June 2008 Research INKlings NIH’s CRISP database gets facelift CRISP (Computer Retrieval of Information on Scientific Projects), the searchable database of federally funded biomedical research projects, is undergoing a series of updates. Throughout the upcoming year, the National Institutes of Health will phase-in several releases of an enhanced version of CRISP on the Web. The new CRISP system will continue to offer the same ability to search NIH-funded research but ultimately will contain more information associated with funded projects, including budget information and links to publications and patents resulting from NIH-funded research. In addition, the updated version of CRISP will offer a new way of searching for grants and contract portfolios that reflects current research investments in specific diseases and other conditions, and research areas. The new public face of CRISP may be accessed by going to http://report.nih.gov/ and clicking on “Search Funded Scientific Projects,” or by going directly to http://report.nih.gov/crisp.aspx. Bookmarking this site will provide you access to the enhanced features as they come on-line. Source: Extramural Nexus, Office of Extramural Research (http://nexus.od.nih.gov/nexus/nexus.aspx?ID=48&Month=4&Year=2008), NIH, April 2008. ORSP offers guidance for requesting No Cost Extension The Office of Research & Sponsored Programs (ORSP) at MUSC has local “Expanded Authorities” to authorize unfunded “no cost” extensions of project periods at the request of the Principal Investigator. However, the PI must submit a request in writing to ORSP at least 15 days prior to the original termination date for the project. The letter, which should be addressed to R. Darren McCants, Director of ORSP, may be emailed as an attachment or faxed to the designated Grants Administrator in ORSP. The content of the letter should contain the following minimum information: • Grant number • Title of the Project • Requested new end date • Estimated total amount of remaining funds (including F&A) • Indication if the level of effort for any Key Personnel (listed in Notice of Award) will be reduced by more than 25% of the level originally proposed, and if so, whether, these reductions in effort will have any affect on the overall scope of the project. • Indication if human/animal/biohazards approvals (as applicable) will be maintained and kept current during the extension period. • Concise technical reason(s) for the requested extension. In addition, the appropriate department head(s) should be copied on the correspondence, thereby indicating their approval of the requested extension. INKlings Page 2 of 30 In addition, the appropriate department head(s) should be copied on the correspondence, thereby indicating their approval of the requested extension. Additional information may be needed, depending on the terms and conditions of the particular award and/or sponsor. Individuals who are considering a no cost extension should contact their assigned Grant Administrator for more specific guidance. Source: Research Roundtable and ORSP, May 7, 2008. Call for Abstracts – Cross-Cultural Mental Health and Human Services Conference The 31st Annual Cross-Cultural Mental Health and Human Services Conference is fast approaching. The upcoming conference to be held in Myrtle Beach, SC, February 22-25, 2009 will focus on youth, family and community violence: strategies for prevention, intervention and post treatment support. The Cross-Cultural Mental Health and Human Services is now accepting abstracts for this event. Interested participants must send their abstracts along with resume or curriculum vita no later than July 30, 2008 to Dr. Stephen McLeod-Bryant Associate Professor Department of Psychiatry & Behavioral Sciences MUSC, 67 President St. Charleston, SC 29425 firstname.lastname@example.org Source: MUSC Listserv email notice, May 14, 2008. NIH expands national CTSA consortium with 14 new awards Fourteen academic health centers in 11 states are the latest members of the National Institutes of Health’s Clinical and Translational Science Award (CTSA) consortium. These fourteen institutions will receive $533 million over 5 years to help researchers turn laboratory discoveries into treatments for patients. Creating a unique network of medical research institutions across the nation, the consortium is working to reduce the time it takes for laboratory discoveries to become treatments for patients and to engage communities in clinical research efforts. It also is addressing the critical need to train the next generation of clinical and translational researchers. The consortium is led by the National Center for Research Resources (NCRR), a component of the NIH. The institutions receiving new CTSA funding are listed below. Descriptions of the CTSA awardees are posted at www.ncrr.nih.gov/ctsa2008: Albert Einstein College of Medicine of Yeshiva University (New York City) Boston University (Boston, MA) Harvard University (Cambridge, MA) Indiana University School of Medicine (Indianapolis, IN) Northwestern University (Chicago and Evanston, IL) The Ohio State University (Columbus, OH) The Scripps Research Institute (La Jolla, CA) Stanford University (Palo Alto, CA) Tufts University (Boston, MA) The University of Alabama at Birmingham (Birmingham, AL) University of Colorado Denver (Aurora, CO) INKlings Page 3 of 30 Tufts University (Boston, MA) The University of Alabama at Birmingham (Birmingham, AL) University of Colorado Denver (Aurora, CO) The University of North Carolina at Chapel Hill (Chapel Hill, NC) The University of Texas Health Science Center at San Antonio (TX) The University of Utah (Salt Lake City, UT) These 14 academic health centers join 24 others announced in 2006 and 2007. The 2008 CTSA grants expand state representation in the consortium to Alabama, Colorado, Indiana, Massachusetts, and Utah. The CTSA initiative grew out of the NIH commitment to re-engineer the clinical research enterprise, one of the key objectives of the NIH Roadmap for Medical Research. Most of the funding is coming from terminating grants to General Clinical Research Centers, supplemented by NIH Roadmap funds. In 2012 when the program is fully implemented, approximately 60 CTSAs will be connected with an annual budget of $500 million. MUSC will be submitting a new application to the CTSA Initiative in October 2008. For more information about the CTSA program, visit www.ncrr.nih.gov/crctsa. Source: NIH news release, May 29, 2008. AHRQ and RWJF release new resource for nurses The Agency for Healthcare Research and Quality (AHRQ) and the Robert Wood Johnson Foundation (RWJF) have jointly sponsored the development of a new patient safety resource for nurses. Patient Safety and Quality: An Evidence- Based Handbook for Nurses examines the broad range of issues involved in providing high quality and safe care across health care settings. This three- volume resource contains 89 contributions that represent the work of a broad range of nurses and other patient safety researchers throughout the nation. Select to review the publication. A print copy of the publication or a CD-ROM is available by sending an e-mail to email@example.com. Source: US Department of Health and Human Services NIH seeks ideas for future roadmap trans-NIH strategic initiatives The NIH is asking the scientific community, health professionals, patient advocates, and the general public to suggest ideas about ways to: 1) address specific barriers to basic, translational or clinical research through development of novel tools, technologies, services, etc., and 2) fill specific knowledge gaps that hinder research across a broad spectrum of health science. Innovative and cross-cutting initiatives relevant to multiple diseases will be considered for funding through the NIH Common Fund. The collection of these ideas is the initial step in the process of identifying a new cohort of Common Fund/Roadmap programs for FY2011. For descriptive information on the Roadmap initiatives go to: http://nihroadmap.nih.gov/initiatives.asp and for Roadmap funded research please visit: http://nihroadmap.nih.gov/grants/fundedresearch.asp. Source: Extramural Nexus, Office of Extramural Research, April 2008. INKlings Page 4 of 30 Scientists form international cancer genome consortium On April 29, 2008, research organizations from around the world announced the launch of the International Cancer Genome Consortium (ICGC), a collaboration designed to generate high-quality genomic data on up to 50 types of cancer through efforts projected to take up to a decade. Initial ICGC members include: • Australia – National Health and Medical Research Council (Observer Status) • Canada – Genome Canada; Ontario Institute for Cancer Research • China – Chinese Cancer Genome Consortium • Europe – European Commission (Observer Status) • France – Institute National du Cancer • India – Department of Biotechnology, Ministry of Science & Technology • Japan – RIKEN; National Cancer Center • Singapore – Genome Institute of Singapore • United Kingdom – The Wellcome Trust; Wellcome Trust Sanger Institute • United States – NIH Each ICGC member intends to conduct a comprehensive, high-resolution analysis of the full range of genomic changes in at least one specific type or subtype of cancer, with studies built around common standards of data collection and analysis. Each project is expected to involve specimens from approximately 500 patients and have an estimated cost of $20 million. As part of its coordination efforts, the ICGC will generate a list of approximately 50 cancer types and subtypes that are of clinical significance around the globe. ICGC members plan to assume responsibility for specific cancers, and one of the ICGC's roles should be to facilitate the exchange of information so participants' efforts do not duplicate each other. Furthermore, the ICGC will make its data rapidly and freely available to the global research community. The ICGC's main criteria for prioritizing cancer types include: impact, including incidence and mortality rates, availability of therapies and age of onset; scientific interest; and feasibility, which includes the ability to obtain enough high-quality samples to conduct a large-scale project. For additional information regarding ICGC please visit http://www.nih.gov/news/health/apr2008/nhgri-29.htm. Source: NIH News release, April 29, 2008. Call for Innovations in Medical Education exhibits at annual AAMC meeting The Association of American Medical Colleges (AAMC) is seeking submissions for Innovations in Medical Education exhibits to be presented Nov. 2-3 at the AAMC annual meeting in Washington, DC. The exhibits provide a forum for exchange of ideas and activities in medical education, and encourage communication among colleagues. Participants are invited to exhibit work in progress and recently introduced innovations, as well as established projects or components along the continuum of medical education. The AAMC encourages entries demonstrating innovation in all aspects of medical education, ranging from instructional design or evaluation of basic sciences to community-based health promotion and disease prevention programs. INKlings Page 5 of 30 Submissions must be received by Aug. 15. For information, please visit the AAMC web site at http://www.aamc.org/members/gea/ime/start.htm. Source: AAMC STAT, May 19, 2008 Grants.gov is making transition to Adobe application forms for NIH and AHRQ proposals In May the National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) announced plans for moving from the current PureEdge forms to Adobe versions of the SF424 (R&R) grant application forms and subsequently making the transition from paper to electronic submission for all Research Career Development (K), Individual National Research Service (F) Institutional National Research Service (T) Awards and other training programs (D) to electronic submission through Grants.gov. NIH will pilot the use of Adobe forms with a couple single submission date Funding Opportunity Announcements (FOAs) that will be issued in late summer. Assuming the pilot goes smoothly, and the forms approval and development process go as planned, NIH will begin posting most FOAs with Adobe forms in December 2008. Applicants can plan to use PureEdge forms for all receipt dates through December of this year. NIH and AHRQ will publish a detailed conversion schedule in the fall. Once NIH completes the move from PureEdge to Adobe forms, it will transition the K, F, T and D programs to electronic submission through Grants.gov using the SF424 (R&R). The transition by mechanism will include all active FOAs for that program/mechanism. Current plans and milestones for the conversion plan are as follows: Feb. 12, 2009 Research Career Development (all Ks except K12) Apr. 8, 2009 Individual National Research Service Awards (F) Sept. 25, 2009 Institutional National Research Service Awards and Other Training Grants (T, D), D43, D71/U2R and K12 Timing of the transition of NIH’s complex, multi-project (P) grant programs has not been set. Questions about transition plans may be directed to NIHElectronicSubmiss@mail.nih.gov. General Information: http://era.nih.gov/ElectronicReceipt/ http://grants.nih.gov/grants/oer.htm or http://www.ahrq.gov/path/egrants.htm Source: NOT-OD-08-073, May 23, 2008, http://grants1.nih.gov/grants/guide/notice- files/not-od-08-073.html INKlings Page 6 of 30 NIH launches undiagnosed diseases program The National Institutes of Health (NIH) just launched a new clinical research program aimed at providing answers for patients with mysterious conditions that have long eluded diagnosis. Called the Undiagnosed Diseases Program, the trans-NIH initiative will focus on the most puzzling medical cases referred by physicians across the nation to the NIH Clinical Center in Bethesda, MD. The goal of NIH's Undiagnosed Diseases Program is two-pronged: to improve disease management for individual patients and to advance medical knowledge in general. The new program, is the culmination of efforts by William A. Gahl, MD, PhD, clinical director at the National Human Genome Research Institute (NHGRI; John I. Gallin, MD, director of the NIH Clinical Center; and Stephen Groft, PharmD, director of the NIH Office of Rare Diseases (ORD). With the program infrastructure now in place, the program is ready to accept patients starting in July 2008. To evaluate each patient enrolled in the new program, NIH will enlist the expertise of more than 25 of its senior attending physicians, whose specialties include endocrinology, immunology, oncology, dermatology, dentistry, cardiology and genetics. Dr. Gahl, who is an expert on rare genetic diseases, will serve as director of the new program. To be considered for this NIH pilot program, a patient must be referred by a physician and provide all medical records and diagnostic test results requested by NIH. Patients who meet the program's criteria – as many as 100 each year – will undergo additional evaluation during a visit to the NIH Clinical Center that may take up to a week. Two nurse practitioners will manage patient recruitment and logistics for the new program, which will utilize existing facilities and staff already at NIH. Funding for the program includes $280,000 per year from the Office of Rare Diseases. For more information about the Undiagnosed Diseases Program, go to: <http://rarediseases.info.nih.gov/Undiagnosed>. Physicians and patients with specific inquiries may call the NIH Clinical Center clinical information research line, at 1-866-444-8806. The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od/index.htm. Source: NIH News Release, http://www.nih.gov/news/health/may2008/nhgri-19.htm INKlings Page 7 of 30 FDA and CMS launch new initiative to improve drug safety The Department of Health and Human Services (HHS) announced recently that the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) will begin efforts to improve drug safety and medical care through a new proactive approach called the Sentinel Initiative. The FDA will use a number of public and private databases to monitor millions of patient records and alert officials to possible adverse effects from medical products sooner than the current system allows. The FDA will work closely with the CMS using data from its 25 million beneficiaries through the Medicare prescription drug program, as well as information from a number of other government and private health care organizations. While patient privacy will continue to be protected, the data will also be made available to state agencies and academic researchers in order to improve various health care services. The idea for the initiative began as a recommendation from the Institute of Medicine outlined in a 2006 report. For more information, please visit the following website: http://www.hhs.gov/news/press/2008pres/05/20080522a.html. Source: AAMC STAT, May 26, 2008 INKlings Page 8 of 30 Medical Research Opportunities & Deadlines University ADDICTIVE DISORDERS of South Other key term: Behavioral Sciences & Mental Health Carolina Title: Mechanisms of Alcohol-Induced Tissue Injury (R01) Agency: National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Heart, Lung, and Blood Institute (NHLBI) Application Deadline: Standard dates apply, please see 173 Ashley Ave, http://grants1.nih.gov/grants/funding/submissionschedule.htm BSB 101 PA Identification: PA-08-164 CFDA Numbers: 93.273, 93.838, 93.839, 93.837, 93.233 Phone: Link: http://grants.nih.gov/grants/guide/pa-files/PA-08-164.html 843-792-5828 The National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Heart Fax: Blood and Lung Institute (NHLBI), National Institutes of Health (NIH), invite grant applications 843-792-1657 to study the cellular and molecular mechanisms of tissue injury caused by ethanol consumption. Virtually every system of the body is impacted by alcohol abuse, and the resulting pathological conditions contribute to increased mortality and morbidity among all E-Mail: groups and genders. The NIAAA is especially interested in comparative and interactive (or firstname.lastname@example.org integrative) research that elucidates mechanisms of injury common to many body and organ systems, with the eventual goal of identifying early markers of ethanol induced pathology and developing therapeutic strategies to serve multiple alcohol-related disorders. The NHLBI is especially interested in research that will enhance understanding of the pathogenesis of Search for alcoholic cardiomyopathy and identify new therapeutic targets for this condition and other Inklings on the cardiomyopathies. Projects that bring together and integrate the work of investigators in Web! diverse scientific disciplines are encouraged. Projects that foster collaborations between investigators in the clinical and basic sciences and/or focus on translational research are especially encouraged. Examples of scientific disciplines include microbiology, immunology (including innate, mucosal, and immune interactions), biochemistry, pathology, neuroscience, systems biology, (proteomics, genomics, metabolomics and lipidomics etc.), molecular genetics, bioengineering, imaging technology, mathematical modeling, nutrition, and chronic disease epidemiology. Excessive alcohol intake often results in life-threatening medical disorders stemming from selective cell and tissue injury. Moreover, ethnic, gender and age differences in onset and severity of clinical pathology are observed. Although the underlying physiology and biochemistry of all cells is similar, manifestations of alcohol damage in adult and fetal tissue and organ systems may appear quite different, depending on the specificity and course of the disease following the alcohol insult. The initiating events at the molecular and cellular levels leading to alcoholic hepatitis, pancreatitis, immune system dysfunction, lung injury, cardiovascular compromise, neoplasia, bone disorders, brain tissue injury, peripheral neuropathy and endocrine dysfunction are not fully understood. However, evidence suggests that some common mechanisms may underlie tissue injury induction. For example, inflammatory mediators are involved in hepatitis, pancreatitis, and vascular disorders associated with alcohol abuse. Oxidant stress caused by alcohol metabolism is a common element in cellular injury in liver, pancreas, heart, lung, and brain. Topics of interest may include exacerbation of tissue injury by inflammatory mediators and their modifications; generation of reactive oxygen species during ethanol metabolism; induction of pro-apoptotic, anti-apoptotic or other pathways involved in ethanol toxicity. Other areas of interest include the horizontal transfer of active genetic elements through apoptotic bodies; and the differential expression of genes that participate in cell injury and regulate downstream signaling pathways. Systems biology approaches utilizing genomics, proteomics, metabolomics and mathematical modeling that can identify changes in gene expression and protein modifications that trigger injury in multiple tissues are encouraged. The knowledge gained from this initiative will provide the foundation for identification of sentinel markers of tissue injury and the development of new therapeutics to control or modify outcomes of alcohol abuse. Areas of investigation under this Funding Opportunity Announcement (FOA) could include, but are not limited to: INKlings Page 9 of 30 Areas of investigation under this Funding Opportunity Announcement (FOA) could include, but are not limited to: • Elucidation of the roles of ethanol and ethanol metabolites, coincident with other factors such as stress, infectious agents, nutritional supplements, iron, fat, antioxidant depletion, and regulatory peptides, inflammation, immune responses on the cell surface and molecular signaling cascades that lead to tissue injury. • Elucidation of the role of vascular organ interface disruption and cell signal processing in the initiation of organ injury promoted by ethanol. • Determination of the impact of ethanol on the cell membrane and molecular signals that instruct stem cells to replace damaged tissue. • Elucidation of the effects of ethanol on stem cell development and function. • Evaluation of the mechanistic basis for adult, fetal, racial/ethnic and sex and gender-based differences in clinical manifestations of organ injury. • Investigation of abnormalities in mitochondrial structure and function in the heart after prolonged alcohol abuse. • Evaluation of the effect of ethanol on calcium handling within myocardium. • Determination of the mechanisms by which free radicals and shifts in redox states during ethanol ingestion and metabolism contribute to cellular damage and the potential value of antioxidant therapy. • Evaluation of interactions between gene regulatory elements and factors that control developmental, tissue-specific, and temporal expression of alcohol metabolizing enzymes in all organs through development and aging. • Identification of genes and genotypes that confer susceptibility and/ or resistance to ethanol-induced cell/tissue damage. • Elucidation of the initiation, progression, and maintenance processes in tissue injury using targeted mutations. • Development of non-invasive biomarkers for the early detection of alcohol induced tissue injuries using new technologies involving organ, molecular and cellular imaging, immunomics, metabolomics, proteomics and lipidomics. • Determination of the relative roles of ethanol and ethanol-induced toxic substances in initiating tissue damage in the brain and nervous systems of multiple organs (i.e. peripheral neuropathies). • Investigation of neuro-immune dysfunction in ethanol/stress induced tissue damage. • Role of ethanol-induced excitotoxicity during withdrawal on organic brain damage. AGING Other index term: Cross-cutting & Interdisciplinary Title: Development of New Tools for Cell Fate Determination and Tissue Homeostasis in the Aged (R21) Agency: National Institute on Aging (NIA) LOI Deadline: September 30, 2008 Application Deadline: October 30, 2008 CFDA Number: 93.866 RFA Identification: RFA-AG-09-004 Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-09-004.html The National Institute on Aging (NIA), National Institutes of Health (NIH), invites Exploratory/Developmental Research Grant (R21) applications from institutions/organizations that propose to develop tools to track cell fate determination (cell lineage) and to determine cell life spans in normal tissue homeostasis and in response to injury or disease in the elderly. This FOA will support basic and applied exploratory/developmental research projects for the development of tools needed to determine cell life spans and cell fates in various tissues of aged mammals, specifically in humans or in model organisms (e.g., rodents or nonhuman primates). Applications will address the design, development and quantitative testing of integrated systems for INKlings Page 10 of 30 cell turnover rates and lineage tracing in one or more cell types. Such systems should be applicable to determine the age-dependent changes in cellular turnover and fates in tissues that lose function with advanced age. Application and submission requirements, and peer review processes will follow NIH guidelines (outlined in this FOA). The objective of this FOA is to foster the development of tools for quantitative measurements of cell turnover and cell lineage tracing in mammals, with the long-term goal of determining the cellular basis of tissue homeostasis in the elderly. It is expected that tools, methods and knowledge of cell fate determination that have been established in the fields of embryology and developmental biology, and more recently in cell birth dating, will be applicable to aging research. It is also hoped that novel tools and methods may be developed. • Mechanism of Support. This FOA will utilize the NIH Exploratory/Developmental Research Grant (R21) grant mechanism. • Funds Available and Anticipated Number of Awards. NIA expects to award $1.0 million in Fiscal Year 2009 (FY2009) to fund up to 5 meritorious projects that are responsive 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. AGING Other index terms: Clinical Research, Neurosciences, Nursing, Nutrition & Dietary, Women’s Health Title: Transdisciplinary Research on Fatigue and Fatigability in Aging (R01), (R21) Agency: National Institute on Aging (NIA) National Cancer Institute (NCI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Nursing Research (NINR) Office of Dietary Supplements (ODS) Office of Research on Women’s Health (ORWH) Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm PA Identifications: PA-08-161, PA-08-162 CFDA Numbers: 93.866, 93.213, 93.393, 93.849, 93.361 Links: http://grants.nih.gov/grants/guide/pa-files/PA-08-161.html (R01) http://grants.nih.gov/grants/guide/pa-files/PA-08-162.html (R21) This FOA solicits proposals for research projects on fatigue and fatigability in aging. Both animal models and humans are appropriate for study under this FOA. Studies involving transdisciplinary collaborations are highly encouraged. Justification should be provided for the selection of a fatigue scale or instrument. Ideally, studies should address fatigability, not just fatigue. Research from a variety of fields has the potential to generate important insights into mechanisms of, contributors to, and potential interventions for, fatigue and fatigability. These fields include, but are not limited to, biometrics, cardiology, cell and molecular biology, endocrinology, epidemiology, exercise physiology, neurology, neuropsychology, nursing science, nutritional science, oncology, physical medicine and rehabilitation, psychiatry, psychoneuroimmunology, and psychology. Collaborations among investigators across disciplines are particularly valuable for understanding the relationships among the various physical, cognitive, emotional, and social factors influencing fatigue and fatigability. Examples of research topics that may be considered under this FOA include, but are not limited to: • Understanding the relationship between self-reported fatigue and effort (in other words, fatigability) associated with physical, mental, emotional, and/or social expenditures in aging. • Understanding the clinical epidemiology of fatigue or fatigability in aging, such as more accurate estimates of prevalence, risk factors, and clinical and functional correlates of different types of fatigue. Secondary analysis of existing datasets is encouraged; however, use of items not originally intended INKlings Page 11 of 30 for measuring fatigue should be thoroughly justified. • Identification of predisposing and/or modulating factors of increased fatigue or fatigability, such as genetic, physiologic, psychosocial, and environmental factors, in aging. • Characterization of the phenotype of fatigued or fatigable individuals to identify potential associated co-morbid conditions and to differentiate sub-groups with unique clinical characteristics. • Understanding the extent to which pathophysiology of a particular disease or condition contributes to fatigue symptomatology in aging. Elucidation of factors beyond disease pathophysiology that influence severity, quality, or impact of fatigue are of particular interest. • Understanding the phenomenology of, and mechanisms underlying, the relationship between increased fatigue or fatigability and commonly associated symptoms such as pain and/or insomnia in aging. • Understanding the relationship between fatigue or fatigability and functional impairment. • Evaluation of instruments for measuring fatigue or fatigability in aging or in subgroups of older adults. Subgroups could include such categories as ethnically diverse individuals or those with cognitive impairment. • Evaluation of observable correlates of increased fatigue or fatigability in aging, such as imaging or performance measures. • Evaluation of interventions for increased fatigue or fatigability in aging, including nutritional, pharmacologic, behavioral, or cognitive modalities. In assessing the efficacy of an intervention, it may be more informative to determine fatigability—not just fatigue—as an outcome. • Elucidating cellular or molecular mechanisms underlying increased fatigue or fatigability in aging. Examples include cardiovascular, pulmonary, musculoskeletal, mitochondrial, neuroendocrine, or neuroimmune mechanisms. • Understanding the relationship between fatigue or fatigability and life decisions, such as retirement or moving to an aggregate or assisted living facility. • Elucidating neurophysiological and psychological mechanism(s) by which fatigue is perceived. • Evaluation of conceptual models of fatigue or fatigability; for example, models using systems biology approaches. • Identification of protective factors against increased fatigue or fatigability in aging. • Evaluation of fatigue or fatigability in novel clinical or animal models; for example: 1) Exceptionally energetic or active individuals 2) Human or animal studies of inducible low or high energy states, such as after administration of pro-inflammatory cytokines or stimulants. In addition, the National Institute of Diabetes and Digestive and Kidney Diseases is interested in applications that examine the potential relationship of fatigue or fatigability in older adults with urologic chronic pelvic pain syndromes, such as Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), using basic science and epidemiological approaches focused on underlying disease pathology and natural history of disease. An additional area of NIDDK interest includes understanding the cause and impact of fatigue or fatigability in patients suffering from chronic kidney disease (CKD) and end stage renal disease (ESRD). The Office of Research on Women’s Health would be interested in applications that address sex/gender differences in fatigue or fatigability in older adults and across the lifespan. Additional Guidance for Applicants Applicants may wonder what age range is appropriate for the study of aging. There is no simple cutoff that separates old from young; rather, the age range will depend on the nature of the question under study. A useful approach may be to study subjects from a broad range of ages, ideally including the oldest old, with analysis of outcomes by age subgroups. Also, studies on aging need not be limited to very old subjects. Aging processes relevant to particular diseases or conditions may occur years or decades before becoming clinically apparent. Appropriate selection of instruments for measuring fatigue will be a critical part of applications responding to this announcement. Instruments should be validated in the proposed study population and should be consistent with the proposed question(s) under study. Analyses of existing datasets are encouraged under INKlings Page 12 of 30 this announcement; however, dataset items that are used to measure fatigue, but that were not originally intended for this purpose, should be well justified. Because the study of fatigue and fatigability encompasses a broad range of disciplines, applications are more likely to succeed through establishment of transdisciplinary research teams. Investigators on such teams should bring expertise from a variety of backgrounds pertinent to the study aims. For clinical studies, teams should include investigators from both the biomedical and social sciences. Such studies would be well served by incorporation of thorough medical evaluations in order to identify underlying disease processes that may contribute to increased fatigue or fatigability as well as to account for potential heterogeneity among study subjects. BEHAVIORAL SCIENCES & MENTAL HEALTH Other index terms: Diabetes, Neurosciences, Obesity Title: Adverse Metabolic Side Effects of Second Generation Psychotropic Medications Leading to Obesity and Increased Diabetes Risk (R01) Agency: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Mental Health (NIMH) Application Deadline: October 22, 2008, June 22, 2009, February 22, 2010, October 22, 2010, June 22, 2011, February 22, 2012 CFDA Numbers: 93.847, 93.242 PAR Identification: PAR-08-160 Link: http://grants.nih.gov/grants/guide/pa-files/PAR-08-160.html The introduction of new medications targeting the symptoms of mental illness has led to improved clinical outcomes for many patients, and has significantly broadened treatment options available for illnesses such as schizophrenia, bipolar disorder, and depression. However, recent reports clearly indicate that many of the newer psychotropic agents are also associated with metabolic risks and side-effects burden, including: weight gain, obesity, type 2 diabetes mellitus, metabolic syndrome, and cardiovascular disease. Further, the results of a recent study (Newcomer JW, Hennekens CH. Severe mental illness and risk of cardiovascular disease. JAMA 2007; 298:1794-1796) showed that compared to the general population, persons with major mental illness lose an average of more than 25 years of potential life, primarily due to cardiovascular disease The intent of this FOA issued by the National Institute of Diabetes and Digestive, and Kidney Diseases (NIDDK) and the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), is to support research that will 1) increase understanding of the nature, rates, and pathophysiology of adverse metabolic effects of psychotropic medications, 2) elucidate biomedical and psychosocial risk factors for the development of metabolic adverse effects of psychiatric therapeutics, and 3) develop interventions to prevent and/or mitigate metabolic adverse effects across the lifespan Examples of research areas of interest are illustrated below; they are not intended to be exhaustive. • Examine individual or treatment factors that predict the development of metabolic abnormalities or risk (i.e. abdominal adiposity, weight gain, dyslipidemia or hypertension) in patients treated with psychotropic medications; including differences in risk across racial and ethnic categories. • Identification of pharmacogenetic and pharmacodynamic determinants that may contribute to age or race/ethnicity related metabolic differences in drug response and metabolic side effect profile. • Studies using existing large patient population databases to identify predictors or risk and estimate the prevalence of drug-induced adverse metabolic effects. These studies might also include an examination of the relationship of these adverse metabolic effects to patient burden, treatment adherence, disease outcomes/complications, quality of life or the cost of treatment. • Studies to develop and test innovative methodologies to collect, classify, and assist in the interpretation of adverse metabolic effects associated with psychotropic medications. • Studies to develop data analytical techniques to meaningfully assess or predict metabolic consequences in relation to psychotropic medication in clinical trials and/or in practice settings. INKlings Page 13 of 30 • Research to evaluate metabolic risks of psychotropic medications that elucidate the health and psychiatric cost-benefit relationship between possible harms and anticipated benefits of these medications. For example, measurement might include mental health and physical health outcomes, economic costs, and quality of life outcomes. • Studies of the effects of psychotropic medications that examine glucose and lipid metabolism as they relate to alterations in beta-cell function, insulin sensitivity in hepatic and peripheral tissues, and alterations in lipid metabolism. • Studies that examine the sensory or behavioral mechanisms (i.e. sense of taste or smell, satiety, appetite, perceived energy, or physical activity levels) of psychotropic medication related weight gain. • Studies of genetic markers associated with, and potentially causally related to, treatment-emergent metabolic adverse effects of antipsychotic or mood stabilizing psychotropic agents. • Studies examining the potential influence of psychotropic drugs on metabolic risk independent of drug effects on body weight and/or body fat. • Studies examine the relationship between the metabolic effects of psychotropic medications and central or peripheral neurologic mechanisms. • Studies examining the role of polypharmacy in the risk metabolic side effects of psychotropic drugs, including drug/drug interactions, drug/food interactions, and drug/dietary supplement interactions. • Studies to develop or test pharmacological or non-pharmacological co-therapies to reduce and/or prevent the negative metabolic, vascular or other side effects of commonly prescribed psychotropic medications. CANCER Other index term: Stem Cell Research Title: Stem Cells and Cancer (R21) Agency: National Cancer Institute (NCI) Application Deadline: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm PA Identification: PA-08-165 CFDA Numbers: 93.393, 93.394, 93.395, 93.396, 93.399 Link: http://grants.nih.gov/grants/guide/pa-files/PA-08-165.html Research Objectives and Scope of this FOA This FOA encourages research on all aspects of tumor stem cell biology. The scope includes the molecular and biochemical regulation of embryonic and adult stem cell behavior relevant to tumor formation. Investigators working in the area of the cellular and molecular biology of embryonic stem cells and adult stem cells, whose work can advance tumor stem cell biology, are encouraged to apply for this FOA. Research topics that are relevant to this FOA include, but are not limited to, the following examples: • What factors determine the proliferation rate of normal and tumor stem cells? • Can oncogenes and (their aberrations) affect asymmetric versus symmetric divisions in stem cells? • What is the nature of stem cell quiescence versus growth (in terms of progression through the cell cycle)? Which stem cell-specific genes alter the cell cycle pathway proteins? • Do tumor stromal cells constitute a unique element of the tumor stem cell niche? Does the tumor stromal niche act as a constituent of a feedback mechanism with tumor stem cells to control their growth? • Are the phenotypes of invasion and metastasis uniquely connected to the tumor stem cell phenotype? • Are normal resident adult tissue stem cells a special target for carcinogenic insults? • Can new and/or better markers and assays for the isolation and enrichment of tumor stem cells be developed? • Can new and/or better in vivo functional assays to identify tumor initiating cells (e.g. engraftment of leukemic stem cells into immunodeficient NOD/SCID mice) be developed? • How do changes to stem cells or their environment due to aging affect formation of tumor stem cells or alter their properties? INKlings Page 14 of 30 CANCER Other index terms: Bioengineering & Bio-imaging, Clinical Research Title: Quick-Trials for Imaging and Image-Guided Interventions: Exploratory Grants (R21) Agency: National Cancer Institute (NCI) LOI Deadline: June 10, 2008 Application Deadlines: August 11, 2008; December 10, 2008; April 10, 2009; August 11, 2009; December 10, 2009; April 9, 2010; August 11, 2010; December 10, 2010; April 11, 2011 PAR Identification: PAR-08-147 CFDA Numbers: 93.393, 93.394, 93.395, 93.396, 93.398, 93.399 Link: http://grants.nih.gov/grants/guide/pa-files/PAR-08-147.html The primary focus of this FOA is to support clinical trials for preliminary evaluation of the safety and efficacy of imaging agents, as well as an assessment of imaging systems, image processing, image-guided therapy, contrast kinetic modeling, and 3-D reconstruction and other quantitative tools. Additional areas of interest may include novel applications of standard imaging methodologies, such as for selection of therapeutic regimens and assessment of responsiveness to cancer therapy. Background Imaging methodologies play a pivotal role in the clinical management of cancer including screening, diagnosis, interventions, and monitoring of response to both therapy and surveillance. The continued progress in research and development of imaging agents, methodologies and technologies holds great promise for improved detection of tumors and their characterization. These new agents and approaches can exploit various pathophysiological and anatomical characteristics of tumors, such as metabolism, proliferation, hypoxia, angiogenesis, alterations in essential signal pathways, and various other modifications in the tumor microenvironment. Some of the newly available IGI include high intensity focused ultrasound ablation and image-guided drug delivery. Moreover, image-guided biopsy methods can characterize tumor heterogeneity or aid in the standardization of biomarker identification via sequential sampling throughout the course of cancer therapy. There has been a significant investment of resources by the NCI in cancer imaging methods, both for the understanding of basic cancer biology and improvement in patient care. These investments have stimulated considerable new research activity in terms of novel methodologies, and development/application of new imaging devices and agents. Consequently, there are currently many more newly available methods in both cancer imaging and IGI at preclinical stages. In the event that agents, modalities and methodologies proceed through preclinical evaluations and validations with some measure of success, they can be further developed, used, and subsequently validated in clinical settings. The clinical validation of cancer imaging technology enables better tumor diagnosis, staging, intervention, and monitoring of response to therapy. For instance, early clinical trials of novel imaging agents are essential to assure their safety and efficacy, before further evaluations of their potential applications can proceed. Similarly, Phase I studies are required for IGI to establish treatment parameters and their early therapeutic efficacy. There is thus a critical need to provide appropriate resources such as quick trials for safety and efficacy, thereby allowing for an accelerated development of these imaging modalities, methodologies and agents. Specific Research Objectives This FOA will provide a mechanism by which to accelerate the development of these modalities, methodologies, and agents through the early stages of clinical development. This FOA will provide investigators with support for either pilot (Phase I and II) cancer clinical trials, or patient monitoring and laboratory studies. The imaging and Image-guided Intervention (IGI) studies, if proven successful in these early clinical trials, can then be validated in larger studies through competitive R01 mechanisms, or through clinical trials in the Specialized Programs of Research Excellence (SPOREs), Cancer Centers and/or Cooperative Groups. This FOA may also serve as a direct extension of the Division of Cancer Treatment and Diagnosis’ (DCTD) Imaging Drug Group (IDG) products. The goal of this FOA is to accelerate peer review and funding for early clinical testing of new agents such as those developed under the IDG program, to ensure the timely INKlings Page 15 of 30 development of new diagnostic approaches. Features of this program include a modular budget, inclusion of the clinical protocol within the grant application, and accelerated peer review with the goal of issuing new awards within 6 months of receipt of the application. Inclusion of the complete clinical protocol within the human subjects section of the application will ensure proper peer review of the application as well as the protocol. Other key features include no prerequisite for extensive preliminary data in the grant application, support for exploratory translational research studies, and rapid development and application of novel clinical imaging and IGI in cancer-related applications. Investigators may apply for a maximum of two years of funding support using the exploratory or developmental (R21) grant mechanism for up to $250,000 direct costs per year. CANCER Other index term: Infectious Diseases, Oral & Craniofacial Diseases Title: Biomarkers of Infection-Associated Cancers (R01) Agency: National Cancer Institute (NCI) National Institute of Dental and Craniofacial Research (NIDCR) Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm CFDA Numbers: 93.393, 93.394, 93.396, 93.121 PA Identification: PA-08-156 Link: http://grants.nih.gov/grants/guide/pa-files/PA-08-156.html This funding opportunity announcement (FOA), issued by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR), of the National Institutes of Health, encourages applications from institutions and organizations that propose to identify biomarkers for cancers where the etiology of the disease is attributed to infectious agents. Background Infection-associated cancers are increasing at an alarming rate. Approximately 15 percent of cancers (about 1.5 million cases per year, worldwide) are linked to viral (11 percent), bacterial (4 percent), and other pathogens (0.1 percent), and the prevalence of these infectious agents is rising. Although the number of people infected is very high, only a minor proportion ever develops cancer. The objective of this FOA is to foster research to increase our knowledge of infectious agent-associated malignancies and identify those who are at increased risk of developing cancer among infected individuals and to detect early stage cancers in this population. In many cases, the infectious agents are nearly ubiquitously present in humans, but only a small fraction of infected individuals develop cancer. For example, 10 million women in the U.S. have cervical human papillomavirus infections, but only 15 thousand develop cancers. In addition, only 1 percent of Helicobacter pylori-infected persons will develop gastric cancer. Thus, it is important to identify subpopulations of exposed individuals who are likely to develop cancer and to develop sensitive and specific screening tools to monitor for early stage cancers in infected populations. Identifying these subpopulations has proven difficult. Molecular markers provide a potential tool to identify the at-risk subpopulation and the presence of early stage cancers. These molecular markers must therefore be able to distinguish ordinary infections per se from infections that contribute to the development of cancer. Cancer-associated infectious agents likely act, at least in part, by predisposing the cell to oncogenic changes that contribute to the progressive steps leading to cancer. It is very likely that these processes lead to a microenvironment conducive to cellular transformation resulting in the development of cancer. Thus, it is important to identify molecular changes that occur during the progression to cancer in infected cells and the tumor microenvironment. It is likely that distinguishing cells destined to become cancerous from all infected cells will require the identification of differential expression patterns of multiple molecular markers, i.e., generating molecular signatures that are specific for risk of developing cancer. These molecular signatures must permit reliable and accurate identification of at-risk individuals at a stage early enough to allow for INKlings Page 16 of 30 effective intervention. Molecular profiles may be used to identify lesions associated with a high risk of developing cancer and then to distinguish high-risk populations. Molecular analyses will also provide valuable insights into the mechanisms by which infectious agents promote cancer and may help identify potential targets for early detection and cancer prevention. There are relatively few reports on precancer molecular markers of infected hosts. With the advent of high- throughput molecular profiling technologies (e.g., gene microarrays, antibody arrays, and peptide mapping using mass spectrometry), it has become easier to identify molecular signatures of infected host cells and to perform correlative studies to identify high-risk populations in an efficient and timely fashion. Proposed studies should apply these technologies or others so that disease-specific markers and/or profiles can be recognized and used to identify infected individuals in whom infected cells are progressing into cancer and to distinguish high-risk populations. Specific Research Objectives This initiative encourages research to identify molecular markers for risk assessment and early detection in individuals exposed to infectious agents that have been linked to cancer. Listed below, but not limited to, are several programmatic areas in need of support for developing molecular signatures for infectious agent- associated cancers. I. Molecular profiles of normal, precancerous, and cancerous lesions following infection and of body fluids from infected individuals: Infectious agents interact with host cells and activate sets of infectious agent- specific and host-specific genes and proteins. Often some of these proteins are secreted into extracellular fluids. Samples utilized for studies may be derived from tissues or body fluids (e.g., serum, nipple aspirate, pancreatic juice, sputum, urine, alveolar lavage, saliva). It is advantageous if marker profiles can be obtained from body fluids that are collected using minimally invasive methodologies. In addition, chronic inflammation in response to the infectious agent may play a role in cancer development. It may be possible that indicators of inflammation or immune activation could also be useful indices of cancer predisposition. II. Evaluation of these molecular profiles for use in gaining a better understanding of the role of infectious agents in cancer development and use in early detection, risk assessment, and prevention of cancer: In all known cases, infectious agents that are associated with cancers persist for long periods in the host before cancer develops. How the host responds to the infectious agents and how the agent modulates this response are critical in allowing for its persistence and may determine the risk of cancer. Molecular profiles should be analyzed to determine whether a single biomarker, panel of biomarkers, or molecular patterns can be used to determine which infected individuals are at risk of developing cancer and to determine the transition from chronic infection to the initiation of cancer. These molecular profiles may also be used to identify targets for cancer prevention and therapeutic vaccine development. Research projects proposed in the applications may involve a number of infectious agents showing associations with cancer. Noteworthy viral agents of interest to this program are human papillomavirus (HPV), Hepatitis B and C viruses, Epstein-Barr virus (EBV), and Simian Virus 40. Furthermore, an escalating prevalence of early cervical, lung, and colon cancers has emerged among HIV patients. Applicants are also invited to investigate bacterial etiology in cancer, such as the role of Helicobacter pylori in the development of gastric cancers. The involvement of parasitic infections in various cancers is also relevant to this FOA. The National Institute of Dental and Craniofacial Research (NIDCR) has particular interest in EBV- and HPV- associated head and neck cancers. Research projects covering basic science (infectious life cycle, viral replication, etc.) or treatment studies of these infectious agents without direct relevance to cancer biomarker development are not encouraged by this FOA. INKlings Page 17 of 30 CANCER Other index term: Clinical Research Title: Prostate Cancer Clinical Consortium Award Modifications Agency: Department of Defense LOI Deadline: Mandatory by June 11, 2008 Application Deadline: July 2, 2008 Identification: W81XWH-08-PCRP-CCA CFDA Number: 12.420 – Military Medical Research and Development Link: http://cdmrp.army.mil/funding/pcrp.htm The PCRP Clinical Consortium Award mechanism was introduced in FY05. Since then, 19 proposals have been received and 11 have been recommended for funding. Of these, 2 proposals were for the Coordinating Center, with one being funded, and 17 were for Clinical Research Sites, with 10 being funded. The Clinical Consortium Award does not provide funding for research, but, rather, provides the support to develop the collaborations and resources necessary for the consortium to rapidly execute Phase II or Phase II-linked Phase I (Phase I/II) clinical trials of therapeutic agents or approaches for the management or treatment of prostate cancer. Trials that incorporate clinical validation of novel biomarkers for risk assessment, early detection, prediction of aggressiveness, and/or progression of prostate cancer are strongly encouraged. The overarching goal of the Clinical Consortium Award is to combine the efforts of leading investigators to bring to market novel therapeutic interventions that will ultimately decrease the overall impact of the disease. PIs from both US and international institutions may apply. Submissions from institutions with enhanced access to patients from disproportionately affected populations are encouraged. It is expected that the consortium will achieve financial self-sufficiency during the award period such that consortium activities can continue after funding through this mechanism ends. The consortium will consist of approximately 12 Clinical Research Sites and one Coordinating Center. These participants will be jointly responsible for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on prostate cancer therapeutic interventions. See the Program Announcement for the full Funding Opportunity Description. Description of Modification The following modifications have been made to the FY08 Clinical Consortium Award Program Announcement. (1) Consortium members are permitted and encouraged to accrue patients to Phase III clinical trials that include validation of novel biomarkers, providing the patients are participating in the biomarker validation (page 4, letter, b, number 1). (2) Consortium members will be granted accrual credit for Phase III trials that include validation of novel biomarkers (page 7, first bullet; page 9, letter b, third bullet; and page 15, fifth bullet). (3) The Coordinating Center will be responsible for preparing two initial clinical trials for immediate consideration by the consortium within the first 3 months of the performance period (page 6; page 8, fourth bullet; page 11, fourth bullet; page 19, number 9). (a) The statement, “Participation in at least one of the initial clinical trials prepared by the Coordinating Center within the first 3 months of the award period,” has been deleted (page 9). (b) The statement, “Therefore, the two initial clinical trials must be ready to initiate patient accrual just prior to or at the initiation of the award,” has been deleted (page 19, number 9). (c) The peer review question, “Whether the trials will be initiated at a time appropriate for implementation by the consortium,” has been deleted (page 24). (4) Patient contribution to trials from other sites shall constitute at least 20% of the minimum number of patients that a site must accrue to all trials (page 7, second bullet). (5) “Implementation of the consortium-developed management plan for acquisition, delivery, and storage of biological samples and data [to the appropriate laboratories for testing or storage].” Bracketed text deleted (page 9, letter b, sixth bullet, second sub-bullet). The submission dates are not changed. INKlings Page 18 of 30 CHILD & ADOLESCENT HEALTH Other index terms: Behavioral Sciences & Mental Health, Biostatistics & Epidemiology, Global Health & International Programs, Translational Research, Women’s Health Title: Indo-US Program on Maternal and Child Health and Human Development Research (MCHDR) (R03) Agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) LOI Deadline: June 30, 2008 Application Deadline: July 30, 2008 CFDA Number: 93.865 PAR Identification: PAR-08-163 Link: http://grants.nih.gov/grants/guide/pa-files/PAR-08-163.html Purpose Through a cooperative program of maternal and child health and human development research, the Republic of India and the United States of America invite collaborative research projects involving U.S. and Indian investigators to enhance maternal and child health, disease prevention, product development and/or technology transfer. The MCHDR program places specific emphasis on the need for more "translational" types of research intended to move beyond basic science and discovery to product development and delivery, and improved care for women, infants and children. An emphasis will also be placed on studies addressing social and behavioral factors affecting prevention, care, and treatment of disease/poor health in women, infants, and children. The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support small research projects that can be carried out in a short period of time with limited resources. Background The Republic of India and the United States of America share a strong commitment to improve the health and well being of women, children, and adolescents through the expansion of cooperative biomedical and behavioral research. Although the health of women, children, and adolescents has improved significantly in both countries, it is recognized that important research questions remain to be answered in order to achieve additional reductions in morbidity and mortality. Building on a 30-year history of maternal and child health research cooperation, representatives of India and the United States signed a joint statement on June 13, 2000 to enhance this cooperation through an expanded program of Maternal and Child Health and Human Development Research. That agreement has been recently renewed at a signing by representatives of both countries. Goal The goal of the MCHDR program is to "facilitate collaboration on maternal and children's health and human development research, in part, to contribute to global understanding of the causes of morbidity and mortality in women, particularly mothers, children and adolescents." To address shared women and children's health and developmental research concerns, Indian and U.S. scientists will undertake a coordinated program that will involve participation in collaborative, peer-reviewed research projects, scientific workshops and conferences, research training, and technology transfer. Building on a history of productive biomedical and behavioral research collaboration, this cooperation will be based on mutual benefit, trust, and a shared commitment to the advancement of scientific knowledge and its application to improve health. INKlings Page 19 of 30 Research Scope The MCHDR program seeks a balance among 1) Research and Development (R&D) of totally new methods of prevention, care and treatment of illness/disability associated with pregnancy, birth, infancy and childhood 2) studies of approaches to increase the acceptability, access and utilization of currently available methods for prevention, care and treatment of illness/disability in at-risk populations of men, women, children and families and 3) efforts to incrementally improve existing methods, i.e., make what is already available, better. Consistent with the previous FOA for the MCHDR program (PAR-07-216), the MCHDR Joint Working Group (JWG) continues to emphasize the need for more "translational" types of research intended to move from basic science and discovery of new leads to product development and delivery and improved evidence-based care for women, infants and children. In addition to areas of historical interest in MCH research (e.g., factors broadly impacting on women’s health, pregnancy, birth, infancy and normal growth and development), and since the publication of the last FOA for the MCHDR program (PAR-07-216), the MCHDR JWG has suggested that greater emphasis be placed on "translational", i.e, development and delivery of high-priority MCH-related interventions/services and operational research to identify best approaches for implementation as well as potential obstacles. Additional emphasis will be placed on studies addressing social and behavioral factors affecting prevention, care, and treatment of disease/poor health in women, infants, and children. Several areas of focus have emerged in this regard. These include studies addressing risk factors, prevention, and treatment for: • Conditions associated with maternal morbidity and mortality in India (e.g., pre- and post-natal complications, infectious diseases including HIV infection, malnutrition); • Adverse birth outcomes, including still birth, low birth weight, intrauterine growth retardation, and other risk factors for infant morbidity and mortality • Pediatric infection including, but not limited to, respiratory tract infections, malaria, diarrheal diseases, and HIV infection. • More specifically and within the context of the above general areas the following have emerged as high priority to the MCHDR program. These include but are not limited to: • Chlorhexadine: in particular, the need for formative research and data analyses to support a well controlled RCT to ensure development of evidence-based practice. Emphasis should be placed on Chlorhexadine both as an intervention and in terms of the spectrum of organisms that it is effective against. • Human Microflora including (genomics of gut/vaginal environment). In addition to characterization of the ontogeny and identification of normal microflora, a need exists to identify the best candidate microorganisms in the gastrointestinal tract and/or vagina for clinical focus. Studies of the potential role of probiotics in gastrointestinal and/or reproductive tract disorders are an additional area of interest. • HIV infection in infants and children including prevention of mother-to-child transmission (PMTCT), rapid diagnosis and infant feeding (in terms not only PMTC but also in terms of both maternal and infant nutrition). Effect of ART on PMTCT, maternal, infant and child health is an additional area of interest. • Hepatitis and pregnancy: diagnostics, prevention and treatment. • Anti-microbial resistance: particular emphasis is placed on projects to develop a more focused systematic approach to this problem and in particular identification of high priority organisms (e.g., klebsiella), mechanisms of drug resistance and the role of environmental hygiene. Particular emphasis will be placed on studies intended to address the impact of anti-microbial resistance on care and treatment of women and children. • Social/behavioral components of anti-microbial resistance including efforts to develop an integrated approach to this problem that includes both clinical and social/behavior aspects of this problem. • Studies related to continued quality control and benchmarking of perinatal care: specific areas of interest would be use of new methods in information technology (IT), and surveillance within and between clinical care centers to improve monitoring and assessment of prevalence and risk factors for INKlings Page 20 of 30 nosocomial infections and microbial resistance. • Domestic violence (including intimate partners, spousal, parent child etc.): applications could include those addressing prevalence, risk factors or potential interventions. • Stillbirths: all aspects from prevalence to risk factors and potential interventions. • Newborn Screening: emphasis will be placed on new technologies that might be developed to target high prevalence conditions in India, such as hypothyroidism, hemoglobinopathies and hemolytic anemia, as well as studies to assess potential treatment strategies at an individual/clinical and programmatic level. • Birth defects, genetic disorders, developmental disabilities (e.g., autism spectrum disorders, Down syndrome, conditions contributing to mental retardation) and factors affecting normal cognitive/behavioral development. • Medical rehabilitative medicine particularly for children who have been injured. CHILD & ADOLESCENT HEALTH Other index terms: Behavioral Sciences & Mental Health, Immune Disorders & Allergies Title: FY08 Autism Research Program (ARP) Agency: Department of Defense LOI Deadlines: Mandatory by June 10 (Concept Award); June 11 (Synergistic Idea Award) Application Deadlines: July 30 (Concept Award); September 3 (Synergistic Idea Award) Link: http://cdmrp.army.mil/funding/arp.htm ARP Concept Award The ARP Concept Award was created in FY07. Since then, 153 Concept Award proposals have been received and 7 have been recommended for funding. The ARP Concept Award supports the exploration of an initial idea or novel observation that could give rise to a testable hypothesis. Presentation of preliminary data is not consistent with the intent of this award mechanism and therefore is not allowed. These awards provide Principal Investigators (PIs) with the opportunity to pursue serendipitous observations. Proposals must describe how the new idea will enhance existing knowledge of ASD or create an entirely new avenue for investigation. Research completed through a Concept Award may provide sufficient preliminary data to enable the PI to prepare a proposal for future research. Given the focus of the award, clinical trials are not acceptable under this mechanism. The FY08 ARP promotes research that will (1) improve clinical outcomes of ASD, (2) lead to better understanding of ASD across the lifespan, including adulthood, of an affected individual, and (3) integrate basic science and clinical observations. To that end, the FY08 ARP encourages proposals that specifically address critical needs of the ASD community. The following areas of research are of particular interest to the FY08 ARP: 1. Co-morbidity (e.g., manifestations such as gastrointestinal disorders, sleep, seizures, tics, immune disorders) 2. Targets for Treating (e.g., clinical, molecular, cellular) 3. Biomarkers and Pathology (e.g., brain and other tissues) 4. Environment (e.g., clinical and basic toxicology, gene/environment interaction) See the Program Announcement for the full Funding Opportunity Description. ARP Synergistic Idea Award The ARP Synergistic Idea Award mechanism is being offered for the first time in FY08. The Synergistic Idea Award supports innovative research that advances the understanding of ASD and leads to improved treatment outcomes. To facilitate innovative research, the Synergistic Idea Award requires collaboration between at least two independent investigators who address an innovative ASD research question from synergistic and complementary perspectives. The Synergistic Idea Award is designed to promote new ideas and new collaborations. Proposals are required to include preliminary data, but it does not necessarily have to come from the ASD research field. Proposals should have a high probability of revealing new avenues of investigation. The Synergistic Idea Award requires the submission of a single proposal that addresses a critical issue in ASD research. Proposals must clearly identify the synergy that will enable or greatly accelerate the evaluation of a single innovative hypothesis. The fiscal year 2008 (FY08) ARP promotes research that will (1) improve clinical outcomes of ASD, (2) lead to better understanding of ASD across the lifespan, including adulthood, of an affected individual, and (3) integrate basic science and clinical observations. To that end, the FY08 ARP encourages proposals that specifically address critical needs of the ASD community. The following areas of research are of particular interest to the FY08 ARP: 1. Co-morbidity INKlings Page 21 of 30 (e.g., manifestations such as gastrointestinal disorders, sleep, seizures, tics, immune disorders) 2. Targets for Treating (e.g., clinical, molecular, cellular) 3. Biomarkers and Pathology (e.g., brain and other tissues) 4. Environment (e.g., clinical and basic toxicology, gene/environment interaction) Multi-institutional and/or multidisciplinary proposals are encouraged but not required. Collaborators not from distinct disciplines must clearly explain why the proposed research is synergistic. Synergy and impact are important aspects of the Synergistic Idea Award. Synergy: Research combinations demonstrating synergy are those that will significantly advance a project beyond what would be possible through individual efforts. Contributions to the synergy of this mechanism are expected to be balanced between the investigators unless otherwise justified. It should be clear that the investigators have an equal level of intellectual input into the proposed project. This award mechanism is designed to support completely new collaborative efforts. New collaborations are strongly encouraged but not required. If the investigators have a history of collaboration, then they must clearly demonstrate how the proposed research is a new synergistic effort. Examples of a collaboration that is not synergistic and will not be considered for funding under this award mechanism include: • Reagents supplied by one collaborator and molecular studies completed by the other collaborator. • Service function or core support providing laboratory investigations or statistical analyses. • Projects that can be accomplished in a single PI’s laboratory. Impact: Research that has high potential impact and may significantly advance the understanding of autism spectrum disorders. It is the responsibility of the PI to clearly and explicitly articulate throughout the proposal the project’s synergy and the potential impact on autism spectrum disorders. See the Program Announcement for the full Funding Opportunity Description. HIV/AIDS Other index terms: Behavioral Sciences & Mental Health, Child & Adolescent Health, Men’s Health, Women’s Health Title: Gender, Youth and HIV Risk (R01), (R21) Agency: The Eunice Kennedy Shriver National Institute of Child Health and Human Development LOI Deadline: June 29, 2008 Application Deadline: July 29, 2008 CFDA Number: 93.865 RFA Identification: RFA-HD-08-013; RFA-HD-08-017 Links: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-08-013.html (R01) http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-08-017.html (R21) Research Requested This FOA calls for in-depth studies that collect a broader range of data on youth than is typical of past research. It calls for research that relates behaviors to local economic and institutional environments; to cultural meanings, values and norms relating to gender, family, and health; to maturational and developmental trajectories in youth; and to the perspectives and experiences of youth in specific settings. As noted above, responsive applications will focus on a specific aspect of HIV risk, in a specific cultural or geographic setting, while integrating understanding of the processes of human development in that population and of the social environment. Both basic studies and intervention research will be considered responsive, but both must be designed to address the contextual and developmental factors stressed in this announcement, using appropriate qualitative and quantitative methods. Applications must propose appropriate interdisciplinary teams with expertise in developmental, social/cultural, and behavioral processes. Applications responsive to this FOA will build upon, develop, or improve and expand knowledge about HIV risk and/or strategies to mitigate risk in one or more specific and developmentally characterized populations of young people. Studies must be theoretically grounded and must identify local understandings of the issues related to HIV-risk behaviors. Studies outside the U.S. may be of particular use. Applications must demonstrate, in specific populations of youth, an understanding of developmental processes, including gender identity processes and their responsiveness to context. Studies addressing youths' developmental INKlings Page 22 of 30 HIV risk in the context of changing sociocultural, economic, and institutional (including health services) environments are of particular interest. Because these are large challenges, successful studies need to focus on interactions among well-specified aspects of the environment and/or a specific aspect of HIV risk, in a specific cultural or geographic setting, acknowledging developmental issues in the population targeted. Any interventions proposed will need to be grounded in basic social science research as well as in a thorough understanding of the biological aspects of development and HIV risk in young populations. Any basic social science research proposed will need to address the potential for findings that might improve the lives of young people by reducing their risks of infection. Possible research topics considered responsive include but are not limited to the following: Studies that relate youths' sexual risk behaviors to local economic and institutional environments; Studies that address sexual behavior in the contexts of cultural meanings, values and norms relating to gender, family, marriage and health; Studies that address maturational and developmental trajectories in youth; and that demonstrate an understanding of developmental processes, including gender identity processes and their responsiveness to context; Studies that pay attention to the perspectives and experiences of youth in specific settings; Studies that focus on a specific aspect of HIV risk, in a specific cultural or geographic setting, while integrating understanding of the processes of human development in that population and of the social environment; Both basic studies and intervention research are appropriate. Studies must be designed to address the contextual and developmental factors stressed in this announcement, using appropriate qualitative and quantitative methods. Any interventions proposed will need to be grounded in basic social science research as well as in a thorough understanding of the biological aspects of development and HIV risk in young populations. Any basic social science research proposed will need to address the potential for findings that might improve the lives of young people by reducing their risks of infection. Studies that build upon, develop, or improve and expand knowledge about HIV risk and/or strategies to mitigate risk in one or more specific and developmentally characterized populations of young people; Studies outside the U.S. may be of particular use; Studies addressing youths' developmental HIV risk in the context of changing sociocultural, economic, and institutional (including health services) environments are of particular interest. Studies that focus on interactions among well-specified aspects of the environment and/or a specific aspect of HIV risk, in a specific cultural or geographic setting, acknowledging developmental issues in the population targeted. Applications that propose appropriate interdisciplinary teams with expertise in developmental, social/cultural, and behavioral processes. Studies that are theoretically grounded and identify local understandings of the issues related to HIV-risk behaviors. INFECTIOUS DISEASES Other index term: Immune Disorders & Allergies Title: Immune Mechanisms of Virus Control (U01/U19) Agency: National Institute of Allergy and Infectious Diseases (NIAID) RFA Identification: RFA-AI 08-013 CFDA Numbers: 93.855, 93.856 LOI Deadline: July 18, 2008 Application Deadline: August 18, 2008 Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-08-013.html INKlings Page 23 of 30 Research Objectives and Scope The IMVC program will support research using appropriate human and animal studies to address basic immunological questions leading to the discovery of novel immune-based mechanisms relevant to the prevention or control of human virus infection. Successful applicants will justify their choices of experimental systems and approaches in the context of their ultimate physiological relevance to human disease. Proposed research must be focused on the analysis and characterization of host immune mechanisms to address basic scientific questions on the immunology of anti-virus responses, generated either to infection or vaccination. Immune recognition of infected cells, anti-virus defenses, and mechanisms of virus clearance in different tissues are among the major research areas in need of further study; several specific areas of interest and examples are briefly described below. These and other research areas may be addressed in response to this FOA in the context of defining new immune mechanisms relevant to viral disease in humans. Early innate immune responses. Innate immune recognition and activation in response to virus infection are not yet well understood, but are of practical importance for several reasons: vaccines and adjuvants may be more effective if they closely mimic (or in certain cases enhance) the immune triggering of natural infections; better understanding of the anti-virus activity of antimicrobial peptides, cytokines, micro RNA molecules and cellular effector mechanisms may lead to novel antiviral therapies; and the ability to prevent or blunt the damaging effects of innate immune system activation (e.g., “cytokine storm” and other undesired inflammatory responses) may lead to better clinical outcomes. Basic studies are needed on innate immune responses to specific viruses as well as virus evasion mechanisms. Examples of research in these areas include, but are not limited to: • Understanding the interaction of viruses with host pattern recognition receptors (PRRs) and subsequent signaling pathways in immune cells • Studying the cross-talk among PRR pathways and the regulation of downstream genes after exposure to virus • Profiling the responses of innate immune cells after viral infection or vaccination Innate/adaptive interface. The generation of protective immunity appears to be an outcome of a tightly regulated, yet poorly understood, transition from innate to adaptive immunity. As the immune response to virus infection or vaccination matures with time, the innate response leads to activation of the adaptive immune system, and expansion of virus antigen-specific T and B cells. This transition to adaptive immunity is a highly dynamic and complex process. In some cases, antibody and cytokine responses do not lead to host protection or clearance of the virus, or there may be a failure to down-regulate acute inflammatory responses and transit to an adaptive response. Important areas for further basic research include studies of mechanisms that induce or repress inflammation, that bias immunity to the most effective type of T cell response or antibody isotype, or that promote optimal virus antigen uptake, processing, and presentation to T cells. Dendritic cells (DC) play a key role in both the innate and adaptive responses, but can also initiate tolerogenic responses. A better understanding of DC subsets, costimulatory molecules, and signaling pathways is needed to optimally define immune mechanisms of virus control. Examples of research in this area include, but are not limited to: • Elucidating the mechanisms of inflammatory responses to viruses including both positive and negative regulators, phagocytosis, and autophagy • Researching the role of DC to bridge the innate and adaptive immune responses during virus infection • Understanding the role of the innate immune system and the mechanisms used to direct specific adaptive immune responses to a virus or anti-virus vaccine Mucosal immunity. Many viruses cause primarily respiratory, gastrointestinal, or urogenital infection, and variant strains may differ in their site of entry, tissue or cellular tropisms, and their capacity to injure particular tissues. Mucosal epithelial cells comprise the initial barrier to pathogen entry and mucosal tissues differ greatly in terms of their local environment and susceptibility to colonization and infection. There is little comprehensive information on the recognition of viruses and the development of protective immunity within the mucosa. The innate immune detection of viruses by PRRs in the mucosal system is not well understood, but will depend on the route of entry of the virus and the cells or tissues that are infected. Adaptive immunity in the mucosal systems is similar to that seen in other parts of the body, but there are populations of specialized cells that function in mucosal immunity. Specialized DC and M cells appear to play a key role in INKlings Page 24 of 30 tolerance to commensal organisms, but their function in anti-virus immunity is not clear. A discrete population of CD8 T cells, the intraepithelial lymphocytes, may interface directly with viruses in mucosal tissues. The role of B cells in mucosal immunity includes not only the production of IgM and IgG, but also of secretory IgA, which provides protective functions such as virus neutralization and formation of antigen-antibody complexes to block entry of viruses across epithelial barriers. The mucosal tissues of the respiratory, gastrointestinal, and urogenital systems differ in many regards, such as architecture, APC types, the viruses and antigens likely to be encountered, and their capacity to release specific cytokines and chemokines. Furthermore, the presence of additional factors such as surfactants and mucosal enzymes, as well as pH and redox variation in mucosal sites, may influence the local immune response and the stability or degradation of soluble mediators, cytokines, adjuvants, and other vaccine components. It will be important to understand the processes that initiate and regulate innate and adaptive immunity in response to viruses in the mucosal sites that serve as major entry points of infectious pathogens. Examples of research in this area include, but are not limited to: • Understanding the unique features of innate and adaptive immunity to viruses in specific mucosal sites and associated cells and tissues • Studying the role of regulatory T (Treg) cells in different mucosal tissues after viral infection or vaccination • Characterizing the generation and maintenance of T and B cell memory to viruses or vaccines in different mucosal sites Immune memory. Both natural infection and vaccination may result in long term protection against subsequent exposure to the same virus, or closely related viruses, due to the generation and maintenance of long term immune memory. Although virus infections generally stimulate strong innate immune responses that should lead to robust adaptive immunity, some infections cause T cells to become unresponsive and unable to develop an effective memory repertoire. In addition, the roles that innate immunity and virus evasion factors play in the development of memory remains an area that requires further exploration. Examples of research in this area include, but are not limited to: • Characterizing the role of survival/apoptosis of immune cells, antigen persistence, cell turnover kinetics, and cytokines necessary for T and B cell memory to viruses • Determining how different T and B cell subsets are generated and maintained during virus infection • Studying the role of adjuvants in the development of protective memory responses • Understanding how B-1 B cells and marginal zone B cells can function in effective B cell memory Protective antibody responses. Studies of virus specific B cell activation and the production of protective antibodies are especially encouraged in this FOA. Antibodies are thought to provide primary protection after vaccination or re-infection with the same virus. However, much of the basic work in model systems has focused on T cell responses, with insufficient investigation of B cell responses or the interdependence of T and B cell regulation. Examples of research in this area include, but are not limited to: • Identifying and elucidating the mechanisms that govern the development, recruitment, and maintenance of long-lived plasma cells • Defining biomarkers of protective humoral responses to virus or vaccination Immunity in vulnerable subpopulations. Immune function and the ability to generate protective immune responses vary with age and underlying health status. Elderly people have a limited repertoire of memory T cells that appear to be functionally compromised as compared to those of young adults. In adults, thymic output of naïve T cells and bone marrow production of new B cells decline with age, resulting in limited repertoires of memory cells to pathogens, including viruses. Very young children have a naïve repertoire of T cells and may lack significant memory responses. Many chronic diseases involve immune dysfunction or require treatments that cause immunodepletion or immunosuppression, including conditions such as transplantation, cancer, or autoimmune diseases. These conditions are characterized by heightened susceptibility to infection or altered requirements for successful vaccination. In other instances, there are major differences among populations in susceptibility to, natural history of, and response to therapy of certain infectious diseases. Identification of differences in virus immunity may facilitate more effective vaccination strategies and treatment modalities. Examples of research in this area include, but are not limited to: • Understanding the mechanisms responsible for the immune defects in populations with suboptimal immune responses to viral infection or vaccination • Profiling the immune responses of susceptible populations during virus infection or vaccination INKlings Page 25 of 30 LUNG & PULMONARY DISEASES Other index term: Clinical & Translational Research Title: Small Grants for Lung Tissue Research (R03) Agency: National Heart, Lung, Blood Institute (NHLBI) LOI Deadline: September 22, 2008 Application Deadline: October 17, 2008 RFA Identification: RFA-HL-08-008 CFDA Number: 93.838 Link: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-08-008.html The goal of this initiative is to promote tissue-based research on COPD and interstitial fibrotic lung conditions, including studies to establish proof-of-concept in humans for novel mechanisms of pathogenesis. Each study must make substantial use of biospecimens and clinical data collected by the Lung Tissue Research Consortium (LTRC). This unique resource is well suited to support studies that seek to correlate lung molecular characteristics with histopathology and the presence, severity, and phenotypic manifestations of interstitial lung diseases and COPD. Apart from acute pneumonias, most serious pulmonary diseases are idiopathic, chronic, progressive conditions that may involve unrecognized etiologic agents and for which no therapy is known to cure or slow progression of the disease. A critical aspect of research in such diseases is recognition of specific cellular and molecular abnormalities in the lung that correlate with disease severity or outcome. Characterization of molecular pathways involved in the pathogenesis of these conditions is invaluable for the identification of therapeutic targets. Knowledge of the molecular and cellular changes that occur in the lungs in diseases such as COPD and the pulmonary fibrotic conditions is inadequate. Hence, there is substantial need in pulmonary research for molecular characterizations that can be correlated, not only with clinical status, but also with tissue structure and specific cell types. The LTRC was established in 2004 to facilitate histopathological research on interstitial lung diseases and COPD by collecting and distributing blood and lung tissue specimens from well phenotyped donor subjects. The LTRC has now obtained lung tissues from over 1,000 subjects and processed the specimens in a standardized manner. Approximately 15,000 samples of fixed or frozen tissue, serum, and DNA are currently available for distribution to investigators. Quality assurance procedures have demonstrated excellent integrity of RNA in >95% of cases. Extensive, standardized phenotypic data are available from most donor subjects, including pulmonary function, high resolution CT images of the lungs, and exercise testing (see http://www.ltrcpublic.com/). While the LTRC provides biospecimens, CT images, and subject phenotypic data to external investigators free of charge, it does not provide funding to support the related research. This solicitation is complementary to the LTRC, in that it will provide small grant support to investigators who propose meritorious studies of COPD and/or interstitial fibrotic lung disease that utilize resources of the LTRC. It is anticipated that these R03 awards will provide sufficient funds for studies that test proof-of-concept in humans of pathogenetic hypotheses suggested by previous in vitro, animal, or biomarker studies. Should additional funding be required to fully evaluate the pathogenetic mechanisms proposed for study, investigators are encouraged to plan for subsequent grant applications (e.g., investigator-initiated R01 research project grant applications) using the results that they obtain through this program as preliminary data. Examples of research areas appropriate to this announcement include, but are not limited to: • Correlate the expression of specific genes in the lung with the presence and/or severity of disease. Determine the specific cell types involved. • Identify lung epigenetic characteristics that are associated with particular environmental exposures and/or lung pathologies. • Use laser-capture microdissection to correlate the molecular phenotype of lung fibroblasts with clinical phenotype in IPF. • Characterize the localization of fibrosis, neovascularization, and growth factor expression in the lungs of INKlings Page 26 of 30 patients with interstitial lung disease. • Compare the localization of specific inflammatory cells with focal emphysematous changes in the lungs of patients with COPD. • Correlate structure and inflammation of the small airways and/or blood vessels with pulmonary function and CT image parameters. • Test for interaction between diseased lung tissue and a nearby carcinoma. Investigate the molecular basis and pathogenetic role of this interaction. ORAL & CRANIOFACIAL HEALTH Other index term: Child & Adolescent Health Title: Samuel Harris Fund For Children's Dental Health Agency: American Dental Association Foundation Application Deadline: July 17, 2008 Link: http://www.ada.org/ada/adaf/grants/harris.asp The American Dental Association (ADA) Foundation (http://www.ada.org/ada/adaf/index.asp) invites applications for the Samuel Harris Fund for Children's Dental Health, a permanent endowment fund dedicated to improving children's oral health. The Harris Fund will award competitive grants of up to $5,000 each to applicants whose oral health promotion programs are designed to improve and maintain children's oral health through community education and outreach programs. In 2008, a total of $325,000 will be available for program grants. The grant program's main objective is to help children whose socioeconomic status impacts their access to professional oral care and adversely affects their oral health habits at home. Proposals from community- based, nonprofit, oral health promotion programs in the United States and its territories that comply with the program's submission guidelines will be considered. Examples of qualified oral health promotion programs include the following: dental health education programs in conjunction with preventive programs such as fluoride and dental sealant application programs; oral health and nutrition education materials designed for parents, caregivers, and/or child care professionals; dental health education conducted at schools, health fairs and social service agencies, or via outreach programs; instruction in the proper use of oral care products; and development of public service announcements to increase awareness of, and appreciation for, proper childhood oral care. Visit the ADA Foundation Web site for complete program guidelines and application procedures: http://www.ada.org/ada/adaf/grants/harris.asp. TRAINING & CAREER DEVELOPMENT Other key term: Clinical Research Title: Midcareer Investigator Award in Patient-Oriented Research (K24) Agency: National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institute of Child Health and Human Development (NICHD) INKlings Page 27 of 30 National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm CFDA Numbers: 93.866, 93.271, 93.855, 93.856, 93.846, 93.286, 93.398, 93.865, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.113, 93.114, 93.115, 93.361, 93.867, 93.233, 93.837, 93.838, 93.839, 93.281, 93.853, 93.213, 93.389 PA Identification: PA-08-151 Link: http://grants.nih.gov/grants/guide/pa-files/PA-08-151.html Purpose: The purpose of the Midcareer Investigator Award in Patient-Oriented Research is to provide support to mid-career health-professional doctorates or equivalent who are typically at the Associate Professor level or the equivalent (see Eligible Individuals below) for protected time to devote to patient- oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. The intent of this award is two-fold: 1) to enable mid-career clinician scientists to devote more time and to augment their capabilities in patient-oriented research; and 2) to enable mid-career clinical scientists to mentor new clinical investigators in the conduct of patient-oriented research. An award recipient who continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to new investigators can continue to contribute to the overall goals of the program after being promoted to Full professor. Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) grant mechanism. Candidates must commit 3-6 person months (equivalent to 25 to 50% effort) to conducting patient-oriented research and mentoring. Eligible Individuals Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and mentoring activities is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are further encouraged to apply for NIH support. The following additional eligibility requirements apply: Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident are eligible to receive this award. Candidates must meet this criterion prior to the time of award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Degree and Research: Candidates for this award must have a health-professional doctoral degree or its equivalent. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing. Candidates with Ph.D. degrees are eligible for this award if the degree is in a clinical field or they perform patient-oriented research (POR). This may include clinical psychologists, clinical geneticists, speech and language pathologists. Career Level: Applicants should typically be at the Associate Professor level or functioning at that rank in an academic setting or equivalent non-academic setting and must have an established record of independent, peer-reviewed patient-oriented research grant funding including at the time of application and record of INKlings Page 28 of 30 publications. This award is intended for individuals who are at a mid-career stage and have a record of supervising and mentoring patient-oriented researchers. Candidates are advised to discuss their eligibility with the Institute or Center contacts listed in Section VII of this program announcement. Effort and Other Support: Candidates must be able to demonstrate the need for protected time, 25-50% of full-time professional effort (equivalent to 3-6 person months) for a period of intensive research focus as a means of augmenting their capabilities in patient-oriented research and mentor new clinical investigators in the conduct of patient-oriented research during this period. Awardees must commit 25-50% effort (equivalent to 3-6 person months) to conducting patient-oriented research and mentoring. Candidates for the K24 award may not have pending or concurrently apply for any other PHS career award. Renewals: K24 awardees may apply for a one-time renewal for an additional three to five years of support if the K24 recipient continues to have independent peer-reviewed patient-oriented research support at the time of submission of the renewal application. Applicants should clearly demonstrate their continuing need for protected time to expand their research and mentoring programs. During the course of the initial award, an investigator may be promoted from Associate Professor to Full Professor. Such investigators are considered to be eligible to apply for renewal of their support, as long as they meet all other eligibility requirements stated in this FOA. Renewal K24 applications will not be rejected, nor will they be unscored, solely based on the applicant’s academic rank. Reviewers will continue to apply their professional judgment in assessing the five review criteria, and in assigning priority scores to specific K24 grant applications. Individual NIH Institutes and Centers may differ in the programmatic priority that they apply to investigator rank in reaching their funding decisions. Differences in the rates of investigator promotion may mean that a Full Professor may or may not be considered mid-career depending on the discipline. TRAINING & CAREER DEVELOPMENT Other index term: Clinical & Translational Research Title: Academic Career Award (K07) Agency: National Cancer Institute (NCI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) Application Deadline: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm PA Identification: PA-08-152 CFDA numbers: 93.392, 93.866, 93.272, 93.281, 93.213 Link: http://grants.nih.gov/grants/guide/pa-files/PA-08-152.html The purpose of the NIH Academic Career Award is to provide support to increase the pool of individuals with academic and research expertise to become academic researchers and to enhance the educational or research capacity at the grantee sponsoring grantee institution. The Academic Career Award supports Development awards for more junior level candidates and Leadership awards for more senior individuals with acknowledged scientific expertise and leadership skills. • Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the NIH Academic Career Award (K07) grant mechanism. Depending on the specific purpose of the award (see Purpose section above) candidates must commit a minimum of 9 person months (75%) (Development) or 3 person months (25%) (Leadership) effort to activities covered under the award. • Funds Available and Anticipated Number of Awards: The total amount to be awarded and the number of anticipated K07 awards will depend upon the quality, duration, and costs of the applications received as determined by the peer review process, available funds and program priorities. The amount funded as salary for a K07 award is not uniform throughout the NIH participating Institutes and Centers (ICs); therefore, the applicant is strongly advised to contact the relevant IC for any distinct guidelines, requirements, and allowable funds (see Section VII. Agency Contacts). INKlings Page 29 of 30 • Budget and Project Period: Applicants may request up to five years of support (at least three years are required for the Development award, and at least two years are required for the Leadership award). Development award: This award provides up to 5 years (a minimum of 3 years is required) of salary and research support for more junior investigators who are interested in developing academic and research expertise in a particular health-related field, as a way to increase the overall pool of individuals capable of research or teaching in the identified area. During the period of the award, the candidate will become a successful academic researcher in the chosen area. Research, teaching, and leadership skills are to be learned during the tenure of the award. Curriculum building skills are encouraged. A mentor is required. A minimum of 9 person months (75%) of full-time professional effort is required annually; the remainder may be devoted to other research related and/or teaching pursuits consonant with the objectives of the award. Leadership award: This award provides support for up to 5 years (a minimum of 2 years is required) for more senior investigators who are interested in improving the curricula and enhancing the health-related research capacity within an academic institution. The Leadership candidate must have acknowledged scientific expertise and leadership skills and sufficient clinical training, research, or teaching experience in the academic area of interest to an NIH awarding component to implement a program of curriculum development within the sponsoring institution. It is expected that support under this award will increase the visibility and the overall research support or academic capacity for the given field of research within the academic medical/health and research community. At least 3 person months (25%) but not more than 6 person months (50%) of full-time professional effort must be devoted to the program annually. K07 Development and Leadership awards are not renewable nor are they transferable from one PD/PI to another. Because the objectives of the K07 are to increase the pool of individuals in academia and/or to implement or enhance curriculum development within the sponsoring institution, awards are not transferable to another institution. Only in exceptional circumstances would consideration be given for the transfer of a Development award. TRAINING & CAREER DEVELOPMENT Other index term: Health Outcomes Title: Postdoctoral Fellowships in Health Outcomes Agency: Pharmaceutical Research and Manufacturers of America Foundation, Inc. Application Deadline: October 01, 2008 Link: http://www.phrmafoundation.org/awards/outcomes/postdoc.php The PhRMA Foundation Postdoctoral program in health outcomes provides stipend support for individuals engaged in a research training program that will create or extend their credentials in health outcomes. The purpose (intent) of this program is to support post doctoral career development activities of individuals prepared (or preparing) to engage in research that will strengthen representation of health outcomes in schools of pharmacy, medicine, nursing and public health. To accomplish these goals, support will be provided for a two-year period to selected individuals who are beginning careers in health outcomes research and who give promise of outstanding development as researchers. The intent of the program is to provide support for a person beginning a Post Doctoral program. Applicants are encouraged to apply at the earliest point of their Post Doctoral research period as possible Amount $80,000 Amount Note The award, consisting of a $40,000 annual stipend, is made to the institution on behalf of the fellow. The second year of this award is contingent upon a progress report approved by the foundation and submission of a financial report. The program provides no other subsidies (travel, tuition, fringe benefit costs, etc.) and indirect costs to the institution are not provided. INKlings Page 30 of 30 Citizenship or Residency United States Requirements Ph.D./M.D./Other Professional These fellowships provide stipend support for individuals engaged in a research training program that will create or extend their credentials in health outcomes. The purpose of this program is to support postdoctoral career development activities of individuals prepared (or preparing) to engage in research that will strengthen representation of health outcomes in schools of pharmacy, nursing, medicine, and public health. Eligibility This program provides stipend funding to well-trained graduates from Pharm.D., M.D., and Ph.D. programs who seek to further develop and refine their research skills through formal postdoctoral training. They must also have a firm commitment from an accredited U.S. university and be a U.S. citizen or permanent resident.