2026 NIAID DMID Omnibus Broad Agency Announcement
ID: HHS-NIH-NIAID-BAA2025-1Type: Presolicitation
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/f450cc7fee4b4df781f7b8647bf9b943/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically 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: the development of therapeutics, vaccines, and diagnostics for antimicrobial-resistant bacterial and fungal pathogens, and the creation of direct-acting antivirals for viral families of pandemic potential. This initiative is critical for addressing public health challenges related to infectious diseases and enhancing biodefense capabilities. Proposals for Research Area 001 are due by February 21, 2025, while those for Research Area 002 are due by January 21, 2025. Interested parties can reach out to primary contact Swee L. Teo at teosl@niaid.nih.gov or 240-669-5173 for further information.

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    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 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.
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    2026 NIAID DMID Omnibus Broad Agency Announcement
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