Attachment_V_Initial_CPFF_Task_Order_SOW.docx

NAMRU-2 INITIAL CPFF TASK ORDER (ITO) STATEMENT OF WORK-R&D SUPPORT SERVICES

Project and Program Management Support

1. BACKGROUND

This acquisition will provide research program and administration of the NAMRU-2 human subject research program.

1.1 The purpose of this Initial Task Order (ITO) SOW is to supplement the PWS contained in the base contract and further define what is required for each of the positions being executed with the initial task order. The base PWS remains in effect and the requirements listed in this ITO-SOW 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 on this task order.

1.2 For the purposes of constructing the cost proposal, the Government estimates that following costs are required to provide the below mentioned services:

Other Direct Costs: $10,000 Travel: $15,000 Subcontracts: $115,000 Offerors shall use the amounts provided above in the construction of their cost proposal. All ODC and Travel costs are estimated amounts and are before contractor burdens. Contractor burdens must 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 COR.

1.3 The period of performance for this task order shall be 12 months from the date of award. The period of performance will be: 12 August 2018 to 11 August 2019.

1.4 Human use research is expected under this task order. A task order that contains research with human subjects may not be awarded unless the contractor (and all subcontractors) possess a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A Human Research Protection Officer (HRPO) review must be in place before the task order is awarded.

1.6 This task order will be issued as Cost Plus Fixed Fee and is considered non severable.

1.7 A Secret clearance is required for this task order.

1.8 This task order requires indemnification and medical liability insurance. The Federal Tort Claims act does not apply.

1.9 The following positions are considered Key Personnel and require a resume to be provided with the offerors technical approach:

Epidemiologist Program Manager

GLOBAL REQUIREMENT

The Naval Medical Research Unit Two (NAMRU-2), based in Singapore, is at the forefront of the U.S. Department of Defense (DoD)’s infectious disease research and surveillance efforts in the US Pacific Command (PACOM) Area of Responsibility (AOR). Within the context of its ongoing infectious disease research and surveillance activities, the NAMRU-2 is well-positioned to evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and to develop local expertise via training to detect and respond to emergent disease threats.

SPECIFIC REQUIREMENTS

This requirement is to put in place personnel and process infrastructure that will facilitate Navy Medicine’s mission to conduct Research & Development (R&D) across its enterprise, including commands that the Navy collaborates with, supports, and reports to (e.g., OASD-Health Affairs, Defense Health Agency, US Army). In addition to providing personnel, materials, equipment, and facilities (non-construction (bonded), non-Government spaces), this requirement addresses process infrastructure (such as basic research, vaccine development, clinical trials, or FDA IND application processing).

Navy Medicine provides high quality, economical health care to beneficiaries in wartime and in peacetime. Highly trained Navy Medicine personnel deploy with Sailors and Marines worldwide –providing critical mission support aboard ship, in the air, and on the battlefield. At the same time, Navy Medicine’s military and civilian health care professionals are providing care for uniformed services’ family members and retirees at military treatment facilities around the globe.

AREAS OF SUPPORT

The intent of this task orders is to support to Navy Medicine in the conduct of biomedical, epidemiological and clinical research efforts. Direct project and program mission support of the following:

1. Research Mission Support – Conduct analyses and develop solutions to provide medical decision support to command, medical logisticians, and research personnel

2. Behavioral Sciences & Epidemiology – Conduct research and development in the areas of epidemiology, predictive profiles, and interventions in recruit and active-duty populations; prevention, sub typing and viral resistance, and diagnostics.

3. Environmental Health Effects– Support Fleet operational readiness, protect the Warfighter, and provide the Department of the Navy, the Bureau of Medicine and Surgery, and other customers with timely solutions to current and anticipated operational problems through an integrated approach to innovative human effects toxicological research.

4. Environmental and Molecular Health Effects: This research can be divided into two main areas. One area is primarily involved in the evaluation of exposure to a variety of materials of interest to military personnel at the molecular (DNA, RNA, protein) level. The second area is involved in the development of improved methodology to assess the impact of operations on the overall health of the environment as it relates to the health of personnel exposed to a potentially contaminated area, as well as to activities occurring in the environment after it is vacated by the military. In addition, a focus of research is the development of biological sensors to protect personnel against a wide range of threats of chemical and biological nature.

5. Etiological Research – Conduct etiological research, which includes studies of emerging infectious enteric and pulmonary diseases and validation of methods for surveillance of such diseases; basic and applied research to support an understanding of the etiologic agents underlying such disease; development and testing of vaccines and therapeutics to address treatment of such diseases; and epidemiological investigations following outbreaks.

6. Human Research Protection and Institutional Review Board Services – Conduct services in support of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB). Based on the Federal Common Rule established under Title 45 CFR Part 46, research institutions and sponsoring agencies follow policies set forth under their respective HRPP. The guiding body of the HRPP is the IRB, a supervisory panel formed in order to provide ongoing monitoring and periodical review of scientific, ethical, and regulatory compliance in Human Subject Research projects. IRBs are governed by Title 45 CFR Part 46 (Department of Health and Human Services – “Protection of Human Subjects”) and Title 21 CFR Part 56 (Food and Drug Administration – “Institutional Review Boards”)’ additionally, Title 21 CFR Part 312 (FDA –“Investigational New Drug (IND) Application”) outlines the protocol for IND research and clinical trial of new drugs and treatments for human use.

7. Developing technical reports, peer-review journal articles and conference presentations as well as any clerical needs required for the aforementioned projects.

PROCESS INFRASTRUCTURE

In addition to R&D support and services, a requirement to address the conventional process for maturation of research into the treatment facility via protocols, clinical trials, and FDA related applications such as those available via a Contract Research Organization. Recent trends show an increasing need to move research results more quickly to clinical settings. Clinical research is a vital component of progress toward improving America's health. Although clinical research helps assure that new treatments are safe and effective, it is a lengthy and sometimes inefficient process. The current system of clinical research must be re-engineered if it is to respond to these changing scientific and health care needs. Meeting these demands will require new and more efficient approaches to discovery and clinical validation of research results. The initiatives within this TO for Medical Research project management aim to contribute to accelerating and strengthening clinical research by adopting a systematic process infrastructure that will better serve the command, Navy Medicine and the warfighter in the evolving field of scientific discovery.

Travel will be required to fulfill the requirements of this contract and may be inside the Contiguous United States (CONUS) or outside of the Contiguous United States (OCONUS). The Contractor may be required to attend various meetings and reviews or to participate in Government projects.

The Contractor shall ensure that the requested travel costs will not exceed what the Government has pre-authorized. Contractor personnel must follow established Government travel requirements, complete all forms, and obtain the required signatures prior to any travel. The Contractor may be required to coordinate with other DOD and industry for travel. Trip reports may be required at the direction of the Government.

Reimbursements for travel will be in accordance with JTR and will in no case exceed those travel costs allowed by the JTR unless approved by the Government. The travel costs must be approved by the COR prior to the contractor incurring any costs.

The Contractor may be required to obtain materials/equipment to be used in performance of this contract. The COR must approve all purchases in advance and prior to the Contractor incurring any charges.

Project: Viet Nam military malaria country plan Location: Cambodia and Singapore

A. Viet Nam military malaria country plan

1. Review previous Viet Nam military malaria reports (2014, 2015 and 2017 reports available from NAMRU-2) to identify program gaps.

2. Conduct interviews with malaria control personnel and agencies in Viet Nam to identify gaps to current program as well as recommendations for training, material, and research to address gaps. Focus should be paid to the state of the current program, national malaria control program goals and interface between military and civilian malaria programs.

3. One area of research already identified by the Viet Nam military is the evaluation of insecticide treated uniforms for military personnel. The contractor shall develop research protocol to evaluate chemical stability over a six month period, durability of uniforms, impact of environmental and operational conditions on uniform/chemical combinations, user acceptability, and effectiveness. The protocol should provide information for cost-benefit analysis as well as reduction of malaria and other vector borne disease transmission.

B. Provide in-country research support services outlined below:

Project Manager (0.50 FTE or 960 Hours)

a. Tasks: The Project Manager will coordinate in-country activities for specific projects, ensuring that all resources (including foreign national labor and subcontractor staff) are maximized effectively. Along with the Program Manager, the Project Manager will interface directly with NAMRU-2 leadership and principal investigators to establish agreements with in-country collaborators and subcontractors, and will manage activity personnel and project budgets.

b. Location: May be US-based with travel indicated to Viet Nam and NAMRU-2

c. Qualifications: Knowledge of human resources practices, laws, and approaches. Knowledge of budgets and accounting. Ability to interface with investigators, vendors, research staff, and in-country partners. Bachelor’s degree required. Knowledge of local language and customs is preferable.

Epidemiologist (0.25 FTE or 480 hours)

a. Tasks: This position will work with NAMRU-2 researchers to conduct data analyses and interpret biosurveillance findings to assist in the development of conclusive research reports related to epidemiological studies. The epidemiologist may also advise on outbreak investigations and response plans in collaboration with in-country research partners.

b. Location: NAMRU-2, Singapore or Cambodia

c. Qualifications: Master’s degree in public health or related field, with 3 years of epidemiological research required. Prefer Ph.D. or M.D. with training and degree in epidemiology.

Anticipated Sub-contracts

Development of military malaria work plan ($85,000)

Treated Uniform study protocol ($30,000)

Deliverables:

1. Report for Viet Nam military malaria program. This report will include identifying gaps to the current program as well as recommendations for training, material, and research to address the identified gaps. Focus should be paid to the state of the current program, national malaria control program goals and interface between military and civilian malaria programs. NAMRU-2 has historic data presented at meetings in 2014 and 2015, this report will expand on those reports and provide recommendations for future projects with the Viet Nam military.

2. Research protocol for the evaluation of uniforms treated with insecticides for use with the Viet Nam military. This protocol should address concerns with chemical stability over a six month period, durability of uniforms, impact of environmental and operational conditions on uniform/chemical combinations, user acceptability, and effectiveness. The protocol should provide information for cost-benefit analysis as well as the reduction of malaria and other vector borne disease transmission.