2027 NIAID DMID Omnibus Broad Agency Announcement: Development of Medical Interventions for Infectious Diseases
Active, responses due . Solicitation posted by HEALTH AND HUMAN SERVICES, DEPARTMENT OF (NATIONAL INSTITUTES OF HEALTH) on October 9, 2026. Solicitation HHS-NIH-NIAID-BAA2026-1.
NAICS 541715 (Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)). Set-aside: No Set aside used. Full description on SAM.gov.
Description
INTRODUCTION:
The National Institute of Allergy and Infectious Diseases (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.Through a variety of research grants and contracts, NIAID’s Division of Microbiology and Infectious Diseases (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.
This Broad Agency Announcement (BAA) is soliciting proposals to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for infectious diseases in each of three (3) Research Areas described below and more thoroughly discussed in the attached BAA Solicitation.
An offeror should carefully review the content of the BAA Solicitation No. HHS-NIH-NIAID-BAA2026-1 for the comprehensive information regarding all requirements, the technical objective of each Research Area of this BAA Solicitation, instructions regarding the proposal submission, and a description of the evaluation and award process.
Please note, due to the competitive nature of the BAA Solicitation, the NIAID is unable to offer advice or feedback regarding an offeror’s specific technical approach. Offerors should exercise their professional judgment when compiling their proposals in line with the requirements and specifications of the BAA Solicitation.
Research Area 001 - Vaccine Candidates:
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.
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.
Research Area 002 - Therapeutic Candidates:
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:
- Viral hemorrhagic fever viruses (e.g., EBOV, SUDV, MARV, LASV, hantavirus) https://www.cdc.gov/viral-hemorrhagic-fevers/about/index.html
- Encephalitic paramyxoviruses (e.g. hendra virus, nipah virus)
- Picornaviruses (broad spectrum approaches that include EV68, EV70 and coxsackie virus)
- 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.
Research Area 002 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 developmental stage of the project being proposed, which is further discussed in the BAA Solicitation.
Research Area 003 - In Vitro Diagnostics
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). The 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)
PROPOSAL SUBMISSION:
Proposals Due Date and Time – December 8, 2026, 3:00 PM Eastern Time
For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.
For directions on using eCPS, go to the website: https://ecps.nih.gov and thenclick on "How to Submit."
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Document | Source | Agency | Posted Date | File Size | Actions | |
|---|---|---|---|---|---|---|
| Solicitation | NATIONAL INSTITUTES OF HEALTH | Oct 9, 2026 | 1.23 MB | |||
| Solicitation | NATIONAL INSTITUTES OF HEALTH | Oct 9, 2026 | 88.78 KB |
Lifecycle
HHS-NIH-NIAID-BAA2026-1- Solicitation
Award typically follows within 30–90 days after the response deadline. (estimate)
- SolicitationCurrentOct 9, 2026
2027 NIAID DMID Omnibus Broad Agency Announcement: Development of Medical Interventions for Infectious Diseases
Similar Opportunities
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This is a SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal of abstracts or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified sources; and (2) whether commercials sources and services are available in the marketplace. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This notice is issued to help determine the appropriate acquisition method including small business socioeconomic set aside possibilities and to determine the availability of commercial or non-commercial companies technically capable of meeting the Government's potential requirement. It is not construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Furthermore, it should be noted that any future solicitations that may be issued as a result of this notice, or in response to this requirement, may be issued using a different solicitation number from the one identified above. Background The National Institute on Drug Abuse (NIDA) was established in 1974, and in 1992 it became part of the National Institutes of Health, Department of Health and Human Services. NIDA’s mission is to advance science on drug use and addiction and to apply that knowledge to improve individual and public health through: 1) strategically supporting and conducting basic, clinical, and epidemiological research on drug use, its consequences, and the underlying neurobiological, behavioral, and social mechanisms involved; and 2) advancing the translation, effective implementation, and dissemination of scientific research findings to improve the prevention and treatment of SUDs, reduce adverse health consequences associated with drug use, and enhance public awareness of addiction as a chronic but treatable medical illness. NIDA’s Clinical Trials Network (CTN) was established in 1999 to bridge the gap between research and practice to improve treatment of substance use disorders (SUD) nationwide. The CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of patients. Over the last two decades, the CTN’s research infrastructure and agenda have evolved to reflect the changing landscape of the SUD treatment community, transformation of health care systems, and emerging scientific advancements. The CTN has been engaging providers in general medical settings and healthcare systems, and in 2015 the Network built upon and expanded its research portfolio encouraging adoption of innovative bioinformatics approaches, new technology, and "learning healthcare system" principles to enhance the efficiency of SUD clinical research and clinical care. The CTN conducts clinical trials in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations, and to transfer research results to physicians, clinicians, providers, and patients. These studies are typically Phase III clinical trials, but can also include Phase I, Phase II, Phase IV, and/or registry trials or surveys. More information on the CTN and the CTN’s research portfolio is available at https://nida.nih.gov/organization/center-clinical-trials-network-cctn/clinical-trials-network-ctn. Requirement NIDA is seeking capability statements from businesses having the capability to act as a data, statistics, and clinical trial service center; providing data and clinical research services and resources in managing and carrying out approximately 20 independent trials in drug use and addiction research at any given time. NIDA requires vendors capable of providing systems for data management, statistical analysis, document management and clinical trial services. The data systems will be used to manage and implement clinical data capture, data analysis, information exchange, scientific discovery efforts and clinical evaluation of promising new substance use disorder treatment medications and interventions in order to further NIDA’s mission. NIDA conducts single and multi-site clinical trials through grants, contracts and cooperative agreements in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. These studies could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry type trials or surveys. Although no actual clinical trials will be conducted under this requirement, the project activities will be integrated and central to NIDA trials in the following areas: Establish and administer state-of-the-art, secured web-based systems for the collection, storage, management, quality assurance, and reporting of study data as well as systems to facilitate the collection and management of participant and site level electronic health records data. Assist in the design and analysis of clinical trials, including the development of the statistical sections of protocols, study design, randomization and stratification methods, power and sample size calculations, interim monitoring and analysis plans, and data analytic plans. Review and monitor the quality of study data including the development and management of a computerized data monitoring system that executes quality assurance and quality control procedures to evaluate accuracy, timeliness and completeness of data submitted by the clinical sites, including verification of the clinical and laboratory data used to determine that study participants have reached protocol-defined endpoints. Monitor trial performance and progress and maintain a secure web-based clinical trial performance monitoring system to track key trial performance metrics (e.g. key dates, recruitment, availability of primary outcomes, missing data, etc.). Coordinate meetings of study Data and Safety Monitoring Boards (DSMB) to include the preparation and presentation of reports on safety, data integrity, and site performance as well as coordination of meeting sites, materials, travel support, etc. Participate in relevant committee and subcommittee meetings including representation by the contract Principal Investigator on the CTN Steering Committee and representation by other senior data and statistical experts on other relevant CTN committees, subcommittees and workgroups. Provide consultation, data analytical services, and expertise in certain fields relating to study design and analysis, compiling and editing of clinical data, and other services related to clinical trials operations that might be required. Instructions: The established NAICS code is 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The U.S. Small Business Administration establishes a size standard for 541715 of 1,000 employees or fewer. Interested large or small business organizations shall demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. Furthermore, information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: Work Experience: Capable Vendors must demonstrate the capability and experience to act as a data, statistics, and clinical trial service center; providing data and clinical research services and resources in managing and carrying out approximately 20 independent trials in drug use and addiction research at any given time. NIDA requires vendors capable of providing systems for data management, statistical analysis, document management and clinical trial services. The data systems will be used to manage and implement clinical data capture, data analysis, information exchange, scientific discovery efforts and clinical evaluation of promising new substance use disorder treatment medications and interventions in order to further NIDA’s mission. Organizational Experience: Capable Vendors should describe previous similar projects in the area(s) specified above and where the work was of a similar size and scope. In the response be sure to indicate if you were the prime contractor or a subcontractor. If a subcontractor, be sure to identify your roles and responsibilities as the subcontractor; what percentage of work your subcontract was responsible for; and identify the prime contractor. Personnel: Capable Vendors should identify personnel with the appropriate education, credentials, training, qualifications, experience, and competence to carry out the projects and the tasks identified above. Knowledge and experience in this field of work is critical, and the overall work efforts should be led by professionals who have earned a doctorate degree in a related field of study. Individual efforts and tasks should be led by professionals who have earned a master’s degrees in a related field of study. Basic credentials for proposed personnel will require experience in clinical trials management, biostatistics, drug use and addiction research, data management, statistics. Capable Offerors shall demonstrate how they have staffed similar key personnel on other contracts. Facilities: Capable Vendors should describe the physical space (e.g. offices, meeting rooms, server room, etc.) necessary to accommodate the required staff and equipment as well as the necessary mechanical systems (e.g. HVAC, fire suppression, redundant power, etc.); IT systems and hardware necessary to support the work including sufficient internet access, electronic data collection systems for study data, in-house or cloud based servers for storage of study data, and business software such as the MS Office suite; and security measures including physical and IT access controls, system monitoring, data backup processes, and firewalls. Interested Offerors should describe their facilities or demonstrate its ability to obtain the facilities necessary to support the requirements discussed above. The Government will assess the appropriateness of the responses based on the described work experience, organizational experience, personnel, and facilities described in the capability statement. If the Vendor proposes to team with another organization, please be sure to include the capabilities of any potential proposed partners. The Government will consider any other specific and relevant information about this procurement that would improve our consideration and assessment of the information presented. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received to provide feedback to respondents with respect to any information submitted. All capability statements must provide the following: 1) company name, address; and DUNS number; 2) point of contact; 3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) the capability information in response to the requirement and qualification identified in this notice; and; 7) type of small business your organization classifies itself as, if applicable (i.e.: women-owned, HUBZONE, etc.). Based on preliminary market research, the Government has determined that the requirements described herein do not meet the definition of a commercial product or commercial service as defined in RFO 2.101, and therefore, RFO Part 12 procedures are not applicable to this requirement. However, if a capable vendor believes that these services or products qualify as commercial under FAR 2.101, the vendor may submit a written justification for the Contracting Officer's consideration. Such submissions must be provided to the Contracting Officer no later than September 30, 2026 at 1:00 PM EST. Capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN 1:00 P.M. (EST) WEDNESDAY, SEPTEMBER 30, 2026 to the primary point of contact. The Subject line for the submission should include the Title and this Sources Sought Number (75N98026R00157OT). | Market Research | 541715 | No Set-Aside | 09/09/2026 | 09/30/2026 | - | |
IDIQ Guaranteed Minimum awarded in the amount of $10,000. | Awarded | 541715 | No Set-Aside | 10/07/2026 | Open | 68464, MD | |
IDIQ Guaranteed Minimum Awarded in the amount of $10,000. | Awarded | 541715 | No Set-Aside | 10/07/2026 | Open | 68464, MD | |
IDIQ Guaranteed Minimum Awarded in the amount of $10,000. | Awarded | 541715 | No Set-Aside | 10/07/2026 | Open | New York, NY | |
IDIQ Guaranteed Minimum Awarded in the amount of $10,000. | Awarded | 541715 | No Set-Aside | 10/07/2026 | Open | 49504, VA |
Additional Details
Solicitation Number
HHS-NIH-NIAID-BAA2026-1
Archive Date
Dec 23, 2026
Office Address
BETHESDA, MD, 20892