Opportunity Information: Apply for RFA FD 14 082
Apply for RFA FD 14 082
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (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 May 19, 2014 and posted on May 19, 2014.
- Applicants must submit their applications by Jun 30, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $600,000.00 to eligible and selected applicants.
- 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 City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Public and State controlled institutions of higher education.
- 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 grant opportunity, titled "Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)" (Funding Opportunity Number RFA-FD-14-082), was issued by the U.S. Food and Drug Administration (FDA) as a discretionary cooperative agreement. The core purpose is to support the development of a mathematical algorithm or integrated modeling framework that can combine and interpret in vitro chemical characterization data and in vitro biological characterization data in a unified way. The practical regulatory problem it targets is the challenge of determining whether a follow-on or generic version of a complex macromolecule or otherwise complex drug substance is sufficiently similar, or effectively the same, as its reference (brand or original) product based on laboratory characterization.
A central emphasis of the project is not merely collecting more assays, but determining the "degree of sufficiency" of the in vitro assay package. In other words, the model is expected to help answer a question that matters for product development and regulatory decision-making: given a set of chemical and biological analytical tests, is that set adequate to support a conclusion of similarity or sameness between a proposed generic/follow-on product and the reference product? The expectation is that an integrated mathematical and analytical approach can pull together multiple streams of evidence, weigh them coherently, and present a clearer overall picture of molecular structure and functional characteristics for complex molecules that are difficult to fully describe with any single method.
The broader outcome FDA appears to be driving toward is a more systematic, science-based pathway to decide when additional studies are needed beyond in vitro characterization. If the integrated model can reliably summarize how well the follow-on product matches the reference product, it may help inform the extent to which preclinical studies and/or clinical studies are necessary. This matters especially for macromolecules and complex drug substances where minor structural differences can potentially affect clinical performance, but where extensive clinical testing for every follow-on product can also be costly, time-consuming, and sometimes avoidable if analytical similarity can be demonstrated with high confidence. In that sense, the project is aimed at improving the evidence framework that connects analytical comparability to downstream study requirements.
In terms of award structure and scale, FDA anticipated making one award under this announcement, with an estimated total funding amount of $600,000 and an award ceiling of $600,000. There was no cost-sharing or matching requirement. The funding instrument type is a cooperative agreement (U01), which generally signals that the agency expects to have substantial programmatic involvement during the project, such as collaboration on milestones, deliverables, and scientific direction, rather than functioning purely as a hands-off grant.
Eligibility was broad and included many categories of domestic applicants, such as state, county, and city/township governments; public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities); small businesses; other for-profit organizations; special district governments; independent school districts; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations. Notably, the announcement also allowed foreign participation: non-U.S. entities (foreign institutions) were eligible to apply, non-U.S. components of U.S. organizations could apply, and foreign components (as defined in the HHS Grants Policy Statement) were permitted.
Administratively, the opportunity was posted on May 19, 2014, with an original and current closing date of June 30, 2014, and an archive date of July 30, 2014. The activity category was listed under consumer protection, food and nutrition, and health, consistent with FDA's public health mission and its role in setting and applying scientific standards for evaluating drugs, including complex products where demonstrating equivalence is analytically challenging.
For applicants or parties seeking the full official details, the announcement referenced an additional information link titled "Full Announcement RFA FD 14 082." The listed grants management contact for access issues was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the official title and funding opportunity number for this grant?
The opportunity is titled "Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)" and the Funding Opportunity Number is RFA-FD-14-082.
Which federal agency issued this funding opportunity?
The opportunity was issued by the U.S. Food and Drug Administration (FDA).
What type of funding mechanism is being used?
The funding instrument is a cooperative agreement (U01). This generally indicates substantial programmatic involvement by the agency during the project, such as collaboration on milestones, deliverables, and scientific direction.
What is the core purpose of the project being funded?
The core purpose is to support development of a mathematical algorithm or integrated modeling framework that combines and interprets in vitro chemical characterization data and in vitro biological characterization data in a unified way.
What problem is this project trying to solve in a regulatory context?
The project targets the challenge of determining whether a follow-on or generic version of a complex macromolecule (or otherwise complex drug substance) is sufficiently similar, or effectively the same, as its reference (brand/original) product based on laboratory characterization.
What kinds of data does the integrated model need to bring together?
The model is expected to integrate multiple streams of in vitro evidence, specifically in vitro chemical characterization data and in vitro biological characterization data, to provide a coherent overall picture of molecular structure and functional characteristics.
Is the focus on developing new assays or on evaluating the sufficiency of an assay package?
A central emphasis is not simply collecting more assays, but determining the "degree of sufficiency" of the in vitro assay package. The model is expected to help assess whether a given set of chemical and biological analytical tests is adequate to support a conclusion of similarity or sameness.
What question should the model help answer for product developers and regulators?
The model is expected to help answer whether the existing set of in vitro chemical and biological analytical tests is sufficient to support a conclusion that a proposed follow-on/generic product matches the reference product closely enough to be considered similar or the same.
How is FDA expecting the integrated model to be used in decision-making?
The broader intended outcome is a more systematic, science-based pathway to decide when additional studies are needed beyond in vitro characterization. If the model can reliably summarize how well the follow-on product matches the reference product, it may help inform the extent to which preclinical and/or clinical studies are necessary.
Why is this particularly important for complex macromolecules or complex drug substances?
For complex molecules, minor structural differences can potentially affect clinical performance, yet these products can be difficult to fully describe using any single method. The project aims to strengthen the evidence framework connecting analytical comparability to downstream study requirements, potentially reducing unnecessary cost and time when strong analytical similarity can be demonstrated.
How many awards did FDA anticipate making under this announcement?
FDA anticipated making one award under this announcement.
What is the estimated total funding amount available?
The estimated total funding amount was $600,000.
What is the award ceiling?
The award ceiling was $600,000.
Is cost sharing or matching required?
No. The opportunity specified that there was no cost-sharing or matching requirement.
What does "cooperative agreement" imply about FDA's involvement during the project?
Because this is a cooperative agreement (U01), FDA is expected to have substantial programmatic involvement, such as collaborating on milestones, deliverables, and aspects of scientific direction, rather than operating purely in a hands-off role.
Who was eligible to apply?
Eligibility was broad and included many categories of domestic applicants, including state, county, and city/township governments; public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities); small businesses; other for-profit organizations; special district governments; independent school districts; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations.
Were foreign organizations allowed to apply?
Yes. The announcement allowed foreign participation, including non-U.S. entities (foreign institutions), non-U.S. components of U.S. organizations, and foreign components (as defined in the HHS Grants Policy Statement).
What was the posting date for the opportunity?
The opportunity was posted on May 19, 2014.
What was the application closing date?
The original and current closing date was June 30, 2014.
When was the opportunity archived?
The archive date was July 30, 2014.
What activity category was associated with this opportunity?
The activity category was listed under consumer protection, food and nutrition, and health.
Where can applicants find the full official details of the announcement?
The opportunity referenced an additional information link titled "Full Announcement RFA FD 14 082" for full official details.
Who is the grants management contact listed for access issues?
The listed grants management contact for access issues was Lisa Ko, Grants Management Specialist.
What email address was provided for the grants management contact?
The email provided was lisa.ko@fda.hhs.gov.
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