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

Nathan Shock Centers of Excellence in Basic Biology of Aging (P30 Clinical Trial Not Allowed)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-AG-15-005

Related Notices
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
  • July 31, 2019 - Notice of Webinar for RFA-AG-20-020. See Notice NOT-AG-19-036.
Funding Opportunity Announcement (FOA) Number

RFA-AG-20-020

Companion Funding Opportunity

RFA-AG-20-021, Nathan Shock Centers Coordinating Center (U24)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.866

Funding Opportunity Purpose

This FOA aims to provide support, including competitive renewals, for the Centers known as the Nathan Shock Centers of Excellence in Basic Biology of Aging (NSC). These Center grants will provide funding for leadership, training, and research activities that will increase and disseminate scientific knowledge in the research areas supported by the NIA's Division of Aging Biology (https://www.nia.nih.gov/research/dab). The NSC provide intellectual leadership and innovation, training, pertinent cores focused on the needs of the field and opportunities for research career development for future leaders, both within and beyond their institutions. They also collaborate substantially with other NSCs, the NSC Coordinating Center and other NIA-funded Centers. The NSC awards are intended for institutions committed to research on the basic biology of aging, but previous funding in this area is not necessary.

Key Dates

 

Posted Date

June 28, 2019

Open Date (Earliest Submission Date)

September 21, 2019

Letter of Intent Due Date(s)

September 21, 2019

Application Due Date(s)

October 21, 2019), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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)

October 21, 2019, 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.

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.

Scientific Merit Review

February/March 2019

Advisory Council Review

May 2020

Earliest Start Date

July 2020

Expiration Date

October 22, 2019

Due Dates for E.O. 12372

Not Applicable

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 FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.

  3. 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

    The Nathan Shock Centers of Excellence in Basic Biology of Aging (NSC) were created in 1995 and have served an ever-increasing role in the development of aging biology research. The Centers provide intellectual leadership and innovation; training; pertinent cores focused on the needs of the field; and opportunities for research career development for future leaders, both within and beyond their institutions. They also collaborate substantially with other NSCs and other NIA-funded Centers. The NSC awards are intended for institutions committed to research on the basic biology of aging, but previous funding in this area is not necessary. The awards will facilitate further sustained progress on basic research on aging biology, either overall or on a key area within the field.

    These grants are not intended to directly support the independent research of the Principal Investigator or the Core Directors and are not intended to support clinical research/clinical trials, or research on the neurobiology of aging, including Alzheimer’s disease.

    Research Objectives

    The goal of this program is to provide leadership and advance knowledge in basic research on aging biology. Applicants may propose to achieve this goal using aging biology as a general term, or they can select a well-defined and focused area within the field. Appropriate areas specifically encouraged include those that have been defined as major pillars or hallmarks of aging research, as well as emerging areas such as integrated physiology of aging. If a focused research area is selected, selection of Core activities (see below) should be consistent with that selection. Reviewers will be instructed to accept either approach (general or focused) as responsive to this FOA. Most importantly, successful applicants will be expected to provide national and international leadership in the field of aging biology, through intellectual and conceptual engagement that will clarify ideas, advance areas of focus and provide general expert opinion through publications, workshops and other venues.

    To achieve these goals, each NSC should promote a sustained research and communications program through which the Center will accomplish the functions of innovation, leadership, collaboration, and research career development described above, both independently as a Center and in conjunction with the NSC Coordinating Center (see companion RFA-AG-20-021).

    Centers are expected to provide visible leadership in the areas of aging biology and geroscience research. In addition to other activities normally carried on by leaders in any field, NSC Directors are expected to coordinate at least two joint conferences during the proposed funding period. These will be plenary conferences with wide attendance, focused on areas of cutting-edge science in the field and/or areas of large controversies where some leadership might be needed. These conferences will be organized jointly by the Directors of all NSCs and the NSC Coordinating Center, with further advice from NIA as needed. Publication of the proceedings will be expected. In addition, Center Directors will be regularly consulted and asked for advice on other leadership activities initiated by NIA staff.

    Applications in response to this Funding Opportunity Announcement must include:

    1) A quantifiable and verifiable proposal for supporting collaborative projects with new investigators;

    2) Development of innovative cores that are uniquely needed for the field of aging biology;

    3) A plan to support training of new faculty and persons new to the aging field;

    4) A verifiable plan to effectively publicize or advertise the activities of the Center to the larger community, so as to encourage collaborations;

    5) Involvement in conceptual leadership in terms of a plan to identify and promote promising areas of research and address controversial subjects; and

    6) Agreement to coordinate a joint conference every 2 years among all Centers, in conjunction with the NSC Coordinating Center and NIA staff. 

    Each application must include at least:

    1) A core to support administrative functions, including an advisory committee (not to be named in the application). This core will manage outreach activities including courses, lectures and symposia – if such activities are proposed – as well as the joint conferences to be held tentatively on years 2 and 4 of the award. This core should also be in charge of advertising the activities of the NSC, through development of a functional web site, and participation in a common Data Coordination Center (see below).

    2) A research development core in charge of supporting pilot/feasibility projects, as well as providing temporary support for investigators just entering the field of biology of aging research to a point where they can compete for independent support.

    3) At least two research core activities uniquely focused on issues of interest to the biology of aging. These are further discussed below.

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

    Section II. Award Information

     

    Funding Instrument

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

    Application Types Allowed

    New

    Renewal

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

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

    NIA intends to commit $7 million in FY 2020 to fund an estimated 6-8 awards.

    Award Budget

    Applications may request a budget of up to $800,000 in direct costs per year.

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is five years.

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

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)
    • 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 not 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) – 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.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    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

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

    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 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.

    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:

     Felipe Sierra, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-451-4515
    Email: sierraf@nia.nih.gov
     

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (Use for Administrative/Program Enrichment Core)

    6

    Research Development (Use for Research Development Core)

    6

    Research Resource (Use for Research Resource Cores)

    6 each

    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.

    The application should consist of the following components:

    • Overall: required; maximum 1
    • Administrative/Program Enrichment Core: required; maximum 1
    • Research Development Core: required; maximum 1
    • Research Resources Cores: required; minimum 2, maximum 4
    Overall Component

    When preparing your application, use Component Type ‘Overall’.

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

    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. Shared resources across cores and with other institutional facilities should be described in the Facilities and Other Resources attachment.

    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. The Center Director should be a scientific leader experienced in the field of aging biology research and must be able to coordinate, integrate, and provide guidance in the establishment of programs in aging biology.

    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)

    Specific Aims: Describe the aims of the overall Center and outline how the different cores will contribute to these aims. 

    Research Strategy: Renewal Applications: Describe any changes in research emphasis. Provide an overall summary that addresses the major scientific achievements, including research utilizing Center resources, during the last funding period. Identify the most significant findings that were facilitated or supported directly through Center resources. Include summaries of progress in achieving the major aims of the Center and highlight major publications. Provide examples of how the presence of the NSC has brought new investigators into the field and has stimulated non-NSC-funded research in the last funding period. Explain the Center’s role in generating new funding from grants, both Federal and other. Discuss the interrelationship of the Center to other activities in the applicant's institution (e.g., other relevant centers) and the extent of institutional, departmental, and interdepartmental cooperation, if appropriate (charts and tables may be included).

    New Applications: In lieu of an overall summary, new applications will be evaluated based on preliminary organizational work, experience with aging biology research, potential for developing new and exciting research, and specific plans for implementation of the new program.

    Focusing on the Center as a whole, address how the Center will facilitate further sustained progress on basic research on aging biology, either overall or in a key area within the field; show how the proposed activities seek to shift current research on the biology of aging through the use of novel approaches, methodologies, or models; show how the approaches of the cores complement each other in terms of their focus within the field of aging biology. If appropriate, discuss how the NSC fits within the institution(s) and how the environment contributes to the success of the NSC, including institutional support (if any) and interactions with other centers planned or already in place. Discuss how the proposed Center achieves a whole that is greater than the individual parts. Describe the mechanisms that will maintain the coherence of the Center and allow collaboration with the other NSCs and the aging biology community at large.

    NIA expects that each NSC will:

    • Provide intellectual leadership and innovation in aging biology;
    • Enhance the performance of innovative research on areas of aging biology currently considered important and likely to advance the field;
    • Provide a rich mentoring environment for junior investigators;
    • Provide research career development for future leaders in basic aging research, both within and outside their institutions;
    • Develop and/or support innovative cores that are uniquely focused on the needs of the field;
    • Collaborate substantially with other NSCs and the Nathan Shock Centers Coordinating Center, including the development of conferences and outreach activities;
    • Serve as a source of advice and collaboration to other investigators both locally and nationwide regarding technology, methodology, analysis, or other expertise relevant to the pursuit of aging biology research; and
    • Leverage institutional resources, including other NIH-supported programs and centers, to maximize efficiency in achieving the NSC's aims.

    Importantly, these grants are not intended to directly support the independent research of the Principal Investigator or the Core Directors and are not intended to support clinical research, clinical trials, or research on the neurobiology of aging, including Alzheimer’s Disease (AD) or AD-related diseases.

    Letters of Support: When appropriate, include letters of support from collaborating institutions, as well as any documents related to institutional commitment to the NSC.

    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:

    Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

    PHS Assignment Request Form (Overall)

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

    Administrative/Program Enrichment Core

    When preparing your application, use Component Type ‘Admin Core.’

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

    SF424 (R&R) Cover (Administrative/Program Enrichment 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/Program Enrichment Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative/Program Enrichment 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/Program Enrichment 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/Program Enrichment 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/Program Enrichment Core)

    Funds should be requested to permit travel by the Center Director and one other senior staff to the NSC Symposium, an annual meeting of Nathan Shock Center Directors, Nathan Shock Centers Coordinating Center, and NIA staff. Currently, these meetings are held as part of the American Aging Association (AGE) Annual Meeting. At least one representative from the Center should register so they can make a presentation at the Symposium.

    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/Program Enrichment Core)

    Introduction to Application: Renewal applications should describe any changes to core activities that derive from the experience of the last cycle.

    Specific Aims: This core is required for the administrative management of the overall Center, as well as for support of the required outside advisory panel and interaction with the Coordinating Center. The Principal Investigator (Director) will be responsible for overseeing all activities of the Center, addressing issues such as resource optimization; quality control; fiscal management; and compliance with institutional, DHHS, NIH, and NIA policies. 

    Research Strategy: The significance in this section should be interpreted as the significance of the core to the Center as a whole. The focus should be on promoting coordination and integration among the other cores to reflect a cohesive program, as well as promoting interactions with other Centers or other organizations. If other institutional resources are available, the core should be the pivot to leverage these resources for use of the Center as a whole.

    The Administrative/Program Enrichment Core must establish an advisory panel of experts from outside the institution. For new application, this panel should not be named in the application, nor should potential members be contacted, until after the review process is completed and awards are made. For renewal applications, list the members of the current panel and specify any anticipated changes. This panel must be convened at least once during the fourth year of funding and must provide a written evaluation of the Center's progress to both the Center and the NIA no later than January 2024. Additional use of this advisory panel shall be at the discretion of the Center Director, but the core should show how often the panel is expected to convene and how the panel's advice will be integrated into the Center's activities. In addition, the Administrative/Program Enrichment Core might oversee the organization of courses, lectures, and symposia that will enhance the visibility of the Center and advance the research goals of the program. Such activities are encouraged, but they are optional. At a minimum, the core should participate in the planning and execution of joint conferences to be held (tentatively) on years 2 and 4 of the award, as described above.

    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.

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Administrative/Program Enrichment Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    Do not enter a Study Record for the Administrative/Program Enrichment Core since the required study record details should be entered into the Overall component.

    Delayed Onset Study

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

    Research Development Core

    When preparing your application, use Component Type ‘Research Development.’

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

    SF424 (R&R) Cover (Research Development 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 (Research Development Core)

    Enter Human Embryonic Stem Cells in each relevant component.

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

    ASSIST will default to “Project Lead.” If you would like to use a different category, then replace “Project Lead” below with a different category (e.g., Core Lead).

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Research Development Core)

    The budget for each pilot project, including salary for the investigator, may not exceed $50,000 per year (direct cost), and the total budget for pilot projects under this core is expected not to exceed $150,000 per year (direct cost). Funds may also be requested for salary support for the director of the Research Development Core, who will be responsible for coordinating all activities within the 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 (Research Development Core)

    Introduction to Application: Renewal applications should describe any changes to core activities that derive from the experience of the last cycle.

    Specific Aims: The Research Development Core will provide support for career development of junior faculty entering the field of basic aging biology or other investigators who wish to change career direction towards basic aging research. This could include funding for pilot projects, enhanced accessibility to cores (both NSC cores and other cores available in the institution), formal and informal advice, or other mechanisms at the discretion of applicants. Interdisciplinary activities that draw on resources from a variety of fields to understand biological processes of aging are specifically encouraged.

    Research Strategy: The Research Development Core will facilitate the development of researchers new to the field of aging biology. Attainment of this goal could use both 'classical' approaches (pilot projects, usage of cores, etc.) as well as more innovative ideas such as one-on-one mentoring, mock review panels, or other activities at the discretion of the applicant.

    The request for Research Development Core support must contain the following: 1) a plan for the selection of faculty/students/postdocs to be supported, including a plan for review and selection of pilot projects; 2) a general plan for the career development of individuals who will be selected for this support; and 3) a list of senior faculty who will participate as mentors in research career development, along with their curriculum vitae and current research support.

    If pilot projects are envisioned, the budget for each, including salary for the investigator, may not exceed $50,000 per year (direct cost), and the total budget for pilot projects under this core is expected to not exceed $150,000 per year (direct cost).  Pilot projects must be focused on issues of interest to the NIA's Division of Aging Biology. For that reason, proposals must receive formal approval from NIA staff prior to review or funds allocation and should be described briefly in annual progress reports. Funds may also be requested for salary support for the Director of the Research Development Core, who will be responsible for coordinating all activities within the core.

    The Research Development Core may also be used to encourage the career development of faculty or students through subsidies for the use of core resources--either those provided by the NSC or other core facilities available elsewhere, in or out of the grantee institution. Such subsidies are especially encouraged for investigators from other institutions, including, but not limited to, investigators from other NSCs. Additionally, support in the form of formal advice to early-stage scientists from within or outside of the institution is encouraged. Finally, this core may include a specific plan for support of research and training of students or faculty with disabilities, from underrepresented ethnic groups, or from disadvantaged backgrounds.

    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.

    Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix

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

    PHS Human Subjects and Clinical Trials Information (Research Development Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    Do not enter a Study Record for the Research Development Core since the required study record details should be entered into the Overall component.

    Delayed Onset Study

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

    Research Resource Cores

    When preparing your application, use Component Type ‘Research Resource.’

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

    SF424 (R&R) Cover (Research Resource Cores)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Research Resource Cores)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Resource Cores)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal Regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

    Project /Performance Site Location(s) (Research Resource Cores)

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Research Resource Cores)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Research Resource Cores)

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Research Resource Cores)

    Introduction to Application: Renewal applications should describe how resources have been used in the last cycle and what changes are being introduced consequent upon the patterns of use observed and emerging needs.

    Specific Aims: These cores will provide support for personnel, equipment, and supplies needed to develop resources that are specifically suited to aging biology research. Research Resource cores must support at least 5 independent (i.e., from distinct PIs) ongoing basic research projects. Support for projects at institutions other than the grantee institution are specifically encouraged.

    Research Strategy: Research Resource cores should be focused on state-of-the-art aging biology research and should add specific and integrative value to the Center. Because gaining insight into the mechanisms of the intrinsic biology of aging requires a variety of molecular/cellular biology capabilities, an NSC might request funds to subsidize usage of commonly available core facilities for research involving aging biology. However, an NSC should not request direct support to establish independent cores in areas supported by cores already present at most academic or research institutions, or to do work that can be done through commercial sources, such as transgenic/KO mouse production, various –omics technologies, bioinformatics, cell sorting, etc.

    In contrast, this FOA encourages the development of novel core facilities that can provide services in areas that are more specialized for research in aging biology. The determination of which cores are acceptable under these guidelines will be at the discretion of NIA after consideration of reviewers’ comments. Examples include, but are not limited to:

    • Production and distribution of aged rodents, including genetically modified strains;
    • Production and distribution of species of high interest for aging research, including comparative biology (e.g., naked mole rats, killifish, marmosets, etc.);
    • Tissue banks from animal models listed above;
    • Specialized techniques generally recognized as being of high impact in aging research (e.g., heterochronic parabiosis, single cell genomics, artificial intelligence, etc.);
    • Comprehensive assessment of major pillars of aging research (e.g., proteostasis, inflammation, stress response, etc.); and
    • Proposals to implement, within established cores available at the institution, aging-specific techniques or capabilities.

    If an important area of focus has been selected for the entire NSC, then the cores must support that area and be capable of promoting a sustained effort in the research area chosen. Justify the cores in terms of how they advance the broader aims of the individual Center and of the broader NSC program.

    Approach: The approach should offer a plan consistent with the particular resources offered and describe the procedure established to monitor their pattern of use, with built-in flexibility to match demand where possible. It is advantageous to offer the resources to a broader community beyond the individual Center (including, but not limited to, other Shock Centers). Centers are encouraged to develop resources that can be used for collaborative research projects with investigators from other institutions, including, but not limited to, other Shock Centers. A plan must be presented to describe how such access to Center resources will be managed to balance demand with availability, so as not to overwhelm the personnel and resources of the Center. 

    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.

    Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Research Resource Cores)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    Do not enter a Study Record for the Research Resource Core since the required study record details should be entered into the Overall component.

    Delayed Onset Study

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

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

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

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

    In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

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

    Overall Impact - Overall

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

    Significance

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

    The following questions are also considered in evaluating the overall significance of the proposed NSC: How likely is it that the NSC will accomplish the innovation, leadership, collaboration, and research career development functions sought? To what extent will the NSC cores facilitate other ongoing research to advance aging research? How well does the proposed Center contribute conceptual leadership to the field of aging biology? How well does it provide an environment to foster sustained collaborative work by investigators from different fields? To what extent does it foster new lines of research and provide a rich mentoring environment for junior investigators? Does the integrated Center function as a coherent whole that is greater than the sum of its parts? If a specific focus is chosen, how important is that area regarding potential advances in the understanding of aging biology? Will the NSC have a significant effect on the concepts or methods used to understand that particular area of aging biology?

    If a renewal: Does prior work show sufficient accomplishment or capacity to expect high productivity and significant accomplishments with this award? Have collaborations with other NSCs and other NIA- or NIH-supported programs and centers yielded significant outcomes? If new cores are proposed, are they consistent with the goals of the Center, the program, and the current status of the field? Is there adequate justification for adding or deleting current activities or cores?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    The following questions are also considered in evaluating the investigators of the overall proposed NSC: Is the PD/PI an established investigator in a major area of focus in aging research? To what extent does the PD/PI have the leadership qualities to establish mechanisms for quality control of the science receiving core funds and to move the NSC into new innovative research areas, as appropriate? Does the team of investigators have the experience and time commitment to serve the Center well?

    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? How well will the integrated activities of the Center succeed in shifting research on the biology of aging? Are the research cores state-of-the-art in aging biology research? Are the research cores unique and not redundant with other, similar activities already available at the hosting institution?  

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    Reviewers will emphasize the following in evaluating the overall approach of the proposed NSC: Considered as a whole, how well will the approaches proposed advance the biology of aging and take it in new directions? Is the Center able to provide adequate infrastructure to support novel approaches to research and has it anticipated current and future needs of the research community? Are the arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among the investigators in the program well-delineated and appropriate? Is the administrative and organizational structure conducive to attaining the objectives of the proposed program? Are there coordination and integration across the proposed cores that reflect a cohesive research support program? Is there value added by having the proposed cores comprise a unique Center? Will the cores allow the Center to leverage additional resources that would not have been possible without an integrated P30 structure?

    Renewal applications: In the last cycle, how well did the approach of the center facilitate the center aims, particularly in advancing the biology of aging?     

    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? Is the academic and physical environment as it bears on research subjects, space, and equipment, and on the potential for interaction with scientists from other departments and institutions, sufficient and conducive for the project?  

    Additional Review Criteria - Overall

    As applicable for the Center 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

    Not Applicable

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    As applicable for the Center 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.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIA in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

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

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

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

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

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

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Prior Approval of Pilot Projects

    All awardee-selected projects will require prior approval by NIH prior to initiation. 

    • In order to ensure that pilot projects are within the scope of research supported by the Division of Aging Biology of the NIA, the goals and specific aims of proposals for pilot projects will be reviewed by NIA staff prior to review by Center-appointed reviewers.
    • Once reviewed by Center-appointed reviewers, further approval by NIA staff will be required before funds are disbursed.
    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. As part of the normal progress report each year, the Center should provide brief reports on the progress of pilot projects supported during that year.  

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

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

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Felipe Sierra, Ph. D.
    National Institute on Aging (NIA)
    Telephone: 301-451-4515
    Email: sierraf@nia.nih.gov

    Peer Review Contact(s)

    Ramesh Vemuri, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9666
    Email: ramesh.vemuri@nih.gov

    Financial/Grants Management Contact(s)

    Traci Lafferty
    National Institute on Aging (NIA)
    Telephone: 301-496-6987
    Email: lafertt@nia.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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