NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

The NIAAA is committed to developing research on the health and well-being of diverse populations, including racial/ethnic minority and other underserved populations. In addition, NIAAA seeks to encourage the participation of researchers from institutions that train professionals from diverse backgrounds and who provide health care to these populations. Hispanic Serving Institutions (HSIs), Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUS), Alaska Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) are particularly encouraged to apply. Such institutions are uniquely positioned to engage them in research and in the translation of research advances into culturally appropriate, measurable and sustained improvements in health outcomes.

The purpose of this funding opportunity is to promote collaborative partnerships between these institutions and NIAAA funded Alcohol Research Centers or other institutions with extensive research efforts focused on alcohol research in communities with health disparities. For the purpose of this FOA, the term "IUCP" refers to academic or other organizations that focus on training professionals from underrepresented backgrounds and provide health care to minority and medically underserved communities and populations, and ARC will refer to institutions with extensive alcohol research programs including NIAAA-funded alcohol research centers. The central aim of the AHDRC program is to enhance the research opportunities for scientists at IUCP by pairing them, through collaborative affiliations, with scientists from alcohol research-intensive institutions.

Alcohol consumption is associated with a broad range of adverse health and social consequences, both acute (e.g., traffic deaths, other injuries) and chronic (e.g., alcohol dependence, liver damage, stroke, cancers of the mouth and esophagus). The scope and variety of these problems are attributable to differences in the amount, duration, and patterns of alcohol consumption; differences in genetic vulnerability to particular alcohol-related consequences; and differences in economic, social, and other environmental determinants of health disparities. Disparities in alcohol-related problems are a pressing public health concern. Alcohol-related death rates (for all categories of alcohol- related mortality combined) are higher among blacks than whites. Research indicates that cirrhosis death rates are higher among white men of Hispanic origin than among non-Hispanic black and white Americans. Alcohol-related traffic deaths are many times more frequent among American Indians or Alaska Natives than among other diverse populations.

Fetal alcohol spectrum disorders (FASD) may differentially affect African American and Native American communities. Research reveals that although African American teenagers typically drink less than their white or Hispanic counterparts, their mortality from cirrhosis is substantially higher as they approach middle age.

Adverse health consequences associated with alcohol consumption such as cirrhosis, alcoholic liver disease, HIV/AIDS, cardiomyopathy, cancer, pancreatitis, psychiatric comorbidity, and alcohol-related sleep disorders also are more prevalent in some diverse populations. Further, increases in risky drinking behavior (i.e., drinking and driving) and increased drinking among underage females have been reported among Hispanics. Since racial/ethnic minority groups have different genetic backgrounds, it is possible that some of the disparities in disease incidence and prevalence are due to differences in genetic predisposition. Genetic and biological factors may interact with behavioral, cultural, and environmental factors to manifest health disparities.

IUCP are effective in educating students from diverse cultures to provide outreach to communities suffering from health disparities. They represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in alcohol research. However, few IUCPs have developed the capacity for a sustained program in alcohol research on health disparities. There is a need to enhance the participation of scientists from diverse backgrounds that are pursuing successful biomedical and behavioral alcohol research careers. Specifically, there remains a serious shortage of scientists from diverse backgrounds conducting independent alcohol research and of scientists who bring the cultural perspectives essential to successful research efforts on the disproportionate incidence, mortality and morbidity rates both within and between racial and ethnic minority populations.

Appropriate topics include but are not limited to those listed below.

• Studies of the patterns of alcohol consumption and alcohol related problems within specific diverse populations.
• Studies of factors contributing to differences in the rates of alcohol dependence between populations.
• Research to determine specific genetic or biological factors that may influence risk for alcohol dependence or organ damage.
• Research among high-risk diverse populations that develop/test interventions to prevent maternal drinking, fetal alcohol spectrum disorder and alcohol related neurological disorders.
• Research to determine biological, genetic, and environmental risk factors that lead to disproportionately high incidence of adverse pregnancy outcomes, cirrhosis and other health consequences of alcohol abuse.
• Research to identify social and cultural factors that influence motivation for prevention, alcohol treatment, adherence to treatment and treatment outcomes.
• Studies to identify and characterize those aspects of minority drinking environments (problems, patterns, community norms, values, etc.) that are likely to influence the outcomes of prevention and intervention studies.
• Research to evaluate the comparative effectiveness of screening and brief interventions in high risk diverse populations, health care, educational or other settings.
• Studies designed to investigate factors contributing to the excess morbidity and mortality associated with alcohol abuse and alcoholism in health disparity populations.

Biological and behavioral studies on the interrelationship of alcohol use and abuse to HIV/AIDS in diverse populations.

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

Hispanic Serving Institutions (HSIs), Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUS), Alaska Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) are particularly encouraged to apply. Such institutions are uniquely positioned to engage them in research and in the translation of research advances into culturally appropriate, measurable and sustained improvements in health outcomes. Each partnership must include both types of organizations: 1) an IUCP; and 2) an ARC. Each IUCP can partner with more than one ARC.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept 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 can access 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.

Most applicants will use NIH s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 sent to:

Abraham P. Bautista, Ph.D.
Fax: 301-443-9737
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	6
Core	12
Project (use for Research Projects)	12

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Cores: optional, 1-2
• Research Projects: required, 3

Each AHDRC application must be submitted as a clear partnership between the IUCP and ARC institutions. An IUCP may partner with more than one ARC. Each participating partner must submit separate applications. The overall objectives and the research plans of the applications should be identical.

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

Descriptive Title of Applicant's Project: To allow NIH to identify the set of collaborative U54 the titles for each application in the set must have the following format: a 1/2 or "2/2" indicator + identical title. Titles may not exceed 200 characters in length, including the tag (i.e., 1/2 or 2/2) at the beginning of the title.

Cover Letter Attachment: The Cover Letter is one pdf file only. Therefore, it must include the information requested below on the collaborative applications from the IUCP and ARC. The following collaborative information is required in the Cover Letter: a listing of ALL applications that are a part of the set of collaborative U54 applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag (i.e., 1/2 or "2/2"), and 3) the Applicant Institution. Each partnering institution should submit an identical listing.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

PD/PIs will have responsibility for planning and coordination of the AHDRC program, and other aspects of management and operation of the AHDRC. In addition, they are responsible for the preparation of the budget and oversight of expenditures, staff appointments, and space allocation at their respective institution(s).

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the theme and goals of the AHDRC and how they will advance research, impact the alcohol research community, and enhance research capacity at IUCPs. Describe how the specific aims of the proposed AHDRC will achieve these goals.

Research Strategy: The separate applications from the IUCP and ARC will be identical, with the exception of the Budget section (see Section II. 2. Funds Available and IV. 6. Other Submission Requirements for greater details).

Each application must include a collaborative plan that, at a minimum, includes a description of the proposed collaborations identifying the specific projects, the collaborators, and the interaction. To adequately address the strength of the AHDRC, describe coordination among the administrative and scientific cores and the research components. Explain how the usefulness of the scientific core components is magnified by their inclusion. Describe the synergistic potential among the different research components and how it will facilitate the AHDRC goals. Provide justification for each research component in terms of the overall research goals of the AHDRC. Demonstrate how the AHDRC has the potential to achieve a whole greater than the sum of its parts.

Letters of Support: Letters of support for the Center as whole should be included in this section.

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.

When preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Administrative Core must be managed by the PD/PI or the Scientific Director. The Administrative Core Lead and other key personnel must be appropriately trained and well suited to carry out the proposed organizational interactions. They must demonstrate that the qualifications, experience, and administrative competence of the Administrative Core Lead are appropriate.
• The applicants also may designate a Scientific Director who will report to the PD/PIs and provide direct supervision of the scientific and operational aspects of the research program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the AHDRC. The Scientific Director also will be responsible for the direct monitoring of ongoing research and identifying (with the assistance of colleagues) research and educational activities to be expanded or decreased, as well as needs for additional resources or reallocation of resources. If a PD/PI also serves as the Scientific Director, his or her functions as Scientific Director also should be described.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The application may request funds for scientific enrichment activities such as lectures, symposia, seminars, training, and workshops for research faculty and staff.

Budget may include recruitment costs and initial salary of highly qualified faculty at the IUCPs.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the specific aims of the Administrative Core

Research Strategy: The Administrative Core provides the organizational framework for the management, direction, collaborative planning process, and coordination of the AHDRC. A clear leadership plan that includes the organizational structure and reporting procedure should be included.

A thorough description of the administrative management and fiscal relationships that will be established within the AHDRC (i.e., between the IUCP and partnering ARCs) should be provided. The applicants should clearly describe the kinds of planning activities that the IUCP and ARC will conduct to ensure a highly interactive and integrated effort between their faculty and scientists. The applicants should relate each planning activity (e.g., workshop) to specific objectives of the AHDRC. The Administrative Core should ensure that all proposed components and related activities will function in an optimal and synergistic manner.

An important function of this core is the administration of the budget. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core.

Plans to facilitate and monitor attainment of AHDRC objectives should be presented. Plans for collaboration, communication, and cooperation among IUCP and ARC investigators should be described. Quality control and oversight mechanisms for ongoing projects and for mentorship across the linked applications should be in place. A system for long-term management and periodic evaluation of goal attainment should be proposed. Describe procedures that will be followed for replacement of key personnel, should that become necessary.

The partnering institutions will establish a Steering Committee that will be composed of PD/PI and other key personnel from all participating institutions, the NIH Project Coordinator and, where appropriate, outside expertise. The function of the Steering Committee is to facilitate the collaboration by monitoring progress and outcomes of individual collaborations, develop new collaborations, and review the strategies of the collaboration to see that it enhances the research environment of the IUCP.

Letters of Support: Letters of support for the Administrative Core should be included.

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.

Planned Enrollment Report (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

When preparing your application in ASSIST, use Component Type Core

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

SF424 (R&R) Cover (Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. Core Leads and other key personnel must be appropriately trained and well suited for the core activities. The qualifications and experience of the Core Leads must be appropriate and well-described.

Budget (Core)

Budget forms appropriate for the specific component will be included in the application package. Core Leads and other key investigators must provide a clear justification of their time and effort commitment.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Core)

Specific Aims: Describe the Specific Aims of the Core.

Research Strategy: Core components are shared research resources that provide AHDRC investigators with techniques, instrumentation, services, or resources that will enhance alcohol-related research to accomplish the common goals of the AHDRC. A core can be a laboratory, facility, service, or other resource that provides support for scientific research projects of the AHDRC. Cores should be used primarily to support projects which are part of the AHDRC award. A shared scientific resource component should be clearly described in terms of the services and resources to be provided to investigators. The description should include a discussion of the core’s contributions to the research objectives of the AHDRC. Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the cores also should be addressed. A core should support two or more of the AHDRC’s scientific research components and also may support independently funded research project grants related to the goals of the AHDRC program. Each separately funded research project associated with the AHDRC and utilizing core facilities should have a brief description that includes its research objectives and how the AHDRC s core facility will impact those objectives. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible to access the core facility. Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the AHDRC to include new technologies that broaden their research initiatives. While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Clearly state the justification for the need of a core service or resource, explaining the scientific and technical merit of the proposed core. Appropriate plans for resource allocation should be clearly described. Quality control procedures should be in place. Demonstrate that the resources and environment are adequate. Collaborative processes between the IUCP and ARC should be well considered.

Letters of Support: Letters of support for the Core should be included.

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.

Planned Enrollment Report (Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Core)

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

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources

A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in proposed studies. The interaction between paired investigators from the IUCP and the ARC should be described in detail. If core facilities are utilized, information on their use should be provided.

The scientific environment in which the work will be done must contribute to the probability of success. Demonstrate that the institutional support, equipment and other physical resources available to the investigators are adequate for the proposed research. Discuss how the research component benefits from unique features of the scientific environment, subject populations, or collaborative arrangements.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD/PI may not be Project Lead on more than one Research Project.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims: Describe the specific aims of the Research Project.

Research Strategy: Research components are collaborative individual scientific research projects that contribute collectively to the goals of the AHDRC program. Each Project Lead should be a qualified investigator who is responsible for the scientific direction and conduct of the individual research component. The application should provide a clear description of the major goals and objectives of the project, and how the project relates to the overall goals of the AHDRC. The hypotheses to be tested should be focused and fully detailed. The research design and procedures should describe the strategies proposed to accomplish the specific aims and innovative aspects of the approach should be highlighted.

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

Discuss the innovation of the proposed research project. Innovation can consist of the introduction of novel theoretical concepts, approaches or methodologies, or can challenge current paradigms in research or clinical practice. Refinements or new applications of theoretical concepts or approaches can be innovative if they advance the field in a significant way.

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

Letters of Support: Letters of support for the Research Project should be included.

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.

Planned Enrollment Report (Research Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Project)

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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, and responsiveness by the National Institute on Alcohol and Abuse Alcoholism, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the National Institute on Alcohol Abuse and Alcoholism 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-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the AHDRC 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 AHDRCr 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 center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?

How will the synergistic potential among the different research components facilitate the AHDRC goals?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

Is the Center Director at each of the partnered institutions capable of providing the scientific leadership and administrative oversight required to lead?

Will the investigators be able to plan and coordinate the AHDRC program, and other aspects of management and operation of the AHDRC?

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?

Will the Center make a significant and innovative contribution or fill a significant gap in addressing alcohol-related research in general, including health disparities?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the Center demonstrate appropriate multidisciplinary and interdisciplinary approaches to ensure highly interactive and integrated efforts between individual scientists and/or institutions?

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?

What is the capacity to provide quality research training, opportunities for independent research career development, and increasing research aptitude at the IUCP?

As applicable for the Center 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.

Coordination and Cohesiveness

What is the strength of the evidence that the researchers and faculty of the IUCP and ARC have worked closely together in preparation of this application, and can establish a lasting partnership?

Is the coordination among the cores and the research components well explained? Is there synergistic potential among the AHDRC s research projects and cores?

Is there justification for each research component in terms of the overall research goals of the Center? Does the Center have the potential to achieve a whole greater than the sum of its parts?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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.

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

Environment

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

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.

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.

The Administrative Core will receive a merit descriptor (outstanding, acceptable or unacceptable). The merit of each Administrative Core will be assessed based on the following criteria:

• Are the leadership plan and organizational structure adequately developed, well integrated and appropriate to the aims of the AHDRC?
• Does the application describe how day-to-day management will be accomplished? Does the application explicate the partnership and collaborative planning processes between the IUCP and ARC?
• Are the plans to facilitate and monitor attainment of AHDRC objectives appropriate?
• Are there adequate plans for collaboration, communication, and cooperation among investigators within and between the IUCP and ARC institution(s)?
• Is there a mechanism proposed for long-term management and periodic evaluation of goal attainment?
• Are contractual, and consortium arrangements described (as applicable)?
• Are there innovative features in the organizational design and decision making process?
• Is the coordination among the administrative core and the research components adequately explained?
• Are procedures in place to coordinate the replacement of key personnel should this become necessary? Are the key personnel appropriately trained and well suited for the administrative core activities and sufficient efforts are maintained?

Each Core must provide essential functions or services for at least two projects. Each Core will receive a merit descriptor (outstanding, acceptable or unacceptable). The merit of each Core will be assessed based on the following criteria:

• Is the Core well matched to meet the needs of the overall program? Does it provide essential facilities or services for two or more research projects? Is the need for core services well justified?
• What is the overall quality of the proposed core services? Will the proposed Core provide cost effective services to the Center? Are quality control procedures in place? Are there appropriate plans for prioritization and usage of Core facilities and/or services?
• Are the qualifications, experience, and commitment of the Core Lead and other key personnel adequate and appropriate for providing the proposed facilities or services? Are the resources and environment adequate to support the Center as proposed?

As applicable for the Cores and Projects, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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), convened by the National Institute on Alcohol Abuse and Alcoholism} in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

• Defining the objectives and approaches of the AHDRC.
• Support the Key Functions/Activities of the Administrative Core, Scientific Core, and Research Components.
• Collaborating with the partnered institution towards developing, adopting and implementing the agreed on policies, procedures, best practices, or other measures identified through the AHDRC Steering Committee.
• Provide information to the NIH Program Officer(s) and Project coordinator concerning progress.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH Responsibilities
An NIAAA Project Coordinator will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards, as described below.

• Interact with the AHDRC, coordinate approaches between the IUCP and ARC institution(s), and contribute to the adjustment of projects/programs or approaches as warranted.
• Provide assistance in reviewing and commenting on all major transitional changes of an individual CMARCD’s activities prior to implementation to ensure consistency with the goals of this FOA.
• Link the approaches developed from these partnerships to each other and to other NIAAA supported Alcohol Research Center networks to ensure that information is shared and utilized on the widest basis possible.
• Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success.
• Provide financial oversight of the AHDRC Program.
• Coordinate activities with other ongoing studies supported throughout national programs to avoid duplication of effort and encourage sharing and collaboration in the development of new clinically useful agents and methodologies.
• Review and comment on critical stages in the AHDRC implementation. Assist in the interaction between the partnering institution awardees to promote collaborations within the AHDRC and with other institutions
• Coordinate access to other resources available through national specialized alcohol research centers.
• Retain the option of recommending termination of support if performance or implementation fails below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner.
• Retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budgets.
• Convene meetings/workshops to address emerging areas of high priority.
• May recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of the initiative.

An NIAAA extramural Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official is distinct from the NIAAA Project Coordinator because their responsibilities lie with the programmatic stewardship of the award. The program official interacts with grants management to approve actions required by NIAAA prior approvals, evaluates the progress reports and fiscal reports to determine if performance is consistent with the objectives and terms and conditions of the award, provides technical assistance requested by awardees, and works with the awardee to resolve unanticipated programmatic or financial deficiencies in awardees performance. The program official will be assigned to the project based on the scientific area of investigation and the area of expertise of the program individual.

Collaborative Responsibilities
The goal of the AHDRC program is to promote the development of alcohol research expertise and infrastructure to strengthen research capacity at IUCP. To assist IUCPs in achieving this goal, IUCPs will submit linked applications that propose partnerships with ARC to form a AHDRC. Awardees are strongly encouraged to participate in national scientific organizations convened to advance collaborative clinical, translations, and health disparities research.

A Steering Committee comprised of representatives from the IUCP, ARC, the NIH Project Coordinator and, where appropriate, outside expert(s) will serve to facilitate collaboration by monitoring progress and outcomes of individual collaborations, develop new collaborations and promote strategies to enhance the research environment of the IUCP.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
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Judy Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: [email protected]

Kathy Jung, Ph.D.
National institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-8744
Email: [email protected]

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

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

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