Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Comprehensive Alcohol Research Centers (P60)

Activity Code

P60 Comprehensive Center

Announcement Type

Reissue of RFA-AA-10-004

Related Notices

  • June 6, 2012 - This RFA has been reissued as RFA-AA-13-002.

Funding Opportunity Announcement (FOA) Number

RFA-AA-12-003

Companion FOA

RFA-AA-12-002, Specialized Alcohol Research Centers (P50)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.273  

FOA Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications for Comprehensive Alcohol Research Centers using the P60 mechanism.  The overall purpose of the NIAAA Alcohol Research Center program is to provide leadership in conducting and fostering interdisciplinary, collaborative research on a wide variety of topics relevant to the Institute’s mission.  These topics include, but are not limited to: the nature, etiology, genetics, diagnosis, treatment, and prevention of alcohol use disorders and their biomedical, psychosocial, and economic consequences across the lifespan.  Centers also are regional or national resources that contribute to the development of new research methods, technologies and approaches that sustain innovative goal-directed research.   

Key Dates
Posted Date

April 4, 2011

Letter of Intent Due Date

November 4, 2011

Application Due Date(s)

December 7, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2012

Advisory Council Review

October 2012

Earliest Start Date(s)

December 2012

Expiration Date

December 8, 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose:  

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad based Alcohol Research Centers program to foster and conduct interdisciplinary, collaborative research on alcoholism, alcohol abuse and the impact of alcohol on health and disease.  The NIAAA Centers Program provides leadership in research, research methodology development and information dissemination on a wide variety of topics relevant to the Institute’s mission.  These topics include, but are not limited to, investigations into the nature, etiology, genetics, diagnosis, treatment, and prevention of alcohol use disorders and their biomedical, psychosocial, and economic consequences across the lifespan.  Centers are also major contributors to the development of new research methods, technologies, and approaches that sustain innovative goal-directed research.

This FOA uses the NIH Comprehensive Research Center (P60) mechanism to support an integrated, broad-based multidisciplinary, multi-investigator, long-term program of research and research support activities planned around a specific major research theme.  In addition, a Comprehensive Alcohol Research Center (P60) is required to develop an effective research translation or information dissemination component to help accelerate the use of research findings for the benefit of public health. Outreach activities could be pursued in collaboration with other Centers, thereby optimizing the impact. Comprehensive Alcohol Research Centers are also expected to function as a regional and National resource in their particular area of expertise; to facilitate research training; to develop research collaborations with outside investigators; and to provide a means to develop new ideas and encourage new investigators via pilot projects. The Alcohol Research Centers program is interrelated with, and complementary to, all other research support mechanisms and scientific activities that comprise NIAAA programs. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated, integrated and synergistic effort.

The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting exceptional alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center.  A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions.  In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. Unique scientific opportunities such as  sharing of resources or expertise may warrant collaboration with investigators from other centers or from other institutions domestic or foreign. The director of a component who proposes a collaborative activity with a foreign organization should be affiliated with a domestic institution.

Research Translation / Information Dissemination Component

Comprehensive centers (P60) must include a component which supports activities designed to translate research findings into health care practice, public information dissemination, or educational curricula or programs for students, health professionals and community agencies. For Centers new to the P60 mechanism, such activities may require a substantial portion of the first year for planning and development with actual implementation beginning near the second year and continuing in subsequent years. These projects shall in a meaningful way reflect the Center's research theme. The following examples are types of projects that may be undertaken but are not intended to be limiting.

Research Translation:

The development of collaborative partnerships for the translation of insights and findings from basic and pre-clinical research to

Dissemination of Scientific Information and Research Progress:

Dissemination of scientific knowledge through educational efforts directed to

Dissemination of scientific knowledge through the establishment of research and research training collaborations for the purpose of expanding the capacity of other institutions including minority serving institutions, in developing rigorous alcohol research programs.

All translational and educational projects should have specific objectives and include a method for monitoring the effectiveness of the effort. 

Section II. Award Information
Funding Instrument

Grant

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 approximately $12 million in FY2013 to fund five to six new and/or renewal Center applications in response to both this FOA and companion FOA. Awards issued under this FOA are contingent upon the availability of funds and the receipt of sufficiently meritorious applications.

Award Budget

A P60 Center may not exceed $2.0 million in total costs per year.

Award Project Period

Applicants may request a project period of up to 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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

Required Registrations

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.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

Letter of Intent

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 sent to:

Dr. Abraham P. Bautista
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3085, MSC 9304
Bethesda, MD 20892 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-443-9737
Email: abraham.bautista@nih.gov

Application Submission

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 the appendix must be sent to:

Dr. Abraham P. Bautista
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3085, MSC 9304
Bethesda, MD 20892 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-443-9737
Email: abraham.bautista@nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the OER Table of Page Limits must be followed, with the following exceptions or additional requirements:

·         Research Strategy section is limited to 12 pages.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The following paragraphs describe the Special Requirements for a Comprehensive Alcohol Research Center application. For a complete description of required NIAAA Center grant application format and page limitations see: http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/RFAs/Supplemental_Instructions.htm.

Only applications that focus on alcohol related research will be considered responsive to this FOA.

The Comprehensive Alcohol Research Center must have a minimum of five (5) components (an administrative core, three research components and a research translation or information dissemination component).  The maximum combined number of components is 10 including core components, research components,  research translation or information dissemination component and a pilot project component. More than a total of 10 components is not acceptable even if some components are in operation for less than the 5-year period. At least three research components must be active at all times.  All applications for NIH funding must be self-contained within specified page limitations per component (12 page limit for Administrative Core; 12 page limit for Scientific Core; 12 page limit for Research Translation or Information Dissemination Component; 12 page limit for each Research Component).  Pages not used for one component may not be used to extend the page limit of other components or cores. In addition to the overall Center budget, each component requires a separate detailed budget.

A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority in order to facilitate coordination among Center personnel and to assure maximum accountability and efficiency in Center operations.

The Center Director will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center.

The applicant also may designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the center program.  The Scientific Director will be responsible for promoting interaction and collaboration among scientists conducting research within the Center in order to facilitate a concerted approach to the research goals of the Center.  The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of colleagues) research and educational activities to be expanded or decreased and the need for additional resources or reallocation of resources.  If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director also should be described.

A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, should be composed of at least five members.  These members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center.  It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the management of pilot projects.  If committees other than the Program Advisory Committee are included in the application, specific plans regarding committee selection and function should be provided.

The Center Director(s) will establish a Steering Committee that will be composed of the Center Director(s) and Core/Research Component Directors from all participating institutions.  The function of the Steering Committee is to facilitate the collaboration by monitoring progress and outcomes of individual projects, develop new collaborations, and review the Center’s strategies for achieving its goals.

Training

While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important secondary function is the training of research and clinical personnel. The applicant institution must therefore demonstrate or give reasonable assurances that it has: a) the capacity to train pre-doctoral and/or postdoctoral students for careers in alcohol research; and b) the capacity to conduct programs of continuing education in the Center's designated research theme in the basic, behavioral, epidemiological, or health service fields.

While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions.  Center grant funds may not be used to pay stipends or other trainee costs; however, Center staff may participate in the development of training programs, and Center resources may be made available for use by trainees.

Center Components:

Administrative Core Component (12 pages)

The Administrative Core provides the organizational framework for the management, direction, and coordination of the Center. It must be managed by the Center Director.  This core should ensure that all proposed components and related activities will function in an optimal and synergistic manner. An important function of this core is also the administration of the budget. It may include funds for scientific enrichment activities such as lectures, symposia, seminars, and workshops for research faculty and staff.  This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally.  In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core.

Scientific Core Component (12 pages)

Core components are shared research resources that provide Center investigators with techniques, instrumentation, services, or resources that will enhance alcohol-related research to accomplish the common goals of the Center. A core component is a laboratory, facility, service, or other resource that provides support for scientific research projects of the Center.  Cores should be used primarily to support projects which are part of the Center Grant award. Each core component is directed by an investigator with established expertise relevant to the support or service to be provided. Each shared scientific resource component should be clearly described in terms of the services and resources to be provided to investigators.  The description should include a discussion of the core's contributions to the research objectives of the Center.  Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the cores should also be addressed.  A core component should support two or more of the Center’s scientific research components and may also support independently funded research project grants related to the Center's theme.  Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact those objectives.  The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible to access the core facility.  Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the Center to utilize new technologies that broaden their research initiatives.  While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Research Components  (12 pages for each Research Component)

Research components are individual scientific research projects, integrated with the overall Center program that contribute collectively to the goals of the Center program. Each Research Component Director should be a qualified investigator and is responsible for the scientific direction and conduct of the individual research component.  A Center Director or Scientific Director may serve as a component Director on not more than one Research Component. Each proposed research component should provide a clear description of its major goals, objectives, and how it integrates with the other research components in relation to the overall Center program. The hypotheses to be tested should be focused and fully detailed. The design and procedures should describe the strategies proposed to accomplish the specific aims and the innovative aspects of the approach should be highlighted. A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, subjects, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in the proposed studies. If core facilities are utilized, information on their use should be provided.

Research Translation or Information Dissemination Component (12 pages)

For each project in the research translation/dissemination component, a clear description of its major goals and objectives should be provided as well as how it integrates with one or more research component and the overall center program. While the specific number of information dissemination projects is at the discretion of the applicant, requested funding for information dissemination component activities may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year.  A staffing plan and rationale for organization of this component should be presented.  Methods, techniques, and technologies to be used for proposed activities should be defined as well as the targeted audience or participants.  Issues of cultural sensitivity with regard to the intended audience should be addressed.  When appropriate, activities should be designed to effectively reach underserved populations and/or subgroups based on age or gender.

Pilot Project Component (12 pages)

The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects.  The PD/PIs of pilot projects may be New, Early Stage, or Established investigators that are well suited to the project. The pilot project component should include the planned pilot studies as well as procedures for selecting new projects.  These pilot project funds are not intended to supplement ongoing research projects. The application must provide thorough and concise descriptions of the projects to be supported in the first two years. For years 03-05, the applicant must specify the number of pilots planned in each year and a brief description of the anticipated directions of these pilots. All proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide sufficient information to enable adequate scientific evaluation by a peer review committee.  The application should include a full description of the management of the pilot project component, including a description of the process used to solicit and select pilot projects.  This includes the selection of new projects to replace those proposed in the application should it become necessary.  Each pilot study proposed in the first 2 years should be fully described, including its rationale, objectives, approach, investigators, and significance for the Center.  The research description of any individual pilot project may not exceed three pages. Also a brief description (up to 2 pages) and anticipated direction of individual pilot projects planned for the 03-05 years, and their potential significance to the Center should be included.  the entire narrative for this Pilot Project Component may not exceed 12 pages irrespective of the number of pilot projects proposed. A budget should be submitted for the pilot project component as a whole for each year in which pilots are proposed and for each individual project.  For years 01 and 02 the budget will reflect costs of pilots proposed in the application. Budget information provided for each project anticipated for the 03-05 years should reflect best estimate costs based on number and kind of pilot projects to be pursued. While the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year.

Other Requirements:

Facilities and Environment

Applicants must demonstrate the availability of adequate laboratory, clinical, office and other facilities needed to carry out the objectives of the proposed Alcohol Research Center program.  To the extent possible it is desirable for Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility.  Internet access to scientific literature and other information must be readily available.  Relevant support services, including for example adequate data processing facilities, must also be readily accessible and documented in the application.

Renewal Applications

A comprehensive progress report is required for renewal applications. A statement describing the progress made by the Center as a regional or national research resource should be included.  Collaborative activities if any, with other NIAAA Alcohol Research Centers should be described along with a list of joint accomplishments. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal.  For each component, a bibliography of publications relevant to the Centers activities should be included in the progress report. Ongoing or completed core activity that has enhanced or facilitated alcohol research should be described.  Past performance and accomplishments of cores should be described, as should the effect of services provided by cores on investigators' productivity. For renewal applications, information should be provided on past experience in utilizing pilot funds to further Center goals.  This should include an assessment of overall benefits derived from the availability of pilot resources. 

Progress Report for Components being extended into the next funding period are to be included in the Administrative/Scientific Core Components (3-page limits for each of these components); and within the 12-page limit for each Research Component.  Progress Reports for Components that have been terminated are limited to 2 pages. 

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:

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,

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute on Alcohol Abuse and Alcoholism. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the center  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 center proposed).

Scored Review Criteria - Overall

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 center that by its nature is not innovative may be essential to advance a field.

Significance

Does the center address an important problem or a critical barrier to progress in the field? If the aims of the center 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 center? 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 center? 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 center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

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

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed center 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

Additional Review Considerations - Overall

As applicable for the center 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

Not applicable.

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.

Scored Review Criteria

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

Administrative Core Component

Investigators:

Approach:

Coordination and Cohesiveness:

Scientific Core Component

Investigators:

Approach:

Coordination and Cohesiveness: 

Research Components

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 component that by its nature is not innovative may be essential to advance a field.

Significance. 

Investigator(s). 

Innovation.

Approach. 

Environment. 

Research Translation or Information Dissemination Component

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 component that by its nature is not innovative may be essential to advance a field.

Significance. 

Investigator(s). 

Approach

Environment. 

 
Pilot Project Component

Significance:

Investigators: 

Approach:

2. Review and Selection Process

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned 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 Absuse and Alcoholism . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Mariela Shirley, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9787
Email: shirleym@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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


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