Opportunity Information: Apply for RFA FD 19 016
This funding opportunity is a discretionary federal grant from the U.S. Department of Health and Human Services (HHS), specifically the Food and Drug Administration (FDA). It is titled "Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional" and is listed under Funding Opportunity Number RFA-FD-19-016 (CFDA 93.103). The FDA component involved is the Center for Drug Evaluation and Research (CDER), through its Office of Medical Policy (OMP). The main purpose is not to launch a brand-new program, but to continue an existing grant award that supports the Kidney Health Initiative (KHI).
At its core, the announcement signals FDA's intent to accept and consider a continuation (renewal) application from the American Society of Nephrology (ASN). In practical terms, this type of notice typically means the agency expects a single award and has a specific recipient in mind based on the ongoing nature of the project and the established role of the organization in running or coordinating the initiative. The grant mechanism is R18, which generally supports research demonstration and dissemination activities, and the opportunity explicitly notes that clinical trials are optional, meaning the funded work may include clinical trial activity but does not have to.
The funding parameters indicate an anticipated single award (Expected Awards: 1) with an award ceiling of $1,500,000. The posting dates show the opportunity was created on April 23, 2019, with an original application closing date of June 25, 2019. The Funding Activity Category is listed as Agriculture, Consumer Protection, Food and Nutrition, which is a broad categorization used in federal listings and does not necessarily mean the project focuses on agriculture; it reflects the way FDA-related opportunities are grouped in the cataloging system.
Eligibility is noted as "Others," with clarification referenced in an additional eligibility text field (not included in the excerpt). However, the description makes clear that FDA is announcing its intent to continue funding ASN for KHI, so the practical eligible applicant for this renewal is the American Society of Nephrology, consistent with a continuation award framework. Overall, this opportunity is designed to maintain FDA-supported work under the Kidney Health Initiative, leveraging an existing partnership and infrastructure rather than competing the award broadly among multiple new applicants.Apply for RFA FD 19 016
- 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: Kidney Health Initiative (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 Apr 23, 2019.
- Applicants must submit their applications by Jun 25, 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 $1,500,000.00 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): Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional
What is the official title of this funding opportunity?
The opportunity is titled "Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional."
Which federal agency is offering this grant?
This is a discretionary federal grant offered by the U.S. Department of Health and Human Services (HHS), specifically through the Food and Drug Administration (FDA).
Which FDA component is associated with this opportunity?
The FDA component involved is the Center for Drug Evaluation and Research (CDER), through its Office of Medical Policy (OMP).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-19-016.
What is the CFDA number listed for this opportunity?
The CFDA number listed is 93.103.
What type of grant mechanism is being used?
The grant mechanism is R18, which generally supports research demonstration and dissemination activities.
Is this funding intended to start a new program?
No. The purpose is not to launch a brand-new program. It is intended to continue an existing grant award supporting the Kidney Health Initiative (KHI).
What is the main purpose of the opportunity?
The main purpose is to support a continuation (renewal) application that maintains FDA-supported work under the Kidney Health Initiative (KHI), leveraging existing partnership and infrastructure rather than starting over or competing a new initiative broadly.
What is the Kidney Health Initiative (KHI) in the context of this announcement?
In this announcement, KHI refers to the ongoing initiative being supported under an existing FDA grant award, and this opportunity is meant to continue that established work.
Who is FDA expecting to submit the renewal application?
The announcement signals FDA's intent to accept and consider a continuation (renewal) application from the American Society of Nephrology (ASN).
Does this opportunity appear to be competitive and open to many applicants?
Based on the description, it is not framed as a broadly competed opportunity. It indicates FDA expects a single award and has a specific recipient in mind due to the continuation nature of the project and the established role of the organization running or coordinating the initiative.
How many awards does FDA anticipate making?
The opportunity lists Expected Awards: 1, indicating FDA anticipates making a single award.
What is the maximum funding amount (award ceiling)?
The award ceiling is $1,500,000.
Are clinical trials required under this funding opportunity?
No. The opportunity explicitly states "Clinical Trials Optional," meaning the funded work may include clinical trial activity but does not have to.
What does "Clinical Trials Optional" mean here?
It means applicants (in this renewal context) can propose activities that include clinical trials, but clinical trials are not mandatory for the project to be funded under this opportunity.
When was this opportunity posted (created)?
The posting indicates the opportunity was created on April 23, 2019.
What was the original application closing date?
The original application closing date was June 25, 2019.
What is the listed funding activity category?
The Funding Activity Category is listed as Agriculture, Consumer Protection, Food and Nutrition.
Does the listed funding activity category mean the project is about agriculture?
Not necessarily. The category is described as a broad cataloging classification used in federal listings and does not automatically mean the project focuses on agriculture; it reflects how FDA-related opportunities may be grouped in the system.
What does the eligibility field say?
Eligibility is noted as "Others," with additional clarification referenced in an eligibility text field that is not included in the provided excerpt.
Based on the description, who is the practical eligible applicant?
Based on the description, the practical eligible applicant for this renewal is the American Society of Nephrology (ASN), consistent with a continuation award framework.
Why would an agency issue a renewal/continuation notice like this?
As described, this type of notice typically indicates the agency intends to continue funding an existing project with an established recipient, relying on the ongoing nature of the work and the recipient's existing role in operating or coordinating the initiative.
Is this opportunity described as discretionary?
Yes. The opportunity is described as a discretionary federal grant.
What is the overall takeaway for potential applicants reading this notice?
The overall message is that this opportunity is designed to maintain ongoing, FDA-supported work under the Kidney Health Initiative through a continuation application, with an anticipated single award and an expected recipient (ASN), rather than a broad competition for new applicants.
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| Funding Opportunity |
|---|
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
| 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 |
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