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Position: Grant/Fellowship - Complex Integrated Multi-Component Projects in Aging Research
Institution: National Institutes of Health
Department: National Institute on Aging
Location: Bethesda, Maryland, United States
Duties: This FOA allows for applications that propose large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions
   
Text: 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 Aging ( NIA ) Funding Opportunity Title Complex Integrated Multi-Component Projects in Aging Research (U19) Activity Code U19 Research Program - Cooperative Agreements Announcement Type New Related Notices NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) Funding Opportunity Announcement (FOA) Number PAR-16-143 Companion Funding Opportunity None Number of Applications See Section III. 3. Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.866 Funding Opportunity Purpose This FOA allows for applications that propose large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions. Key Dates Posted Date March 22, 2016 Open Date (Earliest Submission Date) April 25, 2016 Letter of Intent Due Date(s) 30 days prior to the application due date Application Due Date(s) Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. 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. AIDS Application Due Date(s) Standard AIDS dates apply or Month(s) Day(s), Year(s), by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date September 8, 2019 Due Dates for E.O. 12372 Not Applicable ** ELECTRONIC APPLICATION SUBMISSION REQUIRED** NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review. Required Application Instructions It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review. There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more . Problems accessing or using ASSIST should be directed to the eRA Service Desk . Table of Contents Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I. Funding Opportunity Description Background Aging research frequently entails a multidisciplinary effort, drawing on the expertise and resources of multiple individuals, institutions, and communities. Some studies require large-scale approaches requiring coordination of multiple components or across multiple sites in order to leverage a wide range of necessary resources and expertise. However, the scale and complexity of such projects are often unsuitable for traditional NIH mechanisms (e.g., R01), and instead, require more specialized mechanisms to successfully coordinate their multiple interacting components and allow for adequate presentation of the breadth and complexity of the proposed project to peer reviewers. Scope This FOA allows for applications that propose large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions. Resources and study expertise will be tightly coordinated across multiple sites or cores, such as: One or more coordinating centers Clinical or study sites Specialized cores, such as for data management and analysis, measurement and phenotyping, animal models, etc. Examples of the kinds of studies supported under this announcement include, but are not limited to, one or a combination of the following: Large-scale longitudinal observational studies of diseases or conditions that are common in aging populations involving integration of multiple clinical outcomes with molecular, genetic, or other mechanistic data. Large-scale, multi-site intervention studies in human subjects and/or animal models for aging-related conditions involving multiple endpoints to assess efficacy or effectiveness and to elucidate mechanisms. Translation of basic science findings into pre-clinical or clinical studies, or of clinical findings into practice or community settings, for prevention, diagnosis, or treatment of aging-related conditions, requiring coordination of broad multidisciplinary expertise across multiple settings. The structure and approach of proposed projects will vary depending on the hypotheses under study; however, it is expected that all projects will focus on an overarching scientific question that integrates all study components into a unified whole Additional Guidance Applicants are strongly encouraged to contact NIA Scientific/Research staff at least 6 weeks in advance of the anticipated application due date . This will help applicants ensure their prospective projects are aligned with NIA program priorities and consistent with administrative and budgetary policies. Successful projects are expected to have a sound scientific rationale based on adequate preliminary data; however, investigators may propose preliminary activities where necessary to refine methods or protocols, or to test effectiveness of study component integration prior to full-scale study implementation. In addition, investigators may choose to establish standing committees among study personnel for specialized cross-project functions such as a steering committee, data access and publications oversight, training of study personnel, etc. Applicants may also propose an external advisory committee to regularly review the progress of the multi-component project and provide non-binding recommendations for its activities. Studies involving human interventions should comply with NIH's and NIA's policies on human intervention studies , including development of a data and safety monitoring plan. Specific individuals who may constitute a data and safety monitoring board (DSMB) should not be named in the application. Research infrastructure development necessary to achieve the scientific aims of the planned study may be proposed. See Section VIII. Other Information for award authorities and regulations. Section II. Award Information Funding Instrument Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA. Application Types Allowed New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. 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 Application budgets are not limited but need to reflect the actual needs of the proposed project. Award 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 in response to this FOA. Section III. Eligibility Information 1. Eligible Applicants Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Foreign Institutions 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. Required Registrations Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) - Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code - Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.gov - Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks. 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. 2. Cost Sharing This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 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. This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information 1. Requesting an Application Package Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov . Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide , including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. For information on Application Submission and Receipt, visit Frequently Asked Questions - Application Guide, Electronic Submission of Grant Applications . Letter of Intent 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: Ramesh Vemuri, PhD Telephone: 301-402-7700 Fax: 301-402-0066 Email: vemurir@mail.nih.gov Page Limitations Component Types Available in ASSIST Research Strategy/Program Plan Page Limits Overall 12 Admin Core 6 Core 6 Project 12 Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. 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 should consist of the following components: Overall: required (1) Administrative Core: required (1) Cores: optional (0-9) Projects: required (1-9) Overall Component When preparing your application in ASSIST, use Component Type ‘Overall’. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Overall) Complete entire form. PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Research & Related Other Project Information (Overall) Follow standard instructions. Project/Performance Site Location(s) (Overall) Enter primary site only. A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission. Research & Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. 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 overall scientific objective of the proposed multi-component project, the individual aims of the project, and how the individual components contribute to these aims and the overall objective Research Strategy: Significance. Focusing on the project as a whole address (i) the importance of the problem or critical barrier to the field that the proposed project addresses, (ii) how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. Describe the preliminary data on which the project is based. Renewals. In addition to the above, identify and justify any changes in research emphasis and funds requested. If the structure of individual projects and cores has changed, identify the cores and projects consecutively (numbers for projects and letters for cores) according to how they are arranged in the current application. Show the correspondence to the prior structure. Resubmissions. If the structure of projects and cores has changed, identify the cores and projects consecutively (numbers for projects and letters for cores) according to how they are arranged in the current application. Show the correspondence to the prior structure. Innovation. Considering the project as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Are these concepts, approaches, methodologies, instrumentation or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation or interventions proposed? Approach. Include the major approaches and studies involved in the application showing how the approaches of cores and/or projects are tightly integrated with each other. Describe the mechanisms that will ensure the coherence of the project and maintain a multidisciplinary focus. Renewals. Describe progress from the prior period of support that is of particular significance to the project as a whole. If the current submission omits individual projects or cores that were active in the prior funding period, describe their progress and explain why they are omitted. Identify and justify any substantive differences in approaches from the prior funding period. Protection of Human Subjects: Follow instructions in the SF424 (R&R) Application Guide and also provide a data safety monitory plan (DSMP) for any human intervention study per NIA policies for human intervention studies . Plans for protection of human subjects that are specific to particular cores or projects should be described in those respective components of the application. Letters of Support: Provide any letters of support specific to the Overall component. Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed. Administrative Core When preparing your application in ASSIST, use Component Type ‘Admin Core.’ All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Administrative Core) Complete only the following fields: Applicant Information Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions. Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question. Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component. Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: The Administrative Core provides overall leadership to the program project and the aims of the core should show the elements by which leadership and integration will be achieved. If proposing a new external advisory board do not list proposed members in the application. Instead list intended areas of expertise Research Strategy: Significance. Describe how the activities of the administrative core will implement the overall vision of the program project as an integrated investigation of a scientific field or problem in aging. Approach. Describe how the several elements proposed in the administrative core will be operationalized to achieve transparent communication across projects and cores, cross-project collaboration, and common objectives for the project as a whole. Elements should include, but not be limited to, means for internal quality control of research; management of day-to-day project activities, management of contractual agreements, resolution of disputes, allocation of funds, and plans for joint dissemination of study results. Function and intended areas of expertise of an external advisory board, if proposed, should be described here. Letters of Support: If a renewal project previously had an external advisory board then letters of support should be provided from members continuing in the next proposed period. If this is a new application or a renewal application with new external advisory board members, do not provide letters of support from proposed new members Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. PHS Inclusion Enrollment Report (Administrative Core) When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. Optional Core When preparing your application in ASSIST, use Component Type ‘Core.’ All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Optional Core) Complete only the following fields: Applicant Information Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Optional Core) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Optional 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) (Optional 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 (Optional Core) In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. Budget (Optional 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 (Optional Core) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: Identify which projects the Core will assist and the role of the Core in the overall project. Research Strategy Organize the Research Strategy into sections on a. Significance, and b. Approach. Innovation will be considered in relation to Approach and Significance. Protection of Human Subjects: Follow instructions in the SF424 (R&R) Application Guide and also provide a data safety monitory plan (DSMP) for any human intervention study per NIA policies for human intervention studies . Letters of Support: Provide any letters of support that are specific to the relevant core. Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. PHS Inclusion Enrollment Report (Optional Core) When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. Project When preparing your application in ASSIST, use Component Type ‘Project.’ All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Project) Complete only the following fields: Applicant Information Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Project) Enter Human Embryonic Stem Cells in each relevant component. 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. 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) In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. Budget (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 (Project) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: Describe the aims of the project in relation to the goals of the overall project. Research Strategy The Research Strategy should be organized into sections on Significance, Innovation and Approach. The Significance section should include discussion of how this project relates to the goals of the overall project and the preliminary data on which the project is based. If the same study will be conducted across multiple sites, such as clinical or study sites using the same protocol, describe the study once in this section and indicate the sites where the protocol will be carried out. Protection of Human Subjects: Follow instructions in the SF424 (R&R) Application Guide and also provide a data safety monitory plan (DSMP) for any human intervention study per NIA policies for human intervention studies . Letters of Support: Provide any letters of support that are specific to this project. Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. PHS 398 Inclusion Enrollment Report (Project) When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov. 4. Submission Dates and Times Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review. 6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf . Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues . For assistance with application submission, contact the Application Submission Contacts in Section VII . Important reminders: All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed. Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030 . Section V. Application Review Information 1. Criteria Only the review criteria described below will be considered in the review process. As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. Overall Impact - Overall Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). Scored Review Criteria - Overall Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Significance Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the preliminary data adequate to justify the project? Investigator(s) Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Additional Review Criteria - Overall As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. Protections for Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects . Inclusion of Women, Minorities, and Children When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research . Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section . Biohazards Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. Resubmissions For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Renewals For Renewals, the committee will consider the progress made in the last funding period. Revisions For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. Additional Review Considerations - Overall As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Applications from Foreign Organizations Not Applicable Select Agent Research Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Resource Sharing Plans Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan ; 2) Sharing Model Organisms ; and 3) Genomic Data Sharing Plan . Authentication of Key Biological and/or Chemical Resources For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources. Budget and Period of Support Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Scored Review Criteria - Administrative Core Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an adjectival rating of high, moderate, or low enthusiasm. Reviewers will consider each of the four criteria below in the determination of scientific and technical merit. As cores are generally resources to enable or to advance research, "Innovation" is not considered routinely as a review criterion for these cores. Innovative cores may be valuable and that value will be assessed under Significance or Approach as appropriate. Significance Does the proposed core address the needs of the multi-component project that it will administer? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the multi-component project? How well do the described activities integrate the separate elements of the project and provide overall direction? How well do proposed dissemination activities, if proposed, reflect an integrated project? Investigator(s) Are the Core Leads and other personnel well suited to their roles in the core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the core is collaborative do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the core? Does the applicant have experience overseeing selection and management of subawards, if needed? How well do the administrative, management, and leadership capabilities of the core leader(s) provide oversight and direction to the management activities of the core? Approach Are the operational plan and organizational structure well justified? Is the core adequate to support and encourage optimal interactions among the overall program team? How appropriate are the plans for internal quality control of research; management of day-to-day program activities; management of contractual agreements; resolution of disputes; and allocation of funds? Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the multi-component project that the core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the multi-component project, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Environment Will the institutional environment in which the core will operate contribute to the probability of success in facilitating the multi-component project it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the core proposed? Will the core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Scored Review Criteria - Optional Core Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an adjectival rating of high, moderate, or low enthusiasm. Reviewers will consider each of the four criteria below in the determination of scientific and technical merit. As cores are generally resources to enable or to advance research, "Innovation" is not considered routinely as a review criterion for these cores. Innovative cores may be valuable and that value will be assessed under Significance or Approach as appropriate. Significance Does the core address an important problem or a critical barrier to progress in the field? If the aims of the core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the value of the core to the overall project and to particular projects? Investigator(s) Are the Core Leads, collaborators, and other researchers well suited to the core? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the core is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the core involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the core proposed? Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? How well does the environment enhance integration of cores and projects? How well does it facilitate interactions among cores and projects? Additional Review Criteria - Administrative and Optional Cores As applicable for the core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an adjectival enthusiasm rating, but will not give separate ratings for these items. Protections for Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines. Inclusion of Women, Minorities, and Children When the proposed core involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research . Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section . Biohazards Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. Resubmissions For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Renewals For Renewals, the committee will consider the progress made in the last funding period. Revisions For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. Additional Review Considerations - Administrative and Optional Cores As applicable for the core proposed, reviewers will consider each of the following items, but will not give ratings for these items, and should not consider them in providing an overall impact score. Applications from Foreign Organizations Not Applicable Select Agent Research Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Resource Sharing Plans Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan ; 2) Sharing Model Organisms ; and 3) Genomic Data Sharing Plan . Budget and Period of Support Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Scored Review Criteria - Individual Projects Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Significance Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Investigator(s) Are the Project Lead, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project propos
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