Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers is sponsored by National Institute of Mental Health (NIMH). Funds research centers to develop and test approaches for optimizing mental health interventions, service delivery, and improving reach and impact, directly supporting linkage to care in mental health.

PAR-24-210: Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 - See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy - see Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number(s) Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites applications for centers to support transdisciplinary teams of clinical and mental health services researchers, behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in high-impact studies that will significantly advance clinical practice and generate knowledge that will fuel transformation of mental health care in the United States.

A dvanced L aboratories for A ccelerating the R each and I mpact of T reatments for Y outh and Adults with Mental Illness (ALACRITY) Research Centers will support the rapid development, testing, and refinement of novel and integrative approaches for (1) optimizing the effectiveness of therapeutic or preventive interventions for mental disorders within well-defined target populations; (2) organizing and delivering optimized mental health services within real world treatment settings; and (3) continuously improving the quality, impact, and durability of optimized interventions and service delivery within various care systems that provide mental health interventions and services.

The ALACRITY Centers program is intended to support research that maximizes synergies across various components of the mental health research ecosystem, including new discoveries in clinical research, transformative health care technologies, advances in information science, and new federal and state mechanisms for organizing mental health care.

The Centers are intended for transdisciplinary projects that could not be achieved using standard research project grant mechanisms.

The ALACRITY Centers program is also expected to facilitate widespread sharing of relevant data, methods, and resources that will accelerate clinical research and practice and provide opportunities for graduate students, postdoctoral researchers, and early-career investigators to participate in transdisciplinary, T2 translational mental health research.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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. Required Application Instructions 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 NOFO or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) 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. There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners.

You must use one of these submission options to access the application forms for this opportunity. Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.

gov and eRA Commons to track your application. Check with your institutional officials regarding availability. Part 1.

Overview Information 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 This Notice of Funding Opportunity (NOFO) invites applications for center grants to support A dvanced L aboratories for A ccelerating the R each and I mpact of T reatments for Y outh and Adults with Mental Illness (ALACRITY) Centers.

The purpose of these research Centers is to support transdisciplinary teams of clinical and mental health services researchers, behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in high-impact studies that will significantly advance clinical practice and generate knowledge that will fuel transformation of mental health care in the United States.

Successful ALACRITY Centers will address major mental health problems observed among children, youth, and/or adults (including older adults), and foster innovative research aimed at increasing the effectiveness of existing interventions, improving delivery and quality of evidence-based services, and accelerating the diffusion, implementation, and continuous improvement of new practices in a broad array of settings that deliver mental health interventions and services.

Center-supported research should reflect a deployment-focused model of intervention and services design and testing that considers key characteristics of the settings and providers where optimized mental health interventions and services will be implemented.

The ALACRITY Centers program is intended to support research that maximizes synergies across disciplines and has a high potential for increasing the public health impact of existing and emerging mental health interventions and service delivery strategies. The Centers are intended for transdisciplinary projects that could not be achieved using standard research project grant mechanisms.

Support is provided both for individual research projects and for cores that are critical for the integration across ALACRITY components. Centers are expected to provide plans for rapid, widespread sharing of relevant data, methods, and resources that will promote near-term improvements in clinical practice, as well as plans that further advance research focused on intervention effectiveness and/or services.

A strong vision of how the ALACRITY Center will advance the field beyond the goals of the individual projects is essential for successful applications. With ALACRITY Centers, NIMH encourages opportunities to enhance the participation of graduate students, postdoctoral researchers, and investigators in early stages of independent careers.

Based on data from the 2021 National Survey on Drug Use and Health (NSDUH), it is estimated that more than one in five U.S. adults live with a mental illness; in 2021, an estimated 57. 8 million lived with a diagnosable illness in the past year . NSDUH results further suggest that in 2021, an estimated 11.

4 million American adults suffered from a serious mental illness (SMI) where ability to function in daily life is significantly impaired. We know that mental disorders frequently onset before the age of 18; the National Comorbidity Survey Adolescent Supplement estimated the lifetime prevalence of any mental disorder among U.S. adolescents aged 13-18 at 49. 5%, with an estimated 22.

2% of adolescents with any mental disorder experiencing severe impairment and/or distress. These prevalent illnesses are associated with substantial disability and burden, and it has been documented that individuals with SMI die 10 years earlier than individuals in the general population, on average.

Furthermore, mental illnesses are associated with substantial direct and indirect costs, including but not limited to lost employment, reduced worker productivity, homelessness and criminal justice costs. A conservative estimate places the direct and indirect financial costs associated with mental illnesses in the United States at well over $300 billion annually. At the same time, we know that mental illnesses often go untreated.

For example, according to 2021 NSDUH results, over half of adults with any mental illness and a third of those with SMI reported they did not receive MH services in the past year.

This public health burden and unmet need demands that we combine current knowledge about effective mental disorder treatments with emerging health information and communication technologies, health care informatics, data science tools, and novel organizational structures for delivering health care to achieve significantly better outcomes for these disabling conditions.

The primary purpose of each ALACRITY Center is to support rapid development, testing, and refinement of innovative approaches for (1) optimizing the effectiveness of therapeutic or preventive interventions for mental disorders within well-defined target populations; (2) organizing and delivering optimized mental health services within real world treatment settings; and (3) continuously improving the quality, impact, and sustainability of optimized interventions and service delivery strategies within various care systems that provide mental health interventions and services.

To achieve these ambitious goals, each ALACRITY Center aims to support multidisciplinary teams of leading clinical and mental health services researchers, and experts from allied disciplines, such as behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in studies focused on selected populations for whom existing interventions or services do not adequately address urgent, unmet mental health needs.

The NIMH Strategic Plan for Research was developed to inspire and support research that takes advantage of recent technological advances and opportunities, and to bring into sharper focus questions and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders. Strategic Research Objectives 3. 2, 3.

3, and 4. 1 – 4. 4, which focus on optimizing existing and new interventions, translating effective interventions to community practice settings, and strengthening the public health impact of NIMH-supported research, are particularly relevant to ALACRITY Centers.

ALACRITY Centers provide a unique opportunity for addressing T2 translational priorities outlined in the NIMH Strategic Plan, i.e., effective transfer of findings from clinical studies to practice settings and communities, where research findings can be applied to improve public health.

General characteristics of ALACRITY Centers are listed below: ALACRITY Centers are intended to support a program of science that is defined in terms of (a) a target population for whom existing interventions or services do not adequately address mental health needs; (b) the therapeutic or preventive interventions or service delivery strategies to be studied and optimized; and (c) the service setting(s) intended to implement optimized interventions and/or services.

The scope of science for ALACRITY Centers spans intervention science (optimizing the effectiveness of therapeutic or preventive interventions for mental illness within well-defined target populations) through services research (innovative strategies to improve access, engagement, coordination, and quality of service delivery).

It is not necessary for an individual Center to emphasize intervention refinement and health services research activities equally. An ALACRITY Center focus may include (a) intervention enhancement projects, primarily (b) a combined program of interventions and services research, or (c) mental health services research projects, primarily.

In all cases, however, research studies should address necessary features for rapid dissemination, adoption, implementation, and sustainability of new approaches in clinical and community settings, thus facilitating T2 translation from research to practice.

To facilitate translation into practice, Center projects that are primarily aimed at testing the effectiveness of preventive, therapeutic, or services interventions should be designed as hybrid effectiveness-implementation trials, depending on the level of pre-existing effectiveness evidence and implementation readiness.

Thus, in addition to testing the effectiveness of the intervention, trials should be designed to assess and examine consumer-, provider- and setting- level factors that might be associated with implementation fidelity (i.e., as Hybrid Type-I trials) or to simultaneously test strategies to promote successful implementation (i.e., as Hybrid Type II trials).

Likewise, studies that are primarily aimed at testing an implementation strategy should be designed to also assess the outcomes and effectiveness of the intervention/approach that is being implemented (i.e., as Hybrid Type III trials).

Regardless of where the Center’s focus falls on the continuum of research spanning optimization of therapeutic/preventive interventions through services research, ALACRITY Centers are intended to support research that reflects a deployment-focused model of intervention and services design and testing .

Deployment-focused studies consider the perspectives of relevant stakeholders and key characteristics of settings intended to implement optimized mental health interventions.

This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure that the resultant interventions and service delivery strategies are feasible and scalable, and to ensure that the research results will have utility for end users. Given the focus on research with near-term potential, NIMH encourages scalable, sustainable intervention and service-delivery strategies.

Accordingly, NIMH encourages approaches that can readily be integrated into practice with minimal reconfiguration or adjustment, that can be delivered using existing personnel and typically available resources, and that incorporate features that are specifically designed to prevent threats to implementation fidelity.

Strategies that could be used to enhance scalability and sustained implementation include but are not limited to consumer-facing technology (e.g., self-administered content) and provider-facing technology (e.g., technology to support provider training and sustained implementation fidelity); expert consultation via existing resources or other sustainable means (e.g., telehealth, ECHO model, or collaborative care approaches); or other robust design features that promote provider competence and sustained implementation fidelity.

The goal of ALACRITY Centers is to support transdisciplinary research that brings together teams of clinical scientists, mental health services researchers, and experts from allied disciplines that bring new perspectives and tools relevant to enhancing the effectiveness, delivery, reach, and continuous improvement of mental health interventions for children, adolescents, and adults (including older adults) with unmet mental health needs.

ALACRITY teams should also include members with real world experience of care within target clinical and/or community practice settings, including service users, family members, mental health care providers, program administrators, and payers.

NIMH strongly encourages involvement of stakeholders in multiple roles throughout the research enterprise, including involvement as external consultants who provide input as members of advisory committees, as practice-partners who are members of the research team, and as research participants whose perspectives are systematically assessed via qualitative and quantitative methods.

Given the explicit goal of encouraging synergies across areas of science and technology, and in partnership with relevant stakeholders and end-users, ALACRITY Centers are intended to provide research infrastructure and coordination in the form of Cores that provide support for overall organization, administration, and collaboration with stakeholders (Administrative Core), and support for implementing the Center’s transdisciplinary research projects and additional pilot studies, as well as support for methodological development and consultation (Methods Core).

Beyond methodological, technical, and analytic support to the Center's investigators and projects, the Methods Core should serve as an incubator for innovative methods development and should facilitate opportunities for embedding common data elements and harmonizing data collection and analysis across Center projects.

Each Core should also facilitate the development of new collaborative research opportunities and future directions that extend the Center’s activities. The scope of science should comprise one (1) Signature Project that involves a fully powered study, and three (3) Exploratory Research Projects modeled on the NIMH R34 grant mechanism program.

All projects should address significant problems that are relevant to the goals of the Center and are related to prevention, treatment, management, and/or delivery of services to individuals with mental disorders who are served in the target setting(s).

Signature Projects should exemplify the Center’s focus and should address a significant problem, such that the findings have potential to inform practice (i.e., results will guide decisions about whether to adopt and implement the optimized strategy or otherwise change current practices).

These studies should be adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data.

Signature projects should be of sufficient scale and be designed to examine questions regarding mediators and moderators of effects (e.g., whether the observed results differ across individuals from different racial and ethnic backgrounds; with different health literacy levels; with medical, mental health, or substance-use comorbidities) and address additional exploratory aims to inform future research directions.

The overall scope of research should be based on NIMH R01 research mechanisms for Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions ( PAR-21-130 ) or for Innovative Mental Health Services Research Not Involving Clinical Trials ( PAR-23-095 ).

Exploratory Research Projects should be designed to examine the feasibility of the research approach, (e.g., feasibility of recruiting and retaining participants); should provide an opportunity to refine and pilot test the experimental protocols, including assessment protocols and the experimental intervention protocol, as relevant; and should yield pilot data necessary for informing next steps and for enhancing the probability of obtaining meaningful results in subsequent, well-powered studies.

Exploratory Research Projects should be modeled on the NIMH R34 Research Mechanisms for Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions ( PAR-21-131 ) or for Pilot Services Research not Involving Clinical Trials ( PAR-23-105 ).

ALACRITY Centers are intended to facilitate emerging opportunities for additional pilot research through a process for soliciting, reviewing, and selecting promising pilot feasibility projects of 1-2 years duration similar in scope to the NIH R03 grant mechanism that can be launched within the project period.

Accordingly, the scope of science should include such pilot feasibility projects that can be proposed by new or established investigators to address innovative, interdisciplinary research that is consistent with the Center’s focus in order to position the investigator(s) for subsequent research that aligns with the Center’s program of research.

Consistent with the NIMH experimental therapeutics approach, all Center projects that involve clinical trials must be designed to not only examine the intervention effects on outcomes of interest, but to also inform understanding of the intervention’s mechanisms of action.

As such, the scope of work must include specification of intervention target mechanism(s) and assessment of intervention-induced changes in the presumed target mechanism(s) that are hypothesized to account for the intervention outcomes (see Support for Clinical Trials at NIMH ). ALACRITY Centers are intended to support transdisciplinary science through research projects and cores at a single institution or across multiple institutions.

Collaborations among mental health interventions research programs, services research programs, behavioral and social science programs, and healthcare technology research programs are encouraged, even if this means that investigators are geographically distributed.

ALACRITY Centers are expected to provide opportunities for graduate students, postdoctoral researchers, and investigators in early stages of independent careers to participate in T2 translational mental health research.

ALACRITY Centers are intended to function as a national consultation resource beyond the Center collaborations, and should include plans for developing and disseminating research resources (e.g., new data collection/assessment approaches and analytic methods; web-based platforms for identifying and recruiting participants and accelerating research; data sets that can be shared for re-analysis/meta-analysis; other common-source materials (e.g., new methods and analytic strategies for mining and analyzing "big data" from large-scale data collection efforts, programming for technology-assisted approaches).

To this end, NIMH intends to convene joint Center Directors' meetings to provide opportunities to share strategies: for incorporating common data elements and harmonizing data collection efforts; for building stakeholder partnerships for deployment-focused, practice-based research; for integrating transdisciplinary collaborations; for incorporating technology and other innovations to transform research and the delivery of interventions and services; for soliciting, vetting, and supporting new Center-relevant research; and for integrating early career investigators and providing them opportunities and support to be involved in the Center's research.

Potential applicants are strongly encouraged to discuss their research concept and approach, and alignment of planned Center goals with the NIMH Strategic Plan for Research, with appropriate NIMH contacts before developing their application [see section VII Agency Contacts ].

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application’s Protection of Human Subjects section 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. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Renewal of applications submitted in response to PAR-16-354 and PAR-18-701. Resubmission of applications submitted in response to PAR-20-293 and PAR-23-210 . Revisions of applications submitted in response to PAR-20-293 and PAR-23-210.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. 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 total amount awarded and the number of awards are contingent upon NIH appropriations and will depend on the number, quality, and costs of meritorious applications received. Direct costs are limited to $1,500,000 per year.

The total project period may not exceed 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 allowed. 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.

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. 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. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; 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 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.

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 SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility 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 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 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Centers are limited to one renewal following the initial period of funding.

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 SF424 (R&R) Application Guide , except where instructed in this notice of funding opportunity 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: [email protected] All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Signature Research Project Exploratory Research Projects Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) 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 below may not apply to the revision application. The application must consist of the following components: Signature Research Project; one (1) Exploratory Research Projects; three (3) When preparing the application, use Component Type ‘Overall’. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) 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) 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. It is expected that a Center Director (PD/PI) will have a demonstrated capability to organize, administer, and direct the Center.

The Center Director must demonstrate leadership in the area of the science proposed and have a strong record of high impact scientific achievements. 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.

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 ALACRITY Center focus and aims. Outline how the research projects and Cores will contribute to attaining the Center objectives.

Research Strategy: All items listed below must be included. Begin the Research Strategy with an overview of the Center describing the target population for whom existing interventions or services do not adequately address