Opportunity Information: Apply for RFA FD 13 029
Apply for RFA FD 13 029
- The Food Drug Administration in the business and commerce education sector is offering a public funding opportunity titled "In vitro In vivo Correlations of Ocular Implants" 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 3, 2013 and posted on Apr 18, 2013.
- Applicants must submit their applications by Jun 3, 2013. (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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: County governments City or township governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments State governments Private institutions of higher education Small businesses For profit organizations other than small businesses 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 Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education.
- Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For Profit Organizations Small Businesses For Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith based or Community based Organizations Regional Organizations Non domestic (non U.S.) Entities (Foreign Institutions) Foreign Institutions 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.
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Opportunity Summary:
The grant opportunity titled "In vitro In vivo Correlations of Ocular Implants" (Funding Opportunity Number RFA FD 13 029) is an FDA research initiative focused on improving how ophthalmic intravitreal implants are evaluated, especially when companies seek approval for generic versions. The central problem this project is trying to solve is that, for intravitreal implants placed inside the eye, there are not well established or widely accepted bioequivalence methods that reliably show whether a generic implant performs the same way as a reference product. Because these implants release drug over time directly into ocular tissues, traditional approaches used for tablets or systemic drugs often do not translate well. The FDA is looking for research that can connect what happens in the lab (in vitro drug release testing) to what happens in living systems (in vivo ocular absorption and release), so that future bioequivalence recommendations for generic intravitreal implants can be based on stronger scientific evidence.
At the heart of the project is the development or evaluation of an in vitro dissolution or release test that meaningfully correlates with in vivo performance. In practical terms, the FDA is asking applicants to investigate a laboratory-based dissolution or release method for intravitreal implants and determine whether the release profile measured in vitro can predict ocular exposure or absorption observed in vivo. If a credible relationship can be demonstrated, it can help regulators and developers rely more on well designed bench testing to infer in vivo behavior, potentially reducing uncertainty and improving consistency in generic drug development. This is particularly important for long acting ocular implants, where measuring drug levels in humans can be difficult, invasive, or impractical, and where small differences in release kinetics might have large implications for efficacy or safety.
The opportunity explicitly expects that in vivo studies be conducted in an appropriate animal model. That means proposals should not stop at bench testing; they should include an animal study component capable of measuring ocular pharmacokinetics or drug distribution over time in a way that can be compared back to the in vitro release data. The intent is to generate an in vitro in vivo correlation (IVIVC) framework specifically tailored to intravitreal implants, which behave differently from many other dosage forms because of the unique anatomy, fluid turnover, and barriers of the eye. The resulting data would help clarify the relationship between in vitro release rate and in vivo release or absorption patterns in ocular tissues, supporting a more science based pathway to determine whether two implant products are likely to be therapeutically equivalent.
From an administrative standpoint, this is a discretionary funding opportunity issued by the Food and Drug Administration under CFDA number 93.103 (FDA Research). The award mechanism is a cooperative agreement, which generally indicates substantial involvement by the funding agency during the project, such as scientific collaboration, coordination, or ongoing input on study direction. The announcement lists an expected number of awards of one, with an estimated total funding amount of $500,000 and an award ceiling of $500,000 (with a listed award floor of $5,000). There is no cost sharing or matching requirement stated, so applicants are not required to contribute additional non-federal funds as a condition of receiving the award.
Eligibility is broad and includes many categories of applicants across academia, government, nonprofit, and industry. Eligible applicants include public and private institutions of higher education, including groups that are specifically encouraged to apply for FDA support such as Hispanic Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs. Nonprofits with or without 501(c)(3) status are eligible, as are small businesses and other for profit organizations. Multiple levels of government can apply, including state, county, city or township, special district governments, and tribal governments or tribal organizations (both federally recognized and other than federally recognized). The announcement also notes eligibility for foreign institutions and non U.S. entities, including non domestic components of U.S. organizations, which suggests the FDA is open to global expertise where it supports the research goals.
Key dates in the source information indicate the opportunity was posted on April 18, 2013, with the original closing date listed as June 1, 2013 and a current closing date of June 3, 2013. The agency contact provided for access or administrative issues is Jennerfer Torres Hernandez, a Grants Management Specialist at the FDA, with a phone number (301 827 9607) and email address (Jennerfer.Torres Hernandez@fda.hhs.gov). An additional information link references the NIH Guide for Grants and Contracts as a resource for the full announcement.
Overall, the project is aimed at generating practical, regulator-relevant evidence that links laboratory dissolution or release testing to real ocular drug exposure for intravitreal implants. If successful, the work would help establish more reliable ways to assess and compare implant performance, filling a recognized gap in bioequivalence methodology for generic ophthalmic implants and helping the FDA craft clearer study recommendations for future generic intravitreal implant applications.
FAQs: In vitro In vivo Correlations of Ocular Implants (RFA FD 13 029)
What is the title and funding opportunity number for this grant?
The grant opportunity is titled "In vitro In vivo Correlations of Ocular Implants" and the Funding Opportunity Number is RFA FD 13 029.
Which federal agency is offering this opportunity?
This is a discretionary research funding opportunity issued by the U.S. Food and Drug Administration (FDA).
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.103 (FDA Research).
What problem is the FDA trying to solve with this research project?
The FDA is addressing the lack of well established, widely accepted bioequivalence methods for ophthalmic intravitreal implants. Because these implants release drug over time directly into ocular tissues, traditional bioequivalence approaches used for tablets or other systemic drugs often do not translate well. This creates uncertainty when companies seek approval for generic versions of intravitreal implant products.
What is the main goal of the research?
The main goal is to develop or evaluate an in vitro dissolution or release test for intravitreal implants that meaningfully correlates with in vivo performance. The FDA is seeking evidence that the in vitro release profile can predict ocular exposure or absorption observed in vivo, supporting an intravitreal implant-specific in vitro-in vivo correlation (IVIVC) framework.
What does "in vitro-in vivo correlation (IVIVC)" mean in the context of this opportunity?
In this context, IVIVC refers to a scientifically credible relationship between laboratory-based drug release testing (in vitro dissolution or release) and what happens in living systems (in vivo ocular absorption, exposure, or release in ocular tissues). The objective is to connect bench measurements to in vivo ocular pharmacokinetics or drug distribution over time for intravitreal implants.
What types of products are the focus of this funding opportunity?
The focus is on ophthalmic intravitreal implants placed inside the eye, including long-acting ocular implants where drug is released over time directly into ocular tissues.
Why are traditional bioequivalence methods not sufficient for intravitreal implants?
Intravitreal implants behave differently than many other dosage forms due to the unique anatomy, fluid turnover, and barriers of the eye. Additionally, measuring drug levels in humans can be difficult, invasive, or impractical for these products, and small differences in release kinetics may significantly affect efficacy or safety.
What kind of research approach is the FDA expecting from applicants?
The FDA expects applicants to investigate a laboratory-based dissolution or release method for intravitreal implants and determine whether the in vitro release profile can predict in vivo ocular exposure or absorption. Proposals are expected to go beyond bench testing and include in vivo studies that can be compared back to the in vitro data.
Are in vivo studies required?
Yes. The opportunity explicitly expects that in vivo studies be conducted in an appropriate animal model. Proposals should not stop at bench testing and should include an animal study component capable of measuring ocular pharmacokinetics or drug distribution over time for comparison to the in vitro release data.
What is meant by an "appropriate animal model" in this announcement?
The announcement states that in vivo studies should be conducted in an appropriate animal model, meaning a model that can support measurement of ocular pharmacokinetics or drug distribution over time in a way that can be compared to the in vitro release measurements. The specific model is not defined in the provided information.
What are the expected outcomes or intended impact of the project?
The intended outcome is regulator-relevant evidence linking in vitro dissolution or release testing to real ocular drug exposure for intravitreal implants. If a credible relationship is demonstrated, it could support stronger, science-based bioequivalence recommendations and improve consistency and reduce uncertainty in generic intravitreal implant development.
How could this research affect generic intravitreal implant development?
If an in vitro method can be shown to predict in vivo performance, regulators and developers may be able to rely more on well designed bench testing to infer in vivo behavior. This could help fill a recognized gap in bioequivalence methodology for generic ophthalmic implants and support clearer FDA study recommendations for future generic applications.
What is the award mechanism for this funding opportunity?
The award mechanism is a cooperative agreement.
What does a cooperative agreement imply for applicants and awardees?
A cooperative agreement generally indicates substantial involvement by the funding agency during the project. The provided information notes that this can include scientific collaboration, coordination, or ongoing input from the FDA on study direction.
How many awards does the FDA expect to make?
The announcement lists an expected number of awards of one.
What is the estimated total funding amount?
The estimated total funding amount is $500,000.
What is the maximum award amount (award ceiling)?
The award ceiling is $500,000.
Is there a minimum award amount (award floor)?
Yes. The listed award floor is $5,000.
Is cost sharing or matching required?
No. The provided information states there is no cost sharing or matching requirement, meaning applicants are not required to contribute additional non-federal funds as a condition of receiving the award.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses; other for profit organizations; and multiple levels of government including state, county, city or township, special district governments, and tribal governments or tribal organizations (both federally recognized and other than federally recognized).
Are minority serving institutions specifically encouraged or included in eligibility?
Yes. The eligibility information includes institutions specifically encouraged to apply for FDA support, including Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.
Are foreign institutions or non-U.S. entities eligible?
Yes. The announcement notes eligibility for foreign institutions and non-U.S. entities, including non-domestic components of U.S. organizations, indicating the FDA is open to global expertise where it supports the research goals.
What are the key posted and closing dates listed?
The opportunity was posted on April 18, 2013. The original closing date is listed as June 1, 2013, and the current closing date is June 3, 2013.
Where can applicants find additional information about the full announcement?
An additional information link references the NIH Guide for Grants and Contracts as a resource for the full announcement.
Who is the agency contact for this opportunity?
The agency contact listed is Jennerfer Torres Hernandez, Grants Management Specialist at the FDA.
What contact information is provided for the agency contact?
The phone number provided is (301) 827-9607 and the email address provided is Jennerfer.Torres Hernandez@fda.hhs.gov.
Is this opportunity specifically tied to generic intravitreal implants?
Yes. The research focus is framed around improving evaluation methods for intravitreal implants, especially when companies seek approval for generic versions, by strengthening the scientific basis for bioequivalence recommendations.
Does the opportunity specify a particular in vitro release or dissolution method to use?
No specific method is mandated in the provided information. The FDA is asking applicants to investigate a laboratory-based dissolution or release method and evaluate whether it correlates with in vivo ocular performance.
What kinds of in vivo measurements are implied by the opportunity?
The opportunity indicates that in vivo studies should be capable of measuring ocular pharmacokinetics or drug distribution over time in a way that can be compared to the in vitro release data.
Why is this work considered regulator-relevant?
The project is described as producing practical, regulator-relevant evidence that can inform future FDA bioequivalence recommendations for generic intravitreal implants by clarifying how in vitro release rate relates to in vivo release or absorption patterns in ocular tissues.
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