Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-09-236
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-12-281
Companion Funding Opportunity	PA-12-280, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	Despite progress in HIV/AIDS treatment and prevention and reductions in HIV/morbidity and mortality, HIV/AIDS health disparities remain a challenge that must be addressed. This FOA encourages research to identify the role(s) that drug abuse plays in fueling the epidemic in vulnerable groups (racial/ethnic minorities, men who have sex with men (MSM), youth) in the United States and to develop effective interventions to prevent new infections and to improve the health and well-being of those living with HIV/AIDS. This FOA will support studies in vulnerable populations to: 1) understand the contribution of drug abuse (both injection and non-injection) to the acquisition and/or transmission of HIV; 2) study disease progression and disease outcomes; 3) develop and/or improve prevention and treatment interventions, particularly comprehensive, integrated interventions; 4) improve the availability, delivery and quality of evidence-based prevention and treatment services across a variety of settings; and 5) address organizational, structural, and/or community level factors including social, drug-using, and sexual networks associated with health disparities.

Posted Date	September 10, 2012
Open Date (Earliest Submission Date)	December 7, 2012
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

Purpose

Three decades into the epidemic, HIV/AIDS in the U.S. continues to evolve, and the role of drug abuse in fueling the epidemic has also evolved. Despite progress in HIV/AIDS treatment and prevention and reductions in HIV/morbidity and mortality, HIV/AIDS health disparities remain a challenge that must be addressed. This announcement encourages research to identify the role(s) that drug abuse plays in fueling the epidemic in vulnerable groups and to develop effective interventions to prevent new infections and to improve the health and well-being of those living with HIV/AIDS. To do this, it is essential that research be directed toward understanding the factors (biological, behavioral, psychosocial, environmental, institutional, etc.) responsible for the profoundly disproportionate burden of HIV/AIDS among vulnerable groups (racial/ethnic minorities, sexual minorities, youth) in the United States.

This Funding Opportunity Announcement (FOA) will support studies in vulnerable populations to: 1) understand the contribution of drug abuse (both injection and non-injection) to the acquisition and/or transmission of HIV; 2) study disease progression and disease outcomes in drug using populations; 3) develop and/or improve prevention and treatment interventions, particularly comprehensive, integrated interventions; 4) improve the availability, delivery and quality of evidence-based prevention and treatment services across a variety of settings; and 5) address organizational, structural, and/or community level factors including social, drug-using, and sexual networks associated with health disparities.

Background

There is increasing evidence that outreach to encourage HIV testing (seek), HIV testing (test), engagement in care (treat), and retention in care (retain) are essential for reducing HIV-related morbidity and mortality as well as for reducing community viral load and ultimately HIV transmission. In the U.S., racial/ethnic and sexual minorities are disproportionately affected by HIV. Approximately 20% of HIV-infected Americans are unaware of their HIV status and thus, unknowingly transmit HIV. About 50% of transmissions are from persons unaware of their infection. Rates of undiagnosed HIV vary by race/ethnicity and transmission category. Minorities have higher rates of undiagnosed infections (African Americans had 9 times the rates, and Latinos had 3 times the rates of whites). These disparities are likely due to inaccurate perception of risk and lack of access and/or utilization of health care resources, particularly HIV testing. Even when tested, minorities are disproportionately late testers; they receive an AIDS diagnosis less than three years after their initial HIV diagnosis. National estimates suggest that only 28% of HIV-infected individuals have suppressed viral load--minorities are less likely to be virally suppressed. The National HIV/AIDS Strategy has as one of its aims to reduce HIV-related health disparities and sets targets for 2015 of: increasing the proportion of HIV-diagnosed gay and bisexual men with undetectable viral load by 20%; increasing the proportion of HIV-diagnosed Blacks with undetectable viral load by 20%; and increasing the proportion of HIV-diagnosed Latinos with undetectable viral load by 20%.

Unfortunately, some of the most vulnerable populations for HIV infection do not see themselves as being at risk. For example, African American men who have sex with men (MSM) have similar, sometimes lower levels of risk behavior than their white counterparts, yet much higher rates of infection. Similarly, African American women typically do not engage in high levels of risk behavior but are more often exposed to risky partners than women in other ethnic/racial groups. The high prevalence of HIV/AIDS in minority communities increases the risk of transmission because transmission depends on the reservoir of infection (i.e., HIV prevalence) as well as the levels of risk behaviors that transmit infection. HIV/AIDS risk behaviors, in turn, are influenced by economic, social, and political systems that reinforce socioeconomic disparities.

CDC HIV incidence estimates for 2006-2009 highlight the populations where HIV is most heavily concentrated and have led to the National HIV/AIDS Strategy to prioritize prevention efforts to those with disproportionate rates of new infections gay and bisexual men and African Americans and Latinos. CDC has estimated that the overall HIV incidence has remained relatively stable 2006-2009, except for young (aged 13-29) MSM, who had a 34% increase. This increase was driven by a 48% increase among young, black MSM. There were no statistically significant changes in HIV incidence due to injection drug use 2006-2009, but Blacks accounted for a disproportionate (48%) proportion of incident infections. In 2009, 23% of new HIV infections occurred in women and were principally due to heterosexual transmission. Of new HIV infections in women in 2009, 57% occurred in African Americans, 21% were in whites, and 16% were in Latinas. 2009 estimated rates of new HIV infection per 100, 000 were 103.9 for African American males, 39.9 for Latino males, and 15.9 for white males; for females the rates were 39.7 for African Americans, 11.8 for Latinas, and 2.6 for whites.

There are stark disparities in death rates from HIV disease. The age-adjusted rate of death due to HIV disease has been highest among African Americans and second highest among Latinos. Data from 2008 indicate that persons dying of HIV disease increasingly consist of women (28%), African Americans (55%), residents of the South (53%), and persons 45 years of age or older (61%). Part of this is accounted for by African Americans taking longer to seek medical care and having lower CD4+ cell counts at the time of diagnosis. But even minorities in care are less likely to receive highly active antiretroviral therapy (HAART). While minorities are less likely be adherent to HAART, there are data suggesting that even when on HAART, minorities may have poorer virologic outcomes. Pharmacogenomic differences in medication efficacy or toxicity and differences in the course of comorbid medical conditions may contribute to disparate outcomes.

Research Scope

A range of methodological approaches including basic, clinical, epidemiological, prevention, and treatment research as well as multidisciplinary studies are needed to address the complex interplay of biomedical, behavioral, and social factors that lead to HIV/AIDS disparities among vulnerable populations.

This FOA includes, but is not limited to, the types of studies described below:

Epidemiological Research

Studies are encouraged, but not limited to:

• Characterizing the scope and magnitude of HIV/AIDS and other sexually transmitted infections (STDs) among both injection and non-injection drug users, their sexual partners, peers, and social networks;
• Understanding how specific drug types, drug combinations, and/or routes of drug administration influence vulnerabilities for HIV and other STDs;
• Assessing the contributions and interactions of social, cultural, economic, and community factors, norms, and attitudes to the development and/or perpetuation of fears of discrimination and stigma related to one’s ethnic/racial identity, sexual identity, friends and partners, substance abuse, physical and mental health, and HIV serostatus;
• Examining the role that stigma, including perceived stigma, fear of discrimination, and fear of retribution from one’s family, church, and community may have on decisions about self-disclosure regarding one’s sexual identity, as well as on one’s sexual risk behaviors and partnerships, use of drugs, and knowledge of and willingness to access HIV testing services and health and medical care;
• Characterizing patterns of drug use, including predictors of use, the extent of use, and transitions between non-injection and injection drug use, as well as the association between changing patterns of drug use and HIV risk;
• Examining the role of the Internet and social networking websites on attitudes, perceptions, and norms related to drug use, sexual behavior, partnership formation, and social networking;
• Exploring how advances in and availability of antiretroviral therapies for HIV/AIDS, including pre- and post-exposure prophylaxis, influence attitudes and perceptions about HIV disease, willingness to discount the risks of becoming infected, or perceptions about the risks and vulnerabilities for HIV among social networks;
• Characterizing disparities in the incidence, prevalence, and correlates of HIV and other STDs, including disparities that result from and/or influence an individual’s social mixing patterns; choice of friends, peers and networks; vulnerabilities to acquire and use drugs; psychosocial stress and mental health; sexual partnerships and familial relationships; and access to/use of community-based health and social service programs;
• Disentangling social, cultural, geographic, and environmental factors associated with disproportionate rates of HIV incidence and prevalence among U.S. ethnic/racial minority groups to inform the developments in community-based outreach and participatory research, including new strategies for community-based prevention and HIV/AIDS and drug abuse treatment interventions; and
• Identifying salient social and environmental risk factors (i.e., changes in risk vulnerabilities associated with gentrification and the relocation of neighborhoods, dislocations linked to economic conditions and unemployment rates, new drug trafficking and distribution routes, gang formation and criminal activity, and local law enforcement practices) that impact drug abuse, unsafe sex, and HIV/AIDS to inform new HIV prevention interventions to reach and engage vulnerable groups before drug use and HIV infection and STDs are endemic.

Prevention Research

Prevention efforts should target the most at-risk populations, with consideration of the role of non-injection as well as injection drug use and co-morbidities (mental health, infectious disease, etc.). Many conditions associated with HIV infection suggest the need to intervene at organizational, structural, or community levels, as well as providing constructive attention to social, drug using, and sexual networks.

Studies may include:

• Rapid policy assessment and intervention programs to address emergent aspects of local HIV/AIDS epidemics such as non-injection drug use and related risk factors;
• Development and evaluation of HIV/AIDS interventions that build community capacity for addressing risk and protective factors to reduce HIV/AIDS acquisition/transmission;
• Development and evaluation of HIV/AIDS prevention interventions for African-American and Latino MSM which address the elevated community risks for these populations, such as late diagnosis and elevated prevalence in partner populations;
• Efforts to address gender issues related to substance use and HIV prevention (e.g., drug using couples, female partners of male drug users, stigma associated with drug use and gender).
• Efforts to integrate HIV/AIDS prevention and drug use prevention into settings that routinely serve adolescents and youth (including non-clinic settings) particularly MSM youth and members of ethnic/racial minorities;
• Efforts to integrate reduction of drug-use and other HIV risks into settings that routinely see persons with significant levels of substance use (e.g., STI clinics, mental health centers);
• Development and evaluation of HIV/AIDS interventions that address persistent risks such as continued sexual and drug use risk despite frequent HIV testing, or frequent episodic use of drugs in conjunction with risky sexual behavior;
• Translation of interventions with demonstrated efficacy for HIV/AIDS prevention into new settings and populations, particularly those where HIV/AIDS risk includes non-injection drug use;
• Use of intervention settings such as harm reduction providers as hubs for interventions that more fully address HIV risk reduction;
• Development and evaluation of HIV/AIDS prevention interventions which make use of new technologies to identify recent infection, assess community-level risk for transmission, or identify co-factors for HIV transmission;
• Development and evaluation of culturally competent interventions that integrate HIV/AIDS prevention with drug use treatment or prevention in the criminal justice system;
• Development and evaluation of HIV/AIDS prevention interventions that make use of basic research on the effects of drug use on motivation, neurocognitive functioning, and/or immunology; and
• Development and evaluation of HIV/AIDS prevention interventions that incorporate reduction in stigma toward persons living with HIV/AIDS and persons at elevated risk.

Health Services Research

Health services research is encouraged to improve the quality, delivery, efficiency, implementation, and effectiveness of prevention and treatment services for vulnerable populations with drug use disorders who may be infected with and/or affected by HIV/AIDS. To address these goals, research studies may focus on examining the effectiveness of evidence-based HIV prevention and treatment services for vulnerable populations in naturalistic settings and the extent to which financing systems, organizational structures and processes, management practices, and health technologies affect the accessibility, utilization, effectiveness, cost and quality of drug abuse and HIV/AIDS treatment and prevention services. Also of interest is research on ways stakeholders (providers, payers, school administrators, corrections officials, governmental regulators, etc.) can improve standards of care for HIV+ drug users. New study designs, measurement instruments, and data analytic methods to facilitate a new generation of health services research are needed.

Studies may include but are not limited to:

• Examining integrated universal HIV testing and counseling among high risk vulnerable drug abusing groups (e.g., racial/ethnic and gender minorities) both in and outside of the drug abuse treatment system;
• Improving access and quality of prevention or treatment services for HIV+ drug users from vulnerable populations, including women, adolescents, racial/ethnic minorities, MSM, and those with other co-occurring disorders (such as mental health, HBV, HCV);
• Evaluating the delivery of substance abuse treatment services for vulnerable populations in non-traditional settings such as schools, criminal justice facilities and primary care settings for those with HIV or at risk for HIV;
• Analyzing the impact of local, state, and/or national policies affecting the organization, management, or financing of treatment and prevention services for vulnerable populations with HIV on treatment accessibility, quality of care, patient utilization and retention in care;
• Conducting implementation studies that seek to understand and improve the uptake of evidence-based treatment and care for vulnerable HIV+ persons within real-world service delivery settings, including HIV care settings, drug abuse treatment, and general health care settings serving drug abusers;
• Identifying organizational characteristics (e.g., climate, culture), service delivery models, financing, and managerial approaches to providing the most accessible and effective treatment for HIV, substance use disorders, and comorbid conditions among vulnerable populations; and
• Analyzing the clinical effectiveness, cost-effectiveness, comparative effectiveness or cost-of-illness of various strategies, approaches, guidelines and protocols for the treatment of vulnerable populations with HIV and co-occurring substance use.

Medical Consequences of Drug Abuse, HIV, and Co-Occurring Infections

Research is needed on the medical/clinical consequences of licit and illicit drugs of abuse, HIV, and co-occurring bacterial and viral infections such as hepatitis B, C, and D, tuberculosis (TB), sexually transmitted infections/diseases (STIs/STDs).

Studies may include:

• The effects of substance abuse, HIV, and co-occurring, opportunistic infections (e.g., HCV, TB, STIs and others) and associated comorbidity on all physiological or biochemical systems (e.g., cardiovascular, hepatic, respiratory-pulmonary, endocrine, immune, metabolic, oro-maxillary, and others);
• Natural history of HIV and co-occurring infectious diseases in drug abusers, disease progression and underlying pathophysiology; and role of nutrition in pathogenesis of infection;
• Impact of substance abuse on drug resistance and susceptibility to infection and mucosal integrity;
• Developing innovative non-invasive techniques/methodologies for diagnosis and assessment of drug abuse and HIV associated medical disorders/conditions;
• Studies of drug abuse and HIV-associated oxidative stress/inflammation in vulnerable populations;
• Developing biomarkers for the assessment of immune reconstitution, inflammatory syndrome, infectious diseases; and programmed cell death (apoptosis);
• Pharmacologic interventions for drug abuse and HIV-associated medical/clinical conditions;
• Interactions between drugs of abuse and medications used for the treatment of drug addiction (e.g., methadone, buprenorphine), HIV and co-infections (e.g., ARVs), and mental disorders (e.g., benzodiazepines); and other comorbid conditions; and
• Pharmacological, physiological, genetic, and clinical factors in progression of HIV and co-infections in vulnerable populations.

Clinical Neuroscience Research

Identifying vulnerable individuals with a higher propensity of engaging in HIV risk behavior and/or non-adherence to HIV treatment/prevention interventions is critical to HIV prevention and intervention. Translational studies are encouraged to better understand human neurocognitive and neurobiological factors that could influence disease progression and disease outcomes and could facilitate the development and/or improvement of prevention and treatment interventions in vulnerable populations. Studies may include:

• Characterization and impact of neuroinflammation on disease progression and outcome;
• Characterization and impact of neuroinflammation and altered neurobiological factors on brain function, cognition and behaviors;
• Impact of neurocognitive changes on treatment adherence and prevention in those comorbid for HIV and drug abuse;
• Characterization of biomarkers of disease progression and outcome;
• Brain correlates of risky decision processes;
• Studies of the impact of treatment non-adherence on the decline in daily living function and overall health;
• Behavioral paradigms and self-report as probes for detecting neurocognitive function;
• Vulnerability of HIV+ individuals to initiation and relapse to use of psychoactive agents including cigarette smoking;
• Consideration of emotional and motivational dysfunction and deficits in prospective memory and attention as factors in risky decision-making and as predictors of adherence to intervention/medication;
• Interactive outcomes of HIV and addictive substances effects across multiple domains of functioning; and
• Comorbidity of HIV/hepatitis virus coinfections on CNS function.

Developmental Research

Research topics include but are not limited to:

• Research on the neurobiological, neurodevelopmental, cognitive, behavioral and health sequelae of intrauterine exposure to drugs of abuse, HIV/AIDS and/or to antiretroviral therapy;
• Studies to examine the health and development of children and youth affected by HIV/AIDS and drugs of abuse. Affected children and youth include those with a caregiver or other family member with HIV/AIDS and children orphaned by AIDS;
• Research to understand the development of risk and protective factors associated with drug use and abuse and other HIV risk behaviors among vulnerable youth including youth living with and/or youth affected by HIV/AIDS, homeless youth, and young MSM;
• Research on the development of brain and behavioral processes associated with HIV risk behaviors including decision making, self-regulation, impulsivity, and social influence and the effects of drug use and abuse on these brain and behavioral processes;
• Research on family and developmental processes which may impact risk behaviors, decision making and intervention efficacy and effectiveness of interventions;
• Interventions to ameliorate the negative behavioral and neurodevelopmental consequences for children exposed to drugs of abuse, HIV/AIDS, and/or antiretroviral therapy in utero; and
• Interventions to maintain and improve the health and development of youth living with and/or children and youth affected by HIV/AIDS and substance abuse.

Drug Abuse Treatment

Given the high rates of co-occurring substance abuse and HIV (and related risk behaviors), integrated treatment approaches that promote the prevention of HIV (and related risk behaviors) in the context of substance abuse treatment is critical. For example, interventions that address risky sexual behavior, risky injection practices, and overall risk reduction behaviors can be important to integrate into ongoing protocols of substance abuse treatments for adolescent and adult populations. Relatedly, the intersection of substance abuse and mental health comorbidities (e.g., anxiety, depression) and stressful and adverse life events (e.g., child sexual abuse) may have even more profound or cumulative effects for increasing HIV risk behaviors, further highlighting the need for multi-pronged and integrated behavioral interventions that can target multiple areas of impaired functioning.

Another unmet and critical area of need is behavior interventions that can foster access to care and adherence to HIV treatment regimens. Given that high rates of adherence to HAART are needed long-term to achieve and maintain viral suppression, continued adherence to treatment regimens is clearly significant to reducing morbidity and mortality. However, substance abuse often impairs the ability and willingness of individuals to avail themselves of clinical care, including HIV testing and/or care, particularly if they are not yet HIV symptomatic. Interventions that can simultaneously reduce substance abuse and implement strategies to incentivize populations to access care would have significant public health importance.

Research topics include but are not limited to:

• Generate, adapt or refine interventions to prevent the acquisition or transmission of HIV infection among individuals in drug abuse treatment, including interventions targeting particularly vulnerable adult and adolescent populations (e.g., homeless, sexually abused, mentally ill); and examine mechanisms of behavior change:
• Generate, adapt or refine interventions to promote adherence to drug abuse treatment, HIV (e.g., adherence to HAART) and addiction medications; and examine mechanisms of behavior change;
• Computerize or partially computerize evidence-based HIV prevention interventions for individuals in treatment for drug addiction;
• Research to personalize HIV prevention interventions for individuals in drug abuse treatment; and
• Drug abuse treatment research for HIV+ drug abusers, including smokers, marijuana-dependent and other illicit drug abusers.

Clinical Trials Network Research

The Clinical Trials Network (CTN) involves academic and treatment researchers and community-based service providers in cooperatively developing, validating, refining, and delivering new treatment options. CTN conducts rigorous, multi-site studies of behavioral and pharmacological interventions to determine efficacy and/or effectiveness across a broad range of community-based treatment settings (CTPs) and diverse patient populations. Investigators are encouraged, when appropriate, to utilize the Clinical Trials Network (CTN) (http://www.drugabuse.gov/CTN/Index.htm) infrastructure as a platform for their studies and/or to conduct secondary data analyses on completed HIV Clinical Trials Network protocols www.ctndatashare.org.

Basic Neuroscience and Behavior Research

Studies may include but are not limited to:

• Animal studies to explore the effects of drug abuse and HIV on physiological or biochemical systems; including the CNS, PNS, cardiovascular, hepatic, respiratory-pulmonary, endocrine, and immune system as they relate to disease transmission and progression in vulnerable populations;
• Development of animal model systems that investigate the cognitive and behavioral differences that can lead vulnerable individuals to engage in risky behaviors associated with HIV and drug abuse;
• Studies to determine the molecular and cellular consequence of substance abuse, HIV-1 infection and latency, and their interaction with glia cells within the CNS;
• Comprehensive approaches to identify genetic variants in multiple ethnicities that contribute to HIV-1 vulnerability, AIDS progression, and/or susceptibility to coinfections or opportunistic infections in drug abusing individuals;
• Identification of specific genetic, epigenetic, or proteomic signatures that impact initial immune or inflammatory responses to HIV infection, HAART-induced reconstitution of immune responses, inflammation resulting from immune reconstitution, or HIV-1-induced neuroinflammation and oxidative stress in the presence of drugs of abuse;
• Studies to explore the role of epigenetics in HIV-1 infection and drug abuse; examination of changes in epigenetic host response to HIV infection through DNA methylation, chromatin modification, and/or non-coding RNAs;
• Studies that address characteristics of placental, mucosal, and blood brain barriers associated with increased vulnerability to HIV infection and progression in the presence of drugs of abuse;
• Biomarkers to assess the impact of acute and chronic stress on vulnerability to HIV infection, as well as immune function and host responses to HIV infection;
• Animal studies to explore the pharmacogenetic or pharmacodynamic interactions between HIV-1-related therapies and either drugs of abuse or medications for treatment of drug abuse, as well as treatments for other co-occurring conditions including infections common in drug users;
• Studies to explore sex differences in susceptibility to HIV infection and disease progression;
• Development of an a model system to study various behavioral and biological aspects of HIV susceptibility and transmission in adolescents; and
• Characterize the differences that may lead to increased progression of HIV cognitive impairment or neuropathogenesis in animal models systems.

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
Application Types Allowed	New Renewal Revision 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	Scope of the proposed project should determine project period. The maximum project 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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) 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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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(s)/PI(s), 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

Not Applicable

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(s)/PI(s) 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]

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
Phone: (301) 443-3207
Fax: (301) 443-6814
E-mail: [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
E-mail: [email protected]

Richard A. Jenkins, PhD.
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
E-mail: [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
E-mail: [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
E-mail: [email protected]

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

Pam Fleming
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: (301) 253-8729
Fax: 301-594-6849
E-mail: [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.