Opportunity Information: Apply for RFA FD 18 011
The Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (CERSI) opportunity (RFA-FD-18-011) is a cooperative agreement (U01) run by the Food and Drug Administration (FDA) under the Department of Health and Human Services, specifically through the Office of the Chief Scientist in the Office of the Commissioner. The basic purpose is to continue supporting FDA-affiliated Centers of Excellence in Regulatory Science and Innovation, which are meant to function as academic or institutional hubs that work closely with FDA to solve real, current regulatory science problems. In FDA terms, "regulatory science" is not policy work; it is the science behind better tools, standards, and methods that allow FDA to evaluate the safety, effectiveness, quality, and performance of FDA-regulated products. The CERSI model is built around active collaboration with FDA so that research outputs are practical and directly useful to the agency's public health mission, rather than purely academic.
The announcement lays out three broad sets of scientific priorities that guide what CERSIs should focus on. First are high-priority public health topics that cut across a product's life cycle and across different populations, with an explicit emphasis on differences by sex, gender, age, and race/ethnicity. Within that category, FDA highlights tobacco regulatory science (for example toxicity, addiction, health impacts, behavior, and communications), efforts to reduce healthcare-associated infections (including stronger evidence on sterilization and reprocessing of medical devices, improved pathogen reduction technologies for blood and blood components, and new antimicrobial approaches), and work addressing opioid use, misuse, and dependence. The second priority area is about improving the quality and safety of FDA-regulated products, including making nonclinical testing more predictive of what happens in humans. Examples include better development and manufacturing and quality-control methods for complex generic drugs, biosimilars, biologics, and medical devices; improved biocompatibility and biological risk evaluation for devices and component materials; and evaluation of newer scientific approaches such as microphysiological systems (organ-on-a-chip), advanced computer modeling and simulation (including in silico trials and biocompatibility modeling), and discovery and validation of minimally invasive biomarkers in areas where biomarkers are scarce, like traumatic brain injury, including microbiome-based biomarkers and tools such as EEG and imaging. The third priority area targets methods and tools that make clinical and post-market evaluation more efficient and informative, including valid ways to incorporate patient input (patient preference and patient-reported outcomes) into regulatory decisions, novel trial designs (adaptive and Bayesian approaches), stronger use of large and complex data sources including real-world evidence and mobile technologies, and better evaluation strategies for special populations such as pregnant and lactating women, perinatal and pediatric groups, and older adults. This section also emphasizes evaluating safety and effectiveness across subpopulations and ensuring FDA communications are understandable and usable for diverse groups, aligning with efforts such as the Office of Women's Health roadmap and Office of Minority Health programs.
Funding is structured in a way that reflects how CERSIs are expected to operate over time. FDA provides support at the time of the initial cooperative agreement award for CERSI activities tied to FDA regulatory science priorities, with the actual level depending on available funds and the scope proposed. In addition, FDA anticipates supporting additional "post-award" research projects after the main award is in place. The intent is to keep CERSIs responsive to emerging issues and urgent unmet needs that may not be obvious at the time renewal applications are submitted. These post-award projects are still collaborative with FDA, but the depth of FDA involvement can vary: sometimes FDA primarily advises on planning and evaluation, and sometimes FDA participates hands-on. When FDA participates directly, the agency covers its internal contribution separately from the funds provided to the CERSI under the cooperative agreement. The FOA also makes it clear that FDA expects awardees to leverage the cooperative agreement dollars by bringing in other support, such as other federal funding, non-federal funding, institutional contributions, and in-kind resources like space or other accommodations. There is also an explicit acknowledgement that, in some situations, third parties could partially support CERSI projects.
Programmatically, the FOA describes CERSIs as having three main characteristics: a solid core infrastructure, a strong research portfolio, and optional training. The core infrastructure piece is about the practical mechanics required to run a center effectively: coordination and management, oversight, financial processes, reporting, and ongoing interactive meetings with FDA. CERSIs may include partner institutions through subawards, and they are expected to collaborate not only with FDA but also with investigators within their institution and, when needed, with other external researchers. Even though each CERSI functions independently, the program encourages networking across centers so they can share expertise, avoid duplication, and collaborate where it makes sense.
The central expectation is cutting-edge regulatory science research that addresses FDA's unmet needs, selected and executed in collaboration with FDA so the work translates into better regulatory decision-making. FDA's role consistently includes scientific input and a monitoring and evaluation function to ensure outputs are aligned with public health impact. The FOA also explicitly allows for exploratory pilot projects as long as they align with FDA priorities, with selection based on impact, fit with agency needs, and the likelihood of continued support. Collaboration is not limited to a single center; projects can involve multiple CERSIs and may include partners outside FDA and the CERSI network. The announcement also describes structured scientific exchanges as a mechanism to spark new projects, including FDA staff visiting CERSIs to understand new technologies and CERSI staff visiting FDA using cooperative agreement funds. FDA covers its own travel to CERSIs separately from the cooperative agreement.
Training is described as optional rather than required, and if proposed it is expected to be a relatively small cost to FDA compared to the research mission. Still, the FOA gives a broad menu of acceptable training activities: fellowships at CERSIs and, when feasible, at FDA for advanced-degree scientists working on FDA-CERSI projects; smaller scholar awards for graduate students and postgraduates; embedding regulatory science content into existing coursework in fields FDA needs (like modeling, statistics, and clinical expertise); short courses and mini-courses for emerging areas such as patient-focused methods, real-world evidence, and regenerative medicine; workshops that address unmet agency needs (which may be co-run with FDA or independently hosted); lectures and webinars tied to collaborative projects or priority topics; student competitions to build interest in regulatory science; certificate or degree programs; and other professional development approaches that strengthen the regulatory science workforce. The FOA also flags practical constraints: workshops and lectures done with FDA are chosen collaboratively, FDA-based fellowships must be coordinated for feasibility and placement mechanisms, and any fee-based coursework should largely pay for itself rather than rely on cooperative agreement funds.
From the opportunity metadata, this is a discretionary program with an FDA cooperative agreement mechanism, cataloged under CFDA 93.103. The posting date was March 23, 2018, with an original closing date of June 4, 2018. FDA anticipated making around three awards, with an award ceiling listed at $5,000,000. Eligibility is listed broadly as "Others" with additional clarification in the full FOA, but the structure and language strongly suggest the intended applicants are established institutions capable of running a center-level program and sustaining a close, ongoing working relationship with FDA. Overall, the opportunity is designed to keep a small number of high-capacity centers tightly aligned to FDA's evolving scientific needs, producing practical methods, evidence, and tools that FDA can use in regulatory evaluation across drugs, biologics, devices, tobacco products, and other regulated areas.Apply for RFA FD 18 011
- 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 Applications: Centers of Excellence in Regulatory Science and Innovation (U01)" 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 Mar 23, 2018.
- Applicants must submit their applications by Jun 04, 2018. (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 $5,000,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: OJJDP FY 18 Initiative To Develop a Research-Based Practice Guide To Prevent and Reduce Youth Violence in Communities
Previous opportunity: FY 2018 Notice of Funding Opportunity for global programming to further innovation in addressing gender-based violence (GBV) in conflict-affected humanitarian e
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 18 011
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 18 011) also looked into and applied for these:
| Funding Opportunity |
|---|
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 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: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 18 011", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.