Opportunity Information: Apply for RFA FD 14 017
Apply for RFA FD 14 017
- The Food Drug Administration in the food and nutrition health sector is offering a public funding opportunity titled "Increasing the Quality and Efficiency of Clinical Trials (R18)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on May 27, 2014 and posted on May 27, 2014.
- Applicants must submit their applications by Jun 30, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $7,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $7,500,000.00 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).
- The following organization is eligible to apply Duke Translational Medicine Institute located within Duke University.
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Opportunity Summary:
This grant opportunity, titled "Increasing the Quality and Efficiency of Clinical Trials (R18)" (Funding Opportunity Number RFA-FD-14-017), was issued by the Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER) within the Office of Medical Policy (OMP). The program falls under a discretionary grant mechanism using the R18 activity type, and it is framed around improving how clinical trials are run, with an emphasis on both quality and operational efficiency. The overall intent is to support work that strengthens the clinical trial enterprise, which typically means better trial design and conduct, more reliable and usable data, and processes that reduce unnecessary burden while maintaining participant protections and scientific rigor.
A key feature of this announcement is that it is a single-source funding opportunity. That means the FDA stated up front it intended to accept and consider only one application, and only from one eligible organization: the Duke Translational Medicine Institute (DTMI) within Duke University. In other words, this was not an open competition for multiple institutions; it was a targeted award in which the agency identified a specific recipient it believed was positioned to carry out the proposed work. The eligibility language reinforces that exclusivity by naming DTMI as the only eligible applicant.
From a funding standpoint, the opportunity anticipated one award total. The estimated total funding was $7,500,000, and the award ceiling was also $7,500,000, indicating the grant could fund up to that full amount under this announcement. There was no cost sharing or matching requirement, so Duke was not required under the terms of the opportunity to provide a defined percentage of non-federal funds as a condition of receiving the award. The program is associated with CFDA number 93.103 (Food and Drug Administration Research), and it was categorized under the broad activity area of Food and Nutrition / Health, which reflects FDA's research and policy mission rather than implying the project is limited to nutrition-specific trials.
The timeline for the opportunity shows it was posted and created on May 27, 2014, with an original and current closing date of June 30, 2014, and an archive date of July 30, 2014. These dates indicate a relatively short application window, which is common for single-source announcements where the applicant has often been engaged in prior discussions and the notice serves as the formal public posting step required for transparency. The announcement also points applicants and the public to a Federal Register Notice as the additional information link, which is typically where the government provides the official rationale, background, and administrative details supporting the decision to use a single-source approach.
Administratively, the funding instrument type was a grant, and the contact listed for access issues or administrative questions was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov. This contact detail is standard for federal opportunities and signals where procedural questions about the announcement or submission logistics would be directed.
In practical terms, the opportunity can be read as FDA/CDER/OMP investing in a focused effort at Duke DTMI to develop, test, or disseminate approaches that make clinical trials more trustworthy and less wasteful. While the brief description does not enumerate specific project tasks, initiatives under a title like this commonly involve improving trial quality management, strengthening data integrity and monitoring approaches, advancing efficient trial designs, reducing avoidable protocol complexity, and promoting better operational practices that can shorten timelines and improve the evidence generated for medical product evaluation. The overall structure, funding level, and single expected award underscore that FDA intended this to be a substantial, centralized effort carried out by a designated partner institution rather than a broad, multi-recipient research program.
Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled "Increasing the Quality and Efficiency of Clinical Trials (R18)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-14-017.
Which federal agency issued this funding opportunity?
The opportunity was issued by the U.S. Food and Drug Administration (FDA).
Which FDA center and office are associated with this grant?
The announcement is associated with FDA's Center for Drug Evaluation and Research (CDER), within the Office of Medical Policy (OMP).
What is the purpose or intent of this grant?
The intent is to support work that improves how clinical trials are run, with a focus on both quality and operational efficiency. The overall aim is to strengthen the clinical trial enterprise, such as improving trial design and conduct, producing more reliable and usable data, and reducing unnecessary burden while maintaining participant protections and scientific rigor.
What activity type or grant mechanism is used?
This opportunity uses the R18 activity type under a discretionary grant mechanism.
What type of funding instrument is this?
The funding instrument type is a grant.
Is this an open competitive opportunity for multiple applicants?
No. It is described as a single-source funding opportunity, meaning the FDA stated it intended to accept and consider only one application.
Who is eligible to apply?
The only eligible applicant named in the announcement is the Duke Translational Medicine Institute (DTMI) within Duke University.
How many awards were anticipated?
The opportunity anticipated a total of one award.
What is the estimated total funding amount?
The estimated total funding for this opportunity was $7,500,000.
What is the maximum award amount (award ceiling)?
The award ceiling was $7,500,000, meaning the award could fund up to that full amount under this announcement.
Is cost sharing or matching required?
No. The announcement indicates there was no cost sharing or matching requirement.
What is the CFDA number associated with this program?
The opportunity is associated with CFDA number 93.103 (Food and Drug Administration Research).
What activity area or category is this opportunity listed under?
It was categorized under the broad activity area of Food and Nutrition / Health, reflecting FDA's research and policy mission rather than limiting the project to nutrition-specific trials.
When was this opportunity posted and created?
The opportunity was posted and created on May 27, 2014.
What was the closing date for applications?
The original and current closing date was June 30, 2014.
When was the opportunity archived?
The archive date was July 30, 2014.
What does the short application window suggest about the announcement?
The dates indicate a relatively short application window, which is common for single-source announcements where the applicant has often been engaged in prior discussions and the notice serves as the formal public posting step required for transparency.
Where can someone find additional official details about this opportunity?
The announcement points to a Federal Register Notice as the additional information link, which typically contains the official rationale, background, and administrative details supporting the single-source approach.
Who is the listed contact for administrative or access questions?
The listed contact is Lisa Ko, Grants Management Specialist.
What is the contact email address provided in the announcement?
The email provided is lisa.ko@fda.hhs.gov.
What kinds of project efforts are implied by the opportunity description?
While specific tasks are not enumerated, the description indicates a focused effort to develop, test, or disseminate approaches that make clinical trials more trustworthy and less wasteful. Examples commonly aligned with a title like this include improving trial quality management, strengthening data integrity and monitoring approaches, advancing efficient trial designs, reducing avoidable protocol complexity, and promoting operational practices that can shorten timelines while preserving protections and scientific rigor.
Does the description limit the work to nutrition-related clinical trials?
No. The activity area label (Food and Nutrition / Health) reflects FDA's broader mission and does not, by itself, limit the project to nutrition-specific trials.
What does "single-source" mean in this context?
In this announcement, "single-source" means FDA stated in advance it intended to accept and consider only one application and only from the single eligible organization named: Duke Translational Medicine Institute (DTMI) within Duke University.
What does the overall structure of the opportunity suggest about FDA's intent?
The single expected award, the identified recipient, and the substantial funding level suggest FDA intended a centralized effort carried out by a designated partner institution, rather than a broad program with multiple recipients.
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| U.S. India Bilateral Collaborative Research Partnerships (CRP) on Diabetes Research (R21) Apply for RFA DK 14 006 Funding Number: RFA DK 14 006 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $275,000 |
| Polycystic Kidney Disease (PKD) Research and Translation Core Centers (P30) Apply for RFA DK 14 013 Funding Number: RFA DK 14 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) Apply for PAR 14 257 Funding Number: PAR 14 257 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $4,000,000 |
| Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3) Apply for PAR 14 258 Funding Number: PAR 14 258 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $7,000,000 |
| Chronic Kidney Disease Biomarkers Consortium (CKD BioCon) (U01) Apply for RFA DK 14 011 Funding Number: RFA DK 14 011 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $450,000 |
| Improving Diabetes Management in Young Children with Type 1 Diabetes (DP3) Apply for RFA DK 14 022 Funding Number: RFA DK 14 022 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Critical Path Public Private Partnerships Apply for RFA FD 14 089 Funding Number: RFA FD 14 089 Agency: Food Drug Administration Category: Food and Nutrition Health Funding Amount: $10,500,000 |
| NIDDK Mentored Research Scientist Development Award (K01) Apply for PAR 14 266 Funding Number: PAR 14 266 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition Data Coordinating Center for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (UC4) Apply for RFA DK 14 505 Funding Number: RFA DK 14 505 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $20,000,000 |
| NIAID SBIR Technology Transfer Direct Phase II (SBIR TT) (R44) Apply for RFA AI 14 049 Funding Number: RFA AI 14 049 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
| NIDDK Cooperative Hematology Specialized Core Centers (U54) Apply for RFA DK 14 001 Funding Number: RFA DK 14 001 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
| Limited Competition for the Continuation of the Adult Acute Liver Failure Study Group (U01) Apply for RFA DK 14 504 Funding Number: RFA DK 14 504 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $3,500,000 |
| NIDDK Physician Scientist Diversity Mentoring Award (K05) Apply for RFA DK 14 005 Funding Number: RFA DK 14 005 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Central Repositories Non renewable Sample Access (X01) Apply for PAR 14 301 Funding Number: PAR 14 301 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Type 1 Diabetes TrialNet Clinical Centers (U01) Apply for RFA DK 14 016 Funding Number: RFA DK 14 016 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $450,000 |
| Prevention of Lower Urinary Tract Symptoms in Women Bladder Health Scientific and Data Coordinating Center (PLUS SDCC) (U01) Apply for RFA DK 14 018 Funding Number: RFA DK 14 018 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Prevention of Lower Urinary Tract Symptoms in Women Bladder Health Clinical Centers (PLUS CCs) (U01) Apply for RFA DK 14 004 Funding Number: RFA DK 14 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| Limited Competition Data Coordinating Center for Type 1 Diabetes TrialNet (UC4) Apply for RFA DK 14 507 Funding Number: RFA DK 14 507 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $45,000,000 |
| Identification of Novel Targets and Pathways Mediating Weight Loss, Diabetes Resolution and Related Metabolic Disease after Bariatric Surgery in Humans (R01) Apply for RFA DK 14 025 Funding Number: RFA DK 14 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01) Apply for RFA DK 14 506 Funding Number: RFA DK 14 506 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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