHRC, NHRC military and civilian staff members. Potential efforts include the following severable R&D and O&M Research related tasks:

C.4.1.1. The Contractor shall support a variety of physical, physiological and psychological performance research projects. The goals of these efforts are to improve fitness, human performance, or develop surveillance markers of Traumatic Brain Injury (TBI), or recommend return-to-duty criteria for wounded service members. The Contractor shall assist with recruiting subjects, conducting relevant data collection, administering and maintaining exercise and physical exertion in field and laboratory settings to include assistance with: setting up equipment for conducting and running specified experiments, collecting and analyzing data in accordance with established methods and procedures, performing bio-chemistry analyses, and contributing to data analysis and report submission.

C.4.1.2. The Contractor shall assist with establishing testable research hypotheses addressing the effects of thermal, environmental, psychological, and operational stressors on operationally relevant performance of military personnel. The Contractor shall assist with identifying research questions that are testable within the formulated hypotheses using accepted research methodologies in the area of environmental and operational stressors on military job performance.

C.4.1.3. The Contractor shall assist with cognitive and clinical neuroscience research aimed at identifying and modifying factors implicated in optimal performance in military operational environments. In conducting research, the Contractor shall utilize a variety of neuroimaging techniques, to include functional magnetic resonance imaging (fMRI), functional near-infrared spectroscopy (fNIRS), electroencephalogram (EEG), and magnetoencephalography (MEG).

C.4.1.4. The Contractor shall support a variety of cognitive neuroscience studies designed to assess and modify brain, biology, and behavioral responses to stress in operational settings. The Contractor may provide recommendations for conducting research focusing on underlying neural mechanisms of optimal performance under stress, neurophysiology, and relationships between brain, biology, and behavior. The Contractor shall assist with recruitment of study participants, data acquisition, analyses, interpretation, and preparation of manuscripts for submission to peer-reviewed scientific journals.

C.4.1.5. The Contractor shall support a variety of physiological ashore and afloat research projects designed to improve human performance. The Contractor shall provide recommendations for conducting research focusing on mitigating the effects of heat stress, improving physical fitness, and monitoring environmental conditions Navy personnel are exposed to. The Contractor shall collect data, perform biochemistry analyses, and contribute to data analysis and reporting.

C.4.1.6. The Contractor shall assist with conducting stress physiology research studies designed to investigate individual differences in stress tolerance, resilience and mindfulness training, and susceptibility to post-traumatic stress disorder (PTSD). The contractor shall collect data, perform data entry, data analysis and reporting.

C.4.1.7. The Contractor shall assist with operating, conducting research, and maintaining the NHRC’s Computer Assisted Rehabilitation Environment (CAREN) and associated equipment and data collection tools. Work in this area also includes assisting with project development; hardware and software development; data collection; data analysis; developing briefings, presentations, and reports; along with engineering expansion and creation of virtual environments.

C.4.1.8. The Contractor shall assist with human movement and biomechanics research designed to investigate changes in posture, gait, and other human movements due to military service, gear or equipment, or physical or psychological injury. The Contractor shall collect data, perform data entry, data analysis and report writing.

C.4.1.9. The Contractor shall assist with epidemiology support to ongoing and future projects by developing testable research hypotheses, reporting data trends and data management of longitudinal data sets.

C.4.1.10. The Contractor shall support the evaluation of the effectiveness of the Navy's Substance Abuse Rehabilitation Program (SARP) to treat various subpopulations of abusers, the misuse of opioids with the military, and mental health outcomes within military recruit populations.

C.4.1.11. The Contractor shall assist with sleep and circadian physiology research studies designed to investigate the effects of insufficient sleep and resulting fatigue on human performance, physiology and health. This work includes data collection that requires support overnight and on weekends, study planning, data analysis, data interpretation, as well as developing briefings, presentations, and reports.

C.4.1.12. The Contractor shall support data collection, modeling, and data analysis and develop materials for publication/presentation for research projects relevant to Navy and Marine Corps fitness, environmental and mechanical stress exposure (including load bearing and mechanical shock), and injury prevention.

C.4.1.13. The Contractor shall provide assistance with conducting a variety of physiological and cognitive research studies focusing on Special Warfare (SPECWAR) personnel to include but not limited to evaluating research areas of: hormonal imbalance, quality of sleep, close quarters combat training, equipment evaluation, and increased strength training.

C.4.1.14. The Contractor shall provide assistance in the evaluation of job performance standards for women in certain combat arms specialties relating to research in the area of Women in Service Restricted Review (WISRR).

C.4.1.15. The Contractor shall aid the conductance of research studies investigating hypoxia training and the effects, diagnosis, and treatment of rapid ascent to high altitudes.

C.4.1.16. The Contractor shall provide assistance in the evaluation and development for improving wounded warrior care.

C.4.1.17. The Contractor shall provide assistance in conducting load carriage research to determine changes in lumbar spine and other biomechanical changes with various pack load configurations across different military operational specialties and time of service.

C.4.1.18. The Contractor shall assist with the recruitment of subjects, conduct relevant data collection, administer and maintain exercise and physical exertion laboratory facility; to include setting up equipment for conducting and running specified experiments; collecting and analyzing data and performing other duties as assigned following established methods and procedures.

C.4.1.19. The Contractor shall prepare graphic representation of the data as needed for presentation and publication and report the findings of the research in the forms of letters to the fleet, technical reports, and articles in scientific journals.

C.4.1.20. The Contractor shall provide technical and editorial support for all of these Warfighting performance projects to include project management, expenditures projections, and funding requirements.

C.4.1.21. The Contractor shall assist with the planning and organization of any working group meetings of government, academic, and Contractor subject-matter experts with respect to various aspects of the Warfighter department’s research projects.

C.4.1.22. The Contractor shall provide requisite administrative, graphic, logistic and technical support to R&D activities. The Contractor shall provide technical support such as responses to workshops, coordination of technical review meetings and the preparation and presentation of point papers and other briefings, and will prepare fact sheets and newsletters related to the technical research. The Contractor shall write and adapt text for research proposals, IRB protocols, presentation of work at scientific meetings, writing peer-reviewed articles, and technical reports. The Contractor shall also draft and prepare survey and psychological assessment materials, provide data entry, database management services, and coordination of such with other Navy commands when necessary for all supported research. As directed, the Contractor shall act as a scientific and engineering point of contact to facilitate business, technical and research relationships, and delivery of new technologies to the fleet.

C.4.1.23. Additionally, many of the research studies require the collection, measurement, and analysis of bodily fluids such as sweat, saliva, blood, and urine. The Contractor shall ensure that Contractor personnel are provided with the appropriate training, preventive vaccines (i.e., Hepatitis B, Tetanus, etc.), and protective equipment as needed to support the various research projects.

C.4.2. Potential efforts for the WP Department include the following non-severable R&D related tasks. Actual tasks will be determined at the task order level:

C.4.2.1. Development of a Database for Able-bodied Ambulators while using the Computer Assisted Rehabilitation Environment (CAREN).

C.4.2.2. Balance Training in Patients with Mild TBI.

C.4.2.3. Effectiveness of the Substance Abuse Rehabilitation Program (SARP).

C.4.2.4. The Effect of Personal Protection Equipment (PPE) Design Variations on Alteration in Performance as it Relates to Survivability.

C.4.2.5. Balance Training for Rehabilitation of Patients with Vestibular Disorders.

C.4.2.6. Career Correlates of Attention-Deficit/Hyperactivity Disorder (ADHD) and Associated Conditions for Marine Recruits.

C.4.2.7. Functional Movement Screening: Assessing Injury Susceptibility at Marine Corps Recruit Depot, San Diego.

C.4.2.8. Bio-behavioral Health in Explosive Ordnance Disposal (EOD) Technicians.

C.4.2.9. Characterization of SEAL Delivery Vehicles Unit Level Training.

C.4.2.10. Identifying and Validating Objective Neuromarkers for TBI in an Immersive Virtual Reality Environment (iVRE).

C.4.2.11. Military Opioid Misusers: Demographic Characteristics, Diagnostic History, and Personnel Outcomes.

C.4.2.12. Objective Cognitive Tasks of Operational Personnel Under Stress (OCTOPUS) using a Rapid Assessment of the Mind and Body of Operators (RAMBO) Performance Platform.

C.4.2.13. Evaluation of the Navy's Shipboard Heat Exposure Guidance: Physiological Heat Exposure Limits (PHEL) Curves.

C.4.2.14. Fitness and Body Composition as Predictors of Musculoskeletal Injury Risk

C.4.2.15. Body Composition Assessment of US Navy Men and Women

C.4.2.16. Validity and Reliability of Sleep Assessment Devices

C.4.2.17. Metabolic Demands of Cold Water Diving

C.4.2.18. Novel Approaches for Treating Post Traumatic Stress Disorder (PTSD) with…