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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Research Objectives

The Claude D. Pepper Older American Independence Centers (OAIC) program was established in honor of the late representative to establish centers of excellence in research and research education to increase scientific knowledge leading to better ways to maintain or restore independence in older persons. For additional information about the program, application guidance, and answers to frequently asked questions, please visit the National Institute on Aging's (NIA's) OAIC webpage.

OAIC awards are designed to develop or strengthen awardee institutions’ programs that focus on and sustain progress in a key area of aging research. Applicants should identify an area of focus in which progress could contribute to greater independence for substantial populations of older persons and offer opportunities for education in aging research. This area of focus should be a common theme around which all proposed OAIC activities are organized. NIA's expectation is that an OAIC, in a given area of focus, will:

• Provide intellectual leadership and innovation;
• Facilitate and develop novel multidisciplinary and interdisciplinary research strategies;
• Stimulate incorporation of emerging technologies, methods, and scientific advances into research designs, as appropriate;
• Provide research education for future leaders in geriatric research;
• Stimulate translation between basic and clinical research (e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research or studies to improve understanding of mechanisms contributing to clinical or functional findings);
• Promote translation of clinical research findings into practice in relevant healthcare settings (see also "Health Services Research as an Area of Focus" below);
• Collaborate substantially with other OAICs on multi-center projects such as integrating data systems, supporting multi-center observational studies, and providing infrastructure to support multi-site clinical trials, including pragmatic trials;
• Interface where possible with the NIA Research Centers Collaborative Network (RCCN), Clinician-Scientists Transdisciplinary Aging Research (Clin-STAR) Coordinating Center, and other NIA-funded programs and centers (e.g., Resource Centers for Minority Aging Research (RCMARs), Centers on the Demography and Economics of Aging, Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging, Alzheimer's Disease Centers (ADCs), Nathan Shock Centers, Artificial Intelligence and Technology Collaboratories for Aging Research);
• Leverage institutional resources, including other NIH-supported programs and centers, to achieve the OAIC's aims with efficiency; 
• Serve as a source of advice and collaboration to other investigators locally and on a large scale regarding technology, methodology, analysis, or other expertise;
• Conduct research to understand and ameliorate disparities in health outcomes among impacted populations; and
• Promote inclusivity of both scientific workforce and research participants through comprehensive outreach activities and community engagement, targeted recruitment efforts, enhanced supportive research environments, and equitable distribution of resources.  

Area of Focus

To achieve the objectives listed above, each OAIC should promote a sustained research program in an area of focus through which the Center will accomplish the innovation, leadership, collaboration, and research education functions described above. It is crucial to the design of an OAIC to identify an important research area to be addressed, to specify the goals to be achieved within the five-year OAIC award period, to provide a plan to reach these goals, and to outline a method to evaluate progress toward these goals during the course of the OAIC award. The selection of core activities (see below) should follow from these considerations.

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

• Aging-related issues concerning a specific condition contributing to loss of independence in older persons (e.g., role of aging changes in the etiology of the condition; special issues in the diagnosis, treatment, or prevention of the condition in old age; complications, disability, or symptoms from the condition found principally in older persons).
• Causes, assessment, prevention, and treatment (including rehabilitation) of a specific type of disability in older persons.
• Causes, prevention, and treatment of geriatric syndromes (e.g., sarcopenia, falls, incontinence) that are related to multiple pathologies and/or disabilities.
• Specific aging-related physiologic changes, other risk factors, and/or interventions (e.g., physical activity) that affect risk for multiple conditions or disabilities in old age.
• Interactions of multiple diseases, disabilities, and interventions (e.g., medications) in older persons and their relationship to risk of morbidity, progression of disability, and efficacy of prevention or treatment strategies.
• Factors contributing to amelioration or delay of multiple deleterious aging changes by modulating risk factors or fundamental aging mechanisms.

In general, each research focus described above has the potential for a wide range of developmental and infrastructural activities that are likely to be interdependent and synergistic. Thus, an OAIC strategy of selecting several key activities that address its area of focus may have unique benefits.

As the level of funding for individual OAICs is unlikely to allow such a set of activities for more than one focus area, applicants are strongly encouraged to select an area in which their strengths allow their OAIC to fulfill NIA's goal for the OAIC program and to direct their proposed OAIC activities toward that research area, while also ensuring that opportunities exist for collaboration among other OAICs and other NIA programs and centers. The total impact of an OAIC's activities on progress in the selected field(s) should be a major criterion in selection of the focus area and will be a major criterion in peer review and program evaluation.

To capitalize on important new research opportunities within their institutions, OAICs may also support a limited amount of activity in their cores on topics other than those in their area of focus (see below). Applicants who anticipate providing such support should propose a system for prioritizing these opportunities and needs and for selecting core activities to address them.

Staff in the Office of Planning, Analysis, and Evaluation (OPAE) at NIA expect to conduct a periodic evaluation of the OAICs to inform NIA’s continued investment in this high priority program. As part of this evaluation, OPAE staff may request information from OAIC investigators, OAIC-supported awardees, and other beneficiaries and stakeholders of OAIC activities.

Cognitive and Behavioral/Social Research as an Area of Focus

Cognitive or behavioral/social research should not be the major focus of an OAIC, as these areas are more appropriate for other NIA programs that also use the Center mechanism. However, where appropriate, OAICs are encouraged to support a multidisciplinary approach that includes research in these areas as they relate to the theme or focus of the OAIC.

Health Services Research as an Area of Focus

Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of healthcare providers, is generally appropriate for an OAIC or a component of an OAIC, provided the research is designed to:

• Determine health or risk-factor effects relating to outcomes that are primarily clinical or functional in the individuals treated by the intervention or practice, and
• Obtain new knowledge about the effects of interventions or healthcare practices that clearly specify what will be done for, or by, the individuals treated by these interventions or practices, or
• Obtain new knowledge about the validity or predictive value of diagnostic or assessment techniques that clearly specify what will be measured in individuals.

Components of an OAIC

An OAIC must consist of four required components and up to three optional components. A brief description of each Component is provided below. A complete list of requirements for each Component is detailed in Section IV of this NOFO. Henceforth, the terms “component(s)” and “core(s)” will be used interchangeably to reference the components of this NOFO.

Overall (required) 

This component will comprise the general organizational structure of the OAIC and all its activities.

Leadership and Administrative Core (LAC) (required)

The LAC coordinates and oversees all aspects of the OAIC.

Two advisory panel activities the LAC will organize are the following:

• The constitution and convening of an External Advisory Board (EAB). An EAB, whose members are entirely external to the institution(s) of the proposed OAIC, should convene yearly to review the progress of the OAIC.
• The constitution and convening of an advisory panel (or panels) to assist in selecting Pilot/Exploratory Studies, Developmental Projects, and participants in the Research Education Component (REC).

Additional details regarding the activities above, as well as a full list of LAC activities, are provided in  Section IV of this NOFO.

Research Education Component (REC) (required)

The overarching goal of the Research Education program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral, and clinical needs in aging-related research. The REC will support creative educational activities with a primary focus on providing mentored research experiences to promote the development of future research leaders in the OAIC area of focus, particularly leaders who can integrate clinical insights regarding health/disease and independence/disability in old age with knowledge of advances in the basic sciences to improve clinical interventions for maintaining health and independence.

Resource Core (RC) (required)

RCs will provide resources to do the following:

(a) Enhance or support OAIC-supported projects (i.e., Pilot/Exploratory studies, REC projects) and projects funded primarily by other mechanisms (i.e., External Projects), and 
(b) Develop and validate model systems (e.g., animal models); methods; assays; analytic techniques; equipment; and/or diagnostic, assessment, or survey instruments to advance aging research (i.e., Developmental Projects).

The RC should be based on a research field or function that contributes to the OAIC area of focus. The RC should synergize with other OAIC components rather than merely support existing non-OAIC-funded projects. An RC may be defined in terms of a biomedical or biotechnology field (e.g., clinical trials, endocrinology, geriatric assessment, bioengineering); a service function (e.g., subject recruitment and retention, pathology, genotyping); or a supply function (e.g., animal care and use). Examples of possible RCs include, but are not limited to, the following:

• Recruitment/screening/assessment/registry units for subjects in clinical research protocols, including clinical trials.
• Diagnostic and pathophysiologic units for studies of mechanisms of treatment response and interactions with disease.
• Basic science laboratories providing assays or other measures of cellular, molecular, or biochemical factors for clinical or basic studies.
• Biostatistical/data management units
• Cost-effectiveness analysis units
• Units for the support of laboratory animals used in aging research and the development of animal models of age-associated diseases

In designing an RC, the applicant is strongly encouraged to consider the full range of disciplines, technologies, methodologies, services, and resources that could be applied to the OAIC's selected area of focus; however, there is no requirement that an RC include this full range. The selection of areas for an RC should be made on the basis of the contribution of services and support to the overall goals of the OAIC. In general, RCs are expected to interact with the studies they support, providing expertise in the design, conduct, and analysis of results, as well as technical services or products.

Each proposed RC must support the following:

1) At least two projects (Developmental Projects (DPs) and/or External Projects (EPs) and
2) No more than two DPs:

DPs are projects aimed at technology, resource, and/or methods development in order to establish new methods or technologies that will enrich the resources of the RC or the services it provides. DPs that challenge existing paradigms or develop new methodologies or technologies are highly valued. Examples of activities in DPs are listed below; however, this list does not describe the full range of supported activities, nor is it intended to direct applicants towards these areas:

• Development or preliminary testing of new data acquisition methods or technologies, assays, materials, or instruments to assess their feasibility and potential to provide important information, relevant to the OAIC focus, that is not available or is less feasibly obtained with current methods. The range of approaches in which such projects may be conducted includes genetic, molecular, biochemical, engineering, imaging, clinical diagnostic, functional assessment, bioinformatic, and survey methods. 
• Development and testing of new analytic and computational strategies for data to allow more informative results from studies in the OAIC area of focus. 
• Preliminary evaluation of new animal models for relevant age-related outcomes.

EPs are basic and/or clinical research projects relevant to the OAIC focus whose support is independent of the OAIC (i.e., research funded through other NIH or non-NIH mechanisms). RCs may provide services to enhance and integrate the scientific contributions of EPs, provided that such support contributes to the overall goals of the OAIC.

Pilot/Exploratory Studies Core (PESC) (optional)

OAICs may support Pilot/Exploratory Studies (PESs) to acquire information needed to select or design future crucial studies in the OAIC area of focus.

Information Dissemination Core (IDC) (optional)

An IDC supports activities to disseminate information relating to the OAIC's research areas and/or to enhance translation of clinical research findings into healthcare practice.

Community Engagement Core (CEC) (optional)

A CEC supports activities to develop and maintain mutually beneficial relationships with community partners in order to inform the OAIC's scientific goals, establish culturally sensitive recruitment and retention approaches of underrepresented research participants, disseminate scientific findings to community partners, and foster scientific leadership among community members. Applicants who elect not to include a CEC are strongly encouraged to incorporate community engagement activities into other components of the OAIC.

NIA’s Commitment to Inclusion in Research Involving Human Subjects

NIA is committed to supporting and conducting research on aging that improves the health and well-being of all people. Therefore, NIA will prioritize the advancement of science that represents, in terms of race, ethnicity, sex, age, and comorbidity, the population affected by the condition being studied. Applicants should ensure as applicable that they 1) include proposed planned enrollment tables identifying the population(s) affected by the disease/condition, and 2) address the NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities, as appropriate; as well as other populations that experience health disparities.

Clinical Research Operations Management System

NIA uses a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021, including clinical trials funded as pilots, exploratory studies, or other projects through this Consortium, and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website.

When applicable, all NIA grantees must ensure:

1. The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 §46.116, all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.” If using the NIA informed consent template, please see Section 6: Statement of Confidentiality.

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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 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 How to Apply - Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed.

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 How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 NIA staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Fax: 301-402-0066
Email: [email protected]

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 How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Present a brief overview of the entire application and summarize the general plan and goals for the proposed OAIC.

Facilities and Other Resources: Describe facilities and other resources available at the institution(s) served by the OAIC and how they relate to proposed OAIC organization and activities. Describe institutional commitment to the OAIC. Do not merely list resources. This section should list facilities and resources pertaining to the OAIC as a whole. Information pertaining to specific components should be described in those respective component sections. Per NIH policy, hyperlinks must not be included.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Equipment: Describe equipment available at the institution(s) served by the OAIC and how the equipment relates to proposed OAIC activities. Do not merely list equipment. This section should list equipment pertaining to the OAIC as a whole. Information pertaining to specific components should be described in those respective component sections.

Other Attachments: Provide the following two tables in a single attachment. Title the attachment "Supplemental Tables." Applicants should use the template provided on NIA's OAIC webpage:

1. Resource Core Distribution to Research Projects. List each proposed OAIC-supported and external project and indicate which Resource Core(s) will support the project. It is not necessary to specify the extent to which a Resource Core will support a project; a simple checkmark will suffice.

2. Senior/Key Personnel Roles and Effort. For each Senior/Key Personnel, list their role(s) in the OAIC and first-year effort in calendar-months associated with each role.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

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

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims:

Describe the goals to be achieved by the OAIC, and include the following:

•  The OAIC's selected area of focus and basis for selection; 
• Crucial problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the OAIC would address in the focus area selected; and 
• Advances in regard to these problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the OAIC would achieve over its five-year award period.

Research Strategy:

Significance. Focusing on the OAIC as a whole, address (i) the importance of the problem or critical barrier to progress in the field that the proposed OAIC addresses; (ii) how the proposed OAIC will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields; and (iii) how the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. Describe how it will accomplish the intellectual leadership, translational, interdisciplinary, collaborative, and research education functions expected of an OAIC to advance aging and geriatric research.

Approach. Present the OAIC's overall strategy for serving as a sustained resource to the research program in its selected area of focus regarding technology, methodology, analysis, or other expertise. Describe the specific activities that the OAIC will undertake to accomplish the goals and strategy described above, including how the different components of the OAIC will interact to help accomplish them, how the approaches of the cores complement each other or are inter-dependent, the mechanisms to ensure coherence of the Center and maintenance of an interdisciplinary focus, and the mechanisms to be used in assessing progress toward the OAIC's goals. In short, describe how the whole be greater than the sum of the parts. Additionally, describe how the program will incorporate both fundamental discovery and the development of applied research. Where appropriate, provide timelines and organizational charts. Note the major OAIC cores and other activities, referencing appropriate subsequent sections of this application that contain more detail.

Describe the reach of the proposed OAIC's leadership and collaboration beyond the local level, including collaborations with other OAICs or other NIA- or NIH-supported program and centers. Describe a plan for sharing of responsibilities among investigators and between institutions, and how collaborative arrangements will advance the needs of the OAIC.

New proposed OAIC sites should use this section to present preliminary data and/or evidence of preparatory activities for establishing an OAIC. Renewal applications from existing OAIC sites may use this section to present overall progress report information not contained in specific core sections of the application (with citations where appropriate). Tables of OAIC activities during the previous funding period can be presented here, provided they fit within the page limits of this section.

Renewals. If cores included in the prior period of support are not part of the current submission, describe their progress and explain why they are not included. Identify and justify any substantive differences in approaches from the prior period of support. Identify and justify any changes in research emphasis and level of funds requested. If the structure of cores has changed, show the correspondence to the prior structure.

Innovation. Considering the OAIC as a whole, show how the proposed OAIC seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Show how these concepts, approaches, methodologies, instrumentation, or interventions are novel to the research field or novel in a broad sense. Show how the proposed OAIC will refine, improve, or apply in a new way the concepts, approaches, methodologies, instrumentation, or interventions proposed.  

Eligibility Criteria for Research Involving Human Subjects:

Without duplicating information in the PHS Human Subjects and Clinical Trials Information form, applications in response to this funding opportunity must provide a rationale supporting eligibility criteria that are 1) representative of the population affected by the disease/condition, and 2) address the populations outlined in the NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities, as appropriate; as well as other populations that experience health disparities. The goal is for clinical trials to address inclusion, so that researchers can determine whether the variables being studied affect women or members of any racial and ethnic population group in accordance with the NIH Inclusion Policies.

Study teams must demonstrate that they have considered the NIH Inclusion Policies including proposed planned enrollment tables representative of the population affected by the disease/condition. Where applicable, study teams should also demonstrate that they have critically evaluated whether eligibility criteria from an earlier phase trial should be carried forward into a later phase trial. The eligibility criteria section must:

• Describe how the study results generalize to the wider patient population with this disease/condition.
• Explain how the rationale for selected eligibility criteria justify the level of restriction in the study compared to clinical practice.
• Provide evidence that the eligibility criteria support the proposed research and encourage inclusion of NIH-designated Populations with Health Disparities.

Recruitment and Retention Plan for Research Involving Human Subjects:

Without duplicating information in the PHS Human Subjects and Clinical Trials Information form, applications in response to this funding opportunity must propose innovative and proactive recruitment strategies for involving understudied populations to promote representation as applicable and justified by the scientific goals.  Applicants should ensure that they 1) include proposed planned enrollment tables identifying the population(s) affected by the disease/condition, and 2) address the populations outlined in the  NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities, as appropriate; as well as other populations that experience health disparities. Recruitment and retention plans should demonstrate an understanding of the participant burden involved in research participation and strategies for minimizing this burden, as well as leveraging community partners and outreach efforts. The recruitment and retention plan must:

• Describe potential barriers to participation and plans to minimize these barriers.
• Describe a detailed plan for the recruitment of understudied populations and a plan to leverage existing relationships with and/or conduct outreach to a broad range of community groups.
• Describe staff training to address cultural and linguistic competence. 

Letters of Support:

Place institutional letters of support for the OAIC 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 How to Apply - Application Guide.

Other Plan(s): 

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

• 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 How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide information on data and safety monitoring pertinent to the OAIC as a whole according to the guidance on the NIA OAIC webpage.

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.

Leadership and Administrative Core (LAC)

When preparing your application, use Component Type “LAC.”

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

SF424 (R&R) Cover (LAC)

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 (LAC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (LAC)

Follow standard instructions.

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 Summary/Abstract: Present a brief overview of the LAC.

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.

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the LAC and how they relate to the organization or activities of the LAC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the LAC and how it relates to activities of the LAC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (LAC)

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 (LAC)

• 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.
• In the Core Lead(s)'s' biographical sketch(es), describe their qualifications to lead the LAC in its proposed focus of research, including their ability to (A) work collaboratively with other investigators, (B) establish mechanisms for quality control of the science receiving core funds, (C) move the OAIC into new innovative research areas, and  (D) translate new scientific findings along the translational research continuum.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD(s)/PI(s) for the OAIC application should be the Core Lead(s) for the LAC. The Core Lead(s) should have sufficient expertise in the OAIC's area of research focus to exercise effective scientific judgment and leadership.

Budget (LAC)

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

Up to $150,000 in first-year direct costs may be requested for LAC activities. The LAC budget should include travel expenses for OAIC personnel to attend the annual OAIC investigators meeting. Applicants should budget for a 2 night stay in the Washington, DC area.

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 (LAC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed LAC during the previous review.

Specific Aims: The LAC is responsible for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals of the OAIC. Provide an overview of how the LAC will implement the theme or focus of the OAIC.

Research Strategy: Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Describe the overall role of the LAC in the OAIC. Describe how the LAC will address the needs of the OAIC and bring unique advantages or capabilities to the OAIC.

Approach and Innovation. Describe how the LAC will conduct or organize the following activities:

• Regular review of utilization of core resources by the other OAIC cores and reallocation of resources within or among cores.
• Assessment of scientific opportunities for new utilization of core resources and plans to utilize them. One topic that should routinely be assessed is the potential for translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research, or studies to improve understanding of the mechanisms contributing to clinical or functional findings.
• Assessment of potential areas for collaboration among OAIC cores within the Center and with other OAICs or other projects, and planning for collaborative activities, if merited.
• Review of proposed Developmental Projects and Pilot/Exploratory Studies by an independent panel or panels. The LAC may elect to convene a single panel or separate panels to conduct reviews of the above activities. Panels may meet in person or by teleconference. Ad hoc reviewers may be invited to participate in the panels to address specific projects in their areas of expertise.
• Constitution and convening of an External Advisory Board (EAB). An EAB, whose members are entirely external to the institution(s) of the proposed OAIC, should convene yearly to review the progress of the OAIC. The EAB's non-binding recommendations are communicated directly to the LAC to inform its administration of the OAIC. The operating procedures of the EAB, including the frequency of its meetings and the methods for the identification of members, should be specified; however, for new applications, the names of potential EAB members should not be included in the application, and potential members should not be contacted until the OAIC is awarded. Inclusion of at least one Director or Core Leader from another OAIC is encouraged; however, EAB membership consisting entirely of Directors or Core Leaders from other OAICs is discouraged. Applicants are encouraged to include individuals with varying perspectives, experience, and backgrounds as members, including community members with lived experience. There is no set number of EAB members; however, there should be sufficient expertise represented among the members of the EAB to provide an adequate review of all the functions of the OAIC. EAB meetings can be held in person and/or by remote conferencing, as appropriate to the needs and budget of the OAIC. A report of the EAB's annual review should be included in the yearly NIH progress report.
• Constitution and convening of an advisory panel (or panels) to assist in selecting Pilot/Exploratory Studies, Developmental Projects, and participants in the Research Education Component (REC). At least one-third of the members of each panel should be external to the OAIC and the grantee institution(s). Applicants are encouraged to include individuals on the panel from diverse backgrounds, including those from underrepresented groups. See the Notice of NIH's Interest in Diversity (NOT-OD-20-031). The advisory panel for the REC should be described in that component under Other Attachments. New applicants should not name potential advisors or select advisors prior to award of application. Applicants may propose a single panel that satisfies all these requirements, or multiple panels, as needed. Applicants may choose to use their EAB for some or all of these functions.
• Coordination of attendance of OAIC personnel at an annual OAIC Investigators meeting. Participation of OAIC leadership at the annual meeting is mandatory. Participants include the PD(s)/PI(s), Center Administrator, Core Leads, and others as appropriate for purposes of programmatic coordination and scientific exchange.
• Timely submission of information to the OAIC Coordinating Center for inclusion in the Annual Pepper Center Directory.
• Preparation of administrative documents relating to the award.
• Additional activities, such as research planning meetings (including participants from other institutions), invited scientific presentations, and travel expenses for OAIC staff to visit other OAICs for collaborative projects.

Renewal applications from existing OAIC sites should use this section to present progress report information specific to the LAC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed LAC.

Describe the administrative structure of the LAC, the administrative relationships between the LAC and all other OAIC components, governance strategies, and the ways in which they will interact to achieve the OAIC’s goals and maintain quality of the OAIC. Describe the activities of the LAC leader(s), the Center Administrator, and other LAC staff in carrying out LAC functions including contractual agreements, conflict resolution, and addressing inadequate progress. A crucial component of this description is the activities of the LAC leader in monitoring, stimulating, sustaining, evaluating, and reporting the OAIC’s progress toward the overall goals of the OAIC. Present plans to establish and operate OAIC advisory panels, including criteria for selecting advisors, how they will be identified, the operating procedures of each panel, and the frequency of meetings. Present plans to establish and assess internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among investigators in the 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 (LAC)

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, 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.

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.

Resource Core (RC)

When preparing your application, use Component Type “RC”.

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

SF424 (R&R) Cover (RC)

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 (RC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (RC)

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 Summary/Abstract: Present a brief overview of the RC.

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.

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the RC and how they relate to the organization or activities of the RC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the RC and how it relates to activities of the RC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (RC)

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 (RC)

• 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. Note: Leaders of Developmental Projects are considered Senior/Key personnel.

In the Core Lead(s)' biographical sketch(es), describe their qualifications to lead the RC in its proposed focus of research, including experience and training, demonstrated experience and an ongoing record of accomplishments in managing aging research, significant experience with coordination of collaborative clinical research, establishing mechanisms for quality control of the science receiving core funds, moving the OAIC into new innovative research areas, and ability to translate new scientific findings along the translational research continuum.

• 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.
• Describe any experience of Core personnel in overseeing selection and management of subawards, if appropriate.

Budget (RC)

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

There is no budget limit for an RC per se; rather, budget limits for RCs apply to their Developmental Projects (DPs; see description below). First-year direct costs for each DP should range between $35,000 and $70,000. DPs may last from 1 to 5 years.

Salary and other expenses for the Core leader and administrative staff may be requested. Research-related patient care costs are eligible for support through the RCs, but routine patient care costs may not be requested. Cost-recovery strategies may be proposed but are not required.

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 (RC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed RC during the previous review.

Specific Aims:

Show the intended role of the RC in relation to the Center as a whole and to the theme of the Center. Use this section to summarize the specific aims of each External Project (EP) or Developmental Project (DP).

If an EP is supported by more than one OAIC RC, list the EP in each RC and indicate the RC where the initial description can be found. An RC should be proposed only if it clearly serves the aims and theme of the OAIC. Applicants should consider the feasibility of supporting multiple RCs within the allowable OAIC budget.

Research Strategy:

Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Describe how the RC will bring unique advantages or capabilities to the OAIC. Describe how the RC will contribute to the success of other cores. Provide a clear statement of the way in which an individual RC will enhance the scientific productivity of the projects and assist the Center investigators to realize the OAIC's objectives in its area of focus. Clearly distinguish between material support (e.g., performing assays, facilitating recruitment) and support in the form of guidance or advice. Explain the intended strategy in developing this resource and how research quality and efficiency would be enhanced by use of the services of the RC. Specify pertinent uses of the RC by junior faculty and how such use will promote research leading to increased independence of older persons. Describe how each EP or DP planned for support through this core will achieve the goal of the RC and the overall goals of the OAIC.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the RC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed RC.

Describe the operations of the RC, including any innovative organizational approaches. Plans for the RC's scientific and administrative functioning should be presented. Describe leadership approach, governance, and plans for conflict resolution of the Core Lead(s). Present potential problems, alternative strategies, and benchmarks for success. Describe a plan for work flow and a well-established timeline. Present plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects

If the core is in the early stages of operation, describe how feasibility will be established and how risks associated with the activities of the core will be managed.

Present a detailed plan for how EPs and DPs eligible for RC support will be reviewed, selected, and prioritized for access to the RC resources for all years of the grant period. Include a plan for outreach to promote a heterogeneous applicant pool. Describe how the Core Lead, together with the OAIC PD(s)/PI(s), will monitor and evaluate ongoing progress of EPs and DPs in the context of RC support. This plan should include the use of an advisory committee, the composition and functioning of which should be described in detail in the LAC research strategy.

For each DP, list the Title, Core Lead and Senior/Key Personnel, a description of the approach that the DP will use to achieve its goals, a clear analytic plan, and any innovative aspects. Also describe how DPs will interact with other cores of the OAIC. Each RC may support a maximum of 2 DPs, each lasting 1-5 years.

NIA requires that program staff be notified of DP awards made by an OAIC to its investigators. This can be done at the time of the progress report, unless the DP is a human subject study involving more than minimal risk, in which case a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

For each EP proposed for RC support during the first year of the OAIC grant, list the PD/PI, title of award, source of award, and duration of external support. In addition, briefly present the approach and any innovative aspects of each EP if these descriptions are not presented elsewhere. If the EP is presented elsewhere, indicate the section in the application where the initial description can be found.

Describe how the RC will facilitate and develop novel multidisciplinary and interdisciplinary research strategies, how the RC and its associated Developmental Projects and/or External Projects challenge existing paradigms or develop new methodologies or technologies, how the RC will stimulate translation between basic and clinical research and/or between clinical research and practice, and how the RC will add new research directions that are based on insights from basic aging research or geriatrics.

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 (RC)

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, 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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide RC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

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.

Pilot/Exploratory Studies Core (PESC)

When preparing your application, use Component Type “PESC.”

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

SF424 (R&R) Cover (PESC)

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 (PESC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (PESC)

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 Summary/Abstract: Present a brief overview of the PESC.

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.

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the PESC and how they relate to the organization or activities of the PESC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the PESC and how it relates to activities of the PESC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (PESC)

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 (PESC)

• 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. Pilot/Exploratory Study award recipients, who may be junior or senior investigators, are considered Senior/Key personnel.
• In the Core Lead(s)'s' biographical sketch(es), describe their qualifications to lead the PESC in its proposed focus of research, including appropriate experience and training, demonstrated experience and an ongoing record of accomplishment in managing aging research, ability to work collaboratively with other investigators, establishing mechanisms for quality control of the science receiving core funds, moving the OAIC into new innovative research areas, and ability to translate new scientific findings along the translational research continuum.
• 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.
• Describe any experience of Core personnel in overseeing selection and management of subawards, if appropriate.

Budget (PESC)

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

Up to $300,000 in first-year direct costs may be requested for the PESC. Each Pilot/Exploratory Study (PES) is limited to $100,000 in direct annual costs and 3 years in duration.

Salary and other expenses for the Core leader and administrative staff may be requested. Research-related patient care costs are eligible for support through the PESCs, but routine patient care costs may not be requested.

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 (PESC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed PESC during the previous review.

Specific Aims: Outline the topic areas to be solicited and the expected outcomes for pilot or exploratory study awards. PESs may be led by junior or senior investigators.

Examples of PESs that may be supported by the PESC include, but are not limited to, the following:

• Preliminary testing of an intervention or other research protocol in humans or animals for safety, feasibility, or determination of optimal time course or dosage
• Analysis of data acquired in previous or ongoing studies to explore hypotheses that may guide the selection and design of future studies

Describe up to 5 example PESs to illustrate the function and scope of the PESC. The specific aims of each proposed PES must address the relationship of the PES to the overall theme or focus of the OAIC.

Research Strategy:

Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Describe how the PESs will fit within the goals of the PESC and how they will interact with the OAIC's other cores to contribute to their success and the goals of the OAIC.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the PESC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed PESC.

Describe the operation of the PESC, any novel organizational concepts or management strategies, and the types of applications that will be supported. Describe how the PESC will facilitate and develop novel multidisciplinary and interdisciplinary research strategies, stimulate translation between basic and clinical research and/or between clinical research and practice, and add new research directions based on insights from basic aging research or geriatrics. Present potential problems, alternative strategies, and benchmarks for success. Describe a plan for work flow and a well-established timeline. Present plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects.

If the core is in the early stages of operation, describe how feasibility will be established and how risks associated with the activities of the core will be managed.

Provide a detailed plan for how PESs will be solicited, peer reviewed, selected, prioritized for access to PESC resources, and overseen. In the plan, include strategies for outreach to investigators from diverse backgrounds, including those from underrepresented groups, who may work with their institutions to apply. See the Notice of NIH's Interest in Diversity (NOT-OD-20-031). This plan should include the use of an advisory panel, the composition and functioning of which should be described in detail in the LAC research strategy. Describe how the Core Lead(s), together with the OAIC PD(s)/PI(s), will monitor ongoing progress of studies and assist in the planning for the development of PESs into independently funded grant applications, where appropriate. Describe the leadership approach, governance, and plans for conflict resolution of the Core Lead(s).

Up to 5 PESs may be described. Number each PES sequentially (i.e., PES-1, PES-2, etc.). For each PES, list the Title, Project Lead, and Senior/Key Personnel, and provide a brief description of the significance, approach, and any innovative aspects. Describe how each PES will help inform future studies in the OAIC area of focus. In describing each PES, applicants are encouraged to avoid details that are immaterial to the aims of the PESC or the theme of the OAIC. Descriptions of proposed PESs are intended to illustrate the scope of the PESC and its integration with the rest of the OAIC.

NIA requires that program staff be notified of PES awards made by an OAIC to its investigators. This can be done at the time of the progress report unless the PES is a human subject study involving more than minimal risk, in which case a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

Participating researchers in OAICs are encouraged to consider seeking additional sources of funding for pilot or exploratory studies.

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 (PESC)

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, 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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide PESC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

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.

Information Dissemination Core (IDC)

When preparing your application, use Component Type “IDC.”

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

SF424 (R&R) Cover (IDC)

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 (IDC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (IDC)

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 Summary/Abstract: Present a brief overview of the IDC.

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.

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the IDC and how they relate to the organization or activities of the IDC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the IDC and how it relates to activities of the IDC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (IDC)

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 (IDC)

• 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.
• In the Core Lead(s)'s' biographical sketch(es), describe their qualifications to lead the IDC in its proposed focus of research, including appropriate experience and training, demonstrated experience and an ongoing record of accomplishment in managing aging research, and experience with collaborative clinical research.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (IDC)

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

Up to $60,000 in first-year direct costs may be requested for IDC activities.

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 (IDC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed IDC during the previous review.

Specific Aims: Describe the role of the IDC in enhancing translation of clinical research findings into healthcare practice. IDC activities may include communication with professional societies and private and public organizations responsible for health care of older persons or policies affecting clinical research on older persons. Examples of possible activities include, but are not limited to, preparation of information and organization of briefings for key healthcare organizations, collaborative activities for information exchange among multiple governmental and non-governmental organizations, and participation in the development of evidence-based practice guidelines by professional societies.

Research Strategy: Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Explain the purpose and functions of the IDC. Present a clear statement of how the IDC relates to the theme or focus of the OAIC and how it will contribute to the goals of the OAIC and enhance the function of other OAIC components.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the IDC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed IDC.

Describe the operation and governance of the IDC, including plans for conflict resolution. Describe the types of activities that the IDC will conduct to disseminate information relating to the OAIC’s research areas. Describe the organizations, societies, and institutions that will interact with the proposed IDC and how these relationships will contribute to the goals of the IDC. Provide a plan describing how the proposed activities of the IDC will be selected and evaluated. Describe how the IDC will access and interact with other cores of the OAIC, including the LAC, and other institutional resources for its proposed activities.  Present potential problems, alternative strategies, and benchmarks for success. Describe a plan for work flow and a well-established timeline. 

If the core is in the early stages of operation, describe how feasibility will be established and how risks associated with the activities of the core will be managed.

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 (IDC)

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, 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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide IDC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

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.

Community Engagement Core (CEC)

When preparing your application, use Component Type “CEC.”

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

SF424 (R&R) Cover (CEC)

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 (CEC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (CEC)

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 Summary/Abstract: Present a brief overview of the CEC.

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.

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the CEC and how they relate to the organization or activities of the IDC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the CEC and how it relates to activities of the CEC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (CEC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (CEC)

• 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.
• In the Core Lead(s)'s' biographical sketch(es), describe their qualifications to lead the CEC in its proposed focus of research, including appropriate experience and training, demonstrated experience and an ongoing record of accomplishment in managing aging research, and experience with coordinating collaborative clinical research.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (CEC)

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

Up to $80,000 in first-year direct costs may be requested for CEC activities.

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 (CEC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed CEC during the previous review (if applicable).

Specific Aims: Describe the role of the CEC in developing and maintaining mutually beneficial relationships with community partners in support of the OAIC’s scientific goals. CEC activities may include, but are not limited to, eliciting and incorporating input from communities of interest to inform the OAIC’s scientific activities; establishing culturally sensitive recruitment and retention approaches for underrepresented research participants; enhancing scientific education among community leaders; and disseminating OAIC-relevant scientific findings to community partners, in coordinating with the IDC if applicable. 

Research Strategy: Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Explain the purpose and functions of the CEC. Present a clear statement of how the CEC relates to the theme or focus of the OAIC and how it will contribute to the goals of the OAIC and enhance the function of other OAIC components.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the CEC (if applicable). Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed CEC.

Describe the operation and governance of the CEC, including plans for conflict resolution. Describe the types of activities that the CEC will conduct to foster meaningful and mutually beneficial relationships with community partners. Describe the communities, organizations, and leaders that will partner with the proposed CEC and how these relationships will support the goals of the CEC. Provide a plan describing how the proposed activities of the CEC will be selected and evaluated. Describe how the CEC will access and interact with other cores of the OAIC, including the LAC, and other institutional resources for its proposed activities.

Present potential problems, alternative strategies, and benchmarks for success. Describe a plan for work flow and a well-established timeline.

If the core is in the early stages of operation, describe how feasibility will be established and how risks associated with the activities of the core will be managed.

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 (CEC)

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, 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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide IDC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

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 Education Component (REC) Linked Education Project (RL5)
Successful applicants will receive support through the P30 activity code and the RL5 activity code, which will support the REC.

When preparing your application, use Component Type “REC.”

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

SF424 (R&R) Cover (REC)

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 (REC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (REC)

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 Summary/Abstract: Present a brief overview of the REC.

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.

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the REC and how they relate to the organization or activities of the REC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the REC and how it relates to activities of the REC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Other Attachments: REC Advisory Committee

An Advisory Committee is a required component of the REC. Provide a plan for the appointment of an Advisory Committee to select and monitor progress of REC participants. The composition of the committee, including the inclusion of individuals from diverse backgrounds (see the Notice of NIH's Interest in Diversity, NOT-OD-20-031); roles, responsibilities, experience with mentoring and/or training, and desired expertise of committee members; frequency of committee meetings; and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the REC program. New applications should not include the names of proposed Advisory Committee members, and proposed members should not be contacted prior to application award.

At least one-third of the members of the REC Advisory Committee should be external to the OAIC and the grantee institution(s). REC Advisory Committee membership need not differ, in total or in part, from those of other OAIC advisory panels.

The REC Advisory Committee description must not exceed one page in length and should only include information related to the REC Advisory Committee. Applications that exceed this limit or use this page to describe information unrelated to the REC Advisory Committee may not be reviewed.

Project /Performance Site Location(s) (REC)

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 (REC)

• 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. Note: REC program faculty and REC participants are not considered Senior/Key personnel in the REC. However, appointment and termination of REC participants should be reported through the xTrain system as described further in the Other Reporting Requirements sub-section of Section VI. Award Administration Information.
• 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 (REC)

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

Follow all instructions provided in the SF424 (R&R) Application Guide, with the following additional modifications, as noted.

• Up to $450,000 in first-year direct costs may be requested for REC activities.
• Funds for salaries and other expenses of the Core Lead(s), information resources, and support staff may be requested.
• The REC provides support to participants, including salary, fringe benefits, travel, equipment, and supplies. The REC may also offer short courses or workshops for skills development. REC participant costs must be itemized in the proposed budget.
• Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.
• There is no minimum salary or professional effort requirement for REC participants. REC participants may receive salary support from other federal sources consistent with the institution's salary scale as long as those sources do not specifically prohibit such salary supplementation. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the REC as participants, but may not receive salary or stipend supplementation from the REC.
• Because the RL5 program is not intended as a substitute for an NRSA institutional training program (e.g., T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.
• Expenses for foreign travel must be exceptionally well justified.
• Indirect costs (Facilities & Administrative costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition, fees, and expenditures for equipment).

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 (REC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed REC during the previous review.

Specific Aims:

Describe the contribution of the REC to the OAIC’s overall goals. Describe how the proposed use of REC funds for research education activities will contribute to the OAIC's goals for research education in its selected area of research focus. Describe how the REC Lead(s) and other mentors will help implement the intended goals of the REC.

Research Strategy:

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components (described below):

• Proposed Research Education Program
• Core Lead(s)
• Program Faculty
• Program Participants
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan

1. Proposed Research Education Program

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are ongoing in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the pre-established training program.

The research education program should include mentored research experiences. Outline the goals of the program and describe the objectives and activities that will be used to meet these objectives. Describe the nature and extent of the research education activities, considering the differences in previous training and experiences of the participants.. Include information about mentored research experiences and other educational activities essential for the proposed program.

Describe how the REC will promote development of future research leaders in its area(s) of focus, particularly leaders who can integrate clinical insights regarding health, disease, independence, and disability in old age with knowledge of advances in the basic sciences, including gerontology, to develop better interventions to maintain health and independence.

Describe the plan for recruiting, selecting, mentoring, and monitoring the progress of individuals, including those from underrepresented populations who will receive REC support over the proposed OAIC award period, and describe the abilities that REC candidates will be expected to acquire. The plan should include use of an advisory panel, the composition and functioning of which should be described in detail in the Other Attachments section and be consistent with the requirements for advisory panels as described in the LAC section of this NOFO. Attention to health disparities is highly valued by the OAIC program.

The research education plans for at least some REC participants should provide for the development of combined competence in both basic and clinical research. This should be accomplished either by enhancing the clinical research experience of basic scientists, developing the basic research skills and experience of clinical investigators, or providing a combination of the two approaches. An emphasis on development of skills for translating basic findings into clinical research and clinical findings into mechanistic studies is encouraged. Regarding the goal of developing researchers with combined expertise in clinical and basic aging research, OAIC applicants should consider the previous training of the individual candidate in determining the nature and extent of research education activities for which REC support is requested.

Renewal applications from existing OAIC sites, including those with RECs supported by other similar component mechanisms, should present progress report information specific to the REC in this section. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities relevant to the proposed REC.

2. Core Lead(s)

Describe arrangements for administration of the program. Provide evidence that the Core Lead(s) is/are actively engaged in research and/or teaching in an area related to the mission of NIA and the OAIC program and that the Core Lead(s) can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Core Leads, describe the complementary and integrated expertise of the Leads, their leadership approach, and governance appropriate for the planned program.

3. Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women, are encouraged to participate as Program Faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles, including sufficient institutional support.

Describe how the Program Faculty will serve as preceptors/mentors and provide guidance and expertise appropriate to the level of the participants proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty as role models by virtue of their scientific accomplishments, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research education experience, describe a plan to ensure successful participant guidance by these individuals. Describe the criteria used to appoint and remove individuals as Program Faculty and to evaluate their participation.

Biosketches for Program Faculty should not be included in the application, unless they are senior/key personnel in other cores.

4. Program Participants

REC support is intended mainly for junior faculty and postdoctoral research associates. Describe eligibility criteria and/or specific educational background characteristics required to participate in the proposed research education program. Identify the career levels for which the proposed program is planned. Present brief descriptions of research and training backgrounds, research activities, and mentoring plans of representative participants as examples of the manner in which the REC and other OAIC cores will contribute to the research educational experiences of REC participants.

At least some participants selected for support through the REC should hold a clinical doctoral degree. OAIC research education support should be integrated with other sources of career support that participants may be receiving (e.g., GEMSSTAR, Clin-STAR, fellowships, non-NIH career awards) in concerted programs for research education. REC support is intended primarily for U.S. citizens and permanent residents, unless there is strong justification otherwise based on exceptional relevance to NIH and NIA. Plans for recruiting prospective participants should include plans for outreach to under-represented populations.

If a REC participant will engage in a human subject study involving more than minimal risk, a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

Renewal applications should provide as part of the progress report descriptions of research and career development achievements of previous and current REC participants. New applications should provide descriptions of research and career development achievements of individuals in comparable institutional training or research education programs. Presentation of this information in tabular format is encouraged where appropriate.

5. Recruitment Plan to Enhance Diversity (see NOT-OD-20-031):

All applications must include a Recruitment Plan to Enhance Diversity, which must describe:

• Outreach strategies and activities designed to recruit prospective REC Scholar participants and Program Faculty from the underrepresented groups described in the Notice of NIH's Interest in Diversity.
• Specific efforts to be undertaken by the program and how the proposed plan reflects prior experience in recruiting individuals from underrepresented groups.
• Recruitment plans and processes that include enhanced outreach to a variety of institution types including minority-serving institutions, such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Colleges and Universities (TCUs), and Asian American and Pacific Islander Serving Institutions (AAPISIs).

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

6. Plan for Instruction in the Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction - instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Renewal applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

7. Evaluation Plan

Applications must include a plan for evaluating the activities supported by the research education program. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short- or long-term success of the research education program in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and provide suggestions for improvements.

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 (REC)

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, 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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide REC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

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. 

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 NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO:

• How important is the OAIC's selected area of focus in regard to potential advances in understanding or treating age-related conditions affecting the independence of older Americans? 
• To what extent will the OAIC cores facilitate other ongoing research to advance aging and geriatric research?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

Specific to this NOFO:

•  To what extent will the OAIC stimulate translation between basic and clinical research and/or between clinical research and practice?
•  To what degree will the OAIC add new research directions that are based on insights from basic aging research or geriatrics?  

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the 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 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?

Specific to this NOFO:

• To what extent will the proposed strategy adequately promote a sustained research program in the selected area of focus, through which the OAIC will accomplish the  leadership, collaborative, and research career development functions sought?
• How adequately specified are the goals to be achieved within the five-year OAIC award period?
• How adequate is the plan to reach these goals, and the proposed methods to evaluate progress toward these goals during the course of the OAIC award? 
• To what extent are the individual components of the OAIC integrated with each other?  How effectively does the program incorporate both fundamental discovery and the development of applied research?
• How clear is the plan for defining sharing of responsibilities among investigators and between institutions (if more than one institution is involved)? If collaborative arrangements are proposed, to what extent is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the OAIC?
• How thoughtfully does the applicant acknowledge potential problem areas and consider alternative approaches?
• How effective are proposed collaborations with other OAICs and other NIA- and NIH-supported programs and centers?  
• To what extent does the proposed OAIC demonstrate evidence of leadership and collaboration on a large scale, rather than just locally?
• To what extent have collaborations with other OAICs or other NIA- or NIH-supported programs and centers yielded significant outcomes?

Eligibility Criteria for Research Involving Human Subjects

• To what extent do the eligibility criteria promote inclusion of the population affected by the disease/condition? 
• To what extent is justification provided for eligibility criteria, including inclusion and exclusion of NIH-designated Populations with Health Disparities? 
• Have barriers to participation been assessed adequately?

Recruitment and Retention Plan for Research Involving Human Subjects

• How well does the recruitment and retention plan demonstrate efforts to engage understudied populations in the clinical trial, as applicable and justified by the scientific goals? 
• To what extent will the recruitment efforts increase community engagement, reduce identified barriers, and sustain the engagement of understudied populations? 
• To what extent are plans described to train staff to be sensitive to NIH-designated Populations with Health Disparities?  

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

Specific to this NOFO:

• To what extent is there evidence of significant commitment of the institution to fulfilling the objectives of the OAIC? What is the quality of the academic and physical environment as it bears on patients, space, and equipment, and on the potential for interaction among scientists within the Center and with scientists from other departments, institutions, and OAICs? 
• To what extent will the OAIC serve as a source of advice in the area of its theme regarding technology, methodology, analysis, or other expertise?
• To what extent will the OAIC leverage other institution-, NIA-, and NIH-supported resources, including centers and large collaborative projects, particularly in sharing resources (e.g., Resource Cores) and research education opportunities?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Qualitative Review Criteria - Cores

Reviewers will evaluate each core based on the following criteria:

Leadership and Administrative Core (LAC)

Significance

• To what extent does the proposed core address the needs of the OAIC that it will serve? 
• To what extent is the scope of activities proposed for the core appropriate to meet those needs? 
• To what extent will successful completion of the aims bring unique advantages or capabilities to the OAIC?

Investigators

• To what extent are the Core Lead(s) and other personnel well suited to their roles in the core? 
• To what extent do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? 
• Do core personnel demonstrate significant experience with coordinating collaborative clinical research?
• To what extent is/are the PD(s)/PI(s) (an) established investigator(s) in a major area selected as a focus of OAIC research? 
• To what extent do the PD(s)/PI(s) have leadership qualities, including the ability to work collaboratively with other investigators, to establish mechanisms for quality control of the science receiving core funds, and to move the OAIC into new innovative research areas as appropriate? 
• To what extent do the PD(s)/PI(s) and lead investigators demonstrate the ability to translate new scientific findings along the translational research continuum? 
• To what extent do the PD(s)/PI(s) and lead investigators have the capacity to translate proven interventions into larger-scale clinical or community studies?

Innovation

• To what extent are the concepts or strategies novel to one type of research program or applicable in a broad sense? 
• To what extent is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

• How adequate are plans for regular review of utilization of core resources by other OAIC cores and reallocation of resources within or among cores?
• How adequate are plans to assess scientific opportunities for new utilization of core resources and plans to utilize them?
• How adequate are plans to assess potential areas for collaboration among OAIC cores within the Center and with other OAICs or other projects?
• How adequate are plans for constituting and convening an External Advisory Board?
• How adequate are plans to constitute and convene an advisory panel or panels to assist in selecting Pilot/Exploratory Studies, Developmental Projects, and participants in the Research Education Component (REC)?
• How adequate are plans to coordinate OAIC personnel attendance at the annual OAIC Investigators meeting? 
• To what extent does the administrative structure of the LAC, administrative relationships between the LAC and all other OAIC components, governance strategies, and the ways in which they will interact achieve the OAIC's goals and maintain quality of the OAIC.
• To what extent are the plans clearly stated and are approaches specified to deal with inadequate progress toward achieving goals, should this occur?
• To what extent are the leadership approach, governance strategies, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core?
• To what extent are the arrangements adequate for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among investigators in the program?

Environment

• To what extent will the institutional environment in which the core will operate contribute to the probability of success in facilitating the OAIC? 
• To what extent are the institutional support, equipment, and other physical resources available to the investigators adequate for the core proposed? 
• To what extent will the core benefit from unique features of the institutional environment, infrastructure, or personnel?

Resource Cores (RCs)

Significance

• To what extent does the proposed core address the needs of the OAIC that it will serve? 
• To what extent is the scope of activities proposed for the core appropriate to meet those needs? 
• To what extent will successful completion of the aims bring unique advantages or capabilities to the OAIC?
• To what extent will the RC contribute to the success of other cores? 
• To what extent will the External Projects and Developmental Projects contribute to the aims of the RC and to the overall goals of the proposed OAIC?

Investigators

• To what extent are the Core Lead(s) and other personnel well suited to their roles in the core? 
• To what extent do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? 
• To what extent do core personnel demonstrate significant experience with coordination of collaborative clinical research? 
• To what extent do core personnel have experience overseeing selection and management of subawards, if needed?
• To what extent are the investigators qualified in achieving the proposed aims of their External Projects or Developmental Projects?

Innovation

• To what extent does the core propose novel organizational concepts or management strategies in coordinating the OAIC? 
• To what extent are the concepts or strategies novel to one type of research program or applicable in a broad sense? 
• To what extent is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
• To what extent will the RC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? 
• To what extent do the RC and its associated Developmental Projects and/or External Projects challenge existing paradigms or develop new methodologies or technologies? 
• To what extent will the RC stimulate translation between basic and clinical research and/or between clinical research and practice? 
• To what degree will the RC add new research directions that are based on insights from basic aging research or geriatrics?

Approach

• To what extent are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the core? 
• To what extent are potential problems, alternative strategies, and benchmarks for success presented? 
• If the core is in the early stages of operation, to what extent does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the core? 
• To what extent are an appropriate plan for work flow and a well-established timeline proposed? 
• To what extent are there adequate plans for soliciting, evaluating, and selecting External or Developmental projects for RC support? 
• To what extent have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
• If the RC involves human subjects and/or NIH-defined clinical research, to what extent do the plans 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?
• To what extent does the RC enhance the quality of research, research education, and pilot projects? 
• To what extent is the plan adequate for prioritizing access to RC resources? 
• To what extent are plans adequate for the external review of proposed Developmental Projects and monitoring their progress?

Environment

• To what extent will the institutional environment in which the core will operate contribute to the probability of success in facilitating the OAIC? 
• To what extent are the institutional support, equipment, and other physical resources available to the investigators adequate for the core proposed? 
• To what extent will the core benefit from unique features of the institutional environment, infrastructure, or personnel?

Pilot/Exploratory Studies Core (PESC)

Significance

• To what extent does the proposed core address the needs of the OAIC that it will serve? 
• To what extent is the scope of activities proposed for the core appropriate to meet those needs? 
• To what extent will successful completion of the aims bring unique advantages or capabilities to the OAIC?
• How will the proposed PESs and types of future PESs contribute to the goals of the OAIC? 
• How will the PESs contribute to the success of other cores?

Investigators

• To what extent are the Core Lead(s) and other personnel well suited to their roles in the core? 
• To what extent do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? 
• To what extent do core personnel demonstrate significant experience with coordinating collaborative clinical research? 
• To what extent do core personnel have experience overseeing selection and management of subawards, if needed?

Innovation

• To what extent does the core propose novel organizational concepts or management strategies? 
• To what extent are the concepts or strategies novel to one type of research program or applicable in a broad sense? 
• To what extent is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
• How effectively will the PESC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? 
• To what extent will the PESC stimulate translation between basic and clinical research and/or between clinical research and practice? 
• To what degree will the PESC add new research directions that are based on insights from basic aging research or geriatrics?

Approach

• To what extent are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the core? 
• To what extent are potential problems, alternative strategies, and benchmarks for success presented? 
• If the core is in the early stages of operation, to what extent does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the core? 
• To what extent are an appropriate plan for work flow and a well-established timeline proposed? 
• To what extent have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
• To what extent are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core?
• If the PESC involves human subjects and/or NIH-defined clinical research, to what extent do the plans 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?
• What is the scientific quality of the PESs proposed, and are they likely to acquire information needed to select or design future crucial studies in the OAIC area(s) of focus?
• To what extent are the plans adequate for the external review of the proposed PESs?

Environment

• To what extent will the institutional environment in which the core will operate contribute to the probability of success in facilitating the OAIC? 
• To what extent are the institutional support, equipment, and other physical resources available to the investigators adequate for the core proposed? 
• To what extent will the core benefit from unique features of the institutional environment, infrastructure, or personnel?

Information Dissemination Core (IDC)

Significance

• To what extent does the proposed core address the needs of the OAIC that it will serve? 
• To what extent is the scope of activities proposed for the core appropriate to meet those needs?
• To what extent will successful completion of the aims bring unique advantages or capabilities to the OAIC?
• To what extent will the IDC contribute to the overall goals and theme(s) of the proposed OAIC? 
• To what extent will the IDC enhance the function of other OAIC components?

Investigators

• To what extent are the Core Lead(s) and other personnel well suited to their roles in the core? 
• To what extent do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research?
• To what extent do core personnel demonstrate significant experience with coordinating collaborative clinical research? 

Innovation

• To what extent does the core propose novel organizational concepts or management strategies in coordinating the OAIC? 
• To what extent are the concepts or strategies novel to one type of research program or applicable in a broad sense? 
• To what extent is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
• To what extent does the IDC challenge existing paradigms or develop new methodologies or technologies?

Approach

• To what extent are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the IDC? 
• To what extent are potential problems, alternative strategies, and benchmarks for success presented? 
• If the IDC is in the early stages of development, to what extent will the strategy establish feasibility, and will particularly risky aspects be managed?
• To what extent are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core?
• If the IDC involves human subjects and/or NIH-defined clinical research, to what extent do the plans 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?

Environment

• To what extent will the institutional environment in which the core will operate contribute to the probability of success in facilitating the OAIC? 
• To what extent are the institutional support, equipment, and other physical resources available to the investigators adequate for the core proposed?
• To what extent will the core benefit from unique features of the institutional environment, infrastructure, or personnel?
• To what extent will the IDC be able to access and interact with other institutional resources for its proposed activities? 
• To what extent will existing relationships between the institution and other organizations or societies, as well as those to be developed, contribute to the success of the IDC’s goals?

Community Engagement Core (CEC)

Significance

• To what extent does the proposed core address the needs of the OAIC that it will serve? To what extent is the scope of activities proposed for the core appropriate to meet those needs? 
• To what extent will successful completion of the aims bring unique advantages or capabilities to the OAIC?
• To what extent will the CEC contribute to the overall goals and theme(s) of the proposed OAIC? To what extent will the CEC enhance the function of other OAIC components?

Investigators

• To what extent are the Core Lead(s) and other personnel well suited to their roles in the core? 
• To what extent do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in community engagement for research?
• To what extent do core personnel demonstrate significant experience with coordinating collaborative clinical research? 

Innovation

• To what extent does the core propose novel organizational concepts or management strategies in coordinating the OAIC? 
• To what extent are the concepts or strategies novel to one type of research program or applicable in a broad sense? 
• To what extent is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
• To what extent does the CEC challenge existing paradigms or develop new methodologies or technologies?

Approach

• To what extent are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CEC? 
• To what extent are potential problems, alternative strategies, and benchmarks for success presented? 
• If the CEC is in the early stages of development, to what extent will the strategy establish feasibility, and will particularly risky aspects be managed?
• To what extent are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core?
• If the CEC involves human subjects and/or NIH-defined clinical research, to what extent do the plans 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?

Environment

• To what extent will the institutional environment in which the core will operate contribute to the probability of success in facilitating the OAIC? 
• To what extent are the institutional support, equipment, and other physical resources available to the investigators adequate for the core proposed? 
• To what extent will the core benefit from unique features of the institutional environment, infrastructure, or personnel?
• To what extent will the CEC be able to access and interact with other institutional resources for its proposed activities? 
• To what extent will existing relationships between the institution and other organizations or societies, as well as those to be developed, contribute to the success of the CEC’s goals?

Research Education Component (REC) (RL5)

Significance

• To what extent does the proposed research education program address a key audience and an important aspect or important need in research education? 
• To what extent does the application provide convincing evidence that the proposed program will significantly advance the stated goal of the OAIC program?
• How effectively will the OAIC promote the development of future research leaders in its area(s) of focus, particularly leaders who can integrate clinical insights regarding health, disease, independence, and disability in old age with knowledge of advances in the basic sciences, including gerontology, to develop better interventions to maintain health and independence?

Investigators

• To what extent are the REC Core Lead(s) capable of providing both administrative and scientific leadership to the development and implementation of the proposed program?
• To what extent is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? 
• To what extent does the application describe the participating faculty’s experience in mentoring students and teaching science? 
• If applicable, to what extent dothe faculty serve as role models for the participants? 
• If the REC Core is collaborative or involves multiple REC Core Leads, to what extent do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the REC Core?
• To what extent does the program describe how participants will be engaged toward commitment and potential for a productive career in aging research?
•  How adequate is the pool of potential participants with interest and commitment to aging research?

Innovation

• Taking into consideration the nature of the proposed research education program, to what extent does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? 
• Where appropriate, to what extent is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?
• How effectively will the REC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? 
• To what extent will the REC stimulate translation between basic and clinical research and/or between clinical research and practice? 
• To what degree will the REC add new research directions that are based on insights from basic aging research or geriatrics?

Approach

• To what extent does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? 
• To what extent is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? 
• To what extent is the plan for evaluation sound and likely to provide information on the effectiveness of the program? 
• If the proposed program will recruit participants, to what extent does the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?
• To what extent does the REC provide adequate educational and other career enhancement opportunities for junior investigators associated with the OAIC? 
• How well does the REC provide education or skill development of junior investigators in clinical and translational research?
• How well does the applicant describe the research education activities that considers the differences in previous training and experiences of the participants?

Environment

• To what extent will the scientific and educational environment of the proposed program contribute to its intended goals? 
• To what extent is there tangible evidence of institutional commitment? 
• To what extent is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? 
• Where appropriate, to what extent is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
• To what extent will the resources and environment of the REC lead to selection of high-quality scholars? 
• To what extent will REC resources contribute to the successful development of junior faculty?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

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.

Additional Review Considerations - REC

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the Recruitment Plan to Enhance Diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research (RCR)

Taking into account the specific characteristics of the proposed research education program and the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 

1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 
2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 
3) Faculty Participation - the role of the program faculty in the instruction; 
4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 
5) Frequency of Instruction - instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. 

The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board (IRB) or Independent Ethics Committee Approval (IEC): Grantee institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Pilot Projects

Awardee-selected projects involving greater than minimal risk to human subjects require approval by NIA prior to initiation.

• The awardee institution will provide NIA with specific plans for data and safety monitoring, and will notify the IRB and NIA of serious adverse events and unanticipated problems, consistent with NIA DSMP policies.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an 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 Laws and Regulations Enforced by 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
• NIA may request information to help assess effectiveness of the OAIC program from OAIC investigators, OAIC-supported awardees, and other beneficiaries and stakeholders of OAIC activities. Such individuals may be contacted during and/or after the completion of this award.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year. [bullet] Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.
• Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide. Please hyperlink RPPR Instruction

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 Section 8.6 Closeout. 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.

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 Section 8.6 Closeout. 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.

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: [email protected] (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: [email protected]

Basil Eldadah, MD, Ph.D.
Division of Geriatrics and Clinical Gerontology (DGCG)
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Fax: 301-402-0066
Email: [email protected]

Lesa McQueen, M.Sc.
National Institute on Aging (NIA)
Telephone: 301-402-7738
Email: [email protected]

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.