Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) | RFA FD 16 036

Opportunity Information: Apply for RFA FD 16 036

The FDA grant opportunity titled "Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)" (Funding Opportunity Number RFA-FD-16-036) supports the creation and continued operation of Centers of Excellence in Regulatory Science and Innovation, commonly referred to as CERSIs. It sits under the FDA's Advancing Regulatory Science Initiative and is managed through the Office of the Chief Scientist. The main purpose is to strengthen and modernize regulatory science by funding work that develops new tools, standards, and scientific approaches the FDA can use to evaluate the safety, effectiveness, quality, and real-world performance of products the agency regulates. In practical terms, the program is meant to help the FDA keep pace with rapidly evolving technologies and scientific methods across areas like drugs, biologics, medical devices, and foods, by investing in research and infrastructure that improves how regulatory decisions are made.

This award uses a cooperative agreement mechanism (U01), which generally means the FDA expects active involvement with recipients rather than a hands-off grant relationship. The CERSIs are expected to do more than publish research; they are designed to operate as collaborative hubs that connect academic, nonprofit, government, and industry-relevant expertise with FDA priorities. The announcement emphasizes three major pillars of work: cutting-edge research that addresses regulatory science challenges, high-quality training and educational programming to build the regulatory science workforce, and ongoing collaborative interactions with the FDA and broader stakeholders. Those collaborations can include scientific exchanges, workshops, seminars, and similar convenings that help spread best practices, align on standards, and translate research outputs into tools the agency can actually use.

The funding announcement is structured to support, as funds allow, both the competing continuation of existing CERSIs and the establishment of new ones. That means institutions with an existing center could apply to renew and expand their work, while new applicants could propose building a new center aligned with FDA needs. The program anticipated multiple awards, with an expected total of about six awards listed in the opportunity details. The award ceiling shown for this opportunity is up to $5,000,000, signaling that these centers may be resourced at a level appropriate for multi-project, multi-partner efforts that include research, training, and sustained engagement activities rather than a single narrow project.

Eligible applicants span a broad range of U.S.-based organizations, reflecting the program's interest in building robust, cross-sector regulatory science capacity. Eligibility includes state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. At the same time, the opportunity clearly restricts foreign participation: non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by HHS policy are not allowed. In effect, applicants and the work they propose must be fully domestic.

Administratively, the opportunity is categorized as discretionary funding, with activity areas listed under consumer protection, food and nutrition, and health, and it is associated with CFDA number 93.103. The opportunity was created on April 25, 2016, and the original closing date was June 28, 2016. Even though those dates place this specific announcement in the past, the summary intent is clear: the FDA sought to fund U.S.-based centers that could partner closely with the agency to push forward regulatory science research, develop standards and evaluation methods, and train the next generation of scientists and professionals who can operate at the intersection of science, technology, and FDA regulatory decision-making.

• The Food and Drug Administration in the consumer protection, food and nutrition, health 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.
• This funding opportunity was created on 2016-04-25.
• Applicants must submit their applications by 2016-06-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $5,000,000.00 in funding.
• The number of recipients for this funding is limited to 6 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses.

Apply for RFA FD 16 036

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