Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Drug Abuse Aspects of HIV/AIDS (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-10-129
Related Notices	June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-12-293
Companion Funding Opportunity	PA-12-295, R21 Exploratory/Developmental Grant PA-12-294, R03 Small Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), encourages Research Project Grant (R01) applications to examine the drug abuse aspects of HIV/AIDS, including research on drug-related risk behaviors, addiction and HIV disease, and drug use/HIV-related co-morbidities and consequences. Applications are needed to identify and predict changes in the epidemiology of HIV/AIDS among injection and non-injection drug users and among their sexual partners; to develop and test interventions for primary and secondary HIV prevention, including drug treatment interventions; to improve HIV testing, counseling, and treatment services for those living with HIV/AIDS; and to address basic mechanisms involved in HIV infection and AIDS pathogenesis in the context of drug abuse and addiction.

Posted Date	September 25, 2012
Open Date (Earliest Submission Date)	April 7, 2013
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Not Applicable
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	January 8, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Nature of the Research Opportunity

This Funding Opportunity Announcement (FOA) is issued by the National Institute on Drug Abuse (NIDA) to encourage R01 applications in epidemiological, behavioral, clinical, and basic biomedical research on drug abuse aspects of HIV/AIDS and related co-infections and co-morbidities.  The FOA spans multiple research disciplines, including natural history and epidemiology, etiology and pathogenesis, medical, psychosocial, and economic consequences, prevention and treatment research, the behavioral and social sciences, and therapeutics for both drug addiction and HIV/AIDS.

Background

In the absence of universally effective strategies for the prevention and treatment of HIV/AIDS, significant research challenges remain to understand the complexities, variations, and vulnerabilities associated with the acquisition and transmission of HIV-1 infection and with HIV/AIDS disease progression. More than a million people are living with HIV/AIDS in the U.S., and approximately 56,000 new HIV infections occur every year. An estimated 20 percent of those infected with HIV in the U.S. are unaware of their status, and about 38 percent of people who are diagnosed with HIV are late testers who become diagnosed with AIDS within one year. Sharing syringes and other equipment for drug injection is a well known route of HIV transmission, yet injection drug use contributes to the epidemic’s spread far beyond the circle of those who inject. People who have sex with an injection drug user (IDU) also are at risk for infection through the sexual transmission of HIV. Children born to mothers who contracted HIV through sharing needles or having sex with an IDU may become infected as well.

Men who have sex with men (MSM) account for nearly half of the more than one million people living with HIV in the U.S., and more than half of all new HIV infections. MSM comprise the only risk group in the U.S. in which new HIV infections are increasing, although there are differences by age and racial groups. More new HIV infections are occurring among 13-29 year old African American MSM than any other age or racial group of MSM.  Most new infections among white MSM occur among 30-39 year olds, and then among 40-49 year olds. Substance use among MSM is a significant risk factor for HIV infection and other STDs, particularly non-injection drug use, for example, of such drugs as crack cocaine and methamphetamine, amyl nitrites (poppers), erectile dysfunction drugs, powder cocaine, other club drugs, and to some extent alcohol. These substances are associated with risky sexual behavior that may include sex-for-drug exchanges and unprotected sex with multiple partners. 

Widespread access to highly active antiretroviral therapy (HAART) has made HIV/AIDS a medically manageable but consequential condition in which, while the virus is suppressed, non-AIDS-associated disorders and disorders related to side effects of HAART may appear. HAART has helped to reduce the incidence of AIDS-related dementia; however, other neurocognitive deficits continue to be observed. Evidence also suggests that the neurocognitive effects of HIV are present from early infection onward. Success with HAART may have an unintended consequence of greater complacency about HIV risks as well. Higher rates of risky behaviors have been reported among young MSM, for example, most of whom have missed seeing the toll of AIDS in the pre-HAART years. This has been attributed, in part, to misunderstandings about the need to maintain safer sex practices in the context of an undetectable viral load. Such a situation, especially in the context of substance use, represents one of the major challenges facing the field of HIV prevention research today. 

The next generation of HIV prevention and treatment research needs to integrate and build on the cumulative knowledge from natural history, treated history, social and genetic epidemiology, and behavioral, biological, and clinical studies on the changing risk factors and dynamics of HIV disease.  Research is needed to advance the integration of HIV prevention interventions with drug treatment programs and STD/infectious disease clinics, to link primary care with drug abuse treatment services, and to make HIV testing and counseling a routine part of drug treatment and medical care.  Innovative, multidisciplinary research is needed to address the chronic, relapsing nature of drug addiction and its consequences, including HIV/AIDS, co-infections such as hepatitis B, hepatitis C, tuberculosis, and other STDs, and co-morbid mental health conditions.  Changing patterns of drug abuse, attitudes about HIV/AIDS, demographics of populations at risk, and communications through instant messaging, social networking, and information technology, all combine to increase the complexity and challenges of drug abuse and HIV/AIDS research today. This FOA invites researchers to address these challenges with new applications to advance understanding of the causes and consequences of drug abuse and HIV/AIDS and of effective strategies to intervene early to prevent and treat their associated morbidity, co-morbidity, and mortality.

Scientific Research Scope and Objectives

This FOA envisions a range of national and international research projects within and across the priority areas for NIDA research on HIV/AIDS http://www.nida.nih.gov/about/organization/arp/arp-current.htm including but not limited to the types of studies and issues described below.

Drug Abuse and HIV Prevention--Studies to prevent the acquisition and transmission of HIV among drug-using populations and to improve engagement, recruitment, retention, and adherence of demographically diverse drug users and their sex partners in HIV prevention efficacy trials.

• Prevention interventions directed at youth that use advances in knowledge about the prevention of drug use and other factors that contribute to HIV/AIDS risk in this population.
• Develop and evaluate intervention strategies for highly vulnerable, multi-ethnic/racial populations, MSM, pregnant women, sexual and gender minorities, persons engaged in transactional sex, criminal justice populations, and individuals with co-morbid infectious disease or psychiatric disorders.
• Evaluate the feasibility of biological prevention approaches (e.g., PreP, HIV prevention as treatment) among drug users, as well as the factors that may affect implementation, such as immunologic challenges related to the frequency of injection or the use of shared and other non-sterile injection equipment.
• Behavioral intervention research to enhance the sustainability of HIV/AIDS risk reduction among drug users and their sex partners.
• Develop and test network-based interventions to prevent HIV/AIDS, including social, sexual, drug using network interventions that utilize venue, community, and/or technological and structural factors to support their implementation and effectiveness.
• Implementation and health services research on the barriers to, and facilitators of, the implementation of science-based HIV/AIDS interventions in drug abuse prevention and treatment settings.
• Research that translates basic behavioral, cognitive, and social science findings about sexual and injection risk behaviors (e.g., impulsivity, decision-making, risk-taking, sexual development, partner and peer relationships, etc.) into strategies for preventing HIV acquisition among  drug users.
• Research on family and developmental processes which may impact risk behaviors, decision making and the efficacy and effectiveness of prevention interventions.
• Studies of innovative prevention interventions to ameliorate the negative behavioral and neurodevelopmental consequences for children exposed to drugs of abuse, HIV/AIDS, and/or antiretroviral therapy in utero.
• Research to develop and test interventions to reduce disparities by enhancing the health and development of youth living with and/or children and youth affected by HIV/AIDS and substance abuse.
• Prevention research addressing drug use among MSM, particularly young ethnic/racial minority MSM in the US and in international locations experiencing emergent epidemics of HIV infection and HIV-related health disparities.
• Prevention research that addresses and integrates knowledge about the effects of substances on motivation, behavior, arousal, and cognitive functions, including judgment and decision making.

Drug Abuse and HIV/AIDS Treatment--Domestic and international research on treatment of drug abuse and HIV/AIDS, and of co-occurring infections such as hepatitis C, TB, and other STDs.

• Research on effective behavioral or integrative treatments in response to the changing demographics of drug abuse, HIV/AIDS, and related co-infections, including studies with participation by multi-ethnic/racial populations of drug users, their sexual partners, and their children.
• Studies of drug abuse behavioral treatment interventions that integrate essential components of primary prevention to prevent or delay the acquisition of HIV infection.
• Research on optimal strategies for integrating primary HIV prevention into evidence-based treatment interventions for drug abuse and drug use-related mental health sequelae (depression, PTSD).
• Studies that design, develop, and evaluate HIV behavioral risk reduction interventions to reduce drug use and sexual risks associated with HIV acquisition and transmission.
• Studies of biologic markers, surrogates, and/or other outcomes to evaluate the safety and clinical efficacy of new agents and approaches in the treatment of HIV-associated opportunistic infections and neurologic complications of HIV disease in drug users.
• Studies of antiretroviral adherence among drug users, including methods to assess adherence, to compare adherence measures, to evaluate antiretroviral therapy in the context of viral hepatitis/STI, and to measure behavioral correlates of antiretroviral adherence and drug abuse treatment.
• Studies that utilize criteria set forth in the U.S. National HIV/AIDS Strategy as important quality performance measures (e.g., increase testing, treatment, and access and retention in care).
• Studies to improve access and utilization of HIV counseling and testing and the linkage of HIV-positive drug users to care; use of health technologies to improve HIV prevention, treatment, and services for drug users; and implementation of HIV prevention, treatment, and services in community practice.

Epidemiology and Natural History of HIV/AIDS Among Drug-Using Populations--Studies of the changing epidemiology of HIV/AIDS and drug abuse, of the clinical manifestations of HIV disease and co-infections in the context of drug addiction, and of multi-level factors (socio-demographic, behavioral, biological, psychological, and environmental) that influence HIV transmission risks, disease progression, and differences in disease outcomes among drug users and their sex partners.

• Studies of the changing individual, social, neurobiological, and environmental factors that affect HIV acquisition/transmission, disease progression, or response to antiretroviral therapies.
• Studies of the effects of antiretroviral therapies, adherence interventions, stigma, health disparities, and other biologic, behavioral, and psychosocial factors that influence HIV progression among drug users.
• Studies of viral and host mechanisms in the establishment of HIV infection among drug users and their sexual partners, including mechanisms by which substance use, other infections (e.g., STIs), and co-morbidities affect the efficiency of HIV acquisition and transmission. 
• Studies of the health and development of children, youth, and girls of child-bearing age affected by HIV/AIDS and drugs of abuse, including those with a caregiver or other family member with HIV/AIDS, and those orphaned by AIDS.
• Research to understand the natural history of risk and protective factors associated with substance use and other HIV risk behaviors among vulnerable youth, including youth living with and/or affected by HIV/AIDS, homeless youth, and young MSM.
• Methodological studies to enhance outreach, recruitment, and retention of hard-to-reach drugs users for participation in substance abuse and HIV/AIDS prevention, treatment, and clinical research.
• Studies using novel measures and methods such as GIS and environmental mapping to understand how social, technological, geographic, and other structural and environmental factors influence drug use and HIV risk behaviors, social network dynamics, and behavioral and social norms related to drugs and HIV/AIDS.
• Studies among demographically diverse MSM to understand disparities in risks and rates of new HIV infections, attitudes and perceptions about HIV testing and care in the era of HIV treatment as prevention, and patterns of use of drugs and sexual risk taking.
• Studies of risk contexts as potential time-sensitive opportunities for targeted interventions, including the use of novel strategies to disrupt HIV risks, such as those associated with use of amyl nitrites, stimulants, cocaine, erectile dysfunction drugs, or methamphetamine.
• Studies of attitudes and perceptions toward advances in pre-exposure prophylaxis, post-exposure prophylaxis, and HAART to improve the effectiveness and sustainability of behavioral interventions.
• Studies of effects of the Internet and other social networking technologies on patterns of drug use and HIV/AIDS.
• Research to improve outcome measures and indicators for evaluating and modeling costs, benefits, and health and social impacts of HIV prevention and treatment interventions.

Drug Abuse Related HIV/AIDS and Its Consequences -Basic, clinical, pharmacological, and epidemiological research to understand drug-use related mechanisms that affect  HIV infection and progression and the medical/clinical consequences of drug use and HIV/AIDS, and co-infections, including viral hepatitis, tuberculosis, sexually transmitted infections, and whether these outcomes vary by gender, age, race/ethnicity.

• Research on neurobiological, neurodevelopmental, cognitive, behavioral and health sequelae of intrauterine exposure to drugs of abuse, HIV/AIDS and/or to antiretroviral therapy
• Study etiologic and interactive biologic, biomedical (e.g., metabolic/endocrine/nutritional), behavioral, environmental, and demographic factors that may influence HIV transmission efficiency, disease progression, and medical consequences in drug users.
• Study the impact of drugs of abuse, adulterants, contaminants of drugs of abuse, and drug addiction treatment medications on resistance and susceptibility (e.g., mucosal barriers), onset, and progression of HIV disease, development of antiretroviral-resistant strains, and AIDS-associated OIs in drug abusing populations.
• Research on medical and clinical consequences of drug use, HIV infection, and other co-occurring infections (hepatitis, TB, STIs, and others) across physiological/biochemical systems, including, but not limited to: (a) cardio-renal, hepatic, endocrine, respiratory/pulmonary consequences of drug abuse and HIV and related OIs; (b) development of  integrated medical interventions for drug abuse, and HIV associated medical morbidity; (c) studies of drug-drug interactions between drugs of abuse, medications for drug addiction and other co-morbid conditions, over-the-counter medications, herbal and other health food supplements, and current or potential new antiretroviral medications;  and (d) development of  biomarkers and non-invasive tools to improve the  diagnosis, assessment, and treatment of medical consequences of drug abuse and co-occurring infections. 
• Research using extant genomic/proteomic databases, animal repositories, brain banks with confirmed drug use information for HIV-infected individuals, and/or pre-established clinical or basic research networks to explore potential interactions between, and consequences of, drug abuse and HIV infection.
• Studies using human or animal models to examine how viral factors, host factors, or environmental factors impact the consequences of HIV/SIV infection and how drugs of abuse may modulate these processes.
• Studies that address basic mechanisms of HIV-associated neurological disease progression and neuronal degeneration or dysfunction in HIV-infected persons who abuse drugs.
• Structural, functional, and/or imaging studies, or studies that assess the consequences of co-occurring substance abuse and HIV disease progression in the brain, and/or neural effects of therapeutics for HIV and drug addiction.
• Development of sensitive behavioral, motor, and cognitive assessments to detect subclinical signs and effects of HIV infection and related co-infections in drug users, such as impairments related to neuropathological consequences of viral infection or cellular changes in fronto-striatal neurocircuitry.
• Research on potential etiologic and interactive biologic, biomedical, behavioral, environmental, and demographic factors that may influence HIV transmission efficiency, HIV disease progression, and other medical consequences of drug abuse among diverse drug-using populations.
• Studies of the role of drugs of abuse and related compounds (including adulterants and contaminants of drugs of abuse) or drug abuse treatment medications on susceptibility, onset, and progression of HIV disease, antiretroviral-resistant HIV strains, AIDS-associated opportunistic infections, and drug-associated mental health disorders in drug-abusing populations.
• Studies of medical/clinical consequences of drug abuse and HIV/AIDS and other infections (hepatitis, TB, other STIs) spanning across all physiological systems, including research on (a) the impact of substance abuse on medical/health conditions and physiological or biochemical conditions, e.g., metabolic/nutritional factors that might impact the pathogenesis of HIV/AIDS; (b) factors that affect resistance and susceptibility to infection, e.g., effects of drug abuse on mucosal barriers; (c) integrated medical interventions for drug abuse, psychiatric illness, and HIV and associated clinical conditions; (d) pharmacokinetic and pharmacodynamic interactions of drugs of abuse, medications for drug addiction, and pharmacotherapies for HIV/AIDS and co-morbid conditions;  and (e) biomarkers and non-invasive tools to improve the  diagnosis, assessment, and treatment of medical consequences of drug abuse and co-occurring infections.
• Basic and applied research to develop and advance therapeutic entities to treat HIV, HIV/AIDS-related complications, and potential co-infections among drug users and their sexual partners.  Of particular interest are the potential effects and interactions of drug-drug interactions in the treatment of HIV, HIV-related diseases, and drug addiction among HIV-infected drug users, including the potential effects of over-the-counter drugs, health food supplements, and herbal medicines.

Basic Neuroscience, Clinical, and Behavioral Research-- Studies using in vitro and/or in vivo animal model systems to understand basic mechanisms involved in HIV/AIDS infectivity and pathogenesis in the context of drug abuse and addiction, and clinical neuroscience research to understand neurocognitive and neurobiological factors related to HIV disease progression and disease outcomes among drug users. Investigators are also encouraged to include studies involving chronic drug exposure paradigms.

• Research on cellular, molecular, genetic, and/or epigenetic mechanisms involved in neurobehavioral, neurological, and neuroimmune dysfunction associated with HIV/AIDS pathogenesis and drug abuse.
• Studies that delineate the mechanisms by which drugs of abuse or drug abuse behaviors alter innate, adaptive, and/or mucosal immunities and how such alterations affect HIV infectivity and pathogenesis.
• Research to develop and exploit in-vivo models to assess behavioral and neurobiological influences on, and consequences of, HIV infectivity and progression.
• Research on the effects of drugs of abuse on HIV penetration of the blood brain barrier, placental barrier, and genital tract and rectal epithelial barrier.
• Studies of effects of drugs of abuse on HIV infection in glial cells and peripheral neuropathies.
• Human or animal studies to explore the pharmacogenetic or pharmacodynamic interactions between HIV-1-related therapies, drugs of abuse, or medications for treatment of drug abuse, as well as treatments for HIV-related co-infections among drug users.
• Clinical assessments of neurocognitive changes and effects on HIV treatment adherence and prevention among active, recovered, and intermittent HIV-infected drug users.
• Research to identify and understand inter-relationships between emotional and motivational dysfunction, deficits in prospective memory and attention, and risky decision-making predictive of drug abuse relapse and non-adherence to antiretroviral medication regimens.
• Identify and characterize bio- and behavioral markers that can be used to assess the impact of drug abuse on HIV infection and progression, as well as efficacy of HIV/AIDS treatment.
• Determine how drugs of abuse influence early events that affect the establishment and systemic spread of HIV infection and/or co-infection (hepatitis B, hepatitis C) and subsequent disease progression in physiological organs and compartments.
• Studies to explore hormonal, drug-related, and gender-specific interactions and differences in susceptibility to HIV infection, disease progression, and disease outcomes among drug users.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information seehttp://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Revisions Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	The maximum period is 5 years.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the SAM.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies(GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed..

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

         May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.

         Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

         Scientific and technical merit of the proposed project as determined by scientific peer review.

         Availability of funds.

         Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Albert Avila, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
Neuroscience Center, Room 4279
6001 Executive Boulevard
Bethesda, MD 20892-9555
Telephone: (301) 496-8804
Fax: (301) 594-6043
Email: [email protected]

Richard A. Jenkins, Ph.D.
Prevention Research Branch
Division of Epidemiology, Services & Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Rm. 5185 MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-1923
Fax: (301) 480-2542
Email: [email protected]

Dionne Jones, Ph.D.
Services Research Branch
Division of Epidemiology, Services & Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Rm. 5185 MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1984
Fax: (301) 443-6815
Email: [email protected]

Will Aklin, Ph.D.
Behavioral and Integrative Treatment Branch
Division of Clinical Neuroscience and Behavioral Research 
National Institute on Drug Abuse
6001 Executive Blvd., Rm. 3150, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 443-3207
Fax: (301) 443-6814
Email: [email protected]

Jag H. Khalsa, Ph.D.
Medical Consequences Branch
Division of Pharmacotherapies and Medical
  Consequences of Drug Abuse (DPMC)
National Institute on Drug Abuse
6001 Executive Blvd., Room 4137, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2159
Fax: (301) 443-2599
Email: [email protected] 

Elizabeth Lambert, M.Sc.
Epidemiology Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5147, MSC9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1933
Fax: (301) 443-2636
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Edith Davis
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9560
Rockville, MD   20892
Telephone:  (410) 360-4734
Fax: (301) 594-6849
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.