OpportunityTitle: Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed
AdditionalInformationOnEligibility: Eligible Organizations  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 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
Description: The Food and Drug Administration&apos;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.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592