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					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.
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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
mcleodbs@musc.edu
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)
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              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 ahrqpubs@ahrq.hhs.gov.
           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.
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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.
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           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
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 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
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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
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       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
johnsjn@musc.edu   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:
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  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
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  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
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            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
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 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.
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     •     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?
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  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
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  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
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 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.
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  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.
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  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.
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  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
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            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
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 (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
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 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
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  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
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  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
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  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
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     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)
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                             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
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  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.

				
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