Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)    

Funding Opportunity Title

Limited Competition for the Continuation of the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) Administrative Resource (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-AA-12-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AA-17-004

Companion Funding Opportunity

RFA-AA-17-005, U24 Resource-Related Research Projects

RFA-AA-17-003, U01 Research Project – Cooperative Agreements  

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

93.273; 93.242; 93.279      

Funding Opportunity Purpose

This limited competition Funding Opportunity Announcement (FOA) is to support the continuation of the Administrative Resource for the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA).  Only the current NCANDA Administrative Resource awardee is eligible to apply in response to this FOA.  The NCANDA Administrative Resource coordinates the activities of the nation-wide consortium to study the impact of alcohol drinking on brain structure and function during adolescence and into early adulthood.  RFA-AA-17-005 will support continuation of the NCANDA Data Analysis Resource and RFA-AA-17-003 will support the continuation of the Research Projects Sites within the consortium.  

Key Dates

 

Posted Date

May 31, 2016

Open Date (Earliest Submission Date)

October 9, 2016

Letter of Intent Due Date(s)

October 9, 2016

Application Due Date(s)

November 9, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on  this date.

No late applications will be accepted in response to this FOA.  .

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2017

Advisory Council Review

May 2017

Earliest Start Date

June 1, 2017

Expiration Date

November 10, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

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

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support the continuation of the Administrative Resource for the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA).  The NCANDA Administrative Resource coordinates the activities of the nation-wide consortium to study the impact of alcohol drinking on brain structure and function during adolescence and into early adulthood. 

Background

Adolescent or underage drinking is a serious public health issue not only in terms of increased risk for alcohol-related problems (e.g., driving under the influence, physical and sexual assaults) but also for the untoward effects that drinking may have on the still-developing central nervous system with concomitant effects on behavior and cognition.  Many adolescents drink alcohol with recent statistics from the National Survey on Drug and Alcohol Use showing that by age 15 about 35% of adolescents have had at least one drink with the percentage increasing to around 65% by age 18.  Nearly 90% of the alcohol that is consumed by adolescents is in the dangerous form of binge drinking which is consuming many drinks in a short time period (usually within two hours) that brings the blood alcohol concentration at least up to the legal intoxication level.  In 2012, the NIAAA, with support from NIMH, NICHD and NIDA, funded a nation-wide research consortium to investigate adolescent brain and behavior development with a particular emphasis on the effects of drinking alcohol during this critical period of maturation. 

The funded consortium named the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) consists of an overall Administrative Resource, a central Data Analysis Resource, and five research projects sites where the adolescent participants are enrolled and participate in the standardized study protocol.  The study protocol includes structural and functional imaging of the brain along with detailed neuropsychological and clinical assessments over the course of follow-ups after entry into the study.  The enrolled adolescents are followed in an accelerated longitudinal design that combines short-term longitudinal studies of different cohorts (entering study at different ages) within the five years of the original project period that will be linked to form a common developmental trajectory spanning ages 12 to 24 years of age.  While one of the advantages of accelerated longitudinal designs is that they allow for a wide sampling of ages to model a developmental trajectory within a limited time frame, these designs usually have the drawback of short longitudinal trajectories (few time points) for each of the different age cohorts.  To characterize more fully and accurately the changes in brain and behavior development across the adolescent years and into early adulthood, a longer period of follow-up assessments for each of the different age cohorts is needed.  The NCANDA consortium has successfully met their target enrollment goal of 831 adolescent participants who have completed the baseline protocol and are now on schedule with the longitudinal follow-up assessments.  The detailed information that has already been acquired on these participants and that will be acquired over a longer term follow-up will advance our understanding not only of adolescent brain and behavior development but also of the potential long-lasting effects in adulthood from adolescent alcohol use. 

Objective and Organization of the NCANDA Consortium

The primary objective of NCANDA is to address the following research questions:  1) what are the effects of both long and shorter-term adolescent alcohol exposure on the developing human brain; 2) what is the effect of timing, dose, and duration of alcohol exposure on brain development;  3) to what extent do these effects resolve or persist; 4) understand how key covariates factor into alcohol's effects on the brain; and 5) potentially identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence and onset or worsening of mental illness during adolescence and into adulthood.  

The organization of the NCANDA consortium consists of an overall Administrative Resource, a central Data Analysis Resource, and research project sites: 

The NCANDA Administrative Resource (this FOA) coordinates the activities of the nation-wide consortium and is responsible for the development, tracking, and reporting of performance metrics from the research project sites and for the overall consortium.

The NCANDA Data Analysis Resource (RFA-AA-17-005) has responsibility for the standardization, storage, and analysis of the data acquired by the research project sites of the consortium.

The NCANDA Research Project Sites (RFA-AA-17-003) have responsibility for the acquisition of data according to the standard protocol for the nation-wide consortium and for the development of special research projects related to their expertise and interests that complement and support the overall objectives of the consortium.

Purpose and Functions of the Administrative Resource

The Administrative Resource provides the scientific leadership, overall management, and primary oversight of the activities of the NCANDA consortium. It will coordinate the interactions of the individual Research Project Sites and the Data Analysis Resource.  The Administrative Resource will also be responsible for the standardization of protocols, training of staff, and testing of inter-rater reliability of the core neuropsychological, clinical, and other phenotypic assessments to make sure administration of these measures is consistent across research sites.  The Administrative Resource will work with the Data Analysis Resource to insure standardization of neuroimaging data acquisition, protocols, and data analysis pipelines.   Because the neuroimaging field undergoes rapid technical advances, the Administrative Resource and the Data Analysis Resource will need to plan for integrating technological advances into the longitudinal study and determine how changes in hardware and analytic approaches will be coordinated across the multiple research sites.  The Administrative Resource will include Administrative and Project Management Plans (see below), and will also be responsible for collaborative responsibilities such as the functions of an external Scientific Advisory Board and the overseeing of an internal Steering Committee to help develop protocols, evaluate progress and results, recommend changes to the study, if necessary, and suggest future directions.  The Steering Committee is also responsible for scientific enrichment activities for the benefit of the consortium and the scientific research community.  In addition, the Steering Committee will be responsible for organizing an annual meeting of the consortia investigators.

See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

Cooperative Agreement:  A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAAA and participating ICs intend to commit an estimated total cost of $5.0 M in FY 2017 to fund one consortium in response to this FOA and companion FOAs (RFA AA 17-003, RFA AA 17-005. The participating ICs intend to make 1 award from this FOA.

Award Budget

Applicants may request up to $350,000 in Direct Costs per year.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Only organizations holding an active NIAAA-funded Administrative Resource Project U24 on NCANDA are eligible to apply.

Foreign Institutions

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

Required Registrations

Applicant Organizations

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

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

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

All PD(s)/PI(s) must have an eRA Commons account.  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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

  Only PD(s)/PI(s) from Institutions with active NIAAA-funded Administrative Resource Project U24 on NCANDA are eligible to apply.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
Telephone:  301-443-9737
Fax:  301-443-6077
Email:  bautista@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:   This application should discuss the theme, goals, and specific aims of the consortium.  This application should describe the Administrative and Project Management Plans, as well as plans to oversee training and administration of a common protocol across research project sites, and work with an internal Steering Committee and an external Scientific Advisory Board.  

Administrative and Project Management Plans:   The application must include an Administrative Plan that discusses overarching issues related to the whole consortium, and outlines the policies and procedures for access of participating investigators to the collaborative project resources.  The Administrative Plan should address the flow of information within the consortium, the integration among individual research project sites and the data analysis center, and plans for how the information will be integrated into the solution of the overall questions being addressed.  The application must also include a Project Management Plan (that addresses issues related to evaluating and maintaining progress), including an ongoing evaluation plan, to ensure consistent forward progress of the project.  The priorities for the allocation of resources within the consortium should be described.  The mechanism for monitoring subject recruitment and retention should also be described.  The plan should also include proposed methods for conflict resolution among the participating sites and for information dissemination both within the consortium and to the larger scientific community. 

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.
  • The development of policies, methods, and standards for data sharing are critically important for the NCANDA study.  As such, data from the NCANDA study are expected to be released to the research community as soon as it has undergone basic quality assurance procedures consistent with achieving the goals of the program. The NCANDA awardee is expected to include  plans to develop policies, methods, and standards for the project that will remain consistent with NIH-wide policies on data and resource sharing.
  • The NIH is committed to the principle of rapid data, model, and software release to the scientific community.  Applications are expected to provide specific plans for data and software release.
  • Whereas a critical goal of this project is for this center to further accelerate and advance research by disseminating data and materials, this FOA requires applicants to develop and propose specific plans for sharing the data and materials (e.g., protocols, analytical tools) generated through this large-scale collaborative project.  The Administrative Resource will work with the Data Analysis Resource to develop a consortium-wide plan and justification for meeting the data sharing goals of this project.

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

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

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

See Part 1. 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. Overview Information 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). 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 Policy on Late Application Submission.

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

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

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.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Overall Impact

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

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 proposed Resource address the needs of the research within the NDCANDA Consortium that it will administer? Is the scope of activities proposed for the Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research described in the NCANDA Consortium?  

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Administrative resource of the NCANDA Consortium? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing the Administrative resource? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Administrative resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Administrative resource of the NCANDA consortium? Does the applicant have experience overseeing selection and management of subawards, if needed?  

Innovation

Does the application propose novel organizational concepts and management strategies, in coordinating the research described in the NCANDA Consortium, the Administrative resource will serve? Are the concepts, or strategies novel to one type of management or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, or management strategies proposed?   

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research described the NCANDA consortium, the Administrative resource will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Administrative resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Environment

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

Additional Review Criteria

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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 Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For an Administrative Resource 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.

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • Will receive a written critique.

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

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

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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

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

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

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

Any application awarded in response to this FOA will be subject to 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.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that 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 FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

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

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

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

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

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

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

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

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

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

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

The NIAAA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The NIAAA Program Official may elect to attend the Steering Committee meetings, but not as a member of the committee.

Areas of Joint Responsibility include:

Consortium Coordinator’s Rights and Responsibilities:  The consortium coordinator (the PD(s)/PI(s), see above) is charged with coordinating the scientific and administrative activities of the consortium. The consortium coordinator has the responsibility for the scientific and technical direction of the research projects, and the administration and overall operation of the consortium. Therefore, the consortium coordinator is responsible for ensuring that projects awarded are fully integrated within the scientific scope and mission of that consortium. This includes assuring that all investigators have access to the resources within the resource facilities of the consortium.  A Steering Committee serves to assist the consortium coordinator with the governance of the consortium. The consortium coordinator chairs this committee.  In addition, the consortium coordinator must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the consortium coordinator has agreed to accept participation of NIAAA staff members in those aspects of management of the project described under "NIH Staff Rights and Responsibilities." Lastly, the consortium coordinator ensures the timely dissemination of information generated by the consortium component projects to both the consortium project members and the scientific public.

Scientific Advisory Board:  The consortium includes an external scientific advisory board whose purpose is to meet with the consortium coordinator and the Steering Committee to assess progress and provide feedback to the investigators and NIAAA on proposed goals for the next year of support.  The panel members are designated by the NIAAA in consultation with the Steering Committee, and consist of research scientists not actively involved with the consortia. The Scientific Advisory Board should meet at least once a year immediately prior to the submission of the consortium annual progress report.

Steering Committee:  The consortium has a Steering Committee, which is the main governing board of the consortia. This committee develops collaborative protocols, and functions to set priorities for model derivation, defines the parameters for model validation, identifies technological impediments to success and strategies to overcome them, and decides when models should be made available to the research community for individual investigator-initiated projects.  The members of the Steering Committee for the consortium are selected by the consortium coordinator with input from the NIAAA program staff. The Steering Committee is primarily composed of the consortium coordinator, several principal investigators of the research project components and resource components, and the NIH Staff Collaborators.  The Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed.  The NIAAA also reserves the right to augment the scientific expertise of the Steering Committee when necessary, and to appoint additional NIAAA staff as nonvoting members of the Steering Committee and Subcommittees. Each primary member of the Steering Committee has one vote.  The chairperson of the Steering Committee is the consortium coordinator. The Steering Committee may establish subcommittees as it deems appropriate to facilitate the planning and operation of the consortia. The Steering Committee meets at least twice annually to discuss and refine the scientific mission and objectives of the consortia, and to evaluate the scientific progress being made both within the consortium research components and by outside laboratories. The Steering Committee discusses the various experimental approaches that were proposed in the individual components and any relevant new information, and subsequently sets the research priorities for the consortium. In the interest of facilitating research in the alcohol field, the Steering Committee of the consortium evaluates the progress of any new technology being developed and decides when the technology is sufficiently validated for distribution to the research community. The NIAAA will provide the means to disseminate the technologies and the information related to them.

The Steering Committee will plan one or more meetings a year to which non-consortium participants will also be invited to enable the consortium to explore scientific or technologic advances and innovations that occurs during the course of the project.  For the second and subsequent years of operation of the consortium, the Steering Committee will plan a symposium or workshop to inform the research community of the progress made. The NIAAA Program Official and other NIH staff will provide the Steering Committee with advice on appropriate topics and participants for the workshops and symposia.

Dispute Resolution

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

3. Reporting

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

John Matochik, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:  301-451-7319
Email:  jmatochi@mail.nih.gov

Bethany Deeds, Ph.D., MA
National Institute on Drug Abuse (NIDA)
Telephone:(301) 402-1935
Email:  deedsb@nida.nih.gov 

Shelli Avenevoli, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-8316
Email:  avenevos@mail.nih.gov

Stacia Friedman-Hill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-8458
Email:  Friedmans@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:  301-443-4707
Email:  jfox@mail.nih.gov

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone:  301-774-3803
Email:  mconnell@nida.nih.gov

Rebecca Claycamp, CRA
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email:  rclaycam@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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