Opportunity Information: Apply for RFA FD 13 017
Apply for RFA FD 13 017
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Development of Bio relevant In vitro Assay to Determine Labile Iron in the Parenteral Iron Complex Product (U01)" 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 Apr 2, 2013 and posted on Apr 2, 2013.
- Applicants must submit their applications by May 24, 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 $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments Private institutions of higher education Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized).
- Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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Opportunity Summary:
This funding opportunity, RFA-FD-13-017, is a Food and Drug Administration (FDA) cooperative agreement (U01) focused on improving how parenteral (injectable) iron complex drug products are evaluated, particularly when comparing generic formulations to the reference listed drug (RLD). The core concern driving the project is the possibility that some generic iron complex formulations may contain higher amounts of labile iron, meaning iron that can be more readily released from the complex. If more labile iron is present, it could increase the formation of non-transferrin bound iron (NTBI) in the body after administration. NTBI is clinically important because it is more chemically reactive than transferrin-bound iron and can contribute to oxidative stress and inflammation, potentially leading to direct cellular injury. In plain terms, the FDA is aiming to better understand and measure a quality attribute (labile iron) that could influence real-world biological behavior and safety.
The scientific objectives are twofold. First, the project is intended to evaluate multiple in vitro (laboratory-based) methods that can measure or characterize labile iron in parenteral iron complex formulations. Second, and more importantly, it seeks to develop a bio-relevant in vitro assay that can predict how much NTBI would be generated in vivo (in the body). The emphasis on "bio-relevant" signals that the FDA is not just looking for a sensitive chemistry test, but for an assay whose outputs meaningfully relate to biological conditions and outcomes. The end goal is a predictive laboratory method that can serve as a bridge between in vitro measurements and in vivo performance, helping connect FDA equivalence standards for generics to what actually happens biologically after dosing. If successful, this kind of tool can strengthen regulatory decision-making by offering a more mechanistic and clinically meaningful way to compare products, potentially reducing uncertainty when assessing whether a generic behaves like its RLD.
From an administrative and funding standpoint, the opportunity was posted on April 2, 2013, with an application deadline of May 24, 2013, and it was later archived on June 23, 2013. The FDA anticipated making one award, with an estimated total funding amount of $500,000 and an award ceiling of $500,000. The program did not require cost sharing or matching funds. The activity category is listed under consumer protection, food and nutrition, and health, and it falls under CFDA 93.103 (Food and Drug Administration Research), reflecting the FDA research mission and its relevance to public health and product quality oversight.
Eligibility was broad and included small businesses, for-profit organizations (including those other than small businesses), nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), a variety of government entities (state, county, city/township, special district), public housing authorities/Indian housing authorities, independent school districts, and institutions of higher education (both private and public/state-controlled). Notably, non-U.S. (foreign) institutions were eligible to apply, non-U.S. components of U.S. organizations were also eligible, and foreign components were allowed as defined by the HHS Grants Policy Statement. This wide eligibility suggests the FDA was open to leveraging specialized expertise wherever it exists, including internationally, as long as the proposed work met the program goals.
Because this is a cooperative agreement (U01), it typically implies substantial programmatic involvement by the FDA compared with a standard research grant mechanism. In practice, that often means closer coordination with the agency on study design priorities, milestones, or how the assay development aligns with regulatory needs. The announcement provided an additional information link to the full solicitation on the NIH Guide for Grants and Contracts, and it listed a grants management contact for access issues: Lisa Ko, Grants Management Specialist (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs) - RFA-FD-13-017 (FDA Cooperative Agreement U01)
What is the purpose of funding opportunity RFA-FD-13-017?
RFA-FD-13-017 is an FDA cooperative agreement (U01) focused on improving how parenteral (injectable) iron complex drug products are evaluated, especially when comparing generic formulations to the reference listed drug (RLD). The effort centers on understanding and measuring labile iron as a quality attribute that could affect biological behavior and safety after administration.
What drug products does this opportunity focus on?
The opportunity focuses on parenteral (injectable) iron complex drug products, with particular attention to comparing generic formulations to the reference listed drug (RLD).
Why is the FDA concerned about labile iron in some generic formulations?
The core concern is that some generic iron complex formulations may contain higher amounts of labile iron, meaning iron that can be more readily released from the complex. Higher labile iron could increase the formation of non-transferrin bound iron (NTBI) in the body after administration.
What is labile iron in the context of this grant?
Labile iron refers to iron that can be more readily released from an iron complex formulation. In this opportunity, labile iron is treated as a potentially important quality attribute because it may influence how much NTBI forms in vivo after dosing.
What is non-transferrin bound iron (NTBI), and why does it matter?
NTBI is iron in the body that is not bound to transferrin. It is clinically important because it is more chemically reactive than transferrin-bound iron and can contribute to oxidative stress and inflammation, potentially leading to direct cellular injury.
What are the scientific objectives of the project?
The opportunity describes two main scientific objectives: (1) evaluating multiple in vitro (laboratory-based) methods that can measure or characterize labile iron in parenteral iron complex formulations, and (2) developing a bio-relevant in vitro assay that can predict how much NTBI would be generated in vivo.
What does "in vitro" mean in this announcement?
In vitro refers to laboratory-based testing methods (outside the body). The announcement emphasizes evaluating in vitro methods for labile iron and developing an in vitro assay intended to predict NTBI generation in vivo.
What does "in vivo" mean in this announcement?
In vivo refers to what happens in the body after administration. The announcement highlights a goal of predicting how much NTBI would be generated in vivo using a bio-relevant in vitro assay.
What does "bio-relevant in vitro assay" mean here?
"Bio-relevant" indicates the FDA is looking for more than a sensitive chemistry test. The aim is an assay whose outputs meaningfully relate to biological conditions and outcomes, specifically the prediction of NTBI generation in vivo.
What is the main deliverable or end goal described in the opportunity?
The end goal is a predictive laboratory method that bridges in vitro measurements and in vivo performance, helping connect FDA equivalence standards for generics to what happens biologically after dosing.
How could the results be used in a regulatory context?
If successful, the developed tool could strengthen regulatory decision-making by providing a more mechanistic and clinically meaningful way to compare generic products to the RLD, potentially reducing uncertainty when assessing whether a generic behaves like its reference.
What is the funding mechanism for this opportunity?
The mechanism is a cooperative agreement (U01). This typically implies substantial programmatic involvement by the FDA compared with a standard research grant mechanism.
What does it mean that this award is a cooperative agreement (U01)?
Because it is a U01 cooperative agreement, the FDA typically has more substantial programmatic involvement than it would under a standard research grant. The announcement notes this can mean closer coordination with the agency on priorities such as study design, milestones, and alignment of assay development with regulatory needs.
How many awards did the FDA anticipate making?
The FDA anticipated making one award under this funding opportunity.
What is the estimated total funding amount for this opportunity?
The estimated total funding amount listed is $500,000.
What is the award ceiling?
The award ceiling is $500,000.
Is cost sharing or matching required?
No. The opportunity states that cost sharing or matching funds were not required.
When was the opportunity posted, and what was the application deadline?
The opportunity was posted on April 2, 2013, and the application deadline was May 24, 2013.
Is this opportunity still open?
No. The opportunity was later archived on June 23, 2013.
What activity categories are associated with this opportunity?
The activity category is listed under consumer protection, food and nutrition, and health.
What is the CFDA number associated with this grant?
The opportunity falls under CFDA 93.103 (Food and Drug Administration Research).
Who is eligible to apply?
Eligibility includes small businesses; for-profit organizations (including those other than small businesses); nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities); state, county, city/township, and special district governments; public housing authorities/Indian housing authorities; independent school districts; and institutions of higher education (both private and public/state-controlled).
Are non-U.S. (foreign) institutions eligible to apply?
Yes. Non-U.S. (foreign) institutions were eligible to apply. In addition, non-U.S. components of U.S. organizations were eligible, and foreign components were allowed as defined by the HHS Grants Policy Statement.
Where can applicants find the full solicitation details?
The announcement provided an additional information link to the full solicitation on the NIH Guide for Grants and Contracts.
Who is the grants management contact for access issues?
The listed grants management contact for access issues is Lisa Ko, Grants Management Specialist (lisa.ko@fda.hhs.gov).
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| Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) Apply for RFA FD 15 040 Funding Number: RFA FD 15 040 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
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| Smokeless Tobacco Reference Products (UC2) Apply for RFA FD 15 026 Funding Number: RFA FD 15 026 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $3,000,000 |
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