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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Successful aging research frequently depends on collaborations that draw on expertise from a variety of disciplines. In some cases, these collaborations arise naturally, but in other cases, organizational or fiscal obstacles hinder their effective development. Bridging data platforms, crossing inter-departmental silos, and other such challenges may pose substantial barriers to scientific progress, despite the availability of personnel and resources. At the same time, innovative scientific findings often lead to novel opportunities that require the development of new collaborations. A classic example is translating interventions with demonstrated success in efficacy trials into real-world settings. This NOFO aims to provide needed resources to interdisciplinary groups that collaborate to meet the challenge of developing effective research infrastructure on important aging topics.

Purpose

This NOFO invites applications that propose to develop novel research infrastructure that will advance the science of aging in specific areas requiring interdisciplinary partnerships or collaborations.

Scope

Applications submitted to this NOFO should propose the development of research infrastructure to advance specific topics in aging science that require interdisciplinary partnerships or collaborations. The range of disciplines included in the application should be appropriate to the scientific goals of the proposed collaboration.

This NOFO aims to support the establishment of new interdisciplinary collaborations or the development of existing interdisciplinary collaborations in significantly new directions. For existing collaborations, reviewers will evaluate closely whether the application represents a substantial development in a scientific focus, as opposed to simply maintaining existing operations.

Research infrastructure supported through this NOFO must endeavor to benefit the larger research community, as opposed to solely supporting the investigators research interests.

It is expected that applications funded through this NOFO will not only develop a research infrastructure, but also produce new knowledge, tools, or other tangible scientific results arising from specific research projects that are enabled by the new research infrastructure.

Scientific Focus

The following is an overview of NIA’s research divisions. Accompanying the overview are research topics that each division is interested in supporting.

Division of Aging Biology (DAB)

DAB supports basic, applied, and translational research on the mechanisms and hallmarks of aging. DAB also supports development of interventions that affect lifespan, healthspan, rejuvenation, rates, and heterogeneity of aging. DAB’s areas of interest in infrastructure development suitable for a two-stage grant program with identifiable milestones include, but are not limited to, the following:

• Machine learning (ML) and artificial intelligence (AI) for the development of metrics of aging (e.g., biomarkers of aging and/or molecular clocks based on physiological parameters such as resilience or frailty, but are not trained on time)
• ML and AI for visualization of aging at cellular and subcellular levels, including real-time visualization and tracking of aging
• ML and AI for visualization of aging at higher levels of organization (e.g., tissue, organ, and organism levels)
• Improved use of biopsies, as well as the development of less invasive means, to collect biological and diagnostic data, and ML and AI tools that would be useful in either or both of those contexts
• Transgenic reporter systems for hallmarks of aging in diverse cell types
• In vitro organs on chips and/or organoid systems that can be induced to show cellular or organellar functions similar to in vivo aging and that recapitulate the age and sex of a donor, including the consequences of Y-chromosome loss, X inactivation, or epigenetic modifications related to aging

Applications of any of these areas of interest to the testing and validation of interventions that impact rates or heterogeneity of aging and/or rejuvenation (with or without nuclear reprogramming), and that might contribute to a better understanding of sex differences and health disparities in aging are especially encouraged.

Additionally, DAB encourages interactions between academic investigators and the biotechnology sector.

Division of Behavioral and Social Research (BSR)

BSR supports social, behavioral, psychological, and economic research on the processes of aging at both the individual and societal level (including cross-national comparisons), with a strong focus on health disparities and health inequities, social determinants of health, and the behavioral, social, and structural drivers of health inequities and individual differences in aging trajectories. BSR takes life course perspective, in studies of humans and animals, on the study of aging processes and the role of social and environmental exposures, to understand why some individuals age well and others poorly. In addition, BSR supports research on midlife prevention of the chronic diseases of aging, including Alzheimer’s disease and related dementias (AD/ADRD), seeking to identify malleable behavioral, social, or environmental processes that promote health and resilience. Health is broadly defined to include physical, cognitive, emotional, and social functioning, disability, morbidity, mortality, as well as well-being and successful aging. General topic areas of interest to BSR for research infrastructure development include, but are not limited to, the following:

• Psychological development and cognitive aging
• Behavior genetics and sociogenomics
• Cognitive assessment and dementia prevention
• Dementia care and caregiving
• Health systems and health policy innovation
• Life course exposures and the impact of early adversity on later life outcomes
• Data infrastructure for longitudinal research on aging and the lifecourse
• Demographic, social, economic, institutional, geographic, and other factors at the population level that influence health and mortality at older ages

In addition to general topics, as recommended by the National Advisory Council on Aging’s 2019 review of BSR, the Division invites applications to develop new research infrastructure which aims to accomplish the following:

• Conduct life course research on aging
• Attract a myriad of researchers from various backgrounds to aging science
• Infuse a focus on health disparities into aging research
• Address ongoing needs for advancing integrative behavioral and social science research on aging

Activities of the network/infrastructure-building may include, but are not limited to, the following:

• Meetings to develop novel, trans-disciplinary research areas and to facilitate the development of infrastructure to accelerate those areas
• Small-scale pilot projects
• Dissemination and outreach activities
• Educational activities

BSR seeks to renew critical ongoing network/infrastructure efforts, as well as initiate new programs that hold the potential for spawning transdisciplinary innovation.

Division of Geriatrics and Clinical Gerontology (DGCG)

DGCG supports clinical and translational research on health and disease in the aged and research on aging over the human lifespan, including its relationships to health outcomes. DGCG’s foci includes translational research for the development of new interventions for age-related conditions, prevention and treatment of multiple chronic conditions in older adults, and studies that help to promote evidence-based geriatric care and inform policies affecting older adults. DGCG’s areas of interest for research infrastructure development include, but are not limited to, the following:

• Multimorbidity and complexity
• Wound healing
• Palliative care
• Physical activity and functional independence
• Integration of omics technologies
• Harmonization and data linkage development across multiple data sets
• Development of clinical trial methodology, including pragmatic trials
• Factors in early life that protect against aging changes

Regarding the last topic, applications which propose infrastructures to facilitate analyses of pooled data from cohorts of children and/or enable linking of cohorts with overlapping ages to study the effects of factors in early life on subsequent aging changes are encouraged.

Division of Neuroscience (DN)

DN supports research aimed at elucidating how the central nervous system and behavior are affected by normal as well as pathological aging. An emerging focus is how the processes of aging and age-related cognitive decline intersect with the development of AD and other dementias of aging. DN’s areas of interest for research infrastructure development include, but are not limited to, the following:

• Age-related structural and functional changes in the brain, including mechanisms of selective vulnerability and plasticity of neural cells, synapses, circuits, and networks to neurodegeneration
• Age-related changes in sensory, motor, sleep, and cognitive functioning
• Adaptability of the brain, cognitive reserve, and resilience to neurodegenerative disease
• Etiology, prevention, and intervention for delirium
• The etiology, pathobiology, genetics, epidemiology, drug discovery, diagnosis, and clinical interventions in the dementias, particularly AD, of later life

The Office of Research on Women’s Health (ORWH)

In addition to NIA, ORWH invites applications proposing to develop novel research infrastructure.

ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and throughout the scientific community.

ORWH seeks to support research applications that propose to develop novel research infrastructure that will advance the health of women and reduce disease burden across the life course of women, including health disparities for populations of women at greatest risk for certain diseases. Integrating the purposeful accounting of sex as a biological variable (SABV) in basic science research and sex and gender in translational, interdisciplinary, behavioral, clinical and/or health services research will fill gaps in our knowledge and will inform more effective, personalized approaches to advance the health of women, men, and gender diverse individuals. For additional information, please refer to NIH’s webpage regarding the 2019-2023 Trans-NIH Strategic Plan for the Health of Women Research. To review the complete plan, which identifies the agency’s research interests, goals and objectives, please click here.

To ensure that applications are consistent with NIH/NIA’s program priorities, budgetary limits, and the goals of this NOFO, prospective applicants are strongly encouraged to contact the Scientific/Research Contact(s) of this FOA before preparing an application. The appropriate contact(s) is/are listed in Section VII. Agency Contacts of this NOFO.

Activities of the Project

A variety of activities may be conducted within the scientific scope of this NOFO. These include, but are not limited to, the following:

• Meetings of investigators and other stakeholders to identify research priorities, approaches, or other relevant objectives
• Conducting secondary analyses of existing data sets
• Developing approaches for data harmonization or standardization across different data platforms
• Merging and harmonizing data from existing longitudinal data sets, including cohorts spanning broad age ranges
• Replicating studies of key findings, including both previous findings (through new data collection or re-analyses of existing data) and pre-planned replication of findings from current or planned data collection
• Developing data-mining methodologies
• Combining existing human "omics" databases for performing integrative analyses
• Developing accessible biospecimen repositories
• Developing and validating diagnostic tests or assays; for example, to distinguish physiologic from pathologic responses or processes
• Developing platforms for integrated analysis of different morphometric, phenotypic, and omic data types from single or multiple species
• Developing and phenotyping new animal models for aging research
• Scaling up of research infrastructure
• Conducting feasibility or pilot studies of interventions
• Larger-scale testing of interventions developed in the pilot phase
• Translating screening approaches, diagnostic methods, or interventions into practice or community settings
• Sharing and disseminating data, methodology, practice guidelines, or other research products
• Providing research experiences for early career investigators

Exploratory/Developmental Phased Award

This NOFO utilizes the R61/R33 Exploratory/Developmental Phased Award activity code. The R61 phase provides up to 2 years of support for initial developmental activities. The R33 phase provides up to 3 years of support for expanded activities.

Proposed projects must include both an R61 phase with milestone-driven developmental activities, and an R33 phase with milestone-driven expanded activities that will build on the initial R61 developmental phase to achieve the aims of the entire award. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART).

Applications that only propose R61 or R33 activities will be considered incomplete and will not be accepted.

An R61/R33 award is not renewable.

Preliminary data are not required as part of the application but may be included if available.

R61 Phase

Applicants are required to submit proposed milestones for the R61 phase. Prior to funding an application, program staff will contact the applicant to discuss the proposed milestones. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R61 work.

R33 Phase Transition Process

The application must propose a well-defined set of milestones for the R61 phase and annual milestones for the R33 phase. Prior to the end of the R61 phase, awardees must submit a package to request transition to the R33 phase. The package must include a progress report that describes progress towards each of the milestones negotiated and agreed on in the R61 Phase, and a clear description of how research during the R33 phase will be impacted by attainment of the R61 milestones. These materials will be reviewed by NIA program staff and then, if selected, the grant will be transitioned to an R33 award without the need to submit a new grant application. Decisions on transitioning to the R33 phase will be based on the original R61/R33 peer review recommendations, successful completion of the originally described milestones, program priorities, and availability of funds.

If R61 awardees are not ready to submit an R33 transition package prior to the end of the R61 award, a no-cost extension for up to one year may be requested, during which time awardees may submit an R33 transition package. This one-year no-cost extension period will not count against the 5-year limit for the entire R61/R33 award.

Available Resources

Investigators interested in analyses of existing datasets may consider using NIA-supported observational and interventional studies, such as those listed in the Aging Research Biobank. Investigators interested in using aged animal models may consider NIA’s Aging Rodent Colonies. A variety of other NIA-supported research resources are summarized in NIA’s Research Resources page.

NIA-supported Research Centers may be particularly useful for accessing aging-related research resources. More information about each of these Centers programs can be found at their respective links:

• Alzheimer's Disease Research Centers
• Centers on the Demography and Economics of Aging
• Claude D. Pepper Older Americans Independence Centers
• Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging
• Nathan Shock Centers of Excellence in the Basic Biology of Aging
• Resource Centers for Minority Aging Research
• NIA AD/ADRD Health Care Systems Research Collaboratory
• Artificial Intelligence and Technology Collaboratories for Aging

Coordination among NIA's Centers programs is facilitated through the NIA Research Centers Collaborative Network.

Pilot Projects & Clinical Trials

Pilot Projects

Pilot projects supported through awards under this NOFO require NIA staff approval. Such approval requires, but may not be limited to, an Institutional Federal-Wide Assurance (FWA) with the Office for Human Research Protections (OHRP) and Institutional Review Board (IRB) approval for pilot projects that are conducting non-exempt human subjects research and an adequate data and safety monitoring plan (DSMP) for pilot projects involving human interventions. Guidance on NIA's requirements for DSMPs may be found here. Applicants are strongly encouraged to discuss pilot project approval processes and timing with a program officer.

Human Subjects Research

Applications that propose human subjects research, whether conducted at the start of the project or as delayed onset studies, are expected to conform to all human subjects research policies. Single IRB (sIRB) requirements apply to this mechanism. Human subjects studies conducted entirely at a single subcontracted site are still subject to the sIRB policy because NIH considers the prime awardee to be engaged in the human subjects research conducted by the subawardee institution. For answers to frequently asked questions about the sIRB policy, click here.

Clinical Research Operations Management System

NIA supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the 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. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified.

Non-Responsiveness Criteria

The following types of applications will be considered non-responsive and will be withdrawn prior to review:

• Applications that do not propose development of research infrastructure
• Applications that do not propose R61 and R33 activities

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 the 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 registrations; 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 their 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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Applications must include the specific aims for each phase, with timelines for both the R61 and R33 phases, in the single Specific Aims attachment.

Research Strategy:

The specific goals to be achieved through this network must be clearly stated in the application for the proposed project, including an explanation of how the proposed infrastructure development activities will advance this emerging scientific area and why these goals will serve to advance or accelerate aging research beyond what can be achieved through existing programs or structures (e.g., integrating findings from basic, clinical, and behavioral research to accelerate the development of interventions to improve aging-related outcomes). Applicants must explain how the proposed infrastructure will benefit a larger research community. For applications proposing clinical trials, applicants must explain how risk will be identified and minimized.  Applicants are encouraged to provide strong scientific rationales for their proposed approaches.

Applicants should clearly describe a plan for sustaining the infrastructure developed through this grant following the end of the R61/R33 award period. This may include applying for continued support through PAR-23-054, "Advanced-Stage Development and Utilization of Research Infrastructure for Interdisciplinary Aging Studies (R33 Clinical Trial Optional)," or a reissue of the NOFO. Research awards (e.g., R01s, P01s, U01s), Center grants (e.g., P30s), other infrastructure support awards (e.g., R24s), CTSA-supported resources, and other NIH mechanisms, in addition to non-NIH funding sources, may also be appropriate for future support.

The Research Strategy should include a description of both the R61 and R33 phases in the single Research Strategy attachment.

Include a specific section labeled "Milestones". The application must include milestones the researchers expect to achieve by the end of the R61 phase, as well as milestone-driven-expanded activities for each year of the R33 phase. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound. For applications proposing clinical trials, key stages of the trials must be included as milestones. Milestones should be clearly described, feasible, well developed, quantifiable, and scientifically justified to transition to the R33 phase. A discussion of the milestones relative to the progress of the R61 phase and the implications of successful completion of the milestones for the R33 phase should be included.

The application must propose a study timeline that is appropriate to accomplish the proposed goals, meet the milestones, and address the scientific question(s).

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 Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

All instructions in the How to Apply- 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). 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 the 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.

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

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) 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. See Section III of this NOFO for information on registration requirements.

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 the 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.

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

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 grantdisclosures@oig.hhs.gov.

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 the 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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications 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.

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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 his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 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 or Independent Ethics Committee Approval: Recipient 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).

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. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

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.

4. Reporting

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.

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Dr. Sanoj Suneja
National Institute on Aging (NIA)
Phone: 301-402-7710
E-mail: sunejas@mail.nih.gov

Chyren Hunter, PhD
ORWH - Office of Research on Women's Health
Phone: 301-402-4158
E-mail: hunterc@nih.gov

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

E. C. Melvin
National Institute on Aging (NIA)
Phone: (301) 594-3912
E-mail: e.melvin@nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.