# Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed

Source: https://welltoldgrants.com/grants/rfa-fd-24-026-strengthening-global-competency-and-capacity-in/  
Official notice: https://www.grants.gov/search-results-detail/351619

> Food and Drug Administration offered grants of up to $150,000 to the applicants described in the notice. It expected to make one award worth $150,000 in total. Applications closed on February 27, 2024.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-24-026 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | February 27, 2024 |
| Award ceiling | $150,000 |
| Award floor | not stated |
| Expected awards | 1 |
| Total funding | $150,000 |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- Others (see text field entitled "Additional Information on Eligibility" for clarification)

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. Foreign Institutions Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

## 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

## Questions people ask

### Is RFA-FD-24-026 still open?

No. It closed on February 27, 2024. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed?

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 in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed?

Closed February 27, 2024. 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 $150,000 each. About $150,000 in total for one award.

### 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.