PAR-27-127-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 OF MENTAL HEALTH (NIMH)

Funding Opportunity Title

Silvio O. Conte Centers for Basic Neuroscience or Translational Mental Health Research (P50 Clinical Trial Optional)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of

PAR-22-155

Related Notices

Funding Opportunity Number (FON)

PAR-27-127

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.242

Notice of Funding Opportunity Purpose

This notice of funding opportunity (NOFO) encourages applications for Silvio O. Conte Centers for Basic Neuroscience or Translational Mental Health Research. The National Institute of Mental Health (NIMH) seeks teams of integrative researchers working at different levels of analysis and employing novel, and creative experimental approaches to address high-risk, high-impact questions with the primary objectives of: (a) advancing basic brain and behavior research that will uncover underlying mechanisms that could provide the foundation for understanding mental disorders; (b) supporting the integration and translation of basic and clinical neuroscience research on severe mental illnesses; (c) advancing our understanding of the neurobehavioral mechanisms and trajectories of psychopathology that begin in development. This program is intended only for projects that could not be achieved using other, more standard grant mechanisms.

Funding Opportunity Goal(s)

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

Key Dates

Posted Date

September 01, 2026

Open Date (Earliest Submission Date)

September 15, 2026

The following table includes NIH standard due dates marked with an asterisk.

October 15, 2026

October 15, 2026

Not Applicable

July 2027

May 25, 2027 *

May 25, 2027 *

Not Applicable

April 2028

May 25, 2028 *

May 25, 2028 *

Not Applicable

April 2029

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.

Expiration Date

May 26, 2028

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

The Conte Centers program seeks highly meritorious applications focused on a well-defined and unified scientific question (hypothesis) or problem. A Conte Center application does not need to include both basic neuroscience and translational research; however, it should comprise a collaborative, cutting-edge, multidisciplinary research program that would be difficult to undertake within the confines of a single laboratory or a small-scale collaboration.

Research topics may include any aspect of basic genetics and neuroscience related to cognitive, affective, or social function of the brain and can be conducted at multiple levels of analysis involving genes, cells, synapses, circuits, and behavior, in healthy and/or disease states, in model systems or humans, and from the prenatal period throughout the lifespan. Center projects may also include translational integration of neuroscience to address clinical questions in humans to identify the etiology, pathophysiology, developmental trajectory, potential biomarkers, and/or the mechanistic substrates of interventions with the goal of eventual prevention, treatment, and cure of mental disorders across the lifespan. Discovery-based as well as technology development components in support of the primary scientific question are welcomed. Important features of Conte Centers should include interdisciplinary research training opportunities for future biomedical scientists, and the widespread sharing of replicable, reproducible and generalizable data, as well as newly-developed methods and resources to the community. Thus, the Conte Centers program provides a unique opportunity to address one or more of the NIH priorities and NIMH strategic plan.

General characteristics of Conte Centers are listed below:

In addition to considering the strengths and weaknesses of the scientific premise that form the basis for the questions asked, the application should be constructed to enhance reproducibility through scientific rigor (Guidance: Rigor and Reproducibility in Grant Applications | Grants & Funding).

Student and Postdoctoral Research Experiences It is expected that the Conte Centers will train future biomedical scientists by providing students and postdoctoral fellows opportunities for interdisciplinary research in close coordination with existing formal research training programs at the participating institution(s). As part of the Administrative Core, the Conte Center should provide opportunities for individuals to become engaged in the innovative interdisciplinary collaborative interactions driving the Center's research objectives and to obtain a broad, multidisciplinary perspective in the Conte Center research area.

Communication and Outreach As part of the Administrative Core, Conte Centers should include a communications element that includes a website, public outreach, and dissemination activities. Encouraged outreach activities may include Conte Center-focused partnerships with local school systems, science museums, or related institutions. These activities may involve the participation of Conte Center investigators in special lectures or laboratory demonstrations as part of ongoing outreach programs, such as Brain Awareness Week and National DNA Day. Visits from classroom groups would also be appropriate to include as an outreach activity.

Conte Centers are encouraged to develop and maintain a website for a broad audience that describes the Conte Center and how the research supported by the Center will advance our understanding of the biology of mental disorders.

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

Resubmission

Revision

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

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

Award Budget

Direct costs are limited to $2 million in any one year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 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:

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

Required

NA

Optional

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.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed above may not apply to the revision applications.

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) Follow standard instructions.

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:

Provide a concise description of the overall Center aims. Outline how the projects and core(s) will contribute to attaining the Center objectives.

Research Strategy:

The Research Strategy should begin with a brief overview of the Center describing the scientific problems being addressed, the integration of the Center components, and why these components are essential for accomplishing the goals of the overall Center. The overview should be targeted to a broad audience and be concise. The overview should include:

1. An explanation of how the proposed work uses multiple approaches and experimental systems to cross traditional disciplinary boundaries to address a well-defined hypothesis or question.

2. For the basic neuroscience centers, an explanation of the timeliness and the potential importance and relevance of the proposed research to advancing our understanding of the fundamental mechanisms of brain development, function, gene regulation, or behavior; or preclinical approaches to treatment development, or computational approaches to understanding these mechanisms. For the translational centers, an explanation of how the proposed work integrates component projects (basic, preclinical or clinical) with translational concepts to advance our understanding of disease etiology and/or treatment of mental health disorders. If a clinical trial is proposed, cite prior relevant trials or systematic reviews that would help to justify why this trial is needed. Mental health disorders of interest to NIMH include depression, bipolar disorder, post-traumatic stress disorder, anxiety, schizophrenia, obsessive compulsive disorder, autism spectrum disorders, and other developmental disorders. NIMH is particularly interested in understanding fundamental brain changes that occur during sensitive periods of brain development and periods of increased vulnerability to psychopathology.

3. Value added by the interdisciplinary Center approach. This section should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Center's major objectives, a description of how the Center as a whole will benefit from interdisciplinary interactions, an explanation of why this work cannot be accomplished outside of this funding opportunity, and why the whole is significantly better than the sum of its parts. The section should also address how the Center will ensure appropriate prioritization of research, and identify problems, resolutions, and (if needed) course corrections.

4. If a scientific project or core involves risk, applicants should explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field. Applicants should also explain potential threats (if any) to data integrity and how these threats might affect the feasibility of the proposed research.

5. In this section, applicants should address the strengths and weaknesses of the scientific premise forming the basis of their questions and enhancing reproducibility through rigor (see: NOT-MH-14-004).

The Research Strategy should also include:

1. Preliminary Data: This section should include evidence for feasibility and preliminary findings and/or progress made during the previous funding period. This section should also present very clear evidence that the research team will be able to work together effectively to accomplish the research proposed in the projects.

2. Center Approach: This section should describe the working scientific and logistical design, as well as the resource support necessary to implement the research, demonstrating how the Center mechanism will serve to enhance the individual projects proposed. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements to facilitate communication and collaboration across the sites should be included. Institutional support, if any, should be described in this section.

3. Timeline, Milestones, Evaluation Plan and Advisory Board: A graphic Overall Center Timeline and a descriptive Milestones section for the overall Center must be included in the Research Strategy section for the Overall Center. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include specific proof-of-concept test(s) along with any alternative strategies should any component efforts fail to perform as expected. This Overall Center Timeline is separate from the Study Timeline in section 2.7 of the PHS Human Subjects and Clinical Trials Form. The Overall Center Timeline should include the establishment of a to-be-named external scientific board to be convened annually to assess progress and accomplishments and provide feedback to the Center. It is very important that potential external scientific board members not be contacted or identified in the application to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration. External scientific board members should only be identified after a funding decision is made.

Progress Report (For Renewal Applications):

Additional Instruction for Multi-project:

If you include a Progress Report Publication List attachment, include it in either the Overall Component or within each Other Component, but do not attach the same information in multiple locations.

Protection of Human Subjects:

Applications with data collection plans that involve human participants, including multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (see NOT-MH-19-027). The application's Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Letters of Support:

Include letters of support relevant to the overall Center here. Letters detailing contributions to individual components should be placed in their respective individual Project or Core component. When multiple institutional sites are involved, a letter of support should be included that details the description of the cooperative administrative arrangements.

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:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. For more guidance on submitting data to NDA, refer to the NDA Data Management and Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

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.

Delayed Onset studies are not permitted for Conte Centers.

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 application 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.

Each proposed Center Director must commit a minimum effort of 3 person months per year overall to the Center and be a leader of one of the projects and of the administrative core. The 3 person months should be a total of the Center Director's efforts on his/her project(s) and core(s). The 3 person month requirement also applies to any individual listed as a PD/PI in a multiple PD/PI Center.

The Administrative Core Leader must commit a minimum effort of 1 person month per year to the core. If there are multiple leaders for the Administrative Core, the combined efforts of the identified Administrative Core Leaders must total 1 person month.

The Administrative Core budget should include costs for:

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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a concise description of the goals of the Administrative Core.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary systems biology research, student and postdoctoral research infrastructure and outreach, to foster synergy, and to support planning and evaluation activities. Provide a clear and detailed plan for managing the Center's research and administration.

Highlight features of the Administrative Core that will enhance the collaborative effort, including optimizing communication, decision-making and sharing between the Project and/or Scientific Core teams.

Describe how each Project or Scientific Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Project or Research Support Core needs. The description of the Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be achieved in a coherent manner.

Additional information is encouraged:

Public Outreach/Dissemination Plan: Outreach and dissemination activities that will inform the public about Conte Center activities and enhance science literacy should be described in this section.

Letters of Support: Include letters of support relevant to the administrative core.

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 Delayed Onset studies are not permitted for Conte Centers.

Research Projects 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 Projects) Complete only the following fields:

PHS 398 Cover Page Supplement (Project) Follow application instructions.

Research & Related Other Project Information (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.

Application guide states that Project Narrative is required. However, it is only required for the Overall component Project /Performance Site Location(s) (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 (Project)

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

Leaders of a Project must commit a total minimum effort of 1.8 person months per year to each project. Multiple project leaders are allowed for Projects. If there are multiple leaders on a Project, the combined efforts of the identified project leaders must total 1.8 person months per year per Project.

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 (Project) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: List the specific objectives of the proposed research.

Significance: Describe the overall goals and how the science proposed in the project will advance the state-of-the-art of the field. This section should also explain the contribution of the project to the overall goals of the Center, how the project will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment.

Innovation: Describe the unique and innovative contributions that will be made by this project. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project.

Approach: Describe the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls, and alternative approaches for the project and how these might impact progress in the overall Center.

Environment: Describe the scientific environment in the context of anticipated interactions between this project and other components of the Center and anticipated progress in the overall Center.

Letters of Support: Include letters of support relevant to the project.

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:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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 (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.

Section 2 - Study Population Characteristics

2.7 Study Timeline

Applicants should include a section on Sample Subject Timeline. Address the time it will take for an individual participant to complete all study visits. When possible provide a brief snapshot of the protocol's schedule of events capturing time points and planned activity at study visits. For example:

Applicants should address the Study Duration. Include the estimated time (in months) from when the study opens to enrollment until: (a) completion of data collection; and (b) final data analyses.

Applicants are required to provide detailed project performance and timeline objectives. This section must include an overview of the project timeline for the following general milestones, as applicable:

These milestones will be negotiated at the time of the award, as appropriate.

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

The description of the study population should address demographic group, required health status, and geographic location.

Describe methods and systems to ensure data confidentiality and subject privacy.

3.3 Data and Safety Monitoring Plan

Describe the locations where the monitoring will occur (e.g., participating clinical sites, data center, clinical coordinating center) and what data will be reviewed.

Provide an overall description of the monitoring plan to ensure adherence to the protocol, and the quality and consistency of the study intervention(s), including fidelity monitoring for behavioral interventions. Include methods to monitor study intervention and system to record and manage exceptions and deviations. If applicable, describe monitoring of participating facilities, such as labs or pharmacies, for adequate handling and storage of investigational product(s) and study specimens. Include a description to ensure that the investigational product(s) accountability and reconciliation are performed adequately during and at the end of the trial per applicable regulatory requirements.

Describe plans for handling any deficiencies that are uncovered, and in cases of serious deficiencies, the appropriate reporting to relevant authorities, including but not limited to the IRB of record, DSMB if one is assigned, FDA if applicable, institutional officials, and the NIH.

Describe methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification, and data validation. Describe the data query process and frequencies and any planned mitigation strategies in the event of noncompliance.

Describe the process for locking the final trial datasets and the planned procedures on data access and sharing, as…