JOFOC Redacted.pdf

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. HHS/NIH

b. Sponsoring organization. NIH/NIAID/DIR

c. Project Officer Information.

Project Officer Name.

Mailing address.

E-mail address.

2. Telephone number.

3. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of the acquisition is to extend the period of performance and ceiling of the current contract to meet the needs of the National Institute of Allergy and Infectious Diseases (NIAID) Mali International Center for Excellence in Research (ICER) program and manage the day-to-day operations of Mali Service Center. The Mali Service Center (MSC) was established as a financial service center for the management of research funding provided to University of Sciences Techniques and Technologies of Bamako (USTTB) or other entities within Mali.

The contractor will provide support for the operation of NIAID-funded activities in Mali to include the disbursement of payroll for Malian staff at the University of Sciences Techniques and Technologies of Bamako (USTTB) (funded under a separate NIAID contract); the disbursement of payroll of staff working under NIAID extramural grants; the payment of expenses in support of field studies; the payment of expenses related to the operations of laboratory facilities; the facilitation and payment of travel of ICER scientists; procurement support, and assisting in the management of operations of ICER activities in Mali, Africa and the surrounding region.

The Mitchell Group, Inc.

Contract No. HHSN272201700050I

b. Project background.

The proposed action is to extend Contract No. HHSN2722011700050I with the Mitchell Group entitled “Management and Operation of the Mali Service Center” which was awarded on 31 July 2017 as a single award indefinite delivery/indefinite quantity (IDIQ) type contract for a period of five years by an additional 6.5 months and increase the ceiling by ( The contract resulted from a full and open competitive acquisition.

4. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title: Management and Operation of the Mali Service Center

b. Project description.

As noted above in the section “acquisition purpose and objectives”, the contractor will provide support for the operation of NIAID-funded activities in Mali to include the disbursement of payroll for Malian staff at USTTB (funded under a separate NIAID contract); the disbursement of payroll of staff working under NIAID extramural grants; the payment of expenses in support of field studies; the payment of expenses related to the operations of laboratory facilities; the facilitation and payment of travel of ICER scientists; procurement support, and assisting in the management of operations of ICER activities in Mali, Africa and the surrounding region.

Attached is the Statement of Work (see Attachment 1) for this contract which describes the wide range of activities required for successful completion of the many projects performed under this contract.

Requirement type.

Research & development (R&D) R & D support services x Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement

X Follow-on

Contract No. HHSN272201700050I

Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials

X Indefinite delivery: indefinite quantity Other (specify): ___________ Completion Form Term form

Acquisition identification number: HHSN2722011700050I

c. Total estimated dollar value and performance/delivery period.

The current ceiling of this acquisition is . This J&A will increase the contract ceiling by (

The period of performance of the contract will be extended by 6.5 months, from August 1, 2017 through April 15, 2023 to August 1, 2017 through October 31, 2023.

5. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements, and HHS Acquisition Regulation 306.302-1, only one responsible source and no other supplies or services will satisfy agency requirements.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

6. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Contract No. HHSN272201700050I

1816 11st, N.W.

Washington, D.C. 20001

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The NIAID requires an extension of time in the period of performance and an increase in the contract.

The Mitchell Group (TMG) is the current contractor operating the Mali Service Center, a financial management center in Mali established by NIAID and The University of Bamako, the predecessor of the University of Sciences Techniques and Technologies of Bamako (USTTB),1 to support NIAID-funded research in Mali, including the NIAID International Center for Excellence in Research, a long-standing partnership between the NIAID Intramural program and USTTB. The contract held by TMG provides, among other things, critical support, in the form of supplies and services, including procurement of medications, essential to continuing several ongoing clinical trials of investigational interventions for malaria (multiple candidate vaccine studies and two antibody administration studies for prevention of malaria transmission), as well as clinical studies on COVID-19.

Importantly, these clinical trials cannot be funded through any other support mechanism available to the NIAID Intramural program;

consequently, any interruption between the service provided by TMG through the current MSC contract and the award of a follow-on contract to support the MSC would a result in a suspension of these ongoing clinical trials.2 Disruption of these trials must be avoided to the greatest extent possible because NIAID, as the sponsor of the trials, has an obligation to the participants to complete the trials, including providing appropriate treatments—antimalarial drugs in the case of malaria studies—for trial participants who become infected while in the clinical trials.

At present, the Republic of Mali is designated by the U.S. Department of State (DOS) as a Level 4 country, a designation for countries to which the recommendation is “do not travel” due to crime, terrorism, and kidnapping.” 3 Level 4 is the highest level of travel advisory provided by U.S. Department of State (DOS). Further, the U.S.

Embassy in Bamako ordered the departure of non-emergency U.S.

1 The University of Bamako was dissolved in the Fall of 2011 and restructured into four universities with the University of Science, Techniques and Technologies of Bamako replacing the University of Bamako as the Malian counterpart in the Mali ICER program.

2 Award of a follow-on contract through full and open competition is anticipated 3 Travel.state.gov/content/travel/en/traveladvisories/mali-travel-advisory.html cited on 10 November 2022

Contract No. HHSN272201700050I government employees and family members in July “due to heightened risk of terrorist attacks in areas frequented by westerners.4 The Embassy was under ordered departure from July 2022 through January 2023. While the ordered departure has been lifted, the Department of State travel warning regarding travel to Mali remain in place. Further, the Embassy in Bamako advises it has “limited ability to provide emergency assistance to U.S. citizens in Mali.”5

The security situation in Mali is fueled, in part, by unstable political conditions resulting from the assumption of political leadership by military-led interim governments following the removal of the democratically elected president in a coup d’état in August 2020 and a subsequent shake up of the provisional government nine months later.6 These actions, and the resistance by the provisional government to commit to a firm time frame for the democratic election of a new president, resulted in the imposition of economic sanctions by multiple international parties, most notably, the Economic Community of West African States (ECOWAS). While ECOWAS sanctions were lifted in July of this year, Mali remains suspended from the organization and continues to suffer political and economic consequences that likely will persist at least until elections are held and democratic governance is restored.7

Given the current security environment in Mali, the recommendations by DOS to avoid travel to the country, and the volatile political and economic situation in the country at present, it would be extremely difficult, if not virtually impossible, for another vendor to assume responsibility for the management of the MSC in the near term. No other vendors could hire and retain talent with the necessary expertise to support the program within the government’s timeline, given the tenuous political situation. Therefore, The Mitchel Group is uniquely suited to perform this acquisition, which is required to avoid disruption of NIAID’s ongoing clinical trials. Consequently, the current contractor, the Mitchell Group, which is already fully operational in Mali, is the only responsible source that can ensure uninterrupted operation of the Mali Service Center.

Accordingly, exemption for full and open competition based on TMG being the only responsible source to provide uninterrupted service is justified.

4 ibid 5 ibid 6 Usip.org/publications/2021/12/after-two-coups-malo-needs-regional-suppport-bolter-democracy cited 111 November 2022 7 Ibid.

Contract No. HHSN272201700050I

Given the political volatility in Mali, NIAID has been reconsidering its strategy in Mali, the continuation of the service center and the ICER work. The situation has been changing day by day resulting in decisional delays, and multiple revisions to the acquisition strategy.

These conversations regarding the acquisition strategy have resulted in a delay of the recompetition, which therefore necessitates an extension of the current services to avoid disruption. This is an immediate and urgent situation because simultaneously we have experienced increases in the volume of work due to the COVID pandemic and an increase in the NIAID malaria clinical studies. More specifically, trials on the use of malaria antibodies to prevent transmission of malaria have shown promise leading to an increase in the volume of work required.

To allow this contract to lapse would not only be detrimental to achieving the mission of the Institute, but it would also cause personal harm to the enrollees in the ongoing clinical trials in Mali. The ongoing clinical trials, approved by the NIH Institutional Review Board and the Malian ethics Committee, require the provision of antimalarials to participants who become infected during the trials. We therefore cannot abandon this contract, which provides the financial stability for NIAID funds that support this work.

NIAID has determined that it is critical to continue working in Mali, however, as a result of these changes, significant changes must be made to the SOW of the follow on contract. Therefore, this contract must continue to be available while we revise and solicit (through full and open competition) the follow on contract.

7. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

However, based on the current political situation in Mali, it would be impossible for a new vendor to take over this work without a transition period while avoiding interruption of service, and consequently the ongoing clinical trials.

Based on the current situation in Mali, the COR does not believe that any other organization is capable of providing this service without any delay.

Contract No. HHSN272201700050I

Pre-solicitation/Intent Notices were published on SAM.gov for a period of 15 days on 12/23/2022 and 02/13/2023. No responses were received.

This notice described the work to be performed, stated NIAID’s intent to negotiate with the present Contractor on a sole source basis, under the authority of FAR 6.302-1 and HHSAR 306.302-1, and provided responsible sources with the opportunity to express their interest by submitting a capability statement.

The Sources Sought was completed when the contract was originally competed. Discussions with Program were held to determine whether there are any other potential vendors who could take over these activities without any disruption. Based on the current situation and the competition received when the contract was originally awarded, however, Program could not identify any other potential vendors. The lack of responses to the intent notices confirmed that no other vendors are available to take over this contract without disruption.

8. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Independent Government Cost Estimate (IGCE) was developed using knowledge of this type of work, as well as the historical costs for task orders issued under the current contract. In addition, the Contracting Officer will conduct a cost analysis and cost realism analysis, as part of the award decision. Negotiations will be conducted if needed to ensure that the proposed costs are fair and reasonable for performance of the proposed work. An audit will not be performed, as it is not considered necessary because we have historical cost data to assist in the analysis of the proposed costs.

9. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The NIAID performed market research by: (a) reviewing previously received responses from the original Sources Sought Notice, and (b) published Intent/Presolicitation Notice to identify responsible sources with the opportunity to express their interest by submitting a capability statement.

10. Any other facts supporting the use of other than full and open competition.

No additional information.

Contract No. HHSN272201700050I

11. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

As stated above, under item 6, a market research memo was completed.

A Presolicitation Notice was published on 02/13/2023 on SAM.gov for a period of 15 days. This notice described the work to be performed, stated NIAID’s intent to negotiate with the present Contractor on a sole source basis, under the authority of FAR 6.302-1 and HHSAR 306.302-1, and provided responsible sources with the opportunity to express their interest by submitting a capability statement.

12. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The NIAID is in the process of recompeting the current contract.

13. Program office certification

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Name & Title Signature Date

Project Officer

Contracting Officer’s Representative

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office

Contract No. HHSN272201700050I

15.Competition Advocate signature

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Branch Chief

Chief of the Contracting Office

Head of the Contracting Activity

14. Contracting Officer Certification

STATEMENT OF WORK

Operation and Management of the Mali Service Center

I. BACKGROUND AND INTRODUCTION

The Office of Global Research (OGR), the Division of Intramural Research (DIR), and the Division of Clinical Research (DCR) are major components of the National Institute of Allergy and Infectious Diseases (NIAID) with activities at the International Center for Excellence in Research (ICER) and the University Clinical Research Center (UCRC) at the University of Sciences, Techniques and Technologies of Bamako (USTTB) in Mali, Africa.

International Center for Excellence in Research (ICER)

The ICER program was established based on experience gained from NIAID’s long-standing malaria research collaboration with Malian scientists, academic leadership, and the Malian government.

Malaria researchers from the NIAID Division of Intramural Research initiated a collaboration focused on malaria entomology in 1989, with counterparts at the National School of Medicine and Pharmacy in Bamako.

Today, 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 the Faculties of Medicine and Oral Surgery and of Pharmacy (which were separated when the University of Bamako— previously named the University of Mali—was divided into four universities), with these faculties falling under the University of Sciences, Techniques, and Technology of Bamako or USTTB and several clinical field sites within a 100 km radius of Bamako, in addition to one on the Bandiagara plateau. The current ICER research areas include: malaria epidemiology and vaccine studies; malaria immunological studies; ecological studies on malaria mosquito vectors; basic and clinical studies on leishmaniasis; clinical studies on filariasis; and clinical studies on HIV/TB co-infections.

The purpose of the ICER is to conduct research on infectious diseases important to the NIAID and the people of Mali and the surrounding region. To this effect, various collaborations have been established with Malian scientists within the Faculty of Medicine, Faculty of Pharmacy and the Faculty of Science and Technology, which are all components of USTTB.

University Clinical Research Center (UCRC)

Since 1992, there has been a long and successful history of collaborations between the University of Bamako and the NIAID. In 2013, based on a request from the Minister of Health and the Rector of the University, the concept of a clinical research center to facilitate research in Mali was developed.

The UCRC is a joint initiative between the Ministry of Health, the Ministry of Higher Education, the Faculty of Medicine at USTTB in Mali, and the NIAID Division of Clinical Research in the United States to enhance the infrastructure and resources needed to facilitate clinical research in Mali. This research center is intended to provide core research capabilities in areas like research regulations, data management and diagnostics, and to help investigators initiate and implement protocols. These in-country facilities will also encourage collaborations and be a resource for local investigators when applying for grants.

Specific aims of the UCRC include the following:

HHSN272201700050I

Facilitate the development of a coordinated clinical research program in Mali Enhance the existing clinical research programs and facilitate their growth and sustainability Stimulate clinical research in West Africa that is guided by international standards and principles Develop an excellent research environment that will attract researchers worldwide and foster collaborations

Mali Service Center (MSC)

The Mali Service Center was established by the government of Mali to operate as an independent service center for the management of research funding provided to the USTTB and other entities within Mali.

Currently, the Mali Service Center provides administrative oversight of travel and material purchases, and management of the disbursal of NIAID grant and contract funds in Mali and the surrounding region. The Office of Global Research at NIAID manages a NIAID Mali Office, which currently consists of two individuals, through supervision of the NIAID Representative in Mali. The NIAID Mali Representative works on behalf of all the divisions of NIAID in Mali (intramural and extramural).

The MSC will work with the NIAID Mali Office and NIAID Representatives on this contract to assist with facilitating NIAID operations within the region.

II. SCOPE OF CONTRACT

The scope of this contract is to operate and manage the Mali Service Center to facilitate the research activities of the NIAID or other NIAID collaborative partners in Mali and nearby surrounding countries.

III. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor will be required to furnish all necessary services, qualified personnel, material, equipment and facilities not otherwise provided for by the Government to provide oversight in the disbursal of NIAID grant and contract funds, including those for personnel services issued under separate contracts. In addition, the Contractor will manage transactions for supplies, materials, service and lease agreements, training and travel expenses for the conduct of NIAID-funded research activities in Mali and the surrounding regions.

An MSC Advisory Committee has been established, consisting of representatives of the NIAID and USTTB. The Contractor will work with the MSC Advisory Committee to assist with understanding the legal requirements necessary to build the administrative and financial capacity of the center to include developing or revising the Business Plan and establishing methods of good accounting practice such as record keeping and audit, to assist with growth and development of the MSC to include recruiting sponsorship by third-party clients.

The Contractor shall prepare for and lead the MSC Advisory Committee, to report on the various elements of the MSC’s financial and operational statuses.

Assisting the MSC with developing the tools necessary for independent operation will enable the NIAID, NIH, and other U.S. Government agencies to contract directly with the MSC in the future, thereby expanding the network of global research.

A. Initial Transition

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 required. 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 Contracting Officer’s Representative (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 and an approved resolution pursued.

B. Task Areas

The contractor shall function in the following task areas:

1. Management of the Mali Service Center (MSC)

Mali, Africa is a Francophone country where French is spoken extensively. In order to collaborate with NIAID and Malians and other partnering countries and agencies, it is recommended that the Contractor have fluency to communicate orally and in writing in English and French. We suggest hiring in-country support staff to maintain goodwill within the community.

The contractor will be required to provide administrative and managerial support of the MSC for operation of NIAID-funded scientific research and other partner activities such as trainings and scientific meeting or conference attendance in Mali and the surrounding countries as necessary. Support will include the disbursement of payroll, which is funded under a separate NIAID contract for Malian staff at USTTB; disbursement of payroll of staff working under NIAID extramural grants; payment of expenses in support of field studies; payment of expenses related to the operations of laboratory facilities; facilitation and payment of travel of ICER scientists; and assisting in the management of operations of ICER activities in Mali.

Specific activities include:

a. Recruit a MSC Director as necessary. The MSC Director shall be responsible for day-to-day management of the MSC, ensuring the proper receipt and disbursement of NIAID funds as provided by the Contractor, and sending financial reports including invoices to NIAID officials and officials at institutions for which the MSC provides receipt or disbursement services.

b. Provide a local driver who shall be responsible for providing safe transportation of MSC contractor and consultant staff to and from various locations such as airports, meetings, administrative and University offices, banks, etc., in and around the Mali region.

c. Maintain, operate, and update, as necessary, administrative and financial policies, procedures, and systems for management of NIH funds to include banking; accounting and inventory management; procurement and property management; payroll processing and reporting; and other related administrative activities.

d. Provide training for Malian scientists and administrators on MSC’s policies and standard operating procedures (SOPs) that support implementation of the NIAID collaboration in Mali.

e. Provide legal services, as necessary, principally for the interpretation of Malian laws or regulations related to employment.

f. Update, or develop as necessary, Standard Operating Procedures (SOPs) regarding administrative procedures, and management and financial policies for each of the programs. Topics will be approved in writing by the COR, and the MSC Director will be responsible for the creation and maintenance of the SOPs. Currently there are approximately 25-30 SOPs and supporting documents. The SOPs are developed and maintained in English and French. All SOPs shall be considered deliverables under the contract and reviewed and approved by the COR and MSC Director prior to implementation.

g. Establish and maintain policies and procedures for hiring, retaining, and training employees, as appropriate, to work in the MSC, and for management of the MSC. The existing personnel manual for the management of human resources shall be updated as necessary, and a copy provided to the COR. The MSC Director shall develop evaluation tools for measuring the progress of the MSC staff in gaining the expertise necessary to manage, operate, and expand the 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 expansion activities.

h. Manage the financial resources of the MSC, to include:

1) Operating costs such as salaries and benefits of staff of the Mali Service Center

2) Managing accounting and disbursal of NIAID intramural funds (NIAID funds)

3) Managing accounting and disbursal of NIAID extramural funds (i.e., funds received from other Universities or Institutes holding Agreements with USTTB)

4) Assist the MSC with management of other funds (i.e. third-party clients of the MSC).

These funds will not be paid, or billed, under this Contract; but instead, under and subject to execution of separate agreement(s) between the MSC and other parties collaborating with, or using the services of the USTTB or other infrastructure in Mali or surrounding countries.

5) Provide a quarterly financial and operations report of the MSC to the COR

i. Manage, support, and assist NIAID extramural awardees, and assist in the development of intramural research agreements and associated funds for research programs and other operations in Mali. Fully executed “Agreements for Services provided by the Mali Service Center” are necessary for all new NIAID grantees, contractors or subcontractors of the grant/contract prior to providing support activities. All agreements and service requests shall be entered into a tracking system developed and maintained by the Contractor. An approved and executed “Agreement for Services provided by the Mali Service Center” must be completed by the Contractor whenever a NIAID Contractor, NIH or NIAID grantee needs to utilize the services of the MSC.

j. Establish bank accounts for receipt of United States deposits in order to oversee receipt and disbursement of all funds, to include grantee/contractor funds. The Contractor must maintain accounting methods consistent with generally accepted accounting principles (GAAP) to ensure said funds are accounted for and disbursed according to grant, contract, and subcontract approved budgets, and to ensure appropriate financial reports are submitted by the grantee/contractor to the NIH and the US Department of Health and Human Services (DHHS). Bank accounts may be with local banks in the foreign country for operational purposes or established banks in the United States. All invoices must be submitted in U.S.

currency.

k. Oversee the disbursement of grantee/contractor funds while providing training to administrative and USTTB staff on the appropriate procedures for managing NIH awards, including the use of required NIH, DHHS 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 Contracting Officer (CO) or Contract Specialist (CS).

l. Provide administrative support and assistance to clients of the Mali Service Center, including NIAID, USTTB, and third-party clients established as a result of MSC’s growth and development.

m. Assist with drafting or revising the MSC Business Plan that includes developing actionable steps to enable the MSC to operate independently by building infrastructure and core capacity. The MSC Business Plan is a deliverable under the contract. To the extent necessary, the business model may need to be modified to incorporate updated strategies, projections, or financial data. The Contractor will work with the MSC Advisory Committee and NIAID COR to update the Business Plan as necessary.

n. Comply and assist with the audit requirements of Code of Federal Regulations 2CFR2.200.

The audit results shall be provided to the COR and CO.

o. Provide security for the MSC and MSC Director’s residence, as necessary.

p. Provide support to the Malian Investigational Review Board (IRB) when it meets to review studies in which DIR is involved. While variable from one year to the next, this will occur no more than 5-10 times in a year.

q. Prepare meetings for the MSC Advisory Committee to include scheduling and preparing the agenda, content and presentation materials.

2. Assistance for the USTTB personnel contract

Funds for personnel at USTTB are supported by a separate NIAID contract entitled Scientific, Technical, and Administrative Staff at the USTTB. The Contractor responsible for management of the Mali Service Center shall provide guidance and assistance to USTTB with administration of this personnel contract to include the following:

a. Assist with preparing administrative responses and periodic reports as required or requested by NIAID staff.

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

c. Assist with the development of appropriate subcontracts and consultation agreements between USTTB and individual employees in compliance with Malian law. These agreements will be reviewed by the USTTB and approved by the NIAID Contracting Officer in collaboration with the NIAID Mali technical representative.

d. Ensure, to the maximum extent possible, that the rate of pay for personnel is uniform with the salaries paid through NIAID extramural grants or contracts, and any third-party clients.

e. Keep payroll records and monitor the level of effort of all staff working with intramural and extramural programs, as well as any third-party clients, to ensure that no one employee exceeds 100 percent cumulative effort.

f. Verify payroll and disburse salaries for personnel in accordance with the terms of the Scientific, Technical, and Administrative Staff at USTTB contract. Invoices for payroll expenses shall be verified by the Contractor prior to submission to NIAID for payment.

g. Assist the USTTB Rectorate, as needed, in the preparation and filing of reports.

3. Travel Management

The Contractor will oversee the management of travel and accommodations for investigators associated with NIAID-funded projects. This shall include Malian staff supported under the Scientific, Technical, and Administrative Staff at USTTB contract, Malian staff supported by extramural funds and other invited researchers.

The Contractor shall:

a. Make authorized travel arrangements for approximately 50 people traveling per year from Mali to the United States, or to a third country, to attend professional meetings, or to visit NIH or other US or international research institutions for training.

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

c. Manage and track receipts and disbursements of approved travel expenses and maintain appropriate records and proper accounting of all travel-related activities in a monthly Travel Management Services Summary.

4. Procurement of Services, Supplies, and Equipment

The Contractor shall subcontract with responsible sources and assist USTTB staff to procure supplies and services as needed to support MSC, ICER, and USTTB activities. Any Government-Furnished Property and Contractor-Acquired property will remain in place as part of this contract and be managed in accordance with DHHS policy.

Procurement requests requiring Contracting Officer Approval (COA) include office equipment and supplies; medical or research equipment and supplies; medical, clinical, and basic science laboratory reagents from either local or international vendors; supplies for field studies;

laboratory and guest house equipment and furnishing; and repair parts as necessary to maintain scientific equipment and vehicles for use in-country. Services include subcontracting with appropriate domestic and international entities to establish agreements necessary for 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.

The Contractor shall:

a. The Contractor shall prepare procurement requests for review by the NIAID COR and approval by the NIAID Contracting Office. The Contractor will work with the COR for all project requests with the USTTB, such as space renovation, staffing requests, meetings, and travel planning, etc.

b. Prepare and translate all procurement requests and invoices, including receipts, into English.

c. Manage ordering, receipt and distribution of laboratory supplies and equipment to the appropriate site; ship materials from Mali to NIAID in Bethesda, or other countries or institutions, as requested; contract for services related to the continued day-to-day operations of the ICER laboratories, leased facilities and field sites.

d. Maintain records of such transactions and provide monthly financial reporting of these activities.

e. Handle disbursal of all payments as agreed and upon delivery of services or supplies.

5. Administration and Disbursement of Core Funds, Research Program Funds, and funds to support the University Clinical Research Center (UCRC)

NIAID Division of Intramural Research (DIR) supports several research programs in Mali and maintains core funds that provide support across the DIR research programs. Each DIR research program also has separate program funds for covering expenditures. The programs include:

Malaria vaccine Malaria immunoepidemiology Malaria Pathogenesis Malaria Immunity Malaria Entomology Leishmaniasis Filariasis HIV/TB co-infection Emerging Pathogens

Core funds: cover general support functions, including maintenance of IT systems; vehicles;

offices, laboratories and field sites affiliated with the Mali ICER; and the storage and parking facilities located on the USTTB campus. Core funds are used for non-separable costs and day-to-day expenses. Accordingly, potential core fund distributions include expenditures for repairs, maintenance, and operation of vehicles in the motor pool (approximately 20);

laboratory infrastructure; generators; biomedical research equipment; air conditioners; water system; communications/internet; office support equipment; renovations, repairs, and maintenance of ICER laboratory and clinic facilities at Hôpital Point G (the main hospital associated with USTTB); and ICER field sites, most of which are located within a 100 km radius of Bamako (approximately a 2-3 hour drive from Bamako). At present, there are approximately 10 field research stations, or research sites, utilized by the ICER program.

Additional sites may be added in the future.

Research Program funds: cover all items that can be directly apportioned to the program’s activities, and eventually, could include some of the expenditures listed above as expenditures to be paid for by core funds, specifically in relation to the motor pool and the ICER laboratory.

Accordingly, potential research program fund distributions may include payments for consultants to assist with field-based studies; per diems for Malian research staff to conduct field studies across the country; payment of trial participant compensations/allowances;

payment for institutional review board (IRB) services; payment of medical or travel insurance;

and advanced payment for expenses related to field trips to ICER field study sites. The latter activity includes advanced payments for procuring supplies for field trips; hiring local guides and assistants; obtaining fuel for vehicles; and paying local per diem expenses.

i. Field station trips: The Contractor will pay per diem for Malian research staff and local hired as consultants and field workers (up to 10 per site as needed) to assist with identifying and transporting study participants. There are currently six field sites at which clinical trials are conducted.

ii. Collection trips: The Contractor will pay per diem between 5-20 days for Malian research staff as well as locals hired as consultants and field workers (approximately 5-20, depending on the nature of the specific study) to act as guides. The number of such collection trips is approximately 70 trips per year, but there can be variation depending on the dynamics of the malaria, filariasis or leishmaniasis transmission seasons.

UCRC funds: come from the NIAID Division of Clinical Research (DCR) and will include potentially all of the administration and disbursement management activities required for the DIR Core funds and the DIR program funds as outlined above.

The Contractor will maintain and apply the same procedures and procurement request forms used by the USTTB to the UCRC staff to account for all procurement needs. All procurement request forms must be reviewed by the Principal Investigator (PI), UCRC Director, and NIAID DCR COR and Contracting Office prior to submission for processing by the MSC.

The Contractor will ensure that DCR funds, records, and reports are maintained separately, and not co-mingled with other clients of the MSC.

The Contractor shall:

a. Ensure that proper authorization from the NIAID In-Country Representative, NIAID Resident Scientist, COR, or CO as needed, is received prior to approving and executing disbursements for each transaction. Disburse only verified and authorized transactions.

b. Manage and track all transactions as core fund or program fund expenditures by establishing and maintaining a detailed accounting system.

c. Maintain records of all expenditures by type (core, research program, or UCRC-related), and provide detailed monthly financial reports of all activity, including field trip expenses, of transactions by program.

d. Assist the NIAID/NIH Mali Representative, who is responsible for assigning the use of the vehicles and overall management of the NIAID ICER motor pool, by providing accounting;

disbursement management, including the licensing, operational expenditures, purchase of insurance, and payment of regular and emergency repairs; and auditing services for the motor pool activities. Vehicles must be maintained and operated in accordance with regulations established by the NIH and DHHS.

e. Maintain or revise as necessary, the current fee-for-service plan for apportioning costs to each 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.

f. Assist the NIH/NIAID Mali Representative with the financial management of the NIAID ICER core laboratory resources, consisting of a clinical laboratory operated under Good Laboratory Practices (GLP) and a core immunology laboratory, by providing accounting, disbursement management, and auditing services for the activities undertaken in the core laboratory facilities.

g. Assist the NIAID/NIH Mali Representative with the financial management of the UCRC, by providing accounting, disbursement management, and auditing services for the activities undertaken by or related to the UCRC.

h. Maintain or revise as necessary, the current plan for apportioning costs for use of the core laboratory facilities. The facilities will be utilized by various ICER components, including Malian scientists, contractors, grantees, and possible third-party clients of the MSC. The Contractor will be responsible for tracking these costs under each program. Drafts of changes are to be provided to the COR for review and approval. Final changes shall be incorporated into the contract.

6. Customs Clearance and Shipment

The Contractor shall:

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

b. Use the system of 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 shipments of supplies and reagents on dry ice or liquid nitrogen. No select agents or highly pathogenic agents will be shipped.

c. Make use of the established system for shipping frozen (dry ice or liquid nitrogen) materials from Mali to the U.S. and other destinations. The ICER currently uses the duty-free authority and expeditor of the U.S. Embassy to clear and deliver shipments to the various units.

d. 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 the U.S.

Department of Health and Human Services (DHHS) and the Malian Ministry of Higher Education and Scientific Research signed in the U.S. and Mali, respectively, on 12 and 17 November, 2008, and renewed by Agreement signed on 1 December, 2015. Request 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 4 January 1961.

7. USTTB Guest House

An existing account and funds have been established by USTTB for the operation of the USTTB Guest House for visiting researchers. The Contractor shall provide financial oversight and management of operations of the USTTB Guest House to ensure its habitability. The Contractor, in collaboration with the MSC and USTTB, shall utilize USTTB funds to manage the Guest House to include cleaning and maintenance, payment for utilities, providing security monitoring, and replacing furnishings and bedding as needed.

The Contractor shall maintain and provide detailed monthly records of all financial and operation activities related to the USTTB Guest House. The monthly report shall include record of any problems encountered with the house and the solution to each problem.

C. Final Transition

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.

IV. REPORTING REQUIREMENTS AND DELIVERABLES

All reports and deliverables shall be supplied electronically in English, using a readable MS Word or Adobe PDF format in accordance with the schedule as indicated. Additionally, reports and deliverables as requested, shall be posted on the current, secure Web site for the MSC.

Annual Progress Report

This report includes a summation of the results of the entire contract work for the period covered. An Annual Progress Report will not be required for the period when the Final Report is due.

Final Report

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract.

SCHEDULE OF DELIVERABLES

a. Progress Reports

Item Reports Recipients Delivery Schedule

1. Annual Progress Report

1 Copy to COR 1 Copy to CS

The first report is due on the 30th of the month after of anniversary date of contract. Thereafter, each report is due on/before the 30th of the month following each anniversary date of the contract.

2. Draft Final and Final Report and 1 Copy to COR

1 Copy to the CS

A Draft Final Report is due 30 calendar days prior to the completion date of contract.

Final Report is due on the completion date of the contract.

b. Other Reports and Deliverables

Item Type of Report or Deliverable Location in Sow

Recipients & Number of

Electronic Copies Due Date

1. Initial Transition Plan Page 1

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Within 7 days of the contract start date

2. Financial Reports Page 1 - Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

1st report due 10 days after the completion of the first full month and shall include any fractional part of the initial month.

Subsequent reports are due 10 calendar days after completion of each month.

3. Mali Service Center SOPs

Page 4 – Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Within 30 days of final approval

4.

Agreement for Services Provided by the Mali Service Center

Page 4– Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

190 days after contract award.

Every six months thereafter

5. Personnel Manual Page 4 – Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Within 30 days of any update

6. MSC Business Plan Page 2 and 5 – Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Submitted 180 days after contract award.

Updated every 6 months. Revisions due within 30 days of final approval

7. Audit Results Page 5 – Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Within 30 Days of completion

8.

MSC Quarterly Financial and Operations Report

Page 4 – Management of the MSC

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

1st report due 100 days after contract award. Subsequent reports 10 calendar days after the close of the quarter.

9.

Motor Pool Fee-for- Service and Cost Apportioning Plan

Page 8 – Administration and Disbursement Management of Core Funds and Research Program Funds

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Within 30 days of any update

10. Laboratory Cost Apportioning Plan

Page 9 – Administration and Disbursement Management of Core Funds and Research Program Funds

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Within 30 days of any update

11.

USTTB Guest House Monthly Financial and Operations Report

Page 10 - USTTB Guest House

1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

1st report due 10 days after the completion of the first full month. Shall include any fractional part of the initial month. Subsequent reports are due 10 calendar days after completion of each month.

12. Final Transition Plan Page 9 1 Copy to COR 1 Copy to CO-COR 1 Copy to CS

Draft within 180 days after contract award and…