Opportunity Information: Apply for RFA FD 15 033
Apply for RFA FD 15 033
- The Food Drug Administration in the food and nutrition information and statistics sector is offering a public funding opportunity titled "Data Concepts and Terminology Standards for the Support of Human Drug Development and Evaluation" 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 13, 2015 and posted on May 1, 2015.
- Applicants must submit their applications by Jul 17, 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 $675,000.00 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 3 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 Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Small businesses.
- Hispanic serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)
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Opportunity Summary:
The grant opportunity titled "Data Concepts and Terminology Standards for the Support of Human Drug Development and Evaluation" (Funding Opportunity Number RFA-FD-15-033) is a Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) initiative focused on improving how human drug development and regulatory data are described, structured, and exchanged. CDER receives an increasingly large and complex stream of information through regulatory submissions, coming from many organizations and arriving in many different formats. While this growing body of data could strongly enhance CDER's scientific and regulatory decision-making, the lack of common data concepts and consistent terminology makes it difficult to use efficiently at scale. The core problem the opportunity targets is that non-standard data slows down review work and makes it harder to compare, analyze, store, retrieve, and report information across submissions and across time.
The opportunity emphasizes that data standardization is not just a technical clean-up effort; it is framed as a mission-critical capability for protecting public health. When reviewers cannot quickly acquire and interpret submitted data, routine tasks take longer, analyses become harder to reproduce, and it becomes more difficult to spot patterns or address emerging issues late in a review cycle. CDER argues that improving data quality, accessibility, and predictability would free up reviewers to spend more time on deeper scientific questions rather than manual data wrangling. Standardized data also supports more consistent reviews and makes it more feasible to evaluate evidence across the full drug lifecycle, from pre-market development and approval to post-market safety monitoring, oversight of drug quality, and oversight of drug promotion activities.
A central requirement of the program is alignment with federal policy on standards. In line with Office of Management and Budget (OMB) Circular A-119, FDA indicates it will favor voluntary, consensus-based standards rather than creating government-unique standards, unless a consensus standard conflicts with law or is otherwise impractical. The announcement also highlights the expectation that supported projects will coordinate with standards already in use and align with broader health information technology initiatives, laws, regulations, and mandates. In practical terms, this means awardees are expected to work within the existing standards ecosystem and help strengthen or extend it, rather than producing isolated, custom approaches that cannot be adopted widely.
This funding opportunity uses a cooperative agreement mechanism, signaling that FDA anticipates substantial involvement during the project period rather than a fully hands-off grant. The program anticipated up to three awards, with an estimated total funding amount of $675,000. Individual awards were expected to range from a floor of $50,000 up to a ceiling of $225,000. No cost sharing or matching requirement was listed. The activity category is identified under FDA research (CFDA 93.103), and the listing also tags the broader activity category as Food and Nutrition Information and Statistics, reflecting the data and information management emphasis rather than laboratory bench science.
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including both those with and without 501(c)(3) status, other than institutions of higher education), and small businesses, along with other eligible entities as clarified in the full announcement text. The opportunity explicitly notes inclusion of minority-serving institutions such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), indicating an intent to encourage participation from a diverse set of organizations with relevant expertise.
Key administrative details include a posted date of May 1, 2015, with a closing date of July 17, 2015, and an archive date of August 16, 2015. The FDA contact listed for access or assistance is Vieda Hubbard, Grants Management Specialist, reachable at vieda.hubbard@fda.hhs.gov. Overall, the opportunity is best understood as an effort to build and harmonize data concepts and terminology standards that can be broadly adopted across drug development and regulatory evaluation, reducing friction in submissions and enabling faster, more consistent, and more analytically robust regulatory science.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Data Concepts and Terminology Standards for the Support of Human Drug Development and Evaluation" and the Funding Opportunity Number is RFA-FD-15-033.
Which FDA office is sponsoring this opportunity?
This is an FDA Center for Drug Evaluation and Research (CDER) initiative.
What problem is this program trying to solve?
CDER receives a growing volume of complex information through regulatory submissions from many organizations in many different formats. Without common data concepts and consistent terminology, it becomes difficult to efficiently compare, analyze, store, retrieve, and report information across submissions and over time. Non-standard data slows review work and limits the ability to use submitted information at scale.
Why does CDER consider data standardization mission-critical?
The program frames standardization as essential to protecting public health. If reviewers cannot quickly acquire and interpret submitted data, routine tasks take longer, analyses become harder to reproduce, and it can be harder to spot patterns or address emerging issues late in a review cycle. More predictable and accessible data is intended to reduce manual data wrangling and allow reviewers to spend more time on deeper scientific questions.
What types of activities or outcomes does the opportunity emphasize?
The focus is on improving how human drug development and regulatory data are described, structured, and exchanged by building and harmonizing data concepts and terminology standards that can be broadly adopted across drug development and regulatory evaluation.
How could standardized data help across the drug lifecycle?
Standardized data is described as supporting more consistent reviews and making it more feasible to evaluate evidence across the full drug lifecycle, including pre-market development and approval, post-market safety monitoring, oversight of drug quality, and oversight of drug promotion activities.
Does this opportunity expect alignment with existing standards?
Yes. Projects are expected to coordinate with standards already in use and align with broader health information technology initiatives, laws, regulations, and mandates. The intent is to strengthen or extend the existing standards ecosystem rather than create isolated approaches that are difficult to adopt widely.
What is the role of federal policy on standards in this grant?
The announcement points to Office of Management and Budget (OMB) Circular A-119 and indicates FDA will favor voluntary, consensus-based standards instead of government-unique standards, unless a consensus standard conflicts with law or is otherwise impractical.
What funding mechanism is being used?
This opportunity uses a cooperative agreement mechanism, which signals that FDA anticipates substantial involvement during the project period rather than a fully hands-off grant.
How many awards were anticipated?
The program anticipated up to three awards.
What was the estimated total funding amount for the program?
The estimated total funding amount was $675,000.
What was the expected award size range?
Individual awards were expected to range from $50,000 (floor) up to $225,000 (ceiling).
Is cost sharing or matching required?
No cost sharing or matching requirement was listed.
What is the CFDA number and activity category noted for this opportunity?
The activity category is identified under FDA research (CFDA 93.103). The listing also tags the broader activity category as Food and Nutrition Information and Statistics, reflecting an emphasis on data and information management.
Who is eligible to apply?
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, other than institutions of higher education), and small businesses, along with other eligible entities as clarified in the full announcement text.
Are minority-serving institutions specifically encouraged or included?
Yes. The opportunity explicitly notes inclusion of minority-serving institutions such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
What were the key dates for this opportunity?
The posted date was May 1, 2015. The closing date was July 17, 2015. The archive date was August 16, 2015.
Who is the FDA contact for this opportunity?
The contact listed is Vieda Hubbard, Grants Management Specialist. Email: vieda.hubbard@fda.hhs.gov.
What is the main practical expectation for funded projects?
Based on the description, awardees are expected to work within the existing standards ecosystem, coordinate with standards already in use, and help strengthen or extend consensus-based data concepts and terminology standards so they can be adopted broadly across submissions and regulatory evaluation.
What is the intended benefit to CDER reviewers and decision-making?
The intended benefit is faster and more consistent access to usable data, improved reproducibility of analyses, better ability to compare and analyze information across submissions and time, and reduced manual effort spent on reformatting or interpreting non-standard submissions.
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