RFA-AA-14-001: Limited Competition: Collaborative Study on the Genetics of Alcoholism (COGA) (U10)

Department of Health
and Human Services (HHS)

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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	Limited Competition: Collaborative Study on the Genetics of Alcoholism (COGA) (U10)
Activity Code	U10 Cooperative Clinical Research Cooperative Agreements
Announcement Type	Reissue of RFA-AA-09-005
Related Notices	November 5, 2018 - This RFA has been reissued as RFA-AA-19-001.
Funding Opportunity Announcement (FOA) Number	RFA-AA-14-001
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.273
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) is a limited competition FOA soliciting a cooperative agreement (U10) application from investigators currently supported under an existing study, entitled Collaborative Study of the Genetics of Alcoholism (COGA) to (i) identify genetic variants that affect the susceptibility to develop alcohol dependence in adult and adolescent populations, (ii) determine molecular and functional mechanisms of these variants, (iii) identify and characterize gene x gene and gene x environment interactions leading to alcoholism, (iv) develop and refine phenotypes that will facilitate genetic analysis, (v) perform prospective studies of COGA probands.

Key Dates

Posted Date	November 5, 2013
Open Date (Earliest Submission Date)	December 21, 2013
Letter of Intent Due Date(s)	December 21, 2013
Application Due Date(s)	January 21, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	March-April 2014
Advisory Council Review	May 2014
Earliest Start Date	September 1, 2014
Expiration Date	January 22, 2014
Due Dates for E.O. 12372	Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The Collaborative Study of the Genetics of Alcoholism (COGA) is a joint multi-disciplinary, multi-site project that has been supported by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) since 1989 and more recently also by the National Institute on Drug Abuse (NIDA). It seeks to identify the role of genes in susceptibility to (or protection from) developing alcohol dependence and related phenotypes. The ultimate goal is to understand the functional effects of variation at genes identified in these studies, including effects on expression, at the molecular and cellular level. Investigators with complementary expertise in molecular and cellular biology, neurophysiology, and psychiatry have collaborated over the years to identify genes in which nucleotide sequence variation affects the risk for alcoholism and related disorders. This approach initially was built on linkage and association studies in severely affected individuals within families. The initial sample consisted of 105 families with 987 individuals. The COGA sample now consists of more than 17,000 individuals from over 2000 families with extensive phenotypic and genomic information. This dataset is a rich resource for alcohol researchers and for investigators interested in determining the genetic basis of other complex disorders that frequently influence the development of alcoholism, such as anxiety and major depression. The COGA dataset has also served the larger research community as a resource for examining functionally-based endophenotypes and in testing new analytical approaches.

Results from the first genome-wide scan in the initial sample of 105 families provided evidence of linkage for loci on chromosomes 1 and 7 and suggestive linkage on chromosome 2 with alcohol dependence; linkage on chromosome 2, conferring protection against alcohol dependence, near the alcohol dehydrogenase genes was also found. A follow up study in 157 independent families densely affected with alcoholism was conducted and provided further evidence of linkage to chromosomes 1 and 7 with new loci identified on chromosomes 2 and 3. In addition to genome wide studies of alcohol dependence, COGA has conducted several candidate-gene association studies and found association with more than 20 genes affecting both alcohol dependence and endophenotypes associated with alcoholism. Finally, in recent years COGA has conducted several Genome-Wide Association Studies (GWAS). Family-based and case-control GWAS for alcohol dependence or related phenotypes identified several promising new genetic variants including: C15orf53, KCNJ6, and GABRA2.

During the current period of support, COGA has begun to examine the high-risk offspring from the densely affected families. This includes an adolescent and young adult cross-sectional sample (ages 12-25) that consists of more than 4000 individuals. A prospective sample of adolescent high-risk youth is also included (ages 12-21) and consists of more than 3000 individuals. These novel samples are instrumental in understanding the trajectory of the development of alcoholism over time. In addition, the age range that is being studied captures both the initial experimentation with alcohol and more established and regular patterns of use including the age of highest risk. COGA is using these samples to examine gene x environment interactions (including examining epigenetics and the effects of parental alcoholism, parental monitoring, and peer relations), exploring the relationship between known alcoholism risk genes, clinical phenotypes and neurophysiological phenotypes. To complement these studies, COGA has participated in obtaining longitudinally-derived blood samples for establishing lymphoblastoid cell lines (in collaboration with Rutgers Cell Repository) for examining molecular indicators of effects of alcohol in individuals.

Summary

The COGA project remains a unique opportunity to define the genetic factors that influence alcoholism and related phenotypes. Many significant discoveries have been made using this sample over the last 25 years. New genetic variants have been identified, refined endophenotypes have been characterized, and functional information has been produced on known genetic variants that influence risk and protection on alcoholism. This collaborative study will continue to provide critical information for the field on the genetic and biological underpinnings of alcoholism. The information afforded will suggest better treatments and help identify subsets of individuals who respond better to treatment, making a significant step toward attaining the goal of personalized medicine.

Prospective investigators who wish to collaborate with COGA investigators on this renewal application should first discuss their research plans with appropriate COGA PD(s)/PI(s) so they can be incorporated into the application.

Objectives

The goal of this limited competition is to continue identification and characterization of gene variants that confer risk for, or protection from, the development of alcohol dependence and to understand molecular mechanisms that are impacted by these variants. The following scientific areas are of interest to NIAAA in the continuation period. However, NIAAA recognizes that not all of these studies may be possible due to budget limitations and leaves the justification of the studies selected for this continuation period to principal investigators. Thus, areas of research areas appropriate to this announcement include, but are not limited to:

Advances in our understanding of complex phenotypes:

Advance the understanding of the complex phenotypes related to alcoholism by determining the mechanisms by which different phenotypes observed in early adolescence (e.g., childhood externalizing behaviors) change over time and predict drinking quantity, frequency and problems in high risk families.
Re-assess COGA probands and their families to better understand the course of alcoholism over time, including remission and persistence, treatment response, development of other health conditions, and all-cause mortality.
Develop new neurophysiological and neuropsychological phenotypes that index cognitive function and use them in our search for genes affecting alcoholism risk across adolescence and young adulthood.
Studies that evaluate the role of gender and ethnic differences on a range of cross-sectional and longitudinal phenotypes, and development of models that uses such differences to improve the ability to identify genes and environmental factors contributing to these phenotypes and endophenotypes.

Identification of additional genes that underlie the risk for alcoholism, related phenotypes, co-morbid phenotypes and endophenotypes:

Studies that exploit the informativeness of the extended COGA families to identify novel genes and variants contributing to key phenotypes.
Studies identifying variants along the allelic spectrum that contribute to alcohol dependence and other alcohol-related phenotypes using available genomic technologies (sequencing, genotyping arrays that include exome content, targeted genotyping).
Utilize strategies that allow the ethnic diversity of COGA families to improve the ability to identify novel genetic factors by expanding all studies to include large families of all ethnicities such as European American, African-American and Hispanic families.
Perform targeted resequencing of the most promising genes (both coding and noncoding regulatory regions) and molecular pathways, in large subsets of the COGA sample to confirm the role of novel genes.

Explore potential mechanisms of action of key genes:

Explore potential mechanisms of action of key genes by molecular and functional studies to understand how novel genes identified contribute biologically to risk, protection, or variation in alcohol-related phenotypes.
Create and utilize induced pluripotent stem cells (iPSC) to study the mechanism of action of key risk variants.
Study gene expression, splicing and DNA methylation in older COGA subjects, who have had long histories of alcohol dependence, to explore the long-term epigenetic effects of alcohol that develop during this chronic, relapsing disease and may affect ability to recovery.
Use functional neuroimaging, genetic and alcohol use data from the Human Connectome Project to identify the functional neural networks modified by alcohol dependence risk alleles and examine whether the observed functional differences are modulated by genotypes and drinking behavior.

Prospectively examine the effects of genes and environmental influences on clinical and neurophysiological phenotypes related to risk for alcoholism across development:

Continue prospective studies of adolescents and young adults in the COGA sample to examine genetic effects across development and to determine factors that affect risk at this critical age range. Also, studies that explore how specific alleles that affect risk manifest themselves as adolescent and young adults pass through ages of risk for developing alcohol dependence.
Study genetic influences on changes in drinking patterns from adolescence through emerging adulthood in the COGA Prospective study to understand why some adolescents continue to alcohol dependence and others do not.
Study in the Prospective sample, key transitions that are likely to be involved in desistance or persistence of alcohol-related problems as the participants age through emerging adulthood into their late 20’s and early 30's.
Examine the contributions from gender and ethnicity, and explore how their interaction with genetic and environmental factors varies as a function of developmental stage.
Characterize trajectories of brain development and cognitive functioning through neurophysiological and neuropsychological measures from adolescence through young adulthood and determine the effect of genetic risk factors on these trajectories and their impact on alcoholism.
Examine the effect of drinking behavior, including commencing regular drinking, on both genome-wide expression and methylation. Collect paired samples in participants in the Prospective Study before and after they begin regular drinking, to explore the potential epigenetic effects of alcohol exposure that could influence subsequent risk for problems.
Studies to follow the time course and phenotypic/endophenotypic characteristics of older COGA probands with specific genotypes to treatment response, remission, and relapse.
Studies that determine how genetic, behavioral, social factors, and other environmental factors influence vulnerability to alcohol dependence and/or protection (resilience).

The Role of NIAAA:

The NIAAA staff role in these cooperative agreements will extend the level normally required for stewardships of a grant because of the need for coordination across sites. The NIAAA Program Official will be charged with management decisions required during the course of the project. As the genetic analysis and functional studies are planned, NIAAA will oversee the collection of certain common data elements to be collected across all sites, and provide technical assistance and support as needed to further access genetic variations within COGA samples. In addition, an NIAAA Staff Collaborator(s) will have substantial scientific input, in collaboration with award recipients, in both the planning and conduct of the study. The primary purpose of participation by the Staff Collaborator(s) is to facilitate the coordination necessary to perform this complex collaborative project. The NIAAA Staff Collaborator(s) will participate in monitoring the progress of the ongoing study, aid in quality control, data analysis, and interpretation. To assist in fostering the collaborative nature of this project and to monitor its progress, NIAAA will sponsor an annual meeting at which each site will present the major findings of its activities and plan collaborative efforts to analyze, interpret and disseminate findings based on the common items included across sites. .

Section II. Award Information

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. [
Application Types Allowed	Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIAAA intends to commit $7.5 million to fund one award in FY 2014. Future year amounts will depend on annual appropriations
Award Budget	The application budget needs to reflect the actual needs of the proposed Consortium but must not exceed $7.5 million in total costs per year. These amounts are inclusive of all Facilities and Administrative costs for both the awardee and consortium sites.
Award Project Period	The maximum period of support is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Organizations holding an active NIAAA-funded U10 are eligible to apply.

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

PD(s)/PI(s) should have demonstrated expertise in handling a large clinical alcohol project under this mechanism (U10). In addition, PD(s)/PI(s) should have demonstrated experience in examining clinical phenotypes, neurophysiological phenotypes and genetic and genomic expertise in relationship to alcohol.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

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

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

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

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9737
Fax: 301-443-6077
Email: bautista@mail.nih.gov).

Page Limitations

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	6
Core	12
Project	12

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall: Required
Administrative Core: Required, maximum of 1
Cores: Required, maximum of 2
Projects: Required, maximum of 4

Overall Component

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Center Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

PD(S)/PI(s) should have demonstrated expertise in handling a large clinical alcohol study under this mechanism (U10). In addition, PD(s)/PI(s) should have demonstrated experience in examining clinical phenotypes, neurophysiological phenotypes and genetic and genomic expertise in relationship to alcohol.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the theme and goals of the Collaborative Study.

Research Strategy: An overview section must contain justification for the Collaborative Study and describe those goals that are not readily attainable through individual research grants. This section should include a description of the objectives of the Collaborative Study as a whole that describes the relationship of the individual research projects to the entire collaborative study and the special benefits to be achieved by funding as a Cooperative Agreement grant rather than as a series of individual research grants.

The special benefits associated with being part of the Collaborative Study must be addressed. Support for a resource core should be justified in terms of its essential function and service to the overall goals of the Collaborative Study.

The final progress report of terminated research projects and cores are included in this section. The description must not exceed 2 pages per project.

Letters of Support: Letters of support for the Cores and Projects must be included in the appropriate components.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administrative Core

When preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

The Administrative Core must be managed by the Center Director.
In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Budget must include cost for NIAAA-sponsored annual meeting.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the specific aims of the Administrative Core.

Research Strategy: The Administrative Core provides the organizational framework for the management, direction, and coordination of the Collaborative Study. The Administrative 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. The Administrative 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.

A Collaborative Study Advisory Committee, although not mandatory, may be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals not otherwise involved in any components of this proposed Collaborative Study, should be composed of at least five members. These members should be persons of recognized scientific standing who are generally familiar with this Collaborative Study's activities and represent a cross-section of disciplines that are relevant to the work proposed. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities in this Collaborative Study, including the management of pilot projects. If committees other than the Collaborative Study 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. 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 Collaborative Study’s strategies for achieving its goals.

If a pilot project effort is planned, it should be described as part of the Administrative Core. The investigators of pilot projects may be New, Early Stage, or Established investigators who are well suited to the project. Under this FOA, the U10 will be allowed one pilot project at any time. The component should include the planned pilot study 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 project(s) to be supported in the first two years.

Letters of Support: Letters of support for the Administrative Cores must be included in this component.

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

Cores

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Cores)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cores)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Cores)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Cores)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Cores)

Budget forms appropriate for the specific component will be included in the application package.

PHS 398 Research Plan (Cores)

Specific Aims: Describe the specific aims of the Resource Core.

Research Strategy: Core components are shared research resources that provide investigators of this Collaborative Study with techniques, instrumentation, services, or resources that will enhance alcohol and HIV/AIDS-related research to accomplish the common goals. A core should be used primarily to support projects which are part of the Cooperative Agreement 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 Collaborative Study. 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 this Cooperative Agreement’s scientific research components and may also support independently funded research grants related to the Collaborative Study's theme. Each separately funded research project associated with the Collaborative Study and utilizing core facilities should have a brief description that includes its research objectives and how the U10'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.

Letters of Support: Letters of support for the Core must be included in the in this component.

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Cores)

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

PHS 398 Cumulative Inclusion Enrollment Report (Cores)

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

Projects

When preparing your application in ASSIST, use Component Type Project

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

SF424 (R&R) Cover (Projects)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Projects)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Facilities and Other Resources: 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.

Project /Performance Site Location(s) (Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Projects)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Projects)

Budget forms appropriate for the specific component will be included in the application package.

PHS 398 Research Plan (Projects)

Specific Aims: Describe the specific aims of the Research Project.

Research Strategy: Research components are individual scientific research projects that are integrated and that contribute collectively to the goals of the Collaborative Study. Each Project Lead 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 Project Lead 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 Collaborative Study. 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.

Letters of Support: Letters of support for the Research Projects must be included in this component.

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Projects)

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

PHS 398 Cumulative Inclusion Enrollment Report (Projects)

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at bautista@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

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 score to reflect their assessment of the likelihood for the overall 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 overall project 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, an overall project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the overall 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 overall 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 overall project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

Additional Review Criteria - Overall

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

Integration

Is there evidence of scientific and administrative integration of the proposed overall project? Is there evidence of coordination, interrelationships, and synergy among the individual research projects and core components? Are there clear advantages or value added by conducting the proposed research as a collaborative study rather than through separate research efforts? Is there thematic cohesion to the overall project? Is the interrelationship of individual projects and cores clear and scientifically well-justified? How will the administrative structure of the overall project contribute to its probability of success? Does the application clearly describe and justify the proposed administrative and organizational structure? Is the proposed structure adequate to support and encourage optimal interactions among participants of the overall project? Does the administrative plan provide for internal quality control of ongoing research, management of day-to-day program activities and for fair and effective communication and cooperation among members of this proposed collaborative study, including resolution of disputes and allocation of funds?

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 Guidelines for the Review of Human Subjects.

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 Guidelines for the Review of Inclusion in Clinical Research.

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

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.

Overall Impact - Administrative Core

Reviewers will provide, a merit descriptor (outstanding, acceptable or unacceptable) to reflect their assessment of the likelihood for the administrative core 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 administrative core proposed).

Review Criteria - Administrative Core

Reviewers will consider each of the criteria listed below in the determination of scientific merit, and give a separate merit descriptor (outstanding, acceptable or unacceptable) for each. A component does not need to be strong in all categories to be judged likely to have major scientific impact.

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Administrative Core? 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 Administrative Core 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 Administrative Core?

Approach

Is there a clear, detailed plan for managing the Collaborative Study's research and administration, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources, that conveys a high likelihood of effective, productive management of the Collaborative Study as whole? Are the Administrative Core's personnel qualified and experienced in the administration of a large, multi-component research program? Is there an organizational structure that will facilitate coordination, integration and timely evaluation of activities and progress? Are there innovative features in the organizational design and decision making process? Is the coordination among the Administrative Core and the research components adequately explained? For the Pilot Projects, is there an adequate selection process for new and replacement pilot projects? Are procedures for monitoring, oversight and project continuation explained? Are the pilot research topics important? Does the pilot have the potential to develop into a full-scale independent project? Are the qualifications of the pilot project Component Director and the individual pilot project leaders appropriate for the proposed research? Are the resources and environment for the projects adequate?

Additional Review Criteria - Administrative Core

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

Protections for Human Subjects

Inclusion of Women, Minorities, and Children

When the proposed Administrative Core 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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

Biohazards

Not Applicable

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Administrative Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Resource Sharing Plans

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.

Overall Impact - Cores

Reviewers will provide a merit descriptor (outstanding, acceptable or unacceptable) to reflect their assessment of the likelihood for the core 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 core proposed).

Review Criteria - Cores

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the core? 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 core 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 core?

Approach

Is the proposed Research Core well matched to the needs of the overall Collaborative Study? Does it provide essential facilities or services for two or more research projects? What is the overall quality of the proposed core services? Are there adequate quality control processes proposed for the facilities or services provided by the Research Core (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Research Core products and/or services? Are the qualifications, experience, and commitment of the leader of the Research Core and other key personnel adequate and appropriate for providing the proposed facilities or services? Will the proposed Research Core provide cost effective services to the Collaborative Study? Is the environment for the Research Core adequate to support the Collaborative Study as proposed? Is the coordination among the resource cores and the research components adequately explained?

Environment

Are the resources and environment for the projects adequate?

Additional Review Criteria - Cores

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

Protections for Human Subjects

Inclusion of Women, Minorities, and Children

When the proposed core 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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

Biohazards

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Cores

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Resource Sharing Plans

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.

Overall Impact - Projects

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

Scored Review Criteria - Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. The overall impact score will take into consideration: the scored review criteria and any specified additional review criteria; the extent to which the individual project enhances the strength of the overall Collaborative Study; and the importance of the individual project to the success of the overall Collaborative Study.

Significance

Does the Research Project address an important problem or a critical barrier to progress in the field? If the aims of the Program 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 Project lead(s), collaborators, and other researchers well suited to the Research 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)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the Research Project 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 Research 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? Is the coordination among the cores and the research components adequately explained? Is there synergistic potential among the research projects within the U10?

If the Research 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

Additional Review Criteria - Projects

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

Protections for Human Subjects

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

Biohazards

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Projects

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Resource Sharing Plans

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIAAA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

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’s business official.

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM 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

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:

Coordinate a regular schedule of meetings with NIAAA Project Scientist for review and consultation.
Coordinate project activities with their institutions, with collaborators, and with the NIAAA Project Scientist.
Maintain collaborative partnerships with community health service providers, established alcohol research investigators, and NIAAA Project Scientist.
Accept assistance and seek input from NIAAA Project Scientist to inform the pursuit of project goals.
PD(s)/PI(s) will publish and publicly present and disseminate results of the research project.
Coordinate sharing of GWAS data with qualified investigators.
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:

NIAAA Project Scientist

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

NIAAA Program Official

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

Areas of Joint Responsibility include:

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

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

Dispute Resolution:

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.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Antonio Noronha, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7722
Email: anoronha@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Judy Fox
National Institute on Alcohol Abuse and Alcoholism
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.