Opportunity Information: Apply for RFA FD 15 009
Apply for RFA FD 15 009
- The Food Drug Administration in the education food and nutrition health sector is offering a public funding opportunity titled "Limited Competition for Renewal Applications 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 Mar 26, 2015 and posted on Mar 26, 2015.
- Applicants must submit their applications by Jun 1, 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 $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 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).
- Eligibility is limited to the Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI) at The University of Maryland and Georgetown University
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Opportunity Summary:
This grant opportunity, titled "Limited Competition for Renewal Applications Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)" (Funding Opportunity Number RFA-FD-15-009), is a Food and Drug Administration (FDA) funding announcement designed to renew support for two existing academic centers that partner with the FDA on regulatory science. It sits under the FDAs broader Advancing Regulatory Science Initiative, which is focused on strengthening the scientific foundation behind how FDA-regulated products are evaluated. In practical terms, the program is meant to accelerate the creation and improvement of tools, standards, and evaluation approaches that help determine whether products regulated by the FDA are safe, effective, high quality, and perform as intended.
The funding mechanism is a cooperative agreement (U01), which generally indicates an active partnership between the funding agency and the awardees, rather than a hands-off research grant. The activity category is listed under education, food and nutrition, and health, reflecting the cross-cutting nature of regulatory science and its role in public health. The intent is not just to fund isolated research projects, but to sustain thematically coherent, collaborative programs that can translate scientific advances into better regulatory decision-making and more efficient product development pathways.
Eligibility is narrowly limited, making this a true limited competition. Only two institutions are eligible to apply: the Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI) at the University of Maryland and at Georgetown University. This is described as a renewal opportunity, meaning it is aimed at continuing work already underway at these established centers, rather than launching new centers or opening competition to a broader set of universities or organizations.
The opportunity anticipates two awards in total, aligning with the two eligible CERSI sites. The estimated total funding is $500,000, with an award ceiling of $250,000, implying that each award could be funded up to $250,000. There is no cost sharing or matching requirement, so the applicants are not required to contribute non-federal funds as a condition of receiving the award. The CFDA number associated with this opportunity is 93.103, tied to the Food and Drug Administration.
In terms of scope, the CERSIs are expected to continue advancing regulatory science across a range of disciplines. The announcement explicitly references laboratory sciences, population sciences, behavioral sciences, and manufacturing sciences, signaling that the FDA is looking for a broad, integrated approach. The overarching goal is to make product development and evaluation more effective and more efficient, which can include improving testing methods, developing better standards for evaluation, generating evidence that supports regulatory decisions, and strengthening approaches that help predict real-world performance and safety.
Key administrative dates show the announcement was posted and created on March 26, 2015, with an original and current closing date of June 1, 2015, and an archive date of July 1, 2015. For applicants or interested parties seeking the full formal announcement, the listing points to the NIH Guide for Grants and Contracts as the source for the complete RFA text. The point of contact provided for access issues is Vieda Hubbard, Grants Management Specialist, reachable at Vieda.Hubbard@fda.hhs.gov.
Frequently Asked Questions (FAQs)
1) What is the title and funding opportunity number for this grant?
The opportunity is titled "Limited Competition for Renewal Applications Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)" and the Funding Opportunity Number is RFA-FD-15-009.
2) Which federal agency is offering this funding opportunity?
This is a Food and Drug Administration (FDA) funding announcement.
3) What is the program trying to accomplish?
The program is intended to renew support for existing academic centers that partner with the FDA on regulatory science. Its broader purpose is to strengthen the scientific foundation used to evaluate FDA-regulated products, including the development and improvement of tools, standards, and evaluation approaches that help determine whether products are safe, effective, high quality, and perform as intended.
4) Is this a new center competition or a renewal?
This is a renewal opportunity. It is designed to continue work already underway at established centers, rather than create new centers.
5) What kind of award mechanism is used (and what does it imply)?
The funding mechanism is a cooperative agreement (U01). In general, this indicates an active partnership between the funding agency and awardees, rather than a purely hands-off research grant.
6) What is meant by "limited competition" for this opportunity?
Eligibility is narrowly restricted. Only two institutions are eligible to apply, which makes this a true limited competition rather than an open solicitation.
7) Who is eligible to apply?
Only the Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI) at the University of Maryland and at Georgetown University are eligible to apply.
8) How many awards does the FDA expect to make?
The opportunity anticipates two awards in total, corresponding to the two eligible CERSI sites.
9) How much funding is available under this opportunity?
The estimated total funding is $500,000.
10) What is the maximum award amount (award ceiling)?
The award ceiling is $250,000, which implies each of the two awards could be funded up to $250,000.
11) Is cost sharing or matching required?
No. The announcement states there is no cost sharing or matching requirement, so applicants are not required to contribute non-federal funds as a condition of receiving the award.
12) What is the CFDA number associated with this program?
The CFDA number listed is 93.103 (Food and Drug Administration).
13) What broad initiative does this opportunity fall under?
It sits under the FDA's broader Advancing Regulatory Science Initiative, focused on strengthening the scientific basis for how FDA-regulated products are evaluated.
14) What types of work or disciplines are referenced in the scope?
The announcement references advancing regulatory science across laboratory sciences, population sciences, behavioral sciences, and manufacturing sciences, reflecting a broad and integrated approach.
15) What kinds of outcomes does the program emphasize?
The program emphasizes advances that can translate into better regulatory decision-making and more efficient product development pathways. Examples described include improving testing methods, developing better evaluation standards, generating evidence to support regulatory decisions, and strengthening approaches that help predict real-world performance and safety.
16) How is the activity category described?
The activity category is listed under education, food and nutrition, and health, highlighting the cross-cutting public health role of regulatory science.
17) When was the announcement posted and created?
The listing indicates the announcement was posted and created on March 26, 2015.
18) What were the closing and archive dates?
The original and current closing date is June 1, 2015, and the archive date is July 1, 2015.
19) Where can applicants find the full formal announcement text?
The listing points to the NIH Guide for Grants and Contracts as the source for the complete RFA text.
20) Who is the point of contact for access issues, and how can they be reached?
The point of contact for access issues is Vieda Hubbard, Grants Management Specialist. The email provided is Vieda.Hubbard@fda.hhs.gov.
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