Opportunity Information: Apply for RFA FD 13 032
Apply for RFA FD 13 032
- The Food Drug Administration in the other (see text field entitled explanation of other category of funding activity for clarification) 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 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 25, 2013 and posted on Jun 25, 2013.
- Applicants must submit their applications by Jul 31, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 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 The World Health Organization (WHO) As FDA seeks to proactively work with other countries and identify research and evaluation opportunities that will impact FDA s ability to successfully implement the Tobacco Control Act, further collaboration with WHO is anticipated. With the financial support from the U.S. FDA, WHO is uniquely qualified to undertake these activities, given its mandate, wide access to data, participation of member states, and access to worldwide regulatory expertise.
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Opportunity Summary:
Building Research Capacity in Global Tobacco Product Regulation Program (U18) is a cooperative agreement funding opportunity from the U.S. Food and Drug Administration (FDA), specifically tied to the FDA Center for Tobacco Products (CTP). The agency announced that it intended to accept and consider a single-source application, meaning the award was not broadly competed and eligibility was limited to one organization: the World Health Organization (WHO). The core idea behind the program is to strengthen and coordinate research on tobacco control laws, regulatory approaches, and related policy tools used in countries outside the United States, then translate those findings into practical evidence that can directly support the FDA in carrying out its U.S. tobacco regulatory responsibilities.
The program’s purpose is research-focused but operationally strategic. FDA is looking to identify, support, develop, conduct, and coordinate research efforts centered on foreign tobacco control rules and regulatory experiences. By learning what has worked (or failed) in other national contexts, the FDA can better inform its own decisions about regulating the manufacture, distribution, marketing, and sale of tobacco products in the United States. In other words, global regulatory experience is being treated as a source of evidence that can strengthen domestic U.S. regulation under the Tobacco Control Act framework, particularly where international comparisons can shed light on product standards, marketing restrictions, enforcement practices, and emerging product challenges.
WHO is positioned as the key partner because of its unique global role and infrastructure. The opportunity emphasizes WHO’s mandate, its access to worldwide data and regulatory networks, and the expertise of its Member States. The expectation is that WHO can leverage its international contacts in tobacco control, along with its own programmatic experience, to connect researchers and regulators, gather and synthesize policy-relevant evidence, and help build longer-term global research capacity related to tobacco product regulation. This approach is meant to strengthen FDA’s ability to implement effective protections for public health in the U.S. by drawing from a broader international evidence base.
Although the program is designed to support FDA’s domestic regulatory mission, it is also framed as producing a wider public benefit. By creating opportunities for global collaboration and research development, the effort is intended to contribute to better informed and more effective tobacco product regulation worldwide. It also aims to increase the amount of credible knowledge available publicly about tobacco use and its harms across different countries and populations, which can support both policy and public understanding beyond the United States.
From a funding and administrative standpoint, this was a discretionary grant using a cooperative agreement mechanism (U18), indicating substantial involvement and collaboration from the FDA during the project rather than a hands-off grant. The opportunity anticipated a single award with an estimated total funding amount of $1,000,000, and an award ceiling also set at $1,000,000. There was no cost-sharing or matching requirement. The opportunity was posted June 25, 2013, with a closing date of July 31, 2013, and it was later archived on August 30, 2013. The CFDA program listing associated with it was 93.103 (Food and Drug Administration). For administrative questions, the grants management contact listed was Lisa Ko (lisa.ko@fda.hhs.gov), and a Federal Register notice link was provided as the official public reference for the announcement.
Frequently Asked Questions (FAQs)
What is the "Building Research Capacity in Global Tobacco Product Regulation Program (U18)"?
It is a cooperative agreement grant opportunity from the U.S. Food and Drug Administration (FDA), tied specifically to the FDA Center for Tobacco Products (CTP). The program focuses on strengthening and coordinating research related to tobacco product regulation and tobacco control approaches used in countries outside the United States.
Which federal agency is offering this opportunity?
The opportunity is offered by the U.S. Food and Drug Administration (FDA), specifically connected to the FDA Center for Tobacco Products (CTP).
What type of funding mechanism is used (and what does U18 mean here)?
The funding mechanism is a cooperative agreement (U18). This indicates substantial involvement and collaboration from the FDA during the project, rather than a more hands-off relationship typical of some other grant types.
Is this a competitive grant opportunity open to multiple applicants?
No. The FDA announced it intended to accept and consider a single-source application. That means the award was not broadly competed.
Who was eligible to apply?
Eligibility was limited to one organization: the World Health Organization (WHO).
What is the main purpose of the program?
The program aims to identify, support, develop, conduct, and coordinate research centered on foreign tobacco control rules and regulatory experiences, and translate those findings into practical evidence that can directly support the FDA in carrying out its U.S. tobacco regulatory responsibilities.
Why does the program focus on regulations outside the United States?
The program treats global regulatory experience as a source of evidence. By learning what has worked (or failed) in other national contexts, the FDA can better inform its own decisions about regulating the manufacture, distribution, marketing, and sale of tobacco products in the United States.
How does this research relate to FDA's responsibilities in the United States?
The research is intended to strengthen domestic U.S. regulation under the Tobacco Control Act framework by using international comparisons and evidence relevant to topics such as product standards, marketing restrictions, enforcement practices, and emerging product challenges.
What kinds of issues or topic areas does the program emphasize?
Based on the description, emphasis includes foreign tobacco control laws and regulatory approaches, policy tools used outside the U.S., and lessons that can inform U.S. regulation. Examples referenced include product standards, marketing restrictions, enforcement practices, and emerging product challenges.
Why was the World Health Organization (WHO) selected as the single eligible applicant?
WHO is positioned as the key partner because of its global mandate, access to worldwide data and regulatory networks, and the expertise of its Member States. The opportunity also highlights WHO's ability to leverage international contacts in tobacco control and its programmatic experience to connect researchers and regulators and synthesize policy-relevant evidence.
What role is WHO expected to play under this cooperative agreement?
WHO is expected to leverage international contacts and infrastructure to connect researchers and regulators, gather and synthesize policy-relevant evidence, and help build longer-term global research capacity related to tobacco product regulation, while supporting FDA's domestic public health mission.
Does the opportunity describe benefits beyond supporting FDA's U.S. regulatory mission?
Yes. It is framed as producing a wider public benefit by creating opportunities for global collaboration and research development, contributing to more informed and effective tobacco product regulation worldwide, and increasing the amount of credible public knowledge about tobacco use and its harms across countries and populations.
How much funding was available?
The opportunity anticipated a single award with an estimated total funding amount of $1,000,000. The award ceiling was also set at $1,000,000.
How many awards were anticipated?
A single award was anticipated.
Was cost sharing or matching required?
No. The opportunity stated there was no cost-sharing or matching requirement.
When was the opportunity posted, and when did it close?
It was posted on June 25, 2013, and had a closing date of July 31, 2013.
Is this opportunity still active?
No. It was later archived on August 30, 2013.
What CFDA program listing is associated with this opportunity?
The CFDA program listing associated with it is 93.103 (Food and Drug Administration).
Who is the grants management contact for administrative questions?
The grants management contact listed is Lisa Ko (lisa.ko@fda.hhs.gov).
Where is the official public reference for the announcement?
A Federal Register notice link was provided as the official public reference for the announcement.
What does "single-source application" mean in this context?
In this opportunity, it means the FDA intended to accept and consider only one application and limited eligibility to a single organization (WHO), rather than conducting a broad competition among multiple applicants.
What does it mean that this is a "discretionary" grant?
The opportunity is described as a discretionary grant, indicating it was funded through an agency grant program using the cooperative agreement mechanism, rather than through a mandatory or formula-based funding structure.
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