Grants / Department of Health and Human Services / Food and Drug Administration

Center for Research on Complex Generics (U18) Clinical Trials Optional

Forecast Forecast, no dates yet Opportunity FOR-FD-25-004

• Award ceiling$1.5 million
• Award floor$1.5 million
• Expected awards1
• Total fundingnot stated
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity is open to any type of organization.

• 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
• Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses, individuals.

Is this a realistic fit?

• No cost sharing or match is required.

What the grant funds

The Food and Drug Administration (FDA) seeks to fund a Center for Research on Complex Generics under the terms and conditions of a cooperative agreement. The Center for Research on Complex Generics will support the FDA's efforts to enhance collaborations with the generic drug industry relating to generic drug research, to further the FDA's mission of increasing patient access to high quality, safe, and effective generic drugs. The goals of a Center for Research on Complex Generics include: 1) Facilitating engagement with generic industry representatives to help identify scientific challenges for generic product development or assessment, and helping to inform FDA about priority areas for research to address these challenges by supporting engagement and coordination between the FDA and key generic industry industry associations, companies, and representatives. 2) Providing a forum for experts from FDA, academia, the generic drug industry, and elsewhere to collaborate on research related to generic products. 3) Coordinating and conducting research projects pertaining to generic products, particularly complex generics. 4) Hosting scientific workshops, providing training, and supporting other educational activities pertaining to generic drug research. 5) Providing free and open public access to generic drug research outcomes such as scientific articles, posters, presentations, and other resources that help the generic drug industry to leverage scientific insights from FDA funded generic drug research. The Center for Research on Complex Generics is expected to complement FDA's existing regulatory science programs through its specific focus as a hub for coordination and engagement between FDA and the public, including academic experts, generic industry representatives, and other stakeholders.

Category: Agriculture, Consumer Protection, Food and Nutrition.

How to apply

1. Read the full notice and attachments on Grants.gov. The notice is the official source for deadlines and requirements.
2. Make sure your organization has an active SAM.gov registration and Unique Entity ID; registration can take several weeks.
3. Register on Grants.gov and submit through Workspace before the deadline and time given in the notice. Our application guide walks through each step.

Questions go to Terrin Brown, Grantor, terrin.brown@fda.hhs.gov, 2404027610.

Open the official notice