Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Drug Abuse Dissertation Research (R36)

Activity Code

R36 Dissertation Award

Announcement Type

Reissue of PAR-10-020

Related Notices

  • September 22, 2016 - This PAR has been reissued as PA-16-443.
  • March 15, 2016 - Notice to Extend PAR-13-182. See Notice NOT-DA-16-019.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • 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.
  • April 12, 2013 - See Notice NOT-DA-13-023. Notice to Amend Section IV. Application and Submission Information.

Funding Opportunity Announcement (FOA) Number

PAR-13-182

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.279

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for support of drug abuse doctoral dissertation research.

Key Dates
Posted Date

April 5, 2013

Open Date (Earliest Submission Date)

May 16, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS 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

Standard dates apply

Expiration Date

New Date September 8, 2016 per issuance of NOT-DA-16-019. (Original Expiration Date: May 8, 2016)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Purpose

The National Institute on Drug Abuse (NIDA) announces the availability of NIH Dissertation Award grants (R36) to support drug abuse doctoral dissertation research in NIDA areas of priority (http://www.drugabuse.gov/funding/funding-priorities ). Areas of focus include research on basic and clinical neuroscience and behavior, developmental trajectories, epidemiology, prevention, treatment, services, and/or women and sex/gender differences. Grant support is designed to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to NIDA. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

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 most recent report on 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: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention of individuals from disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

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

Research Objectives

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 applied sciences related to the underlying mechanisms and health effects of drugs of abuse. This FOA is to provide students with grant-in-aid support to perform drug abuse dissertation research on a topic related to the study of 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.

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 HIV/AIDS and Health Disparities are encouraged.

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 influece 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: (http://grants.nih.gov/grants/guide/pa-files/PA-13-078.html; http://grants.nih.gov/grants/guide/pa-files/PA-13-077.html; http://grants.nih.gov/grants/guide/PA-files/PA-13-079.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, etc.), and evaluating their resulting potency.

Developing sleep hygiene modules for incorporation into drug abuse treatment protocols for drug abusers with insomnia.

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 in HIV+ drug users.

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 Related 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 that are 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 include, but are not limited to the following:

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.

The development and evaluation of sex/gender-specific interventions directed at preventing HIV infection and treating HIV/AIDS among drug using populations.

For additional background and research areas of interest dealing with women and sex/gender differences, see http://grants.nih.gov/grants/guide/pa-files/PA-11-047.html.

Questions on the relevance of a particular research topic to NIDA's scientific mission and other questions about this FOA should be addressed to the program contact listed under INQUIRIES. Potential applicants are strongly encouraged to discuss their application with the appropriate program contact.

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 see http://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.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (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

Grants to support dissertation research will provide no more than $50,000 in direct costs per year.

Award Project Period

The maximum period is two years, with the possibility of extension without additional funds for up to 12 months.

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Foreign Institutions

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.

Required Registrations

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.

Program Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, clinical, behavioral, and social sciences workforce. NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly the NIH encourages institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

For the purpose of this announcement, institutions are encouraged to identify applicants who will increase diversity on a national basis. As indicated in Section I, the NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

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 most recent data and report at http://www.nsf.gov/statistics/wmpd/). 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.

C. Individuals from disadvantaged backgrounds who are defined as:

The applicant must have a baccalaureate degree and be enrolled in a Ph.D. or equivalent doctoral-degree program (e.g., Dr. PH., D.NSC. and Sc.D.), a formally combined M.D. /Ph.D. program or other combined professional/clinical and research doctoral program in the biomedical, behavioral and social, and clinical sciences at an accredited domestic institution.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketches: Biographical Sketches must be provided as attachments for each Senior/Key Person. The mentor is considered a key person on the proposed project and his/her profile must be included under the Senior/Key Person Profile(s) Component. For the doctoral candidate, the attached Biographical Sketch must also contain a scientific autobiography in the Personal Statement that states his/her career goals, including reference to their interest in the specific areas of research designated in this FOA and a description of their intended career trajectory. This information will be used by NIDA program staff to determine how the proposed study addresses program priorities.

R&R Budget

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

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

Research Strategy: The subheadings within the Research Strategy Section of the applications should remain Significance, Innovation, and Approach as described in the SF424 Application guide, but the expectation is that the information outlined here will be conveyed within this portion of the application.

The applicant must provide a narrative project description that contains a detailed scientific and technical discussion of the following specific points:

a. A description of the research project and what it is intended to accomplish.

b. A summary of related published research that addresses the identified problem(s).

c. The questions to be answered or the hypotheses to be tested by the project.

d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be used, and steps that will be taken to protect human subjects.

e. The management of the project including a schedule of the main steps of the proposed investigation.

Letters of Support: The application must include a letter or recommendation from the student's program advisor or program chair in support of the candidate and the proposed research dissertation. Letters of support should include information on the student's academic standing as well as a commitment from the school to implement the study as proposed.

A Certification Letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. This typically comes from the student’s dissertation committee chair or program chair. The letter must: (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIDA support; and (d) briefly describe the facilities and resources for the project and certify that they are adequate to conduct the proposed research.

Since only one attachment is allowed for the Letters of Support item of the Research Plan form, applicants must combine all letters into one file. For cases in which the certification and support letters would be provided by the same person, one letter addressing both issues will be acceptable.

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

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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.

Important reminders:
The All PD/PI 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.



1. Criteria

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 total award project period may not exceed two years and dissertation awards are not renewable.

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

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.

Overall Impact

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).

Scored Review Criteria

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)/Mentor(s)

Is the PD/PI, 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)? Are the faculty advisor/dissertation chair and other doctoral committee members appropriately qualified to provide guidance as needed? Have the faculty advisor/dissertation chair and any other participating members of the committee indicated that they will provide sufficient time to allow completion of the dissertation? Will the faculty advisor/dissertation chair provide the necessary supervision and mentoring to the applicant?

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?

Additional Review Criteria

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.

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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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.

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.

2. Review and Selection Process

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Debra Dudley
Grants Management Branch/OPRM
National Institute on Drug Abuse (NIDA)
Telephone: 202-722-4093
Email: ddudley@nida.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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