Opportunity Information: Apply for RFA FD 18 024
Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) (Funding Opportunity Number RFA FD 18 024) is a Food and Drug Administration (FDA) cooperative agreement intended to reinforce and expand global regulatory alignment around pharmaceutical Good Manufacturing Practices. The central idea is to fund one highly experienced institution that already has a strong, internationally recognized track record working with inspectorates from National Regulatory Authorities (NRAs). Through that institution and its established network, the program aims to promote modern, data-driven, science-based inspectional approaches that support public health and track closely with FDA domestic and global priorities. The opportunity is structured to help integrate multiple elements of pharmaceutical quality oversight, specifically bringing together assessment, inspection, policy, and research so that regulatory decisions and inspection practices are consistent, current, and grounded in evolving manufacturing science.
A major focus of the award is building consensus on two related topics: what “optimal” GMP should look like in practice, and what competencies inspectors need to effectively evaluate increasingly complex pharmaceutical manufacturing. The notice highlights that manufacturing science and innovation are advancing quickly, which creates new challenges for inspectors and regulators who must evaluate sophisticated processes, novel technologies, and emerging quality risks. In that context, the funded institution is expected to catalyze collaborative work that clarifies shared expectations for GMP quality manufacturing and defines the knowledge, skills, and approaches inspectors need to apply those expectations consistently. Rather than treating inspections as isolated events, the opportunity emphasizes a systems approach, meaning the work should support coherent, end-to-end quality oversight frameworks that can be sustained across different regulatory environments.
The intended outcome is stronger alignment across and among NRA inspectorates worldwide, so that regulators are more consistent in how they interpret GMP principles, how they conduct inspections, how they use evidence and data, and how they translate findings into regulatory and public health actions. By strengthening global competency and capacity, the program is designed to improve the reliability and comparability of inspectional approaches, which in turn supports confidence in pharmaceutical quality across international supply chains. The cooperative agreement mechanism also implies substantial involvement from the FDA during the project, with collaboration and coordination between the award recipient and the agency being a defining feature of the work.
From an administrative standpoint, this is a discretionary cooperative agreement in the Agriculture, Consumer Protection, Food and Nutrition activity category, listed under CFDA 93.103. The opportunity was created June 11, 2018, with an original application closing date of August 13, 2018. FDA anticipated making a single award (Expected Awards: 1) with an award ceiling of $1,500,000. Eligibility was broad enough to include public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), and other entities as described in the opportunity’s additional eligibility language. Overall, the program is best understood as an FDA-supported effort to use an established global collaboration hub to harmonize GMP inspection capability and expectations internationally, reflecting the reality that pharmaceutical manufacturing and supply chains are global and require regulatory cooperation to effectively protect patients.Apply for RFA FD 18 024
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jun 11, 2018.
- Applicants must submit their applications by Aug 13, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA FD 18 024.
Which federal agency is offering this grant?
The opportunity is offered by the Food and Drug Administration (FDA).
What type of award mechanism is being used?
This is a cooperative agreement under the U01 mechanism, which indicates substantial involvement by the FDA during the project and an expectation of active collaboration between the award recipient and the agency.
What is the main purpose of this cooperative agreement?
The main purpose is to reinforce and expand global regulatory alignment around pharmaceutical Good Manufacturing Practices (GMP) by promoting modern, data-driven, science-based inspectional approaches that align with FDA domestic and global priorities.
What is the central idea behind how the program will achieve its goals?
The program is designed to fund one highly experienced institution that already has a strong, internationally recognized track record working with inspectorates from National Regulatory Authorities (NRAs). That institution is expected to use its established network to catalyze collaboration and alignment on GMP expectations and inspection competencies worldwide.
How many awards did FDA expect to make?
FDA anticipated making a single award (Expected Awards: 1).
What is the maximum funding amount available under this opportunity?
The award ceiling listed for this opportunity is $1,500,000.
When was this opportunity created?
The opportunity was created on June 11, 2018.
What was the original application closing date?
The original application closing date was August 13, 2018.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.103.
What activity category is this opportunity listed under?
It is listed under the Agriculture, Consumer Protection, Food and Nutrition activity category.
What is the program trying to align globally?
The program aims to strengthen alignment across and among NRA inspectorates worldwide in how GMP principles are interpreted, how inspections are conducted, how evidence and data are used, and how inspection findings are translated into regulatory and public health actions.
What does the opportunity emphasize about inspectional approaches?
It emphasizes modern, data-driven, science-based inspectional approaches and encourages moving away from viewing inspections as isolated events. Instead, it promotes a systems approach that supports coherent, end-to-end quality oversight frameworks.
What does a "systems approach" mean in the context of this opportunity?
Based on the notice description, a systems approach means supporting integrated and coherent quality oversight frameworks that connect assessment, inspection, policy, and research so that regulatory decisions and inspection practices are consistent, current, and sustainable across different regulatory environments.
What specific elements of pharmaceutical quality oversight does the program seek to integrate?
The opportunity highlights integration of assessment, inspection, policy, and research to ensure decisions and inspection practices remain consistent, up to date, and grounded in evolving manufacturing science.
What are the two major consensus-building topics highlighted in the notice?
The notice calls for building consensus on (1) what "optimal" GMP should look like in practice, and (2) what competencies inspectors need to effectively evaluate increasingly complex pharmaceutical manufacturing.
Why is the program focusing on inspector competencies?
The notice states that manufacturing science and innovation are advancing quickly, creating challenges for inspectors and regulators who must evaluate sophisticated processes, novel technologies, and emerging quality risks. The program therefore seeks to define the knowledge, skills, and approaches inspectors need to apply GMP expectations consistently.
What is meant by "optimal" GMP in this opportunity?
The opportunity describes "optimal" GMP as a practical, shared understanding of GMP-quality manufacturing expectations that can be applied consistently by regulators, especially as manufacturing technologies and risks evolve.
Who is the program intended to work with internationally?
The program is intended to work with inspectorates from National Regulatory Authorities (NRAs) through the awardee institution and its established international network.
What is the expected outcome for global regulator alignment?
The expected outcome is stronger alignment among NRA inspectorates worldwide, leading to more consistent interpretation of GMP, more comparable inspection practices, better use of evidence and data, and more consistent regulatory and public health actions.
How does this opportunity relate to global pharmaceutical supply chains?
The notice frames the effort as responding to the reality that pharmaceutical manufacturing and supply chains are global, and that regulatory cooperation is necessary to protect patients by supporting confidence in pharmaceutical quality across international supply chains.
What kinds of organizations were eligible to apply?
Eligibility included public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), and other entities as described in the opportunity's additional eligibility language.
Does the opportunity prioritize a particular type of applicant?
Yes. The notice is structured around funding one highly experienced institution with a strong, internationally recognized track record working with NRA inspectorates and an established network capable of serving as a global collaboration hub.
What role does the FDA play during the project?
Because this is a cooperative agreement, FDA involvement is expected to be substantial, with collaboration and coordination between the award recipient and the agency described as a defining feature of the work.
What does "data-driven, science-based" mean in this program description?
As described in the notice, it refers to inspectional approaches and regulatory decisions that make systematic use of evidence and data and that remain grounded in evolving manufacturing science.
Is this opportunity aimed at isolated training events or broader regulatory frameworks?
The notice emphasizes broader, sustainable oversight frameworks rather than treating inspections as isolated events, with the intent to support end-to-end systems that integrate multiple parts of pharmaceutical quality oversight.
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| Funding Opportunity |
|---|
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
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