Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title
Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Administrative Resource (U24) (Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-AA-17-008
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AA-21-011
Companion Funding Opportunity
RFA-AA-21-010 , U01 Research Project (Cooperative Agreements)
RFA-AA-21-012 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-AA-21-013 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-AA-21-014 , UH2 Exploratory/Developmental Cooperative Agreement Phase I
Assistance Listing Number(s)
93.273
Funding Opportunity Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks applications to continue the previously funded “Collaborative Initiative on Fetal Alcohol Spectrum Disorders” (CIFASD). Responsive applications are expected to address urgent and important unmet needs in the fetal alcohol spectrum disorders (FASD) field through an integrated and multidisciplinary research approach. These unmet needs include identifying FASD cases early and accurately, improving interventions to mitigate FASD outcomes; expanding basic and mechanistic understanding of alcohol teratogenesis aimed at accelerated translation, and reducing prenatal alcohol exposure and the incidence of FASD.

Cooperative Agreement (U24) applications in response to this FOA should propose the Administrative Resource (U24) component of the CIFASD consortium.

Key Dates

Posted Date
June 2, 2021
Open Date (Earliest Submission Date)
July 16, 2021
Letter of Intent Due Date(s)

July 15, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
August 16, 2021 August 16, 2021 Not Applicable February 2022 May 2022 June 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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 Funding Opportunity Announcement.

Expiration Date
August 17, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks applications to continue the previously funded “Collaborative Initiative on Fetal Alcohol Spectrum Disorders” (CIFASD). Responsive applications are expected to address urgent and important unmet needs in the fetal alcohol spectrum disorders (FASD) field through an integrated and multidisciplinary research approach. These unmet needs include identifying FASD cases early and accurately, improving interventions to mitigate FASD outcomes; expanding basic and mechanistic understanding of alcohol teratogenesis aimed at accelerated translation, and reducing prenatal alcohol exposure and the incidence of FASD.

Cooperative Agreement (U24) applications in response to this FOA should propose the Administrative Resource (U24) component of the CIFASD consortium.

Background

Prenatal alcohol exposure is a major public health concern as it causes a spectrum of lifelong, debilitating consequences for the affected individual, including birth defects, mild to severe cognitive impairment, and emotional and behavioral issues. Collectively these deficits known as fetal alcohol spectrum disorders (FASD) affect an estimated 1-5% of all school-aged children in the US. The most serious of these is fetal alcohol syndrome (FAS), a developmental disorder characterized by craniofacial abnormalities, growth retardation, and nervous system dysfunction that may include mental retardation. In addition to FAS, other FASD diagnostic categories include: partial FAS, which includes the facial and neurodevelopmental deficits of FAS but not the growth deficits; alcohol-related neurodevelopmental disorder (ARND), in which neurobehavioral deficits are present but the facial and physical features of FAS are absent; and alcohol-related birth defects (ARBD), where physical attributes of FAS are seen in the absence of the full syndrome. Children with FASD may exhibit multiple cognitive, behavioral, and emotional deficits that impair daily functioning in many domains. Recently, a new diagnostic schema, Neurobehavioral Disorder Associated with Prenatal Alcohol Exposure (ND-PAE), was developed with an emphasis on the mental health symptoms associated with PAE.

Over the last two decades, the FASD research field has seen significant advances in many areas. Our understanding of prenatal alcohol exposure (PAE)-induced brain pathology and associated facial features, especially among diverse populations and across the lifespan, has been expanded significantly by new imaging and analytical approaches. The range of defects associated with FASD has been better defined at the level of timing, frequency, and amount of PAE; as well as the contribution of genetic and environmental risk factors. Towards interventions, select behavioral-based approaches, as well as medication and nutrition-based therapies, have shown promise of beneficial effects.

Despite this progress, challenges remain. There is an urgent need for more reliable and accurate diagnostic schemes and rapid screening tools for diverse populations and across the lifespan. Development of new therapies and interventions that are efficacious in mitigating multiple domains of dysfunction is critical for improving the lives of individuals with FASD. Moreover, given the high prevalence of FASD, there continues to be a need for new and effective FASD prevention strategies.

In 2003, NIAAA established the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), a consortium designed to inform and develop effective interventions and treatment approaches for FASD through a highly integrated multidisciplinary research approach involving basic scientists and clinical investigators and projects. The initiative also supports multiple study cohorts to overcome the limitations of smaller individual studies. Past iterations of the consortium have made significant advances in a number of areas, including human interventions with choline and multi-vitamins, 2D/3D imaging of sentinel and non-sentinel facial features and neurobehavioral profiling for improved diagnosis, longitudinal studies of brain development, biomarker discovery to predict FASD outcomes in children, and mHealth and imaging technologies for case identification and intervention. Many of these advances are poised for translation to improve the clinical management of FASD in diverse populations. And importantly, CIFASD has been successful in training of a new generation of FASD researchers for both independent and collaborative research.

Goals and Objectives of the Administrative Resource

The Administrative Resource (U24) component will serve as the lead application that describes the overall theme and goals of the proposed CIFASD consortium. It should also include a scientific rationale for the various research projects and resources that make up the proposed consortium. Led by the Consortium Coordinator, the Administrative Resource will provide oversight, coordination, and leadership to the consortium. It will coordinate the use of resources among the research projects, monitor recruitment of subjects and data collection, and facilitate communications among the PD(s)/PI(s). It will also provide leadership in consortium outreach activities to facilitate recruitment of study subjects, engage with stakeholders including those individuals and families affected by FASD, and increase public awareness of advances in FASD research. The Consortium Coordinator will be responsible for establishing an external Scientific Advisory Board (SAB) and may appoint a Scientific Director, if desired. Lastly, the Consortium Coordinator will oversee the activities of the Steering Committee, comprised of consortia PI(s), and will act as the main liaison between the consortium investigators, the SAB, and NIAAA.

The Administrative Resource of the consortia will require the inclusion of a detailed description of the leadership succession plan to ensure continued leadership. The consortia must also plan for how the next generation of scientists from diverse background would be elevated to leadership positions.

Other Considerations:

Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that NIAAA-supported research consortia will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT-OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators.

Organization of the CIFASD Consortium

The CIFASD consortium will consist of a group of integrated cooperative agreement research projects (U01), resources (U24), and exploratory/developmental projects (UH2). The consortium will include one Administrative Resource (U24) (this FOA) led by the Consortium Coordinator. The Consortium will also include other resources (U24), namely, Diagnostic and Telemedicine Resource and Data Coordinating Resource, to support the individual research projects (U01/UH2) . The use of common methodology among various research projects and sharing of technical expertise are highly desirable.

Applications that include the following topics will not be considered responsive to this RFA, and will be withdrawn without review:

  • HIV/AIDS related research
  • Applications not linked into a consortium

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
New
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 FOA.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAAA intends to commit an combined $4.6 million in total costs in FY2022 to fund this FOA and its companion FOAs (RFA-AA-21-010, RFA-AA-21-012, RFA-AA-21-013, RFA-AA-21-014).

Up to one U24 application is expected to be funded from this FOA.

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

The scope of the proposed project should determine the 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 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) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

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

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-9737
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: The administrative resource must include a detailed description of the leadership succession plan to ensure continued leadership, as well as plans to ensure that next generation of scientists from diverse background would be elevated to leadership positions.

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.

The following modifications also apply:

  • 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 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-19-020.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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

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.

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 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) 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 NIAAA, 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 the policy. Any instructions provided here are in addition to the instructions 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 the NIH in support of the NIH mission 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 Administrative Resource address the needs of the research consortium that it will administer? Is the scope of activities proposed for the Administrative Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium? Does the application describe the overall significance vision or theme, goals, and specific aims of the consortium?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Administrative Resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing FASD research? Do the investigators demonstrate significant experience with coordinating collaborative basic and clinical research? If the Administrative Resource is multi-PD/PI, do they have complementary and integrated expertise and skills? Are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Administrative Resource? Do they 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 consortium the Administrative Resource will serve? Are the concepts, strategies, or instrumentation novel to one type of research program 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 consortium the Administrative Resource will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Does it include a description of the administrative and project management plans, for effective collaboration among the projects within the consortium, administration of common protocol across research project sites and resource projects?  Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? 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?

Specific to this FOA:

How adequate are the leadership succession plans to ensure continued leadership and how the next generation of scientists from diverse background would be elevated to leadership positions?

Environment

Will the institutional environment in which the Administrative Resource will operate contribute to the probability of success in facilitating the research consortium it 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 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 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 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.

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.

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 FOA.

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

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

3. Anticipated Announcement and Award Dates

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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 awardee 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. 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In 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 45 CFR Part 75.205 “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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 recipient 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 recipientsof each component of the consortium, although specific tasks and activities may be shared among the recipientsand the NIH as defined below.

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

  • The Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)] retains primary responsibility for the performance of the scientific activity and agrees to abide by the policies and rules set up by the CIFASD consortium. This includes accepting the actions and recommendations approved by the CIFASD Steering Committee.
  • Each PD(s)/PI(s) agrees to accept input from NIAAA staff in scientific and technical matters in accordance with the terms formally and mutually agreed upon prior to award.
  • The responsibility for the planning, direction, and execution of the proposed research project or resource will be solely that of the PD(s)/PI(s).
  • The recipientsis expected to establish mutually beneficial, collaborative relationships with other research projects (U01), exploratory projects (UH2), and/or resources (U24) of the CIFASD consortium.
  • Recipientswill be required to attend monthly CIFASD conference calls and are expected to attend web-based meetings of the CIFASD Steering Committee.
  • Recipientswill 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.

NIAAA Project Scientist: A designated NIAAA Program Director, acting as a Project Scientist will have substantial programmatic & scientific involvement, as described below:

  • The NIH Project Scientist will be an extramural staff person from the NIAAA, who is a partner within the consortium representing the NIH’s interest in the substantive work of the CIFASD consortium.
  • The primary role of the Project Scientist is to facilitate the coordination necessary to accomplish the goals of the CIFASD consortium.
  • The Project Scientist may 1) provide advice and technical assistance as needed to the U01 and UH2 PD(s)/PI(s); 2) facilitate integration of the U01 research projects and exploratory projects (UH2) within the CIFASD consortium; 3) monitor progress of ongoing research and 4) assist in the interpretation and reporting of findings in the scientific literature.
  • The NIAAA Project Scientist may assist in the analysis, interpretation, and reporting of findings in the scientific literature and is subject to the same publication/authorship policies governing all participants in the consortium, as well as to the official NIH publication policy governing extramural employees.
  • The NIAAA Project Scientist will have full voting membership (one vote) on the Steering Committee and will attend all meetings of the Steering Committee.
  • The Project Scientist will provide liaison between the CIFASD consortium, the Steering Committee, and the NIAAA.
  • The Project Scientist may not attend peer review meetings and shall not be involved in funding decisions.

NIAAA Program Official: NIAAA Program Director, acting as the Program Official, will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. If program objectives are not met, the Program Official may recommend withholding of support, suspension, or termination of a cooperative agreement award for lack of adherence to required policies and/or procedures.

NIAAA Extramural Staff may not have dual or concurrent role as Project Scientist and Program Official.

Areas of Joint Responsibility include:

Scientific Advisory Board- The CIFASD consortium will include an external scientific advisory panel of at least 3 members whose purpose is to assess progress and provide feedback to the Steering Committee on the proposed goals of the consortium each year. The panel will also advise the Steering Committee on research design issues and data quality and analysis. The external advisors will be appointed by the Consortium Coordinator in consultation with NIAAA Project Scientist. They will be research scientists not involved in the consortium.

Scientific Director- If the Consortium Coordinator deems it necessary, a Scientific Director may be appointed to provide scientific leadership and an independent assessment of the scientific merits of the various research projects. The Scientific Director would be a voting member (one vote) of the Steering Committee.

Consortium Coordinator- The Consortium Coordinator coordinates the scientific and administrative activities of the CIFASD consortium and is responsible for the overall operation of the consortium, including the scientific and technical direction of the research projects. The Consortium Coordinator ensures that all projects within the consortium are fully integrated within the scientific scope and mission of the consortium, including full access to all resources. In addition, the Consortium Coordinator chairs the Steering Committee (see below) and like all other participating investigators, must abide by the operating rules and guidelines developed by the Steering Committee. The Consortium Coordinator agrees to accept participation of NIAAA Project Scientist in those aspects of management of the project described under “NIH Responsibilities.” The Consortium Coordinator ensures the timely dissemination of information generated by the individual consortium projects to both the consortium investigators and the scientific public. Finally, the Consortium Coordinator will be responsible for developing and/or maintaining a public website for the consortium as well as facilitating activities of the CIFASD Data Access and Publication subcommittees.

Steering Committee -The Steering Committee of the CIFASD consortium will be comprised of research project and resource core PD(s)/PI(s), the NIAAA Project Scientist, and the Scientific Director (if appointed by the Consortium Coordinator). The Consortium Coordinator or his/her designee will serve as the chairperson of the Steering Committee. The Steering Committee represents the main governing board of the consortium. The committee develops collaborative protocols, sets research priorities, defines parameters for study, identifies technological impediments to success and strategies to overcome them, and decides when data and resources generated by the respective consortium resources and/or projects should be made available to the scientific community. In addition, the Steering Committee will review the policies and procedures for oversight of the consortium currently in place and amend them as necessary. The Committee will also be responsible for monitoring compliance with those policies and procedures.

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 expertise of the Steering Committee when necessary, and to appoint additional NIAAA staff as non-voting members of the Steering Committee and any sub-committee. A sub-committee may be established to facilitate the planning and operation of the respective consortium resources and projects.

The Steering Committee will conduct monthly telephone conferences and will meet two times each year to review progress and to set research priorities, modify goals or scientific directions of its respective research projects, integrate relevant new information, and discuss any proposed modifications to the scientific approaches of individual projects. One of these meetings will be in person and held at NIH. The other meeting will be a web-based, preferably day-long, teleconference.

Each full member will have one vote. Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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. 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 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.

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 45 CFR Part 75 – Award Term and Conditions 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: http://grants.nih.gov/support/ (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: 301-945-7573

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)

H. Joe Wang, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-0747
Email: joe.wang1@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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


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