Opportunity Information: Apply for RFA FD 14 089
Apply for RFA FD 14 089
- The Food Drug Administration in the food and nutrition health sector is offering a public funding opportunity titled "Critical Path Public Private Partnerships" 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 Jul 2, 2014 and posted on Jun 19, 2014.
- Applicants must submit their applications by Jul 28, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $10,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled 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.
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Opportunity Summary:
The FDA grant opportunity titled "Critical Path Public Private Partnerships" (Funding Opportunity Number RFA-FD-14-089) is a cooperative agreement designed to strengthen and sustain public-private collaboration work carried out under the FDA Critical Path Initiative. The basic idea is to keep high-value, shared research infrastructure in place so that multiple stakeholders across government, academia, nonprofits, and industry can continue to work together on tools that make drug development more efficient, more reliable, and ultimately faster for patients. Rather than funding a single narrow research study, the opportunity is aimed at supporting the administrative and scientific backbone that allows large collaborative consortia to operate and produce deliverables that can be used broadly across medical product development programs.
A central focus of the opportunity is continued support for the Critical Path Institute and its established network of consortia, which at the time of the announcement included eight major groups: the Coalition Against Major Disease Consortium (CAMD), the Multiple Sclerosis Outcome Assessment Consortium (MSOAC), the Patient Reported Outcomes Consortium (PRO), the Electronic Patient Reported Outcomes Consortium (ePRO), the Coalition for Accelerating Standards and Therapies (CFAST), the Predictive Safety Testing Consortium (PSTC), the Polycystic Kidney Disease Outcome Consortium (PKD), and the Critical Path to TB Drug Regimens Consortium (CPTR). These consortia have been actively working on developing biomarkers and clinical outcome assessment tools and moving them toward formal qualification through the FDA Drug Development Tool (DDT) Qualification Program. In practical terms, that means creating measurement tools, endpoints, and testing methods that the FDA can recognize as scientifically credible and fit-for-purpose, so that they can be reused across multiple drug development programs without every sponsor having to re-litigate the same foundational evidence from scratch.
The program goals described in the announcement are twofold. First, it seeks to maintain the administrative and scientific infrastructure that keeps these consortia functioning, including the coordination and governance mechanisms that enable data sharing, scientific consensus building, and project execution across many participating organizations. Second, it aims to support the creation and execution of both ongoing and new projects under the Critical Path Initiative, explicitly noting that new efforts could include something like a Neonatal Consortium. This signals that the FDA is not only interested in sustaining existing successful collaborations, but also in expanding the model into additional therapeutic areas or populations where the lack of qualified tools is a bottleneck for developing safe and effective therapies.
From a funding and administrative standpoint, this was a discretionary grant using a cooperative agreement mechanism, meaning the FDA expected to have substantial involvement in the funded activities compared with a standard grant. The announcement listed an estimated total funding amount of $10,500,000, with an award ceiling of $10,500,000 and an award floor of $1,500,000, and anticipated making one award. The opportunity did not require cost sharing or matching. It was categorized under Food and Nutrition / Health, tied to the FDA CFDA number 93.103 (Food and Drug Administration - Research). The posting date was June 19, 2014, with an original and current closing date of July 28, 2014, and an archive date of August 27, 2014.
Eligibility was relatively broad within the nonprofit and higher education space. Eligible applicants included 501(c)(3) nonprofits (excluding institutions of higher education), nonprofits without 501(c)(3) status (excluding institutions of higher education), public and state-controlled institutions of higher education, and private institutions of higher education. For applicants, the key takeaway is that the funding is meant to support large-scale collaborative platforms that produce broadly usable regulatory science tools, particularly biomarkers and clinical outcome assessments that can be qualified under FDA programs and then leveraged across the ecosystem to improve the drug development process.
For access issues or questions related to the full announcement, the listed contact was Daniel Lukash, Grants Management Specialist at the FDA (phone: 240-402-7596), referenced as the point of contact if an applicant had difficulty accessing the full announcement electronically.
FAQs: FDA Cooperative Agreement - Critical Path Public Private Partnerships (RFA-FD-14-089)
What is this FDA funding opportunity?
This opportunity is the FDA grant titled "Critical Path Public Private Partnerships" (Funding Opportunity Number RFA-FD-14-089). It is a cooperative agreement designed to strengthen and sustain public-private collaboration carried out under the FDA Critical Path Initiative.
What is the main purpose of the award?
The main purpose is to keep high-value, shared research infrastructure in place so multiple stakeholders (government, academia, nonprofits, and industry) can continue working together on tools that make drug development more efficient, more reliable, and ultimately faster for patients.
Is this funding meant to support a single research study?
No. The opportunity is not aimed at funding a single narrow research study. Instead, it supports the administrative and scientific backbone that allows large collaborative consortia to operate and produce deliverables that can be used broadly across medical product development programs.
What kind of activities does the FDA expect the funding to support?
The announcement emphasizes support for the infrastructure that enables large collaborations to function, including coordination, governance mechanisms, data sharing, scientific consensus building, and project execution across many participating organizations. It also supports the creation and execution of ongoing and new projects under the Critical Path Initiative.
What are the two major program goals described in the announcement?
The goals are (1) maintaining the administrative and scientific infrastructure that keeps the consortia functioning, and (2) supporting the creation and execution of both ongoing and new projects under the FDA Critical Path Initiative.
Which organization and network of consortia are central to this opportunity?
A central focus is continued support for the Critical Path Institute and its established network of consortia.
Which consortia were listed in the announcement?
The announcement listed eight major groups: the Coalition Against Major Disease Consortium (CAMD), the Multiple Sclerosis Outcome Assessment Consortium (MSOAC), the Patient Reported Outcomes Consortium (PRO), the Electronic Patient Reported Outcomes Consortium (ePRO), the Coalition for Accelerating Standards and Therapies (CFAST), the Predictive Safety Testing Consortium (PSTC), the Polycystic Kidney Disease Outcome Consortium (PKD), and the Critical Path to TB Drug Regimens Consortium (CPTR).
What kinds of deliverables are these consortia working on?
They have been actively working on developing biomarkers and clinical outcome assessment tools and moving them toward formal qualification through the FDA Drug Development Tool (DDT) Qualification Program.
What does it mean for a tool to be qualified through the FDA DDT Qualification Program (as described here)?
In practical terms (as described in the opportunity), it means creating measurement tools, endpoints, and testing methods that the FDA can recognize as scientifically credible and fit-for-purpose, so they can be reused across multiple drug development programs without each sponsor having to rebuild the same foundational evidence from scratch.
Does the announcement mention expansion into new areas?
Yes. It explicitly notes that new efforts could include something like a Neonatal Consortium, signaling interest in sustaining existing collaborations while also expanding the model into additional therapeutic areas or populations where qualified tools are a bottleneck.
What funding mechanism is being used?
This is a discretionary grant using a cooperative agreement mechanism. The cooperative agreement approach indicates the FDA expected to have substantial involvement in the funded activities compared with a standard grant.
How much funding was estimated for this opportunity?
The estimated total funding amount listed was $10,500,000.
What were the award ceiling and award floor?
The award ceiling was $10,500,000 and the award floor was $1,500,000.
How many awards did the FDA anticipate making?
The announcement anticipated making one award.
Is cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What is the CFDA number and program category associated with this opportunity?
It is tied to the FDA CFDA number 93.103 (Food and Drug Administration - Research) and was categorized under Food and Nutrition / Health.
When was this opportunity posted, and what were the closing dates?
The posting date was June 19, 2014. The original and current closing date was July 28, 2014. The archive date was August 27, 2014.
Who was eligible to apply (based on the announcement)?
Eligible applicants included: 501(c)(3) nonprofits (excluding institutions of higher education), nonprofits without 501(c)(3) status (excluding institutions of higher education), public and state-controlled institutions of higher education, and private institutions of higher education.
What is the key takeaway for applicants about the type of work this funding supports?
The funding is meant to support large-scale collaborative platforms that produce broadly usable regulatory science tools, particularly biomarkers and clinical outcome assessments that can be qualified under FDA programs and leveraged across the ecosystem to improve the drug development process.
Who is the point of contact for access issues related to the full announcement?
The listed contact for applicants who had difficulty accessing the full announcement electronically was Daniel Lukash, Grants Management Specialist at the FDA. Phone: 240-402-7596.
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