Opportunity Information: Apply for RFA FD 16 020
Apply for RFA FD 16 020
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Therapeutic Areas for Data Standards 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.
- 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 $225,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education, 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.
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Opportunity Summary:
The Therapeutic Areas for Data Standards Development (U01) funding opportunity (RFA FD 16 020) is a cooperative agreement offered by the U.S. Department of Health and Human Services Food and Drug Administration (HHS-FDA), specifically tied to the FDA Center for Drug Evaluation and Research (CDER) priorities around clinical study data standardization. The central idea behind the program is that the FDA receives a massive and continuously growing volume of clinical trial data, and that data becomes far more valuable when it can be compared, aggregated, and analyzed consistently across studies. By pushing toward shared standards for study data elements, terminology, and data structures, the FDA and the broader research community can automate and streamline important analyses, improving the speed and consistency of regulatory review and decision-making and, ultimately, helping new therapies reach patients sooner.
This opportunity was motivated by a concrete need identified by CDER: in 2011, CDER created and published a prioritized list of disease and therapeutic areas where additional standardization work was especially necessary, with a particular emphasis on concepts and terminologies that affect efficacy analyses. The grant program is meant to directly support projects aligned to that need, meaning applicants are expected to work in specific therapeutic areas where the lack of harmonized standards creates inefficiency, confusion, or barriers to cross-study learning. Rather than funding general research on a disease, the focus is on the infrastructure of how clinical trial data in that disease area is represented and organized, so that common measurements and outcomes can be captured in consistent, reusable ways.
In practical terms, the main objective is to produce therapeutic-area specifications that describe how commonly collected data and outcome measures in disease-focused clinical trials should be structured. These specifications are intended to function as a shared blueprint for organizing trial data, including defining standardized data elements and aligning the meaning of outcomes and endpoints so they can be interpreted uniformly. The goal is that, when sponsors submit study data to the FDA or when researchers attempt to synthesize results across studies, the information is already arranged according to a predictable structure with consistent terminology, enabling more efficient review workflows and more reliable comparisons.
The award mechanism is a U01 cooperative agreement, which typically implies substantial involvement by the funding agency compared with a standard grant. That structure supports close coordination between awardees and the FDA to ensure that the specifications being developed actually meet regulatory and stakeholder needs and are fit for purpose within FDA review contexts. The funding instrument sits under an activity category that includes consumer protection, food and nutrition, and health, reflecting the FDA public health mission and the downstream impact that better data standards can have on the safety and effectiveness evaluation of medical products.
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations other than small businesses, and small businesses. In other words, the program is open to universities, nonprofits, and industry entities that have the expertise to convene stakeholders and translate clinical trial practice into well-defined data standards for particular disease areas.
From an administrative and budget standpoint, the opportunity was posted and created on April 1, 2016, with an application deadline of June 3, 2016. The program anticipated making about three awards, with an award ceiling of $225,000. The Catalog of Federal Domestic Assistance (CFDA) number associated with the opportunity is 93.103. Overall, the grant is best understood as targeted funding to accelerate the creation of therapeutic-area-specific clinical data standards that make clinical trial datasets more interoperable and more immediately usable for analysis, thereby supporting faster, more consistent, and more evidence-driven regulatory decisions.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Therapeutic Areas for Data Standards Development (U01)" and is associated with funding opportunity number RFA FD 16 020.
Which agency is offering this grant?
This is a cooperative agreement offered by the U.S. Department of Health and Human Services Food and Drug Administration (HHS-FDA), tied specifically to priorities of the FDA Center for Drug Evaluation and Research (CDER).
What is the main purpose of the program?
The program supports the development of shared clinical study data standards in specific disease and therapeutic areas so that clinical trial data can be compared, aggregated, and analyzed consistently across studies.
Why is FDA/CDER investing in data standards for therapeutic areas?
CDER receives a large and growing volume of clinical trial data. When data uses consistent standards for elements, terminology, and structure, it becomes easier to streamline analyses, improve consistency in regulatory review, and support faster, more reliable decision-making.
Is this grant intended to fund general disease research?
No. The emphasis is not on general biomedical research in a disease area. The focus is on the "infrastructure" of how clinical trial data for that disease area is represented and organized, including harmonized data elements, terminology, and structures.
What specific need motivated this opportunity?
CDER identified a concrete need for additional standardization work and, in 2011, created and published a prioritized list of disease and therapeutic areas where more standardization was especially necessary, with particular emphasis on concepts and terminologies that affect efficacy analyses.
What kinds of projects is the program meant to support?
The program is meant to support projects aligned with CDER-identified therapeutic areas where lack of harmonized standards creates inefficiency, confusion, or barriers to learning across studies.
What is the primary expected output or deliverable from an award?
The main objective is to produce therapeutic-area specifications describing how commonly collected data and outcome measures in disease-focused clinical trials should be structured, including standardized data elements and aligned meanings for outcomes and endpoints.
What are "therapeutic-area specifications" in this context?
They are intended to function as a shared blueprint for organizing clinical trial data within a specific disease/therapeutic area, defining what data elements to capture and how to structure and describe them so they can be interpreted uniformly.
How would these specifications be used?
The goal is that when sponsors submit study data to FDA or when researchers synthesize results across studies, the data is already arranged in a predictable structure with consistent terminology, enabling more efficient review workflows and more reliable comparisons.
What does the U01 cooperative agreement mechanism mean for applicants?
U01 is a cooperative agreement, which typically implies substantial involvement by the funding agency compared with a standard grant. This structure supports close coordination between awardees and FDA so the specifications meet regulatory and stakeholder needs and are fit for purpose for FDA review contexts.
Which FDA center is specifically connected to this opportunity?
The opportunity is specifically tied to the FDA Center for Drug Evaluation and Research (CDER).
How is this opportunity categorized at a high level?
The funding instrument sits under an activity category that includes consumer protection, food and nutrition, and health, reflecting FDA's public health mission and the downstream impact of better standards on evaluating the safety and effectiveness of medical products.
Who is eligible to apply?
Eligibility includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations other than small businesses, and small businesses.
Does eligibility include universities?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are both listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with or without 501(c)(3) status are eligible, as long as they are not institutions of higher education in those categories.
Are for-profit companies eligible?
Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.
When was this funding opportunity posted and created?
It was posted and created on April 1, 2016.
What was the application deadline?
The application deadline was June 3, 2016.
How many awards were anticipated?
The program anticipated making about three awards.
What is the award ceiling?
The award ceiling was $225,000.
What is the CFDA number for this opportunity?
The CFDA number associated with the opportunity is 93.103.
What is the broader public health impact described for this program?
By making clinical trial datasets more interoperable and immediately usable for analysis, the program supports faster, more consistent, and more evidence-driven regulatory decisions, helping new therapies reach patients sooner.
What is the emphasis within standardization work mentioned in the description?
The description highlights a particular emphasis on concepts and terminologies that affect efficacy analyses.
What problem is the program trying to solve for cross-study learning?
It targets inefficiency, confusion, and barriers to comparing and aggregating findings across studies that arise when clinical trial data is not captured and structured using harmonized standards.
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