Opportunity Information: Apply for RFA FD 18 003
The Building Research Capacity in Global Tobacco Product Regulation Program (U18) is a cooperative agreement funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), designed to strengthen research that helps FDA regulate tobacco products in the United States. Through this program, FDA states its intent to make a single-source award to the World Health Organization (WHO). The central idea is to use WHO's unique global reach, its network of Member States, and its deep experience in tobacco control to gather and coordinate research on how other countries design, implement, and enforce tobacco laws and regulations. That international evidence is intended to directly inform FDA's work regulating the manufacture, distribution, marketing, and sale of tobacco products to protect public health in the U.S.
At its core, the program focuses on building and coordinating research capacity related to tobacco control laws and rules in foreign countries. This includes identifying research needs, supporting and developing research projects, conducting studies, and coordinating efforts across different partners and jurisdictions. The FDA's Center for Tobacco Products (CTP) is the main beneficiary within the agency, because the outputs are meant to strengthen CTP's ability to make well-informed regulatory decisions. By learning what has worked (and what has not) in other countries, FDA can better evaluate regulatory approaches, anticipate industry responses, and understand the public health impact of different policy tools in real-world settings.
Although the immediate purpose is to support U.S. tobacco product regulation, the opportunity also emphasizes broader global public health value. By creating structured opportunities for international collaboration and research development, the program aims to improve the overall evidence base for tobacco product regulation worldwide. In practical terms, that means more shared knowledge in the public sphere about tobacco use patterns, the harms of tobacco, and the effectiveness of regulatory interventions, which can help governments and public health organizations craft more effective policies across countries.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U18), which typically means FDA expects to have substantial involvement in shaping, overseeing, or coordinating the work alongside the award recipient. The opportunity is listed under CFDA 93.103 and categorized within Agriculture, Consumer Protection, Food and Nutrition. The funding opportunity number is RFA-FD-18-003. FDA anticipated making one award, with an award ceiling of $450,000. The notice was created on October 24, 2017, and had an original closing date of December 18, 2017. Eligibility is effectively limited by design, because the announcement specifies a single-source application intended for WHO, reflecting the rationale that WHO's international convening power and established tobacco control expertise are essential to executing the program's goals.Apply for RFA FD 18 003
- 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 "Building Research Capacity in Global Tobacco Product Regulation Program (U18)" 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 Oct 24, 2017.
- Applicants must submit their applications by Dec 18, 2017. (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 $450,000.00 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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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 18 003) also looked into and applied for these:
| Funding Opportunity |
|---|
| Vet-LIRN Network Capacity-Building Projects Apply for PAR 18 604 Funding Number: PAR 18 604 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $225,000 |
| National Laboratory Curriculum Framework Development Apply for RFA FD 18 005 Funding Number: RFA FD 18 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Cooperative Agreement to Support the Western Center for Food Safety (U19) Apply for RFA FD 18 008 Funding Number: RFA FD 18 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Data Standards for Clinical Research and Drug Development (U24) Apply for RFA FD 18 015 Funding Number: RFA FD 18 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) Apply for RFA FD 18 010 Funding Number: RFA FD 18 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| 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 |
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