Opportunity Information: Apply for RFA FD 11 033
Apply for RFA FD 11 033
- The Food Drug Administration in the education health information and statistics science and technology and other research and development sector is offering a public funding opportunity titled "Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)" 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 Jul 15, 2011 and posted on Jul 15, 2011.
- Applicants must submit their applications by Aug 15, 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 $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- MD and PhD granting institutions of higher education within a 50 mile radius of FDAs Silver Spring, Maryland campus, including Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions
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Opportunity Summary:
The FDA funding opportunity titled "Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)" (Funding Opportunity Number RFA-FD-11-033) was a discretionary cooperative agreement designed to strengthen the agency's regulatory science capacity through close, structured collaboration with academic partners. Issued under the FDAs Advancing Regulatory Science Initiative and led by the Office of the Chief Scientist, the program aimed to support new ideas, tools, and approaches that would make the development and evaluation of medical products more modern, evidence-based, and efficient, while maintaining a strong focus on safety and effectiveness for products intended to diagnose, treat, and prevent diseases and other conditions.
The core purpose of the announcement was to establish one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI) located in the national capital region. These centers were intended to create an innovative and thematically coherent research and training environment focused on advancing regulatory science across multiple domains. The FOA explicitly framed regulatory science broadly, encompassing laboratory sciences, population sciences, behavioral sciences, and manufacturing sciences, reflecting the wide range of scientific questions that influence how FDA evaluates product quality, safety, performance, and real-world use. In addition, the centers were expected to contribute to the FDAs Critical Path Initiative, which is focused on improving the scientific tools and methods used to translate discoveries into dependable medical products and to streamline product development without compromising standards.
Funding was structured as a cooperative agreement (U01), which generally signals a more hands-on partnership between the funder and awardees than a traditional grant. That model fits the intent of CERSI awards: to align academic work with FDA priorities, encourage regular interaction with FDA experts, and ensure that outputs are directly relevant to regulatory decision-making and product evaluation challenges. The announcement anticipated making two awards, with an estimated total program funding level of $2,000,000 and an award ceiling of $1,000,000 per award. No cost sharing or matching funds were required, lowering a common barrier to participation and allowing institutions to focus resources on the proposed scientific and programmatic work.
Eligibility was intentionally narrow and place-based. Applicants had to be MD- and PhD-granting institutions of higher education located within a 50-mile radius of the FDAs Silver Spring, Maryland campus, reinforcing the expectation of frequent engagement, collaboration, and practical integration with FDA staff and activities. Both public/state-controlled and private institutions were eligible. The FOA also highlighted that certain institution types are always encouraged to apply for FDA support, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian-serving institutions, signaling an interest in broadening participation and building inclusive pipelines in regulatory science.
From an administrative perspective, the opportunity was posted on July 15, 2011, with an original and final closing date of August 15, 2011, and it was archived on August 16, 2011. The CFDA program listing associated with the funding was 93.103 (Food and Drug Administration Research). The activity categories spanned education, health, information and statistics, and science and technology/other research and development, which reflects the mixed nature of what a CERSI is meant to do: generate useful science, develop methods and data resources, and strengthen training and workforce development connected to regulatory challenges. A grants management contact was provided for applicants who had trouble accessing the full announcement materials.
Frequently Asked Questions (FAQs)
What is the name of this FDA funding opportunity?
The opportunity is titled "Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-11-033.
What type of award is this?
This is a discretionary cooperative agreement under the U01 activity code.
What does a U01 cooperative agreement imply for applicants and awardees?
A U01 generally reflects a more substantial, structured partnership with the funder than a traditional grant. In this program, it aligns with the intent to support close collaboration with FDA experts, regular interaction with FDA, and work products that directly inform regulatory science and regulatory decision-making.
Which FDA initiative is this opportunity associated with?
It was issued under the FDA's Advancing Regulatory Science Initiative and led by the Office of the Chief Scientist.
What is the overall purpose of this funding opportunity?
The purpose is to strengthen FDA's regulatory science capacity through close, structured collaboration with academic partners, supporting new ideas, tools, and approaches to modernize and improve how medical products are developed and evaluated while maintaining strong safety and effectiveness standards.
What is a CERSI in the context of this announcement?
CERSI stands for Collaborating Centers of Excellence in Regulatory Science and Innovation. The FOA aimed to establish one or more centers that create an innovative, thematically coherent research and training environment focused on advancing regulatory science across multiple domains.
Where were the CERSI centers expected to be located?
The centers were intended to be located in the national capital region, with eligibility tied to proximity to FDA's Silver Spring, Maryland campus.
How close to FDA did applicant institutions need to be?
Applicants had to be located within a 50-mile radius of FDA's Silver Spring, Maryland campus.
Why does the FOA require proximity to the FDA Silver Spring campus?
Based on the FOA description, the place-based requirement reinforces expectations for frequent engagement, collaboration, and practical integration with FDA staff and activities.
Who was eligible to apply?
Eligibility was limited to MD- and PhD-granting institutions of higher education within 50 miles of FDA's Silver Spring campus. Both public/state-controlled and private institutions were eligible.
Were any specific types of institutions encouraged to apply?
Yes. The FOA highlighted that certain institution types are always encouraged to apply for FDA support, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian-serving institutions.
Is cost sharing or matching required?
No. The FOA stated that no cost sharing or matching funds were required.
How many awards were anticipated?
The announcement anticipated making two awards.
What was the estimated total program funding?
The estimated total program funding level was $2,000,000.
What was the maximum award amount (award ceiling) per award?
The award ceiling was $1,000,000 per award.
What kinds of activities or outputs were the centers expected to support?
The centers were expected to support an integrated research and training environment and to advance regulatory science by developing new ideas, tools, and approaches that help make medical product development and evaluation more modern, evidence-based, and efficient, while maintaining a strong focus on safety and effectiveness.
How does the FOA define or frame "regulatory science"?
The FOA framed regulatory science broadly, spanning laboratory sciences, population sciences, behavioral sciences, and manufacturing sciences. This reflects the range of scientific questions that influence how FDA evaluates product quality, safety, performance, and real-world use.
How is this opportunity connected to the FDA Critical Path Initiative?
The centers were expected to contribute to FDA's Critical Path Initiative, which focuses on improving scientific tools and methods used to translate discoveries into dependable medical products and to streamline development without compromising standards.
What product areas does this program focus on?
The FOA emphasized medical products intended to diagnose, treat, and prevent diseases and other conditions, with continued emphasis on safety and effectiveness.
What were the posting and closing dates for this opportunity?
The opportunity was posted on July 15, 2011. The original and final closing date was August 15, 2011.
Is this funding opportunity still open?
No. The FOA was archived on August 16, 2011.
What CFDA program listing is associated with this opportunity?
The associated CFDA listing was 93.103 (Food and Drug Administration Research).
What activity categories were associated with the program?
The activity categories spanned education, health, information and statistics, and science and technology/other research and development.
Why do the activity categories span multiple areas like education and science?
The FOA described CERSI as having a mixed purpose: generating useful science, developing methods and data resources, and strengthening training and workforce development connected to regulatory challenges.
Who led the program within FDA?
The program was led by the FDA Office of the Chief Scientist.
What kind of relationship with FDA was expected during the award?
The cooperative agreement model and the CERSI concept indicate an expectation of close, structured collaboration, alignment with FDA priorities, regular interactions with FDA experts, and deliverables that are relevant to regulatory evaluation challenges.
Was a contact provided for administrative or access issues?
Yes. The opportunity noted that a grants management contact was provided for applicants who had trouble accessing the full announcement materials.
Browse more opportunities from the same category: Education Health Information and Statistics Science and Technology and other Research and Development
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Previous opportunity: FY 2011 Degrees at a Distance Program
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