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 Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Effects of Adolescent Binge Drinking on Brain Development (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

  • 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-12-028

Companion FOA

PA-12-027, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.273

FOA Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), encourages Exploratory/Developmental Research Grant (R21) applications proposing to conduct mechanistic studies on the effects of adolescent binge alcohol consumption on synaptic maturation and myelin formation in the developing brain.

Key Dates
Posted Date

November 18, 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

May 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.


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), encourages Research Project Grant (R01) applications proposing to conduct mechanistic studies on the effects of adolescent binge alcohol consumption on synaptic maturation and myelin formation in the developing brain. Alcohol is by far the most widely used intoxicant among adolescents in the U.S. and the incidence of adolescent binge drinking is increasing. Critical developmental processes occurring in the adolescent brain may render it uniquely sensitive to the harmful effects of excessive alcohol consumption; however, the long-term consequences of adolescent binge drinking for maturation of brain structure and function remain poorly understood. Similarly, whether such changes might be permanent, reversible or amenable to treatment has yet to be determined.  The objective of this FOA is to promote research in animal models on the genetic, molecular and cellular mechanisms underlying the effects of excessive alcohol consumption on specific aspects of adolescent brain development. Studies examining the trajectory of ethanol-related effects from adolescence through adulthood are particularly encouraged.

Related Funding Opportunity:  Investigators who are interested in proposing exploratory and developmental research projects, should submit applications in response to the partner FOA of identical scientific scope (PA-12-027), which uses the NIH R01 Research Project Grant mechanism.

Background

Alcohol is by far the most widely used intoxicant among adolescents in the U.S., with 17% of eighth graders, 34% of tenth graders and 45% of twelfth graders reporting ethanol use in the past month.  Furthermore, the incidence of adolescent binge drinking is increasing, with 30% of high school seniors reporting binge levels of alcohol consumption in the past month. Heightened sensitivity of adolescents to the rewarding aspects of alcohol and diminished sensitivity to the aversive effects reinforces this trend. Early development of the limbic system and associated regions governing motivated behavior likely increases the vulnerability of adolescents to impulsive and sensation-seeking behaviors, including binge drinking. The later development of the pre-frontal cortex (PFC) promotes regulatory and executive functions and may decrease tendencies to engage in impulsive behaviors. Attenuated frontal cortical development and function may be among the long-term neurocognitive consequences of adolescent alcohol abuse and could act as determinants of continuing patterns of excessive alcohol consumption.      

Adolescent binge drinking raises concern because it can lead to increased delinquency, aggression, risky sexual behaviors, hazardous driving, and comorbid substance use. Additionally, adolescent binge drinking has been shown to result in deficits in neurocognitive functioning, visuospatial functioning, and learning and retrieval of verbal and nonverbal information. Furthermore, developmental processes occurring in the adolescent brain may increase its vulnerability to the long-term health consequences of excessive alcohol consumption.  These processes include decreases in grey matter volume, thought to reflect pruning and refinement of synaptic connections during adolescence, and reciprocal increases in white matter volume, which likely indicate consolidation and increased myelination of fiber tracts. Both of these processes are essential for maturation of brain function and are likely to play critical roles in the acquisition of adult behaviors. Binge levels of alcohol consumption could delay or disrupt these critical developmental processes, with profound consequences for structural and functional aspects of the adult brain. However, despite these concerns, the long-term effects of adolescent binge drinking on gray and white matter development remain poorly understood. Similarly, whether such changes might be permanent, reversible or amenable to treatment has yet to be determined.  

Synapse pruning is one of the critical aspects of adolescent brain maturation.  Anatomical studies in monkeys have shown that synaptic density in the prefrontal cortex is relatively stable from early adolescence through puberty, with a subsequent slow but steady decline.  Ultimately, about 40% of the peak number of synapses is eliminated.  Several MRI analyses in humans have documented significant reductions in frontal cortical grey matter volume and cortical thickness during adolescence; a corresponding decrease in EEG power during this period suggests that the loss in gray matter may reflect the loss of synapses. However, this conclusion has been questioned and histological analyses are likely necessary to identify the precise cellular and developmental processes which are reflected by decreases in gray matter volume. Cortical synapse maturation during adolescence can also involve changes in synaptic protein expression, as proteomic analysis in the rat shows that the nature of synaptic proteins in the PFC changes dramatically between adolescence and adulthood, with early expression of plasma membrane proteins and a later increase in the expression of proteins related to the exocytotic machinery.   These changes in protein expression during adolescence are more prominent in the PFC than in the motor cortex. Although there does not appear to be a significant change in the number of synapses in the rat brain during adolescence, there are decreases in the numbers of neurons in the rat ventral, but not dorsal, medial prefrontal cortex in this species. 

Diffusion Tensor Imaging is a modification of MRI that permits analyses of structural aspects of white matter in the brain and has been used extensively to assess changes in both fiber tracts and subcortical white matter during adolescence. Results of these studies indicate that there are significant alterations in the properties of many fiber tracts during adolescence, with those associated with frontal and temporal lobes appearing to mature relatively later.  Maturation of white matter is correlated with acquisition of complex tasks like attention, learning and recall. Although the DTI imaging studies provide strong indications that both fiber tracts and total volumes of subcortical white matter are changing during adolescence, the precise cellular and molecular nature of these changes have not been determined and the mechanisms involved remain poorly understood. MRI studies show reductions in the size of the PFC in adolescent alcohol abusers due to a decrease in white matter in this region; other brain areas do not appear to be affected to the same extent. However, it has not been determined if there is a critical period for these effects of ethanol on PFC development or whether these changes might be reversible during abstinence.

Several neurotransmitter systems in the PFC undergo dynamic alterations during adolescence. For example, the density of dopaminergic inputs to the PFC increases, accompanied by changes in the levels of several dopamine receptor subtypes. Modulation of dopaminergic function in the PFC may have unique influences on reward sensitivity in the adolescent. GABAergic inputs to the PFC from the amygdala also increase during adolescence and may be responsible for increases in PFC-mediated executive function during this period. In contrast, glutamatergic synapses in the PFC decrease during adolescence and there is a transient over expression of NMDA receptors followed by a decline. These results indicate that the activities of several neurotransmitter systems are in flux during adolescence and establishment of a balance among these systems is likely critical for function of the adult brain. Binge drinking may disrupt this balance but the precise outcomes and mechanisms involved have not been determined.

Several recent studies have revealed that astrocytes may play prominent roles in neurodevelopment. These cells have traditionally been thought to play somewhat passive roles in the nervous system, such as maintaining homeostasis by removing excess extracellular potassium and glutamate. However, recent investigations have shown that astrocytes ensheath synapses and can modulate synaptic structural and functional plasticity by releasing a variety of neuroactive molecules. Astrocytes may also modulate neuronal function and synaptogenesis via direct contact, possibly involving cell adhesion molecules. As a single astrocyte may interact with as many as 100,000 synapses, this influence could be widespread.  Astrocytes also appear to play significant roles in the establishment of synapses in the developing nervous system via released factors—for example, astrocyte-derived thrombospondin promotes synaptogenesis by retinal ganglion cells and additional secreted molecules appear to regulate later aspects of synaptic maturation, including membrane insertion of receptors.  Furthermore, astrocytes also appear to be involved in synapse elimination; in the developing visual system this occurs via stimulation of neuronal expression of complement factor C1Q, which may ultimately result in phagocytosis of excess synapses. Finally, recent studies suggest that astrocytes may facilitate myelination by promoting oligodendrocyte maturation and increasing myelin ‘wrapping’. The astrocyte-oligodendrocyte interaction involves both secreted growth factors (e.g. TIMP-1) and cell-cell contact, mediated by adhesion molecules and gap junctions. Taken together, these results suggest that astrocytes are involved in synapse maturation, elimination and myelination and could therefore play important roles in adolescent brain development. 

Thus the available evidence suggests that several developmental processes are occurring in the brain during adolescence, and the sensitivity of these processes to alcohol may be responsible for some of the long-term consequences of adolescent binge drinking. Previous studies have suggested some of the mechanisms involved, but the précised effects of excessive alcohol consumption during adolescence on synapse refinement and white matter maturation remain incompletely understood. Research that addresses these issues, particularly in animal models amenable to genetic and/or mechanistic analyses is therefore solicited.  As adolescence is a transitional period, investigators are encouraged to incorporate a longitudinal approach, as restricting studies to a small number of time points may not permit an accurate assessment of the extent, trajectory or potential reversibility of the changes being monitored.

Research Objectives:

Appropriate topics include but are not limited to:

Anatomical and/or functional studies on cortical synapse pruning or refinement in models of adolescent binge drinking

Proteomic analyses of the effects of adolescent binge drinking on brain synapse maturation, particularly in the frontal cortex

Analyses of cortical neuronal loss during adolescence and the effects of excessive alcohol consumption on this process

Investigations of the effects of excessive alcohol consumption on maturation of brain fiber tracts, myelination, axon fasciculation, or consolidation of sub-cortical white matter

Analysis of the effects of adolescent alcohol consumption on expression of neurotransmitters and their receptors  in the PFC and characterization of the underlying molecular genetic mechanisms

Characterization of potential thresholds for dose and/or duration of ethanol exposure for effects on adolescent brain development and determination of possible critical periods for these effects

Studies on the effects of adolescent binge drinking on modulation of synapse pruning and elimination by astrocytes.

Investigations on the influence of adolescent alcohol consumption on astrocyte-mediated myelin formation and maturation

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
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

Application budget is limited to a total of $275,000 for the entire project.  No more than $200,000 may be requested in any single year..

Award Project Period

The maximum period for R21 projects is two 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 Institutions

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.

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 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 four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.   

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.

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

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 submission of applications for this FOA. 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 Institutions

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.

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(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.

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.

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.

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(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?

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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

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. 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(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.

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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 301-435-0714
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)

Dr. Lawrence Baizer
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-9334
Email: baizerl@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)

Ms. Judy Fox
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-4705
Email: jfox@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.


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