Opportunity Information: Apply for PAR 11 209
Apply for PAR 11 209
- The Food Drug Administration in the health information and statistics other (see text field entitled explanation of other category of funding activity for clarification) 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 (R24)" 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 Dec 20, 2012 and posted on May 3, 2011.
- Applicants must submit their applications by Jun 2, 2011 The revised date reflects the correct close date for the receipt date of June 1, 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 $300,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education 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.
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Opportunity Summary:
The Food and Drug Administration (FDA), through the Center for Drug Evaluation and Research (CDER), offered this discretionary grant opportunity to speed up the creation and practical use of shared data concepts and terminology that make clinical research and drug development easier to compare, combine, review, and reuse. The core aim is to strengthen nonproprietary, consensus-based national data standards that can be applied broadly across clinical studies involving human drugs and biologics. In plain terms, CDER is looking for projects that help the field speak the same language when collecting and reporting clinical study data, so that regulators, researchers, sponsors, and other stakeholders can interpret results consistently and efficiently.
The program is structured as an R24 grant, which is typically used to support resource-related research projects that build or improve shared tools, infrastructure, or standards. Under this announcement, applicants could propose work that tackles general obstacles to data standards development and implementation, such as how to gain multi-stakeholder agreement, how to ensure a standard is usable in real-world study operations, how to align terminology across existing systems, or how to improve adoption and interoperability across organizations. Alternatively, projects could focus on a particular clinical concept or domain where standardization is urgently needed, for example specific types of endpoints, assessments, safety data, lab data, disease-specific measures, or other areas where inconsistent definitions and coding create avoidable friction in analysis and regulatory review. The emphasis on consensus-based approaches signals that CDER is not looking for a single organization’s internal schema, but rather work that can credibly become a shared national reference adopted across the clinical research ecosystem.
Administratively, the opportunity is identified as Funding Opportunity Number PAR 11-209, titled "Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24)." It is categorized under Health Information and Statistics and also under Science and Technology and other Research and Development, reflecting the blend of informatics, standard-setting, and applied research needed to produce usable standards. The assistance listing (CFDA) number is 93.103 for the Food and Drug Administration. The funding instrument is a grant, and the announcement indicated an expectation of around five awards.
Funding levels were relatively modest but designed to support targeted, high-impact standardization efforts. The estimated total funding was $300,000, with individual awards ranging from a floor of $50,000 to a ceiling of $150,000. There was no cost-sharing or matching requirement, which generally lowers the barrier to participation for academic groups and nonprofits. Eligible applicants included public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) status (other than institutions of higher education), and nonprofits without 501(c)(3) status (other than institutions of higher education). This eligibility profile fits the collaborative nature of standards work, where universities, consortia, and nonprofit standards bodies often play central roles.
Timing details in the source show the announcement was posted May 3, 2011, with an original closing date of June 16, 2011, later corrected to reflect a close date tied to a June 1, 2011 receipt date, with a current closing date listed as June 2, 2011. The opportunity was later archived on November 16, 2013. The listing also referenced additional information via the NIH Guide (published April 28, 2011), indicating that applicants were expected to rely on the full notice for specifics about application requirements, review criteria, and program expectations.
For applicants needing help accessing the full announcement, the contact listed was Gladys M. Bohler, Grants Management Officer/Specialist at the FDA, with a phone number (301-827-7175) and an FDA office email referenced in the notice. Overall, the opportunity is best understood as CDER investing in the foundational "plumbing" of clinical research data: standard definitions and terminology that reduce ambiguity, improve data quality and interoperability, and ultimately support more efficient drug development and regulatory evaluation.
FAQs: Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24) - PAR 11-209
What is this FDA/CDER grant opportunity about?
This discretionary grant opportunity from the Food and Drug Administration (FDA), through the Center for Drug Evaluation and Research (CDER), focused on speeding up the development and real-world use of shared data concepts and terminology for clinical research and drug development. The goal was to help the field use consistent, nonproprietary, consensus-based data standards so clinical study data can be compared, combined, reviewed, and reused more efficiently.
What is the main purpose of funding data concepts and terminology standards?
The core purpose was to strengthen national data standards that can be broadly applied across clinical studies involving human drugs and biologics. In practical terms, CDER aimed to reduce ambiguity and inconsistency in how studies define, capture, and report data so regulators, researchers, sponsors, and other stakeholders can interpret results in a consistent way.
What does "nonproprietary, consensus-based national data standards" mean in this context?
It means CDER was looking for standards that are not tied to a single organization’s internal system and that are developed through multi-stakeholder agreement. The intent was for the outputs to be credible shared references that could be adopted broadly across the clinical research ecosystem.
What is an R24 grant and why was it used here?
The program used the R24 mechanism, which is typically intended for resource-related research projects that build or improve shared tools, infrastructure, or standards. In this announcement, the R24 structure aligned with supporting standards work that benefits many users and organizations, not just one project or one institution.
What types of projects were encouraged under this announcement?
Applicants could propose projects addressing broad barriers to standards development and implementation (for example, how to gain multi-stakeholder agreement or how to improve adoption and interoperability), or they could focus on standardizing a specific clinical concept or domain where inconsistency causes problems in analysis and regulatory review.
What are examples of "general obstacles" projects could address?
The announcement described examples such as: approaches to achieving multi-stakeholder agreement; ensuring a standard is usable in real-world study operations; aligning terminology across existing systems; and improving adoption and interoperability across organizations.
Could a project focus on a specific clinical domain rather than broad methodology?
Yes. The opportunity allowed projects to focus on a particular clinical concept or domain where standardization was urgently needed, such as specific types of endpoints, assessments, safety data, laboratory data, disease-specific measures, or other areas where inconsistent definitions and coding create avoidable friction.
Which kinds of studies were these standards intended to support?
The standards were intended to be broadly applicable across clinical studies involving human drugs and biologics, supporting clinical research and drug development activities where consistent data definitions and terminology improve comparability and reuse.
What is the official Funding Opportunity Number and title?
The opportunity was identified as PAR 11-209 and titled "Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24)."
How is this opportunity categorized?
It was categorized under Health Information and Statistics and also under Science and Technology and other Research and Development, reflecting that it involved informatics, standard-setting, and applied research to produce usable standards.
What is the CFDA (Assistance Listing) number for this program?
The assistance listing (CFDA) number provided for the Food and Drug Administration was 93.103.
What funding instrument was used?
The funding instrument was a grant.
How many awards were expected?
The announcement indicated an expectation of around five awards.
What was the estimated total funding available?
The estimated total funding was $300,000.
What was the expected award size range?
Individual awards ranged from a minimum of $50,000 to a maximum of $150,000.
Was cost-sharing or matching required?
No. The announcement stated there was no cost-sharing or matching requirement.
Who was eligible to apply?
Eligible applicants included: public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with 501(c)(3) status (other than institutions of higher education); and nonprofits without 501(c)(3) status (other than institutions of higher education).
Why does the eligibility list emphasize universities and nonprofits?
The eligible applicant types fit the collaborative nature of standards work, where universities, consortia, and nonprofit standards bodies often lead or coordinate multi-stakeholder efforts to create shared terminology and data concepts.
When was the opportunity posted and when did it close?
The announcement was posted May 3, 2011. The source also shows timing corrections: an original closing date of June 16, 2011 was later corrected to reflect a close date tied to a June 1, 2011 receipt date, with a current closing date listed as June 2, 2011.
Is this grant opportunity still active?
No. The opportunity was archived on November 16, 2013.
Where was additional official information referenced?
The listing referenced additional information via the NIH Guide (published April 28, 2011), indicating applicants were expected to rely on the full notice for detailed requirements, review criteria, and program expectations.
Who was the listed contact for questions about the full announcement?
The contact listed was Gladys M. Bohler, Grants Management Officer/Specialist at the FDA. The notice included the phone number 301-827-7175 and referenced an FDA office email.
What problem was CDER trying to solve with this funding?
CDER was investing in foundational infrastructure for clinical research data: shared definitions and terminology that reduce ambiguity, improve data quality and interoperability, and support more efficient drug development and regulatory evaluation.
What kind of output was CDER likely expecting from funded projects?
Based on the description, CDER expected deliverables that advance shared data concepts and terminology that can be used in practice across organizations, including standards that are usable in real-world operations and can be adopted as shared national references.
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