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 Clinical Trial Not Allowed)
Activity Code

U10 Cooperative Clinical Research – Cooperative Agreements

Announcement Type
Reissue of RFA-AA-19-001
Related Notices
  • February 29, 2024 - Notice of Change to Application Due Date for RFA-AA-24-003,"Limited Competition: Collaborative Study on the Genetics of Alcoholism (COGA) (U10 Clinical Trial Not Allowed)". See Notice NOT-AA-24-006
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-AA-24-003
Companion Notice of Funding Opportunity
None
Assistance Listing Number(s)
93.273, 93.307
Notice of Funding Opportunity Purpose

This Notice of Funding Opportunity Announcement (NOFO) is a limited competition NOFO soliciting a cooperative agreement (U10) application from investigators currently supported under an existing study, entitled “Collaborative Study on the Genetics of Alcoholism (COGA).” The purpose of COGA is to identify genetic variants that affect the susceptibility to develop alcohol use disorder (AUD). The goals of this limited competition are to continue to advance the understanding of the complexity of the genotypes and phenotypes that contribute to the heterogeneity of AUD, integrate the analysis of multiple data sources, and generate mechanistic hypothesis to understand the contributions of genetic, behavioral, and environmental factors on the development of (or resilience from) AUD.

Key Dates

Posted Date
February 14, 2024
Open Date (Earliest Submission Date)
February 17, 2024
Letter of Intent Due Date(s)

February 17, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable April 17, 2024 Not Applicable June 2024 August 2024 September 2024

All applications are due 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date
New Date April 18, 2024 (Original Date: March 18, 2024) per issuance of NOT-AA-24-006
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.



  3. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The Collaborative Study on the Genetics of Alcoholism (COGA) is a longitudinal cohort study that began in 1989 and continues to this day. The objectives for COGA are to significantly advance knowledge about the complex influences of gene and environment on development and progression of alcohol use disorder (AUD). From its inception, COGA generated and utilized extensive arrays of genotypic and phenotypic data from families densely affected by AUD and from comparison families to identify genes and understand their role in susceptibility to (or protection from) developing AUD and related phenotypes. The COGA cohorts now consist of more than 17,000 individuals from over 2,200 families with a wide age range (7-90).  The COGA investigators with complementary expertise in molecular and cellular biology, neurophysiology, genetics and genomics, and psychiatry have collaborated in the discovery of genes in which nucleotide sequence variations and epigenetic modifications affect the risk for AUD. Linkage and genome-wide association studies (GWAS) identified genes for metabolism (e.g., ADH1B), glutamate signaling (e.g., KCNJ6), inhibitory signaling (e.g., GABRA2), and the stress response (e.g., CRHR1). Subsequent large scale GWAS meta-analyses of AUD have revealed many loci defined by both common and rare genomic variants reflecting the complex genetic architecture, as has been discovered for other complex traits. As additional genes and variants continue to be identified, it is critical to understand how they contribute to the risk for AUD.

During the current support period, COGA researchers extended their studies to include high-risk offspring from the densely affected families (Prospective Study).  This includes prospective generational analysis of samples from adolescent and young adult high-risk offspring from COGA cohort families and comparison offspring from community families. Collecting samples with a deep phenotype assessment instrument is of critical importance in mapping the trajectories of the development of AUD within an individual’s lifespan and across generations. COGA has collected a data set of older (50+ years) individuals and their health outcomes and alcohol drinking behavior over 20+ years. The age range that is being studied captured the initial experimentation with alcohol and more established and regular patterns of use including the ages of highest risk. These data provide information about behavioral and genetic trajectories in the understudied aging population. While discovery of genetic variants and identification of individual risk factors provided insights into biological mechanisms, the polygenic nature of AUD can be leveraged with tools such as genome-wide polygenic risk scoring (PRS) to assess genetic and environmental contributions to risk and resilience. The trans-generational (Prospective Study) and the older subject datasets (from Lifespan Study) are unique to the COGA and will provide insights into how genetic risk unfolds across the lifespan and in response to environmental factors. For example, a higher PRS for AUD is associated with lower likelihood of recovery.

The purpose of this announcement is to advance integrative research efforts of COGA, by focusing and capitalizing on the progress made during the previous funding period, to enhance the knowledge and understanding of the complexity of the trajectories of AUD and their sequelae across the lifespan.  The goals of research include: 1) to comprehensively understand biological mechanisms underlying chronic AUD in later life moving beyond the identification of genetic loci, 2) to investigate longitudinal courses of development and biological consequences of AUD in later life, and 3) to examine genomic, neurocognitive, socio-environmental risk factors to develop an integrated model of resilience and remission from AUD in later life. Longitudinal multi-modal COGA datasets provide opportunities for researchers to investigate the complex genomic architecture of AUD and generate new therapeutic targets and preventive strategies applying new and emerging technological advances and paradigms for data analysis (e.g., AI and machine learning).

COGA datasets have been deposited in the public NIH-designated controlled-access database for Genotypes and Phenotypes (dbGaP), and newly generated data will be made available through the NIAAA Data Archive to be widely shared with the broad scientific community in accordance with the Final NIH Policy on Data Management and Sharing, which includes the Genomic Data Sharing Policy.

Summary

The COGA project remains a unique opportunity to define the genetic factors that influence AUDs as well as co-morbid conditions. Genetic analyses included initial linkage analyses and more recently GWAS of COGA datasets. These complementary approaches have led to the identification of more than 20 genetic loci and alleles affecting AUD and related disorders. These studies have provided critical information to better understand the genetic and biological underpinnings of AUD. However, there is a need for a framework to unify these findings. This will facilitate identification of therapeutic targets and development of prevention strategies for AUD, supported by data generation, curation and bioinformatic analyses. Such a framework will need to incorporate state-of-the-art, multi-disciplinary, multimodal genomic and epigenomic data from the two COGA family cohorts, consisting of adolescent and young adults in Prospective Study and older participants in Lifespan Study, into analysis pipelines to reveal underlying genetic and molecular mechanisms.

Thus, COGA Program Directors (PD) and PIs on this renewal application are strongly encouraged to make outreach efforts to identify potential investigators with the scientific research expertise not available among the current COGA investigators, who are interested in collaborative projects that can be incorporated into the application.

Research Objectives

The goal of this initiative is to identify and understand the roles of genes in susceptibility to (or protection from) developing AUD by building on the significant scientific progress COGA has made and the rich research resources accumulated during the previous funding period. COGA is poised to make significant and valuable contributions to the field, based on its unique strengths as a family-based multi-generation, longitudinal study with multimodal data over the lifespan. A focus should be placed on understanding how genes and gene variants, identified thus far, act to affect the risk for AUD or support recovery in current COGA cohorts, particularly the study on older subjects (participants 50+ years). Examination of the influences of environmental factors continues to be essential for delineating the heterogeneity and underlying biological mechanisms of AUD phenotypes. Thus, areas of research that are appropriate to this announcement include, but are not limited to:

  • Continue to advance the understanding of the complexity of AUD leveraging existing multi-generational COGA genetic and genomic data.
    • Analyze the genetics of COGA families with multigenerational pedigrees utilizing state-of-the-art genomic, epigenomic and multi-omic technologies, such as WGS (whole genome sequencing), RNA-seq, methylome, metabolome, and proteome analyses
    • Perform fine-mapping to identify genes having a causal role in AUD based on genome-wide significant loci from GWAS.
    • Develop workflows and analysis pipelines for curation, harmonization and sharing of data obtained from previous COGA studies in an integrated database resource(s), that is available with open-access to researchers interested in AUD.   
    • In collaboration with geneticists and data scientists, generate tools and methodology to perform current, integrative, comprehensive analyses leveraging the entire COGA and other large-scale datasets (e.g. genetics and genomics, transcriptomics, and epigenomics) across the alcohol addiction cycle and life cycle, providing mechanistic hypotheses for follow-up studies.
    • Facilitate the field to move from identification of genetic loci to understanding mechanisms underlying chronic AUD and associated comorbidities (using functional genomics approaches, and social-environmental contributions).
    • Develop an integrated model of risk, resilience, and recovery of AUD that includes genomic, physiological, and socio-environmental factors over the lifespan.
  • Continue to collect genetic and phenotype data on COGA aging families focusing on the understudied period of later life to investigate lifespan perspective. This includes longitudinal course of chronic AUD through late life, and medical, neurocognitive, and mental health correlates and consequences of AUD (including cognitive decline, dementia, liver disease, premature death and other medical and mental health comorbidities).
  • Build a web-based portal to make COGA research findings and publications accessible to the scientific community and to communicate the key COGA findings with public health implications and relevance to the public. 

NIAAA recognizes the need for the applicant to coordinate curation, storage, and wide sharing of extensive COGA datasets and biomaterials. This includes:

  • All COGA genetic and genomic data with related comprehensive phenotypic data must be shared with the broader research community through a public NIH-designated database such as dbGaP and NIAAA Data Archive, consistent with achieving the goals of the NOFO and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) and NIAAA notices (NOT-AA-23-001 and NOT-AA-23-002).
  • Basic processing, harmonization, imputation, and integration of multi-modal COGA datasets should be performed: 1) to build an integrated COGA database resource for a wide variety of analyses, and 2) make the integrated database resource available to researchers interested in AUD through a controlled-access procedure.   
  • Biological reagents and bioinformatic analysis tools should be provided to researchers outside of COGA to enable further investigation (e.g. investigator-initiated, R01-based) of various aspects of AUD.
  • Activities should be coordinated that promote FAIR (Findable, Accessible, Interoperable and Reusable) practices and open access to COGA data and biomaterials (e.g., immortalized lymphoblastoid cell lines and/or induced pluripotent stem cells (iPSC)), clear policies for access to data and materials, and an approval process for projects that is fair and balanced.

 Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Applicants are encouraged to recruit potential participants from diverse backgrounds, including those from underrepresented groups (for more information, see the Notice of NIH's Interest in Diversity), through means consistent with applicable law.

AIDS-related research applications will not be considered.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance 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. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIAAA intends to commit $6.5 M in FY 2025 to fund one award.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

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 from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM) – 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.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants.gov registration.

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

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

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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019

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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity 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.

 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:

Philippe Marmillot, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-2861
Email: philippe.marmillot@nih.gov

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Admin Core Admin Core 6 Required 1 1
Data Management and Coordination Core Core 12 Required 1 1
Biomaterials Repository Core Core 12 Required 1 1
Project Project 12 Required 2 4

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required 1
  • Administrative Core: required 1
  • Cores (Data Management Core, Biomaterials Repository Core): required 1 each
  • Projects: minimum 2, maximum 4

Overall Component

When preparing the application, 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 Locations (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 and Related Senior/Key Person Profile (Overall)

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

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 as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. For this U10 NOFO, the DMS plan is required in the overall component.

Genetic and genomic data with related phenotypic data must be shared with the broader research community through a public NIH-designated database such as dbGaP and NIAAA Data Archive, consistent with achieving the goals of the NOFO and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013). 

As described in NOT-AA-23-001, NIAAA expects specific information in the Data Management and Sharing Plan (DMS Plan) to be included in NIAAA grant applications for due dates on or after January 25, 2023. In addition to the general NIH guidance regarding the information to include in the DMS Plan (NOT-OD-21-014, Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan, and the NIH Data Management and Sharing Plan format page), NIAAA expects that the DMS Plan elements contain the following specific information:

Elements of the Data Management and Sharing Plan

Data Type:

This section should include details about the research subject, including species, sex, and cohort size. If specimens are collected from specimen sources, the type of specimen is to be listed, e.g., blood, tissue, urine, and whether the sample was collected in a prospective or retrospective time period

The data type specifies the nature of data: omics, medical and non-medical imaging, biological types (biochemical assays and biophysical such as X-ray and NMR, preclinical assays, electrophysiology), and phenotypic. Additional data to be included, i.e., associated metadata, epidemiology and surveillance, social/behavioral, clinical trials results, survey/questionnaire, and algorithms or simulations.

Standards:

For human subject data, a measure(s) of alcohol quantity and frequency is expected to be reported. Measures may include lifetime use, 30-day quantity and frequency, and/or maximum drinks per 24 hours. Demographic data should include sex, age, race, and ethnicity. Applicants are encouraged to consult the PhenX (www.phenxtoolkit.org) website and the Alcohol, Tobacco and Other Substances and the Demographics domains for protocols.

Studies that include animal models should include the alcohol exposure paradigm, age of the animal at the start and end of the alcohol exposure, and a measure of alcohol consumption or exposure. A blood alcohol concentration measurement is recommended.

Data Preservation, Access, and Associated Timelines:

For additional information on submitting scientific data from studies with human subjects, see "Notice of NIAAA Data-Sharing Information for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [5th Revision]" (NOT-AA-23-002). For data types without human subjects, applicants will provide the name(s) of the repositories where the scientific data and metadata will be archived.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

 Administrative Core  

When preparing your application, use Component Type ‘Insert Name.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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)

  • 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 (Administrative Core)

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

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.  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 collaboration by monitoring progress and outcomes of individual projects, develop new collaborations, and review the Collaborative Study’s strategies for achieving its goals.

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

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

 
Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applications that include human subject research in one or more components of the U10 are also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT-AA-23-002 and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013).

COGA data will be shared through NIAAA-sponsored data repositories (such as the NIAAA Data Archive [NIAAADA] hosted by the NIMH Data Archive [NDA]). COGA committees such as a Collaborative Study Advisory Committee, a Steering Committee, or a COGA Proposal Review Committee will not be responsible for data sharing access such as approving data access requests. Instead, data sharing will be the responsibility of the NIH repositories, following repository policies (in part by requiring investigators requesting data to initiate a Data Access Request, and complete the NDA Data Use Certification).

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 

Data Management and Coordination Core

When preparing your application, 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 (Data Management and Coordination 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 (Data Management and Coordination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management and Coordination 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project/Performance Site Location(s) (Data Management and Coordination 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 (Data Management and Coordination Core)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

  • 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 (Data Management and Coordination Core)

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

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 (Data Management and Coordination Core)

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-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, time-saving, 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 this component.

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applications that include human subject research in one or more components of the U10 are also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT-AA-23-002 and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013). 

COGA data will be shared through NIAAA-sponsored data repositories (such as the NIAAA Data Archive [NIAAADA] hosted by the NIMH Data Archive [NDA]). COGA committees such as a Collaborative Study Advisory Committee, a Steering Committee, or a COGA Proposal Review Committee will not be responsible for data sharing access such as approving data access requests. Instead, data sharing will be the responsibility of the NIH repositories, following repository policies (in part by requiring investigators requesting data to initiate a Data Access Request, and complete the NDA Data Use Certification).

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

PHS Human Subjects and Clinical Trials Information (Data Management and Coordination Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

 

Biomaterials Repository Core

When preparing your application, 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 (Biomaterials Repository 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 (Biomaterials Repository Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomaterials Repository 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project/Performance Site Location(s) (Biomaterials Repository 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 (Biomaterials Repository Core)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

  • 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 (Biomaterials Repository Core)

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

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 (Biomaterials Repository Core)

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-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, time-saving, 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 this component.

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applications that include human subject research in one or more components of the U10 are also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT-AA-23-002 and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013). 

COGA data will be shared through NIAAA-sponsored data repositories (such as the NIAAA Data Archive [NIAAADA] hosted by the NIMH Data Archive [NDA]). COGA committees such as a Collaborative Study Advisory Committee, a Steering Committee, or a COGA Proposal Review Committee will not be responsible for data sharing access such as approving data access requests. Instead, data sharing will be the responsibility of the NIH repositories, following repository policies (in part by requiring investigators requesting data to initiate a Data Access Request, and complete the NDA Data Use Certification).

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

PHS Human Subjects and Clinical Trials Information (Biomaterials Repository Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

Project

When preparing your application, 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 (Project)

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 (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project)

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 (Project)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

  • 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 (Project)

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

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 (Project)

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 Project must be included in this component.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applications that include human subject research in one or more components of the U10 are also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT AA-23-002 and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013).  

COGA data will be shared through NIAAA-sponsored data repositories (such as the NIAAA Data Archive [NIAAADA] hosted by the NIMH Data Archive [NDA]). COGA committees such as a Collaborative Study Advisory Committee, a Steering Committee, or a COGA Proposal Review Committee will not be responsible for data sharing access such as approving data access requests. Instead, data sharing will be the responsibility of the NIH repositories, following repository policies (in part by requiring investigators requesting data to initiate a Data Access Request, and complete the NDA Data Use Certification).

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

PHS Human Subjects and Clinical Trials Information (Project)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start)."

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply- Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How To Apply- Application Guide.

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

In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at philippe.marmillot@nih.gov when the application has been submitted. Please include the NOFO 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 the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission 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 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 - 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 project that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific to this NOFO:

How well justified is the research strategy to move the field beyond the identification of genetic loci toward biological mechanisms underlying chronic AUD?

How well do the proposed aims and research plans align with the goals to advance the understanding of the complexity of the genotypes and phenotypes that contribute to the heterogeneity of AUD, integrate the analysis of multiple data sources, and generate mechanistic hypothesis to understand the contributions of genetic, behavioral, and environmental factors on the development of (or resilience from) AUD?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Specific to this NOFO:

How appropriate is the expertise of the  collaborative team(s) indata science  to generate tools and methodology for integrating and analyzing multiple large datasets and generating new hypotheses?

How strong are the opportunities described in the application for junior investigators to gain skills and experiences in leading teams and projects?

Howdetailed is the leadership succession plan to ensure that a pipeline of leaders will be available when they are needed, in the event that the Principal Investigator retires, becomes incapacitated or for some other reasons?

How well described is the plan to promote future leadership of the center and develop alcohol researchers with experience and expertise to lead multi-investigator research projects?

How adequate is is the description that the project will promote and support the scientific workforce in alcohol research?

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?

Specific to this NOFO:

How adequate is the description that the research strategy will use state-of-the-art genomic, epigenomic and multi-omic technologies?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How strong is the approach toward a model of risk, resilience, and recovery?

How adequate is the description of the model for the inclusion of genomic, physiological, and socio-environmental factors from multiple data sources?

How well justified is the description of the workflows and analysis pipelines for the inclusion of  previous and proposed COGA datasets, including comprehensive genotypic and phenotypic data?

How well detailed is the description of proposed  studies with geneticists and data scientists to generate tools and methodology for integrative analysis of COGA data with other large-scale datasets?

Is the proposed integrated database open-access and available to researchers in alcohol use disorder?

How well-designed are the integrative analyses in order to span the lifecycle and provide mechanistic hypotheses for follow-up studies?

How adequately does the application outline the generation of a web-based portal to communicate the research findings to the scientific and lay communities?

How well does the application outline processes of sharing all biological samples collected as well as biological materials generated by COGA such as cell lines?

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?

Specific to this NOFO:

Does the environment encourage a variety of scientific approaches, and methodology?

Additional Review Criteria - Overall

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

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 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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?

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

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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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

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, (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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

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 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

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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals 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 - 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

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, (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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? Is there a strong scientific premise for the project? 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? Have the investigators described in the application, the scientific premise that is used to form the basis for the proposed research question(s)? Have the investigators described the general strengths and weaknesses of the prior research cited in the application as crucial to support the research? Have the investigators considered the general strengths and weaknesses that could include attention to the rigor of the previous experimental designs, as well as the incorporation of relevant biological variables and authentication of key resources?

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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Have the investigators ensured that the scientific method is robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results and if there is full transparency in reporting experimental details so that others may reproduce and extend the findings? Have the investigators described the quality of resources used to conduct research, which is critical to the ability to reproduce the results?


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 individuals of all ages (including children and older adults), 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 - 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

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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals 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 - Projects

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, (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 NIAAA, in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

n accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

  • Coordinate a regular schedule of meetings with NIAAA/NIH Project Scientist for review and consultation.
  • Coordinate project activities with their institutions, with collaborators, and with the NIAAA/NIH Project Scientist.
  • Maintain collaborative partnerships with community health service providers, established alcohol research investigators, and NIAAA/NIH Project Scientist.
  • Accept assistance and seek input from NIAAA/NIH 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 genotype and phenotype data with qualified investigators.
  • Recipients 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/NIH Program Official/Director

  • 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/NIH Program Official/Director will be charged with management decisions required for normal monitoring and stewardship of the project including review and approval of all progress and budgetary decisions. Additionally, an agency program official or IC program director will be named in the notice of award. NIAAA/NIH Program Official/Director may recommend withholding of support, suspension, or termination of award for lack of adherence to required policies and/or procedures.

NIAAA/NIH 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/NIH 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.
  • The NIAAA/NIH Project Scientist coordinates and facilitates the interactions with the recipients under this initiative;
  • Serves as liaison between the research recipientsand NIAAA staff members and investigators involved in the program, facilitating interactions and scientific integration with the recipients;
  • Promotes and helps coordinate collaborative research efforts that involve interactions with other NIAAA-sponsored programs, projects, and centers;
  • Participates in program meetings;
  • Reviews all major transitional changes that the recipients 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 NOFO;
  • Provides technical assistance and advice to the awardees as appropriate;
  • Assists in the interaction between the recipients and investigators at other institutions, as appropriate for the program;
  • Assists in avoiding unwarranted duplication of effort with other NIH efforts;
  • Monitors institutional commitments and resources to the recipients;
  • Suggests reprogramming efforts, including options to modify projects/programs when certain objectives of this NOFO are not met; develops working groups and trans-project efforts as needed; and organizes and conducts regular meetings to share progress either by teleconference, video conference, or face-to-face, as needed between the recipients.
  • As the genetic analysis and functional studies are planned, NIAAA/NIH Project Scientist will oversee the collection of certain common data elements to be collected across all sites, and provides technical assistance and support as needed to further access genetic variations within COGA samples.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the NIAAA/NIH Project Scientist 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 who will participate as an ex-officio member. Every participating site and the NIAAA/NIH Project Scientist will have a collective vote on the Steering Committee.  All Steering Committee decisions and recommendations that require voting, will be based on a majority vote.

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 recipient. This special dispute resolution procedure does not alter the recipient'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. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

Genetic and genomic data with related phenotypic data must be shared with the broader research community through a public NIH-designated database such as dbGaP and NIAAA Data Archive, consistent with achieving the goals of the NOFO and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013).

Data management activities include basic processing, harmonization, imputation, and integration of multi-modal datasets.

Applicants coordinate activities that promote FAIR (Findable, Accessible, Interoperable and Reusable) and open access to COGA data and biomaterials (e.g., immortalized lymphoblastoid cell lines and/or induced pluripotent stem cells (iPSC), clear policies for access to data and materials, and an approval process for projects that is fair and balanced. For proposed analyses with legacy data, the legacy data and new results should be shared in the NIAAA Data Archive upon publication or end of award. Costs for sharing legacy data can be included in the project budget.

4. Reporting

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

A final RPPR, 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Elizabeth Powell, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0786
Email: elizabeth.powell3@nih.gov

Peer Review Contact(s)

RV Srinivas, PhD
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: judy.fox@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 2 CFR Part 200.

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