Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed
ID: 351621Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $350K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351621

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-020.html
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a funding opportunity aimed at addressing nitrosamine impurities in human drugs through a cooperative agreement (U01). The initiative seeks to enhance research methodologies and practices that mitigate risks associated with nitrosamines while ensuring continued access to essential medications. This funding, totaling $350,000 for a one-year project, invites applications from a diverse range of organizations, including higher education institutions and nonprofits, with a submission deadline of February 27, 2024. Interested applicants can find more information and guidelines by contacting Terrin Brown at terrin.brown@fda.hhs.gov or visiting the official announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-020.html.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-020.html
    The Food and Drug Administration (FDA) is announcing a Notice of Funding Opportunity (NOFO) aimed at addressing nitrosamine impurities in human drugs through research projects financed under a cooperative agreement (U01). The initiative aligns with the FDA's mission of safeguarding public health by requiring significant advancements in research methodologies and practices that mitigate risks while ensuring access to essential medications. The funding, set at $350,000 for one year, invites applications from a wide array of eligible organizations including higher education institutions, nonprofits, and various levels of government, starting from December 27, 2023, with an expected award date of April 2024. Key objectives include identifying and prioritizing research on nitrosamine assessment methods, determining the feasibility of a nitrosamine-specific database, and ensuring ongoing research continuity post-funding. Applicants must adhere to strict submission guidelines, including registering with relevant federal systems and following specified application formats. The review process will evaluate criteria such as significance, innovation, and approach, ultimately impacting the selection for funding. This NOFO represents a proactive approach to ensuring drug safety within established public health frameworks.
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