NIH Funding Opportunities

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Weekly Funding Opportunities and Policy Notices from the National Institutes of Health.
Updated: 1 hour 12 min ago

Request for Information (RFI): Input on In-depth Stem Cell Characterization

Thu, 02/07/2019 - 10:44
Notice NOT-HL-19-679 from the NIH Guide for Grants and Contracts
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Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)

Thu, 02/07/2019 - 10:34
Funding Opportunity RFA-FD-19-010 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis and dermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
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Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)

Thu, 02/07/2019 - 10:27
Funding Opportunity RFA-FD-19-009 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to support research relevant to topical semisolid drug products that will help elucidate the relationship between a product's quality attributes and its functional properties. A specific purpose is to elucidate how characterizations of the arrangement of matter, including rheological characterizations (e.g., texture analysis, tribology) may correlate with and/or be predictive of sensorial differences perceived by human subjects (or patients). Upon the successful completion of this research, it should be possible to predict, based upon product quality characterizations, whether test and reference products that may be compositionally different are likely to have a comparable look and feel, including comparable perceptions of grittiness, silky-smoothness, and cooling sensation.
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Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)

Thu, 02/07/2019 - 07:59
Funding Opportunity RFA-FD-19-008 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to support the research and development necessary to elucidate specific considerations that may be uniquely relevant to evaluating the bioequivalence (BE) of ungual (nail), scalp, vaginal, or rectal topical drug products. A specific emphasis of this funding opportunity involves the development of in vitro or ex vivo, comparative product characterization-based BE approaches.
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Updates to NIH Policy on ESI Application Status

Thu, 02/07/2019 - 07:40
Notice NOT-OD-19-072 from the NIH Guide for Grants and Contracts
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Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed)

Thu, 02/07/2019 - 00:51
Funding Opportunity RFA-NS-19-022 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) is aimed at discovering, determining the selectivity and sensitivity, and externally validating biological measures to be used for assessing, prognosing and monitoring recovery of youth who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion. Resultant biological measures should be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in children ages 9 - 14.
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Notice of NIA's Participation in RFA-OD-19-001 "Botanical Dietary Supplements Research Centers (BDSRC) (U19 Clinical Trial Optional)"

Wed, 02/06/2019 - 23:01
Notice NOT-AG-19-006 from the NIH Guide for Grants and Contracts
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Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required)

Wed, 02/06/2019 - 07:56
Funding Opportunity RFA-FD-19-014 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to support research to develop and qualify a Patient Reported Outcome (PRO) for Non-Cystic Fibrosis Bronchiectasis (NCFB) under FDAs Drug Development Tools Qualification Program. This would include the qualitative phase of developing the instrument, quantitative phase of testing the instrument, and qualification of the instrument. It is expected that this qualified PRO would help improve upon the current design, conduct, and interpretation of anti-infective clinical trials in NCFB patients, for which optimal endpoints are currently lacking. This work directly aligns with FDAs research area of interest to stimulate innovation in clinical evaluations and personalized medicine to improve product performance and patient outcomes.
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Secondary Data Analysis to Examine Long-Term and/or Potential Cross-Over Effects of Prevention Interventions: What are the Benefits for Preventing Mental Health Disorders? (R01 Clinical Trial Not Allowed)

Wed, 02/06/2019 - 06:57
Funding Opportunity RFA-MH-20-110 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to encourage research to integrate/harmonize existing data sets from preventive intervention trials implemented early in life to: 1) examine risk and protective factors relevant to later mental health outcomes in childhood, adolescence and young adulthood; and 2) determine whether preventive interventions delivered earlier in life have long-term effects, and/or cross-over effects (e.g., unanticipated beneficial effects), on important mental health outcomes, including serious mental illness (e.g., depression, anxiety, suicide ideation and behaviors, psychosis behaviors).
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Transformative Research Award for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project (R01 Clinical Trial Not Allowed)

Tue, 02/05/2019 - 01:35
Funding Opportunity RFA-OD-19-016 from the NIH Guide for Grants and Contracts. The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project is soliciting applications for this Request for Applications (RFA) for Transformative R01 to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research with the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies. Applications from individuals with diverse backgrounds and in any topic relevant to Down syndrome research are welcome. Little or no preliminary data are expected. Projects must clearly demonstrate the potential to produce a major impact in research related to Down syndrome.
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Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required)

Tue, 02/05/2019 - 01:35
Funding Opportunity RFA-OD-19-018 from the NIH Guide for Grants and Contracts. This funding opportunity announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition of up to four years of expanded clinical trial support (R33), although the total duration of the award may not exceed five years. This FOA requires measurable R61 milestones.
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INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)

Tue, 02/05/2019 - 01:35
Funding Opportunity RFA-OD-19-015 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. The initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials.
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Biology of Bladder Cancer (R21 Clinical Trial Optional)

Mon, 02/04/2019 - 23:45
Funding Opportunity PAR-19-184 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits applications investigating the biology and underlying mechanisms of bladder cancer. Bladder cancer is a significant health problem both in the United States and globally. Because of the high incidence and frequent tumor recurrence, bladder cancer exacts an outsized medical burden. While recent progress has been made in the molecular profiling of bladder cancers and identification of mutated genes, relatively little is known regarding the molecular mechanisms driving initiation, progression, and malignancy of bladder cancer. Furthermore, our understanding of biological processes of the normal bladder at the molecular, cell and organ levels is limited. Fundamental knowledge of how molecular and cellular functions of the bladder are altered in cancer will aid our understanding of bladder cancer biology and interventions. Applications that involve multidisciplinary teams and use clinical specimens or investigate both normal and cancer processes are encouraged.
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