Opportunity Information: Apply for RFA FD 20 005
The Heart Failure Collaboratory (R18) Clinical Trials Optional funding opportunity (RFA-FD-20-005) is a discretionary grant program offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It is administered within the FDA's Center for Drug Evaluation and Research (CDER), specifically under the Office of New Drugs (OND) and the Division of Cardiovascular and Renal Products (DCRP). The core purpose of the opportunity is to provide grant support for a single award to establish or sustain a "Heart Failure Collaboratory," meaning a coordinated effort that brings together relevant stakeholders to improve how heart failure clinical evidence is generated and evaluated in ways that are useful for drug development, regulatory decision-making, and patient care. As indicated by the "Clinical Trials Optional" designation, applicants may propose clinical trials as part of their project, but they are not required to do so.
This opportunity was posted on November 21, 2019, with an original application deadline of January 22, 2020. The program anticipated making one award, with an award ceiling of $2,150,000, signaling that the FDA intended to fund one major, centralized effort rather than multiple smaller projects. The listing is associated with CFDA number 93.103, and the funding activity category is labeled under Agriculture, Consumer Protection, Food and Nutrition, which reflects FDA's broader cataloging structure rather than the clinical focus of the project itself.
Eligibility is broad and includes many types of organizations capable of leading a national or multi-institution effort. Eligible applicants include federal recognized Native American tribal governments and tribal organizations, state and local governments (including counties, cities, townships, special districts, and public housing/Indian housing authorities), public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education where applicable), for-profit organizations (other than small businesses), small businesses, and additional eligible entities as clarified in the full eligibility text referenced by the announcement. In practical terms, this wide eligibility suggests the FDA was looking for an applicant with the capacity to convene partners, manage complex collaborative work, and develop deliverables that can influence heart failure drug development and evaluation.
In summary, this grant opportunity is FDA CDER's mechanism to support a structured, collaborative program focused on heart failure, with flexibility to include clinical trials but not limited to them. The funding level and single expected award point to an emphasis on a centralized leadership organization that can coordinate a broad collaboratory effort and produce outputs that align with FDA's cardiovascular and renal product evaluation mission.Apply for RFA FD 20 005
- 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 "Heart Failure Collaboratory (R18) 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 Nov 21, 2019.
- Applicants must submit their applications by Jan 22, 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 $2,150,000.00 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 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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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Heart Failure Collaboratory (R18) Clinical Trials Optional and is identified by the announcement number RFA-FD-20-005.
Which federal agency is offering this grant?
This is a discretionary grant program offered by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).
Which part of the FDA administers the program?
The program is administered within the FDA's Center for Drug Evaluation and Research (CDER), specifically under the Office of New Drugs (OND) and the Division of Cardiovascular and Renal Products (DCRP).
What is the main purpose of the Heart Failure Collaboratory grant?
The core purpose is to provide support for a single award to establish or sustain a Heart Failure Collaboratory, meaning a coordinated effort that brings together relevant stakeholders to improve how heart failure clinical evidence is generated and evaluated in ways that are useful for:
- Drug development
- Regulatory decision-making
- Patient care
What does "Heart Failure Collaboratory" mean in this announcement?
In this context, a Heart Failure Collaboratory refers to a structured, coordinated collaboration designed to convene stakeholders and produce improvements in the generation and evaluation of clinical evidence for heart failure, particularly as it relates to FDA's cardiovascular and renal product evaluation mission.
Are clinical trials required under this funding opportunity?
No. The opportunity is labeled "Clinical Trials Optional", which means applicants may propose clinical trials as part of the project, but they are not required to do so.
If clinical trials are optional, can an application still be competitive without them?
Based on the information provided, the announcement emphasizes establishing or sustaining a coordinated collaboratory to improve clinical evidence generation and evaluation. Since clinical trials are explicitly optional, proposals may focus on collaboratory-building and outputs that support drug development, regulatory decision-making, and patient care without necessarily including trials.
How many awards did the FDA anticipate making?
The program anticipated making one award.
What is the maximum funding amount (award ceiling)?
The award ceiling listed is $2,150,000.
Does the program fund multiple smaller projects or one centralized effort?
The announcement indicates an expectation of one award with a relatively high ceiling, which signals an intention to fund one major, centralized effort rather than multiple smaller projects.
When was this opportunity posted?
The opportunity was posted on November 21, 2019.
What was the original application deadline?
The original application deadline was January 22, 2020.
What is the CFDA number associated with this grant listing?
The listing is associated with CFDA number 93.103.
What is the funding activity category shown in the listing?
The funding activity category is labeled under Agriculture, Consumer Protection, Food and Nutrition. The provided description notes that this reflects FDA's broader cataloging structure rather than the clinical focus of the project itself.
Who is eligible to apply?
Eligibility is broad and includes multiple organization types, including:
- Federal recognized Native American tribal governments and tribal organizations
- State and local governments (including counties, cities, townships, special districts, and public housing/Indian housing authorities)
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Independent school districts
- Nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education where applicable)
- For-profit organizations (other than small businesses)
- Small businesses
- Additional eligible entities as clarified in the full eligibility text referenced by the announcement
Are for-profit organizations allowed to apply?
Yes. The eligibility list includes for-profit organizations (other than small businesses) and also lists small businesses as eligible.
Can nonprofit organizations apply if they do not have 501(c)(3) status?
Yes. The eligibility list includes nonprofit organizations with or without 501(c)(3) status (with an exclusion note regarding institutions of higher education where applicable).
What types of institutions of higher education are eligible?
The announcement indicates that both public and state-controlled institutions of higher education and private institutions of higher education are eligible.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes federal recognized Native American tribal governments and tribal organizations.
Are local government entities like counties and cities eligible?
Yes. The eligibility list includes state and local governments, including counties, cities, townships, special districts, and public housing/Indian housing authorities.
What kind of applicant is this opportunity trying to attract?
Based on the description provided, the broad eligibility and the single, large award suggest the FDA was looking for an applicant with the capacity to:
- Convene relevant partners and stakeholders
- Manage complex collaborative work across organizations
- Develop deliverables that influence heart failure drug development and evaluation
- Align outputs with FDA CDER's cardiovascular and renal product evaluation mission
What does the "R18" mechanism indicate in this opportunity title?
The opportunity name includes (R18) as part of its title, but the provided information does not define what R18 means beyond identifying the opportunity as the Heart Failure Collaboratory (R18) program.
What is meant by "discretionary grant program" here?
The announcement describes this as a discretionary grant program offered by HHS through FDA. No additional definition is provided in the text beyond that classification.
Does the information provided specify required partners or specific stakeholder groups?
No specific stakeholder categories are listed in the provided text. It states that the collaboratory should bring together relevant stakeholders, but it does not enumerate which groups must be included.
Does the information provided describe specific deliverables or work products?
The provided summary does not list specific required deliverables. It broadly states that the collaboratory should improve the generation and evaluation of heart failure clinical evidence in ways that support drug development, regulatory decision-making, and patient care.
Does this opportunity focus only on patient care, or also on regulatory and drug development needs?
It explicitly emphasizes usefulness for drug development, regulatory decision-making, and patient care, indicating the scope is not limited to patient care alone.
Which FDA mission area does this opportunity align with most directly?
The announcement situates the program within CDER, OND, and DCRP, and notes that the effort should align with FDA's cardiovascular and renal product evaluation mission.
Is this opportunity intended for a national or multi-institution effort?
The description suggests the program is aimed at organizations capable of leading a national or multi-institution effort, reflecting the expectation of a broad collaboratory rather than a single-site activity.
Is this grant intended to create a new collaboratory or maintain an existing one?
Either is allowed. The purpose is to establish or sustain a Heart Failure Collaboratory.
Does the information provided indicate whether this opportunity is currently open?
No. The information provided only includes the posting date and the original application deadline. It does not state whether the opportunity has been re-opened, extended, or is currently accepting applications.
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| 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 |
| 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 |
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