Opportunity Information: Apply for RFA FD 11 026
Apply for RFA FD 11 026
- 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 Development of Innovative Methodologies in the area of Antimicrobial Development (U01)" 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 25, 2011 and posted on May 23, 2011.
- Applicants must submit their applications by Jul 2, 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 $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Higher Education institutions as defined in section 101 of the Higher Education Act of 1965 (or a consortium of such institutions). Nonprofits Other Than Institutions of Higher Education A nonprofit organization described in section 501(c)(3) of the Internal Revenue Code of 1986 which is exempt from tax under section 501(a) of that code. An eligible organization that wishes to enter into a colaborative 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 assurance in its agreement with the FDA that the results of the Critical Path Public Partnership project will not be influenced by any source of funding. The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FDC Act (21 U.S.C. 360bbb 5).
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Opportunity Summary:
This funding opportunity, titled "Advancing Regulatory Science Through Development of Innovative Methodologies in the area of Antimicrobial Development (U01)" (RFA-FD-11-026), is an FDA cooperative agreement focused on developing and testing new scientific methods that can improve how antimicrobial drugs are dosed and combined to slow or prevent the emergence of antimicrobial resistance. It sits within the FDA's broader Advancing Regulatory Science effort and is specifically tied to the Critical Path Initiative, which is meant to modernize and accelerate medical product development by creating better tools, standards, and evaluation approaches for FDA-regulated products. The central idea is that smarter, evidence-based approaches to dose selection and combination therapy can be built using modern pharmacokinetic and pharmacodynamic (PK/PD) science and innovative modeling systems, ultimately strengthening regulatory decision-making and improving real-world treatment outcomes.
The problem the FOA is responding to is the accelerating rise of antimicrobial resistance, including in drug classes that once seemed reliably effective, such as fluoroquinolones. The announcement notes that traditional approaches to controlling resistance have included limiting use of certain agents, tightening infection-control practices, and implementing antimicrobial stewardship programs. While these remain important, the FOA emphasizes growing evidence that treatment design itself can influence resistance: specifically, that combination therapy and/or high-dose, short-duration regimens may reduce the likelihood that resistant subpopulations survive and expand during therapy. From a PK/PD perspective, the FDA is pointing to the concept that higher effective drug exposure can be required to suppress resistance, and that exposure can be increased through higher doses, more frequent dosing, or altered administration methods such as extended infusion times. The FOA also highlights the established precedent for combination therapy in diseases like tuberculosis, H. pylori infection, HIV, and malaria, where multi-drug regimens are standard partly because they reduce treatment failure and resistance development.
A key motivation behind the program is the recognition that antibacterial development has often centered on demonstrating primary efficacy while giving comparatively less attention to resistance suppression as a core development goal. The FOA frames this as contributing to a legacy in which resistance eventually becomes widespread across most available agents. In response, the FDA is seeking research that directly investigates whether novel PK/PD-driven dosing strategies and rational antimicrobial combinations can reduce the emergence of resistance, and how such strategies can be evaluated using methods that are robust enough to inform development programs and, by extension, regulatory science.
Methodologically, the FOA signals interest in innovative experimental and modeling platforms that can help clarify the value of these approaches. One example explicitly mentioned is in vitro hollow fiber infection models, which can simulate human-like drug concentration-time profiles and allow investigators to study bacterial kill dynamics and resistance emergence under controlled, repeatable exposure conditions. More broadly, the emphasis is on developing or applying modeling systems and analytical methods that can link drug exposure to both efficacy and resistance outcomes, supporting better selection of dosing regimens and combination strategies.
In terms of pathogens and clinical context, the FOA places particular weight on Gram-negative bacteria that are commonly encountered in both healthcare settings and the community and are often treated with single-agent therapy, including infections such as uncomplicated urinary tract infections. The announcement lists organisms of concern including Escherichia coli, Klebsiella pneumoniae, Serratia species, Acinetobacter species, Proteus species, Pseudomonas aeruginosa, and Enterobacter species, noting that many of these show increasing resistance to multiple antimicrobial agents. The focus on these pathogens reflects both their public health impact and the challenge they pose for therapy selection, especially when resistance narrows treatment options.
Administratively, the mechanism is a U01 cooperative agreement, which generally indicates substantial programmatic involvement from the funding agency compared with a standard grant. The opportunity is categorized as discretionary, within health science and technology and other research and development. The FDA anticipated making about six awards, with an estimated total funding level of $500,000. Individual awards were expected to fall within a range of $50,000 to $100,000 (floor to ceiling). No cost sharing or matching was required.
Eligibility included higher education institutions as defined under the Higher Education Act (including consortia of such institutions) and nonprofit organizations with 501(c)(3) status (other than institutions of higher education). The FOA also includes an important assurance requirement for entities entering collaborative agreements under the Critical Path Public-Private Partnership framework: applicants must provide assurances related to independence from funding sources connected to manufacturers or distributors of FDA-regulated products, unless safeguards are in place to ensure that results are not influenced by funding. This reflects the FDA's attention to scientific integrity and conflict-of-interest risk in partnership-based regulatory science projects.
Key dates provided in the source information include a posted date of May 23, 2011, with an original and current closing date of July 2, 2011, and an archive date of August 1, 2011. The CFDA listing is 93.103 (Food and Drug Administration). For scientific or programmatic contact, the FOA corrects the project officer information and specifies Nancy Masiello as the project officer, reachable by telephone at 301-796-8498 and fax at 301-847-8614. For grants management support, the announcement lists Gladys Melendez, Grants Management Specialist, at 301-827-7168, with an FDA office email referenced in the source text.
Frequently Asked Questions (FAQs)
What is the title and number of this funding opportunity?
The opportunity is titled "Advancing Regulatory Science Through Development of Innovative Methodologies in the area of Antimicrobial Development (U01)" and is identified as RFA-FD-11-026.
Which agency is offering this opportunity?
This is an FDA (Food and Drug Administration) cooperative agreement funding opportunity.
What type of award mechanism is being used?
The mechanism is a U01 cooperative agreement. This typically means there is substantial programmatic involvement from the FDA compared with a standard grant mechanism.
What is the main purpose of the program?
The program supports the development and testing of innovative scientific methods to improve how antimicrobial drugs are dosed and combined, with the goal of slowing or preventing the emergence of antimicrobial resistance. A central emphasis is using modern PK/PD science and innovative modeling systems to strengthen evidence-based dose selection and combination therapy approaches.
How does this opportunity relate to FDA regulatory science priorities?
It sits within the FDA's broader Advancing Regulatory Science effort and is specifically tied to the Critical Path Initiative, which aims to modernize and accelerate medical product development by creating improved tools, standards, and evaluation approaches for FDA-regulated products.
What problem is this FOA trying to address?
The FOA responds to the accelerating rise of antimicrobial resistance, including resistance in drug classes that have historically been widely effective (for example, fluoroquinolones). It emphasizes that treatment design itself (including dosing strategies and combination regimens) can influence whether resistant subpopulations survive and expand during therapy.
What kinds of treatment strategies are highlighted as potentially reducing resistance?
The FOA points to growing evidence that combination therapy and/or high-dose, short-duration regimens may reduce the likelihood that resistant subpopulations persist. From a PK/PD standpoint, it notes that higher effective exposure may be required to suppress resistance, and exposure can be increased through higher doses, more frequent dosing, or altered administration methods (such as extended infusion times).
Does the FOA give examples of where combination therapy is already a precedent?
Yes. The FOA references established precedents for combination therapy in diseases including tuberculosis, H. pylori infection, HIV, and malaria, where multi-drug regimens are used in part to reduce treatment failure and resistance development.
What is the FOA saying is missing from traditional antibacterial development approaches?
The FOA notes that antibacterial development has often focused on demonstrating primary efficacy, while giving comparatively less attention to resistance suppression as a core development goal. The program seeks research that directly investigates resistance suppression through PK/PD-driven dosing strategies and rational combinations.
What types of methodologies or platforms is the FDA interested in supporting?
The FOA signals interest in innovative experimental and modeling platforms that can link drug exposure to both efficacy and resistance outcomes. One explicitly mentioned example is in vitro hollow fiber infection models, which can simulate human-like concentration-time profiles and enable controlled studies of bacterial kill dynamics and resistance emergence.
What is the role of PK/PD in the projects envisioned by this FOA?
PK/PD concepts are central. The FOA emphasizes approaches that use exposure-response relationships to improve dose selection and to evaluate combination strategies, including analytical methods that connect drug exposure to both efficacy and resistance endpoints.
Which pathogens does the FOA emphasize?
The FOA places particular weight on Gram-negative bacteria commonly encountered in healthcare and community settings, including organisms often treated with single-agent therapy. The organisms listed include Escherichia coli, Klebsiella pneumoniae, Serratia species, Acinetobacter species, Proteus species, Pseudomonas aeruginosa, and Enterobacter species.
What clinical context or infection types are mentioned?
The FOA highlights common infections where single-agent therapy is often used, including uncomplicated urinary tract infections.
How many awards did FDA anticipate making, and what was the total funding level?
The FDA anticipated making about six awards, with an estimated total funding level of $500,000.
What was the expected award size?
Individual awards were expected to range from $50,000 to $100,000 (floor to ceiling).
Is cost sharing or matching required?
No cost sharing or matching was required.
Who is eligible to apply?
Eligibility included higher education institutions as defined under the Higher Education Act (including consortia of such institutions) and nonprofit organizations with 501(c)(3) status (other than institutions of higher education).
Are there special assurance or independence requirements for applicants?
Yes. For entities entering collaborative agreements under the Critical Path Public-Private Partnership framework, the FOA requires assurances related to independence from funding sources connected to manufacturers or distributors of FDA-regulated products, unless safeguards are in place to ensure results are not influenced by funding. This is intended to protect scientific integrity and address conflict-of-interest risks.
What are the key dates for this opportunity?
The posted date was May 23, 2011. The original and current closing date was July 2, 2011. The archive date was August 1, 2011.
What is the CFDA number associated with this opportunity?
The CFDA listing is 93.103 (Food and Drug Administration).
Who is the scientific or programmatic contact (project officer)?
The FOA specifies Nancy Masiello as the project officer. Telephone: 301-796-8498. Fax: 301-847-8614.
Who is the grants management contact?
The grants management contact listed is Gladys Melendez, Grants Management Specialist, at 301-827-7168. The source also references an FDA office email for grants management support.
How is this opportunity categorized?
It is categorized as discretionary, within health science and technology and other research and development.
What is the overall intended impact of the supported research?
The FOA aims to generate methods and evidence that can improve regulatory decision-making around antimicrobial dosing and combination strategies, with downstream goals of improving real-world treatment outcomes and slowing the development and spread of antimicrobial resistance.
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