About this grant
This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts. FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach. These projects can help foster drug product innovation to 1) support efforts to accelerate drug product development; 2) support approaches to advanced manufacturing; 3) facilitate translation of basic science discoveries into therapeutics; and 4) facilitate approaches to enhance the safety, efficacy, quality, and performance of drug products. Projects are identified by FDA. Multiple awards may be funded under this NOFO and are directly dependent on drug development priorities and subject to the availability of funding.
Who can apply
What it funds
How to apply
Read the full announcement on Grants.gov before you start. Federal applications are submitted through Grants.gov (or the agency's own system) and require a Unique Entity ID from SAM.gov. Registration can take several weeks, so start early. Contact: Terrin Brown Grantor · terrin.brown@fda.hhs.gov · (240) 402-7610
What are the odds for a first-time applicant?
A realistic target for an established nonprofit. 16% of awards go to first-time applicants and nonprofits win 20%. Based on 388 new awards in FY2023–25. The median award is $549,857. Expect about 70 days between posting and deadline.
Who can apply for Collaborations to Enhance Drug Development and Regulatory Science?
Eligible applicants: State governments; For-profit organizations; Public & state-controlled colleges; City or township governments; Private colleges & universities; Unrestricted (open to anyone); Federally recognized tribal governments; 501(c)(3) nonprofits; Special district governments; Public & Indian housing authorities; Small businesses; Native American tribal organizations; County governments; Nonprofits without 501(c)(3) status; Independent school districts.
When is the deadline?
The funder has forecast this opportunity but hasn't announced a deadline yet. Sign up for a reminder and we'll email you when it opens.
How much funding is available?
Individual awards: Up to $5.0M. Expected number of awards: 6.
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