Opportunity Information: Apply for RFA FD 24 020
This funding opportunity is a U.S. Food and Drug Administration (FDA) cooperative agreement (U01) issued through the Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), focused on identifying and evaluating practical ways to address nitrosamine impurities in human drug products. Nitrosamines are chemical impurities that can arise during manufacturing, formulation, packaging, or storage, and some are considered probable or known carcinogens. The overall purpose of the award is to directly support FDA's public health mission by reducing unacceptable nitrosamine-related risks while also helping maintain reliable access to important medicines. The work is intended to move beyond purely theoretical research and instead generate translational, implementable approaches that can be used in real-world drug development and manufacturing settings to prevent, detect, assess, and control nitrosamine impurity liabilities.
The FOA emphasizes that, even though FDA and stakeholders have already undertaken substantial experimental work and regulatory or policy efforts in this area, there is still a gap in methods and practices that can be broadly adopted across the drug supply chain. The project is therefore aimed at developing and refining approaches that can be put into practice by manufacturers and other stakeholders, with the ultimate goal of improving the safety profile of marketed and pipeline drugs that may be vulnerable to nitrosamine formation or contamination. A notable requirement is forward-looking sustainability: in addition to the core research and practices development, the awardee must evaluate and propose how the resulting work can continue after the FDA-funded period ends, including mechanisms for ongoing collaboration and upkeep among industry, nonprofit organizations, and academic institutions. In other words, the FDA is not just funding a one-time study; it is looking for work that can be carried forward and maintained as an active, evolving body of practice once the cooperative agreement concludes.
From an administrative and eligibility standpoint, this is a discretionary grant mechanism under a cooperative agreement structure, meaning the FDA is expected to have substantial involvement during the project period compared with a standard grant. The opportunity is labeled "Clinical Trials Not Allowed," indicating that applicants should not propose clinical trials as part of the scope; the work is expected to center on impurity science, analytical methods, risk assessment approaches, manufacturing controls, or other non-clinical translational practices relevant to nitrosamine impurities in drugs. The funding opportunity number is RFA-FD-24-020, associated with CFDA number 93.103, and it falls within the broad activity category of agriculture/consumer protection/food and nutrition, consistent with FDA's public health regulatory mission.
The applicant pool is intentionally broad and includes government entities (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including those other than small businesses), small businesses, and essentially unrestricted applicants. The FOA anticipates making a single award (Expected Awards: 1), with an award ceiling of $350,000. The original application closing date listed is February 27, 2024, and the opportunity was created on December 21, 2023. Taken together, these details point to a single, targeted project designed to generate usable, durable practices that strengthen FDA and stakeholder capability to manage nitrosamine impurity risks across human drugs, without involving clinical trial activities.Apply for RFA FD 24 020
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - 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 2023-12-21.
- Applicants must submit their applications by 2024-02-27. (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 $350,000.00 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, Unrestricted.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is a U.S. Food and Drug Administration (FDA) cooperative agreement (U01) issued through the Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND). It focuses on identifying and evaluating practical ways to address nitrosamine impurities in human drug products.
What is the main purpose of the award?
The overall purpose is to directly support FDA's public health mission by reducing unacceptable nitrosamine-related risks while also helping maintain reliable access to important medicines. The project is intended to produce translational, implementable approaches that can be used in real-world drug development and manufacturing settings.
What are nitrosamine impurities, and why are they important?
Nitrosamines are chemical impurities that can arise during manufacturing, formulation, packaging, or storage of human drug products. Some nitrosamines are considered probable or known carcinogens, which makes preventing, detecting, assessing, and controlling them a significant drug quality and public health priority.
What kinds of work is FDA looking to fund under this FOA?
The FOA emphasizes work that moves beyond purely theoretical research and instead generates approaches that are practical and can be implemented across real-world drug development and manufacturing settings. The expected scope includes impurity science and translational practices relevant to nitrosamine impurities in drugs.
What types of activities are specifically called out as in-scope examples?
Based on the FOA description, in-scope work may center on practical approaches related to impurity science, analytical methods, risk assessment approaches, manufacturing controls, and other non-clinical translational practices relevant to nitrosamine impurities in human drug products.
Is this opportunity meant to create broadly adoptable practices across the drug supply chain?
Yes. The FOA highlights that despite substantial experimental and regulatory or policy work already done by FDA and stakeholders, there remains a gap in methods and practices that can be broadly adopted across the drug supply chain. The project is aimed at developing and refining approaches that can be put into practice by manufacturers and other stakeholders.
How is this different from purely academic or theoretical research?
The FOA is focused on translational, implementable approaches that can be used in real-world settings. The intent is not limited to generating theory; it is to produce methods, tools, or practices that stakeholders can actually use to prevent, detect, assess, and control nitrosamine impurity liabilities.
Are clinical trials allowed under this funding opportunity?
No. The opportunity is labeled "Clinical Trials Not Allowed," meaning applicants should not propose clinical trials as part of the scope.
What award mechanism is being used?
This is a cooperative agreement under the U01 mechanism. It is described as a discretionary grant mechanism under a cooperative agreement structure.
What does a cooperative agreement (U01) imply for FDA involvement?
The FOA indicates that FDA is expected to have substantial involvement during the project period compared with a standard grant.
What is the overarching goal for outcomes and impact?
The ultimate goal is to improve the safety profile of marketed and pipeline human drugs that may be vulnerable to nitrosamine formation or contamination, while supporting reliable access to important medicines.
Is sustainability after the funding period a requirement?
Yes. A notable requirement is forward-looking sustainability. In addition to the core work, the awardee must evaluate and propose how the resulting work can continue after the FDA-funded period ends.
What does "sustainability" mean in the context of this FOA?
It means the awardee is expected to propose mechanisms for ongoing collaboration and upkeep after the cooperative agreement concludes, including continued engagement among industry, nonprofit organizations, and academic institutions, so the work remains active and can evolve.
Is FDA funding a one-time study here?
No. The FOA explicitly signals that FDA is looking for work that can be carried forward and maintained as an active, evolving body of practice once the cooperative agreement ends.
Who is eligible to apply?
The eligible applicant pool is broad and includes government entities (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including those other than small businesses), small businesses, and essentially unrestricted applicants.
How many awards does FDA expect to make?
The FOA anticipates making a single award (Expected Awards: 1).
What is the maximum funding amount available?
The award ceiling is $350,000.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-24-020.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
Which FDA offices are associated with this opportunity?
This opportunity is issued through FDA's Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND).
What is the closing date for applications?
The original application closing date listed is February 27, 2024.
When was this opportunity created?
The opportunity was created on December 21, 2023.
What general category does this opportunity fall under?
It falls within the broad activity category of agriculture/consumer protection/food and nutrition, consistent with FDA's public health regulatory mission.
What kinds of drug products are the focus?
The FOA focuses on nitrosamine impurities in human drug products, including marketed and pipeline drugs that may be vulnerable to nitrosamine formation or contamination.
Where in the drug lifecycle can nitrosamine impurities arise, according to the FOA summary?
The FOA notes that nitrosamines can arise during manufacturing, formulation, packaging, or storage.
What is the central problem the FOA is trying to address?
The central problem is the ongoing gap in broadly adoptable methods and practices to manage nitrosamine impurity risks across the drug supply chain, despite substantial work already undertaken by FDA and stakeholders.
What does the FOA emphasize about real-world adoption?
It emphasizes developing and refining approaches that can be put into practice by manufacturers and other stakeholders, rather than producing outputs that are only theoretical or limited to a single setting.
What is the intended benefit to the drug supply and patients?
The intended benefit is reducing unacceptable nitrosamine-related risks to improve drug safety, while also helping maintain reliable access to important medicines.
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