Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Molecular Genetics of Drug Addiction and Related Co-Morbidities (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-07-073
Related Notices	December 10, 2013 - This PA has been expired and reissued as PA-14-025. 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 3, 2012 - See Notice NOT-DA-12-013. National Institute on Drug Abuse (NIDA) Seeks Applications Using the JAX Diversity Outcross (DO) Mice.
Funding Opportunity Announcement (FOA) Number	PA-11-026
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.279
FOA Purpose	This FOA encourages applications for research projects that identify and/or validate chromosomal loci and variations in genes that are associated with vulnerability to addiction and that inform the likelihood of responsiveness to treatment. Applications that propose to examine intermediate phenotypes or endophenotypes to assess the molecular genetics of drug addiction, addiction vulnerability and/or their associated co-morbidities and how they are related to drug addiction are especially encouraged. Also encouraged are genetic as well as computational and large-scale genomic approaches, which may include but are not limited to linkage, linkage disequilibrium, case-control or family-based studies, and integration of data from other databases that may supplement substance abuse genetics and genomics data. Data may be collected from the general population, special populations, recent admixed populations, and/or animal models. Investigators are encouraged to include, as a component of their project and as appropriate, gene x gene interactions, gene x environment interactions, gene x environment x development interactions, pharmacogenetics, and non-human models.

Posted Date	November 9, 2010
Open Date (Earliest Submission Date)	January 5, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply or Month Day, Year, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply or Month Day, Year, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply or Month(s), Year
Advisory Council Review	Standard dates apply or Month, Year
Earliest Start Date(s)	Standard dates apply or Month, Year
Expiration Date	(Now Expired December 10, 2013 per issuance of PA-14-025), Originally January 8, 2014
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

This FOA is a continuation of the program initiated by RFA-DA-99-003, PA-00-115, PA-03-155, and PA-17-073 Genetics of Drug Addiction Vulnerability, http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-99-003.html. For additional NIDA funding opportunities in genetics, refer to the NIDA genetics workgroup homepage: http://www.nida.nih.gov/about/organization/Genetics/GeneticsHome.html.

This FOA seeks investigator-initiated applications for genetic and genomic research projects that identify chromosomal loci and/or genetic variation and haplotypes that are associated with either increased or decreased vulnerability to drug addiction, including stimulants (e.g., cocaine, amphetamine, caffeine), narcotics (e.g. opiates), nicotine/tobacco products, benzodiazepines, barbiturates, cannabis, hallucinogens, and/or multiple drugs of abuse and, as needed, accounting for associated co-morbidities (e.g., HIV/AIDS, major depression, schizophrenia, bipolar disorder, alcoholism) in human beings or animal models.

The state of the science on genetics of addiction for a given drug may be quite different. For example, the literature is robust with genome-wide association studies (GWAS) on nicotine dependence, but replicated genetic findings are limited for certain other drugs of abuse. Similarly, there is interest in chromosomal loci and/or genetic variation and haplotypes that are associated with differences in responses to treatment for addiction to these drugs of abuse and related disorders. Applicants are encouraged to analyze and explicitly state how their research project leverages data from past studies and how the study will advance the scientific knowledgebase. It is highly recommended that applicants contact NIDA program staff during the early planning stages of project development to gauge interest in the genetics of the particular phenotype proposed, as well as the genetic approach being taken.

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. Animal models provide an alternative way for understanding the underlying biology of these complex diseases. In addition, many databases (e.g., 1000 Genomes, HapMap, dbGaP) are available to supplement existing studies, and/or mine directly. These and related approaches are likely to have applicability to the brain diseases of addiction. Thus, molecular and computational characterization of all types of genetic variation identified through genetic studies is also encouraged.

Identifying specific genes and gene variants that mediate addiction or other complex, multi-genic diseases is complicated by the fact that analytical methods developed for single-gene disorders do not necessarily incorporate the effects of gene interactions. Investigators are encouraged to consider using innovative genetic models, pedigree structure, haplotypes, and other methods of statistical analyses for the identification of genetic variations conferring vulnerability to complex genetic disorders such as drug addictions with or without co-morbid mental disorders, and response to pharmacotherapies for these disorders.

Phenotype definition of both case and control (both exposed and unexposed) individuals is a central issue in the analysis of complex traits such as addiction and is an essential component to applications responding to this FOA. Investigators are encouraged to use existing instruments that have been used by the NIDA Genetics Consortium, http://nidagenetics.org/ and browse through the study information links to access the instruments used.

In addition, NIDA has developed a series of core elements for assessing and harmonizing demographic information and substance use history for genetic studies. The core elements can be accessed through this link: http://www.drugabuse.gov/about/organization/Genetics/ngcdomains/. NIDA strongly encourages all applicants to discuss how these core elements are addressed in their data sharing plan by either assessing them directly or indirectly by proxy measures.

This FOA particularly seeks applications that propose to study intermediate or endophenotypes. For these studies, emphasis should be placed on how these intermediate phenotypes and endophenotypes map onto the phenotypic outcome of drug addiction (e.g. DSMIIIR or DSMIV criteria or other validated and heritable outcome measures). Endophenotypic measures in some cases may afford greater reliability compared to an overt addiction diagnosis. Although genetic effect sizes associated with endophenotypes have not necessarily been larger than those reported for other phenotypes for many psychiatric disorders, their usefulness for identifying addiction loci remains to be determined.

However, alternative phenotype definition may better describe the genetic aspects of addiction. Therefore, investigators may propose the use of other phenotypic information such as the presence or absence of biological markers or exhibition of unique individual traits, as well as combinations of these and/or co-morbid conditions. Justification for the use of proposed alternative phenotypes and how it relates to the addiction phenotype should be clearly stated and evidence for heritability provided.

Investigators including the exploration of environmental factors should include detailed explanations of how the environments were measured, and how they may impact outcome. Gender and ethnic specific analyses in the molecular genetics of addiction vulnerability is encouraged.

Detailed plans for data sharing acknowledging a willingness to adhere to new genomic data sharing policies that have been indicated in http://grants.nih.gov/grants/guide/notice-files/NOT-HG-10-006.html must be addressed for all human genetics studies.

Examples of broad research topics include, but are not limited to:

Molecular genetics approaches:

• Research on human sample populations examining family-based linkage studies, linkage disequilibrium, case-control and/or family-based association studies using candidate gene approaches, haplotype,high-density whole genome scanning, deep sequencing, or whole genome sequencing to identify chromosomal loci and/or genes, gene variants, and haplotypes associated with phenotypes and endophenotypes of addiction vulnerability with or without co-morbid mental disorders
• Deep sequencing to follow-up GWAS or other approaches that have identified SNPs to find all variants (common, rare, structural, copy number, etc) in the associated region
• Examine intermediate phenotypes or endophenotypes to assess the molecular genetics of drug addiction and addiction vulnerability
• Use advanced analytical methods such as principal-components analysis, discriminant analysis, artificial neural networks, spectral analysis of EEG, neuroimaging for drug activity/re-activity, and/or pharmacokinetic/ pharmacodynamic genetic profiling may help define groups of phenotypes with a higher heritability for complex traits such as drug response phenotypes and treatment response phenotypes
• Analyses of family studies to identify biomarkers, endophenotypes, and sub clinical phenotypes associated with addictive disorders with or without co-morbid conditions, and environmental factors and processes that may moderate or mediate individual risk and protection
• Research examining the pharmacogenetics of treatments used for addiction (including pharmacotherapies and/or behavioral therapies) with or without co-morbid mental disorders; Construction and analysis of SNP haplotypes that predict therapeutic response or adverse reactions to drugs;
• Correlation of drug response profiles with intermediate phenotypes (e.g., brain imaging, learning and memory, executive function);
• Identification of biomarkers to resolve clinical heterogeneity and heterogeneity of therapeutic drug response; studies of genetically determined functional changes in nuclear and cell surface receptors to explain the adverse or paradoxical drug responses to therapeutic agents; studies of allelic variation occurring in individual transporter genes that are associated with a functional consequence. Studies on dose and safety and efficacy are not appropriate for this FOA.
• Research on animal models, including non-human primates, to study the genetics of addiction vulnerability; approaches using knock-out, knock-in, non-coding RNAs, or other novel technologies
• Animal models with careful attention to phenotype definition are needed to refine QTLs and identify genes associated with addiction
• Research incorporating the evaluation of environmental exposures or psychosocial stressors with the molecular approaches
• Research involving molecular characterization, and/or functional genomic, and/or proteomic screens of genes or gene variants identified as being associated with addiction vulnerability, including cross-species comparisons to evaluate the effects of a particular allele across organisms.
• Studies analyzing the combined effects of gene variants from a gene family or pathway shown to be involved in addiction and/or co-morbid mental disorders.
• Studies examining gene expression, tissue specificity, and epigenetic mechanisms, and/or non-coding RNA approaches to better understand the effects of a particular SNP or group of SNPs on addiction vulnerability; especially encouraged are studies that examine these paradigms according to developmental stage or across tissue types.
• Studies examining the genetic vulnerability to HIV acquisition and/or disease progression among drug using populations. HIV/AIDS questions must be fully integrated into the application.

Statistical genetics and computational approaches:

• Computational approaches that incorporate other data resources, such as HapMap, 1000 Genomes, Epigenomics, dbGaP, etc are encouraged, especially as they relate to understanding relationships among genes and environment, genes and phenotype, and systems biology of addiction
• Combining of computational and experimental approaches is encouraged. For example:
  • Analyzing 1000 Genomes data for drug abuse and addiction related pharmacokinetic and pharmacodynamic genes to make predictions on how particular genetic variants may affect the activity of the genes when exposed to drugs of abuse
  • Combining GWAS or sequence data with 1000 Genomes data to look for rare and structural variants that may be more frequent in datasets with drug addiction phenotypes
  • Analyzing 1000 Genomes data for genes known to be associated with drug addiction to understand their genetic architecture in various populations (what is the repertoire of genetic variation in the genomic regions of genes associated with addiction phenotypes, and is it any different from genes not associated with addiction phenotypes)
• Studies that narrow the set of variants identified in an associated region to prioritize them for functional analysis
• Research on statistical analyses of large data sets examining the genetics of addiction with or without co-morbid mental disorders, as well as use of innovative analytical approaches such as admixture designs and Bayesian methods; secondary data analyses are also of interest
• Research examining gene x gene, gene x environment, gene x gender, gene x treatment, gene x development, or any combinations thereof
• Addiction vulnerability traits have been linked to multiple regions of the genome and research is needed to identify specific genes and polymorphisms within and around those genes that lie within these linkage regions

The NIDA Genetics Consortium (NGC)

The NIDA Genetics Consortium (NGC) consists of investigators who have modified their projects to conform to the guidelines listed in a previous FOA to use the resources provided by the NIDA Center for Genetics Studies. The NIDA Center for Genetics Studies is funded by a contract awarded to Rutgers University with a subcontract to Washington University at St. Louis for the purpose of creating databases, cryopreserved lymphocytes, and DNA samples, and for wide distribution of the data and DNA to the scientific community. After a proprietary period, the NIDA Center for Genetics Studies will, upon proper application and approval, distribute both the data and DNA samples to qualified researchers.

In addition, when preparing an application, researchers are strongly encouraged to present a rationale that carefully balances important substantive, methodological, and budgetary issues. In addition to contacting program staff early in the development of a project, applicants are advised to address each of the following points in the link provided, when appropriate: http://www.drugabuse.gov/about/organization/Genetics/humanapp/index.html.

NIDA Genetics Consortium Membership and Meetings:

Applications related to human genetics research, especially if applicant plans to join the NIDA Genetics Consortium (NGC) (http://www.nida.nih.gov/about/organization/Genetics/FAQ_NGC.html) should include the cost for attendance at the NGC meetings twice per year in the budget.

Members of the NGC meet two times a year to discuss issues related to the molecular genetics of addiction vulnerability. Plans for membership in the NGC for all human genetics applications collecting blood samples are encouraged, but not required. Due to budget limitations on the contract, not all applicants requesting membership can be accepted into the consortium. For further information, see http://www.nida.nih.gov/about/organization/Genetics/FAQ_NGC.html.

NIDA Genetics Consortium Budget Justification:

A NIDA contract supports the NIDA Center for Genetic Studies and provides funds for the processing of samples and storing them in the Repository for a variety of drug addiction research. The Repository has a limited budget and a maximum capacity, therefore some proposals requesting NGC membership may not be accepted into the Repository. If, for budgetary or capacity reasons the contract cannot cover samples to be place in the Repository, it is advised that the PD/PI plan to include the addition of their samples into the Repository as if it were a sub-contract. If the PD/PI includes this alternative method in the grant application, then the samples will be covered either by the contract or the grant if it is awarded. If the NIDA contract can cover the costs and has the capacity, then the budget allocated for that activity in the grant application will be administratively cut. In the grant application, appropriate language could be, "We plan to request access to the NIDA Center for Genetic Studies for submitting our samples. If the study and the samples are approved, the NIDA contract will provide funds for receiving, processing, storing, and distributing the samples. If the study and samples are not approved, we provide budgetary justification for submitting the samples to the NIDA Repository using funds received through this grant application."

Available Genotyping and Expression Array Resources

Investigators should note that there are sevaral existing resources available to investigators for genotyping and expression array studies. One is the Center for Inherited Disease Research (CIDR), which is supported by a contract to Johns Hopkins University by eight NIH institutes including NIDA. CIDR was established in 1996 to provide high-throughput genotyping and statistical services for complex genetic diseases to the scientific community at large. Introductory no cost access to CIDR resources is available to investigators who have been approved by the CIDR Access Committee (CAC) and who are supported by one of the eight supporting NIH institutes (including NIDA). Thus, projects supported by this FOA are eligible for no cost access to CIDR resources following CAC approval.

Investigators should request access to CIDR resources, if needed, and obtain NIDA and CIDR approval before the requested start date of the grant. CIDR Applications are accepted via continuous receipt (http://grants.nih.gov/grants/guide/notice-files/NOT-HG-09-015.html) and will be reviewed by the CIDR Access Committee (CAC) no later than 120 days after receipt see the CIDR Web site at http://www.cidr.jhmi.edu or contact and http://grants.nih.gov/grants/guide/pa-files/PAR-08-258.html. Camilla Day at 301-402-0838 or at [email protected].

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 years.

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

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For profit Organizations

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

Governments

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

Other

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

Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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 Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. 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.

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 application submission. 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.

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) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

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

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

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

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

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

Environment

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

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

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

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 National Advisory Council on Drug Abuse . The following will be considered in making funding decisions:

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

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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]

Jonathan Pollock, PhD
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1309
Email : [email protected]

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

Cheryl Nathaniel
National Institute on Drug Abuse (NIDA)
Telephone: (202) 526-0108
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

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.

Networking Website for Consultation and Collaboration

NIDA has established a web-based Networking Project (NNP) to encourage investigators to collaborate with other scientists to gain access to specialized expertise, unique research resources, diverse populations, or geographic locations not otherwise available. For applicants interested in identifying potential collaborators, the NNP website is available at http://nnp.drugabuse.gov, as a source of information on the mission, focus, and leadership of NIDA’s research networks. The website features an interactive map with more than 300 local network sites, a directory of close to 400 addiction researchers and practitioners, and the extensive resources of 14 NIDA-supported research networks located across the country. If appropriate for the proposed research, NIDA encourages grant applicants to use the resources of the NNP and make reference in the grant application when they are utilized.