Attachment 3 - IDIQ Statement of Work.pdf

BASE IDIQ STATEMENT OF WORK

Operation and Management of the Mali Service Center (MSC)

1) BACKGROUND AND INTRODUCTION

A. National Institute of Allergy and Infectious Diseases (NIAID)

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has a mission to conduct and support basic and applied research to better understand, treat and ultimately prevent infectious, immunologic, and allergic diseases. NIAID research has led to new therapies, vaccines, diagnostics, and other technologies that have improved the health of millions of people in the United States and globally.

In addition to supporting a research portfolio on allergy, immunology, and infectious diseases, NIAID also has a mandate to launch a rapid research response to emerging public health threats. Recent examples include research responses to Ebola virus, Zika virus, and SARS-CoV-2 outbreaks. NIAID achieves these mandates through intramural and extramural research programs.

NIAID intramural research activities are conducted by the Division of Intramural Research (DIR), Division of Clinical Research (DCR), and Vaccine Research Center (VRC). NIAID intramural laboratories are led by federal scientists and are in Maryland and Montana.

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, mpox, and Marburg).

NIAID extramural research activities are supported by the Division of Microbiology and Infectious Diseases (DMID), Division of Allergy, Immunology, and Transplantation (DAIT), Division of AIDS (DAIDS), and Division of Extramural Activities (DEA). NIAID’s extramural research portfolio supports grants and contracts that are awarded to U.S. and international biomedical research institutions.

Both NIAID intramural scientists and extramural grantees have developed collaborative research partnerships with international investigators to study diseases in affected geographical regions. NIAID supports a large portfolio of research activities on the African continent, including dedicated research programs in Mali.

B. Mali Research Program

NIAID has more than 34 years of research collaboration with institutions in Mali.

NIAID-supported research has included intramural and extramural projects.

1. International Center for Excellence in Research (ICER)

NIAID’s research program in Mali was initiated in 1989 as a partnership between DIR investigators and Malian scientists at the National School of Medicine and Pharmacy in Bamako (now the University of Sciences Technologies and Techniques of Bamako [USTTB]) to conduct research on Anopheles mosquitoes, which is the vector responsible for the transmission of malaria. The research program expanded over time to include other aspects of malaria research, such as vaccine development, and other infectious diseases, including leishmania, filariasis, tuberculosis (TB), and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). In 2002, the Mali research program was subsumed into the Mali International Center for Excellence in Research (ICER). The Mali ICER consists of multiple laboratories, including a College of American Pathologists (CAP)-accredited clinical laboratory and a Biosafety Level 3 (BSL-3) laboratory at USTTB. In addition, there are several clinical field sites within a 100 km radius of Bamako. Mali ICER research projects have focused on malaria epidemiology and vaccine studies; malaria immunological studies;

ecological studies on malaria mosquito vectors; basic and clinical studies on leishmaniasis; clinical studies on filariasis; clinical studies on HIV/TB co-infections; and research on emerging infectious diseases.

2. University Clinical Research Center (UCRC)

In 2014, DCR partnered with the Mali Ministry of Health (MOH), Ministry of Higher Education and Scientific Research (MHESR), and USTTB to launch the University Clinical Research Center (UCRC). This collaborative partnership aims to facilitate the development of a coordinated clinical research program in Mali, enhance the existing clinical research programs and encourage their growth and sustainability. The UCRC aspires to stimulate clinical research in West Africa that is guided by international standards and principles, and to develop an excellent research environment that will attract, and foster collaborations with, researchers worldwide. The UCRC is intended to provide and coordinate core research capabilities in areas of research regulations, data management, and diagnostics, and to help investigators initiate and implement protocols. These facilities will also encourage collaborations and be a resource for local investigators when applying for grants or other funding mechanisms, and/ or leveraging opportunities to conduct clinical research studies, trainings, and initiatives funded through other mechanisms.

3. Mali Service Center (MSC)

The Mali Service Center (MSC) is a financial services organization that was created in 2004. The MSC was established and fully funded as an independent center by NIAID in partnership with the Mali Ministry of Health (MOH) and the USTTB. The MSC provides financial management, guidance, and oversight for the administration and disbursement of research grant and contract funds in Mali. The MSC ensures compliance with all funding institutions’ grant and contract policies, as well as international and local regulations. It supports a variety of programs funded by several governmental and non-governmental organizations conducting research in Mali, including U.S. government agencies, U.S. and international non-governmental organizations (NGOs), European research funding entities, and U.S. and international academic institutions. The MSC is located on the campus of USTTB and, since its inception, has been managed by a U.S.-based entity supported through a contract with NIAID. This contract supports the continuation of the MSC for NIAID-supported research activities.

This contract will support the management and operation of the Mali Service Center. The Mali Service Center is responsible for managing funds, provided by the U.S. Government or other entities, to support biomedical research with collaborators working within Mali. NIAID recognizes that other entities, such as private vendors, other governments, and other biomedical research funders, may utilize the services of the Mali Service Center. However, if any staff who support this Contract works on any project related to the third-party vendor/non-NIAID funded work, the U.S. Government will not be charged for the hours for any work performed for a third-party vendor/non-NIAID funded work.

2) SCOPE

The Contractor shall provide NIAID with management and operational support of the Mali Service Center (MSC) to facilitate NIAID-supported research activities in Mali and nearby surrounding countries.

3) TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work as stated herein.

The requirements as described in the scope of this SOW are for management and operational support of a financial services center in Mali, for NIAID- supported activities. Additional requirements may be included in the Task Order(s) at the discretion of NIAID.

A. General The Contractor shall facilitate research activities of NIAID-funded projects in Mali, including intramural research conducted by NIAID directly, extramural grants, and extramural contracts, and funds provided to USTTB for the “Support Services for the NIAID Mali ICER” contract. Extramural grants and extramural contracts are defined as funds received from other universities or institutions holding agreements or grants that are funded by NIAID. Specific requirements include procurement of supplies and services, travel management, funds disbursement, accounting and invoicing, and customs clearance for NIAID-funded activities in Mali.

Mali is a Francophone country where French is spoken extensively. To collaborate with NIAID, Mali, and other partnering countries and agencies, the Contractor must have staff members fluent in written and spoken French and English.

The Contractor will be required to provide administrative and managerial support of the MSC for the operation of NIAID-funded scientific research and other NIAID activities, such as trainings, scientific meetings, and/or conference attendance in Mali and the surrounding region.

B. Project Management

1. Provide and implement overall project management to coordinate and integrate a Project Plan with sufficient detail to enable monitoring at intervals directed by the Task Order (e.g., weekly, monthly, or activity/milestone). The draft Project Plan will be available no later than 30 calendar days after the effective date of any Task Order award. The Project Plan shall be developed in accordance with best practices and address Task Order requirements, key personnel, process, procedures, timing, and risk.

2. The Contractor shall identify a Project Manager for each Task Order who will serve as a point of contact for NIAID. The Contractor shall provide sufficient staff to ensure management and monitoring of all Task Order activities.

3. The Project Manager will ensure effective communications with the Contracting Officer’s Representative (COR), Contract Specialist (CS), and the Contracting Officer (CO). This includes regular reports and meetings (teleconference, web conference, or face-to-face), as well as additional communication when there is a significant deviation from the Project Plan. The Project Manager will ensure meeting scheduling enables attendance by key personnel including, Contractor, Subcontractor (if applicable), COR, CS, CO, and others, as appropriate and required for the Task Order. For each meeting described in the Task Order, the Contractor shall be responsible for:

• Preparing and distributing agendas and background materials, as requested by the COR, CS, and/or CO, at least one business day prior to each meeting; and

• Preparing and submitting written summaries of all major decisions and action items to the COR within seven calendar days after each meeting.

4. The following meeting examples may be included in Task Order award(s):

• Task Order Initiation Meeting will take place within 10 calendar days after the effective date of the Task Order, or before the start of any tasks, to review the Task Order requirements and timelines, discuss Task Order Project Plan and approaches, and identify any anticipated obstacles to completing the Task Order requirements.

• Progress review meetings shall be conducted in intervals specified in the Task Order. The purpose of these meetings shall be to review and discuss:

o Ongoing and planned activities, protocols, and associated data;

o Timelines for task initiation and completion, submission of data and other information; and o Any other matters relevant to the administration of the Task Order.

5. Investigator, protocol, working group, strategic planning, and/or network meetings. As directed by NIAID, the Contractor shall travel to conference venues to support administrative meetings organized between NIAID staff, foreign investigators that are collaborating on NIAID-funded projects, and Service Center staff.

6. The Project Manager shall alert NIAID to significant deviation from the Project Plan within 48 hours and have key personnel available for an ad-hoc team meeting no later than 48 hours after the notification. The Project Plan shall be updated when it significantly deviates from Task Order progress.

7. This is a high-volume contract which will require significant administrative oversight. The Contractor will be required to provide financial statements, pipeline analyses, account balances, and other ad hoc reports, as requested by the COR, CS, and/or CO, within two (2) business days of the request. Accuracy and timeliness for reports, data requests, and invoices generated by the Contractor are a critical component of this contract.

C. Financial Management and Support

1. The Contractor shall be responsible for day-to-day financial management, ensuring the proper receipt and disbursement of funds, and sending detailed, accurate, and timely financial reports to the COR, and others as designated by the COR.

2. Manage MSC operating costs, such as salaries and benefits for MSC staff.

3. Manage accounting and disbursal of NIAID intramural core, research program, and UCRC funds.

4. Manage accounting and disbursal of NIAID extramural grant and contract funds (e.g., funds received from other universities or institutions holding agreements or grants with NIAID).

5. The Contractor shall track advance accounts, ensuring that all funds advanced are accounted for with valid, and appropriate receipts. While the receipt approval process varies by project, once they are approved, the Contractor shall then categorize and code the expenses.

6. Maintain, operate, and update administrative and financial policies, procedures, and systems for management of funds, to include banking;

accounting and inventory management; procurement and management of fixed assets, supplies, and consumables; payroll processing and reporting; VAT and/or sales tax exemption if applicable: and other related administrative activities.

7. The Contractor shall provide detailed financial analyses and give NIAID access to accurate information on expenditures. The Contractor shall monitor, track, and report budget/funding vs. actual for each project and/or program. Contractor’s reports shall include, as requested, cash flow analyses, general ledger information, financial reports, and analyses of expenditures vs. budget.

8. Provide financial reports, including monthly invoices to NIAID or other NIAID-supported research institutions; monthly financial reports to NIAID program staff; and ad hoc expenditure and activity reports. All reports shall be in a format determined by the CO.

9. Establish bank accounts for receipt of funds to oversee receipt and disbursement of all funds, to include grantee/contractor funds.

10. The Contractor shall provide training to administrative and Special Project staff on the appropriate procedures for managing NIAID awards, including the use of required NIH and HHS reporting forms. The Contractor will serve as the disbursement agent only up to the life of this contract as agreed to by the COR and approved by the CO or CS.

11. Absent of stricter local legal requirements, at a minimum the Contractor must maintain U.S. Generally Accepted Accounting Principles (GAAP) to ensure said funds are disbursed according to the Federal Acquisition Regulation (FAR).

12. Comply and assist with the audit requirements of Code of Federal Regulations 2 CFR 2.200. The audit results shall be provided to the COR and CO.

13. Ensure appropriate financial reports are submitted by the extramural grantee and/or contractor to the NIH and HHS. All invoices shall be submitted in U.S. dollars (USD).

D. Human Resources and Performance Management

1. Provide best practices for human resources and performance management.

The Contractor shall provide qualified staff to fulfill the requirements of Task Order award(s). For each position, the staff shall have all the required and customary training, experience, and licensure or certification needed to fulfill their assigned role within each Task Order.

2. Assist with the development of research & development management services in compliance with Malian law; and ensure, to the maximum extent possible, that the compensation for personnel is consistent with local market compensation rates.

3. Verify records for payroll and disbursed salaries for personnel in accordance with the terms of the service agreement. Invoices for payroll expenses shall be verified by the Contractor prior to payment.

4. Provide a local driver with a Malian vehicle operator license required for transport of passengers. The driver shall be responsible for providing safe transportation of MSC, Contractor, and consultant staff to and from various locations in and around the Mali region, such as airports, meetings, administrative and university offices, banks, etc.

5. Establish and maintain policies and procedures for hiring, retaining, and training employees as appropriate to work. Contractor shall implement pre-and-post hire processes to ensure no conflicts of interests for Service Center staff (for example, MSC staff should not be relatives of local university leadership or NIAID-funded investigators).

6. Develop and update a personnel manual for the management of human resources and provide a copy to the COR and the individual research collaborators served.

7. The MSC Director shall develop evaluation tool(s) for measuring the progress of the MSC staff in gaining the expertise necessary to manage, operate, and expand MSC as the research infrastructure in the country grows. The MSC Director must also work collegially with the USTTB leadership on the development and implementation of any activities resulting from the expansion of MSC responsibility.

E. Project Management

1. Provide and implement overall project management to coordinate and integrate a Project Plan with sufficient detail to enable monitoring at intervals directed by the Task Order (e.g., weekly, monthly, or activity/milestone). The draft Project Plan will be available no later than 30 calendar days after the effective date of any Task Order award. The Project Plan shall be developed in accordance with best practices and address Task Order requirements, key personnel, process, procedures, timing, and risk.

2. Identify a Project Manager for each Task Order who will serve as a point of contact for NIAID. The Contractor shall provide sufficient staff to ensure management and monitoring of all Task Order activities.

3. The Project Manager will ensure effective communications with the COR, CS, and CO. This includes regular reports and meetings (teleconference, web conference, or face-to-face), as well as additional communication when there is a significant deviation from the Project Plan. The Project Manager will ensure meeting scheduling enables attendance by key personnel including, Contractor, Subcontractor (if applicable), COR, CS, CO, and others, as appropriate and required for the Task Order. For each meeting described in the Task Order, the Contractor shall be responsible for:

• Preparing and distributing agendas and background materials, as requested by the COR, CS, and/or CO, at least one business day prior to each meeting; and

• Preparing and submitting written summaries of all major decisions and action items to the COR within seven calendar days after each meeting.

4. The following meeting examples may be included in Task Order award(s):

• Task Order Initiation Meeting will take place within 10 calendar days after the effective date of the Task Order, or before the start of any tasks, to review the Task Order requirements and timelines, discuss Task Order Project Plan and approaches, and identify any anticipated obstacles to completing the Task Order requirements.

• Progress review meetings shall be conducted in intervals specified in the Task Order. The purpose of these meetings shall be to review and discuss:

o Ongoing and planned activities, protocols, and associated data;

o Timelines for task initiation and completion, submission of data and other information;

o Problems or deficiencies identified with respect to the accuracy, timeliness, and completeness of research, trials, and studies, including outcomes such as data submission; and o Any other matters relevant to the administration of the Task Order.

• Investigator, protocol, working group, strategic planning, and/or network meetings. As directed by NIAID, the Contractor shall travel to conference venues to support administrative meetings organized between NIAID staff, foreign investigators that are collaborating on NIAID-funded projects, and Service Center staff.

5. The Project Manager shall alert NIAID to significant deviation from the Project Plan within 48 hours and have key personnel available for an ad-hoc team meeting no later than 48 hours after the notification. The Project Plan shall be updated when it significantly deviates from Task Order progress.

F. General Meeting Support

Provide for general support activities include meeting arrangements, agendas, facilitation, travel, graphics and video support, logistics and materials preparation and distribution, translation, and meeting notes, minutes, summaries and/or summary reports as directed by the COR. When applicable, deliverables must meet agreed upon standards, formats, applicable policies, and regulations.

G. Administrative and Logistics Support

1. The MSC Director shall be responsible for developing and/or updating SOPs regarding MSC administrative procedures, management, and financial policies. SOP topics will be approved by the COR and the Contractor shall maintain copies in English and French. Approximately 25-30 SOPs and supporting documents currently exist for the MSC. The MSC shall provide training for Malian scientists and administrators on MSC policies and SOPs.

2. Manage, support, and assist NIAID extramural grantees and NIAID contractors, and assist in the development of research agreements and associated funds for research programs and other operations in Mali.

3. An approved and executed “Agreement for Services provided by the Service Center” must be completed by the Contractor whenever a NIAID-funded contractor or grantee needs to utilize the services of the MSC. This agreement documents the financial and administrative services that will be provided by the Service Center for each NIAID-funded research project and grant. All agreements and service requests shall be entered into a tracking system that is developed and maintained by the Contractor. These Agreements must be made available to the COR and/or CO upon request.

4. Provide administrative support and assistance to NIAID-funded clients of the MSC, including NIAID, USTTB, and third-party clients.

5. Provide legal services for the interpretation of Malian laws or regulations related to employment and other legal matters that may impact NIAID-funded research activities in Mali.

6. Provide administrative management; logistics; procurement of services, supplies and equipment; travel; specialist administrative assistance; and system development.

7. Ensure that local investigators and administrators are fully knowledgeable and aware of the MSC policies and SOPs that support implementation of the collaborations Mali.

8. Assist with preparing administrative responses and reports as required or requested by NIAID-supported investigators.

9. Oversee the management of travel and accommodations for investigators associated with NIAID-supported projects. This includes Malian staff supported under the “Support Services for the NIAID Mali ICER” contract, Malian staff supported by extramural grants and contracts, and other invited researchers.

10. Make authorized travel arrangements for approximately 50 people traveling per year, as guests of NIAID, from Mali to the United States, or other countries, to attend professional meetings, visit the NIH, or visit other U.S. or international research institutions for training.

• Purchase airline tickets, arrange for and purchase accommodations, and provide payment for meeting registration fees. Disburse cash advances to cover meals and incidental expenses in compliance with Federal Travel Regulations for all approved travel.

• Manage and track receipts and disbursements of approved travel expenses.

Maintain appropriate records and proper accounting of all travel-related activities in a monthly Travel Management Services Summary report.

All initial travel authorizations shall be submitted at least six (6) weeks before proposed international travel, and four (4) weeks before proposed domestic travel. Exceptions to this rule will be granted on an individual basis.

H. Procurement of Services, Supplies, and Equipment

The Contractor shall, based on requests reviewed and approved by NIAID in-country staff, subcontract with vendors and assist with procurement of supplies and services to support MSC, ICER, UCRC, and USTTB activities. Any Government- Furnished Property and Contractor-Acquired property will remain in place as a part of this contract and shall be managed in accordance with HHS policy.

Procurement requests requiring Contracting Officer Approval (COA) include travel;

office equipment; medical or research equipment; supplies for field studies;

vaccines; insurance, including clinical trial insurance; laboratory equipment and furnishings; and repair parts to maintain infrastructure, scientific equipment, and vehicles for use in-country. Services include subcontracting with appropriate domestic and international entities to establish agreements for leasing field site housing, ambulance rentals; installation, maintenance, repair, or upgrade of infrastructure, laboratory, and field site equipment, telecommunications, security, and IT systems and equipment; and for shipment of reagents and samples domestically and internationally. Procurement requests and approvals are managed through a web-based portal developed by NIAID.

In support of procurement activities, the Contractor shall:

1. Provide services with responsible sources (through the best means possible for the requirement) and to procure supplies and services as needed to support research activities funded by NIAID. Note: The Service Center will not provide customs clearance assistance for illegal or illicit materials.

2. Prepare procurement requests for review by NIAID PIs (if applicable), NIAID in-country staff, COR, CS, and CO. The Contractor will work with the COR for all project requests related to USTTB, such as space renovations, staffing requests, meetings, travel planning, etc.

3. Perform functions necessary to execute NIAID-funded project budgets, including procuring resources or lab supplies, obtaining quotes, and ensuring best quality/best pricing.

4. Prepare all procurement requests, quotes, invoices, and receipts and translate them to English.

5. Manage ordering, receipt, and distribution of laboratory supplies and equipment to the appropriate site(s).

6. Ship materials between Mali and NIAID, and to other countries and institutions, as requested.

7. Contract for services that are required for maintaining day-to-day operations of ICER laboratories, leased facilities, and field sites.

8. Maintain records of all transactions, payments, and deliveries of services and supplies.

9. Disburse all payments as agreed and upon delivery of services or supplies.

I. Facilities, Equipment, and Resource Support

1. Provide and maintain facilities, equipment, space, and other resources and facilities that comply with all local, domestic, in-country, NIH, state and/or federal government regulations.

2. Provide for safe and secure operations and access to MSC facilities.

• Develop and update a security plan to ensure the continued operation to the greatest extent possible in the event of a heightened security threat consequent to political, military, or civil unrest. The plan should address potential options for physical protection and evacuation of staff and sensitive data in the event this becomes necessary.

• Establish processes and procedures to ensure that only approved staff have access to physical sites, systems, equipment, technology, internet, and/or data.

3. Comply with the physical security, protection of government property, protection of information (FISMA), cyber security, safe disposal and waste handling of financial records, and personal security requirements set forth by local, domestic, in-country, NIH, state, and/or federal regulations.

4. Be responsible for maintaining Government Furnished Property per FAR 52.245-1. The Contractor is required to develop and implement a Preventive Maintenance (PM) plan that includes Service Agreements. The Contractor shall maintain a library of operating and maintenance manuals for all scientific equipment and other essential equipment required for the completion of the activity in English, and local language when appropriate, and make them accessible for inspection of Government personnel. The Contractor shall take full advantage of manufacturer warranty obligations and maintain a log of all active warranties for the facilities and equipment.

Equipment procured by the Contractor that requires tracking per NIAID property policy shall receive a NIAID property tag prior to installation and use. Disposal of NIAID-tagged equipment shall be arranged by NIAID staff.

J. Administration and Disbursement of Intramural Funds DIR maintains core funds that provide support across the Mali ICER. Core funds cover general support functions and are used for non-separable costs and day-to-day expenses. Core funds support procurement, renovations, maintenance, repair, and operation of communications and IT systems; ICER motor pool (approximately 26 vehicles); storage and parking facilities located on USTTB campus; office equipment; laboratory infrastructure; biomedical research equipment; clinic facilities at Point G Hospital; generators, air conditioners, and water systems; and field sites affiliated with the Mali ICER. There are approximately 10 field sites utilized by the ICER and additional sites may be added in the future.

DIR has separate research program funds for covering research expenditures for eight programs: Malaria Vaccine, Malaria Immunoepidemiology, Malaria Pathogenesis, Malaria Immunity, Malaria Entomology, Leishmaniasis, Filariasis, and Emerging Pathogens. Research program funds are individually managed for each of the eight programs, and additional programs may be added in the future.

Research program funds cover all items that can be directly attributed to the program’s research activities and may also include some expenditures related to use of ICER core infrastructure (for example, fuel costs associated with using the motor pool). Research program fund distributions may include payments for consultants to assist with field studies; per diems for Malian research staff to conduct field studies;

compensations or allowances for clinical trial participants; IRB services; and medical or travel insurance. Research program funds also cover advanced payment for expenses related to ICER field site trips. This includes procuring supplies; hiring local guides and assistants; obtaining fuel for vehicles; and local per diem expenses.

DCR provides funds for to support the UCRC, which may include administration and disbursement management activities that are similar to the DIR core and program funds outlined above.

To support of the administration and disbursement of intramural funds, the Contractor shall:

1. Maintain and apply the same accounting and procurement procedures for the ICER and UCRC.

2. Manage and track all transactions as core funds, program funds, or UCRC funds by establishing and maintaining a detailed accounting system. Ensure that all intramural funds, records, and reports are maintained separately, and not comingled with each other or other MSC clients.

3. Ensure that proper authorizations are received from NIAID in-country staff, COR, CS, and/or CO prior to approving and executing disbursements.

4. Ensure all UCRC procurement requests are reviewed by the PI (if applicable), UCRC Director, COR, and CS prior to submission for processing by the MSC.

5. Provide detailed monthly financial reports of all activity, including field trip expenses, for core fund, program funds, and UCRC funds.

6. Pay per diem for Malian research staff, locally hired consultants, and field workers to assist with identifying and transporting study participants for field site trips.

7. Pay per diem for 5-20 Malian research staff, locally hired consultants, and field workers (depending on the nature of the specific study) for 5-20 days to act as guides for collection trips. There are approximately 70 collection trips anticipated per year, but this number can vary depending on the dynamics of malaria, filariasis, and leishmaniasis transmission seasons.

8. Maintain and update the fee-for-service plan for apportioning costs for each research program’s usage of the motor pool. Maintain records of program usage and update monthly financial reports. Drafts of changes to the fee-for-service plan are to be provided to the COR for review. Final changes shall be incorporated into the contract after approval by the COR.

9. Assist NIAID in-country staff, who are responsible for assigning the use of vehicles and overall management of the ICER motor pool, by providing accounting; disbursement management, including licensing, operational expenditures, insurance procurement, and payment of regular maintenance and emergency repairs; and auditing services for the motor pool. Vehicles must be maintained and operated in accordance with regulations established by HHS and NIH.

10. Assist NIAID in-country staff with the financial management of ICER core laboratory resources, which includes a clinical laboratory operated under Good Laboratory Practices (GLP) and a core immunology laboratory. Provide accounting, disbursement management, and auditing services for the activities undertaken by core laboratory facilities.

11. Assist NIAID in-country staff with the financial management of the UCRC, by providing accounting, disbursement management, and auditing services for UCRC activities.

K. Assistance for the “Support Services for the NIAID Mali ICER” Contract

Research support services at USTTB are funded under a separate NIAID contract, “Support Services for the NIAID Mali ICER,” which is awarded to USTTB. The Contractor responsible for management of the MSC shall provide guidance and assistance to USTTB with the administration of the support services contract, including the following activities:

1. Assist USTTB with maintaining a roster of scientists, technicians, administrative, and support personnel required by NIAID to conduct research programs in Mali.

2. Assist with the development of appropriate subcontracts and consultancy agreements between USTTB and individual employees in compliance with Malian law. These agreements will be approved by USTTB and shall be shared with NIAID in-country staff, COR, CS, and CO.

3. Report to NIAID when the rate of pay is not uniform with salaries paid through NIAID extramural grants or contracts.

4. Maintain payroll records and monitor the level of effort for all Malian investigators and research staff of the USTTB working with intramural programs, extramural programs, and third-party clients to ensure that each employee does not exceed 100 percent cumulative effort for NIAID funded projects.

5. Verify payroll and disburse salaries for personnel in accordance with the terms of the “Support Services for the NIAID Mali ICER” contract. Invoices for payroll expenses shall be verified by the Contractor prior to submission to NIAID for payment.

6. Develop and maintain SOPs for USTTB staff recruitment, terminations, and transitions between grant and contract funding mechanisms.

7. Assist the USTTB Rectorate, as needed, in the preparation and filing of reports and employee evaluations.

L. Other Administrative Support

1. Provide support to the Malian Investigational Review Board (IRB) when it meets to review studies in which DIR is involved. Frequency of meetings are variable, but they will occur no more than 5-10 times per year.

2. Prepare meetings for the MSC Advisory Board, which includes members from NIAID and USTTB. Meetings occur twice per year. Support shall include scheduling and preparing the agenda, content, minutes, and presentation materials. Materials must be provided to MSC Advisory Board members one week prior to the meeting.

3. Provide financial and other relevant reports for activities in accordance with the Reporting Requirements set forth in each Task Order award, or as requested by the COR outside of the Reporting Requirements.

M. Customs Clearance and Shipments

1. Utilize the established Federal authority for duty-free importation of supplies and equipment.

2. Facilitate delivery from the customs storage facility to the appropriate ICER program site. This is particularly important for shipments via express services, such as DHL, and for the shipment of frozen supplies and reagents (preserved with dry ice or liquid nitrogen). No select agents or highly pathogenic agents will be shipped.

3. Facilitate shipment of frozen materials (preserved with dry ice or liquid nitrogen) ) between Mali, the United States, and other destinations.

4. Request, on behalf of the MSC, exoneration of custom duties and all taxes on goods acquired with funds provided by NIAID, based on the arrangement between HHS and the Malian Ministry of Higher Education and Scientific Research (MHESR) signed in the U.S. and Mali in December 2015 and extended by the Agreement signed in February 2021.

5. Request, on behalf of the MSC, exoneration of custom duties and all taxes on goods acquired with funds provided by other U.S. Government Agencies based on the Agreement for Economic and Technical Assistance between the U.S. and Mali, dated January 4, 1961.

All requested documents pertaining to the tasks of Sub-Sections A-M of this Base IDIQ SOW are due within ten (10) days of initial request. Any extensions must be requested and approved of by the CS and/or CO.

4) TRANSITION PLAN

A. Initial Transition Plan

The Contractor shall develop and submit a draft initial transition plan at the time of the proposal, which will describe the Contractor’s strategy for taking over work from the incumbent Contractor, if applicable. The plan must include details on the provision of key employees, transition of equipment, and transfer of relevant files and records. Upon award, the draft initial transition plan will be revised, if necessary, and the draft initial transition plan will become the final initial transition plan upon approval of the COR. The final initial transition plan shall be followed to ensure an orderly, efficient, and expedient transition of all contract activities as soon as possible, but not later than 30 days after contract award. Problems or concerns, anticipated or encountered, shall be immediately communicated to the COR, CS, and CO, and an approved resolution pursued.

B. Final Transition Plan

Within 180 days of contract award, the Contractor shall submit a draft final transition plan that will describe the Contractor’s strategy for transferring work from this contract to a successor contract, in the event a transition would be necessary. The plan must include policies and procedures for transfer of equipment, leases, and agreements, as well as relevant administrative and financial data to include SOPs maintained as manuals and electronic files. The draft final transition plan will be revised as necessary in collaboration with the COR and CO and the approved Final Transition Plan shall be incorporated into the Contract. The Contractor’s approved final transition plan shall be followed to ensure an orderly, efficient, and expedient transition of all contract activities by the contract completion date.