Opportunity Information: Apply for RFA FD 18 025
The Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) (Funding Opportunity Number RFA FD 18 025) is a discretionary funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). Created on May 17, 2018, with an original application deadline of July 18, 2018, this opportunity was designed to support a single, substantial award (expected awards: 1) with an award ceiling of up to $4,000,000. The funding instrument is a cooperative agreement, meaning the FDA anticipated having significant involvement with the recipient during the project, rather than operating at arm's length as it typically would under a more traditional grant.
The central purpose of the program is to strengthen FDA decision-making and implementation work tied to two major policy frameworks: the 2018 reauthorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act. In practical terms, the award is meant to help generate supporting research, surface and clarify key regulatory and scientific issues, and convene relevant subject matter experts. The work is aimed at informing major FDA initiatives focused on process improvement and regulatory science, which are critical themes under PDUFA VI commitments and the Cures Act. Rather than funding basic biomedical discovery, the emphasis here is on applied research and expert engagement that can directly inform how FDA evaluates products, runs review programs, and modernizes its regulatory approaches.
The activities supported under this opportunity center on three connected functions. First is performing or coordinating research that can serve as an evidence base for FDA policy and operational improvements related to drug development and review. Second is identifying and framing key issues that may affect FDA initiatives under PDUFA VI and the 21st Century Cures Act, such as gaps in knowledge, methodological challenges, or emerging areas where guidance and regulatory approaches need strengthening. Third is convening appropriate experts, which implies organizing workshops, panels, meetings, and other structured engagements to bring specialized knowledge to bear on complex regulatory science questions and process challenges. The idea is to combine analysis and evidence generation with high-quality expert input so that FDA efforts under these statutory commitments are informed by current science and informed stakeholder perspectives.
Eligibility is broad and spans many organization types, reflecting the cross-sector nature of regulatory science and process improvement work. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and additional applicants as further clarified in the opportunity materials. This wide eligibility suggests the FDA was open to partnering with a range of capable entities, including academic centers, nonprofit research organizations, and other institutions with the technical depth and convening power needed to deliver research and expert consultation at a national level.
From a classification standpoint, the opportunity falls under the funding activity category of Agriculture, Consumer Protection, Food and Nutrition and is listed under CFDA 93.103. While that label can sound broad, it aligns with FDA's public health and consumer protection mission, including ensuring the safety and effectiveness of prescription drugs and advancing the science that supports regulatory oversight. Overall, this opportunity is best understood as a targeted, high-value cooperative agreement intended to help FDA meet legislated performance and modernization commitments by funding coordinated regulatory research and expert-driven issue analysis tied directly to PDUFA VI and the 21st Century Cures Act.Apply for RFA FD 18 025
- 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 "Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19)" 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 May 17, 2018.
- Applicants must submit their applications by Jul 18, 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 $4,000,000.00 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, Independent school districts, Public and State controlled institutions of higher education, 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Funding Opportunity |
|---|
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| 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 |
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