Opportunity Information: Apply for RFA FD 23 003
The "Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed" opportunity (RFA-FD-23-003) is a U.S. Food and Drug Administration (FDA), Department of Health and Human Services funding announcement that uses a cooperative agreement mechanism (U18). A cooperative agreement generally means the funder expects to be substantially involved in the direction, coordination, or oversight of the work, rather than simply providing funds with minimal interaction. The program sits within an activity area tied to consumer protection and public health (listed under agriculture/consumer protection/food and nutrition in the classification used for federal listings) and is associated with CFDA/Assistance Listing number 93.103.
This opportunity is unusually narrow in eligibility: the only organization eligible to apply is the World Health Organization (WHO). The rationale stated in the announcement is that FDA is seeking to proactively engage with other countries and identify research and evaluation opportunities that can strengthen FDA's ability to implement the U.S. Tobacco Control Act. Because tobacco product markets, manufacturing, marketing, and regulatory challenges are global, FDA anticipates that collaboration with WHO will help generate evidence and build research capacity that can inform effective tobacco product regulation both internationally and in ways that support FDA's domestic regulatory mission.
The announcement emphasizes why WHO is positioned to carry out this work. WHO's mandate in global health, its access to worldwide regulatory expertise, and its ability to convene member states and leverage broad data access are highlighted as key advantages. In practical terms, this signals that the funded activities are expected to involve international coordination, evidence gathering, and evaluation work that benefits from WHO's global network and convening authority. The overall intent is capacity building and research support in the area of tobacco product regulation, with an eye toward producing insights and infrastructure that can improve regulatory approaches and implementation.
The program explicitly states that clinical trials are not allowed. That typically means the funded work should not involve prospective assignment of human participants to interventions to evaluate health-related outcomes. Instead, the allowable scope is more consistent with non-trial research and evaluation activities such as policy and regulatory science analyses, surveillance and monitoring approaches, methodological development, secondary data analysis, regulatory impact evaluation, and cross-country learning and technical capacity strengthening, so long as these do not cross into clinical trial territory.
From an administrative standpoint, the opportunity was created on November 2, 2022, with an original closing date of January 17, 2023. The expected number of awards is one, and the award ceiling is $400,000. Taken together, those details point to a single, targeted award intended to support a specific collaboration between FDA and WHO, rather than an open, competitive program for a broad set of applicants.Apply for RFA FD 23 003
- 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) Clinical Trials Not Allowed" 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 Nov 02, 2022.
- Applicants must submit their applications by Jan 17, 2023. (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 $400,000.00 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 full name of this funding opportunity?
The opportunity is titled "Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed" and is identified as RFA-FD-23-003.
Which federal agency is offering this opportunity?
This funding announcement is offered by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS).
What type of funding mechanism is being used?
The mechanism is a cooperative agreement (U18). Under a cooperative agreement, the funder generally expects to be substantially involved in the direction, coordination, or oversight of the work, rather than simply providing funds with minimal interaction.
What is the Assistance Listing (CFDA) number for this program?
The opportunity is associated with CFDA/Assistance Listing number 93.103.
How is this opportunity classified in federal listings?
It is listed within an activity area tied to consumer protection and public health, and is categorized under the agriculture/consumer protection/food and nutrition classification used for federal listings.
Who is eligible to apply?
Eligibility is extremely limited: the only organization eligible to apply is the World Health Organization (WHO).
Can universities, nonprofits, companies, or U.S. state/local agencies apply?
No. Based on the announcement, only WHO is eligible to submit an application. Other organizations are not eligible applicants under this opportunity.
Why is eligibility limited to the World Health Organization (WHO)?
The announcement explains that FDA is seeking to proactively engage with other countries and identify research and evaluation opportunities that can strengthen FDA's ability to implement the U.S. Tobacco Control Act. Because tobacco markets, manufacturing, marketing, and regulatory challenges are global, FDA anticipates that collaboration with WHO will help generate evidence and build research capacity that supports effective tobacco product regulation internationally and informs FDA's domestic regulatory mission.
What is the overall purpose of the program?
The overall intent is to build research capacity and provide research support related to tobacco product regulation, with a focus on producing insights and infrastructure that can improve regulatory approaches and implementation.
What kinds of activities are expected to be supported?
Based on the description, supported activities are expected to involve international coordination, evidence gathering, and evaluation work that benefits from WHO's global network and convening authority. Examples consistent with the stated scope include policy and regulatory science analyses, surveillance and monitoring approaches, methodological development, secondary data analysis, regulatory impact evaluation, cross-country learning, and technical capacity strengthening (as long as these do not become clinical trials).
Are clinical trials allowed under this opportunity?
No. The program explicitly states that clinical trials are not allowed.
What does "Clinical Trials Not Allowed" mean in practical terms?
It typically means the funded work should not include prospective assignment of human participants to interventions to evaluate health-related outcomes. The allowable scope is described as being more consistent with non-trial research and evaluation activities (for example, analyses, surveillance approaches, secondary data work, and regulatory impact evaluation) rather than clinical trials.
How does WHO's role relate to the objectives of the program?
The announcement emphasizes WHO's mandate in global health, access to worldwide regulatory expertise, ability to convene member states, and ability to leverage broad data access. These advantages are presented as reasons WHO is positioned to carry out internationally coordinated research and capacity-building activities relevant to tobacco product regulation.
How many awards does FDA expect to make?
The expected number of awards is one.
What is the maximum funding amount (award ceiling)?
The award ceiling is $400,000.
When was this opportunity created?
The opportunity was created on November 2, 2022.
What was the original closing date?
The original closing date was January 17, 2023.
Is this an open, broadly competitive grant program?
No. The combination of a single expected award and eligibility limited to WHO indicates a single, targeted award intended to support a specific collaboration between FDA and WHO, rather than an open competitive opportunity for a broad set of applicants.
How does this program connect to the U.S. Tobacco Control Act?
The announcement states that FDA is seeking research and evaluation opportunities that can strengthen its ability to implement the U.S. Tobacco Control Act. The global focus reflects that tobacco product markets and regulatory challenges often cross borders, and the work is intended to generate evidence and build capacity that can inform regulation in ways that also support FDA's domestic regulatory mission.
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| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Clinical Trials Not Allowed Apply for RFA FD 23 020 Funding Number: RFA FD 23 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed Apply for RFA FD 23 027 Funding Number: RFA FD 23 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $565,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 23 019 Funding Number: RFA FD 23 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Renewal-Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 23 032 Funding Number: RFA FD 23 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal-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 23 031 Funding Number: RFA FD 23 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Vet-LIRN Capacity-Building Project and Equipment Grants (U18) Apply for PAR 23 202 Funding Number: PAR 23 202 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Laparoscopic Abdominal Surgeries (U01) Clinical Trials Not Allowed Apply for RFA FD 23 035 Funding Number: RFA FD 23 035 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Acute Low Back Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 23 034 Funding Number: RFA FD 23 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Data Standards for Tobacco Research and Scientific Review Phase 2 Apply for RFA FD 24 001 Funding Number: RFA FD 24 001 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Manufacturing Sector Research Initiative Apply for RFA FD 17 009 Funding Number: RFA FD 17 009 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $35,000,000 |
| Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition, JIFSAN (U19) Apply for RFA FD 17 003 Funding Number: RFA FD 17 003 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,300,000 |
| National Laboratory Curriculum Framework Development Apply for RFA FD 17 012 Funding Number: RFA FD 17 012 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,750,000 |
| Developing Biomarkers for Trastuzumab-induced Cardiotoxicity Apply for RFA FD 17 006 Funding Number: RFA FD 17 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $140,000 |
| CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) Clinical Trials Apply for PAR 22 063 Funding Number: PAR 22 063 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| 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 24 013 Funding Number: RFA FD 24 013 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Strengthening Regulatory Systems to Improve Global Food and Medical Product Quality and Safety (U01) Clinical Trials Not Allowed Apply for RFA FD 24 014 Funding Number: RFA FD 24 014 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 24 024 Funding Number: RFA FD 24 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Public Health Regulatory Systems Strengthening - U01 Clinical Trials Not Allowed Apply for RFA FD 24 015 Funding Number: RFA FD 24 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| National Project to Support and Promote Consistent Implementation of the Regulatory Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption and Produce Regulatory Standards (PRPS) (U2F) -Cooperative Agreements Apply for RFA FD 24 012 Funding Number: RFA FD 24 012 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Produce Safety Alliance-U01 Clinical Trials Not Allowed Apply for RFA FD 24 018 Funding Number: RFA FD 24 018 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
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