Opportunity Information: Apply for RFA FD 19 028
The Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed), RFA-FD-19-028, is an FDA funding opportunity designed to speed up the development and qualification of drug development tools (DDTs). DDTs are broadly defined as methods, materials, or measures that make it easier, faster, or more reliable to develop and evaluate drugs. In practice, this can include things like biomarkers that help select the right patients for studies (trial enrichment), clinical outcome assessments (COAs) that measure whether a patient is actually benefiting, or animal models used to test medical countermeasures when human efficacy testing is not ethical or feasible under rules commonly referred to as the Animal Rule.
A central idea behind this program is FDA "qualification" of a DDT. Qualification is a formal FDA conclusion that a specific tool can be relied on, within a clearly defined Context of Use (COU), for a specific interpretation and application in drug development and FDA regulatory review under the Federal Food, Drug, and Cosmetic (FD&C) Act. The COU matters because qualification is not a blanket approval for every possible situation; it only applies to the specific setting described in the qualification materials. The practical benefit is significant: once a DDT is qualified for a COU, it can be used by any sponsor across relevant INDs, NDAs, or BLAs without each sponsor having to resubmit separate justification packages to FDA for the tool's use in that same qualified context. That makes qualified tools "shareable infrastructure" for the broader drug development ecosystem.
The grants specifically support developers who are already participating in CDER's Drug Development Tool Qualification Program and have an accepted Letter of Intent (LOI). Funding is meant to help these developers move forward toward either a Qualification Plan or a Full Qualification Package, following FDA's published program structure. Applicants are expected to align their grant application with the outline and expectations of the qualification documentation for the DDT program area they are in (for example, biomarker qualification, COA qualification, or animal model qualification). Importantly, the funding is restricted to work that directly supports progress toward the Qualification Plan or the Full Qualification Package; it is not general research funding and it is not intended for unrelated tool development outside the qualification pathway.
The public health rationale is that increasing the number and availability of qualified DDTs should improve the efficiency and quality of drug development across many programs, not just for a single company. FDA highlights anticipated benefits such as enabling more effective drugs to be developed, helping patients gain earlier access to therapies, and improving understanding of how drugs work during development. The opportunity also emphasizes collaboration and precompetitive development, encouraging efforts like consortia and public-private partnerships where multiple stakeholders can contribute data and expertise to produce tools that the entire field can use.
Administratively, this is a discretionary cooperative agreement (U01), meaning FDA expects to have substantial involvement during the project rather than acting only as a passive funder. The opportunity sits under CFDA 93.103 and is offered by the Department of Health and Human Services, Food and Drug Administration. Eligibility is broad and includes federal recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), and for-profit organizations including small businesses. The award ceiling listed is $250,000, with an anticipated 30 awards under this announcement. The notice was created June 10, 2019, with an original closing date of August 5, 2019.
A key restriction captured in the title is "Clinical Trial Not Allowed," which signals that the supported activities cannot include clinical trials under this funding mechanism. The funded work is intended to advance tool qualification materials and the supporting evidence packages needed for FDA's DDT qualification decision, with the expectation that once a tool is qualified it will be made publicly available to address unmet needs in drug development.Apply for RFA FD 19 028
- 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 "Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)" 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 10, 2019.
- Applicants must submit their applications by Aug 05, 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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 30 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), 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.
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Frequently Asked Questions (FAQs)
What is the Drug Development Tools Research Grants opportunity (RFA-FD-19-028)?
RFA-FD-19-028 is an FDA funding opportunity that supports work to speed up the development and FDA qualification of drug development tools (DDTs). It is offered as a discretionary cooperative agreement (U01) under CFDA 93.103 through the Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is a Drug Development Tool (DDT) in this program?
DDTs are broadly defined as methods, materials, or measures that make drug development and evaluation easier, faster, or more reliable. Examples mentioned include biomarkers (such as those used for trial enrichment), clinical outcome assessments (COAs), and animal models used to test medical countermeasures in situations where human efficacy testing is not ethical or feasible (often discussed in connection with the Animal Rule).
What does FDA "qualification" mean for a DDT?
Qualification is a formal FDA conclusion that a specific tool can be relied on for a specific interpretation and application in drug development and FDA regulatory review under the Federal Food, Drug, and Cosmetic (FD&C) Act.
What is a Context of Use (COU), and why does it matter?
The Context of Use (COU) describes the specific setting in which the tool is intended to be used and how its results will be interpreted. Qualification is not a blanket approval for all uses; it applies only within the defined COU described in the qualification materials.
Why is DDT qualification valuable to sponsors and the broader field?
Once a DDT is qualified for a COU, it can be used by any sponsor across relevant INDs, NDAs, or BLAs in that same qualified context without each sponsor needing to submit separate justification packages to FDA for that tool use. This makes qualified tools a form of shared infrastructure for the drug development ecosystem.
Who is this grant meant to support?
The grant is intended for DDT developers who are already participating in CDER's Drug Development Tool Qualification Program and have an accepted Letter of Intent (LOI).
Is an accepted Letter of Intent (LOI) required before applying?
Yes. The opportunity specifies that the grants support developers who are already in CDER's DDT Qualification Program and have an accepted LOI.
What types of qualification submissions does the funding aim to support?
Funding is meant to help developers progress toward either a Qualification Plan or a Full Qualification Package, following FDA's published program structure.
How should applicants align their grant application with FDA expectations?
Applicants are expected to align the grant application with the outline and expectations of the qualification documentation for the relevant DDT program area, such as biomarker qualification, COA qualification, or animal model qualification.
What activities are allowed under this funding?
Supported activities must directly support progress toward the Qualification Plan or Full Qualification Package for the DDT. The focus is on advancing qualification materials and the supporting evidence packages needed for FDA's DDT qualification decision.
What activities are not supported by this grant?
This is not general research funding and is not intended for unrelated tool development outside the qualification pathway. In addition, the funding mechanism is explicitly "Clinical Trial Not Allowed," meaning clinical trials cannot be included as supported activities under this award.
What does "Clinical Trial Not Allowed" mean in practice?
It indicates that the supported work cannot include clinical trials under this funding mechanism. The grant is intended to support work tied to DDT qualification materials and evidence packages rather than conducting clinical trials.
What is the public health rationale for funding DDT qualification work?
FDA emphasizes that increasing the number and availability of qualified DDTs should improve the efficiency and quality of drug development across many programs, not just one organization. Anticipated benefits include enabling more effective drugs to be developed, helping patients gain earlier access to therapies, and improving understanding of how drugs work during development.
Does the program encourage collaboration or consortia?
Yes. The opportunity emphasizes collaboration and precompetitive development and encourages efforts such as consortia and public-private partnerships where multiple stakeholders contribute data and expertise to create tools the entire field can use.
What type of award is this (U01), and what does it imply?
This is a discretionary cooperative agreement (U01). FDA expects to have substantial involvement during the project rather than serving only as a passive funder.
Which FDA center and program does this opportunity connect to?
It is tied to CDER's Drug Development Tool Qualification Program and supports developers working within that program structure.
Who is eligible to apply?
Eligibility is broad and includes federally recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), and for-profit organizations including small businesses.
What is the award ceiling for this opportunity?
The listed award ceiling is $250,000.
How many awards were anticipated under this announcement?
The opportunity anticipated 30 awards.
Which federal program listing is associated with this funding?
The opportunity is listed under CFDA 93.103.
When was the notice created and when was it originally due?
The notice was created on June 10, 2019, and the original closing date was August 5, 2019.
What is expected after a tool is qualified?
The opportunity describes an expectation that, once a tool is qualified, it will be made publicly available to address unmet needs in drug development.
Does qualification mean the tool is approved for any use?
No. Qualification applies only to the specific Context of Use (COU) described in the qualification materials, not to every possible use case.
What regulatory applications can benefit from a qualified DDT?
The opportunity notes that qualified tools can be used by any sponsor across relevant INDs, NDAs, or BLAs without resubmitting separate justification packages for use within the same qualified context.
What kinds of DDT areas are referenced as examples in the announcement?
Examples include biomarkers, clinical outcome assessments (COAs), and animal models, including models relevant when human efficacy testing is not ethical or feasible under the Animal Rule framework.
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| 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 |
| 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 |
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