Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

The Development Of Frontal Cortex And Limbic System And Their Roles In Drug Abuse (R01)

Activity Code

R01 Research Project Grant



Announcement Type

Reissue of PA-07-121

Related Notices

  • December 11, 2013 - This PA has been expired and reissued as PA-14-026.
  • 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 -11-027

Companion FOA

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by NIDA encourages Research Project Grant (R01) applications from institutions/organizations that propose to study the development of the frontal and prefrontal cortices, together with the subcortical areas of the limbic system, that play significant roles in mediating emotional and motivated behavior. This initiative is designed to support the basic neuroscience research into the fundamental mechanisms of development of the frontal and prefrontal cortices, as well as the midbrain and basal forebrain structures that mediate a number of functions related to drug abuse and psychiatric disorders including: the euphoric properties of drugs, actions of psychotherapeutic agents, and memory, cognitive and emotional functions. An additional major goal of this initiative is to understand how exposure to drugs of abuse affects the cellular and molecular mechanisms underlying nervous system development of circuits implicated in drug reward and addiction.

Key Dates
Posted Date
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 12, 2013 per issuance of PA-14-026), 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

This funding opportunity announcement (FOA) encourages research project (R01) grant applications to study the development of the frontal and prefrontal cortices which, together with the subcortical areas of the limbic system, play significant roles in mediating emotional and motivated behavior. The proper development of these forebrain and midbrain regions is essential for formation of the neuronal pathways that mediate a number of important functions, including learning and memory, cognition and decision making, the hedonic properties of food and sex, as well as the rewarding properties of drugs of abuse. Furthermore, the development of these complex neural circuits occurs over a wide developmental period from early embryogenesis through late adolescence. Elucidation of the molecular and cellular processes underlying the development of these cortical areas and the limbic system will provide critical insights into the adaptive processes associated with drug addiction as well as insights into mechanisms that might underlie increased vulnerability to drug addiction and co-morbid mental disorders. This initiative is designed to support basic neuroscience research into the fundamental mechanisms of development of the frontal and prefrontal cortices, and the midbrain and basal forebrain structures that mediate the euphoric properties of drugs, as well as understanding how the exposure to drugs of abuse affects the cellular and molecular mechanisms underlying nervous system development of circuits relevant to drug reward and addiction. Vertebrate model systems (such as rat, mouse, chick, frog, zebrafish and non-human primates) and invertebrate systems (such as Drosophila and C. elegans) provide unique insights into mechanisms of development and are also likely to provide new information about the formation and specification of prefrontal and frontal cortices and the limbic system. Approaches using these or other model systems both in vitro and in vivo are highly relevant to this program announcement. In addition, investigators are encouraged to analyze developmental mechanisms that contribute to sexual dimorphisms in drug addiction and in certain psychiatric disorders relevant to drug abuse and addiction.

Examples of research that may be considered appropriate to this program announcement include, but are not limited to, those listed below:

Neural Induction and Pattern Formation in Embryonic, Fetal and Adolescent Brain

Studies centered on understanding the cellular and molecular mechanisms by which the limbic cortex, midbrain, dorsal and ventral striatum, prefrontal cortex and associated area are specified from neural ectoderm. These studies can include: identifying gene transcription regulation, determining critical cell-cell interactions, neuron and glial cell differentiation and migration, and understanding how multiple secreted signals are integrated to drive these processes.

How psychostimulants (cocaine, amphetamine, etc.), opiates, barbiturates, hallucinogens, benzodiazepines, cannabinoids, inhalants, and any other class of abused substances affect the cellular and molecular mechanisms of neural induction and pattern formation.

Examination of the mechanisms by which alterations in gene expression and function induced by epigenetic and environmental influences during early development result in alterations/deviations in neural induction, cell-cell interaction, and patterning of cortical and subcortical circuits that may be relevant to drug addiction.

Stem Cells, Progenitors, Cell Fate and Cell Specification in Embryonic, Fetal and Adolescent Brain

The cellular and molecular mechanisms of stem cell and progenitor cell induction, proliferation, and phenotypic restriction in forebrain and midbrain, nucleus accumbens, striatum, prefrontal cortex and limbic regions of the cortex in the embryonic and adolescent brain. Understanding how neuronal and glial precursor cells are influenced by signals that specify their specific fate, differentiation and maturation, as well as studies focused on therapy and treatment of substances of abuse-induced brain abnormalities by manipulating endogenous and/or exogenous stem cell populations, are of particular interest.

The mechanisms by which neuronal and glial cell fate is specified by origin, developmental stages, cell-cell interaction, growth factors, cytokines, hormones, and by neurotransmitters in the midbrain, dorsal and ventral striatum, prefrontal cortex, and cerebellar regions.

How drugs of abuse modulate the cellular and molecular mechanisms involved in determining cell fate and specifications in all brain regions.

Examination of how environmental, genetic and/or epigenetic factors can induce alterations in cell fate, specification, circuit formation, and in neural replacement, and how these may contribute to drug addiction and substance abuse.

Neural and Glial Differentiation in Embryonic, Fetal and Adolescent Brain

The transcriptional and post-transcriptional regulation of the acquisition of differentiated phenotype of dopamine neurons in the ventral tegmental area and substantia nigra, as well as cholinergic neurons, GABAergic neurons, and glutamatergic neurons and glia in the midbrain, nucleus accumbens, striatum, prefrontal cortex, and limbic areas (including cell morphology, excitability, growth factor responsiveness, and expression of neurotransmitters and receptors).

The molecular and cellular processes by which substances of abuse alter neuronal differentiation by interrupting or augmenting the signal transduction mechanisms involved in the acquisition of the differentiated neuronal and glial phenotypes in all brain regions during embryonic, fetal and adolescent stages.

Examination of the role of glial function, including myelination, in early and adolescent development in circuits or brain regions relevant to drug addiction.

Cell Migration in Embryonic, Fetal and Adolescent Brain

The cellular and molecular substrates that direct and guide neuronal and glial migration in the areas that form the midbrain, nucleus accumbens, striatum, prefrontal cortex, and limbic areas.

How drugs of abuse modulate or alter fundamental mechanisms involved in cell migration in all areas of the brain.

Examination of candidate genetic, epigenetic, cellular and molecular influences that may alter the migration and placement of neural cells circuits or brain regions relevant to drug addiction.

Process Outgrowth, Navigation, and Target Selection in Embryonic Fetal and Adolescent Brain

The cellular and molecular mechanisms that regulate dendritic and axonal outgrowth, navigation, and target selection (including axonal guidance, branching, fasciculation; the formation of topographic and laminar-specific projections in the midbrain, nucleus accumbens, striatum, prefrontal cortex and limbic areas).

How drugs of abuse affect the fundamental cellular mechanisms mediating process outgrowth, navigation, and target selection in all areas of the brain during embryonic, fetal and adolescent stages.

Examination of how alterations in neuronal outgrowth and targeting during critical developmental periods may alter the maturation of circuits or brain regions relevant to drug addiction or the pathophysiology of drug abuse and addiction.

Synapse Formation and Plasticity During Development

The cellular and molecular mechanisms governing the formation of synapses and developmental plasticity as well as the role of cell-cell recognition molecules, growth factors, electrical activity, and experience in the development of the midbrain, nucleus accumbens, striatum, prefrontal cortex, and limbic systems.

Analysis of how abused substances affect the cellular and molecular mechanisms governing the formation of synapses and developmental plasticity throughout the central and peripheral nervous system.

As the developmental periods are highly vulnerable to the effects of substances of abuse, studies on understanding how the growth and pruning of axons and dendrites occurs at multiple stages of development, especially during adolescence are of interest.

Understanding the complex interplay and factors involved between neurons and glia during synaptogenesis is of interest.

Examination of the role of synaptic pruning or modification during adolescent development, and the means by which aberrant growth or pruning in relevant circuits or brain regions may contribute to the etiology of substance abuse and co-morbid disorders.

Programmed Cell Death

Investigations into the cellular and molecular mechanisms of programmed cell death in the midbrain, nucleus accumbens, striatum, prefrontal cortex, and limbic systems during embryonic, fetal and adolescent stages.

Investigations on how abused drugs may alter or modulate signal transduction pathways that mediate cell survival, cell fate and cell death in vertebrate and invertebrate nervous systems.

Examination of the means by which altered cell survival may contribute to aberrant circuitry formation and maintenance of brain regions or circuits relevant to drug addiction.

Molecular Imaging

Non-invasive imaging of genes and epigenetic factors that play roles in brain morphogenesis and regionalization, neuronal and glial differentiation and migration, and circuit formation during embryonic, fetal and adolescent stages.

Development and adaptation of agents, biomarkers and tracers for the non-invasive imaging of genetic and epigenetic factors with roles during brain development and relevant to drug abuse and addiction.

Section II. Award Information
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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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.

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.

Eligible Individuals (Project Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application 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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Required and Optional Components

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.

Page Limitations

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

PHS 398 Research Plan Component

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 Organizations

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the 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.

Requests of $500,000 or more for direct costs in any year

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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).

Scored Review Criteria

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

Significance

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

Investigator(s)

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?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/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.

Additional Review Considerations

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

2. Review and Selection Process

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:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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: commons@od.nih.gov

Scientific/Research Contact(s)

Da-Yu Wu, PhD
Program Director
Genetics and Molecular Neurobiology Research Branch
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
Telephone: 301-443-1887
Email: wudy@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Diana Haikalis
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1373
Email: dhaikali@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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.


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