AGING

Title: Renal Function and Chronic Kidney Disease in Aging (R01), (R21)
Agency:  National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications:  PA-09-165; PA-09-166
CFDA Number: 93.866
Links:  http://grants.nih.gov/grants/guide/pa-files/PA-09-165.html (R01)
http://grants.nih.gov/grants/guide/pa-files/PA-09-166.html (R21)

This Funding Opportunity Announcement (FOA) issued by the National Institute on Aging (NIA) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, invites applications that propose basic, clinical, and translational research on chronic kidney disease (CKD) and its consequences in aging and in older persons.  Applications should focus on the 1) biology and pathophysiology of CKD in animal models; 2) etiology and pathophysiology of CKD in the elderly; 3) epidemiology and risk factors for the development of CKD with advancing age; and/or 4) diagnosis, medical management and clinical outcomes of CKD in this population.  Research supported by this initiative should enhance knowledge of CKD and its consequences in the elderly and provide evidence-based guidance in the diagnosis, prevention, and treatment of CKD in older persons.

SCOPE OF RESEARCH:
This FOA invites research applications in both animal models and in humans, addressing the etiology, pathophysiology, risk factors, consequences, prevention, or treatment of CKD in older patients.  Areas of interest include, but are not limited to, the following areas:

Etiology and Pathophysiology

• Contributions of age-related changes in renal vascular structure and function on the development of CKD (e.g., changes in renal blood flow, vascular resistance, and sensitivity to ischemia), and the mechanisms by which these changes occur.
• Mechanisms of kidney fibrosis underlying CKD progression.
• Contributions of cellular senescence and gene polymorphisms to CKD during aging and in older adults and their mechanisms of action.
• Relationship of CKD to age-related changes in renal morphology, pathology, structure (e.g., tubular atrophy, glomerulosclerosis, interstitial fibrosis) and function (e.g., changes in renal hemodynamics, GFR, urine concentrating and diluting ability, secretion of renin and erythropoietin, and activation of vitamin D).
• Roles of oxidative stress and endothelial dysfunction in the development of CKD during aging and in aged adults.
• Possible differences in pathology and pathophysiology of CKD in younger vs. older patients or animals.
• Complications and long-term consequences of CKD in the elderly (e.g., development of osteoporosis, CVD, and anemia; impact on vitamin D metabolism and phosphate balance; effects on coagulation mechanisms; and modulation of secretion of renin and erythropoietin).
• Role of CKD and its complications in functional impairment and disability among older patients.

Epidemiology, Risk Factors, and Comorbid Interactions

• Natural history of age-related decline in kidney function, and progression from early stage CKD to ESRD in the elderly.
• Clinical consequences and long-term outcomes of different stages of CKD in older adults, including effects of mild decreases in GFR on long-term health outcomes. 
• Role of established CKD risk factors (e.g., hypertension, diabetes and acute kidney injury) and potential new risk factors (e.g., oxidative stress, age-related endothelial dysfunction) in development and progression of CKD in the elderly. 
• Studies that distinguish risk factors for progression to different stages of CKD, and the extent to which risk factors are the same or differ across different stages of CKD.  Studies on the relationships between acute kidney injury and CKD are encouraged. 
• Relationships of comorbidities to development of CKD in the elderly and its progression to ESRD, and the interaction of coexisting diseases with CKD on morbidity and functional outcomes in older patients. 
• Relationships of CKD and/or its treatment to cognitive impairment in the elderly.

Early Detection and Diagnosis

• Development and validation of new methods or biomarkers to accurately, reliably, and efficiently measure renal function and identify early stages of declining function in older persons or animal models.
• Studies to analyze and improve the performance of current GFR estimating equations in older patients.
• Development and validation of new tests of age-related acute and chronic renal damage, including measures of age-related decline in kidney functions other than glomerular filtration, e.g., kidney endocrine functions.
• Development and validation of screening algorithms for early detection of CKD in community-dwelling elderly, particularly older adults at increased risk for CKD, to optimize timing of screening, frequency of testing, sensitivity and specificity of screening tests, and cost–benefit ratios.

Prevention and Treatment

• Efficacy of treatments for CKD risk factors (e.g., cardiovascular disease and diabetes) to prevent or delay onset of CKD in older persons.
• Effects of various interventions applied at early stages of CKD in preventing or slowing further adverse effects in older patients (e.g., risk factor management, vitamin D, dietary regimen such as protein restriction, salt restriction and calorie restriction, and physical activity interventions).
• Testing new treatment approaches in elderly CKD patients who have conditions contributing to its progression (e.g., diabetes/hypertension), e.g., angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers and aldosterone blockade; optimal targets for blood pressure and glucose control.
• Testing of clinical strategies for the management of complications and long-term consequences of CKD in older patients (e.g., cardiovascular and peripheral vascular disease, Vitamin D deficiency, hyperphosphatemia, osteodystrophy and hematologic problems).
• Studies evaluating whether interventions to slow progression in CKD are efficacious in preventing or slowing further functional loss when applied at earlier levels of decrease in GFR.

Development and testing of interventions to maintain functional status, cognitive function, and quality of life among older CKD patients.

ALTERNATIVE & COMPLEMENTARY MEDICINE

Title: Developmental Projects in Complementary Approaches to Cancer Care and Treatment (R21) (R03)
Agency: National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-167, PA-09-168
CFDA Numbers: 93.395, 93.361
Links: http://grants.nih.gov/grants/guide/pa-files/PA-09-167.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-168.html (R03)

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), and the National Institute of Nursing Research (NINR), of the National Institutes of Health, invites applications for basic, pre-clinical, and clinical complementary cancer research. The research should relate to the areas of prevention, diagnosis, and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. In addition, this FOA encourages the development and application of emerging and innovative technologies, including identification of novel therapeutics in the pharmacopoeia of Traditional Medical Systems (as defined by the World Health Organization), use of complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies, and research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g., response to conventional cancer therapy, survival). The overarching goals of these FOAs are to encourage investigators to submit high quality, preliminary research of humans that will advance the science of Complementary and Alternative Medicine (CAM) and provide a solid foundation and justification for future research project (R01) grant applications to definitively determine the efficacy of CAM approaches.

Specific Research Objectives for the R21
The intent of this initiative is to encourage and support the development of basic and clinical (prevention, therapeutic, and palliative) cancer research in complementary approaches. Another goal of this initiative is to facilitate communication and collaboration between practitioners in complementary approaches and the conventional cancer research communities.

For the purpose of this FOA, applicants may consider complementary approaches as they relate to the prevention, diagnosis, and treatment of cancer, cancer-related symptoms, and side effects of conventional treatment. In addition, applicants may consider research that focuses on the potential interactions of complementary approaches with conventional cancer therapies. Complementary approaches that are considered appropriate to this announcement include (but are not limited to) those involving nutritional approaches, natural products, mind-body approaches, energy therapies, herbal medicines, and interventions based upon those within traditional medical systems (as defined by the World Health Organization), such as traditional Chinese medicine or ayurvedic medicine.

Topics of programmatic interest include, but are not limited to:

• Approaches related to management of cancer-related symptoms and side effects of conventional treatment;
  
• Exploratory studies of complementary approaches in combination with conventional regimens, and outcome, effectiveness, and quality of life assessments.
  
• Design and pilot testing of interventions for comparative studies of complementary modalities as interventions for end of life and palliative care (e.g., relaxation therapy, music therapy);
  
• Development of methodologies to improve assessment of the impact of complementary approaches to treatment; e.g., instrument development, biobehavioral markers, acceptance of longitudinal designs or prevention;
  
• Feasibility studies of behavioral interventions that incorporate principles of cultural competency, in particular within populations that utilize culture-specific traditional methods of treating cancer;
  
• Applications relevant to understudied populations (i.e. the use of complementary approaches in children or older adults). Descriptive studies of the prevalence of complementary and alternative medicine (CAM) use in understudied populations including the impact of such use on the primary modality of treatment are also appropriate;
  
• Nutritional approaches in the prevention and treatment of cancer as well as to prevent disease recurrence;
  
• Preclinical studies of candidate-complementary approaches with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• Preclinical studies to advance understanding of mechanism of actions a well as drug-drug interactions;
  
• Isolation and pharmacological studies of active ingredients from herbal or other traditional medicine preparations, including a defined reconstitution of more than one pure ingredient, such as drug-drug interaction; and
  
• Applications that seek to clarify markers of exposure to bioactive food components and their biological response in specific targets are also appropriate.

CAM research is integrated through various program areas of the Extramural Divisions and Intramural research programs (http://www.cancer.gov/cam/research_portfolio.html), such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research.

The National Institute of Nursing Research (NINR) also encourages applications that are consistent with its strategic plan and research themes for the future. In keeping with its research themes, projects that may lead to improved strategies for managing the effects of illness to improve quality of life, reducing health disparities, and enhancing the end-of-life experience for patients and their families are particularly welcome. For further information on NINR’s strategic plan.

Specific Research Objectives for the R03
This FOA aims to support pilot projects, and allow CAM researchers to ascertain preliminary data that could provide the basis for more extended research that can otherwise not be achieved in the area of CAM research. While definitive and costly studies are best supported by other mechanisms, a small grant (R03) can provide resources for essential tasks such as preliminary assessments of alternative or new medical systems or techniques, encourage innovative applications of new CAM approaches, and ascertain pilot data that can be essential for larger R01 projects.

CAM research is integrated through various program areas, of the Extramural Divisions and Intramural research programs such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research;

R03 small grants encourage investigators to initiate research in areas not typically explored by R01 investigators. Moreover, it can foster coordination of small research project collaborations, and promote collaborative research between national and international studies for comparative or validation trials. This is particularly relevant to initiate research on CAM practices that are identified via the NCI Best Case Series Program has warranting NCI-initiated research (for further details, go to: http://www.cancer.gov/cam/research_information.html). Examples of such therapeutic regimens include the treatment approach of the P. Banerji Homeopathic Research Foundation, insulin potentiation therapy, and macrobiotic lifestyle as per the Kushi Institute. Research of these approaches is high-risk and previous efforts to stimulate investigations via single contract mechanisms have not been fruitful. The small grant R03 mechanism can provide support for preliminary explorations of these approaches.

Broad areas of Complementary and Alternative Medicine (CAM)-related research activities appropriate for this FOA include, but are not limited to, the following:

• Alternative Medical Systems
  
• Botanical Extracts
  
• Medicinal herbs and herbal mixtures
  
• Energy Therapies
  
• Exercise Therapies
  
• Manipulative and Body-Based Methods
  
• Mind-body Interventions
  
• Nutritional Therapeutics
  
• Pharmacological and Biologic Treatments

For further details, go to: http://www.cancer.gov/cam/research_information.html).

The common characteristic of the small grant (R03) is provision of limited funding for a short period of time. Examples of the types of projects that ICs support with the R03 include, but are not limited to, the following:

• Pilot or feasibility studies
• Secondary analysis of existing data
  
• Small, self-contained research projects
  
• Development of research methodology
  
• Development of new research technology
  
• Nature of the research opportunity
  
• Pertinent background information that establishes the need for the research

 

BIOENGINEERING & BIO-IMAGING

Title: Partnerships for Development of Vaccines for Selected Pathogens (R01)
Agency: National Institute on Allergy and Infectious Diseases (NIAID)
LOI Deadline: June 26, 2009
Application Deadline: July 27, 2009
RFA Identification: RFA-AI-09-016
CFDA Number: 93.856
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-09-016.html

This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) invites research applications for projects that will advance development of vaccines against five pathogens that have a significant impact on public health: cytomegalovirus, respiratory syncytial virus, Staphylococcus aureus, Pseudomonas aeruginosa and Clostridium difficile. The formation of collaborative partnerships between academic (or non-profit) researchers from different disciplines or with industry is strongly encouraged, but not required.

• Mechanism of Support. This FOA will utilize the R01 grant mechanism.
• Funds Available and Anticipated Number of Awards. The NIAID intends to commit $4.0 million in total costs in FY2010 to fund three to five applications in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
• Budget and Project Period. An applicant may request a project period of up to five years and a budget for direct costs of no more than $500,000 in any single year.
• Application Research Plan Component Length: The R01 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm

Partnerships
A key component of this FOA is the formation of collaborative partnerships, which may be between academic researchers from different disciplines or between academic and industry researchers. For the purpose of this FOA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this FOA will support partnerships between industry and collaborator(s) from academic (or non-profit) research organizations. For this FOA, partnerships are strongly encouraged, but not required.

Applications submitted in response to this FOA will include a Product Development Plan (PDP) to assist reviewers and program staff in project evaluation. The PDP will define the general goals of the project, intended use/indication of the proposed therapeutic or diagnostic, and biodefense/public health gap the product is intended to fill. Additionally, the PDP will detail the stage-specific product development activities that will be performed during the project period and outline plans for further development after completion of the project.

The Principal Investigator of the project may be affiliated with industry, an academic organization or non-profit research organization.

Research Goals and Objectives
To facilitate the development and testing of candidate vaccines, it is imperative that promising basic research findings/technologies be translated rapidly into new approaches and strategies for product development. The involvement of experts from diverse disciplines (e.g., biochemists, structural biologists, protein chemists, pharmacologists, immunologists, molecular biologists, engineers and clinicians) within academia and industry is needed to enable development of well-designed candidates for vaccines.

The objectives of this FOA are:
1. To support research that will advance the development and/or production of vaccines specific for the pathogens described above. Developmental research is not required to result in a "final" product but must advance the development of a candidate product; and
2. To stimulate scientifically sound, original, and innovative research requiring a comprehensive team and multidisciplinary effort that will facilitate advancement of a promising candidate product or platform technology through the product development pathway.

To most effectively achieve these objectives, applications must include in vivo efficacy data in at least one animal model with accompanying general safety and immunogenicity data. It is understood that the animal studies may involve a vaccine or endpoint that does not precisely replicate the planned human vaccine.

NOTE: While clinical development strategies may be included within an overall product development plan, this FOA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this FOA and will not be reviewed. However, utilization of appropriate human cell lines and human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive and is encouraged.

For all vaccine projects, approaches should consider the ultimate potential of candidate vaccines to induce safe and protective responses in a diverse population. Projects may include, but are not limited to, one or more of the following areas:
• Improvement of existing candidates, including assessment of alternate formulations, stabilization, immunopotentiation, regimen optimization and evaluation of novel adjuvants.
• Evaluation of novel vaccine strategies, such as recombinant DNA; reverse genetics leading to live-attenuated strains and vectors; chimeras and mono- or multi-valent subunits.
• Advanced preclinical studies, including: safety and toxicology studies; further efficacy testing in animal models; assessment of host response; determination of clinically-relevant correlates of immunity and surrogate endpoints.

BIOINFORMATICS

Title: Novel Statistical Methods for Human Gene Expression Quantitative Trait Loci (eQTL) Analysis (R01)
Agency: National Institute of Mental Health (NIMH)
LOI Deadline:  August 16, 2009
Application Deadline: September 16, 2009
RFA Identification:  RFA-RM-09-006
CFDA Number: 93.310
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-09-006.html  

This FOA solicits applications to develop innovative statistical methods to detect the influence of genetic variation on tissue-specific gene expression and regulation. The goal of the FOA is to seek proposals to develop statistical methods to appropriately analyze the forthcoming complex data sets generated by the NIH Roadmap initiative entitled “Genotype-Tissue Expression (GTEx) Project”.  Applicants are encouraged to take advantage of existing tissue-specific gene expression datasets and/or simulated datasets, but will also be strongly encouraged to utilize GTEx-generated data, if and when it is available.

• Mechanism of Support. This FOA will utilize the R01 grant mechanism.
• Funds Available and Anticipated Number of Awards.  The total amount of funds available for these awards is $1 million total costs per year for two years; we anticipate making two to three awards.
• Budget and Project Period. The total project period may not exceed two years. Direct costs are expected to be $200,000 to $300,000 per year per award. 
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

This RFA seeks proposals to develop innovative and advanced statistical methods to appropriately analyze the forthcoming complex data sets to assess the influence of genetic variation on tissue-specific gene expression and regulation.  Applicants are encouraged to take advantage of the availability of the SNP and tissue specific gene expression data (both chip- and next-generation sequencing based RNA expression data) from multiple tissues generated by the GTEx pilot project.  However, since the data generated from the GTEx pilot may not be available until very late in the funding period, if at all, analyses based on existing human genotype-gene expression datasets, and simulation-based studies, are also appropriate.  In terms of the data resources, applicants are encouraged to use the data generated by GTEx if/when it is available; they may also use existing data through collaborative efforts, the GTEx portal of NCBI (http://www.ncbi.nlm.nih.gov/gtex/), or simulated data sets. All proposed analyses must have relevance to human eQTL mapping, and those that focus entirely or predominantly on human data, or those that involve direct comparison of human data to other mammalian systems, have the highest programmatic priority.

Examples of research areas that applicants may work on include the following (note this is not an all-inclusive list, and applicants are encouraged to address more than one area):

• Extend existing methods, such as regression approaches, or develop new methods, such as structural equations, Bayesian models, or causal inference models, as a framework to integrate analysis of genotype and gene expression for eQTL identification, for simultaneous analysis of multiple genetic variants, for joint analysis of gene expression levels in multiple tissues, and for analysis of regulatory networks.
• Extend existing models or develop new ones to make predictions about the functional relevance of genetic variants to gene regulation, in terms of expression levels, gene splicing, and/or regulatory networks.
• Modify existing data reduction tools to make analytical procedures more efficient.
• Develop methods to use multiple datasets or multiple tissue types to reduce the number of false negative results.
• Develop creative methods to quantify RNA expression levels from next-generation sequencing generated data, compare it to chip-based estimates, and evaluate its impact on the ability to identify eQTLs.
• Model and explore the overlap in eQTLs between different tissues.
• Model and explore the incremental identification of new eQTLs as the number of tissues is increased.
• Compare the ability to identify eQTLs in samples obtained under different conditions (for example, the same organ from autopsy and surgery cases).
• Model and explore the influence that having expression data from multiple tissues from each donor has on statistical power to detect trans-eQTLs.
• Develop new methods to take diverse population structure into account in data analysis.

Biostatistics & Epidemiology

Title: Novel Statistical Methods for Human Gene Expression Quantitative Trait Loci (eQTL) Analysis (R01)
Agency: National Institute of Mental Health (NIMH)
LOI Deadline:  August 16, 2009
Application Deadline: September 16, 2009
RFA Identification:  RFA-RM-09-006
CFDA Number: 93.310
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-09-006.html  

This FOA solicits applications to develop innovative statistical methods to detect the influence of genetic variation on tissue-specific gene expression and regulation. The goal of the FOA is to seek proposals to develop statistical methods to appropriately analyze the forthcoming complex data sets generated by the NIH Roadmap initiative entitled “Genotype-Tissue Expression (GTEx) Project”.  Applicants are encouraged to take advantage of existing tissue-specific gene expression datasets and/or simulated datasets, but will also be strongly encouraged to utilize GTEx-generated data, if and when it is available.

• Mechanism of Support. This FOA will utilize the R01 grant mechanism.
• Funds Available and Anticipated Number of Awards.  The total amount of funds available for these awards is $1 million total costs per year for two years; we anticipate making two to three awards.
• Budget and Project Period. The total project period may not exceed two years. Direct costs are expected to be $200,000 to $300,000 per year per award. 
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

This RFA seeks proposals to develop innovative and advanced statistical methods to appropriately analyze the forthcoming complex data sets to assess the influence of genetic variation on tissue-specific gene expression and regulation.  Applicants are encouraged to take advantage of the availability of the SNP and tissue specific gene expression data (both chip- and next-generation sequencing based RNA expression data) from multiple tissues generated by the GTEx pilot project.  However, since the data generated from the GTEx pilot may not be available until very late in the funding period, if at all, analyses based on existing human genotype-gene expression datasets, and simulation-based studies, are also appropriate.  In terms of the data resources, applicants are encouraged to use the data generated by GTEx if/when it is available; they may also use existing data through collaborative efforts, the GTEx portal of NCBI (http://www.ncbi.nlm.nih.gov/gtex/), or simulated data sets. All proposed analyses must have relevance to human eQTL mapping, and those that focus entirely or predominantly on human data, or those that involve direct comparison of human data to other mammalian systems, have the highest programmatic priority.

Examples of research areas that applicants may work on include the following (note this is not an all-inclusive list, and applicants are encouraged to address more than one area):

• Extend existing methods, such as regression approaches, or develop new methods, such as structural equations, Bayesian models, or causal inference models, as a framework to integrate analysis of genotype and gene expression for eQTL identification, for simultaneous analysis of multiple genetic variants, for joint analysis of gene expression levels in multiple tissues, and for analysis of regulatory networks.
• Extend existing models or develop new ones to make predictions about the functional relevance of genetic variants to gene regulation, in terms of expression levels, gene splicing, and/or regulatory networks.
• Modify existing data reduction tools to make analytical procedures more efficient.
• Develop methods to use multiple datasets or multiple tissue types to reduce the number of false negative results.
• Develop creative methods to quantify RNA expression levels from next-generation sequencing generated data, compare it to chip-based estimates, and evaluate its impact on the ability to identify eQTLs.
• Model and explore the overlap in eQTLs between different tissues.
• Model and explore the incremental identification of new eQTLs as the number of tissues is increased.
• Compare the ability to identify eQTLs in samples obtained under different conditions (for example, the same organ from autopsy and surgery cases).
• Model and explore the influence that having expression data from multiple tissues from each donor has on statistical power to detect trans-eQTLs.
• Develop new methods to take diverse population structure into account in data analysis.

 

Title: Renal Function and Chronic Kidney Disease in Aging (R01), (R21)
Agency:  National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications:  PA-09-165; PA-09-166
CFDA Number: 93.866
Links:  http://grants.nih.gov/grants/guide/pa-files/PA-09-165.html (R01)
http://grants.nih.gov/grants/guide/pa-files/PA-09-166.html (R21)

This Funding Opportunity Announcement (FOA) issued by the National Institute on Aging (NIA) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, invites applications that propose basic, clinical, and translational research on chronic kidney disease (CKD) and its consequences in aging and in older persons.  Applications should focus on the 1) biology and pathophysiology of CKD in animal models; 2) etiology and pathophysiology of CKD in the elderly; 3) epidemiology and risk factors for the development of CKD with advancing age; and/or 4) diagnosis, medical management and clinical outcomes of CKD in this population.  Research supported by this initiative should enhance knowledge of CKD and its consequences in the elderly and provide evidence-based guidance in the diagnosis, prevention, and treatment of CKD in older persons.

SCOPE OF RESEARCH:
This FOA invites research applications in both animal models and in humans, addressing the etiology, pathophysiology, risk factors, consequences, prevention, or treatment of CKD in older patients.  Areas of interest include, but are not limited to, the following areas:

Etiology and Pathophysiology

• Contributions of age-related changes in renal vascular structure and function on the development of CKD (e.g., changes in renal blood flow, vascular resistance, and sensitivity to ischemia), and the mechanisms by which these changes occur.
• Mechanisms of kidney fibrosis underlying CKD progression.
• Contributions of cellular senescence and gene polymorphisms to CKD during aging and in older adults and their mechanisms of action.
• Relationship of CKD to age-related changes in renal morphology, pathology, structure (e.g., tubular atrophy, glomerulosclerosis, interstitial fibrosis) and function (e.g., changes in renal hemodynamics, GFR, urine concentrating and diluting ability, secretion of renin and erythropoietin, and activation of vitamin D).
• Roles of oxidative stress and endothelial dysfunction in the development of CKD during aging and in aged adults.
• Possible differences in pathology and pathophysiology of CKD in younger vs. older patients or animals.
• Complications and long-term consequences of CKD in the elderly (e.g., development of osteoporosis, CVD, and anemia; impact on vitamin D metabolism and phosphate balance; effects on coagulation mechanisms; and modulation of secretion of renin and erythropoietin).
• Role of CKD and its complications in functional impairment and disability among older patients.

Epidemiology, Risk Factors, and Comorbid Interactions

• Natural history of age-related decline in kidney function, and progression from early stage CKD to ESRD in the elderly.
• Clinical consequences and long-term outcomes of different stages of CKD in older adults, including effects of mild decreases in GFR on long-term health outcomes. 
• Role of established CKD risk factors (e.g., hypertension, diabetes and acute kidney injury) and potential new risk factors (e.g., oxidative stress, age-related endothelial dysfunction) in development and progression of CKD in the elderly. 
• Studies that distinguish risk factors for progression to different stages of CKD, and the extent to which risk factors are the same or differ across different stages of CKD.  Studies on the relationships between acute kidney injury and CKD are encouraged. 
• Relationships of comorbidities to development of CKD in the elderly and its progression to ESRD, and the interaction of coexisting diseases with CKD on morbidity and functional outcomes in older patients. 
• Relationships of CKD and/or its treatment to cognitive impairment in the elderly.

Early Detection and Diagnosis

• Development and validation of new methods or biomarkers to accurately, reliably, and efficiently measure renal function and identify early stages of declining function in older persons or animal models.
• Studies to analyze and improve the performance of current GFR estimating equations in older patients.
• Development and validation of new tests of age-related acute and chronic renal damage, including measures of age-related decline in kidney functions other than glomerular filtration, e.g., kidney endocrine functions.
• Development and validation of screening algorithms for early detection of CKD in community-dwelling elderly, particularly older adults at increased risk for CKD, to optimize timing of screening, frequency of testing, sensitivity and specificity of screening tests, and cost–benefit ratios.

Prevention and Treatment

• Efficacy of treatments for CKD risk factors (e.g., cardiovascular disease and diabetes) to prevent or delay onset of CKD in older persons.
• Effects of various interventions applied at early stages of CKD in preventing or slowing further adverse effects in older patients (e.g., risk factor management, vitamin D, dietary regimen such as protein restriction, salt restriction and calorie restriction, and physical activity interventions).
• Testing new treatment approaches in elderly CKD patients who have conditions contributing to its progression (e.g., diabetes/hypertension), e.g., angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers and aldosterone blockade; optimal targets for blood pressure and glucose control.
• Testing of clinical strategies for the management of complications and long-term consequences of CKD in older patients (e.g., cardiovascular and peripheral vascular disease, Vitamin D deficiency, hyperphosphatemia, osteodystrophy and hematologic problems).
• Studies evaluating whether interventions to slow progression in CKD are efficacious in preventing or slowing further functional loss when applied at earlier levels of decrease in GFR.

Development and testing of interventions to maintain functional status, cognitive function, and quality of life among older CKD patients

 

CANCER

 Title: Developmental Projects in Complementary Approaches to Cancer Care and Treatment (R21) (R03)
Agency: National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-167, PA-09-168
CFDA Numbers: 93.395, 93.361
Links: http://grants.nih.gov/grants/guide/pa-files/PA-09-167.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-168.html (R03)

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), and the National Institute of Nursing Research (NINR), of the National Institutes of Health, invites applications for basic, pre-clinical, and clinical complementary cancer research. The research should relate to the areas of prevention, diagnosis, and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. In addition, this FOA encourages the development and application of emerging and innovative technologies, including identification of novel therapeutics in the pharmacopoeia of Traditional Medical Systems (as defined by the World Health Organization), use of complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies, and research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g., response to conventional cancer therapy, survival). The overarching goals of these FOAs are to encourage investigators to submit high quality, preliminary research of humans that will advance the science of Complementary and Alternative Medicine (CAM) and provide a solid foundation and justification for future research project (R01) grant applications to definitively determine the efficacy of CAM approaches.

Specific Research Objectives for the R21
The intent of this initiative is to encourage and support the development of basic and clinical (prevention, therapeutic, and palliative) cancer research in complementary approaches. Another goal of this initiative is to facilitate communication and collaboration between practitioners in complementary approaches and the conventional cancer research communities.

For the purpose of this FOA, applicants may consider complementary approaches as they relate to the prevention, diagnosis, and treatment of cancer, cancer-related symptoms, and side effects of conventional treatment. In addition, applicants may consider research that focuses on the potential interactions of complementary approaches with conventional cancer therapies. Complementary approaches that are considered appropriate to this announcement include (but are not limited to) those involving nutritional approaches, natural products, mind-body approaches, energy therapies, herbal medicines, and interventions based upon those within traditional medical systems (as defined by the World Health Organization), such as traditional Chinese medicine or ayurvedic medicine.

Topics of programmatic interest include, but are not limited to:

• Approaches related to management of cancer-related symptoms and side effects of conventional treatment;
  
• Exploratory studies of complementary approaches in combination with conventional regimens, and outcome, effectiveness, and quality of life assessments.
  
• Design and pilot testing of interventions for comparative studies of complementary modalities as interventions for end of life and palliative care (e.g., relaxation therapy, music therapy);
  
• Development of methodologies to improve assessment of the impact of complementary approaches to treatment; e.g., instrument development, biobehavioral markers, acceptance of longitudinal designs or prevention;
  
• Feasibility studies of behavioral interventions that incorporate principles of cultural competency, in particular within populations that utilize culture-specific traditional methods of treating cancer;
  
• Applications relevant to understudied populations (i.e. the use of complementary approaches in children or older adults). Descriptive studies of the prevalence of complementary and alternative medicine (CAM) use in understudied populations including the impact of such use on the primary modality of treatment are also appropriate;
  
• Nutritional approaches in the prevention and treatment of cancer as well as to prevent disease recurrence;
  
• Preclinical studies of candidate-complementary approaches with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• Preclinical studies to advance understanding of mechanism of actions a well as drug-drug interactions;
  
• Isolation and pharmacological studies of active ingredients from herbal or other traditional medicine preparations, including a defined reconstitution of more than one pure ingredient, such as drug-drug interaction; and
  
• Applications that seek to clarify markers of exposure to bioactive food components and their biological response in specific targets are also appropriate.

CAM research is integrated through various program areas of the Extramural Divisions and Intramural research programs (http://www.cancer.gov/cam/research_portfolio.html), such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research.

The National Institute of Nursing Research (NINR) also encourages applications that are consistent with its strategic plan and research themes for the future. In keeping with its research themes, projects that may lead to improved strategies for managing the effects of illness to improve quality of life, reducing health disparities, and enhancing the end-of-life experience for patients and their families are particularly welcome. For further information on NINR’s strategic plan.

Specific Research Objectives for the R03
This FOA aims to support pilot projects, and allow CAM researchers to ascertain preliminary data that could provide the basis for more extended research that can otherwise not be achieved in the area of CAM research. While definitive and costly studies are best supported by other mechanisms, a small grant (R03) can provide resources for essential tasks such as preliminary assessments of alternative or new medical systems or techniques, encourage innovative applications of new CAM approaches, and ascertain pilot data that can be essential for larger R01 projects.

CAM research is integrated through various program areas, of the Extramural Divisions and Intramural research programs such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research;

R03 small grants encourage investigators to initiate research in areas not typically explored by R01 investigators. Moreover, it can foster coordination of small research project collaborations, and promote collaborative research between national and international studies for comparative or validation trials. This is particularly relevant to initiate research on CAM practices that are identified via the NCI Best Case Series Program has warranting NCI-initiated research (for further details, go to: http://www.cancer.gov/cam/research_information.html). Examples of such therapeutic regimens include the treatment approach of the P. Banerji Homeopathic Research Foundation, insulin potentiation therapy, and macrobiotic lifestyle as per the Kushi Institute. Research of these approaches is high-risk and previous efforts to stimulate investigations via single contract mechanisms have not been fruitful. The small grant R03 mechanism can provide support for preliminary explorations of these approaches.

Broad areas of Complementary and Alternative Medicine (CAM)-related research activities appropriate for this FOA include, but are not limited to, the following:

• Alternative Medical Systems
  
• Botanical Extracts
  
• Medicinal herbs and herbal mixtures
  
• Energy Therapies
  
• Exercise Therapies
  
• Manipulative and Body-Based Methods
  
• Mind-body Interventions
  
• Nutritional Therapeutics
  
• Pharmacological and Biologic Treatments

For further details, go to: http://www.cancer.gov/cam/research_information.html).

The common characteristic of the small grant (R03) is provision of limited funding for a short period of time. Examples of the types of projects that ICs support with the R03 include, but are not limited to, the following:

• Pilot or feasibility studies
• Secondary analysis of existing data
  
• Small, self-contained research projects
  
• Development of research methodology
  
• Development of new research technology
  
• Nature of the research opportunity
  
• Pertinent background information that establishes the need for the research

Title:   Developmental Research in Cancer Prognosis and Prediction (R21), (R33)
Agency: National Cancer Institute (NCI)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-158; PA-09-159
CFDA Numbers: 93.394, 93.395
Links: http://grants.nih.gov/grants/guide/pa-files/PA-09-158.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-159.html (R33) 

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages research applications from institutions and organizations to evaluate the utility and pilot the application of new strategies for determining prognosis or predicting response to therapy for cancer. The purpose of this FOA is to develop newly discovered biomarkers from initial correlative observations into assays or test systems suitable for use in clinical trials or other types of confirmatory clinical research studies. This program will provide tools whose purpose is to improve clinical decision-making in the care of cancer patients.
   

• Mechanism of Support. This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-09-159, that encourages applications under the Exploratory/Developmental Phase II Grant (R33) mechanism.
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism, numbers, quality, duration, and costs of the applications received.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed two years. 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.
• Application Research Plan Component Length: The R21 application Research Plan component of the PHS398 (Items 2-5) may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.

• Specific Research Objectives: The objective of this FOA is to continue the development of novel prognostic and predictive biomarkers beyond the point of initial discovery into new laboratory assays and test systems that will be suitable for application in clinical trials or in larger clinical research studies such as those supported by R33 awards, in which the clinical utility of the biomarker can be evaluated.

 

 

Titles: Exploratory/Developmental Grants Program for Basic Cancer Research in Cancer Health Disparities (R21)
Basic Cancer Research in Cancer Health Disparities (U01)
Agency: National Cancer Institute (NCI)
LOI Deadline: Not Applicable
Application Deadlines: June 23, 2009; November 23, 2009; June 23, 2010; November 23, 2010; June 23, 2011; November 23, 2011
CFDA Numbers: 93.393, 93.396, 93.399
PAR Identifications: PAR-09-160; PAR-09-161
Links:  http://grants.nih.gov/grants/guide/pa-files/PAR-09-160.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PAR-09-161.html (U01)

Through this Funding Opportunity Announcement (FOA), the Center to Reduce Cancer Health Disparities (CRCHD) and the Division of Cancer Biology (DCB), at the National Cancer Institute (NCI), invite grant applications from investigators interested in conducting basic research studies into the causes and mechanisms of cancer health disparities. These awards will support pilot and feasibility studies, development and testing of new methodologies, secondary data analyses, and innovative mechanistic studies that investigate biological/genetic bases of cancer health disparities. This FOA is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research and to provide resources for those investigators that may need additional support on their path to successfully compete for R01/R01* funding in basic research in understanding cancer health disparities.

• Mechanism of Support.  This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with an FOA of identical scientific scope, PAR-09-161, which encourages applications under the Cooperative Agreement (U01) mechanism.
• Funds Available and Anticipated Number of Awards.  Awards issued under this FOA are contingent upon the availability of funds. Budgets of up $275,000/two years (not to exceed to $200,000/year) direct costs are allowed.
• Budget and Project Period.  The total project period for an application submitted in response to this funding opportunity may not exceed two years. 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.

Background
Cancer health disparities represent a major public health concern in the United States.  Regardless of socioeconomic factors, minority populations have higher overall incidence rates and worse outcomes than the overall population.  Understanding the causes of genomic/genetic/epigenetic variability between ethnic groups that impact cancer susceptibility and/or response to therapy, is vital to reducing the observed cancer outcome gaps in this country.  Several recent studies (2006-2007) suggest there may be a biological basis for the observed unequal burdens of cancer across the racial/ethic populations. The NCI specifically encourages evidence-based mechanisitc investigations of factors that are designed to increase our understanding of the basic biology of cancer health disparities.

Specific Research Objectives
Research applications should focus on basic cancer research and cancer health disparities, consistent with the research interests of both the Division of Cancer Biology (DCB,) and the Center to Reduce Cancer Health Disparities (CRCHD). The DCB supports research in the broad areas of cancer cell biology, cancer etiology, cancer immunology and hematology, DNA and chromosome aberrations, structural biology, and the tumor microenvironment.  The CRCHD supports cancer health disparity research focused on basic, hypothesis-driven studies that explicitly address the unequal burden of cancer amongst racial/ethnic minorities or other underserved populations across the cancer continuum (prevention, early detection, diagnosis, treatment and survivorship).

For this FOA, the NCI is particularly interested in the interplay of race/ethnicity with cancer biology, such as the use of biospecimens from different racial/ethnic groups or the use of ancestral markers in determining more genetically defined measures of race and ethnicity.  These awards will provide support for pilot or feasibility studies, for development and testing of new methodologies, development and testing of new research technology, secondary analysis of existing data, self-contained research projects, and innovative studies that provide a basis for more extended research (see also http://dccps.nci.nih.gov/smallgrants/).

Research topics of interest include but are not limited to:

• Examination of ethnic differences in HPV strain types/infection prevalence;
• Studies of polymorphisms in liver detoxification enzymes;
• Examination of differences in gene expression profiles in triple negative breast tumors in African-American women;
• Studies on the role of TP53 haplotypes in lung cancer among African-Americans;
• Genetic/epigenetic susceptibility differences between ethnic populations; and
• New animal and cell culture models/systems designed to investigate cancer disparities

 

Title: Susan G. Komen for the Cure® – 2009-2010 Research Grant Request for Applications
Agency: Susan G. Komen for the Cure®
Pre-App Deadline: June 1, 2009
Application Deadline: July 31, 2009
Link: http://www.komengrantsaccess.org/ OR www.komen.org/grants

Komen’s commitment to supporting life-saving research has never been stronger. Building on 27 years of funding research to find the causes and cures of breast cancer, Komen continues its important new focus on research that will speed the translation of discoveries into reductions in breast cancer mortality and/or incidence within the next decade and on addressing disparities in breast cancer across populations.

Important Changes to Pre-Application Requirements
The content and requirements for research and training pre-applications are changing! Pre-applications will now require more detailed and specific information about proposed research, such as specific aims and a clear description of the timeline from research results to impact on breast cancer incidence and/or mortality. Read the RFA requirements for pre-applications carefully and start preparing your pre-application early!!

Research Funding Opportunities
This year, Komen completes its transition to a two cycle RFA schedule in which recurring research RFAs will be announced each April and May and training RFAs will be announced each September. Announcements about additional special topic RFAs may be made at other times during the year.

April and May 2009 – Announcement of Research RFAs:

• Investigator-Initiated Research (IIR): IIR grants provide up to $600,000 over three years to stimulate exploration of new ideas and novel approaches in breast cancer research and clinical practice that will lead to reductions in breast cancer incidence and mortality within the next decade. 

• Career Catalyst Research (CCR) Grants: CCR grants provide unique opportunities for scientists in the early stages of their career to achieve research independence with an independent award of up to $450,000 over three years. 


• Career Catalyst in Disparities Research (CCDR): CCDR awards provide a unique opportunity for scientists in the early stages of their career to achieve research independence. This award provides up to $450,000 over 3 years for research exploring the basis for differences in breast cancer outcomes and the translation of this research into clinical and public health practice interventions.

CHILD & ADOLESCENT HEALTH

Title:  Barth Syndrome Foundation Announces 2009 Request for Research Proposals
Agency:  Barth Syndrome Foundation
Application Deadline: October 31, 2009
Link: http://www.barthsyndrome.org/english/View.asp?x=1635    

The Barth Syndrome Foundation, a nonprofit organization that strives to save lives through education, advances in treatment, and pursuit of a cure for Barth syndrome, has announced the availability of funding for research internationally on the natural history, biochemical basis, and treatment of Barth syndrome.

Barth syndrome is a serious X-linked genetic condition associated with cardiomyopathy, neutropenia, skeletal muscle weakness, exercise intolerance, growth delay, and diverse biochemical abnormalities (including defects in mitochondrial metabolism and phospholipid biosynthesis). Because many clinical and biochemical abnormalities of Barth syndrome remain poorly understood, the foundation is seeking proposals for research that may shed light on any aspect of the syndrome.

The foundation is most interested in providing "seed money" to be used by experienced investigators for the testing of initial hypotheses and collection of preliminary data leading to successful long-term funding by the National Institutes of Health and other major granting institutions around the world. In addition, the foundation is especially interested in attracting new investigators to the very interesting field of Barth syndrome research.

The foundation anticipates awarding several one- or two-year grants of up to $40,000 each.  Complete program guidelines are available at the Barth Syndrome Foundation Web site (http://www.barthsyndrome.org/english/View.asp?x=1635).

CARDIOVASCULAR

Other index terms: Cardiovascular
Title: Barth Syndrome Foundation Announces 2009 Request for Research Proposals
Agency: Barth Syndrome Foundation
Application Deadline: October 31, 2009
Link: http://www.barthsyndrome.org/english/View.asp?x=1635    

The Barth Syndrome Foundation, a nonprofit organization that strives to save lives through education, advances in treatment, and pursuit of a cure for Barth syndrome, has announced the availability of funding for research internationally on the natural history, biochemical basis, and treatment of Barth syndrome.

Barth syndrome is a serious X-linked genetic condition associated with cardiomyopathy, neutropenia, skeletal muscle weakness, exercise intolerance, growth delay, and diverse biochemical abnormalities (including defects in mitochondrial metabolism and phospholipid biosynthesis). Because many clinical and biochemical abnormalities of Barth syndrome remain poorly understood, the foundation is seeking proposals for research that may shed light on any aspect of the syndrome.

The foundation is most interested in providing "seed money" to be used by experienced investigators for the testing of initial hypotheses and collection of preliminary data leading to successful long-term funding by the National Institutes of Health and other major granting institutions around the world. In addition, the foundation is especially interested in attracting new investigators to the very interesting field of Barth syndrome research.

The foundation anticipates awarding several one- or two-year grants of up to $40,000 each.  Complete program guidelines are available at the Barth Syndrome Foundation Web site (http://www.barthsyndrome.org/english/View.asp?x=1635).

Clinical & Translational Research

Title: Developmental Research in Cancer Prognosis and Prediction (R21), (R33)
Agency:  National Cancer Institute (NCI)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-158; PA-09-159
CFDA Numbers: 93.394, 93.395
Links:  http://grants.nih.gov/grants/guide/pa-files/PA-09-158.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-159.html (R33) 

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages research applications from institutions and organizations to evaluate the utility and pilot the application of new strategies for determining prognosis or predicting response to therapy for cancer. The purpose of this FOA is to develop newly discovered biomarkers from initial correlative observations into assays or test systems suitable for use in clinical trials or other types of confirmatory clinical research studies. This program will provide tools whose purpose is to improve clinical decision-making in the care of cancer patients.
   

• Mechanism of Support. This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-09-159, that encourages applications under the Exploratory/Developmental Phase II Grant (R33) mechanism.
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism, numbers, quality, duration, and costs of the applications received.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed two years. 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.
• Application Research Plan Component Length: The R21 application Research Plan component of the PHS398 (Items 2-5) may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.

• Specific Research Objectives: The objective of this FOA is to continue the development of novel prognostic and predictive biomarkers beyond the point of initial discovery into new laboratory assays and test systems that will be suitable for application in clinical trials or in larger clinical research studies such as those supported by R33 awards, in which the clinical utility of the biomarker can be evaluated.

 

Title: NLM Applied Informatics Grants (G08)
Agency:  National Library of Medicine (NLM)
LOI Deadline: June 1, 2009
Application Deadline: July 1, 2009 
CFDA Number: 93.879
RFA Identification:  RFA-LM-09-001
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-LM-09-001.html     

• Purpose. The National Library of Medicine (NLM) offers Applied Informatics grants to health-related and scientific organizations that wish to optimize the utility and use of clinical and research information. These grants are for organizations that wish to exploit the capabilities of information technology to bring usable, useful biomedical knowledge to end users by translating the findings of informatics and information science research into practice through novel or enhanced systems and services.
• Mechanism of Support. This FOA will utilize the G08 grant mechanism.
• Funds Available and Anticipated Number of Awards. NLM anticipates making 3 – 5 awards, spending approximately $800,000 to support this program. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. Individual awards may not exceed $150,000 for one year, $300,000 over two years or $450,000 over three years, in direct costs. The total amount requested need not be the same in each year of a multi-year project. The project period can be one to three years. This program does not cover costs for facilities and administration, also called overhead or indirect costs.  

These grants can be used to support a variety of health-related information activities relating to clinical or scientific information, including but not limited to:

Designing, deploying and evaluating a unique digital information resource that has the potential to meet national needs.This might involve such activities as:

• Integrating digital information that comes from different sources to create tailored views
• Introducing tools and techniques into existing online resources that help users visualize and understand the information they find
• Improving the usability of interfaces

Fundamental features of a project proposal for this program include discussion of the following points:

• The information problem and its context, supported by published evidence
• Rationale for the system, resource or service
• Evidence of a user-centered approach to development and deployment
• A timeline and milestones for the proposed work
• Outcome-oriented evaluation of the proposed system or service
• Plan for disseminating the results of the project
• Plan for supporting the system after grant funding ends

These grants are not merely grants for technology or online access to publications. They should bring to end-users the high-quality scientific or health-related information they seek. Applicants should describe their approach to providing systems and services, address mechanisms for promoting use of the proposed system, provide details of training and evaluation plans, and discuss their plans for managing and supporting the work after grant funding ends. Applicants who propose to create a web-based resource should discuss how they will address content features such as selection, source credibility, currency, accuracy and completeness.

NLM Applied Informatics grant projects must result in an operational service activity. This may involve installation of a whole system, the testing of a prototype followed by a fuller implementation, establishing connectivity of existing system components, or enhancing features of an existing system or resource. A small planning activity may be included within the proposed project. Development projects must demonstrate the involvement of intended users, and present a plan for training them and gathering feedback from them.

Evaluation is a key feature of any application in this grant program. Where possible, applicants are encouraged to design evaluations that measure real outcomes for users. Applicants proposing outreach initiatives are encouraged to make use of resources such as Measuring the Difference: a Guide to Planning and Evaluating Health Information Outreach http://nnlm.gov/evaluation/guide/, or to find evaluation consultants to work with them. Applicants who propose to create a web-based resource or service should discuss how they will track use, growth, user characteristics and content features such as currency, accuracy, timeliness and completeness.

Dissemination of results to a larger community of interest is a fundamental feature of this grant program. Applicants should explain how they will share what they learned with others, and indicate what kinds of access to resources or services they will provide to interested parties outside the participating organizations.

The following types of projects are considered outside the scope of NLM’s Applied Informatics grant program:

• Installation of Online library catalogs
• Electronic health record systems, single-purpose or closed clinical systems such as a stand-alone laboratory system or picture archiving system (PACS)
• Digitization of print materials
• Projects that duplicate NLM products and databases such as Go Local consumer health initiatives or biomedical literature indexing projects

 

Title: Renal Function and Chronic Kidney Disease in Aging (R01), (R21)
Agency:  National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications:  PA-09-165; PA-09-166
CFDA Number: 93.866
Links:  http://grants.nih.gov/grants/guide/pa-files/PA-09-165.html (R01)
http://grants.nih.gov/grants/guide/pa-files/PA-09-166.html (R21)

This Funding Opportunity Announcement (FOA) issued by the National Institute on Aging (NIA) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, invites applications that propose basic, clinical, and translational research on chronic kidney disease (CKD) and its consequences in aging and in older persons.  Applications should focus on the 1) biology and pathophysiology of CKD in animal models; 2) etiology and pathophysiology of CKD in the elderly; 3) epidemiology and risk factors for the development of CKD with advancing age; and/or 4) diagnosis, medical management and clinical outcomes of CKD in this population.  Research supported by this initiative should enhance knowledge of CKD and its consequences in the elderly and provide evidence-based guidance in the diagnosis, prevention, and treatment of CKD in older persons.

SCOPE OF RESEARCH:
This FOA invites research applications in both animal models and in humans, addressing the etiology, pathophysiology, risk factors, consequences, prevention, or treatment of CKD in older patients.  Areas of interest include, but are not limited to, the following areas:

Etiology and Pathophysiology

• Contributions of age-related changes in renal vascular structure and function on the development of CKD (e.g., changes in renal blood flow, vascular resistance, and sensitivity to ischemia), and the mechanisms by which these changes occur.
• Mechanisms of kidney fibrosis underlying CKD progression.
• Contributions of cellular senescence and gene polymorphisms to CKD during aging and in older adults and their mechanisms of action.
• Relationship of CKD to age-related changes in renal morphology, pathology, structure (e.g., tubular atrophy, glomerulosclerosis, interstitial fibrosis) and function (e.g., changes in renal hemodynamics, GFR, urine concentrating and diluting ability, secretion of renin and erythropoietin, and activation of vitamin D).
• Roles of oxidative stress and endothelial dysfunction in the development of CKD during aging and in aged adults.
• Possible differences in pathology and pathophysiology of CKD in younger vs. older patients or animals.
• Complications and long-term consequences of CKD in the elderly (e.g., development of osteoporosis, CVD, and anemia; impact on vitamin D metabolism and phosphate balance; effects on coagulation mechanisms; and modulation of secretion of renin and erythropoietin).
• Role of CKD and its complications in functional impairment and disability among older patients.

Epidemiology, Risk Factors, and Comorbid Interactions

• Natural history of age-related decline in kidney function, and progression from early stage CKD to ESRD in the elderly.
• Clinical consequences and long-term outcomes of different stages of CKD in older adults, including effects of mild decreases in GFR on long-term health outcomes. 
• Role of established CKD risk factors (e.g., hypertension, diabetes and acute kidney injury) and potential new risk factors (e.g., oxidative stress, age-related endothelial dysfunction) in development and progression of CKD in the elderly. 
• Studies that distinguish risk factors for progression to different stages of CKD, and the extent to which risk factors are the same or differ across different stages of CKD.  Studies on the relationships between acute kidney injury and CKD are encouraged. 
• Relationships of comorbidities to development of CKD in the elderly and its progression to ESRD, and the interaction of coexisting diseases with CKD on morbidity and functional outcomes in older patients. 
• Relationships of CKD and/or its treatment to cognitive impairment in the elderly.

Early Detection and Diagnosis

• Development and validation of new methods or biomarkers to accurately, reliably, and efficiently measure renal function and identify early stages of declining function in older persons or animal models.
• Studies to analyze and improve the performance of current GFR estimating equations in older patients.
• Development and validation of new tests of age-related acute and chronic renal damage, including measures of age-related decline in kidney functions other than glomerular filtration, e.g., kidney endocrine functions.
• Development and validation of screening algorithms for early detection of CKD in community-dwelling elderly, particularly older adults at increased risk for CKD, to optimize timing of screening, frequency of testing, sensitivity and specificity of screening tests, and cost–benefit ratios.

Prevention and Treatment

• Efficacy of treatments for CKD risk factors (e.g., cardiovascular disease and diabetes) to prevent or delay onset of CKD in older persons.
• Effects of various interventions applied at early stages of CKD in preventing or slowing further adverse effects in older patients (e.g., risk factor management, vitamin D, dietary regimen such as protein restriction, salt restriction and calorie restriction, and physical activity interventions).
• Testing new treatment approaches in elderly CKD patients who have conditions contributing to its progression (e.g., diabetes/hypertension), e.g., angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers and aldosterone blockade; optimal targets for blood pressure and glucose control.
• Testing of clinical strategies for the management of complications and long-term consequences of CKD in older patients (e.g., cardiovascular and peripheral vascular disease, Vitamin D deficiency, hyperphosphatemia, osteodystrophy and hematologic problems).
• Studies evaluating whether interventions to slow progression in CKD are efficacious in preventing or slowing further functional loss when applied at earlier levels of decrease in GFR.

Development and testing of interventions to maintain functional status, cognitive function, and quality of life among older CKD patients.

CLINICAL RESEARCH

Title: Developmental Projects in Complementary Approaches to Cancer Care and Treatment (R21) (R03)
Agency: National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-167, PA-09-168
CFDA Numbers: 93.395, 93.361
Links: http://grants.nih.gov/grants/guide/pa-files/PA-09-167.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-168.html (R03)

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), and the National Institute of Nursing Research (NINR), of the National Institutes of Health, invites applications for basic, pre-clinical, and clinical complementary cancer research. The research should relate to the areas of prevention, diagnosis, and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. In addition, this FOA encourages the development and application of emerging and innovative technologies, including identification of novel therapeutics in the pharmacopoeia of Traditional Medical Systems (as defined by the World Health Organization), use of complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies, and research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g., response to conventional cancer therapy, survival). The overarching goals of these FOAs are to encourage investigators to submit high quality, preliminary research of humans that will advance the science of Complementary and Alternative Medicine (CAM) and provide a solid foundation and justification for future research project (R01) grant applications to definitively determine the efficacy of CAM approaches.

Specific Research Objectives for the R21
The intent of this initiative is to encourage and support the development of basic and clinical (prevention, therapeutic, and palliative) cancer research in complementary approaches. Another goal of this initiative is to facilitate communication and collaboration between practitioners in complementary approaches and the conventional cancer research communities.

For the purpose of this FOA, applicants may consider complementary approaches as they relate to the prevention, diagnosis, and treatment of cancer, cancer-related symptoms, and side effects of conventional treatment. In addition, applicants may consider research that focuses on the potential interactions of complementary approaches with conventional cancer therapies. Complementary approaches that are considered appropriate to this announcement include (but are not limited to) those involving nutritional approaches, natural products, mind-body approaches, energy therapies, herbal medicines, and interventions based upon those within traditional medical systems (as defined by the World Health Organization), such as traditional Chinese medicine or ayurvedic medicine.

Topics of programmatic interest include, but are not limited to:

• Approaches related to management of cancer-related symptoms and side effects of conventional treatment;
  
• Exploratory studies of complementary approaches in combination with conventional regimens, and outcome, effectiveness, and quality of life assessments.
  
• Design and pilot testing of interventions for comparative studies of complementary modalities as interventions for end of life and palliative care (e.g., relaxation therapy, music therapy);
  
• Development of methodologies to improve assessment of the impact of complementary approaches to treatment; e.g., instrument development, biobehavioral markers, acceptance of longitudinal designs or prevention;
  
• Feasibility studies of behavioral interventions that incorporate principles of cultural competency, in particular within populations that utilize culture-specific traditional methods of treating cancer;
  
• Applications relevant to understudied populations (i.e. the use of complementary approaches in children or older adults). Descriptive studies of the prevalence of complementary and alternative medicine (CAM) use in understudied populations including the impact of such use on the primary modality of treatment are also appropriate;
  
• Nutritional approaches in the prevention and treatment of cancer as well as to prevent disease recurrence;
  
• Preclinical studies of candidate-complementary approaches with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• Preclinical studies to advance understanding of mechanism of actions a well as drug-drug interactions;
  
• Isolation and pharmacological studies of active ingredients from herbal or other traditional medicine preparations, including a defined reconstitution of more than one pure ingredient, such as drug-drug interaction; and
  
• Applications that seek to clarify markers of exposure to bioactive food components and their biological response in specific targets are also appropriate.

CAM research is integrated through various program areas of the Extramural Divisions and Intramural research programs (http://www.cancer.gov/cam/research_portfolio.html), such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research.

The National Institute of Nursing Research (NINR) also encourages applications that are consistent with its strategic plan and research themes for the future. In keeping with its research themes, projects that may lead to improved strategies for managing the effects of illness to improve quality of life, reducing health disparities, and enhancing the end-of-life experience for patients and their families are particularly welcome. For further information on NINR’s strategic plan.

Specific Research Objectives for the R03
This FOA aims to support pilot projects, and allow CAM researchers to ascertain preliminary data that could provide the basis for more extended research that can otherwise not be achieved in the area of CAM research. While definitive and costly studies are best supported by other mechanisms, a small grant (R03) can provide resources for essential tasks such as preliminary assessments of alternative or new medical systems or techniques, encourage innovative applications of new CAM approaches, and ascertain pilot data that can be essential for larger R01 projects.

CAM research is integrated through various program areas, of the Extramural Divisions and Intramural research programs such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research;

R03 small grants encourage investigators to initiate research in areas not typically explored by R01 investigators. Moreover, it can foster coordination of small research project collaborations, and promote collaborative research between national and international studies for comparative or validation trials. This is particularly relevant to initiate research on CAM practices that are identified via the NCI Best Case Series Program has warranting NCI-initiated research (for further details, go to: http://www.cancer.gov/cam/research_information.html). Examples of such therapeutic regimens include the treatment approach of the P. Banerji Homeopathic Research Foundation, insulin potentiation therapy, and macrobiotic lifestyle as per the Kushi Institute. Research of these approaches is high-risk and previous efforts to stimulate investigations via single contract mechanisms have not been fruitful. The small grant R03 mechanism can provide support for preliminary explorations of these approaches.

Broad areas of Complementary and Alternative Medicine (CAM)-related research activities appropriate for this FOA include, but are not limited to, the following:

• Alternative Medical Systems
  
• Botanical Extracts
  
• Medicinal herbs and herbal mixtures
  
• Energy Therapies
  
• Exercise Therapies
  
• Manipulative and Body-Based Methods
  
• Mind-body Interventions
  
• Nutritional Therapeutics
  
• Pharmacological and Biologic Treatments

For further details, go to: http://www.cancer.gov/cam/research_information.html).

The common characteristic of the small grant (R03) is provision of limited funding for a short period of time. Examples of the types of projects that ICs support with the R03 include, but are not limited to, the following:

• Pilot or feasibility studies
• Secondary analysis of existing data
  
• Small, self-contained research projects
  
• Development of research methodology
  
• Development of new research technology
  
• Nature of the research opportunity
  
• Pertinent background information that establishes the need for the research

 

 

Title: NIDCD Definitive Phase III Clinical Trial Planning Grant (R34)
Agency: National Institute on Deafness and Other Communication Disorders (NIDCD)
Application Deadline:  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PAR Identification: PAR-09-142
CFDA Number: 93.173
Link: http://grants.nih.gov/grants/guide/pa-files/PAR-09-142.html   

• Purpose. The goal of this FOA is to provide support to complete the development of a comprehensive research protocol for large-scale, multicenter Phase III Definitive Clinical Trials (DCT).  The planning grant is designed to permit early peer review of the proposed clinical trial in terms of its rationale, general design, organizational structure and implementation plan.  The planning grant is used to support the development of a detailed Manual of Procedures (MOP), which is required for submission when applying for a Phase III Definitive Clinical Trial (PAR-08-205).  The planning grant will provide support to establish the research team, develop tools for data management and oversight of the research, define recruitment strategies, and develop and finalize the MOP. The Planning Grant is NOT intended to support small Phase I/II Preliminary Clinical Trials.  Applications for Phase I/II Preliminary Clinical Trials should use the NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (PAR-08-204).  
• Mechanism of Support. This FOA will utilize the R34 funding mechanism.
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
• Budget and Project Period.  The total project period for an application submitted in response to this FOA may not exceed two years. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year.

• Application Research Plan Component Length: The R34 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm

COMMUNITY CARE & OUTREACH

Title: NLM Applied Informatics Grants (G08)
Agency:  National Library of Medicine (NLM)
LOI Deadline: June 1, 2009
Application Deadline: July 1, 2009 
CFDA Number: 93.879
RFA Identification:  RFA-LM-09-001
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-LM-09-001.html     

• Purpose. The National Library of Medicine (NLM) offers Applied Informatics grants to health-related and scientific organizations that wish to optimize the utility and use of clinical and research information. These grants are for organizations that wish to exploit the capabilities of information technology to bring usable, useful biomedical knowledge to end users by translating the findings of informatics and information science research into practice through novel or enhanced systems and services.
• Mechanism of Support. This FOA will utilize the G08 grant mechanism.
• Funds Available and Anticipated Number of Awards. NLM anticipates making 3 – 5 awards, spending approximately $800,000 to support this program. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. Individual awards may not exceed $150,000 for one year, $300,000 over two years or $450,000 over three years, in direct costs. The total amount requested need not be the same in each year of a multi-year project. The project period can be one to three years. This program does not cover costs for facilities and administration, also called overhead or indirect costs.  

These grants can be used to support a variety of health-related information activities relating to clinical or scientific information, including but not limited to:

Designing, deploying and evaluating a unique digital information resource that has the potential to meet national needs.This might involve such activities as:

• Integrating digital information that comes from different sources to create tailored views
• Introducing tools and techniques into existing online resources that help users visualize and understand the information they find
• Improving the usability of interfaces

Fundamental features of a project proposal for this program include discussion of the following points:

• The information problem and its context, supported by published evidence
• Rationale for the system, resource or service
• Evidence of a user-centered approach to development and deployment
• A timeline and milestones for the proposed work
• Outcome-oriented evaluation of the proposed system or service
• Plan for disseminating the results of the project
• Plan for supporting the system after grant funding ends

These grants are not merely grants for technology or online access to publications. They should bring to end-users the high-quality scientific or health-related information they seek. Applicants should describe their approach to providing systems and services, address mechanisms for promoting use of the proposed system, provide details of training and evaluation plans, and discuss their plans for managing and supporting the work after grant funding ends. Applicants who propose to create a web-based resource should discuss how they will address content features such as selection, source credibility, currency, accuracy and completeness.

NLM Applied Informatics grant projects must result in an operational service activity. This may involve installation of a whole system, the testing of a prototype followed by a fuller implementation, establishing connectivity of existing system components, or enhancing features of an existing system or resource. A small planning activity may be included within the proposed project. Development projects must demonstrate the involvement of intended users, and present a plan for training them and gathering feedback from them.

Evaluation is a key feature of any application in this grant program. Where possible, applicants are encouraged to design evaluations that measure real outcomes for users. Applicants proposing outreach initiatives are encouraged to make use of resources such as Measuring the Difference: a Guide to Planning and Evaluating Health Information Outreach http://nnlm.gov/evaluation/guide/, or to find evaluation consultants to work with them. Applicants who propose to create a web-based resource or service should discuss how they will track use, growth, user characteristics and content features such as currency, accuracy, timeliness and completeness.

Dissemination of results to a larger community of interest is a fundamental feature of this grant program. Applicants should explain how they will share what they learned with others, and indicate what kinds of access to resources or services they will provide to interested parties outside the participating organizations.

The following types of projects are considered outside the scope of NLM’s Applied Informatics grant program:

• Installation of Online library catalogs
• Electronic health record systems, single-purpose or closed clinical systems such as a stand-alone laboratory system or picture archiving system (PACS)
• Digitization of print materials
• Projects that duplicate NLM products and databases such as Go Local consumer health initiatives or biomedical literature indexing projects

DRUG DISCOVERY & DEVELOPMENT

Title: Partnerships for Development of Vaccines for Selected Pathogens (R01)
Agency: National Institute on Allergy and Infectious Diseases (NIAID)
LOI Deadline: June 26, 2009
Application Deadline: July 27, 2009
RFA Identification: RFA-AI-09-016
CFDA Number: 93.856
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-09-016.html

This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) invites research applications for projects that will advance development of vaccines against five pathogens that have a significant impact on public health: cytomegalovirus, respiratory syncytial virus, Staphylococcus aureus, Pseudomonas aeruginosa and Clostridium difficile. The formation of collaborative partnerships between academic (or non-profit) researchers from different disciplines or with industry is strongly encouraged, but not required.

• Mechanism of Support. This FOA will utilize the R01 grant mechanism.
• Funds Available and Anticipated Number of Awards. The NIAID intends to commit $4.0 million in total costs in FY2010 to fund three to five applications in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
• Budget and Project Period. An applicant may request a project period of up to five years and a budget for direct costs of no more than $500,000 in any single year.
• Application Research Plan Component Length: The R01 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm

Partnerships
A key component of this FOA is the formation of collaborative partnerships, which may be between academic researchers from different disciplines or between academic and industry researchers. For the purpose of this FOA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this FOA will support partnerships between industry and collaborator(s) from academic (or non-profit) research organizations. For this FOA, partnerships are strongly encouraged, but not required.

Applications submitted in response to this FOA will include a Product Development Plan (PDP) to assist reviewers and program staff in project evaluation. The PDP will define the general goals of the project, intended use/indication of the proposed therapeutic or diagnostic, and biodefense/public health gap the product is intended to fill. Additionally, the PDP will detail the stage-specific product development activities that will be performed during the project period and outline plans for further development after completion of the project.

The Principal Investigator of the project may be affiliated with industry, an academic organization or non-profit research organization.

Research Goals and Objectives
To facilitate the development and testing of candidate vaccines, it is imperative that promising basic research findings/technologies be translated rapidly into new approaches and strategies for product development. The involvement of experts from diverse disciplines (e.g., biochemists, structural biologists, protein chemists, pharmacologists, immunologists, molecular biologists, engineers and clinicians) within academia and industry is needed to enable development of well-designed candidates for vaccines.

The objectives of this FOA are:
1. To support research that will advance the development and/or production of vaccines specific for the pathogens described above. Developmental research is not required to result in a "final" product but must advance the development of a candidate product; and
2. To stimulate scientifically sound, original, and innovative research requiring a comprehensive team and multidisciplinary effort that will facilitate advancement of a promising candidate product or platform technology through the product development pathway.

To most effectively achieve these objectives, applications must include in vivo efficacy data in at least one animal model with accompanying general safety and immunogenicity data. It is understood that the animal studies may involve a vaccine or endpoint that does not precisely replicate the planned human vaccine.

NOTE: While clinical development strategies may be included within an overall product development plan, this FOA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this FOA and will not be reviewed. However, utilization of appropriate human cell lines and human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive and is encouraged.

For all vaccine projects, approaches should consider the ultimate potential of candidate vaccines to induce safe and protective responses in a diverse population. Projects may include, but are not limited to, one or more of the following areas:
• Improvement of existing candidates, including assessment of alternate formulations, stabilization, immunopotentiation, regimen optimization and evaluation of novel adjuvants.
• Evaluation of novel vaccine strategies, such as recombinant DNA; reverse genetics leading to live-attenuated strains and vectors; chimeras and mono- or multi-valent subunits.
• Advanced preclinical studies, including: safety and toxicology studies; further efficacy testing in animal models; assessment of host response; determination of clinically-relevant correlates of immunity and surrogate endpoints.

GENETICS

Title: Novel Statistical Methods for Human Gene Expression Quantitative Trait Loci (eQTL) Analysis (R01)
Agency: National Institute of Mental Health (NIMH)
LOI Deadline:  August 16, 2009
Application Deadline: September 16, 2009
RFA Identification:  RFA-RM-09-006
CFDA Number: 93.310
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-09-006.html  

This FOA solicits applications to develop innovative statistical methods to detect the influence of genetic variation on tissue-specific gene expression and regulation. The goal of the FOA is to seek proposals to develop statistical methods to appropriately analyze the forthcoming complex data sets generated by the NIH Roadmap initiative entitled “Genotype-Tissue Expression (GTEx) Project”.  Applicants are encouraged to take advantage of existing tissue-specific gene expression datasets and/or simulated datasets, but will also be strongly encouraged to utilize GTEx-generated data, if and when it is available.

• Mechanism of Support. This FOA will utilize the R01 grant mechanism.
• Funds Available and Anticipated Number of Awards.  The total amount of funds available for these awards is $1 million total costs per year for two years; we anticipate making two to three awards.
• Budget and Project Period. The total project period may not exceed two years. Direct costs are expected to be $200,000 to $300,000 per year per award. 
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

This RFA seeks proposals to develop innovative and advanced statistical methods to appropriately analyze the forthcoming complex data sets to assess the influence of genetic variation on tissue-specific gene expression and regulation.  Applicants are encouraged to take advantage of the availability of the SNP and tissue specific gene expression data (both chip- and next-generation sequencing based RNA expression data) from multiple tissues generated by the GTEx pilot project.  However, since the data generated from the GTEx pilot may not be available until very late in the funding period, if at all, analyses based on existing human genotype-gene expression datasets, and simulation-based studies, are also appropriate.  In terms of the data resources, applicants are encouraged to use the data generated by GTEx if/when it is available; they may also use existing data through collaborative efforts, the GTEx portal of NCBI (http://www.ncbi.nlm.nih.gov/gtex/), or simulated data sets. All proposed analyses must have relevance to human eQTL mapping, and those that focus entirely or predominantly on human data, or those that involve direct comparison of human data to other mammalian systems, have the highest programmatic priority.

Examples of research areas that applicants may work on include the following (note this is not an all-inclusive list, and applicants are encouraged to address more than one area):

• Extend existing methods, such as regression approaches, or develop new methods, such as structural equations, Bayesian models, or causal inference models, as a framework to integrate analysis of genotype and gene expression for eQTL identification, for simultaneous analysis of multiple genetic variants, for joint analysis of gene expression levels in multiple tissues, and for analysis of regulatory networks.
• Extend existing models or develop new ones to make predictions about the functional relevance of genetic variants to gene regulation, in terms of expression levels, gene splicing, and/or regulatory networks.
• Modify existing data reduction tools to make analytical procedures more efficient.
• Develop methods to use multiple datasets or multiple tissue types to reduce the number of false negative results.
• Develop creative methods to quantify RNA expression levels from next-generation sequencing generated data, compare it to chip-based estimates, and evaluate its impact on the ability to identify eQTLs.
• Model and explore the overlap in eQTLs between different tissues.
• Model and explore the incremental identification of new eQTLs as the number of tissues is increased.
• Compare the ability to identify eQTLs in samples obtained under different conditions (for example, the same organ from autopsy and surgery cases).
• Model and explore the influence that having expression data from multiple tissues from each donor has on statistical power to detect trans-eQTLs.
• Develop new methods to take diverse population structure into account in data analysis.

Global & International Health

Title: International Collaborations in Infectious Disease Research (ICIDR) (U01)
Agency: National Institute of Allergy and Infectious Diseases (NIAID)

LOI Deadline: June 23, 2009
Application Deadline: July 23, 2009
RFA Identification: RFA-AI-09-010
CFDA Number: 93.856
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-09-010.html

• Purpose. This Funding Opportunity Announcement (FOA) encourages applications from U.S. institutions proposing collaborative research with foreign [non-U.S.] investigators and organizations to study infectious diseases of the greatest public health significance in resource-constrained countries. This work is expected to increase scientific knowledge on public health related issues, enhance relevant research experience for U.S. and foreign investigators, promote the development of research capacity, and encourage future collaborative relationships.
• Mechanism of Support. This FOA will utilize the U01 cooperative agreement grant mechanism.
• Funds Available and Anticipated Number of Awards. The NIAID expects to award $6.3 million in total costs in response to this FOA to support 5 to 9 new and/or competing renewal grants.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed five years. Direct costs are limited to $500,000 in year 1. Future year recommended levels are limited to 3% escalation costs.

All applications must be focused on a single pathogen or disease entity.

Topics of interest for this program are limited to research on infectious diseases, including emerging infections that are of the greatest public health significance within the collaborating country. Except as noted below, research on any relevant infectious disease is appropriate. Applications proposing studies on the following diseases and pathogens are specifically encouraged:
• Zoonotic diseases, including Leptospirosis, Brucellosis, Melioidosis, Rickettsioses
• Leprosy and Buruli ulcer
• Viral pathogens, especially Enterovirus 71 and Monkey Pox
• Respiratory diseases, including Tuberculosis, Pneumococcal infections, Influenza, N. meningitides, and S. pneumoniae.
• Sexually transmitted infections: Bacterial Vaginosis, Haemophilus ducreyi and Trichomoniasis
• Parasitic diseases and vectors
• Hepatitis E in pregnant women
• NIAID Category A, B, and C priority pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm, especially Enterotoxigenic E. coli, Shigella, Hantaviruses, Dengue, Rift Valley Fever, Japanese Encephalitis Virus and West Nile Virus

HEALTH DIFFERENCES & DISPARITIES

Titles: Exploratory/Developmental Grants Program for Basic Cancer Research in Cancer Health Disparities (R21)
Basic Cancer Research in Cancer Health Disparities (U01)
Agency: National Cancer Institute (NCI)
LOI Deadline: Not Applicable
Application Deadlines: June 23, 2009; November 23, 2009; June 23, 2010; November 23, 2010; June 23, 2011; November 23, 2011
CFDA Numbers: 93.393, 93.396, 93.399
PAR Identifications: PAR-09-160; PAR-09-161
Links:  http://grants.nih.gov/grants/guide/pa-files/PAR-09-160.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PAR-09-161.html (U01)

Through this Funding Opportunity Announcement (FOA), the Center to Reduce Cancer Health Disparities (CRCHD) and the Division of Cancer Biology (DCB), at the National Cancer Institute (NCI), invite grant applications from investigators interested in conducting basic research studies into the causes and mechanisms of cancer health disparities. These awards will support pilot and feasibility studies, development and testing of new methodologies, secondary data analyses, and innovative mechanistic studies that investigate biological/genetic bases of cancer health disparities. This FOA is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research and to provide resources for those investigators that may need additional support on their path to successfully compete for R01/R01* funding in basic research in understanding cancer health disparities.

• Mechanism of Support.  This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with an FOA of identical scientific scope, PAR-09-161, which encourages applications under the Cooperative Agreement (U01) mechanism.
• Funds Available and Anticipated Number of Awards.  Awards issued under this FOA are contingent upon the availability of funds. Budgets of up $275,000/two years (not to exceed to $200,000/year) direct costs are allowed.
• Budget and Project Period.  The total project period for an application submitted in response to this funding opportunity may not exceed two years. 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.

Background
Cancer health disparities represent a major public health concern in the United States.  Regardless of socioeconomic factors, minority populations have higher overall incidence rates and worse outcomes than the overall population.  Understanding the causes of genomic/genetic/epigenetic variability between ethnic groups that impact cancer susceptibility and/or response to therapy, is vital to reducing the observed cancer outcome gaps in this country.  Several recent studies (2006-2007) suggest there may be a biological basis for the observed unequal burdens of cancer across the racial/ethic populations. The NCI specifically encourages evidence-based mechanisitc investigations of factors that are designed to increase our understanding of the basic biology of cancer health disparities.

Specific Research Objectives
Research applications should focus on basic cancer research and cancer health disparities, consistent with the research interests of both the Division of Cancer Biology (DCB,) and the Center to Reduce Cancer Health Disparities (CRCHD). The DCB supports research in the broad areas of cancer cell biology, cancer etiology, cancer immunology and hematology, DNA and chromosome aberrations, structural biology, and the tumor microenvironment.  The CRCHD supports cancer health disparity research focused on basic, hypothesis-driven studies that explicitly address the unequal burden of cancer amongst racial/ethnic minorities or other underserved populations across the cancer continuum (prevention, early detection, diagnosis, treatment and survivorship).

For this FOA, the NCI is particularly interested in the interplay of race/ethnicity with cancer biology, such as the use of biospecimens from different racial/ethnic groups or the use of ancestral markers in determining more genetically defined measures of race and ethnicity.  These awards will provide support for pilot or feasibility studies, for development and testing of new methodologies, development and testing of new research technology, secondary analysis of existing data, self-contained research projects, and innovative studies that provide a basis for more extended research (see also http://dccps.nci.nih.gov/smallgrants/).

Research topics of interest include but are not limited to:

• Examination of ethnic differences in HPV strain types/infection prevalence;
• Studies of polymorphisms in liver detoxification enzymes;
• Examination of differences in gene expression profiles in triple negative breast tumors in African-American women;
• Studies on the role of TP53 haplotypes in lung cancer among African-Americans;
• Genetic/epigenetic susceptibility differences between ethnic populations; and
• New animal and cell culture models/systems designed to investigate cancer disparities

HEALTH INFORMATICS

Title: NLM Applied Informatics Grants (G08)
Agency:  National Library of Medicine (NLM)
LOI Deadline: June 1, 2009
Application Deadline: July 1, 2009 
CFDA Number: 93.879
RFA Identification:  RFA-LM-09-001
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-LM-09-001.html     

• Purpose. The National Library of Medicine (NLM) offers Applied Informatics grants to health-related and scientific organizations that wish to optimize the utility and use of clinical and research information. These grants are for organizations that wish to exploit the capabilities of information technology to bring usable, useful biomedical knowledge to end users by translating the findings of informatics and information science research into practice through novel or enhanced systems and services.
• Mechanism of Support. This FOA will utilize the G08 grant mechanism.
• Funds Available and Anticipated Number of Awards. NLM anticipates making 3 – 5 awards, spending approximately $800,000 to support this program. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. Individual awards may not exceed $150,000 for one year, $300,000 over two years or $450,000 over three years, in direct costs. The total amount requested need not be the same in each year of a multi-year project. The project period can be one to three years. This program does not cover costs for facilities and administration, also called overhead or indirect costs.  

These grants can be used to support a variety of health-related information activities relating to clinical or scientific information, including but not limited to:

Designing, deploying and evaluating a unique digital information resource that has the potential to meet national needs.This might involve such activities as:

• Integrating digital information that comes from different sources to create tailored views
• Introducing tools and techniques into existing online resources that help users visualize and understand the information they find
• Improving the usability of interfaces

Fundamental features of a project proposal for this program include discussion of the following points:

• The information problem and its context, supported by published evidence
• Rationale for the system, resource or service
• Evidence of a user-centered approach to development and deployment
• A timeline and milestones for the proposed work
• Outcome-oriented evaluation of the proposed system or service
• Plan for disseminating the results of the project
• Plan for supporting the system after grant funding ends

These grants are not merely grants for technology or online access to publications. They should bring to end-users the high-quality scientific or health-related information they seek. Applicants should describe their approach to providing systems and services, address mechanisms for promoting use of the proposed system, provide details of training and evaluation plans, and discuss their plans for managing and supporting the work after grant funding ends. Applicants who propose to create a web-based resource should discuss how they will address content features such as selection, source credibility, currency, accuracy and completeness.

NLM Applied Informatics grant projects must result in an operational service activity. This may involve installation of a whole system, the testing of a prototype followed by a fuller implementation, establishing connectivity of existing system components, or enhancing features of an existing system or resource. A small planning activity may be included within the proposed project. Development projects must demonstrate the involvement of intended users, and present a plan for training them and gathering feedback from them.

Evaluation is a key feature of any application in this grant program. Where possible, applicants are encouraged to design evaluations that measure real outcomes for users. Applicants proposing outreach initiatives are encouraged to make use of resources such as Measuring the Difference: a Guide to Planning and Evaluating Health Information Outreach http://nnlm.gov/evaluation/guide/, or to find evaluation consultants to work with them. Applicants who propose to create a web-based resource or service should discuss how they will track use, growth, user characteristics and content features such as currency, accuracy, timeliness and completeness.

Dissemination of results to a larger community of interest is a fundamental feature of this grant program. Applicants should explain how they will share what they learned with others, and indicate what kinds of access to resources or services they will provide to interested parties outside the participating organizations.

The following types of projects are considered outside the scope of NLM’s Applied Informatics grant program:

• Installation of Online library catalogs
• Electronic health record systems, single-purpose or closed clinical systems such as a stand-alone laboratory system or picture archiving system (PACS)
• Digitization of print materials
• Projects that duplicate NLM products and databases such as Go Local consumer health initiatives or biomedical literature indexing projects

HEALTH SERVICES RESEARCH

Title: NLM Applied Informatics Grants (G08)
Agency:  National Library of Medicine (NLM)
LOI Deadline: June 1, 2009
Application Deadline: July 1, 2009 
CFDA Number: 93.879
RFA Identification:  RFA-LM-09-001
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-LM-09-001.html     

• Purpose. The National Library of Medicine (NLM) offers Applied Informatics grants to health-related and scientific organizations that wish to optimize the utility and use of clinical and research information. These grants are for organizations that wish to exploit the capabilities of information technology to bring usable, useful biomedical knowledge to end users by translating the findings of informatics and information science research into practice through novel or enhanced systems and services.
• Mechanism of Support. This FOA will utilize the G08 grant mechanism.
• Funds Available and Anticipated Number of Awards. NLM anticipates making 3 – 5 awards, spending approximately $800,000 to support this program. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. Individual awards may not exceed $150,000 for one year, $300,000 over two years or $450,000 over three years, in direct costs. The total amount requested need not be the same in each year of a multi-year project. The project period can be one to three years. This program does not cover costs for facilities and administration, also called overhead or indirect costs.  

These grants can be used to support a variety of health-related information activities relating to clinical or scientific information, including but not limited to:

Designing, deploying and evaluating a unique digital information resource that has the potential to meet national needs.This might involve such activities as:

• Integrating digital information that comes from different sources to create tailored views
• Introducing tools and techniques into existing online resources that help users visualize and understand the information they find
• Improving the usability of interfaces

Fundamental features of a project proposal for this program include discussion of the following points:

• The information problem and its context, supported by published evidence
• Rationale for the system, resource or service
• Evidence of a user-centered approach to development and deployment
• A timeline and milestones for the proposed work
• Outcome-oriented evaluation of the proposed system or service
• Plan for disseminating the results of the project
• Plan for supporting the system after grant funding ends

These grants are not merely grants for technology or online access to publications. They should bring to end-users the high-quality scientific or health-related information they seek. Applicants should describe their approach to providing systems and services, address mechanisms for promoting use of the proposed system, provide details of training and evaluation plans, and discuss their plans for managing and supporting the work after grant funding ends. Applicants who propose to create a web-based resource should discuss how they will address content features such as selection, source credibility, currency, accuracy and completeness.

NLM Applied Informatics grant projects must result in an operational service activity. This may involve installation of a whole system, the testing of a prototype followed by a fuller implementation, establishing connectivity of existing system components, or enhancing features of an existing system or resource. A small planning activity may be included within the proposed project. Development projects must demonstrate the involvement of intended users, and present a plan for training them and gathering feedback from them.

Evaluation is a key feature of any application in this grant program. Where possible, applicants are encouraged to design evaluations that measure real outcomes for users. Applicants proposing outreach initiatives are encouraged to make use of resources such as Measuring the Difference: a Guide to Planning and Evaluating Health Information Outreach http://nnlm.gov/evaluation/guide/, or to find evaluation consultants to work with them. Applicants who propose to create a web-based resource or service should discuss how they will track use, growth, user characteristics and content features such as currency, accuracy, timeliness and completeness.

Dissemination of results to a larger community of interest is a fundamental feature of this grant program. Applicants should explain how they will share what they learned with others, and indicate what kinds of access to resources or services they will provide to interested parties outside the participating organizations.

The following types of projects are considered outside the scope of NLM’s Applied Informatics grant program:

• Installation of Online library catalogs
• Electronic health record systems, single-purpose or closed clinical systems such as a stand-alone laboratory system or picture archiving system (PACS)
• Digitization of print materials
• Projects that duplicate NLM products and databases such as Go Local consumer health initiatives or biomedical literature indexing projects

HEARING & COMMUNICATION DISORDERS

Title: NIDCD Definitive Phase III Clinical Trial Planning Grant (R34)
Agency: National Institute on Deafness and Other Communication Disorders (NIDCD)
Application Deadline:  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PAR Identification: PAR-09-142
CFDA Number: 93.173
Link: http://grants.nih.gov/grants/guide/pa-files/PAR-09-142.html   

• Purpose. The goal of this FOA is to provide support to complete the development of a comprehensive research protocol for large-scale, multicenter Phase III Definitive Clinical Trials (DCT).  The planning grant is designed to permit early peer review of the proposed clinical trial in terms of its rationale, general design, organizational structure and implementation plan.  The planning grant is used to support the development of a detailed Manual of Procedures (MOP), which is required for submission when applying for a Phase III Definitive Clinical Trial (PAR-08-205).  The planning grant will provide support to establish the research team, develop tools for data management and oversight of the research, define recruitment strategies, and develop and finalize the MOP. The Planning Grant is NOT intended to support small Phase I/II Preliminary Clinical Trials.  Applications for Phase I/II Preliminary Clinical Trials should use the NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (PAR-08-204).  
• Mechanism of Support. This FOA will utilize the R34 funding mechanism.
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
• Budget and Project Period.  The total project period for an application submitted in response to this FOA may not exceed two years. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year.

• Application Research Plan Component Length: The R34 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm

 

 

INFECTIOUS DISEASES

Title: Partnerships for Development of Vaccines for Selected Pathogens (R01)
Agency: National Institute on Allergy and Infectious Diseases (NIAID)
LOI Deadline: June 26, 2009
Application Deadline: July 27, 2009
RFA Identification: RFA-AI-09-016
CFDA Number: 93.856
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-09-016.html

This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) invites research applications for projects that will advance development of vaccines against five pathogens that have a significant impact on public health: cytomegalovirus, respiratory syncytial virus, Staphylococcus aureus, Pseudomonas aeruginosa and Clostridium difficile. The formation of collaborative partnerships between academic (or non-profit) researchers from different disciplines or with industry is strongly encouraged, but not required.

• Mechanism of Support. This FOA will utilize the R01 grant mechanism.
• Funds Available and Anticipated Number of Awards. The NIAID intends to commit $4.0 million in total costs in FY2010 to fund three to five applications in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
• Budget and Project Period. An applicant may request a project period of up to five years and a budget for direct costs of no more than $500,000 in any single year.
• Application Research Plan Component Length: The R01 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm

Partnerships
A key component of this FOA is the formation of collaborative partnerships, which may be between academic researchers from different disciplines or between academic and industry researchers. For the purpose of this FOA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this FOA will support partnerships between industry and collaborator(s) from academic (or non-profit) research organizations. For this FOA, partnerships are strongly encouraged, but not required.

Applications submitted in response to this FOA will include a Product Development Plan (PDP) to assist reviewers and program staff in project evaluation. The PDP will define the general goals of the project, intended use/indication of the proposed therapeutic or diagnostic, and biodefense/public health gap the product is intended to fill. Additionally, the PDP will detail the stage-specific product development activities that will be performed during the project period and outline plans for further development after completion of the project.

The Principal Investigator of the project may be affiliated with industry, an academic organization or non-profit research organization.

Research Goals and Objectives
To facilitate the development and testing of candidate vaccines, it is imperative that promising basic research findings/technologies be translated rapidly into new approaches and strategies for product development. The involvement of experts from diverse disciplines (e.g., biochemists, structural biologists, protein chemists, pharmacologists, immunologists, molecular biologists, engineers and clinicians) within academia and industry is needed to enable development of well-designed candidates for vaccines.

The objectives of this FOA are:
1. To support research that will advance the development and/or production of vaccines specific for the pathogens described above. Developmental research is not required to result in a "final" product but must advance the development of a candidate product; and
2. To stimulate scientifically sound, original, and innovative research requiring a comprehensive team and multidisciplinary effort that will facilitate advancement of a promising candidate product or platform technology through the product development pathway.

To most effectively achieve these objectives, applications must include in vivo efficacy data in at least one animal model with accompanying general safety and immunogenicity data. It is understood that the animal studies may involve a vaccine or endpoint that does not precisely replicate the planned human vaccine.

NOTE: While clinical development strategies may be included within an overall product development plan, this FOA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this FOA and will not be reviewed. However, utilization of appropriate human cell lines and human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive and is encouraged.

For all vaccine projects, approaches should consider the ultimate potential of candidate vaccines to induce safe and protective responses in a diverse population. Projects may include, but are not limited to, one or more of the following areas:
• Improvement of existing candidates, including assessment of alternate formulations, stabilization, immunopotentiation, regimen optimization and evaluation of novel adjuvants.
• Evaluation of novel vaccine strategies, such as recombinant DNA; reverse genetics leading to live-attenuated strains and vectors; chimeras and mono- or multi-valent subunits.
• Advanced preclinical studies, including: safety and toxicology studies; further efficacy testing in animal models; assessment of host response; determination of clinically-relevant correlates of immunity and surrogate endpoints.

 

 

Title: International Collaborations in Infectious Disease Research (ICIDR) (U01)
Agency: National Institute of Allergy and Infectious Diseases (NIAID)

LOI Deadline: June 23, 2009
Application Deadline: July 23, 2009
RFA Identification: RFA-AI-09-010
CFDA Number: 93.856
Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-09-010.html

• Purpose. This Funding Opportunity Announcement (FOA) encourages applications from U.S. institutions proposing collaborative research with foreign [non-U.S.] investigators and organizations to study infectious diseases of the greatest public health significance in resource-constrained countries. This work is expected to increase scientific knowledge on public health related issues, enhance relevant research experience for U.S. and foreign investigators, promote the development of research capacity, and encourage future collaborative relationships.
• Mechanism of Support. This FOA will utilize the U01 cooperative agreement grant mechanism.
• Funds Available and Anticipated Number of Awards. The NIAID expects to award $6.3 million in total costs in response to this FOA to support 5 to 9 new and/or competing renewal grants.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed five years. Direct costs are limited to $500,000 in year 1. Future year recommended levels are limited to 3% escalation costs.

All applications must be focused on a single pathogen or disease entity.

Topics of interest for this program are limited to research on infectious diseases, including emerging infections that are of the greatest public health significance within the collaborating country. Except as noted below, research on any relevant infectious disease is appropriate. Applications proposing studies on the following diseases and pathogens are specifically encouraged:
• Zoonotic diseases, including Leptospirosis, Brucellosis, Melioidosis, Rickettsioses
• Leprosy and Buruli ulcer
• Viral pathogens, especially Enterovirus 71 and Monkey Pox
• Respiratory diseases, including Tuberculosis, Pneumococcal infections, Influenza, N. meningitides, and S. pneumoniae.
• Sexually transmitted infections: Bacterial Vaginosis, Haemophilus ducreyi and Trichomoniasis
• Parasitic diseases and vectors
• Hepatitis E in pregnant women
• NIAID Category A, B, and C priority pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm, especially Enterotoxigenic E. coli, Shigella, Hantaviruses, Dengue, Rift Valley Fever, Japanese Encephalitis Virus and West Nile Virus

NURSING

Title: Developmental Projects in Complementary Approaches to Cancer Care and Treatment (R21) (R03)
Agency: National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-167, PA-09-168
CFDA Numbers: 93.395, 93.361
Links: http://grants.nih.gov/grants/guide/pa-files/PA-09-167.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-168.html (R03)

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), and the National Institute of Nursing Research (NINR), of the National Institutes of Health, invites applications for basic, pre-clinical, and clinical complementary cancer research. The research should relate to the areas of prevention, diagnosis, and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. In addition, this FOA encourages the development and application of emerging and innovative technologies, including identification of novel therapeutics in the pharmacopoeia of Traditional Medical Systems (as defined by the World Health Organization), use of complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies, and research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g., response to conventional cancer therapy, survival). The overarching goals of these FOAs are to encourage investigators to submit high quality, preliminary research of humans that will advance the science of Complementary and Alternative Medicine (CAM) and provide a solid foundation and justification for future research project (R01) grant applications to definitively determine the efficacy of CAM approaches.

Specific Research Objectives for the R21
The intent of this initiative is to encourage and support the development of basic and clinical (prevention, therapeutic, and palliative) cancer research in complementary approaches. Another goal of this initiative is to facilitate communication and collaboration between practitioners in complementary approaches and the conventional cancer research communities.

For the purpose of this FOA, applicants may consider complementary approaches as they relate to the prevention, diagnosis, and treatment of cancer, cancer-related symptoms, and side effects of conventional treatment. In addition, applicants may consider research that focuses on the potential interactions of complementary approaches with conventional cancer therapies. Complementary approaches that are considered appropriate to this announcement include (but are not limited to) those involving nutritional approaches, natural products, mind-body approaches, energy therapies, herbal medicines, and interventions based upon those within traditional medical systems (as defined by the World Health Organization), such as traditional Chinese medicine or ayurvedic medicine.

Topics of programmatic interest include, but are not limited to:

• Approaches related to management of cancer-related symptoms and side effects of conventional treatment;
  
• Exploratory studies of complementary approaches in combination with conventional regimens, and outcome, effectiveness, and quality of life assessments.
  
• Design and pilot testing of interventions for comparative studies of complementary modalities as interventions for end of life and palliative care (e.g., relaxation therapy, music therapy);
  
• Development of methodologies to improve assessment of the impact of complementary approaches to treatment; e.g., instrument development, biobehavioral markers, acceptance of longitudinal designs or prevention;
  
• Feasibility studies of behavioral interventions that incorporate principles of cultural competency, in particular within populations that utilize culture-specific traditional methods of treating cancer;
  
• Applications relevant to understudied populations (i.e. the use of complementary approaches in children or older adults). Descriptive studies of the prevalence of complementary and alternative medicine (CAM) use in understudied populations including the impact of such use on the primary modality of treatment are also appropriate;
  
• Nutritional approaches in the prevention and treatment of cancer as well as to prevent disease recurrence;
  
• Preclinical studies of candidate-complementary approaches with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• Preclinical studies to advance understanding of mechanism of actions a well as drug-drug interactions;
  
• Isolation and pharmacological studies of active ingredients from herbal or other traditional medicine preparations, including a defined reconstitution of more than one pure ingredient, such as drug-drug interaction; and
  
• Applications that seek to clarify markers of exposure to bioactive food components and their biological response in specific targets are also appropriate.

CAM research is integrated through various program areas of the Extramural Divisions and Intramural research programs (http://www.cancer.gov/cam/research_portfolio.html), such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research.

The National Institute of Nursing Research (NINR) also encourages applications that are consistent with its strategic plan and research themes for the future. In keeping with its research themes, projects that may lead to improved strategies for managing the effects of illness to improve quality of life, reducing health disparities, and enhancing the end-of-life experience for patients and their families are particularly welcome. For further information on NINR’s strategic plan.

Specific Research Objectives for the R03
This FOA aims to support pilot projects, and allow CAM researchers to ascertain preliminary data that could provide the basis for more extended research that can otherwise not be achieved in the area of CAM research. While definitive and costly studies are best supported by other mechanisms, a small grant (R03) can provide resources for essential tasks such as preliminary assessments of alternative or new medical systems or techniques, encourage innovative applications of new CAM approaches, and ascertain pilot data that can be essential for larger R01 projects.

CAM research is integrated through various program areas, of the Extramural Divisions and Intramural research programs such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research;

R03 small grants encourage investigators to initiate research in areas not typically explored by R01 investigators. Moreover, it can foster coordination of small research project collaborations, and promote collaborative research between national and international studies for comparative or validation trials. This is particularly relevant to initiate research on CAM practices that are identified via the NCI Best Case Series Program has warranting NCI-initiated research (for further details, go to: http://www.cancer.gov/cam/research_information.html). Examples of such therapeutic regimens include the treatment approach of the P. Banerji Homeopathic Research Foundation, insulin potentiation therapy, and macrobiotic lifestyle as per the Kushi Institute. Research of these approaches is high-risk and previous efforts to stimulate investigations via single contract mechanisms have not been fruitful. The small grant R03 mechanism can provide support for preliminary explorations of these approaches.

Broad areas of Complementary and Alternative Medicine (CAM)-related research activities appropriate for this FOA include, but are not limited to, the following:

• Alternative Medical Systems
  
• Botanical Extracts
  
• Medicinal herbs and herbal mixtures
  
• Energy Therapies
  
• Exercise Therapies
  
• Manipulative and Body-Based Methods
  
• Mind-body Interventions
  
• Nutritional Therapeutics
  
• Pharmacological and Biologic Treatments

For further details, go to: http://www.cancer.gov/cam/research_information.html).

The common characteristic of the small grant (R03) is provision of limited funding for a short period of time. Examples of the types of projects that ICs support with the R03 include, but are not limited to, the following:

• Pilot or feasibility studies
• Secondary analysis of existing data
  
• Small, self-contained research projects
  
• Development of research methodology
  
• Development of new research technology
  
• Nature of the research opportunity
  
• Pertinent background information that establishes the need for the research

NUTRITION & DIETARY

Title: Developmental Projects in Complementary Approaches to Cancer Care and Treatment (R21) (R03)
Agency: National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications: PA-09-167, PA-09-168
CFDA Numbers: 93.395, 93.361
Links: http://grants.nih.gov/grants/guide/pa-files/PA-09-167.html (R21)
http://grants.nih.gov/grants/guide/pa-files/PA-09-168.html (R03)

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), and the National Institute of Nursing Research (NINR), of the National Institutes of Health, invites applications for basic, pre-clinical, and clinical complementary cancer research. The research should relate to the areas of prevention, diagnosis, and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. In addition, this FOA encourages the development and application of emerging and innovative technologies, including identification of novel therapeutics in the pharmacopoeia of Traditional Medical Systems (as defined by the World Health Organization), use of complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies, and research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g., response to conventional cancer therapy, survival). The overarching goals of these FOAs are to encourage investigators to submit high quality, preliminary research of humans that will advance the science of Complementary and Alternative Medicine (CAM) and provide a solid foundation and justification for future research project (R01) grant applications to definitively determine the efficacy of CAM approaches.

Specific Research Objectives for the R21
The intent of this initiative is to encourage and support the development of basic and clinical (prevention, therapeutic, and palliative) cancer research in complementary approaches. Another goal of this initiative is to facilitate communication and collaboration between practitioners in complementary approaches and the conventional cancer research communities.

For the purpose of this FOA, applicants may consider complementary approaches as they relate to the prevention, diagnosis, and treatment of cancer, cancer-related symptoms, and side effects of conventional treatment. In addition, applicants may consider research that focuses on the potential interactions of complementary approaches with conventional cancer therapies. Complementary approaches that are considered appropriate to this announcement include (but are not limited to) those involving nutritional approaches, natural products, mind-body approaches, energy therapies, herbal medicines, and interventions based upon those within traditional medical systems (as defined by the World Health Organization), such as traditional Chinese medicine or ayurvedic medicine.

Topics of programmatic interest include, but are not limited to:

• Approaches related to management of cancer-related symptoms and side effects of conventional treatment;
  
• Exploratory studies of complementary approaches in combination with conventional regimens, and outcome, effectiveness, and quality of life assessments.
  
• Design and pilot testing of interventions for comparative studies of complementary modalities as interventions for end of life and palliative care (e.g., relaxation therapy, music therapy);
  
• Development of methodologies to improve assessment of the impact of complementary approaches to treatment; e.g., instrument development, biobehavioral markers, acceptance of longitudinal designs or prevention;
  
• Feasibility studies of behavioral interventions that incorporate principles of cultural competency, in particular within populations that utilize culture-specific traditional methods of treating cancer;
  
• Applications relevant to understudied populations (i.e. the use of complementary approaches in children or older adults). Descriptive studies of the prevalence of complementary and alternative medicine (CAM) use in understudied populations including the impact of such use on the primary modality of treatment are also appropriate;
  
• Nutritional approaches in the prevention and treatment of cancer as well as to prevent disease recurrence;
  
• Preclinical studies of candidate-complementary approaches with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• Preclinical studies to advance understanding of mechanism of actions a well as drug-drug interactions;
  
• Isolation and pharmacological studies of active ingredients from herbal or other traditional medicine preparations, including a defined reconstitution of more than one pure ingredient, such as drug-drug interaction; and
  
• Applications that seek to clarify markers of exposure to bioactive food components and their biological response in specific targets are also appropriate.

CAM research is integrated through various program areas of the Extramural Divisions and Intramural research programs (http://www.cancer.gov/cam/research_portfolio.html), such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research.

The National Institute of Nursing Research (NINR) also encourages applications that are consistent with its strategic plan and research themes for the future. In keeping with its research themes, projects that may lead to improved strategies for managing the effects of illness to improve quality of life, reducing health disparities, and enhancing the end-of-life experience for patients and their families are particularly welcome. For further information on NINR’s strategic plan.

Specific Research Objectives for the R03
This FOA aims to support pilot projects, and allow CAM researchers to ascertain preliminary data that could provide the basis for more extended research that can otherwise not be achieved in the area of CAM research. While definitive and costly studies are best supported by other mechanisms, a small grant (R03) can provide resources for essential tasks such as preliminary assessments of alternative or new medical systems or techniques, encourage innovative applications of new CAM approaches, and ascertain pilot data that can be essential for larger R01 projects.

CAM research is integrated through various program areas, of the Extramural Divisions and Intramural research programs such as:

• pre-clinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management;
  
• preclinical studies of mechanism of actions and drug-drug interactions;
  
• clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy;
  
• research on symptom management during active treatment and/or at the end of life; and
  
• survivorship research;

R03 small grants encourage investigators to initiate research in areas not typically explored by R01 investigators. Moreover, it can foster coordination of small research project collaborations, and promote collaborative research between national and international studies for comparative or validation trials. This is particularly relevant to initiate research on CAM practices that are identified via the NCI Best Case Series Program has warranting NCI-initiated research (for further details, go to: http://www.cancer.gov/cam/research_information.html). Examples of such therapeutic regimens include the treatment approach of the P. Banerji Homeopathic Research Foundation, insulin potentiation therapy, and macrobiotic lifestyle as per the Kushi Institute. Research of these approaches is high-risk and previous efforts to stimulate investigations via single contract mechanisms have not been fruitful. The small grant R03 mechanism can provide support for preliminary explorations of these approaches.

Broad areas of Complementary and Alternative Medicine (CAM)-related research activities appropriate for this FOA include, but are not limited to, the following:

• Alternative Medical Systems
  
• Botanical Extracts
  
• Medicinal herbs and herbal mixtures
  
• Energy Therapies
  
• Exercise Therapies
  
• Manipulative and Body-Based Methods
  
• Mind-body Interventions
  
• Nutritional Therapeutics
  
• Pharmacological and Biologic Treatments

For further details, go to: http://www.cancer.gov/cam/research_information.html).

The common characteristic of the small grant (R03) is provision of limited funding for a short period of time. Examples of the types of projects that ICs support with the R03 include, but are not limited to, the following:

• Pilot or feasibility studies
• Secondary analysis of existing data
  
• Small, self-contained research projects
  
• Development of research methodology
  
• Development of new research technology
  
• Nature of the research opportunity
  
• Pertinent background information that establishes the need for the research

RENAL & KIDNEY DISEASE

Title: Renal Function and Chronic Kidney Disease in Aging (R01), (R21)
Agency:  National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
PA Identifications:  PA-09-165; PA-09-166
CFDA Number: 93.866
Links:  http://grants.nih.gov/grants/guide/pa-files/PA-09-165.html (R01)
http://grants.nih.gov/grants/guide/pa-files/PA-09-166.html (R21)

This Funding Opportunity Announcement (FOA) issued by the National Institute on Aging (NIA) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, invites applications that propose basic, clinical, and translational research on chronic kidney disease (CKD) and its consequences in aging and in older persons.  Applications should focus on the 1) biology and pathophysiology of CKD in animal models; 2) etiology and pathophysiology of CKD in the elderly; 3) epidemiology and risk factors for the development of CKD with advancing age; and/or 4) diagnosis, medical management and clinical outcomes of CKD in this population.  Research supported by this initiative should enhance knowledge of CKD and its consequences in the elderly and provide evidence-based guidance in the diagnosis, prevention, and treatment of CKD in older persons.

SCOPE OF RESEARCH:
This FOA invites research applications in both animal models and in humans, addressing the etiology, pathophysiology, risk factors, consequences, prevention, or treatment of CKD in older patients.  Areas of interest include, but are not limited to, the following areas:

Etiology and Pathophysiology

• Contributions of age-related changes in renal vascular structure and function on the development of CKD (e.g., changes in renal blood flow, vascular resistance, and sensitivity to ischemia), and the mechanisms by which these changes occur.
• Mechanisms of kidney fibrosis underlying CKD progression.
• Contributions of cellular senescence and gene polymorphisms to CKD during aging and in older adults and their mechanisms of action.
• Relationship of CKD to age-related changes in renal morphology, pathology, structure (e.g., tubular atrophy, glomerulosclerosis, interstitial fibrosis) and function (e.g., changes in renal hemodynamics, GFR, urine concentrating and diluting ability, secretion of renin and erythropoietin, and activation of vitamin D).
• Roles of oxidative stress and endothelial dysfunction in the development of CKD during aging and in aged adults.
• Possible differences in pathology and pathophysiology of CKD in younger vs. older patients or animals.
• Complications and long-term consequences of CKD in the elderly (e.g., development of osteoporosis, CVD, and anemia; impact on vitamin D metabolism and phosphate balance; effects on coagulation mechanisms; and modulation of secretion of renin and erythropoietin).
• Role of CKD and its complications in functional impairment and disability among older patients.

Epidemiology, Risk Factors, and Comorbid Interactions

• Natural history of age-related decline in kidney function, and progression from early stage CKD to ESRD in the elderly.
• Clinical consequences and long-term outcomes of different stages of CKD in older adults, including effects of mild decreases in GFR on long-term health outcomes. 
• Role of established CKD risk factors (e.g., hypertension, diabetes and acute kidney injury) and potential new risk factors (e.g., oxidative stress, age-related endothelial dysfunction) in development and progression of CKD in the elderly. 
• Studies that distinguish risk factors for progression to different stages of CKD, and the extent to which risk factors are the same or differ across different stages of CKD.  Studies on the relationships between acute kidney injury and CKD are encouraged. 
• Relationships of comorbidities to development of CKD in the elderly and its progression to ESRD, and the interaction of coexisting diseases with CKD on morbidity and functional outcomes in older patients. 
• Relationships of CKD and/or its treatment to cognitive impairment in the elderly.

Early Detection and Diagnosis

• Development and validation of new methods or biomarkers to accurately, reliably, and efficiently measure renal function and identify early stages of declining function in older persons or animal models.
• Studies to analyze and improve the performance of current GFR estimating equations in older patients.
• Development and validation of new tests of age-related acute and chronic renal damage, including measures of age-related decline in kidney functions other than glomerular filtration, e.g., kidney endocrine functions.
• Development and validation of screening algorithms for early detection of CKD in community-dwelling elderly, particularly older adults at increased risk for CKD, to optimize timing of screening, frequency of testing, sensitivity and specificity of screening tests, and cost–benefit ratios.

Prevention and Treatment

• Efficacy of treatments for CKD risk factors (e.g., cardiovascular disease and diabetes) to prevent or delay onset of CKD in older persons.
• Effects of various interventions applied at early stages of CKD in preventing or slowing further adverse effects in older patients (e.g., risk factor management, vitamin D, dietary regimen such as protein restriction, salt restriction and calorie restriction, and physical activity interventions).
• Testing new treatment approaches in elderly CKD patients who have conditions contributing to its progression (e.g., diabetes/hypertension), e.g., angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers and aldosterone blockade; optimal targets for blood pressure and glucose control.
• Testing of clinical strategies for the management of complications and long-term consequences of CKD in older patients (e.g., cardiovascular and peripheral vascular disease, Vitamin D deficiency, hyperphosphatemia, osteodystrophy and hematologic problems).
• Studies evaluating whether interventions to slow progression in CKD are efficacious in preventing or slowing further functional loss when applied at earlier levels of decrease in GFR.

Development and testing of interventions to maintain functional status, cognitive function, and quality of life among older CKD patients.

 

WOMEN’S HEALTH

Title: Susan G. Komen for the Cure® – 2009-2010 Research Grant Request for Applications
Agency: Susan G. Komen for the Cure®
Pre-App Deadline: June 1, 2009
Application Deadline: July 31, 2009
Link: http://www.komengrantsaccess.org/ OR www.komen.org/grants

Komen’s commitment to supporting life-saving research has never been stronger. Building on 27 years of funding research to find the causes and cures of breast cancer, Komen continues its important new focus on research that will speed the translation of discoveries into reductions in breast cancer mortality and/or incidence within the next decade and on addressing disparities in breast cancer across populations.

Important Changes to Pre-Application Requirements
The content and requirements for research and training pre-applications are changing! Pre-applications will now require more detailed and specific information about proposed research, such as specific aims and a clear description of the timeline from research results to impact on breast cancer incidence and/or mortality. Read the RFA requirements for pre-applications carefully and start preparing your pre-application early!!

Research Funding Opportunities
This year, Komen completes its transition to a two cycle RFA schedule in which recurring research RFAs will be announced each April and May and training RFAs will be announced each September. Announcements about additional special topic RFAs may be made at other times during the year.

April and May 2009 – Announcement of Research RFAs:

• Investigator-Initiated Research (IIR): IIR grants provide up to $600,000 over three years to stimulate exploration of new ideas and novel approaches in breast cancer research and clinical practice that will lead to reductions in breast cancer incidence and mortality within the next decade. 

• Career Catalyst Research (CCR) Grants: CCR grants provide unique opportunities for scientists in the early stages of their career to achieve research independence with an independent award of up to $450,000 over three years. 


• Career Catalyst in Disparities Research (CCDR): CCDR awards provide a unique opportunity for scientists in the early stages of their career to achieve research independence. This award provides up to $450,000 over 3 years for research exploring the basis for differences in breast cancer outcomes and the translation of this research into clinical and public health practice interventions.