FDA’s CDER/OCQC Cooperative Agreement for Outsourcing Facility Industry Education and CGMP Training

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 Institutions
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

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 this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.

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.

Through a Congressional appropriation, FDA is directed to increase direct engagement and provide education and training to outsourcing facilities, compounders, federal and state regulators.