Opportunity Information: Apply for RFA FD 16 018
Apply for RFA FD 16 018
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (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 $200,000.00 in funding.
- The number of recipients for this funding is limited to 3 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 grant opportunity, titled "Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01)" (Funding Opportunity Number RFA-FD-16-018), is a cooperative agreement offered by HHS-FDA focused on improving how bioequivalence (BE) studies handle unusual or unexpected data points, often called aberrant observations. In pharmacokinetic BE studies, a small number of atypical concentration or exposure measurements can disproportionately influence key statistical quantities, such as residual variability and within-subject variability for both the test and reference products. Because these variability estimates feed directly into BE analyses and decision-making, aberrant observations can shift confidence intervals, change conclusions about whether products are bioequivalent, and ultimately affect regulatory outcomes and product approval pathways.
The central purpose of the project is to evaluate and compare different quantitative methods used to identify or define aberrant observations across a variety of BE study design features. In practice, BE studies can differ in design (for example, crossover structures, replicate designs, and other design elements that affect how variability is estimated), and an approach that works well in one setting may perform poorly or create bias in another. This funding announcement is aimed at systematically studying how well various statistical or quantitative detection methods perform under these differing design conditions, with an emphasis on their ability to flag aberrant observations in a defensible, reproducible way while minimizing false positives or inappropriate data exclusions.
From a regulatory science standpoint, the work is intended to strengthen the scientific basis for interpreting BE study results when irregular observations appear. Better tools and clearer understanding can help regulators and researchers distinguish between data anomalies caused by measurement error, protocol deviations, sample handling issues, adherence problems, or genuine biological variability. The expected payoff is improved consistency and transparency in BE assessments, with the longer-term goal of supporting reliable decision-making around generic drug evaluation. The announcement also highlights practical value for industry: stronger, more validated approaches to detecting aberrant observations can help generic companies assess the quality and in vivo performance of proposed products and anticipate how outlying data might affect their BE conclusions.
Administratively, the opportunity is categorized as a discretionary grant using a cooperative agreement mechanism (U01), which typically implies substantial scientific involvement or collaboration from the funding agency compared with a standard research project grant. The activity category is listed under consumer protection, food and nutrition, and health, and the CFDA number is 93.103. The FDA anticipated making about three awards, with an award ceiling of $200,000. The opportunity was posted and created on April 1, 2016, with an application closing date of June 3, 2016.
Eligibility was broad and included many types of applicants, such as state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those specific categories); for-profit organizations (including those other than small businesses); small businesses; and other applicants as described in the additional eligibility text referenced in the announcement. This broad eligibility aligns with the applied, cross-sector nature of BE methodology work, which can involve academic statisticians, clinical pharmacology researchers, contract research organizations, and other stakeholders engaged in study design and analysis.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01)" and the Funding Opportunity Number is RFA-FD-16-018.
Which agency is offering this opportunity?
This is a cooperative agreement offered by HHS-FDA (U.S. Department of Health and Human Services, Food and Drug Administration).
What is the main purpose of this grant?
The central purpose is to evaluate and compare quantitative methods for identifying or defining aberrant observations in pharmacokinetic bioequivalence (BE) studies, and to understand how these methods perform under different BE study design features.
What are "aberrant observations" in the context of bioequivalence studies?
Aberrant observations are unusual or unexpected data points in BE studies, such as atypical concentration or exposure measurements, that can disproportionately influence statistical quantities used in BE analysis.
Why do aberrant observations matter for bioequivalence (BE) decisions?
A small number of atypical measurements can affect residual variability and within-subject variability estimates for test and reference products. Because these variability estimates feed into BE analyses, aberrant observations can shift confidence intervals and change conclusions about whether products are bioequivalent, which can affect regulatory outcomes and product approval pathways.
What types of BE study designs are relevant to this funding opportunity?
The opportunity references that BE studies can differ in design, including crossover structures and replicate designs, along with other design elements that influence how variability is estimated.
What does the project aim to compare across different study designs?
It aims to systematically study how well different statistical or quantitative detection methods perform under differing design conditions, focusing on defensible and reproducible identification of aberrant observations while minimizing false positives or inappropriate data exclusions.
What does "minimizing false positives" mean in this context?
It refers to reducing the likelihood that a detection method incorrectly flags normal observations as aberrant, which could lead to unjustified exclusions or biased results.
How is this work expected to help regulatory science?
The work is intended to strengthen the scientific basis for interpreting BE study results when irregular observations appear, improving consistency and transparency in BE assessments and supporting reliable decision-making in generic drug evaluation.
What kinds of causes of irregular observations does the announcement mention?
It notes that irregular observations may stem from measurement error, protocol deviations, sample handling issues, adherence problems, or genuine biological variability.
How could the results be useful to industry?
More validated approaches to detecting aberrant observations can help generic companies assess the quality and in vivo performance of proposed products and anticipate how outlying data might affect BE conclusions.
What type of funding mechanism is used for this opportunity?
The mechanism is a cooperative agreement (U01), categorized as a discretionary grant.
What does a U01 cooperative agreement imply compared with a standard research grant?
It typically implies substantial scientific involvement or collaboration from the funding agency compared with a standard research project grant.
What is the activity category listed for this grant?
The activity category is listed under consumer protection, food and nutrition, and health.
What is the CFDA number for this opportunity?
The CFDA number is 93.103.
How many awards did FDA anticipate making?
FDA anticipated making about three awards.
What is the award ceiling for this opportunity?
The award ceiling is $200,000.
When was this funding opportunity posted and created?
It was posted and created on April 1, 2016.
What was the application closing date?
The application closing date was June 3, 2016.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those specific categories); for-profit organizations (including those other than small businesses); small businesses; and other applicants as described in the additional eligibility text referenced in the announcement.
Why is eligibility described as broad for this opportunity?
The announcement links broad eligibility to the applied, cross-sector nature of BE methodology work, which can involve academic statisticians, clinical pharmacology researchers, contract research organizations, and other stakeholders engaged in study design and analysis.
What is the main methodological focus of the work supported by this grant?
The main focus is on evaluating methods to identify aberrant observations and understanding their impact on BE statistical quantities (like residual and within-subject variability) and on BE conclusions.
What is the longer-term goal described in the announcement?
The longer-term goal is improved consistency and transparency in BE assessments, supporting reliable decision-making around generic drug evaluation.
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| Therapeutic Areas for Data Standards Development (U01) Apply for RFA FD 16 020 Funding Number: RFA FD 16 020 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $225,000 |
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| Integrating Supersaturation-precipitation Mechanisms in Mechanistic Oral Absorption Models for Predicting In- vivo Performance of Associated Formulations (U01) Apply for RFA FD 16 025 Funding Number: RFA FD 16 025 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $250,000 |
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