PSPPS Statement of Work.pdf

ATTACHMENT 1: STATEMENT OF WORK

Title: NIAID DCR PROFESIONAL STRATEGIC AND

PROGRAM PLANNING SERVICES (PSPPS)

1.0 INTRODUCTION/OVERVIEW

National Institute of Allergy and Infectious Diseases (NIAID) has a unique dual mandate to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases and to respond rapidly to emerging public health threats.

The Division of Clinical Research (DCR) is a program within NIAID. The DCR’s mission is to provide multi-disciplinary trans-NIAID services for facilitating clinical research and managing special projects as directed by NIAID leadership. New and expanding Congressional mandates, changing policies and information technologies, expanding research programs, and NIAID’s leadership role in the global community have resulted in a critical requirement for NIAID to obtain strategic and program planning services.

2.0 BACKGROUND

The DCR plays an integral role in facilitating the efficient and effective performance of NIAID research programs on both the domestic and the international level. This is accomplished through a multi-faceted approach to the provision and support of services vital to the research infrastructure that include oversight and management of intramural and extramural clinical research, program planning and management, regulatory monitoring and compliance, statistical consultation and research methodology, and clinical research capacity building.

The NIAID DCR vision is to facilitate high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious diseases. DCR provides multi-disciplinary trans-NIAID services for facilitating clinical research and managing special projects as directed by NIAID leadership.

One aspect of DCR critical to its functioning is the management of DCR Special Projects (SPs). Special Projects are requested and directed by NIAID leadership, typically managed through government-to-government agreements and shared governance frameworks. Support to the SPs are often initiated during an infectious disease outbreak. Post-outbreak, many of these networks are strategically maintained to support rapid response to any additional future outbreaks or scientific questions (see Attachment for details on each project).

3.0 SCOPE

The purpose of this contract is to provide assistance in professional strategy management, financial and program implementation/planning services to support the optimal functioning of the DCR in performing its mission. The required services include assisting DCR in the following areas: program deployment and implementation, strategy management and evaluation, organizational effectiveness analyses and facilitation, financial management, analyses and evaluation, operations management support, administrative support, acquisitions support and related activities necessary to the conduct of NIAID DCR business.

4.0 SERVICE AREAS

Independently, and not as an agent of the Government, the Contractor must provide sufficient technical, supervisory, and administrative personnel to ensure performance of the services defined in this SOW. In performing the tasks described herein, the contractor will not make final decisions with respect to determining agency policy, budget guidance or strategy, or determining what supplies or services are to be acquired by the Government. Specifically, the contractor must provide support in the following service areas:

4.1 Strategy Management and Program Planning Support

4.2 Administrative and Financial Management

4.3 Acquisitions Support

4.4 Organizational Effectiveness

4.1 Strategy Management and Program Planning Support

Required services in this area include:

• Provide expertise and guidance in strategic management, operations management, and program planning.

• Plan and facilitate meetings and/or strategy sessions to assist in the development and implementation of DCR’s strategic plans to include provision of expertise and facilitation with domestic and international partners.

• Assist with developing and maintaining strategic planning and implementation, as well as evaluation activities.

• Suggest, develop, and assign key performance metrics for the DCR branches and offices, as well as Special Projects for strategic planning purposes. Area(s) to include: analysis of goals and objectives, as well as the business processes that support them; assessment of program performance and analysis of key performance indicators; development of implementation plans, including resource plans, to support execution of strategic plans; assistance in execution and implementation of new programs and initiatives; and preparing various management reports that provide analysis of performance against plan. Metrics are assigned to strategic plan goals and objectives.

• Make recommendations to DCR staff and others that will help NIAID DCR maximize operating efficiency and achieve its strategic goals.

• Track and provide guidance related to DCR’s performance against its strategic goals, any ascertained organizational development issues, and researching solutions for domestic and international DCR settings.

• Develop materials and train DCR staff and others related to DCR in strategy management and operational support, including those in both clinical and non-clinical research settings.

• Liaise with other NIH/NIAID offices regarding strategic planning and training requirements.

• Actively participate in or guide working groups for new strategic management initiatives.

• Support multi-year business planning depicting contribution by partners.

• Assist in the development and implementation of new strategic planning initiatives and programs that further the strategy, with domestic and international partners.

• Assist in the review of federal policy, regulations, and standards and provide recommendations and feedback on their application to the division’s mission or work. Make recommendations to

DCR leadership concerning organizational strategic planning and prepare recommendations concerning adjustments to programs and special projects.

• Assess needs, develop information, and provide assistance to leadership and program areas to help define project objectives, strategic direction, and methodology.

• Facilitate and/or participate in operational planning sessions with NIAID leadership, NIAID representatives, and collaborating partner(s) to identify program objectives and action plans to be utilized in strategic plans. Review strategic plans and identify/recommend opportunities to enhance strategic goals and objectives.

Deliverables:

Description Recipient Delivery Schedule

Initial Draft Strategic Plans COR, DCR Project Lead, and stakeholders identified by DCR

Within 30 days of completion by Contractor of facilitated strategic planning sessions

Final Draft Strategic Plans COR, DCR Project Lead, and stakeholders identified by DCR

Within 30 days of DCR response to Initial Draft Strategic Plans

Initial Draft Operational Plan COR, DCR Project Lead, and stakeholders identified by DCR

Within 30 days of completion by Contractor of facilitated operational planning sessions

Final Draft Operational Plan COR, DCR Project Lead, and stakeholders identified by DCR

Within 30 days of DCR response to Initial Draft Operational Plan

4.2 Administrative and Financial Management Support

• Provide professional expertise in assessment of ongoing administrative practices, processes, and systems within NIAID DCR.

• Provide recommendations and options for improvement as needed.

• Provide comprehensive financial management support services for DCR branches, offices, and

Special Projects (see Attachment 2 for details on each project).

• Perform complex evaluations of existing procedures, processes, techniques, models, and/or systems related to management problems or contractual issues which would require a report and recommend solutions.

• Develop and provide recommendations, prepare charts, tables, graphs, and diagrams to assist in analyzing problems.

• Assist with developing, maintaining, and providing accurate comprehensive financial tracking, budget formulation, execution, and overall financial support, including ensuring budgets are available in Excel format on DCR designated shared drive.

• Support the development of fiscal year program budget assumptions and quarterly Management Discussion and Analysis Reports (MD&A).

• Provide support with a variety of management activities, program initiatives, special projects, and data calls.

• Actively support DCR fiscal year end close-out activities, including submitting draft end of year funding submissions using the NIAID Budget and Financial Management Branch (BFMB) format (provided annually at the time of close out).

• Monitor, track, and report DCR spending by Intramural, Extramural, and Research Management Support categories and program identifiers such as non-AIDS, AIDS, Biodefense, and Immunologic/Infectious Diseases, as well as by any emergency supplemental funding.

• Proactively monitor DCR spending in real time to ensure adherence to allocated funding and DCR mission strategy.

• Serve as Subject Matter Experts (SME) and actively participate in or guide financial and administrative working groups for new initiatives.

Draft Consolidated DCR FY Funding Budget

COR and DCR Director / Deputy Directors

Prior to commencement of fiscal year – September 15 or as defined by DCR COR

Verbally present the consolidated budget, including providing paper copies and other presentation materials

DCR Director and Deputy Directors

Prior to commencement of fiscal year – September 15 or as defined by DCR COR

Draft Branch/Office Funding and Operating Budget per DCR Branch/Office with assumptions

COR and DCR Branch Chiefs/Office Directors for their respective area of oversight

Prior to commencement of fiscal year – September 1 or as defined by DCR COR

Verbally present Branch/Office Budgets, including providing paper copies and other presentation materials

COR and DCR Branch Chiefs/Office Directors for their respective area of oversight

Prior to commencement of fiscal year – September 15 or as defined by DCR COR

Draft Funding Budget vs. Actual Reports for Consolidated DCR FY Budget

COR, DCR Deputy Director, and/or PPAB Branch Chief

June 30 and as frequently as requested by DCR Deputy or PPAB Branch Chief

Draft Funding and Operating Budget vs. Actual Reports for DCR Branches and Offices

COR and DCR Branch Chiefs/Office Directors for their respective area of oversight

In accordance with frequency as defined by DCR Branch Chief or Office Director

Written Summary with Recommendations

COR and DCR Branch Chiefs/Office Directors for their respective area of oversight

Within 10 days of facilitated organizational effectiveness initiatives completion

Draft End of Year Funding Submissions using NIAID BFMB format

DCR leadership Within one day of BFMB deadline for submission (varies annually)

4.3 Acquisitions Support

• Provide professional expertise and guidance in support of DCR acquisition requirements, including supporting market research needs.

• Review draft Statements of Work and provide advice, including language recommendations to ensure NAID DCR’s interests are aligned with program strategy and mission.

• Provide the Contracting Officer’s Representative (COR) feedback on planned acquisitions and draft documents to assist with the COR’s decision-making process.

• Develop tools to assist NIAID DCR with program and contract management activities, to include tracking spreadsheets, draft Standard Operating Procedures, job aids, as well as conduct training as requested by program staff on best practices for utilization of the tools created.

• Draft, review and provide recommendations to leadership and program staff on a variety of documents including but not limited to SOWs, Task Orders, SOPs, IAAs, and MOUs.

• Support the conduct of market research.

• Draft Independent Government Cost Estimates (IGCE) delivered electronically in MS Excel format.

• Draft Interagency Agreements (IAAs), Memorandum of Understandings (MOUs), and other similar agreement documents.

• Provide training to DCR staff on drafting SOWs, SOPs, IAAs, and MOUs, conduct of market research, development of IGCE’s and utilizing tools for contract management.

• Work with program support staff to develop and/or train to utilize tracking tools for contract management on various government financial systems.

• Actively participate in working groups for new initiatives.

Draft Statements of Work, delivered electronically in MS Word format

COR and DCR representative based on request

Within timeframe negotiated at time of request or as revised by

DCR

Draft IGCEs, delivered electronically in MS Word format

COR and DCR representative based on request

Within timeframe negotiated at time of request or as revised by

DCR

Draft IAAs, MOUs, and other similar agreement documents, delivered electronically in MS Word format

COR and DCR representative based on request

Within timeframe negotiated at time of request or as revised by

DCR

4.4 Organizational Effectiveness

• Assist in development of DCR’s strategy related to its mission and vision to facilitate high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious disease and support sharing information within DCR and to stakeholders external to the DCR.

Stakeholders can be internal and external to NIAID and both international and domestic.

• Assist in the identification of applicable resources (financial, human, supplies/equipment, training, etc.) needed for DCR to achieve its strategy (inputs).

• Facilitate focus groups and/or interviews to determine root causes of needed organizational effectiveness efforts.

• Track ability for DCR to advance toward outcomes using available resources (performance capacity) typically done as part of the operations and/or strategic plans in the DCR branches/offices/special projects by preparing various management reports that provide analysis of performance against the plan.

• Determine and measure DCR activities towards outcomes (performance actions).

• Track results of DCR organizational performance through use of metrics and outcomes (outputs).

• Suggest and track changes as a result of performance (outcomes).

• Gather and collate for review feedback from staff, partners, key other stakeholders about how well

DCR is achieving its desired outputs and outcomes (feedback from the environment).

• Assist the DCR in using feedback to drive continuous improvement of strategy, which in turn drives continuous improvement, performance capacity, and performance actions, to drive continuous improvement of outputs and outcomes.

• Identify and facilitate requisite DCR organizational effectiveness activities which may include strategic planning, leaning and professional development activities, needs for organizational development activities, operational planning, partnership development, performance plan alignment to strategic plans to assist with facilitation of high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious disease and support sharing information within DCR and to stakeholders external to the DCR.

• Diagnose and determine root causes for organizational dysfunction or ineffectiveness and develop recommended solutions with proposed implementation strategies.

• Provide options and suggestions to DCR leadership on response methods when an organizational effectiveness initiative is identified.

• Provide support for various organizational effectiveness activities.

• Perform evaluation of activities either as a formal tracking in an operational plan or as a verbal/written quality assessment.

Written suggestions for organizational effectiveness

COR and DCR representative based on request

Within timeframe negotiated at time of request or as revised by

DCR

Written summary and recommendations from facilitated organizational effectiveness initiatives

COR and DCR representative based on request

Within timeframe negotiated at time of request or as revised by

DCR

5.0 CONTRACT MANAGEMENT

5.1 Contract Management

The Contractor must establish processes and assign appropriate resources to effectively administer the contract. Duties include, but are not limited to, responding to Government requests for contractual actions in a timely fashion, maintaining proper/accurate timekeeping records of personnel assigned to work on the contract and submitting monthly reports. The monthly reports are to include identification of projects completed, progress of ongoing activities, timekeeping records, any problems identified and plans for resolution of those problems. Monthly written reports must be delivered electronically to the COR.

Monthly Progress Report, delivered electronically COR

During the first week of every month or as directed by the

COR

5.2 Quality Control

The Contractor must provide quality services and management oversight of all processes. The Contractor must provide accurate data/reports and meet contract objectives. The Contractor must successfully integrate and coordinate all activity needed to execute the task order, including the timeliness, completeness and quality of problem identification, corrective actions plans, proposal submittals, timely identification of issues in controversy, effective/responsive management of employees and subcontractors, customer satisfaction, and professional and ethical behavior of the Contractor management personnel.

5.3 Managing Conflicts of Interest

All work related to acquisition support services will be in accordance with the requirements of FAR 37.203, FAR 3.11, FAR 9.505-2, and FAR clause 52.203-16 Preventing Personal Conflicts of Interest (Jun 2020).

The services under 4.3 Acquisitions Support fall under the FAR 3.1101 definition of an acquisition function closely associated with inherently governmental functions since they support and provide advice on acquisition planning and developing statements of work.

As such, the Contractor is required to have a system in place to screen for and prevent personal conflicts of interest for individuals involved in providing acquisition services in accordance with FAR clause 52.203-16 Preventing Personal Conflicts of Interest (Jun 2020).

Further, in accordance with FAR 9.505-2(b), the Contractor may not supply the services for any acquisitions where they provided assistance with preparing work statements or other acquisition support documents.

5.4 Contractor Performance

The Contractor must periodically meet with the CO, COR, and other Government personnel, as appropriate, to review the Contractor's performance. At these meetings, the CO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor must apprise the Government of problems, if any, being experienced. Appropriate action will be taken to resolve outstanding issues.

During the life of this contract, Contractor performance will be evaluated pursuant to FAR Subpart 42.15 using the Contractor Performance Assessment Report System (CPARS). CPARS is an on-line reporting system and can be found at the following location: http://www.cpars.csd.disa.mil/cparsmain.htm. The http://www.cpars.csd.disa.mil/cparsmain.htm evaluation is completed by the Contracting Officer and/or Contracting Officer's Representative electronically. It is the responsibility of the Contractor to respond to the CPARS report at the end of each performance period as an interim report and at the end of the contract performance as a final report. After review by the Contracting Officer, the report becomes a permanent record of the Contractor’s past performance.

6.0 SUCCESSION ACTIVITIES

6.1 Transition-In Plan

The Contractor must ensure an orderly, secure, and efficient transition of contract-related materials and activities from the successor contractor or from the Government. A description of transition activities, timelines, and assigned staff will be provided in a Draft Transition Plan, which will be reviewed and approved by the Contracting Officer’s Representative. The Draft Transition Plan must be submitted within 5 business days of contract award. If new staff (not currently already working at NIH) is part of the team, approximately 10 – 12 weeks is required for federal security clearances and badging to allow staff to come on-site and work. This timeframe should be considered within the Draft Transition Plan.

6.2 Transition-Out Plan

The Contractor must provide a Succession Plan 90 days prior to the expiration date of the contract which demonstrates the capability to ensure a smooth succession to a new Contractor, as needed. The Contractor will ensure minimal service disruptions and degradations to service quality. To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor must have personnel on board during the succession period.

Deliverables

Draft Transition Plan COR 5 days of award

Succession Plan COR 90 days before expiration

7.0 CONTRACTOR EMPLOYEES

7.1 Personnel

The Contractor must provide personnel with the necessary skills and level of expertise required to support the service areas to be performed under the SOW.

7.2 Identification of Contractor Employees

All contract personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

They must also ensure that all documents or reports produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed. Contractor personnel working on the NIH campus or in a Government facility will be required to obtain an ID badge granting access to campus from the Security Office.

7.3 Confidentiality

Contractor staff will be required to handle proprietary information in the strictest confidence and will be bound by the same terms as the Government in this respect.

7.4 Recruitment and Retention

The Contractor must employ hiring, management, and retention practices that ensure the Contractor is able to identify, screen, place, monitor, evaluate, train, and retain qualified candidates to fulfill service requirements under this contract.

7.5 Training

The Contractor must provide an appropriate orientation outlining guidelines for working at NIH and NIH’s policies for on-site Contractors, and any applicable company policies. The Contractor, at its own expense, will perform training, except that the Government may provide training on NIH-specific systems related to the work to be performed by the Contractor. The Contractor must ensure that each Contractor/subcontractor employee completes all NIH required training courses.

8.0 KEY PERSONNEL

Key personnel are considered to be essential to work performance and at least thirty (30) days prior to the Contractor voluntarily diverting any of the individuals identified as Key Personnel to other contracts the Contractor must notify the CO and must submit a justification and request to replace the individual in accordance with HHSAR clause 352.237-75 Key Personnel. The request must identify the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed the contract requirements.

If the Contractor employee is terminated for cause or separates from the Contractor voluntarily with less than thirty days’ notice, the Contractor must provide the maximum notice practicable under the circumstances. The Contractor must not divert, replace, or announce any such change to key personnel without the written consent of the CO. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

9.0 PERIOD OF PERFORMANCE

The anticipated period of performance will be for one (1) twelve (12) month base year with two (2) option years. The option years may be exercised at the discretion of the Government.

10.0 PLACE OF PERFORMANCE

The Contractor’s principal place of work will be Rockville, Maryland, and in Contractor-leased spaces in the Washington, DC, metropolitan area. The Contractor will be allowed to fulfill services sought with support personnel working remotely (Contractor facility or telework) after receiving approval from the

COR.

11.0 GOVERNMENT FURNISHED EQUIPMENT AND FACILITIES

11.1 Facilities, Supplies and Services

Basic facilities such as workspace and its associated operating requirements (i.e., phones, desks, utilities, information technology, consumable and general-purpose office supplies) will be provided while working in Government facilities.

11.2 Information

The Government will provide information, material and forms unique to the Government for supporting the work. All Government unique information related to this requirement, which is necessary for Contractor performance, will be made available to the Contractor. The COR will be the point of contact for identification of any required information to be supplied by the Government.

11.3 Documentation

All existing documentation, relevant to the required work, will be made available to the Contractor. The Contractor will be required to prepare documentation in accordance with defined guidelines provided by the Government.

12.0 INHERENTLY GOVERNMENTAL SERVICES

This Statement of Work does not include any services that are expressly listed as inherently Governmental. In carrying out this contract, Contractor staff must not make decisions on behalf of the Government and must not exercise any federal approval authority. They must not determine agency policy, the content or application of regulations, budget strategy or guidance, or which products or services the agency will purchase. They must not draft any Congressional testimony, responses to Congressional correspondence, or agency responses to audit reports. All services that involve or relate to budget preparation, policy development, acquisition support, and interpretation of regulations must be performed on an advisory basis, with any substantial discretionary authority being exercised solely by government personnel.

13.0 GENERAL REQUIREMENTS

13.1 Communications

Contractor staff may be required to present findings at meetings, both inside and outside of the Government. All information to be presented must be cleared by the COR.

13.2 Insurance Requirements

The Contractor must meet requisite insurance requirements as is customary for the services being performed (e.g. automobile, Standard Workman’s Compensation, Employer’s Liability Insurance).

13.3 Hours of Operation

The Contractor is responsible for conducting business from 8:30 a.m. to 5:00 p.m. ET, Monday through Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government-directed facility closings. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within the Statement of Work when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor will keep in mind that the stability and continuity of the workforce are essential.

13.4 Recognized Holidays

Contractor, subcontractor, and consultant work schedules must allow for the ten Federal Holidays listed below. In the instance of an unscheduled facility closing due to snow or other inclement weather, Presidential Order or another contingency as determined by the Department, NIH or the Office of Personnel Management, the Government will not grant Contractor personnel paid time off for that day.

The Contractor will be responsible for ensuring clear communications and providing contract staff with procedures regarding unscheduled facility closings or possible Government shutdowns.

It will be the Contractor’s responsibility to determine how its employees, subcontractors, and consultants are compensated for any workday lost to a contingency event. Observance of holidays by Government personnel will not be cause for additional period of performance or entitlement to compensation. If the contractor' s personnel work on a holiday, no form of holiday or other premium compensation will be reimbursed. The costs of salaries or wages of contractor personnel for any periods during which such personnel are dismissed from, or do not have access to, NIAID facilities will not be reimbursed.

• New Year’s Day (January 1)

• Martin Luther King, Jr.’s Birthday (Third Monday in January)

• President’s Day (Third Monday in February)

• Memorial Day (Last Monday in May)

• Independence Day (July 4)

• Labor Day (First Monday in May)

• Columbus Day (Second Monday in October)

• Veterans Day (November 11)

• Thanksgiving Day (Fourth Thursday in November)

• Christmas Day (December 25)

If the holiday falls on a Saturday, the preceding Friday is the holiday. If the holiday falls on a Sunday, the following Monday is the holiday. When Inauguration Day falls within the regularly scheduled tour of duty of an employee in the Metropolitan Washington, DC area, it is observed as a holiday.

13.5 Travel Requirements

The Contractor may be required to travel to domestic or international locations. Possible travel could involve visiting overseas NIAID project sites to assist with strategic and operational planning with the special projects identified in Attachment 2. Ability to speak foreign language(s) is not a requirement, but would be beneficial to the Federal Government. Anticipated travel would be approximately 2 weeks per year.

Costs incurred by contractor personnel on official government business travel are allowable and reimbursable, subject to Contracting Officer's Authorization prior to incurring any travel costs and the limitations of government CONUS and OCONUS rates prescribed by US Government Services Administration, (GSA).

13.6 Safety Requirements

The Contractor is solely responsible for compliance with all federal, state and local laws, the Occupational, Safety and Health Act (OSHA) (Public Law 91-596) and the resulting standards, OSHA Standards 29 CFR 1910 and 1926, as applicable, and the protection of their employees.

13.7 Priority Rights

Unless a different arrangement is established for work under this SOW, all tangible and intangible/ intellectual property purchased or created under this contract (excepting Contractor-internal business records) will become the sole property of the NIAID (including but not limited to work products, reports and other writings, inventions, copyrightable representations, source or object code, scripts, applications, customizations, materials, tools, machines, and/or configurations of devices/systems/services), and the Contractor/subcontractor/consultant (or any Contractor employee or individual consultant or subcontractor at any tier working for the prime Contractor company) will retain no usage rights to any of it following the completion of the contract.

13.8 Definitions

CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

CONTRACTING OFFICER (CO). A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

CONTRACTING OFFICER’S REPRESENTATIVE (COR). A person appointed by the Contracting Officer to administer the contract. Such appointment must be in writing and must state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

DELIVERABLE. Anything that can be physically delivered but may include non- manufactured things such as meeting minutes or reports.

KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the SOW. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

SUBCONTRACTOR. One that enters into a contract with a prime Contractor. The Government does not have privity of contract with the Subcontractor.

WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

WORK WEEK. Monday through Friday, unless specified otherwise.

ATTACHMENT 1: ANTICIPATED LABOR CATEGORIES

Labor Category Description Position Requirements

Executive Level Senior Operations Officer/Subject Matter Expert III

1 Position, Key Personnel

Experience in strategy management, business and acquisitions operations, organizational effectiveness, and financial planning/management/evaluation.

Minimum of a bachelor’s degree or equivalent

Minimum of ten (10) years’ experience. Past experience must include federal experience and work in biomedical, scientific, and/or healthcare environments.

Senior Business Analyst V/Senior Functional Analyst

2 Positions

Experience in business/financial consulting, project management, data analysis and business process analysis. Provides strategic business analysis services to business partners. Responsible for reviewing assigned business processes from end-to-end to identify and address operational, financial, and technological risks. Identify opportunities to improve efficiency.

Minimum of five (5) years’ experience.

Business Analyst/ Functional Analyst

1 Position

Develops and prepares functional, technical and/or financial documentation, analyzes and interprets functional performance data and prepares reports of status and findings as directed by a functional lead. Performs program monitoring and analysis of items not limited to cost, schedule performance status issues.

Minimum of three (3) years’ experience.

ATTACHMENT 2: NIAID DCR SPECIAL PROJECTS

The contractor is expected to provide services and support to Special Project efforts, and include the following:

Infectious Disease Clinical Research Program (IDCRP)

The IDCRP works to substantially reduce the impact of infectious diseases in the military population through a unique, adaptive, collaborative clinical research network. The IDCRP conducts infectious disease clinical research that is important to the military for informing health policy and clinical practice and disseminates findings throughout the scientific community. The work of the program has a direct impact on force readiness.

Main Areas of Focus

• To conduct infectious disease clinical research, important to the military, through a unique, adaptive, and collaborative network, informing health policy and clinical practice, and disseminating findings throughout the scientific community

• To substantially reduce the impact of infectious diseases in the military population through collaborative clinical research

Indonesia Research Partnership on Infectious Diseases (INA-RESPOND) The INA-RESPOND is a collaboration between NIAID, the National Institute of Health Research and Development, Ministry of Health of the Republic of Indonesia, and ten major university and clinical centers in Indonesia.

• To improve the health of the people of Indonesia and benefit the international community by conducting high-quality infectious disease research through a collaborative, sustainable, and well-recognized research network

University Clinical Research Center Mali (UCRC)

UCRC is an initiative between the Malian Ministry of Health, the Ministry of Higher Education, University of Science, Technology and Technology of Bamako (USTTB) and NIAID. The purpose of the collaboration is to enhance the infrastructure and resources needed to facilitate clinical research in Mali. NIAID has had a longstanding partnership with the USTTB. In 2013 the Minister of Health in Mali, recognizing this and the role of the partnership in establishing the country’s first biosafety level 3 laboratory, approached NIAID to request continued support for clinical research. This research center provides core research capabilities and staff to in scientific research, operations, data management, pharmacy, and diagnostics (with an immunocore, molecular, hematology, and BSL-3 laboratory).

• To facilitate the development of a coordinated clinical research program in Mali

• To enhance the existing clinical research programs and facilitate their growth and sustainability

• To stimulate clinical research in West Africa that is guided by international standards and principles

• To develop an excellent research environment that will attract researchers worldwide and foster collaborations

Mexican Emerging Infectious Disease Clinical Research Network (La Red)

In response to the outbreak of the H1N1 pandemic in 2009, the Ministry of Health of Mexico identified the need to create a clinical research network with the mission to lead and promote discoveries and advances in the field of emerging infectious disease. The resulting network, the Mexican Emerging Infectious Disease Clinical Research Network (La Red), was established in September 2009. Ten institutions have joined in this partnership, working collaboratively to share resources that enhance the conduct of research ranging from natural history studies to highly regulated multi-site clinical trials. The LaRed Network has conducted over 9 multi-center studies and enrolled over 7,800 subjects. Several sites are currently conducting studies in Influenza, Serious Acute Respiratory Infections (SARI), and the ZIKA virus.

Main Area of Focus

• The mission of the network is to lead and promote discoveries and advances in the field of emerging infectious disease.

Partnership of Clinical Research in Guinea (PREGUI)

PREGUI was established between the Government of Guinea and the United States. The Government of Guinea is represented through the Ministry of Health (MOH). The United States government is represented through the Department of Health and Human Services (DHHS), specifically through the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR).

• The mission of the partnership is to conduct and implement a program of national and international, high quality research on public health priorities in Guinea and build and develop sustainable research capacity.

Partnership for Research on Ebola Virus in Liberia (PREVAIL)

The PREVAIL partnership was established between the governments of Liberia and the United States.

The Government of Liberia is represented through the Ministry of Health (MOH) and three autonomous agencies: The National Public Health Institute of Liberia (NPHIL), the University of Liberia (UL), and the John F. Kennedy Medical Center. The United States government is represented through the US Ambassador to Liberia and the US Department of Health and Human Services (DHHS), specifically the National Institutes of Health

(NIH) and the Centers for Disease Control (CDC). In addition, the World Health Organization has been included as a member of the partnership following an invitation from the Governments of Liberia and the United States. PREVAIL Sites: John F Kennedy Hospital, CH Rennie Hospital, Duport Road Clinic, and Redemption Hospital.

PREVAIL Studies: PREVAIL I: Partnership for Research on Ebola Vaccine in Liberia PREVAIL II: A Multicenter Randomized Safety and Efficacy Study of Putative Investigational Therapeutics in the Treatment of Patients with Known Ebola Infection.

PREVAIL III: Ebola Natural History Study.