Opportunity Information: Apply for RFA FD 15 006
Apply for RFA FD 15 006
- 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 Levonorgestrel Intrauterine System (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 $125,000.00 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 1 candidate(s).
- Eligible applicants include: Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments Public and State controlled institutions of higher education Small businesses 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) Native American tribal governments (Federally recognized) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments City or township governments State governments.
- 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. See more at http://grants.nih.gov/grants/guide/rfa files/RFA FD 15 006.html#sthash.60X4gtYR.dpuf
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Opportunity Summary:
The grant opportunity titled "Dissolution Methods for Long acting Levonorgestrel Intrauterine System (U01)" (Funding Opportunity Number RFA FD 15 006) is a Food and Drug Administration research initiative focused on improving how long-acting levonorgestrel intrauterine systems (IUS), specifically those intended for a 5-year duration of use, are evaluated in the lab for drug release performance. The core problem the announcement highlights is that there is not currently a strong set of compendial (standards-based) or biorelevant (clinically meaningful) in vitro drug release tests for these types of long-acting contraceptive devices. Because these products release drug slowly over years and are physically complex drug-device combinations, standard dissolution approaches used for tablets or capsules often do not translate well, which creates challenges for consistent quality evaluation and for comparing brand and generic versions.
The main objective of the funded study is to investigate and develop dissolution or in vitro release methods for a levonorgestrel IUS under both real-time and accelerated testing conditions. Real-time testing is meant to mirror how the device releases drug over extended periods, while accelerated conditions are designed to speed up release in a controlled way so performance can be assessed more quickly without losing the ability to distinguish meaningful differences. The project is expected to examine whether these methods can do three things that are central to regulatory science: first, detect manufacturing differences (for example, variations in materials, drug loading, polymer properties, device geometry, or processing conditions that might shift the release rate); second, help predict in vivo performance (how the product behaves in the body), which is crucial for confidence that the lab test is clinically relevant; and third, demonstrate method robustness, meaning the test produces reliable, reproducible results across reasonable variations in conditions, operators, instruments, and labs.
A key intended outcome is regulatory impact: the FDA indicates that results from this study will support development of recommendations for determining bioequivalence for generic intrauterine systems. Bioequivalence, in this context, is about showing that a generic product performs similarly enough to a reference product that it can be relied on to deliver the same therapeutic effect and safety profile. For long-acting drug-device products like an IUS, it can be particularly difficult to rely on traditional pharmacokinetic studies alone, and well-designed in vitro release methods can become an important part of the evidence package used to compare products. By improving dissolution testing approaches, the agency is aiming to strengthen the scientific basis for assessing product sameness and performance, which can ultimately support development and approval pathways for generics.
In terms of administrative details, this opportunity was offered as a cooperative agreement (U01), which generally means the FDA anticipates substantial involvement during the project, such as scientific coordination, input on study design, or collaboration on deliverables. The activity category is listed under consumer protection, food and nutrition, and health, reflecting the FDA public health mission. The opportunity anticipated a single award (Expected Awards: 1) with an estimated total funding amount of $125,000 and an award ceiling of $125,000. It did not require cost sharing or matching. The posting and creation date were February 17, 2015, with an original and current closing date of April 27, 2015, and an archive date of May 27, 2015.
Eligibility was broad and included many types of domestic applicants such as state and local governments, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including entities other than small businesses as well as small businesses), school districts, housing authorities, and tribal governments and organizations. Importantly, the announcement also stated that non-U.S. entities were eligible to apply, including foreign institutions, non-U.S. components of U.S. organizations, and other foreign components as defined by HHS grants policy, meaning the FDA was open to international expertise where it could advance the research goals.
The administering agency was the Food and Drug Administration, with the program indexed under CFDA 93.103 (Food and Drug Administration Research). The announcement referenced the NIH Guide for Grants and Contracts as the place to access the full solicitation text (RFA FD 15 006). For access issues related to the full announcement, the listed grants management contact was Lisa Ko, Grants Management Specialist, at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Dissolution Methods for Long acting Levonorgestrel Intrauterine System (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA FD 15 006.
Which agency is offering this grant?
The administering agency is the U.S. Food and Drug Administration (FDA).
What type of award mechanism is used?
This opportunity was offered as a cooperative agreement (U01), which typically means the FDA expects to have substantial involvement during the project (for example, scientific coordination, input on study design, and collaboration on deliverables).
What is the main purpose of the project?
The main objective is to investigate and develop dissolution or in vitro drug release methods for a levonorgestrel intrauterine system (IUS) under both real-time and accelerated testing conditions.
What product type is this research focused on?
The research is focused on long-acting levonorgestrel intrauterine systems (IUS), specifically those intended for a 5-year duration of use.
Why is FDA funding research on dissolution or in vitro release methods for levonorgestrel IUS?
The announcement highlights that there is not currently a strong set of compendial (standards-based) or biorelevant (clinically meaningful) in vitro drug release tests for these long-acting contraceptive drug-device combination products. Standard dissolution approaches commonly used for tablets or capsules often do not translate well to devices that release drug slowly over years and have complex physical designs.
What is meant by "real-time" testing in this project?
Real-time testing is intended to mirror how the IUS releases drug over extended periods, aligning the laboratory evaluation with the product's long-duration release behavior.
What is meant by "accelerated" testing in this project?
Accelerated testing refers to conditions designed to speed up drug release in a controlled way so performance can be assessed more quickly, while still maintaining the ability to detect meaningful differences between products.
What key capabilities should the proposed methods be able to demonstrate?
The project is expected to examine whether the methods can: (1) detect manufacturing differences that may shift the release rate; (2) help predict in vivo performance (behavior in the body) to support clinical relevance; and (3) demonstrate robustness by producing reliable, reproducible results across reasonable variations in conditions, operators, instruments, and laboratories.
What kinds of manufacturing differences is the study expected to detect?
Examples listed include variations in materials, drug loading, polymer properties, device geometry, or processing conditions that could change the drug release rate.
What does "biorelevant" mean in the context of this funding announcement?
In this announcement, "biorelevant" refers to in vitro release tests that are clinically meaningful, meaning the laboratory results can help relate to (or help predict) how the product performs in vivo.
What does "compendial" mean in the context of this funding announcement?
"Compendial" refers to standards-based test methods, such as methods that could align with established public standards used for consistent quality evaluation.
How is this research expected to impact FDA regulatory decision-making?
A key intended outcome is regulatory impact: results are expected to support development of FDA recommendations for determining bioequivalence for generic intrauterine systems.
How does improved in vitro release testing relate to bioequivalence for generic IUS products?
Bioequivalence here means demonstrating that a generic product performs similarly enough to a reference product to deliver the same therapeutic effect and safety profile. For long-acting drug-device products like an IUS, the announcement notes that it can be difficult to rely on traditional pharmacokinetic studies alone, so well-designed in vitro release methods can be an important part of the evidence used to compare products.
How many awards were expected under this opportunity?
The opportunity anticipated a single award (Expected Awards: 1).
What was the estimated total funding available?
The estimated total funding amount was $125,000.
What was the award ceiling?
The award ceiling was $125,000.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What was the posting date for the opportunity?
The posting and creation date was February 17, 2015.
What was the application closing date?
The original and current closing date listed was April 27, 2015.
When was the opportunity archived?
The archive date was May 27, 2015.
What broad topic or mission area does this opportunity fall under?
The activity category was listed under consumer protection, food and nutrition, and health, consistent with the FDA public health mission.
What is the CFDA number associated with this program?
The program was indexed under CFDA 93.103 (Food and Drug Administration Research).
Who was eligible to apply?
Eligibility was broad and included many types of domestic applicants, including state and local governments, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses and other-than-small businesses), school districts, housing authorities, and tribal governments and organizations.
Were non-U.S. or international applicants eligible?
Yes. The announcement stated that non-U.S. entities were eligible to apply, including foreign institutions, non-U.S. components of U.S. organizations, and other foreign components as defined by HHS grants policy.
Where could applicants find the full solicitation text?
The announcement referenced the NIH Guide for Grants and Contracts as the place to access the full solicitation text for RFA FD 15 006.
Who was the grants management contact for access issues related to the full announcement?
The listed grants management contact was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
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