Opportunity Information: Apply for RFA FD 16 028
Apply for RFA FD 16 028
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Bioequivalence of Topical Products: Comparing Dermal Pharmacokinetics by Microdialysis or Microperfusion Techniques (U01)" 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 Apr 01, 2016 and posted on Apr 01, 2016.
- Applicants must submit their applications by Jun 03, 2016. (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 $500,000.00 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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Opportunity Summary:
The Bioequivalence of Topical Products: Comparing Dermal Pharmacokinetics by Microdialysis or Microperfusion Techniques (U01) funding opportunity (RFA-FD-16-028) was issued by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA) to push forward practical, science-based ways to evaluate whether topical drug products deliver drug into the skin in a comparable manner. The central focus is dermal pharmacokinetics: directly measuring how much of a topically applied drug becomes available within the dermis over time, close to where many topical drugs are intended to act. Rather than relying only on indirect clinical outcomes or systemic blood levels (which may be low or not informative for topical products), this opportunity emphasizes methods that sample the skin compartment itself to capture drug exposure at the site of action.
The project goal is research and development that improves microdialysis or open flow microperfusion techniques for topical bioequivalence assessment. These are specialized sampling approaches that can measure local drug concentrations in skin tissue fluids. The intent is not just to run a study, but to refine and validate the underlying method, the study designs used with it, and the analytical approaches used to interpret the resulting data. The FDA is looking for a final approach that is accurate (measures what it should measure), sensitive (can detect relevant concentration changes), and reproducible (gives consistent results across runs, sites, and conditions). In other words, the funded work is expected to produce a dependable framework that can quantify the amount of drug present in the dermis over time, which is the core information needed to compare two topical products on rate and extent of dermal availability.
This opportunity used a cooperative agreement mechanism (U01), meaning the FDA anticipated substantial scientific or programmatic involvement during the project compared to a standard grant. The activity category aligns with health and consumer protection, and it is associated with CFDA number 93.103. The solicitation was posted on April 1, 2016, with an application closing date of June 3, 2016.
Funding details indicate an award ceiling of $500,000, with an expectation of making about two awards. Eligibility was broad and included many common applicant types: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of universities); for-profit organizations (including those other than small businesses); small businesses; and other applicants as described in the additional eligibility language of the full announcement. Overall, the opportunity was structured to attract a mix of academic, government, nonprofit, and industry capabilities, reflecting the technical and translational nature of building robust bioequivalence tools for topical drug products.
In practical terms, the funded research was meant to strengthen how dermal drug exposure is measured and compared, so that regulators and developers have better, more direct evidence when determining whether a generic topical product is equivalent to a reference product. By improving microdialysis and/or microperfusion-based dermal pharmacokinetic methods, the work would support more reliable evaluations of topical bioequivalence, potentially reducing uncertainty and improving efficiency in the development and review of topical medications.
FAQs: Bioequivalence of Topical Products (U01) - RFA-FD-16-028
What is the name of this funding opportunity?
The opportunity is titled "The Bioequivalence of Topical Products: Comparing Dermal Pharmacokinetics by Microdialysis or Microperfusion Techniques (U01)" and is identified as RFA-FD-16-028.
Which agency issued this opportunity?
It was issued by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA).
What is the main purpose of this grant?
The main purpose is to advance practical, science-based methods to evaluate whether topical drug products deliver drug into the skin in a comparable manner, with a central focus on dermal pharmacokinetics.
What does "dermal pharmacokinetics" mean in the context of this opportunity?
Here, dermal pharmacokinetics refers to directly measuring how much of a topically applied drug becomes available within the dermis over time, near where many topical drugs are intended to act.
Why does this opportunity emphasize measuring drug levels in the skin rather than in blood?
Because for topical products, systemic blood levels may be low or not informative, and indirect clinical outcomes may not directly reflect drug exposure at the site of action. This opportunity emphasizes sampling the skin compartment itself to capture local drug exposure.
What specific techniques are the focus of the funded research?
The focus is on improving microdialysis and/or open flow microperfusion techniques for topical bioequivalence assessment.
What do microdialysis and open flow microperfusion do?
They are specialized sampling approaches intended to measure local drug concentrations in skin tissue fluids, enabling estimation of dermal drug exposure over time.
Is the goal simply to conduct a single study using these techniques?
No. The intent is to refine and validate the underlying method, the study designs used with it, and the analytical approaches used to interpret the resulting data, aiming for a dependable framework rather than just a one-off experiment.
What qualities does FDA want in the final approach produced by the project?
The funded work is expected to yield an approach that is accurate (measures what it should measure), sensitive (detects relevant concentration changes), and reproducible (consistent across runs, sites, and conditions).
What kind of data is the approach expected to generate for bioequivalence comparisons?
The approach is expected to quantify the amount of drug present in the dermis over time, which supports comparison of two topical products on the rate and extent of dermal availability.
How does this work support topical generic drug development and review?
By strengthening how dermal drug exposure is measured and compared, the research supports more direct evidence for determining whether a generic topical product is equivalent to a reference product, potentially reducing uncertainty and improving efficiency in development and regulatory review.
What funding mechanism is used (and what does it imply)?
The opportunity uses a cooperative agreement mechanism (U01), which means FDA anticipated substantial scientific or programmatic involvement during the project compared to a standard grant.
What is the activity category associated with this opportunity?
The activity category aligns with health and consumer protection.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
When was the solicitation posted?
The solicitation was posted on April 1, 2016.
What was the application closing date?
The application closing date was June 3, 2016.
What was the maximum award amount?
The award ceiling was $500,000.
How many awards were expected to be made?
About two awards were expected.
Who was eligible to apply?
Eligibility was broad and included: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of universities); for-profit organizations (including those other than small businesses); small businesses; and other applicants as described in the additional eligibility language of the full announcement.
Was the opportunity intended for academia only, or could industry and other organizations apply?
It was structured to attract a mix of academic, government, nonprofit, and industry capabilities, reflecting the technical and translational nature of building robust topical bioequivalence tools.
What is the central scientific outcome FDA is looking for from the funded work?
A dependable, validated framework using microdialysis and/or microperfusion-based dermal pharmacokinetic methods to measure and compare drug exposure in the dermis over time for topical bioequivalence assessment.
Does the opportunity specify that the method should work across different settings?
Yes. Reproducibility is specifically emphasized, including consistency across runs, sites, and conditions.
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