Opportunity Information: Apply for RFA FD 15 026
Apply for RFA FD 15 026
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Smokeless Tobacco Reference Products (UC2)" 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 Jul 13, 2015 and posted on May 26, 2015.
- Applicants must submit their applications by Sep 30, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts For profit organizations other than small businesses Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments State governments.
- Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply.Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
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Opportunity Summary:
The Food and Drug Administration (FDA), through its Center for Tobacco Products (CTP), offered a cooperative agreement grant opportunity titled "Smokeless Tobacco Reference Products (UC2)" under Funding Opportunity Number RFA-FD-15-026. The central goal of the project is to establish a smokeless tobacco reference products program, which FDA indicates will require substantial collaboration and coordinated research with external organizations. In practical terms, the awardee would be responsible for developing standardized "reference products" that represent, at a minimum, two categories of smokeless tobacco products that are commercially available. These reference products are intended strictly for investigational, non-clinical uses, supporting consistent research and testing across the tobacco science community, including tobacco manufacturers, contract laboratories, government laboratories, and academic institutions. FDA also notes it will prioritize which smokeless tobacco product types should be addressed, meaning applicants would be expected to align their proposed product selection and development plan with FDA-CTP priorities.
This opportunity was structured as a cooperative agreement, which typically means FDA-CTP expected to have a meaningful level of involvement during the project period rather than providing funding with minimal interaction. The activity category is listed under consumer protection, food and nutrition, and health, and the program aligns with broader regulatory science needs by creating shared, well-characterized materials that can be used to compare results across studies and laboratories. By developing common reference products, the program aims to reduce variability that comes from labs using different commercial brands or batches, and to improve the reliability and comparability of non-clinical investigative work involving smokeless tobacco.
The expected number of awards was one, with an estimated total funding amount of $3,000,000 and an award ceiling of $3,000,000. There was no cost-sharing or matching requirement. The listing is associated with CFDA number 93.103 (Food and Drug Administration). Key timeline details include an original closing date of July 31, 2015, later extended to a current closing date of September 30, 2015, with the opportunity archived on October 30, 2015. The posting date was May 26, 2015, and the creation date was July 13, 2015.
Eligibility covered a broad range of U.S.-based entities across government, education, nonprofit, and industry sectors. Eligible applicants included state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits other than institutions of higher education); for-profit organizations other than small businesses; small businesses; independent school districts; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments as well as other tribal organizations. At the same time, the announcement clearly excluded foreign participation: non-U.S. entities were not eligible to apply, non-U.S. components of U.S. organizations were not eligible, and foreign components (as defined by the HHS Grants Policy Statement) were not allowed.
For applicants seeking the complete details and requirements, FDA pointed to the full announcement in the NIH Guide for Grants and Contracts. For access issues or administrative questions, the contact listed was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the title of this FDA funding opportunity?
The cooperative agreement opportunity is titled "Smokeless Tobacco Reference Products (UC2)" under Funding Opportunity Number RFA-FD-15-026.
Which FDA office is offering this grant?
The opportunity is offered by the Food and Drug Administration (FDA) through its Center for Tobacco Products (CTP).
What is the main goal of the project?
The central goal is to establish a smokeless tobacco reference products program. FDA indicated this effort will require substantial collaboration and coordinated research with external organizations.
What is meant by "reference products" in this opportunity?
"Reference products" are standardized smokeless tobacco products that are developed to support consistent research and testing across the tobacco science community. They are intended to be shared, well-characterized materials that different labs and researchers can use to compare results more reliably across studies.
How many types of smokeless tobacco products must the reference products represent?
At a minimum, the awardee would be responsible for developing standardized reference products representing two categories of smokeless tobacco products that are commercially available.
Are these reference products intended for clinical use or consumer distribution?
No. The reference products are intended strictly for investigational, non-clinical uses.
Who is expected to use the reference products?
FDA described use across the tobacco science community, including tobacco manufacturers, contract laboratories, government laboratories, and academic institutions.
Why is FDA creating smokeless tobacco reference products?
The program is intended to reduce variability that occurs when laboratories use different commercial brands or batches, and to improve the reliability and comparability of non-clinical investigative work involving smokeless tobacco.
What role will FDA-CTP play during the project?
This opportunity is a cooperative agreement, meaning FDA-CTP expected to have a meaningful level of involvement during the project period rather than providing funding with minimal interaction.
Will FDA-CTP decide which smokeless tobacco product types should be addressed?
FDA noted it will prioritize which smokeless tobacco product types should be addressed. Applicants would be expected to align their proposed product selection and development plan with FDA-CTP priorities.
What is the activity category associated with this opportunity?
The activity category is listed under consumer protection, food and nutrition, and health.
How many awards did FDA expect to make?
The expected number of awards was one.
What was the estimated total funding amount?
The estimated total funding amount was $3,000,000.
What is the award ceiling for this opportunity?
The award ceiling was $3,000,000.
Is cost sharing or matching required?
No. There was no cost-sharing or matching requirement.
What is the CFDA number associated with this listing?
The listing is associated with CFDA number 93.103 (Food and Drug Administration).
When was the opportunity posted?
The posting date was May 26, 2015.
What was the original closing date?
The original closing date was July 31, 2015.
Was the deadline extended?
Yes. The closing date was extended to September 30, 2015.
When was the opportunity archived?
The opportunity was archived on October 30, 2015.
What is the creation date shown for the opportunity?
The creation date was July 13, 2015.
Who was eligible to apply?
Eligibility covered a broad range of U.S.-based entities across government, education, nonprofit, and industry sectors. Eligible applicants included:
- State governments
- County governments
- City or township governments
- Special district governments
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
- Independent school districts
- Public housing authorities/Indian housing authorities
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
Are foreign organizations allowed to apply?
No. The announcement excluded foreign participation: non-U.S. entities were not eligible to apply.
Can a U.S. organization include a non-U.S. component in the application?
No. Non-U.S. components of U.S. organizations were not eligible.
Are foreign components permitted under this opportunity?
No. Foreign components (as defined by the HHS Grants Policy Statement) were not allowed.
Where can applicants find the complete announcement and requirements?
FDA pointed applicants to the full announcement in the NIH Guide for Grants and Contracts.
Who is the contact for access issues or administrative questions?
The contact listed was Lisa Ko, Grants Management Specialist. Email: lisa.ko@fda.hhs.gov.
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