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The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a grant to the Duke Universitys Duke Translational Medicine Institute (DTMI) to support increasing the quality and efficiency of clinical trials.
Funding Opportunity Number: RFA-FD-14-017. Assistance Listing: 93.103. Funding Instrument: G. Category: FN,HL. Award Amount: Up to $7.5M per award.
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Search similar grants →Based on current listing details, eligibility includes: Eligible applicants: Others (see text field entitled Additional Information on Eligibility for clarification). The following organization is eligible to apply: Duke Translational Medicine Institute located within Duke University. Applicants should confirm final requirements in the official notice before submission.
Current published award information indicates Up to $7.5M per award Always verify allowable costs, matching requirements, and funding caps directly in the sponsor documentation.
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The Center for Drug Evaluation and Research (CDER) receives a vast and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. This wealth of data holds great potential to advance CDER’s regulatory and scientific work, but the present lack of standardized data creates significant challenges to realizing that potential.The volume and complexity of drug-related information submitted to CDER for regulatory review is creating significant challenges to the Center’s ability to efficiently and effectively perform its critical public health mission.The lack of standardized data affects CDER’s review processes by curtailing a reviewer’s ability to perform integral tasks such as rapid acquisition, analysis, storage and reporting of regulatory data. Improved data quality, accessibility and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions and address late-emerging issues. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. This will enhance the Center’s performance across key drug regulatory functions and ongoing business operations, including pre-market review, post-market safety, oversight of drug quality, and oversight of drug promotion.In accordance with the Office of Management and Budget (OMB) Circular A-119, the FDA will: use voluntary, consensus-based standards development processes in place of government unique standards unless such standards are inconsistent with law or otherwise impractical; advocate to align these standards with existing health information technology initiatives, laws, regulations, and mandates; and promote coordination with other standards currently in use. The projects selected under this funding opportunity must adhere to these principles. Funding Opportunity Number: RFA-FD-15-033. Assistance Listing: 93.103. Funding Instrument: CA. Category: FN,IS. Award Amount: $50K – $225K per award.
The Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety (OFS) is announcing its intent to award a single source cooperative agreement to the Interstate Shellfish Sanitation Conference (ISSC). The purpose of this cooperative agreement is to enhance the FDA’s molluscan shellfish sanitation program and provide the public greater assurance of the quality and safety of these products. Molluscan shellfish have been recognized by FDA as a significant source of seafood-borne illnesses and continue to be the subject of congressional, state, industry, and public concern. FDA has given high priority to enhance the agency's shellfish safety program and to provide the public greater assurance of the quality and safety of these products. FDA administers the National Shellfish Sanitation Program (NSSP). Under that program, the NSSP Model Ordinance serves as guidance for State shellfish sanitation programs and the promulgation of state regulations and laws concerning shellfish safety. This cooperative agreement will enhance FDA efforts to help ensure that shellfish are free of harmful pathogens. Funding Opportunity Number: RFA-FD-16-006. Assistance Listing: 93.103. Funding Instrument: CA. Category: AG,CP,FN. Award Amount: Up to $500K per award.
The goal of these cooperative agreements is to facilitate long-term improvements to the national integrated food safety system by unifying and coordinating federal/state/local food/feed emergency response efforts including: 1) Strengthening the link among epidemiology, lab and environmental health/regulatory components; 2) Improving States' regulatory and surveillance food/feed protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards food/feed emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and 3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national capacity/capability development. This will be accomplished through the provision of funding to support development of multi-jurisdictional, multi-disciplinary Rapid Response Teams (RRTs) and will require extensive cooperation and coordination with FDA District Offices and other FDA program offices. Funding Opportunity Number: RFA-FD-16-032. Assistance Listing: 93.103. Funding Instrument: CA. Category: CP,FN,HL. Award Amount: Up to $300K per award.