[Food and Drug Administration](https://www.fda.gov/)

To be announced (forecasted opportunity)

$20,000,000 (single award; cooperative agreement)

Supports the continued management of consortia established by the Critical Path Institute to advance drug innovation, development, and regulatory science.

Eligibility is limited to the Critical Path Institute; this is a renewal of a prior cooperative agreement.

--- ## Description This funding opportunity from the Food and Drug Administration (FDA) is a forecasted cooperative agreement intended to support the ongoing maintenance and management of existing consortia groups convened and established by the Critical Path Institute. The award is part of the FDA's Critical Path Initiative, which aims to foster innovation in drug product development, accelerate the development and manufacturing of therapeutics, and enhance the safety, efficacy, quality, and performance of medical products. The selected recipient will be responsible for developing and implementing innovative, collaborative projects in research, education, and outreach. These efforts are designed to advance regulatory science, promote drug innovation, and facilitate the translation of new therapies from research to clinical use. This opportunity is a renewal of cooperative agreement #5U18FD005320 and is authorized under Section 566 of the Federal Food, Drug, and Cosmetic Act. --- ## Due Dates - The application due date has not yet been announced; this is a forecasted opportunity. - Researchers should monitor the [official Grants.gov listing](https://www.grants.gov/search-results-detail/351251) for updates. --- ## Funding Amount - Total funding: $20,000,000 - Expected number of awards: 1 - Funding instrument: Cooperative agreement - Award ceiling and floor: $20,000,000 - Funding is subject to availability of FDA appropriations. --- ## Eligibility - **Eligible applicant:** Critical Path Institute (as specified in the opportunity). - No cost sharing or matching requirement. - This is a renewal opportunity; only the Critical Path Institute is eligible to apply. --- ## Application Process - Application details and deadlines will be provided upon official posting of the opportunity. - Interested parties should regularly check the [Grants.gov opportunity page](https://www.grants.gov/search-results-detail/351251) for updates and application instructions. - The application will require a detailed plan for maintaining and managing the consortia, as well as proposals for collaborative research, education, and outreach activities. --- ## Additional Information - This opportunity is part of the FDA's ongoing efforts to support regulatory science and drug development innovation. - The award supports the FDA's Critical Path Initiative, which seeks to modernize the scientific process through which medical products are developed, evaluated, and manufactured. - The funding is contingent on the availability of appropriated funds. --- ## External Links - [FDA Home Page](https://www.fda.gov/) - [Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/351251) - [Critical Path Initiative (Section 566, FD&C Act)](https://uscode.house.gov/view.xhtml?req=(title:21%20section:360bbb-5%20edition:prelim)) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|---------------------------------------|----------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | (240) 402-7610 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888) 463-6332 | ---

Critical Path Public Private Partnerships Clinical Trials Optional

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