Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to continue supporting the Integrative Neuroscience Initiative on Alcoholism (INIA). With this Funding Opportunity Announcement (FOA), support is sought for integrated, multidisciplinary, collaborative research projects studying neuronal mechanisms of excessive alcohol intake associated with alcohol dependence. One focus of the initiative will be to examine brain immune signaling mechanisms promoting and controlling excessive alcohol consumption. A second focus will be to examine enduring consequences of stress challenges on adaptations in brain circuitry leading to excessive drinking and to altered stress responsiveness. An additional emphasis to be promoted within this initiative is the identification of drugable genomic targets to lay the foundations for new treatments for alcohol dependence. As in prior years, projects supported under this initiative are expected to integrate approaches at the molecular, cellular, synaptic, physiological and behavioral level of analysis. Integration will be promoted by supporting two consortia each comprised of an administrative core, multiple component projects and relevant scientific resource cores as needed.

This FOA solicits Administrative Resources (U24, cooperative agreement) to provide administrative support to the individual research projects (U01) and scientific resource cores (U24) within each of the two INIA consortia. Applications for Research Resource components (U24, cooperative agreement) should be submitted in response to the companion FOA (RFA-AA-16-005). Applications for individual research projects (U01, cooperative agreements) should be submitted in response to the companion FOA (RFA-AA-16-004).

NIAAA currently supports two INIA consortia comprised of collaborative, multidisciplinary research projects from multiple research institutions. While the goal of each has been to elucidate the mechanisms underlying neuroadaptation to chronic alcohol exposure, and to determine mechanisms through which neuroadaptation ultimately contributes to excessive alcohol intake and stress responses, each consortium has a different emphasis. The "Neurobiological Basis of Excessive Drinking" consortium, previously known as INIA-West, examines adaptations occurring in specific brain neurocircuitries that result in excessive alcohol consumption. This multidisciplinary consortium focuses on the molecular and cellular neuroadaptations in brain circuits associated with the basal forebrain, including circuitry in the ventral striatum and circuitry in the extended amygdala and their connections with each other and other structures at lower and higher levels. This consortium identified gene array pathways associated with excessive drinking and validated several as small-molecule targets in rodent models of alcohol drinking including targets within neuroimmune and neuroinflammatory pathways.

Questions pursued in the INIA consortium "Stress, Anxiety and Alcohol Abuse", also known as INIA Stress, focus on defining the genetic, neural, endocrine and behavioral adaptations produced by excessive ethanol exposure as a platform for studying the reciprocal relationship between stress and excessive drinking. In particular, the consortium examined how neuroadaptation to chronic alcohol influences responses to further ethanol exposure and also responses to other stressors. The consortium identified a number of stressors capable of elevating alcohol drinking in alcohol dependent animals and identified gene pathways, endocrine mechanisms, and brain regions associated with elevated alcohol drinking.

The Administrative Resource component will serve as the lead application that describes the overall theme and goals of the consortium; it should also include a scientific rationale for the various research project components and resource projects that make up the consortium. The administrative resource will provide oversight, coordination, and direction to the consortium. It will coordinate the use of resources among the research projects, facilitate communications among the PD/PIs, and facilitate data collection. It will be responsible for managing the Scientific Advisory Panel and research Steering Committees, managing data accessibility to the consortium and scientific community at large as appropriate, and integrating and interpreting data from the consortium.

Prior research supported by the INIA initiative provides a foundation for addressing emerging NIAAA research priorities. Discovery of brain immune signaling pathway involvement in the development of alcohol dependence and other CNS disorders sets the stage for studying brain immune signaling mechanisms underlying brain adaptations to excessive alcohol intake with the goal of discovering and validating novel approaches for treating alcohol dependence. Identifying stress challenges that reliably increase alcohol drinking and the discovery of underlying brain and endocrine mechanisms contributing to stress-alcohol interactions allow for further investigation of the contribution of stress to the development of excessive drinking and the influence of chronic alcohol exposure on stress responses particularly as it informs alcohol dependence comorbidity with other stress disorders.

In the phase of the INIA initiative addressed by this FOA, NIAAA supports goals which include, but are not limited to: (1) understanding the genomics, electrophysiology, and pharmacology of brain immune signaling systems and their role in causes and treatments of alcohol dependence; (2) identifying changes in brain circuitry and mechanisms underlying how alcohol alters responses to stress; (3) examining how altered stress responses contribute to the transition from regulated drinking to excessive and habitual drinking; (4) promoting replicability and translation of data through testing in multiple species (including humans), multiple laboratories and multiple assays; (5) using emerging computational resources (e.g., lincscloud.org) that connect gene networks to drugs (e.g., connectivity mapping) and identify or repurpose potential efficacious compounds to reduce excessive alcohol drinking; (6) developing models to study chronic alcohol- recurrent stress interactions; (7) using new technologies to study neural circuits involved in the development of excessive alcohol drinking.

As in the past, the overarching theme of INIA will be brain mechanisms underlying the development of excessive alcohol drinking.

Each INIA Consortium will consist of a cluster of integrated cooperative agreement research projects (U01s) and resource-related research projects (U24s). The research projects (U01s) affiliated with one consortium will focus on the common theme of brain neuroimmune mechanisms of alcohol dependence and those affiliated with the second consortium will focus on temporal aspects of stress and chronic alcohol interactions. Both consortia are encouraged to identify potential drugable genomic targets that can be applied to future medication development efforts. Each U01 research project will have collaborative studies with other U01 projects within its Consortium. The use of common methodology among various research projects and sharing of technical expertise are highly desirable. Each consortium will include one administrative unit (U24) led by the Consortium Coordinator. Each consortium may also include research resources (U24) to provide service to individual research projects described in this FOA as needed.

Therefore, for each consortium, this set of companion FOAs solicits a set of linked U01 applications (RFA-AA-16-004), two to three Research Resource U24 applications (RFA-AA-16-005), and one Administrative Resource U24 application (this FOA).

The following FOAs will support the research and administrative resource units of the consortium:

Research Projects (RFA-AA-16-004) Collaborative research projects will focus on goals described below. Consistent with achieving the goals of this program, the composition of research projects should be collaborative and highly integrated within each INIA consortium.

Research Resources (RFA-AA-16-005) These applications are expected to provide resource and technological support to research projects in the areas such as behavioral and genetic models, data management, electrophysiology, etc.

Administrative Resource (this FOA) - The PD/PI of the Administrative Resource will be the Consortium Coordinator. The Administrative Resource will provide oversight, coordination, and direction to the consortium. It will be responsible for managing the Scientific Advisory Board and the research Steering Committee. It will coordinate use of resources among the research projects, facilitate communications among the PD(s)/PI(s), and facilitate data collection. See below for additional information.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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, including Supplemental Grant Application Instructions 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Abraham P. Bautista, Ph.D.
Telephone: 301-443-9737
Fax: 301-443-9737
Email: bautista@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

Facilities & Other Resources

Application should describe how the institutional environment in which the Administrative Resource will operate contributes to the probability of success in facilitating the consortium it serves. Also, application should include a description of the institutional support, equipment and other physical resources available to the investigators and how it is relevant to the proposed Administrative Resource. Application should also describe how the Administrative Resource will benefit from unique features of the institutional environment, infrastructure, or personnel, and what are the resources available within the scientific environment to support electronic information handling

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

Applicant must provide a description of investigator’s and key personnel's experience in the administration of large, complex research programs

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

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

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

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

Research Strategy

The Administrative Resource application should discuss the theme and goals of the Consortium and should include a scientific rationale for the various research project components and resource core applications that make up the consortium. It should further describe the benefits of the proposed integration between projects and how the individual applications complement each other to enhance the scientific goals of the consortium. Given that an important element of the initiative is the collaboration between scientists at various institutions, the Administrative Resource application should also discuss how the consortium will achieve that goal.

The application's research strategy should include the following:

• Overall scientific goals of the consortium and how these goals are to be addressed by each research project and core within the consortium.
• Description of integration among consortium components. A description of how the administrative resource project will provide oversight, coordination, and direction to the consortium should be included in the application as well as a description of plans to coordinate and facilitate data collection and the use of resources among the research projects, and facilitate communications among the PD/PIs.
• Description of the Scientific Advisory Panel and research Steering Committees as well as a plan for how the Consortium Coordinator will interact with them to provide oversight to the consortium.
• Plans for overseeing efforts by the consortium's research projects, resource cores and administration, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources among members of the consortium that conveys a high likelihood of effective, productive management of the consortium as appropriate.
• Plans for organizing and supporting meetings among consortium investigators as well as interactions between the two INIA consortia should be addressed in the application. An important consideration will be the proposed Consortium Coordinator’s prior experience managing multi-investigator, multi-site, multidisciplinary efforts addressing the neurobiology of alcohol dependence
• Adequate explanation on how coordination among the administrative resource and the research projects will be able to support the overall research program

Innovation

Application must include a description of novel organizational concepts, management strategies, or instrumentation in coordinating the consortium this Administrative Resource will serve, and how they relate to one type of research program or applicable in a broad sense. Also, application must describe any refinement, improvement, or new application of organizational concepts, management strategies or instrumentation. Finally, application must describe the innovative features in the organizational design and decision making process.

Approach

Administrative plan must provide a description of the management of day-to-day program activities. In addition, application must include a detailed plan for managing the consortium' research projects, resource components and administration, for ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and for effective sharing of resources among members of the consortium to promote a high likelihood of effective, productive management of the consortium. Finally, application must describe the organizational structure that will facilitate coordination, integration and timely evaluation of activities and progress of the consortium's research.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

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 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.

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?

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the consortium the Administrative Resource will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? Are there innovative features in the organizational design and decision making process?

Does the administrative plan provide for management of day-to-day program activities? Is there a clear, detailed plan for managing the consortium' research projects, resource components and administration, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources among members of the consortium that conveys a high likelihood of effective, productive management of the consortium? Is there an organizational structure that will facilitate coordination, integration and timely evaluation of activities and progress of the consortium's research?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the institutional environment in which the Administrative Resource will operate contribute to the probability of success in facilitating the consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Administrative Resource proposed? Will the Administrative Resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

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.

Not Applicable

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

Not Applicable

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

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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) convened by the National Institute on Alcohol Abuse and Alcoholism , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Alcohol Abuse and Alcoholism . 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’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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD/PI will have the primary responsibility for:

• Coordinate a regular schedule of meetings with NIAAA Project Collaborator for review and consultation.
• Coordinate project activities with their institutions, with collaborators, and with the NIAAA Project Collaborator.
• Accept assistance and seek input from NIAAA Project Collaborator to inform the pursuit of project goals.
• PD(s)/PI(s) will publish and publicly present and disseminate results of the research project.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIAAA Project Collaborator:

• A designated NIAAA Program Director, acting as a Project Collaborator, will have substantial programmatic involvement, as described below.
• The NIAAA Project Collaborator will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NIAAA waiver according to the NIAAA procedures for management of conflict of interest.
• Coordinate and facilitate the interactions among, the U01 awardees under this initiative;
• Serve as liaison between the research awardees and NIAAA staff members and investigators involved in the program, facilitating interactions and scientific integration between the U01 awardees;
• Promote and help coordinate collaborative research efforts that involve interactions with other NIAAA-sponsored programs, projects, and centers;
• Participate in program meetings;
• Review all major transitional changes that the awardees might propose (e.g., a change in partnering institution) and advice on their appropriateness prior to implementation to assure consistency with the goals of this FOA;
• Provide technical assistance and advice to the awardees as appropriate;
• Assist in the interaction between the U01 Research awardees and investigators at other institutions, as appropriate for the program;
• Assist in avoiding unwarranted duplication of effort with other NIH efforts;
• Monitor institutional commitments and resources to the awardees;
• Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- Specifically, the NIAAA Project Scientist may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures;
• Develop working groups and trans-project efforts as needed; and
• Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees.

NIAAA Program Official:

• NIAAA Program Director, acting as the Program Official, will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the NIAAA Staff Collaborator will participate in Steering Committee meetings to coordinate implementation and evaluation of the ongoing projects. The Steering Committee will consist of members from participating sites and the NIAAA Staff Collaborator. Every participating site and the NIAAA Staff Collaborator will each have a single vote on the Steering Committee. All Steering Committee decisions and recommendations that require voting, will be based on a majority vote.

Additionally, the PIs and the NIAAA Staff Collaborator will participate in a yearly meeting to present major findings, to plan collaborative efforts, to assist in analysis, interpretation, and dissemination of scientific findings.

Dispute Resolution Process:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Mark Egli, PhD.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6382
Email: megli@mail.nih.gov

Lindsey Grandison, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0606
Email: lgrandis@mail.nih.gov

Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

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 Part 75.