Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
Food and Drug Administration
Description
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.
Award amount
$350,000 – $350,000
Eligibility
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statementfrom the review of the previous new (A0) application.
Who can apply: For-Profit Businesses, Government & Tribal, Schools & Colleges, Nonprofits, Individuals, Small Businesses
This is a forecasted opportunity. Watch Grants.gov for the official notice; applications open once it is posted. You'll need SAM.gov (UEI) and Grants.gov registrations.
The purpose of the R01 grant program is to (1) improve understanding of the risks and conditions associated with occupational diseases and injuries, (2) identify and evaluate methods to reduce risks and prevent or minimize exposure to hazardous workplace conditions, and (3) translate scientific findings into practical prevention strategies, interventions, and products that reduce work-related illnesses and injuries. The Research Project Grant (R01) supports a discrete, specified research project in scientific areas that reflect the investigator's expertise and interests and that align with the mission of NIOSH. Applicants must concisely describe the occupational health problem their proposal addresses and explain how the proposed research activities will lead to outputs that help address this problem. Applicants should clearly describe the expected impacts of the proposed research, both during the project period and beyond.
Established in 1985, the Department of War Multidisciplinary University Research Initiative (MURI) program funds U.S. academic research teams to conduct high-impact basic research that addresses future challenges faced by the Department of War. The MURI program specifically supports U.S. university teams investigating complex, DoW-relevant problem sets at the intersection of multiple scientific disciplines. MURI teams bring together world-class faculty, postdoctoral researchers, and graduate students - helping to develop a technically advanced, defense-aware scientific workforce and strengthen the U.S. defense industrial base.
The purpose is to ensure funds generated by the sales of upland game bird hunting validations and stamps are used in programs and projects to benefit upland game bird species and their constituents.
CDFW may make grants to, reimburse, or enter into contracts or other agreements, as defined in subdivision (a) of Section 1571, with public and private entities, including universities, nonprofit organizations, and California Native American tribes, as defined in Section 21073 of the Public Resources Code, for the use of the funds from the Upland Game Bird Account to carry out the purposes of Fish and Game Code §3684, including related habitat conservation projects. Any proposal fitting the criteria in this statue is qualified to be funded.
Environment and ConservationResearch and EvaluationScience
The National Library of Medicine (NLM) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for Regional Medical Libraries of the Network of the National Library of Medicine (NNLM).
Established in 1965 and organized geographically across the United States and its territories, the NNLM promotes and supports the initiatives, products, and services of the NLM and the National Institutes of Health (NIH). Over the years, the network has expanded its impact through strategic partnerships with a broad array of member organizations, including health sciences, hospital, academic, and public libraries; health professionals; data organizations; and community-based groups.
The NNLM’s core mission is to enable the effective use of - and contribution to - health information and data made available by the NLM and NIH. The network achieves this by providing professional development for librarians and information specialists, and by supporting access to health information and outreach through libraries and community organizations. A central emphasis of the NNLM is increasing awareness of and engagement with NIH programs and resources.
While the NNLM has traditionally focused on promoting NLM-specific products, it is now poised to expand its reach across the broader NIH community. The network will play a vital role in disseminating research findings, fostering community engagement and partnerships, and supporting participation in local clinical research. In doing so, the NNLM will enhance public understanding of NIH’s contributions and increase the use of NIH-supported information and data resources.
The NNLM consists of three major components: 1) the Network Coordinating Center (NCC), 2) Regional Medical Libraries (RMLs), and 3) the Network Training Center (NTC). This announcement specifically pertains to RMLs, with companion NOFOs forthcoming for the NCC and NTC.
The RMLs will be responsible for generating and maintaining an active, engaged membership of organizations focused on biomedical health information and data dissemination, training, and literacy. The RMLs will work with the NCC and NTC to promote the activities, products, and services of the NLM as well as the NIH. The RMLs will work with the NCC to evaluate progress, performance, and impact of the Network, including the use of common metrics (standardized measures collected and reported), as well as proposed site-specific goals. The RMLs will collaborate with the NTC to identify training needs and execute professional development or information access programming.
The RMLs should have strong competencies in building and managing long-term partnerships with groups and organizations, deep understanding of biomedical information and data sciences, and institutional connections with a health science library.
Grant authority that allows NLM to forecast this opportunity is as follows: Medical Library Assistance Act of 1965 (MLAA, P.L. 89-291).
Arts and CultureLiteracy and LibrariesHealth and Medical