National Institutes of Health (NIH)
National Institute on Aging (NIA)
U24 Resource-Related Research Projects – Cooperative Agreements
See Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO) invites applications for a Demography and Economics of Aging and Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) Coordinating Center (D&E CC) whose purpose is to act as a hub, serving the needs of the Centers on the Demography and Economics of Aging, including AD/ADRD (D&E Centers) as well as the needs of NIA program staff. The D&E Centers Program focuses on advancing aging research in demography, economics, and related interdisciplinary population-based social science areas, including those with a focus on AD/ADRD. The CC will be a bridge among D&E Centers, institutions, individual scholars, NIA, and the research and policy communities. The CC will enhance the scientific impact of the D&E Centers Programs and foster synergies across D&E Centers, other NIA-funded P30 Centers Programs, and NIA-funded research infrastructure (e.g., longitudinal datasets, contextual data repositories, etc.) as well as promote inclusion and representation across a varied group of scholars and institutions, including via shared mentorship and training activities. The D&E CC will also build and execute approaches to raise the profile of the D&E Centers Programs and the demography and economics of aging, including AD/ADRD.
New Date December 10, 2024 per NOT-AG-24-071 (Prior Date October 01, 2024).
Dates in bold and italics reflect changes per NOT-AG-24-071
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
January 10, 2025 | January 10, 2025 | Not Applicable | May 2025 | August 2025 | September 2025 |
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).
Not Applicable
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 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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The Centers on the Demography and Economics of Aging (D&E Centers) (P30) Program was initiated in 1994. The program has supported high-impact and innovative social science on aging, created shared resources that benefit the broader scientific community, facilitated the career enhancement of early-career and new investigators to aging research, and enabled investigators to act on emerging and urgent scientific opportunities quickly and effectively through Center research infrastructure. The program reflects the recognition that the collaboration between and among demography, economics, and related fields are integral to advancing population science.
Since its inception, the program has worked towards the objective of cultivating the fields of demography and economics of aging via a range of activities, including supporting pilot projects, establishing research networks, holding conferences and workshops on scientific areas of focus, developing and promoting research resources and infrastructure, and sharing results and resources with scientific and policy communities as well as the public. In the current cycle of the D&E Centers Programs which began in 2020, almost 200 pilot grants have been funded, 22 networks and 10 external research resources have been established, and other types of activities have occurred such as providing reports and resources to the research community, holding seminars, conferences, and workshops, and bringing new investigators to aging studies.
As part of the current cycle, the program was expanded to include D&E Centers on AD/ADRD. These centers expand upon the overall program objectives by addressing areas of demography, economics, and health services research relevant to AD/ADRD. The current cycle of the program also added a separate R24 coordinating center. In all, the D&E Centers Programs includes 15 P30s (3 focused on AD/ADRD) and one coordinating center R24. Information on the 15 currently active D&E Centers is available here.
This NOFO invites applications for a Coordinating Center for the Centers on the Demography and Economics of Aging, including Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) (D&E CC) whose purpose is to act as a hub, serving the needs of the Centers on the Demography and Economics of Aging, including AD/ADRD (D&E Centers) as well as the needs of NIA program staff. The objectives of the D&E Centers Program are to:
1) Seed new and innovative lines of research in the demography and economics of aging and related interdisciplinary population-based social science areas.
2) Integrate approaches that address the disproportionate distribution of health within and/or across populations, including with respect to those defined as Health Disparity Priority Populations in the NIA Health Disparities Research Framework.
3) Incorporate strategies that will identify and engage scholars across disciplines, career stages, and institutions.
The CC will be a bridge among D&E Centers, institutions, individual scholars, NIA, and the research and policy communities. The CC will enhance the scientific impact of the D&E Centers Programs and foster synergies across D&E Centers, other NIA-funded P30 Centers Programs (e.g., Edward R. Roybal Centers for Translational Research on Aging, the Resource Centers for Minority Aging Research, the Claude D. Pepper Older American Independence Centers, the Alzheimer's Disease Research Centers, Nathan Shock Centers of Excellence, etc.), and NIA-funded research infrastructure (e.g., longitudinal datasets, contextual data repositories, research networks, etc.), as well as promote inclusion and representation across a diverse group of scholars and institutions, including via shared mentorship and training activities. The CC will also build and execute approaches to raise the profile of the D&E Centers Programs and the demography and economics of aging, including AD/ADRD.
The D&E CC is intended to serve as a hub for the D&E Centers Program, enhancing the impact of the D&E Centers and assisting NIA staff in coordinating activity across the population sciences and disseminating resources and progress to the field at large. For information on the D&E Centers Program research objectives, required and optional cores, priority topic areas, and expectations for tracking and progress, see Section I of RFA-AG-25-007. To accomplish the objectives of the D&E Centers Program, the CC will work collaboratively with all D&E Centers to:
NIA shares reports outlining Institute priorities, including:
NIA provides a variety of research resources to facilitate population-based behavioral and social research including:
Responses to frequently asked questions about this NOFO will be posted here.
The continued success and sustainability of the D&E Centers Programs requires that the Centers complete their proposed Core activities. Throughout the project period, NIA expects that a Center will be able to demonstrate how its Core activities advance the three Center Program objectives described in Research Objectives above.
Centers are responsible for tracking and monitoring progress and success through Core tracking criteria described in Section IV of RFA-AG-25-007 via semi-annual reporting to the D&E CC and the annual non-competing continuation (Type 5). The CC is responsible for developing a template for collecting and organizing the tracking criteria information provided by the Centers and reporting the information to NIA on a semiannual basis. Based on tracking criteria and other considerations, staff in the Office of Planning, Analysis, and Evaluation at NIA may evaluate the overall D&E Centers Program and may provide recommendations for continuation and/or modification of the D&E Centers Program.
This NOFO uses a phased award approach. Proposed projects must include an overall timeline of both phases of the award. The timeline should incorporate the milestones for Phase 1 (2 years) as outlined below as well as the major goals of the entire project.
Phase 1
Milestones: This funding opportunity includes milestones that must be met at the end of Year 2.
Funding of Phase 1 does not guarantee support of Phase 2. If milestones are not achieved, as determined by the NIA Program Official assessment of recipient progress, NIA can choose to terminate the award, provide a mid-project extension (without additional funds), or modify aspects or conditions of the Coordinating Center at NIAs discretion. Milestones will be included in the Terms and Conditions of the grant, if awarded. As with any award, continuation, even during the period recommended for support, is conditional upon satisfactory progress.
By the end of Phase 1/Year 2, the Coordinating Center is expected to accomplish the following milestones:
Phase 2
Prior to the end of the first phase, awardees will submit a package that requests transition to the second phase of support. This package will include a progress report that describes progress towards each of the initial milestones and a clear description of how research during the Phase 2 will be impacted by attainment of those milestones. These materials will be reviewed by NIA program staff and then, if approved, the grant will transition to Phase 2 of support without the need to submit a new grant application. Decisions on transitioning to Phase 2 will be based on the successful completion of the originally described milestones, program priorities, and availability of funds.
The following types of applications will be considered non-responsive and will be withdrawn prior to review:
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 studys 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.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
NIA intends to commit approximately $1,320,000 in FY 2025 to fund 1 award.
Applications are limited to $800,000 in first-year direct costs.
The maximum project period is 6 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
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.
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.
The PD/PI and the CC team are expected to have significant knowledge about priority areas in social science research on aging; experience in promoting collaboration across different research groups or institutions; and experience in program management and coordination.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
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:
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.
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 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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Amelia Karraker, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
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.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Timeline: (2 page limit)
All applications must include a project timeline labeled Timeline under Other Attachments.
The Timeline must contain separate sections for Phase 1 and 2 of the proposed project, outlining the major goals of the project plan, as well as a sub-section devoted to describing milestones to be achieved during Phase 1, to quality for the transition to Phase 2.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Describe the investigative team's experience and expertise in project management and coordination relevant to the role of D&E CC, including fostering cooperation across interdisciplinary population sciences and broad scientific and policy communities.
All instructions in the How to Apply - Application Guide must be followed.
The CC application budget should include funds for organizing and attending an in-person/hybrid annual Center Directors Meeting and separate annual Workshop on the Demography and Economics of Aging. The CC may budget for presenters travel costs to the annual Workshop on the Demography and Economics of Aging and may establish a travel fund program to support workshop participants attendance. The CC is not responsible for the travel of participants from individual Center sites to the annual Center Directors Meeting. Requested costs should reflect the proposed activities for this meeting.
Requested costs should reflect the proposed dissemination activities, including the website and plans to make it sustainable beyond the award period, as well as other forms of outreach.
Inflationary Increases for Future Years: Inflationary salary increases for future year commitments are not allowed for applications submitted to this NOFO. However, necessary increases for other costs (e.g., supplies, equipment, etc.) are allowable if the out-year increase for a specific cost is well justified in the Budget Justification. Additional information can be found in the NIH guidance on developing budgets.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Specific Aims:
The specific aims page must directly address the core functions of the D&E CC, including administration, collaboration, dissemination, and tracking and reporting activities.
Research Strategy:
The application must explain how the proposed activities will enable the CC to serve as a hub for the D&E Centers Programs. The application must explain how the CC will achieve the stated purpose of the NOFO and effectively engage and collaborate with the Centers, as well as with NIA as part of the Cooperative Agreement Terms and Conditions of Award. CC activities must include, but are not limited to, the following:
Administration Activities – Applications must propose an organizational governance structure to support proposed collaboration, dissemination, and tracking and reporting activities. Applications must describe how the CC will carry out the following:
Applications must also describe how the CC will implement an annual in-person/hybrid Center Directors Meeting at the Population Association of America (PAA) Annual Meeting or alternative location, planned in coordination with relevant NIA program staff. The purpose of the meeting is to accomplish the following:
The meeting will be attended by representatives from key personnel (e.g., PD/PI) of D&E Centers Programs, pilot project awardees, and NIA program staff. The D&E CC will propose the agenda and chair the meeting, with guidance and agenda approval from NIA program staff. The CC will set aside a portion of its funds to support the annual Center Directors Meeting.
Collaboration Activities – Applications must describe how the D&E CC will facilitate collaborative research, training, and career enhancement activities across the Centers. Applications must describe how the D&E CC will carry out the following:
Dissemination Activities – Applications must describe how the D&E CC will ensure wide dissemination of all products and resources developed by the Centers and D&E CC to the broader research community. Applications must describe how the D&E CC will carry out the following:
Tracking and Reporting Activities – Applications must describe how the D&E CC will develop a tracking template and maintain a centralized database through which Centers progress and outcomes (Tracking Criteria as described in Section IV of RFA-AG-25-007) can be tracked and synthesized for semiannual reporting by the D&E CC to Centers and to NIA program staff, and for future program tracking by NIA. In order to achieve this objective, it is expected that the D&E CC will develop a template and process for collecting, organizing, and sharing Centers Tracking Criteria data with NIA.
Timeline: (2 page limit)
All applications must include a project timeline labeled Timeline under Other Attachments.
The Timeline must contain separate sections for Phase 1 and 2 of the proposed project, outlining the major goals of the project plan, as well as a sub-section devoted to describing milestones to be achieved during Phase 1, to quality for the transition to Phase 2.
Tracking criteria: Organize annual Center Directors Meeting at PAA or alternate site; organize annual Workshop on the Demography and Economics of Aging and AD/ADRD; creation and maintenance of Centers website; number and description of D&E CC-created shared resources, networking opportunities, and research synergies for Emerging Scholars Pilot Project awardees and Mentorship Programs; list of D&E CC-created meetings, workshops, webinars with names and number of attendees (including discipline, career stage, institutional affiliation) to assess population-representation in demography and economics; (optional) support of cross-center pilot projects.
Progress Report for Renewal Applications
Renewal applications must include descriptions of progress resulting from activities supported in the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits.
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:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
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.
All instructions in the How to Apply - Application Guide must be followed.
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
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, NIHs 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.
This initiative is not subject to intergovernmental review.
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 organizations 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 [email protected] 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 [email protected].
Applicants are required to follow the instructions for post-submission materials, as described in the policy
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.
For this particular announcement, note the following:
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.
Does the proposed Coordinating Center address the needs of the research programs that it will coordinate and serve? Is the scope of activities proposed for the Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs?
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?
Specific to this NOFO:
To what extent will the proposed activities enable the D&E CC to serve as a hub for the D&E Centers Programs, to serve the needs of the D&E Centers, as well as the needs of NIA program staff to track and monitor program success? Is the scope of proposed activities appropriate to meet those needs?
To what extent will successful completion of the aims bring added value or unique advantages or capabilities to the scientific activities and accomplishments of the Center programs served?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing social science research? Do the investigators demonstrate significant experience with coordinating collaborative social science research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
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?
Specific to this NOFO:
To what extent does the investigative team have relevant experience and expertise in project management and coordination required for this D&E CC?
To what extent will the proposed investigative team be able to facilitate cooperation across a wide range of demography, economics, and related fields of aging, including fields relevant to AD/ADRD?
To what extent is there strong evidence of the availability of sufficient scientific expertise and of the ability to work with scientists to serve as the overall D&E Centers' point-of-contact for a broad scientific and policy-oriented community?
Does the application propose novel organizational concepts or management strategies in coordinating the research programs the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
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?
Specific to this NOFO:
To what extent are the strategies innovative for carrying out the administration, collaboration, dissemination, as well as tracking and reporting activities?
To what extent are the concepts, strategies, or training/mentoring activities novel to one type of research program as opposed to applicable to a broad range of programs?
To what extent does the application propose a refinement, improvement, or new application of organizational concepts or management strategies?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the programs are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the programs? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
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?
Specific to this NOFO:
To what extent is the proposed timeline appropriate for the meeting of milestones?
To what extent will the implementation of the proposed activities address the objectives of this NOFO?
How well justified are the plans for carrying out the proposed administration activities?
To what extent are the proposed procedures for communication, cooperation, and fostering collaboration among the Centers adequate?
How well justified are the plans for carrying out the proposed collaboration activities?
To what extent are there appropriate plans to coordinate interaction between the D&E Centers Programs and other NIA Center Programs?
How well justified are the plans for carrying out the proposed dissemination activities?
How well justified are the plans for carrying out the proposed tracking and reporting activities?
Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research programs it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Center proposed? Will the Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
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?
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.
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)?
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.
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.
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.
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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
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.
Not Applicable.
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).
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.
For [programs/projects/networks/consortia/resources] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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:
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 applicants 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 applicants 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.
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.
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 recipients 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).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
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.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of joint responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
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.
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.
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]
Amelia Karraker, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]
Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]
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.