HHS-NIH-NIAID-BAA2026-1 - Solicitation.pdf

Requiring Office: National Institute of Allergy and Infectious Diseases 5601 Fishers Lane, MSC 9821, Bethesda, MD 20892-9821

Issuing Office: National Institutes of Health NIH OD/OA/R&D Division A-3, OALM 6701 Rockledge Drive, RKL2, 4th Floor

Bethesda, MD 20817

Contracting Officer: Alexandra J. Buck, JD Email: NIAID_DMIDOmnibusBAAQuestions@nih.gov

This solicitation contains opportunities to submit a proposal under the following distinct Research Areas, which are identified below:

RESEARCH

AREA

TITLE PAGE

NO.

PROPOSALS DUE*

Vaccine Candidates

December 8, 2026

Therapeutic Candidates

In Vitro Diagnostics

* Proposals must be received before 3:00 PM Eastern Standard Time on the date specified herein. Please see the Proposal Submission Instructions (Section 4.3.2.1) for more information. For planning purposes, the Government requests potential Offerors to submit a Notice of Intent. Please see Notice of Intent (Section 4.3.2.1.4) for more information.

Offers will be valid for 240 days unless a different period is specified by the Offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043”.

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2027 Division of Microbiology & Infectious Diseases (DMID)

Omnibus Broad Agency Announcement (BAA):

Development of Medical Interventions for Infectious Diseases

No. HHS-NIH-NIAID-BAA2026-1

Solicitation Issue Date: October 9, 2026

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2027 DMID Omnibus Broad Agency Announcement No. HHS-NIH-NIAID-BAA2026-1

TABLE OF CONTENTS

SECTION 1 – Broad Agency Announcement Information…………………………………………………….p. 3

SECTION 2 – Contracting Officer Point of Contact……………………………….………..…………….........p. 3

SECTION 3 – Research Areas and Technical Objectives……………………………….……..…..…………...p. 3

3.1 – Division of Microbiology and Infectious Diseases (DMID) Background………………….………p. 3

3.2 – Funding and Award Information………………………………...………...………………..………p. 4

3.3 – Research Areas

3.3.1 – Research Area 001: Vaccine Candidates……………………………….…………..p. 5

3.3.2 – Research Area 002: Therapeutic Candidates……………………… ……………...p. 7

3.3.3 – Research Area 003: In Vitro Diagnostics………………………………………....p. 10

3.4 – Research Areas 001 and 002: Additional Technical Proposal Instructions………………..........p. 12

3.5 – Research Areas 001 and 002: Reporting Requirements and Deliverables …………………….p. 15

3.6 – Research Area 003: Additional Technical Proposal Instructions ………..…………………….p. 21

3.7 – Research Area 003: Reporting Requirements and Deliverables………………………………p. 23

SECTION 4 – Instructions, Conditions, and Notice to Offerors……………………………………………….p. 26

4.1 – General Instructions to Offerors …………………………………………………………………...p. 26

4.2 – General Information………………………………………………………………………………p. 29

4.3 – Instructions to Offerors…………………………………………………………………………...p. 31

4.3.1 – General Information…………………………...………………...………...……...........p. 31

4.3.2 – Technical Proposal Instructions …………………………………………….…….…....p. 36

4.3.3 – Business Proposal Instructions……………………………………………………………p. 68

SECTION 5 – Special Contract Requirements………………………………………………………………....p. 84

SECTION 6 – Evaluation Factors for Award...……………………………………………………………….p. 115

SECTION 7 – Definitions…………………….……………………………………………………………….p. 123

SECTION 8 – Attachments…………………...……………………………………………………………….p. 125

SECTION 1. - BROAD AGENCY ANNOUNCEMENT INFORMATION

You are invited to submit a proposal in accordance with the requirements of this BROAD AGENCY ANNOUNCEMENT (BAA). The BAA is governed by the Revolutionary Federal Acquisition Regulation (RFO FAR) Overhaul 6.102 and further described in RFO FAR 35.016 as well as the National Institutes of Health (NIH) Policy Manual, Manual Chapter 6035, Broad Agency Announcements. A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and that part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature, identifying areas of research interest, and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.

This BAA contains three (3) distinct Research Areas 001, 002 and 003. Offerors may submit a proposal in response to one, or more, of the Research Areas contained herein. Offers submitted in response to this BAA must present separate detailed technical and business proposals designed to meet the Technical Objectives described for each Research Area proposed. The Statement of Work (SOW), including the specific technical requirements and performance specifications, is developed and proposed by the Offeror, not the Government.

Proposals are NOT evaluated against each other since they are not submitted in accordance with a common SOW issued by the Government. Instead, Research and Technical Objectives are provided in the BAA that describe individual Research Areas in which the Government is interested. Proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in Section 6. The Government reserves the right to conduct discussions about all, some, one, or none of the proposals received in response to this BAA. If discussions are conducted, the National Institute of Allergy and Infectious Diseases (NIAID) reserves the right to suggest modifying, adding, or deleting milestones, decision points, research plans, processes, schedules, budgets, or products. The Government also reserves the right to make awards without discussions. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award. Multiple awards are anticipated. The selection for award under this BAA will be based upon the evaluation factors, importance to agency priorities, and the availability of funds.

SECTION 2. - CONTRACTING OFFICER POINT OF CONTACT

This BAA contains Research Areas issued by the Division of Microbiology and Infectious Diseases (DMID) within NIAID. The Contracting Officer (CO) point of contact for BAA questions is identified below.

Point of Contact:

Alexandra J. Buck, JD National Institutes of Health NIH OD/OA/R&D Division A-3, OALM

6701 Rockledge Drive, RKL2, 4th Floor Bethesda, MD 20817

Email: NIAID_DMIDOmnibusBAAQuestions@nih.gov

SECTION 3. - RESEARCH AREAS AND TECHNICAL OBJECTIVES

3.1 – DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID) BACKGROUND

NIAID, one of 27 institutes of the NIH, an agency within the Department of Health and Human Services (DHHS); conducts and supports research to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten the health and longevity of human lives.

mailto:NIAID_DMIDOmnibusBAAQuestions@nih.gov

Through a variety of research grants and contracts, NIAID’s DMID specifically supports extramural research to develop new medical interventions against infectious disease threats to include drug-resistant pathogens. NIAID/DMID intends to use this BAA to help address goals articulated in a number of strategic plans, such as in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan (https://aspr.hhs.gov/PHEMCE/2024-PHEMCE-SIP/Pages/default.aspx), as well as current prioritized antimicrobial resistant threats identified by national death and infection estimates as determined by the Centers for Disease Control and Prevention’s (CDC) to prevent and control antimicrobial resistance (https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html) In addition, NIAID/DMID intends to use this BAA to encourage projects that align with the NIH priorities of enhancing rigor & reproducibility, improving biosafety and biosecurity, and the use of complementary non-animal testing methods where appropriate.

NIAID intends to use this BAA to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for infectious diseases in each of three (3) Research Areas described in Section 3.3 below.

3.2 – FUNDING AND AWARD INFORMATION

Contract funding for therapeutic and vaccine development will support preclinical candidate development, Investigational New Drug (IND)-enabling studies, manufacturing, and Phase 1 and/or early Phase 2 clinical trials. Within funding and under special circumstances, platform trials that allow simultaneous comparison of multiple intervention groups against a single control group or a trial that includes sequential stages are permitted. Contract funding for diagnostics will support phases of in vitro diagnostic (IVD) product development from late-stage feasibility research through planning and design, development, up to and including final clinical validation. Contracts resulting from this BAA shall not reimburse costs incurred in connection with work performed outside the contract’s period of performance. Costs incurred before the contract’s effective date or after its completion date are unallowable and cannot be charged to the contract.

For all Research Areas, the total duration of a proposed contract should be consistent with the nature and complexity of the Offeror’s proposed research and may vary depending on the scope of the project and the technical objectives. The total performance period includes the Base Requirement plus all Options proposed by an Offeror and shall not exceed an estimated 5 years. If applicable, clinical trial activities are encouraged to start as soon as possible and be completed within the 5-year period. Revisions to the completion date will be considered by the Government during contract performance.

Research Areas 001, 002 and 003: For Fiscal Year (FY) 27, NIAID estimates up to $16 million for the award of up to 4 cost reimbursement completion type contracts. The estimated FY 27 funding is for the non-severable Base Requirement (direct and indirect costs combined) only. If options are proposed by an Offeror, they will be evaluated in accordance with Section 6 of the BAA. The number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

For Research Area 001, 002 and 003 awards are anticipated to be made in or around May 2027. At the discretion of the Government, awards may be streamlined to meet agency needs.

https://aspr.hhs.gov/PHEMCE/2024-PHEMCE-SIP/Pages/default.aspx https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html https://www.nih.gov/about-nih/nih-director/statements/advancing-nihs-mission-through-unified-strategy

3.3 – RESEARCH AREAS

3.3.1.1 – Technical Objectives

The objective is to develop vaccine candidates through an early phase clinical trial that use a needle free (i.e., alternative to classical needle and syringe, see below for description) route of delivery to protect against infections caused by viral pathogens that include but are not limited to respiratory and vector borne viruses.

3.3.1.2 – Technical Approach

The scope of this vaccine research area includes the preclinical development of a needle free vaccine candidate, IND enabling studies, limited process development, Good Manufacturing Practice (GMP) compliant manufacturing, regulatory submissions to the U.S. Food and Drug Administration (FDA) and conduct of a Phase 1 or early Phase 2 clinical trial. The scope of work must include a clinical trial.

Offerors must propose a single vaccine candidate for protection against a specific viral pathogen. The vaccine candidate may provide a breadth of protection against other viral strains or viruses.

A strong justification is required to support (1) the proposed vaccine antigen and platform for the disease indication, (2) the use of a clinically relevant adjuvant (if needed), and (3) a clinically relevant needle free route of delivery.

The required quality of the proposed vaccine antigen and platform is defined below:

• The proposed antigen must be already defined; Antigen discovery is not allowed.

• The proposed platform may include but is not limited to live attenuated viruses, chimeric viruses, inactivated subunit vaccines, mRNA and nanoparticles.

• Prefer to have GMP material available within the second year of the contract award.

• May propose limited process development, GMP manufacture, and release of vaccine drug product within the second year of the contract award.

Adjuvant(s) may be included as part of the vaccine formulation. The proposed adjuvant(s) must have the required quality as defined below:

• New adjuvant development is not allowed.

• Adjuvant(s) must have been used in a prior Phase 1 clinical trial and demonstrated safety

• GMP adjuvant(s) must be available within the second year of the contract award.

Needle free delivery system and/or device includes but is not limited to microneedle or microarray patches, peel and stick technologies, needle free injection devices, mucosal sprayers and atomizers, oral tablets, liquids, and films. The proposed delivery system and/or device must have the required quality as defined below:

• Preference will be given to systems or devices that have been used in a prior Phase 1 clinical trial.

• GMP material must be available within the second year of the contract award.

3.3.1- Research Area 001 – Vaccine Candidates

The vaccine candidate proposed, i.e., the combination of antigen, platform, adjuvant (if relevant), and needle-free device, must have preliminary preclinical data to demonstrate immunogenicity as proof of concept.

NIAID will prioritize technically acceptable proposals based on programmatic need, maturity of the candidate product, and risk/benefit assessment.

The scope of work awarded will depend on the developmental stage of the clinically relevant vaccine candidate as demonstrated by the background and existing preliminary data provided in the proposal.

The background should include:

1. Disease indication and gaps in corresponding medical intervention pipeline.

2. Justification/rationale based on disease indication for the antigen, platform, adjuvant, and delivery system.

3. Any clinical data to support selection of the antigen, platform, adjuvant, or delivery system.

4. Any proof-of-concept data in a relevant animal model study or clinical trial to support the proposed vaccine candidate.

5. Description of current manufacturing processes, critical reagents including master banks, vaccine components in proposed final formulation, characterization and release assays, and stability studies.

Describe the current quality of these items as non-GMP, GMP, developed, qualified, and/or validated.

6. Any ongoing or completed IND enabling activities including toxicology studies and regulatory submissions.

Proposals must provide a development plan for the vaccine candidate based on the current development stage of the candidate that should include:

1. A Target Product Profile (TPP).

2. Plan to procure, develop and manufacture all required critical reagents including master banks and vaccine components including drug substance, drug product, adjuvants, and delivery systems.

3. Any relevant intellectual property (IP) or relevant collaborations/partnerships required for access to vaccine components.

4. Plan for assay development, release testing, and stability studies.

5. Development, submission, and sponsorship of an IND or equivalent regulatory submission in compliance with all regulatory requirements.

6. Plan for any IND enabling activities including toxicology studies and point of use studies.

7. Clinical trial development synopsis/plan.

Offerors responding to this Research Area, collectively with the proposed subcontractors and consultants where applicable, must have documented expertise in vaccine development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against infectious diseases identified in the Technical Objectives.

3.3.1.3 - Contracts awarded under Research Area 001 will NOT support the following activities. Proposals containing any of these activities will be excluded from peer review and will not be considered further for award:

a. Basic research and discovery of new antigens, adjuvants, or vaccine candidates.

b. Development of devices or diagnostics in the absence of a companion vaccine product.

c. Development of therapeutics.

d. Monoclonal antibodies, including those intended for prophylactic use.

e. Trained immunity: vaccine candidates that do not elicit an antigen-specific adaptive immune response and that are unlikely to elicit a memory immune response that persists beyond 28 days.

f. Adenoviral and DNA based vaccines.

g. Vaccines for SARS-CoV-2, Zika, filoviruses, and Lassa virus.

3.3.2 – Research Area 002- Therapeutic Candidates

3.3.2.1 – Technical Objectives

The objective is to develop safe, effective, new therapeutic products that will improve patient outcomes against serious infectious diseases for which there are no approved therapeutics, or for those that are refractory to treatment despite appropriate antimicrobial therapy or due to pathogen resistance. Infectious diseases caused by the following viruses, bacteria and fungi pathogens are targeted:

a. Viral hemorrhagic fever viruses (e.g., EBOV, SUDV, MARV, LASV, hantavirus) https://www.cdc.gov/viral-hemorrhagic-fevers/about/index.html

b. Encephalitic paramyxoviruses (e.g. hendra virus, nipah virus)

c. Picornaviruses (broad spectrum approaches that include EV68, EV70 and coxsackie virus)

d. At least two of the following (i.e., addressed with a broad spectrum antimicrobial): susceptible and carbapenem-resistant Enterobacteriaceae (CRE), susceptible and multidrug resistant (MDR) Pseudomonas aeruginosa, and susceptible and Carbapenem-resistant Acinetobacter (CRAB), with potential to improve patient outcomes in the clinic; Candida auris, Cryptococcus spp., Aspergillus fumigatus, and/or Mucorales

Adjunct medical interventions to support or enhance effectiveness of antimicrobial agents to address underlying pathology that is not resolved after clearance of pathogens, may be considered.

Important notice to Offerors: For this Research Area, “therapeutic” activity means curing disease by eliminating or substantially reducing infective pathogens by administering antimicrobial pharmaceutical agents, with or without a host-directed therapy. Additionally, proposed therapeutic products should consider the impact on a healthy microbiome.

Preventative treatments are not included in the scope of this Research Area.

A therapeutic candidate refers to an advanced lead series, preclinical candidates, or a clinical candidate, that is a new chemical entity. This includes small molecules, natural products, nucleosides, or peptides of </= 40 amino acids, monoclonal antibodies, nanobodies, nanobody conjugate/fusion products, microbiome-based therapeutics or bacteriophages.

3.3.2.2 – Technical Approach This Research Area will support lead optimization, pre-clinical Investigational New Drug (IND) enabling studies, and Phase 1 clinical trials (or proof of concept Phase 2 clinical trials) of lead candidates with demonstrated therapeutic activities. This includes support for traditional, novel (e.g., small molecules) and non-traditional (e.g., including but not limited to phage, and host-directed) therapeutics for infectious diseases where patients lack effective interventions, as well as therapeutics that promote host-mediated resolution of disease. The scope of support differs depending on the https://www.cdc.gov/viral-hemorrhagic-fevers/about/index.html developmental stage of the project being proposed, as outlined below:

Entry Point of the Proposal Desired End Point Lead Optimization Selection of pre-clinical candidate(s) and completion of non-Good Laboratory Practice (non-GLP) IND enabling activities with no Good Manufacturing Practice (GMP) manufacturing (3 years period of performance)

Pre-Clinical Candidate Completion of IND enabling activities, GMP manufacturing and Phase 1 clinical trial (3-5 years period of performance)

Clinical Candidate Completion of clinical trial (3 years period of performance)

Proposals that include Lead Optimization are expected to select a single pre-clinical candidate therapeutic by the end of the base period and complete non-GLP IND-enabling activities (non-GMP manufacturing) within 3 years of performance. Lead optimization activities must be performed within the base period. Projects that include lead optimization must not include GMP manufacturing or a Phase 1 clinical trial.

Proposals that do not include Lead Optimization and have identified a pre-clinical (or later stage) candidate are expected to complete any required preclinical and IND-enabling studies as well as evaluation in a Phase 1 clinical trial within the proposed 3-5 years period of performance. The Government will consider any revision to the Phase 1 completion date beyond the 3-5 years during contract performance.

Proposals only seeking support for Phase 1 clinical trial conduct will also be considered if successful completion of all required IND-enabling studies is demonstrated.

Description of Activities within Each Development Stage:

Lead Optimization

• Optimizing a lead series by generation of new analogs with improved indicators of potency, safety, pharmacokinetics, and physiochemical properties compatible with the Target Product Profile (TPP).

• Conducting non-GLP in vivo toxicology aligned with the TPP.

• Conducting in vivo efficacy determination in the appropriate models of disease consistent with the

TPP.

• Conducting experiments to identify pharmacokinetic/pharmacodynamic (PK/PD) relationships and define efficacious exposure targets for further pre-clinical and clinical studies.

• Selecting a preclinical candidate and initiating IND-enabling studies.

Pre-Clinical (IND Enabling) Studies

• Demonstrating acceptable absorption, distribution, metabolism, and excretion (ADME) characteristics in non-GLP animal studies as necessary for IND filing of selected lead(s).

• Conducting non-GLP and GLP non-clinical studies for toxicology, pharmacology, and immunogenicity (as appropriate).

• Continuing development/refinement of appropriate models (includes animal and non-animal/alternative; the use of the latter is encouraged) for determining efficacy and defining PK/PD relationships for further preclinical and clinical studies.

• Developing a scalable and reproducible manufacturing process amenable to GMP manufacturing of the drug substance (DS) and drug product (DP).

• Manufacturing and stability testing of non-GMP and GMP-compliant DS and DP.

• Developing in-process assays and analytical methods for product characterization and release, including assessments of potency, purity, identity, strength, sterility, and quality as appropriate.

• Preparing and submitting an IND to the FDA.

Phase 1 Clinical Trial

• Conducting Phase 1 clinical safety trial(s) to determine the initial adverse event profile and pharmacokinetics of the clinical test article.

Phase 2 Clinical Trial Conducting an early Phase 2 clinical safety and preliminary efficacy trial to determine adverse effect profiles , pharmacokinetics, and efficacy of the clinical test article in a sufficient number of patients to achieve adequate statistical power.

3.3.2.3 - Additional Requirements

1. Stage-appropriate data must be provided. For proposals that include Lead Optimization, stage-appropriate data demonstrates achievement or near-achievement of lead (i.e., preclinical candidates) selection criteria by exemplars of the proposed lead series. For all other proposals, a single entity, the proposed preclinical candidate, or clinical candidate (i.e., drug substance or product) to be developed under the contract, must demonstrate achievement or potential to achieve all minimally acceptable criteria of the TPP.

2. In addition to proposal requirements in Sections 3.4 and 4 of this solicitation, proposals submitted to this Research Area must include the following additional criteria and supporting data:

a. For non-bacteriophage products:

1. Complete chemical structure of the most advanced lead, preclinical, and clinical candidate, or, in the case of monoclonal antibody - or nanobody conjugates/fusion, a precise description of the product candidate composition. The proposal is confidential and the composition of matter pertaining to the proposal must be disclosed in the proposal.

2. Monoclonal antibody and nanobody conjugate/fusion production, purification, and release assay data. The purity and size of the nanobody product as detected; e.g., by SDS-PAGE, size exclusion chromatography, etc.

3. Complete chemical structures or compositions for all entities for which experimental data is provided.

4. A Medicinal Chemistry Plan (small molecules) or a Protein Engineering Plan (mAb and nanobody-conjugate fusion product), to be executed in the base period of performance if Lead Optimization for small molecule- and monoclonal antibody, nanobody conjugate/fusion product, respectively is proposed. Lead optimization may only be proposed in the base period of performance.

5. In vitro efficacy against the target or targets identified in the TPP. In vitro activity against animal-adapted pathogens is acceptable with reasonable justification; however, the proposal should include planned studies against clinically relevant microbes identified in the TPP.

6. In vitro assessment of absorption, distribution, metabolism, excretion, and toxicity

(ADMET).

7. Therapeutic efficacy in an animal model of disease is relevant to the indication identified in the TPP. Efficacy testing must include studies where the first dose occurs after the challenge.

8. In vivo toxicology using a dosing route and regimen consistent with the TPP.

9. In vivo PK in a relevant species with a dosing route and regimen consistent with the

TPP.

b. For bacteriophage products:

1. Must be relevant to the indication identified in the TPP. Efficacy testing must include dosing after the challenge.

2. A full discussion on the characterization of the phage or phage cocktail product including, but not limited to, specificity, spectrum, complete phage sequence(s) and sequences of engineered genes, and confirmation of absence of deleterious genes,

3. Potential for toxicology requirements if the phage or phage cocktail product contains engineered genes.

4. Other relevant data on product purity, toxicity, tissue, distribution, PK, etc.

Offerors responding to this Research Area, collectively with the proposed subcontractors and consultants, where applicable, must have documented expertise in drug discovery and development, including demonstrated knowledge of regulatory guidelines, and submission processes for candidate products directed against emerging infectious diseases.

3.3.2.4 – Contracts awarded under Research Area 002 will NOT support the following activities and proposals containing any of these activities will be excluded from peer review and will not be considered further for award:

a. Basic research, including target validation, high throughput screening, mechanism elucidation, lead series discovery, hit-to-lead optimization, and in vitro assay development.

b. Development of a product that is prophylactic, post-exposure prophylactic, or otherwise not therapeutic.

c. Development of only backup candidates.

d. Development of a product that is derived from, substantially similar to, or identical to an entity that has ever entered a Phase 3 clinical trial or has been approved for human or veterinary use in any jurisdiction worldwide. Such products include, but are not limited to, combinations not containing a novel agent, prodrugs, alternate salt forms, crystal forms, formulations, dosing regimens, or clinical indications.

e. Development of a product that functions as a topical antiseptic.

f. Development of a product derived from serum.

g. Development of a device as the product or as a component of a product (such as a diagnostic or drug delivery device). Use of an existing device that does not require development is allowed.

h. Research involving human fetal tissue.

3.3.3 – Research Area 003 - In Vitro Diagnostics

3.3.3.1 Technical Objectives

The objective of Research Area 003 is to develop innovative, technology platforms that will speed detection and identification of infectious viruses covering a broad panel of virus families, including viruses causing acute infections as well as those causing chronic infections. Technology platform innovation to achieve faster actionable sequencing results (approaching 2 hr) direct from primary clinical specimens, as well as more accessible workflow and configuration (i.e., point-of-care) are preferred. Furthermore, full sample-to-answer platform solutions are preferred.

The system should accept specimen volumes from 0.5 to 5 milliliters (mL). System should include nearly full automation (little or no hands-on activity after specimen has been loaded into system).

Sample preparation components of the system should yield sufficient analyte recovery from a starting titer of 10-100 genomic copies per mL of biofluid for downstream analysis, including detection, identification, and characterization of the nucleic acid material.

Innovations during platform development might include, for example:

• Automated sample prep for high recovery from low pathogen load.

• Faster specimen-to-answer for total test time <2 hours.

• Broad viral pathogen detection capability, covering one or more members of the priority pathogen families (see below).

• Targeted, or even untargeted pathogen detection and identification via long-read sequencing or other detection methods.

• Multiple specimen throughput per run for reduced cost.

• Analytical sensitivity approaching 5-50 genome copies per mL of starting biofluid.

• Assay reconfigurability to respond rapidly to a novel pathogen in days or weeks rather than months

(i.e., agnostic diagnostic solution).

Priority Pathogens

The diagnostic test system must detect analytes from at least one, and preferably several, of the following agents and markers:

• Arenaviridae (e.g., Lassa virus)

• Phenuviridae (e.g., Rift Valley fever virus)

• Peribunyayviridae (e.g., Oropouche virus)

• Hantaviridae (e.g., Hantavirus)

• Nairoviridae (e.g., Crimean Congo Hemorrhagic fever virus)

• Filoviridae (e.g., Sudan virus, Ebola virus, Marburg virus)

• Flaviviridae (e.g., Hepatitis C virus, West Nile Virus)

• Paramyxoviridae (e.g., Nipah virus)

• Togaviridae (e.g., Chikungunya virus)

• Picornaviridae (e.g., Enterovirus)

3.3.3.2 – Technical Approach

Technical Approach should begin with a target product profile (TPP) table as an introductory summary description of what the diagnostic test will be and will do. The TPP should be followed by a presentation of completed foundational preliminary data that go beyond proof-of-concept and are part of feasibility-phase testing, justifying the continued development of the diagnostics test. The approach should continue with a well-defined product development plan that demonstrates a path to Design Verification and Validation and towards regulatory submission, including a description of, e.g., quality systems, regulatory strategy, systems integration, infectious disease expertise, clinical affairs, etc.

Further, offerors should confirm that they have, or plan to obtain, access to all reagents, isolates, clinical samples, as well has demonstrate that they have the facilities and capabilities to perform all proposed development work.

3.3.3.3 - Contracts awarded under Research Area 003 will NOT support the following activities.

Proposals containing any of these activities will be excluded from peer review and will not be considered further for award:

a. Development of a diagnostic test that does not include at least one of the above-listed agents in the

Priority Pathogens section.

b. Development of a diagnostic test that relies solely on host-response markers (antibodies, other proteins, or RNA).

c. Development of diagnostic test that will only be validated using surrogate organisms.

d. Development of only a single component or subsystem of an entire viral detection platform.

3.4 – RESEARCH AREAS 001 AND 002 - ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS

The following information supplements Section 4 – Instructions, Conditions, and Notices to Offerors of this solicitation, and should be used for preparing proposals in response to Research Area 001 and 002.

Separate and distinct proposals must be submitted for each Research Area to which you are proposing.

3.4.1 - CLINICAL TRIAL PROTOCOL DEVELOPMENT AND IMPLEMENTATION

Human subjects research may be carried out under this contract with the approval of DMID. A clinical trial can be conducted within the U.S. and/or globally. If successful, clearance by the U.S. Department of State must be obtained prior to awarding a foreign contract, a foreign subcontract, or a domestic contract with a foreign component. Describe experience in the conduct of human subjects research and clinical trials in accordance with DMID, NIAID, and NIH policies and guidelines and provide a statement acknowledging willingness to conduct clinical research according to these policies and in accordance with applicable International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and FDA regulations and guidance. NIH policy is published at https://grants.nih.gov/policy/clinical-trials.htm; NIAID policy can be found at https://www.niaid.nih.gov/research/niaid-clinical-research-standards; DMID forms and policies are at https://www.niaid.nih.gov/research/dmid-clinical-research-policies. A synopsis of Instructions for the Conduct of Contractor-Held IND Clinical Trials Performed under a Contract can be found here (https://www.niaid.nih.gov/sites/default/files/baaclinical.pdf). Upon completion of protocol development, DMID will determine if the Offeror will hold the IND and conduct the clinical trial, using the form “Request to Sponsor an IND/Investigational Device Exemption (IDE) for a DMID-Funded Clinical Trial.” The form will be included as an attachment to the contract award.

Provide a Protocol Synopsis for each proposed clinical trial, including a brief description of the following:

• Study objectives and endpoints.

• Human subjects protections.

• Provisions for data monitoring and safety reports.

• Draft inclusion/exclusion criteria and recruitment, and retention of study participants.

• Planned enrollment by racial and ethnic categories and sex.

• Summary of statistical approaches.

• Platform trials proposed must include details about the interventions to be included. Platform trials must contain sufficient detail to assess the totality of planned interventions and overall study size.

Document experience of the Offeror and any proposed subcontractor(s) and consultant(s) with designing early phase clinical trials, executing early phase clinical trials and managing early phase clinical trials in compliance with regulatory requirements and Good Clinical Practice (GCP).

https://grants.nih.gov/policy/clinical-trials.htm https://www.niaid.nih.gov/research/niaid-clinical-research-standards https://www.niaid.nih.gov/research/dmid-clinical-research-policies https://www.niaid.nih.gov/sites/default/files/baaclinical.pdf

Provide a plan that specifies at which points in the SOW it will be critical to engage in communications with the FDA and how NIAID will be kept apprised of such communications.

3.4.2 - REGULATORY COMPLIANCE, QUALITY CONTROL & ASSURANCE, AND

DATA MANAGEMENT

• Describe the data management and quality control systems/procedures that will be used for all studies and procedures in accordance with 21 Code of Federal Regulations (CFR) 11.

• Describe the statistical design and analysis resources that will be used to support contract activities.

• Provide a plan to develop and maintain quality assurance documentation to support adherence to FDA regulatory standards and guidance.

• Document experience of the Offeror and any proposed subcontractors and consultants experience with performing regulated studies in accordance with FDA regulations and guidance, including Good Laboratory Practices (GLP), Current Good Manufacturing Practices (cGMP), and/or GCP guidelines as appropriate to their proposed SOW.

• Provide an audit history and audit plan to determine when audits need to be performed, timely scheduling of audits, performance of audits, and responding to audit reports.

• Additional NIAID audits may be performed on nonclinical studies for products anticipating market approval under the FDA Animal Rule.

3.4.3 - UNIFORM COST ASSUMPTIONS

Offerors should use the following assumptions for the purposes of estimating costs and preparing the technical proposal:

1. Audits: Assume Quality Assurance (QA) audits of critical phases for the duration of the contract period of performance. For example, anticipate a GLP audit of toxicology site, GMP audit of manufacturing site, and GCP audit of clinical site.

2. Purchase of Equipment: Cost will NOT be allowed for the purchase of any equipment, hardware, or software under this contract.

3. Alterations and Renovations: Cost will NOT be allowed for any facility construction, alterations, or renovations under this contract.

4. Programmatic Presentations and Meetings:

a. Post Award Contract Initiation Meeting

The Contractor shall be responsible for arranging a one-day meeting at 5601 Fishers Lane, Rockville, MD or at the Contractor’s facility within 60 days from effective date of award and shall be attended by the Contractor and the key personnel. Assume all cost for the travel of key personnel. Non-key personnel may participate virtually.

b. Annual Contract Review Meetings

For each year of performance, the Contractor shall arrange a one-day Annual Contract Review Meeting and shall be attended by the Contractor, and the key personnel; non-key personnel may attend virtually. The meeting may be held at either the Contractor’s facility or at 5601 Fishers Lane, Rockville, MD, at the discretion of the Contracting Officer’s Representative (COR). The first annual meeting will be held 12-18 months after effective date of award and thereafter, every 12 months from anniversary date. Assume all cost for the travel of key personnel.

c. Monthly Meetings/Teleconferences

The Contractor Principal Investigator (PI) and Project Manager shall plan, conduct, and participate in meetings with the COR at a minimum of monthly intervals via teleconference to discuss progress, problems, proposed solutions, and any matter that is relevant to the scientific and financial administration of the project and future activities. The schedule for these meetings will be established by the COR after contract award. The Contractor shall prepare the meeting agenda and distribute the agenda and background materials to all meeting participants at least 2 business days in advance of the meeting. The Contractor shall prepare and provide a summary of all meeting and teleconferences to the COR within the timeframe stated in the delivery schedule and include each summary in the Monthly Progress Reports.

3.4.4 - POST-AWARD REQUIREMENTS

The following post-award requirements will apply to all awards made under Research Areas 001 and 002 of this BAA.

Offerors are instructed to address responsibility for complying with these requirements in the proposed SOW for the Technical Proposal. Offerors are NOT required to submit documentation to address these post-award requirements in their technical proposals. Instructions for submitting documentation associated with post-award requirements will be provided during negotiations.

3.4.4.1 - Contractual Commitments

Upon award of a contract, the Contractor shall be required to make legal commitments through acceptance of Government contract clauses. The outline that follows is illustrative of the types of provisions required by the Federal Acquisition Regulations (RFO FAR) that shall be included in the contract. This is not a complete list of provisions to be included in contracts, nor does it contain specific wording of these clauses. Copies of complete terms and conditions applicable to your contract will be provided during negotiations.

1. Inspection: Work performed under the contract is subject to Government audits, inspections, and evaluations at all times.

2. American-made Equipment and Products: When purchasing equipment or products under a contract award, the Contractor shall purchase American-made items whenever possible.

3. Termination for Default: The Government may terminate the contract for default if the

Contractor fails to perform the work described in the contract and such failure is not the result of excusable delays.

4. Contract Work Hours: The Contractor may not require an employee to work more than eight hours a day or forty hours a week unless the employee is compensated accordingly (i.e., overtime pay).

5. Covenant Against Contingent Fees: No person or agency has been employed to solicit or secure the contract upon an understanding for compensation except bona fide employees or commercial agencies maintained by the Contractor for the purpose of securing business.

6. Disputes: Any dispute concerning the contract that cannot be resolved by agreement shall be decided by the Contracting Officer, with right of appeal.

7. Equal Opportunity: The Contractor will not discriminate against any employee or applicant for employment because of race, color, religion, sex, or national origin.

8. Gratuities: The Government may terminate the contract if any gratuities have been offered to any representative of the Government to secure the contract.

9. Termination for Convenience: The Government may terminate the contract at any time for convenience if it deems termination to be in its best interest, in which case the Contractor will be compensated for work performed and for reasonable termination costs.

10. Patent Infringement: The Contractor shall report each notice or claim of patent infringement based on the performance of the contract.

3.5 - RESEARCH AREAS 001 AND 002 – REPORTING REQUIREMENTS AND

DELIVERABLES

3.5.1 - Reporting Requirements

In addition to reporting requirements and deliverables identified elsewhere in this solicitation, it is expected that awards resulting from Research Areas 001 and 002 will include the following reports and deliverables:

a. Monthly Progress Reports

This report shall include a description of the technical activities (for the prime contractor and any associated subcontractor activities), results during the reporting period, and the activities planned for the ensuing reporting period. In addition, this report shall include a budget summary for costs incurred during the monthly reporting period for the base period and each option and milestone. The funding level shall be presented in correlation with percent completion of the activities under the base, option and/or milestone. A risk analysis must be included in the monthly report and address identified risks and mitigation plans associated with the specific tasks included in the monthly report. A Monthly Progress Report is not required when the Annual Progress Report is due.

b. Annual Progress Reports

This report shall include a summary of the technical activities and results for the entire one-year period.

This report shall also include a description of the technical activities performed and results obtained during the annual reporting period. A budget summary for costs incurred during the annual reporting period for the base period, each option and milestone shall be presented in correlation with percent completion of the activities under the base, option and/or milestone. An Annual Progress Report is not required when the Final Report is due.

c. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of racial and/or ethnic minority groups and their subpopulations (when appropriate) for each study being performed under this contract.

The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative

Inclusion Enrollment Reports.

In addition, the “NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups as Subjects in Clinical Research”, effective August 16, 2025 also applies. If this contract is for Phase III clinical trials, see Section B of these guidelines. The Guidelines may be found at the following website:

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex , racial, and/or ethnic groups, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex, racial and/or ethnic groups.

d. Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent , the following information shall also be included in each Annual Progress Report:

1. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a

Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

2. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

a. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b https://www.selectagents.gov/regulations/index.htm ) or listed on the U.S. Federal Select Agents Registry restricted experiments website ( https://www.selectagents.gov/compliance/guidance/restricted/index.htm);

c. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Annual Progress Report.

https://grants.nih.gov/policy/inclusion/women-and-minorities.htm https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html https://www.selectagents.gov/regulations/index.htm https://www.selectagents.gov/regulations/index.htm https://www.selectagents.gov/compliance/guidance/restricted/index.htm https://www.selectagents.gov/compliance/guidance/restricted/index.htm

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report.

e. Final Report

This report includes 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. An annual report will not be required when the Final Report is due. The Contractor shall submit, with the Final Report, a summary of salient results (not to exceed 250 words) achieved during the performance of the contract. A draft of the Final Report will be due 30 days prior to the completion date of the contract.

f. Product Development Plan (PDP) and Work Plan

The Contractor shall provide a PDP and Work Plan for review within thirty (30) calendar days of the effective date of the contract and prior to initiation of product development activities. A revised PDP shall be submitted 30 days after the technical kickoff meeting, if requested during the kickoff. An updated PDP shall be submitted when there are changes to the technical details and plan for the proposed candidate/product. This schedule may be negotiated with the Contracting Officer and the

COR.

The PDP shall include:

1. All progress from the effective date of the contract

2. Background regarding the disease, product, and relevant work previously performed

3. Development plan

4. Clearly defined goals, product…