Opportunity Information: Apply for RFA FD 19 027
This funding opportunity, titled "Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional," is a U.S. Food and Drug Administration (FDA) cooperative agreement intended to renew and continue an existing Critical Path public-private partnership or consortium. It sits under FDA's broader Critical Path Initiative, which focuses on improving and modernizing the scientific and technical processes used to develop, evaluate, manufacture, and monitor medical products. The central idea is that some of the biggest barriers to faster, safer medical product development are too complex for any single organization to solve alone, so FDA uses a cooperative agreement structure to support structured collaboration among government, industry, academia, nonprofits, and other stakeholders.
The award is framed as a public-private partnership/consortium mechanism meant to carry out innovative, collaborative projects that can span research, education, and outreach. In practical terms, the funded work is expected to generate tools, methods, and shared knowledge that make it easier to translate scientific discoveries into safe and effective medical products. The opportunity emphasizes medical product innovation and acceleration of development timelines, with attention to multiple parts of the lifecycle, including development, manufacturing, and translational therapeutics. It also explicitly highlights enhancing medical product safety, which can include efforts that improve how safety issues are detected, understood, predicted, and mitigated across product types.
This is a discretionary funding opportunity from the Department of Health and Human Services (HHS), administered by FDA, and it uses a cooperative agreement (U18) rather than a standard grant. That distinction matters because a cooperative agreement typically involves substantial FDA involvement during the project period, such as active collaboration, shared planning, or ongoing technical input, rather than a hands-off fund-and-monitor approach. Clinical trials are listed as optional, meaning the scope can include clinical trial activities if they fit the partnership's objectives, but applicants are not required to propose clinical trials to be responsive.
The opportunity number is RFA-FD-19-027, and it is associated with CFDA number 93.103. It was created on May 29, 2019, with an original closing date of July 29, 2019. The notice indicates an expected number of awards of 1, suggesting FDA intended to fund a single renewal application at a very large scale rather than multiple smaller awards. The listed award ceiling is up to $100,000,000, which signals that FDA anticipated a major, multi-stakeholder consortium effort with substantial resources, potentially supporting broad infrastructure, coordination, and multi-project programs rather than a narrow, single-lab research study.
Eligibility is described broadly as "Others," with additional eligibility details referenced in the full announcement text. This wording commonly signals that the opportunity may be restricted to specific types of organizations or, in the case of a renewal, potentially limited to an existing awardee or a narrowly defined group that already operates an FDA-recognized Critical Path consortium. Because it is explicitly a renewal application, the intent is not to create a brand-new partnership from scratch, but to continue and expand a previously funded collaborative structure that has already demonstrated value and alignment with FDA's Critical Path goals.
Overall, the opportunity is designed to keep a high-impact, FDA-collaborative consortium operating and evolving, with work that helps modernize the evidence and tools used in medical product development and oversight. The themes are speed and efficiency without sacrificing rigor, better translation from bench to bedside, improved manufacturing and development pathways, and stronger safety science, all pursued through coordinated public-private collaboration under FDA's active engagement.Apply for RFA FD 19 027
- 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 "Renewal Application: Critical Path Public Private Partnerships (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 May 29, 2019.
- Applicants must submit their applications by Jul 29, 2019. (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 $100,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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| Funding Opportunity |
|---|
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Implementing Alternative Methods to Expand the Reach across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 19 022 Funding Number: RFA FD 19 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,750,000 |
| Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed Apply for RFA FD 20 002 Funding Number: RFA FD 20 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,400,000 |
| Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 029 Funding Number: RFA FD 19 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 028 Funding Number: RFA FD 19 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Heart Failure Collaboratory (R18) Clinical Trials Optional Apply for RFA FD 20 005 Funding Number: RFA FD 20 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,150,000 |
| Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 006 Funding Number: RFA FD 20 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 004 Funding Number: RFA FD 20 004 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: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed Apply for RFA FD 20 019 Funding Number: RFA FD 20 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed Apply for RFA FD 20 018 Funding Number: RFA FD 20 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials Not Allowed Apply for RFA FD 20 017 Funding Number: RFA FD 20 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Center for Collaborative Research on Complex Generics (U18) Clinical Trials Optional Apply for RFA FD 20 007 Funding Number: RFA FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| 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 |
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