Opportunity Information: Apply for RFA FD 15 007
Apply for RFA FD 15 007
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Dissolution Methods for Long acting Periodontal Drug Products (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 Feb 17, 2015 and posted on Feb 17, 2015.
- Applicants must submit their applications by Apr 27, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $125,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts 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 Private institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses State governments Special district governments County governments City or township governments Small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than 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:
The grant opportunity "Dissolution Methods for Long acting Periodontal Drug Products (U01)" (Funding Opportunity Number RFA-FD-15-007) is a cooperative agreement program run by the U.S. Food and Drug Administration (FDA) to address a specific scientific gap affecting development and approval of generic long-acting periodontal drug products. The core problem the FDA is trying to solve is that, for several types of sustained-release products designed for delivery into periodontal pockets, there are not enough standardized (compendial) or clinically meaningful (biorelevant) in vitro drug release tests. Without reliable dissolution or release methods that reflect how these products behave in the mouth, it becomes difficult to consistently evaluate product performance and, importantly, to determine whether a proposed generic product is bioequivalent to a reference listed drug.
The opportunity focuses on long-acting periodontal dosage forms such as biodegradable microspheres, in situ forming implants, and matrix tablets. These dosage forms are intended to release drug over extended periods in a challenging local environment, where factors like limited fluid volume, variable pH, enzymatic activity, inflammation, and mechanical stresses can influence release behavior. Traditional dissolution methods that work well for immediate-release tablets or even many extended-release oral products may not translate to periodontal systems, which is why the FDA is emphasizing development of a biorelevant dissolution method tailored to at least one long-acting periodontal dosage form. Alongside method development, the project is expected to identify the key physicochemical attributes of the product that drive dissolution or release behavior and, by extension, could influence local exposure and bioavailability. In practical terms, this means connecting formulation and material properties (for example, polymer type and molecular weight, drug loading, particle size or implant geometry, porosity, crystallinity, degradation rate, and drug-polymer interactions) to the observed release profile under conditions meant to mimic periodontal use.
A major intended outcome is regulatory impact. The FDA is seeking results that will help it build scientific recommendations for evaluating bioequivalence of generic long-acting periodontal drug products. Because bioequivalence decisions for complex locally acting products can be especially sensitive to the quality of in vitro tools, the agency is signaling that better dissolution methods and clearer understanding of critical attributes will support more consistent, evidence-based guidance. Ultimately, the work is meant to reduce uncertainty for both regulators and developers by enabling tests that are reproducible, discriminating (able to detect meaningful formulation or process differences), and more predictive of in vivo performance than existing approaches.
From an administrative standpoint, this was a discretionary funding opportunity using a cooperative agreement mechanism (U01), which generally means substantial FDA scientific involvement is expected during the project compared to a standard grant. The activity category is listed under Consumer Protection, Food and Nutrition, and Health, with FDA CFDA number 93.103. The program anticipated up to two awards, with an estimated total funding level of $250,000 and an award ceiling of $125,000 per award. No cost sharing or matching was required. The opportunity was posted on February 17, 2015, and the application deadline (original and final) was April 27, 2015, with the listing archived May 27, 2015.
Eligibility was broad and included state and local governments, tribal governments (including federally recognized tribes), public and private institutions of higher education, nonprofit organizations (including those without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, among others. Importantly, foreign participation was allowed: non-U.S. entities were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by HHS policy were permitted. For applicants who needed the full announcement, the opportunity referenced an NIH Guide posting, and the listed grants management contact was Lisa Ko (lisa.ko@fda.hhs.gov).
Taken together, the opportunity is best understood as a targeted FDA research investment aimed at creating practical, scientifically grounded dissolution or release testing methods for complex, locally acting periodontal drug delivery systems, while also clarifying which material and formulation features most strongly control release and bioavailability. The expected payoff is improved FDA recommendations and a clearer pathway for demonstrating bioequivalence for generic versions of these long-acting periodontal therapies.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Dissolution Methods for Long acting Periodontal Drug Products (U01)" with Funding Opportunity Number RFA-FD-15-007.
Which federal agency runs this program?
This is a U.S. Food and Drug Administration (FDA) funding opportunity.
What grant mechanism is being used?
The program uses a cooperative agreement mechanism (U01), which typically involves substantial FDA scientific involvement during the project compared with a standard grant.
What is the main problem the FDA is trying to solve with this opportunity?
The FDA is addressing a scientific gap: for several sustained-release drug products designed for delivery into periodontal pockets, there are not enough standardized (compendial) or clinically meaningful (biorelevant) in vitro drug release tests. This makes it difficult to evaluate product performance consistently and to assess bioequivalence for proposed generic products.
Why are improved dissolution or release methods important for long-acting periodontal drug products?
Without reliable dissolution or release methods that reflect how these products behave in the mouth, it is hard to determine whether a generic product is bioequivalent to a reference listed drug. Better methods can reduce uncertainty for regulators and developers by enabling tests that are reproducible, discriminating, and more predictive of in vivo performance.
What types of dosage forms are included in the focus of this funding opportunity?
The opportunity focuses on long-acting periodontal dosage forms such as biodegradable microspheres, in situ forming implants, and matrix tablets intended for delivery into periodontal pockets.
What makes the periodontal environment challenging for dissolution or release testing?
The periodontal pocket is a challenging local environment where factors such as limited fluid volume, variable pH, enzymatic activity, inflammation, and mechanical stresses can influence drug release behavior.
Why might traditional dissolution methods not work well for these products?
Traditional dissolution methods that work for immediate-release tablets (and many extended-release oral products) may not translate to locally acting periodontal systems because the use conditions and release drivers differ substantially in periodontal pockets.
What is the core scientific objective expected from the project?
The project is expected to develop a biorelevant dissolution (or release) method tailored to at least one long-acting periodontal dosage form.
Beyond method development, what else is the project expected to identify?
In addition to developing a method, the project is expected to identify key physicochemical attributes that drive dissolution or release behavior and could influence local exposure and bioavailability.
What kinds of physicochemical attributes are mentioned as potentially important?
Examples listed include polymer type and molecular weight, drug loading, particle size or implant geometry, porosity, crystallinity, degradation rate, and drug-polymer interactions.
What characteristics should the resulting dissolution/release test ideally have?
The FDA emphasizes methods that are reproducible, discriminating (able to detect meaningful formulation or process differences), and more predictive of in vivo performance than existing approaches.
How is this work intended to impact FDA regulation and generic drug development?
A major intended outcome is regulatory impact: the results are expected to help FDA build scientific recommendations for evaluating bioequivalence of generic long-acting periodontal drug products and support more consistent, evidence-based guidance.
How many awards were anticipated and what was the total estimated funding?
The program anticipated up to two awards, with an estimated total funding level of $250,000.
What was the maximum award amount per recipient?
The award ceiling was $125,000 per award.
Was cost sharing or matching required?
No cost sharing or matching was required.
When was the opportunity posted and what were the deadlines?
The opportunity was posted on February 17, 2015. The application deadline (original and final) was April 27, 2015. The listing was archived on May 27, 2015.
What is the CFDA number and program category listed for this opportunity?
The CFDA number is 93.103, and the activity category is listed under Consumer Protection, Food and Nutrition, and Health.
Who was eligible to apply?
Eligibility was broad and included state and local governments, tribal governments (including federally recognized tribes), public and private institutions of higher education, nonprofit organizations (including those without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and others.
Was foreign participation allowed?
Yes. Non-U.S. entities were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by HHS policy) were permitted.
Where could applicants find the full announcement?
The opportunity referenced an NIH Guide posting for applicants who needed the full announcement.
Who was the listed grants management contact?
The listed grants management contact was Lisa Ko (lisa.ko@fda.hhs.gov).
What is the overall purpose of the FDA investment described in this opportunity?
The opportunity is a targeted FDA research investment to create practical, scientifically grounded dissolution or release testing methods for complex, locally acting periodontal drug delivery systems, while clarifying which material and formulation features control release and bioavailability. The intended payoff is improved FDA recommendations and a clearer pathway for demonstrating bioequivalence for generic versions of these therapies.
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