Attachment_IV_Initial_CPFF_Task_Order_PWS.docx

ATTACHMENT IV-INITIAL CPFF TASK ORDER PERFORMANCE WORK STATEMENT-NAVAL MEDICAL RESEARCH UNIT- 6- RESEARCH AND ADMINISTRATIVE SUPPORT SERVICES

1.0. BACKGROUND

1.1. The purpose of this Initial Task Order (ITO) Performance Work Statement (PWS) is to supplement the PWS contained in the base Indefinite Delivery Indefinite Quantity (IDIQ) contract and further define what is required for each of the positions being executed with the ITO. The base IDIQ PWS remains in effect and the requirements listed in this ITO PWS provide further elaboration and clarification pertaining to duties, tasks, work schedule, work location, and any additional requirements that may be necessary for each of the required positions in this ITO.

1.2. The Naval Medical Research Unit-6 (NAMRU-6) mission is to conduct biomedical research in infectious diseases and global health to meet U.S. Navy requirements and deliver lifesaving products including knowledge, technology, and medical materiel to sustain the effectiveness of the uniformed service members. NAMRU-6 conducts research studies to support US military personnel readiness and Force Health Protection (FHP). Moreover, NAMRU-6 provides sustainable infectious diseases research support to the host nation Ministry of Health, other government agencies, universities and military through field studies, infectious diseases surveillance and epidemiologic studies, vaccine and drug clinical trials, test/evaluation of technologies and training.

1.3. This task order provides research support services in the form of scientific, technical, and administrative support to execute current and ongoing research studies (human and animal subjects) including those to advance medical product development for the warfighter, current and ongoing ecologic studies, current and ongoing infectious diseases epidemiology studies, current and ongoing infectious diseases surveillance, current and ongoing vector surveillance and laboratory testing for NAMRU-6. The exact places of performance are outlined in Section 2 and 3 of this PWS.

The contractor shall provide research support services by performing the tasks outlined in Section 2 of this ITO PWS.

1.4. For the purposes of constructing your cost proposal, offeror shall use the following figures for Other Direct Costs (ODCs) and travel. The estimated amounts are for the 12 month Period of Performance (POP) of the initial task order.

ODCs: $836,305.50.

Travel: $73,703.00.

Offerors shall use the amounts provided above in the development of their cost proposal. All ODC and Travel costs are estimated amounts and are before contractor burdens. Contractor burdens shall be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

ODCs and Travel shall be approved in advance and in writing by the Contracting Officer’s Representative (COR) prior to the contractor incurring any cost.

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

1.5. The POP for this task order shall be twelve (12) months from the date of award.

1.6. Intramural human use research is expected under this task order. Research with human subjects may not begin until the contractor (and all subcontractors) obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research shall be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A Human Research Protection Officer (HRPO) review shall be in place before any funding can be placed on this task order.

1.7. Intramural human use research can include interaction with study participants; therefore, the contractor shall possess medical liability and indemnity insurance. The Federal Tort Claims Act does not apply.

1.8. Intramural animal use is expected under the task orders that will be issued under this base IDIQ. As such, research involving the use of animals 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.

1.9. This ITO is for non-personal services and considered a severable effort.

1.10. This ITO will be an incrementally-funded Cost Plus Fixed Fee (CPFF) task order.

1.11. There is a potential OCI within this task order. The potential OCI that exists under this requirement, 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 and facilitation of intramural and extramural grant applications for studies. The offeror’s proposal shall include an OCI Mitigation Plan for review/approval by the Government / Contracting Officer. Acceptance of this task order 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 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.”

1.12. Government Furnished Equipment:

1.12.1. For performance at the NAMRU-6 site, the Government will provide office space, computers, and necessary office supplies, equipment, and materials to perform tasks on a daily basis.

1.12.2. For the NAMRU-6 Iquitos, NAMRU-6 Puerto Maldonado and NAMRU-6 satellite laboratory at US Joint Task Force-Bravo (JTF-B) at Soto Cano Air Force Base in Comayagua, Honduras, the Government will also provide office space, computers, equipment, supplies and materials to perform daily tasks.

1.12.3. There is no known Government Furnished Property (GFP) associated with this task order. The contractor shall not remove anything furnished by NAMRU-6 from any NAMRU-6 site, unless a post-award modification has been executed to assign the items to a specific contractor personnel. If a post-award modification is required for this purpose, the task order PWS shall be modified to include the contractor employee name and the serial number associated with the item(s). A revised NMCARS Annex 9 checklist (notating that GFP has been issued under this task order) will be added as an attachment to the task order via the modification and the GFP module will be completed in PIEE.

1.13. Work Location and Schedule: The majority of work will take place at NAMRU-6, a Government installation. Contractor personnel shall be eligible for issuance of a Department of Defense (DoD) Common Access Card (CAC) in order to gain access to the installation and computer network. Support is also required at the Iquitos, and Puerto Maldonado sites in Peru, and JTF-B, Soto Cano Air Force Base in Honduras.

1.13.1. The normal work schedule for NAMRU-6 Lima is Monday through Friday 6:00 AM to 8:00 PM.

1.13.2. The normal work schedule for NAMRU-6 Iquitos is Monday through Friday 7:00 AM to 8:00 PM.

1.13.3. The normal work schedule for NAMRU-6 Puerto Maldonado is Monday through Friday 8:00 AM to 5:00 PM.

1.13.4. The normal work schedule for the NAMRU-6 satellite laboratory in JTF-B, Soto Cano AFB is Monday through Friday 8:00 AM to 4:30 PM.

1.14. It is the contractor’s responsibility to supervise its personnel.

2.0. AREAS OF SUPPORT AND TASKS/ DUTIES

2.1. Area of Support: Viral and Emerging Infectious Department (VEID) in the Department of Lima, Peru.

2.1.1. The Contractor shall provide scientific and technical support for epidemiological and clinical studies conducted by the VEID.

2.1.1.1. NAMRU-6 Protocol: 2015:0001: Effectiveness of Influenza Vaccine in Preventing Influenza Virus Infection, Missed Work, and Patient Exposure: A Prospective Cohort Study of Healthcare Personnel (HCP).

2.1.1.2. This study estimates the effectiveness of influenza vaccine, examines if influenza vaccination modifies disease severity/duration, and explores the association between repeated influenza vaccination and healthcare worker response to influenza vaccines.

2.1.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.1.4.

2.1.2. The estimated level of effort for this task is provided in Section 3.

2.1.3. The location of performance is provided in Section 3.

2.1.4. Tasks/ Duties

- Administer informed consents and complete participant enrollment and the active follow-up activities at selected hospital study sites in the Loreto region.

- Conduct the collection of respiratory samples for participants and testing of respiratory samples in accordance with the study protocol.

- Ship collected research samples to US labs.

- Provide administrative and logistical support for the study, as specified by the Principal Investigator. Logistical support for the study will include study site set-up, transport and tracking of all materials, supplies, equipment to the study site, tracking of supplies and equipment, and tracking of study subjects and study related materials and documentation.

- Monitor supply of study materials and request supplies as needed following established ordering procedures (Subject to PWS Section 1.4).

- Accurately enter collected research data into database programs.

- Assist Government and contractor research staff with operation of research equipment.

- Perform a range of additional functions incidental to research activities.

2.2. Area of Support: VEID in the Department of Lima, Peru.

2.2.1. The Contractor shall provide scientific and technical support for epidemiological and clinical studies conducted by the VEID.

2.2.1.1. NAMRU-6 Protocol: TBD: High-dose vaccine trial in Health-Care Personnel (HD).

2.2.1.2. This study determines if high dose influenza vaccine induces superior immunogenicity than standard dose influenza vaccine.

2.2.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.2.4.

2.2.2. The estimated level of effort for this task is provided in Section 3.

2.2.3. The location of performance is provided in Section 3.

2.2.4. Tasks/ Duties

- Identify, screen and enroll study participants at selected healthcare facilities at specified sites in Peru.

- Administer informed consent, questionnaires/surveys and take human research (pharyngeal, nasal, respiratory samples and blood) samples in accordance with the study protocol.

- Perform surveillance monitoring.

- Provide scientific, administrative, and logistical support for the study, as specified by the Principal Investigator. Logistical support for the study will include study site set-up, transport and tracking of all materials, supplies, equipment to the study site, tracking of supplies and equipment (Subject to PWS Section 1.4, and tracking of study subjects and study related materials and documentation.

2.3. Area of Support: VEID in the Department of Lima, Peru.

2.3.1. The Contractor shall provide scientific and technical support for epidemiological and clinical studies conducted by the VEID.

2.3.1.1. NAMRU-6 Protocol: 2019.0003: Epidemiology of norovirus in children between 5 months and 2 years of age in Latin America.

2.3.1.2. This field study determines the incidence, clinical severity, genotypes and presence of co-infections in acute gastroenteritis (AGE) associated with norovirus of pediatric participants, determine household attack rates for AGE and norovirus AGE following index cases in children under surveillance.

2.3.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.3.4.

2.3.2. The estimated level of effort for this task is provided in Section 3.

2.3.3. The location of performance is provided in Section 3.

2.3.4. Tasks/ Duties

- Identify, screen and evaluate prospective participants and perform informed consent process, on subjects, their household members and other personal contacts in accordance with the protocol.

- Enroll subjects and perform interviews/questionnaires.

- Provide proficient phlebotomy experience with the ability to work with or without supervision and/or the ability to supervise work at a health establishment or in the field enrolling volunteers in research studies and taking biological samples (blood, stool, pharyngeal swabs) following biosafety measures.

- Records and collects study data in an accurate manner for submission to investigators.

- Perform periodic study visits at subject homes or at health care facilities according to the protocol.

- Perform clinical visits during AGE episodes.

- Provide scientific, administrative and logistical support for the study as required by the Principal Investigator. Logistical support for the study will include study site set-up, transport and tracking of all materials, supplies, equipment to the study site, tracking of supplies and equipment, and tracking of study subjects and study related materials and documentation.

- Prepare the study sites for subsequent phase 2b vaccine trial in the same study areas.

2.4. Area of Support: VEID at Department of Piura, Department of Tumbes, Department of Loreto, Department of Ucayali, Department of Arequipa, Department of Cusco, Department of Madre de Dios, Department of Lima and Department of Ica, Peru.

2.4.1. The Contractor shall provide scientific and technical support for epidemiological and clinical studies conducted by the VEID.

2.4.1.1. NAMRU-6 Protocol: 2019.0004: Development of long-term dengue cohort studies in differentially exposed populations of Peru.

2.4.1.2. New field sites consisting of passive and cohort-based surveillance systems in different areas of Peru will be established to capture dengue serotype-specific primary infectious in residents and dengue transmission patterns in endemic urban areas for the purpose of characterizing populations for dengue vaccine studies.

2.4.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.5.4.

2.4.2. The estimated level of effort for this task is provided in Section 3.

2.4.3. The location of performance is provided in Section 3.

2.4.4. Tasks/ Duties

- Establish healthcare center-based and cohort dengue surveillance in two areas (Northwestern and Southeastern] of Peru.

- Identify, screen and enroll study participants.

- Administer informed consents and complete participant enrollment and the active follow-up activities at selected community sites in the stated regions.

- Provide proficient phlebotomy experience with the ability to work with or without supervision and/or the ability to supervise work at a health establishment or in the field/communities enrolling volunteers in research studies and taking biological samples (blood, stool, pharyngeal swabs) following biosafety measures.

- Ship collected research samples to NAMRU-6 Lima.

- Provide administrative and logistical support for the study, as specified by the Principal Investigator. Logistical support for the study will include study site set-up, transport and tracking of all materials, supplies, equipment to the study site, tracking of supplies and equipment, and tracking of study subjects and study related materials and documentation.

- Monitor supply of study materials and request supplies as needed following established ordering procedures (Subject to PWS Section 1.4).

- Accurately enter collected research data into database programs.

- Assist Government and contractor research staff with operation of research equipment.

- Perform a range of additional functions incidental to research activities.

- Research and collect data through complex laboratory/scientific experiments, techniques, and procedures, including real-time RT-PCR testing for dengue serotypes and viral isolation for acute cases.

2.5. Area of Support: VEID at Department of Loreto, Peru.

2.5.1. The Contractor shall provide scientific and technical support for epidemiological and clinical studies conducted by the VEID.

2.5.1.1. NAMRU-6 Protocol: 2017.0008: Clinical Evaluation of the FilmArray Global Fever Panel.

2.5.1.2. This study evaluates the clinical severity and specificity of assays comprising the FilmArray Global Fever Panel when used to test whole blood collected from individuals with or recently had acute febrile illness, compared with a well-validated molecular based method. The data will be used to support the presentation of the FilmArray Global Fever Panel as an in vitro diagnostic device.

2.5.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.6.4.

2.5.2. The estimated level of effort for this task is provided in Section 3.

2.5.3. The location of performance is provided in Section 3.

2.5.4. Tasks/ Duties

- Identify, screen/evaluate prospective participants, perform informed consent process, on subjects, household members, and other contacts, in accordance with the study protocol.

- Enroll subjects at various sites in Peru in accordance with the protocol.

- Conduct subject interviews and questionnaires. Obtain informed consent from each participant prior to whole blood specimen collection.

- Provide proficient phlebotomy experience with the ability to work with or without supervision and/or the ability to supervise work at a health establishment or in the field/communities enrolling volunteers in research studies and taking biological samples (blood, stool, pharyngeal swabs) following biosafety measures.

- Carry out FilmArray GF Panel testing and purification of nucleic acid, using the MagNA Pure Compact system.

2.6. Area of Support: VEID at Department of Tumbes, Department of Lima and Department of Ica, Peru.

2.6.1. The Contractor shall provide scientific and technical support for epidemiological and clinical studies conducted by the VEID.

2.6.1.1. NAMRU-6 Lines of Effort:P0143_19_N6_06.01 and P0143_19_N6_06.02: Passive surveillance of respiratory viral pathogens in Latin America meeting ILI/SARI case definition, including sequencing, advanced characterization, and pathogen discovery.

2.6.1.2. This project collects respiratory samples from passive surveillance of respiratory viral pathogens in Latin America (military and civilian populations meeting the influenza-like illness (ILI)/severe acute respiratory infections (SARI) case definition. This activity also involves the collection of cloacal samples from wild birds and respiratory samples from pigs in farms/slaughter houses.

2.6.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.7.4.

2.6.2. The estimated level of effort for this task is provided in Section 3.

2.6.3. The location of performance is provided in Section 3.

2.6.4. Tasks/ Duties

- Collect respiratory samples from passive surveillance and carry out laboratory techniques, such as PCR, real-time PCR, sequencing, next-generation sequencing, shotgun sequencing, amplicon sequencing, ribosome profiling, cell culture, and molecular cloning.

- Assist in production of next generation sequencing (NGS) libraries, and carrying out sequencing on both Illumina and Ion sequencing platforms, as well as ribosome profiling.

- Perform specialized egg culture for viruses.

- Determine the diversity of mammals existing in the assessment area using live capture traps.

- Take the biometric data of each of the captured specimens.

- Identify the important species or flag species and their categorization according to national legislation and international legislation.

- Identify bird species from distance and have a photographic record to link evidence of species.

- Take environmental fecal samples of birds.

- Identify the important species or flag species and their categorization according to national legislation and international legislation.

2.7. Area of Support: Entomology Department at Iquitos, Peru.

2.7.1. The Contractor shall provide scientific and technical support for research studies conducted by the Entomology Department.

2.7.1.1. NAMRU-6 Protocol: NAMRU6.2019.0002: Development of a deployable biodegradable attractive toxic sugar bait system.

2.7.1.2. This study will involve laboratory and field evaluations of artificial sweeteners as toxicants couple with a biodegradable matrix as a baiting system for malaria and arbovirus mosquito control in the Peruvian Amazon.

2.7.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.8.4.

2.7.2. The estimated level of effort for this task is provided in Section 3.

2.7.3. The location of performance is provided in Section 3.

2.7.4. Tasks/ Duties

- Assist with laboratory assays, prep, and mosquito rearing to evaluate the toxicity of sugar alcohols on Amazonian mosquitoes.

- Assist with semi-filed assays, prep, mosquito rearing and collections;

- Assist with field assays, prep, mosquito rearing and collections.

- Maintain project databases.

2.8. Area of Support: Entomology Department at NAMRU-6 Iquitos.

2.8.1. The Contractor shall provide scientific and technical support for research studies conducted by the Entomology Department.

2.8.1.1. NAMRU-6 Line of Effort: F0642_20_WR_CS_OC: Sustainment of an Anopheles darling experimental infection system for Plasmodium vivax sporozoite production and nonhuman primate infections to support malaria vaccine development efforts and Infectivity of Anopheles species with Plasmodium species for use in human clinical vaccine studies.

2.8.1.2. Reserved.

2.8.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.9.4.

2.8.2. The estimated level of effort for this task is provided in Section 3.

2.8.3. The location of performance is provided in Section 3.

2.8.4. Tasks/ Duties

- Identify, screen and enroll study participants.

- Administer informed consents and complete participant enrollment and the active follow-up activities at selected study sites in the Loreto region.

- Conduct phlebotomy to collect samples from donor patients infected with malaria once enrolled.

- Process informed consent forms.

- Conduct thorough screening of blood for infectious agents.

- Set up, maintain and membrane feeding system to infect Anopheles mosquitoes.

- Perform dissections of mosquito salivary glands.

- Count and quantify number of malaria sporozoites produced in mosquito.

- Compare, record and analyze differences in number of sporozoites among groups per direction of the Principal Investigator.

- Maintain all project databases.

2.9. Area of Support: Entomology Department at Iquitos - Peru, Quito - Ecuador, Comayagua - Honduras, Medellin, Bello and Antioquia - Colombia and across USSOUTHCOM.

2.9.1. The Contractor shall provide scientific and technical support for research studies conducted by the Entomology Department.

2.9.1.1. NAMRU-6 Protocol: NAMRU6.2019.0005. Assessing vector-borne disease risk in military relevant areas in Honduras and Peru through integrated DoD surveillance approaches.

2.9.1.2. These studies conduct routine annual biosurveillance of arthropods of medical importance in the form of collection, identification, insecticide resistance testing and pathogen screening of arthropod vectors (Mosquitoes, Sand flies, Triatomines/Reduviids and Ticks) in Peru, Ecuador, Honduras, Colombia and across USSOUTHCOM.

2.9.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.10.4.

2.9.2. The estimated level of effort for this task is provided in Section 3.

2.9.3. The location of performance is provided in Section 3.

2.9.4. Tasks/ Duties

- Conduct all field arthropod collections, density estimations via standard department procedures, trapping mechanisms.

- Maintain cold-chain solutions of vector specimens for pathogen screening.

- Maintain meticulous collection record data.

- Assist with management of collection databases.

- Assist with logistical support prior to and upon completion of trips.

- Assist with labeling, packing, shipping of equipment to collection sites.

- Assist with labeling, packing, shipping of specimens to the United States for testing.

- Assist with voucher specimen preservation.

2.10. Area of Support: Entomology Department at Iquitos, Peru.

2. 10.1. The Contractor shall provide scientific and technical support for research studies conducted by the Entomology Department.

2.10.1.1. NAMRU-6Line of Effort: U0501_17_AF_CS_OC: Maintenance of mosquito and sand fly insectaries at Navy laboratories.

2.10.1.2. This activity supports insect colony maintenance for the entomology department, NAMRU-6, and collaborating agencies and institutions across the globe.

2.10.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.11.4.

2.10.2. The estimated level of effort for this task is provided in Section 3.

2.10.3. The location of performance is provided in Section 3.

2.10.4. Tasks/ Duties

- Assist with all aspects of mosquito colony maintenance, feeding schedules, temperature regulation, larval production, pupal care-taking, adult rearing, cage cleaning, water pH, temp, turbidity, organic matter.

- Assist with preparation of mosquitoes upon request from collaborator or Principal Investigator.

- Maintain colony databases and records, mortality rates and production rates.

2.11. Area of Support: Parasitology Department in Peru, Honduras, Colombia, Brazil and across USSOUTHCOM.

2.11.1. The Contractor shall provide scientific and technical support for laboratory, immunologic, and clinical research studies conducted by the Parasitology Department.

2.11.1.1. NAMRU-6 Protocol: NMRCD.2007.0004; NMRCD.2007.0018, NAMRU6.2018.0008: Parasite surveillance activities in the USSOUTHCOM area of responsibilities.

2.11.1.2. These activities aim to expand malaria and leishmaniasis surveillance activities in Honduras, Colombia, Brazil and Peru, provide field work support in the cohort studies conducted in Peru, and perform laboratory assays for drug resistance.

2.11.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.12.4.

2.11.2. The estimated level of effort for this task is provided in Section 3.

2.11.3. The location of performance is provided in Section 3.

2.11.4. Tasks/ Duties

- Provide general administrative support to set up study sites in endemic regions of Peru including (but not limited to) Madre de Dios, Loreto, Piura and Tumbes.

- Set up study sites in Honduras including (but not limited to) Hospital la Escuela Tegucigalpa and other health centers in surrounding areas.

- Set up study sites in Brazil including (but not limited to) Boa Vista, Javari and Brasilia.

- Set up study sites in Colombia including (but not limited to) Cucuta, Ocanna, Tibu and other health centers.

- Administer informed consent to study participants in Peru.

- Provide quality assurance on all ethical approvals and regulatory permits required for collecting clinical specimens by NAMRU-6.

- Collect human samples from Peru for malaria screening.

- Collect human samples from Peru for leishmaniasis screening.

- Perform molecular methods for malaria detection in human samples.

- Perform molecular methods for leishmaniasis detection and species identification on samples from humans, vectors or animal reservoirs.

- Perform next generation sequencing on malaria and leishmania samples.

- Perform drug susceptibility testing on malaria samples.

- Perform drug susceptibility testing on leishmaniasis samples.

- Perform data analysis of clinical and laboratory data.

- Provide support on shipments of materials and clinical specimens from study sites to NAMRU-6 Lima.

2.12. Area of Support: Parasitology Department in Peru.

2.12.1. The Contractor shall provide scientific and technical support for laboratory, immunologic, and clinical research studies conducted by the Parasitology Department.

2.12.1.1. NAMRU-6 Protocol: NAMRU-6 19-02: Development of a Plasmodium vivax challenge model in Aotus nancymaae monkeys.

2.12.1.2. This study proposes to establish a reliable, consistent, and predictable challenge model of Plasmodium vivax parasites using Aotus nancymaae monkeys, while also providing live parasites for other vaccine efforts. The availability of this monkey challenge model will accelerate vaccine development to protect the U.S. military from Plasmodium vivax malaria.

2.12.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.13.4.

2.12.2. The estimated level of effort for this task is provided in Section 3.

2.12.3. The location of performance is provided in Section 3.

2.12.4. Tasks/ Duties

- Conduct pilot experiments to determine the capability of parasite transmission of pre-erythrocytic infections from mosquitoes to monkeys to mosquitoes, replicating the complete life cycle of P. vivax for monkey-adapted and non-adapted parasites isolated from human samples.

-Determine the potential of sub-curative doses of anti-malarial drugs for the induction of gametocytogenesis.

-Evaluate the consistency and reproducibility of the sporozoite challenge model using a larger set of Aotus monkeys.

2.13. Area of Support: Parasitology Department in Lima, Peru.

2.13.1. The Contractor shall provide scientific and technical support for laboratory, immunologic, and clinical research studies conducted by the Parasitology Department.

2.13.1.1. NAMRU-6 Protocol: NAMRU-6 19-05: Evaluation of protective efficacy of prophylactic administration of malaria-specific monoclonal antibodies against Plasmodium falciparum malaria challenge in Aotus monkeys.

2.13.1.2. NAMRU-6 collaborator has isolated four non-competing RH5-specific antibodies that neutralize a wide range of laboratory and clinical strains of the most dangerous malaria parasite, Plasmodium falciparum. The tested strains included some of which are resistant to current antimalarials. The antibodies are not synergistic when combined in vitro, but the antibodies could be combined to avoid resistance. This study will test whether one of the monoclonal antibodies will provide prophylactic protection against malaria infection in Aotus monkeys.

2.13.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.14.4.

2.13.2. The estimated level of effort for this task is provided in Section 3.

2.13.3. The location of performance is provided in Section 3.

2.13.4. Tasks/ Duties

- Assess the efficacy of prophylactic administration of a GIA-inducing monoclonal antibody against malaria challenge in Aotus monkeys using the Plasmodium falciparum strain FVO.

- Evaluate polyclonal antibodies to down-select functional vaccine candidates.

2.14. Area of Support: Parasitology Department in Lima, Peru.

2.14.1. The Contractor shall provide scientific and technical support for laboratory, immunologic, and clinical research studies conducted by the Parasitology Department.

2.14.1.1. NAMRU-6 Protocol: NAMRU-6 18-05: Assessing immunogenicity of malaria vaccine candidates in the mouse model

2.14.1.2. This study will establish the humanized liver chimeric mouse as a model for P. vivax sporozoite infection. It will support testing of novel vaccines, immunoprophylactics and drugs that can target P. vivax infection and relapse.

2.14.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.15.4.

2.14.2. The estimated level of effort for this task is provided in Section 3.

2.14.3. The location of performance is provided in Section 3.

2.14.4. Tasks/ Duties

- Production of mosquitos infected with P. vivax sporozoites from field isolates.

- Use sporozoites to infect humanized mice.

- Establish protocols for measuring infection.

- Establish protocols for generating and shipping infected liver samples to collaborators for further analysis.

- Use laboratory assays to visualize liver infection.

- Perform antibody passive transfer and sporozoite infection using above protocols.

2.15. Area of Support: Bacteriology Department in Lima, Peru and Comayagua, Honduras.

2.15.1. The Contractor shall provide scientific and technical support for clinical research studies conducted by the Bacteriology Department. The objectives are to conduct diarrheal disease surveillance in travelers and US military personnel, and antimicrobial resistance surveillance at various sites in Peru and Honduras and to evaluate investigational drugs, vaccines and other immunoprophylactic products against diarrheal pathogens in animal models.

2.15.1.1.

NAMRU-6 Protocol: 2013.0006: The epidemiology of acute respiratory and diarrheal illness and health related quality of life in the US military populations during and after deployment in Latin America.

NAMRU-6 Protocol: 2013.0024. The Global Travelers Diarrhea (GTD) Study; an evaluation of study design and laboratory methodologies standardization in a multisite protocol assessing the epidemiology and etiology of acquired diarrhea among US military or civilian travelers.

2.16.1.2. Reserved.

2.15.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.16.4.

2.15.2. The estimated level of effort for this task is provided in Section 3.

2.15.3. The location of performance is provided in Section 3.

2.15.4. Tasks/ Duties

- Collect de-identified laboratory specimens.

- Research and collect data through complex laboratory/scientific experiments, techniques, and procedures.

- Assist research and support staff on the technical procedures associated with laboratory testing.

- Perform laboratory testing (bacterial culture, antibiotic sensitivity testing, etc.) on laboratory specimens.

- Maintain project databases.

- Perform or manage a range of additional functions incidental to research activities.

- Using the Aotus animal model, perform preclinical evaluation of drugs, vaccines and other immunoprophylactic products against diarrheal pathogens such as ETEC, Shigella and Campylobacter.

2.16. Area of Support: Bioinformatics Department in NAMRU-6, Lima, Peru.

2.16.1. The Contractor shall provide scientific and technical support for research and development efforts conducted by the Bioinformatics Department.

2.16.1.1. NAMRU-6 Protocol: TBD: Development of health informatics products and services for global health research.

2.16.1.2. NAMRU-6 collaborates with U.S. Department of Defense HIV /AIDS Prevention Program (DHAPP), the Walter Reed Army Institute of Research (WRAIR) and industry in the execution of the Site Improvement Monitoring System (SIMS) software, HIV Patient Monitoring System (HIV-MS) and the Electronic Data Capture (EDC) tools to ensure adequate software adoption and adequate transfer of skills, knowledge, and technologies at sites in Peru and Africa. Performance is solely at NAMRU-6 in Lima, Peru.

2.16.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.17.4.

2.16.2. The estimated level of effort for this task is provided in Section 3.

2.16.3. The location of performance is provided in Section 3.

2.16.4. Tasks/Duties

Develop, deploy and implement updates for the SIMS for DHAPP. Provide data management services and technical support for the DHAPP. Provide support for activity planning. Develop agile software development methodology. Meet requirements according to project’s needs, through adaptive planning and software development, early delivery, continuous improvement of the software products. Develop and deploy EDC tool for VEID’s norovirus epidemiological study.

2.17. Area of Support: Animal Research Facility in NAMRU-6, Lima, Peru.

2.17.1. The Contractor shall provide technical support for the activities of the Animal Research Facility.

2.17.1.1. NAMRU-6 Protocol:

2.17.1.2. This support will assist the Animal Facility to maintain AAALAC-accredited animal care and use program that meets all DoD mission requirements for preclinical studies and model development.

2.17.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.18.4.

2.17.2. The estimated level of effort for this task is provided in Section 3.

2.17.3. The location of performance is provided in Section 3.

2.17.4. Tasks/ Duties

- Provide continuous support for IACUC approved animal use protocols for the departments of Bacteriology, Parasitology and Virology/Emerging Infections.

- Perform high-quality husbandry care for mouse breeding colony and nonhuman primates (Aotus monkey model). - Provide support for superior veterinary medical and surgical care.

- Provide technical assistance with experimental procedures.

- Provide support for training, and administrative activities in support of NAMRU-6 animal research activities.

- Maintain project databases.

2.18. Area of Support: Evaluation of a Dengue Rapid Diagnostic Device in Peru (Clinical Trial Unit)

2.18.1. The contractor will support NAMRU-6 in performing the following tasks which will provide scientific, logistical, and administrative support for the execution of a clinical research study that will evaluate the performance characteristics of a dengue rapid diagnostic device. The contractor shall provide the necessary support detailed in the requirements.

2.18.1.1. NAMRU-6 Protocol: TBD: Evaluation of a Dengue Rapid Diagnostic Device Based on Immunochromatographic Test Technology for the Identification of Causative Etiological Agents in Persons Exhibiting Signs and Symptoms of Febrile Illnesses.

2.18.1.2. The study is intended to assess a rapid test for diagnosing acute dengue infection to assess the device feasibility as an alternative rapid and accurate diagnostic test.

2.18.1.3. The contractor shall provide all supervision, labor, supplies and services required to perform the tasks and duties outlined in Section 2.19.4.

2.18.2. The estimated level of effort for this task is provided in Section 3.

2.18.3. The location of performance is provided in Section 3. (Department of Loreto, Peru).

2.18.4. Tasks/ Duties

- Perform set up of study site in accordance with NAMRU-6 requirements and other activities in support of starting up the study.

-Identify, screen and evaluate study participants for eligibility; administer informed consent and complete subject eligibility evaluation and screening procedures such as subject interview for medical history and physical examination.

-Enroll eligible participants and complete enrollment procedures, including the completion of all the required forms, including all source documents and case report forms (CRFs).

-Perform initial and follow up visits and perform all necessary procedures in support of the study protocol. These tasks may include but are not limited to medication administration, setting IVs, updating subject source documents, providing emotional support, patient education, basic diagnostics, and other medical procedures in support of research protocols. Supervision of other nurses employed by the contractor in support of this requirement in a research/field environment, if required.

-Provide phlebotomy services with the ability to work with or without supervision and/or the ability to supervise work at a health establishment or in the field taking biological samples (blood) from study participants following biosafety measures and in accordance with the study protocol.

-Accurately record and enter collected research data into database programs. Manage appropriate databases in accordance with the study protocol and the DoD requirements for government furnished equipment, if applicable.

-Assist in the interpretation of test results to support the writing of manuscripts and required reports.

-Research and collect data through complex laboratory/scientific procedures, experiments, techniques, and procedures.

Assist research and support staff on the technical procedures associated with laboratory testing.

-Ship samples collected to NAMRU-6 facility or to the US laboratory in accordance with the study protocol and local regulations, if applicable.

-Perform periodically reports of the study progress to the NAMRU-6 Principal Investigator.

-Monitor supply of study materials and request supplies as needed following established ordering procedures.

-Assist research staff with operation of research equipment. Be proactive and attentive to all communications; Perform or manage a range of additional functions incidental to research activities, including the periodic reporting of accountability for any government furnished equipment (GFE) that may be provided by NAMRU-6 in accordance with DoD regulations.

2.19. Area of Support: Parasitology Department at NAMRU-6 Lima.

2.19.1. The Contractor shall provide administrative and secretarial support for the Parasitology Department at the NAMRU-6 Lima site.

2.19.2. The estimated level of effort for this task is provided in Section 3.

2.19.3. The location of performance is provided in Section 3.

2.19.4. Tasks/ Duties

- Perform general clerical duties to include, but not limited to, bookkeeping, copying, faxing, mailing and filing.

- Provide administrative support to department staff with office management responsibilities to include preparing reports, recordkeeping and document translation (subject to final Government approval).

- Maintain office calendar to coordinate work flow and meetings.

- Open, sort and distribute incoming correspondence, including faxes and email.

- Prepare responses to correspondence containing routine inquiries (subject to final Government approval and distribution).

- Provide administrative support for projects requiring research and preparation of briefing charts and presentation materials (subject to final Government approval and distribution).

- Assist military and civilian staff with their travel request (TDY request, reservations, etc.).

2.20. Area of Support: Various Science Departments at NAMRU-6 Lima.

2.20.1. The Contractor shall provide data entry support and services for epidemiological and clinical studies conducted by the various Science Departments at NAMRU-6 Lima.

2.20.2. The estimated level of effort for this task is provided in Section 3.

2.20.3. The location of performance is provided in Section 3.

2.20.4. Tasks/ Duties

- Operates keyboard controlled data entry device to transcribe data into a form suitable for computer processing.

- Operates word processing equipment to compile, type, revise, combine, edit, print and store study documents.

- Proofreads and edits document for grammar, spelling, punctuation and format (subject to final Government approval and distribution).

- Verify or perform work involved in abstracting and/or coding information from schedules, questionnaires, reports, documents, and other written or printed material according to instructions and related codes involving words, numerical and alphabetical symbols.

- Format source material into documents such as reports, conference materials, or presentation handouts.

- Handles materials involved in data to be entered and maintained in computer files and performs other duties such as scanning, opening, sorting, marking, tabulating, and filing various study documents.

- Work with various source documents that have been coded and may require additional selecting, coding, or interpreting of data to be entered. Such work may require the application of experience and judgement in selecting procedures to be followed and in searching for, interpreting, selecting, or coding items to be entered from a variety of source documents.

2.21. Area of Support: All Departments at NAMRU-6 Lima.

2.21.1. The Contractor shall provide Occupational Health Program services to all NAMRU-6 staff (to include Government personnel and contractors) at NAMRU-6 Lima.

2.21.2. The estimated level of effort for this task is provided in Section 3.

2.21.3. The location of performance is provided in Section 3.

2.21.4. Tasks/ Duties

- Conduct Occupational Health Program medical evaluation of government and contractor personnel for medical surveillance, fitness for duty and job certification requirements

- Assist in maintenance and execution of occupational health and safety program, including support to all research activities and staff working in or out of US government facilities (subject to final Government approval). These responsibilities may extend to activities at contract sites depending on specific activities being conducted, requiring travel within and possibly outside of Peru in support of up to 300 government employees and contractor personnel.

- Assist the occupational health nurses at all research sites or other designated care providers in record review of personnel, tracking of individual occupational health programs.

- Conduct physical examinations related to occupational medicine, make appropriate referrals, if required, and make medically relevant recommendations concerning suitability for employment or return to work secondary to medically limiting conditions in accordance with Naval Occupational Health publications, US and Peruvian labor laws.

- Assist ensuring maintenance of occupational health supplies for contingency events (post exposure prophylaxis materials, epi-pens, first aid materials, etc., subject to final Government approval).

2.22. Area of Support: All Departments at NAMRU-6 Lima.

2.22.1. The Contractor shall provide Facilities – Administration Department services to all NAMRU-6 staff (to include Government personnel and contractors) at NAMRU-6 Lima.

2.22.2. The estimated level of effort for this task is provided in Section 3.

2.22.3. The location of performance is provided in Section 3.

2.22.4. Tasks/ Duties

- Work includes fabrication, installation, maintenance, operation, modification, and repair of research laboratory equipment. All duties are restricted to laboratory equipment and shall not extend to the modification of the building or facility itself.

- Work includes checking equipment for proper operation; and operating and making minor repairs to auxiliary equipment and identifying electrical lab equipment malfunctions.

- Laborer shall provide labor assistance to Biomedical Technician with biological safety cabinet certification.

- Provide support for the Safety Officer and the Environmental Officer; such as: support for monthly inspections of the fire extinguishers, monthly inspections of AED, monthly inspections of eye wash station and perform related duties as required.

- Laborer shall prepare hazardous waste for sterilization and removal. Laborer will work around biologically contaminated items which require them to observe common safety precautions, e.g., to look for a color change of the pressure sensitive sterilization tape before handling items.

- Participate in moving when required of heavy furniture and/or laboratory equipment.

- Laborer shall coordinate with local courier company (subject to GS approval) for all deliveries except confidence materials.

- Laborer shall provide assistance in the processing of all material received by the Government and delivered by the courier service (Receipt of material can only be completed by a GS or military staff).

- Laborer shall move supplies to proper storage areas, using hand truck and other material handling equipment.

- Laborer shall clean floor and furniture of laboratories and any other assigned area.

2.23. Area of Support: All Departments at NAMRU-6 Lima.

2.23.1. The Program Manager duties listed in 2.23.4, apply to all task orders issued under the Base IDIQ contract.

2.23.2. The estimated level of effort for this task is provided in Section 3.

2.23.3. The location of performance is provided in Section 3.

2.23.4. Tasks/ Duties

- Facilitate information flow between the COR, the contractor, and contract personnel.

- Oversee the onboarding of new contractor personnel and serve as a key resource for all contract personnel.

- Provide on-site administrative oversight of contract personnel, to include pay, promotions, leave, work hours, conflict resolution, and disciplinary actions.

- Identify and evaluate problems affecting research project and mission goals and provide solutions in a timely manner.

- Work closely with the COR to document the need for any changes to requirements.

- Ensure timely delivery of required reports.

2.24. Area of Support: Research Science Director in NAMRU-6 Lima, Peru.

2.24.1. The Contractor shall provide scientific and technical support for the Research Science Director.

2.24.2. The estimated level of effort for this task is provided in Section 3.

2.24.3. The location of performance is provided in Section 3.

2.24.4. Tasks/ Duties

- Support grant writing activities (subject to final Government approval and submission).

- Provide all necessary technical support, prepares tables, graphs and other documents for the project reports, including preparation of scientific presentation materials.

- Maintain project databases.

3.0. Labor Categories / Estimated Level Of Effort

3.1. Labor Categories

3.1.1.