Office of Research

Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed

Limited Submissions

The objective of the Cooperative Agreement is to work directly with an established and experienced technical training provider with Current Good Manufacturing Practice (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).

 

Application Instructions

Please submit:

  1. A one‐page letter of intent with a description of proposed aims and approach.
  2. If the final application requires a diversity statement or statement of broader impacts, please summarize your plans to address the specific requirements on an additional page.
  3. CV (not biosketch) of the PI.

to limitedsubs@uw.edu by 5:00 PM Wednesday, May 24, 2023. Proposals are due to the sponsor 6/30/2023, so you will need to have your materials in to the Office of Sponsored Programs by 6/21/2023 if given the go‐ahead by the Limited Submissions review committee.

Opportunity Details

Program web page

Program Announcement No.

RFA-FD-23-02

Deadlines
05/24/2023 UW Internal Deadline Closed
06/21/2023 OSP Deadline
06/30/2023 Sponsor Deadline
Sponsor

National Institutes of Health (NIH)

Funding amount

$5,500,000

Maximum Number of Applications

1

Eligible groups
  • All campus

Inquiries and Contact Information

Investigators who identify a grant, award or fellowship program that restricts the number of applications that can be submitted from an Institution should immediately contact their Chairperson, Associate Dean for Research (or Dean, if no ADR) and the Office of Research (see below) if they intend to prepare a response. Failure to do so, or to meet the deadlines for submission of pre-proposal, will preclude submission of the application through the Office of Sponsored Programs.

For general inquiries, or to request a listing of a limited submission opportunity that should be but is not already listed, please email us at limitedsubs@uw.edu.