FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
ID: FDABAA-26-00123Type: Special Notice
Overview

Buyer

DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONFDA Office of Acquisitions and Grants ServicesRockville, MD, 20857, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; BASIC RESEARCH (AJ11)
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is soliciting proposals through the FY26 Broad Agency Announcement (BAA) for advanced research and development in regulatory science. This initiative aims to modernize the development and evaluation of FDA-regulated products, enhance post-market surveillance, and bolster public health preparedness, inviting participation from all responsible sources, including small businesses and academic institutions. Proposals must focus on key research areas such as new methodologies, advanced manufacturing, and AI/computational methods, with submissions due by February 24, 2026, for consideration in the current fiscal year. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.

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    The provided document outlines the essential components and formatting requirements for a Statement of Work (SOW) template, intended for incorporation into federal government RFPs, grants, and state/local RFPs. It emphasizes that the SOW must be non-proprietary and releasable under the Freedom of Information Act (FOIA). Key sections include a 'Scope' describing the general work, 'Requirements' detailing tasks using mandatory terms and chronological order, and 'Deliverables' defining all expected products such as reports, software, or hardware. The document stresses clarity, logical arrangement, and adherence to industry standards, ensuring mutual understanding between the contractor and the government.
    This document outlines the detailed cost proposal requirements for a government contract, applicable to prime contractors and subcontractors. It emphasizes the need for comprehensive and well-supported cost data for both the base period and any priced options, explicitly stating that unpriced options will not be accepted. The proposal structure requires a breakdown of costs by task and by period of performance, covering direct labor, fringe benefits, labor overhead, subcontracts, consultants, other direct costs (materials, equipment, travel), material handling, general and administrative costs, and cost of money. Offerors are responsible for providing adequate supporting documentation and demonstrating the reasonableness of all proposed costs, in accordance with FAR 15.403-4 regarding certified cost or pricing data. The document also provides instructions on how to complete the cost worksheets, including identifying personnel and their labor categories, indicating the accounting system's fiscal or calendar year, and defining the split of labor hours across different rate years. It clarifies that profit or fees are generally not allowed on direct costs for equipment, government entities, or cost-share contracts.
    The provided document indicates that the proper contents could not be displayed, suggesting an issue with the PDF viewer. It advises users to upgrade to the latest version of Adobe Reader for Windows, Mac, or Linux by visiting http://www.adobe.com/go/reader_download, or to seek further assistance at http://www.adobe.com/go/acrreader. The document also includes trademark information for Windows, Mac, and Linux. This file, likely part of a government RFP, federal grant, or state/local RFP, serves as a placeholder or error message, guiding users to resolve technical viewing issues rather than presenting substantive content related to the RFP itself.
    The FDA's Broad Agency Announcement (FDABAA-26-00123) seeks advanced research and development proposals to enhance regulatory science and innovation. This BAA, open to all responsible sources including small businesses, FFRDCs, and academic institutions, focuses on three core charges: modernizing product development and evaluation, strengthening post-market surveillance and labeling, and invigorating public health preparedness. Proposals should address specific research areas like New Approach Methodologies, Advanced Manufacturing, Analytical and Computational Methods (including AI), Biomarkers, Clinical Outcome Assessments, and Complex Clinical Trial Designs. The FDA encourages early submissions by February 24, 2026, and prefers cost-reimbursement contracts. The goal is to advance scientific knowledge to protect and promote national health, with an emphasis on underrepresented populations and reducing animal testing.
    The FDA Broad Agency Announcement (BAA) FDABAA-26-00123 seeks advanced research and development proposals to support regulatory science and innovation. This BAA, open to all responsible sources including private sector, FFRDCs, and academic institutions, focuses on three charges: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Proposals are for procurement contracts only, not grants. Submissions require a checklist, concept paper, and full proposal by February 24, 2026, for consideration in the current fiscal year, with early applications encouraged. The FDA prioritizes projects advancing regulatory science to ensure product safety, efficacy, quality, and performance across various regulated areas and for diverse populations, including those often underrepresented in clinical research. The document details specific research areas of interest under each charge, emphasizing new methodologies, advanced manufacturing, analytical and computational approaches (including AI/ML), biomarkers, clinical outcome assessments, and novel clinical trial designs. Evaluation criteria include scientific merit, program relevance, capabilities, and cost. The BAA also outlines reporting requirements, proposal submission guidelines, and regulatory considerations such as human subject protection and animal welfare.
    The FDA Broad Agency Announcement (BAA) FDABAA-26-00123 invites proposals for advanced regulatory science research to modernize the development and evaluation of FDA-regulated products, strengthen post-market surveillance and labeling, and invigorate public health preparedness. Open to all responsible sources, including small businesses, academic institutions, and FFRDCs, the BAA seeks proposals for procurement contracts only, not grants. Submissions must include a checklist, concept paper, and full proposal by February 24, 2026, for consideration in the current fiscal year. Key research areas include new approach methodologies, advanced manufacturing, AI/computational methods, biomarkers, clinical outcome assessments, and real-world data. Proposals are evaluated based on scientific merit, program relevance, capabilities, experience, and cost, with a preference for cost-reimbursement models.
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