Opportunity Information: Apply for RFA FD 20 007
The FDA, through the Department of Health and Human Services and its Office of Generic Drugs (OGD), launched this funding opportunity to create a single national-style hub called the Center for Collaborative Research on Complex Generics. The broader purpose sits inside the Generic Drug User Fee Amendments (GDUFA) research program, which is designed to strengthen the scientific tools FDA uses to assess whether a generic is truly equivalent to its reference product and, at the same time, make it easier and more predictable for companies to develop and submit high-quality Abbreviated New Drug Applications (ANDAs). The emphasis here is on "complex" generic products, meaning products that are harder to copy and evaluate than standard tablets or capsules. Under GDUFA II (the 2017 reauthorization), FDA specifically committed to improving how it supports complex generic development, including better product-specific guidance and more effective pre-ANDA scientific engagement. This center is meant to help make those commitments real by filling scientific gaps that slow down development or create uncertainty during FDA review.
A key part of the rationale is that complex products often involve complicated active ingredients, formulations, routes of delivery, or dosage forms, and they can also include drug-device combination products (for example, inhalers or injectors where the device is integral to how the drug works). FDA also treats as "complex" any product where the approval pathway has enough uncertainty that early scientific discussion could prevent wasted effort and delays. Because FDA updates its generic drug research priorities annually, the agency wants a durable partner that can coordinate work across changing priority areas while keeping industry meaningfully involved. In practice, the center is expected to function as a bridge between FDA, academic and research experts, and generic drug manufacturers, so that research questions are aligned with real regulatory needs and real-world development barriers.
The program is structured as a cooperative agreement (U18), which signals a hands-on partnership with FDA rather than a traditional grant where the recipient operates largely independently. The center is expected to drive collaborative interactions that increase participation from the generic drug industry and speed progress in areas that matter both to OGD and industry. One example highlighted in the announcement is a visiting scientist style exchange: FDA staff may spend time at the center or partner sites to give lectures, join workshops, learn emerging technologies, and interact with program leadership and research staff. The exchange is intended to go both ways, with center members also visiting FDA to present work, participate in workshops, visit FDA labs, and engage FDA scientists directly. The FOA also anticipates that industry scientists may visit the center to learn technologies and help shape research proposals around practical scientific hurdles companies face. All of this is expected to be done with careful attention to ethics rules, conflict-of-interest safeguards, and restrictions on sharing non-public information.
Another major activity is convening workshops focused on generic drug research, designed to include FDA, the center and its membership, industry, and the broader public. These workshops may be co-sponsored with FDA when permitted by agency policy, and they can serve both as educational events and as "horizon scanning" sessions to identify emerging scientific trends that could affect generic development. Applicants are expected not only to show they can run the types of engagements described in the FOA, but also to propose additional interaction formats that deepen public and industry engagement and keep the center plugged into real needs.
Beyond convening and coordination, the FOA requires that applicants build and describe the infrastructure for a core center program. That includes a clear organizational structure capable of managing collaborations across multiple entities and investigators, supporting project coordination, and maintaining ongoing engagement with FDA and industry stakeholders. In other words, FDA is not looking for a single research project; it is looking for an operating center with governance, partnership mechanisms, and the ability to manage a portfolio of activities tied to complex generics.
Scientifically, the center is expected to support cutting-edge research that advances methods and evidence-generation for complex generic drug products. The FOA names several areas of interest: analytical methods (for characterizing complex ingredients and formulations), modeling and simulation (to predict performance and support equivalence arguments), formulation science, and clinical and pre-clinical development approaches relevant to generics. Applicants need to demonstrate that they have access to, or formal partnerships with, investigators who have deep expertise in these domains and who understand the regulatory science goals of the generic drug research program. Just as importantly, applicants must show they can engage effectively with the generic industry, since one of the center's core purposes is to ensure research questions are grounded in actual development challenges and can translate into practical regulatory pathways.
The opportunity (RFA-FD-20-007) is listed under CFDA 93.103 and uses the cooperative agreement funding mechanism. The agency expected to make one award, with an award ceiling of $5,000,000. Eligibility is broad and includes many types of organizations: public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various governmental entities and tribal organizations. While clinical trials are labeled "optional," the center is fundamentally aimed at generating the science and collaborations that help FDA evaluate equivalence and help industry develop complex generics more efficiently, whether that involves laboratory methods, computational approaches, preclinical work, or clinical studies when appropriate.
Finally, the FOA underscores an important expectation around dissemination: when research resources are developed using FDA funds and the findings are published, those outputs should be made readily accessible to the broader scientific community. That reflects the public-health intent of the program: to build shared tools, data, and understanding that reduce uncertainty, shorten development timelines, and ultimately expand access to safe, effective, high-quality generic drugs, especially in categories where complexity has historically limited competition.Apply for RFA FD 20 007
- 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 "Center for Collaborative Research on Complex Generics (U18) Clinical Trials Optional" 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 Jan 07, 2020.
- Applicants must submit their applications by Apr 13, 2020. (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 $5,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Funding Opportunity |
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| Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional Apply for PAR 20 083 Funding Number: PAR 20 083 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed Apply for RFA FD 20 020 Funding Number: RFA FD 20 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional) Apply for RFA FD 20 021 Funding Number: RFA FD 20 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Optional) Apply for RFA FD 20 009 Funding Number: RFA FD 20 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial Not Allowed Apply for RFA FD 20 013 Funding Number: RFA FD 20 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional Apply for RFA FD 20 025 Funding Number: RFA FD 20 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18) Clinical Trials Not Allowed Apply for RFA FD 20 012 Funding Number: RFA FD 20 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $70,000 |
| Cooperative Agreement for Data Collection on Antimicrobial Use in Dogs and Cats (UO1) Clinical Trials Not Allowed Apply for RFA FD 20 026 Funding Number: RFA FD 20 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Apply for PAR 20 105 Funding Number: PAR 20 105 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed Apply for RFA FD 20 027 Funding Number: RFA FD 20 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $8,000,000 |
| FDA's National Curriculum Standard Development and Training Delivery and Development (U18) Clinical Trial Not Allowed Apply for RFA FD 20 024 Funding Number: RFA FD 20 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) Clinical Trials Not Allowed Apply for PAR 20 124 Funding Number: PAR 20 124 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 031 Funding Number: RFA FD 20 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed Apply for PAR 20 132 Funding Number: PAR 20 132 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 030 Funding Number: RFA FD 20 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 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 FDA Land and Water Initiative (U01) Clinical Trial Not Allowed Apply for RFA FD 20 034 Funding Number: RFA FD 20 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 20 029 Funding Number: RFA FD 20 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Drug Development Science Support (U01) Clinical Trials Optional Apply for RFA FD 20 033 Funding Number: RFA FD 20 033 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed Apply for RFA FD 20 032 Funding Number: RFA FD 20 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
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