Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed | RFA FD 23 002

Opportunity Information: Apply for RFA FD 23 002

This funding opportunity (RFA-FD-23-002) is a cooperative agreement from the U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services, focused on strengthening Good Laboratory Practices (GLP) training for work performed in the most restrictive biocontainment setting, Biosafety Level 4 (BSL-4). The goal is to support the continued development and delivery of a certified, academic training program that teaches GLP concepts specifically as they apply in high-containment environments, where normal laboratory routines are complicated by stringent safety, security, operational, and regulatory constraints. Clinical trials are not allowed under this announcement, which keeps the effort centered on training, education, and laboratory practice standards rather than human subject research.

A key feature of the program described is its emphasis on collaboration and problem-based learning. FDA is looking for a structured educational model that brings researchers and regulators together in a shared learning environment, with the idea that each group has practical knowledge the other needs. Researchers can surface real-world challenges encountered when applying GLP in BSL-4 conditions, while regulators can clarify expectations, compliance considerations, and the reasoning behind regulatory approaches. The training is intended to do more than present rules; it should use realistic scenarios and applied problem-solving to help participants identify workable solutions that are scientifically sound and also acceptable from a regulatory standpoint. In other words, the course is meant to reduce friction between scientific practice and compliance by building a common understanding of constraints, documentation needs, quality systems, and decision-making in high-containment labs.

The project’s core deliverable is the continued development and implementation of a certified academic course. That implies an organized curriculum with defined learning objectives, instructional content tailored to GLP in high containment, and some form of assessment or certification mechanism to demonstrate competency or completion. Because the setting is BSL-4, the program likely needs to address how GLP principles translate when access is limited, procedures are performed in specialized suits or containment equipment, samples and materials must be handled under strict chain-of-custody and decontamination requirements, and normal documentation practices may need to be adapted without sacrificing traceability, data integrity, or quality assurance. While the announcement text provided does not list specific modules, the focus suggests training that connects GLP fundamentals (such as standard operating procedures, protocol adherence, deviations, corrective and preventive actions, equipment qualification, recordkeeping, and audit readiness) to the unique operational realities of BSL-4 work.

Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, which typically means FDA expects substantial involvement during the project period compared with a standard grant. The opportunity sits within activity areas tied to consumer protection and science and technology research and development, reflecting FDA’s interest in ensuring that high-containment laboratory work that may underpin regulated products or public health decisions is conducted under rigorous, well-understood quality systems. The program is designed to be robust and ongoing rather than a one-time workshop, with a clear emphasis on sustaining an educational pipeline that can train personnel and promote consistent standards in a niche but high-stakes laboratory domain.

Funding details indicate a single expected award, with an award ceiling of $400,000. The original posting timeline shows a creation date of August 2, 2022 and an original closing date of October 3, 2022. Eligibility is broad and includes various levels of government, public and private institutions of higher education, tribal governments and organizations, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and other entities as allowed by the announcement’s additional eligibility language. This breadth suggests FDA is primarily focused on finding the most capable organization to develop and run the training program, whether that capability resides in academia, a specialized training institution, a nonprofit, or an appropriately qualified private-sector group.

In practical terms, a competitive proposal for this opportunity would be expected to describe how the applicant will maintain or expand an academically grounded, certified GLP training course tailored to BSL-4 realities, how problem-based learning will be used to connect theory to real compliance and operational challenges, and how the program will facilitate constructive interaction between laboratory practitioners and regulators. The overall intent is capacity-building: improving the quality, consistency, and regulatory alignment of laboratory practices in high-containment environments by investing in a formal training program that produces graduates who can operate effectively under GLP expectations in BSL-4 settings.

• The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed" 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 Aug 02, 2022.
• Applicants must submit their applications by Oct 03, 2022. (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 $400,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

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