Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed

The summary for the Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed: The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.The proposed work directly supports the U.S. FDA's stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities. In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.

Federal Grant Title:	Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Agriculture Consumer Protection Food and Nutrition
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-24-020
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	February 27th, 2024
Original Application Deadline:	February 27th, 2024
Posted Date:	December 21st, 2023
Creation Date:	December 21st, 2023
Archive Date:	March 28th, 2024
Total Program Funding:	$350,000
Maximum Federal Grant Award:	$350,000
Minimum Federal Grant Award:
Expected Number of Awards:	1
Cost Sharing or Matching:	No
Last Updated:	December 21st, 2023

Applicants Eligible for this Grant: 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 below), subject to any clarification in text field entitled "Additional Information on Eligibility"
Grant Announcement Contact: Terrin Brown
Grantor
Phone 2404027610
[email protected]
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