Opportunity Information: Apply for RFA FD 13 030
Apply for RFA FD 13 030
- The Food Drug Administration in the business and commerce education sector is offering a public funding opportunity titled "In vitro In vivo Correlations of Parenteral Microsphere 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 Jun 3, 2013 and posted on Apr 18, 2013.
- Applicants must submit their applications by Jun 4, 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: For profit organizations other than small businesses Private institutions of higher education County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Special district governments.
- 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:
This grant opportunity, Funding Opportunity Number RFA-FD-13-030 from the U.S. Food and Drug Administration (CFDA 93.103), supports a research project focused on building and evaluating in vitro-in vivo correlations (IVIVC) for parenteral (injectable) microsphere drug products. The central aim is to determine whether an in vitro dissolution or release test can be developed that meaningfully predicts what happens in vivo, specifically the absorption and resulting bioavailability of the drug after administration. The FDA is looking for work that improves scientific understanding of how microspheres release their payload over time and how lab-based performance tests might be used to anticipate real biological performance, which is critical for product development, regulatory evaluation, and ultimately ensuring consistent therapeutic outcomes.
The scope of the research is specific: the dosage form must be an injectable microsphere formulation, and the active ingredient encapsulated in the microspheres may be either a small molecule drug or a peptide. Applicants are expected to investigate an in vitro dissolution or release method and then link those in vitro results to in vivo behavior. That means designing a release test that is sensitive to the key formulation and process attributes that control release, and then performing in vivo studies in a suitable animal model to measure absorption over time. The project is intended to produce data and analysis that clarify microsphere release mechanisms (for example, the roles of diffusion, polymer degradation/erosion, pore formation, burst release, or microsphere size distribution) and to determine how well in vitro tests can serve as predictors of in vivo drug exposure.
The funding mechanism is a Cooperative Agreement, which typically indicates substantial federal involvement during the project, such as scientific coordination, input on study design, or collaboration on project milestones. The opportunity anticipated a single award, with an estimated total funding amount of $500,000. The award ceiling is $500,000 and the floor is $5,000, and there is no cost sharing or matching requirement. The funding activity categories listed include business and commerce and education, reflecting the applied, translational nature of IVIVC work and its relevance to product quality, manufacturing, and regulatory science.
Eligibility is broad and explicitly inclusive. Eligible applicants include small businesses and other for-profit organizations, nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, and multiple levels of government (state, county, city/township, special district), as well as tribal governments and tribal organizations. The FDA also encourages applications from a range of higher-education institution types, including Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs. Notably, foreign institutions and other non-U.S. entities are also eligible to apply, and non-domestic components of U.S. organizations may participate, which signals openness to the best available expertise and relevant models regardless of location.
Key dates associated with the announcement include a posted date of April 18, 2013, with an original closing date of June 1, 2013, and a current closing date listed as June 4, 2013. The announcement references the NIH Guide for Grants and Contracts as an additional information link, which is commonly used as a hosting and dissemination platform for federal biomedical and regulatory science funding notices.
From a deliverables standpoint, the FDA is essentially seeking evidence-based methods that can connect in vitro release testing to in vivo absorption for injectable microspheres. Strong projects under this call would be expected to generate rigorous dissolution/release profiles, high-quality in vivo pharmacokinetic (and possibly pharmacodynamic) data in an appropriate animal model, and robust modeling approaches that quantitatively relate the two. If successful, the outcome would help regulators and developers rely more confidently on in vitro tools to predict in vivo performance, potentially streamlining development, supporting post-approval changes, improving batch-to-batch comparability, and reducing uncertainty around bioavailability for this complex class of long-acting injectable products.
For administrative or access issues related to the full announcement, the listed contact is Jennerfer Torres Hernandez, Grants Management Specialist at the FDA, reachable by phone at 301-827-9607 or by email at Jennerfer.Torres-Hernandez@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the funding opportunity number for this grant?
The funding opportunity number is RFA-FD-13-030.
Which federal agency is offering this grant?
This opportunity is offered 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.
What is the main purpose of this grant opportunity?
The project focuses on building and evaluating in vitro-in vivo correlations (IVIVC) for parenteral (injectable) microsphere drug products. The goal is to determine whether an in vitro dissolution or release test can meaningfully predict in vivo behavior, particularly drug absorption and resulting bioavailability after administration.
What dosage forms are in scope for this research?
The scope is specific to injectable microsphere formulations (parenteral microsphere drug products).
What types of active ingredients are allowed in the microspheres?
The active ingredient encapsulated in the microspheres may be either a small molecule drug or a peptide.
What does the FDA want applicants to do in this project?
Applicants are expected to (1) investigate an in vitro dissolution or release method, (2) design the method so it is sensitive to key formulation and process attributes that control release, and (3) link in vitro results to in vivo behavior by conducting in vivo studies in a suitable animal model to measure absorption over time.
What kinds of in vivo studies are expected?
The opportunity calls for in vivo studies in an appropriate animal model to measure absorption over time, supporting evaluation of how in vitro release relates to in vivo exposure/bioavailability.
What kinds of mechanisms or factors might the project examine regarding microsphere drug release?
The project is intended to generate data and analysis clarifying microsphere release mechanisms and contributing factors such as diffusion, polymer degradation/erosion, pore formation, burst release, and microsphere size distribution.
What is meant by IVIVC in this context?
Here, IVIVC refers to a quantitative or meaningful relationship between an in vitro dissolution/release test (what happens in the lab) and the in vivo absorption/bioavailability profile (what happens in a living system after administration), for injectable microsphere products.
Why is the FDA interested in IVIVC for injectable microspheres?
Because reliable in vitro tools that predict in vivo performance can support product development and regulatory evaluation, improve confidence in product quality and consistent therapeutic outcomes, and potentially help with comparability and changes by reducing uncertainty around bioavailability for long-acting injectable microsphere products.
What funding mechanism is being used for this award?
The funding mechanism is a Cooperative Agreement.
What does a Cooperative Agreement imply for the project?
A Cooperative Agreement typically indicates substantial federal involvement during the project, such as scientific coordination, input on study design, or collaboration on project milestones.
How many awards are anticipated under this opportunity?
The announcement anticipates a single award.
What is the estimated total funding amount?
The estimated total funding amount is $500,000.
What are the award ceiling and award floor?
The award ceiling is $500,000 and the award floor is $5,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What funding activity categories are listed for this opportunity?
The listed funding activity categories include business and commerce and education, reflecting the applied and translational nature of the work and its relevance to manufacturing, product quality, and regulatory science.
Who is eligible to apply?
Eligibility is broad and includes small businesses and other for-profit organizations; nonprofit organizations (with or without 501(c)(3) status); public and private institutions of higher education; state, county, city/township, and special district governments; tribal governments and tribal organizations.
Are foreign institutions eligible to apply?
Yes. Foreign institutions and other non-U.S. entities are explicitly eligible to apply.
Can non-domestic components of U.S. organizations participate?
Yes. The opportunity states that non-domestic components of U.S. organizations may participate.
Does the FDA encourage applications from specific types of higher education institutions?
Yes. The FDA encourages applications from a range of institution types, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs.
When was this opportunity posted?
The posted date is April 18, 2013.
What were the original and current closing dates listed?
The original closing date was June 1, 2013, and the current closing date listed is June 4, 2013.
Where is additional information referenced for this announcement?
The announcement references the NIH Guide for Grants and Contracts as an additional information link.
What types of deliverables or outputs is the FDA seeking?
Based on the description, expected outputs include rigorous in vitro dissolution/release profiles, high-quality in vivo absorption (pharmacokinetic) data in a suitable animal model, and robust modeling approaches that quantitatively relate in vitro release to in vivo exposure for injectable microsphere products.
Who is the listed contact for administrative or access issues?
The listed contact is Jennerfer Torres Hernandez, Grants Management Specialist at the FDA.
How can the contact person be reached?
Phone: 301-827-9607. Email: Jennerfer.Torres-Hernandez@fda.hhs.gov.
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