SS Attachment 1 - Draft SOW.docx

ATTACHMENT 1: DRAFT STATEMENT OF WORK

NIAID DCR PROFESSIONAL STRATEGIC AND PROGRAM PLANNING SERVICES (PSPPS)

34/62/2024

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. Comment by McDermott, Tamara (NIH/NIAID) [E]: Sentence duplicated above in 1.0. Suggest revising or deleting. Comment by Yi, Susan (NIH/NIAID) [E]: Deleted duplicate sentence in 2.0 - Background.

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 established through government-to- government agreements and shared governance frameworks. Support to the SPs is 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 to answer scientific questions (see Attachment Appendix 1 for information on each project). Comment by Yi, Susan (NIH/NIAID) [E]: 1/18/24: Do we have attachment with details on Special Projects to include with SOW? Comment by Smolskis, Mary (NIH/NIAID) [E]: We have provided so seems resolved. Comment by McDermott, Tamara (NIH/NIAID) [E]: Seth - where is this attachment and how do you plan to present it? Comment by Yi, Susan (NIH/NIAID) [E]: Attachment will be added to the end of the SOW as an Appendix.

Objectives Comment by McDermott, Tamara (NIH/NIAID) [E]: Recommend including an Objective section which explains to the contractor why these services are needed and what they are meant to achieve. How these services will support NIAID/DCR mission. The intro briefly alludes to why (changing/expanding policies & programs) but more details would help the contractor understand what goals/objectives you expect these services to meet. Comment by Yi, Susan (NIH/NIAID) [E]: We will get more clarification on the objectives. Comment by Yi, Susan (NIH/NIAID) [E]: 3/26/24: List of objectives have been inserted into SOW. Comment by McDermott, Tamara (NIH/NIAID) [E]: Objectives are written to describe "how" you plan to achieve to purpose/goals for this project. Instead of pointing requirements a contractor must meet, suggest briefly explaining the goals and how (contractor services) will be used to meet those goals. For example 1st bullet, "DCR requires services to prepare and manage budgets for SPs to help ensure smooth operation with no lapses in research activities." If you want to include some of the requirements that a contractor must meet/do, suggest adding another section after 3.0 scope such as "Overarching Requirements" that apply to all the task areas.

· TBD

3.0 SCOPE Comment by McDermott, Tamara (NIH/NIAID) [E]: Is there anything not in scope that should be specifically called out for clarity? If so, please add. Comment by Yi, Susan (NIH/NIAID) [E]: This section is fine as-is. We have gotten feedback regarding the different DCR service areas.

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, financial management guidance and administration support, operations management support, acquisitions support, and related activities necessary to the conduct of NIAID DCR business.

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 Financial Management Guidance and Administration Support Comment by Smolskis, Mary (NIH/NIAID) [E]: Removing the term “administrative” allows this to be both conduct of financial management and admin duties as needed. Plus, administrative practices is covered in the first bullet below. Comment by Yi, Susan (NIH/NIAID) [E]: Service area changed to "Financial Management Guidance and Administration Support".

4.2 Strategy Management Program Planning, and Evaluation Support

4.3 Acquisitions Support

4.1 Financial Management Guidance and Administration Support Comment by Yi, Susan (NIH/NIAID) [E]: Add appropriate service area title for financial management in all sections. Comment by Smolskis, Mary (NIH/NIAID) [E]: I think this is done.

Services in this area include the following required tasks as well as tasks as directed by DCR Leadership and/or Contracting Officer’s Representative (COR) when appropriate:

· Provide professional expertise in assessment of ongoing financial 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 Appendix 1 for information on each project). Comment by Yi, Susan (NIH/NIAID) [E]: 1/18/24: Do we have attachment with details on Special Projects to include with SOW? Comment by Smolskis, Mary (NIH/NIAID) [E]: Provided so this is resolved.

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

· Develop and provide recommendations, prepare charts, tables, graphs, and diagrams to assist in analyzing financial concerns/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).

· Support multi-year business planning depicting contribution by DCR partners.

· Provide support with a variety of administrative management activities, program initiatives, and assist with preparing responses and data calls reports as required or requested.

· 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 relevant DCR teams, including SP teams and Working Groups with implementation of new initiatives.

Deliverables:

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

Written Summary with Recommendations

Draft End of Year Funding Submissions using NIAID BFMB format

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

4.2 Strategy Management, Program Planning, and Evaluation Support

· Assist with developing and maintaining strategic plans and related implementation plans, and support evaluation activities.

· Provide expertise and guidance in strategic management, operations management, and program planning to enhance organizational effectiveness.

· 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.

· Suggest, develop, and support tracking of key performance metrics for the DCR branches, offices, and SPs as part of strategy management, including analysis of goals and objectives, and associated business processes; 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 plans.

· Conduct environmental scans and SWOT analysis by gathering, collating, and sharing information collected from DCR staff, partners, and stakeholders as appropriate and supporting development of goals, objectives, and measurable outcomes.

· Gather and collate for review feedback from staff, partners, key stakeholders about how well DCR and or DCR SPs are achieving desired strategic outputs and outcomes.

· Facilitate and/or participate in operational planning sessions with NIAID leadership, NIAID representatives, and collaborating partners 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.

· Assess and make recommendations to DCR staff and others that will help NIAID DCR maximize operational efficiency and achieve its strategic goals.

· Track and provide support to help optimize DCR’s performance against its strategic goals, identify issues or obstacles impeding progress and provide recommended solutions.

· Develop materials; support DCR staff, DCR partners, and SPs; and guide working groups in strategy management, development of action plans and operational planning initiatives, including those in both clinical and non-clinical research settings.

· Liaise with other NIH/NIAID offices regarding strategic planning and organizational development and/or evaluation activities as requested by Leadership and/or COR.

· Support organization development initiatives, including identification of priorities for change and implementation of change efforts.

· 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.

Deliverables:

Initial Draft Strategic Plans

Final Draft Strategic Plans

Initial Draft Operational Plan

Final Draft Operational Plan

4.3 Acquisitions Support

Services in this area include the following required tasks as well as tasks as directed by DCR Leadership and/or COR when appropriate:

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

· Review draft Statements of Work (SOW) 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 (SOPs), job aids, and 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, Interagency Agreements (IAAs), Letters of Intent (LOIs), and Memorandums of Understanding (MOUs).

· Support the conduct of market research.

· Draft Independent Government Cost Estimates (IGCEs) for SP teams delivered electronically in MS Excel format.

· Provide training to DCR staff on drafting SOWs, SOPs, IAAs, LOIs, and MOUs, conduct of market research, development of IGCEs and utilizing tools for contract management.

· Work with program support staff to develop and/or train to utilize tracking tools for contracts management on various acquisitions financial systems.

Deliverables:

5.0 CONTRACT MANAGEMENT Comment by McDermott, Tamara (NIH/NIAID) [E]: Would you like the contractor to provide an Orientation Briefing (kick off) shortly after award to initiate communications and introduce key personnel, communication ground rules, and assuring common understanding of task areas and requirements? If so, please include or we can provide some example language. Comment by Yi, Susan (NIH/NIAID) [E]: Yes, we would like a kick-off meeting and orientation briefing. Can you provide sample language to include this in the SOW? Comment by McDermott, Tamara (NIH/NIAID) [E]: Two versions of sample language added under 5.1 Contract Management. Provide an overview of the topics to be covered as well as any preliminary reports/plans, if any, that should be ready for review. Typically held onsite but have seen some virtual.

5.1 Contract Management Comment by McDermott, Tamara (NIH/NIAID) [E]: Do you want the contractor to provide and maintain a Management Plan? If so, please add details and deliverable. We can provide example language if requested. Comment by Yi, Susan (NIH/NIAID) [E]: Yes, Management Plan would be good to include in the SOW. This should include staff utilized, their expertise and level of experience, number of years performing the duties, plans for hiring replacements for when staff leave and if any staff will be spread across multiple projects, what is the percentage of time allocated to those projects. Would conflict resolution of staff fall under Management Plan? Please suggest sample language. Comment by McDermott, Tamara (NIH/NIAID) [E]: Sample language with deliverable provided in Section 5.1 under kickoff meeting. Yes, how the contractor plans to manage conflict resolution is appropriate for the Management Plan.

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.

· Kickoff meeting /

· Orientation Briefing: TBD

· Management Plan: TBD

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 activities needed to execute the task order, including the timeliness, completeness and quality of problem identification, corrective actions plan, 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: https://www.cpars.govHYPERLINK "http://www.cpars.csd.disa.mil/cparsmain.htm" \hhttp://www.cpars.csd.disa.mil/cparsmain.htm. The 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 by ensuring that all SOPs, documents, templates including job aids on navigation of the financial systems developed by the transitioning contractor are transitioned to the successor. Additionally, 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

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 period year with two (2) twelve (12) month option yearsperiods. The option years periods 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 Comment by Smolskis, Mary (NIH/NIAID) [E]: We may need to expand on this a bit in terms of communication expectations to internal and external stakeholders and other contractors. Comment by Sardana, Ratna (NIH/NIAID) [E]: I included some language, not sure what direction you were going with this:-) Comment by Yi, Susan (NIH/NIAID) [E]: Changes accepted. Comment by Smolskis, Mary (NIH/NIAID) [E]: Resolved.

The Contractor will summarize and communicate any known, identified, or projected (resource or funding) issues or discrepancies that may impact timelines, result in exceeding the allocated project funds with Program Leads and Leadership so that issues can be managed and resolved appropriately and promptly.

Contractor shall involve the Program Lead and/or COR when engaging in discussions/communications with other NIAID contracting entities or collaborators. Contractor will notify the Program Lead and/or COR if any collaborative discussion is anticipated or is adversely affecting the Contractor’s scope of work with NIAID. Problems or concerns, anticipated or encountered, shall be immediately communicated to the COR, Contract Specialist (CS), and Contracting Officer (CO), and an approved resolution pursued.

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 and approved 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 eleventen (101) 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)

· Washington’s Birthday (aka President’s Day) (Third Monday in February)

· Memorial Day (Last Monday in May)

· Juneteenth National Independence Day (June 19)

· 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 Comment by McDermott, Tamara (NIH/NIAID) [E]: Besides travel, will the contractor be providing any supplies (ODCs)? Comment by Yi, Susan (NIH/NIAID) [E]: They typically do not provide supplies for their staff. Government provides equipment and other accountable property needed to perform their duties.

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 Appendix 12. 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. Comment by McDermott, Tamara (NIH/NIAID) [E]: Seth - attachment 2? I assume it’s the same attachment as mentioned near the beginning of the SOW Comment by Yi, Susan (NIH/NIAID) [E]: Yes, it is the same attachment. See attached document. Comment by Yi, Susan (NIH/NIAID) [E]: Where is Attachment 2 with detailed list of SPs?

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). Travel shall be in accordance with the Federal Travel Regulations (FTR). Contractor travel within the local commuting area will not be reimbursed.

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.

Appendix 1: Summary of DCR Special Projects

DCR deploys resources to facilitate the conduct of time sensitive, high priority, global, collaborative clinical research critical to the mission of the NIAID and advancement of NIH and U.S. Department of Health and Human Services (HHS) global health agendas. These response activities are known as “Special Projects” within the DCR and typically emanate under government-to-government engagements. DCR has developed and continues to maintain critical clinical research infrastructure in its Special Projects. From a strategic perspective, these research infrastructures are imperative to maintain given the current environment of global pandemic threats and many of them native to Africa (i.e., Ebola, Lassa Fever, Yellow Fever, SARS COV-2, MPOX, and Marburg).

DCR has developed collaborative research partnerships with international investigators to study diseases in affected geographical regions. DCR supports a large portfolio of research activities including dedicated research programs in Mali, Guinea, Liberia, Democratic Republic of the Congo (DRC), Indonesia and Mexico. A brief summary highlighting each of these Special Projects is provided below.

1. University Clinical Research Center (UCRC), Mali

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 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).

Main Areas of Focus

· 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

2. 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

3. Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL) The Liberian-U.S. Partnership for Research on Vaccines and Infectious Diseases in Liberia, formerly the Partnership for Research on Ebola Virus in Liberia, was formed in 2014 at the height of the West African Ebola outbreak to accelerate the development of Ebola vaccines and therapeutics. Since then, PREVAIL has developed core clinical research capacities and infrastructure including trained staff at four sites (JFK Medical Center, Redemption Hospital, CH Rennie Hospital, and Duport Road Health Center) as well as a research lab at the Liberia Institute for Biomedical Research (LIBR).

Following the 2014 Ebola epidemic, the Liberian Ministry of Health aimed to create a sustainable research infrastructure in order to avoid another health disaster. PREVAIL’s focus shifted from emergency response to a long-term research network, and its scope was expanded to include other diseases of public health importance in Liberia. To date, PREVAIL has initiated 15 clinical trials including several (PREVAC, InVITE) that are part of larger multi-country studies.

Maintenance of this research capacity is an important aspect of Liberian and West African security given the current environment of global pandemic threats, many of them native to West Africa (e.g., Ebola virus, Lassa Fever, Yellow Fever, Marburg virus).

Main Areas of Focus As PREVAIL transitions from emergency response to a sustainable, long-term research network, the strategy will be to:

· Support a limited number of existing clinical research resources necessary to sustain and ensure readiness across the existing clinical sites

· Accommodate research participant visits and follow-up care for ongoing and future clinical studies

· Support clinical laboratories and biospecimen storage areas, specialized eye and neurology clinics, pharmacy operations, administrative and research operations offices, and the research lab and biorepository at LIBR

4. 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.

Main Areas of Focus

· 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

5. Mexican Emerging Infectious Disease Clinical Research Network (LaRed):

In response to the influenza pandemic of the H1N1 virus 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 influenza and other emerging infectious disease. The resulting network, the Mexican Emerging Infectious Disease Clinical Research Network (LaRed), was established between the Mexico Ministry of Health and the National Institute of Allergy and Infectious Diseases, USA in September 2009. Greater than ten institutions are involved in LaRed, strategically located in Mexico City, San Luis Potosi (not sure if what to include SLP), Oaxaca, Tapachula and Ixtapaluca working collaboratively to share resources that enhance the conduct of research ranging from observational studies to highly regulated multi-site domestic and international clinical trials.

The LaRed Network has conducted over a dozen multi-center studies, including the pivotal ACTT 1 Remdesivir study for the treatment of COVID-19 and ACTT 2-4, the InVITE study an international multi-country study comparing COVID-19 vaccine regimens and studies in influenza and Zika.

Main Area of Focus The mission of LaRed is to be a collaborative network of academic health institutions that leads and promotes relevant, timely, efficient, ethical and high-quality clinical research on the nature and behavior of emerging infectious diseases, influenza and other viruses in order to improve health.

6. Partnership of Clinical Research in Guinea (PREGUI) The Partnership of Clinical Research in Guinea (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).

Main Areas of Focus 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.

7. Pamoja Tulinde Maisha (PALM) [“Together Save Lives” in the Kiswahili language], DRC PALM was first conceived following the 2018 Ebola virus epidemic in the North Kivu and Ituri provinces of the Democratic Republic of Congo, when the World Health Organization initiated a series of discussions and working groups to determine how experimental therapeutics should be assessed in the context of the next Ebola virus disease outbreak. The first study, PALM 001, aimed to evaluate the most promising experimental therapeutics for treating EVD in a randomized, controlled trial. The study concluded that both Mab114 and REGN-EB3 were superior to ZMapp and remdesivir for reducing mortality from Ebola virus disease and showed that scientifically and ethically sound research could be conducted during disease outbreaks.

Today, PALM has grown to include eight clinical trials across four sites in the Democratic Republic of Congo.

Main Areas of Focus PALM has also expanded its scope to include other infectious diseases of global concern, including COVID-19, monkeypox, and malaria, and has established several large biorepositories with hundreds of thousands of samples from recent Ebola virus disease outbreaks, COVID-19, and more. In conjunction with the Democratic Republic of Congo’s Institut National de la Recherche Biomédicale, PALM’s goal is to continue growing as a resource for researching infectious diseases and improving global health.