Opportunity Information: Apply for RFA FD 21 016
This funding opportunity, titled "Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed," is a U.S. Food and Drug Administration (FDA) cooperative agreement focused on research methods rather than clinical testing. The core goal is to advance laboratory and analytical approaches that can better characterize ferric derisomaltose, an iron carbohydrate complex considered a complex drug product. Because products like ferric derisomaltose have intricate structures and multiple critical quality attributes, they can be difficult to compare using routine tests. The FDA is seeking research that strengthens the scientific tools used to measure, describe, and compare these products in a way that supports confidence in quality, safety, and performance.
The opportunity emphasizes the development of advanced analytical methods for characterization and comparative analysis. In practical terms, this means creating or improving techniques that can map and quantify key product attributes, identify meaningful differences between products, and connect those attributes to what matters for product quality and, ultimately, clinical performance. The underlying public health purpose is to make it easier to develop and evaluate generic versions of complex products by providing robust, reproducible analytical evidence that a proposed generic is sufficiently similar to the reference product. The notice explicitly states that clinical trials are not allowed, reinforcing that the work should be analytical and method-development oriented, potentially including physicochemical characterization, structural profiling, and other non-clinical comparative assessments.
Administratively, this is a discretionary funding opportunity issued by the Department of Health and Human Services (HHS) through the FDA. The funding instrument is a cooperative agreement (U01), which generally indicates substantial scientific or programmatic involvement by the agency during the project compared with a traditional grant. The activity area is categorized under consumer protection and research and development, consistent with FDA's mission to support regulatory science that improves product evaluation and oversight.
Key details include the Funding Opportunity Number RFA-FD-21-016 and CFDA number 93.103. The opportunity was created on January 7, 2021, with an original application closing date of March 31, 2021. FDA anticipated making one award, with an award ceiling of $600,000. Eligibility is broad and includes multiple types of organizations: state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations (including those other than small businesses); and small businesses, with a note that applicants should consult the additional eligibility text for any clarifications.
Overall, the project supported by this opportunity is intended to generate advanced, fit-for-purpose analytical methods and comparative data for ferric derisomaltose. The expected impact is regulatory-science focused: improving the scientific foundation FDA can use to review and assess generic ferric derisomaltose submissions by enabling clearer, more defensible comparisons of complex product attributes without relying on clinical trials for this specific award.Apply for RFA FD 21 016
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) 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 Jan 07, 2021.
- Applicants must submit their applications by Mar 31, 2021. (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 $600,000.00 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The funding opportunity is titled "Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed."
Which agency is offering this opportunity?
This is offered by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS).
What type of funding mechanism is being used?
The award mechanism is a cooperative agreement (U01), which generally involves substantial scientific or programmatic involvement by the FDA during the project compared with a traditional grant.
What is the main purpose of the project?
The main purpose is to advance laboratory and analytical approaches to better characterize ferric derisomaltose, an iron carbohydrate complex considered a complex drug product. The focus is on improving the scientific tools used to measure, describe, and compare these products to support confidence in quality, safety, and performance.
Is this opportunity intended to fund clinical trials?
No. The notice explicitly states "Clinical Trials Not Allowed," meaning the work should be analytical and method-development oriented rather than clinical testing.
What kinds of research activities does FDA emphasize for this award?
The opportunity emphasizes development of advanced analytical methods for characterization and comparative analysis. This includes creating or improving techniques that can map and quantify key product attributes, identify meaningful differences between products, and connect those attributes to what matters for product quality and, ultimately, clinical performance, using non-clinical evidence.
What product is the analytical method development focused on?
The work is focused on ferric derisomaltose, described as an iron carbohydrate complex and a complex drug product with intricate structures and multiple critical quality attributes.
Why does FDA consider ferric derisomaltose difficult to evaluate with routine tests?
Because products like ferric derisomaltose have complex structures and multiple critical quality attributes, routine tests may not be sufficient to compare products with high confidence. The goal is to strengthen analytical methods that can better capture and compare these attributes.
What is the public health or regulatory-science goal behind this project?
The stated public health purpose is to make it easier to develop and evaluate generic versions of complex products by providing robust, reproducible analytical evidence that a proposed generic is sufficiently similar to the reference product.
How is "comparative analysis" described in this opportunity?
Comparative analysis is described as developing or improving techniques that can identify meaningful differences between products and support clearer, more defensible comparisons of complex product attributes using advanced, fit-for-purpose analytical methods.
What kinds of non-clinical assessments are mentioned as examples?
The description mentions potential activities such as physicochemical characterization, structural profiling, and other non-clinical comparative assessments.
How many awards did FDA anticipate making?
FDA anticipated making one award.
What is the maximum (ceiling) amount for the award?
The award ceiling is $600,000.
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-FD-21-016.
What is the CFDA number listed for this opportunity?
The CFDA number listed is 93.103.
When was the opportunity created?
The opportunity was created on January 7, 2021.
What was the original application closing date?
The original application closing date was March 31, 2021.
What categories does the activity area fall under?
The activity area is categorized under consumer protection and research and development, consistent with FDA's regulatory-science mission.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (including those other than small businesses); and small businesses. Applicants are advised to consult any additional eligibility text for clarifications.
What kind of outcome or impact is expected from the funded work?
The expected impact is regulatory-science focused: generating advanced, reproducible analytical methods and comparative data for ferric derisomaltose that strengthen the scientific foundation FDA can use to review and assess generic ferric derisomaltose submissions, without relying on clinical trials for this award.
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