Abstract
Behavioral Mechanisms in Biomedical Strategies to Prevent Hiv Infections (R01): Rfa-Mh-11-090
Also note: Behavioral Mechanisms in Biomedical Strategies to Prevent HIV Infections (R34): RFA-MH-11-092
Details at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-11-092.html
National Institute of Mental Health
Application Receipt Date(s): January 04, 2011
This Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), seeks research grant applications to advance understanding of the complex behavioral and social factors that partially determine the efficacy and effectiveness of new biomedical strategies to curb HIV infections. This FOA will utilize the NIH Research Project Grant (R01) award mechanism and runs in parallel to FOAs of identical scientific scope, RFA-MH-11-091 and RFA-MH-11-092, which encourage applications under the R21 and R34 mechanisms, respectively. The R21 mechanism would be used for projects that propose research in the exploratory or preliminary phases. The R34 mechanism would be used for early phases of treatment development. The NIMH intends to commit approximately $2,000,000 in FY 2011 to fund four to six grants in response to this FOA and the companion announcements. The total project period for an application submitted in response to this FOA may not exceed five years. Budgets for direct costs may not exceed $500,000 per year.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribally designated organizations; county governments; city or township governments; special district governments; Independent School Districts; public housing authorities/Indian housing authorities; U.S. territories or possessions; Indian/Native American tribal governments (other than federally recognized); regional organizations; non-domestic (non-U.S.) entities (foreign organizations); eligible agencies of the Federal Government, and faith-based or community-based organizations. Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. Applicants may submit more than one application, provided each application is scientifically distinct. Resubmission applications are not permitted in response to this FOA. Renewal applications are not permitted in response to this FOA This FOA uses non-standard due dates.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-11-090.html.
Asthma in Older Adults (R21): Pa-10-264
Also note: Asthma in Older Adults (R03): PA-10-265
Details at: http://grants.nih.gov/grants/guide/pa-files/PA-10-265.html
National Institute on Aging
National Heart, Lung, and Blood Institute
National Institute of Allergy and Infectious Diseases
Application Due Date(s): Standard dates apply, see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
This FOA encourages Exploratory/Developmental Grant (R21) applications that propose to study the pathophysiology, epidemiology, diagnosis, and/or management of asthma in older adults. Much of what is known about asthma in adults is based on studies in younger adult populations; however, the mechanisms underlying asthma in some older adults may differ, which may impact on diagnostic, treatment, and prevention strategies. This FOA is intended to stimulate research to address knowledge gaps and research opportunities in asthma in later life. A variety of study approaches are encouraged with this FOA including basic, translational, clinical, and epidemiological studies.
This FOA will use the NIH Exploratory/Developmental (R21) award mechanism and runs in parallel with a FOA of identical scientific scope, PA-10-263, that encourages applications under the R01 research grant mechanism, and PA-10-265, that encourages applications under the R03 small research grant mechanism. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribally designated organizations; county governments; city or township governments; special district governments; Independent School Districts; public housing authorities/Indian housing authorities; U.S. territories or possessions; Indian/Native American tribal governments (other than federally recognized); regional organizations; non-domestic (non-U.S.) entities (foreign organizations); eligible agencies of the Federal Government, and faith-based or community-based organizations. Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. Applicants may submit more than one application, provided that each application is scientifically distinct. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Exploratory/developmental grant support is for new projects only; renewal applications will not be accepted.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-10-264.html.
Pharmacological Development of Treatment Agents and Formulations for Tobacco Dependence (Sttr [R41]): Rfa-Da-11-004
National Institute on Drug Abuse
Application Receipt Date(s): January 13, 2011
The goal of this Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA) is to facilitate the development of new, more effective treatments for tobacco dependence. This FOA will utilize the STTR (R41) grant mechanisms for Phase I applications. The estimated amount of funds available for support of 4-7 projects awarded as a result of this announcement is $1,500,000 for fiscal year 2011. Future year amounts will depend on annual appropriations. For these Phase I projects, budgets up to $300,000 total costs for a time period of up to one year may be requested.
Only United States small business concerns (SBCs) are eligible to submit STTR applications. A small business concern is one that, at the time of award, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term “affiliates” is defined in greater detail in 13 CFR 121.3-2(a). The term “number of employees” is defined in 13 CFR 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a sub-contractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when “key employees of one concern organize a new concern… and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise.” Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA's size regulations, 13 CFR 121.106 - Small Business Size Regulations.
In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.
All STTR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an STTR award until the SBA provides a determination.
An applicant organization that has been determined previously by SBA to be “other than small” for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. On an STTR application, the PD/PI may be employed with the SBC or the single, partnering non-profit research institution as long as he/she has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. More than one PD/PI, (i.e., multiple PDs/PIs), may be designated on the application. Applicant SBCs may submit more than one application, provided each application is scientifically distinct. Resubmissions are not allowable under this FOA. Renewal applications are not permitted under this FOA. This FOA uses non-standard due dates.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-11-004.html.
Niaaa Collaborative Centers for Hiv/Aids and Alcohol Outcomes Research (U01, U24): Rfa-Aa-11-003
Application Receipt Dates(s): January 11, 2011
National Institute on Alcohol Abuse and Alcoholism
This FOA issued by the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, solicits grant applications from consortiums of researchers across different institutions that propose to 1) measure both short-term and long-term outcomes among HIV+ alcohol using, abusing, and dependent populations and 2) develop and strategically test interventions to reduce alcohol use and alcohol-related consequences in a coordinated way to prevent morbidity and mortality in the impacted population. In addition, this research seeks to develop a new framework for sustainable implementation research among HIV+ alcohol users with the goal of high impact on health care systems. This initiative is intended to build on existing cohorts of patients or HIV+ individuals in the process of being identified with new infections, entering, and/ or continuing treatment.
This FOA will utilize the Cooperative Agreement grant mechanism (U01) and the Resource-Related award mechanism (U24). NIAAA intends to commit up to $ 4.5 million in total costs in FY2011 to fund up to two research consortium applications in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Each consortium may request up to $2.25 million in total cost per year. The total project period for an application submitted in response to this funding opportunity may not exceed five years.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribally designated organizations; county governments; city or township governments; special district governments; Independent School Districts; public housing authorities/Indian housing authorities; U.S. territories or possessions; Indian/Native American tribal governments (other than federally recognized), and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. However, such institutions may participate as subcontractors on the application.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Applicants may submit more than one application, provided they are scientifically distinct. Resubmission applications are not permitted in response to this FOA. Renewal applications are not permitted in response to this FOA. This FOA uses non-standard due dates.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AA-11-003.html.
Planning Grants for Translating Chronic Kidney Disease (Ckd) Research into Improved Clinical Outcomes (R34): Rfa-Dk-10-011
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): February 28, 2011
Chronic kidney disease (CKD) is an important medical and public health problem in the U.S. The Centers for Disease Control (CDC) recently estimated that 16.8% of the U.S. population >20 years of age has chronic kidney disease. The health disparities associated with CKD have been well described, including an incidence rate of End-Stage Renal Disease (ESRD) which is more than three times higher among African Americans than White Americans. A number of studies have identified the natural history (e.g., the Chronic Renal insufficiency Cohort Study and the Chronic Kidney Disease in Children Prospective Cohort Study) and the growing burden of CKD (e.g. United States Renal Data System). Progress has been made in the identification of strategies to slow the progression of CKD, including use of specific antihypertensive (“renoprotective”) drugs (angiotensin converting enzyme inhibitors or angiotensin receptor blockers), intensive glycemic control, and control of blood pressure, among others. Despite this evidence, screening, detection and treatment of CKD remains inadequate in the US, particularly in the ethnic and racial groups that bear a disproportionate burden of CKD. There is a need to translate scientific evidence into measures that will reduce the burden of CKD by the adoption of effective approaches to prevention, pre-emption, treatment and management in daily clinical practice.
The R34 submitted in response to this FOA should be designed to maximize generalizability and minimize bias in testing interventions which address barriers to implementation of evidence-based care for chronic kidney disease in populations and communities at highest risk. Studies should be designed within the context of the Chronic Care Model (or a similar comprehensive model): patient self-management support, delivery system design, decision support, and clinical information systems.
Relevant topics may include but are not limited to:
Strategies to improve the identification of CKD and promote early intervention in populations which bear a disproportionate burden of disease
Strategies to slow progression of CKD and reduce risk factors for the development of the multiple complications such as cardiovascular disease, malnutrition, metabolic bone disease, and decreased quality of life
Studies that test innovative approaches to promote the adoption and maintenance of behavior shown to improve outcomes in CKD
Studies that test approaches that might lead to improved clinical status at the time of initiation of dialysis
Studies to improve utilization of kidney transplantation and home dialysis in populations with decreased utilization of these modalities
Studies to test innovative approaches for adoption of patient self-management strategies that slow progression of CKD or reduce complications
Strategies to overcome health care system barriers that reduce the efficiency or effectiveness of patient/provider interactions and lead to improved health outcomes for CKD patients
The primary outcomes of proposed studies must include objective measures of clinical status such as blood pressure, laboratory measures of metabolic control or nutritional status, change in kidney function or initiation of renal replacement therapy. Behavior change (such as changes in diet and/or physical activity patterns or behaviors) or knowledge acquisition may be included as secondary outcomes. Applications will not be considered responsive to this FOA if they fail to include objective clinical measures as primary outcomes.
Studies must be designed to translate interventions that have previously been shown to be efficacious in large randomized controlled clinical trials. It is not the intent of this FOA to support the development of initial efficacy trials or the development or dissemination of chronic kidney disease programs.
Applications must also propose to study the capacity of the tested approach to be widely disseminated, its sustainability once the research is concluded, and evaluate the cost of implementation in relation to the improvement in clinical outcomes. Applications must also include an evaluation of whether the intervention is delivered as intended (process assessment).
Studies addressing minority and other high-risk groups for chronic kidney disease are strongly encouraged but the intervention must be applicable to a broad segment of the at risk population. It is not the intent of this FOA to support research studies which replicate interventions previously shown to be efficacious in a different population (e.g., different age, gender, race/ethnic, co-morbid illnesses, SES). Studies of the development and validation of culturally appropriate patient education materials will be considered non-responsive to this FOA.
The design of the intervention and its analysis plan must be related to the research question(s) and the hypotheses to be tested. The study designs must emphasize the generalizability of the intervention.
Applications must provide a detailed description of the target population to be studied, a clear rationale for selection of the population, characteristics of the target population including age, gender, sex and race/ethnicity. Personnel with experience in recruiting CKD patients and the proposed recruitment strategies must be described. The sample size needed for the proposed study, including the assumptions used when estimating the sample size, should be detailed in relation to the analysis plan. Methods for assuring privacy and maintaining confidentiality must be included in the application. A data and safety-monitoring plan must also be described.
Studies may use study designs and methods methodology of biomedical, social or behavioral sciences, epidemiology, clinical trials, and health services and dissemination research. Interventions designed to result in behavioral change should be based on behavior change theory(ies) and must be described in the application.
Applicants must document the prior experience and expertise of the research team to conduct the proposed research study. Use of a multidisciplinary research team is strongly encouraged. The expertise may include, but not limited to, nephrologists, public health physicians, primary care physicians, epidemiologists, statisticians, clinical trialists, psychologists, health educators, sociologists, nurses, nutritionists and other health related professionals. The interdisciplinary nature of the research team should be fully described and justified.
Brief descriptions, as appropriate, of the process for biologic sample collection, storage and handling; the laboratory tests that are needed; physical facilities, data management and computer resources, and facilities for data retrieval and storage; and a plan for randomization of patients or settings (if applicable) for delivery of interventions into protocols should be provided.
Applicants are encouraged to consider use of patient, physician and other health care provider resources developed by the National Kidney Disease Education Program (NKDEP) (http://nkdep.nih.gov/).
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations (other than institutions of higher education); nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); for-profit organizations; small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the federal government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations; regional organization, and non-domestic (non-U.S.) entities (foreign organizations). Foreign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) - must be renewed at least annually
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-10-011.html.
Type I Diabetes Impact Award (Dp3): Rfa-Dk-10-012
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): March 11, 2011
Type 1 diabetes (T1D) occurs when cells of the immune system attack and destroy insulin-producing beta cells in the pancreas. Autoimmune destruction and loss of insulin results in an increase in blood glucose levels that over time damage a wide variety of organ systems. In order to survive, patients must compensate for the loss of insulin production through daily insulin administration. Even with close attention to maintenance of normal blood glucose levels, many patients will experience significant diabetes-associated complications in major organ systems. These diabetic complications include cardiovascular disease, end-stage kidney disease, blindness, sensory and autonomic nerve damage, and amputations. While our understanding of the role played by genetics in promoting disease risk has advanced significantly over recent years, many key questions remain regarding the root causes of autoimmune destruction in Type 1 diabetes and its downstream pathologic consequences. A more thorough mechanistic understanding of the T1D disease process in at risk individuals, as well as the development of new approaches to ensure maintenance of normoglycemia in affected patients, will ultimately lead to new avenues to explore for disease prevention and therapy.
The goal of this initiative is to support bold and creative research projects that confront major challenges in Type 1 diabetes research. Collaborative investigative teams or individual scientists with novel perspectives, new ideas and innovative approaches are encouraged to apply. Studies should address major unmet needs and/or compelling opportunities and have the potential to dramatically advance the field. Successful projects will be expected to have a significant impact on Type 1 diabetes research and/or therapy.
This initiative seeks to foster innovation and creativity in investigators focused on major unanswered questions in Type 1 diabetes research. Pioneering investigations across the translational spectrum are encouraged and will be considered responsive to this FOA. Multidisciplinary or interdisciplinary teams attacking fundamental issues or large intractable problems are particularly encouraged to apply.
This FOA solicits applications focused on areas of opportunity relevant to Type 1 diabetes identified in the draft diabetes research plan Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the DMICC, available at http://www2.niddk.nih.gov/AboutNIDDK/ReportsAndStrategicPlanning/DiabetesPlan. Specifically, the FOA solicits applications in four areas of T1D research highlighted in the draft Strategic Planning Report: Autoimmunity, Imaging and Biomarker Development, Diabetic Complications, and Engineering the Artificial Pancreas. In addressing major issues or barriers in T1D research, responsive studies should employ interdisciplinary approaches that capitalize on clinical resources, as well as emerging technologies, tools, and model systems. Examples of advanced tools and technologies to be employed might include:
Innovations in high throughput screening, discovery and analysis;
Progress in nanotechnology, bioinformatics and systems biology tools;
Advances in genetic, epigenomic, and gene x environment (GEI) approaches;
Development and use of patient sample repositories;
Therapeutic applications of adult stem cells;
Novel imaging agents and technologies.
Questions to be explored in this initiative include:
Autoimmunity: What properties of immune cells and their pancreatic targets are responsible for the selective destruction of beta cells in T1D patients?
Examples of how this question may be explored include:
Applying comprehensive high-throughput technologies to profile immune cell populations and networks in Type 1 diabetic patients and to correlate disease status with cell phenotypes, activation status, receptor structures, HLA variants, and HLA associated peptides;
Using molecular approaches to better understand the relationship between HLA alleles and T1D risk or protection, including studies to determine how specificity of the autoimmune attack is determined;
Developing epigenomic fingerprints of purified immune cell populations in T1D patients that correlate with immune cell function and disease status;
Defining molecular signatures of human pancreatic cells and their progenitors in the context of active or resolving immune attack, including studies to determine how target cells may resist autoimmune attack but retain the ability to be cleared by the immune system if infected or cancerous;
Identifying and optimizing lead compounds for new therapeutics for Type 1 diabetes and its complications.
Imaging and Biomarker Development: Can we develop imaging assays and/or biomarkers capable of measuring early events in the development and progression of T1D?
Examples of how this question may be examined include:
Developing and validating novel approaches for noninvasive imaging of islet mass and function in humans;
Advancing techniques for imaging of pathologic processes in T1D patients, including noninvasive assays to measure immune cell function and islet inflammation and methods to link findings to disease status and intervention outcomes;
Applying novel molecular profiling methodologies, including mass spectrometry coupled to laser capture microdissection or MALDI imaging, to the analysis of pathological slides or tissue biopsies recovered from patients with T1D and its complications.
Diabetic Complications: What are the precise molecular pathways and sequence of events that lead to organ damage and dysfunction in T1D (including diabetes-induced damage to renal, nervous, cardiovascular, visual, urinary, gastrointestinal, as well as other systems)?
Examples of how this area may be explored include:
Examining the effect of T1D on the capacity of adult stem cells to repair or reverse diabetic complications;
Applying epigenomics to define the long-term and long-range modifications that explain the presence and/or extent of organ damage, including studies to define molecular mechanisms responsible for “metabolic memory”;
Using high throughput technologies and network approaches to correlate disease status with molecular profiles of individual cell types in multiple affected end organs;
Defining mechanisms of diabetes-induced damage to the neurovasculature that lead to diabetic neuropathy, neuro-retinal abnormalities and cerebral dysfunction.
Engineering the Artificial Pancreas: Can a closed loop artificial pancreas system be designed that will maintain euglycemia and avoid hypoglycemia?
Examples of how this question may be addressed include:
Combining principles of engineering, nanotechnology, universal design, computer science and informatics to develop novel closed loop systems or components;
Optimizing formulations of insulin and/or glucagon as well as improving accuracy, reliability and accessibility of delivery systems;
Developing new glucose detection principles, more accurate and robust continuous glucose sensing devices, and/or real-time detection platforms capable of measuring multiple factors with high sensitivity and precision;
Developing reliable and integrated algorithms that translate glucose measurements into changes in the delivery of insulin, and/or observation and control modules to create individually tailored algorithms.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations; regional organizations, and non-domestic (non-U.S.) entities (foreign organizations). Foreign (non-U.S.) components of U.S. organizations are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) - must be renewed at least annually
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-10-012.html.
Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21): Par-10-282
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Application Receipt/Submission Date(s): November 18, 2010, March 1, 2011, July 1, 2011; November 1, 2011, March 1, 2012, July 2, 2012; November 1, 2012, March 1, 2013, July 1, 2013
This FOA, issued by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health, encourages exploratory/developmental clinical research related to the prevention or treatment of arthritis and musculoskeletal and skin diseases, conditions, and/or injuries. The Pilot and Feasibility Clinical Research Grants Program is designed to allow initiation of exploratory, short-term clinical studies, so that new ideas may be investigated without stringent requirements for preliminary data. The short-term studies should focus on research questions that are likely to gather critical preliminary data in support of a future, planned clinical trial. They can include testing new or prevention strategies, a new intervention, or unique combinations of therapies. A high priority is the use of such studies to help stimulate the translation of promising research developments from the laboratory into clinical practice.
This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism, number, quality, duration, and cost of the applications received. The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribally designated organizations; county governments; city or township governments; special district governments; Independent School Districts; public housing authorities/Indian housing authorities; U.S. territories or possessions; Indian/Native American tribal governments (other than federally recognized); regional organizations; non-domestic (non-U.S.) entities (foreign organizations); eligible agencies of the Federal Government, and faith-based or community-based organizations.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. Applicants may submit more than one application, provided that each application is scientifically distinct. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. This FOA uses non-standard due dates.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-10-282.html.
Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01): Par-10-283
National Cancer Institute
Application Receipt/Submission Date(s): March 8, 2011, July 6, 2011, November 10, 2011, March 6, 2012, July 6, 2012, November 8, 2012, March 8, 2013, July 10, 2013, November 8, 2013
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites grant applications to provide targeted infrastructure support for the core functions of Cancer Epidemiology Cohorts (CECs) and methodological research. This infrastructure can support existing or new CECs. This FOA will support core functions for CECs currently funded through other grant mechanisms by the Epidemiology and Genetics Program (EGRP) and other components of the Division of Cancer Control and Population Sciences (DCCPS) at the National Cancer Institute (NCI).
This FOA will utilize the U01 cooperative agreement award mechanism. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. A project duration of up to 5 years may be requested.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; U.S. territories and possessions; regional organizations; non-domestic (non-U.S.) entities (foreign organizations); eligible agencies of the Federal Government, and faith-based or community-based organizations.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application. Applicants may submit more than one application, provided that each application is scientifically distinct (i.e., pertains to a different cohort). Applicants may submit a resubmission application, but such an application must address the previous peer review critique (Summary Statement) in the Introduction section of the application. See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Renewal applications are not permitted in response to this FOA.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-10-283.html.
National Institute on Aging: Revision Requests for Active Program Projects (P01): Par-10-284
National Institute on Aging
Application Receipt/Submission Date(s): Multiple dates, see announcement
The National Institute on Aging (NIA) invites current NIA program project directors to submit revision applications to expand the scope of the current award. The proposed topic must both be related to the current focus of the funded research and be relevant to the mission of the National Institute on Aging. The revision may propose to expand existing subprojects and cores or create new subprojects and cores. However, NIA will not accept revision applications that propose to create or expand cores only, with no changes to subprojects. Revision applications should be submitted as appropriate to the science being proposed. So, for example, if two different ideas are being considered then they should be submitted as two different revisions. On the other hand if a single concept spans several subprojects or cores then that concept should be submitted as a single revision.
A revision application may be submitted only after the Parent P01 project has been funded.
Eligibility is limited to applications from currently active, NIA-funded Program projects (P01) with at least one year of non-competing renewal support remaining at the time of submission.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) must be renewed at least annually
eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
Multiple principal investigators/ program directors are not allowed on NIA program projects (P01s).
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-10-284.html.
Nhlbi Program Project Applications (P01): Par-10-285
National Heart, Lung, and Blood Institute
Application Receipt/Submission Date(s): Multiple dates, see announcemen.
This Funding Opportunity Announcement (FOA), issued by the National Heart, Lung, and Blood Institute (NHLBI) continues the long standing program project program detailed at http://www.nhlbi.nih.gov/funding/resmech.htm and invites submission of investigator-initiated Program Project (P01) applications. The proposed programs may address scientific areas relevant to the NHLBI mission including the biology and diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Each P01 application submitted in response to this FOA must include at least three related research projects that share a common central theme, focus, and/or overall objective.
This FOA will utilize the NIH Program Project (P01) grant mechanism. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received. Applicants may request support for up to 5 years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Direct costs (not including indirect cost for collaborating institutions) for new awards for Program Project Grants (P01s) may be requested for up to $1,515,000. Please see “Allowable Requested Direct Costs for Program Projects”.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribally designated organizations; county governments; city or township government; special district governments; Independent School Districts; public housing authorities/Indian housing authorities; U.S. territories or possessions; Indian/Native American tribal governments (other than federally recognized); regional organizations; eligible agencies of the Federal Government, and faith-based or community-based organizations. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible, however foreign collaborations are encouraged.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may not be designated on the overall application, nor on individual research projects or cores. Applicants may submit more than one application, provided that each application is scientifically distinct.
Applicants may submit a resubmission application, but such applications must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Applicants may submit a renewal application.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-10-285.html.
Cancer Diagnostic and Therapeutic Agents Enabled by Nanotechnology (Sbir [U43/U44]): Par-10-286
National Cancer Institute
Application Receipt/Submission Date(s): December 7, 2010; March 10, 2011; July 7, 2011; November 10, 2011; March 8, 2012; July 9, 2012; November 8, 2012; March 8, 2013; July 8, 2013
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), invites Small Business Innovation Research (SBIR) cooperative agreement applications from small business concerns (SBCs) that propose to develop new, or to improve existing application(s) of nanotechnology-based therapeutics or/and in vivo diagnostics. This FOA will specifically support pre-clinical optimization and testing of these cancer-relevant nanotechnology applications against the intended cancer type. The proposed projects must be milestone-driven and must be clearly directed toward development of an ultimate commercial product. The outcomes are expected to advance the discovery and pre-clinical optimization phase so that an Investigational New Drug (IND) or Investigational Device Exemptions (IDE) application could be submitted to the Food and Drug Administration (FDA) by the end or shortly after completion of the Phase II project period. To facilitate these steps, the NCI will assist the awardees in various ways, including the support through the NCI-sponsored Nanotechnology Characterization Laboratory. This FOA will NOT support basic research projects, studies on disease mechanisms, and clinical trials.
This FOA will utilize the SBIR (U43/U44) cooperative agreement mechanisms for Phase I and Phase II applications. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. Phase I awards normally may not exceed $150,000 total for a period normally not to exceed 6 months. Phase II awards normally may not exceed $1,000,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that is reasonable and appropriate for completion of the research project.
Only United States (U.S.) small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award of SBIR Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the U. S., which operates primarily within the U. S. or which makes a significant contribution to the U. S. economy through payment of taxes or use of American products, materials, or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the U. S., or it must be a for- profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the U. S., except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the U. S.; and;
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term “affiliates” is defined in greater detail in 13 C.F.R. 121.3-2(a). The term “number of employees” is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when “key employees of one concern organize a new concern… and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise.” Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the SBIR Program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA's size regulations, 13 CFR 121.106-Small Business Size Regulations.
In determining size, the SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.
All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.
An applicant organization that has been determined previously by SBA to be “other than small” for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. On an SBIR application, the PD/PI must have his/her primary employment (more than 50%) with the SBC at the time of award and for the duration of the project.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application. Applicant SBCs may submit more than one application, provided each application is scientifically distinct. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
SBIR Phase II Competing Renewal applications are not permitted under this FOA. This FOA uses non-standard due dates.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-10-286.html.
Tumor Microenvironment Network (Tmen) (U54): Rfa-Ca-10-021
National Cancer Institute
National Institute of Neurological Disorders and Stroke
Application Receipt Date(s): January 20, 2011
This Funding Opportunity Announcement (FOA) is designed to promote research on tumor microenvironment with the focus on understanding the role of host stroma in tumorigenesis and responses to treatment. Through this FOA, the National Cancer Institute (NCI) and National Institute of Neurological Disorders and Stroke (NINDS) invite cooperative agreement applications from groups of investigators interested in forming Research Centers serving as components of an interactive NCI Tumor Microenvironment Network (TMEN). The main scientific objectives of TMEN are: 1) to generate a comprehensive understanding of composition of the stroma in normal tissues as well as its roles in tumor initiation, progression, and metastasis; 2) to delineate mechanisms of tumor-stroma interactions in human cancer; and 3) to identify the mechanism(s) by which tumor stroma may affect responses to treatment. In addition to these general NCI priorities, NINDS is particularly interested in research programs relevant to primary brain tumors or peripheral nervous system tumors. TMEN members will be expected to participate in collaborative efforts (to be developed within TMEN) that are directed at: 1) developing resources and reagents critical to the analysis of the tumor microenvironment; 2) developing novel technologies for use in tumor microenvironment research; and 3) outreach activities to facilitate dissemination of such resources and technologies to the broader research community. TMEN infrastructure is expected to establish repositories of critical reagents, resources, and information as well as promote and facilitate interdisciplinary collaborations both within and outside the Network.
This FOA will utilize the U54 cooperative agreement mechanism. The NCI expects to commit approximately $9.05 million per year to fund up to 9 Research Centers with programs relevant to NCI priorities. The NINDS expects to commit up to $1.4 million per year to support fully or co-fund 2-3 Research Centers with tumor microenvironment programs relevant to NINDS-specific priorities. An applicant may request a project period of up to 5 years and a budget up to $700,000 per year (direct costs).
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); for-profit organizations (other than small businesses); state governments; U.S. territories or possessions, and units of local governments. Foreign institutions are NOT eligible to apply. Investigators from Foreign institutions may participate as a component of an application submitted by a PI from an institution within the United States of America.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. An applicant institution may submit more than one application, provided they are scientifically distinct and proposed by different PDs/PIs. Resubmission applications are not permitted in response to this FOA. Renewal applications are not permitted in response to this FOA. All applications will be reviewed as new applications This FOA uses non-standard due dates.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-10-021.html.
Research on Malignancies in the Context of Hiv/Aids (R01): Pa-10-290
Also note: Research on Malignancies in the Context of HIV/AIDS (R21): PA-10-291
Details at: http://grants.nih.gov/grants/guide/pa-files/PA-10-291.html
National Cancer Institute
National Institute on Dental and Craniofacial Research
Application Receipt/Submission Date(s): Multiple dates, see announcement
The purpose of this funding opportunity announcement (FOA) is to continue advancing our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying Human Immunodeficiency (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS). The NCI and NIDCR seek to encourage research in areas such as the study of the etiologic factors, cofactors, immunopathogenesis, diagnosis, and consequences of both AIDS-defining and non-AIDS defining malignancies in diverse populations in the context of an underlying HIV infection. This FOA solicits research efforts that will: (i) provide information on the clinical outcomes of such cancers in the HIV-infected population; and (ii) identify specific contributions resulting from HIV infection and its potential interaction with other pathogens for the development and pathogenesis of these cancers. Ultimately, such efforts could inform screening approaches and therapies targeted to the HIV-infected population.
Specific areas of study in the indicated categories may include, but are not limited to, the following examples:
Biomarkers, Diagnostics, and Therapeutics
Discovery of reliable molecular or immunological diagnostic and prognostic biomarkers, or pathogen markers, useful for early detection, progression, or response to treatment of AIDS-defining and non-AIDS-defining malignancies;
Discovery and development of novel targets and efficacious new therapeutic agents, interventional strategies, or improved delivery systems for the treatment of persons afflicted with AIDS-defining and non-AIDS-defining malignancies;
Development, and evaluation of novel, selective chemical entities generated by combinatorial chemistry or combinatorial genomics methodologies for therapeutic agents
Studies to understand the pharmacokinetics of targeted therapies for AIDS-defining and non-AIDS defining malignancies in the context of highly active antiretroviral therapy;
Etiology, Pathogenesis and Immunology
Studies to determine pathogenic or immunological mechanisms involved in HCV, HBV, KSHV/HHV8, EBV, HPV, Merkel cell polyomavirus, or other oncogenic infectious agent mediated tumor initiation and promotion of malignancies, concurrent with underlying HIV infections;
Development of animal and/or cell-based models for AIDS-defining and non-AIDS-defining malignancies;
Studies to determine the cellular proteome and transcriptome of virally induced tumors in the context of HIV infection;
Studies to determine the effects of prolonged moderate immunosuppression and/or incomplete or failed responses to combination antiretroviral therapy (cART) on the development of either AIDS-defining or non-AIDS-defining malignancies;
Studies aimed at identifying the roles of HIV infection in the immunology and pathogenesis of non-AIDS-defining cancers;
Studies to determine the effects of the concomitant prolonged exposure of HIV-infected patients to antiretroviral therapy and viruses with oncogenic potential on the development of either AIDS-defining or non-AIDS-defining malignancies;
Molecular Epidemiology and Prevention
Studies to characterize the host genetic susceptibility to AIDS-defining and non-AIDS-defining malignancies;
Assessment of risk factors that impact cancer in the context of HIV infection, in different geographic locations in domestic and international settings;
Studies to characterize the immunologic, virologic, genetic, and epigenetic differences between those patients on cART who develop pre-neoplastic and neoplastic conditions and those patients who resolve these conditions or do not develop them;
Studies to identify host and/or life-style factors (e.g., alcohol, drug use, tobacco, energy balance, environment, and nutrition) that may play roles in affecting immunocompetence, enhancing immunosuppression and exacerbating the pathogenesis of either AIDS-defining or non-AIDS-defining malignancies;
Studies to elucidate the interplay of routes of acquisition of oncogenic viruses and other host cofactors and concomitant pathogens on the molecular epidemiology and natural history of AIDS-defining or non-AIDS-defining malignancies;
Studies to better determine the role of infectious pathogens in the development and clinical course of AIDS-defining or non-AIDS-defining malignancies;
Studies that focus on the development of better prevention strategies that may reduce the burden of infectious-related malignancies in diverse HIV/AIDS populations;
Studies to investigate the effects of smoking on mitochondrial DNA (mtDNA) and mitochondrial toxicity in-utero and its role in AIDS-defining and non-AIDS defining cancers;
Studies to identify alterations in mitochondrial function and mitochondrial mutations in smokers vs. non-smokers that may play a role in tobacco- related cancer risks in various ethnic populations; and
Studies to better determine alterations in miRNA profiles in HPV, EBV or KSHV/HHV-8 and HIV co-infected populations which may contribute to viral pathogenesis;
In addition to a focus on the oral cavity in the areas listed above, NIDCR encourages research in the following areas listed below:
Studies to characterize the host genetic susceptibility to HIV-associated oral malignancies and other tumors in infected persons;
Studies to determine the cellular proteome, metabolome, and transcriptome of virally induced tumors of the oral cavity in the context of HIV infection;
Studies to determine the mode of entry, latency, reactivation, translocation, and transformation of mucosal cells of the oral cavity by oncogenic viruses during HIV infection;
Studies to determine the immunological, molecular, virological, and pathological mechanisms that are involved in EBV, HPV, KSHV/HHV8, or other oncogenic infectious agent that drive oral malignancies and tumors in the context of HIV infection;
Studies to determine the effects of prolonged moderate immunosuppression and/or incomplete or failed responses to cART on the development of oral malignancies and tumors;
Studies to determine the molecular epidemiology of the viral strains that are implicated in the promotion of HIV-associated malignant transformations of the oral cavity;
Studies that use novel or well-characterized animal-based models for HIV-associated oral malignancies in the research categories described in this FOA;
Studies to determine the similarities and differences between HIV-associated tumors of the oral mucosa and other anatomical (e.g. vaginal, gastrointestinal, rectal) mucosal surfaces;
Studies that are geared towards identifying reliable diagnostic and prognostic host biomarkers and oral oncogenic pathogen markers useful for detection of HIV-associated oral malignancies and their progression. Commercial application of host biomarkers in diagnostic assays for HIV-associated oral malignancies and their progression.
Studies that use novel immunotherapies or combination of novel and standard therapies for modulation of the immune response and controlling oncogenesis of oral pathogens and oral AIDS malignancies through the use of cytokines, chemokines, adjuvants, antibodies, other molecules of the immune system, and other treatment modalities (e.g., chemotherapeutic agents);
Studies that develop oral topical formulations with potentially combined effects (microbicidal, viricidal, analgesic and anti-inflammatory) to enhance oral mucosal defenses and control or treat oral AIDS malignancies;
Studies that use metagenomic approaches to characterize the oral virome associated with oral AIDS malignancies and compare it with that of healthy (non-HIV/AIDS cohorts);
Studies that address oral pathogen translocation with potential interaction with HIV and other infectious agents in the oral cavity of HIV-infected/AIDS subjects to induce exacerbation of inflammation and oral AIDS malignancies.
This FOA is not designed to support clinical trials of treatment for HIV-associated malignancies. Nonetheless, some aspects of clinical research may be incorporated in projects proposed in response to this FOA. Depending on a specific project proposed, such aspects may include: analysis of samples and data collected from clinical trials, analysis of identified costs for patient visits, or specimen shipping and handling.
In addition, descriptive research and recruitment or retention of cohorts are not appropriate for this FOA. However, proposed analysis of samples and data acquired from existing cohorts and tissue banks is encouraged. Examples of such cohorts and repositories include the Women's Interagency HIV Study (WIHS) (https://statepiaps.jhsph.edu/wihs/), the Multicenter AIDS Cohort Study (MACS) (http://statepi.jhsph.edu/macs/macs.html), and the AIDS and Cancer Specimen Resource (http://acsr.ucsf.edu). Investigators are encouraged to utilize infrastructure support of the Centers for AIDS Research (http://www.niaid.nih.gov/research/cfar/) or the NCI-designated Cancer Centers if located at those institutions.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations; regional organizations, and non-domestic (non-U.S.) entities (foreign organizations). Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) must be renewed at least annually
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide. All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-10-290.html.