2024 NIAID Omnibus Broad Agency Announcement: "Development of Medical Countermeasures for Biodefense and Emerging Infectious Diseases"

Introduction: The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.

This Broad Agency Announcement is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH. The Research Areas included in this NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2024-1, as well as the projected amounts of available funding, are discussed below.

Research Areas 001, 002, and 003: For FY 25, the NIAID estimates up to $16 million for the award of 5 cost reimbursement type base contracts across all three Research Areas (001, 002 & 003). The estimated FY 25 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.

DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEAES (DMID), NIAID, NIH Research Area 001: Vaccine Candidates The goal of Research Area 001 is to protect human health and well-being by advancing specific vaccine candidates that utilize technology platforms that ideally elicit a rapid onset of immunity following a single dose, provide a durable response and are readily adaptable to multiple emerging pathogens. These vaccine technologies and platforms may include, but are not limited to, any of the following:

novel adjuvant vaccine formulations, delivery platforms that are scalable or produce mucosal immunity, nucleic acid-based platforms, viral vectors, and nanoparticle/VLP approaches.

Research Area 002: Therapeutic Candidates The objective of Research Area 002 is the development of new therapeutic products for diseases caused by specific viral, bacterial and fungal pathogens and their drug resistant variants in the following list: Viral Hemorrhagic Fever viruses (e.g.. https://www.cdc.gov/vhf/index.html) Coronaviruses, targeting a novel mechanism of action (MOA) different from SARS-CoV-2 approved drugs or with demonstrated pan-coronavirus activity Pseudomonas aeruginosa Candida auris, Aspergillus fumigatus or Mucorales Important notice to Offerors: Research Area 002 only supports development of therapeutic products. “Therapeutic” activity refers to elimination or substantial reduction of infective pathogens by administration of a pharmaceutical agent after challenge. “Pan-coronavirus” activity requires demonstrated SARS-CoV-1, SARS-CoV-2 and MERS-CoV activity.

A candidate therapeutic may be a lead series, a preclinical candidate, or a clinical candidate. The product must be based on a small molecule (e.g., natural products, nucleosides, oligonucleotides or peptides) or bacteriophages. The following are not included: proteins, monoclonal antibodies, other biologic entities (except bacteriophages), and conjugates of such entities.

Research Area 003: In Vitro Diagnostics NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Untargeted (Agnostic) and Targeted Nucleic Acid Sequencing on Portable or Laboratory-Automated Systems The first objective of Research Area 003 is to improve the overall performance of nucleic acid sequencing solutions on portable or laboratory-automated commercial sequencing platforms for the targeted or agnostic detection and identification of viral pathogens for biodefense, emerging infectious diseases, and pandemic preparedness.

2. Multiplex Protein or Nucleic Acid Detection in Near-Patient Testing Systems The second objective of Research Area 003 is to develop methods that improve pathogen analyte detection in one of two ways: First, protein technology improvements such as protein sequencing or mass spectrometry, especially in ways that bring protein-identification testing nearer to the patient; or near-patient rapid antigen testing improvements for rapid and highly sensitive toxin or other protein detection; or solutions for rapid development of synthetic binding moieties for capture of novel proteins.

The emphasis here is on methods improvement in time and analytical sensitivity. Second, multiplex nucleic acid detection that is near-patient, rapid, low-complexity, low-cost, and sensitive for detection of sexually transmitted infections. Design and development can be for testing from care provider-collected or self-collected specimens. The emphasis here is on expanded breadth of infectious pathogens detected, especially, but not limited to, those identifiable from genital ulcer diagnostic (GUD) testing.

3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization The third objective of Research Area 003 is to improve direct-from-blood or other biofluid detection and identification of microbial infection coupled with phenotypic antibiotic susceptibility testing (AST) characterization Contract Proposal Receipt Date: Proposals submitted in response to the BAA Solicitation must be received by 3:00 p.m. Eastern Standard Time on March 12, 2024. Any responsible offeror may submit a proposal which shall be considered by the Agency.

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."