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.

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

Purpose/Research Objectives:

The purpose of this Funding Opportunity Announcement (FOA) is to continue support for consortia on HIV/AIDS and alcohol-related outcomes research (in Boston, Connecticut, Florida, Maryland, Rhode Island, and VACS sites, as well as CNICs and WIHS sites) and to solicit applications to provide support to the research projects as part of the consortia on HIV/AIDS and alcohol-related outcomes research.

The overall goal of this research activity 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.

This FOA supports NIAAA's existing consortiums on HIV/AIDS and alcohol outcomes research, which comprise programs of multidisciplinary research organized around a unifying or well-defined goal or targeted area of research focused on the intersection of problem drinking and HIV/AIDS. Consortiums supported through this FOA are expected to demonstrate research expertise and leadership to accelerate the pace of science and the translation of HIV/AIDS and alcohol research to practice. This includes research on the co-morbidities known to be associated with HIV and alcohol use (e.g., HCV, TB, other comorbidities).

The Consortia for HIV/AIDS and Alcohol-Related Research Trials (CHAART) 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).

Potential research topics may include both the assessment of wide-ranging outcomes and proposed intervention effects, as well as foundational research related to behavioral and biological mechanisms impacting disease 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 reliable information related to engagement in care. Consortia may also explore several evolving areas of research, including HIV and aging, dynamic modeling of medical/intervention decision-making, and prophylaxis/prevention of disease-related consequences related to synergistic adverse effects of co-occurring HIV and alcohol misuse.

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.

For example:

Intervention Research

The target for research on these interventions is to 1) facilitate the identification of alcohol related problems among HIV+ individuals and 2) ameliorate these problems through the effective use of existing and new intervention strategies. Interventions may be behavioral, pharmacological, or both in combination (e.g., brief motivational interviewing, cognitive behavioral therapy, structural or contextual interventions in treatment settings, multilevel interventions for individuals, groups, or settings) to reduce alcohol use and/or improve adherence to HIV medications. In addition, researchers can test adaptive interventions in a variety of designs to address the complexities of patient care and provide the most effective medical decision making. Some of these designs include adaptive interventions related to severity of alcohol use, complexity of comorbid diagnoses, or patient frailty.

e-Health Interventions

New technologies for alcohol monitoring are being rapidly developed and applied for ensuring the awareness of the role of alcohol for both patients and providers. These technologies may assist in the implementation of interventions and effective and timely follow-up for patients. High priority goals of the proposed interventions may be to achieve sustained viral suppression if possible, improve immunological functioning, and reduce mortality.

Inflammation

Microbial translocation may prove to be a detrimental pathway for inflammation and subsequent organ injury as a result of chronic alcohol use. Research on accumulated toxicities and organ injury (e.g., gut, liver, and/or brain) may provide additional insight into developing new modalities for interventions to reduce alcohol/HIV injury or improve organ function. The results of this research should emphasize both behavioral and/or biological mechanisms (e.g., patterns of interaction between alcohol use and ARV exposure) that could be contributing to the unresolved problem of activation/inflammation and emergence of non-AIDS defining co-morbidities despite effective HAART in targeted populations. These populations include pregnant women, HIV+ or ARV exposed youth, and adults who show a propensity increased morbidity or mortality related to alcohol use.

Nutritional Supplementation

The combination of heavy alcohol consumption and HIV infection results in serious health problems and an increased risk of death. Although it is not exactly clear how alcohol and HIV do this, inflammation appears to play an important role. Nutritional supplementation (e.g., zinc, other micronutrients) has anti-inflammatory properties. NIAAA seeks to understand how giving supplementation to HIV infected people who are heavy drinkers reduces the risk of serious health problems and death.

Frailty

Patients with HIV are aging in the U.S. and a majority will be over age 50 by 2020. Alcohol, other medication use, HIV infection and antiretroviral therapy may affect a wide range of health indicators related to assessed frailty and associated underlying indicators (e.g., bone health and increase fracture risk, inflammation, cardiovascular functioning, cognitive decline). Research on frailty should collect appropriate measures and carry out analysis of cohort data to determine the independent effect of alcohol consumption on changes in structural and functional measures of frailty in the context of aging. This research should be examined prospectively and avenues for preventive health measures identified.

Highly Impacted Communities

The state of Florida has the highest rate of new HIV diagnoses in the U.S. and micro-epidemics exist in specific regions and among social networks. These ongoing epidemics are characterized by significant racial disparities and special populations including women and men who have sex with men (MSM) and older adults vulnerable to HIV. Research in highly impacted communities should identify intervention strategies that can be readily adopted into routine clinical practice settings, including public health HIV clinics among multiple racial and ethnic minority populations. Researchers should also seek to expand multilevel interventions (i.e., individual, group, community, and societal) that employ new methodologies to optimize intervention strategies and clinical decision making using multiple approaches including use of implementation research strategies. This research may address transient, migrant, homeless or other vulnerable populations not usually found in clinical settings (e.g., run away and homeless youth).

Measuring Disease Progression in HIV+ ARV Na ve and newly treated Adults

Whether heavy alcohol consumption accelerates HIV disease progression is a fundamental unanswered question with far-reaching public health implications. Alcohol is one of the most commonly used drugs in the world, and heavy alcohol consumption is very common among those infected with HIV. The main goal is to determine the impact of heavy alcohol consumption on HIV disease progression, as measured by viral load increase, CD4 cell count decline, other immune and inflammatory disease markers specific to alcohol/HIV among those who are treatment na ve or have become treatment resistant. In addition, previous methodological limitations for the measurement of alcohol use should be addressed by using a biomarker (e.g., phosphatidylethanol - PEth) or unique collection strategies (blood spots) of alcohol consumption to correctly assess alcohol exposure and misuse.

Organization of the CHAART Consortium

The CHAART Consortium 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 is 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 described in this FOA.

Therefore, this set of companion FOAs solicits sets of linked applications of multiple U01s (this FOA), one application for the Administrative Resource U24 (RFA-AA-16-002) and at least one application for the Research Resource U24 (RFA-AA-15-003.).

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

• Administrative Resource (RFA-AA-16-002) PD/PI of the Administrative Resource will be the Consortium Coordinator.  The 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. 
• Research Resources (RFA-AA-16-003) these applications are expected to provide support in the areas of epidemiology, behavioral sciences, informatics, data management, repositories, etc.

Individual research projects should apply to this FOA.

• 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 CHAART consortium. 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 collaborate 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.

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.

Only organizations holding an active NIAAA-funded Research Project U01 in HIV/AIDS and Alcohol Outcomes Consortiums are eligible.

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.

Applicant Organizations

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

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

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

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

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 U01(s) are eligible to apply.

This FOA supports linked applications. Multiple PDs/PIs are allowed on any single application. Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.

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

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).

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.

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.

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. The LOI should outline the framework for the consortium renewal and the relationship of the proposed U01 to the companion U24 applications.

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

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

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.

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

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a 1/N indicator + Identical Title (e.g., 1/3 , where the 1/3 means this is site 1 of 3 sites in

the set. The other sites will be labeled 2/3, etc.) Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.

Cover Letter Attachment: The Cover Letter is one pdf file only. The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., 1/3 ), and 3) the Applicant Institution. Each site should submit an identical listing.

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

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

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

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

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

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

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

Research Strategy

The application from each site must contain a Research Strategy that clearly describes those aspects of the project that are common to all sites of the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." In this subsection, PDs/PIs should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, (etc).

Coordination and integration of linked applications

The application must include under this heading the following information:

• Description of coordination, integration, synergy, and mutual reinforcement between the individual research projects and resources.
• Description of scientific and administrative integration of the proposed program.
• Description of value added of conducting the proposed research as a consortium rather than through separate research efforts.
• Description of thematic cohesion to the consortium and scientific interrelationship of individual research projects and resources.

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.

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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.

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

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.

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).

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.

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?

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?

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?

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? 

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?

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?

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.

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.

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.

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.

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.

Not Applicable

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

Not Applicable

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.

Not Applicable

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).

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.

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

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.

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.

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.

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 U01 awardees under this initiative;
• Serve as liaison between the research awardees and NIAAA staff members and investigators involved in the program, facilitating interactions and scientific integration between the U01 awardees;
• Promote and help coordinate collaborative research efforts that involve interactions with other NIAAA-sponsored programs, projects, and centers;
• Participate in program meetings;
• Review all major transitional changes that the awardees might propose (e.g., a change in partnering institution) and advice on their appropriateness prior to implementation to assure consistency with the goals of this FOA;
• Provide technical assistance and advice to the awardees as appropriate;
• Assist in the interaction between the U01 Research awardees and investigators at other institutions, as appropriate for the program;
• Assist in avoiding unwarranted duplication of effort with other NIH efforts;
• Monitor institutional commitments and resources to the awardees;
• Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- Specifically, the NIAAA Project Scientist may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures;
• Develop working groups and trans-project efforts as needed; and
• Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees.

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

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the NIAAA Staff Collaborator will participate in regularly scheduled 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.

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.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

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

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

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

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.

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.