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

Limited Competition:  Consortia for HIV/AIDS and Alcohol-Related Research Trials (CHAART) Resource Core (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AA-16-003

Companion Funding Opportunity

RFA-AA-16-002, U24 Resource-Related Research Projects--Cooperative Agreements Resource-Related Research Projects--Cooperative Agreements
RFA-AA-16-001, U01 Research Project--Cooperative Agreements Research Project--Cooperative Agreements

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

93.273 

Funding Opportunity Purpose

The overall goal of this Funding Opportunity Announcement (FOA) is to advance operations or implementation research in the context of alcohol and HIV/AIDS 1) to continue to develop a broader systems approach for monitoring complex HIV and alcohol-related morbidity and mortality and 2) to intervene to reduce the impact of alcohol and HIV disease progression and transmission.  This proposed research initiative is aligned with the research priorities set forth in the Trans-NIH Plan for HIV-Related Research.  The purpose of this FOA is to solicit applications to provide scientific core support to the research projects as part of the consortia on HIV/AIDS and alcohol-related outcomes research.    

Key Dates
Posted Date

July 8, 2015

Open Date (Earliest Submission Date)

December 15, 2015

Letter of Intent Due Date(s)

December 15, 2015

Application Due Date(s)

January 15, 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 for this Funding Opportunity Announcement.

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)

January 15, 2016, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

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.

Scientific Merit Review

March-April 2016

Advisory Council Review

May 2016

Earliest Start Date

July 1, 2016

Expiration Date

January 16, 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/Research Objectives 

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to provide scientific core support to the research projects as part of the Consortia on HIV/AIDS and Alcohol-Related Trials (CHAART). 

The overall goal of this research activity is to advance translational, operations or implementation research in the context of alcohol and HIV/AIDS 1) to continue to develop a broader systems approach for monitoring complex HIV and alcohol-related morbidity and mortality and 2) to intervene to reduce the impact of alcohol and HIV disease progression and transmission. 

This proposed research initiative is aligned with the research priorities set forth in the Trans-NIH Plan for HIV-Related Research

Consortiums supported through this FOA are expected to demonstrate research expertise and leadership to accelerate the pace of science in the area of HIV/AIDS and alcohol research, including co-morbidities known to be associated with HIV and alcohol use (e.g., HCV, TB, Tobacco, Depression, other substance abuse comorbidities). 

The CHAART consortiums' studies must focus on already established patient cohorts and populations supported by NIAAA in Connecticut, Florida, Maryland, Massachusetts, Rhode Island, Texas, India, Russia and Uganda, as well as those in Veterans Aging Cohort Study (VACS) and the Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS).

A consortium application must continue a program of multidisciplinary research around a unifying or well-defined goal or targeted area of research.  It can include both the assessment of wide-ranging outcomes and proposed intervention effects as well as foundational research related to behavioral and biological mechanisms impacting progression and/or intervention success (e.g., frailty, impaired cognitive function, etc.).  In addition, it is generally encouraged that emerging new methodologies focused on analysis and representation of large/complex datasets also be explored particularly in relationship to the use of electronic medical records and/or other sources of information related to engagement in care.  Several evolving areas of research may also be explored in the context of these consortia including HIV and Aging, dynamic modeling of medical/intervention decision making, elimination or control of viral reservoirs in virally suppressed patients, and prophylaxis/prevention of disease-related consequences related to synergisms of HIV and alcohol.

This specific U24 FOA is intended to develop Research resources, for example:  data management (integration, cleaning, validation, statistical analyses), pharmacy/polypharmacy, biospecimens repository, laboratory, informatics, ethics, survey/methods development and intervention development, training and implementation for research purposes.

The research resources are expected to provide support only to research projects within the consortium. 

Specific Areas of Research Interest

 Areas of research appropriate to this announcement include, but are not limited to:

  • Addressing the clinical epidemiology of alcohol use in HIV infection (e.g., mild, moderate, and severe)
  • Evaluating alcohol treatment interventions in HIV infected persons in care
  • Understanding the role of comorbidities in determining clinical outcomes in HIV infection
  • Understanding how the severity of alcohol use in alcohol use disorders (i.e., mild, moderate, and severe) impacts clinical outcomes in HIV infected individuals
  • Identifying new ways of engaging and retaining the target population in effective treatment
  • Understanding the differential distribution of health care resources that result in health disparities in care in underserved populations
  • Developing translational and interdisciplinary research that will improve health outcomes and reduce HIV transmission among a diverse range of populations and communities 

This Funding Opportunity Announcement is exclusively for human studies only.

These Research resources would support the above areas of research.  Examples of these Research Resources include but are not limited to:

Analytic Biostatistics Core

A sound study design, appropriate analytic techniques, and the proper management of data are essential components of a study to ensure valid inferences on the impact of alcohol use. The Biostatistics Core within domestic and international projects should provide statistical and data management leadership in all phases of research including:  study design, development of data collection instruments, implementation of the study protocols, performance of data analyses, and the preparation of manuscripts. The Biostatistics Core should actively collaborate in the design, conduct, and analyses of clinical research studies with the aim of conducting scientifically rigorous research and providing definitive answers to the important scientific questions described within each project-specific proposal.  In addition, the Biostatistics Core should ensure the use of the most appropriate and timely analyses, and stimulate the use of advanced analytic qualitative and quantitative technologies (e.g., geospatial, g—estimation, marginal structural models, splines, etc.) within the CHAART consortiums.  The Biostatistics Core may place special emphasis on the analysis and investigation of health disparities in HIV risk and alcohol misuse among racial/ethnic subgroups of MSM and other sexual minority populations, with a particular focus on disparities among African American and Hispanic MSM or regions with the highest incidence of infection and problematic consumption patterns.

Biological: Specimen Repositories (Biorepository)

The purpose of a Biorepository is to maintain biological specimens, and associated information, for current and future use in research.  The Biorepository should assure the quality, and manages the accessibility and distribution/disposition of the biospecimens in its collection.  The goal of an NIAAA biorepository for the CHAART consortium is to provide a resource across the relevant scientific research projects for translational research on the role of alcohol in changing the course of HIV disease through improved measurement of alcohol use and related organ and tissue injury.  This resource should allow identification of the processes underlying increased progression, immune associated aging, and accumulated toxicities in treatment and prevention of HIV.  Research conducted through the biorepository by the consortium should provide a wide range of appropriate services including blood and tissue procurement and storage and transportation of samples.  The primary objective of this resource would be to ensure the highest quality specimens through adherence to strict operating procedures including the timely transport and analysis of samples.  These procedures may include the use of automated storage and emergency response planning in accordance with the use of Good Laboratory Practice and compliant with accreditation processes adopted for domestic and/or international procedures. Research using these specimens needs appropriate oversight on the use and allocation of specimens in a timely way to ensure the aims of the proposed research projects associated with the consortia (e.g., analysis of inflammatory markers, additional measurement of alcohol use biomarkers, assessment of liver and other organ damage, immune activation, control of viral reservoirs, etc.).

Behavioral Science Core

The purpose of a Behavioral Science Core is to provide resources for the analysis of behavioral interactions of HIV+ individuals with their providers, caretakers, and social and physical environment. Resources should be provided for the analysis of qualitative and quantitative assessments of patient behavior in the treatment milieu.  For example, the Behavioral Science Core can learn more about the kinds of provider and patient language that predict behavior change following counseling on heavy alcohol use and HIV-relevant behaviors such as HIV medication adherence and high-risk sex.  The results of this research can inform providers about the most effective methods for communicating with patients about multiple behaviors that have an important impact on the HIV epidemic.  This includes:  analysis of dialogs, geospatial tracking, time-limited actions related to medication use and adherence.  Interaction systems can examine factors related to motivational counseling sessions, expectancies, in-the-moment impulsive decision making, and other psychological facets regarding behavioral and biomedical interventions.  Coding and analysis of provider-patient information may predict alcohol use, stress related self-medication, acceptance and use of pharmacological agents, sexual risk behaviors, and compliance with HIV and other co-infection testing.  Analysis of these dyadic and group interactions may provide information for constructing improved intervention protocols for providers and design of implementation research activities directed at alcohol/HIV interventions. 

International Cohorts: The international cohorts allow study of clinical issues that would not be possible in the United States, yet have important implications for U.S. HIV-infected populations, including:  untreated populations, early treatment, limited resources, complex alcohol use/home brew, etc.

Organization of the CHAART:

The CHAART will consist of a cluster of integrated cooperative agreement research projects (U01s) and resource-related research projects (U24s) The research projects (U01s) will focus on the common theme of HIV/AIDS and alcohol and will have collaborative studies with other U01 projects within the Consortium. The use of common methodology among various research projects and sharing of technical expertise are highly desirable.  The consortium will include one administrative unit (U24) led by the Consortium Coordinator. The consortium will also include at least two research resources (U24) to provide service to individual research projects (U01).

 Therefore, a CHAART application is composed of  one set of linked applications of multiple U01s (RFA-AA-16-001), one application for the Administrative Resource Core U24 (RFA-AA-16-002) and at least one application for the Research Resource U24 (this FOA.).

The following FOAs will support the resource units of the consortium:

  • Research Resources (described in this FOA) – these applications are expected to provide support in the areas of epidemiology, behavioral sciences, informatics, data management, repositories, etc.
  • Administrative Resource Core (RFA-AA-16-002) –PD/PI of the Administrative Resource  will be the Consortium Coordinator.  This Administrative  Resource will provide oversight, coordination, and direction to the consortium.  It will be responsible for managing the Scientific Advisory Panel and the research Steering Committee. It will coordinate use of resources among the research projects, facilitate communications among the PD(s)/PI(s), and facilitate data collection. 

Individual research projects should use the U01 activity code described in RFA-AA-16-001.

  • Research Projects – Collaborative research projects will focus on animal studies described above. Consistent with achieving the goals of this program, the composition of research projects should be collaborative and highly integrated within the CHAART. The proposed research project applications must utilize the resources of, and the new technologies developed within, one or more of the resource core facilities and collaboration with other U01 research projects. It is anticipated that several of the research projects within a consortium will address the same research domain, but will differ in emphasis, approaches and the research questions addressed.
Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Renewal

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

Funds Available and Anticipated Number of Awards

NIAAA intends to commit $7 million in FY 2016 for this FOA and companion FOAs (RFA-AA-16-001 and RFA-AA-16-002). For this FOA, NIAAA expects to fund up to 12 applications.  Future year amounts will depend on annual appropriations.

Award Budget

The application may not exceed $250,000 in total 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 Resource Project U24 on Alcohol and HIV/AIDS Outcomes Consortiums are eligible.

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) (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.
  • 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.

PD(s)/PI(s) from Institutions with active NIAAA-funded CHAART U24(s) 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 download 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 (LOI) 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
Telephone: 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, with the following additional instructions:

This application must include a description of qualifications, experience, and commitment of the PD/PI and other key personnel with respect to providing the proposed facilities or services to the consortium

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

Application must include the following information:

  • Description of the proposed research resource services
  • Description of how the research resource is an essential facility or service provider for two or more U01 research projects.
  • Description of quality control processes proposed for the facilities or services provided by the research resource (including procedures, techniques, and quality control)
  • Description of criteria for prioritization and usage of research resource products and/or services

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.

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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.

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Are the qualifications, experience, and commitment of the PD/PI and other key personnel       adequate and appropriate for providing the proposed facilities or services to the consortium?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

Does the research resource provide essential facilities or services for two or more U01 research projects? What is the overall quality of the proposed research resource services? Are adequate quality control processes proposed for the facilities or services provided by the research resource (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of research resource products and/or services?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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:

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

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

Applications will be assigned 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

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.

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:

  • 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.
  • Awardees will regularly provide updates, progress, new/pending publications, new development and changes in future plans to the NIAAA Scientific Collaborator.
  • Coordinate a regular schedule of meetings with NIAAA Project Collaborator  for review and consultation.
  • Coordinate project activities with their institutions, with collaborators, and with the NIAAA Project Collaborator.
  • Accept assistance and seek input from NIAAA Project Collaborator  to inform the pursuit of project goals.
  • PD(s)/PI(s) will publish and publicly present and disseminate results of the research project.

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

NIAAA Project Collaborator:  A designated NIAAA Program Director, acting as a Project Collaborator, will have substantial programmatic involvement, as described below.

  • The NIAAA Project Collaborator will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NIAAA waiver according to the NIAAA procedures for management of conflict of interest.
  • Coordinate and facilitate the interactions among, the U24 awardees under this initiative;
  • Serve as liaison between the research awardees and NIAAA staff members and investigators involved in the program, facilitating interactions and scientific integration between the U24 awardees;
  • Promote and help coordinate collaborative research efforts that involve interactions with other NIAAA-sponsored programs, projects, and centers;
  • Participate in program meetings;
  • Review all major transitional changes that the awardees might propose (e.g., a change in  partnering institution) and advice on their appropriateness prior to implementation to assure consistency with the goals of this FOA;
  • Provide technical assistance and advice to the awardees as appropriate;
  • Assist in the interaction between the U24 Research awardees and investigators at other institutions, as appropriate for the program;
  • Assist in avoiding unwarranted duplication of effort with other NIH efforts;
  • Monitor institutional commitments and resources to the awardees;
  • Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- Specifically, the NIAAA Project Scientist may recommend withholding of support, suspension, or termination of a U24 award for lack of adherence to required policies and/or procedures;
  • Develop working groups and trans-project efforts as needed; and
  • Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees.

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

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the NIAAA Staff Collaborator will participate in regularly scheduled quarterly Steering Committee meetings to coordinate implementation and evaluation of the ongoing projects.  The Steering Committee will consist of a minimum of one member from each participating site and the NIAAA Staff Collaborator. Every participating site and the NIAAA Staff Collaborator will each have a single vote on the Steering Committee.  All Steering Committee decisions and recommendations that require voting, will be based on a majority vote. Additionally, the PIs and the NIAAA Staff Collaborator will participate in a yearly meeting/workshop to present major findings, to plan collaborative efforts, to assist in analysis, interpretation, and dissemination of scientific findings.

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

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: 301-710-0267

Scientific/Research Contact(s)

Kendall J. Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: NIAAA-HIV-Initiatives@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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

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