Opportunity Information: Apply for RFA FD 17 013
The grant opportunity titled "Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24)" is a Food and Drug Administration (FDA) cooperative agreement designed to create and deliver a certified academic training program focused on Good Laboratory Practices (GLP) specifically within Biosafety Level 4 (BSL-4) high containment laboratories. The core purpose is to strengthen the quality, consistency, and regulatory readiness of laboratory work conducted in the highest-containment research settings, where the pathogens involved may pose severe risks and where the operational constraints of containment can make routine GLP implementation far more complicated than in standard laboratory environments.
This funding opportunity (RFA-FD-17-013) was issued by the U.S. Department of Health and Human Services (HHS), FDA, under the assistance listing/CFDA number 93.103. It falls under the discretionary opportunity category and uses a cooperative agreement funding mechanism, which typically means FDA expects to have substantial involvement during the project period rather than acting solely as a pass-through funder. The activity category is listed under Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA's broader public health and regulatory mission, including ensuring that data used in regulatory decision-making is generated under systems that support integrity, traceability, and reproducibility.
A key feature of this FOA is that it is effectively a single-source competition. FDA states its intent to accept and consider only one application, specifically from the University of Texas Medical Branch (UTMB) Galveston National Laboratory (GNL). In practice, that means the program is structured around UTMB GNL as the intended awardee and implementing site, likely because of its specialized BSL-4 capabilities and existing infrastructure suited to building a formal training environment. While the eligibility field is broadly described as "Others (see text field entitled Additional Information on Eligibility for clarification)," the description makes clear that the agency plans to make one award to UTMB GNL.
The project itself centers on developing and implementing a certified, academic course that teaches GLP in the context of a BSL-4 containment setting. The emphasis is not just on generic GLP principles, but on how to realistically apply them when working in high containment, where factors like restricted movement, specialized personal protective equipment, strict decontamination procedures, and limited access to equipment can complicate documentation practices, sample handling, instrument calibration, chain-of-custody, deviation management, and other core GLP expectations. By focusing on certified training, the FOA signals an interest in formal, repeatable instruction that can credibly prepare participants to generate data suitable for regulatory use and to understand what regulators are looking for when evaluating studies conducted in these environments.
FDA also highlights a strong educational design component: the training program is expected to be robust, collaborative, and grounded in problem-based learning. That approach implies participants will learn through realistic scenarios and practical challenges rather than relying only on lectures or static compliance checklists. A major goal is to bring researchers and regulators together in the same learning space so they can educate each other. Researchers can surface the operational realities and constraints of BSL-4 work that affect study conduct, while regulators can clarify expectations related to GLP compliance and data integrity. The FOA frames this as a two-way exchange meant to identify solutions that work scientifically and meet regulatory standards, which is especially important when conventional GLP workflows need adaptation to fit the containment environment without undermining quality or safety.
From a funding and scale standpoint, the opportunity anticipates a single award with an award ceiling of $1,500,000 and an expected number of awards equal to 1. The FOA was created on June 26, 2017, with an original closing date of August 29, 2017. Taken together, these details describe a targeted investment intended to produce a structured training capability at a premier high-containment laboratory, with FDA involvement, and with an explicit focus on improving how GLP is taught, interpreted, and implemented when the work must be performed under BSL-4 constraints.
In plain terms, this grant is about building a formal, academically anchored GLP training course tailored to the realities of BSL-4 labs, using hands-on, scenario-driven learning and deliberate interaction between scientists and regulators. The outcome FDA is aiming for is a stronger shared understanding of what high-quality, regulator-ready laboratory practice looks like in maximum-containment environments, and a training model that helps close the gap between scientific execution and regulatory acceptability in some of the most challenging laboratory settings.Apply for RFA FD 17 013
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jun 26, 2017.
- Applicants must submit their applications by Aug 29, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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| Data Standards for Clinical Research and Drug Development (U24) Apply for RFA FD 18 015 Funding Number: RFA FD 18 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) Apply for RFA FD 18 010 Funding Number: RFA FD 18 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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