American Recovery and Reinvestment Act of 2009 (Recovery Act)

Overview of the Recovery Act

The American Recovery and Reinvestment Act of 2009 (Recovery Act) was signed into law by President Obama on February 17th, 2009. It is an unprecedented effort to jumpstart our economy, create or save millions of jobs, and put a down payment on addressing long-neglected challenges so our country can thrive in the 21st century. The Act is an extraordinary response to a crisis unlike any since the Great Depression, and includes measures to modernize our nation's infrastructure, enhance energy independence, expand educational opportunities, preserve and improve affordable health care, provide tax relief, and protect those in greatest need.

Message from the NIDA Director

As you know, NIDA has several programs in process within the overall American Recovery and Reinvestment Act (ARRA).

The response to each of these programs has been tremendous, and we are excited by the range of science that is being considered. Unfortunately, with the tremendous response, NIDA will not be able to support some of the meritorious applications we received for each of the announcements. For example, May 15 was our deadline for Administrative Supplement requests.The response to this announcement was unexpectedly robust, and we are just in the process of reviewing these applications in order to make decisions about which ones to fund. As this process unfolds, I wanted to alert you that NIDA is putting limited support into this particular component of the ARRA. I realize that, as a result, there will be many worthy requests that cannot be funded. This will also be the case with the Challenge and GO programs.

I know that many of you will be disappointed, and I encourage you to work with your program officials at NIDA to find alternative mechanisms for your scientific concepts. In particular, note that our regular grant program continues without interruption and may provide multiple opportunities for development of innovative, important scientific studies.

Thank you for your interest in NIDA programs.

Sincerely, Nora D. Volkow, M.D., Director

Announcements

NIDA's FOA Summary for Pathfinder Award to Promote Diversity in the Scientific Workforce

Recovery Act Limited Competition: The NIH Director's ARRA Funded Pathfinder Award to Promote Diversity in the Scientific Workforce (DP4) (RFA-OD-10-013) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications for the NIH Director's ARRA Pathfinder Award to Promote Diversity in the Scientific Workforce. The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects all of its efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. This new FOA introduces a new research grant program to encourage exceptionally creative individual scientists to develop highly innovative and possibly transforming approaches for promoting diversity within the biomedical research workforce. To be considered highly innovative, the proposed research must reflect ideas substantially different from those already being pursued or it must apply existing research designs in new and innovative ways to unambiguously identify factors that will improve the retention of students, postdocs and faculty from diverse backgrounds. Awardees must commit a major portion (generally 30% or more) of their research effort to activities supported by the Director's Pathfinder Award and the proposed research must be endorsed by the highest levels of institutional management.

This initiative is one of several being offered to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research.

Additional Information:

The NIH Director's ARRA Pathfinder Award to Promote Diversity in the Scientific Workforce is designed to foster new ways of thinking about research related to scientific workforce diversity. It is expected to fill fundamental knowledge gaps and to encourage the development of new approaches to this complex problem that has eluded solution for decades

Biomedical research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences that have the potential to improve public health. The scientific workforce includes all individuals who work in biomedical research including undergraduate and graduate students, postdoctorates, and faculty. Interventions designed to improve diversity can include these populations as well as populations that feed into these levels. For the Director's Pathfinder program, diversity can address the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences on a national basis including: individuals from underrepresented racial and ethnic groups; individuals with disabilities; individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research; and women at the faculty level. The research conducted with support by Director's Pathfinder Award can address diversity on a national or institutional basis.

The Director's Pathfinder initiative is designed to support investigators who intend to pursue new research directions related to workforce diversity. Applications for projects that are extensions of ongoing research should not be submitted. Director's Pathfinder awardees are required to commit a major portion (generally 30% or more) of their research effort to activities supported by the Director's Pathfinder Award. Those with effort levels less than 30% must provide evidence that the effort committed will be sufficient to carry out the proposed research.

Funding Information:

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. NIH has designated approximately $10 M to provide up to 5 awards, contingent upon the submission of a sufficient number of meritorious applications.

Budget proposals are limited to $2,000,000 in total costs over a three year project period. Facilities and Administrative (F&A) costs are included within this total award amount.

This program is supported by funds provided to the NIH under the Recovery Act. The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Eligible Institutions: Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. Foreign organizations/institutions are not permitted as the applicant organization.

Other Information:

Only one PD/PI (i.e., no multiple PDs/PIs) may be designated on the application.
Because this is a one-time-only solicitation, resubmission applications are not permitted in response to this FOA. Future Director's Pathfinder announcements depend on the success of this program.
Renewal applications are not permitted in response to this FOA.
The DP4 application Research Strategy section may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.
Appendices are not allowed and will not be accepted. Applications that contain attachments other than those specified may be rejected during the agency validation process.

Key Dates:

Release/Posted Date: March 5, 2010
Opening Date: April 4, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 5, 2010
Application Due Date(s): May 4, 2010
Peer Review Date(s): July 2010
Earliest Anticipated Start Date(s): August 31, 2010
Expiration Date: May 5, 2010

Letter of Reference:

Letters of reference are an important component of the Director's Pathfinder application. Applicants must arrange to have three (and no more than three) letters of reference submitted on their behalf.

Contact Information:

Program Contact(s):

Pre and Post-award
Clifton Poodry, Ph.D.
Division of Minority Opportunities in Research
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.37 MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3900
FAX: (301) 480-2753
Email: poodryc@nigms.nih.gov
Email: arrapathfinder@mail.nih.gov (e-mail is the strongly preferred method for
inquiries)

Peer Review Contact(s):

John Firrell Ph.D.
Scientific Review Officer
Surgical Sciences, Biomedical Imaging and Bioengineering IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Dr, Room 5118
Bethesda, MD 20892
Phone: (301) 435-2598
Fax (301) 480-2241
firrellj@csr.nih.gov
Email: arrapathfinder@mail.nih.gov (e-mail is the strongly preferred method for inquiries)

Grants Management Contact(s):

Mr. E.C. Melvin
Grants Management Officer
Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, Rm 2As.32E, MSC 6200
Bethesda, MD 20892-6200
Telephone: 301-594-3912
FAX: 301-480-2554
Email: melvine@nigms.nih.gov

NIDA's FOA Summary for Program to Enhance NIH-supported Global Health Research Involving Human Subjects

Recovery Act Limited Competition: Program to Enhance NIH-supported Global Health Research Involving Human Subjects (S07) (RFA-OD-10-006) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications from U.S. institutions for one year of support for resources and activities that will strengthen oversight of NIH supported human subjects research conducted collaboratively with institutions in low- to middle-income countries (LMIC).

Additional Information:

The ARRA International Human Subjects Research Enhancement Program will provide short-term support for U.S. and developing country institutions already collaborating on NIH supported human subjects' research to jointly strengthen the ethical review and monitoring of such projects through enhanced collaboration and communication. This support is meant to improve the quality as well as enhance the efficiency of the ethical review and monitoring and accelerate global health research. It is expected that the enhancements supported will be sustained by the U.S. and foreign institutions after the award ends.

Objectives: Applications will be supported to develop collaborative processes and training as well as jointly used tools and systems to address the specific needs and capabilities for improved review and monitoring of protocols for NIH supported research conducted at a developing country institution. The grants will provide one year of support for an applicant U.S. Institutional Review Board (IRB) to collaborate with a developing country counterpart IRB which reviews some of the same NIH research protocols to do any of the following:

Develop sustainable electronic systems, procedures and communication methods to facilitate collaboration on review and monitoring of protocols sent to both IRBs;
Increase administrative, scientific, socio-cultural and ethical competencies of IRB members and staff related to research reviewed by both IRBs through joint workshops, short-term exchange and training activities;
Create sustainable international research ethics training resources for global health researchers at both institutions to improve research protocols and practices involving human subjects in the collaborating developing country.

Participation: Participants may include ethical review committee members, IRB administrators, NIH supported researchers and research trainees, research program administrators as well as others with expertise relevant to ethical review and monitoring of protocols from the proposed U.S. and developing country institutions.

Collaboration: Applicants are expected to demonstrate full partnership with the proposed developing country institution ethical review committee in the needs analysis to serve as the basis for the application and in proposed leadership, resource sharing and program activities. Applicants are strongly encouraged to designate multiple PIs on their application naming their primary developing country collaborator as a PI. Applications should include plans for sustaining proposed collaborative systems, processes, training components and resources after the end of the grant period at the U.S. and developing country institutions.

This funding opportunity announcement (FOA) solicits applications from applicant organizations that propose innovative IRB resource development and targeted IRB-related professional development programs related to the mission of FIC, NIAID, NIDA, NIMH and other NIH Institutes and Centers to strengthen capacity for the ethical review of NIH sponsored international human subjects research.

Funding and Budget Information:

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. FIC has designated $650,000 in FY 2010 to fund 12-13 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications. FIC will fund only one application from any single U.S. institution. FIC will fund only one application involving a particular developing country institution.

Budget proposals are limited to $50,000 direct costs per year for one year.

F&A costs will not be provided.

This FOA will use the NIH Biomedical Research Support Grants (S07) mechanism which is a flexible and specialized mechanism designed to strengthen NIH supported research programs at grantee institutions by improving human and physical research resources such as those needed for ethical review of human subject research capacity.

Allowable Costs:

Personnel: Individuals (PD/PIs), faculty and staff designing, directing, and implementing the proposed research resource program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the U.S. or collaborating institution's policy for similar positions and may not exceed the congressionally mandated cap.
Resource Program-Related Expenses: Consultant costs, short-term fellowships, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research resource program and must not duplicate items generally available from other sources at the applicant or collaborating institution. Expenses for foreign travel must be exceptionally well justified. Applicants should include travel expenses to participate in a network meeting of all grantees supported as a result of this funding opportunity at NIH (or another venue identified by the program staff) at the end of grant period.
Participant Costs: Participant costs must be justified as specifically required for the proposed research resource program. Allowable participant costs depend on the educational level/career status of the individuals involved in the program. Amounts for all participants must conform to the established, consistently applied salary and wage policies of the U.S. or collaborating institution and reflect the percentage of time/effort devoted to the program.

The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Eligible Institutions: Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization.

Other Information:

The PD/PI should be capable of providing both administrative and research ethics leadership to the development and implementation of the proposed program. The PD/PI should have documented experience in international research ethics and an ethics review committee at the applicant organization. Due to the collaborative nature of the proposed program, applicants are strongly encouraged to designate a developing country collaborator as a PI (i.e multiple PDs/PIs).
More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a "team science" approach and therefore clearly do not fit the single-PD/PI model.
This is a one-time-only solicitation, resubmissions are not permitted.
Renewal applications are not permitted in response to this FOA.
Institutional Commitment: Applications are expected to include letters from the appropriate head research administrator at the U.S. and developing country institution substantiating the institutions commitment to the proposed research resource development and to sustaining the results of the proposed activities. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program.
Developing country collaboration: Applicants are expected to apply with a developing country collaborating institution as defined by the World Bank (according to Gross National Income (GNI) per capita as "low-income," "lower-middle-income," and "upper-middle-income".

Key Dates:

Opening Date: January 22, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 22, 2010
Application Due Date(s): March 22, 2010
Peer Review Date(s): June/July 2010
Earliest Anticipated Start Date(s): August 31, 2010

Application and Submission Information:

Letter of Intent:

Although the Letter of Intent (LOI) is not required, not binding and does not enter into the review of the subsequent application, an applicant may choose to submit one.

The information that the LOI contains allows IC staff to estimate and plan for the potential review workload.

Prospective applicants are asked to submit a LOI that includes the following information:

Descriptive title of proposed research resources program.
Name, address, and telephone number of the PD(s)/PI(s).
Names of other key personnel.
Participating institutions.
Number and title of this funding opportunity.

The letter of intent is due February 22, 2010.

The letter of intent should be sent to:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email: sinab@mail.nih.gov

Contact Information:

Program Contact(s):

NIDA's FOA Summary for Methodology Development in Comparative Effectiveness Research

Recovery Act Limited Competition: Methodology Development in Comparative Effectiveness Research (RC4) (RFA-OD-10-009) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications to enhance, develop, or evaluate methodologies to improve the efficiency, validity, and credibility of comparative effectiveness research (CER) studies. CER encompasses a wide array of methodologies, including technology assessment, meta-analysis, systematic reviews, observational studies, and experimental trials. Each of these methodologies suffers from substantial weaknesses that limit their ability to rapidly provide information sought by patients, clinicians, and other stakeholders to make robust evidence-based decisions on clinical practice and public policy. Research is needed to develop better methods for measuring or reducing these weaknesses, which include, for example, confounding bias in observational studies and selection bias in randomized trials. Research in methodology development focuses on approaches to design, implement, analyze, and report CER, as opposed to CER projects that focus on comparing specific interventions for preventing or treating a given medical condition. It is hoped that this line of research will lead to significantly greater efficiency, validity, and credibility of CER among researchers, health care providers, and policy makers, and therefore will enhance the quality of the nation's health.

Participating NIH Institutes:

National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Library of Medicine (NLM) (http://www.nlm.nih.gov)
National Institute on Aging (NIA) (https://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)

Additional Information:

This FOA invites applications to enhance, develop, or evaluate methodologies to improve the efficiency, validity, and credibility of comparative effectiveness research (CER) studies. Research to improve CER methods is seen to be necessary given the well-known limitations of commonly applied methods, ranging from technology assessments to prospective observational studies and large-scale randomized trials. Recent advances in the capacity and uptake of information technology and statistical sciences present a unique opportunity to address a number of long-standing barriers to expansion of CER and CER findings, including assessing and limiting confounding biases in observational studies and improving efficiency and generalizability of randomized trials. These advances, however, have not been adequately studied in the area of comparative effectiveness, leaving a substantial opportunity for improvement that could be met in part by successful applications to this FOA.

For the purposes of this FOA, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council given at http://wayback.archive-it.org/3909/20130926125230/http://www.hhs.gov/recovery/index.html: "Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in "real world" settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results."

The term "comparative" refers to comparisons of interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The term "effectiveness" refers to applicability "to real-world needs and decisions faced by patients, clinicians, and other decision makers" within "real-world settings," i.e. not the ideal settings created in efficacy investigations. CER investigations compare two or more interventions and strategies that are currently available to practicing clinicians (i.e., not innovative or experimental drugs, devices, or approaches that might more typically be part of an FDA-regulated efficacy study). These interventions and strategies can include "medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies." As examples, CER investigations could:

Compare two or more different existing, available drugs for prevention of major morbidity or mortality in a given medical condition
Compare for a given medical condition the clinical outcomes of medical and surgical strategies, where all medications or surgical techniques are already available in practice
Compare for a given medical condition the clinical outcomes of existing medical and lifestyle strategies within the framework of different health care delivery approaches

Priority-Setting Process and Inputs for use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS CER funds: public input, an internal Departmental workgroup, the FCC report, and the IOM report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

Included within statutory limits of ARRA and the Council's definition of CER;
Potential to inform decision-making by patients, clinicians or other stakeholders;
Responsiveness to expressed needs of patients, clinicians or other stakeholders;
Feasibility of research topic (including time necessary for research).

The CER-CIT will require the use of the FCC's prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,
Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
Addresses a need or is unlikely to be addressed through other organizations,
Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

One of the 100 IOM topic recommendations or the 10 general recommendations and/or
An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed;
Fall into one of the AHRQ identified evidence gaps or be identified in the FCC report to the Congress.

The current list of priority conditions includes:

Arthritis and nontraumatic joint disorders (Muscle, bone, and joint conditions)
Cancer (Cancer)
Cardiovascular disease, including stroke and hypertension (Heart and blood vessel conditions)
Dementia, including Alzheimer's Disease (Brain and nerve conditions)
Depression and other mental health disorders (Mental health)
Developmental delays, attention-deficit hyperactivity disorder, and autism (Developmental delays, ADHD, autism)
Diabetes mellitus (Diabetes)
Functional limitations and disability (Functional limitations and physical disabilities)
Infectious diseases including HIV/AIDS (Infectious diseases and HIV/AIDS)
Obesity (Obesity)
Peptic ulcer disease and dyspepsia (Digestive system conditions)
Pregnancy including preterm birth (Pregnancy and childbirth)
Pulmonary disease/asthma (Breathing conditions)
Substance abuse (Alcohol and drug abuse)

Scope: This FOA solicits applications for 3-year projects proposing innovative approaches to enhance, develop, or evaluate methodologies to improve the efficiency, validity, and credibility of CER studies. (Note: this FOA does not target establishment of new CER findings, but rather research of CER methods.)

There are a wide range of valid CER study types and methods that are legitimate targets for research. Broad areas of methodology research include (but are not limited to) control for confounding and bias in observational studies, systematic combination of data from randomized and observational studies to streamline comparative assessments, linkage and use large amounts of data derived from practice-based warehouses, health economics, decision analysis, altered treatment effects in the setting of multiple comorbidities, value-of-information research and CER simulations, robust sub-group or personalized treatment interactions, rapid roll-out of observational studies and pragmatic trials within integrated health care systems or existing large-scale registries, use of Internet platforms to perform mega-randomized trials at low cost, and innovative approaches for rapid and efficient design, implementation, and completion of large-scale pragmatic trials and implementation studies, including Bayesian, adaptive, and cluster designs.

When appropriate, this FOA encourages investigators to produce publicly available CER tools, such as software, computerized trial algorithms, and web tools for study management.

Applicants should be aware of the fact that any proposed project should be feasible within a three year period and a total costs budget of $1.5 million.

The scope of possible approaches to CER methods has also been left open. The general guideline is that the results of grants following from this RFA could set the stage for other, future studies establishing the value of the methods proposed.

Funding Information:

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. Contingent upon the submission of a sufficient number of scientifically meritorious applications, NIH intends to commit at least $10 million in response to this FOA. We anticipate that 6-7 awards will be made in fiscal year 2010, pending the number and quality of applications and availability of funds. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA. Budget proposals are limited to $500,000 total costs per year over three years and the total cannot exceed $1,500,000.

Grants that are awarded will have to use a non-modular budget. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

This program is supported by funds provided to the NIH and AHRQ under the Recovery Act. The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Other Information:

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
This is a one-time-only solicitation, resubmissions are not permitted.
The RC4 application Research Strategy component of the PHS398 (Items 3-5) may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

Key Dates:

Release/Posted Date: December 28, 2009
Opening Date: January 26, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): February 26, 2010
Peer Review Date(s): May/June 2010
Earliest Anticipated Start Date(s): August 31, 2010
Expiration Date: February 27, 2010

Contact Information:

Program Contact(s):

Michael S. Lauer, MD
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8128
Bethesda, MD 20892
Telephone: (301) 435-0422
Fax: (301) 480-7971
Email: lauerm@nhlbi.nih.gov

NIDA's FOA Summary for Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Pilot Research

Recovery Act Limited Competition: Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Pilot Research (RC4) (RFA-OD-10-002) (NIH Site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications to study how the principles of behavioral economics could be used to enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. (For this FOA, applications should be thought of as large pilot or preliminary studies rather than definitive trials.) This funding opportunity seeks applications that will investigate whether the principles of behavioral economics could be used to enhance the uptake of the results CER among health care providers and also enhance the maintenance of such treatments in patient populations. Behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions. It is hoped that this line of research will lead to significantly greater understanding of the adoption of CER by health care providers and therefore enhance the quality of the nation's health.

Participating NIH Institutes:

National Institute on Aging (NIA) (https://www.nia.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)

Additional Information:

This FOA invites applications to understand better how the principles of behavioral economics could be used to enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. In addition, the projects could also be designed to understand the maintenance of CER-supported treatments and procedures once prescribed in patient populations. Moreover, this FOA also encourages applications to use behavioral economics to examine the sustained uptake of CER - to investigate the dynamics of why a provider may delay uptake, later adopt a CER result, and then later stop using it.

For the purposes of this FOA, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council: "Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in "real world" settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results."

It should, however, be noted that applicants are not restricted to focusing on CER from any one source. Valid CER findings can be taken from a variety of sources including the findings of AHRQ (http://effectivehealthcare.ahrq.gov/), the conclusions of NIH Consensus Conferences, the recent Institute of Medicine (IOM) report on Initial National Priorities for Comparative Effectiveness Research, or sufficiently convincing CER results from literature. Note also that this FOA is dedicated to enhancing the uptake of existing CER research rather than to find new comparatively effective treatments.

In the context of this FOA, behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions. For a recent review of behavioral economics from an economic perspective, Dellavigna (2009) is useful; from a psychological standpoint, Kahneman and Tversky (2000) provides useful data and historical context. There is growing evidence that such approaches may hold more promise than approaches based on either conventional theories of behavior change or neoclassical economics. The application of approaches from behavioral economics to the health care field could be valuable in the development of incentives or disincentives to motivate sustainable changes in provider and patient behavior.

Priority-Setting Process and Inputs for use of ARRA OS Funds

Included within statutory limits of ARRA and the Council's definition of CER;
Potential to inform decision-making by patients, clinicians or other stakeholders;
Responsiveness to expressed needs of patients, clinicians or other stakeholders;
Feasibility of research topic (including time necessary for research).

The CER-CIT will require the use of the FCC's prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,
Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
Addresses a need or is unlikely to be addressed through other organizations,
Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

One of the 100 IOM topic recommendations or the 10 general recommendations and/or
An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed;
Fall into one of the AHRQ identified evidence gaps or be identified in the FCC report to the Congress.

The current list of priority conditions includes:

Arthritis and nontraumatic joint disorders (Muscle, bone, and joint conditions)
Cancer (Cancer)
Cardiovascular disease, including stroke and hypertension (Heart and blood vessel conditions)
Dementia, including Alzheimer's Disease (Brain and nerve conditions)
Depression and other mental health disorders (Mental health)
Developmental delays, attention-deficit hyperactivity disorder, and autism (Developmental delays, ADHD, autism)
Diabetes mellitus (Diabetes)
Functional limitations and disability (Functional limitations and physical disabilities)
Infectious diseases including HIV/AIDS (Infectious diseases and HIV/AIDS)
Obesity (Obesity)
Peptic ulcer disease and dyspepsia (Digestive system conditions)
Pregnancy including preterm birth (Pregnancy and childbirth)
Pulmonary disease/asthma (Breathing conditions)
Substance abuse (Alcohol and drug abuse)

Scope: This FOA solicits applications for small, 3-year projects proposing pilot clinical trials, observational studies, or demonstration projects from multidisciplinary teams with relevant expertise in behavioral economics, psychology, and health services targeting the uptake of specific, previously identified CER. (Note: this FOA does not target establishment of new CER findings, but the uptake of previously validated CER.)

The scope of possible approaches to the behavioral economics/CER problem is left open. The general guideline is that the results of grants following from this FOA could set the stage for other, future studies establishing the effectiveness of the intervention proposed. But the intervention itself could have been identified as promising as the result of a small-scale randomized clinical trial (RCT) or clustered randomized trial (CRT), or identified as a result of secondary analysis of provider performance or claims data, or identified as a possible intervention in an observational study of health care delivery programs that systematically differ in their uptake of CER (possibly due to differences in standard operating procedure or payment systems), or identified using any other valid method. Applicants must provide a rationale for the specific behavioral economic methods they propose to evaluate, and demonstrate how they differ from currently implemented pay for performance (P4P) methods.

Applicants should plan to attend an AHRQ CER conference of awardees supported under this FOA for dissemination purposes. For budgetary purposes, applicants should plan for two representatives to travel to the Washington, DC, area for conference presentations as arranged by AHRQ and NIA. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such a conference.

In addition, applicants should plan to attend an annual investigator's meeting including grantees from this FOA and, the companion Clinical Trials FOA, and other currently funded investigators working in the areas of behavioral economics and increasing the uptake of CER.

Funding Information:

This initiative is supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. The NIH and AHRQ intend to commit $5,000,000 for use under this FOA. We anticipate that 4-5 awards will be made for fiscal year 2010, pending the number and quality of applications and availability of funds.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA; total costs are limited to $1,250,000 over an RC4 three-year period, with no more than $500,000 in total costs allowed in any single year. Grants that are awarded will have to use a non-modular budget.

Other Information:

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
This is a one-time-only solicitation, resubmissions are not permitted.
The RC4 application Research Strategy component of the PHS398 (Items 3-5) may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

Key Dates:

Release/Posted Date: December 28, 2009
Opening Date: February 19, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): March 19, 2010
Peer Review Date(s): May/June 2010
Earliest Anticipated Start Date(s): August 31, 2010
Expiration Date: March 20, 2010

Submission Information:

Applicants are requested to notify the National Institute on Aging Referral Office by email (vemuriR@nia.nih.gov) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Contact Information:

Program Contact(s):

Jonathan W. King, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave. #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: kingjo@nia.nih.gov

Bill Encinosa, Ph.D.
Center for Delivery, Organization and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301-427-1437
Fax: 301-427-1430
Email: William.encinosa@ahrq.hhs.gov

NIDA's FOA Summary for Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Clinical Trials

Recovery Act Limited Competition: Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Clinical Trials (RC4) (RFA-OD-10-001) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications proposing clinical trials using the principles of behavioral economics to enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. For this FOA, applicants must propose controlled trials that randomize units (whether individuals or clusters such as practices, hospitals, or larger units) to conditions, resulting in a randomized clinical trial (RCT) or cluster randomized trial (CRT). Behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions

Participating NIH Institutes:

National Institute on Aging (NIA) (https://www.nia.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)

Additional Information:

This FOA invites applications proposing a large-scale clinical trial whose primary outcome would be to determine whether a specific approach to changing provider behavior based on the principles of behavioral economics could enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. In addition, such trials could also be designed to examine levels of patient compliance at a brief (e.g., 6 month) interval resulting from the level of CER uptake as a secondary outcome.

To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results."

In the context of this FOA, behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions. Behavioral economics acknowledges the important role that a specific context (or frame) may have on decisions, and takes into account people's apparently irrational preferences (e.g., losses count more than gains, an object that is owned is more valuable than the same object that is not owned). For a recent review of behavioral economics from an economic perspective, Dellavigna (2009) is useful; from a psychological standpoint, Kahneman and Tversky (2000) and Kahneman (2003) provide useful data and historical context.

Priority-Setting Process and Inputs for use of ARRA OS Funds

Included within statutory limits of ARRA and the Council's definition of CER;
Potential to inform decision-making by patients, clinicians or other stakeholders;
Responsiveness to expressed needs of patients, clinicians or other stakeholders;
Feasibility of research topic (including time necessary for research).

The CER-CIT will require the use of the FCC's prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,
Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
Addresses a need or is unlikely to be addressed through other organizations,
Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

One of the 100 IOM topic recommendations or the 10 general recommendations and/or
An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed;
Fall into one of the AHRQ identified evidence gaps or be identified in the FCC report to the Congress.

The current list of priority conditions includes:

Arthritis and nontraumatic joint disorders (Muscle, bone, and joint conditions)
Cancer (Cancer)
Cardiovascular disease, including stroke and hypertension (Heart and blood vessel conditions)
Dementia, including Alzheimer's Disease (Brain and nerve conditions)
Depression and other mental health disorders (Mental health)
Developmental delays, attention-deficit hyperactivity disorder, and autism (Developmental delays, ADHD, autism)
Diabetes mellitus (Diabetes)
Functional limitations and disability (Functional limitations and physical disabilities)
Infectious diseases including HIV/AIDS (Infectious diseases and HIV/AIDS)
Obesity (Obesity)
Peptic ulcer disease and dyspepsia (Digestive system conditions)
Pregnancy including preterm birth (Pregnancy and childbirth)
Pulmonary disease/asthma (Breathing conditions)
Substance abuse (Alcohol and drug abuse)

Scope: This FOA solicits applications for large-scale, multi-site, 3-year projects proposing randomized clinical trials (RCTs), cluster randomized trials (CRTs), or other robust randomized trial designs from multidisciplinary teams with relevant expertise in behavioral economics, psychology, epidemiology, clinical and health services research targeting the uptake of specific, previously identified CER. (Note: this FOA does not target establishment of new CER findings, but the uptake of previously validated CER.)

The overall intent of this FOA is to provide applicants maximum freedom in the design of their proposed trial, limited only by the requirement that behavioral economic techniques be used to change provider behavior and that the uptake of validated CER results be the primary outcome.

Applicants should plan to attend an AHRQ CER conference of awardees supported under this RFA for dissemination purposes. For budgetary purposes, applicants should plan for two representatives to travel to the Washington, DC, area for conference presentations as arranged by AHRQ and NIA. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such a conference.

Funding Information:

This initiative is supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. The NIH has designated $15,000,000 in FY(s) 2010, 2011, and 2012 to fund 2 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed three years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA; total costs are limited to $7,500,000 over a three-year period. Grants that are awarded will have to use a non-modular budget.

Other Information:

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
This is a one-time-only solicitation, resubmissions are not permitted.
The RC4 application Research Strategy component of the PHS398 (Items 3-5) may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

Key Dates:

Release/Posted Date: December 28, 2009
Opening Date: March 7, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): April 7, 2010
Peer Review Date(s): May/June 2010
Earliest Anticipated Start Date(s): August 31, 2010
Expiration Date: April 8, 2010

Submission Information:

Contact Information:

Program Contact(s):

NIDA's FOA Summary for NIH Director's Opportunity for Research in Five Thematic Areas

Recovery Act Limited Competition: NIH Director's Opportunity for Research in Five Thematic Areas (RC4) (RFA-OD-10-005) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, solicits through this limited competition applications from domestic (United States) institutions/organizations proposing to develop and implement critical research innovations in one or more of the following five thematic areas:

Applying Genomics and Other High Throughput Technologies
Translating Basic Science Discoveries into New and Better Treatments
Using Science to Enable Health Care Reform
Focusing on Global Health
Reinvigorating the Biomedical Research Community

This program is a trans-NIH effort supported by Recovery Act funds from the Office of the Director. Applicants may propose to address either a specific disease- or technology-related research question relevant to the mission of one or more participating Institutes and Centers, or propose the creation of a unique infrastructure/resource designed to accelerate scientific progress in the future.

Additional Information:

This FOA is designed to provide investigators and institutions with the opportunity to address these unique challenges by engaging in new avenues of research where progress would produce a significant impact on growth and investment on biomedical or behavioral science and/or health research.

Applicants to the Program must clearly specify the thematic area that their research addresses in the Project Summary/Abstract Component of the application. Applicants must also clearly articulate how the proposed studies would significantly extend our understanding of biomedical or behavioral science and/or health as it relates to the thematic area.

Scope. This grants program is aimed at research endeavors that address one or more of the following five thematic areas:

Applying Genomics and Other High Throughput Technologies: In the past, many basic biomedical science projects were limited in scope to some aspect of genetics, cell biology, or physiology. The revolution now sweeping the field is the ability to be comprehensive - for example, to define all of the genes of the human, model organisms or the human microbiota, all of the human proteins and their structures, or all of the major pathways for signal transduction in the cell. Technologies contributing to these advances, many of which became practical at scale only in the last few years, include DNA sequencing, microarray technology, nanotechnology, small molecule screening capabilities, new imaging modalities, and computational biology. These comprehensive approaches coupled with systems-level integration, analysis and mining of large datasets now hold the promise of major advances in the understanding of the mechanisms of diseases.
Translating Basic Science Discoveries into New and Better Treatments: The opportunity is here for translational science to develop small molecule-based, gene-based, protein/peptide-based and cell-based therapies for common as well as rare diseases.
Using Science to Enable Health Care Reform: Quality, affordable health care for all Americans cannot occur without significant advances in the underlying science that will enable effective and efficient disease prevention and diagnosis, as well as better and cheaper treatments to be identified. Clinical research targeted toward health disparities, social and behavioral factors, large-scale prospective population cohort analysis, comparative effectiveness, cost-effective prevention and personalized medicine, and pharmacogenomics will allow us to assess and mitigate disease risks, predict outcome and optimize treatment. Health services research that includes health information technology and health research economics will enhance the safety, quality and efficiency of the health care delivery system, as well as facilitate health promotion.
Focusing on Global Health: This theme encourages a greater focus on global health and new emphasis on formulating prevention and intervention strategies to tackle a number of infectious and parasitic diseases, chronic non-communicable diseases and injuries, and other neglected diseases striking the developing world, with the goal to reduce morbidity and mortality associated with these diseases worldwide.
Reinvigorating the Biomedical Research Community: This theme encourages investigators to cultivate new collaborations and to assemble multidisciplinary or interdisciplinary teams in conducting innovative research on the most challenging biomedical and behavioral areas. The goal is to strengthen our research capacity, to broaden our research base and to enhance cross-fertilization of disciplines by recruiting new investigators and new expertise into the research community, and by developing and retaining these talents in a collaborative environment that fosters creativity and exploration.

Requirements. Projects submitted in response to this FOA are expected to demonstrate the following:

The project addresses one or more of the five research themes.
The work cannot be reasonably expected to be carried out successfully without the requested support.
Specific outcomes of the proposed project promote and advance the mission of the NIH to improve health.
The project is ready to be deployed immediately upon funding.
A rapid infusion of significant funding will accelerate current and future research in the area of study and there are appropriate measurable outcomes to evaluate the short and long-term effects of the project.
The proposed project is something that no other entity is likely or able to do, and there is a public health benefit to having the results of the research in the public domain.
The project or generated results and resources can be expected to become integrated with other NIH and privately funded research within a reasonable timeframe.
Projects that would require funding beyond this timeframe should provide a detailed plan for maintaining the research efforts without any expectation of further financial assistance from the sponsoring IC or other NIH components. Applicants are expected to provide a list of outcomes and include plans to obtain long-term support for research endeavors carried out with this funding.

Key resources and data acquired with the support of this FOA will be expected to be shared rapidly with the public and the scientific community as described under the NIH Policy for Sharing of Data and the NIH Policy for Sharing Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Timeline. Applicants should construct the project timeline to include critical milestones, measurable outcomes, and mid-term and end of project results to be publicly shared as expeditiously as possible. Awards will be made for a three-year budget period.

Funding and Budget Information:

Contingent upon the submission of a sufficient number of scientifically meritorious applications, approximately $80 million of ARRA funds will be obligated by September 30, 2010 to support requests submitted in response to this FOA.

Budget and Project Period. Only projects with a scientific scope that requires an annual budget greater than $500,000 in total costs are expected to be considered. The total cost amount for individual awards will vary and should be commensurate with the scope and complexity of the project. However, the duration of the awards issued under this FOA will be limited to three years.

The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, with the exception of projects submitted to address topics identified as included in the Focusing on Global Health theme, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less. Projects in response to the Focusing on Global Health theme could propose a larger foreign component. NIH will consider these requests in the context of the research being proposed and its potential for critically advancing research in global health.

Other Information:

A detailed statement addressing the scope and the requirements should be included as part of the application Research Plan and in summary form in the Letter of Intent.
More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
This is a one-time-only solicitation, resubmissions are not permitted.
The Research Strategy component may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.
Long Term Sustainability Plan: Applications requesting new infrastructure support must include a plan that describes how the infrastructure and services will be maintained and supported beyond the initial NIH funded period

Key Dates:

Letters of Intent Receipt Date: February 15, 2010
Application Due Date: March 15, 2010
Peer Review Date(s): June/July 2010
Earliest Anticipated Start Date: September 30, 2010
Expiration Date: March 16, 2010

Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Number and title of this funding opportunity.
Descriptive title of proposed research.
Name, address, and telephone number of the PD(s)/PI(s).
Names of other key personnel.
Participating institutions.
Description of the research areas, including any subprojects
Significance of the proposed research
Evidence that the project is ready for immediate implementation
Description of how the goal and outcomes of the project match the goals of the grants program and Recovery Act
Preliminary list of the expected project milestones.
Direct, contract F&A, and total costs for each year

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate and plan for the potential review workload.

The letter of intent should be sent to:

Cathleen Cooper, Ph.D.
Chief, Oncology 1: Basic Translational (OBT) IRG
NIH/Center for Scientific Review
6701 Rockledge Drive, Rm 6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone: 301-443-4512
Fax: 301-480-0287
Email: cooperc@csr.nih.gov

Contact Information:

Program Contact(s):

Your NIDA PO or

Christine Colvis, PhD
NIDA, NIH
Director, Program Integration
Neuroscience Center, Rm 5261
6001 Executive Blvd.
Bethesda, MD 20892
Phone: 301-443-6480
Email: ccolvis@nida.nih.gov

Grants Management Contact(s):

Carol Alderson
Office of Management
Grants Management Branch
NIDA, NIH
6001 Executive Boulevard, 5th Floor, MSC 9560
Bethesda, MD 20892-9560
Phone: 301-933-6196
Fax: 301-594-6869
Email: ca10h@nih.gov

NIDA's FOA Summary for Building Sustainable Community-Linked Infrastructure Awards

Recovery Act Limited Competition: Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4) (RFA-OD-09-010) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009, Public Law 111-5, solicits applications from domestic (United States) institutions/organizations proposing to support the development, expansion, or reconfiguration of infrastructures needed to facilitate collaboration between academic health centers and community-based organizations for health science research. The NIH has established a new program entitled "Building Sustainable Community-Linked Infrastructure to Enable Health Science Research," hereafter called the "Community Infrastructure" grants program. Such collaboration should transform the way in which health science research is conducted in communities, and accelerate the pace, productivity, dissemination, and implementation of health research; applications that build upon extant collaborative infrastructures supported by other Federal agencies are strongly encouraged.

This initiative is one of several being offered by the NIH to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research.

Additional Information:

The Community Infrastructure grants program will support the development, expansion, or reconfiguration of bi-directional relationships between academic health centers and community entities in the pursuit of improved public health through research. Projects could involve the development of public-private partnerships; connections between academic health centers and their constituent institutions and community entities; facilitate development of practice-based research; create needed information technology to support research, etc. The Academic Health Center (AHC), in order to facilitate this bi-directionality, may need to plan significant training of the community entities in the rationale and skills necessary to achieve equity in these partnerships. To maximize their potential, community infrastructure projects will ideally span scientific disciplines, diseases, and conditions, and will offer the potential for sustained collaboration and future research.

The NIH strongly encourages applicants to propose infrastructures that may build upon or be linked to extant infrastructures supported by other Federal agencies (e.g., Administration on Aging [AoA], Agency for Healthcare Research and Quality [AHRQ], Centers for Disease Control and Prevention [CDC], Health Resources and Services Administration [HRSA], Indian Health Service [IHS], Substance Abuse and Mental Health Services Administration [SAMHSA], US Department of Agriculture [USDA], etc.) and thus heighten their potential for long-term sustainability. Examples of potential community-linked infrastructure projects include, but are not limited to:

Collaborations that develop community organizations' infrastructure for developing tools and skills for building research portfolios.
Collaborations that establish or expand community-based infrastructure for collaborative clinical and translational research addressing health disparities in medically underserved areas, including health promotion, disease prevention research and dissemination.
Collaborations that develop or expand telehealth networks linking academic health centers and health care providers in rural and other medically underserved areas by leveraging existing telehealth and related programs to increase community capacity for clinical and translational research.

Funding Information:

NIH has designated up to $30 million in FY2009-2010 to fund 30 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Budget and Project Period. Budget requests should be commensurate with project needs. However, the requested duration may not exceed three years. (Research & Related Budget required for all applications; No modular budgets will be accepted.) The total cost for individual awards is expected to vary, depending on the scope of the project, but is limited to a maximum of $1 million total costs for the full project period.

The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component may not exceed 10% of the total requested direct costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Eligible Institutions: Applications are invited from domestic (United States) institutions/organizations proposing to develop or expand needed infrastructures that will fundamentally transform collaboration and communication between academic health centers and local communities. Foreign organizations/ institutions are not permitted as the applicant organization.

Other Information:

NIH intends that academic health centers will be the applicant organizations for this RFA. Please see "Section III. Eligibility Information" of the RFA for more information
Applicants must designate a Community Research Associate, who will be a community representative and serve as a primary liaison facilitating communication and collaboration between the academic health center and the community.
More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
This is a one-time-only solicitation, resubmissions are not permitted.
The research plan may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

Key Dates:

Letters of Intent Receipt Date(s): November 12, 2009
Application Due Date(s): December 11, 2009
Peer Review Date(s): February/March 2010
Earliest Anticipated Start Date(s): July 2010
Expiration Date: December 12, 2009

Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research.
Name, address, and telephone number of the PD(s)/PI(s).
Names of other key personnel.
Participating institutions.
Number and title of this funding opportunity.

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov

Contact Information:

Program Contact(s):

Lori J. Ducharme, Ph.D.
Health Scientist Administrator Services Research Branch / DESPR
National Institute on Drug Abuse
6001 Executive Blvd., Rm 5180 MSC 9589
Rockville, MD 20892-9589
Phone: (301) 443-2279
Fax: (301) 443 6815
Email: ducharmel@nida.nih.gov

Grants Management Contact(s):

Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., RM 4000 MSC 9560
Rockville, MD 20892-8403
Phone: (301) 253-8729
FAX: (301) 594-6849
Email: pfleming@nida.nih.gov

NIDA's areas of scientific interest for Small Business Catalyst Awards

Recovery Act Limited Competition: Small Business Catalyst Awards for Accelerating Innovative Research (R43) (RFA-OD-09-009) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 invites grant applications from small business concerns that propose to accelerate innovation through high risk, high reward research and development (R&D) that has commercial potential and is relevant to the mission of the NIH. The Small Business Catalyst Award is further expected to support entrepreneurs of exceptional creativity, drawn from scientific and technological environments beyond NIH, who propose pioneering and possibly transformative approaches to addressing major biomedical or behavioral challenges with the potential for downstream commercial development. The outcomes of the research supported should have potential to lead to products that will improve public health and create significant value and economic stimulus. Specifically, this FOA solicits early-stage ideas that represent advancement in a technological area that promises to lead to major leaps forward, not merely incremental improvements of existing technologies, e.g., projects that have the potential to generate high impact results and/or innovative research applications, research tools, techniques, devices, inventions, or methodologies.

This initiative is one of several being offered by IC to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research.

General Information:

High-risk, high reward R&D that is unlikely to be undertaken by ongoing academic efforts or within industrial firms is strongly encouraged. In addition, NIH encourages technologies stemming from an emerging scientific field or technological capacity that would be beneficial if successfully commercially developed. Applicants that have been supported by other Federal agencies for R&D that draw from the mathematical, computational, physical, behavioral or social sciences are encouraged.

Funding Information:

NIH intends to commit as least $5 million under this FOA.
20-25 awards will be made for fiscal year 2010

Budget: Budget requests are limited to $200,000 total costs for a maximum project period of one year.

Eligibility: Only United States small business concerns (SBCs) are eligible to submit SBIR applications

Other Information:

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. Under the SBIR program, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project.
Resubmissions are not permitted.
The Research Plan is limited to a total of 7 pages, including 1 page for the Specific Aims and 6 pages for Research Design and Methods.

Key Dates:

Letters of Intent Due Date: August 3, 2009
Application Due Date(s): September 1, 2009
Earliest Anticipated Start Date(s): April 2010
Expiration Date: September 2, 2009

Timeline for Review:

Applications will be reviewed by November/December 2009.

Contact Information:

Program Contact(s):
Dr. Cathrine Sasek
Phone: 301-443-6071
Email: csasek@nih.gov

Grants Management Contact(s):
Ms. Diana Haikalis
Grants Management Specialist
Phone: 301-443-6710
Email: dhaikali@mail.nih.gov

NIDA's areas of scientific interest for the BRDG-SPAN Pilot Program Award

Recovery Act Limited Competition: Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3)(RFA-OD-09-008) (NIH site)

This Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 solicits grant applications for a new initiative called Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3). The purpose of this pilot program is to address the funding gap between promising research and development (R&D) and transitioning to the market by contributing to the critical funding needed by applicants to pursue the next appropriate milestone(s) toward ultimate commercialization; i.e., to carry out later stage research activities necessary to that end.

General Information:

The BRDG-SPAN pilot program encourages projects representing, for example, the following:

a novel, first in class therapy;
a material improvement over existing technologies;
a potential substantial reduction in cost over existing technologies/products;
U.S. alternative to foreign suppliers;
a product for unmet, under-addressed medical needs (e.g., technologies to produce solid medication dosage forms for children, and therapeutic devices appropriate for children in terms of size and functionality)
a significant and demonstrable potential U.S. and/or global markets;

Funding Information: NIH intends to commit at least $35 million in response to this FOA. It is anticipated that at least 10 awards will be made in fiscal year 2010

Budget: The requested budget is limited to $1 million total costs per year for a maximum of three years.

Eligibility: A U.S.-owned, for-profit enterprise/commercial organization doing a majority of its business in the United States may apply for RC3 funding.

Other Information:

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
This is a one-time-only solicitation, resubmissions are not permitted.
The RC3 application Research Plan component of the PHS398 is limited to a total of 13 pages, including 1 page for the Specific Aims and 12 pages for Research Design and Methods. This page limit includes tables, graphs, figures, diagrams, and charts.

Key Dates:

Letters of Intent Due Date: August 3, 2009
Application Due Date(s): September 1, 2009
Earliest Anticipated Start Date(s): April 2010
Expiration Date: September 2, 2009

Timeline for Review:

Applications will be reviewed by November/December 2009.

Contact Information:

Program Contact:
Dr. Cathrine Sasek
Phone: 301-443-6071
Email: csasek@nih.gov

Grants Management Contact:
Ms. Diana Haikalis
Grants Management Specialist
Phone: 301-443-6710
Email: dhaikali@mail.nih.gov

<em>Signature Projects</em> of the National Institute on Drug Abuse

NIDA has identified two major goals to highlight for support under the American Recovery and Reinvestment Act (ARRA): Eradicate Tobacco Abuse and Addiction and Understand How Genes Influence the Development and Morphology of the Human Brain. NIDA intends to identify Signature Grants from those funded under ARRA, particularly those submitted in response to the Challenge and Grand Opportunities FOAs, which hold promise for making significant advances towards achieving these goals. NIDA is seeking OD-ARRA co-funding for the second topic.

Eradicate Tobacco Abuse and Addiction

Tobacco use is the leading cause of preventable death in the United States, being associated with close to half a million deaths per year. World-wide that toll rises to five million deaths each year and, if current smoking patterns continue globally, tobacco use will kill 10 million persons annually by 2020. In addition it contributes significantly to a wide array of medical conditions including pneumonia, coronary heart, cardiovascular, and chronic lung diseases, various types of cancers, cataracts, sudden infant death syndrome, ADHD and addiction.

Public health interventions and biomedical advances have led to dramatic reductions in the prevalence of tobacco use. However, despite the availability of various medications and behavioral treatments to aid smoking cessation, the prevalence of nicotine addiction remains unacceptably high and exorbitantly expensive. This highlights the urgent need for additional research into the development of new therapeutic and prevention interventions. Selecting from American Recovery and Reinvestment Act (ARRA)-funded projects, NIDA will identify projects that hold promise for making significant advances toward the eradication of tobacco abuse and addiction over the next two years. Because of their importance and potential impact on human health, these projects will constitute one of the groups of "Signature Projects" of the National Institute on Drug Abuse.

NIDA will identify Signature Projects that will accelerate the research and development of novel pharmacotherapeutic agents and vaccines to treat tobacco addiction through two major research avenues. First, we seek to promote investigations into new antibody-based approaches (i.e., vaccines) to boost or enable the body's immune system to mount an effective response against nicotine, even before it reaches the brain, blocking its rewarding effects. A nicotine vaccine will dramatically reduce the morbidity and mortality of tobacco use by preventing the progression to addiction in those who seek to initiate tobacco use and by facilitating cessation in those who seek to stop smoking. Second, we will also tap into the vast potential of novel compounds and in-license discoveries (e.g, chemical libraries) for the development of new medications for smoking cessation.

How do genes influence the development and morphology of the human brain?

In its second group of Signature Projects, NIDA seeks to merge genetics data from whole genome sequencing with brain morphology data, specifically as it changes through development, in well-characterized subjects. While the typical range and timing of brain morphological changes that occur during normal human development are becoming better characterized, we have little understanding of the interplay between genes and environment in shaping human brain development. Moreover, we still have very little knowledge of the genes expressed during different stages of brain development. Normative data are needed so that brain development can be correlated with individual environmental and genetic factors. Such data would be invaluable as a basis for understanding (1) the contribution of specific genes to neuropsychiatric disorders and (2) how exposure to certain environmental factors can trigger disease in those that are genetically vulnerable.

Studies in animal models that capitalize on genetics, such as transgenics and genetic mutations, and on comparisons across species to quickly validate the discoveries of the clinical studies and help identify genes that distinguish the brain complexity between the species are also a high priority.

The success of this program hinges on researchers' ability to build up novel bioinformatic approaches and algorithms capable of extracting meaningful information out of the overlaying of growing genomic and imaging databases (both preclinical and clinical), particularly across periods of active brain development. Equally critical, will be the ability of this program to spur and support intensely collaborative studies by a diverse array of interdisciplinary scientists. If successful, this strategy will generate critical information about normal brain development and the biological precursors and correlates of complex brain disorders, such as ADHD, autism, schizophrenia, and drug addiction.

NIDA's areas of scientific interest for the Academic Research Enhancement Award

Recovery Act Limited Competition: Academic Research Enhancement Award (R15) (RFA-OD-09-007) (NIH site)

The purpose of the Academic Research Enhancement Award (AREA) program is to stimulate research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. These AREA grants create opportunities for scientists and institutions otherwise unlikely to participate extensively in NIH programs, to contribute to the Nation's biomedical and behavioral research effort. AREA grants are intended to support small-scale health-related research projects proposed by faculty members of eligible, domestic institutions.

Areas of Scientific Priority:

At institutions that have not been major recipients of NIH support, AREA grants may support, new or renewal, meritorious projects in biomedical, behavioral research or clinical research, including:

pilot research projects and feasibility studies
development, testing, and refinement of research techniques
secondary analysis of available data sets
similar discrete research projects that demonstrate research capability

NIDA is interested in AREA awards that address a variety of aspects of drug abuse research. The institute's highest priority areas are listed on our GO grants and our revision applications below. Applicants are also encouraged to read about the areas NIDA has identified for the institute's Signature Projects.

Budget and Project Period. Applicants may request up to a total of $300,000 direct costs. The total project period for an application submitted in response to this funding opportunity may be up to three (3) years. Note: The entire budget MUST be requested under Budget Period 1. Do not complete PHS 398 Budget, Periods 2, 3, 4, or 5. They are not required and will not be accepted with the application.

Eligibility: The applicant organization must offer baccalaureate or advanced degrees in the sciences related to biomedical and behavioral sciences and meet the requirement of receiving research grants and/or cooperative agreements from the NIH totaling not more than $6 million per year (in both direct and F&A/indirect costs) in each of four (4) or more of the last seven (7) years.

Note that this criterion of financial eligibility is based on the amount of NIH research grant monies received, not by the institution (university or college) as a whole, but by the individual school/college or aggregation of "other academic components" (see definition below) where the PD/PI has an appointment (e.g., School of Medicine, College of Nursing, etc.). er of applications: Only one application per institution will be accepted.

To determine the eligibility of a school or component with regard to this requirement, applicants should consult the list of eligible/ineligible schools/components on the AREA program Web site at http://grants.nih.gov/grants/funding/area.htm. If the name of the school or component does not appear on the list, applicants should check with their own institutions to verify the status.

Foreign organizations/institutions are not permitted as the applicant organization.

Other information: The AREA program is primarily a research grant program and not a training or fellowship program. Active involvement of undergraduate and graduate students in the proposed research is encouraged, and reviewers will consider whether the proposed project will expose undergraduate (preferably, if available) and graduate students to meritorious research. However, the application should not focus on training objectives and training plans should not be provided.

Key Dates:

Opening Date: August 24, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): September 24, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Earliest Anticipated Start Date(s): April 1, 2010
Expiration Date: September 25, 2009

Peer Review Date(s): October/November 2009

Contact Information:

Program Contact:
Christine Colvis, Ph.D.
301-443-6480
ccolvis@nida.nih.gov

Grants Management Contact:
Pamela G. Fleming
301-253-8729
pfleming@nida.nih.gov

NIDA's areas of scientific interest for the Core Centers grants

Recovery Act Limited Competition: Supporting New Faculty Recruitment to Enhance Research Resources through Biomedical Research Core Centers (P30) (RFA-OD-09-005) (NIH site)

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications from U.S academic institutions/organizations for developing resources to support research projects within the context of Biomedical Research Core Centers. Specifically, Core Center Grants are institutional awards that provide support for shared resources for categorical research by investigators from different disciplines who provide a multidisciplinary approach to a joint research effort, or from the same discipline who focus on a common research problem.

This initiative is one of several being offered by NIDA to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research.

Areas of Scientific Priority:

The National Institute on Drug Abuse (NIDA) offers the P30 Core Center Grant program for the recruitment of faculty members conducting drug abuse and addiction research. Applicants that are hiring new faculty in these underrepresented areas of drug abuse and addiction research will be given additional consideration:

Medications Development
Vaccines
Biomarkers
Chemistry
Neuroinformatics
Underrepresented Populations
Clinical Research
Inter- and Transdisciplinary Research
Comorbidity
Genetics & Epigenetics
HIV/AIDS
Brain Development and Genetics
Neuroeconomics

Applications should specify the department(s) or center(s) in which this P30 capacity building will be focused.

Eligibility: Eligible organizations include U.S. public or private institutions of higher education.

Number of applications: Only one application per institution will be accepted.

Other information: Applicant institutions should plan to hire new faculty within the first year of receiving the award; i.e. faculty candidate(s) should accept the institution's offer of employment within 1 year of the project start date. Faculty hires who begin their new employment more than 90 days prior to the initial budget period (see RFA for terms of pre-award costs) will not be considered new hires under this initiative.

NIDA requires that any faculty members hired under this initiative receive joint appointment(s) with other academic unit(s) at the applicant institution, allowing new faculty to access University-wide research resources and core facilities, and to serve as mentors for graduate programs affiliated with other academic unit(s).

Funds Available and Anticipated Number of Awards. NIDA expects to make between 4 and 5 awards during FY 2009, with total funding of approximately $7 million over the two-year period of FY 2009 and 2010.

Budget and Project Period. Budgets for direct costs of up to $500,000 per year and project duration of up to two years may be requested, for a maximum of $1,000,000 direct costs over a two-year project period.

Key Dates:

Release Date: March 30, 2009
Letters of Intent Receipt Date: April 29, 2009
Application Receipt Date: May 29, 2009
Peer Review Date: July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009
Expiration Date: May 30, 2009

Contact Information:

Program Contact(s): Mimi M. Ghim, PhD
Phone 301-443-6071
Email: ghimm@nida.nih.gov

Division of Pharmacotherapies and Medical Consequences of Drug Abuse
Jane Acri, jacri@nida.nih.gov
Jamie Biswas,jbiswas@nida.nih.gov

Division of Basic Neuroscience and Behavioral Research
Beth Babecki, bbabecki@nida.nih.gov

Division of Epidemiology, Services and Prevention Research
Aria Crump,acrump@nida.nih.gov

Division of Clinical Neuroscience and Behavioral Research
Debbie Grossman, dgrossma@nida.nih.gov

AIDS Research Program
Diane Lawrence,lawrencedi@nida.nih.gov

Grants Management Contact(s): Pamela G. Fleming
Phone (301) 253-8729
Email: pfleming@nida.nih.gov

Letters of Intent Contact:
Please send letters to NIDAletterofintent@mail.nih.gov.
With subject line: "RFA-OD-09-005"

Review Contact:
Teresa Levitin, Ph.D.
Telephone: (301) 443-2755
E-mail: TL25u@NIH.GOV

NIDA's topics for the NIH 'GO' Grants

NIH has established a new program entitled Research and Research Infrastructure "Grand Opportunities" (RFA-OD-09-004) (NIH site) hereafter called the "GO" grants program. This new program will support projects that address large, specific biomedical and biobehavioral research endeavors that will benefit from significant 2-year funds without the expectation of continued NIH funding beyond two years. The research supported by the "GO" grants program should have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery.

The purpose of the Research and Research Infrastructure Grand Opportunities program is to support high impact ideas that lend themselves to short-term, non-renewable funding, and may lay the foundation for new fields of investigation. The program will support large-scale research projects that accelerate critical breakthroughs, early and applied research on cutting-edge technologies, and new approaches to improve the synergy and interactions among multi and interdisciplinary research teams.

Overall, NIDA expects to devote $40,000,000 over 2 years to the Grand Opportunity program.

Areas of Scientific Priority:

While NIDA is interested in research on all drugs of abuse, for this initiative we are particularly interested in nicotine and tobacco research. Areas of scientific interest include:

Vaccines and Immunotherapies
Small Molecule Development for Substance Related Disorders
Brain Development, Morphology and Genetics
Biomarkers
Genetics
Harmonizing Phenotypes and Envirotypes
Epigenetics
Pharmacogenomics
Drug Abuse Treatment Clinical Trials Network (CTN)
Criminal Justice
Building Prevention Infrastructures

Send Letters of Intent to

NIDAletterofintent@mail.nih.gov cite RFA-OD-09-004 in the subject line. In the letter, please state the NIDA priority area (see above list) to which the application would be responding.

Vaccines/Immunotherapies for Substance Related Disorders

Immunotherapies in the form of vaccines or antibodies are offering a window of opportunity to discover safe and effective treatments for substance-related disorders (SDR). Unlike conventional small molecule therapy, which targets the neural pathways/receptors involved in drug addiction, immunotherapy targets the drug itself through pharmacokinetic antagonism. Drug-specific antibodies bind the drug in the blood and prevent its access and distribution into the brain. The result is preventing the toxic effects of the drug to the brain or the access and stimulation of the brain reward systems by the drug. Through this RFA, NIDA is soliciting applications to expand the knowledge about the safety and efficacy of immunotherapies for SRDs. The goal is to encourage, complement, and accelerate the process of developing new, innovative, safe and effective immunotherapies for SRDs. Research topics may include 1) preclinical studies required for the IND-targeted development of immunotherapies such as design, synthesis, formulation, toxicology, and pharmacokinetics of proposed immunotherapy candidates, 2) human laboratory (Phase I) studies of the safety and preliminary efficacy of immunotherapies as well as interaction studies to evaluate the effects of immunotherapies and the concurrent use of drugs of abuse, 3) Phase II and Phase III randomized clinical trials to evaluate the safety and/or efficacy of immunotherapies for the treatment of substance use or substance-induced disorders or any of their specific symptoms. When considering the appropriateness of research projects for this RFA, it should be kept in mind that completion of all work within two years must be feasible. Interactions and relationships between academia and industry are encouraged.

Contact: Nora Chiang nchiang@nih.gov 301-443-5280 or 301-443-8099 or Jamie Biswas, jb168r@nih.gov 301-443-8096

Small Molecule Development for Substance Related Disorders

There is a great public health need to develop safe and effective medications for the treatment of drug addictions. Scientific advances in understanding the neurobiology of addictions coupled with the development of new medications and the identification of new targets offers a unique opportunity for the development of safe and effective medications to treat these disorders. Through this RFA, NIDA will support preclinical and clinical studies to evaluate the safety and efficacy of potential medications for the treatment of drug addictions. Applications may focus on the pharmacotherapy of one or various addictions with or without other comorbid medical or psychiatric conditions. Applications may also focus on pharmacotherapies for specific clinical manifestations of addictions (e.g, drug withdrawal or craving) or their complications (e.g., cognitive impairments, sleep disorders). Under this RFA, the applicants may submit FDA-defined Phase I, Phase II or Phase III clinical trials of new compounds or marketed medications that have theoretical or empirical evidence of efficacy to treat drug addictions. The rationale for choosing the medication(s) or compounds to be investigated can be based on a top-down approach, a bottom-up approach, or both approaches combined. The top-down approach would be the testing of marketed medications that are available for other indications and which may be promising candidates for the treatment of drug addiction. The bottom-up approach involves the preclinical evaluation of promising new chemical entities with a strong rationale for clinical efficacy. Preclinical projects must include the evaluation of compounds with novel mechanisms of action in addiction-related animal models and/or the completion of IND-enabling studies. When considering the appropriateness of research projects for this RFA, it should be kept in mind that completion of all work within two years must be feasible. Results from studies funded with this RFA are expected to advance the development of medications to treat drug addiction. Interactions and relationships between academia and industry are encouraged.

Contact: Nora Chiang nchiang@nih.gov 301-443-5280 or 301-443-8099 or Jamie Biswas, jb168r@nih.gov 301-443-8096

Brain Development, morphology and genetics

To generate critical information about normal brain development and the biological precursors and correlates of complex brain disorders, such as ADHD, autism, schizophrenia, and drug addiction, NIDA is interested in studies that integrate clinical, behavioral, imaging, and/or genetic assessments of brain development in humans or animal models. Specifically, NIDA will support studies that:

Conduct whole genome sequencing or genotyping and brain imaging/morphology scans on children or mouse models to provide normative data for understanding factors related to brain development, as well as to provide a reference for further addiction-specific analyses.

Examine genetic contributions of brain imaging and structural morphology across inbred strains of mice across developmental stages and/or exposed to drugs of abuse
Develop and analyze a brain atlas of gene expression in nicotine exposed mice
Establish a brain bank for substance use disorders (e.g. nicotine addiction) and integrate with existing brain banks around the world
Molecular profiling of cell types in brain regions associated with addiction and their response to addictive substances.
Establish and validate knockouts, knock-ins, and conditional knockouts in mice for addiction studies. Priority will be given to requests using the NIH knockout project resource (www.komp.org) if the requested knockout alleles are available in the resource.

Contact: Jonathan Pollock 301-435-1309 jpollock@mail.nih.gov or Cheryl Boyce, cboyce@nida.nih.gov, 301-443-4877

Biomarkers

The need for accurate, reliable screens for drug exposure and vulnerability to addiction is of critical importance to substance abuse prevention and treatment. Although tests of bodily fluids or hair, and surveys using self-report questionnaires are common options, their value is compromised by their less-than-perfect reliability, low sensitivity, and limited scope. On the other hand, "peripheral" biomolecules promise to provide the type of comprehensive biological information needed to advance drug abuse research in the following areas:

Prevention - One challenge for prevention researchers is to develop and test emerging technologies to explicate under-explored mechanisms of neurobiological risk and to facilitate understanding of the biological and neurobiological effects of social, emotional, and behavioral preventive interventions. For example, researchers have successfully integrated measures of hypothalamic-pituitary-adrenal (HPA) axis functioning into clinical prevention research to help elucidate changes in stress hormone systems that may accompany changes in clinical studies. This FOA seeks to increase the availability of technologies that can be used in prevention trials to provide insight into biological and neurobiological mediators of drug abuse prevention interventions.
Treatment/Early Intervention - The ability to identify acute or chronic drug exposure will facilitate early intervention, assessment of treatment adherence, prediction of treatment response, monitoring of the recovery process, and may potentially serve as surrogates for changes taking place in the brain resulting from drug exposure, withdrawal, or relapse. For example, identification of biomarkers for nicotine addiction that are suitable for subsequent validation efforts for personalized therapies and predicting treatment response and relapse risk are of high interest.

Through this FOA, NIDA solicits applications for animal or human research to search for "peripheral" biomarkers (not the drug itself or its metabolites). The biomaterials selected must be clinically accessible (e.g., blood, lymphocytes, bladder epithelial cells, stem cells, etc.) or indirect measures such as EEG, and the proposed research should be directed at identifying the best class or classes of molecules (proteins, peptides, RNA, miRNA, etc.) suitable for assay development. The overall goal in this priority area is to address technical issues such as sensitivity and signal-to-noise ratio, in addition to predictive validity of the putative biomarkers selected and studied.

Contact: Elena Koustova 301-496-8768 Koustovae@mail.nih.gov or Elizabeth Ginexi (301) 402-1755 lginexi@nida.nih.gov or Cecelia McNamara Spitznas, cs613p@nih.gov, 301-402-1488

Genetics

Individual genetic variation may confer vulnerability or resistance to drug abuse and addiction. Recently developed genetic methodologies (e.g., genome wide association studies, deep sequencing) make it possible to better understand the genetic factors underlying drug abuse and addiction and their relationship to various drug abuse phenotypes. To capitalize on these advances, this FOA is requesting applications to:

Understand genes and biological systems involved in addiction and co-morbid disorders by:
- Producing a unique supplementary addiction genotype array for characterizing a variety of neuropsychiatric disorders, such as addictions, depression, and schizophrenia that would compliment a standard genotype array (e.g 300K - 1M SNP arrays). This resource would allow a single standardized SNP platform to be screened for genetic variants related to substance abuse and related psychiatric disorders in existing DNA samples.
- Conducting GWAS using existing samples collected from research grants
- In depth data mining or meta analyses of genotypes and genomic sequencing to leverage the investment in GWAS and maximize scientific output from the analyzed datasets leveraging large-scale NIH programs to drug abuse research (e.g. applying 1000 Genomes project data to addiction genetics)
- Deep sequencing of high priority regions associated with addiction across the genome is needed to fully understand the genomic structure, the common and rare alleles contributing to disease, and possibly establish insights to function and phenotype.
- Long-range phasing and haplotype imputation of phenotypes associated with nicotine addiction in specific populations
- Conducting whole genome sequencing in a well-characterized set of non-smokers and dependent smokers with and without lung cancer and chronic obstructive pulmonary disease (COPD) to develop a full functional understanding of the genomes sequenced in individuals with a highly common disease (nicotine dependence) and its mortal consequences (lung cancer and COPD). Analyses of these data will help to inform potential tailored treatments, to predict those at high risk of these diseases, and to provide important insights into understanding pathogenesis of different disease endpoints from a common exposure.
Conducting functional genomics studies of nicotine addiction, including:
- Studies of bioactive molecules (e.g. non-coding RNAs, enzymes, ligands, or compounds) that interact with gene variants associated with addiction; such as genetic variants within nicotinic receptor subunit genes, genes that metabolize drugs of abuse (e.g. CYP2A6 and nicotine), and/or genes involved in the addiction process (e.g. COMT, DRDs, MAO, etc)
- Studies to understand how specific drug exposures differentially alter gene networks in addiction
- Studies examining in vivo gene variant effects using imaging strategies
- Studies that use protein structure/function relationships to predict functional effects of gene variants associated with addiction phenotypes
- Development of computational approaches that facilitate medication development of compounds targeting gene variants associated with addiction, and include infrastructure for in vitro and/or in vivo validation
- Maping addiction associated phenotypes/traits using collaborative cross or advanced intercross strains of mice
- Translational studies for functional genomics (animal to human)
- High throughput assay development for functional studies of genetic and epigenetic variants that contribute to drug abuse
- Computational methods for integrating sequence, genotype, and epigenetic data
- Bayesian modeling for gene x gene (SNP x SNP) interactive effects, including gene x gene x environment

Contact: Joni Rutter 301-435-0298, jrutter@nida.nih.gov or Jonathan Pollock 301-435-1309 jpollock@mail.nih.gov or Harold Gordon, hgordon1@nida.nih.gov, 301-443-4877

Harmonizing Phenotypes and Envirotypes across Studies for Genomic Research on Drug Abuse

Over many years, NIDA and other NIH Institutes have funded numerous high-quality studies that contain a wealth of data (genetic, phenotypic, envirotypic) from individuals who are at risk for, or are in the course of development, progression, and desistance of, substance abuse and related phenotypes. This FOA seeks to increase the potential for comparability, replication, and pooling of data across research studies by harmonizing phenotypic and exposure measures for large-scale genome-wide association studies (GWAS) and other genomic research efforts. Applications qualifying for submission under this FOA must rely exclusively on existing studies of human subjects; funding is permitted only for the purpose of supporting the requisite labor-intensive work of harmonizing the phenotypic and envirotypic variables for genetic analyses. Contacts: Kevin P. Conway, 301-443-6504, kconway@nida.nih.gov or Joni Rutter 301-435-0298, jrutter@nida.nih.gov

Epigenetics

There is emerging evidence that epigenetic processes play a pivotal role at the fulcrum between the environment and the genome. No where is this more apparent than in the nervous system. The National Institute on Drug Abuse is very interested in the intersection of drug abuse and epigenetic research. Studies investigating one or more of the following areas are of interest:

The role of epigenetic changes and/or non-coding RNAs in addictive processes, co-occuring psychiatric conditions, or neuroplasticity
Identification and/or development of therapeutic molecules that function via modulation of epigenetic regulatory proteins
Identification of epigenetic or non-coding RNA signatures associated with drugs of abuse. Studies that seek to correlate brain signatures with those from readily accessible tissues such as blood.
Technologies that will facilitate the epigenetic analysis and profiling of heterogenous neuronal tissues
Technologies enabling in vivo imaging of epigenetic marks, modifying enzymes, or effector molecules in the brain
Studies investigating parental imprinting and contributions to allele-specific gene expression in tissues or processes relevant to addiction
Studies investigating transgenerational epigenetic effects of drugs of abuse
Integration of epigenetic measures with ongoing genetic and/or epidemiological studies, especially studies on nicotine dependence
Studies examining gene silencing and/or over-expression due to first-hand, second-hand, and third-hand exposure to tobacco smoke induced epigenetic modifications

Contact: John Satterlee satterleej@nida.nih.gov 301-435-1020 or Steven Grant, sgrant@nida,nih.gov, 301-443-8869

Pharmacogenomics

Pharmacogenetics research has made great strides in recent years, however, our knowledge of all genetic predictors of drug responses is far from complete and further research is needed to clearly establish genotype-phenotype relationships. NIDA is interested in applications to conduct research into understanding the genetic/genomic basis of variable drug responses, both to optimize efficacy and prevent adverse effects. The proposed research studies should include efforts not only to identify the genes, pathways, and systems that produce inter-individual differences in drug responses, but also to establish the mechanistic basis of these differences. Specifically, NIDA seeks applications:

To identify the variability in addiction-related genes and evaluate the functional consequences of that variability leading to clinical application of the knowledge.
For high-throughput studies of approved treatments for drugs of abuse in human populations that will incorporate replication studies as well as analysis of function/mechanism.
Using translational approaches that apply genetic knowledge with other knowledge (such as well-characterized enzymatic assays) to define, test, and validate a sensitive and specific test for success regardless of cessation method or treatment.
To explore drug-drug interactions (for example, drugs of abuse combined with medications, or medications for drugs of abuse combined with other medications), pharmacogenetics of safety and efficacy in phase II and III trials,
To develop methods for prediction of treatment success for addiction.
That associate responses to pharmaceutical treatments of patients with addictive disorders (or at high risk for these disorders) with genomic variation. Novel approaches, including the use of biomarkers and other component- or intermediate-based phenotypes correlated with the clinical disorder, are also encouraged.
Detecting low levels of metabolic changes in binge drug taking (e.g. do cotinine and 3-hydroxycotinine metabolic profiles fluctuate following episodes of acute or "power" smoking)
To explore HIV treatment x drug of abuse interactions (e.g. efficacy of HAART therapy in nicotine addicts)
Using pharmacogenetic approaches to differentiate smoking cessation genetics from smoking dependence genetics to establish gene variants associated with relapse risk and/or quit success.

Contact: Joni Rutter 301-435-0298, jrutter@nida.nih.gov or Steven Grant, sgrant@nida,nih.gov, 301-443-8869

Increasing the Impact of Trial Results from the NIDA Drug Abuse Treatment Clinical Trials Network

The CTN provides an enterprise in which NIDA, treatment researchers, and community-based service providers cooperatively develop, validate, refine, and deliver new treatment options to patients in community-level clinical practice. To achieve this mission, the CTN conducts studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatments multi-site clinical trials to determine effectiveness across a broad range of community-based settings and diversified patient populations. These special populations include adolescents, young adults and persons at high risk for HIV and other sexually transmitted diseases. Recent trial results have indicated that behavioral and pharmacological interventions can affect drug use and other risky behaviors in adolescents or young adults, but the longer term effects of these treatments is unknown. Another area where vulnerable populations intersect, and which is under investigation at CTN, concerns the risk of HIV infection relating to drug use and subsequent behavior. The use of HIV rapid testing, counseling, and provision of test results may affect the spread of HIV; however, the usefulness and flexibility of these procedures remains to be tested in clinics that treat drug abuse clients. A current trial ongoing at CTN is proving feasible in drug abuse clinics, and expansion of this trial to include additional sites, specifically those which concentrate on STD/STI would add considerable information to NIDA's effort to treat HIV infection and drug abuse. These opportunities to augment research are time-limited.

Contact: Ron Dobbins rd220p@nih.gov 301-451-9575 or Mary Ellen Michel mm108w@nih.gov 301-435-0883

Technology to Deliver Evidence Based Practices to Criminal Justice Populations

Criminal justice settings are key domains for the implementation of effective drug abuse and drug-related HIV prevention and treatment interventions. In juvenile justice settings virtually all clients could benefit from some level of intervention - for example, primary drug and HIV prevention for those who have not started abusing drugs, and drug abuse treatment (combined with HIV prevention) for those with a drug use disorder. In adult settings, a large portion of offenders have significant histories of drug abuse or addiction; yet, treatment is often unavailable. Part of the problem is that treatment is often complicated to deliver and is provided inconsistently. One solution is to use novel technologies to address this problem. Technologies include DVD and web-based approaches to intervention delivery, use of automated systems for monitoring and tracking offenders, and new systems for tracking and implementing treatment.

This FOA will support the development and testing of novel uses of electronic and media-based technologies for delivery of the full range of drug abuse and drug-related HIV prevention interventions to juvenile and adult criminal justice populations. Topics of interest include:

Development of feasible and tested screening tools for juvenile and adult criminal justice settings that would efficiently and effectively identify the full range of substance abuse problems: at risk, use/abuse, and addiction, as well as HIV risk behaviors. The end products could be used in assignment to appropriate levels of intervention, whether prevention, early intervention or treatment.
Development and testing of technology-based interventions. These might include DVD, web-based, PDA-based or other approaches to efficiently and effectively deliver high-quality, consistent care.
Development and testing of technologies to assist in the management of treatment services. Key to this goal is the development of technologies which allow more efficient and effective management of information and coordination of care among multiple systems (e.g. probation/parole, courts, specialty substance treatment, employment agencies, etc.).
Development and testing of training materials for criminal justice personnel to encourage more widespread implementation of evidence-based practices.

Contact person: Akiva Liberman, Ph.D. Libermana@nida.nih.gov 301-443-6504 or Will Aklin, Ph.D. aklinwm@nida.nih.gov, 301-443-3207

Building Prevention Infrastructures

Even though effective substance use prevention programs have been developed and their long-term positive impact established, a small proportion of prevention service settings implement evidence-based programs, significantly limiting the public health impact of those research and development efforts. Type 2 translation research (e.g., research on factors associated with the adoption and utilization of scientifically validated interventions by service systems under controlled, uncontrolled or uncontrollable conditions) is needed to move effective drug abuse and HIV/AIDS prevention interventions into service settings. The 2009 National Research Council and Institute of Medicine report "Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities" report highlights the need for "research questions related to the adoption of a prevention program into a service system, which routinely involves the formation of partnerships and the development of an infrastructure to support the technical, financial, administrative, monitoring, evaluative, and logistical needs related to the program (p.323)." Here are examples of work that needs to be completed in order to build prevention infrastructures for moving efficacious interventions into effectiveness trials and can be completed within a two-year period:

Developing and testing systems and models for training, assessing, and monitoring implementation.
- Some of this work can be done online (e.g., measuring implementation and monitoring online).
Adapting interventions and getting feedback on them so that they can be most easily delivered within a specific system.
- Cross-cultural adaptations (cross-cultural specific versus broad).
Putting interventions into modalities that are easily accessible (e.g., online, DVD).
Studying the needs of the deliverers and recipients of the interventions for uptakes of the interventions.
- Social marketing, focus groups.
- Workforce interventions
- Providing military provider access through web-based prevention platforms
Economic analyses that compare highly vulnerable multi-problem youth to low and moderated risk groups embedded within universal prevention interventions to demonstrate the cost benefits for untargeted and targeted prevention interventions.

Contact: Belinda E. Sims, Ph.D. 301-402-1533 bsims@nida.nih.gov

General Information

Funding Priorities

Overall, NIDA expects to devote $40,000,000 over 2 years to the Grand Opportunity program.

Key Dates

Release/Posted Date: March 20, 2009
Opening Date: April 27, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 27, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Changed to May 29, 2009 (see NOT-OD-09-0900)
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): June/July 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 30, 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 28, 2009

Send Letters of Intent to

NIDAletterofintent@mail.nih.gov cite RFA-OD-09-004 in the subject line. In the letter, please state the NIDA priority area (see above list) to which the application would be responding.

Contact Information

Christine Colvis, Ph.D.
301-443-6480
ccolvis@nida.nih.gov

SRO contact:
Teresa Levitin, Ph.D.
(301) 443-2755
TL25u@NIH.GOV

Grants Management Contact(s):
Pamela G. Fleming
Phone (301) 253-8729
pfleming@nida.nih.gov

NIDA's topics for the NIH Challenge Grants in Health and Science Research

The NIH has designated at least $200 million in FYs 2009—2010 for a new initiative called the NIH Challenge Grants in Health and Science Research (RFA-OD-09-003) (NIH site). This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds - 3/4/09.

NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.

This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.

The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.

NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy." Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

The application due date is April 27, 2009.

Broad Challenge Areas and Specific Challenge Topics

Each NIH funding component (Institute/Center) has identified specific challenges within the broad Challenge Areas related to its mission. Those marked with an asterisk (*) are high priority areas

For the National Institute on Drug Abuse, these Challenge Topics are:

(01) Behavior, Behavioral Change, and Prevention

01-DA-101 New Tools for Social Neuroscience and Neurofeedback. NIDA is soliciting research to validate existing measures and techniques, and to encourage the development, improvement and/or adaptation of technologies which, by the end of the funding period, will be verified field-deployable tools that can detect and deliver feedback with maximum precision and reliability. Building on currently available technologies, these tools will be effective and practical instruments for the early identification of children and adolescents with insufficient self-regulation and for incorporation into therapeutic programs facilitating the amelioration of these individuals' dysregulation. Contact: Dr. Elizabeth M. Ginexi, 301-402-1755, LGinexi@nida.nih.gov and Steven Grant, Ph.D. 301-443-4877sgrant@nida.nih.gov

01-DA-102 Individual-based model of social behavior. Employ animal behavioral models to understand social behaviors as antecedents to, or vulnerability for, drug abuse and addiction; effects of drugs of abuse on social interactions; and the consequences of addiction on social behaviors. Includes studies of neurobiological substrates and environmental influences on the complex interplay between social behaviors and drug abuse behavior. Also includes changes in social repertoire that emerge during the developmental course of addiction. Contact: Dr. Minda Lynch, 301-435-1322, mlynch1@nida.nih.gov and Bethany Deeds, Ph.D., 301-402-1935, bdeeds@nida.nih.gov

01-DA-103 Identifying phenotypic markers for positive behavioral change. Identify intermediate phenotypes that predict sensitivity to interventions designed to block the development of drug abuse, block or reduce compulsive drug- taking, or promote abstinence. Phenotypes can be identified using physiological, behavioral, cognitive or neurobiological assessments in animal models or human studies. Research with animal models should manipulate environmental, behavioral or neurobiological variables that alter the sensitivity to these interventions. Contact: Dr. Minda Lynch, 301-435-1322, mlynch1@nida.nih.gov and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov and James Bjork, Ph.D.. 301-443-4209 jbjork@nida.nih.gov

01-DA-104 Functional Roles of Glia-Derived Factors in Mediating Drug Abuse Behavior. Emerging data suggest that the physiological functions of neuroimmune factors such as cytokines and chemokines, and of other factors derived from glia residing within the nervous system actively participate in modulating neuronal function and processes that contribute to and underlie behavioral change. This offers a new framework towards understanding the roles of glia-derived factors in the development and progression of drug abuse and addiction. Contact: Dr. Roger G Sorensen,301-443-3205, rsorense@mail.nih.govand Woody Lin, Ph.D. 301 435-1318 ylin1@nida.nih.gov

01-DA-105 Capturing social network information for groups at high risk for negative health behaviors. Research in this area is needed to enhance existing methodologies and/or devise novel methods that will capture social network information among groups at heightened risk for particular negative health behaviors such as smoking, and use or abuse of illicit drugs and prescription medications. Furthermore, research on characterizing social networks (e.g., sexual networks, drug use networks) to identify protective and risk factors that affect HIV transmission among drug using populations is needed. Novel methods and strategies for doing so are encouraged. Contacts: Dr. Harold I Perl, 301-443-9982, hperl@nida.nih.gov and Dr. Jacques Normand, 301-443-1470, jnormand@nida.nih.gov and Dr. Jessica Chambers, 301-443-2237,jcampbel@mail.nih.gov and Peter Hartsock, Dr.P.H., 301-402-1964, phartsoc@nida.nih.gov

01-DA-106 Development of behavioral and social interventions that reduce stigma and improve quality and accessibility of health care services in low resource settings. Residents of economically deprived neighborhoods in this country have limited access to health care. Accessing HIV/AIDS health care services, including HIV testing is further exacerbated by the stigma associated with drug abuse and HIV infection in those settings. This initiative is soliciting applications that would translate existing knowledge related to the causes and consequences of stigma into pilot interventions that can prevent or mitigate stigma and its associated negative effects on HIV/AIDS health care services among drug users. Contact: Dr. Jacques Normand, 301-443-1470, jnormand@nida.nih.gov and Aria Crump, Sc.D., 301-435-0881, acrump@nida.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov. Cecelia Spitznas, Ph.D., spitznasc@mail.nih.gov, 301-402-1488.

01-DA-107 Identifying phenotypic markers for positive behavior change.Identify reliable, robust intermediate phenotypic markers (using cognitive neuroscience and behavioral economics) that can be used to personalize approaches to support positive health behavior change related to substance abuse and HIV risky decision making behavior. Examples include behavioral disinhibition, delay discounting and other measures of impulsivity, risk perception, sensitivity to reward and punishment, and implicit cognition. Contact: Dr. Lynda Erinoff, 301-443-1470, lerinoff@nida.nih.gov and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318 ylin1@nida.nih.gov

01-DA-108 Test default options to promote healthier behaviors.Exploration by behavioral economists and clinicians to develop and test default options (e.g., placement of fresh fruit displays in stores, the location of parking spaces at the workplace) to promote healthier behaviors. Studies may include incentives and policies for healthier behavior by program staff and providers (e.g. stop smoking programs for drug abuse treatment staff). Contact: Debbie Grossman, M.S., 301-443-2249 Dg9a@nih.gov and Jacqueline Lloyd, Ph.D., M.S.W., 301-443-8892, lloydj2@nida.nih.gov and James Bjork, Ph.D.. 301-443-4209 jbjork@nida.nih.gov

01-DA-109 Behavioral and/or pharmacotherapeutic intervention research in the area of neonatal exposure to substances of abuse. Develop and test behavioral and or pharmacotherapeutic interventions for the neonate to regulate behavior in problem areas, such as feeding problems, irritability, and vomiting problems that ensue due to substance exposure in utero. The behaviors of the neonate exposed to substances are going to constantly change with a developing nervous system and in a milieu in which the mother may have non-appropriate caregiver response. Contact: Steve Oversby, 301-435-0762 soversby@mail.nih.gov and Nicolette Borek, Ph.D. 301-402-0866 nborek@nida.nih.gov

01-DA-110 Identify and/or evaluate dietary supplements that could be used in treating substance abuse disorders. There is abundant preclinical and clinical evidence that suggest dietary therapies and behavioral interventions can promote neurogenesis, diminish susceptibility to metabolic and excitotoxic injury (e.g., diets rich in antioxidants), and/or counteract stress responses within the brain. Dietary regimens or supplements can be evaluated as individual treatments or as adjuncts to FDA-approved medications. Contact: Kris Bough, 301-443-9800, boughk@mail.nih.gov and Allison Hoffman, Ph.D., 301-402-5088, hoffmanal@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318 ylin1@nida.nih.gov

01-DA-111 Approaches to study the interactions among individual behaviors, social and physical environments, and genetic/epigenetic processes during critical developmental periods. NIDA is soliciting research that integrates environmental and developmental variables with genotypic information in order to permit comprehensive model-building and hypothesis testing for determining genetic, environmental, and developmental contributions to substance abuse and related phenotypes. Contact: Dr. Karen Y. Sirocco, 301-451-8661, sirocco@nih.gov and Joni Rutter, Ph.D., 301-435-0298, jrutter@nida.nih.gov and Naimah Weinberg, M.D., 301-443-6504, nweinber@nida.nih.gov

(02) Bioethics

02-DA-101 Research on Obtaining Consent for Illicit Drug Users. NIDA is soliciting research to evaluate the consent form and the procedure to obtain consent from individuals seeking to participate in drug abuse clinical trials. Research to determine their impact on the ability to recruit potential study subjects into drug abuse trials would be needed to determine what measures may be necessary to ensure research subjects are protected. Contact: Bob Walsh, (301) 443-9825, rwalsh@nih.gov and Carmen L. Rosa, M.S., 301-443-9830, crosa@nida.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

02-DA-102 Confidentiality in Electronically Shared Information of Illicit Drug Use Behaviors. NIDA is soliciting research assessing current areas of risk with web-based electronic capture of research data in drug abuse treatment clinical trials as well as suggestions for improvements to existing paradigms to ensure secure transmission of data. Identification of potential future areas of risk regarding the use of data standards and changing regulatory requirements should also be explored. Contact: Bob Walsh, (301) 443-9825, rwalsh@nih.gov and Carmen L. Rosa, M.S., 301-443-9830, crosa@nida.nih.gov

02-DA-103 Translation of genetic knowledge to clinical practice. Address ethical issues related to access to broad sharing and use of new genetic information and technologies for addiction research to improve treatment and prevention options for addicts. Important issues include the identifiability of genetic/genomic information, return of research results and incidental findings to high risk subjects, and alternative models of informed consent for broad data sharing for research. Contact: Dr. Joni Rutter, 301-435-0298 jrutter@nida.nih.govand Hal Gordon, Ph.D., 301-443-4877, hgordon1@nida.nih.gov, Shoshana Y. Kahana, Ph.D., 301-443-2261, kahanas@mail.nih.gov. Elizabeth M. Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov.

02-HG-101* Informed consent and data access policies. The creation of large databases that include genomic information on individual participants, coupled with the move to universal electronic medical records, makes it increasingly possible to identify individual research participants in databases, despite efforts to "de-identify" their data, and potentially to unearth an individual's private medical information. Research is urgently needed to address the implications of this for recruitment, informed consent, and data access policies in biomedical research. NIDA Contact: Dr. Marsha Lopez, 301-402-1846, lopezmar@nida.nih.gov, Cecelia Spitznas, Ph.D., 301-402-1488, spitznasc@mail.nih.gov. Carol A. Cushing, B.B.A., R.N., 301-443-9815, ccushing@nida.nih.gov. Jonathan D. Pollock, Ph.D., 301-435-1309, jpollock@mail.nih.gov.

02-OD(OSP)-101* Unique Ethical Issues Posed by Emerging Technologies. Advances in biotechnology and biomedical science raise novel ethical, legal, and social issues. Research in this area is needed to understand the unique ethical concerns related to emerging technologies (e.g. biotechnology, tissue engineering, nanomedicine, and synthetic biology). These include issues such as dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Research is also needed to assess how these novel issues are addressed under current oversight and regulatory structures and identify where there may be gaps and/or need for revised or new oversight approaches. NIDA Contact: Dr.Kathy Etz, 301-402-1749, ketz@nida.nih.gov, Jessica Chambers, Ph.D., 301-443-2237, jcampbel@mail.nih.gov. Thomas Aigner, Ph.D., 301-435-1314, taigner@nida.nih.gov.

02-RR-101* Recontact Issues in Genotype and Genome-Wide Association Studies. Genotype and genome-wide association studies create challenging re-contact issues if subjects are later to be asked to return for clinical research including phenotyping. Applicants would propose 2-year awards for pilot programs that would be implemented at 3 or more affiliated sites to develop and apply IRB guidelines that addressed ethical barriers (e.g., re-contacting) in genotype - phenotype studies. This idea is submitted through NCRR on account of the ethics work underway at the Clinical and Translational Science Awards (CTSAs) and, if accepted, would be developed with NHGRI's ELSI Division. NIDA Contact: Dr. Louise Wideroff, 301-443-8663, wideroffl@nida.nih.gov, Hal Gordon, Ph.D., 301-443-4877, hgordon1@nida.nih.gov. Jonathan D. Pollock, Ph.D, 301-435-1309, jpollock@mail.nih.gov.

(03) Biomarker Discovery and Validation

03-DA-101* Biomarkers for Pain. Pain research has been greatly hampered by the unreliable nature of self-report based instruments. The establishment of objective, affordable and reliable pain biomarkers and measurements would advance our understanding of pain mechanisms, provide a basis for improved clinical management of pain, help assess an individual's risk for becoming addicted to opiate analgesics, and establish much needed objective measures of treatment success or failure. Contact: Dr. Yu Lin, 301-435-1318, ylin1@nida.nih.gov and Richard Denisco, M.D., M.P.H., 301-594-4371, deniscor@nida.nih.gov and David Thomas, Ph.D., 301-435-1313, dthomas1@mail.nih.gov

03-DA-102* Novel Molecular Targets From Unexpected Sources. The quiescent databases left behind by unsuccessful medication trials represent an incredibly rich resource with the potential to turn failure into success. Through the use of strategic alliances (e.g., with FDA Critical Path Initiative) and novel approaches, such as target deconvolution and network pharmacology, these databases, can be transformed into engines of discovery to dramatically increase our ability to recognize novel molecular targets that underlie robust biological responses such as liability to drug abuse. Contact: Dr. Elena Koustova, 301-496-8768, koustovae@mail.nih.gov and Nora Chiang, Ph.D., 301-443-5280 or 301-443-8099, nchiang@nih.gov

03-DA-103* Comprehensive biomolecular mass spectrometry. Current detection methodologies provide a narrow window into just 1% of the molecular universe. As a consequence, there is a strong need to develop new mass spectrometric technologies for the faster, more sensitive, more specific, and more comprehensive identification of biomolecules (both charged and neutral proteins and lipids) in tissue samples and single cells. This initiative seeks to leverage the potential of cutting edge technologies in the areas of ion mobility and vacuum ultraviolet photofragmentation for developing molecular identification and quantitation instruments that could be deployed in the clinical as well as research environments. Contact: Dr. Christine Colvis, 301-443-6480, ccolvis@nida.nih.gov

03-DA-104* Biosignatures of Drug Exposure. Chronic exposure to a pathogenic agent is one of the defining features of conditions such as infectious diseases and substance use disorders. This characteristic presents a unique opportunity to develop and harness the power of biosignatures that could reliably predict disease vulnerability, trajectory, and treatment outcome. This initiative is specifically designed to uncover and validate peripheral endogenous biomarkers in animal models exposed to chronic drug exposure, withdrawal, or relapse that may serve as surrogates for CNS changes in humans. The results are also likely to spur significant advances in a host of related disorders. Contacts: Dr. Ivan D. Montoya, 301-443-8639, Imontoya@mail.nih.gov and Jeffrey Schulden,M.D., 301-402-1526, and schuldenj@nida.nih.gov, and Elena Koustova, 301-496-8768, koustovae@mail.nih.gov

03-DA-105 Biomarkers, stress and immune function. Stress is known risk factor for substance abuse and relapse, and stress, substance abuse and withdrawal are known to impact immune function. There is a need to identify biomarkers to assess the impact of stress, both social and biological (including substance abuse and withdrawal), on immune function. Studies addressing specific immune or inflammatory responses to HIV/SIV infection are of particular interest. Dr. Diane Lawrence, 301-443-1470, lawrencedi@nida.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov and Hal Gordon, Ph.D., 301-443-4877, hgordon1@nida.nih.gov, and Albert Avila, Ph.D., 301-496-8804, aavila@nida.nih.gov and Ivan D. Montoya, 301-443-8639, Imontoya@mail.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov. Hal Gordon, Ph.D., 301-443-4877, hgordon1@nida.nih.gov. Albert Avila, Ph.D., 301-496-8804, aavila@nida.nih.gov

03-DA-106 Biomarkers in mental disorders. There is a need for innovative approaches to identify biomarkers that can predict illness onset, define diagnosis, identify potential individualized therapeutic targets, and/or assess treatment responses related to HIV-associated neurological and neurocognitive impairment. Studies incorporating substance abusers or model systems that include exposure to abused substances would be appropriate. Dr. Diane Lawrence, 301-443-1470, lawrencedi@nida.nih.gov and Marsha Lopez, Ph.D., 301-402-1846, lopezmar@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318 ylin1@nida.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov. Shoshana Y. Kahana, Ph.D., 301-443-2261, kahanas@mail.nih.gov.

03-DA-107 Biomarkers of substance abuse comorbidity. This initiative will support the development of molecular/proteomic biomarkers that will help in the detection, assessment and treatment of drug abuse comorbidity consisting of infections; and provide objective testing methods, help in the understanding of molecular bases of diseases, disease processes and progression. Contact: Jag H. Khalsa, (301) 443-2159 jk98p@nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318ylin1@nida.nih.gov

(04) Clinical Research

04-DA-101 Evaluation of novel, rationalized poly-pharmacotherapeutic treatment strategies for substance abuse. Phenotypic robustness is underpinned by redundant and compensatory functional signaling routes. Network biological analysis predicts that modification of a single target by a drug is not nearly as likely to affect disease outcome as would rational combinations of drugs that target multiple, complementary mechanisms. Applications will focus on combination of medication strategies for the treatment of substance use disorders. Contact: Kris Bough, 301-443-9800, boughk@mail.nih.gov

04-DA-102 A New Look at Longitudinal Data. NIH has funded numerous prospective longitudinal epidemiologic, developmental, prevention, and treatment studies that have resulted in extensive data sets. A real need exists for additional funding to analyze these rich data resources; much of these data remain unmined due to budget and time constraints. The Challenge Grants could provide support for new research questions from already collected data. The grants could also support research to add outcome measures that were not originally included in the longitudinal project, for example, adding substance use and other behavioral outcomes to a study of smoking and asthma. Contact: Dr. Nicolette Borek, 301-402-0866, nborek@nida.nih.gov and Marsha Lopez, Ph.D., 301-402-1846, lopezmar@nida.nih.gov

04-DA-103 Extending the Reach of Web-Based Drug Abuse Prevention and Treatment to Rural and Other Remote Locations. Many persons living in remote or rural locations have limited opportunities to obtain drug abuse treatment services, due to a lack of available service settings, the barrier of traveling long distances, and/or the perceived lack of private and confidential treatment options. This program seeks to develop web-based drug abuse treatment interventions that do not necessitate frequent in-person visits to a central facility. The interventions could take various forms, including: accessing interactive web-sites, video linkages with an individual counselor, video linkages with counselor-led group sessions, and asynchronous linkages with moderated chat rooms. Contacts: Dr. Harold Perl, 301-443-9982, hperl@nida.nih.gov and Dr. Jacqueline Lloyd, 301.443.8892, Lloydj2@nida.nih.gov and Dr. Cecelia Spitznas, 301-402-1488, spitznasc@mail.nih.gov

04-DA-104 Primary Screening for Psychiatric Problems. A standardized screening assessment for behavioral and psychiatric problems would greatly increase the identification of patients' problems in medical settings and would also promote adoption of a standardized core research assessment, facilitating substance abuse, comorbidity and other psychiatric disorder identification across multiple clinical and research settings and maximize data utilization and cross situational analyses. It would also facilitate research use of diagnostic and treatment data from the intervention field and the translation of empirical data into applied contexts. The goal is to develop a relatively brief, easily administered and scored assessment with strong abuse and addiction validity. Contact: Dr. Jeffrey Schulden, 301-402-1526, schuldenj@nida.nih.gov

04-DA-105 HIV - Viral Hepatitis Co-Morbidity. The aims of this research topic area are to investigate the feasibility, acceptability, efficacy, and effectiveness of combined screening for HIV, Hepatitis-B and Hepatitis-C at general and specialty medical clinics, emergency departments, trauma centers, intensive care units, community treatment centers for alcohol and substance abuse, sexual transmitted disorders clinics, detention centers, educational centers, etc. Furthermore, research is needed to examine the effectiveness of linking screening for HIV and viral hepatitis to appropriate medical care for those infected. Contact: Dr. Raul N. Mandler, 301-435-0645, mandlerr@nida.nih.gov and Jag H. Khalsa, Ph.D., (301) 443-2159 jk98p@nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

04-DA-106 Integrating cost-effectiveness analysis into clinical research.This initiative calls for cost-effectiveness analysis of new and innovative HIV/AIDS interventions (i.e., prevention and treatment) as well as of existing interventions with demonstrated effectiveness. Such cost-effectiveness research should provide information that can inform and guide future policies that support the allocation of health resources for the prevention and/or treatment of HIV/AIDS. Contact: Dr. Jacques Normand, 301-443-1470, jnormand@nida.nih.gov and Sarah Duffy, Ph.D., 301-451-4998, duffys@nida.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov

04-DA-107 Improving quality of life of patients and family following a war-related traumatic injury. Develop and test personalized behavioral or pharmacological interventions to prevent development of or treat psychiatric disorders, addictions, or other complications in persons with war-related traumatic injuries both in theatre and during the post hospitalization transition period, with the ultimate goal of improving the health and quality of life of affected individuals and families. Preventive and treatment interventions for families would be applicable during pre-deployment, deployment, and post-deployment stages. Contact: Dr. Steve Sparenborg, 301-496-4844, Sparenborgs@nida.nih.gov and Eve Reider, 301-402-1720, ereider@nida.nih.gov and Dr. Cecelia Spitznas, 301-402-1488 spitznasc@mail.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov

04-DA-108 Development of effective approaches to increase minority recruitment and retention into clinical trials. Minority participation in substance abuse and HIV/AIDS clinical trials has been very low and new tools are needed to improve this in order to advance knowledge in treatments that are most effective in helping minority groups. This initiative encourages researchers to develop and evaluate innovative approaches to promote subject retention and initiatives that build partnerships and utilize new and non-traditional approaches to recruitment and retention. Contacts: Dr. Lynda Erinoff, 301-443-1470, lerinoff@nida.nih.gov and Carmen L. Rosa, M.S., 301-443-9830, crosa@nida.nih.gov

04-DA-109 Medication development for hepatic fibrosis. HIV/HCV co-infection among drug abusers is a major cause of hepatic fibrosis, and HCV-related liver disease is the leading cause of death among those on HAART therapy. Given the morbidity/mortality associated with this disease, there is an urgent need for translation of emerging antifibrotic molecules into effective therapies. Expediting clinical trials for compounds that have successfully undergone preclinical studies has the potential to make much needed medications available and reduce the need for liver transplantation. Contact: Dr. Lynda Erinoff, 301-443-1470, lerinoff@nida.nih.gov and Jag H. Khalsa, Ph.D., (301) 443-2159 jk98p@nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

04-DA-110 Screening, Brief Intervention, and Referral to Treatment (SBIRT). Excessive use, abuse, and/or dependence on drugs and alcohol have a tremendous impact on individual health status, contributing to a variety of medical conditions having high levels of associated mortality and morbidity. The attention required to attend to these conditions also places increased burden on the medical system, including considerable costs that are often not recovered. Under the NIH Challenge Initiative, the aim of this research topic area is to investigate the feasibility, efficacy, effectiveness, sustainability and cost benefits of using screening, brief intervention and referral to treatment (SBIRT) strategies to decrease the medical and social burden of alcohol and/or drug abuse in the US. Contact: Dr. Raul N. Mandler, 301-435-0645, mandlerr@nida.nih.gov and Dr. Cecelia Spitznas, 301-402-1488, spitznasc@mail.nih.gov and Richard Denisco, M.D., M.P.H., 301-594-4371, deniscor@nida.nih.gov

04-DA-111 Clinical Neurobiology of Chronic Opioid Use and Misuse. There is an urgent need for research that will more thoroughly delineate the neurobiological implications of long-term opioid use. This knowledge gap is of particular concern when it comes to the developing brain - and the urgency is underscored by the fact that increasing numbers of adolescents and young adults are using opioid medications, prescribed and otherwise. Research funded in this area could be instrumental in the development of evidence-based clinical guidelines for prescribing and managing long-term opioid pharmacotherapy for chronic pain and opioid dependence, and in furthering our understanding of the treatment needs of opioid dependent patients. Contact: Dr. David Liu, 301-443-9802, dliu@nida.nih.gov and Petra Jacobs, M.D., 301-451-6338, pjacobs@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318 ylin1@nida.nih.gov

04-DA-112 Enhancing the Impact of Behavioral Interventions using New and Innovative Technology. The ultimate goal of the NIH is to improve public health as measured in terms of biological well-being, which is multidimensional and is strongly shaped by behavioral variables. Neuroscience research on brain plasticity has demonstrated, unequivocally, that the brain changes as a result of behavior changes. Technological advancements have made it possible to better measure the impact of behavioral interventions on specific biological targets and processes. Innovative 2-year projects that will utilize technology to enhance efficacious behavioral interventions by targeting specific neurobehavioral and/or biological processes (e.g., risk taking, impulsivity, decision making) involved in drug abuse/addiction. Contact: Dr. Lisa Onken, 301-443-2235, Lisa_Onken@nih.gov and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov

04-DA-113 Development of behavioral and social interventions that reduce stigma and improve quality and accessibility of health care services in low resource settings. In the same manner that the effects of stigma magnify the personal and societal problems related to substance use disorders and HIV infection, addressing, preventing, or mitigating stigma of these disorders and their effects on recovery can profoundly improve the lives of individuals with these disorders, their families, and the larger society. The engagement of key stakeholders (such as professional treatment programs, healthcare-delivery disciplines, and informal care-giving networks) in offering viable treatments that reduce the stigma of substance use disorders and HIV infection may be critical to implementation of treatments that enhance and sustain positive health. Thus, there is a critical need in substance abuse and HIV treatment to translate existing knowledge related to the causes and consequences of stigma into scalable pilot interventions that can measure stigma and prevent or mitigate its negative effects on recovery from these disorders. Contact: Dr. Udi E. Ghitza, 301-443-9983, ghitzau@nida.nih.gov and Dionne Jones, Ph.D., 301-402-1984, Djones1@nida.nih.gov

04-DA-114 New and innovative technologies to monitor patient behaviors and clinical status in clinical trials. Develop and test new affordable, technologies to enable remote, centralized monitoring of physiologic, behavioral and neurologic indices across various health and mental disorders as well as study medication compliance and overall treatment compliance, and adverse effects in clinical trials. These technologies should provide opportunities to enhance efficiency in clinical trials, as well as to collect more "real life" data. Identity verification and time stamp information will be needed in some cases. Contacts : Dr. Cecelia Spitznas, 301-402-1488, spitznasc@mail.nih.gov and Tom Hilton, Ph.D., 301-443-6504, thilton@nida.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

04-DA-115 The effect of drug addiction treatment immunotherapies (monoclonal antibodies or vaccines) on the fetus. Preclinical assessment of changes in maternal and fetal (organ) drug distribution following maternal administration of an immunotherapy. Preclinical studies to assess teratology and pharmacokinetics of immunotherapies, alone and in combination with drugs of abuse or nicotine. Contact: Jamie Biswas, 301-443-8096, jb168r@nih.gov

04-DA-116 Research to develop novel pharmacotherapy strategies for the treatment of pregnant/postpartum women with substance related disorders. Substance abuse during pregnancy often occurs in the context of complex environmental factors and poly-drug exposure, as well as medical conditions which are associated with adverse neonatal consequences. Much is known in regard to the negative effects of substances of abuse on the pregnant/post partum women and their substance exposed neonates but relatively little is known in regard to medication treatment strategies and research methodology. Contact: Steve Oversby, 301-435-0762, soversby@mail.nih.gov

04-DA-117 Drug response and toxicity. Application of pharmacogenetics and pharmacogenomics to addiction research by the development or use of pre-clinical models, new technologies and approaches to complement pharmacogenomic studies to enhance signal to noise ratios and aid mechanistic studies, and consensus standards for normal and altered phenotypes in response to drugs of abuse, or treatments for drug addiction. Contact: Dr. Joni Rutter, 301-435-0298, jrutter@nida.nih.gov and Ivan Montoya, M.D., M.P.H., 301-443-8639, Imontoya@mail.nih.gov

04-DA-118 Role of the human gut microbiome in chronic diseases.Applications will be invited to understand the interactive effects of drugs of abuse and gut microbiome on the pathogenesis of chronic diseases such as HIV and HCV. Contact: Dr. Vishnu Purohit, 301-594-5754, vpurohit@nida.nih.gov and Jag H. Khalsa, Ph.D., (301) 443-2159 jk98p@nih.gov

04-DA-119 Novel methods in mucosal immunology. Gut-associated lymphoid tissue (GALT) is the largest mucosal lymphoid organ and the major site of HIV replication which is associated with severe CD4+ T cell depletion. Various drugs of abuse have also been shown to compromise immune system as well as disrupt intestinal integrity. Understanding the interactive effects of drugs of abuse and HIV infection on GALT may help prevent progression of HIV-associated pathological conditions. Contact: Dr. Vishnu Purohit, 301-594-5754, vpurohit@nida.nih.gov

04-DA-120 Medication development for hepatic fibrosis. Liver fibrosis is a common feature of chronic liver diseases such as Hepatitis C, alcoholic liver diseases and nonalcoholic steatohepatitis, and it can progress to cirrhosis without intervention. There is an urgent need for translation of potential antifibrotic molecules into effective therapies. Activation of cannabinoid 2 (CB2) receptors and inactivation of cannabinoid 1 (CB1) receptors have been shown to attenuate liver fibrosis in animal model of fibrosis. Preclinical studies are required to test the efficacy of various CB1 antagonists and CB2 agonists in the treatment of liver fibrosis. Contact: Dr. Vishnu Purohit, 301-594-5754, vpurohit@nida.nih.gov and Jag H. Khalsa, Ph.D., (301) 443-2159 jk98p@nih.gov

(05) Comparative Effectiveness Research

05-DA-101* Behavioral and Medication Interventions To Treat Drug Abuse Disorders in Non-Specialty Care Settings. Treatment for substance use disorders has most commonly been provided in specialty care settings such as residential therapeutic communities, methadone maintenance treatment clinics, and dedicated inpatient or outpatient substance abuse treatment programs. One way to broaden access to substance abuse treatment would be to expand care in non-specialty care settings (i.e., primary care settings such as emergency departments, general medicine and public health clinics), and the criminal justice system. Research is needed on the comparative effectiveness of treatment interventions delivered in non-specialty care settings compared to those in traditional settings. Contact: Dr. Redonna Chandler, 301-443-8768, rc274k@nih.gov and Dr. Will Aklin, 301-4433207, aklinwm@nida.nih.gov and Petra Jacobs, M.D., 301-451-6338, pjacobs@nida.nih.gov

05-DA-102* Treatment of Substance Abuse and Related Health Consequences Using Web-Based Technologies. Evidence-based behavioral therapies are not routinely integrated in substance abuse treatment programs because of financial constraints or inadequate provider training. Technology is increasingly being harnessed as a low-cost option for teaching behavioral skills to substance users, thereby broadening their availability. Research is needed to compare the effectiveness of already developed web-based technologies (e.g., cognitive behavioral therapy; community reinforcement; HIV risk reduction) with traditional modes of treatment delivery (e.g., counselors, physicians, etc.) in order to optimize use of the web for expanding delivery of science-based behavioral treatment, with fidelity, and in a manner that reduces cost and staff burden. Contact: Dr. Cecilia Spitznas, 301-4021488, spitznasc@mail.nih.gov and Tom Hilton, Ph.D., 301-443-6504, thilton@nida.nih.gov

05-DA-103* Integrated vs. Separate Treatment of Substance Abuse and Comorbid Conditions. Comorbid psychiatric disorders as well as other serious medical conditions such as infectious diseases (e.g., HIV/AIDS) and chronic pain commonly co-occur with substance use disorders. Additionally, people addicted to one substance are frequently addicted to others. Comparative effectiveness research could fill a knowledge gap regarding the benefits of treating conditions in an integrated manner versus separately, pointing treatment providers and physicians toward the most effective intervention strategies for multiple disorders, identifying optimal methods of coordinating and delivering treatment while ensuring its quality and access, reducing costs, preventing further illness and disability, and improving community functioning and integration. Contact: Bennett Fletcher, Ph.D., 301-443-6504, bfletche@nida.nih.gov and Shoshana Kohana, Ph.D. 301-443-2261, kahanas@mail.nih.gov and David Liu, M.D., 301443-9802, dliu@nida.nih.gov

05-DA-104* Comparing Drug Treatment Effectiveness in Ethnic Minority Populations. Research suggests that treatment response can vary among different minority populations due to genetic, environmental and cultural factors. Still, it is unknown which treatments work best for which ethnicities. Comparative effectiveness studies in ethnic minorities would test pharmacotherapies and behavioral treatments for substance abuse that have already shown efficacy in some populations. Results could reveal optimal treatment types for various populations, many of which are currently under-studied or under-served in terms of treatment need, including African Americans, Native Americans, and Hispanics. Contacts: Dr. Mary Ellen Michel, 301-443-6697, michelm1@nida.nih.gov and Dr. Lula Beatty, 301-443-0441, Lb75x@nih.gov and Tom Brady, Ph.D., 304-443-6504, Bradyt22@mail.nih.gov

05-DA-105* Comparing Episodic and Continuous Care for Drug Abuse Treatment. Concerns have been raised over the mismatch between usual drug abuse treatment, which follows an acute care model, and emergent perspectives that addiction is a chronic illness. To treat drug abuse and addiction as a chronic illness implies that treatment providers should follow acute care with long-term monitoring and interventions to prevent a recurrence of drug use and to re-engage relapsed patients in treatment in order to minimize the consequences of the relapse. Research is needed on the comparative effectiveness of usual drug abuse treatment with drug treatment based on a model of continuing chronic illness care. Contacts: Shoshana Kohana, Ph.D., 301-443-2261, kahanas@mail.nih.gov and Bennett Fletcher, Ph.D., 301.443.2274, bf31v@nih.govand Petra Jacobs, M.D., 301-451-6338, pjacobs@nida.nih.gov

(06) Enabling Technologies

06-AT-101* Imaging correlates of brain states. Exploration of brain imaging technologies to provide insight into higher-order states such as awareness of self, focused attention, stress, meditative states, calm and other emotional states; utilize brain imaging to develop objective measures and rigorous, quantitative evaluation of subjective states. NIDA Contact: Dr. Steven Grant, 301-443-4877, sgrant@nida.nih.gov

06-DA-101 Epigenome-Wide Association Studies (EWAS). Given current technology, it would be prohibitively expensive to perform epigenome-wide association study in which epigenome-wide analysis is performed on thousands of cases and controls. This barrier significantly impedes our ability to identify epigenotypes important in common human diseases. The development of an approach enabling low cost EWAS scans would transform epigenomic investigations into diseases such as addiction. Contact: Dr. John Satterlee, 301-435-1020, satterleej@nida.nih.gov

06-DA-102 Tool Development for the Neurosciences. Tools that unambiguously identify, manipulate, and report from neurons in vivo and in vitro are needed to help us understand interactions within neural circuits, to examine the functions of types of neurons that are derived from different brain regions, and to determine how selective and conditional silencing or activation of individual neurons or groups of similar neurons may alter functional outcomes, including behavior. This methodology can contribute greatly to the identification of real-time responses to drugs of abuse or to therapeutic interventions, and can play a key role in helping us understand endogenous neuroprotective mechanisms and the repair of frank brain damage or neural dysfunction as a result of drug abuse. Contact: Dr. Nancy Pilotte, 301-435-1317, npilotte@nih.gov and Steven Grant, Ph.D. 301-443-4877 sgrant@nida.nih.gov

06-DA-103 Identification of chemical modulators of epigenetic regulators.There are a limited number of pharmacological agents available to manipulate the in vivo activity of most epigenetic modifying enzymes, effector molecules, etc. High-throughput small-molecule screening strategies targeted at specific epigenetic regulatory molecules could identify chemical reagents targeting a broad range of epigenetic regulatory molecules. These high impact reagents have the potential to transform the way epigeneticists conduct in vivo disease research. Contact: Dr. John Satterlee, 301-435-1020, satterleej@nida.nih.gov

06-DA-104 Development of new technologies to change patient and provider behaviors to improve adherence. New and innovative strategies to improve patient adherence to HIV/AIDS medical regimens and utilization of adherence-enhancing strategies in clinical practice would greatly enhance the health impact of efficacious treatments. This challenge invites the development of novel strategies to change patient and provider behaviors to enhance adherence to HIV/AIDS therapeutics among drug users. Contact: Dr. Jacques Normand, 301-443-1470, jnormand@nida.nih.gov and Thomas Hilton, Ph.D., 301- 435-0808, thilton@nida.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov, Jessica Chambers, Ph.D., 301-443-2237, jcampbel@mail.nih.gov.

06-DA-105 Improving health through ICT/mobile technologies. Enhancing patient compliance. ICT applications hold the prospect of dramatically improving patient health and treatment compliance in the US and abroad at greatly reduced cost. To realize these potentials, implementation research is required to identify behavior modification strategies at all levels (patient, provider and institutions) which will yield the most effective treatment outcomes using these technologies. Development and programming and feasibility testing of applications for computer and mobile devices will also be considered especially for evidence based therapies. Contact: Dr. Cecelia Spitznas, 301-402-1488, spitznasc@mail.nih.gov and Liz Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov

06-DA-106 Predictive models of potential drug addiction treatment agents. Develop predictive models of compound interactions with receptors and transporters known to be involved in drug addiction or targets for drug addiction treatment. Models developed can be intended to predict various pharmacological properties (i.e., affinity, function, toxicity, etc.). Contact: Dr. Richard Kline, 301-443-8293, rkline@nida.nih.gov and Rao Rapaka, Ph.D., 301-435-1304,rrapaka@mail.nih.gov

06-DA-107 Measuring the body burden of emerging contaminants: Biosensors and lab "on-chip" technology for measuring in vivo environmental agents. New advances in biosensors and lab-on-chip technology create novel ways to measure the sub-clinical health effects of second-hand and third-hand smoke in the environment. Development or field testing of the most promising environmental sensors that detect tobacco smoke combined with their use within existing epidemiologic studies are encouraged. Contact: Dr. Joni Rutter, 301-435-0298, jrutter@nida.nih.gov and Paul Hillery, Ph.D., 301-435-1306, phillery@mail.nih.gov

06-DA-108 Infrastructure for biomedical knowledge discovery.Development of collaborative, research-community and concept based, integrated scientific knowledge environments to promote and accelerate articulation, discovery, exploration, discussion, testing, analysis, and sharing of hypotheses and the scientific evidence supporting them in basic neuroscience and behavioral addiction research. Contact: Dr. Karen Skinner, 301-435-0886, ks79x@nih.gov

06-DA-109 Developing new computational approaches to Information Retrieval. Development of computational approaches which query multiple data sources and types relevant to basic neuroscience and behavioral addiction research, and which (1) employ or add to the Neurolex vocabulary of the NIH Blueprint Neuroscience Information Framework and (2) focus on enabling user-friendly complex queries based on concepts, anatomical coordinates, and other query parameters relevant to addiction research, that return source data elements directly within a format and context that makes them easily interpreted and accessible. Contact: Dr. Karen Skinner, 301-435-0886, ks79x@nih.gov

06-MD-101* Development of Telehealth Tools to Promote Health and Connect At-Risk Youth to the Health System via Low-Cost, Mobile, and Wireless Technologies. NCMHD is interested in the development of telehealth messages utilizing various forms of technology, aimed at high-risk youth as well as innovative culturally and linguistically appropriate media strategies for connecting at-risk youth with the healthcare system. NIDA Contact: Dr. Jacqueline Lloyd, 301-443-8892, lloydj2@nida.nih.gov, Jessica Chambers, Ph.D., 301-443-2237, jcampbel@mail.nih.gov.

06-RR-101* Virtual environments for multidisciplinary and translational research. Virtual networking environments like Science Commons, Facebook, and Second Life, create platforms that can eliminate many barriers in scientific collaborations. These environments integrate fragmented information sources, enable "one-click" access to research resources, and assist in re-use of scientific workflows. Funded projects would develop and implement virtual collaborative environments to facilitate biomedical and translational research, e.g. addressing issues of privacy, technology transfers, and sharing resources. NIDA Contact: Dr. David Thomas, 301-435-1313, dthomas1@nida.nih.gov, Bethany Deeds, Ph.D. 301-402-1935, bdeeds@nida.nih.gov. Cecelia Spitznas, Ph.D., 301-402-1488, spitznasc@mail.nih.gov.

(07) Enhancing Clinical Trials

07-DA-101 Enhancing medications development for drug addiction treatment by addressing the increasing complexity of designs, increasing costs, and regulatory hurdles of clinical trials. NIDA is soliciting grant applications focusing on strategies to enhance the success of clinical trials of medications for the treatment of drug addiction. Applications may focus on improving the design, implementation, data management, data analysis, and/or treatment outcomes to increase the chances of obtaining NDA approvals. Approaches and goals may involve but shall not be limited to the use of new technologies, electronic data capture, web-base data transmission, real-time data collection, biomarker electronic monitoring, adaptive clinical trial designs, early identification and management of safety concerns, and improvement of subject recruitment and retention in clinical trials. Contact: Dr. Ivan D. Montoya, 301-443-8639, Imontoya@mail.nih.gov

07-DA-102 Development of methodologies and scientific tools for improving and/or assessing the external validity of randomized clinical trial (RCT) results to known populations. Typically, participants in NIDA's RCTs are volunteer patients with substance abuse disorders who are seeking treatment. The fact that these patients are not randomly selected, and are recruited from non-randomly selected clinical or community settings limits the generalizability of results, a critical problem for comparative effectiveness research. Research is needed to develop scientific tools for improving and/or assessing the external validity of RCT results to known populations, including methods for applying probability sampling in the identification and recruitment of RCT participants, measuring biases in RCT participant pools, and accounting for such biases in the analysis of RCT results. Contact: Dr. Paul G. Wakim, 301-402-3057, pwakim@nida.nih.gov and Debbie Grossman, M.S., 301-443-2249, Dg79a@nih.gov and Belinda Sims, 301-402-1533, bsims@nida.nih.gov

07-DA-103 Development of methodologies and scientific tools for improving and or assessing the external validity of randomized clinical trial (RCT) results to known populations. Develop a strategy utilizing existing data from substance abuse clinical trials to identify and compare the evaluation period and methodology utilized for measuring primary outcome success. Consideration should be given to both the achievement and duration of success and the optimal measurement strategy for treatment success. Explore long-term outcomes of study participants and patients in treatment to determine how the short term outcome correlates to long term results. Contact: Michele M. Straus, RPh, MS, 301-443-8888, mstraus@nida.nih.gov

07-DA-104 Development of methodologies and scientific tools for improving and/or assessing the external validity of randomized clinical trial (RCT) results to known populations. Often in substance abuse and HIV/AIDS research, potential participants are involved with the criminal justice system and minority groups are overrepresented; frequently they are either excluded from the studies or included in such a way that their data cannot be collected in a systematic manner. Research is needed for assessing the impact of exclusion/missing data and the external validity of RCT results to this important group of individuals with substance abuse problems and criminal justice involvement. Contact: Carmen L. Rosa, M.S., 301-443-9830, crosa@nida.nih.govand Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

07-DA-105 Enhanced Technologies to Monitor Illicit Drug Use Behaviors in Clinical Trials. To develop and validate new and innovative technologies that may improve the validity and reliability of data collected on illicit drug use behaviors in clinical trials. Applications may involve but are not limited to the use of technologies to enhance the quality of the report of illicit drugs and associated behaviors such as drug craving and withdrawal as well as adverse events and concomitant use of medications by participants in clinical trials. Contact: Dr. Ivan Montoya, 301-443-8639, Imontoya@mail.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

07-DA-106 Impact of drug abuse treatments on quality of life. Research to determine the impact on quality-of-life of medications and other interventions employed to treat drug abuse, particularly in the stimulant abuse area. Validation of existing measures and techniques, and to encourage the development, improvement and/or adaptation of instruments that measure quality-of-life and cost-effectiveness of treatments employed in drug abuse research. Contact: Dr. Ivan Montoya, 301-443-8639, Imontoya@mail.nih.gov and Bennett Fletcher, Ph.D., 301-443-6504, bfletche@nida.nih.gov

(08) Genomics

08-DA-101 An Epigenomic "Neurochip". Individual genomic variation is likely to influence epigenomic variation significantly. One solution to the challenge of conducting epigenomic investigations into neuropsychiatric disorders could thus be to computationally identify genomic regions or single nucleotide polymorphisms in known or suspected regions of epigenomic variation. This composite data could be used to develop a "neurochip" for use in case and control studies to identify gene variants (and corresponding epigenotypic variants) important in neuropsychiatric disorders such as addiction Contact: Dr. John Satterlee, 301-435-1020, satterleej@nida.nih.gov

08-DA-102 Improved Bioinformatics Analysis for Deep Sequencing. The current estimate of sequencing an entire human genome is $5000 and can be accomplished in a few months. However, current bioinformatic and analytic capabilities are inadequate to analyze the volumes of data that would be generated by deep sequencing many individuals. Specifically, RC1 applications are sought to (1) optimize base calls from next-generation sequencing machines, (2) develop and improve optimal alignment/mapping methods that tackle uncertainty and multiple potential placements, (3) identify methods for SNP calling from multiple reads and multiple samples, (4) identify copy-number variation calling from next-generation sequencing data, and (5) develop automated methods for searching sequence databases that could be used to give probabilities that a variant is real. Contact: Dr. Jonathan D. Pollock, 301-435-1309, jpollock@mail.nih.gov

08-DA-103 Genetic and epigenetic predictors of symptom severity.Research on the genetic and epigenetic underpinnings of symptom severity in acute or chronic HIV-associated neurological and neurocognitive impairment, and identify individuals at greatest risk for these symptoms. Individuals with a history of substance abuse or current substance users, or SIV models incorporating substances of abuse, must be included in the analyses. Dr. Diane Lawrence, 301-443-1470, lawrencedi@nida.nih.gov and Joni Rutter, Ph.D., 301-435-0298, jrutter@nida.nih.gov

08-DA-104 Cross-disease research to identify commonly targeted pathways or mechanisms between low incidence, neurogenetic disorders with high incidence, population-based disease. Progress in treating drug addiction and related disorders has been hindered by the complex genetics and heterogeneous etiologies of these disorders. Analyzing related or clinically overlapping disorders (e.g., smoking and schizophrenia, substance abuse and conduct disorder, or poly-substance abuse) or studying rare genetic variants of large effect can yield unique biological insight into the mechanisms of underlying common diseases. Dissecting pathways common to complex genetic disorders of addiction and other neurobehavioral comorbidities will help identify potential therapeutic targets. Contact: Dr. Joni Rutter, 301-435-0298, jrutter@nida.nih.gov

08-DA-105 Beyond GWAS: Deep sequencing of mental disorders. Over the past few years, genotyping studies have identified several candidate risk genes for addiction and related disorders. Exploit new sequencing technologies that move beyond genotyping to identify rare and/or structural variants and novel risk genes for these disorders in existing DNA samples. Contact: Dr. Joni Rutter, 301-435-0298, jrutter@nida.nih.gov

08-DA-106 Technology and resources for high-throughput functional analysis of functional elements in genomic sequences. Develop robust, high-throughput methods to carry out functional assays to determine whether and how putative functional elements (e.g., genes and regulatory sequences) operate to determine cell states in development, health, the addicted states, and response to abused drugs. Such new methods should include both cellular and whole organism methods to allow systematic analysis of the effects of both genetic (normal variation and mutation) and environmental perturbations, and should include methods for both molecular (transcriptomic, proteomic) analysis and high-throughput phenotyping. Contact: Dr. Jonathan D. Pollock, 301-435-1309,jpollock@mail.nih.gov

08-NR-101* Genetic and Epigenetic Predictors of Symptom Severity. This initiative will support research on the genetic underpinnings of symptom severity. The findings from this research will identify individuals at greatest risk for symptoms from both acute and chronic conditions and design individualized interventions that will maximize symptom management. NIDA Contact: Dr.John Satterlee, 301-435-1010, satterleej@mail.nih.gov, Shoshana Y. Kahana, Ph.D., 301-443-2261, kahanas@mail.nih.gov. Kevin Conway, Ph.D., 301-443-6504, kconway@nida.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov.

(09) Health Disparities

09-DA-101 Health disparities and access to participation in research.Assess the under-representation in biomedical and clinical research on HIV/AIDS of drug using U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence. Often these groups do not participate or are not adequately represented in research; however their inclusion is critical for addressing health disparities. Additionally, assess the impact and ethical considerations of conducting biomedical and clinical research on HIV/AIDS among drug using populations internationally in resource-limited countries. Contact: Dr. Lynda Erinoff, 301-443-1470, lerinoff@nida.nih.gov and Aria Crump, Sc.D., 301-435-0881, acrump@nida.nih.gov and Carmen L. Rosa, M.S., 301-443-9830, crosa@nida.nih.gov

09-DA-102 Trans-disciplinary research to integrate the biological and non-biological determinants of health to address health disparities.Addressing HIV/AIDS health disparities in minority communities requires trans-disciplinary approaches incorporating epidemiology, ethnography, prevention interventions including: HIV testing, access to HIV/AIDS care and integration with STI and other infectious disease (hepatitis, TB) services and drug abuse treatment services. Collaborative efforts that make use of existing cohorts or other infrastructure are encouraged as are strategies that develop community infrastructure and networks, including non-traditional partnerships. Contact: Dr. Lynda Erinoff, 301-443-1470, lerinoff@nida.nih.gov and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov, LeShawndra Price, Ph.D., 301-402-1850,price@nida.nih.gov. Lula Beatty, Ph.D., 301-443-0441, lbeatty@nida.nih.gov

09-DA-103 Initiating innovative interventions to prevent family violence.Focus on strategies to prevent family violence including domestic and intimate partner violence, and enhance behavioral efforts that build workforce infrastructure. Develop culturally and linguistically appropriate messages and tools, non-traditional methods, and marketing strategies. Explore the nature of the relationship between family violence and substance abuse. Develop and, or test strategies for prevention of, and interventions to reduce, family violence in substance using population. Contact: Dr. Petra Jacobs, 301-451-6338, pjacobs@nida.nih.gov and Aleta Meyer, Ph.D., 301-402-1725, Meyer2@nida.nih.gov, Jessica Chambers, Ph.D., 301-443-2237, jcampbel@mail.nih.gov. Belinda Sims, Ph.D., 301-402-1533, bsims@nida.nih.gov.

09-DA-104 Evaluation and treatment of substance use disorders in aging populations. Research on the long-term effects of substance abuse, the clinical characteristics of aging drug abusers, and/or their age-specific substance abuse treatment needs. Research may include the evaluation of changes in cognitive abilities, behavior, psychosocial interactions, and emotional response in relation to the trajectory of drug use disorders and drug abuse treatment outcomes in older populations. Contact: Jamie Biswas, 301-443-8096, jb168r@nih.gov and Karen Sirocco, Ph.D. 301-451-8661 sirocco@nih.gov

09-DA-105 Strategies for enrollment of vulnerable or underserved patient populations in substance abuse treatment clinical trials. Identify the barriers (psychosocial, economic, familial, administrative) to enrollment of vulnerable patient populations (e.g., adolescents, pregnant women, minorities, prisoners, subjects with comorbidity of a psychiatric disorder and substance use disorder) with substance use disorders into medications development and/or behavioral treatment trials, with the purpose of finding improved enrollment, recruitment, and retention strategies. Contact: Jamie Biswas, 301-443-8096, jb168r@nih.gov and Carmen L. Rosa, M.S., 301-443-9830, crosa@nida.nih.gov

09-DA-106 Increase implementation of clinical research programs in the vulnerable population area of pregnant women and their in utero substance exposed neonates. Development of a standardized 'toolbox' for research implementation in this area. The research may focus on methodology, design, outcome measures, ethics, human subject protection, and recruitment in this vulnerable population to provide a platform of research feasibility. Contact: Steve Oversby, 301-435-0762 soversby@mail.nih.gov

09-MD-101* Creating Transformational Approaches to Address Rural Health Disparities. Research will focus on approaches, partnerships, and technologies for improving rural health outcomes. In addition, NCMHD is interested in proposals that utilize innovative outreach strategies that involve collaboration among traditional and non-traditional groups including new categories of community health workers, non-traditional occupations and settings. NIDA Contact: Dr. Lula Beatty, 301-443-0441, lbeatty@nida.nih.gov, Dionne Jones, Ph.D.,301-402-1984, Djones1@nida.nih.gov. Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov. Cecelia Spitznas, Ph.D., 301-402-1488, spitznasc@mail.nih.gov.

(10) Information Technology for Processing Health Care Data

10-DA-101 Dynamic Simulations of Drug Abuse. Dynamic Simulation Models are being used in many fields to reduce the resource burden of research, to maximize the use of collected data, and to combine and consider the interaction of findings from multiple sources. The development of drug abuse simulations may be useful in a wide variety of situations including the screening of pharmacological compounds, the development of enhanced computational algorithms to increase the predictive validity of animal models, for facilitating the adoption of interventions, to more effectively tailor interventions for special populations and newly emerging abusable drugs and drug use patterns, for the exploration of the impact of policy changes, cultural and public health developments, and to improve the anticipation of epidemiological trends. Contact: Dr. Tom Hilton, 301-435-0808, thilton@nida.nih.gov and Steven Grant, Ph.D. 301-443-4877 sgrant@nida.nih.gov

10-DA-102 Development of innovative information and communication technology (ICT) to enhance capabilities of U.S. institutions in global health research and research training. Drug use is a global problem and driving the HIV epidemic in many developing and transitional countries. Widespread implementation of effective drug treatments and HIV risk reduction interventions targeting drug users is an urgent priority. This initiative encourages the development of innovative strategies for rapid refinement, dissemination, and expansion of drug treatment and HIV risk reduction interventions using ICT targeting the specific local circumstances and cultures of drug users in developing and transitional countries. Contact: Dr. Jacques Normand, 301-443-1470, jnormand@nida.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov

10-DA-103 Data warehouse of drug abuse pharmacotherapy clinical trials.Creation of a database system for entry of efficacy as well as safety data from drug abuse clinical trials that will facilitate the analysis of data across multiple clinical trials that have evaluated multiple medications. Contact: Dr. Ivan Montoya, 301-4435-8631 Imontoya@mail.nih.gov

10-OD-101* Adapt existing genetic and clinical databases to make them interoperable for pharmacogenomics studies. In order for personalized approaches to drug therapy to be developed, genetic data and clinical data need to be superimposed. Analysis of the superimposed data will generate hypotheses concerning genetic control of drug efficacy. Contact: Dr. Joni Rutter (NIDA), 301-435-0298, jrutter@mail.nih.gov

(13) Smart Biomaterials - Theranostics

13-DA-101 Theranostics: Combined delivery of diagnostic and therapeutic agents for drug abuse/HIV research/treatment. Development of novel, nanotechnologically-based multimodal imaging approaches (e.g. optical, MR) to deliver combined diagnostic and therapeutic agents to (appropriate) targeted sites with high specificity and in adequate concentrations to realize the promise of combined diagnosis and treatment of drug abuse and HIV/AIDS in a single sitting ("theranostics"). Contact: Dr. Thomas Aigner, 301-435-1314, taigner@nida.nih.gov

13-DA-102 Methods to evaluate the health and safety of nanomaterials.Develop novel tools and approaches to determine the impact on biological systems and health outcomes of an array of engineered nanomaterials used to study drug abuse and HIV/AIDS. Conduct biological, physical and chemical characterization of selected nanomaterials to aid in setting standards for health and safety, and developing computational models for the prediction of long-term secondary effects. Contact: Dr. Thomas Aigner, 301-435-1314, taigner@nida.nih.gov

(14) Stem Cells

14-DA-101 Generating human neurons with iPS to screen and develop bioactive agents for the treatment of nicotine addiction. Studies are encouraged that use iPS cells for the induction of dopaminergic neurons and other cortical neurons, for the screening and development of bioactive agents for the treatment of nicotine addiction. iPS cells will be generated from addicts and individuals who have been exposed to drugs of abuse but have not become addicted, for biological responses that are genome and genetic specific. In addition, other tissues such as liver, heart, kidney and lung will also be generated to screen for drug toxicity. Contact: Dr. Jonathan D. Pollock, 301-435-1309, jpollock@mail.nih.gov

14-DA-102 Generating germline-competent ES cells for rodent strains. The generation of germline-competent ES cells ES cells from many rat and mouse inbred strains has been problematic. This has made the generation of targeted mutations in different genetic background difficult and has prevented the creation of better animal model of disease. Furthermore, ES cell panels, with their broad differentiation potential, are powerful tools for performing complex genetic experiments in vitro. Thus, the development of germline-competent ES cells using iPS or other technologies for different rodent strains is requested. Contact: Dr. Jonathan D. Pollock, 301-435-1309, jpollock@mail.nih.gov

14-DA-103 Developing iPS cells for addiction and co-morbid mental disorders. NIDA seeks applications that characterize the physiological response of neurons and glia derived from induced pluripotent stem cells from individuals with addiction and co-morbid mental disorders (autism, schizophrenia, mood disorders). Contacts: Dr. Jonathan D. Pollock, 301-435-1309, jpollock@mail.nih.gov and Dr. Geraline C. Lin, (301) 435-1305 glin@nida.nih.gov

14-DA-104 Exploratory studies of induced pluripotent stem (iPS) cells from healthy individuals and patients with mental/nervous system disorders. NIDA seeks to support studies that generate and characterize neurons and glia derived from iPSCs from individuals addicted to drugs and controls. Research topics can include maximizing derivation efficiency, maintenance, or reproducibility, studies of cellular differentiation, screening bioactive agents, or profiling the molecular signature as well as the functional properties of cells from controls vs patients. There will be an emphasis on appropriate validation of iPS cells and their derivatives, evaluating the hetero/homogeneity of any cell populations to be screened and use of cellular assays relevant to normal development, organ function and disease. Contacts: Dr. Jonathan D. Pollock, 301-435-1309, jpollock@mail.nih.gov and Dr. Geraline C. Lin, (301) 435-1305, glin@nida.nih.gov

14-DA-105 Induced pluripotent stem cells: Cellular and humanized mouse models of disease. Studies are encouraged that use iPS cells for the induction of dopaminergic neurons and other cortical neurons, for the screening and development of bioactive agents for the treatment of nicotine addiction. iPS cells will be generated from addicts and individuals who have been exposed to drugs of abuse but have not become addicted, for biological responses that are genome and genetic specific. In addition, other tissues such as liver, heart, kidney and lung will also be generated for functional genomics and for drug toxicity screens. Contacts: Dr. Jonathan D. Pollock, 301-435-1309, jpollock@mail.nih.gov and Dr. Geraline C. Lin, (301) 435-1305, glin@nida.nih.gov

14-DA-106 Induced-Pluripotent Stem Cells (iPS) and Cellular Reprogramming Technology in Drug Abuse and Addiction. Induced pluripotent stem (iPS) cells and cellular reprogramming technology will be used to define the pathophysiology of drug abuse and addiction, including drug-induced neurotoxicity. The knowledge gained will be utilized to repair/restore functions, develop treatment drugs, screen drug toxicity, replace defected cells (where damages are beyond repair/restoration), and make disease diagnosis. Contact: Dr. Geraline C. Lin, (301) 435-1305, glin@nida.nih.gov

(15) Translational Science

15-DA-101* Novel Approaches to Improve Immunogenicity of Vaccines Against Small Molecules. Innovative approaches to enhance the immunogenicity of small molecules (e.g., toxins, carcinogens, influenza epitopes, drugs of abuse) could lead to revolutionary advances in our ability to preempt, minimize the impact, or help reverse the course of preventable diseases. These approaches may leverage a variety of research strategies, including nanoparticle technology, hapten-tagging of virus-like particles, synthetic adjuvant systems, and novel immunomodulators and delivery systems. Contact: Dr.Nora Chang, 301-443-5280 or 301-443-8099, nchiang@nih.gov

15-DA-102 NIH partners in research program: Pathways for translational research. Develop strategies for dissemination of interventions with demonstrated effectiveness for translation into clinical practice by teams of academic and community research partners. The National Drug Abuse Treatment Clinical Trials Network (CTN) fosters collaborative relationships between academic investigators and front-line community-based substance abuse treatment providers. This well-established network provides a fertile platform for quick-turnaround projects that can advance knowledge on rapidly moving scientific findings into communities to improve health. Contact: Dr. Harold I Perl, 301-443-9982, hperl@nida.nih.gov and Belinda Sims, Ph.D., 301-402-1533, bsims@nida.nih.gov, Elizabeth M. Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov. Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov. Debbie Grossman, M.S., 301-443-2249, Dg9a@nih.gov.

15-DA-103 Development and Testing of Clinical Practice Algorithms to Improve Quality and Outcomes of Substance Abuse Treatment. In recent years, many efficacious substance abuse treatment interventions, both pharmacotherapeutic and behavioral, have been developed and validated, and subsequently adopted into clinical practice. However, treatment providers still face a lack of evidence to guide decisions on choosing treatment approaches for individual patients, combining or sequencing interventions, particularly for patients with co-occurring substance use and other mental health disorders, and identifying optimal "rescue" treatments when an initial intervention fails. Research on these questions is needed to facilitate the development of clinical practice algorithms that can guide providers' decision-making and ultimately improve the quality and outcomes of substance abuse treatment. Contact: Dr. Petra Jacobs, 301-451-6338, pjacobs@nida.nih.gov and Thomas Hilton, Ph.D., 301- 435-0808, thilton@nida.nih.gov

15-DA-104 Intervention Providers, Settings, and Pragmatic Constraints.Successful implementation of empirically supported preventive programs and treatments is dependent on multiple factors, but some of which are related to the characteristics of the intervention work force, the nature of the intervention settings, and the practical limitations working against optimal intervention utilization. Well documented national information is not available nor are more local characterizations. This program would determine the characteristics of the treatment work force and prevention providers, characterize the settings and organizations providing interventions, and identify major impediments to program adoption and implementation. Examples of implementation barriers might include competing demands in school settings, inadequate specialized treatment facilities in some areas, etc. Approaches to overcoming the successful adoption of effective evidence based interventions would be determined as part of the expected scope of this program. Contact: Dr. Lori J. Ducharme, 301-443-2279, Lori.Ducharme@nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov.

15-DA-105 Manipulating the blood-brain barrier to deliver CNS therapies for mental/nervous system disorders. Substance abuse has been shown to impact the neurological, behavioral, and neurocognitive consequences of HIV infection. A variety of strategies, including use of antiretroviral, anti-inflammatory, and/or neuroprotective therapeutics, have been proposed as potential treatments for neuroAIDS, but delivery of potentially effective agents across the blood-brain barrier remains a hurdle. This initiative is aimed at developing potentially useful CNS drug targeting and delivery systems that will be effective in the context of substance abuse. Contact: Dr. Diane Lawrence, 301-443-1470, lawrencedi@nida.nih.gov and Rao Rapaka, Ph.D., 301-435-1304, rrapaka@mail.nih.gov

15-DA-106 Exploring the earliest events in HIV infection and use this information to develop new interventions for preventing and treating HIV infection. Substance abuse is a major cofactor in HIV/AIDS. Early events in HIV infection are important for establishing the rate of progression to AIDS and possibly the development of neurologic and neurocognitive impairment. There is a need to understand how substance abuse affects the earliest stages of HIV infection and pathogenesis in order to identify new targets for interventions. Dr. Diane Lawrence, 301-443-1470, lawrencedi@nida.nih.gov and Raul N. Mandler, M.D., 301-435-0645, mandlerr@nida.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, jenkinsri@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318ylin1@nida.nih.gov

15-DA-107 The identification, validation, and exploitation of new molecular targets for the treatment of drug addiction disorders. Projects may utilize techniques ranging from gene knockout technologies, behavioral evaluations, assay development, and targeted library synthesis and screening that could lead to the development of medications for drug addiction treatment. The focus may be on the identification of new molecular targets, and/or the discovery of small molecule selective ligands for previously identified targets, such as muscarinic M5 antagonists, neuropeptide Y antagonists, and neurotensin agonists. Contact: Jane B. Acri, 301-443-8489, jacri@nih.gov

15-DA-108 Developing approaches for presenting relevant genomic information in an understandable way, in the context of a patient's electronic health record. As data becomes available on drug abuse and addiction genetics, these data must eventually be integrated into electronic health records in ways that help clinicians and patients to understand the significance of the data. There is a need to provide an avenue for alerting clinicians and patients when new knowledge from basic and clinical research arises to the level of potential clinical impact; and enable linking to effective decision support and treatment implementation. Contact: Dr. Joni Rutter, 301-435-0298, jrutter@nida.nih.gov

15-DA-109 Effects of environmental exposures on phenotypic outcomes using non-human models. Environmental effects mediated thru the central nervous system (especially via the HPA axis) can affect drug abuse behavior and the development of addiction. These exposures may include prenatal drug effects, physical and social stressors, and epigenetic or neurobiological consequences of early adverse experiences. How these exposures change nervous system structure and function to influence drug abuse behavior and the development of addiction is of interest. Contact: Dr. Minda Lynch, 301-435-1322, mlynch1@nida.nih.gov

15-DA-110 Determining if and how adolescent behaviors affect connections in the developing brain. Research is needed to understand how drug abuse during adolescence affects stem cell and progenitor cell induction, myelination, programmed cell death, guidance of glial and neuronal migration, and regulation of dendritic and axonal outgrowth, navigation, target selection, and synapse formation in the nervous system. Contact: Dr. Da-Yu Wu, 301-435-4649, wudy@nida.nih.gov, Lula Beatty, Ph.D., 301-443-0441, lbeatty@nida.nih.gov. Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov. Karen Y. Sirocco, Ph.D., 301-451-8661, Sirocco@nida.nih.gov. James Bjork, Ph.D., 301-443-3209, jbork@mail.nih.gov.

15-DA-111 Manipulating the blood-brain barrier to deliver CNS therapies for mental/nervous system disorders. Methods to deliver peptide/peptidomimetic drugs to CNS, develop drugs that pass blood brain barrier but do not pass through the placental barrier, use of nanotechnology based methodologies for CNS delivery, methods to deliver drugs only through placental barrier but do not cross the BBB, innovative in-vitro models to predict BBB and placental barrier. Contact: Dr. Rao S. Rapaka, 301-435-1304, Rr82u@nih.gov

15-DA-112 New models and measures in pre-clinical chronic pain research. Existing animal models of pain conditions inadequately reflect the pathology or the phenotypes of the human state. New animal models to study the transition from acute to chronic pain are needed. These could include new functional and behavioral assays of acute and chronic pain. Further, it is important to characterize the impact of analgesics of various classes in these pain models. Of special interest is identifying when drugs without abuse potential (e.g. NSAIDS) are of comparable or better efficacy in attenuating or stopping the transition to chronic pain. Contact: Dr. David Thomas, 301-435-1313, dthomas1@nida.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov.

15-RR-101* Applied translational technology development. This program will support two-year applied translational projects to move advanced technologies from the prototype stage into the clinic. Novel, cost-effective tools for clinical care or clinical research will be modified, hardened, and tested. Interdisciplinary teams of technology developers, basic researchers and clinicians will address scientific and engineering problems associated with clinical applications of new technologies. NIDA Contact: Dr. Kris Bough, 301-443-9800, boughk@mail.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, imontoya@mail.nih.gov

For general information on the National Institute on Drug Abuse implementation of NIH Challenge Grants, contact:

Christine Colvis, Ph.D.
NIDA Challenge Grant Program Coordinator
National Institute on Drug Abuse
National Institutes of Health
Phone: 301-443-6480
Email: ccolvis@nida.nih.gov

For Financial or Grants Management questions, contact:
Pamela G. Fleming
Chief Grants Management Officer
National Institute on Drug Abuse
National Institutes of Health
Phone: (301) 253-8729
Email: pfleming@nida.nih.gov

Additional Links

NIH Announces the Availability of Recovery Act Funds for Supplements to Research Grants - 3/18/09.

NIH's Role in the American Recovery and Reinvestment Act (ARRA) (National Institutes of Health web site)