Opportunity Information: Apply for RFA FD 11 016
Apply for RFA FD 11 016
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Advancing Regulatory Science through Novel Biomarker Research and Science Based Technologies" 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 5, 2011 and posted on May 3, 2011.
- Applicants must submit their applications by Jun 16, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- The number of recipients for this funding is limited to 20 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education.
- PLEASE NOTE The synopsis is being revised to reflect a change in eligibility requirements as follows The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FDC 21 U.S.C. 360bbb 5. Higher Education Institutions as defined in Section 101 of the Higher Education Act of 1965(or a consortium of such institutions). An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Critical Path Public Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public Private Partnership project will not be influenced by and source of funding.
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Opportunity Summary:
The grant opportunity "Advancing Regulatory Science through Novel Biomarker Research and Science Based Technologies" (Funding Opportunity Number RFA-FD-11-016) is an FDA cooperative agreement program built around the agency's Advancing Regulatory Science Initiative and the Critical Path Initiative. Through the Office of Critical Path Programs (OCPP), the FDA is looking to fund projects that strengthen the science used to evaluate medical and veterinary products, with a specific emphasis on biomarkers that can make product development and regulatory decision-making faster, more reliable, and more informative. The core idea is to support practical, science-driven work that helps translate emerging technologies into tools regulators and product developers can use to better predict safety, toxicity, and effectiveness, ultimately improving patient outcomes and getting useful products to patients sooner.
The focus of the announcement is on developing new biomarkers (and biomarker-enabling technologies) for well-defined human or veterinary diseases and for toxicity assessment, especially in areas where there is a clear unmet need. The FDA is specifically interested in applications that propose novel technologies and approaches rather than incremental improvements, and that can credibly argue their biomarker(s) show substantial promise to either speed development and evaluation of products or improve how effectiveness and safety are assessed in real-world healthcare. In other words, the most responsive projects are likely to be those that connect biomarker discovery or development to a clear regulatory science use case, such as improving preclinical-to-clinical translation, strengthening endpoints, identifying toxicity earlier, stratifying patients, or supporting more efficient trial designs or evaluation methods.
This program is offered as a discretionary funding opportunity using the cooperative agreement mechanism, which generally implies a more collaborative relationship with the FDA than a standard grant. Awards were expected to total about 20, with an estimated total funding amount of $1,000,000. Individual awards were projected to fall between an award floor of $250,000 and a ceiling of $350,000. There is no cost sharing or matching requirement noted in the synopsis. The funding activity category is Health, Science and Technology, and other Research and Development, and the CFDA number associated with the opportunity is 93.103 (Food and Drug Administration).
Eligibility is presented with some nuance because the synopsis notes it was revised to reflect changes. The listed eligible applicants include 501(c)(3) nonprofit organizations other than institutions of higher education, as well as private institutions of higher education, but the eligibility language also points to Section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-5), which governs entities eligible to enter partnerships with the FDA. It further highlights higher education institutions as defined in Section 101 of the Higher Education Act of 1965 (or consortia of such institutions). A key condition is a conflict-of-interest style assurance: an eligible organization entering a collaborative agreement must assure it will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes FDA-regulated products, unless the agreement with FDA includes assurances that the project results will not be influenced by the funding source. This requirement is essentially about protecting scientific independence and credibility for work intended to inform regulatory science.
Timeline-wise, the opportunity was posted on May 3, 2011, with an original and current closing date of June 16, 2011, and an archive date of July 16, 2011. The full announcement was referenced as being available via the NIH Guide (published April 28, 2011). For administrative or access issues, the contact listed is Gladys Bohler, Grants Management Officer/Specialist, at 301-827-7175, with an FDA work email referenced in the synopsis.
Overall, this FOA is best understood as targeted support for biomarker-centered regulatory science: projects that can deliver or mature biomarkers and related technologies into credible tools for assessing disease and toxicity, reducing uncertainty in development, and enabling the FDA's Critical Path mission to facilitate the development of safe and effective human and veterinary products for diagnosing, treating, and preventing disease.
Frequently Asked Questions (FAQs)
What is the name and funding opportunity number for this grant?
The opportunity is titled "Advancing Regulatory Science through Novel Biomarker Research and Science Based Technologies" and the Funding Opportunity Number is RFA-FD-11-016.
Which federal agency is offering this opportunity?
This is an FDA funding opportunity administered through the Office of Critical Path Programs (OCPP) and aligned with the FDA's Advancing Regulatory Science Initiative and the Critical Path Initiative.
What is the main purpose of this program?
The program is designed to support practical, science-driven projects that strengthen the evidence and tools used to evaluate medical and veterinary products. A major emphasis is on developing biomarkers and biomarker-enabling technologies that can make product development and regulatory decision-making faster, more reliable, and more informative.
What kinds of projects is the FDA looking to fund?
The FDA is looking for projects focused on developing new biomarkers (and technologies that enable biomarkers) for well-defined human or veterinary diseases and for toxicity assessment, especially where there is a clear unmet need.
Are incremental biomarker improvements responsive to this announcement?
The announcement emphasizes interest in novel technologies and approaches rather than incremental improvements. Projects are expected to make a credible case for substantial promise, such as speeding product development/evaluation or improving real-world assessment of safety and effectiveness.
What makes an application "most responsive" to this FOA?
The most responsive projects are likely to connect biomarker discovery or development to a clear regulatory science use case. Examples described in the synopsis include improving preclinical-to-clinical translation, strengthening endpoints, identifying toxicity earlier, stratifying patients, or supporting more efficient trial designs or evaluation methods.
Does this opportunity cover both human and veterinary product-related research?
Yes. The synopsis explicitly references strengthening the science used to evaluate both medical (human) and veterinary products, including biomarker work tied to human or veterinary diseases as well as toxicity assessment.
What is the funding mechanism for this program?
The FDA is using a cooperative agreement mechanism. This generally implies a more collaborative relationship with the FDA than a standard grant mechanism.
Is this a discretionary funding opportunity?
Yes. The synopsis describes it as a discretionary funding opportunity.
How many awards were expected under this program?
Around 20 awards were expected, based on the synopsis.
What was the estimated total funding amount available?
The estimated total program funding amount was $1,000,000.
What is the expected funding range for an individual award?
Individual awards were projected to fall between an award floor of $250,000 and a ceiling of $350,000.
Is cost sharing or matching required?
No cost sharing or matching requirement is noted in the synopsis.
What are the activity categories for this funding opportunity?
The funding activity categories listed are Health; Science and Technology and other Research and Development.
What CFDA number is associated with this opportunity?
The CFDA number associated with the opportunity is 93.103 (Food and Drug Administration).
Who is eligible to apply?
The synopsis lists eligibility categories that include 501(c)(3) nonprofit organizations other than institutions of higher education, as well as private institutions of higher education. It also references Section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-5) regarding entities eligible to enter partnerships with the FDA, and highlights higher education institutions as defined in Section 101 of the Higher Education Act of 1965 (or consortia of such institutions).
Are higher education consortia mentioned as eligible?
Yes. The synopsis highlights higher education institutions (as defined in Section 101 of the Higher Education Act of 1965) and notes consortia of such institutions.
Is there a conflict-of-interest or independence requirement tied to funding sources?
Yes. A key condition described is that an eligible organization entering a collaborative agreement must assure it will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes FDA-regulated products, unless the FDA agreement includes assurances that the project results will not be influenced by the funding source. The stated intent is to protect scientific independence and credibility for work intended to inform regulatory science.
What is the scientific emphasis of the program?
The scientific emphasis is on biomarkers and biomarker-enabling technologies that can be translated into credible tools to better predict safety, toxicity, and effectiveness, and that can reduce uncertainty in development and evaluation of regulated products.
What outcomes is the FDA trying to enable through these awards?
The synopsis frames desired outcomes as improving patient outcomes and helping useful products reach patients sooner by enabling better prediction and evaluation of safety, toxicity, and effectiveness, and by strengthening the science that supports regulatory decision-making.
When was this opportunity posted and what were the key dates?
The opportunity was posted on May 3, 2011. The original and current closing date was June 16, 2011. The archive date was July 16, 2011.
Where was the full announcement referenced as being available?
The synopsis references that the full announcement was available via the NIH Guide (published April 28, 2011).
Who is the contact for administrative or access issues?
The contact listed is Gladys Bohler, Grants Management Officer/Specialist. The synopsis provides the phone number 301-827-7175 and references an FDA work email address.
What is the overall theme of the FOA in plain terms?
The FOA is targeted support for biomarker-centered regulatory science: maturing biomarkers and related technologies into practical tools for assessing disease and toxicity, strengthening development decisions, and supporting the FDA Critical Path mission to facilitate development of safe and effective products for diagnosing, treating, and preventing disease.
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