Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products (UC2) Clinical Trials Not Allowed | RFA FD 21 003

Opportunity Information: Apply for RFA FD 21 003

The Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products (UC2) Clinical Trials Not Allowed is a U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP) funding opportunity intended to solve a practical but important research bottleneck: most commercially available smoking machines were originally built around the size, shape, and draw characteristics of conventional cigarettes, which makes it difficult to test newer or non-cigarette tobacco products in a consistent, repeatable way. Through this cooperative agreement, FDA CTP is looking for an outside organization (or organizations) to design and develop a smoking machine adaptor solution that allows electronic nicotine delivery systems (ENDS), cigars, and heated tobacco products to be attached to existing cigarette-based smoking machines so these products can be evaluated using standardized laboratory methods. The emphasis is on creating either one universal adaptor or a standardized family of adaptors that can cover the range of product designs found across these categories while still fitting the interfaces and operating constraints of current smoking machine platforms.

The project is framed as collaborative and research-intensive rather than a simple procurement of an off-the-shelf part. Because it is a cooperative agreement, the FDA is signaling that it expects substantial involvement and coordination during the work, including iterative development, testing, and alignment with regulatory science needs. The end goal is not just a prototype for a single lab, but a broadly usable adaptor approach that can be made available to a wide set of stakeholders, including tobacco industry stakeholders, contract laboratories, government laboratories, and academic institutions. In practical terms, that means the adaptor design needs to be robust, reproducible, and transferable, with enough standardization that different labs can use it and still generate comparable data.

The opportunity is identified as RFA FD 21 003 under Assistance Listing (CFDA) 93.103, and it falls within research and development-related activity areas spanning health, science and technology, and related domains. It was posted by the Department of Health and Human Services (HHS), FDA, with a creation date of April 13, 2020, and an original application closing date of July 10, 2020. The funding instrument type is a cooperative agreement, with an award ceiling of $2,000,000 and an expectation of a single award, indicating the agency likely intends to support one primary team to deliver a unified adaptor solution rather than funding multiple competing designs.

Eligibility is broad and includes many types of organizations that could plausibly contribute engineering, aerosol science, product testing, or standards-development expertise. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The title includes the note “Clinical Trials Not Allowed,” which clarifies that the work is not meant to involve human subjects clinical research; it is focused on laboratory methods development, engineering design, and related testing and validation activities suitable for regulatory science.

Overall, the grant is aimed at creating standardized hardware infrastructure that helps laboratories generate more consistent emissions and aerosol data across a diverse set of non-cigarette products. By enabling ENDS, cigars, and heated tobacco products to interface reliably with existing smoking machines, the project supports more comparable testing, better method harmonization, and wider access to measurement capability across public, private, and academic research settings.

• The Department of Health and Human Services, Food and Drug Administration in the business and commerce, food and nutrition, health, science and technology and other research and development sector is offering a public funding opportunity titled "Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products (UC2) 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 Apr 13, 2020.
• Applicants must submit their applications by Jul 10, 2020. (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 $2,000,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses.

Apply for RFA FD 21 003

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: