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

Resource support for Consortiums for HIV/AIDS and Alcohol-Related Outcomes Research Trials (CHAART) U24

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AA-12-010

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.273 

FOA Purpose

This funding opportunity (FOA) issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) solicits Cooperative Agreement (U24) applications to continue to support the currently NIAAA-funded " Consortiums for HIV/AIDS and Alcohol-Related  Research Translation” (CHARRT) or Alcohol and HIV/AIDS Centers (P01, P50, P60) to enhance their capacity to carry out multidisciplinary, transdisciplinary, and/or integrative behavioral and biological research. The CHARRT consortiums and Alcohol and AIDS Centers aim to accelerate specific areas of research related to the goals of improving HIV/AIDS treatment among infected individuals  affected by alcohol use, and to prevent the transmission of HIV within U.S. and international populations.  Specifically, the three primary goals of the U24 resource cores are to: 1) increase levels of collaboration between existing research projects focusing on alcohol and HIV/AIDS, in particular to improve their capacity to carry out translational, operational, or implementation science research studies; and/or 2)  provide enhanced capacity to evaluate the impact of alcohol use and HIV within longitudinal research designs, with particular attention to aging; and/or 3) facilitate the implementation of alcohol  and HIV/AIDS interventions within targeted populations at greatest risk within the United States). The U24 mechanism is used to support and provide resources to existing consortiums and centers. Thus, this FOA is a limited competition open to currently NIAAA-funded HIV/AIDS consortiums (U01) and centers (P01,P50,P60). This FOA is also open to investigators who are not part of the consortiums and centers as long as they provide documentation of pre-existing collaboration with a CHAART consortium or alcohol and AIDS research center prior to submission.

Key Dates
Posted Date

January 31, 2012

Letter of Intent Due Date

March 2, 2012

Application Due Date(s)

April 2, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June-July , 2012

Advisory Council Review

August, 2012

Earliest Start Date(s)

September 1, 2012

Expiration Date

April 3, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to continue support of the previously funded “Consortiums for HIV/AIDS and Alcohol-Related Research Translation” (CHAART, RFA-AA-11-003) and related Alcohol and HIV/AIDS Research Centers (P01,P50, P60).  This previous opportunity resulted in the development of several multidisciplinary consortiums to accelerate the translation of key findings from basic and applied research on alcohol and HIV to clinical practice by providing the infrastructure for interdisciplinary collaboration in the design and conduct of studies at the cutting edge of alcohol and HIV/AIDS science.  The current FOA solicits U24 applications to develop administrative and/or resource cores to support the research efforts of the CHAART consortiums (or alcohol and AIDS research centers), building upon existing infrastructure within these consortiums. Applications from investigators not currently part of the consortiums (or centers) may be submitted as long as documentation is provided to establish pre-existing collaboration with a CHAART consortium  (or alcohol and AIDS research center) prior to the time of submission. The U24 projects should substantially enhance the formulation of directions and goals for the associated consortium, and accelerate the progress of ongoing and future investigations. 

BACKGROUND

The CHAART initiative is responsive to pragmatic changes in the National HIV/AIDS Strategy (NHAS) to focus HIV/AIDS research on building optimized systems of care to stem the tide of the ongoing epidemic, and to enable people who are living with HIV/AIDS to achieve the best possible quality of life in an environment of shrinking public health resources.

“People with HIV also have other significant challenges. Many people living with HIV have other co-occurring conditions, such as heart disease, depression or other mental health problems, or drug or alcohol addiction. In addition, poverty, unemployment, domestic violence, homelessness, hunger, lack of access to transportation, and other issues can prevent people from accessing health care. There are also differences in health care access and treatment outcomes by race/ethnicity, gender, and geography. HIV-positive African Americans and Latinos are more likely to die sooner after an AIDS diagnosis compared to HIV-positive Whites; HIV-positive women are less likely to access therapy compared to HIV-positive men; and access to care and supportive services is particularly difficult for HIV-positive persons in rural areas, as well as other underserved communities.  While research has already brought us a long way (toward controlling the epidemic within the U.S.), continued research is needed to develop safer, less expensive, and more effective treatments and drug regimens, as well as to evaluate new approaches to meeting HIV treatment needs while also responding to co-occurring conditions or other barriers to care.” National HIV/AIDS Strategy (NHAS) and NHAS Federal Implementation Plan.

Within the next decade, more than half of the patients in the U.S. living with HIV will be over fifty years old and with appropriate treatment may expect to live for multiple decades after detection of infection. However, the extended course of HIV disease increases the need for attention to the impact of co-occuring disorders on HIV transmission and disease progression.  Large-scale studies have revealed a high prevalence of alcohol use, abuse, and dependence among HIV-infected patients both in and out of care. From 30-75% of HIV+ individuals have been identified with current alcohol use disorders in various domestic and international studies, with the highest levels in minority or stigmatized populations.  Alcohol use disorders are increasingly recognized as factors in morbidity and mortality among HIV-infected individuals, particularly among those who are coinfected with HCV or have multiple other disorders that may be exacerbated by alcohol use and/or environmental circumstances where alcohol plays a significant role in vulnerability and recovery (e.g., homelessness).

While HIV treatment has improved and many patients successfully suppress viral replication, maintaining adequate immune function throughout many years of treatment, a significant portion of alcohol users do not. Alcohol use has been associated with late entry into HIV treatment, higher viral set points, reduced adherence, increased cART toxicities, more rapid progression of disease, neurocognitive impairment and liver failure. Recent studies have demonstrated that there is no safe level of drinking for some patients infected with HIV, and that even low levels of drinking may be associated with increased morbidity and mortality over the lifespan. In addition, research indicates that over half of alcohol users who are HIV- infected may be receiving little or no treatment as a result of having exhausted their treatment options or of having inadequate access to appropriate care. 

The overarching goal of the CHAART Consortiums and Alcohol and HIV/AIDS Research Centers is to conduct research that will inform the development of optimized systems of care for people with co-occurring HIV/AIDS, harmful drinking, and other comorbid health and mental health conditions.  They aim to accelerate the translation of key findings from basic and applied research on alcohol and HIV to clinical practice by providing the infrastructure for interdisciplinary collaboration in the design and conduct of studies at the cutting edge of alcohol and HIV/AIDS science.  It is anticipated that this interdisciplinary, collaborative approach to research on alcohol and HIV/AIDS will generate the strongest possible platform for the strategic development and testing of new interventions for co-occurring harmful/hazardous drinking and HIV/AIDS, and for measuring the comparative efficacy of established interventions for these conditions.   Interventions of interest include but are not limited to pharmacological, behavioral, nutritional, and exercise therapies that may improve outcomes related to HIV/AIDS, harmful drinking, and other co-occurring physical and mental health disorders.  Potentially effective interventions are identified as part of a broader plan to create an implementation/operations research framework which allows for evaluation of both individual interventions and the impact of important structural factors, such as training, coordination of care and service integration, quality assurance processes, and community poverty and violence.

The current FOA solicits U24 applications to develop additional administrative and/or resource cores to support the research efforts of the CHAART consortiums and Alcohol and HIV/AIDS Centers (P01, P50, P60), building upon existing infrastructure within these consortiums and centers.  Applications from investigators not currently part of the CHAART consortiums or alcohol and HIV/AIDS research centers may be submitted as long as documentation is provided to establish pre-existing collaboration with one of these consortiums or centers prior to submission. 

Research Objectives

The overarching goals of the Consortiums for HIV/AIDS and Alcohol-Related Research Translation and the Alcohol and HIV/AIDS Research Centers include but are not limited to developing and testing both medical and non-medical interventions to improve medical, mental health, and social outcomes among people with co-occurring HIV/AIDS  and harmful drinking; developing and evaluating enhanced models of care and service delivery (e.g., integrated alcohol , HIV, housing, and employment interventions, etc.); and measuring and improving the cost and cost-effectiveness of care.  It is anticipated that their interdisciplinary, collaborative approach to research on alcohol and HIV/AIDS will significantly accelerate the translation of critical research findings in multiple domains of interest to effective strategies for significantly improving patients' quality of life. 

This FOA solicits U24 applications  to develop additional administrative and/or resource cores to support the research efforts of the CHAART consortiums and Alcohol and HIV/AIDS Centers (P01, P50, P60), building upon existing infrastructure within these consortiums and centers.  These U24 resource cores are conceptualized as separate components of a consortium or center that provide research support only, including support for both basic methodological and applied research focused on patient outcomes.  A successful U24 project will substantially enhance the formulation of directions and goals for its associated consortium/center, and accelerate the progress of ongoing and future investigations.  Specifically, the primary goals of the U24 administrative and resource core projects are to: 1) increase levels of collaboration between existing components of an established CHAART consortium or Alcohol and HIV/AIDS Research Center (P01, P50, P60); 2) increase the capacity of existing alcohol and HIV/AIDS consortiums and centers to carry out translational, operational, or implementation science research studies; 3) enhance the capacity of the consortiums and centers to evaluate the impact of alcohol use on HIV disease progression within longitudinal research designs, with particular attention to aging; and 4) facilitate the implementation of alcohol  and HIV/AIDS interventions within targeted U.S. populations at greatest risk.  Examples of proposals for research support components that would be responsive to this FOA may include but are not limited to: 

Administrative Coordinating Cores.   Such cores will provide oversight, coordination, and direction to the consortium or research center.  Specifically, they will manage the Steering Committee, Scientific Advisory Panel, and Data and Safety Monitoring Board, facilitiating communications among the PD(s)/PI(s) and advisors/consultants; coordinate the use of core resources among research projects; and facilitate optimal collaboration between basic, epidemiological, and clinical research components.

Informatics Cores.  Such cores will provide support and guidance to the research project components with respect to data colletion, data entry, use of advanced communications technologies ,and statistical analyses.    

Biological Repository Cores. Will provide adequate storage and analysis facilities for targeted tissue sampling and blood product storage in compliance with existing requirements for the storage and handling of specimens.

Organization

Each CHAART consortium or center comprises a unique configuration of core administrative and central resource components (e.g. U24 mechanism) and U01 or R01 projects addressing key topics in the epidemiology and treatment of co-occurring harmful drinking and HIV/AIDS.  The CHAART consortiums are led by Steering Committees comprising senior investigators, site coordinators, and topic experts who serve on an ad hoc basis, with substantial input from the NIAAA scientific collaborator. New support core personnel are expected to participate substanitively in these teams  of investigators. The approach to research in both the consortiums and centers involves multidisciplinary teams such as clinician researchers, behavioral scientists, health services researchers, biostatisticians, and health economists who work together to develop and evaluate novel approaches to improving outcomes for HIV+ individuals who engage in hazardous or harmful drinking.  It is anticipated that the involvement of multidisciplinary teams will enable the integration of knowledge from different perspectives and the use of state-of-the-art techniques to understand the effects of selected interventions at multiple levels.

Through the addition of the proposed U24 administrative and resource cores, the consortium/center research project components will have access to resources, information, technologies, ideas, and expertise that are beyond the scope of any single research team. The U24 application should discuss 1) the theme and goals of the consortium in general and the impact of the additional collaborative arrangements facilitated by the U24 activities; and 2) should include a scientific rationale for linkages of the various research project components and additional resource core projects.  It is acceptable for the Consortium Coordinator or Center Director to submit a U24 resource core application in addition to the currently funded lead application.  While each U24 application will originate from the principal investigator(s)'s research institution and awards will be made directly to those institutions (i.e., where the core resource resides), it is the responsibility of the applicant to seek documentation of the consortium coordinator's/center director's intent to collaborate prior to submission of the application. (See Application Procedures and Application Submission Section).

Section II. Award Information
Funding Instrument

Cooperative Agreement.

Application Types Allowed

New
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NIAAA intends to fund an estimate of four awards, corresponding to a total of 2.5 million dollars, for fiscal year 2012. Future year amounts will depend on annual appropriations. Although the financial plans of the NIAAA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Award Budget

The proposed project costs must be less than $ 500k in Direct Costs.

Award Project Period

Award Project period should be consistent with the length of duration of the period of collaboration with the consortium. This period of time will not exceed 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

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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  eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

This announcement is limited to applicant organizations that have active NIAAA-funded HIV/AIDS CHAART Consortiums (U01s) and HIV/AIDS-Alcohol Research Centers (P01, P50 and P60). The goal of this FOA is to solicit resource applications (U24) to support the research efforts of the CHAART consortiums (or alcohol and AIDS research centers), building upon existing infrastructure within these consortiums. PD(s)/PI(s) not currently part of the above-mentioned consortiums (or centers) may submit an application,  as long as they provide documentation of pre-existing collaboration with a CHAART consortium  (or alcohol and AIDS research center) prior to submission. The U24 projects should substantially enhance the formulation of directions and goals for the associated consortium, and accelerate the progress of ongoing and future investigations.  

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service, non-USPS)
Telephone: (301) 443-9737
FAX: (301) 443-6077
Email: bautista@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service, non-USPS)
Telephone: (301) 443-9737
FAX: (301) 443-6077
Email: bautista@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed,

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

Not Applicable

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115

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 - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of 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 - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority 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) Genome Wide Association Studies (GWAS).

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 the National Institute on Alcohol Abuse and Alcoholism in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 OMB administrative guidelines, HHS 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 (U01), 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:

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

Areas of Joint Responsibility include:

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 arbitration. An Arbitration 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Kendall J. Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9389
Email: kbryant@mail.nih.gov

Peer Review Contact(s)

Ranga V 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 Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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