Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Funding Opportunity Title	Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	September 17, 2015 - This RFA has been reissued as RFA-AA-16-004.
Funding Opportunity Announcement (FOA) Number	RFA-AA-11-006
Companion FOA	RFA-AA-11-007, U24 Resource-Related Research Projects--Cooperative Agreements
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.273
FOA Purpose	The purpose of this funding opportunity announcement (FOA) is to provide renewed support for two previously funded consortia under the Integrative Neuroscience Initiative on Alcoholism (INIA) by supporting the most scientifically meritorious projects. New research project proposals from investigators not previously affiliated with INIA can also respond to this FOA. Wherever possible the projects should take advantage of the infrastructure that was established in the previous funding periods of the INIAs. Please see the companion FOA (RFA-AA-11-007) regarding submission of proposals for resource-related and support cores.

Posted Date	November 17, 2010
Open Date (Earliest Submission Date)	Not Applicable
Letter of Intent Due Date	January 23, 2011
Application Due Date(s)	February 23, 2011
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May-July, 2011
Advisory Council Review	August 2011
Earliest Start Date(s)	September 01, 2011
Expiration Date	February 24, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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 two previously funded consortia under the Integrative Neuroscience Initiative on Alcoholism (INIA). Continuing support is sought for highly integrated, multidisciplinary, collaborative research projects focusing on neurobiological mechanisms of neuroadaptation leading to excessive alcohol intake as well as on stress and anxiety mechanisms and their relationship to neuroadaptation and excessive alcohol intake. A multidisciplinary focus should integrate neurobiological, behavioral and molecular genetic approaches to the study of mechanisms of excessive alcohol intake through the use of established core resource facilities and integrated research component projects in each consortium. Proposals for established and new research related cores will be funded under the U24 mechanism (please see companion RFA-AA-11-007 for submission of resource-related core proposals).

Background

NIAAA currently supports two INIA consortia. The original charge of INIA was (1) to support highly integrated multidisciplinary research across different research institutions in order to elucidate the neurobiological mechanisms underlying various aspects of neuroadaptation to alcohol (e.g., reinforcement, tolerance, sensitization, withdrawal and relapse), (2) to integrate neurobiological, behavioral, and molecular approaches in order to determine how these aspects of neuroadaptation ultimately contribute to excessive alcohol intake, and (3) to integrate existing resources within the alcohol research community and create new resources that are crucial for the success of the research questions being addressed under this initiative.

Each consortium has a different emphasis. The "Neurobiological Basis of Excessive Drinking" consortium, known as INIA-West, is led by The Scripps Research Institute. The defining goals of this consortium include: (1) establishing animal models to study, at the molecular, cellular, and neural circuit level of analysis, neurobiological vulnerability leading to excessive alcohol consumption; (2) identifying specific gene networks whose expression is regulated by alcohol exposure and which are responsible for excessive alcohol drinking; (3) attracting new and innovative investigators to the alcohol research field. The other INIA consortium, "Stress, Anxiety and Alcohol Abuse" is led by the Oregon Health Sciences University. The defining questions pursued by this group include: (1) defining the involvement of stressor-induced anxiety and the anxiolytic action of alcohol in stress-induced alcohol consumption; (2) determining the role of altered stress responsiveness and altered stress response circuitry in excessive alcohol consumption following chronic alcohol exposure and withdrawal; and (3) identifying the contribution of genetic variability in stress responsiveness or alcohol effects on such responses to the increased risk for excessive alcohol intake.

Organizational Structure

Each INIA consortium consists of a cluster of scientific research projects and a set of core resource facilities. During this funding cycle the resource-related and support cores will be funded through the U24 mechanism (see companion RFA-AA-11-007). An Administrative Coordinating Core lead by a Consortium Coordinator provides the framework for the management, direction, and overall coordination of the consortium activities. Through the core facilities associated with each consortium, the research groups have access to resources, information, technologies, and expertise that are beyond the scope of any single research team. Individual projects within each consortium focus on specific goals and may employ different models to address the central hypothesis of the consortium. Each INIA consortium has a Scientific Advisory Board composed of non-affiliated scientists with expertise in relevant areas of research who can provide guidance to the consortium as well as NIAAA. A Steering Committee composed of consortium members and NIAAA staff members facilitates coordination and maintains focus. Each consortium supports Pilot Projects in order to respond to promising ideas within a short time frame. An important feature of the INIA structure is the ability to collectively adjust scientific focus to capitalize on new INIA research findings and discoveries.

Research Goals

This FOA intends to provide support for continuation of these integrated, multidisciplinary consortia which are addressing neuroadaptation leading to excessive drinking and also stress effects on excessive alcohol drinking. It is anticipated that during any future support the most productive research projects will be selected. The composition of research projects is anticipated to reflect the progress made during the previous funding periods and the need for components that address and develop the findings of past efforts.

To ensure integration within an INIA consortium, the proposed research project applications must utilize the resources of, and the new technologies developed within, one or more of the resource core facilities for that consortium. However, the research proposed in a research project application can be performed at a research site other than the one housing the resource core facility. Furthermore, the research project is expected to be integrated with the other current research projects within the INIA consortium. It is anticipated that several of the research projects within a consortium will address the same research domain, but will differ in emphasis, approaches and the research questions addressed.

NIAAA encourages investigators who are current INIA participants as well as investigators not part of INIA but who have an interest in participating in INIA to contact the appropriate consortium coordinator or NIAAA staff and discuss their interest in joining the consortium as well as to familiarize themselves with the different resource cores and usage policies for that consortium. A list of the themes of the consortia, resource cores, participants and NIAAA staff can be accessed at the websites: http://www.iniastress.org/ and http://www.scripps.edu/cnad/inia/index.html

A description of how the proposed project adds to, and integrates with, the scientific mission of the INIA consortium that the applicant seeks to join, and how the proposed research will make use of the

resources within that consortium, should be included as a separate section within the text of the research application. Incorporation of previously funded pilot projects as full research projects and recruitment of new investigators who can add needed direction could enhance the progress of future investigation. In addition, the structure and function of cores should be adapted to facilitate ongoing consortium goals (see companion RFA-AA-11-007). It is anticipated that data sharing and dissemination will evolve fully in order to make available the unique resources from the consortium and the findings to the entire alcohol research community and to the wider scientific community.

The success of the INIA in discovering genes and pathways associated with heavy drinking and stress and anxiety states associated with heavy drinking sets the stage for launching studies on the translational potential of these findings. This includes pharmacotherapy as well as other therapeutic interventions. While true medication development efforts require budgets far exceeding those allotted for this FOA, research serving to validate targets emerging from data generated by these consortia in previous years is an important goal of this FOA. Because of NIAAA’s investment in INIA and the valuable scientific resources that have emerged as a result, NIAAA strongly encourages resource sharing and scientific collaboration between the two INIA consortia and with other significant scientific entities outside of INIA (e.g., COGA). In this phase of the INIA initiative, NIAAA is encouraging (1) translational projects, (2) projects identifying drugable targets for future medication development and (3) collaborative projects between the two INIA consortia and/or with major research entities in the alcohol and general neuroscience community.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIAAA intends to commit up to $7.8 million to fund one consortium in FY2011 and 4.7 million to fund a second consortium in FY2012.
Award Budget	No more than $5.1 million per year in Direct Costs may be requested in FY2011 for the first consortium (i.e., cluster of research component projects plus resource-related and administrative cores) and no more than $3.4 million may be requested in FY2012 for the second consortium..
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed five years.

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

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For profit Organizations

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

Governments

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

Other

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

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

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

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

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

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

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be emailed to:

Abraham P. Bautista , Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2089
Rockville, MD 20852
Telephone: 301-443-9737
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of of the appendix files must be sent to:

Abraham P. Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2089, MSC 9304
Bethesda, MD 20892-9304 [for express mail, use: Rockville, MD 20852-1705]
Telephone: 301-443-9737
Email: [email protected]

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 Application Guide must be followed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

• 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 (please note all format requirements) as described in the PHS398 Application Guide

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will be returned to the applicant without review.

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

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

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

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

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

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

Environment

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

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

Integration and collaboration

Do the scientific aims of the proposal significantly complement other projects within the consortium and advance the overarching goals of the consortium? Is there evidence of significant collaboration with other projects or cores in the consortium?

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

Not Applicable

Renewals

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

Revisions

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/priority score.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Alcoholism and Alcohol Abuse (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 will:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 business official.

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

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

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

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(s)/PI(s) will have the primary responsibility for:

• coordinating project activities both scientifically and administratively with their respective INIA consortium. The Principal Investigator will be responsible for the scientific and technical direction of the project and agrees to abide by the policies and rules set up by the consortium. This includes accepting the actions and recommendations approved by the Steering Committee. In addition, each Principal Investigator will agree to accept close coordination, cooperation and participation of the NIAAA in those aspects of management of the project as described below. Each U01 research project and U24 resource or support core will receive a separate award, and the Principal Investigator will have control over the project's operating budget. Awardees will be required to attend INIA Committee meetings and participate in the cooperative nature of the INIA consortium. Awardees will retain custody of, and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees will implement the approved Data Sharing Plan (see Submitting An Application), which will be incorporated as an additional term of award, and will be expected to share (make available) these data both within the consortium and with the scientific community. Awardees should comply with their institutional intellectual property policies and practices as approved in the award.
• 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 have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIAAA Project Collaborator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIAAA Project Collaborator will not attend peer review meetings of renewal or supplemental applications related to the project (unless IC waiver is obtained) and may not be involved in the normal programmatic stewardship of the project. If such participation is essential, this individual will seek NIAAA waiver. An NIAAA Program Official will handle the normal stewardship of the award, as described below.

NIAAA Staff Responsibilities

The two NIAAA Project Collaborators will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the NIAAA Program Official, and the NIAAA Project Collaborators.

The two NIAAA Project Collaborators will have voting membership (one combined vote) on the Steering Committee and, as determined by that committee, its subcommittees.The NIAAA Project Collaborators will coordinate and facilitate the INIA Consortium programs, will attend and participate as a voting member in all meetings of the INIA Steering Committee, and will provide liaison between the Steering Committee, the INIA Consortium, and the NIAAA.

The NIAAA Project Collaborators will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.

The NIAAA Program Official will review the scientific progress of individual components, and review them for compliance with the operating policies developed by the Steering Committee, and may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.

The NIAAA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Consortium Coordinator’s Rights and Responsibilities: The consortium coordinator is charged with coordinating the scientific and administrative activities of the INIA consortium. The consortium coordinator has the responsibility for the scientific and technical direction of the research projects, and the administration and overall operation of the consortium. In addition the consortium coordinator will administer the selection and award of pilot projects in consultation with the Steering Committee and Scientific Advisory Board and report on their progress. Therefore, the consortium coordinator is responsible for ensuring that projects awarded are fully integrated within the scientific scope and mission of that consortium. This includes assuring that all investigators have access to the resources within the core resource facilities of the INIA consortium. A Steering Committee serves to assist the consortium coordinator with the governance of the consortium. The consortium coordinator chairs this committee. In addition, the consortium coordinator must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the consortium coordinator has agreed to accept participation of NIAAA staff members in those aspects of management of the project described under "NIAAA Staff Rights and Responsibilities." Lastly, the consortium coordinator ensures the timely dissemination of information generated by the consortium component projects to both the consortium project members and the scientific public.
• Scientific Advisory Board: Each INIA consortium includes an external scientific advisory board whose purpose is to meet with the consortium coordinator and the Steering Committee to assess progress and provide feedback to the INIA investigators and NIAAA on proposed goals for the next year of support. The panel members are designated by the NIAAA in consultation with the Steering Committee, and consist of research scientists not actively involved with the consortia. The NIAAA staff collaborators attend the meeting of the scientific advisory board as members of the steering committee, but are not members of the scientific advisory board. The scientific advisory board should meet at least once a year immediately prior to the submission of the INIA consortium annual progress report.
• Steering Committee: Each INIA consortium has a Steering Committee, which is the main governing board of the INIA consortia. This committee develops collaborative protocols, and functions to set priorities for model derivation, defines the parameters for model validation, identifies technological impediments to success and strategies to overcome them, and decides when models should be made available to the research community for individual investigator-initiated projects. The members of the Steering Committee for each INIA consortium are selected by the consortium coordinator with input from the NIAAA science officers. The Steering Committee is primarily composed of the consortium coordinator, several principal investigators of the research project components and core resource facilities, and the NIAAA science officers. The Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed. The NIAAA also reserves the right to augment the scientific expertise of the INIA Steering Committee when necessary, and to appoint additional NIAAA staff as nonvoting members of the INIA Steering Committee and Subcommittees. Each primary member of the Steering Committee has one vote. The chairperson of the Steering Committee is the consortium coordinator. The Steering Committee may establish subcommittees as it deems appropriate to facilitate the planning and operation of the INIA consortia. The Steering Committee meets at least twice annually to discuss and refine the scientific mission and objectives of the INIA consortia, and to evaluate the scientific progress being made both within the INIA consortium research components and by outside laboratories. The Committee discusses the various models and experimental approaches that were proposed in the individual component and core applications and any relevant new information, and subsequently sets the research priorities for the consortium. In the interest of facilitating research in the alcohol field, the Steering Committee of each consortium evaluates the progress of any animal model or new technology being developed and decides when the model or technology is sufficiently validated for distribution to the research community. The NIAAA will provide the means to disseminate the models and the information related to them.
• To support the scientific mission of the consortium, the Steering Committee organizes one or more workshops a year. Workshops from each consortium can be held separately, but workshops from each of the consortia may be combined and held jointly. These workshops, attended by both INIA and non-INIA participants, enable the INIA consortium members to explore current scientific or technologic advances and innovations that occur during the course of the project. The Steering Committee also plans a symposium to inform the research community of the progress being made towards the derivation or refinement of animal models, their characterization and validated uses, and any technological advances related to the design and derivation of these models. The NIAAA science officers and other NIAAA staff provide the Steering Committee with advice on appropriate topics and participants for the workshops and symposia.

Dispute Resolution:

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

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

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

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

Antonio Noronha, Ph.D
Director, Division of Neuroscience and Behavior.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7722
Email: [email protected]

Ranga Srinivas, Ph.D.
Chief, Extramural Projects Review Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: [email protected]

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

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

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