Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	International Research Collaboration on Drug Abuse and Addiction Research (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	Reissue of PA-09-021
Related Notices	March 17, 2015 - This PA has been reissued as PA-15-143. January 7, 2015 - Notice of an Extension of Expiration Date. See Notice NOT-DA-15-009. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-12-041
Companion FOA	PA-12-040, R01 Research Project Grant PA-12-042, R03 Small Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
FOA Purpose	This Funding Opportunity Announcement (PA) encourages collaborative research applications on drug abuse and addiction that take advantage of special opportunities that exist outside the United States. Special opportunities include access to unusual talent, resources, populations, or environmental conditions in other countries that will speed scientific discovery. Projects should have relevance to the mission of NIDA and where feasible should address NIDAs scientific priority areas. While the priorities will change from year to year, in FY12 priority areas include: linkages between HIV/AIDS and drug abuse, and prevention, initiation, and treatment of nicotine and tobacco use (especially among vulnerable populations such as children, adolescents, pregnant women, and those with co-morbid disorders).

Posted Date	November 29, 2011
Open Date (Earliest Submission Date)	January 16, 2012
Letter of Intent Due Date	Not Applicable.
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	New Date March 17, 2015 per issuance of PA-15-143. (Original Expiration Date: May 8, 2015) May 8, 2015 per NOT-DA-15-009 (Previously January 8, 2015)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

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

The National Institute on Drug Abuse (NIDA) invites applications for international collaborative research on drug abuse and drug addiction. NIDA is the single largest supporter of research on the causes, consequences, prevention, and treatment of drug addiction in the world. The mission of the Institute is to bring the power of science to bear on drug abuse and addiction through support and conduct of research across a broad range of disciplines, and ensure rapid and effective dissemination and use of results to improve prevention, treatment, and policy. The International Program extends the Institute mission internationally through programs that: 1) take advantage of unique opportunities to advance scientific knowledge through research, 2) address the global impact of addiction on public health through activities that build research capacity internationally, and 3) effectively disseminate and share the knowledge gained through NIDA-supported research to scientists, treatment providers, and policy makers around the world. Activities sponsored and coordinated by the International Program include:

• Support of international collaborations to conduct research that allow U.S. scientists to take advantage of unique research opportunities.
• Development of bilateral and multilateral interchanges with other countries and international organizations to share research knowledge for mutual benefit.
• Administration of fellowships and professional development activities for U.S. and non-U.S. addiction researchers.
• Co-sponsorship of meetings and symposia with other countries or international organizations.
• Dissemination of NIDA research and International Program activities to a broad international audience.

Several NIH and NIDA International Program tools help scientists identify potential research partners and build international partnerships. For more information, see these sections of the NIDA International Program Web site:

Collaboration Tools

Find a Research Partner

In summary, the International Program advances NIDAs mission through fostering international cooperation in drug abuse and addiction research, while integrating NIDAs Divisional research priorities and crosscutting research issues within the frameworks of NIDA, NIH, and HHS health policy and U.S. economic and foreign policy considerations.

This funding opportunity announcement is part of NIDAs effort to encourage rigorous collaborative international research and will provide funding for projects conducted in whole or in part outside the U.S. The research must be conducted by U.S. investigators in collaboration with non-U.S.-based investigators. Either the U.S. or the non-U.S. investigator may serve asProgram Director(s)/Principal Investigator(s) (PD(s)/PI(s) , but the project must include significant contributions of resources by each participant. Resources may include in kind contributions of personnel, access to study populations, laboratory and other research facilities, etc., as well as funding. This is a broad call for innovative research and applications are encouraged in all areas of science addressing drug addiction including but not limited to prevention, basic science, epidemiology, treatment and health services. Of particular interest are projects, that take advantage of a unique set of resources or subject populations which would otherwise be difficult to access domestically.

Background

Some 210 million people use drugs each year, and 200,000 die from drugs. The United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) report that illicit drug use is 1 of the top 20 health risk factors globally: Drug use disorders are associated with an increased risk of HIV/AIDS, hepatitis, tuberculosis, suicide, overdose deaths, and cardiovascular diseases. Injecting drug use a primary vector for transmission of HIV and other infections is reported by 151 countries. According to the 2011 UNODC World Drug Report, nearly one-fifth (17.9%) of the world’s injection drug users have HIV; more than half (50.3%) have hepatitis C; and nearly one-quarter (22%) have hepatitis B. Outside of sub-Saharan Africa, 30% of global HIV infections are due to injecting drug use.

UNODC finds that drug abuse is also expensive: In some countries and regions, the value of the illicit drug trade far exceeds the size of the legitimate economy. In addition to drug-related health problems, associated crime and social problems also add to the economic cost of drug abuse, which UNODC and WHO estimate can approach 2% of the gross domestic product in some countries.

Of the nearly 4.5 billion people aged 15 to 64 in 2009, UNODC estimated that between 149 million and 272 million (3.3% to 6.1%) used drugs at least once in the past 12 months. Between 15 million and 39 million people (0.3% to 0.9%) were problem drug users, and between 11 million and 21.2 million people (0.25% to 0.5%) injected drugs. The World Drug Report 2011 found cannabis remained the most widely used drug in all regions, accounting for more than 202 million people worldwide. Amphetamines and Ecstasy were used most frequently in Asia; more than 56 million people used amphetamines, with about 28 million people using ecstasy. Some 34 million people used opioids, which were used most frequently in the Americas. Heroin consumption stabilized in Europe following years of rapid growth. Around 20 million people used cocaine, mostly in the Americas, where declines in North America were offset by increased consumption in South America. Cocaine use doubled in Europe during the past decade. The misuse of prescription drugs is a significant problem in North America, with increasing prevalence worldwide. Both UNODC and the European Monitoring Centre for Drugs and Drug Dependence report the emerging trend of synthetic substance abuse, noting with particular concern the increasing prevalence of the stimulant substitute mephedrone and the synthetic cannabinoid known as Spice.

Assessing drug use by demand for treatment provides insight into which drugs are most problematic for users and their communities. UNODC finds that opiates primarily heroin dominated treatment with a disproportionally high percentage of demand. Opiates accounted for the overwhelming majority of all treatment demands in Europe and Asia, as well as nearly one-third of treatment demand in Oceania. Although amphetamine-type stimulant (ATS) use was predominant in Asia, treatment services focus on opiate abuse, raising concerns about unmet treatment demand for ATS. Cannabis, the most frequently used drug in any region, also contributed significantly to treatment demand, with regional differences in prevalence of use reflected by similar differences in demand for treatment. Cannabis abuse was the primary reason people sought treatment in Africa and Oceania, and accounted for a significant portion of treatment demand in Central and South America. North America was unique in that treatment demand was almost evenly split between cannabis, opioids, cocaine, and other drugs. Cocaine remained the major reason people sought addiction treatment in Central and South America.

The WHO Atlas on Substance Use (2010) identified the prevention and treatment services available for substance use disorders around the world, noting that more than two-thirds of all nations report having a national substance abuse policy and almost as many countries have a government office responsible for substance use issues. However, only about half of all countries budgeted funds for prevention or treatment programs. The proportion of countries reporting the availability of the scientifically proven opioid agonists methadone, buprenorphine, or buprenorphine/naloxone to treat opioid dependence varied widely, from near 90 percent in Europe to less than 10 percent in Africa. Less than half of all nations reported prevention programs, needle and syringe programs, or screening and brief intervention programs. About half of all countries reported having specialized treatment centers for drug abuse, national standards for treatment providers, and guidelines on pharmacotherapies.

The Joint UNODC-WHO Programme on Drug Dependence Treatment and Care calls for the development of a comprehensive, integrated, health-based approach to drug policy that can reduce demand for illicit substances, relieve suffering, and decrease drug-related harm to individuals, families, communities, and societies. The program stresses that services must address drug use disorders in a pragmatic, science-based, and humanitarian way.

NIDA was one of the first drug abuse research agencies to adopt this public health, evidence-based approach to drug abuse and addiction. Since its founding in 1990, the NIDA International Program has built partnerships with countries, organizations, and individual researchers to advance multinational cooperation, promote new research initiatives, expand international research capacity, and share knowledge about drug abuse and addiction. By promoting global and regional scientific networks, the NIDA International Program disseminates NIDA research methods and findings around the world, while simultaneously introducing NIDA grantees to talented drug abuse researchers from other countries. NIDA-supported collaboration stimulates the discovery of evidence-based interventions and contributes to global efforts to develop, adopt, and evaluate government policies, prevention programs, and treatment protocols that effectively address drug abuse and its consequences.

Areas of Research Focus include, but are not limited to:

This funding opportunity announcement is open to researchers in all areas of NIDA-supported science, including basic laboratory studies, clinical studies, epidemiological studies, community-based studies, and services research. The intent of this program is to stimulate state-of-the-science collaborative research between investigators from domestic U.S. institutions and researchers in other countries. Funds are being made available to take advantage of new opportunities to establish collaborative relationships with scientists conducting research or with a potential to conduct research in other countries as well as to support new research projects from established collaborators. NIDA is also very interested in establishing relationships with science-funding organizations in other countries, and so programmatic priority funding will be given to projects that are collaboratively funded by an agency of the foreign country.

Research priority areas have been identified that are international in scope, are associated with substantial detrimental health consequences, and for which an international collaborative research may provide a unique opportunity to expand our knowledge and ability to effectively respond. While this call is meant to be very broad and inclusive, the following areas of research are current priority areas:

• Active drug use is often associated with increased risk of HIV transmission, non-adherence to HAART or lapses in HIV treatment. Studies are needed to discern the best strategy to reach and test high-risk individuals and initiate and monitor HAART therapy for those who test positive. Known as Seek, Test, Treat, and Retain, this approach has been shown to reduce viral load and also HIV incidence at the population level.
• Amphetamine type stimulant abuse and synthetic and other designer drug abuse are growing problems in the United States and around the world. Studies are encouraged to assess the nature and extent of amphetamine type stimulant abuse and synthetic and other designer drug abuse, its long term sequela, and prevention and treatment options.
• Inhalant abuse continues to be an under-recognized public health problem in many countries. Studies are encouraged to improve epidemiological data on the nature and extent of abuse, to develop and implement effective prevention programs, to better understand the neurobiological impacts of these agents, and to increase public awareness of their impact.
• Smoking during pregnancy studies are encouraged to increase our knowledge of the prenatal impact of smoking and the effects of early exposure to tobacco in young people and adolescents on development of addiction and other diseases and on cognitive development.
• Drugged driving studies are encouraged to develop and utilize accurate drug testing technologies to assess the prevalence of driving under the influence of drugs, the role of drugs in accidents, and to assess the costs and benefits of laws and other programs to reduce the incidence and impact of drugged driving.

Other areas of interest include, but are not limited to:

• Given that there has not been any systematic implementation research on comprehensive prevention and treatment approaches for drug users, especially for interventions to prevent HIV infection, this program announcement strongly encourages applications on implementation research. That is, applications that addresses issues of scale-up in diverse settings, effectiveness and cost-effectiveness of interventions, and how to best integrate diverse evidence-based interventions to optimize their impact;
• Development of surveillance systems to track and respond to emerging drug epidemics, identifying abuse of novel drugs; optimal ways to respond to emerging epidemics and consider the range of linked services (e.g., drug treatment, primary care, health, social, recreational, educational, juvenile justice) for defined populations in various cultural settings;
• Optimal ways to respond to emerging epidemics and evaluate the impact of a range of linked services (e.g., drug treatment, primary care, health, social, recreational, educational, juvenile justice) for defined populations in various cultural settings;
• Research on systems or practices that enhance technology transfer and investigate how to integrate research findings into practice in a timely manner across different cultures; this may include a new research methodology or approach (e.g., valid/reliable cross-cultural measure of quality of care), rapid testing of drug use for screening drivers, or physician based education on smoking cessation treatments for pregnant women);
• Research to adapt and test innovative prevention interventions or treatments; test replicability of established prevention/treatment programs, identify key intervention components that impede or account for success in the adaptation process; culturally related barriers and facilitators to implementation; and processes and mechanisms that increase program fidelity and the potential for sustainability;
• Identification of factors that underlie treatment-seeking behavior in different countries and address the unmet need for treatment (for example, outreach interventions aimed at children at highest risk for inhalant abuse);
• Secondary data analysis of existing data sources and when available comparison of international data;
• Basic biomedical studies are needed to understand the genetic and biological basis for HIV infection and persistence, AIDS-related disease progression, and related co-infections or co-morbidities, in combination with use of licit or illicit substances (including alcohol, tobacco, cannabis, stimulants, opiates). Effects of past or continuing chronic substance use, including smoking and polysubstance use, on factors that impact disease progression and responses to current therapies as well as responses to potential vaccines or new treatment strategies are encouraged;
• Recent advances in statistical genetics, molecular biology, and genomic approaches have greatly accelerated the ability to identify the etiology of diseases that have a genetic basis. Genetic approaches, such as genome-wide association studies, deep sequencing, or whole genome sequencing are needed to identify chromosomal loci, gene variants, and haplotypes in non-US based populations to examine genetic associations with phenotypes and endophenotypes of addiction vulnerability with or without co-morbid disorders, including HIV-1 infection. Interested applicants should refer to the following links while preparing their applicaiton: http://www.drugabuse.gov/about/organization/genetics/humanapp/index.html and http://www.drugabuse.gov/about/organization/Genetics/ngcdomains/.
• Research that takes advantage of particular population characteristics (e.g., genotype, drug use patterns, cultural sanctions) to isolate and study variables underlying risk for drug addiction and impact of use ;
• Basic research in behavior, cognition and neurobiology that capitalizes on unique opportunities in populations of abusers that are characterized by different patterns of abuse than is typically seen in the United States; for example, select groups that use unusual routes of administration, drug combinations, or whose abuse is directed at only one particular drug of abuse rather than the polydrug abuse that typifies users and addicts in the United States;
• And preclinical and other human or animal laboratory studies relevant to the study of addiction and addictive processes. For example, basic research that expands our knowledge of the impact of drug use on brain development among children and adolescents, as well as knowledge regarding gene and environment interactions.

In summary, the overall purpose of this funding opportunity announcement is to support state-of-the-science collaborative research between investigators from domestic U.S. institutions and researchers in other countries. Priority will be given to projects that address linkages between HIV/AIDS and drug abuse, amphetamine type stimulant abuse and synthetic and other designer drug abuse, inhalant abuse, smoking during pregnancy, and drugged driving; as well as research projects that address NIDA's Divisional research priorities and crosscutting research issues within the frameworks of NIDA.

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://www.nida.nih.gov/about/organization/nacda/CouncilStatement.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.

Funding Instrument	Grant
Application Types Allowed	New Revisions Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
Award Project Period	The maximum period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Resource Sharing Plan

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

Appendix

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

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

See more tips for avoiding common errors.

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

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

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

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

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

Environment

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

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

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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

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

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

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

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

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

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

Steven Gust, Ph.D.
Director, International Program
Office of the Director
National Institute on Drug Abuse
9000 Rockville Pike, Room 1B59
Bethesda, MD 20892-9581
Telephone: (301) 443-6480
Fax: 301-443-9127
Email: [email protected]

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

Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd.
Bethesda, MD 20892-9560
Telephone: 301-253-8729
Email: [email protected]

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

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