RFA-FD-23-022: Strengthening Global Competency and Capacity for Pharmaceutical Inspections
Closed
This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2023.
Food and Drug Administration offered grants of up to $450,000 (at least $50,000) to the applicants described in the notice. Applications closed on June 20, 2023.
From the official notice on Grants.gov, last changed April 14, 2023. Checked November 7, 2026.
- Award ceiling$450,000
- Award floor$50,000
- Cost sharingNot required
- Funding typeCooperative Agreement
Key dates
| Posted | April 14, 2023 |
|---|---|
| Deadline | June 20, 2023 |
| Archived by Grants.gov | July 20, 2023 |
Who can apply
This opportunity was open to the applicants described in the notice.
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
Eligible Organizations Only the following organization is eligible to apply: The Pharmaceutical Inspection Cooperation Scheme (PIC/S) The applicant must: 1) have strong institutional linkages with NRA Inspectorates around the globe; 2) have extensive knowledge of procedures and systems across the globe in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use; 3) be a leader in international development, implementation, and maintenance of harmonized GMP standards and quality systems; and 4) have a proven record of working with a varied and wide range of NRA inspectorates aiming at harmonizing and better aligning inspection procedures worldwide by developing common standards, practices and approaches in the field of GMP, by providing capacity building opportunities to inspectors, and facilitating cooperation and networking among competent inspectional authorities, regional, and international organizations, thus increasing mutual confidence in the GMP inspectional arena in the field of pharmaceutical products; and 5) have a proven record in the development of competency- and capacity-building activities and programs to build and strengthen skills and expertise of GMP Inspectors and the development of harmonized inspectional procedures.
Is this a realistic fit?
- Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $450,000 per award.
- Most of the program's money (35% over five years) went to nonprofits.
- No cost sharing or match is required.
What the grant funds
The Cooperative Agreement will build upon the extensive experience of an institution with well-established and globally recognized expertise and quality standards for drug inspectorates of National Regulatory Authorities (NRAs) around the globe in support of data-driven and science-based regulatory public health strategies and approaches. The organization's best practices should align with the FDA domestic and global priority of assuring of the integration of pharmaceutical good manufacturing practice (GMP) inspections and risk assessment activities including data modeling for a risk-based inspection prioritization and workplan. The funding will catalyze and support the institution's activities that are focused on building a global consensus on criteria for an optimal good manufacturing practice inspection, the core competencies for Inspectors or investigators, and planning, prioritizing and conducting inspections based on well informed risk assessments within the context of the increasingly complex and evolving science and innovation in the manufacturing of pharmaceutical products. Based on such consensus, the institution and its network of NRA Inspectorates will work toward a systems-approach and sustainable alignment across NRA Inspectorates in training inspectors and regulatory experts in best practices for maintaining oversight of pharmaceutical supply chains.
Who has won Food and Drug Administration Research grants before
From fiscal 2021 to 2025, Food and Drug Administration Research (93.103) awarded $1.2 billion across 940 grant awards, an average of $1.3 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Critical Path Institute | Arizona | 13 | $94.0 million |
| National Environmental Health Association | Colorado | 9 | $55.4 million |
| Association of Food & Drug Officials | Pennsylvania | 14 | $50.3 million |
| The Medical Device Innovation Consortium | Virginia | 1 | $48.6 million |
| Duke University | North Carolina | 11 | $35.6 million |
Applying now
This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-FD-23-022 still open?
No. It closed on June 20, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.
Who can apply for Strengthening Global Competency and Capacity for Pharmaceutical Inspections?
Food and Drug Administration accepted applications from the applicants described in the notice. The notice adds further conditions, so read its eligibility section.
What is the deadline for Strengthening Global Competency and Capacity for Pharmaceutical Inspections?
Closed June 20, 2023. Applications are no longer accepted; the program's newer notices are on this page when there are any.
How much funding is available?
Awards of up to $450,000 each.
Who has won Food and Drug Administration Research grants before?
The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.