Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Research on Comparative Effectiveness and Implementation of HIV/AIDS and Alcohol Interventions (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	February 10, 2014 - This RFA has been reissued as RFA-AA-14-004. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. April 3, 2013 - See Notice NOT-DA-13-021. Notice of NIDA's Participation.
Funding Opportunity Announcement (FOA) Number	RFA-AA-13-003
Companion Funding Opportunity	RFA-AA-13-004, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.273, 93.279
Funding Opportunity Purpose	HIV+ alcohol users remain an underserved group at high risk for medication non-adherence and rapid disease progression, medication toxicities, organ failure, and poor viremic control leading to increased risk of transmission and premature death. It has been estimated that the effective implementation of alcohol interventions for HIV+ individuals may reduce the rates of new infections by nearly 20% and extend life by up to 15 years in some at-risk and patient populations respectively. This new initiative seeks to advance knowledge of the effective implementation and comparative effectiveness of alcohol-focused interventions among HIV+ individuals. Multiple factors need to be investigated, including potentially important patient and provider characteristics, and the organizational, financial, and structural factors that facilitate or inhibit the delivery of evidence-based services for HIV+ individuals with a range of alcohol use disorders. The overall goal is to inform clinical decision-making that will enhance treatment outcomes and reduce harms associated with interventions for HIV+ individuals with alcohol use disorders. This solicitation is divided into two parts, one or both of which an applicant may choose to address. These parts include: 1) comparative effectiveness research focused on understanding factors related to patient engagement in appropriate alcohol and HIV care and retention in treatment; and 2) modeling and testing alternative approaches to the implementation of effective interventions to reduce HIV disease transmission and progression. This announcement addresses the need to further develop patient- centered approaches for making informed health care decisions and to improve research on health care delivery and outcomes.

Posted Date	March 27, 2013
Open Date (Earliest Submission Date)	April 29, 2013
Letter of Intent Due Date(s)	April 29, 2013
Application Due Date(s)	May 29, 2013, 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)	May 29, 2013, by 5:00 PM local time of applicant organization.
Scientific Merit Review	July-August 2013
Advisory Council Review	October 2013
Earliest Start Date	November 2013
Expiration Date	May 30, 2013
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.

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

HIV+ alcohol users remain an underserved group at high risk for medication non-adherence and rapid disease progression, medication toxicities, organ failure, and poor viremic control leading to increased risk of transmission and premature death. This new initiative seeks to advance knowledge of the comparative effectiveness and implementation of alcohol-focused interventions among HIV+ individuals. Multiple factors need to be investigated, including potentially important patient and provider characteristics, and the organizational, financial, and structural factors that facilitate or inhibit the delivery of evidence-based services for HIV+ individuals with alcohol use disorders. Interventions may focus on one or more levels/types of approach to achieve the optimal outcomes. The overall goal is to inform clinical decision-making that will enhance treatment outcomes and reduce harms associated with interventions for HIV+ individuals with alcohol use disorders. This solicitation is divided into two parts, one or both of which an applicant may choose to address. These parts include: 1) testing alternative approaches to the implementation of effective alcohol interventions to reduce HIV disease transmission and progression in a variety of settings; and/or 2) comparative effectiveness research focused on understanding factors related to alcohol reduction and patient engagement in appropriate alcohol and HIV care leading to long-term retention in treatment.

Comparative Effectiveness Research (CER): For the purposes of this FOA, CER is defined in accordance with the Institute of Medicine’s (2009) definition:

CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.

Specific research objectives of this Funding Opportunity Announcement (FOA) include, but are not limited to: (1) comparative research on medications for the treatment of alcohol use disorders in real world clinical settings; (2) comparative research on behavioral interventions for alcohol use disorders in real world clinical settings; (3) comparative research contrasting pharmacotherapeutic and behavioral interventions in real world clinical settings; (4) comparative health services research on individual patient characteristics, venues, organizations and management approaches for delivery of alcohol/HIV services; (5) research that seeks to address the aforementioned objectives for the population as a whole and in specific subpopulations at highest risk for HIV progression or transmission as a result of alcohol misuse; and (6) research on the implementation of these interventions, with emphasis on elucidating disparities among at-risk and HIV+ racial/ethnic groups with respect to alcohol treatment, health services, and prevention.

Comparative Effectiveness of Pharmacotherapies and Behavioral Therapies

Well-controlled clinical trials have identified both pharmacological and behavioral therapies for alcohol dependence, yet less is known about the response to these interventions among patients seen in typical HIV clinical settings with multiple co-morbidities and different levels of severity. Such information might reveal which treatments work best among different subsets of HIV+ patients and identify factors that could predict the safety, benefits and risks associated with a particular intervention. Multiple agents for the treatment of alcohol dependence topirimate, disulfiram, naltrexone, and acamprosate are now approved for use in the United States and many other countries. Currently Naltrexone, Vivitrol (Injectable Naltrexone), and Ondansetron are being tested for their effectiveness in HIV+ samples in adaptive and case-control designs. However, some patients do not respond to these medications, and their effectiveness among adolescents, minority groups, HIV+ individuals with comorbid psychiatric/medical/other substance abuse disorders, and other special populations at highest risk for HIV infection and transmission remains uncertain. Advances in the development of medications for the treatment of alcohol dependence have been accompanied by the development of novel and enhanced behavioral interventions for alcohol abuse and dependence, including but not limited to motivational enhancement therapy, brief interventions, cognitive behavioral therapy, couples therapy, twelve-step facilitation therapy, and community reinforcement approaches. Although these interventions are effective in reducing or preventing drinking in the general population, little is known about the effectiveness of these treatments for people living with HIV/AIDS in real world clinical settings, or in head to head comparisons of the various pharmacologic and behavioral therapies available.

Comparative Service Delivery Research

In addition to the many unanswered questions about the comparative effectiveness of various treatments for alcohol use disorders, it is unknown how decision-makers and clinicians will choose to use these interventions based on their perceived efficacy and effectiveness, available resources in specific settings, or characteristics of specific populations (e.g. minority gay men, AA women).

Individuals with HIV and alcohol use disorders (alcohol abuse and dependence) are typically identified and treated in a variety of venues and organizations ranging from individual private practice offices to community clinics, academic health centers, HMOs, HIV clinics and specialized substance abuse treatment facilities. Some of these venues are privately funded, while others are carved out of health insurance plans. Some are provided through Federal support (e.g., Dept. of Veteran’s Administration), and others are folded into global health care packages. Still others are funded through County or State-supported healthcare financing systems. Little data is available comparing the effectiveness of delivering services in these various venues and/or shedding light on the relative cost and cost/benefit of various service delivery and financing systems. Understanding the comparative utility and relative costs of delivering services in particular types of venues in different patient populations could help to guide policy in the context of health care reform. An operations research approach will be needed to assess individual interventions and combinations of interventions (i.e., packages or baskets of interventions) in specific settings, and to improve understanding of optimal implementation strategies to achieve maximum impact on the health of affected individuals and populations.

Implementation Research

Implementation science is the scientific study of methods to promote the integration of research findings and evidence-based interventions into health care policy and practice and hence to improve the quality and effectiveness of health services and care. Implementation science is distinguished from monitoring and evaluation by its emphasis on the use of the scientific method. (Schackman, 2010). Implementation research for HIV+ Alcohol Users is a new initiative which includes both dissemination of existing alcohol interventions to HIV+ individuals and expanding the scope of existing interventions to include integrated alcohol and HIV/AIDS risk reduction. Some well-established interventions for alcohol use disorders are already being integrated into existing systems of HIV care such as the Veterans Administration or other comprehensive care systems (Kaiser Permanente). Manualized brief alcohol interventions and other therapies are being evaluated, but need to be tested in a wider variety of settings for fidelity, acceptability and ease of use, and effectiveness. In addition, training for both researchers and interventionists needs to be increased to ensure appropriate implementation. The primary goals of this activity are to ensure the development of a framework for comprehensive research on the implementation of interventions for co-occurring alcohol and HIV/AIDS, and to facilitate the uptake of effective alcohol-focused interventions in both alcohol and HIV testing and treatment venues.

Translating Comparative Effectiveness and Implementation Research into the Community

The highest priority for this activity is to assess the comparative effectiveness and cost-effectiveness of accurate, reproducible, and affordable methods for identifying, testing, and intervening with comorbid alcohol and other substance use disorders and HIV/AIDS. Specific goals for this translational research include but are not limited to the development and testing of novel methods for: a) identifying HIV+ individuals in need of alcohol interventions; b) linkage to acute care for co-occurring HIV/AIDS and alcohol use disorders in specific community treatment settings; and c) linkage to care over the lifespan for substance using, abusing, and dependent individuals, with a particular focus on alcohol and other licit drugs (e.g., nicotine, prescription drugs, etc.). Of particular interest are interventions to reduce the impact of polypharmacy for multiple comorbid illnesses. This includes combined or sequential interventions to optimize the treatment of comorbid illnesses (including minimizing the number of medications for these illnesses), improve adherence to antiretroviral medications, and enhance monitoring of response to care in a variety of community- and hospital-based settings. Also of special interest are studies comparing intervention strategies that target a single stage in the identification, engagement and retention continuum to those that employ an equivalent amount of resources to target multiple stages simultaneously. Multi-stage studies may shed light on the relative effectiveness of concentrating resources in one or more areas vs. others.

Additional priorities for translational research include: 1) to improve measures relevant to processes and outcomes within these comorbid populations, including the development of indices of disease risk, severity, and mortality (e.g., VACS index); 2) to assess the costs and comparative effectiveness of new technologies associated with point of care medical diagnostics (e.g., EMR informatics, electronic reminders, etc.) and improved technologies for monitoring substance use events and virologic failure in large systems of care. This includes the application of improved real-time approaches to clinical decision-making to improve pharmacological and behavioral methods to reduce viral replication associated with alcohol/substance abuse and relapse events over the life course; and the development of novel strategies for identifying comorbid alcohol and substance using populations (AOS) at highest risk for HIV transmission, but with poorest knowledge of their HIV status and/or problematic beliefs about alcohol-associated risks.

These initiatives address the following critical elements identified in the FY2014 NIH Plan for HIV/AIDS Research:

• Identify best mixtures of existing effective interventions in multiple settings with different admixtures of HIV and/or alcohol treatment providers through additional support for implementation and operations research activities.
• Identify translational research methods to foster scale-up and optimal use of existing efficacious strategies to eradicate HIV within alcohol abusing and dependent populations.
• Develop and test behavioral and social science interventions to improve adherence to therapeutic regimens, as well as strategies that would optimize implementation of eradication strategies and cure approaches that involve changing drinking beliefs and behaviors.
• Conduct ecologically valid studies of HIV transmission, HIV treatment and care interventions with alcohol using, abusing, and dependent individuals at the population level, with a focus on comparisons of large systems and venues of care (e.g., Veterans Administration, Kaiser Permanente) with community-based systems of care (e.g., alcohol treatment facilities, STD clinics). This priority includes, in both domestic and global settings, the development and maintenance of HIV cohorts and appropriate controls, population-based approaches, and randomized community-based study designs.
• Conduct studies to improve the uptake, implementation and translation of research findings into diverse practice settings with high rates of drinking, HIV/AIDS and related conditions (e.g., HCV, TB). This priority includes implementation science studies that address the complexity of the scale-up of prevention and treatment interventions for high impact populations such as minority gay men and vulnerable women. These implementation and translational studies include research on integrated alcohol/HIV interventions and multi-level interventions; studies in non-traditional settings (i.e., bars, schools, etc.) involving under-served populations; and studies evaluating the economic impact (cost-effectiveness) of interventions.
• Develop novel methods and perform the next generation of trans-disciplinary alcohol/HIV research over the life span using the established NIAAA consortium base. Develop research methods and measures for improving the uptake of HIV testing and treatment protocols, including evaluation of preventive interventions, linkages to care, and strategies for improving retention in care and adherence to treatment. Innovative approaches to monitoring alcohol-related dynamics of the epidemic in domestic and international settings are also of interest. Trans-disciplinary approaches to examine the prevention, testing and treatment continuum will include integration of data from early phase observational studies with data from clinical trials, simulation studies involving mathematical modeling based on advanced statistical methods, and molecular epidemiological studies.
• Training, Infrastructure, and Capacity Building

NIAAA programmatic priorities also include projects that:

• Provide training for alcohol and HIV/AIDS researchers to more fully understand potential synergies between biomedical, social and behavioral, intervention and implementation research necessary to address the challenges of HIV and alcohol-related complications, co-infections, and comorbidities (e.g. HCV, TB, severe anemia, malnutrition, etc.).
• Increase focus on multidisciplinary research in populations that are diverse with respect to age, gender, race, and culture, including marginalized populations in domestic and international settings. In the global arena, countries with high HIV incidence and/or high prevalence of both HIV infection and alcohol misuse are of particular interest.
• Accelerate operations-focused research by integrating data from comparative effectiveness and observational studies on alcohol and other substance-related HIV using existing simulation and modeling activities (including the development of dynamic data sharing and analysis protocols).

Support collaborative activities with domestic and international agencies (e.g., World Health Organization, etc.) that are currently supporting similar modeling activities. The goal of this activity is to advance the integration of advanced statistical methods to assess the short and long-term outcomes of alcohol and other substance-related preventive and therapeutic interventions with potential for high public health impact in domestic and international settings.

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 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 NIH appropriations and the submission of a sufficient number of meritorious applications. NIAAA intends to fund approximately 4 awards, corresponding to $ 2.5 million in total cost, for fiscal year 2013. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets must not exceed $500,000 in direct cost.
Award Project Period	The award project period may 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.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

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 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.

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.

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.

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

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

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

The letter of intent should be emailed to:

Abraham P. Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301 443 9737
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required 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.

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.

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:

• 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.

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.

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.

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 by the Center for Scientific Review, NIH and responsiveness by the NIAAA Office of Review. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at [email protected] 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-10-115.

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.

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?

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

Not Applicable

Renewals

Not Applicable

Revisions

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.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) in 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 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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

Not Applicable

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Kendall Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-402-9389
Email: [email protected]

Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-451 2067
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-4704
Email: [email protected]

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 Parts 74 and 92.