JOFOC Presolicitation Notice.pdf

PRESOLICITATION NOTICE

RFP Number: 2023-NIAID-AMOB-2

Type of Requirement

New Requirement Re-competition (Contract No.:_____________) Follow-on (Contract No. HHSN272201700050I)

Place of Performance

Place of performance is unknown at this time Place of performance is: University of Sciences, Technologies, and Techniques of Bamako (USTTB), Bamako, Mali

Contracting Office Address Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 5601 Fishers Lane, Room 3B21 Bethesda, MD 20852

Primary Point of Contact Rosemary Gomes Contracting Officer Rosemary.Gomes@nih.gov Phone: 240-669-5374

Secondary Point of Contact Kristel Turansky Kristel.Turansky@nih.gov Phone: 301-594-8181

Purpose:

The purpose of this action is to increase the ceiling of the IDIQ conract and extend the ordering and delivery period.

The anticipated period of performance is April 15, 2023 through October 31, 2023.

The anticipated delivery period is 99 months.

Anticipated award date: April 15, 2023

The NAICS Code is 541990.

Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The Division of Intramural Research (DIR) within NIAID supports government sicentists who conduct research and clinical studies, principally in NIH laboratories; however, given the mission of NIAID includes research on diseases such as malaria, tuberculosis and other parasitic diseases that are not mailto:Rosemary.Gomes@nih.gov mailto:Kristel.Turansky@nih.gov endemic in the U.S., the NIAID Division of Intramural Research has established research partnerships with scientists in coutries in Africa, Asia, and Latin America to study such diseases.

The International Centers for Excellence in Research (ICER) program was launched in 2002 by DIR/NIAID to develop and sustain research programs in disease-endemic countries through partnerships with local scientists. The Mali ICER involves partnerships with scientists based at the University of Sciences, Techniques, and Technologies of Bamako (USTTB) to conduct research on infectious diseases important to the people of Mali, the region, and to the NIAID. The current Mali ICER research areas include malaria epidemiology and vaccine studies, malaria immunological studies, ecological studies on the malaria mosquito vectors;

clinical studies on filariasis and studies on emerging pathogens, including Lassa virus and Crimean-Congo Hemorrhagic Fever Virus.

Mali Service Center (MSC) The Mali Service Center (MSC) was established as a financial service center for the management of research funding provided to USTTB or other entities within Mali.

The contractor operates the MSC to manage 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. In addition, the Contractor works with the MSC Advisory Committee, an oversight Board established at the founding of the MSC and consisting of representatives from NIAID and USTTB, 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.

Finally, the contractor supports similar service centers in Guinea and Liberia that require principally the financial management services provided by the MSC.

A indefinite delivery, indefinite quantity contract for ”Management and Operation of the Mali Service Center” was awarded in July 2017 through full and open competition to the Mitchell Group based in Washington, D.C. The total value of the contract, including all options, was $19,569,696. The contract included a base and four option years, as well as a provision to extend the ordering period for an additional six months. On January 30, 2023 the ceiling was increased and the ordering period extended through April 15, 2023.

Due to political and economic factors in Mali as well as the expansion of the research activities, including research on COVID-19, which could not have been foreseen at the time of award, the contract ceiling needs to be increased to ensure the ongoing research activities, particularly ongoing clinical trials on malaria vaccines, malaria antibodies to prevent infection and COVID-19, can continue without interruption. This is critical given the ongoing trials in malaria provide malaria treatment for participants who become infected during the trials.

The above-mentioned policitical and economic factors in Mali have not changed, however the critical need for the government remains. To avoid any disruption of the ongoing research activities, which includes clinical trials on malaria vaccines, malaria antibodies to prevent infection and COVID-19, the contract ceiling and ordering and delivery periods need to be increased.

Based on the foregoing, the Government intends to negotiate under the authority of FAR Part 6.302-1 and HHSAR 306.302-1, on a sole source basis, with The Mitchell Group to increase the contract ceiling and ordering period to support the current ongoing activities from August 1, 2017 through October 31, 2023. No other source is able to provide these critical/essential services beginning on April 15, 2023 without causing unacceptable delays to the government in fulfilling the agency’s requirements.

Specifically, the Contractor will be responsible for continued support of the Mali Service Center and financial service centers in Guinea and Liberia by providing the following services:

1. Management of the Mali Service Center

Manage the financial resources of the MSC, to include:

a. Operating costs such as salaries and benefits of staff of the Mali Service

Center

b. Managing accounting and disbursal of NIAID intramural funds (NIAID funds)

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

d. Provide a quarterly financial and operations report of the MSC to the COR

2. Provide for payroll disbursment for the USTTB contract for Support Services for te

National Institute of Allergy and Infectious Diseases Mali International centers for Excellence in Research (ICER)

3. Travel Management

The Contractor will oversee the management of travel and accommodations for investigators associated with NIAID-funded projects, including for international travel. This shall include Malian staff supported under the Scientific, Technical, and Administrative Staff by the USTTB contract entitled “Support Services for the National Institute of Allergy and Infectious Diseases Mali International Centers for Excellence in Research,” Malian staff supported by extramural funds.

4. 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 NIAID Division of Clinical Research also supports a University Clinical Research Center (UCRC) that provides clinical trial support to both NIAID-funded trials, as well as trials supported by third-party clients. The contract also includes disbursement of funds for NIAID-supported trials conducted by the UCRC.

5. Customs Clearance and Shipment The Contractor shall utilize the established current authority for duty-free importation of supplies and equipment provided by the government of Mali under the bilateral agreement between the U.S. Department of Health and Human Services and the Malian Ministry of Higher Education and Scientific Research for the Continuation of Cooperation on the International Center of Excellence in Research.

As stated in FAR Clause 6.302-1, full and open competition need not be provided for when there is only one responsible source, and no other supplies or services will satisfy agency requirements. The current contractor, The Mitchell Group, is considered as the “only responsible source” capable of ensuring uninterrupted service of the MSC, which is critical to ensure continuation without interruption of NIAID-supported 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. 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.1 Level 4 is the highest level of travel advisory provided by U.S. DOS. Further, the U.S. Embassy in Bamako ordered the departure of non-emergency U.S. government employees and family members in July “due to heightened risk of terrorist attacks in areas frequented by westerners.”2 Further, the Embassy in Bamako advises it has “limited ability to provide emergency assistance to U.S. citizens in Mali.”3

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’detat in August 2020 and a subsequent shake up of the provisional government nine months later.4 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.5 At present, no timeframe has been agreed for new elections.

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; an action that would be required to avoid disruption of NIAID’s ongoing clinical trials. Consequently, the

1 Travel.state.gov/content/travel/en/traveladvisories/mali-travel-advisory.html cited on 10 November 2022 2 ibid 3 ibid 4 Usip.org/publications/2021/12/after-two-coups-malo-needs-regional-suppport-bolter-democracy cited 111 November 2022 5 Ibid.

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.

This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fifteen days from the date of the publication of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Contracting Office Address