Opportunity Information: Apply for RFA FD 14 004
Apply for RFA FD 14 004
- The Food Drug Administration in the health information and statistics science and technology and other research and development sector is offering a public funding opportunity titled "Data Concepts and Terminology Standards for Clinical Research and Drug Development (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 16, 2014 and posted on Apr 29, 2014.
- Applicants must submit their applications by Jun 16, 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 $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: Private institutions of higher education Small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments Public and State controlled institutions of higher education County governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- Foreign Organizations
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Opportunity Summary:
The FDA's Center for Drug Evaluation and Research (CDER) launched this cooperative agreement opportunity to tackle a practical but high-impact problem: drug and biologics submissions arrive with huge amounts of clinical, nonclinical, and product-quality data, but the data are often organized differently across sponsors, therapeutic areas, and submission types. That lack of standardization makes it harder for CDER reviewers to quickly find what they need, compare studies across programs, run consistent analyses, store and retrieve information efficiently, and generate clear reports. The program is built around the idea that better, more predictable data structures and shared terminology free up reviewer time for the work that truly requires expert judgment, such as deeper analysis, probing questions to sponsors, and resolving late-emerging scientific and safety issues. In the longer view, standardized data also supports more consistent decision-making across the full drug lifecycle, from premarket review to postmarket safety surveillance, drug quality oversight, and monitoring of promotional claims.
A central feature of the opportunity is that FDA is not looking to create government-unique standards. In line with OMB Circular A-119, the agency emphasizes voluntary, consensus-based standards developed through open processes, unless that approach is legally impossible or otherwise impractical. Applicants are expected to align any work with existing health information technology initiatives, relevant laws and regulations, and other standards already in use, and to coordinate rather than fragment the standards landscape. Put simply, the award is meant to strengthen the shared infrastructure of regulatory-grade data standards, not create a new silo.
The overarching program goals reflect that orientation toward sustainable, community-driven standards. CDER's Data Standards Program aims to (1) support open, consensus-based data standards development, (2) maintain and promote a clear governance function for standards, (3) promote electronic submission of regulatory data using established standards, and (4) optimize FDA's regulatory review by fully leveraging data that conform to standards. The funded projects are intended to produce non-proprietary standards that can actually be used in real submissions and reviews, improving data quality, accessibility, and consistency.
In terms of what projects should do, FDA is seeking work focused on "data concepts and terminology standards" that support human drug development and evaluation, especially for clinical studies of human drugs and biologics. The scope is intentionally broad enough to cover persistent pain points across the submission package: general clinical and nonclinical study data, specific therapeutic areas, and even other submission sections such as quality and Chemistry, Manufacturing, and Controls (CMC). The common thread is that the project should identify a concrete standardization target and move it forward through a credible, consensus-building development process.
Applications are expected to be operationally detailed, not just conceptual. FDA asks for an overall program plan that explains the approach and process for standards development in the chosen area, identifies any technologies to be used (and the team's experience with them), and clearly states deliverables. Applicants must also include a structured progress-tracking method, such as a Gantt chart, that breaks deliverables into interim steps with timelines and highlights risks or issues that could affect deadlines. Beyond planning mechanics, the application needs to define the project scope using a clear use case, describe exactly what will be produced (for example, a concept model, terminology set, domain standard, therapeutic-area standard, or a completed implementation guide), and explain how consensus will be achieved through coordination with subject matter experts, stakeholder organizations, and standards development organizations. FDA also expects applicants to show how the proposed standard aligns with existing standards and to explain the approach for making the final standard publicly available, reinforcing the emphasis on non-proprietary, reusable outputs.
CDER also signals particular interest in therapeutic areas where standardization would have outsized value: areas with heavy drug-development pipeline activity, emerging or complex analytical challenges, or major public health importance. The announcement references an FDA web page listing therapeutic areas and their status, implying applicants should consult that list when selecting a focus and justify why the chosen area is timely and impactful.
From a funding and administrative standpoint, this opportunity is a U24 cooperative agreement, meaning FDA expects substantial involvement and collaboration during the project rather than a hands-off grant relationship. The announcement anticipated up to 4 awards, with an estimated total funding amount of $1,000,000. Individual awards were expected to fall roughly in the $200,000 to $225,000 range, with no cost-sharing or matching requirement. The funding opportunity number is RFA-FD-14-004, posted April 29, 2014, with a closing date of June 16, 2014 (now archived). Eligibility was broad and included many domestic applicant types (universities, nonprofits, governments, small businesses, and for-profit entities) and also allowed foreign organizations, which is notable for standards work that benefits from international participation and alignment.
Overall, the grant is best understood as an FDA-led push to improve the usability of regulatory data by investing in the shared building blocks of standard concepts and vocabulary. The expected products are practical standards artifacts developed through open, consensus-based processes, designed to fit into existing standards ecosystems, and aimed at making regulatory review faster, more consistent, and more analytically powerful.
FAQs: FDA CDER Data Concepts and Terminology Standards (U24) - RFA-FD-14-004
What is the main purpose of this cooperative agreement?
This opportunity supports development of practical, non-proprietary data concepts and terminology standards that make FDA CDER review more efficient and consistent. The underlying problem is that drug and biologics submissions contain large volumes of clinical, nonclinical, and product-quality data, but sponsors often organize and label that data differently, making it harder for reviewers to find information, compare studies, run consistent analyses, and generate clear reports.
Which FDA organization is sponsoring the program?
The program is sponsored by the FDA Center for Drug Evaluation and Research (CDER), through its Data Standards Program.
Why does FDA care about data standards in submissions?
When submission data are standardized, reviewers can spend less time reformatting, searching, and reconciling differences in data structures and terminology. That frees up time for higher-value scientific work, such as deeper analysis, asking targeted questions to sponsors, and resolving late-emerging scientific and safety issues. Over time, standardized data can also support more consistent decision-making across the drug lifecycle, including premarket review, postmarket safety surveillance, quality oversight, and monitoring of promotional claims.
Is FDA trying to create government-unique standards?
No. A central feature of the opportunity is that FDA is not looking to create government-unique standards. Consistent with OMB Circular A-119, the agency emphasizes voluntary, consensus-based standards developed through open processes, unless that approach is legally impossible or otherwise impractical.
What kinds of projects is FDA looking to fund?
FDA is seeking projects focused on "data concepts and terminology standards" that support human drug development and evaluation, especially for clinical studies of human drugs and biologics. The scope is broad enough to include standardization targets across clinical and nonclinical study data, specific therapeutic areas, and other submission sections such as quality and Chemistry, Manufacturing, and Controls (CMC), as long as the work advances a concrete standardization need through a credible consensus-building process.
What are the program goals for CDER's Data Standards Program?
The stated goals are to: (1) support open, consensus-based data standards development, (2) maintain and promote a clear governance function for standards, (3) promote electronic submission of regulatory data using established standards, and (4) optimize FDA's regulatory review by fully leveraging data that conform to standards.
What does FDA mean by "non-proprietary" standards outputs?
The funded projects are intended to produce standards artifacts that are not proprietary and can be used broadly in real regulatory submissions and reviews. The application is expected to explain how the final standard will be made publicly available, reinforcing the expectation of reusable outputs.
What types of deliverables could a funded project produce?
Examples of expected products include a concept model, a terminology set, a domain standard, a therapeutic-area standard, or a completed implementation guide. The application should clearly describe what will be produced.
How specific does the application need to be?
Applications are expected to be operationally detailed, not just conceptual. FDA requests an overall program plan explaining the approach and process for standards development, the technologies to be used (and the team's experience with them), and clearly stated deliverables.
Is a project management plan required?
Yes. The application must include a structured progress-tracking method, such as a Gantt chart, that breaks deliverables into interim steps with timelines and highlights risks or issues that could affect deadlines.
How should applicants define the scope of the proposed standardization work?
The application is expected to define the project scope using a clear use case. It should identify a concrete standardization target and explain how the work will move that target forward through a credible, consensus-based development process.
How is consensus expected to be achieved?
FDA expects applicants to describe how consensus will be achieved through coordination with subject matter experts, stakeholder organizations, and standards development organizations, and how the effort will coordinate with (rather than fragment) the existing standards landscape.
Do projects need to align with existing standards and initiatives?
Yes. Applicants are expected to align proposed work with existing health information technology initiatives, relevant laws and regulations, and other standards already in use. The intent is to strengthen shared infrastructure for regulatory-grade data standards, not create a new silo.
Are there any priority areas mentioned for standards development?
CDER signals interest in therapeutic areas where standardization would have outsized value, such as areas with heavy drug-development pipeline activity, emerging or complex analytical challenges, or major public health importance. The announcement references an FDA web page listing therapeutic areas and their status, suggesting applicants should consult it, select a focus, and justify why it is timely and impactful.
What is the award mechanism and what does it imply for working with FDA?
The award mechanism is a U24 cooperative agreement. This implies FDA expects substantial involvement and collaboration during the project, rather than a hands-off relationship typical of some grant mechanisms.
How many awards were anticipated and what funding levels were expected?
The announcement anticipated up to 4 awards, with an estimated total funding amount of $1,000,000. Individual awards were expected to be roughly $200,000 to $225,000.
Is cost-sharing or matching required?
No cost-sharing or matching requirement was described for this opportunity.
What is the funding opportunity number and key dates?
The funding opportunity number is RFA-FD-14-004. It was posted April 29, 2014, with a closing date of June 16, 2014. The opportunity is now archived.
Who was eligible to apply?
Eligibility was broad and included many domestic applicant types such as universities, nonprofits, governments, small businesses, and for-profit entities. Foreign organizations were also allowed, which is notable for standards work that benefits from international participation and alignment.
What is the intended long-term impact of the funded work?
The long-term intent is to improve the usability and consistency of regulatory data so that review and oversight can be faster, more consistent, and more analytically powerful across the full drug lifecycle, including review, surveillance, quality oversight, and promotional monitoring.
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