2026 NIAID DMID Omnibus Broad Agency Announcement
ID: HHS-NIH-NIAID-BAA2025-1Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIAIDBETHESDA, MD, 20892, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Original Source

https://sam.gov/opp/44a2b2c9f0c04ba09a1365281b912b1b/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing research and development of medical countermeasures against antimicrobial-resistant pathogens and viruses with pandemic potential. The BAA encompasses two primary research areas: Research Area 001 focuses on developing therapeutics, vaccines, and diagnostics for antimicrobial-resistant bacterial and fungal pathogens, while Research Area 002 targets the creation of Direct Acting Antivirals for viruses of pandemic potential. This initiative is critical for addressing public health challenges related to infectious diseases, with an estimated funding of $28.5 million available for awards in fiscal year 2026. Proposals for Research Area 001 are due by February 21, 2025, and for Research Area 002 by January 21, 2025; interested parties can contact Swee L. Teo at teosl@niaid.nih.gov or Brian Madgey at brian.madgey@nih.gov for further information.

    Files
    Title
    Posted
    Attachment 14_PHS Human Subjects and Clinical Trials Information Form.docx
    The document outlines the requirements for the PHS Human Subjects and Clinical Trials Information, focusing on the submission of clinical trial data crucial for federal oversight. Key sections demand a unique study title, exemption status, and a clinical trial questionnaire that establishes if a study qualifies as a clinical trial based on criteria involving human participants, interventions, and health-related outcomes. It details the study population characteristics, such as conditions of study, eligibility criteria, and demographic inclusivity regarding women and minorities. Additionally, it emphasizes the necessity of recruitment strategies, study timelines, and inclusion enrollment reports, including the breakdown of enrollment demographics by race and ethnicity. Sections further elaborate on protections for human subjects, study design parameters, overall team structure, outcome measures, and any FDA-regulated interventions involved. Submission attachments for data protection, monitoring plans, and additional study materials are also part of the required documentation. The structure indicates a systematic approach to ensure compliance with federal regulations while advancing research in clinical trials.
    HHS-NIH-NIAID-BAA2024-1 - Amendment One.pdf
    The National Institute of Allergy and Infectious Diseases (NIAID) issued Amendment One to the Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2025-1 for the 2026 Division of Microbiology and Infectious Diseases (DMID) research initiatives. The solicitation focuses on developing therapeutics, vaccines, and diagnostics for antimicrobial-resistant pathogens and direct-acting antivirals for viruses with pandemic potential. Key proposal deadlines range from January 21 to February 21, 2025. The amendment provides responses to offeror questions and clarifies rules around foreign subcontractors and budget expectations, stating that NIAID estimates up to $20 million for funding three to four contracts in Research Area 002. It emphasizes that the contracts will be cost-reimbursement types with non-severable bases that do not exceed five years. Offerors must acknowledge receipt of the amendment, and a cut-off date for further questions is established. This document serves to facilitate understanding and compliance for potential contractors in the development of critical health interventions, reflecting NIAID’s initiative to advance public health research through open competition.
    HHS-NIH-NIAID-BAA2025-1.pdf
    The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals through a Broad Agency Announcement (BAA) focusing on the development of medical countermeasures to combat antimicrobial resistance and emerging infectious diseases. The BAA outlines two primary research areas for proposal submissions: Research Area 001 involves developing therapeutics, vaccines, and diagnostic tools for antimicrobial-resistant (AMR) bacterial and fungal pathogens, while Research Area 002 emphasizes the creation of Direct Acting Antivirals (DAA) for viruses of pandemic potential. The solicitation provides detailed technical objectives, eligibility criteria, and funding opportunities, estimating a combined total of $28.5 million for award in fiscal year 2026 across these areas. Proposals should showcase innovation and a robust plan for research that aligns with NIAID's broader strategies, including the National Biodefense Strategy and Pandemic Preparedness Plan. Each proposal will be evaluated based on its technical merit and the potential to address public health needs related to infectious diseases. Contract funding will support various phases from preclinical studies through early clinical trials, emphasizing expedited research and development processes.
    HHS-NIH-NIAID-BAA2025-1 - Amendment Five.pdf
    The National Institute of Allergy and Infectious Diseases (NIAID) issued Amendment Five to the 2026 DMID Omnibus Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2025-1, effective January 10, 2025. The amendment clarifies responses to questions from potential offerors regarding research proposals focused on developing therapeutics, vaccines, and diagnostics against antimicrobial-resistant pathogens and direct acting antivirals for viral families with pandemic potential. Key proposal due dates vary by research area, with the first due on January 21, 2025, and the second by February 21, 2025. It specifies that contract research organizations are to be treated as subcontractors but provides no list of accepted vendors, placing responsibility on offerors for documentation and selection. The amendment reiterates that certain types of protein therapeutics are excluded and emphasizes that the BAA will culminate in a contract rather than a grant. Offerors must adhere to a minimum margin standard for proposal formats and include stage-appropriate Technical Product Profiles. The amendment underscores the competitive nature of the solicitation, maintaining the original solicitation’s terms and conditions while updating necessary information.
    HHS-NIH-NIAID-BAA2025-1 - Amendment Four.pdf
    The National Institute of Allergy and Infectious Diseases (NIAID) issued Amendment Four to the 2026 DMID Omnibus Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2025-1, effective December 27, 2024. This amendment provides responses to questions pertaining to the solicitation, which encourages proposals in two research areas: the development of therapeutics for antimicrobial-resistant pathogens and direct antiviral agents for pandemic-prone viruses, with deadlines for proposal submission on February 21 and January 21, 2025, respectively. Key inquiries addressed include budget guidelines related to travel and training costs, the submission process for Small Business Subcontracting Plans, and specifications for bibliographies and optional proposals. The amendment emphasizes that responses are non-modifying and reiterates the competitive nature of the BAA, highlighting that no technical guidance will be provided regarding specific proposals. Notably, various projects must adhere to strict eligibility criteria and proposal submission rules, including time commitments for investigators involved in other federal projects. This BAA is critical for advancing research in combating infectious diseases and promoting public health initiatives.
    HHS-NIH-NIAID-BAA2025-1 - Amendment Six.pdf
    The document presents Amendment Six to the National Institute of Allergy and Infectious Diseases (NIAID) 2026 DMID Omnibus Broad Agency Announcement (BAA), identified as HHS-NIH-NIAID-BAA2025-1. Issued on January 16, 2025, this amendment updates the proposal due date for Research Area 001 to February 21, 2025, while the date for Research Area 002 remains January 21, 2025. The document outlines two primary research areas focused on developing therapeutics and diagnostics for antimicrobial-resistant pathogens and direct acting antivirals for pandemics. Key points include the need for offerors to acknowledge receipt of this amendment, the cut-off dates for submitting questions, and guidance on proposal submission requirements. The amendment also contains the government's responses to various questions posed by potential offerors, offering clarification on proposal formats. Overall, the purpose of this amendment is to provide updates and guidance while maintaining the integrity and continuity of the original solicitation.
    HHS-NIH-NIAID-BAA2025-1 - Amendment Three.pdf
    The National Institute of Allergy and Infectious Diseases (NIAID) has issued Amendment Three to its 2026 DMID Omnibus Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2025-1, which outlines amendments regarding proposals for two main research areas: the development of therapeutics for antimicrobial-resistant pathogens and direct-acting antivirals for virus families potentially causing pandemics. Proposal due dates remain unchanged for each area. The amendment addresses queries from potential offerors about the solicitation, providing clarification on proposal components such as budget details, sample types, and specific technical requirements for submissions. It emphasizes that the proposals should be well-structured and adhere to the guidelines laid out in the solicitation, particularly regarding financial documentation and the inclusion of work plans. Importantly, it reminds offerors that the final decision on awards will hinge on evaluations based on the government’s evaluations and the availability of funds, and that costs incurred prior to contract award cannot be reimbursed. This document highlights NIAID's intention to support innovative solutions to pressing public health challenges while ensuring adherence to federal contracting protocols.
    HHS-NIH-NIAID-BAA2025-1 - Amendment Two.pdf
    The National Institute of Allergy & Infectious Diseases (NIAID) has issued Amendment Two to the Broad Agency Announcement (BAA) for the 2026 DMID Omnibus. This amendment clarifies proposal submission guidelines and adds responses to questions concerning the solicitation. Proposals for two research areas are highlighted: one focusing on developing therapeutics and diagnostics for antimicrobial-resistant pathogens due by February 21, 2025, and the other on direct-acting antivirals for viruses of pandemic potential due by January 21, 2025. Terms and conditions remain unchanged, and acknowledgments of the amendment are mandatory. Key questions addressed include clarifications on proposal content, eligibility for diversity among principal investigators, and issues regarding intellectual property rights for awardees. The responses aim to guide prospective offerors in their proposals but do not provide specific technical direction due to the BAA's competitive nature. The document reflects the NIAID's commitment to fostering innovative research while maintaining rigorous proposal standards.
    Pre-solicitation Notice - BAA2025-1 Final.pdf
    The 2026 NIAID Omnibus Broad Agency Announcement (HHS-NIH-NIAID-BAA2025-1) seeks proposals for research to enhance medical countermeasures against infectious diseases. NIAID, under the NIH, is soliciting innovative projects in two main research areas. Research Area 001 focuses on therapeutics, vaccines, and diagnostics for antimicrobial-resistant bacterial and fungal pathogens. It comprises three topics: developing therapeutics for severe infections caused by specified pathogens, advancing vaccine candidates against ESKAPE bacterial pathogens, and creating diagnostic technologies for identifying fungal infections. Research Area 002 emphasizes the development of direct acting antivirals targeting viruses with pandemic potential, requiring proposals for new chemical entities that reduce viral load in early disease stages. Funding estimates range from $8.5 million for Research Area 001 to $20 million for Research Area 002, with expectations of one to two and three to four awards, respectively, each contract lasting up to five years. Proposals will be evaluated independently based on technical objectives set by the NIAID, with no guarantee of contract awards. Submission guidelines mandate online proposals via the NIAID electronic platform, with no provision for acceptance through email or fax. The announcement will be available around November 22, 2024, signaling the government's commitment to advancing public health through innovative research.
    Lifecycle
    Title
    Type
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Currently viewing
    Solicitation
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Presolicitation
    Similar Opportunities
    In Vitro Assessments of Antimicrobial Activity
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for the In Vitro Assessments of Antimicrobial Activity (IVAAA) program through solicitation RFP 75N93024R00024. This initiative aims to support in vitro testing to evaluate the therapeutic potential of compounds against over 270 infectious agents, facilitating the development of vaccines, therapeutics, and diagnostics for infectious diseases. The program is critical for enhancing public health preparedness and response capabilities, particularly in addressing emerging health threats such as bioterrorism and infectious diseases. Proposals are due by March 10, 2025, with a funding range of $2,500 to $15 million available through January 14, 2033. Interested parties can direct inquiries to Alexander Beraud at alexander.beraud@nih.gov or Brian Madgey at brian.madgey@nih.gov.
    Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals under the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004 for advanced research and development of Medical Countermeasures (MCMs) aimed at addressing public health threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, as well as emerging infectious diseases and pandemic influenza. The initiative seeks to foster public-private partnerships to enhance the development and responsiveness of life-saving MCMs, emphasizing the importance of technological maturity, regulatory compliance, and manufacturing standards in the evaluation process. This opportunity is critical for strengthening national health security and improving preparedness for future public health emergencies, with an open submission period running until September 25, 2028, at 4:30 PM Eastern Time. Interested parties can direct inquiries to BARDA-BAA@hhs.gov for further information.
    Clinical Studies of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), is seeking small business contractors to conduct clinical studies focused on infectious agents, vaccines, and antivirals for both adult and pediatric populations. The primary objectives include evaluating the safety, immunogenicity, and efficacy of vaccines against various viruses, including emerging threats like Zika, with a project duration anticipated from August 2026 to August 2033 under a cost-reimbursement IDIQ contract structure. This initiative builds on decades of NIH-led research and aims to advance medical research through strategic partnerships with capable small businesses. Interested parties should submit their capability statements, including prior experience and qualifications, to the primary contact, Uju Obii-Obioha, at uju.obii-obioha@nih.gov, by the specified deadlines.
    FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is soliciting proposals through the FY25 Broad Agency Announcement (BAA) aimed at advancing regulatory science and innovation. This opportunity invites organizations, particularly small businesses, to submit research and development proposals that address critical areas such as alternative drug development methods, advanced manufacturing technologies, and predictive toxicology, with a strong emphasis on including diverse populations in research. Proposals must be submitted by February 24, 2025, and will undergo a two-tier evaluation process, with the potential for multiple contracts awarded based on proposal quality and funding availability. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.
    BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting innovative research proposals under the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which is open until October 18, 2027. The initiative aims to address high-risk biomedical challenges related to public health emergencies, with specific Areas of Interest (AOIs) including drug repurposing, at-home diagnostics, and vaccine development. This program is crucial for enhancing the nation’s preparedness against emerging infectious diseases and other health threats, emphasizing the importance of innovative solutions in medical countermeasures. Interested parties must have active registration with SAM.gov and are encouraged to schedule pre-submission calls; key deadlines for abstract submissions vary by AOI, with multiple awards anticipated based on scientific merit and alignment with program goals.
    Development of Radiation/Nuclear Medical Countermeasures (MCMs) And Biodosimetry Devices
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the development of Radiation/Nuclear Medical Countermeasures (MCMs) and biodosimetry devices. The primary objectives are to create effective MCMs that mitigate normal tissue injuries from ionizing radiation and to advance biodosimetry tools that enhance triage and treatment strategies during radiation emergencies. This initiative is crucial for national preparedness against potential radiological incidents, as it aims to address the urgent need for medical interventions and diagnostic capabilities in mass casualty scenarios. Proposals are due by March 19, 2025, with an estimated funding of $2 million annually for successful applicants over a typical three-year contract period, totaling a possible award of $6 million. For further inquiries, interested parties may contact Albert Nguyen at nguyenal@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov.
    Pre-Solicitation FY 2025 CDC OS Emerging Public Health Priorities BAA
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is preparing to issue a Fiscal Year 2025 Broad Agency Announcement (BAA) for Applied Research aimed at addressing Emerging Public Health Priorities. This initiative seeks innovative research proposals in various areas, including infectious disease surveillance, wastewater surveillance, and substance use disorder recovery, to enhance public health strategies and responses to emerging threats. The BAA will be open for full and open competition, with a tentative issuance date of December 30, 2024, and a due date for concept papers set for January 30, 2025. Interested contractors must ensure they are registered in the System for Award Management (SAM) to be eligible for award, and further details will be available on SAM.gov.
    NIAID Virology Quality Assurance
    Health And Human Services, Department Of
    The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals for the Virology Quality Assurance (VQA) program under RFP number 75N93024R00030, aimed at providing comprehensive quality assessment for virologic testing related to HIV and other viral pathogens in clinical trials. The program's objectives include ensuring the validity of laboratory data through proficiency testing, real-time assay validation, and the development of performance standards, while also addressing public health emergencies and increasing laboratory demands. This initiative is crucial for maintaining high-quality laboratory practices and supporting ongoing research in virology. Proposals are due by April 8, 2025, and interested parties should direct inquiries to the primary contact, Shawnice Williams, at shawnice.williams@nih.gov or 301-761-5431.
    CIVICs Data Management and Coordinating Center (DMCC)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide services for the renewal of the CIVICs Data Management and Coordinating Center (DMCC). The DMCC will support the CIVICs program by managing data, conducting analyses, and facilitating communication and coordination among various stakeholders, with a focus on advancing influenza vaccine research and development. This initiative is critical for enhancing the immunogenicity and durability of seasonal influenza vaccines and involves the operation of a scalable data management system, maintenance of public and private portals, and comprehensive program coordination. Interested parties must submit their tailored Capability Statements by 3:00 PM (Eastern Time) on January 23, 2025, to Maribel Miranda at maribel.miranda@nih.gov, with the anticipated contract award date around July 2026.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services to support the development of drug products. The objective of this procurement is to ensure the delivery of high-quality formulated drug products for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic development. This opportunity encompasses a wide range of services, including formulation development, manufacturing under current Good Manufacturing Practices (cGMP), and necessary testing to meet regulatory standards. Proposals are due by February 3, 2025, with a contract period extending from September 30, 2025, to July 31, 2031, and a maximum funding amount of $49,885,703. Interested parties can contact Michelle Cecilia at michelle.cecilia@nih.gov or Valerie Whipple at valerie.whipple@nih.gov for further information.