The Food and Drug Administration’s (FDA), Center for Drug Evaluation and Research (CDER)/Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC), is announcing the Education and Training Program for Outsourcing Facility Industry (UE5).
Donor Name: Food and Drug Administration (FDA)
State: All States
County: All Counties
U.S. Territories: American Samoa, Guam, Commonwealth of Puerto Rico, Commonwealth of Northern Mariana Islands, U.S. Virgin Islands
Type of Grant: Grant
Deadline: 06/30/2023
Size of the Grant: up to $1,750,000
Grant Duration: 4 years
Details:
The goals of this Cooperative Agreement are to: continue the development of the Compounding Quality Center for Excellence Training Program, providing education and training for the Outsourcing Facility (OF) industry and other stakeholders with the capacity to expand into other program areas as directed; research and assess stakeholder training needs; and revise, develop and deliver and evaluate new and existing Current Good Manufacturing Practice (CGMP) training courses to stakeholders nationwide (Outsourcing Facility (OF), compounders, federal and state, regulators). This training and research program is intended to improve compounding quality to protect patients from unsafe, ineffective, and poor-quality drugs that may cause serious health consequences, impairment, harm, or death.
Objectives
The objective of the Cooperative Agreement is to work directly with an established and experienced technical training provider with CGMP compliant facilities and subject matter expertise and experience to continue the existing training program of the Compounding Quality Center of Excellence as well as research and expand the program with new trainings. These trainings help outsourcing facilities and other stakeholders increase technical capabilities and improve facility operations, by gaining an overview of FDA regulatory framework for compounding, identifying insanitary conditions in their facilities, and implementing appropriate corrective actions. Protecting patients from poor-quality compounded drugs is a shared responsibility among the FDA, outsourcing facilities, compounders, state regulators and other stakeholders. The Compounding Quality Center of Excellence, through training and other modalities, engages proactively with these stakeholders to enhance the quality of compounded drugs for human use.
Training formats may include in-person classroom, laboratory, and cleanroom environments; live, in virtual environments; and self-guided, online and be specifically to the CGMP requirements for the outsourcing facility industry (as opposed to customized training or consulting).
The funding opportunity contains three main parts:
- Instructor-Led, Live In-Person and Virtual Training,
- Self-guided Online Training, and
- Registration and Logistical Support.
Funding Information
FDA/CDER/OC intends to fund up to $1,750,000 in FY 2023 to fund 1 (one) award.
Project Period
The scope of the proposed project should determine the project period. The maximum project period is FOUR (4) years.
Eligibility Criteria
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institution
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits
- Nonprofits with 501(c)(3) IRS Status
- Nonprofits without 501(c)(3) IRS Status
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
Foreign Institutions
- Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
For more information, visit Grants.gov.
