Opportunity Information: Apply for RFA FD 12 020
Apply for RFA FD 12 020
- The Food Drug Administration in the health sector is offering a public funding opportunity titled "Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (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 May 4, 2012 and posted on Apr 27, 2012.
- Applicants must submit their applications by Jun 22, 2012. (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 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 For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Private institutions of higher education Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Independent school districts Small businesses State governments City or township 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The FDA grant opportunity "Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)" (Funding Opportunity Number RFA-FD-12-020) is a discretionary research program intended to improve scientific understanding of how the measurable physical and chemical characteristics of ophthalmic dosage forms influence how much drug actually becomes available in the eye after topical administration. The project focuses specifically on ophthalmic suspensions and emulsions, two common formulation types used in eye drops because they are practical for topical use and can help deliver drugs that are poorly soluble or otherwise challenging to formulate as simple solutions.
A central motivation behind the announcement is that two products can contain the same active ingredient and the same inactive ingredients at the same concentrations, yet still behave differently in the eye because manufacturing differences can change the formulation's physicochemical profile. Those differences can affect key processes like how quickly the product is cleared from the ocular surface, how the drug distributes through ocular tissues, and how the drug is released from the formulation. Because these factors ultimately shape ocular exposure, they also matter for assessing whether a generic product is truly equivalent in performance to a reference listed drug.
The funded study is expected to investigate a defined set of physicochemical properties that the FDA highlights as particularly relevant to ocular bioavailability for suspensions and emulsions. These include globule or particle size distribution (which influences surface area, dissolution or release rates, and potential residence behavior), surface charge (which can affect interactions with ocular mucus and epithelial surfaces as well as stability), osmolality (important for comfort, reflex tearing, and therefore dilution and clearance), pH (which can influence drug ionization, stability, tolerability, and permeability), viscosity (which affects drop behavior and ocular residence time), and dispersibility (which relates to how uniformly the formulation re-suspends or maintains dose uniformity during use). In practical terms, the project is aimed at linking variations in these parameters to measurable changes in ocular drug availability and performance, building a clearer cause-and-effect picture rather than treating formulation attributes as isolated quality metrics.
Another major theme of the announcement is the acknowledged gap in appropriate bioequivalence approaches for many generic ophthalmic products, especially for suspensions and emulsions where conventional pharmacokinetic sampling in blood may not reflect local ocular exposure and where direct tissue sampling is difficult. The FDA is seeking research that can support better bioequivalence methodologies or recommendations by clarifying which physicochemical properties are most predictive of ocular bioavailability and therefore most critical to match between a generic and its reference product. The anticipated output is the kind of evidence that can inform regulatory decision-making, such as identifying sensitive in vitro characterization tests, defining acceptable similarity ranges for key properties, and guiding when additional studies are needed to demonstrate equivalence.
In terms of award structure and funding, this opportunity is offered as a cooperative agreement (U01), which generally means the FDA expects to have substantial scientific or programmatic involvement during the project rather than acting only as a pass-through funder. The announcement anticipates a single award with an estimated total funding amount of $500,000, and an award ceiling of $500,000. There is no cost-sharing or matching requirement listed.
Eligibility is broad and includes many types of U.S. organizations and governments, such as public and private institutions of higher education, state and local governments, nonprofits (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), and small businesses, among others. Importantly, the opportunity also allows participation by non-U.S. entities and foreign components under HHS policy, meaning foreign institutions can apply and foreign components of U.S. organizations are permitted.
Key dates provided in the source information include a posted date of April 27, 2012, with the original closing date of May 31, 2012, later extended to a current closing date of June 22, 2012, and an archive date of July 22, 2012. The program is administered under the FDA and is associated with CFDA number 93.103. For administrative questions, the listed grants management contact is Lisa Ko (lisa.ko@fda.hhs.gov), and the full announcement is referenced as "Full Announcement RFA FD 12 020" in the NIH Guide for Grants and Contracts.
Frequently Asked Questions (FAQs)
What is the name of this FDA grant opportunity?
The opportunity is titled "Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)."
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-FD-12-020.
What type of funding mechanism is being used?
This opportunity is offered as a cooperative agreement (U01), which indicates FDA expects substantial scientific or programmatic involvement during the project.
What is the overall purpose of this research program?
The program is intended to improve scientific understanding of how measurable physical and chemical characteristics of ophthalmic dosage forms influence ocular bioavailability (how much drug becomes available in the eye) after topical administration.
Which dosage form types are the focus of the project?
The project focuses specifically on ophthalmic suspensions and ophthalmic emulsions.
Why does the FDA emphasize suspensions and emulsions for topical eye products?
Suspensions and emulsions are common formulation types used in eye drops because they are practical for topical use and can help deliver drugs that are poorly soluble or otherwise challenging to formulate as simple solutions.
Why can two products with the same ingredients still behave differently in the eye?
Even if two products contain the same active ingredient and the same inactive ingredients at the same concentrations, differences in manufacturing can change the formulation's physicochemical profile. Those changes can alter how the product behaves in the eye.
What kinds of in-eye processes can be affected by physicochemical differences?
The announcement highlights effects on processes such as how quickly the product is cleared from the ocular surface, how the drug distributes through ocular tissues, and how the drug is released from the formulation. These processes influence ocular exposure.
How does this research relate to generic ophthalmic products and bioequivalence?
The project is motivated in part by the need to assess whether a generic product is equivalent in performance to a reference listed drug, especially when formulation attributes can change ocular exposure even with similar ingredient lists.
What major scientific gap does the FDA describe for ophthalmic bioequivalence?
The announcement notes a gap in appropriate bioequivalence approaches for many generic ophthalmic products, particularly suspensions and emulsions, where blood pharmacokinetics may not reflect local ocular exposure and direct tissue sampling is difficult.
What is the study expected to do with physicochemical properties?
The funded study is expected to investigate a defined set of physicochemical properties highlighted by FDA as relevant to ocular bioavailability for suspensions and emulsions, and to link variations in those parameters to measurable changes in ocular drug availability and performance.
Which physicochemical properties does the FDA highlight as particularly relevant?
The opportunity highlights: globule or particle size distribution, surface charge, osmolality, pH, viscosity, and dispersibility.
Why is globule or particle size distribution important in this program?
The description states that size distribution influences surface area, dissolution or release rates, and potential residence behavior on the eye.
Why is surface charge included as a key property?
Surface charge can affect interactions with ocular mucus and epithelial surfaces, and it can also influence formulation stability.
Why does osmolality matter for ocular bioavailability?
Osmolality is described as important for comfort and reflex tearing, which can drive dilution and clearance of the product from the ocular surface.
Why is pH considered relevant for these ophthalmic formulations?
pH can influence drug ionization, stability, tolerability, and permeability, all of which can affect ocular exposure after topical dosing.
How does viscosity factor into ocular performance?
Viscosity affects drop behavior and ocular residence time, which can influence how long the drug remains available at the site of action.
What does dispersibility mean in the context of this grant?
Dispersibility relates to how uniformly a formulation re-suspends or maintains dose uniformity during use.
Is the goal only to measure these properties as quality metrics?
No. The stated aim is to build a clearer cause-and-effect understanding by linking changes in these properties to measurable changes in ocular drug availability and performance, rather than treating the attributes as isolated metrics.
What kinds of regulatory-relevant outputs does the FDA anticipate from the research?
The announcement anticipates evidence that can inform regulatory decision-making, such as identifying sensitive in vitro characterization tests, defining acceptable similarity ranges for key properties, and guiding when additional studies are needed to demonstrate equivalence.
How many awards does the FDA anticipate making under this announcement?
The announcement anticipates a single award.
What is the estimated total funding amount for this opportunity?
The estimated total funding amount is $500,000.
What is the award ceiling?
The award ceiling is $500,000.
Is cost-sharing or matching required?
No cost-sharing or matching requirement is listed.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. organizations and governments, such as public and private institutions of higher education, state and local governments, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), and small businesses, among others.
Are non-U.S. organizations allowed to apply?
Yes. The opportunity allows participation by non-U.S. entities and foreign components under HHS policy, meaning foreign institutions can apply and foreign components of U.S. organizations are permitted.
Which agency administers this grant?
The program is administered under the U.S. Food and Drug Administration (FDA).
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
When was the opportunity posted?
The posted date provided is April 27, 2012.
What was the original closing date, and was it extended?
The original closing date was May 31, 2012, and it was later extended.
What is the current closing date listed?
The current closing date listed is June 22, 2012.
When was the opportunity archived?
The archive date listed is July 22, 2012.
Where is the full announcement referenced?
The full announcement is referenced as "Full Announcement RFA FD 12 020" in the NIH Guide for Grants and Contracts.
Who is the listed grants management contact for administrative questions?
The listed grants management contact is Lisa Ko.
What is the contact email for administrative questions?
The contact email is lisa.ko@fda.hhs.gov.
Browse more opportunities from the same category: Health
Next opportunity: Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01)
Previous opportunity: Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 12 020
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 12 020) also looked into and applied for these:
| Funding Opportunity |
|---|
| Minority Fellowship Program Apply for SM 12 010 Funding Number: SM 12 010 Agency: Substance Abuse Mental Health Services Adminis. Category: Health Funding Amount: $825,000 |
| Increasing Adolescent Immunization Rates through Healthcare Provider Partnerships Apply for CDC RFA IP12 1202 Funding Number: CDC RFA IP12 1202 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $175,000 |
| Increasing Adult Immunization Rates through Healthcare Provider Partnerships Apply for CDC RFA IP12 1205 Funding Number: CDC RFA IP12 1205 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $175,000 |
| Mentored Career Award for Faculty at Institutions That Promote Diversity (K01) Apply for RFA HL 13 018 Funding Number: RFA HL 13 018 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Cooperative Agreement for a National Research and Training Organization for People with Developmental and Other Disabilities Apply for CDC RFA DD07 0030501SUPP12 Funding Number: CDC RFA DD07 0030501SUPP12 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: Case Dependent |
| Part B AIDS Drug Assistance Program (ADAP) Emergency Relief Awards Apply for HRSA 12 177 Funding Number: HRSA 12 177 Agency: Health Resources and Services Administration Category: Health Funding Amount: $7,000,000 |
| Rapid Assessment Post Impact of Disaster (R03) Apply for PAR 12 180 Funding Number: PAR 12 180 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Rapid Assessment Post Impact of Disaster (R21) Apply for PAR 12 181 Funding Number: PAR 12 181 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| National Spina Bifida Initiatives Prevention, Resources, and Quality of Life Apply for CDC RFA DD07 7090501SUPP12 Funding Number: CDC RFA DD07 7090501SUPP12 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: Case Dependent |
| Comprehensive District Based Support for Better HIV/TB Patient Outcomes Apply for RFA 674 12 000005 Funding Number: RFA 674 12 000005 Agency: South Africa USAID Pretoria Category: Health Funding Amount: $20,000,000 |
| T32 Training Program for Institutions That Promote Diversity (T32) Apply for RFA HL 13 021 Funding Number: RFA HL 13 021 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| FY12 Eliminating Lupus Health Disparities Initiative (ELHDI) Apply for MP CPI 12 001 Funding Number: MP CPI 12 001 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $1,000,000 |
| FY12 Youth Empowerment Program (YEP) Apply for MP YEP 12 001 Funding Number: MP YEP 12 001 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $300,000 |
| FY12 Peer to Peer Outreach Model to Curb HIV/AIDS Transmission Among High Risk Minority Youth and Adolescents (CHAT) Apply for MP HHP 12 001 Funding Number: MP HHP 12 001 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $250,000 |
| FY12 American Indian/Alaska Native Health Disparities Program Apply for MP AIA 12 001 Funding Number: MP AIA 12 001 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $250,000 |
| Health Finance and Governance Project (HFG) Apply for RFA OAA 12 000011 Funding Number: RFA OAA 12 000011 Agency: Agency for International Development Category: Health Funding Amount: $200,000,000 |
| HealthComm Capacity RFA Apply for SOL OAA 12 000017 Funding Number: SOL OAA 12 000017 Agency: Agency for International Development Category: Health Funding Amount: $99,000,000 |
| Service Delivery and Support for Families Caring For Orphans and Vulnerable Children (OVC) Apply for RFA 674 12 000006 Funding Number: RFA 674 12 000006 Agency: South Africa USAID Pretoria Category: Health Funding Amount: $20,000,000 |
| PPHF12 Viral Hepatitis National Education Provider, financed solely by 2012 Prevention and Public Health Funds Apply for CDC RFA PS08 8620501PPHF12 Funding Number: CDC RFA PS08 8620501PPHF12 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $250,000 |
| Achieving Universal Diagnosis and Appropriate Case Management for Malaria Apply for RFA OAA 12 000014 Funding Number: RFA OAA 12 000014 Agency: Agency for International Development Category: Health Funding Amount: $50,000,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 12 020", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.