Opportunity Information: Apply for RFA FD 14 009
Apply for RFA FD 14 009
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Dissolution Methods for Suspension and Emulsion Ocular 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 Apr 1, 2014 and posted on Mar 31, 2014.
- Applicants must submit their applications by May 8, 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 $500,000.00 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: Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education State governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) City or township governments Special district governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- Foreign Recipients
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Opportunity Summary:
The FDA funding opportunity "Dissolution Methods for Suspension and Emulsion Ocular Drug Products" (RFA FD 14 009) focuses on improving how dissolution, or in vitro drug release, is measured for ophthalmic suspension and emulsion products. The underlying problem it is trying to solve is that, while generic ocular products are typically expected to match the reference listed drug (RLD) in inactive ingredients (Q1 sameness) and inactive ingredient concentrations (Q2 sameness), manufacturing differences can still change key physical and chemical properties of the dosage form. Those differences can affect how much drug becomes available at the eye (bioavailability). Because direct clinical bioequivalence studies for ocular products can be difficult, expensive, and sometimes insensitive, the FDA is emphasizing dissolution testing as one of the practical, standardized tools that can reveal meaningful product differences and support bioequivalence evaluations for generics.
The scientific purpose of the project is to investigate, develop, and compare dissolution methods specifically suited to either an ocular suspension or an ocular emulsion, with the end goal of identifying an approach that can reliably discriminate between formulations made under different manufacturing conditions. In other words, the project is not simply asking applicants to run a single release test. It is asking them to build multiple Q1/Q2-equivalent formulations, intentionally vary manufacturing parameters, characterize how those variations change the product, and then determine which in vitro release method best detects those differences in a robust and scientifically defensible way. The deliverable the FDA is implicitly aiming for is evidence that supports future regulatory recommendations on dissolution testing as part of bioequivalence demonstrations for generic ophthalmic suspensions and emulsions.
Applicants are instructed to pick one dosage form category for their application: either a suspension or an emulsion. The FDA planned separate awards so that each dosage form receives focused attention, since suspensions and emulsions can behave very differently in terms of particle or droplet behavior, viscosity, phase behavior, and how drug partitions and releases into a receiving medium. The announcement also notes that formulations with semisolid properties fall under a related funding opportunity (RFA FD 14 008), signaling that the FDA is dividing ocular products into practical categories to avoid forcing one testing paradigm onto fundamentally different material types.
The work described in the objectives follows a clear progression. First, the investigator should select a reference product, which can be either a marketed product or an investigational formulation, and then create multiple test formulations that are Q1/Q2 the same as that reference but manufactured under different conditions. Those manufacturing differences might include variations in mixing or homogenization intensity and time, order of addition, temperature profiles, milling approaches, or other processing factors that can shift critical quality attributes. Next, the project requires physicochemical characterization of the resulting formulations to identify attributes that may influence ocular bioavailability. While the solicitation does not list specific tests, it strongly implies characterization of properties such as particle size distribution for suspensions, droplet size distribution for emulsions, viscosity or rheology, drug content uniformity, polymorphic form or crystallinity for suspended drug, zeta potential, phase stability, and any other measurable features that link manufacturing to performance.
Second, before starting lab dissolution experiments, the investigator is expected to perform a structured review of existing dissolution or in vitro release methods used for suspension and emulsion drug products. This is meant to be more than a literature summary. The FDA wants a comparative analysis that lays out practical advantages and disadvantages of each method and evaluates each method against three criteria that matter for regulatory use: whether it can detect manufacturing differences, whether it has any ability to predict in vivo performance (or at least align with physiological release conditions), and whether it is robust (repeatable, reproducible, not overly sensitive to minor operational changes). Only after that evaluation should the investigator select test formulations for the dissolution study, with an emphasis on those showing the largest and most meaningful physicochemical differences that are expected to affect bioavailability.
Third, the investigator must conduct dissolution studies using various in vitro release methods and then identify a method that can discriminate among the formulations. The method development is expected to consider both product properties and the physiological release environment, which for ocular products involves small fluid volumes, tear turnover, ocular surface residence time, and other constraints that can make traditional dissolution setups less representative. The project then requires an end-of-study analysis of the dissolution methods actually used, again documenting pros and cons and specifically judging their ability to detect manufacturing differences, their potential relevance to in vivo performance, and their robustness. The core output is, therefore, not just dissolution curves, but a reasoned recommendation for which approach (or approaches) best serves regulatory decision-making for bioequivalence assessment in these product types.
From an administrative standpoint, this was a discretionary funding opportunity using a cooperative agreement mechanism, meaning the FDA anticipated substantial involvement during the project rather than a hands-off grant. The posting dates were March 31 to April 1, 2014, with an original and current closing date of May 8, 2014, and an archive date of June 7, 2014. The solicitation states a total estimated funding amount of $500,000, with an award ceiling of $250,000 and floor of $200,000. It also indicates no cost sharing or matching requirement. While one section of the text mentions two awards (one for a suspension and one for an emulsion), the source data lists expected awards as five; the practical takeaway is that the FDA intended to support multiple related projects but ensure that both dosage form categories (suspension and emulsion) were covered by at least one funded award each.
Eligibility was broad and included many domestic applicant types such as higher education institutions (public and private), nonprofits (including those with and without 501(c)(3) status), small businesses, other for-profit organizations, and multiple levels of government and tribal entities. The listing also explicitly allowed foreign recipients, which is notable for FDA opportunities and suggests the agency was prioritizing scientific capability and method development expertise wherever it could be found. The program fell under CFDA 93.103 (FDA research). A grants management contact was provided for applicants who could not access the full announcement electronically.
Overall, the opportunity is best understood as targeted regulatory science. It aims to produce practical, validated knowledge about which dissolution or in vitro release approaches can meaningfully distinguish Q1/Q2-equivalent ophthalmic suspensions or emulsions made with different manufacturing processes, and to translate those findings into future FDA recommendations that help the generic drug program assess bioequivalence for complex ocular dosage forms.
Frequently Asked Questions (FAQs)
What is the name and identifier of this FDA funding opportunity?
The funding opportunity is titled "Dissolution Methods for Suspension and Emulsion Ocular Drug Products" and is identified as RFA FD 14 009.
What problem is the FDA trying to solve with this project?
The FDA is trying to improve how dissolution (in vitro drug release) is measured for ophthalmic suspension and emulsion products. Even when a generic product matches the reference listed drug (RLD) in inactive ingredients (Q1 sameness) and inactive ingredient concentrations (Q2 sameness), manufacturing differences can change physical and chemical properties of the dosage form. Those changes can affect how much drug becomes available at the eye (bioavailability). Because clinical bioequivalence studies for ocular products can be difficult, expensive, and sometimes not sensitive enough, dissolution testing is being emphasized as a practical, standardized tool to detect meaningful product differences and support bioequivalence evaluations.
What is the main scientific purpose of the project?
The purpose is to investigate, develop, and compare dissolution methods specifically suited to either an ocular suspension or an ocular emulsion, and to identify an approach that can reliably discriminate between Q1/Q2-equivalent formulations made under different manufacturing conditions.
Is the FDA asking for a single dissolution test or something broader?
It is broader than running a single release test. Applicants are expected to build multiple Q1/Q2-equivalent formulations, intentionally vary manufacturing parameters, characterize the resulting products, and then determine which in vitro release method best detects differences in a robust and scientifically defensible way.
What deliverable is the FDA implicitly aiming for?
The implicit deliverable is evidence that can support future FDA regulatory recommendations on dissolution testing as part of bioequivalence demonstrations for generic ophthalmic suspensions and emulsions.
Do applicants have to study both suspensions and emulsions?
No. Applicants are instructed to pick one dosage form category for their application: either a suspension or an emulsion. The FDA planned separate awards so each category receives focused attention because suspensions and emulsions can behave very differently.
Why does the opportunity separate suspensions and emulsions?
Suspensions and emulsions can differ substantially in particle or droplet behavior, viscosity, phase behavior, and how drug partitions and releases into a receiving medium. The FDA designed the opportunity so method development is tailored to each dosage form rather than forcing a single testing paradigm across fundamentally different material types.
Are semisolid ophthalmic formulations included?
No. The announcement notes that formulations with semisolid properties fall under a related funding opportunity (RFA FD 14 008), indicating semisolids are being handled separately.
What are the major project steps or progression described in the objectives?
The objectives follow a progression: (1) select a reference product and prepare multiple Q1/Q2-equivalent formulations manufactured under different conditions, (2) perform physicochemical characterization to identify attributes that may influence ocular bioavailability, (3) conduct a structured comparative review of existing dissolution/in vitro release methods and evaluate them against key criteria, (4) select formulations showing the largest meaningful differences for dissolution study, (5) conduct dissolution studies using various methods and identify a discriminating method, and (6) complete an end-of-study analysis documenting pros/cons and judging each method for discrimination, in vivo relevance, and robustness.
What can be used as the reference product?
The reference product can be either a marketed product or an investigational formulation.
What does Q1 and Q2 sameness mean in the context of this opportunity?
Q1 sameness refers to matching the inactive ingredients, and Q2 sameness refers to matching the inactive ingredient concentrations, relative to the reference product. The opportunity highlights that Q1/Q2 sameness does not guarantee identical performance if manufacturing differences alter key product attributes.
What kinds of manufacturing differences does the opportunity expect applicants to vary?
The opportunity gives examples such as variations in mixing or homogenization intensity and time, order of addition, temperature profiles, milling approaches, and other processing factors that can shift critical quality attributes.
What kinds of physicochemical characterization are implied?
While specific tests are not listed as mandatory in the text provided, it strongly implies characterization of attributes such as particle size distribution (for suspensions), droplet size distribution (for emulsions), viscosity or rheology, drug content uniformity, polymorphic form or crystallinity (for suspended drug), zeta potential, phase stability, and other measurable features linking manufacturing to performance.
Is a literature review required before conducting dissolution experiments?
Yes. Before starting lab dissolution experiments, the investigator is expected to perform a structured review of existing dissolution or in vitro release methods used for suspension and emulsion drug products.
What does the FDA mean by a "structured" review in this context?
It is intended to be more than a summary of the literature. The review should compare methods, describe practical advantages and disadvantages, and evaluate each method against regulatory-relevant criteria: ability to detect manufacturing differences, ability to predict in vivo performance (or align with physiological release conditions), and robustness (repeatability and reproducibility, without undue sensitivity to minor operational changes).
How should formulations be selected for the dissolution study?
After the method review and characterization work, the investigator should select test formulations for dissolution studies with an emphasis on those showing the largest and most meaningful physicochemical differences expected to affect bioavailability.
What is the role of ocular physiology in method development?
The method development is expected to consider the physiological release environment for ocular products, including small fluid volumes, tear turnover, ocular surface residence time, and other constraints that can make traditional dissolution setups less representative.
What are the key criteria the FDA wants dissolution methods judged against?
The opportunity highlights three main criteria: (1) whether the method can detect manufacturing differences (discriminatory power), (2) whether it can predict in vivo performance or at least align with physiological release conditions (relevance), and (3) whether it is robust (repeatable, reproducible, and not overly sensitive to minor operational changes).
What is the core output expected at the end of the project?
The core output is not just dissolution curves. It is a reasoned recommendation for which dissolution or in vitro release approach (or approaches) best supports regulatory decision-making for bioequivalence assessment of ophthalmic suspensions or emulsions, including documented pros/cons and performance against the key criteria.
What funding mechanism is used for this opportunity?
This was a discretionary funding opportunity using a cooperative agreement mechanism, meaning the FDA anticipated substantial involvement during the project rather than a hands-off grant.
When was the opportunity posted and when did it close?
The posting dates were March 31 to April 1, 2014. The original and current closing date was May 8, 2014. The archive date was June 7, 2014.
How much funding was available and what were the award limits?
The total estimated funding amount was $500,000. The award ceiling was $250,000 and the award floor was $200,000.
Is cost sharing or matching required?
No. The solicitation indicates there was no cost sharing or matching requirement.
How many awards did the FDA expect to make?
The text contains mixed signals. One section mentions two awards (one focused on a suspension and one on an emulsion), while the source data lists expected awards as five. The practical takeaway provided is that the FDA intended to support multiple related projects while ensuring both dosage form categories were covered by at least one award each.
Who was eligible to apply?
Eligibility was broad. It included many domestic applicant types such as public and private higher education institutions, nonprofits (with and without 501(c)(3) status), small businesses, other for-profit organizations, and multiple levels of government and tribal entities.
Were foreign applicants allowed?
Yes. The listing explicitly allowed foreign recipients, which is notable for FDA opportunities and suggests the agency prioritized scientific capability and method development expertise regardless of location.
What CFDA program number is associated with this opportunity?
The opportunity fell under CFDA 93.103 (FDA research).
What should applicants do if they cannot access the full announcement electronically?
A grants management contact was provided for applicants who could not access the full announcement electronically.
How should this opportunity be understood in the broader context of FDA work?
It is targeted regulatory science aimed at generating practical, validated knowledge about which dissolution or in vitro release methods can meaningfully distinguish Q1/Q2-equivalent ophthalmic suspensions or emulsions made with different manufacturing processes, with the intent to translate findings into future FDA recommendations supporting generic drug bioequivalence assessments.
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