Opportunity Information: Apply for RFA FD 13 034
Apply for RFA FD 13 034
- The Food Drug Administration in the agriculture business and commerce consumer protection education employment, labor and training environment food and nutrition 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 Jun 25, 2013 and posted on May 17, 2013.
- Applicants must submit their applications by Jul 8, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,400,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,400,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education 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
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The Food and Drug Administration (FDA) grant opportunity titled "Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)" (Funding Opportunity Number RFA-FD-13-034) was designed to fund one or more academic-based Collaborating Centers of Excellence in Regulatory Science and Innovation, commonly referred to as CERSIs. The central purpose of the program is to strengthen and modernize regulatory science, which FDA defines as the science of developing new tools, standards, and approaches to better evaluate the safety, efficacy, quality, and performance of products regulated by FDA. In practical terms, the FDA was looking to partner with top-tier institutions that can help generate new methods and evidence that make product development, review, and oversight more effective, more efficient, and more scientifically current.
This funding mechanism is a cooperative agreement (U01), which generally indicates substantial scientific or programmatic involvement by the FDA during the project period. Rather than operating as a traditional, hands-off research grant, the CERSI model emphasizes active collaboration between FDA and the awardee(s). The overall vision is to create internationally recognized centers with deep expertise in one or more regulatory science domains and to build a coherent, theme-driven program of work that aligns with FDA priorities, including those described in FDA's Strategic Plan for Regulatory Science and the broader goals of the Critical Path Initiative aimed at streamlining and improving product development and evaluation.
The scope of regulatory science under this announcement is intentionally broad. It includes laboratory science, population-based science, behavioral science, and manufacturing science, along with other relevant program areas tied to FDA's regulatory mission. The expectation is that CERSIs will contribute not only through research, but also through activities that build capacity and spread best practices, such as training programs, applied collaborative science projects with FDA, professional development opportunities, and scientific exchanges. In other words, the centers are intended to be hubs where practical regulatory questions can be tackled with strong science while also developing the workforce and partnerships needed to keep that science moving into real-world use.
The opportunity anticipated making about two awards, with an estimated total funding amount of $1.4 million. Individual awards were expected to fall between $700,000 (award floor) and $1.4 million (award ceiling). There was no cost-sharing or matching requirement stated. Eligible applicants included public and state-controlled institutions of higher education as well as private institutions of higher education. The announcement also specifically identified eligibility-relevant institution types such as Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions. Applicants could apply as a single institution or as a consortium involving multiple institutions, which signals that FDA was open to center models that combine complementary strengths across organizations.
A notable feature of this FOA is the emphasis on sustainability beyond the period of federal support. Applicants were encouraged to include plans and business models describing how the center would continue functioning as an FDA-partnering expert scientific resource after the CERSI funding ends. This highlights that FDA was not just funding isolated projects, but trying to seed durable partnerships and infrastructure that could continue to contribute to regulatory science priorities over time.
Administratively, the opportunity was posted on May 17, 2013, with a closing date of July 8, 2013, and an archive date of August 7, 2013. The associated CFDA number listed is 93.103 (Food and Drug Administration Research). For applicants needing support accessing the full announcement, the listed grants management contact was Vieda Hubbard, Grants Management Specialist, reachable at 301-827-7177 or vieda.hubbard@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the title of this FDA grant opportunity?
The grant opportunity is titled "Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)," commonly referred to as CERSIs.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-13-034.
What is the main goal of the CERSI program?
The central goal is to strengthen and modernize regulatory science by supporting academic-based centers that can help develop new tools, standards, and approaches to better evaluate the safety, efficacy, quality, and performance of products regulated by the FDA.
How does the FDA define "regulatory science" in this announcement?
FDA defines regulatory science as the science of developing new tools, standards, and approaches to better evaluate the safety, efficacy, quality, and performance of products regulated by FDA.
What type of award mechanism is used for this opportunity?
This opportunity uses a cooperative agreement mechanism (U01).
What does a U01 cooperative agreement imply about FDA involvement?
A U01 generally indicates substantial scientific or programmatic involvement by the FDA during the project period, meaning the work is designed to be actively collaborative rather than a hands-off research grant.
What kind of organizations was FDA looking to fund through this program?
FDA was looking to fund one or more academic-based Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSIs), described as top-tier institutions capable of contributing new methods and evidence to improve product development, review, and oversight.
How many awards were anticipated?
The opportunity anticipated making about two awards.
What was the estimated total funding amount for this opportunity?
The estimated total funding amount was $1.4 million.
What was the expected funding range per award?
Individual awards were expected to range from an award floor of $700,000 up to an award ceiling of $1.4 million.
Was cost sharing or a match required?
No cost-sharing or matching requirement was stated.
Who was eligible to apply?
Eligible applicants included public and state-controlled institutions of higher education and private institutions of higher education.
Which institution types were specifically highlighted as eligible or relevant?
The announcement specifically identified eligibility-relevant institution types including Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Could applicants apply as a consortium?
Yes. Applicants could apply as a single institution or as a consortium involving multiple institutions, indicating FDA was open to center models that combine complementary strengths across organizations.
What kinds of regulatory science areas were included in the scope?
The scope was intentionally broad and included laboratory science, population-based science, behavioral science, and manufacturing science, along with other program areas tied to FDA's regulatory mission.
Beyond research, what activities were CERSIs expected to contribute?
In addition to research, CERSIs were expected to build capacity and spread best practices through activities such as training programs, applied collaborative science projects with FDA, professional development opportunities, and scientific exchanges.
What is the overall vision for CERSIs under this FOA?
The vision is to create internationally recognized centers with deep expertise in one or more regulatory science domains and to build a coherent, theme-driven program of work aligned with FDA priorities.
What FDA priorities or frameworks were referenced as alignment targets?
The program was described as aligning with FDA priorities, including those in FDA's Strategic Plan for Regulatory Science, and with broader goals of the Critical Path Initiative aimed at improving and streamlining product development and evaluation.
Why does the announcement emphasize sustainability?
Applicants were encouraged to include plans and business models describing how the center would continue functioning as an FDA-partnering expert scientific resource after CERSI funding ends, signaling that FDA was aiming to seed durable partnerships and infrastructure rather than isolated projects.
When was the opportunity posted?
The opportunity was posted on May 17, 2013.
What was the application closing date?
The closing date was July 8, 2013.
When was the opportunity archived?
The archive date was August 7, 2013.
What is the CFDA number associated with this program?
The associated CFDA number listed is 93.103 (Food and Drug Administration Research).
Who was the listed grants management contact for assistance with the full announcement?
The listed grants management contact was Vieda Hubbard, Grants Management Specialist.
How could applicants contact the grants management specialist?
The contact phone number was 301-827-7177 and the email address was vieda.hubbard@fda.hhs.gov.
What is meant by "theme-driven" work in the context of this FOA?
The announcement described an expectation for a coherent, theme-driven program of work, meaning the center's activities should fit together under a clear set of regulatory science themes aligned with FDA priorities, rather than being a collection of unrelated projects.
In practical terms, what was FDA trying to achieve by partnering with academic centers?
FDA was looking to partner with institutions that could generate new methods and evidence to make product development, review, and oversight more effective, more efficient, and more scientifically current.
Browse more opportunities from the same category: Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Food and Nutrition Health Information and Statistics Science and Technology and other Researc
Next opportunity: National Public Health Practice and Resource Centers for Children with Attention Deficit/Hyperactivity Disorder or Tourette Syndrome
Previous opportunity: FY12 Crossroads of American Rail Improvements
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 13 034
[Watch] how do funding administrators access proposals?
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 13 034", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.