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

Research on Alcohol and HIV/AIDS (R21)

Activity Code

R21 Exploratory/Developmental Research Project Grant  

Announcement Type

Reissue of PA-10-105

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • March 21, 2013 - See Notice NOT-AA-13-003. Notice of Change of Open Date.

Funding Opportunity Announcement (FOA) Number

PA-13-122

Companion Funding Opportunity

PA-13-121, R01 Research Project Grant
PA-13-120, R03 Small Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.273 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is intended to appeal to a broad audience of alcohol and HIV/AIDS researchers, including alcohol researchers with no prior experience in HIV/AIDS research but with a keen appreciation for the relationship between problem drinking and HIV/AIDS and a strong interest in acquiring such experience; HIV/AIDS researchers with no prior alcohol research experience who realize the importance of more intensive alcohol interventions to improving clinical outcomes among HIV-infected individuals; and those with prior research experience in the area of co-occurring HIV/AIDS and alcohol and other substance abuse. The primary objectives for this announcement are to increase innovative developmental research: 1) to characterize the relative importance of reducing alcohol misuse in the prevention of acquisition and transmission of HIV in order to identify and apply appropriate alcohol and HIV interventions as public health measures;  2) to more fully understand and prevent the progression of HIV disease in the presence of continued alcohol exposure;  and 3) to develop operational research frameworks for addressing the occurrence and persistence of infections in high-risk populations (e.g. minority women, young gay men, etc.), and translate findings into effective, culturally appropriate preventive and treatment interventions for  these targeted populations. Given the breadth of research objectives included in this announcement, potential applicants are encouraged to carefully review all sections of the announcement for research opportunities.   

Key Dates
Posted Date

February 21, 2013

Open Date (Earliest Submission Date)

(New Date April 7, 2013 per NOT-AA-13-003), Originally May 16, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

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)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

May 8, 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.


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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


Background

Alcohol consumption and its consequences together with HIV/AIDS are major public health burdens in many parts of the world. Chronic and abusive alcohol use can lead to life-threatening organ system damage. Light to moderate consumption can induce behavioral and organ system changes which may influence HIV transmission, pathogenesis, and disease progression.  There is overlap between persons at risk for alcohol-related problems and individuals at risk for HIV infection. Regardless of the level consumed, alcohol is likely to influence the health status and behaviors both of persons infected with HIV and those whose behaviors place them at risk for acquiring the virus.

Approximately 17.6 million adult Americans are living with alcohol abuse and dependence, and an additional 40,000 to 60,000 new cases of HIV infection are reported each year. Estimates of the co-occurrence of alcohol abuse/dependence among individuals infected with HIV range from approximately 30 to 70% in different samples. The prevalence of alcohol dependence among HIV-infected men is approximately three times that of women, and both prevalences substantially exceed those for men and women in the U.S. population overall. As HIV/AIDS research becomes more focused, there is growing evidence that alcohol consumption may play an important role in sexual transmission, susceptibility to infection, and progression of HIV disease. In addition, alcohol use, abuse, and dependence may have a significant impact on the occurrence and course of comorbid conditions such as HCV and TB, adherence to medications and provider advice, provider and patient attitudes toward treatment, and survival.

NIAAA places special emphasis on research that examines the effectiveness of interventions that extend beyond the level of the individual, with the aim of bringing all of the resources of a given community to bear on the twin epidemics of alcohol and other substance abuse and HIV/AIDS.  This focus is, in turn, consistent with goals articulated by the international AIDS research community in its attempt to stem the spread of HIV/AIDS in resource-poor areas of the world.  With increasing knowledge of the dimensions of the HIV epidemic in parts of Asia and Africa has come heightened awareness of the critical importance of involving community members as equal partners in every aspect of the research process.

In addition to being a possible risk factor in the acquisition and progression of HIV disease, alcohol misuse is likely to impact adherence to complex HIV medication regimens and to physician advice. Recent evidence has indicated interactive effects of alcohol use and HIV infection on brain functioning and cognitive processes. Whether alcohol consumption increases susceptibility to opportunistic infections in HIV+ patients and whether alcohol-induced immunosuppression affects pathogenesis and disease progression are important questions. However, carrying out research on the effects of alcohol consumption and drinking behaviors on HIV-related health outcomes is challenging. While clinical findings have associated increased levels of chronic alcohol consumption with diminished immune function, as evidenced by reduced levels of CD4 and CD8 activity, many questions about the relationship between alcohol consumption, increased susceptibility to HIV infection, and accelerated progression to AIDS remain unanswered. Strain variations of HIV, individual differences in susceptibility, long incubation time following seroconversion, and varying patterns of adherence to HIV medications are only some of the challenges in studying disease progression. Comorbid mental and somatic illnesses and environmental stress are additional confounding factors.  It is therefore of continuing importance to conduct research which clarifies the role of alcohol in HIV transmission and disease progression, and to develop and test preventive interventions which both reduce the risk of alcohol-related HIV transmission and improve the treatment of HIV-infected individuals with hazardous drinking, alcohol abuse and/or alcohol dependence.

Research Objectives

The complex and global nature of unresolved questions surrounding alcohol and HIV/AIDS relationships underscores the need for a multidisciplinary approach to research. Investigators representing a broad array of academic disciplines and engaged in cross-cutting fields of science are encouraged to consider designing hypotheses-driven studies that utilize rigorous methodologies from epidemiological, clinical, and experimental research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the R03 small grant mechanism.

Special emphasis areas include, but are not limited to the following.

Reducing New Infections

Epidemiology and Natural History of Alcohol Use and HIV/AIDS:

Improved understanding of the epidemiology of alcohol use, abuse, and dependence in HIV infection and AIDS will help to identify high-risk groups and promote development of effective HIV prevention and treatment efforts, including improved medical management of HIV/AIDS disease.

Examples of alcohol and HIV/AIDS-related epidemiology studies needed include, but are not limited to:

Investigations of the impact of alcohol-related social policies, including those affecting legal and illegal alcohol production, access, taxation, etc., on the spread of HIV and other STDs.

New Methods to Address Additive and Interactive Effects of Alcohol Use and HIV Risk Behavior, Infection, Progression, Transmission, Polypharmacy, and Other Substance Use:

Little information is available about the most effective approaches to managing co-occurring HIV/AIDS and multi-substance use.  This significant gap in scientific knowledge presents many methodological challenges for HIV prevention and treatment research, as well as for patient care.  Among the complex clinical problems complicating treatment and research in this population are abuse and dependence on prescribed medications (polypharmacy), as well as medication toxicities resulting from adverse interactions with alcohol.  Multiple patterns of alcohol and other substance use (AOD) have been documented in most cohorts of HIV-infected individuals, but more information is needed to fully understand the clinical impact of distinct patterns of substance use, and to develop optimal treatments tailored to distinct drug use scenarios.  In particular, licit substances such as nicotine and opiates in prescription analgesics are often used by patients to self-manage symptoms of HIV disease. Single substances, as well as mixtures of psychoactive substances, may become highly addictive with continued use, and may lead to abuse or dependence on multiple substances, in turn resulting in perturbations of normal metabolism and physiology related both to single drugs and drug combinations.  In addition, medications for frequently co-occurring diseases such as hepatitis C or tuberculosis are also being prescribed by physicians and used by patients in the context of AOD use. These drugs, while not addictive, may have serious side-effects when mixed with alcohol.  Of particular interest is the impact of various patterns of AOD and medication use over the lifespan, and best long-term approaches to preventing problems related to polypharmacy.  In addition to new research using creative and cutting-edge approaches, there is a need for secondary analyses of existing datasets from healthcare organizations, completed and ongoing clinical trials (among other sources) which are often rich sources of information about individual clinical encounters, medication refills, and self-reports of alcohol and other drug use.  In particular, the integration of existing quantitative and qualitative data and use of integrated quantitative and qualitative methods going forward will be essential to the development of accurate and clinically meaningful profiles of multi-substance use among people living with HIV/AIDS. Examples of the application of new methods include:

Prevention of HIV Risk Behaviors Related to Alcohol:

Behavioral, affective, and cognitive factors affect the risk for HIV infection and the efficacy of HIV prevention and treatment among people who use and abuse alcohol.  Models should be developed to integrate these individual factors with contextual and social factors that influence alcohol misuse, sexual risk-taking, and other HIV risk behaviors. Development and testing of new interventions are needed at various levels, including: individual, dyadic, social network, organizational, and community.

The following areas are suggested and not exclusive:

Improving Disease Outcomes for HIV-infected Individuals

Medical Aspects of Treatment for HIV-Positive Individuals with Alcohol Use Disorders:

Alcohol use may be a key determinant in disease transmission and progression, adherence and response to therapeutic regimens, and other effects. Many questions remain unanswered with regard to how the co-occurrence of HIV/AIDS and alcohol abuse/dependence currently influences clinical decision-making, and how provider practices could be modified to improve clinical outcomes. Research is needed to determine whether and how alcohol affects disease progression in various organ systems in HIV+ individuals; to develop and evaluate pharmacological interventions for the treatment of alcohol dependence in HIV+ individuals; to guide the development of HIV treatment regimens tailored to the needs of people with coexisting alcohol abuse/dependence; and to improve motivation for treatment and adherence to treatment.  Specifically, there is a need to expand and enhance research in these and other areas:

Multi-level Behavioral and Psychosocial Approaches to the Treatment of Individuals with Co-occurring HIV/AIDS and Alcohol Abuse/Dependence:

The implementation of research-based behavioral/psychosocial interventions that will complement state-of-the-art pharmacologic interventions for the treatment of alcohol dependence in HIV+ individuals will be critical in achieving improved clinical outcomes.  Research is needed to better characterize and address the impact of behavioral and psychosocial factors on access to treatment and on drinking and HIV/AIDS outcomes, and to ameliorate negative behavioral, affective, physical, cognitive and social consequences of HIV infection in alcohol-using and -abusing populations through multilevel interventions.  Such interventions may target, separately or in combination, individuals, families, treatment programs and networks of programs, and communities.  For example, alcohol and HIV/AIDS-related research efforts are needed in, but not limited to, the following areas:

Aging

Close to 50% of all HIV-infected patients are now age 50 or older and many have lived with HIV infection for more than 20 years. A significant number (~15%) of all new HIV infections are found in this cohort as well.  Significantly, continued alcohol and other substance abuse are common among older individuals living with HIV. Although moderate alcohol consumption is associated with a reduced mortality in the general population, there is no protective effect among HIV-infected individuals.    Compared to the general population of the same age, HIV-infected individuals have more aging-related medical problems, which sometimes follow an accelerated disease course ending in early death.  Major chronic co-occurring conditions include hepatic injury, cardiovascular dysfunction, peripheral neuropathies, and neurocognitive impairment.  Many of these conditions are thought to have an inflammatory component which is made worse by drinking.  Most of the research on the health effects of alcohol in the context of HIV infection to date has focused on hepatic injury, secondary both to the direct effects of alcohol on the liver and its interactions with antiretroviral medications.  Alcohol has been identified as a key factor in the excess mortality related to liver disease in populations living with HIV, yet examples of successful community and system-level activities to address this issue are rare.  In fact, health systems are increasingly falling short in their efforts to meet the needs of HIV+ patients with multiple comorbidities, and few individuals are achieving continued viral suppression over long periods of time.  Complicating the direct effects of alcohol on all organ systems are its effects on adherence to antiretroviral medications and retention in treatment, and the resulting emergence of viral resistance.  To be maximally effective, future research on drinking in aging HIV+ populations will need to simultaneously address both the biological effects of alcohol in the setting of HIV and the need to develop integrated systems of care that can effectively identify and address alcohol misuse in people living with HIV.  Areas of special interest include, but are not limited to:

Reducing HIV-related Disparities and Capacity Building

Community-Based Translational Research: 

Community-based translational research in public health is a partnership approach to research that equitably involves, for example, community members, organizational representatives, and researchers in all aspects of the research process.  The partners contribute their expertise and share responsibilities and ownership to enhance understanding of a particular phenomenon, and to integrate the knowledge gained with action to improve the health and well-being of community members.  Community-based translational research is important because it emphasizes conducting research in a community as a place or setting, and conducting research with members of a community who are full and equal partners.  Such research recognizes the community as a social, cultural, and geospatial entity with the active engagement and influence of community members in all aspects of the research process.  Within the area of community-based translational research, suggested special emphasis areas include, but are not limited to:

Dissemination and Diffusion of Research Findings:

Despite advances in our knowledge of effective approaches to preventing HIV infection, it is clear that information, strategies, and models for HIV prevention have not always reached community program levels.  Likewise, information developed by community programs has frequently not reached or influenced HIV prevention researchers.  It is extremely important that more effective collaborative relationships between the research community and the community of public organizations delivering prevention programs to high-risk populations be developed in such a way that a sustainable research infrastructure is established or enhanced at the level of local communities.  Models of technology transfer need to be developed and validated in large-scale community settings.  These models must include effective training for community providers as well as ongoing assessment of what happens to research-based interventions when they are put into practice.  Critical to the success of these efforts will be an awareness of the cultures in which the interventions were implemented and ways in which existing interventions may have to be modified to be successful.  Interventions which leave in place infrastructures capable of complex problem-solving, program evaluation, and ongoing two-way communication with the research community should facilitate future technology transfer. 

Suggested areas of operations and implementation research include but are not limited to:

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

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

Award Budget

The combined budget for direct costs for the two year project period may not exceed $275,000.  No more than $200,000 may be requested in any single year.

Award Project Period

The total project period may not exceed two 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 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 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.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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, 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following modification:

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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 deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application before the deadline 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.

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.

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 (SAM). 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 by the Center for Scientific Review, NIH. Applications that are incomplete 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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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?   

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

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 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Center for Scientific Review, 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:

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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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/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 the DUNS, SAM 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

Not Applicable

3. Reporting

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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 Bryant, Ph.D.
AIDS Coordinator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-403-9289
Email: kbryant@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Judy Fox
Chief, Grants Management Branch
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.


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