Amendment_0003_FINAL.docx

N6264519R0057

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:

QUESTION AND ANSWERS

QUESTIONS AND ANSWERS

1. SUPTXT204-9400 (9-18) / Section L – Security Clearance requirements

Question: The socitation states that "The offeror shall submit documentation verifying that they can provide contract employees that can possess a secret clearance. A DD Form 254 will be provided at the time of task order award. However, Per solicitation Section 2.7, a facility clearance is not required and The Regional Security Office (RSO), U.S. Embassy, Lima, Peru serves as the investigative authority for NAMRU-6. It is our understanding that the contractor only needs to prepare the required documents and submit them to the NAMRU6 security officer for Embassy processing. Is this the case? If so is a facility level clearance required, XXXredactedXXX is in the process of obtaining a facility level clearance however DISS and JPAS alike need an awarded contract in country prior to granting a temporary clearance.

Answer: All contractor employees under this contract are recognized as Non-Critical Sensitive [ADP/IT-II] positions requiring a favorably completed NACLC or T3 or T3R equivalent investigation. Refer to SUPTXT204-9400 (9-18) herein.

Note: No classified material will be handled under task orders executed under this vehicle. As such, a DD Form 254 and facility level clearance (FCL) are not required.

2. See Section L – Instructions to Offerors – Section L.8.2. - Volume Submissions

Question: How many documents need to be turned in, it appears that the initial task order is captured in VOLUME I, it is our understanding only two documents need to be submitted Volume 1 and Volume II, is this correct?

Answer: See Section L – Instructions to Offerors – Volume submissions - Volume I: Non-Price/Cost Volume II: Price/Cost

3. See Section L – Instructions to Offerors – Section L.9.6.4. – Required Cost Support

Question: Regarding the DCAA audit, we are in the process of obtaining and would like to know if this will be counted against us. We do however have a third party audit that we are planning to attach.

Answer: See the revised section L.9.6.4 Section E. Offerors will not be penalized if the offer does not have a DCAA approved audit as long as the cost volume contains adequate support for proposed contract rates or cost.

4. Section M - Evaluation Factors for Award – Section M.3.1 – OGITT and OGIT Certification

Question: OGITT and OGIT certifications are specific to a study, can these certs be obtained after award?

Answer: In accordance with the solicitation, the study site of the awardee shall be certified by the General Office for Research and Technology Transfer (OGITT). To clarify, the OGITT approval of a study protocol that will be implemented to execute NAMRU-6 research cannot be obtained after the award.

5. Section C – Performance Work Statement – 5.3.36 Program Manager – Minimum Education

Question: 5.3.36 Program Manager (of the RFP) Minimum Education: Master's degree in Business Administration, Public Health, or other related business or health science field. Will the government consider years of experience in lieu of a Master’s degree?

Answer: In accordance with the solicitation, all minimum qualification requirements, as currently required by the Performance Work Statement, are required.

6. Section L – Instructions to Offerors – Section L.9.2.– Volume I, Subpart II – OGITT and REPEC Registrations

Question: 2.22 (of the RFP) For executing tasks for Clinical Trials, the prime contractor (or a subcontractor) shall possess and demonstrate the ability to conduct clinical trials in Peru or show the ability to subcontract with a contractor that is capable of conducting clinical trials in Peru. They shall be certified by the General Office for Research and Technology Transfer (OGITT, OGIT in Spanish); this entails being registered at the Peruvian Clinical Trial Registry (REPEC) to conduct clinical trials in the field of infectious diseases. If the ability to conduct clinical trials in Peru is held by a subcontractor, and the Prime and Subcontractor end their contractual relationship, the Prime contractor shall notify the Contracting Officer within 24 hours. Can the contractor obtain the OGITT and REPEC registrations upon award of the contract? In order to currently obtain an OGITT and REPEC registration they have to currently be operating a Clinical Trial in Peru.

Answer: The contractor shall have OGITT and REPEC registrations at the time of proposal. The OGITT and REPEC registrations must be in place before the contract is awarded. The offeror cannot obtain the OGITT and REPEC registrations upon award of the contract. There is a lead time associated with obtaining such a registration and therefore, registration with REPEC and OGITT at the time of the award can lead to study delays.

In order to obtain and OGITT and REPEC registrations, the offeror must meet certain qualifications that can be obtained by contacting OGITT and REPEC offices. These qualifications can be found on the respective websites. It is the offerors responsibility to obtain the necessary registrations prior to proposal submission.

7. Section M - Evaluation Factors for Award – Section M.3.1. – OGITT Registration

Question: Page 121; Section M.3.1 “Contractor must possess a certification by the General Office for Research and Technology Transfer (OGITT)” this certification can only be received if currently and actively performing a clinical trial in Peru. Please confirm that this certification can be received after contract award.

Answer: The contractor shall demonstrate the ability to conduct clinical trials in Peru by meeting the required qualifications to obtain the necessary registrations, in accordance with Peruvian regulations. Thus, OGITT and REPEC registrations shall be in place before the contract is awarded.

8. Section L – Instructions to Offerors – Section L.9.4.1 - Past Performance Information Sheets (PPIS).

Question: Subcontractors. Will the Government please define the percentage of work to be completed by a subcontractor in order for them to supply a Past Performance questionnaire? Prior RFPs have defined Past Performances as only required for Major Subcontractors with a work share percentage of 40%.

Answer: Refer to section L.9.4.1. Past Performance Information Sheets (PPIS).

The offeror may include contracts that demonstrate the prior experience of key personnel or subcontractors/teaming partners who will be performing in support of the contract resulting from this solicitation; such contracts shall be clearly identified to show the relationship of the past performance entry to the offeror.

The Offeror shall submit up to four (4) PPIS for contracts over the past three (3) years which are similar to the size and scope of the PWS in this solicitation. A maximum of two contracts can be held by the prime offeror’s proposed subcontractors.

9. Section L/M – Instructions to Offerors/Evaluation – Past Performance Question: Past Performance; Will the Government allow Cooperative Agreements and/or Grants to be submitted as Past Performance references?

Answer: No, Refer to section L.9.4.1. Past Performance Information Sheets (PPIS). The Offeror shall submit up to four (4) PPIS for contracts over the past three (3) years which are similar to the size and scope of the PWS in this solicitation. A maximum of two contracts can be held by the prime offeror’s proposed subcontractors.

10. General: Pricing

Question: Pricing; Please confirm that all contractors will have to pay VAT at the current rate of 18 percent. Or is this contract exempt from this requirement as a bi-lateral agreement?

Answer: The VAT tax is applicable in Peru. The current rate is 18%, but is subject to change by the Peruvian Government. Please refer to FAR 52.228-8, which has been added to the RFP. NMLC is not currently aware of any exemptions that apply to the U.S. Government through an agreement with the Government of Peru. However, should the contractor become aware that it or any subcontractor is exempt under the laws of Peru, then the contractor may not be reimbursed for this cost under the contract.

11. Section L – Instructions to Offerors - L.8.2.1. – Line Spacing

Question: L.8.2.1 Type shall be Times New Roman and no smaller than a font size of eleven (11) and shall have 1.0 line spacing. Does the government consider 1.0 line spacing to be the same thing as single-spaced? MS Word does not offer a 1.0 option in its line spacing options.

Answer: Solicitation has been amended to remove the requirement for “have 1.0 line spacing” and replaced with “shall have 1.0 line spacing (single spaced)”.

12. Section L – Instructions to Offerors – Proposal Page Content

Question: L.8.2.1 The page limits described below do not include Title Page, Table of Contents, and Glossary. The proposal-sections table on RFP p. 112 does not include a glossary. Is a glossary required, and if so, may bidders include only those terms that are not already defined in the solicitation documents?

Answer: A glossary is not required. However, it is at the offerors discretion to submit and what to include in the glossary to aid in review of the proposal. Refer to Solicitation L.8.2.1. Page limitations include all text, graphs, pictures, appendices, references and exhibits unless otherwise noted. Cross reference matrices, tabs, index sheets, tables of contents, dividers and other such aids that are solely used to assist the evaluator in locating information and are advisory in nature, imparting no other information other than the identification of content, will not be counted against any page limits stated within this RFP.

13. Section C – Performance Work Statement – 2.8.1.1 and 2.8.4 - Duties

Question: Area of Support: Entomology Department at NAMRU-6 Iquitos; Section 2.8.1.1 and 2.8.4. The LOE listed on 2.8.1.1 is focused on maintaining a vivax malaria sporozoite production system with mosquitos and non-human primates. However, in Section 2.8.4 the first 5 tasks/duties are focused on conducting human enrollments and collections associated with a vaccine study which isn’t in alignment with the work performed in the lab described in the LOE statement nor the assigned staffing. Is this a misprint?

Answer: The LOEs go hand-in-hand, hence the verbiage “production system.” This was not a misprint in the solicitation.

14. Section L Instructions to Offerors - Attachment B; Federalwide Assurance

Question: L.9.2 Attachment B; Federalwide Assurance (FWA). Will the Government please confirm that any subcontractors that currently do not have an active FWA can receive one after award as long as they do not perform any human study work until the FWA is received and the Government approves? This is due to the fact that no foreign companies currently have an FWA as they are not required by foreign governments.

Answer: All FWA’s must be active and not expired upon submission of the proposal. Refer to Section L.9.2 VOLUME I, SUBPART II: EVALUATION FACTOR I: MANAGEMENT APPROACH/RISK, Attachment B: Human Use Documentation: The offeror shall include in their proposal, proof of an active (i.e., not expired) FWA. If a subcontractor may perform human subject research, they shall have their own active (i.e., not expired) FWA. The subcontractors FWA must be possessed by the subcontractor and they are not allowed to work under the prime contractor’s FWA. You must state clearly if a subcontractor employee will not be performing human subject research and that is why proof of an active FWA is absent.

Proof of each active FWA must include: Entity name as it appears on FWA, full FWA number, and FWA expiration date.

15. Section L - Instructions to Offerors – Government Furnished Equipment

Question: L.9.3 Government Furnished Equipment. Will the Government consider removing this requirement as the new NAMRU-6 lab is currently being outfitted with equipment and the Contractor has no control over what equipment they want? Equipment has always been specified by the Government and order by the Contractor under the ODC line. The RFP also says typical lab equipment is provided, but Contractors have had proposals penalized in the past for not providing an expansive equipment list.

Answer: As stated in the solicitation in section L.9.3 VOLUME I, SUBPART III: EVALUATION FACTOR II: TECHNICAL APPROACH/RISK FOR THE INITIAL TASK ORDER. Government Furnished Equipment. If the offeror does not require GFE past other than what is typically available for contractors in an office environment, the offeror shall provide a statement affirming this fact in their proposal. Responses regarding GFE are limited to 5 pages and do not count towards the overall page limit.

16. Section C – Performance Work Statement – Section 5.3.56 – Labor Categories - Initial Task Order

Question: Given that testing of software code is an integral part of the software development process, please confirm that the Software Quality Assurance Tester described in 5.3.56 of the IDIQ PWS is not needed in the initial task order despite the inclusion of several Developers.

Answer: The Software QA test process is not needed in the initial task order; however, the exact time that the tester will be needed is not known at this time as this depends on the development process. The tester would be added (through a future modification, as needed) when BID department head requests the services.

17. SUPTXT204-9400 (9-18) / Section L – Security Clearance requirements

Question: In sections 5.3.8 and 5.3.9 of the IDIQ PWS, Secret/T3 clearance is required for the Cloud System Engineer I and II. Given that US citizenship is required to obtain this clearance, please confirm that these positions will be based in the US and not in Peru.

Answer: Both labor categories will require performance of the work in Peru. Further, the solicitation has been amended to revise “Clearance: Secret/T3 required” to “Background Investigation; completed NACLC or T3 or T3R equivalent investigation, within the periodicity of 10 years, to obtain a favorable determination for assignment to a non-critical sensitive”. Refer to SUPTXT205-9400 (9-18). No classified material will be handled under this task order.

18. Section M - Evaluation Factors for Award – Section M.3.1. – Management Approach

Question: Given the scope and size of this contract we believe it would be beneficial to divide the responsibilities of the Prime’s onsite Program Manager between two functions, one of them focused on communications with the COR, contract reports, contract administration, and quality management, and the other one on personnel onboarding and oversight (e.g., a Prime PM and a Prime Deputy PM). This approach would allow for a better back-up strategy and more effective succession planning and would result in deeper subject matter expertise since experienced Government program managers do not usually have technical expertise in infectious diseases basic and clinical research. Please, confirm if this approach is acceptable.

Answer: All offerors shall propose methodologies, processes, and capabilities which reflect an ability to effectively and efficiently manage and execute the base contract and subsequent task orders. The Government will evaluate proposals in accordance with Section M of the solicitation.

19. Section L – Instructions to Offerors - Government Human Research Protection Officer (HRPO)

Question: Are all the labor positions listed in the Initial Task Order (ITO) and the RFP to be located on-site at NAMRU 6 and the other locations specified in the ITO Section 3.5.1 Estimated Level of Effort table? Additionally, and more specifically, Human Research Protection Officer/Office By which institute (Contractor, NAMRU) and where (US, Peru) this Office/Position will be designed?

Answer: Yes, all the labor positions listed in the ITO and the RFP are to be located on-site at NAMRU-6 and at other locations specified in the Level of Effort table in section 3.1.5. The Human Research Protection Officer (HRPO) is NAMRU-6’s HRPO. This position is currently located in Peru.

20. Section L – Instructions to Offerors - Volume II: Cost - Service Contract Labor Standards

Question: Does the contractor need to be registered on Wide Area Work Flow (WAWF) at time of proposal submission?

Answer: No, the contractor does not need to be registered on Wide Area Work Flow (WAWF) at time of proposal submission.

21. Section L – Instructions to Offerors - Section L.9.2 – Attachment C - Indemnification and Medical Liability Insurance

Question: According to FAR Clause 52.237-7 (INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE) “The Contractor shall maintain during the term of this contract liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence: (to be delineated at the task order level).” Will the Government please confirm that as long as the contractor can show proof of the ability to obtain these policies upon contract award that these insurances do not have to be in place at the time on proposal submission?

Answer: In accordance with the solicitation - Section L.9.2 – Attachment C, The supporting documentation shall prove that the offeror possesses current insurance and shall show the expiration date of the policies as well as including individual and aggregate limits for each of the required area of coverage in accordance with Attachment D: Liability Insurance (IAW Section H –“Standard Liability Insurance” and FAR 52.228-7): The supporting documentation shall prove that the offeror possesses current insurance and shall show the expiration date of the policies as well as the including individual and aggregate limits for each of the required areas of coverage.

22. General – Transition Period

Question: Will there be a seamless transition without any lag between the existing contract and the new contract?

Answer: This would be the Government’s intent unless unforeseen circumstances arise.

23. Section C – Performance Work Statement – Work Locations

Question: Will the contractor personnel be located in Loreto or in Iquitos?

Answer: Contractor personnel will be located in Loreto. Please note that Loreto is a department of the country located in the northeastern Peru. Iquitos is a city located in the department of Loreto. (Contractor personnel will actually be located in Iquitos and other parts of the Loreto department.

24. Section C – Performance Work Statement – Principal Investigator

Question: Will the contractor be responsible as the sole investigator in clinical research?

Answer: In accordance with the solicitation, this is a non-personal research support services requirement in support of NAMRU-6. As such, the awardee will perform in conjunction with NAMRU-6 counterparts; the Principal Investigator will be a Government or Military employee. Final approvals are subject to Government approval.

25. Attachment IV – Initial CPFF Task Order Performance Work Statement

Question: 2.1.1 to 2.14.1: “provide scientific and technical support” For the “Scientific support” does this mean to provide VEID expertise?

Answer: 2.1.1 through 2.14.1 scientific support means Viral and Emerging Infections Department (VEID) and Parasitology expertise (depending on what the paragraph title states). Each section, designated by X.X has a title associated with a specific Department Area of Support. For example 2.1. (2.1.1 through 2.1.3) Area of Support requires VEID expertise. However, 2.13 (2.13.1 through 2.13.4) will require Parasitology expertise. The paragraphs have associated clear titles for each Area of Support.

26. Section C – Performance Work Statement – Occupational Health Program

Question: Does the Government have an existing “Occupational Health Program” that they wish for the contractor to implement or does the contractor need to develop one?

Answer: In accordance with the solicitation the contractor will support multiple departments and programs, to include but not limited to, Occupational Health; the contractor will not implement an Occupational Health Program. Refer to the Performance Work Statement for required duties/scope.

SECTION A - SOLICITATION/CONTRACT FORM

The required response date/time has changed from 18-Sep-2019 10:00 AM to 02-Oct-2019 10:00 AM.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

PWS

NAVAL MEDICAL RESEARCH UNIT-6 RESEARCH AND ADMINISTRATIVE SUPPORT SERVICES

1.0 INTRODUCTION AND BACKGROUND:

1.1 The PWS located in Section C of the base contract applies to all subsequent task orders issued under the base contract.

1.2 The Naval Medical Research Unit-6 (NAMRU-6) mission is to conduct biomedical research in the field of infectious diseases and global health that is responsive to U.S. Navy requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the effectiveness of the uniformed service members through respectful cooperation with our collaborators. NAMRU-6 is a component of the Navy Bureau of Medicine and Surgery (BUMED).

The vision of NAMRU-6 is to be the premier tri-service overseas biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, and sustains uniformed service members today, invents global medical solutions for the future, and keeps service members and Allies on point for the Nation.

NAMRU-6 conducts research studies in support of the readiness and Force Health Protection (FHP) of US military personnel. In addition, NAMRU-6 conducts basic research and provides sustainable infectious disease research support to the host nation Ministry of Health, military, and universities through field studies, infectious diseases surveillance, vaccine and drug clinical trials, test & evaluation of new infectious diseases detection/diagnosis technologies and training. NAMRU-6 also conducts field/medical entomology, epidemiologic studies and disease bio-surveillance of a wide range of infectious diseases of military and/or public health significance in the U.S. Southern Command (USSOUTHCOM) area of responsibility.

NAMRU-6 ensures that, when feasible, host nation investigators are included in the planning, performance, and publication of NAMRU-6 research, thereby providing the most effective sustainable improvement in infectious disease research.

1.3 The effort required under this Performance Work Statement (PWS) is to provide non-personal research support services to NAMRU-6.

2.0 ASSUMPTIONS AND CONSTRAINTS

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.

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

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 Statement of Work (SOW).

2.5 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)

2.6 TOPRs will include the Government’s Estimated Level of Effort (LOE). The Government’s estimate will include the estimated labor mix (comprised of labor categories from the base contract PWS) and the estimated LOE will include the number of Full Time Employees (FTE). If applicable, TOPRs will also include estimated Other Direct Cost (ODC) Travel and Subcontract amounts. The TOPR will also include the required assurances for human subject research or animal research (if applicable). In addition the TOPR will contain all other information for the contractor to propose, such as the necessary security clearance level and insurance requirements etc.

2.7 All labor categories performing under task orders issued under the base contract require a background investigation in accordance with the DODI 5200.02 and DODI 1000.13. A facility level clearance is not required. Labor categories may require a security clearance up to the level of Secret. Contractors who require access to NAMRU-6 Government computer systems (requiring a Common Access Card or CAC) are required to be fingerprinted. The exact requirements for security levels will be delineated at the task order level.

The Regional Security Office (RSO), U.S. Embassy, Lima, Peru serves as the investigative authority for NAMRU-6.

2.8 This effort is not considered a new requirement (legacy contract N62645-16-F-0066, Parsons Government Services) and therefore the right of first refusal concerning incumbent employees with the successful offeror may apply.

2.9 Intramural human use research is expected under the task orders that will be issued under this base IDIQ contract. Research with human subjects shall not begin until the contractor (and all subcontractors) obtains a 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 (or on any Option CLIN where human use research is segregated from the remainder of the task order).

2.10 Intramural human use research 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.

2.11 Intramural animal use is expected under the task orders that will be issued under this base IDIQ. Task orders involving the use of animals in research shall be compliant with all applicable federal and DoD regulations, specifically including 7 U.S.C. 2131 et. Seq. and 9 CFR 1-4, “Animal Welfare Act”; DoDI 3216.01, “Use of Animals in DoD Programs”; and specific DoD component management plans. The contractor shall support the investigation of animal use and care regulations and the establishment of training plans developed to educate researchers regarding their animal use and care responsibilities. The contractor shall support Institutional Animal Care and Use Committee (IACUC) functions and comply with any procedures required for IACUC approval, including research protocol submission, Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation, Department of Health and Human Services (DHHS) Office of Laboratory Animal Welfare (OLAW) assurance, and USDA site inspections.

2.12 Travel is expected in support of the research efforts at NAMRU-6. Travel approval must be processed in accordance with NAMRU-6 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 Contracting Officer’s Representative (COR). All travel must be approved by the COR in writing via e-mail prior to the contractor incurring costs.

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.

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).

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

2.13 Other Direct Costs (ODC) are expected in support of the research efforts at NAMRU-6. ODCs may include equipment, research supplies, services and other costs that will accomplish the mission objectives such as 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 by the COR in writing via e-mail prior to the contractor incurring costs.

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).

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

2.14 Subcontracts: Subcontracts are expected in support of the research efforts at NAMRU-6.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 data quality assurance and regulatory filing and support.

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).

2.15 There is a potential Organizational Conflict of Interest (OCI) at the task order level. The potential OCI is that contractor personnel may have access to financial data regarding funding for research studies. Contractors may also be assisting the Government in the preparation of intramural and extramural grant applications for studies. Since there is a potential OCI, the offeror’s proposal shall include an OCI Mitigation Plan for review/approval by the Government / Contracting Officer. In consideration of the contractor's legacy work currently being performed under other contracts or future work to be bid or performed, the Contractor warrants that no OCI condition will be created by acceptance of this base IDIQ contract award or any subsequently awarded task orders. The OCI Mitigation Plan shall include Non-disclosure Agreements signed by the personnel performing on this task order 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.”

2.16 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 Governments’ estimated level of effort for each task order. Positions may be requested at less than a full time status.

2.17 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 NAMRU-Six’s instruction. If contractor use of GSA Fleet vehicles is allowable under NAMRU-6’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).

2.18 Work Location and Schedule: NAMRU-6 is headquartered in Lima, Peru. NAMRU-6 also has a Naval Laboratory in Iquitos (Loreto), Peru, a Naval Laboratory in Puerto Maldonado (Madre de Dios), Peru and a satellite laboratory at U.S. Joint Task Force-Bravo (JTF-B), Soto Cano Air Force Base in Comayagua, Honduras.

Other locations where research support services may be required at are (located in Peru unless a separate country is noted): Centro de salud de Pachitea, Piura, Hospital Santa Gema, Yurimaguas, Loreto, Cuzco Piura, Tumbes, Bagua (Amazonas), Yurimaguas and Iquitos (Loreto), Trujillo (La Libertad), La Merced (Junin), Cuzco, Cartagena, Medellin, Villavicencio (Bogota), Cobenas (Colombia), San Pedro de Sula and Tegucigalpa (Honduras), Ecuador. The locations provided above are examples and the exact locations will be delineated at the task order level.

The normal work schedule is outlined in Section H. 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 will be authorized by the COR.

The need for telework will be delineated at the task order level. Telework may be granted on a case-by-case basis and must be endorsed by the NAMRU-6 COR and approved by the NMLC 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. Contractor personnel shall be listed by name and the applicable GFP information shall be included in the task order PWS via a modification to the task order.

2.19 Government Furnished Property (GFP) and Contractor Acquired Property: The Government may provide some necessary research equipment, supplies, and office supplies to conduct tasks under this contract. For contractor personnel, including (subcontractor personnel) working in a DoD facility in Lima and Iquitos, Peru, Government will provide all information technology and laboratory equipment requirements. Contractor personnel assigned to specific sites other than the facilities in Lima and Iquitos, Peru may be required to provide ancillary support services, research equipment, laboratory supplies, and office supplies necessary to accomplish all of their work. The contractor will be responsible for implementing property management procedures for accountability and reporting of GFP issued to contractor personnel, including Subcontractor personnel. GFP will be delineated at the task order level.

2.20 Contingency Situations: Contingency situations (natural disasters, military peacetime and wartime contingency operations/exercises, serious accidents, civil disturbances, major mobilization or repatriation of non-combatants) may necessitate that the contractor be flexible in arranging different levels of support and service operational hours. The contractor shall respond to contingency situations and revise priorities as directed by the COR. If the contractor cannot accomplish normal activities due to activation or exercise of any contingency plan, the contractor shall not be held liable for nonsupport of lower priorities. The Government will determine the priorities that can be temporarily relaxed in contingency situations.

If appropriate, the contractor shall be reimbursed for contingency operations requiring a higher level of response and resources. The contractor shall submit a request for equitable adjustment detailing the impact resulting from the incorporation and operation of such contingency actions prior to the beginning of the contingency operations.

In the event that NAMRU-6 operations are curtailed as a result of weather emergencies or other unplanned mission-related events, contractor personnel may be considered non-essential personnel and thus, are not required to be at the work site. They may, however, be required to be on call, to work at a designated evacuation site, to telework (if authorized), or to be part of a crisis response team at a nearby site.

The Contracting Officer shall be notified by the COR (as soon as it is reasonable to do so), if any part of section 2.20 becomes applicable.

2.21 Access to Government Controlled IT Networks: If the COR determines that contract personnel require access to a Government computer network, the contractor shall provide all requested information to the Embassy Regional Security Office via NAMRU-6 Administration Department prior to access and continuation of tasks. The requirement for access to Government controlled IT networks will be delineated (on a position basis) at the task order level.

2.22 For executing tasks for Clinical Trials, the prime contractor (or a subcontractor) shall possess and demonstrate the ability to conduct clinical trials in Peru or show the ability to subcontract with a contractor that is capable of conducting clinical trials in Peru. They shall be certified by the General Office for Research and Technology Transfer (OGITT, OGIT in Spanish); this entails being registered at the Peruvian Clinical Trial Registry (REPEC) to conduct clinical trials in the field of infectious diseases. If the ability to conduct clinical trials in Peru is held by a subcontractor, and the Prime and Subcontractor end their contractual relationship, the Prime contractor shall notify the Contracting Officer within 24 hours.

2.23 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.

3.0 MANAGEMENT

The contractor shall provide direct on-site supervision of all 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.

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.

The Commanding Officer of NAMRU-6 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.

4.0 SCOPE OF WORK

4.1 Departments/General: The contractor shall provide research support services to the following NAMRU-6 departments:

Scientific Departments: Bacteriology, Biomedical Informatics, Entomology, Parasitology, Veterinary services, Virology and Emerging Infections, Clinical Trials and Research Administration Program.

Support Departments and Programs: Command Suite, Resource Management Directorate, Directorate for Administration, Materiel Management, Engineering and Facilities, Occupational Health, Information Management/ Information Technology, and Safety/Environmental.

The support departments and programs provide financial and administrative support to the scientific departments.

The Contractor will provide all managerial, administrative, direct labor personnel, materials, transportation, and other pertinent services that are necessary to accomplish all work required. For contractor at NAMRU-6 sites in Iquitos and Lima and at other specified locations, NAMRU-6 may provide office supplies, cleaning supplies, printing supplies, office furniture, communications device and government furnished equipment (GFE) to accomplish the work. At more remote study sites, these items will be provided by the contractor as ODCs. The GFE provided will be delineated at the task order level.

The Contractor shall support research such as (but not limited to) a) vaccine trials b) drug studies c.) test and evaluation of new technology, d.) epidemiologic studies and biosurveillance of infectious diseases, surveillance of vectors, e.) development / evaluation of devices and therapeutic countermeasures for malaria, bacterial causes of infectious diarrhea, emerging viral pathogens (e.g., dengue, chikungunya, Zika), influenza viruses, leishmaniasis, and multi-drug resistant bacteria. The contractor shall support the collection of data and support regulated studies. The Contractor shall provide support in maintaining U.S. Federal Drug Administration (FDA) regulatory standards to conduct clinical studies in accordance with Good Clinical Practices (GCP) and the International Conference on Harmonization (ICH).

4.2 Bacteriology. The contractor shall support the following research objectives:

4.2.1. Main research objectives/areas:

a. Global partner on diarrhea surveillance and pathogen characterization.

b. Vaccine development against enteric pathogens (e.g., Enterotoxigenic Escherichia Coli [ETEC], Shigella, Campylobacter).

c. Epidemiology of hospital-acquired infections and antibiotic resistance surveillance.

d. Surveillance of sexually transmitted infections (STIs) and human immunodeficiency (HIV) prevention.

e. Use of bacteriophages as therapeutics.

4.2.2 Diagnostic assay development:

a. Development of polymerase chain reaction (PCR) assay to detect clustered regularly-interspaced short palindromic repeats (CRISPR) sequences for rapid identification of antibiotic resistant bacteria.

b. Antigen discovery for development of rapid field test for pathogenic Leptospira in clinical and environmental sources.

c. Evaluation of FilmArray field testing for detection of diarrheal and respiratory pathogens in operational environments.

4.2.3 Drug Testing/Therapeutics/Interventions:

a. Clinical trials of antibiotic prophylaxis and optimized treatment regimens against diarrhea in deployed U.S. military.

b. Development of bacteriophage cocktails against drug-resistant wound pathogens Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus.

c. Evaluation of HIV prevention and education strategies in military populations.

d. Phase 2, Phase 3 and Phase 4 trials in support of DOD programs of records and pharma investigational new drug applications (INDs) and new drug applications (NDAs) for the benefit of the warfighter.

4.3 Biomedical Informatics (BID). The contractor shall support the following research objectives:

4.3.1 BID staff is comprised of subject-matter experts in public health and information and communication technologies professionals who work on the development, implementation, adoption, monitoring, and evaluation of informatics solutions for capture, transmission, storage, visualization, and dissemination of medical and public health information.

4.3.2 Main department objectives. The contractor shall support the following research objectives:

a. Develop a centralized unified system for data management and quality assurance (QA) and collaborate with strategic partners to build technical informatics capacity in host countries through research, development, testing, and evaluation of products and services in the intersection of information and communication technologies, biomedical science and public health.

4.4 Entomology. The contractor shall support the following research objectives:

4.4.1 Main research objectives:

a. Test novel topical and spatial repellents.

b. Development support for Plasmodium vivax vaccine.

c. Vector incrimination of mosquitoes and sandflies.

d. Biology, taxonomy, distribution of vectors in Latin America.

e. As part of the Military Infectious Diseases Research Program (MIDRP) and Deployed War-Fighter Protection Program (DWFP), NAMRU-6 supports testing and development of spatial repellents for protection forward deployed troops in the SOUTHCOM area of responsibility.

f. As part of the MIDRP, support production of Plasmodium vivax sporozoites for use in the DoD Malaria Vaccine Research Program.

g. Testing of novel control tools, such as insecticides (e.g., Ivermectin) to protect forward deployed troops.

h. GEIS supported surveillance and identification of important insect vectors in Peru and across SOUTHCOM region to develop real-time risk models for control of vector-borne pathogens.

4.5 Parasitology. The contractor shall support the following research objectives:

4.5.1 Main research objectives:

a. Conduct disease surveillance for parasites of military relevance.

b. Develop products and conduct clinical trials (vaccines, drugs, and diagnostics) to protect the warfighter from multiple parasites, with a focus on malaria and leishmaniasis.

c. Conduct clinical trials to support FDA clearance and approval of devices, vaccines, and novel candidate drug compounds.

d. Support and train host nation and partners in performing clinical diagnostics and responding to infectious disease outbreaks.

e. Identify novel P. vivax Pre-erythrocyte stage antigens to develop vaccine candidates to protect the warfighter from infection.

f. Develop a chimeric humanized liver model of P. vivax infections to test novel vaccines and drugs.

g. Explore blood stage malaria vaccine candidates and challenge models (models to control rather than prevent infection).

h. Test and evaluate Leishmania rapid diagnostic devices.

i. Perform Malaria and Leishmania surveillance and diagnosis in Peru.

j. Monitor malaria drug resistance in South America.

4.6 Veterinary Services. The contractor shall support the following research objectives:

4.6.1 The Department of Veterinary Services provides consistent and superior care and oversight for all NAMRU-6 research animal use activities in order to ensure maximized production of high-quality research outcomes, while optimizing personnel safety and animal welfare. In addition, maintains a top-tier, Association for Assessment and Accreditation of Lab Animal Care Use (AAALAC)-accredited animal care and use program that meets all DoD mission requirements, sets the standard in Latin America for biomedical research, and enables researchers to succeed at developing life-saving solutions to infectious disease threats affecting U.S. troops and allies. The primary functions are: animal husbandry, Institutional Animal Care Use Committee (IACUC) support and advising, veterinary medical care, training, protocol support, animal health surveillance, protocol consultation, advising, training outside collaborators.

4.6.2 Main objectives:

a. Providing high-quality husbandry and care for all assigned animals.

b. Providing superior veterinary medical and surgical care.

c. Conducting animal health surveillance and quality assurance of the research population

d. Training on animal care and use and research methodologies.

e. Technical assistance with experimental procedures.

f. Advising investigators on proper design of animal use studies.

g. Providing expert advice to the IACUC and the command on animal care & use.

4.6.3 Key assets & capabilities:

a. Animal housing and protocol support at Animal Biosafety Level 1-3s (ABSL) 1-3

b. Capabilities to perform surgical procedures and endoscopy

c. Clinical pathology and necropsy capabilities.

d. Housing and husbandry for Primates, Rodents, and other species as requested by investigators and the IACUC.

4.7 Virology and Emerging Infections Department (VEID). The contractor shall support the following research objectives:

4.7.1 Main research objectives:

a. Characterize the epidemiology and ecology of endemic and emerging viruses.

b. Perform active and passive surveillance of febrile and respiratory diseases throughout Latin America.

c. Conduct exploratory studies of emerging pathogens with emphasis on pathogens emerging from the animal-human interface. Perform active and/or passive surveillance in wild and domestic fauna.

4.7.2 Molecular biology: Molecular tests detecting respiratory, arboviral, hemorrhagic, and enteric infections using the following platforms:

a. Real-Time polymerase chain reaction (PCR-single and multiplex).

b. Conventional PCR.

c. Sanger and next –generation sequencing.

d. Mag-Pix (respiratory, enteric panels).

e. TaqMan array (Viia7).

f. Bioinformatics.

g. Cloning.

4.7.3 Virus isolation for detection of influenza viruses.

a. Cultures in embryoanted eggs

b. Haemagglutination test.

4.7.4 Serology: Immunological tests to identify evidence of past infection using:

a. Plaque Reduction Neutralization Test (PRNT), Elisa, Micro-neutralization (Microneut). Western Blot, Protein determination.

b. Pathogen Discovery: Next-generation sequencing technology and phylogenic analysis on: influenza, dengue, hantavirus, enterovirus, Zika and novel pathogens.

c. Conduct clinical trials for the development of drugs,…