Opportunity Information: Apply for RFA FD 15 012
Apply for RFA FD 15 012
- The Food Drug Administration in the food and nutrition health information and statistics science and technology and other research and development sector is offering a public funding opportunity titled "Strengthening the Operating Framework and Furthering the Objectives of Coalition For Accelerating Standards And Therapies (CFAST) Initiative (U24)" 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 27, 2015 and posted on May 27, 2015.
- Applicants must submit their applications by Jul 20, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $700,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $700,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- The following organization is eligible to apply Critical Path Institute
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Opportunity Summary:
The grant opportunity titled "Strengthening the Operating Framework and Furthering the Objectives of Coalition For Accelerating Standards And Therapies (CFAST) Initiative (U24)" is a U.S. Food and Drug Administration (FDA) cooperative agreement focused on expanding and strengthening the operating framework of the CFAST initiative. The central purpose of this specific expansion is to improve how medical product development efforts are supported by more effectively leveraging SHARE, and then using that strengthened approach to extend support into additional therapeutic areas beyond the ones previously emphasized. In practical terms, the opportunity is aimed at making the development process more efficient and consistent by promoting shared standards, tools, and collaborative methods that can be applied across multiple disease or treatment domains.
This funding announcement was issued as a discretionary opportunity under a cooperative agreement mechanism, meaning the FDA expected to have substantial involvement in the project rather than simply providing a grant with minimal federal participation. The activity areas listed for the opportunity span food and nutrition, health information and statistics, and science and technology and other research and development, reflecting the cross-cutting nature of standards development and data or tool-sharing efforts in biomedical research and regulatory science. The initiative name itself, CFAST (Coalition For Accelerating Standards And Therapies), signals the program's emphasis on developing and advancing standards that can speed therapy development, improve the quality and interoperability of evidence, and reduce friction in translational and regulatory pathways.
The opportunity was posted on May 27, 2015, and had an application closing date of July 20, 2015, with an archive date of August 19, 2015. The total expected funding was $700,000, and both the award ceiling and award floor were also $700,000, indicating that the FDA planned a single, fixed-size award rather than a range of possible award amounts. Consistent with that structure, the expected number of awards was 1. There was no cost sharing or matching requirement, so the applicant was not required to contribute non-federal funds as a condition of receiving the award.
Eligibility for this particular announcement was unusually narrow and explicitly restricted. The only eligible applicant identified in the announcement was the Critical Path Institute. This indicates the FDA intended the award to support a continuation or targeted expansion of ongoing work being conducted by that organization under the CFAST umbrella, rather than opening the competition broadly to universities, nonprofits, or other entities. The CFDA listing associated with the opportunity was 93.103, linked to FDA research.
For applicants or stakeholders needing assistance with the announcement materials, the listed grants management contact was Vieda Hubbard, Grants Management Specialist at the FDA, reachable by phone at 240-402-7588 or by email at vieda.hubbard@fda.hhs.gov.
FAQs: Strengthening the Operating Framework and Furthering the Objectives of the CFAST Initiative (U24)
What is the title of this grant opportunity?
The opportunity is titled "Strengthening the Operating Framework and Furthering the Objectives of Coalition For Accelerating Standards And Therapies (CFAST) Initiative (U24)."
Which federal agency is offering this opportunity?
This is a U.S. Food and Drug Administration (FDA) funding opportunity.
What type of funding mechanism is this?
It is a cooperative agreement (U24). Under a cooperative agreement, the FDA expects to have substantial involvement in the project rather than providing funding with minimal federal participation.
What is the main purpose of the award?
The central purpose is to expand and strengthen the operating framework of the CFAST initiative. This expansion is intended to improve how medical product development efforts are supported by more effectively leveraging SHARE, and then to extend that strengthened support into additional therapeutic areas beyond those previously emphasized.
What does the opportunity aim to improve in practical terms?
It aims to make the medical product development process more efficient and consistent by promoting shared standards, tools, and collaborative methods that can be applied across multiple disease or treatment domains.
What is CFAST?
CFAST stands for Coalition For Accelerating Standards And Therapies. The initiative emphasizes developing and advancing standards that can speed therapy development, improve the quality and interoperability of evidence, and reduce friction in translational and regulatory pathways.
Which activity areas are associated with this funding announcement?
The listed activity areas span food and nutrition, health information and statistics, and science and technology and other research and development, reflecting the cross-cutting nature of standards development and sharing data/tools in biomedical research and regulatory science.
When was the opportunity posted?
The opportunity was posted on May 27, 2015.
What was the application deadline?
The application closing date was July 20, 2015.
When was the opportunity archived?
The archive date was August 19, 2015.
How much total funding was expected to be awarded?
The total expected funding amount was $700,000.
What were the award floor and award ceiling?
Both the award floor and the award ceiling were $700,000, indicating a single fixed-size award rather than a range of award amounts.
How many awards were expected?
The expected number of awards was 1.
Is there a cost sharing or matching requirement?
No. The announcement stated there was no cost sharing or matching requirement, so the applicant was not required to contribute non-federal funds as a condition of receiving the award.
Who was eligible to apply?
Eligibility was explicitly restricted to a single organization: the Critical Path Institute.
Does this mean other organizations (universities, nonprofits, companies) could apply?
No. The announcement identified only the Critical Path Institute as eligible, indicating the FDA intended this award to support a continuation or targeted expansion of ongoing work under the CFAST umbrella rather than a broadly open competition.
What CFDA number was associated with this opportunity?
The CFDA listing associated with the opportunity was 93.103 (linked to FDA research).
Who was the listed grants management contact for questions?
The grants management contact listed was Vieda Hubbard, Grants Management Specialist at the FDA.
How can the grants management contact be reached?
Vieda Hubbard could be reached by phone at 240-402-7588 or by email at vieda.hubbard@fda.hhs.gov.
What is a key distinguishing feature of this announcement compared to many other grant opportunities?
Two distinguishing features are (1) the cooperative agreement structure, where the FDA expects substantial involvement, and (2) the unusually narrow eligibility, which limited applications to the Critical Path Institute only.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 15 012) also looked into and applied for these:
| Funding Opportunity |
|---|
| Cooperative Agreement for Research, Education, and Outreach in support of the FDA Food Safety Modernization Act Apply for RFA FD 15 035 Funding Number: RFA FD 15 035 Agency: Food Drug Administration Category: Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development Funding Amount: $5,000,000 |
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