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NIH pályázatok

NIH Mechanism for Time-Sensitive Research Opportunities in Environmental Health Sciences (R21). .5

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Parkinson's Disease Biomarker Program (PDBP) Discovery Projects (U01)............................................6

Research on Autism Spectrum Disorders (R03)......................................................................................7



Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)........................................................................10

Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01)...................................................................................................................................11

The Role of Extracellular RNA in Mediating the Health Effects of Alcohol (R21)..................................12

Structural Interventions, Alcohol Use, and Risk of HIV/AIDS (R21)......................................................13

Structural Interventions, Alcohol Use, and Risk of HIV/AIDS (R01)......................................................14

Addressing Health Disparities in NIDDK Diseases (R01)........................................................................15

Academic-Industrial Partnerships for Translation of in vivo Imaging Systems for Cancer Investigations (R01).....................................................................................................................................................16

Secondary Analyses of Existing Data Sets and Stored Biospecimens to Address Clinical Aging Research Questions (R01)....................................................................................................................................17

Alcohol Use Disorders: Treatment, Services, and Recovery Research (R03)........................................19

Alcohol Use Disorders: Treatment, Services, and Recovery Research (R21)........................................20

Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21/R33)..........................................................21

Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R21)...........................................................................................................................22

Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R01)...........................................................................................................................23

Acute Kidney Injury in Older Adults (R21)............................................................................................24



Bioengineering Research Grants (BRG) (R01).......................................................................................27

Program for Extramural/Intramural Alcohol Research Collaborations (U01).......................................28

Understanding and Promoting Health Literacy (R21)...........................................................................29



Research on Alcohol and HIV/AIDS (R21).............................................................................................32



Mechanisms, Models, Measurement, & Management in Pain Research (R03)....................................35

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Mechanistic Insights from Birth Cohorts (R01).....................................................................................36

School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes (R01). .37

School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes (R03). .38

School Nutrition and Physical Activity Policies, Obesogenic Behaviors, and Weight Outcomes (R21). 39

Accelerating the Pace of Drug Abuse Research Using Existing Data (R01)...........................................40

Prescription Drug Abuse(R21)..............................................................................................................41

Prescription Drug Abuse (R01).............................................................................................................42

Secondary Dataset Analyses in Heart, Lung, and Blood Diseases and Sleep Disorders (R21)...............43

Epigenetic Inheritance and Transgenerational Effects of Alcohol (R21)...............................................44

Epigenetic Inheritance and Transgenerational Effects of Alcohol (R01)...............................................45

Effects of In Utero Alcohol Exposure on Adult Health and Disease (R21).............................................46

Effects of In Utero Alcohol Exposure on Adult Health and Disease (R01).............................................47

Physical Activity and Weight Control Interventions Among Cancer Survivors: Effects on Biomarkers of Prognosis and Survival (R21)................................................................................................................48

NIH Exploratory/Developmental Research Grant Program (Parent R21).............................................49

NIH Small Research Grant Program (Parent R03).................................................................................50

Research Project Grant (Parent R01)....................................................................................................51

Dissemination and Implementation Research in Health (R03).............................................................52



Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Development Projects (UH2/UH3).......................................................................................................55

Biomarkers for the Lewy Body Dementias (U01)..................................................................................56

NIAID Clinical Trial Implementation Cooperative Agreement (U01).....................................................57

NIAID Clinical Trial Planning Grant (R34)..............................................................................................59

NIAID Clinical Trial Implementation Grant (R01)..................................................................................60

Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01)....................61

Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products (U01)....................................................................................................................................................62

Pre-application: Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (OT1).........................63

International Bioethics Research Training Program (D43)....................................................................64

NIGMS Program of Administrative Supplements for Equipment (Admin Supp)...................................65

The Early Detection Research Network: Biomarker Developmental Laboratories (U01).....................66

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NIH Mechanism for Time-Sensitive Research Opportunities in Environmental Health Sciences (R21)

PAR-13-136

Objectives: This funding opportunity announcement (FOA) is intended to support environmental health research in which an unpredictable opportunity has arisen to collect human biosample or exposure data (e.g., following natural or made-made disasters, health care policy changes, etc).

Topics / Research areas: The three distinguishing features of an eligible study are: 1) the unforeseeable nature of the opportunity; 2) the clear scientific value and feasibility of the study; and 3) the need for rapid review and funding (substantially shorter than the typical NIH grant review/award cycle) in order for the scientific question to be approached and for the research design to be implemented.

Who can apply / eligible applicants / criteria for participation / Beneficiaries:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Budget: The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year period.

Deadline: 05-03-2016

Other information (link): http://grants.nih.gov/grants/guide/pa-files/PAR-13-136.html

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http://grants.nih.gov/grants/guide/pa-files/PAR-13-136.html

Parkinson's Disease Biomarker Program (PDBP) Discovery Projects (U01)

PAR-14-259

Objectives: The purpose of this funding opportunity announcement (FOA) is to support up to three years of study for the discovery, assay optimization, and replication stages required for the development of biological biomarkers for Parkinson’s disease (PD).

Topics / Research areas: It is expected that studies funded under this FOA will integrate with and enhance theNINDS Parkinson's Disease Biomarker Program (PDBP). Discovery or pilot projects may use samples from either the PDBP or other extant biospecimens and data, as long as consent for the extant biospecimens and data enables deposition of all data into the PDBP Data Management Resource (DMR). It is expected that the replication stage study will use PDBP biospecimens and data. This FOA is only for studies related to human biomarkers; animal or other disease model studies are not appropriate for this FOA. A timeline including milestones is required for all studies. Annual milestones will provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years.



Budget: Application budgets are not limited but need to reflect the actual needs of the proposed project. Application budgets are expected to be between $200,000 to $490,000 per year in direct costs.

The project period for this FOA is 2 to 3 years. Award length is dependent upon whether discovery, assay qualification and replication stages are included, or whether the study targets replication only.



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https://pdbp.ninds.nih.gov/jsp/biorepository.jsp?parent=researchers

https://pdbp.ninds.nih.gov/jsp/data-management-resource.jsp

http://pdbp.ninds.nih.gov/

Research on Autism Spectrum Disorders (R03)

PA-13-218

Objectives: The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service delivery in relation to autism spectrum disorders (ASD).

Topics / Research areas: Autism Spectrum Disorders share a cluster of impairments in reciprocal social interaction, communication and the presence of stereotyped behavior, interests, or activities. These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation at home, in school, and in the community, thus representing a pressing public health need. The etiologies of these disorders are poorly understood, but are thought to include genetic, metabolic, immunologic, infectious or other environmental influences.



Budget: The combined budget for direct costs for the two year project period may not exceed $100,000. No more than $50,000 in direct costs may be requested in any single year.


Other information (link): http://grants.nih.gov/grants/guide/pa-files/PA-13-218.html

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PA-13-217


Topics / Research areas: Autism Spectrum Disorders share a cluster of impairments in reciprocal social interaction, communication, and the presence of stereotyped behavior, interests, or activities. These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation at home, in school, and in the community, thus representing a pressing public health need. The etiologies of these disorders are not yet understood, but may include a combination of genetic, metabolic, immunologic, infectious or other environmental influences.



Budget: The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.



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PA-13-216


Topics / Research areas: Autism Spectrum Disorders share a cluster of impairments in reciprocal social interaction, communication, and the presence of stereotyped behavior, interests, or activities. These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation at home, in school, and in the community, thus representing a pressing public health need. The etiologies of these disorders are not yet understood, but may include a combination of genetic, metabolic, immunologic, infectious or other environmental influences.



Budget: Application budgets are not limited, but need to reflect the actual needs of the proposed project.



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http://grants.nih.gov/grants/guide/pa-files/PA-13-216.html

Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)

PA-13-195

Objectives: This FOA encourages investigator-initiated R01 applications that propose to identify, validate and/or calibrate physiologic and/or behavioral measures in preclinical animal models of disorders associated with intellectual and developmental disabilities (IDD), particularly in the pediatric population

Topics / Research areas: This FOA addresses a significant need in the field: the identification of sensitive, reliable, and valid endpoints that can be used in preclinical animal testing and human clinical trials of therapeutic compounds for IDD. One of the goals of this FOA is to align and validate outcome measures and biomarkers developed for preclinical animal testing with endpoints currently or potentially used in human trials; this FOA focuses on preclinical measures that will predict safety and efficacy of interventions in humans with developmental disabilities. Applications may also propose preclinical animal trials or replication studies conducted in a rigorous, controlled and standardized manner. This FOA is designed to stimulate and accelerate ongoing clinical and translational research in the IDDs.



Budget: Budgets for direct costs of up to $499,999 per year may be requested.



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Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01)

PA-13-213

Objectives: This funding opportunity announcement (FOA) encourages Research Project Grant (R01) applications from institutions/organizations that propose to develop, validate, and/or calibrate informative outcome measures for use in clinical trials for individuals with intellectual and developmental disabilities (IDD). This FOA will address a significant need in the field, one that is especially apparent in efforts to develop pharmacological treatments for these populations.

Topics / Research areas:

Types of research appropriate for this FOA may include:

Research that identifies and demonstrates the efficacy of measures or instruments that currently exist and that can be used to effectively assess treatments for IDD population(s)

Research that identifies and demonstrates the efficacy of measures or instruments that currently exist but need modification to be used to effectively assess treatments for IDD population(s)

Research that develops and demonstrates the efficacy of new measures or instruments that can be used to effectively assess treatments for IDD population(s)

Development of measures or instruments for specific disorders or for combinations of phenotypes commonly observed in multiple disorders across IDD populations

Development of clinical rating scales for use in groups that are "challenging to assess" (e.g., non-verbal; those with sensory impairments, physical impairments, or attention deficits)



Budget:

Budgets for direct costs of up to $499,999 per year may be requested for a maximum of $2,499,996 direct costs over a five-year project period.



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The Role of Extracellular RNA in Mediating the Health Effects of Alcohol (R21)

PA-13-197

Objectives: The purpose of this FOA is to provide support for innovative research into the role of extracellular RNA (exRNA) in the development of alcohol-related diseases and end-organ injuries

Topics / Research areas:

Areas of alcohol research to which exRNA biology could be applied include but are not limited to:

Investigation of exRNAs in urine or serum as biomarkers of reversible alcohol-related tissue injury, in either human clinically relevant samples or animal models.

Investigation of exRNAs from exosomes in urine or serum as biomarkers of the beneficial effects of moderate alcohol consumption, in either human clinically relevant samples or animal models.

ExRNA signaling in relation to fetal alcohol exposure. Alterations in HDL-associated exRNAs under conditions of alcohol abuse and/or

obesity The role of exRNA signaling in gut-brain-liver-adipose tissue communication under

conditions of damaging or beneficial alcohol consumption. The role of exRNA signaling from peripheral organs in the addictive properties of

alcohol Studies of exRNA released from gut microbiota in relation to alcohol consumption Transcriptomic investigation of exRNA composition in different animal models of

alcohol exposure. Changes in hepatic exRNA production during the initiation and progression of

alcohol-related liver diseases including alcoholic hepatitis. The role of exRNA in mediating or modulating the effects of alcohol on immune

signaling and inflammation.



Budget: Direct costs may not exceed $200,000 in any year or $275,000 over the 2 year project period.



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Structural Interventions, Alcohol Use, and Risk of HIV/AIDS (R21)

PA-13-192

Objectives: This FOA requests research on the effectiveness of structural interventions that reduce the risk of HIV/AIDS transmission by changing the environment of alcohol use. Although a variety of structural and environmental interventions have been employed successfully to reduce other drinking-related problems, there has been relatively little research that extends such efforts into the realm of HIV/AIDS risk reduction.

Topics / Research areas: This FOA focuses on intermediate-level factors that directly affect the drinking environment. Hence, applications appropriate for this announcement will assess the impacts on HIV/AIDS risk of changes in one or more features of the alcohol consumption environment, including—but not limited to—changes in:

the form of alcohol availability (e.g., the sale of distilled spirits by the individual drink; ban on beer keg sales to individuals).

alcohol server training programs access of underage persons to alcohol establishment/enforcement of curfews to limit hours of alcohol sales to young

people, including restrictions on “happy hours” at alcohol-serving establishments alcohol counter-advertising campaigns retail prices of alcoholic beverages restrictions placed on alcohol advertisements enforcement of restrictions on public drinking establishment of Employee Assistance Programs implemented at work settings to

aid workers in curbing their alcohol use and related problems local zoning of alcohol outlets screening, assessment, and referral for intervention/treatment for mental disorders,

problem drinking, and HIV risk behavior physicians’ communication approaches with new HIV-positive patients concerning

their alcohol use policies and procedures in drinking establishments that affect intoxication levels

and/or the likelihood of engaging in subsequent hi-risk sex salience of warning labels on antiretroviral medications concerning drinking-

associated risks



Budget: The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.



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Structural Interventions, Alcohol Use, and Risk of HIV/AIDS (R01)

PA-13-191

Objectives: This FOA encourages research on the effectiveness of structural interventions that reduce the risk of HIV/AIDS transmission by changing the environment of alcohol use. Although a variety of structural and environmental interventions have been employed successfully to reduce other drinking-related problems, there has been relatively little research that extends such efforts into the realm of HIV/AIDS risk reduction.

Topics / Research areas: This FOA focuses on intermediate-level factors that directly affect the drinking environment. Hence, applications appropriate for this announcement will assess the impacts on HIV/AIDS risk of changes in one or more features of the alcohol consumption environment, including—but not limited to—changes in:

the form of alcohol availability (e.g., the sale of distilled spirits by the individual drink; ban on beer keg sales to individuals).

alcohol server training programs access of underage persons to alcohol establishment/enforcement of curfews to limit hours of alcohol sales to young

people, including restrictions on “happy hours” at alcohol-serving establishments alcohol counter-advertising campaigns retail prices of alcoholic beverages restrictions placed on alcohol advertisements enforcement of restrictions on public drinking establishment of Employee Assistance Programs implemented at work settings to

aid workers in curbing their alcohol use and related problems local zoning of alcohol outlets screening, assessment, and referral for intervention/treatment for mental disorders,

problem drinking, and HIV risk behavior physicians’ communication approaches with new HIV-positive patients concerning

their alcohol use policies and procedures in drinking establishments that affect intoxication levels

and/or the likelihood of engaging in subsequent hi-risk sex salience of warning labels on antiretroviral medications concerning drinking-

associated risks






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Addressing Health Disparities in NIDDK Diseases (R01)

PA-13-183

Objectives: The overall objective of this Funding Opportunity Announcement (FOA) is to understand and mitigate health disparities in the development, diagnosis, and treatment of diseases of high priority to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institutes of Health (NIH). It is recognized that both biologic and non-biologic factors may be operating in these underrepresented populations.

Topics / Research areas: Research approaches may include metabolic, genetic, clinical, behavioral, and/or epidemiologic studies in representative populations. Advantage might be taken of extant cohort studies that have been established for investigation of diabetes or other diseases.

Appropriate topics for investigation in NIDDK diseases would include but are not limited to:

Testing approaches that influence healthcare delivery to reduce disparities in prevention and treatment;

Better understanding of the racial and ethnic differences in screening, diagnosis, incidence, and prevalence of NIDDK diseases and whether there are differences among sub-groups in the rates of progression; with an emphasis on identifying factors that help inform treatment development, practice, or policy designed to reduce or eliminate disparities;

State-of-the-art, hypothesis-driven mechanistic studies to determine whether there are biological differences that might influence disease outcomes;

Studies to investigate environmental or behavioral factors, such as medical care, lifestyle, and socioeconomic status that may contribute to risk for development and progression of NIDDK diseases and related complications; and

Studies of effects of medications or other therapies for prevention or treatment of NIDDK diseases in racial or ethnic minority populations, including differences across the lifespan in these populations.






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Academic-Industrial Partnerships for Translation of in vivo Imaging Systems for Cancer Investigations (R01)

PAR-13-169

Objectives: This Funding Opportunity Announcement (FOA) encourages applications from research partnerships formed by academic and industrial investigators to accelerate the translation of either preclinical or clinical in vivo imaging systems and/or methods that are designed to solve a targeted cancer problem

Topics / Research areas: The proposed imaging system/methods may include single or multi-modality in vivo imaging and spectroscopy systems, image guided and drug delivery systems, image analysis, and related research resources.






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Secondary Analyses of Existing Data Sets and Stored Biospecimens to Address Clinical Aging Research Questions (R01)PA-13-168

Objectives: This funding opportunity will support activities addressing specific hypotheses in clinical aging research and/or inform the design and implementation of future epidemiologic or human intervention studies, or current geriatric practice in maintenance of health, management of disease, and prevention of disability.

Topics / Research areas: Secondary analyses of clinical data sets or stored biospecimens may include, but are not limited to:

Physiological factors affecting aging changes (e.g., endocrine, musculoskeletal health, reproductive aging) at different points in the life span, including factors contributing to healthy aging across the life span.

Variability in rates of aging changes and its determinants (e.g., genetic and other factors influencing slow rates of change in body composition/muscle mass, bone density, etc., with age).

Genetic and other determinants of exceptionally healthy aging, such as protective factors that prevent or slow common adverse age-related changes or events.

Differences in risk factors for age-related conditions at different ages, at different stages of disease progression, and in the presence or absence of co-existing conditions.

Early-life changes (e.g., during pubertal transition, adolescence) that influence health, either increased or decreased risk for diseases, in young adulthood or at later stages of life.

Complex effects of sustained caloric restriction in humans on protective and risk factors for aging processes and diseases associated with aging.

Physiologic, molecular, cellular and genetic mechanisms of sustained caloric restriction in humans.

Long-term health effects of interventions that are administered over a large part of the life span (e.g., antihypertensives, lipid lowering agents, analgesics).

Long-term effects of physical activity and lifestyle on health and functional outcomes throughout the life span.

Factors contributing to decline in functional status, development of disability, and loss of independence that are potential targets for interventions (1) in different care settings (community/outpatient; acute-care/hospital; long-term care facilities) and transitions between settings, and (2) in sub-groups of elders with special needs (e.g., cognitive impairment, vision or hearing loss, economic hardship).

Effects of specific combinations of two or more comorbid conditions or combinations of medications on risks for specific beneficial and/or adverse health outcomes.

Public health and cost impact of specific combinations of two or more chronic conditions.

Differences in health outcomes (effectiveness and safety) between alternative treatment regimens or health care management strategies for older patients with specific common conditions in old age, or with specific combinations of two or more chronic conditions.

Interactions among medications, disease processes, and health outcomes in complex older patients with multiple chronic conditions.

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Validation, revision, or development of new phenotypes for geriatric syndromes and conditions in older populations and population subgroups.

Occurrence and management of geriatric complaints, syndromes, or multi-factorial problems (e.g., fatigue, pain, frailty, unexplained anemia, urinary incontinence, falls, mobility disorders).

Potential differential effects of interventions due to age, race, gender or other factors through subgroup analyses of data from completed clinical trials.

Exploratory analyses, including assays on stored biospecimens, to explore effects of interventions on additional outcomes.

Analysis and meta-analysis of existing data sets to inform designs of future clinical trials (e.g., to determine prevalence of a disease or condition, or a combination of conditions in a population of interest; to estimate effects size of an intervention and duration of treatment in a population of interest, etc.)

Analysis or meta-analysis of existing data sets to explore opportunities for and determine the need for comparative effectiveness clinical trials in a topic area.

Methodology development. Single or multiple data sets may be used to develop and test new analytic approaches for any of the above topics. Methodological studies that address inferential issues in observational data on treatment effects, such as confounding by indication.






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Alcohol Use Disorders: Treatment, Services, and Recovery Research (R03)

PA-13-162

Objectives: This Funding Opportunity Announcement (FOA) invites applications to support research on various topics in the field of alcohol treatment and services for alcohol use disorders.

Topics / Research areas: Research objectives of this FOA include, but are not limited to, research within the following four broad research domains: (1) medications development for the treatment of alcohol use disorders and alcohol-induced tissue damage; (2) behavioral therapies and mechanisms of behavioral change; (3) health services research; and (4) recovery research. Cutting across these domains, NIAAA encourages treatment and health services-related studies on a number of special emphasis populations and topics including: (a) psychiatric/substance abuse/medical comorbidity, (b) adolescents, (c) fetal alcohol spectrum disorders, (d) health disparities/special populations, and (e) use of novel methods and technologies.



Budget:

Direct costs of up to $50,000 per year may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).

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Alcohol Use Disorders: Treatment, Services, and Recovery Research (R21)

PA-13-161

Objectives: This Funding Opportunity Announcement (FOA) invites applications to support research on various topics in the field of alcohol treatment and services for alcohol use disorders.

Topics / Research areas: Research objectives of this FOA include, but are not limited to, research within the following four broad research domains: (1) medications development for the treatment of alcohol use disorders and alcohol-induced tissue damage; (2) behavioral therapies and mechanisms of behavioral change; (3) health services research; and (4) recovery research. Cutting across these domains, NIAAA encourages treatment and health services-related studies on a number of special emphasis populations and topics including: (a) psychiatric/substance abuse/medical comorbidity, (b) adolescents, (c) fetal alcohol spectrum disorders, (d) health disparities/special populations, and (e) use of novel methods and technologies.



Budget:

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Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project.

Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.


Other information (link):http://grants.nih.gov/grants/guide/pa-files/PA-13-161.html

Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21/R33)

PA-13-158

Objectives: The purpose of this Funding Opportunity Announcement (FOA) is to facilitate the development of PET and SPECT probes for molecular targets that are implicated in the pathophysiology of brain and behavioral disorders (e.g., receptors, intracellular messengers, disease-related proteins).

Topics / Research areas: The following objectives would make appropriate topics for proposed R21/R33 projects. This list is not meant to be all-inclusive.

Lead compound identification/development and syntheses of chemicals with suitable binding affinity, biodistribution, pharmacokinetics, and physiochemical properties allowing radiochemical synthesis.

Pre-clinical studies, including: initial pharmacology and toxicology to screen out compounds that are unlikely to be promising candidates for PET or SPECT imaging; radiolabeling procedures; in vitro and ex vivo autoradiography; in vivo imaging including micro PET (rodent and/or primate); and studies of pharmacological specificity, biodistribution, and pharmacokinetics.

Determination of toxicology (FDA approved) for submission of an exploratory Investigational New Drug (IND) application or IND application.

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Exploratory IND or IND application development and submission to the FDA prior to pilot human studies.

Pilot human imaging studies with normal controls, pharmacological challenges with analyses of radiometabolites under the auspices of IRB approval (e.g., exploratory IND or IND development and submission).

Pilot studies of the PET or SPECT radiotracer in patient/disease populations to assess its utility for research in pathophysiology, drug discovery, or biomarker development.

The development and strengthening of partnerships between scientists from academia and the pharmaceutical industry is a highly desirable outcome of this FOA and is strongly encouraged.



Budget: Direct costs are limited to a maximum of $175,000 per year for the R21 phase and less than $500,000 per year for the R33 phase.



Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R21)

PA-13-154

Objectives: This FOA requests innovative applications for exploratory pilot/feasibility study and small clinical trial (R21) applications to test novel approaches for the prevention or management of overweight in infants and children (up to 6 years of age at the time of enrollment) in the context of the home environment, including parental/family involvement.

Topics / Research areas: This FOA is designed to encourage research applications that will identify behavioral and environmental interventions appropriate for infants and young children (less than age 6 years) with potential to improve prevention or management of overweight and obesity in childhood and contribute to reduced overweight later in life.



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Budget: The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.



Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R01)

PA-13-153

Objectives: This FOA requests innovative applications for randomized controlled trials to test novel approaches for the prevention or management of overweight in infants and children (up to 6 years of age at the time of enrollment) in the context of the home environment, including parental/family involvement.

Topics / Research areas: This FOA is designed to encourage research applications that will identify behavioral and environmental interventions appropriate for infants and young children (less than age 6 years) with potential to improve prevention or management of overweight and obesity in childhood and contribute to reduced overweight later in life.


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Budget:

Application budgets are not limited, but need to reflect the actual needs of the proposed project.



Acute Kidney Injury in Older Adults (R21)

PA-13-143

Objectives: Among all age groups, older adults are the most vulnerable to develop acute kidney injury (AKI), defined as a precipitous decline in glomerular filtration rate (GFR). Overall AKI incidence has increased over the past decades, and the rate has grown fastest in those over 75 years old, who also comprise the most rapidly expanding age group in the U.S. population.

Topics / Research areas: This FOA invites mechanistic and clinical research applications in both animal models and in humans, addressing the etiology and risk factors, pathophysiology, diagnosis, prevention, treatment and/or consequences of AKI in older patients. This funding initiative supports small research projects that can be carried out in a short period of time with limited resources including pilot and feasibility studies,

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secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.







PA-13-142


Topics / Research areas: This FOA invites mechanistic and clinical research applications in both animal models and in humans, addressing the etiology and risk factors, pathophysiology, diagnosis, prevention, treatment and/or consequences of AKI in

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older patients. This funding initiative supports small research projects that can be carried out in a short period of time with limited resources including pilot and feasibility studies, secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.







PA-13-141


Topics / Research areas: This FOA invites mechanistic and clinical research applications in both animal models and in humans, addressing the etiology and risk

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factors, pathophysiology, diagnosis, prevention, treatment and/or consequences of AKI in older patients.






Bioengineering Research Grants (BRG) (R01)PAR-13-137

Objectives: The goal for a bioengineering research grant (BRG) is to foster the development of an innovative technology, model, technique, design, or method that has the potential for significant impact on biomedical research by infusing principles and concepts from the quantitative sciences.

Topics / Research areas: The purpose of this FOA is to encourage BRG applications that: 1) apply a multidisciplinary approach to the solution of a biomedical problem; and 2)

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integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. A BRG application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and is appropriate for small teams applying an integrative approach that can increase our understanding of and solve problems in biological, clinical or translational science.






Program for Extramural/Intramural Alcohol Research Collaborations (U01)

PAR-13-133

Objectives: The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from extramural research scientists who will develop projects

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addressing contemporary issues in alcohol research in close collaboration with NIAAA intramural scientists with unique expertise in those areas.

Topics / Research areas: The specific scientific knowledge to be gained from research supported by this special program could fit into any broad area of alcohol research of interest to the Institute, such as treatment, recovery, prevention, neuroscience and behavior, metabolism and health effects.



Budget: Application budgets need to reflect actual needs of the proposed project and may not exceed $250,000 direct cost per year. Exceptions to the cost limitation will require extensive justification, documentation and prior approval from NIAAA. These funds may only be used to support the activities within the PD(s)/PI(s) (extramural scientists) research laboratory.



Understanding and Promoting Health Literacy (R21)

PAR-13-132

Objectives: Researchers are encouraged to address health literacy as it pertains to health care, prevention, healthy living, chronic disease management, community health, cultural competence, and health disparities.

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Topics / Research areas: Research questions can focus on consumers, patients, providers, health care teams, educators, communities and organizations or systems.



Budget: The combined budget for direct costs for the two-year project may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitations of $275,000 for the combined, two-year project




PAR-13-131

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Budget: Project period is limited to $50,000 per year with a maximum of two years and $100,000. Budget needs to reflect actual needs of the proposed project.




PAR-13-130

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Budget:




Research on Alcohol and HIV/AIDS (R21)

32

PA-13-122

Objectives: The complex and global nature of unresolved questions surrounding alcohol and HIV/AIDS relationships underscores the need for a multidisciplinary approach to research.

Topics / Research areas: Investigators representing a broad array of academic disciplines and engaged in cross-cutting fields of science are encouraged to consider designing hypotheses-driven studies that utilize rigorous methodologies from epidemiological, clinical, and experimental research.



Budget:

The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.



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PA-13-121





Budget: Application budgets are not limited, but need to reflect actual needs of the proposed project.



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PA-13-120





Budget: The budget for direct costs may not exceed two $25,000 modules or $50,000 per year for up to two years.



35

Mechanisms, Models, Measurement, & Management in Pain Research (R03)

PA-13-117

Objectives: The purpose of this Funding Opportunity Announcement (FOA) is to inform the scientific community of the pain research interests of the various Institutes and Centers (ICs) at the National Institutes of Health (NIH) and to stimulate and foster a wide range of basic, clinical, and translational studies on pain as they relate to the missions of these ICs.

Topics / Research areas: New and innovative advances are needed in every area of pain research, from the microperspective of molecular sciences to the macro perspective of behavioral/social sciences. Although great strides have been made in some areas, such as the neural pathways of pain, chronic pain and the challenge of its treatment have remained uniquely individual and largely unsolved. Applications that seek to improve the understanding of the causes, costs, and societal effects of both acute and chronic pain and the relationships between the two are highly encouraged. Studies on the mechanisms underlying the transition from acute to chronic pain are also needed. Additionally, applications that link such understandings to the development of better approaches to therapeutic interventions, including complementary and alternative medicine (CAM) interventions, and self-management of acute and chronic pain are in keeping with the current translational focus of NIH and are encouraged



Budget:

Budgets for direct costs of up to $50,000 per year and a project duration of up to two years may be requested for a maximum of $100,000 direct costs over a two-year project period.



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Mechanistic Insights from Birth Cohorts (R01)

PAR-13-109

Objectives: Emerging epidemiological evidence has shown that prenatal exposures such as placental function, maternal over- or under-nutrition, maternal physical activity behaviors, and maternal sleep disorders may be associated with an increased risk of chronic diseases in the offspring, either as a child or adult. Little is known about the mechanisms by which such prenatal exposures lead to diabetes or obesity, renal, pulmonary, or cardiovascular or hematologic disease, neurodevelopmental disorders, or reproductive health (i.e. fertility) It is necessary to better understand: 1) The factors in utero that mediate these effects; 2) The critical periods in prenatal exposure/development that have untoward effects; and 3) The measurements/biomarkers along the developmental path that can predict disease in the offspring. Ultimately, a better mechanistic understanding of how prenatal exposures contribute to the etiology of chronic diseases and health conditions later in life will allow for the development of effective interventions during pregnancy or early life that may have a profound impact on disease prevention and the future health of the offspring.

Topics / Research areas: Applications submitted to this FOA should target diabetes or obesity, renal, pulmonary, or cardiovascular or hematologic disease, neurodevelopmental disorders, or reproductive health (i.e. fertility). Research areas may include, but are not limited to, the following topics.

Prenatal exposures that alter the epigenetic profile and predispose to disease susceptibility.

Factors that alter the maternal or offspring microbiome. Specific gene-environment interactions influenced by prenatal exposure. Prenatal exposure to maternal disease, condition, or medication. Presence of significant inflammation in utero and how it might be quantitatively

related to altered function of specific cell types in the offspring.



Budget:

Application budgets are limited to less than $500,000 in direct costs per year and need to reflect actual needs of the proposed project.



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School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes (R01)

PA-13-100

Objectives: The specific research objectives of this FOA are to understand how school-related policies impact the school and home environment, promote positive nutrition and physical activity behaviors, and decrease childhood obesity.

Topics / Research areas: The FOA encourages Research Project Grant (R01) applications that propose to: (1) foster multidisciplinary research that will evaluate how policies (federal, state and school district levels) can influence school physical activity and nutrition environments, youths’ obesogenic behaviors (e.g., nutrition and physical activity behaviors), and weight outcomes; (2) understand how schools are implementing these policies and examine multi-level influences on adoption and implementation at various levels (e.g. federal, state, school district, and school); and (3) understand the synergistic or counteractive effect of school nutrition and physical activity polices on the home and community environment and body weight. The Social Ecological Framework is one of several frameworks that can be used to examine the interrelations among polices aimed at the school and home environment, individual diet and physical activity behaviors and weight outcomes.



Budget:




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School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes (R03)

PA-13-099





Budget:

Application budgets are limited to $50,000 in direct costs per year.



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School Nutrition and Physical Activity Policies, Obesogenic Behaviors, and Weight Outcomes (R21)

PA-13-098





Budget:

Direct costs are limited to $275,000 over a two-year project period. No more than $200,000 may be requested in any single year.



40

Accelerating the Pace of Drug Abuse Research Using Existing Data (R01)

PAR-13-080

Objectives: NIH and other funders have invested millions of dollars in the collection of data to inform our understanding of drug abuse etiology, neurodevelopmental risk, epidemiology, treatment, prevention, and services, as well as associated HIV risk behaviors and outcomes. Yet much of these data have not been analyzed to their full potential, and further investigation provides opportunities to answer novel research questions at relatively low cost.

Topics / Research areas: The NIDA, NIAAA, and NCI are particularly interested in innovative analyses of extant data, including new aims that are being addressed with existing data, new or advanced methods of analyses, or novel combination and integration of datasets to allow the exploration of new questions.



Budget:

Budgets for direct costs of up to $150,000 direct costs per year and a project duration of up to three years may be requested, for a maximum of $450,000 direct costs over a three-year project period.



41

Prescription Drug Abuse(R21)

PA-13-016

Objectives: Through this announcement, NIDA encourages a broad range of research strategies to address the problem of prescription drug abuse.

Topics / Research areas: Across proposed research strategies, there is an interest in stimulating the development and integration of novel technologies (e.g., genetic, imaging, proteomic, and/or metabolomic methodologies) to observe and understand the etiology and biological and behavioral mechanisms associated with prescription drug abuse.



Budget: Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.



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Prescription Drug Abuse (R01)

PA-13-015

Objectives: Through this announcement, NIDA encourages a broad range of research strategies to address the problem of prescription drug abuse.

Topics / Research areas: Across proposed research strategies, there is an interest in stimulating the development and integration of novel technologies (e.g., genetic, imaging, proteomic, and/or metabolomic methodologies) to observe and understand the etiology and biological and behavioral mechanisms associated with prescription drug abuse.






43

Secondary Dataset Analyses in Heart, Lung, and Blood Diseases and Sleep Disorders (R21)

PAR-13-009

Objectives: The purpose of this funding opportunity is to stimulate well-focused secondary analyses of existing human datasets to test innovative hypotheses concerning the epidemiology, pathophysiology, prevention or treatment of diseases/conditions relevant to the NHLBI mission. Analyzing existing datasets in novel ways provides a cost-effective method to address research questions and generate preliminary data for subsequent research proposals.

Topics / Research areas: The following are examples of areas where analyses using existing datasets might be proposed under this program. These are only examples and are not meant to be inclusive. Applicants can propose other research consistent with the goals of the NHLBI.

Areas of cardiovascular research could include: medical and surgical management of atherosclerosis, treatment of hypertension, acute and chronic ischemia, outcomes in heart failure, therapies for peripheral vascular disease, treatment of various arrhythmias, management of valvular heart disease, and utilization of implantable devices. Examples of dataset sources that can support this research include; OAT, WHI, ACCORD, BARI2D, ESCAPE and large-scale epidemiologic research projects such as Framingham, CHS, CARDIA, and MESA as well as the NHLBI datasets.

Areas of research in blood diseases and transfusion medicine could include: treatment of sickle cell disease, studies of umbilical cord and bone marrow transplantation, outcomes of transfusion therapy with red blood cells or platelets, studies of other secondary outcomes such as multiple organ dysfunction, sepsis and transfusion related acute lung injury (TRALI). Examples of available dataset sources include the COBLT Study, the BMT Clinical Trials Network, Baby Hug, and TMH Clinical Trials Network.

Areas of research in lung diseases could include: risk factors and therapies for chronic pulmonary conditions such as COPD and asthma, causes of acute lung injury, treatments for cystic fibrosis, and diagnosis and treatment of sleep disordered breathing. Existing data on sleep and circadian phenotypes offer opportunities for novel investigations of lifestyle, stress, diet, physical activity and environmental risk factors for cardiopulmonary disease risk and outcomes. Examples of available dataset sources that would be amenable to secondary analyses include data from the ARDS Network, Asthma Net, Interstitial Pulmonary Fibrosis, PANDA, Framingham, Jackson Heart Study, ARIC, Cardiovascular Health Study, Sleep Heart Health Study, CARDIA, MESA, and others.

Who can apply / eligible applicants / criteria for participation / Beneficiaries:Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.




44

Epigenetic Inheritance and Transgenerational Effects of Alcohol (R21)

PA-13-004

Objectives: This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), encourages Exploratory/Developmental Research Grant Award (R21) applications proposing to conduct studies on alcohol-induced transgenerational effects and the role of epigenetic inheritance in these effects.

Topics / Research areas: Types of studies relevant to this FOA include, but are not limited to:

Define if there are critical times during the lifespan (including early development through adulthood) in which alcohol exposure results in stable transgenerational epigenetic modifications.

Tease apart the genetic vs. epigenetic vs. behavioral contributions (e.g., maternal care) to the transgenerational effects of alcohol.

Use genome-wide studies to characterize the transmission of epigenetic marks in multiple generation pedigrees; these could include studies in non-vertebrate and vertebrate model organisms and/or human populations.

Describe the alcohol-induced epigenetic modifications that produce specific transgenerational phenotypes.

Define the genomic regions most sensitive to epigenetic modifications that are transmitted across generations; e.g., the role of transposable elements in transgenerational epigenetic effects, how transposable elements escape silencing etc.

Characterize alcohol-induced epigenetic modifications in both somatic tissue (e.g., brain) and germ cells (e.g., egg and sperm).





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Epigenetic Inheritance and Transgenerational Effects of Alcohol (R01)

PA-13-003

Objectives: This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), encourages Exploratory/Developmental Research Grant Award (R21) applications proposing to conduct studies on alcohol-induced transgenerational effects and the role of epigenetic inheritance in these effects.

Topics / Research areas: Types of studies relevant to this FOA include, but are not limited to:

Define if there are critical times during the lifespan (including early development through adulthood) in which alcohol exposure results in stable transgenerational epigenetic modifications.

Tease apart the genetic vs. epigenetic vs. behavioral contributions (e.g., maternal care) to the transgenerational effects of alcohol.

Use genome-wide studies to characterize the transmission of epigenetic marks in multiple generation pedigrees; these could include studies in non-vertebrate and vertebrate model organisms and/or human populations.

Describe the alcohol-induced epigenetic modifications that produce specific transgenerational phenotypes.

Define the genomic regions most sensitive to epigenetic modifications that are transmitted across generations; e.g., the role of transposable elements in transgenerational epigenetic effects, how transposable elements escape silencing etc.

Characterize alcohol-induced epigenetic modifications in both somatic tissue (e.g., brain) and germ cells (e.g., egg and sperm).





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Effects of In Utero Alcohol Exposure on Adult Health and Disease (R21)

PA-12-292

Objectives: This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is intended to support novel research on how prenatal alcohol exposure may contribute to the etiology of chronic diseases and health conditions later in life.

Topics / Research areas: In response to this FOA, investigators are encouraged to examine health conditions and chronic diseases not typically associated with FAS/FASD. The resulting information may be critical in optimizing strategies for disease prevention in individuals with a wide range of alcohol exposure. This FOA does not seek to support applications limited to traditional examination of physical abnormalities or neurobehavioral deficits of FAS/FASD.


Budget: The combined budget for direct costs for the two (2) year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.



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Effects of In Utero Alcohol Exposure on Adult Health and Disease (R01)

PA-12-291

Objectives: This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is intended to support novel research on how prenatal alcohol exposure may contribute to the etiology of chronic diseases and health conditions later in life.

Topics / Research areas: In response to this FOA, investigators are encouraged to examine health conditions and chronic diseases not typically associated with FAS/FASD. The resulting information may be critical in optimizing strategies for disease prevention in individuals with a wide range of alcohol exposure. This FOA does not seek to support applications limited to traditional examination of physical abnormalities or neurobehavioral deficits of FAS/FASD.


Budget:

Application budgets are not limited, but need to reflect actual needs of the proposed project.



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Physical Activity and Weight Control Interventions Among Cancer Survivors: Effects on Biomarkers of Prognosis and Survival (R21)

PA-15-310

Objectives: The goal of this Funding Opportunity Announcement (FOA) is to stimulate transdisciplinary and translational research that will identify the specific biological or biobehavioral pathways through which physical activity and/or weight control (either weight loss or avoidance of weight gain) may affect cancer prognosis and survival.

Topics / Research areas: Applications submitted to this FOA should test the effects of physical activity or weight control or both interventions on biomarkers of cancer prognosis among cancer survivors. Applications may use experimental research designs (e.g., RCTs, fractional factorial designs…etc.) or non-experimental designs. Applications should bring together transdisciplinary teams of investigators with expertise in behavioral intervention, cancer biology, and other basic and clinical science disciplines relevant to the pathways being studied.


Budget: The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.



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NIH Exploratory/Developmental Research Grant Program (Parent R21)

PA-13-303

Objectives: The National Institutes of Health (NIH) Exploratory/Developmental Grant (R21) funding opportunity supports the development of new research activities in categorical program areas.

Topics / Research areas: These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.





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NIH Small Research Grant Program (Parent R03)

PA-13-304

Objectives: The National Institutes of Health (NIH) Investigator-Initiated Small Research Grant (R03) funding opportunity supports small research projects that can be carried out in a short period of time with limited resources.

Topics / Research areas: The R03 activity code supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.





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Research Project Grant (Parent R01)

PA-13-302

Objectives: The Research Project Grant (R01) supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in areas representing the specific interests and competencies of the investigator(s).

Topics / Research areas: The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on descriptions of their programs.


Budget: Application budgets are not limited but need to reflect the actual needs of the proposed project.



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Dissemination and Implementation Research in Health (R03)

PAR-13-056

Objectives: This Funding Opportunity Announcement (FOA) encourages investigators to submit research grant applications that will identify, develop, evaluate and refine effective and efficient methods, systems, infrastructures, and strategies to disseminate and implement research-tested health behavior change interventions, evidence-based prevention, early detection, diagnostic, treatment and management, and quality of life improvement services, and data monitoring and surveillance reporting tools into public health and clinical practice settings that focus on patient outcomes.

Topics / Research areas: Key characteristics of high-priority dissemination and implementation (D&I) research applications may include but are not limited to:

Use and testing or refinement of intervention and evaluation models appropriate for D&I

Understanding of the complexity of health interventions, including those with multiple components and those for low resource settings and for populations traditionally underrepresented in research, for which D&I may not be a simple process

Understanding the incentives and/or barriers to the D&I of novel tools and practices to improve public health

Consideration and characterization of the multi-level context and environment in which the proposed research will be conducted,

Development and/or use of applicable outcomes, measures and analyses related to the models used and the project specific aims

Attention to issues of resources expended, programs costs, cost-effectiveness or other economic outcomes

Incorporation of stakeholder relevant outcomes of research (including relevant outcomes for patients, families, providers, administrators, policymakers).


Budget: Budgets for direct costs of up to $50,000 per year and a project duration of up to two years may be requested for a maximum of $100,000 direct costs over a two-year project period.



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PAR-13-055











Budget:




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PAR-13-054














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Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Development Projects (UH2/UH3)

RFA-NS-16-020

Objectives: The purpose of this funding opportunity announcement (FOA) is to support research that evaluates and further develops candidate predictive, diagnostic, target engagement and progression candidate biomarkers of small vessel cerebrovascular disease in human vascular contributions to cognitive impairment and dementia (VCID) and vascular/Alzheimer's mixed dementias.

Topics / Research areas: This FOA is for studies to develop candidate human biomarkers of small vessel cerebrovascular disease in human VCID and vascular/Alzheimer's mixed dementias. The goal is to develop candidate biomarkers to readiness to enter into (under future separate funding) large scale multi-site clinical validation studies toward FDA qualification for phase II and phase III clinical trials.


Budget: Application budgets are limited to $750,000 in direct costs per year, and must reflect the actual needs of the proposed project.


Other information (link): http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-16-020.html

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Biomarkers for the Lewy Body Dementias (U01)

RFA-NS-16-022

Objectives: Since current research suggests that different pathophysiological mechanisms may underlie the numerous syndromes in which Parkinson's disease and dementia are co-morbid, this FOA invites applications to expand the NINDS PDBP's current collection of longitudinal clinical and biospecimen data to include data and samples from subjects who have been diagnosed with the LBDs, i.e., Parkinson's Disease with Dementia (PDD) or Dementia with Lewy Bodies (DLB).

Topics / Research areas: The purpose of this funding opportunity announcement (FOA) is to 1) expand the collection of clinical data and biological specimens in the NINDS Parkinson’s Disease Biomarkers Program (PDBP), a community research resource, to include data from patients with Lewy Body Dementias (including Dementia with Lewy Bodies and Parkinson's Disease with Dementia), and 2) to support hypothesis-driven clinical research to discover biomarkers that will improve the efficiency and outcome of Phase II clinical trials for the Lewy Body dementias and to provide an expansion of this existing research resource center for dissemination of information and access by the scientific community for further advancing research in this field. Applications may include both of these goals if justified.


Budget: Application budgets are not limited but need to reflect the actual needs of the proposed project.


Other information (link): http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-16-022.html

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NIAID Clinical Trial Implementation Cooperative Agreement (U01)

PAR-13-151

Objectives: This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.

Topics / Research areas: Scope

The NIAID Clinical Trial Implementation (U01) Grant supports implementation of clinical trials that address high-priority research areas that are well matched with the mission and goals of NIAID. A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:

provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;

administration of an unlicensed product; or administration of a licensed product for an unapproved indication.

A non-high-risk trial would not have any of the attributes listed above; for example, it would involve provision of a routine intervention and administration of a licensed product for an approved indication. Applicants are strongly encouraged to contact NIAID staff listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial.

For the purposes of this FOA, implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:

training of study personnel; enrollment and recruitment of study subjects; data collection, management and quality control; laboratory work and data analyses; study management and oversight; establishment of committees to manage the complexity of the trial; and preparation of the final study report; and other related post-enrollment activities.

Each NIAID Clinical Trial Implementation (U01) award will support the implementation of a single clinical trial. Applications that include more than one clinical trial will not be reviewed. An overview of the state of the science, current status and relevance of the trial, and discussion of the clinical protocol must be presented in the application. Applicants must propose a time-sensitive, milestone-driven clinical trial and describe the clinical trial stages, criteria for completion of the stages and contingency plans for each stage. Any anticipated impediments that could require a revision in the timeline must be identified and accompanied by a discussion of alternative approaches. The trial must be hypothesis-driven and have clear primary and secondary endpoints. A description of the study population, why it is an appropriate group to study the research question(s) posed, subject

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eligibility, inclusion and exclusion criteria, and a feasible recruitment and enrollment plan must also be included. Statistical methods appropriate for the study design, and adequate plans for data monitoring and safety are required.

All clinical trial planning activities must be completed prior to the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

NIAID reserves the right to specify: 1) whether an IND (Investigational New Drug)/IDE (Investigational Device Exemption) application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; and 3) the requirements for the establishment of a DSMB (Data Safety Monitoring Board)/SMC (Safety Monitoring Committee).

Investigators are referred to NIAID’s Clinical Research Toolkit website (http://www.niaid.nih.gov/labsandresources/resources/toolkit/pages/default.aspx ) for protocol templates and guidance, clinical research resources, and links to program divisions. Investigators are strongly encouraged to contact NIAID’s program divisions (Agency Contacts) for information regarding division-specific clinical research policies and procedures.





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NIAID Clinical Trial Planning Grant (R34)

PAR-13-150

Objectives: This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites applications that propose the complete planning, design, and preparation of the documentation necessary for implementation of investigator-initiated clinical trials.

Topics / Research areas: The trials must be hypothesis-driven, milestone-defined, related to the research mission of the NIAID and considered high priority by the Institute. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/ ).


Budget: Application budgets are limited to $150,000 direct costs.



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NIAID Clinical Trial Implementation Grant (R01)

PAR-13-149

Objectives: This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for implementation of investigator-initiated, non-high-risk clinical trials.

Topics / Research areas: The trials must be hypothesis-driven, related to the research mission of the NIAID and considered a high priority by the Institute. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/ ). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation (R01) Grant application.


Budget:




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Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01)

FD-16-026

Objectives: The purpose of this project is to develop and implement a robust optimization algorithm that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models so that knowledge of parameter distributions in the population(s) of interest can be derived. The models developed will be used to generate predictions that can inform bioequivalence assessments and regulatory decisions relating to generic drug development.

Topics / Research areas: Although novelty is highly encouraged, proposals could entertain approaches such as:

1. Implementing the non-linear mixed effects theory

a. Maximum log-likelihood algorithms (stiff, non-stiff Ordinary Differential Equation solving methods with linearization)

b. Exact maximum likelihood with Expectation-Maximization algorithms (no linearization)

2. Introducing a Bayesian population PBPK approach (Markov Chain Monte Carlo)

3. Nonparametric methods

Proposals should include, but are not limited to, methods to evaluate the robustness of the proposed algorithm in terms of bias to initial estimates, precision, accuracy, convergence rate, and computation time, in full-body PBPK models of low, intermediate, and high complexity using simulated and real (rich and sparse) datasets.


Budget: Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $250,000YR 02: $250,000


Other information (link): http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-026.html

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Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products (U01)

RFA-FD-16-024

Objectives: FDA's CDER is seeking depositional data obtained with a computational modeling approach for small airway delivery to adults with orally inhaled drug products (OIDPs) that are indicated for management of asthma.

Topics / Research areas: Possible sources of intersubject variability include lengths and diameters of various airway segments, heterogeneous or homogeneous constriction, and inhalation patterns. An expected outcome is regional deposition data for reference listed drugs that can indicate whether or not the drug product targets small airways in asthmatic patients and the key product attributes that affects the deposition.


Budget: Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $200,000YR 02: $200,000


Other information (link): http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-024.html

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Pre-application: Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (OT1)

RFA-RM-16-002

Objectives: The purpose of this Funding Opportunity Announcement (FOA) is to invite pre-applications from applicants who have an interest in ultimately submitting an application to "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (OT2)" (RFA-RM-16-003).

The OT1 SPARC pre-application is the required first step in the application process for the companion OT2 FOA (RFA-RM-16-003). Potential applicants should read both FOAs.

Applicants whose OT1 pre-applications are found to be meritorious and programmatically relevant will be invited to submit a full application to the OT2 "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System" FOA (RFA-RM-16-003). There will be substantial interaction with NIH Program Staff leading to the development of programmatic and budget elements for an acceptable OT2 application. OT2 applications must include a copy of the Invitation to Submit from the SPARC program as a requirement for submission. The Invitation to Submit an OT2 application is not an indication of any award.

No Other Transaction awards will be made under this FOA.

Topics / Research areas: This NIH Funding Opportunity Announcement (FOA) solicits pre-applications to develop new and/or enhance existing tools and technologies to be used to elucidate the neurobiology and neurophysiology underlying autonomic control of organs in health or disease, which will ultimately inform next generation neuromodulation therapies. These two-year projects will facilitate technology development for neural mapping activities through the NIH SPARC Common Fund program.


Budget: Not Applicable


Other information (link): http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-16-002.html

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International Bioethics Research Training Program (D43)

PAR-16-082

Objectives: The overall goal of this initiative is to support the development of a sustainable critical mass of bioethics scholars in low and middle income country (LMIC) research intensive institutions with the capabilities to conduct original empirical or conceptual ethics research that addresses challenging issues in health research and research policy in these countries as well as provide research ethics leadership to their institutions, governments and international research organizations.

Topics / Research areas: FIC will support LMIC-U.S. collaborative institutional bioethics doctoral and postdoctoral research training programs that incorporate didactic, mentored research and career development components to prepare a number of individuals with ethics expertise for positions of scholarship and leadership in health research institutions in the LMIC.

Who can apply / eligible applicants / criteria for participation / Beneficiaries:Non- Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Applications must be submitted by academic education or research institutions in LMICs (as defined by the World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups; low-income, lower-middle-income, and upper-middle-income countries are included ). NOT-TW-12-011 'Notice of Change in Country Eligibility for Fogarty International Training Grants') applies to this FOA. With the exception of Sub-Saharan African countries FIC no longer accepts applications from upper-middle-income countries that are also members of the G20 major economies (https://www.g20.org/).

Budget: Applicants may request up to $230,000 direct costs per year.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.



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http://grants.nih.gov/grants/guide/notice-files/NOT-TW-12-011.html

http://grants.nih.gov/grants/guide/notice-files/NOT-TW-12-011.html

http://data.worldbank.org/about/country-classifications/country-and-lending-groups

NIGMS Program of Administrative Supplements for Equipment (Admin Supp)

PA-16-125

Objectives: The National Institute of General Medical Sciences (NIGMS) announces the availability of funds for Administrative Supplements to NIGMS-funded R01, R37, P01, and U01 grants.

Topics / Research areas: These funds are intended for the purchase of single pieces of equipment with requested direct costs between $50,000 and $250,000. Equipment in this price range is often difficult to purchase under the parent grant. Two or more NIGMS grantees at the same institution with similar equipment needs are encouraged to submit separate requests (each between $50,000 and $250,000) that cross-reference each other. It is expected that the amount of funds requested for such joint purchases will reflect the actual proportion of the time that the shared equipment would be used by each PI. However, under no circumstances may a joint request exceed $400,000 direct costs. NIGMS encourages requests that reflect institutional commitment.



Budget: Application budgets are limited to no more than the amount of the current parent award, and must reflect the actual needs of the proposed project.

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Funds may only be requested for the equipment. These supplements will not support staff or service contracts.

Budget limit for joint requests: Two or more NIGMS grantees at the same institution with similar equipment needs are encouraged to submit separate requests for the joint purchase of a single piece of equipment to be shared among the requesting investigators. The budget for each separate request should reflect the actual proportion of the time that the shared equipment would be used by the relevant PD/PI. Each separate budget is limited to no more than the amount of the awarded direct costs of the parent grant. Joint requests should typically total between $50,000 and $250,000 direct costs. In rare circumstances with extremely compelling justification, two or more PD/PIs may submit applications for equipment that would total more than $250,000. However, under no circumstances may a joint request exceed $400,000 direct costs.



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The Early Detection Research Network: Biomarker Developmental Laboratories (U01)

RFA-CA-16-009

Objectives: The purpose of this Funding Opportunity Announcement (FOA) is to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN).

Topics / Research areas: The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.

Budget: A budget of up to $400,000 per year in direct costs may be requested. The indicated budget limit may be appropriate for larger projects involving multiple laboratories (and possibly multiple PDs/PIs). Smaller projects (e.g., involving one PD/PI and a single laboratory) are expected not to exceed $250,000 per year in direct costs.

Application budgets need to reflect the actual needs of the proposed project.


Other information (link): http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-16-009.html

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