Part 1. Overview Information

Key Dates

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

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

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

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.
   
   



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The NSC were created in 1995 in honor of Nathan Shock, founding head of the NIH Gerontology Research Center. The NSC provide, both within and beyond their institutions, intellectual leadership and innovation; training; pertinent service cores focused on the needs of the field; and opportunities for research career development. They each collaborate substantially with other NSC and other NIA-funded Centers through the Research Centers Collaborative Network (RCCN). The NSC awards are intended for institutions committed to research on the basic biology of aging, The awards will facilitate further sustained progress on basic research on aging biology, either overall or on a key area within the field.  

Research Objectives  

To achieve the objectives above, applicants may propose a sustained research program focused on aging biology as a general term, or by identifying a well-defined and focused area within the field. If a focused research area is selected, service 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 NOFO. It is crucial to the design of each NSC that applicants specify the goals to be achieved within the five-year award period, to provide a plan to reach these goals, and to outline a method to evaluate progress toward these goals. The selection of core activities (see below) should follow from these considerations. 

Applications in response to this NOFO must include the following: 

• Provide intellectual leadership in biology of aging research, serving as a resource for experimental design and guidance on the appropriate uses and limitations of aging metrics. 
• Support multidisciplinary and translational research. 
• Provide access to technologies through the cores. 
• Develop technology (in the cores) for emerging areas of research in biology of aging. 
• Leverage local institutional resources. 
• Collaborate with other NSC and The Nathan Shock Centers Coordinating Center (NSC3) on multi-center research education, mentorship, and outreach programs. 
• Interface with other NSC, the NSC3, and other NIH funded centers directly (as appropriate) or through the NIA-supported RCCN. 

To support these goals, each application must include the following: 

• A core to support administrative functions. This core will manage outreach activities including courses, lectures and symposia – if such activities are proposed. This core will also be responsible for advertising the activities of the NSC, through development of a functional website, and participation in a common Data Coordination Center (see below). The leader of this core must be a PD/PI. 
• A research development core to support pilot/feasibility projects, as well as provide support for investigators entering the field of biology of aging research. 
• At least two research core activities uniquely focused on issues of interest to the biology of aging. These are further discussed below. 

Support for Research 

Each NSC may select an area of research focus from a broad range of topics, including, but not limited to, the following examples: 

• Drivers of aging (often considered hallmarks); 
• Metrics of aging, including biomarkers, clocks, computer-based modeling, imaging, etc.; 
• Life course approaches to aging biology; 
• Species-differences and similarities in aging;  
• Medicinal chemistry for development of gerotherapeutics and geroprotective pharmacological interventions; 
• Development and dissemination of new technologies to retain age-of-donor traits for in vitro systems; 
• Facilitation of translation to clinical research; and 
• Support for biology of aging research in IDeA states. 

Support for Outreach and Education 

Each NSC should place special emphasis on career development, engaging the public and providing education around the topic of aging biology, including, but not limited to the following examples: 

• Mini-sabbaticals for mid-career and senior investigators (emphasizing new-to-aging research);  
• Community engagement – inform about biology of aging and opportunities for citizen science; 
• Webinars; and 
• Symposia. 

Applicants must provide plans for the following elements: 

• Leadership succession; 
• Fostering an inclusive and accessible research training environment; and 
• Evaluation: Applications must include a clear description of their objectives and a plan for evaluating the NSC, including all activities supported by the NSC, in line with the broader NSC program goals. The application must specify baseline metrics of NSC activities (e.g., numbers and characteristics of workshop participants, scientific dissemination, databases, networking opportunities with other funders, users of resources, etc.), as well as clearly defined milestones with metrics to gauge the short- or long-term success of the NSC in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. The NSC evaluation plan should focus on the activities of the NSC, not the entire NSC program. NIH will evaluate the entire NSC program and NSC in five years, including the role of the NSC in fostering the success of the program. Based on the review, NIA will evaluate the effectiveness of the program, and determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program after sunset and review period.

Pre-Application Webinar

A webinar is planned to provide prospective applicants the opportunity to understand and ask questions on the scientific scope of this NOFO and technical details for applying. The webinar will be open to all prospective applicants. Participation in the webinar is not a prerequisite to applying to this NOFO, but prospective applicants will need to register in order to participate. Prospective applicants are also encouraged to submit their questions in advance of the webinar; further details on where to submit the questions will be provided once the webinar has been scheduled. Please refer to the registration page for further details on the pre-application webinar, including the time and date and registration information.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise 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:

Christy Carter, Ph.D.
National Institute on Aging (NIA) 
Telephone: 301-827-1382 
Email: christy.carter@nih.gov 
 

Page Limitations

All page limitations described in the How to Apply- 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 How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

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

All instructions in the 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 Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

For all leaders, applicants should include the following:

• Suitability of PD(s)/PI(s), collaborators, and other researchers to the NSC;
• Assurance the PD/PI is an established investigator in a major area of focus in aging biology research;
• Description of the extent to which 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;
• Assurance that the team of investigators has the experience and time commitment to serve the Center;
• Description of the appropriate experience and training of Early-Stage Investigators or those in the early stages of independent careers;
• Evidence that for established investigators, there is demonstration an ongoing record of accomplishments that have advanced their field(s);
• When submitting with collaborative or multi-PD/PI, ensure the investigators have complementary and integrated expertise and that the leadership approach, governance, and organizational structure appropriate for the project; and
• Evidence that the leadership and mentoring teams of the proposed NSC are varied or heterogeneous in perspectives, academic backgrounds, and scientific and technical disciplines. Please note that the race, ethnicity, or sex of members of the leadership and mentoring teams, key personnel, participating researchers or trainees, or the student bodies of participating institutions will not be considered in the application review process or when making funding decisions. 

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 NSC goals, including the NSC’s selected area of focus and basis for selection; crucial problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the NSC would address in the focus area selected; and advances in regard to these problems or limitations the NSC would achieve over its five-year award period.

Research Strategy

Significance. Explain how the Center, as a whole, will facilitate sustained progress in basic aging biology research, either overall or in a key area within the field.  

Approach. NIA expects that each NSC will achieve the following: 

• Provide intellectual leadership and innovation in aging biology and provide information that explains how the leadership team is richly varied and heterogeneous in perspectives, academic backgrounds, and scientific and technical disciplines and how they are participating in team science. Please note that the race, ethnicity, or sex of members of the leadership and mentoring teams, key personnel, participating researchers or trainees, or the student bodies of participating institutions will not be considered in the application review process or when making funding decisions; 
• Enhance the performance of innovative research on areas of aging biology (to mid-career, senior and junior investigators) currently considered important and likely to advance the field; 
• Provide a rich mentoring environment for career development of junior and new to the field mid-career and senior investigators including multiple career pathways, both within and outside their institutions; 
• Develop and/or support innovative cores that are uniquely focused on the needs of the field not currently met; 
• Core support for other aspects of research including ongoing clinical trials;  
• Collaborate substantially with other NSCs and the NSC3, 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, building mentoring teams for junior faculty, fostering an inclusive and accessible research training environment, or other expertise relevant to the pursuit of aging biology research; and 
• Leverage institutional resources, including institutes, departments, offices, and 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 trials, or research on the neurobiology of aging, including Alzheimer’s Disease (AD) or AD-related dementias(ADRD). However, leveraging collaborations between NSC, Claude D. Pepper Older Americans Independence Centers (OAICs) and Alzheimer Disease Research Centers (ADRC) are encouraged.  

Innovation. Demonstrate how the proposed activities expand current research using novel approaches, methodologies, or models. Illustrate complementary approaches of the cores in supporting the goals of the center. 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, NSC3, and the aging biology research community at large

Letters of Support: Place institutional letters of support for the NSC as a whole in this section.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

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

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative/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 from the NSC3 and one other senior staff to the yearly NSC Symposium, an annual meeting including NSC and NSC3 Directors, and NIA staff.

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)

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 External Advisory Committee that will meet annually to advise the NSC on significant scientific impact in its area of scientific focus through pilot funding and infrastructure development activities. Summary recommendations from the External Advisory Committee should be included with the non-competing continuation (Type 5) application. New applications must not select committee members prior to peer review of the Center application, but rather describe the composition of the committee, including diversity of academic backgrounds and professional experience, and area of science of membership, roles, responsibilities, and desired expertise of committee members. 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 2028. Additional use of this advisory panel shall be at the discretion of the Center Director, but the core should describe 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, development of a website 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) in years 2 and 4 of the award, as described above.

Renewal Applications: Describe any changes in research emphasis and any changes to core activities that derive from the experience of the last cycle. Provide an overall summary addressing major scientific achievements derived from Center resources during the last funding period. Include progress summaries 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, including matching funds and/or in-kind contributions (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, the gap in aging biology services not provided by other centers, and specific plans for implementation of the new program.

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.

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 may not exceed $50,000 per year in direct cost), and the total budget for pilot projects under this core is expected not to exceed $400,000 per year in direct costs (salary for pilot investigator not allowed). 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 junior researchers and those new to the field of aging biology. Attainment of this goal could use both 'classical' approaches (e.g., pilot projects, usage of cores, etc.) as well as more innovative ideas such as the following:

• One-on-one mentoring;
• Mock review panels;
• Structured career development for junior faculty pilot awardees;
• Junior scholar exchanges or mini-sabbaticals;
• Enhance opportunities to support junior researchers in multiple career pathways through mentorship in NIA's Division of Aging Biology (DAB)-supported K award mechanisms;
• Provide support to establish mentoring teams for DAB-sponsored K, T32, and R25 funded grants

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 structured 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 biosketch and current research support.

Pilot projects must be focused on issues of interest to DAB. For that reason, applications 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 including mentoring of junior investigators to ensure success in applying for subsequent grant applications as outlined below.

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 the institution is encouraged. Finally, this core may include a specific plan to foster an inclusive and accessible research and training environment for all participating students and faculty, including those living with disabilities, those from underrepresented racial and ethnic groups, and those from disadvantaged backgrounds. Please note that the race, ethnicity, or sex of participating or prospective students or faculty will not be considered in the application review process or when making funding decisions. If the pilot PI is a junior faculty member, a structured plan of how these funds will lead to their career development is required (including monthly progress discussions with core leaders involved in the 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.

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 five 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.

In contrast, this NOFO 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, the following:

• 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.);
• Expertise and clear planning for  for the handling, storage, and data management of laboratory specimens; 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 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.

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 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply- Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How To Apply- Application Guide.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NIA, 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@mail.nih.gov when the application has been submitted. Please include the NOFO 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.

Section V. Application Review Information

1. Criteria

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

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).

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 center 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:

• What is the likelihood 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?
• To what extent will the NSC contribute to conceptual leadership to the field of aging biology?
• How well does the NSC provide an environment to foster sustained collaborative work by investigators from different fields and career levels?
• Does the NSC foster new lines of research and provide a rich mentoring environment for junior investigators?
• How well does the NSC function as a coherent whole that is greater than the sum of its parts?
• If a specific focus is chosen, what is the importance of that area regarding potential advances in the understanding of aging biology?
• Does the NSC demonstrate a significant effect of the NSC on the concepts or methods used to understand that particular area of aging biology?

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 center 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 center?

• 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?
• Is there assurance that the team of investigators have the experience and time commitment to serve the Center?
• Is there evidence that the leadership and mentoring teams of the proposed NSC are varied or heterogeneous in perspectives, academic backgrounds, and scientific and technical disciplines?

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 center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed center? 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 center 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 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:

• What is the value added by having the proposed cores comprise a unique NSC and will the cores allow the Center to leverage additional resources that would not have been possible without an integrated P30 structure?
• When considered as a whole, how well will the approaches proposed advance the biology of aging and take it in new directions?
• What are the assurances that the NSC has the ability to provide adequate infrastructure and institutional commitment to support novel approaches to research and has it anticipated current and future needs of the research community?
• To what extent 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 administrative and organizational structure conducive to attaining the objectives of the proposed program?
• Do coordination and integration across the proposed cores that reflect a cohesive research support program?

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 center proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

How well does the application describe the following:

• Will the scientific environment in which the work occurs, contribute to the probability of success?
• Are the institutional support, equipment, and other physical resources available to the investigators adequate for the NSC?
• How will the NSCbenefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
• How do 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 NSC?

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.

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.

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

• If there are changes in leadership, is the new plan is in line with required expertise for the role?
• If new cores are proposed, is there consistency with the goals of the Center, the program, and the current status of the field?
• Are they adequate justifications for adding or deleting current activities or cores?
• In the past funding cycle, how did the approach facilitate the center aims, particularly in advancing the biology of aging in the context of innovation and career development?
• To what extent were their significant outcomes noted through collaborations with other NSCs, NSC3 and other NIA- or NIH-supported programs?

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 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 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 policies and practices, 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 will receive a written critique.

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.

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

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 NOFO. 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 their 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 2.4.4 Disposition of Applications.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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 DAB, 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.

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, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

n 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition 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.

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: https://www.era.nih.gov/need-help  (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: 301-480-7075

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

Christy Carter, Ph.D.
National Institute on Aging (NIA) 
Telephone: 301-827-1382 
Email: christy.carter@nih.gov 

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

Terry Pham
National Institute on Aging (NIA)
Telephone: 301-402-6982
Email: terry.pham@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.

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 2 CFR Part 200.