RFA-AA-28-001-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Specialized Alcohol Research Centers (P50 Clinical trial Optional)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of

RFA-AA-24-007

Related Notices

Funding Opportunity Number (FON)

RFA-AA-28-001

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.273

Notice of Funding Opportunity Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad-based Alcohol Research Centers program to foster and conduct interdisciplinary, collaborative research on alcohol misuse, Alcohol Use Disorder (AUD), and alcohol-related problems, and other health-related consequences across the lifespan. The NIAAA Centers Program provides leadership in research, and research methodology development on a wide variety of topics relevant to the Institute's mission. The focus of the NIAAA Centers program should be on generating a critical mass of researchers in a given understudied and/or innovative topic area relevant to the NIAAA mission with an emphasis on interdisciplinary coordination and cooperation among independent researchers and development and mentorship of young investigators. A center must contribute more to the alcohol field than the sum of its parts. Topics include but are not limited to, the nature, etiology, genetics, diagnosis, treatment, and prevention of alcohol misuse, AUD, alcohol-related end-organ diseases, and their biomedical, psychosocial, and population health consequences across the lifespan. Centers are also major contributors to the development of research methods, technologies, and approaches that sustain innovative goal-directed research on understanding the chronic disorder of alcohol misuse that is such a personal, social and medical burden to US society.

Funding Opportunity Goal(s)

To develop a sound fundamental knowledge base which can be applied to the development of improved methods of treatment and more effective strategies for preventing alcoholism and alcohol-related problems. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports research in a broad range of disciplines and subject areas related to biomedical and genetic factors, psychological and environmental factors, alcohol-related problems and medical disorders, health services research, and prevention and treatment research.

Key Dates

Posted Date

October 15, 2026

Open Date (Earliest Submission Date)

December 27, 2026

January 27, 2027

January 27, 2027

Not Applicable

December 2027

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date

January 28, 2027

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Research Objectives This NOFO uses the NIH Specialized Research Center (P50) mechanism to support an integrated, broad-based multidisciplinary, multi-investigator, long-term program of research and research support activities planned around a specific major research theme. Specialized Alcohol Research Centers are also expected to function as a regional and national resource in their particular area of expertise; to provide students and early-stage investigators opportunities to build research expertise; and to develop research collaborations with outside investigators. Centers have the option of proposing pilot projects to support early-stage investigators, attract new scientific perspectives and research sites to the center, and expand research into areas addressing novel research hypotheses relevant to health outcomes associated with AUD (e.g., trauma, adversity). The Alcohol Research Centers program is interrelated with, and complementary to, all other research support mechanisms and scientific activities that comprise NIAAA programs. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated, integrated, and synergistic effort.

The Specialized Alcohol Research Center provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting exceptional alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure, such as a university, medical center, or a consortium of affiliated cooperating institutions. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. Unique scientific opportunities including the sharing of resources or expertise warrant collaboration with investigators from other centers or other institutions, domestic or foreign. The director of component(s) in which collaborative activity with a foreign organization is proposed should be affiliated with a domestic institution.

Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed:

P50 Applications that include one or more components (core, research project, pilot project) focusing on HIV/AIDS-related topics.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed

New

Renewal

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAAA intends to commit $1.5 million in FY 2027 to fund up to one award.

Award Budget

Application budgets may not exceed $1.15 million direct costs per year.

Award Project Period

Applications may request a project period of up to five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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.

Required Registrations

Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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 How to Apply - Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

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 per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package 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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Optional

Optional

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type 'Overall'.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) 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.

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

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

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the theme and goals of the Center and how they will advance research and impact the alcohol research community. Describe how the specific aims of the Center will achieve these goals

Research Strategy: The Research Strategy for the Overall component must describe the central theme, purpose and objectives of the entire Center. It gives the philosophy and general plan for the proposed grant period and how the Center will achieve its major objectives. The reason a Center approach is needed for this work should be well articulated. The unique contribution for the Center and each component (including pilot projects component, if applicable) to the center should be described. The significance of the overall research goal and research theme are described and the importance and relevance of these to the mission of the Center's program.

Research Strategy for the Overall component must also describe the following:

For Renewal applications:

The Research Strategy for the Overall component must include an introductory overview to provide a history of the Center and, and without duplicating information in the Progress Report, give a summary of major research accomplishments and progress toward achievement of goals since the last competitive application.

Progress Report:

Letters of Support:

Letters of support for the Specialized Center as a whole should be included in this section (e.g., letters of institutional support). Letters of support relevant to specific Projects or Core(s) should be attached to the relevant Project or Core components. Include a table summarizing the names, institutions and role, e.g., collaborator, consultant, resource user, Center Advisory Board (PAB) member.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative Core When preparing your application, use Component Type 'Admin Core.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core) Follow standard instructions.

Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

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

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

Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component.

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

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

Budget (Administrative Core) 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 (Administrative Core) Specific Aims: Describe the specific aims of the Administrative Core Research Strategy: The Administrative Core provides the organizational framework for the management, direction, and coordination of the Center. This core should ensure that all proposed components and related activities will function in an optimal and synergistic manner. An important function of this core is also the administration of the budget. It may support scientific enrichment activities such as lectures, symposia, seminars, and workshops for research faculty and staff. 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. 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 Center 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.

A Program Advisory Committee (PAC) shall be established and chaired by the Center Director. The PAC will be composed of at least five (5) members, selected by the Center Director from individuals outside the Center. These members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of the PAC to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the management of pilot projects. For new applications, do not contact, recruit, or name potential external advisory council members in the application (not until after peer review and as directed by NIH Program staff). For renewal applications, provide the names of current and former external advisory council members but do not contact, recruit, or name potential new members. The current PAC members should not be identified as key personnel. Plans should be provided for selection of new PAC members, if applicable.

The Center Director(s) will establish a Steering Committee that will be composed of the Center Director(s) and Core/Research Component Directors. The function of the Steering Committee is to facilitate collaboration by monitoring progress and outcomes of individual projects, develop new collaborations, and review the Center's strategies for achieving its goals.

Renewal Applications: A succinct account of the published and unpublished results must be provided, indicating progress toward achieving aims of the Administrative Core. 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.

Progress Report Publications List: Provide a bibliography of publications credited to the Administrative Core.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Resource Core When preparing your application, use Component Type 'Core.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Resource Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Resource Core) Follow standard instructions.

Research & Related Other Project Information (Resource 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) (Resource 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 (Resource Core)

Budget (Resource Core) 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 (Resource Core) Specific Aims: Describe the specific aims of the Resource Core Research Strategy: A shared scientific resource core 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 Center. Relevant aspects of cost-effectiveness, time saving, and increased efficiency attributable to the existence of the cores should also be addressed.

A core should support two or more of the Center's scientific research components and may also support independently funded research project grants related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact those objectives. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible to access the core facility. Cores are intended to enhance opportunities for investigators at the Center to utilize 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.

Renewal Applications: A succinct account of the published and unpublished results must be provided, indicating progress toward achieving aims of the Resource Core(s). 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 the Resource Cores on investigators' productivity.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Resource 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Pilot Projects Core When preparing your application, use Component Type 'Core.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Pilot Projects Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot Projects Core) Follow standard instructions.

Research & Related Other Project Information (Pilot Projects 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) (Pilot Projects 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 (Pilot Projects Core)

Budget (Pilot Projects Core) 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 (Pilot Projects Core) Specific Aims: Describe the specific aims of the Pilot Projects Core Research Strategy: The application must provide thorough and concise descriptions of the projects to be supported in the first two years. All proposed pilot projects need not be ongoing at any one time but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for the management of pilot project funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide sufficient information to enable adequate scientific evaluation by a peer review committee. The application should include a full description of the management of the pilot projects core, including a description of the process used to solicit, evaluate, and select pilot projects. This includes the selection of new projects to replace those proposed in the application should it become necessary. Each pilot study proposed in the first 2 years should be described, including its rationale, objectives, approach, investigators, and significance for the Center. The research description of any individual pilot project may not exceed two pages. Describe how the projects will benefit from the unique features of the scientific environment, subject populations or collaborative arrangements. Describe how individual pilot projects have the potential to develop into full-scale independent projects.

Renewal Applications: A succinct account of the published and unpublished results must be provided, indicating progress toward achieving the aims of the Pilot Projects. Ongoing or completed activities that have enhanced or facilitated alcohol research should be described. Past performance and accomplishments of the pilot project core should be described. Describe if any of the pilot projects from the previous funding cycle developed into full-scale independent projects.

Progress Report Publications List: Provide a bibliography of publications credited to the Pilot Projects Core.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Pilot Projects 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Research Project When preparing your application, use Component Type 'Project.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project) Complete only the following fields:

PHS 398 Cover Page Supplement (Research Project) Follow standard instructions.

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.

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)

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: The application should provide a clear description of the project's major goals, and objectives, and how it integrates with the other research components in relation to the overall Center program. The hypotheses to be tested should be focused and fully detailed. The design and procedures should describe the strategies proposed to accomplish the specific aims and the innovative aspects of the approach should be highlighted. If core facilities are utilized, information on their use should be provided.

Renewal Applications: A succinct account of the published and unpublished results must be provided, indicating progress toward achieving aims of the Research Projects. This must include a bibliography of publications credited to this component. Past performance and accomplishments of the research projects should be described.

Progress Report Publications List: Provide a bibliography of publications credited to each Research Project.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project) 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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

4. Submission Dates and Times Part I. 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…