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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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled Building Research Capacity in Global Tobacco Product Regulation Program (U18).
Which federal agency is offering this funding?
This is a funding opportunity from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What type of funding mechanism is being used?
The program uses a cooperative agreement mechanism, specifically U18. In general, a cooperative agreement indicates the FDA expects to have substantial involvement in shaping, overseeing, or coordinating the work with the award recipient.
What is the main purpose of the program?
The core purpose is to strengthen research that helps the FDA regulate tobacco products in the United States by building and coordinating research capacity focused on tobacco control laws and regulations in other countries.
How does international research help the FDA regulate tobacco products in the U.S.?
The program is designed to gather and coordinate evidence on how other countries design, implement, and enforce tobacco laws and regulations. That international evidence is intended to inform FDA regulatory work related to the manufacture, distribution, marketing, and sale of tobacco products in order to protect public health in the U.S.
Who is the intended award recipient?
FDA states its intent to make a single-source award to the World Health Organization (WHO).
Is this opportunity open to multiple applicants?
No. Eligibility is effectively limited by design because the announcement specifies a single-source application intended for WHO, based on the rationale that WHO has unique global reach, an established network of Member States, and deep tobacco control expertise needed to carry out the program.
Why does the FDA intend to fund the World Health Organization (WHO) specifically?
The opportunity cites WHO's global reach, network of Member States, and long-standing experience in tobacco control as essential for gathering and coordinating evidence across countries and jurisdictions.
Which part of the FDA is expected to benefit most directly from the work?
The primary beneficiary within FDA is the Center for Tobacco Products (CTP), since the outputs are meant to strengthen CTP's ability to make well-informed regulatory decisions.
What kinds of activities does the program support?
Based on the description, activities include building and coordinating research capacity related to foreign tobacco control laws and rules, such as:
- Identifying research needs
- Supporting and developing research projects
- Conducting studies
- Coordinating efforts across partners and jurisdictions
What research topics or evidence is the program trying to generate?
The focus is on real-world evidence from other countries about tobacco regulation, including what approaches have worked, what has not worked, how policies are enforced, how the industry responds, and the public health impact of different regulatory tools.
Is the program only about U.S. regulation, or does it have global public health goals too?
While the immediate purpose is to support U.S. tobacco product regulation, the opportunity also emphasizes broader global public health value by expanding international collaboration and improving the worldwide evidence base for tobacco product regulation.
How is public knowledge expected to improve through this program?
The description notes that the program aims to create more shared knowledge in the public sphere related to:
- Tobacco use patterns
- The harms of tobacco
- The effectiveness of regulatory interventions
This shared evidence can help governments and public health organizations develop more effective policies across countries.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-18-003.
What is the CFDA number listed for this opportunity?
The opportunity is listed under CFDA 93.103.
How is this opportunity categorized?
It is categorized within Agriculture, Consumer Protection, Food and Nutrition.
How many awards did the FDA anticipate making?
FDA anticipated making one award.
What is the award ceiling?
The award ceiling stated in the description is $450,000.
When was the notice created?
The notice was created on October 24, 2017.
What was the original closing date?
The original closing date was December 18, 2017.
What does it mean that this is a discretionary funding opportunity?
The opportunity is described as discretionary, meaning it is offered at the agency's discretion under the program's authority and priorities, rather than being an automatic or entitlement-based funding stream.
What does the cooperative agreement structure suggest about FDA's role during the project?
Because the mechanism is a U18 cooperative agreement, the description indicates FDA expects to have substantial involvement in shaping, overseeing, or coordinating the work together with the recipient.
What is the overall rationale for coordinating research across multiple countries?
The rationale is that evidence from different national contexts can reveal how regulatory approaches perform in practice, help anticipate industry responses, and improve understanding of the public health impacts of various policy tools, which in turn can inform FDA's regulatory decision-making in the U.S.
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Applicants who have applied for this opportunity (RFA FD 18 003) also looked into and applied for these:
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|---|
| 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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