Internal Deadline: Contact RII.
LOI: May 15, 2023
External Deadline: June 30, 2023, 5pm PT
Award Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Award Amount: $1,750,000
Who May Serve as PI: Standard NIH requirements.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-029.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template
Materials to submit include:
- (1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
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:
1. Instructor-Led, Live In-Person and Virtual Training, 2. Self-guided Online Training, and 3. Registration and Logistical Support.
This Cooperative Agreement seeks support for the following tasks: instructor-led, live in-person and virtual laboratory-based training in CGMP specifically tailored for the entire outsourcing facility industry at or using the firm’s onsite microbiology laboratory and cleanroom facility, self-guided online training tailored specifically for the outsourcing facility industry, and registration and logistical support. Awardee should be able to manage and expand a multi-faceted training program specific to the outsourcing facility industry that includes ongoing administration of multiple in-person, virtual and self-guided online trainings while simultaneously handling all training associated registration/logistics and development and delivery of new in-person, virtual and self-guided online training courses annually.
All three parts will collectively establish the foundation for building a sustainable training program for the FDA Compounding Quality Center of Excellence and its direct technical training partner, the Awardee.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.