It is critical that applicants follow the instructions in the Research Instructions for the SF424 (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

The goal of this FOA is to enhance the diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This support will enhance the pool of highly talented drug abuse scientists who conduct research within the funding priority areas of NIDA (http://www.drugabuse.gov/funding/funding-priorities), within the areas of the NIDA strategic plan (https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan), or within the HIV/AIDS research priorities (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html) that relate to NIDA's mission. Applications are encouraged from doctoral candidates in a variety of academic disciplines and programs. This program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations. This two-year award supports the completion of the doctoral dissertation research project.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences.

NIDA is committed to recruiting and retaining in its research workforce talented individuals from the diverse fabric of U.S. society. In 2011, a workgroup of the National Advisory Council on Drug Abuse (NACDA) issued a report (https://www.drugabuse.gov/sites/default/files/2011_dhd_council_report.pdf) highlighting the need for enhancing the diversity of the substance abuse research and training. By having a diversity of perspectives represented is important in terms of enhancing the diversity of the workforce to foster research opportunities for the next generation of scientists to address the mission of NIDA.

Although the NIH currently provides opportunities to develop research careers and improve participation for individuals from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation and others provide strong evidence that low representation remains an important problem. The NIDA workforce is receiving doctoral degrees in neuroscience, genetics, clinical psychology, and other related fields, yet the extant national data on U.S. citizen/permanent resident recipients of the doctorate demonstrate a continued need to enhance diversity in those disciplines (Doctorate Recipients from U.S. Universities; http://www.nsf.gov/statistics/sed/). For example, of those earning a neuroscience doctorate in 2013, <1% were Native American, 2% were Black/African American, and 6% were Hispanic/Latino. Of those earning a doctorate in genetics in 2013, <1% were Native American, 3% were Black/African American, and 4% were Hispanic/Latino. Similarly, among those earning a doctorate in clinical psychology in 2013, <1% were Native American, 4% were Black/African American and 8% were Hispanic/Latino.

Institutions must play a role in this funding mechanism by identifying candidates who will increase the diversity of researchers. Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups as well as individuals with disabilities.

Recent national data on doctorates earned by underrepresented minority U.S. citizens and permanent residents demonstrates a continued need to enhance diversity (http://www.nsf.gov/statistics/sed/2011/start.cfm).

NIDA supports more than 85 percent of the world's research on the health aspects of drug abuse and addiction. Research supported by NIDA encompasses basic, behavioral, and treatment research related to the underlying mechanisms and health effects of drugs of abuse. This FOA will provide students with support to perform drug abuse dissertation research on a topic related to the study of basic and clinical, development, epidemiology, prevention, treatment, services, or women and sex/gender differences, and thereby increase the pool of highly talented drug abuse scientists who conduct research in these areas. NIDA is especially interested in improving the research career preparedness of individuals from underrepresented groups by providing funding support to complete the dissertation. This FOA seeks to help individuals obtain the necessary qualifications at the doctoral-level with an intent to subsequently establish and lead a research program in NIDA-relevant fields. The R36 program provides support to complete drug abuse-related dissertation research and includes funds that may not be readily or sufficiently available in NRSA predoctoral programs, which limit support to stipends, tuition and fees, and institutional allowance. .

The descriptions below are examples of the research foci of this grant program and are provided to guide potential applicants to determine whether a given scientific topic may be appropriate for this initiative. These descriptions are not intended to be comprehensive. In addition, given the complexity of drug abuse research, it is permitted to conduct the proposed dissertation research in conjunction with an ongoing research study or to use extant data. Research studies focused on high-priority HIV/AIDS topics (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html) and health disparities are encouraged.

Basic and Clinical Research:

• Studies in cognitive neuroscience to understand the neural basis of interrelationships between addictive and cognitive processes.
• Studies on pain and analgesia to understand neurobiological processes involved in pain and mitigation of pain.
• Studies of basic HIV and substance abuse using big data approaches to understand interactions of substances of abuse with non-neuronal cells and tissues impacted by HIV infection.
• Studies in the clinical neurobiology of HIV/AIDS to investigate how substance abuse affects the onset, progression, and severity of HIV/AIDS-related alterations of the CNS.
• Studies of innovative chemical design of new entities and probes based on computer-aided drug design.
• Studies of pharmacokinetics and pharmacodynamics of drugs of abuse to characterize drug absorption, disposition, elimination, and kinetics.
• Studies of the genetic and epigenetic basis of vulnerability and adaptation and the identification of molecular mechanisms underlying substance preference and related behaviors.

Development and Epidemiology:

• Studies of multiple factors that influence drug use outcomes. That is, studies that examine genetic, neurological, biomedical, familial, behavioral, environmental, social, cultural, developmental, psychopathological, and psychological factors, their interactions, and mediating characteristics.
• Studies of the underlying physiological and psychosocial mechanisms associated with the transition from lower to higher levels of drug involvement and from higher levels of drug involvement to dependence and addiction.
• Development and improvement of techniques for studying drug abuse, including enhancements in measurement, development of improved sampling procedures, and refinement of analytic methods for diverse populations across human development.
• Development of innovative approaches to identify both physical (ecological) and social environmental/contextual characteristics of local communities that influence drug use, emerging drug use patterns, and adverse drug-related outcomes.
• Delineation of the underlying dynamic causal mechanisms associated with drug use patterns and adverse drug-related outcomes by integrating individual, family, peer and community level factors. Mechanistic studies and research that address critical time points in development which may influence risk or resilience are of interest.
• Studies of emerging trends (e.g., club drugs, illicit prescription drug abuse, tobacco and other smoke products, etc.), including studies that relate these trends to influences such as changes in social attitudes, new drugs of abuse, new patterns of social interaction and social media, new technologies, new drug trafficking patterns, and similar macro-level changes.
• Research on drug use and drug-related consequences among racial/ethnic minority groups and other underserved populations. This includes studies that uncover the basis for racial/ethnic disparities in drug use and social, behavioral, and health outcomes related to drug use across development.
• Research to assess the impact of mental health interventions in childhood on subsequent drug abuse.
• Studies to assess the nature, scope, and consequences of drug-related trauma, violence and crime including violent and nonviolent crime, interpersonal violence, and substance abuse and other comorbid physical and mental health problems.
• Research to assess the impact of drug use on adverse behavioral, social, and health consequences (e.g., trauma, violence, educational attainment, HIV) as well as the role of adverse consequences on further drug involvement.

Prevention:

• Studies that apply insights from genetics, neurobiology, neurocognition, and physiology to inform prevention interventions and test the effects of prevention interventions.
• Studies on the efficacy and/or effectiveness of drug abuse prevention programs and strategies that are widely used but largely untested.
• Studies to develop and test the efficacy/effectiveness of interventions adapted for different contexts, for example health care settings and schools.
• Methodological research to improve the analysis of complex prevention trial data for example, statistical modeling for multi-level data, analysis of longitudinal data, and research examining complex interactions between qualitative and quantitative outcome data.
• Studies on the adoption, implementation, and sustainability of evidence-based drug abuse prevention interventions, including analysis of process data to determine factors that account for quality of implementation and outcomes, or program sustainability.
• Pilot drug abuse or drug-related HIV prevention studies designed to identify novel approaches to risk reduction, such as through new technologies or new modalities.
• Research aimed at developing improved alcohol and drug abuse prevention strategies for high risk populations such as subgroups with elevated rates of substance use, children of substance users, and underage drinkers.

Treatment:

Behavioral and integrative treatment research at NIDA is guided by a stage model of therapy development. For a detailed description of this model, as well as NIDA's therapy development and testing priorities, please see the Behavioral Therapies Development Program Announcements at: (https://grants.nih.gov/grants/guide/pa-files/PA-16-074.html; https://grants.nih.gov/grants/guide/pa-files/PA-16-073.html; https://grants.nih.gov/grants/guide/pa-files/PA-16-072.html).

Examples of behavioral treatment research appropriate for this announcement include, but are not limited to the following:

• Utilizing genetic, neurobiological, neuropsychological, behavioral, or other diagnostic data to tailor treatment to specific subgroups.
• Utilizing relevant research from the animal model literature (e.g., avoidance and impulsivity paradigms) to develop or improve treatments/interventions.
• Utilizing relevant research from the developmental (e.g., basic research on familial and peer influences during adolescence) or social psychology (e.g., basic research on stereotyping) literatures to improve treatments.
• Stage I studies developing or adapting behavioral interventions that promote adherence to drug and alcohol abuse pharmacotherapy.
• Adapting/modifying evidence-based treatments for use in non-traditional and community settings, into community-friendly formats (e.g., individual to group, briefer formats, less intensive delivery, computer-assisted delivery), and evaluating their resulting potency.
• Developing and assessing treatment provider training procedures for evidence-based treatments (e.g., computerizing training procedures; this can include initial training as well as supervision requirements).
• Developing interventions to promote adherence to medical treatment regimens.
• Computerizing, or partially computerizing evidence-based treatments for substance abuse disorders, as well as for HIV prevention interventions for individuals in drug abuse treatment.
• Developing interventions to reduce pain in individuals addicted to prescription drugs, non-drug abusing populations, or individuals with chronic pain.
• Research involving secondary analyses of existing behavioral treatment research data sets to identify predictors, moderators, or mediators of treatment outcome, mechanisms of action of treatment, or secondary effects of treatment on participants in various contexts (e.g., peer group, school, work, family) or on participants' family members (e.g., children).
• Conducting secondary analysis of combined behavioral and pharmacological treatment clinical trials.
• Research on instrument development and/or psychometric analysis of tools for the clinical assessment of drug abuse, treatment efficacy, treatment fidelity, and HIV risk, or for constructs believed to be related to mechanisms of action of behavioral treatment efficacy.
• Research to develop and test a therapy module to be added to an existing therapy to address targeted issues (e.g., adding an HIV risk reduction module to a family therapy for drug-abusing adolescents).
• Research to integrate innovative health technologies into new or existing behavioral and integrative treatments.
• Research testing a principle of behavior change among drug-abusers in treatment (e.g., by adding more frequent or multi-method assessments to an existing study in order to track behavior change over time).
• Development of improved medication compliance markers.
• Development of medications to treat Substance Use Disorders, including medications for smoking cessation.
• Studies of the neurodevelopmental differences among adolescents in the neurobiological processing of drug-related information, as well as differences in general reward valuation, and reinforcement (both positive and negative) in laboratory decision-making or imaging paradigms relevant to treatment development.
• Studies of developmental cognitive processes of rewards, losses, social cues in decision-making, and value incentives relevant to treatment and integration of relevant developmental cognitive processes into the development of treatments.
• Studies to inform our understanding of how peer influence contributes to decision making processes in group treatment settings.
• Studies that use neuroimaging and other techniques to characterize specific neurobiological circuitry during adolescence to inform treatment development (e.g., to determine incentive-motivational circuitry that can be are involved in emotional regulation, drug seeking, addiction, reward, relapse, and maintenance of behavioral change).

Services:

• Studies to assess the impact of financing and organizational and managerial factors on access to and use, quality, efficiency, costs, and outcomes of prevention and treatment services.
• Research to measure the effectiveness, cost-effectiveness, and cost-benefits of drug abuse prevention and treatment services.
• Drug abuse service delivery systems and models, such as continuity of care, development of therapeutic rapport, service linkages and integration models.
• Studies that advance the adoption and implementation of evidence-based drug abuse prevention and treatment interventions into service delivery systems (e.g., specialty care, primary care, criminal justice, child welfare).
• Drug abuse treatment and prevention services for HIV seropositive patients and for those at risk of HIV infection and other diseases that are a consequence of drug abuse.
• Studies focusing on management strategies (e.g., work team models, quality management) and business practices aimed at improving the quality, effectiveness, and efficiency of drug abuse treatment and prevention services.
• Research focusing on the development or improvement of research methods---including but not limited to study design, measurement, data collection, and analytic procedures---for studying the societal impact of drug abuse and/or the delivery, quality, outcomes, and economics of drug abuse prevention or treatment services.

Women and Sex/Gender Differences:

Through this dissertation award program, NIDA seeks to foster research on females (both humans and in animal models) and sex/gender differences in all areas of drug abuse research. From basic cellular and genetics research to epidemiology, prevention, treatment, and services research, investigators are encouraged to explore the possible importance of sex/gender differences in their chosen area of study and to explore drug abuse issues specific to females.

Examples of research areas appropriate for this announcement:

• Sex/Gender differences in the basic behavioral, physiological, neurobiological and genetic mechanisms underlying drug abuse and addiction; and laboratory (both human and animal), clinical, and epidemiological studies of sex/gender differences in the determinants of initiation, progression, maintenance of drug use and addiction, and responsiveness to treatment.
• Laboratory (both human and animal), field, and clinical research aimed at: (1) identifying sex/gender differences in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining drug-related consequences that are unique to females.
• Clinical studies aimed at characterizing sex differences in the effects of drug exposure on the developing brain, or studies aimed at detecting sex differences in acute and chronic drug use effects (and abstinence effects) on the brains of children, adolescents and adults.
• The application of sex/gender-specific theories and empirical research on the origins, pathways, and risk and protective factors related to drug use, progression/transition, and maintenance, to the design, development, and testing of gender-sensitive prevention and treatment strategies and interventions to determine effectiveness and efficacy.
• The development and testing of theoretically-based drug treatment approaches (including behavioral treatment and pharmacotherapies) that address sex/gender-specific topics related to the effective and efficient delivery of drug abuse treatment services.

Drug abuse and HIV/AIDS research from a sex/-gender-based perspective that addresses the high priority topics of research set forth in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html are highly encouraged.

For additional background and research areas of interest dealing with women and sex/gender differences, see https://grants.nih.gov/grants/guide/pa-files/PA-14-038.html.

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 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 see https://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.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

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://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

See Section VIII. Other Information for award authorities and regulations.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

In addition, eligible institutions must have a doctoral degree-granting program in the candidate's area of study. The applicant institution must be the institution at which the PD/PI is pursuing doctoral studies.

Institutions must have staff and facilities available on site to provide a suitable environment for performing high-quality research. The research training should occur in a strong research environment that has appropriate human and technical resources and is demonstrably committed to research training in the research area proposed by the PD/PI.

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 allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

The PD/PI must have an appointment at the applicant institution (e.g., research assistant).

Eligible PD/PIs are predoctoral students at the dissertation stage of training with the skills, knowledge, and resources necessary to carry out the proposed research. The applicant must have an approved dissertation proposal (at the time of award), show evidence of high academic performance in the sciences, and a commitment to a career as an independent research scientist, or as an independent physician-scientist or other clinician-scientist (dual-degree training).

The applicant must be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, PsyD, ScD), a formally combined MD/PhD program, or other combined professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical, behavioral, or clinical sciences.

For the purpose of this announcement, institutions must identify applicants who will enhance diversity on a national basis (see NOT-OD-15-053) as defined below:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27), and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

Multiple PD/PIs are not allowed.

By the time of the award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a valid Permanent Resident Card USCIS Form I-551 or other legal verification of such status).

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

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

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Office of Extramural Policy and Review

National Institute on Drug Abuse/NIH/DHHS

6001 Executive Boulevard, Suite 4243, MSC 9550

Bethesda, MD 20892-9550

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

A Mentor must be identified for this application by specifying a Project Role of Other and an Other Project Role category of Mentor .

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Letters of Support: All letters must be combined into a single pdf file.

Letter of Certification: The faculty advisor, dissertation committee chair, or university official directly responsible for supervising the dissertation research must submit a letter certifying that the PD/PI meets the eligibility criteria for this award.

Advisor and Reference Letters: The faculty advisor and at least one other member of the dissertation committee must submit letters, each no longer than 2 pages, that assess (a) the doctoral candidate’s progress to date; and (b) the candidate’s commitment to mental health-related research and her/his prospect of becoming an independent investigator in this area.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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.

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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 SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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.

For this particular announcement, note the following:

This FOA will use the National Institutes of Health (NIH) Dissertation Award (R36) mechanism. The R36 mechanism is intended to support the completion of a dissertation research project. It is expected that the doctoral candidate will have already completed core coursework and other didactics required for design and interpretation of the research. The predoctoral student is the Project Director/Principal Investigator (PD/PI) of the application, and is solely responsible for planning, directing, and executing the proposed project under the supervision, and with the approval, of a university-approved and appointed doctoral committee. Reviewers will consider the same review criteria used to evaluate other research project grants (listed below) and the overall impact will be evaluated within the context of a doctoral dissertation.

Reviewers will provide an overall impact 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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

Not Applicable

Not Applicable

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 score.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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)convened by CSR in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH NIH may request information from databases and from PD/PIs. Where necessary, PD/PIs may be contacted after the completion of a research education experience for periodic updates on PD/PI subsequent educational or employment history and professional activities.

NIDA will evaluate the overall success of this FOA with respect to enhancing diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This review will follow the trajectory of the announcement and continue two years after the FOA expiration date. The overall evaluation of the Drug Abuse Dissertation Research Award (R36) will be based on core metrics that may include, but are not limited to, the following:

• Number and percentage of program participants who complete graduate or professional doctoral degrees in mental health-related sciences
• Completion of graduate or professional doctoral degrees by gender, race/ethnicity, and disability
• Distribution of completed graduate or professional degree fields of study among participants
• Distribution of graduate degree fields of study by gender, race/ethnicity, and disability
• Number and percentage of program participants who apply for postdoctoral training/research opportunities in drug abuse-related fields
• Pursuit of postdoctoral training/research opportunities by gender, race/ethnicity, and disability
• Publication of research arising from the dissertation project and/or authorship of other scientific publications relevant to drug abuse
• Number and percentage of program participants who obtain independent faculty positions in drug abuse-related fields

Upon the completion of Drug Abuse Dissertation Research Award (R36) evaluation, NIDA will determine whether to (a) continue the program as currently configured; (b) continue the program with modifications; or (c) discontinue the program.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Will M. Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-3207
Email: aklinwm@mail.nih.gov

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

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 410-254-1853
Email: wellse2@nida.nih.gov

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 Part 75.