Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed | RFA FD 23 029

Opportunity Information: Apply for RFA FD 23 029

The Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed (RFA-FD-23-029) is a discretionary funding opportunity from the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services. It is administered through FDA's Center for Drug Evaluation and Research (CDER), specifically the Office of Compliance (OC) and the Office of Compounding Quality and Compliance (OCQC). The award mechanism is a cooperative agreement, which generally means the FDA expects to have substantial involvement during the project period, such as collaborating on priorities, reviewing progress, and helping guide deliverables rather than simply providing funds with minimal federal interaction.

The main purpose of the award is to continue building and operating the Compounding Quality Center for Excellence Training Program. The program is meant to deliver education and practical training targeted primarily at the outsourcing facility (OF) industry, while also serving other key groups that influence compounding quality nationwide. Those stakeholders include compounders more broadly and both federal and state regulators. A central emphasis is on Current Good Manufacturing Practice (CGMP) training, with the expectation that the recipient will assess evolving training needs across these audiences, update existing course materials, develop new trainings where gaps exist, deliver courses at a national scale, and evaluate whether the trainings are effective and lead to meaningful improvements.

A key theme running through the opportunity is patient protection. The FDA frames this work as directly tied to improving the quality of compounded drugs and reducing the risk that patients are exposed to unsafe, ineffective, contaminated, or otherwise poor-quality products. The agency specifically points to the potential for serious health consequences, including impairment, harm, or death, if compounding quality is inadequate. In other words, the training and associated research and assessment activities are not just educational; they are positioned as a public health intervention aimed at preventing quality failures and strengthening compliance culture and technical capability in the compounding and outsourcing facility space.

The FOA also highlights that the initiative is supported by a Congressional appropriation with a clear directive: increase direct engagement and provide education and training to outsourcing facilities, compounders, and federal and state regulators. That directive helps explain why the program is expected to have broad reach and why it is structured as a cooperative agreement, since the FDA intends to stay closely engaged and ensure the training program aligns with regulatory expectations and national needs.

In terms of award scale and competitiveness, the opportunity anticipated a single award (expected awards: 1) with an award ceiling of $5,500,000. The listing is associated with CFDA number 93.103 and falls under funding activity areas that include consumer protection and science and technology/research and development. Eligibility is listed as "Others (see text field entitled Additional Information on Eligibility for clarification)," indicating that applicant types may be limited or defined in the full announcement beyond standard categories, and that prospective applicants would need to verify they meet the specific eligibility language in the FOA.

Administratively, the opportunity was created on April 27, 2023, with an original closing date of June 30, 2023. The title explicitly states "Clinical Trials Not Allowed," signaling that the funded work is not intended to involve clinical trial activities; instead, the focus is on training development and delivery, stakeholder needs assessment, and evaluation and related research activities that support education and compliance improvements rather than clinical research with human subjects.

• The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Education and Training Program for Outsourcing Facility Industry (UE5) 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 Apr 27, 2023.
• Applicants must submit their applications by Jun 30, 2023. (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 $5,500,000.00 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).

Apply for RFA FD 23 029

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