Opportunity Information: Apply for RFA FD 21 012
This grant opportunity, titled "Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional" (RFA-FD-21-012), is a cooperative agreement funding program from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It focuses on advancing physiologically based pharmacokinetic (PBPK) modeling specifically for oral drug absorption, with the practical goal of simulating what traditional in vivo bioequivalence (BE) studies would show, but under a range of conditions that may be difficult, expensive, or time-consuming to test through human pharmacokinetic studies.
At the core of the opportunity is the idea that PBPK models can combine multiple sources of information into a mechanistic, physiology-driven simulation framework. That includes product-specific factors (such as formulation attributes and drug release behavior), human physiological factors (including gastrointestinal conditions that influence dissolution and absorption), and population variability (differences across individuals that affect exposure). By integrating these pieces, oral PBPK models can simulate drug absorption and systemic disposition and, in some cases, reduce the need for certain in vivo studies while still supporting sound scientific and regulatory decisions. The FDA highlights PBPK modeling as a promising tool for generic drug development because BE is a central requirement for approving generics, and simulation approaches can help address questions about when and how BE might change across patient groups, dosing conditions, or formulation scenarios.
The specific purpose of the solicitation is to expand the application of oral PBPK models to "emerging issues" in the generic drug space by enabling the simulation of bioequivalence studies under various conditions. In practice, this signals interest in research that strengthens the credibility, applicability, and regulatory usefulness of oral PBPK absorption models. Projects responsive to this type of announcement typically aim to improve model structure and parameterization, demonstrate robust validation strategies, and show how simulations can reliably predict BE outcomes across relevant scenarios (for example, different dosing conditions, physiological states, or sources of variability that could alter absorption). Because the mechanism is a U01 cooperative agreement, awardees should expect substantial involvement from the FDA in the scientific direction of the work compared with a standard research grant, with an emphasis on deliverables and regulatory relevance.
The program is categorized under research and development connected to consumer protection, food and nutrition, and science and technology, and it is associated with CFDA number 93.103. The funding opportunity was posted on January 7, 2021, and originally closed on March 15, 2021, indicating it was a time-limited call rather than an always-open solicitation. The award ceiling is listed at $600,000, and the FDA expected to make 2 awards, suggesting a relatively selective competition designed to fund a small number of focused, high-impact projects that can move the field forward in ways that are directly useful for generic drug evaluation.
Eligibility is broad and includes many types of U.S. organizations and governmental entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities; nonprofits both with and without 501(c)(3) status (excluding higher education institutions where specified); for-profit organizations other than small businesses; small businesses; and other entities as described in the full eligibility text. This broad eligibility reflects the multidisciplinary nature of PBPK work, which often involves collaboration among academia, industry, and specialized modeling groups.
Finally, the "Clinical Trials Optional" designation indicates that applicants were not required to include a clinical trial to be responsive, but could propose clinical data collection if it was scientifically justified and necessary for model development, calibration, or validation. Overall, the opportunity is aimed at generating practical modeling advances that help simulate and interpret bioequivalence for oral generic drugs, with the long-term intent of supporting efficient generic development and strengthening the scientific basis for FDA regulatory decision making.Apply for RFA FD 21 012
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jan 07, 2021.
- Applicants must submit their applications by Mar 15, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $600,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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