Attachment 3 - Base IDIQ Statement of Work.pdf

STATEMENT OF WORK Attachment 3 RFP # 75N93024R00024 Page 1 of 8

ATTACHMENT 3 : BASE CONTRACT STATEMENT OF WORK

IN VITRO ASSESSMENTS OF ANTIMICROBIAL ACTIVITY

I. BACKGROUND AND INTRODUCTION

The National Institute of Allergy and Infectious Diseases (NIAID) supports and facilitates research that focuses on understanding, treating and, ultimately, preventing infectious, immunologic, and allergenic diseases that threaten the lives of millions of people. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports and facilitates research to understand, control and prevent human disease caused by infectious agents.

Basic, applied, and translational research to develop and assess therapeutics, vaccines, and diagnostics are supported through research grants, cooperative agreements, and contracts.

In turn, DMID supports and facilitates these funding mechanisms via an array of resources and services. These programs include bioinformatics, structural biology, biorepositories, biocontainment facilities, and pre-clinical and clinical translational research resources:

https://www.niaid.nih.gov/research/product-development-services

NIAID supports nearly all stages of the product development pipeline from in vitro therapeutic evaluation through advanced therapeutic and vaccine testing and manufacturing using multiple support services contracts. The In Vitro Assessment of Antimicrobial Activity (IVAAA) multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) program addresses a critical stage in this pipeline by providing an efficient means to assess the therapeutic potential of compounds through in vitro testing. The overarching goal of the IVAAA program is to provide capability in a broad range of in vitro testing capabilities to assess promising candidate countermeasures against the more than 270 infectious agents and vectors that are within the purview of DMID. The breadth of the IVAAA program has enabled a rapid and effective response to emerging threats such as SARS-CoV-2 and other emergency preparedness priorities.

In addition to meeting the needs of extramural researchers, the IVAAA contracts will provide crucial data to be used by NIAID partners at other agencies within the Department of Health and Human Services. Such data will facilitate the advancement of promising candidate medical countermeasures against priority emerging and bioterror infectious agents to approval or licensure and, in some cases, eventual deposit in the Strategic National Stockpile.

The IDIQ contract program has supported the evaluation of hundreds of candidate countermeasures against bacteria, fungi, and viruses. As such, in response to requests from extramural investigators for early-stage testing of their products, these contracts facilitated critical go/no-go decisions and provided data that permitted advancement of promising countermeasures into further preclinical testing.

https://www.niaid.nih.gov/research/product-development-services

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The Task Areas of the IVAAA multiple-award IDIQ Program are as follows:

Task Area A – Bacteria, Fungi, and Toxins Task Area B – Viruses Task Area C – Parasites and Vectors

Task Area D – New Techniques to Culture Difficult-to-Grow Pathogens

II. SCOPE

The Contractor shall provide a broad and flexible range of in vitro assay capabilities for human infectious diseases or diseases of human importance caused by infectious agents in one or multiple Task Areas including but not limited to product screening, assay development, and development of improved systems for in vitro culturing of difficult-to-grow pathogens.

III. DEFINITIONS

For the purposes of the IVAAA Program the following definitions apply:

• Assays – in vitro procedures for determining biological activity of a substance by measuring its effect on an organism, tissue, cell, enzyme or receptor preparation. In addition, in vitro procedures for determining the concentration, and/or purity of a substance.

• Products – broadly defined and include therapeutic substances targeting the host or the pathogen (May be used interchangeably with test article).

• Pathogens – bacteria, viruses, parasites, and fungi

• Toxins –products of microbial origin that induce a pathological effect in a host but are not the microbe itself.

• Vectors – arthropods (usually insects) or mollusks that carry pathogens from infected to uninfected hosts.

• Reagents – biochemical, genomic, molecular, cellular, and immunologic materials integral to research on these pathogens, toxins, and vectors

IV. 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.

A. TASK AREAS A, B, and C

1. In vitro Assay Development & Performance

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The Contractor shall design and develop new in vitro assay procedures, refine, or modify current in vitro assay procedures, or use available in vitro assay procedures to screen products for activity against infectious disease pathogens, toxins and/or vectors. Products to be screened will be provided to the Contractor by the Government or by third-party organizations.

The Contractor shall perform advanced studies to further evaluate product activity, e.g., combination drug testing, mechanism of action studies targeting specific steps in pathogen replication, toxin activity, and other more detailed testing. Assays pertinent to special studies shall be designed, developed, compared to existing assays, standardized, validated, and performed, as necessary.

The Contractor shall update existing assays to allow for state-of-the art evaluation of products. Assay characterization shall include: the development of positive and negative controls; optimization of assay parameters; qualification of assays with a variety and appropriate number of study samples; other studies to explore whether new assays provide meaningful data for the intended purpose; quality assurance testing of reagents, as appropriate.

a. Task Area A – Bacteria, Fungi and Toxins

Evaluation of products targeting bacteria and fungi may include: Minimal Inhibitory Concentrations (MICs) and Minimal Bactericidal Concentrations (MBCs), Post Antibiotic Effect (PAE), and disruption of biofilms. Evaluation of products targeting toxins may include the performance of enzyme kinetics, neutralization and binding assays.

All bacterial and fungal pathogens and microbial toxins that cause human disease are within the scope of contract activities for Task Area A.

b. Task Area B – Viruses

Evaluation of products targeting viruses may include, for example, CytoPathic Effect (CPE) and Viral Yield Reduction (VYR) to calculate test article effective concentration (EC50, EC90), cytotoxic concentration (CC50), selectivity index (SI), and incorporation of other endpoints such as additional mechanism of action studies, and evaluations of dose response curve slope.

All viral pathogens that cause human disease are within the scope of contract activities for Task Area B.

c. Task Area C – Parasites and Vectors Tasks involving parasitic pathogens and pathogen vectors may include the ability to determine inhibition of parasitic replication, establishment and maintenance of vector cell lines, and production of parasite and vector life cycle stages.

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All parasitic species that cause human disease and all human pathogen vectors are within the scope of contract activities for Task Area C.

B. TASK AREA D – New Techniques to Culture Difficult-to-Grow Pathogens

To produce and characterize new or difficult to cultivate pathogens, the Contractor shall systematically investigate, establish, and document conditions under which these pathogens grow in vitro. As specified in each Task Order Statement of Work, the Contractor shall submit detailed technical reports describing all effort expended towards developing and implementing strategies for culturing these pathogens, whether the strategies prove successful or unsuccessful. Detailed and reproducible Standard Operating Procedures (SOPs) shall be developed for the purpose of public dissemination for each strategy that results in successful pathogen isolation and cultivation.

V. ALL TASK AREAS

The Contractor shall provide the following services for the pathogenic agents and vectors applicable to the Task Area(s) included in the Contractor’s Base IDIQ Award:

A. Maintenance of quality-controlled stocks of pathogenic agents and vectors, cell lines, and control and test articles

1. Provide or receive stocks of cell lines, pathogenic agents, and vectors through an

NIAID repository or other sources authorized by the Contracting Officer’s Representative (COR).

2. Provide or receive reference or quality control stocks of cell lines, pathogenic agents, and/or vectors as required for quality control and quality assurance of reference products.

3. Maintain quality-controlled, viable, preserved (e.g., frozen or lyophilized) stocks of all cell lines, pathogenic agents, and/or vectors under appropriate conditions.

Where appropriate or as detailed in Task Order Statements of Work, establish, maintain, and provide master and/or working banks of pathogenic agents, cell lines, and/or vectors.

4. Assure identity of stocks to the species level using appropriate assay methods.

Assess identity beyond the species level as detailed in the Task Order Statements of Work or as directed by the COR.

5. Confirm phenotypic and, as required, genotypic resistance/susceptibility profiles for drug resistant organisms.

6. Provide SOPs for producing and characterizing pathogenic agents and vectors.

7. Maintain and document current inventory, purity, and identity assessment for each strain, cell line, or isolate.

8. Provide detailed records noting the use and disposal of pathogenic agents and/or vector stocks.

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9. Maintain stocks of control and test articles under conditions specified by the COR.

10. Provide detailed and routine quality control assessment for the performance of all cell lines, pathogenic agents, and/or vectors, and control and articles using appropriate published testing guidelines, wherever available. Clinical and Laboratory Standard Institute (CLSI) methods must be used when available unless otherwise determined by the Government.

11. Acquire, validate, and use standardized assay/organism-specific reagents and controls.

B. Protocol Development

1. Coordinate with the Government and, as necessary, Government-designated third-party product submitters, to develop study protocols to outline the establishment or execution of assays along with all method qualification or validation procedures.

2. Provide written recommendations and rationale for protocol amendments to integrate new knowledge, new or improved technologies or qualification/validation procedures, or to improve processes based on an ongoing study.

3. Prepare, implement, and deliver SOPs for methods developed as part of approved protocols.

C. Reagent Production

1. Produce new reagents and generate and/or expand renewable reagents.

2. Deposit reagents integral to new or refined in vitro assays or the development of culture systems into a NIAID repository (e.g., https://www.beiresources.org/).

D. Material Receipt, Storage, Shipping and Inventory

1. Develop, implement and maintain efficient and effective procedures for the inventory and shipment of all test and control articles, pathogens, specimens, and reagents whether developed in-house or received from third parties:

a. Obtain the appropriate licenses and permits required by international, Federal, state, and local authorities for safe transport, storage, and distribution of products, pathogenic agents or vectors, specimens, and reagents.

b. Provide for safe packaging compliant with pertinent shipping regulations, labeling, and shipping of test and control articles, pathogens, specimens, and reagents by certified carriers to ensure timely receipt.

2. Receive, catalog, track and maintain an inventory of all products, pathogens, specimens, materials, and reagents received, produced, stored, and shipped.

3. Provide secure, safe, and stable storage of products, pathogens, specimens, and reagents under the required conditions and according to specifications provided by the supplier or developed by the contractor.

E. Technical Reporting Requirements https://www.beiresources.org/

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Provide technical and other reports, records of communications with the Government, and raw data generated under Task Orders in accordance with the Reporting Requirements and Delivery Schedule set forth in each Task Order.

F. Facilities, Equipment, Other Resources, and Safety

1. Provide safe facilities, equipment, space and other resources necessary to conduct work with hazardous biological materials in compliance with all Federal and NIH regulations in accordance with current Biosafety in Microbiological and Biomedical Laboratories (BMBL), guidelines available at:

https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final- 3.pdf.

2. Where applicable, ensure compliance with the Select Agent Regulations through the Centers for Disease Control (CDC) and/or the United States Department of Agriculture (USDA) 42 CFR Part 73, 7 CFR Part 331, and/or 9 CFR Part 121. Conduct work in accordance with all applicable Federal, state and local laws, codes, ordinances and regulations.

G. Sharing Research Resources

1. Prepare and submit Technology Transfer Packages that may include operational instructions for the transfer of pathogenic agents or vectors, assays, processes, SOPs, reagents, products, and/or other materials generated under Task Order(s), to the Government, another contractor, or a designated third-party within 60 calendar days of completing development of the material generated.

a. Technology Transfer Packages for in vitro assays shall include a description of all critical features, including:

i. Pathogenic agent (source, strain, isolate or line), production methods, characterization methods, and acceptance criteria

ii. Cell lines (source, passage history where relevant, and propagation materials and methods)

iii. Detailed assay and culture methods including all critical parameters or ranges as well as expected performance of controls

iv. Control materials, such as reference standards, proficiency panels, quality control reagents, antigens, immunological reagents, etc.

v. Any required components that are commercially available, such as assay kits, cell lines, equipment, reagents, etc.

vi. Required reagents

vii. Development, qualification, and validation reports https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73 https://www.ecfr.gov/current/title-7/subtitle-B/chapter-III/part-331 https://www.ecfr.gov/current/title-9/chapter-I/subchapter-E/part-121

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b. Technology Transfer Packages for pathogenic agents shall include a description of all its critical features, including:

i. Growth or production methods, including all media components, cell lines, and environmental conditions

ii. Purification methods for toxins

iii. Quality control methods, including tests for identity, purity, concentration/titer, virulence, microscopic characteristics, growth characteristics, special plating and/or stains, sequencing, confirmation of resistance/susceptibility phenotype, etc.

iv. Provenance of the pathogenic agent, in vitro and in vivo culture or passage history, and data supporting its use

2. Submit reagents and pathogen stocks generated under this contract to an NIAID repository as directed by Task Order Statement(s) of Work, including documentation to support the production, characterization, and history.

H. Project Management

1. Overall Project Management:

a. Provide for the overall management, integration, and coordination of all contract activities, including the technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all activities carried out under this contract.

b. Provide and implement plans for the management, integration, and coordination of all timelines and budgets.

2. Communication Management:

Plan and conduct meetings in accordance with the requirements set forth in each Task Order.

a. Task Order Kickoff Meetings

i. Within 30 calendar days of the effective date of each Task Order award, participate in a Task Order initiation meeting or teleconference.

ii. To orient the Contractor to NIAID task order procedures, review contract/task order requirements, and to plan implementation of Task Order activities.

b. Regular Task Order Teleconference(s)

Plan, conduct, and record the meeting minutes for teleconferences held to review protocols, data, and the status of in-progress studies, and to discuss any matters relevant to the scientific and financial administration of the contract and

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c. Site Visit(s)/Audit(s) Arrange for and host site visits or audits with the Government to review and discuss project progress; obstacles and approaches to overcome them;

recommendations for modifications to project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans.