Opportunity Information: Apply for RFA FD 14 010
Apply for RFA FD 14 010
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Characterization of Critical Quality Attributes for Semisolid Topical Drug Products" 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 Jun 2, 2014 and posted on Mar 31, 2014.
- Applicants must submit their applications by Jun 9, 2014 A Grace period has been provided through June 9, 2014 for the University of Cincinati due to Grants.gov technical issues resulting in need to install a patch to enable applications submitted through the Coeus interface.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: 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 Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Private institutions of higher education Independent school districts For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) State governments County governments Public and State controlled institutions of higher education.
- Foreign Instituttions
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Opportunity Summary:
The FDA cooperative agreement opportunity "Characterization of Critical Quality Attributes for Semisolid Topical Drug Products" focuses on a persistent regulatory science problem: semisolid topical products such as creams, gels, lotions, ointments, and pastes can look similar on paper yet behave differently in real use. Even when a proposed generic is Q1/Q2 equivalent to a reference listed drug (same ingredients and same ingredient amounts), it may still differ in Q3 attributes, meaning the microstructure or "arrangement of matter" inside the product. Those structural differences can change how the drug is released, how it permeates skin, how stable it is over time, and how acceptable it feels to patients. Because semisolids span many formulations and microstructures, FDA notes that it is also hard to anticipate and detect failure modes (for example, phase separation, crystal growth, changes in globule size, viscosity drift, or other instabilities) using traditional, one-size-fits-all approaches. The overall intent is to keep regulatory evaluation aligned with modern characterization tools so FDA can more efficiently and reliably assess complex semisolid quality and equivalence, particularly for generics.
The core objective is to generate a scientific foundation that can be translated into regulatory standards and industry guidance for developing and assessing semisolid topical drug products. In practical terms, the project aims to define which measurable properties truly matter (critical quality attributes and performance attributes) for different categories of semisolids, and then connect those attributes to product performance and potential failure modes. The emphasis is not just on listing tests, but on identifying which attributes are actually critical to therapeutic performance and patient acceptability, and which ones are most sensitive to formulation choices, manufacturing conditions, and storage or stability factors.
A major piece of the proposed work is to build a preliminary classification system for semisolid dosage forms. Instead of treating "cream" or "gel" as broad labels, the classification would differentiate products based on components and expected microstructure, such as single-phase versus multi-phase gels, oleaginous suspensions, pluronic lecithin organogels, polyethylene glycol- or petrolatum-based ointments, oil-in-water versus water-in-oil creams, lotions, and pastes. The classification explicitly recognizes that active pharmaceutical ingredients may be fully dissolved, partially dissolved, or suspended, and may reside in one or multiple phases. Alongside this classification, the research would develop a theoretical framework of potential failure modes for each class. Importantly, the container-closure system is included because packaging can contribute to or trigger failure modes (for example, evaporation, water loss, interaction with container materials, or changes caused by repeated use).
From there, the project calls for identifying a comprehensive set of potentially measurable quality attributes for each class of semisolid. These can include straightforward sensory and physicochemical measures such as opacity, smoothness, odor, color, consistency, water content, osmolality, and pH. However, FDA highlights a key distinction: not everything measurable is necessarily critical. The intent is to separate "nice to know" attributes from those that truly influence performance, stability, or patient use. The work explicitly targets Q1/Q2/Q3 concepts, with particular emphasis on Q3. At the molecular and microstructural level, this can include phase state and relative phase proportions, globule size and distribution in emulsions, particle size and distribution of suspended or crystallized drug, polymorphic form of the drug substance, and other structural features that may control release and delivery. At the macroscopic level, it can include rheology (flow and viscoelastic behavior), density, homogeneity, and related physical properties that affect application, dose uniformity, and robustness during shipping and storage.
Another central deliverable is linking failure modes to variations in critical quality attributes and tracing those variations back to controllable variables in formulation, manufacturing, and stability. The announcement gives a concrete example: cream homogenization speed can affect globule size, which could alter therapeutic performance. This is the kind of cause-and-effect chain the project is meant to map across multiple semisolid classes, so that regulators and developers can better predict risk, design appropriate controls, and select tests that are genuinely discriminating for meaningful differences.
To determine which attributes are truly critical, the research plan includes systematic studies where formulation or manufacturing conditions are deliberately altered to shift specific quality attributes, followed by performance testing to see what changes actually matter. Performance evaluation may rely on discriminating in vitro release testing (IVRT), including approaches described in USP <1724>, and in some situations in vitro permeation testing (IVPT) using human skin. The opportunity also allows for other methods capable of evaluating relative bioavailability, acknowledging that different product types and failure concerns may require different tools.
The work is organized into four study phases. First is a comprehensive description of potentially measurable physical and chemical qualities across semisolid dosage forms, aligned with their components, microstructures, and plausible failure modes. Second is identifying or developing methods to measure those attributes for each semisolid class (which implies method selection, optimization, and ensuring methods are appropriate and discriminating). Third is characterizing how formulation and manufacturing variables influence the measured attributes within each class. Fourth is using in vitro and/or in vivo performance measures to determine which attributes are critical to therapeutic performance and which are associated with specific failure modes.
On the funding and administrative side, this was an FDA discretionary funding opportunity (Funding Opportunity Number RFA-FD-14-010) using the cooperative agreement mechanism, meaning FDA expects substantial involvement or collaboration during the project rather than a fully hands-off grant. The activity category is health science and technology and other research and development. FDA anticipated up to five awards with an estimated total funding of $1,250,000, with individual awards ranging from $150,000 to $250,000. There was no cost sharing or matching requirement. The opportunity was posted March 31, 2014, with an original closing date of June 2, 2014 and a grace period to June 9, 2014 due to a Grants.gov technical issue affecting the University of Cincinnati. Eligibility was broad across many domestic organization types (including higher education institutions, nonprofits, for-profits other than small businesses, small businesses, and various government entities), and foreign institutions were also listed in the eligibility information. The program falls under CFDA 93.103 (Food and Drug Administration).
Frequently Asked Questions (FAQs)
1) What is the title of this FDA funding opportunity?
The cooperative agreement opportunity is titled "Characterization of Critical Quality Attributes for Semisolid Topical Drug Products."
2) What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-14-010.
3) What type of funding mechanism is being used?
This opportunity uses a cooperative agreement mechanism. That means FDA expects substantial involvement during the project, rather than a fully hands-off relationship typical of some grants.
4) What problem is FDA trying to solve with this project?
FDA is addressing a persistent regulatory science challenge: semisolid topical products (creams, gels, lotions, ointments, pastes) can appear equivalent based on formulation listings yet behave differently in real-world use due to microstructural differences inside the product. Those differences can affect drug release, skin permeation, stability over time, and patient acceptability (how the product feels and performs during use).
5) Which dosage forms are in scope?
Semisolid topical dosage forms are in scope, including creams, gels, lotions, ointments, and pastes. The description also discusses multiple subtypes within these broad labels.
6) What do Q1, Q2, and Q3 mean in this context?
Q1/Q2/Q3 are quality concepts used for topical semisolids. Q1 refers to having the same ingredients as the reference listed drug. Q2 refers to having the same ingredient amounts. Q3 refers to differences in the microstructure or "arrangement of matter" within the product, which can exist even when Q1 and Q2 match.
7) Why does FDA emphasize Q3 (microstructure) for semisolid topicals?
Because Q3 attributes can change how a product releases the drug, how it permeates skin, how stable it is, and how acceptable it feels to patients, even when the product is Q1/Q2 equivalent to a reference listed drug.
8) What kinds of real-world differences can microstructure cause?
Microstructural differences can alter drug release and delivery to/through the skin, contribute to instability over time, and affect patient experience (for example, spreadability, perceived consistency, or overall acceptability).
9) What are examples of failure modes FDA is concerned about?
Examples include phase separation, crystal growth, changes in globule size, viscosity drift, and other instabilities that may not be well predicted by one-size-fits-all testing approaches.
10) What is the overall intent of the project from a regulatory science perspective?
The intent is to create a scientific foundation that can be translated into regulatory standards and industry guidance so FDA can assess semisolid topical product quality and equivalence more efficiently and reliably, particularly for generic products.
11) What is the core objective of the research?
The core objective is to define which measurable properties are truly important (critical quality attributes and performance attributes) for different categories of semisolids and to connect those attributes to product performance and potential failure modes.
12) Is the goal simply to compile a list of tests?
No. The emphasis is on distinguishing which attributes are actually critical to therapeutic performance and patient acceptability, and which are most sensitive to formulation choices, manufacturing conditions, and storage/stability factors.
13) What is meant by a classification system for semisolid dosage forms?
The project proposes building a preliminary classification system that goes beyond broad labels like "cream" or "gel" by differentiating products based on components and expected microstructure (for example, single-phase versus multi-phase gels, different emulsion types, and different ointment bases).
14) What are examples of semisolid classes mentioned for classification?
Examples mentioned include single-phase versus multi-phase gels, oleaginous suspensions, pluronic lecithin organogels, polyethylene glycol- or petrolatum-based ointments, oil-in-water versus water-in-oil creams, lotions, and pastes.
15) How does the active pharmaceutical ingredient (API) factor into the classification approach?
The classification recognizes that APIs may be fully dissolved, partially dissolved, or suspended, and may reside in one or multiple phases of the semisolid system.
16) Why is the container-closure system included in the scope?
Packaging is included because it can contribute to or trigger failure modes, such as evaporation or water loss, interactions with container materials, or changes caused by repeated use.
17) What kinds of measurable attributes are considered in the project?
The project considers a comprehensive set of potentially measurable attributes, spanning sensory, physicochemical, microstructural, and macroscopic properties.
18) What are examples of sensory and physicochemical attributes mentioned?
Examples include opacity, smoothness, odor, color, consistency, water content, osmolality, and pH.
19) What are examples of microstructural (molecular-level) attributes mentioned?
Examples include phase state and relative phase proportions, globule size and distribution in emulsions, particle size and distribution of suspended or crystallized drug, polymorphic form of the drug substance, and other structural features that may control release and delivery.
20) What are examples of macroscopic attributes mentioned?
Examples include rheology (flow and viscoelastic behavior), density, and homogeneity, which can affect application, dose uniformity, and robustness during shipping and storage.
21) Does FDA treat all measurable attributes as equally important?
No. A key point is that not everything measurable is necessarily critical. The work aims to separate "nice to know" attributes from attributes that truly influence performance, stability, or patient use.
22) What does the project aim to do with failure modes and critical quality attributes?
The project aims to link failure modes to variations in critical quality attributes and then trace those variations back to controllable variables in formulation, manufacturing, and stability conditions.
23) What is an example of a cause-and-effect chain the project wants to map?
The announcement provides an example: cream homogenization speed can affect globule size, and that could alter therapeutic performance. The project aims to map similar chains across multiple semisolid classes.
24) How will the research determine which attributes are truly critical?
The plan includes systematic studies where formulation or manufacturing conditions are deliberately altered to shift specific quality attributes, followed by performance testing to see which changes actually matter.
25) What performance testing approaches are mentioned?
Performance evaluation may use discriminating in vitro release testing (IVRT), including approaches described in USP <1724>. In some situations, in vitro permeation testing (IVPT) using human skin may be used. The opportunity also allows other methods capable of evaluating relative bioavailability.
26) Does the opportunity require a single performance method for all products?
No. The description acknowledges that different product types and different failure concerns may require different tools, including IVRT, IVPT, or other approaches to evaluate relative bioavailability.
27) How is the work organized (study phases)?
The work is organized into four phases: (1) describe potentially measurable physical and chemical qualities across semisolid dosage forms aligned with components, microstructures, and plausible failure modes; (2) identify or develop methods to measure those attributes for each semisolid class; (3) characterize how formulation and manufacturing variables influence measured attributes within each class; and (4) use in vitro and/or in vivo performance measures to determine which attributes are critical to therapeutic performance and which are associated with specific failure modes.
28) What is the activity category for this opportunity?
The activity category is health science and technology and other research and development.
29) How many awards did FDA anticipate making?
FDA anticipated up to five awards.
30) What was the estimated total funding amount?
The estimated total funding was $1,250,000.
31) What was the expected award size per recipient?
Individual awards were expected to range from $150,000 to $250,000.
32) Was cost sharing or matching required?
No. There was no cost sharing or matching requirement.
33) When was the opportunity posted?
The opportunity was posted on March 31, 2014.
34) What were the application deadline dates, including the grace period?
The original closing date was June 2, 2014. A grace period extended the date to June 9, 2014 due to a Grants.gov technical issue affecting the University of Cincinnati.
35) Who was eligible to apply?
Eligibility was broad across many domestic organization types, including higher education institutions, nonprofits, for-profits other than small businesses, small businesses, and various government entities. Foreign institutions were also listed in the eligibility information.
36) What CFDA number is associated with this program?
The program falls under CFDA 93.103 (Food and Drug Administration).
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