It is critical that applicants follow the Multi-Project (M) 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

The purpose of this funding opportunity is to support NIAAA Collaborative Partnership

between Research Centers in Minority Institutions (RCMI) and other institutions with extensive alcohol research programs, including NIAAA-funded alcohol research centers and consortia (ARC). RCMI are institutions that offer doctorate degrees in the health professions or in a health-related science and have a historical and current commitment to educating underrepresented students, and for institutions that deliver health care services, providing clinical services to medically underserved communities. ARC refers to institutions with extensive alcohol research programs including, but not limited to, NIAAA-funded alcohol research centers. Through productive partnership with ARC, this FOA aims to build and promote alcohol research expertise and to develop alcohol research infrastructure and capacity at RCMI. RCMI are uniquely positioned to engage in health disparity research and in the translation of research advances into culturally appropriate, measurable and sustained improvements in health outcomes. It is expected that both the RCMI and ARC engage diverse group of scientists in biomedical research, which includes but is not limited to participation of individuals from underrepresented backgrounds (i.e. racial and ethnic minorities, persons with disabilities, or persons from disadvantaged backgrounds), women, early-stage and experienced investigators with a track record of funding, and investigators from various disciplines/departments and specialties. NOT OD 20-031 (Notice of NIH's Interest in Diversity).

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 use disorder, liver damage, stroke, cancers of the mouth and esophagus, and brain neurodegeneration). 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 African-Americans than white Americans. 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. 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 brain neurodegeneration, cirrhosis, alcohol-associated liver diseases, 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 in drinking among underage females have been reported among Hispanics. Racial/ethnic minority groups have different genetic backgrounds, and some of the disparities in disease incidence and prevalence are due to differences in genetic predisposition. Large-scale genome-wide association studies have identified known loci in alcohol-metabolizing enzyme ADH1B gene that differed between populations of European and African ancestries. Furthermore, genetic and biological factors influencing risk for alcohol consumption and alcohol use disorder may interact with behavioral, cultural, and environmental factors to manifest health disparities.

Studying the effects of alcohol on all populations requires a diverse biomedical workforce. Diverse groups provide a better understanding of the research problem and varied approaches and solutions. To better address the health disparities associated with alcohol consumption, NIAAA is seeking to increase the diversity of the alcohol research workforce. RCMIs are effective in educating students from diverse cultures to conduct research and to provide outreach to communities experiencing health disparities. RCMIs represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in alcohol research. However, few RCMIs have developed the capacity for a sustained program in alcohol research. For many years, NIAAA has supported more than 20 Alcohol Research Centers (ARCs), which are regional resources focused on scientific activities that investigate the causes, diagnosis, treatment, control, prevention, and consequences of alcohol use disorder. These NIAAA funded ARCs provide research training opportunities across disciplines and professions.

Recognizing a critical need to establish and continue to support alcohol research programs to promote the participation of scientists from diverse backgrounds, NIAAA has supported collaborative partnerships between under resourced institutions and alcohol research intensive institutions. The collaborative partnerships between the RCMI and the ARC, initiated by either partner, build a diverse alcohol research workforce and research capacity at the RCMI. However, there remains a serious shortage of scientists from diverse backgrounds conducting independent alcohol research and of scientists who bring the socio-cultural perspectives essential to successful research efforts on alcohol use disorders. Through this FOA, NIAAA intends to continue to support cooperative partnerships to enhance biomedical and behavioral alcohol research on the disproportionate incidence, mortality and morbidity rates both within and between racial, ethnic, gender, sexual identity, age, disability, socioeconomic status, and geographic location diverse populations.

Appropriate research topics include but are not limited to studies that seek to:

• Examine patterns of alcohol consumption and alcohol related problems within specific diverse populations.
• Evaluate factors contributing to differences in the rates of alcohol use disorder between populations.
• Identify and investigate the mode of actions of specific genetic or biological factors that may influence risk for alcohol use disorder or systemic organ damage in animal model systems.
• Develop/test interventions to prevent drinking across the life span; including maternal drinking, fetal alcohol spectrum disorder and alcohol related neurological disorders.
• Investigate cellular and molecular mechanisms underlying altered gene expression and behavioral phenotypes in response to alcohol exposure.
• Determine biological, genetic, and environmental risk factors that lead to disproportionately high incidence of adverse pregnancy outcomes, cirrhosis and other health consequences of alcohol use.
• Evaluate the comparative effectiveness of screening and brief interventions in high risk diverse populations, health care, educational or other settings.
• Investigate factors contributing to the excess morbidity and mortality associated with alcohol use disorder in diverse populations.
• Treat problem alcohol use, including development of novel culturally grounded intervention, cultural adaption of existing evidence-based interventions or dissemination of existing evidence-based intervention in diverse populations.

Activities to promote the participation of scientists from diverse backgrounds may be focused at any training or career level, and may include:

• Individual research experiences for undergraduate students in associate and/or bachelor's degree programs that count towards degree requirements
• Short-term alcohol research experiences that enhance postdoctoral studies
• Programs that introduce or initiate alcohol research components into faculty research programs
• Supplemental research activities for clinical and behavioral health professionals

This funding opportunity is intended to support the active collaborations of RCMIs, NIAAA supported Alcohol Research Centers (https://www.niaaa.nih.gov/niaaa-funded-research-centers), and other alcohol research intensive institutions to promote research in alcohol in diverse populations and increase the diversity of the alcohol research workforce. Activities are anticipated to contribute to a long-term self-sustaining integrated research community. NIAAA encourages ARCs and other alcohol research intensive institutions to seek partnerships with local and regional RCMIs, and likewise for RCMIs to engage alcohol research intensive institutions in alcohol-related research and training.

AIDS-related research will not be accepted in response to this funding opportunity announcement.

NIAAA will accept a set of collaborative U54 from an RCMI with no more than one (1) ARC partner.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)

To be eligible for this FOA, the RCMI applicant institution must be a domestic institution located in the United States and its territories which:

1. Have received an average of less than $50 million per year of NIH support for the past three fiscal years;

2. Award doctorate degrees in the health professions or the sciences related to health;

3. Have a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities); and

4. Have a documented track record of: (1) recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers and, (2) for institutions that deliver health care services, providing clinical services to medically underserved communities.

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

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.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9737
Email: [email protected]

Available Component Types	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: 1, required
• Cores: maximum 2, optional
• Research Projects: 3, required

When preparing your application, use Component Type Overall .

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

Complete entire form. with the following additional instructions:

Descriptive Title of Applicant's Project: To allow NIH to identify linked applications as a related pair of collaborative U54s, the titles for each U54 in must have the following format: a 1/N indicator + Identical Title (e.g., 1/2 , where the 1/2 means, 1 for RCMI and 2 for the ARC partner. Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.

E-submission Cover Letter Attachment: An e-submission cover letter in one PDF file only, is required for each application that is a part of the pair. The following collaborative information is required in the letter: a listing of all the applications that are a part of the set of collaborative U54s being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., 1/2 the Applicant Institution. Each site should submit an identical listing.

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

Follow standard instructions.

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.

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

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.

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.

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

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

The separate applications from the RCMI 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 collaborative partnership, 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 collaborative partnership goals. Provide justification for each research component in terms of the overall research goals of the collaborative partnership. Demonstrate how the collaborative partnership has the potential to achieve a whole greater than the sum of its parts.

The overall plan should describe how the past achievements, including strategies to enhance research capacity, can build a sustainable long-term collaboration between the RCMI and the ARC. Renewal applications should provide a transition plan to sustain the research program and workforce activities Progress Report: Renewal applications must provide a Progress Report according to the instructions in the SF424 (R&R) Application Guide.

Letters of Support: Letters of support for the collaborative partnership as whole should be included in this section

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applications that include human subject research in one or more components of the U54 are also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT AA-18-010.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Admin core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• 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 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 collaborate partnership. The Scientific Director also will be responsible for the direct monitoring of ongoing research and identifying (with the assistance of colleagues) research 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 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.

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 collaborative partnership. 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 collaborative partnership (i.e., between the RCMI and partnering ARCs) should be provided. The applicants should clearly describe the kinds of planning activities that the RCMI 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 collaborative partnership. The Administrative Core should ensure that all proposed components and related activities will function in an optimal and synergistic manner.

In addition, this core should include a detailed description of the leadership succession plan to ensure that a pipeline of leaders will be available when they are needed, in the event that the RCMI and /or ARC Director retires, becomes incapacitated or for some other reasons. The core should also include a plan to promote future leadership of the center and develop alcohol researchers with experience and expertise to lead multi investigator research projects.

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 collaborative partnership objectives should be presented. Plans for collaboration, communication, and cooperation among RCMI and ARC investigators should be described. Quality control and oversight mechanisms for ongoing projects 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 Scientist 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 RCMI.

The Administrative core is expected to provide diverse undergraduate and/or graduate students opportunity to gain significant biomedical research experience through active involvement in one of the research components of the RCMI and ARC U54 Centers. The Administrative Core will manage the recruitment of students and will coordinate with the Center’s Project Leads who will accommodate and include the students, as active participants in the research projects. The administrative Core will evaluate the success of the students participation through presentations and publications.

Applications must include a plan for evaluating the activities supported by the award.

Renewal Applications: A succinct account of the published and unpublished results must be provided, indicating progress toward achieving aims of the Administrative Core. Identify manuscripts where undergraduate and graduate students are listed as co-authors. Ongoing or completed core activity that has enhanced or facilitated alcohol research should be described. Past performance and accomplishments of cores should be described, and the effect of services provided by this core on investigators' productivity, and progress on engaging undergraduate and graduate students in research.

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 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. Applications that include human subject research in one or more components of the U54 re also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT AA-18-010.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, 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.
• 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 collaborative partnership. 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 (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 investigators with techniques, instrumentation, services, or resources that will enhance alcohol-related research to accomplish the common goals of the collaborative partnership. A core can be a laboratory, facility, service, or other resource that provides support for scientific research projects of the collaborative partnership. Cores should be used primarily to support projects which are part of the 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 collaborative partnership. 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 collaborative partnership’s scientific research components and may support independently funded research project grants related to the goals of the program. Each separately funded research project associated with the collaborative partnership and utilizing core facilities should have a brief description that includes its research objectives and how the 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 within the collaborative partnership 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 RCMI 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 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. Applications that include human subject research in one or more components of the U54 re also expected to describe basic plans for submitting grant-related human subjects data to the NIAAA-sponsored data repository, as described in NOT AA-18-010.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, 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 RCMI 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 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.

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 collaborative partnership. 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 collaborative partnership. 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 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:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. 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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at [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 the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this FOA, note the following:

The emphasis of this FOA is on highly meritorious collaborative research partnership between RCMI and NIAAA-funded ARC. These research efforts must be focused on the specific goals of establishing or sustaining alcohol research infrastructure at RCMIs. To be viewed as highly meritorious, the proposed U54 application must also have a distinct emphasis professional enhancement opportunities for participating investigators from diverse backgrounds, including those from underserved communities and populations, and particularly those at the early stage levels

Scoring. Reviewers will provide an overall impact score for the entire U54 application (Overall). In addition, assigned reviewers will provide individual "criterion scores" for the Overall application but not for the other components.

Other components of the U54 application [i.e., Administrative Core, each individual Research Project, Developmental Core, and optional Other Core(s)] will be evaluated but each will receive only one overall adjectival (not numerical) rating.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

Does the collaborative partnership address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the collaborative partnership 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?

Specific to this FOA

How strongly and effective will the synergistic potential among the different research components facilitate the collaborative partnership goals?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the collaborative partnership? If Early Stage Investigators or those 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?

Specific to this FOA

How well does the proposed Center achieve the objectives in enhancing the infrastructure of alcohol research at RCMI in collaboration with the ARC? How likely is the collaboration capable of increasing the pool of diverse investigators skilled in alcohol research? How likely is the proposed research to serve in reducing burden of AUD in underserved populations?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

Specific to this FOA

Will the collaborative partnership make a significant and innovative contribution or fill a significant gap in addressing alcohol-related research and the development of diverse alcohol investigators?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the collaborative partnership? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the collaborative partnership 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA

How well does the center demonstrate appropriate multidisciplinary and interdisciplinary approaches to ensure highly interactive and integrated efforts between individual scientists and/or institutions? How well does the center present a plan for the long-term development of the research programs and alcohol investigators?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed collaborative partnership 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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not applicable

For Renewals, the committee will consider the progress made in the last funding period. The committee will consider the long-term sustainability of the program, and assess the ability of the collaborative partnership to enhance alcohol research programs and workforce at the RCMI

Not applicable

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

Not applicable

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

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 provide an overall merit descriptor score to reflect their assessment of the likelihood for the core 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).

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 collaborative partnership?

Is the leadership succession plan clear and appropriate in order to ensure that a pipeline of leaders will be available when they are needed, in the event that the RCMI and/or ARC Director retires, becomes incapacitated or for some other reasons?

Is the plan to promote future leadership adequate for the center to develop alcohol researchers with experience and expertise to lead multi investigator research projects?

How well does the Core describe management of day-to-day activities in order to establish and maintain productive and efficient collaborative partnership between the RCMI and ARC?

Are the plans to facilitate and monitor attainment of objectives appropriate?

Are the plans for collaboration, communication, and cooperation among investigators within and between the RCMI and ARC institution(s) adequate?

How innovative are the organizational design and decision-making process?

Is the coordination among the administrative core and the research components adequately explained?

Do the PD(s)/PI(s) or Leads of the cores and research project components have suitable experience in supervising and engaging undergraduate and graduate students in research?

How well described are the procedures in place to coordinate the replacement of key personnel, should this become necessary? How well does these procedures address the identification and/or training of key personnel appropriate for the administrative core activities?

Reviewers will provide an overall merit descriptor score to reflect their assessment of the likelihood for the core(s) 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).

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, such as providing 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 Cooperative Agreement? 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 Cooperative Agreement as proposed?

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).

In addition, for applications involving clinical trials

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. The overall impact score for individual research projects will take into consideration: the scored review criteria and any specified additional review criteria; the extent to which the individual project enhances the strength of the overall Collaborative partnership; and the importance of the individual project to the success of the Collaborative partnership.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

For FOAs that allow but do not require clinical trials ("CT-optional FOAs"), include the heading below. These questions should be placed below any FOA-specific questions that apply to both CT and non-CT applications.

Specific to applications involving clinical trials

For all CT FOAs, add the following questions, before the Human Subjects Protections criterion.

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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 collaborative partnership 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) Genomic Data Sharing Plan .

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 NIAAA in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 75, 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 cooperative agreement.
• 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 Cooperative Agreement 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

Project Scientist

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

• Interact with and coordinate approaches between the RCMI 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 component of the Cooperative Agreement’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 cooperative agreement 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 implementation of the collaborative partnership. Assist in the interaction between the partnering institution awardees to promote collaborations within the collaborative partnership 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.

Program Official/Director

• 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.
• The Program Official 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, and 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.

Collaborative Responsibilities

The goal of the collaborative partnership is to promote the development of alcohol research expertise and infrastructure to strengthen research capacity at RCMI. To assist RCMIs in achieving this goal, RCMIs will submit linked applications that propose partnerships with ARC to form a collaborative partnership. Awardees are strongly encouraged to participate in national scientific organizations convened to advance collaborative clinical, translations, and diversity related research.

A Steering Committee comprised of representatives from the RCMI, 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 RCMI.

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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Judith Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0 717
Email: [email protected]

Hemin Chin, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:301 443 1282
Email: [email protected]

RV Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:3010-451-2067
Email: [email protected]

Ms. Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 Part 75.