March 8, 2022
None
National Institute of Allergy and Infectious Diseases (NIAID)
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. The NIAID, NIH, of the DHHS 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.
The Omnibus BAA is governed by Federal Acquisition Regulation (FAR) 6.102(d)(2) and FAR 35.016, as well as the 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.
Offers submitted in response to this BAA will be required to 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, shall be developed and proposed by the Offeror, not the Government.
Proposals received in response to this BAA 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 will be provided in the BAA that describe individual Research Areas in which the Government is interested. Proposals received in response to the BAA will be evaluated in accordance with the Evaluation Factors for Award specified in the announcement. The Government reserves the right to conduct discussions with all, some, one, or none of the proposals received in response to this BAA. If discussions are conducted, the Government reserves the right to suggest modifying, adding or deleting milestones, decision points, research plans, processes, schedules, budget or product. 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. Selection for award under this BAA will be based upon the evaluation factors, importance to the agency programs, and the availability of funds.
The Research Areas included in this NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2022-1, as well as the projected amounts of available funding, are discussed below. Dates for receipt of proposals will be identified separately for each Research Area within the solicitation.
Research Area 001 - Advanced Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) and Emerging Infectious Diseases
The goal of Research Area 001 is to protect human health and well-being by advancing vaccine candidates, technologies and platforms that could be deployed against agents that include:
- Vaccines for the NIAID Emerging Infectious Diseases/Pathogens including Category A, B, and C priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens), such as but not limited to:
- RNA viruses of pandemic potential
- Coronaviridae [e.g., Middle East Respiratory Syndrome (MERS), SARS-CoV-2]
- Bunyavirales (e.g., Lassa, Junin, Rift Valley Fever Virus, Andes, Sin Nombre, LaCrosse, California Encephalitis, Crimean Congo Hemorrhagic Fever)
- Filoviruses (e.g., Ebola, Marburg; excluding Ebola Zaire)
- Flaviviruses (e.g., Dengue, Zika, West Nile)
- Paramyxoviridae (e.g., Nipah, Hendra)
- Picornaviridae [e.g., Enterovirus (EV)-D68, EV-A71]
- Togaviridae [e.g., Chikungunya, Eastern equine encephalitis (EEE), Venezuelan equine encephalitis (VEE), and Western equine encephalitis (WEE)]
- RNA viruses of pandemic potential
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- Burkholderia spp
- Group A & B Streptococci
- Hepatitis C
- Mycobacterium tuberculosis
- New or improved vaccines against Streptococcus pneumoniae or Bordetella pertussis
- Tick-borne viruses
- Bacillus anthracis is excluded
- Vaccines for Antimicrobial Resistant (AMR) Organisms including biodefense, Gram-negative and Gram-positive bacteria, and fungal pathogens. Pathogens of particular interest are described below:
- Vaccines focused on antimicrobial resistant Gram-negative bacteria, such as but not limited to, Pseudomonas aeruginosa, Escherichia coli, Salmonella, and Shigella spp.
- Vaccines focused on multi drug resistant Gram-positive bacteria, such as but not limited to, Staphylococcus aureus and Mycobacterium tuberculosis
- Vaccines focused on fungal pathogens, such as but not limited to, Candida auris, other AMR Candida species, Aspergillus fumigatus, Mucorales and Coccidioides.
For the purposes of this solicitation, a vaccine candidate must be an antigen/immunogen design and technology platform previously selected and well characterized, with demonstrated proof of immunogenicity in relevant animal model(s), with preferably, evidence of proof-of-concept efficacy, be manufactured by processes sufficient to produce research grade material and with potential for scalable Good Manufacturing Practice (GMP) production, and be characterized by well-controlled release assays including potency assay(s).
Research Area 001 will support vaccine candidates that can be rapidly developed and tested in Phase I clinical trials to facilitate identification of promising candidates and/or vaccine platforms.
Research Area 002 - Development of Therapeutic Products for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases
The objective of Research Area 002 is the development of promising new therapeutics to address infections and diseases caused by the NIAID Emerging Infectious Diseases/Pathogens including Category A, B, and C priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) and select bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf).
For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident. Solicited products include antimicrobial therapeutics, antiviral therapeutics and antitoxin therapeutics. A therapeutic candidate may be an advanced lead series, a small number of advanced leads from which a preclinical candidate will be selected, a preclinical candidate, or a clinical candidate. It may be a small molecule (e.g., synthetic or natural products), a drug conjugate or a biological product (e.g., monoclonal antibodies, recombinant proteins, or nucleic acid-based products).
Research Area 002 will support lead optimization, pre-clinical (IND enabling) studies and clinical trials that include Phase 1 or Phase 2 studies or confirmatory trials of no greater than 120 subjects. For some pathogens or toxins, therapeutic candidate efficacy determination under the Animal Rule is supported.
Research Area 003 - Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential
The objective of Research Area 003 as described in https://www.niaid.nih.gov/research/antivirals is the development of antivirals that:
- Directly block viral targets and function, AND
- Act against RNA viruses of pandemic potential (Coronaviridae, Bunyavirales, Filoviridae, Flaviviridae, Paramyxoviridae, Picornaviridae, and Togaviridae), AND
- Are new chemical entities which include small molecules and small biotherapeutics (e.g., nucleic acids or peptides) that are directly acting against viral targets and functions (not through the modulation of the host responses) AND
- Have suitable routes of administration (e.g., oral or intranasal) and safety profiles for broad use in the outpatient setting to treat early stages of infection by reducing viral burden
For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident. A therapeutic candidate refers to an advanced lead series, optimized leads, or product candidate, that is a new chemical entity and either a small molecule or biotherapeutic (Note: monoclonal antibodies are not in the scope of this Research Area).
Research Area 003 will support lead optimization, pre-clinical (IND enabling) studies and Phase 1 clinical trial only. Phase 2 trial studies in human are not supported.
Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases
The objective of Research Area 004 is to support the development of promising diagnostics technologies in the following three areas for detection of signatures from biothreat pathogens as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness:
- Next-Generation Nucleic Acid Sequencing on Portable Systems
The first objective of Research Area 004 is to improve the overall performance of nucleic acid sequencing solutions on portable commercial sequencing platforms for the targeted and agnostic detection and identification of microbial pathogens for biodefense, antimicrobial resistance, emerging infectious diseases, and pandemic preparedness.
- Rapid Protein Detection
The second objective of Research Area 004 is to develop methods that improve near-patient, rapid and sensitive detection of proteins or other biomolecules, including methods that simplify sample preparation, enhance target capture and detection, and increase signal output. Rapid diagnostic testing devices, so-called RDTs, are fast, simple, and cost-effective, but suffer from lower clinical sensitivity than other methods of pathogen analyte detection.
- Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization
The third objective of Research Area 004 is to improve direct-from-blood or other biofluid detection and identification of microbial infection coupled with phenotypic antimicrobial resistance characterization which can play a central role in limiting the onset of sepsis.
The proposed program must have sufficient feasibility research completed and working in early (planning and design) through late-stage (design verification) development for diagnostic test system that supports biodefense and naturally emerging and re-emerging infectious pathogen preparedness. Diagnostic test system must detect one of the following agents:
- Bacillus anthracis, including genotypic resistance markers
- Yersinia pestis, including genotypic resistance markers
Francisella tularensis, including genotypic resistance markers - Burkholderia spp, including genotypic resistance markers
- Botulinum toxin, including identifying and distinguishing relevant serotypes
- ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp), including genotypic resistance markers
- Lassa virus
- Nipah virus
- Rift Valley Fever virus
- Enterovirus D68 virus
- Candida auris
- Coccidioides sp.
- Novel coronaviruses
Contract duration
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 upon the scope of the project and the technical objectives. The total performance period comprised of combined Base Period and all Options proposed by an Offeror shall not exceed 5 years. If applicable, clinical trial activities are encouraged to start as soon as possible and be completed within the 5-year period.
The total budget estimated in FY23
- Research Areas 001, 002, and 004: For FY 23, the NIAID estimates up to $12.8 million for the award of 5-6 cost reimbursement type contracts across all three Research Areas (001, 002 & 004). The estimated FY 23 funding is for the non-severable Base period (direct and indirect costs combined) only. The number of awarded contracts will depend on the number of technically meritorious proposals, importance to agency programs, and availability of funds.
- Research Area 003: For FY 23, the NIAID estimates up to $34 million for the award of 2 or more cost reimbursement type contracts in Research Area 003 only. The estimated FY 23 funding is for the non-severable Base period (direct and indirect costs combined) only. The number of awarded contracts will depend on the number of technically meritorious proposals, importance to agency programs, and availability of funds.
Contract Proposal Receipt Date:
The NIAID 2022 OMNIBUS BROAD AGENCY ANNOUCEMENT (BAA) NO. HHS-NIH-NIAID-BAA2022-1 contains four (4) distinct Research Areas, each with a specified closing date and time. The proposal due date of March 18, 2022, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Area 001, 002, and 004. The proposal due dates for each Research Area are identified below:
Research Area 001 - Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases
Proposals Due Date and Time - 3:00PM Eastern Time on April 18, 2022
Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases
Proposals Due Date and Time - 3:00PM Eastern Time on April 18, 2022
Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential
Proposals Due Date and Time - 3:00PM Eastern Time on March 18, 2022
Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases
Proposals Due Date and Time - 3:00PM Eastern Time on April 18, 2022
Primary Contact:
Julie C. Rodriguez, Esq., Contracting Officer
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7735
Email: julie.rodriguez@nih.gov
Secondary Contact:
Brian Madgey, M.B.A., Contracting Officer, Team Lead
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3712
Email: brian.madgey@nih.gov
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