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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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional."
Which agency is offering and administering this opportunity?
This is a U.S. Department of Health and Human Services (HHS) discretionary funding opportunity that is administered by the U.S. Food and Drug Administration (FDA).
What is the funding mechanism (U18), and why does it matter?
The mechanism is a cooperative agreement (U18), not a standard grant. A cooperative agreement typically means FDA is expected to have substantial involvement during the project period, such as active collaboration, shared planning, and ongoing technical input, rather than only monitoring progress from a distance.
What does "Renewal Application" mean in this context?
"Renewal Application" indicates the intent is to renew and continue an existing FDA Critical Path public-private partnership or consortium, rather than establish a brand-new partnership from scratch.
What is the Critical Path Initiative referenced in the announcement?
The Critical Path Initiative is FDA's broader effort to improve and modernize the scientific and technical processes used to develop, evaluate, manufacture, and monitor medical products. It focuses on making medical product development faster and more efficient without sacrificing rigor, and on strengthening safety science across the medical product lifecycle.
What is the primary purpose of this opportunity?
The purpose is to continue a high-impact, FDA-collaborative consortium that conducts innovative, collaborative projects. The funded work is expected to generate tools, methods, and shared knowledge that help translate scientific discoveries into safe and effective medical products.
What kinds of activities can the consortium support?
The partnership/consortium is described as a mechanism that can span research, education, and outreach. The emphasis is on collaborative projects that produce broadly useful tools, methods, or knowledge to improve medical product development and oversight.
What topics and themes does FDA emphasize for this consortium?
The opportunity emphasizes medical product innovation and acceleration of development timelines, including work across development, manufacturing, and translational therapeutics. It also explicitly highlights enhancing medical product safety, including improving how safety issues are detected, understood, predicted, and mitigated across product types.
Are clinical trials required under this opportunity?
No. Clinical trials are listed as optional, meaning clinical trial activities may be included if they fit the partnership's objectives, but they are not required to be responsive to the opportunity.
What is the opportunity number and CFDA number?
The opportunity number is RFA-FD-19-027, and it is associated with CFDA number 93.103.
When was this opportunity created, and what were the key dates provided?
The opportunity was created on May 29, 2019. The original closing date listed is July 29, 2019.
How many awards did FDA expect to make?
The notice indicates an expected number of awards of 1, suggesting FDA intended to fund a single renewal application rather than multiple awards.
What is the maximum funding amount (award ceiling)?
The listed award ceiling is up to $100,000,000, indicating FDA anticipated a major, large-scale consortium effort that could support broad infrastructure, coordination, and potentially multi-project programs.
Who is eligible to apply?
Eligibility is described broadly as "Others," with additional eligibility details referenced in the full announcement text. Because this is explicitly a renewal application, the intent appears to be focused on continuing an existing consortium structure rather than opening competition to entirely new partnerships.
Why does the opportunity emphasize public-private partnership/consortium work?
The announcement notes that some barriers to faster, safer medical product development are too complex for any single organization to solve alone. The cooperative agreement structure is intended to support structured collaboration among government, industry, academia, nonprofits, and other stakeholders.
What kinds of outputs are expected from the funded work?
Based on the description, outputs are expected to include tools, methods, and shared knowledge that modernize and improve medical product development and oversight, potentially affecting development, manufacturing, translation of therapeutics, and safety science.
Is this opportunity intended for small, single-lab research projects?
The combination of an expected single award and a ceiling up to $100,000,000 suggests the intent is a large, multi-stakeholder consortium effort, potentially supporting broad coordination and infrastructure, rather than a narrow, single-lab research study.
How involved will FDA be during the project period?
Because this is a cooperative agreement (U18), FDA involvement is expected to be substantial, including active collaboration and ongoing technical input as part of executing the consortium's work.
What parts of the medical product lifecycle are in scope?
The description references multiple parts of the lifecycle, including development, manufacturing, translational therapeutics, and the monitoring and mitigation of safety issues.
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