Therapeutics Development NOFOsRFA-OD-24-014: Botanical Dietary Supplements Translational Research Teams (RM1 Clinical Trial Required)RFA-DA-25-028: Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders …

ברוכים הבאים לאזור שירותים לסטודנט/ית . חדש: ניתן לשלוח אישורים ותדפיסים ישירות למוסדות אקדמיים נוספים דרך אישורים ותדפיסים -> לחיצה על סמליל הדוא"ל בצמוד לאישור המבוקש. לידיעתכם: לשאלות, הצעות שיפור או תגובות אחרות, נא ...

PAR-22-192 and PAR-22-193 support applications to develop and implement investigator-initiated multi-site clinical trials. Clinical trials supported by these NOFOs include Phase …

UG3: Describe the milestones to be completed during this 1-year time, including their rationale and justification. These can include, for example, establishing the sIRB, contracts and reliance agreements with sites, production of …

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As part of a bi-phasic approach to funding exploratory and/or developmental research, the UG3 provides support for the first phase of the award. This activity code is used in lieu of the UH2 activity code when larger budgets and/or project periods are required to establish feasibility for the project.

The UG3/UH3 application must be submitted as a single application at the time of the initial application. The UG3 phase will permit both scientific and operational planning activities. The UH3 phase of the award will support the clinical trial of the drug, biologic, device, or behavior intervention (and if needed, additional scientific studies).

The UG3/UH3 is a phased cooperative agreement award. The BPN uses the UG3/UH3 award to pay for work that will be conducted by the Principal Investigator (PI). The UG3 …

The purpose of these Notices of Funding Opportunities is to encourage investigators (UG3/UH3 mechanism) and Small Business Concerns (SBCs) (U44 mechanism) to pursue translational activities and clinical feasibility studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or …

Yes, if your proposed structural intervention involved multi-sectoral collaborations and focused on prevention. However, you will need to modify your application to fit the requirements of PAR-24-053 and the UG3/UH3 activity code. The required application sections, components, page limits, and review criteria differ from those in the CHESI …

Therefore, a UG3/UH3 award will support the planning phase (UG3) and the implementation phase (UH3) of a single trial that has met the scientific milestones and feasibility requirements for transition. Applications designed to test the efficacy of a behavioral intervention will not be supportedby this FOA. Scope of the UG3/UH3 FOA

The UG3 planning-exploratory phase will be focused on the recruitment of study participants and data collection. Milestones to be accomplished in the UG3 phase for transition to the …

What is the UG3/UH3 mechanism? The UG3/UH3 mechanism is a Cooperative Agreement that involves two phases. The UG3 phase will support projects with specific milestones to be accomplished by the end of the first 2 years. Applications must include Transition Milestones to be assessed at the end of the UG3 phase.

This NOFO uses a phased innovation approach (UG3/UH3). In the UG3 phase, milestones should be designed around the next stage of device or treatment development. The UG3 phase provides support for up to two years with specific milestones determined by the investigator and expected to be accomplished by the end of the UG3 phase.

This project involves the construction of a manual to assist researchers with submitting an NHLBI grant application using the funding opportunity announcement PAR-18-407 for …

Funding Opportunity Description) "During the UG3/UH3 phase, multiple clinical/community awardees that receive the UG3 awards will work together with the RCC (RFA-HL-22-008) and project office staff to develop one common protocol (including study design, analytic plan, sample size) to be used across multiple awardee sites in the UH3 phase.

The maximum period of the combined UG3 and UH3 phases is 7 years, with up to 2 years for the UG3 phase, and up to 5 years for the UH3 phase. The scope of the proposed project should determine the project period. Only those UG3 trials that meet the scientific milestones and award requirements of the UG3 may transition to the UH3 phase.

The UG3 phase, for up to two years, is designed to support a project with specific milestones to be accomplished by the end of the period. The UH3 phase is to provide funding for up to three additional years following successful completion of the UG3. UG3 projects that meet their milestones will be administratively considered by the National ...

For UG3/UH3 and U44 awards, IRB/FDA approval is required prior to release of funds for the clinical studies. All Applicants are strongly encouraged to contact translational devices staff at least two months prior to the receipt date. Resources and Tools Contacts. NINDS-Devices@nih.gov.

A2. Here you will find the webinar slides for the DECIPHeR UG3/UH3 FOA RFA-HL-20-003. Likewise, the link to the webinar slides for DECIPHeR U24 FOA RFA-HL-20-004 is …

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The UG3 phase will permit both scientific and operational planning activities. The UH3 phase of the award will support the clinical trial of the drug, biologic or device. The UG3 …

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This program utilizes a two-phase, milestone-driven cooperative agreement (UG3/UH3) mechanism consisting of a start-up phase of up to one year (UG3) and a full enrollment and clinical trial execution phase (UH3). Proposed projects should be investigator-initiated, single or multi-site, interventional clinical trials with clear objectives for ...

The UG3 phase will provide support for late stage pre-clinical work and clinical trial planning that is conducted at applicant institutions. The goal of any collaboration with TDB is to …

Specifically, this FOA will support research that tests the impact of cancer-related interventions on cancer-related outcomes across the cancer control continuum using a …

Requirements: UH3 Phase. UH3 Phase of the application must include plans and activities to test the. effect of a cancer-related intervention on a cancer-related outcome in a …

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The Pain Therapeutics Development Program is supported by notice of funding opportunity: RFA-NS-21-010, "Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)". The goal of this grant program is to accelerate the development of novel, non-opioid, non-addictive ...

r21, r01, ug3/uh3 07/01/2025 Notice of Special Interest (NOSI): Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42, R43/R44 Clinical Trial Not Allowed)

This NOFO will utilize the UG3/UH3 phased cooperative agreement activity code. A UG3 milestone plan is required. Details of the planned NOFO are provided below. Research Initiative Details This Notice encourages investigators to prepare to apply for large clinical trial implementation cooperative agreements within the NIAMS mission areas. ...

The UG3 Planning-Exploratory Phase is focused on the recruitment of study participants and data collection, and the UH3 Implementation Phase is focused on completing the research agenda. UH3s will be awarded pending administrative review of eligible UG3s that have met the scientific milestones necessary for the UH3 phase, depending on the ...

Research Grants (UG3/UH3 or U44) All projects that enter BPN-Biologics begin with a UG3 phase (or U44 Phase I) of up to two years, which should be used to complete all lead optimization activities (for Discovery-stage projects) or any additional preparatory activities needed to initiate IND-enabling studies (for Development-stage projects).