Part 1. Overview Information

Key Dates

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

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

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

It is critical that applicants follow the 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The mistreatment of older and vulnerable adults is a complex and pervasive problem, which may include physical, sexual, emotional, or psychological abuse; neglect; abandonment; and financial or material exploitation (hereafter referred to as “abuse and neglect” or “AN”). Although AN is known to have serious psychological and physical health consequences, and many related risk factors and indicators have been identified, AN frequently goes undetected in clinical practice. Clinical encounters tend to be brief with minimal time for assessment, let alone intervention. Moreover, older adults rarely disclose experiences of AN and may go to great lengths to conceal it, especially when family members accompany them to medical appointments, as is often necessary.

While people living with impaired cognitive function are considered to be particularly vulnerable to AN, clinicians may miss red flags because common physical and psychological symptoms of Alzheimer's disease (AD) and Alzheimer's disease related dementias (ADRD) and treatment can overlap with the sequelae of AN. Issues of capacity and competency often cast doubt on the validity of claims shared by people living with dementia. Moreover, as AN can be charged as a felony-level offense or a high-end misdemeanor, raising the topic creates an ethical challenge for clinicians if alternative caregiving options are not available, and when intervention and treatment options are limited.

Primary care providers play an increasingly critical role in the care and treatment of AD/ADRD patients. Screening patients at risk of AN prior to, or early in the course of, cognitive decline could create an opportunity for providers to deliver a brief psychoeducational intervention and/or to direct patients and families to the appropriate health and social services. However, clinicians currently lack evidence-based screening tools with high specificity and sensitivity that improve the diagnostic accuracy and early detection of AN and AN perpetration, and they also lack strategies for AN prevention and early intervention. Despite the potential benefits of screening, results of a systematic evidence review, conducted by the US Preventive Services Task Force (USPSTF) in 2018, concluded that current evidence is insufficient to assess the balance between the benefits and harms of screening for abuse and neglect in older or vulnerable adults.

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to support research that can lead to the development of primary care-based screening tools and early interventions to detect and prevent AN in older and vulnerable adults living with, or at risk for, mild cognitive impairment (MCI) and AD/ADRD. In the interest of supporting early-stage research that can lead to the development of screening tools and behavioral interventions that can be successfully implemented in primary care settings with diverse patient populations, this NOFO invites five-year, R61/R33 phased award applications. The R61 planning and pilot phase will provide up to two years of funding to support Stage I and Stage III research to develop, modify, and/or adapt, as well as pilot test screening tools and/or behavioral interventions. The R33 implementation phase will provide up to three years of additional funding to support a Stage III, preliminary efficacy study in primary care and primary care-referable settings. Research responsive to this NOFO will explicitly address priority research needs and gaps highlighted in the U.S. Preventive Services Task Force’s (USPSTF) 2018 final recommendation statement on Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening (e.g. counseling, case management, home visitation, and referral to community services). Applications submitted to this NOFO must use the NIH Stage Model framework as a common language in the description of the proposed study aims and research activities.

Research Objectives and Scope

In continuation of the National Institute on Aging's (NIA) efforts to address the significant public health problem of AN, the overarching goal of this NOFO is to support research that can lead to the development of sensitive and specific screening tools and potent interventions for primary and secondary AN prevention in the context of MCI and AD/ADRD. NIA is interested in studies that focus on the development and validation of the following:

1. Tools and interventions that can be easily implemented in a primary care setting or that can lead to appropriate referrals by primary care professionals.
2. Instruments or assessments for the accurate screening of older and vulnerable adults without recognized signs or symptoms of AN in primary care settings at diagnosis or follow-up for MCI or AD/ADRD.
3. Instruments or assessments for the accurate screening of companions attending primary care visits that will enable the early identification of risk factors for both perpetration and victimization.
4. Brief and effective point-of-care psychoeducational and behavioral interventions for the prevention of AN in high-risk patients.
5. Resources or interventions to aid primary care clinicians in referring patients to the appropriate health and/or social services. For example, the Screening, Brief Intervention, Referral to Treatment (SBIRT) intervention has proven to be an effective public health approach for early intervention and treatment of substance abuse.

Study Populations of Interest

Projects are required to focus on participants from populations disproportionately affected by AN, including, but not limited to: older and vulnerable adults living with cognitive impairments; individuals experiencing deterioration in cognitive function, MCI, or AD/ADRD; and/or high-risk individuals in midlife, including people with a family history of AD/ADRD, and those with predisposing risk factors. NIA is particularly interested in supporting research that is guided by the NIA Health Disparities Framework, that can promote health equity and address disparities in health and health care access in groups that are underrepresented in MCI and AD/ADRD intervention research (Milestone 13.N). These populations include, but are not limited to, racial and ethnic minorities; sexual and gender minority populations (as defined on the homepage of NIH’s Sexual & Gender Minority Research Office | DPCPSI); people with comorbid conditions or disabilities from socially, culturally, economically, or educationally disadvantaged backgrounds and/or with low literacy; and non-English speakers.

Ethical Considerations

Given that research on AN is a sensitive issue, research proposed to this NOFO must be guided by ethical principles. Therefore, applications must include a plan to ensure adherence to the ethical principles of autonomy, beneficence, nonmaleficence, and justice for both patients and medical visit companions. In addition, applications are also required to present an explicit protocol for reporting suspected and confirmed abuse according to laws, local regulations, and statutory mandates, both federal and state. Furthermore, applications must discuss procedures for determining decisional capacity and competency in the context of informed consent, and for determining MCI or AD/ADRD in the context of the proposed research study.

Experience and Expertise

• The investigative team must include key personnel with research and clinical experience in the care of adults with cognitive impairments and/or AD/ADRD in primary care settings and research expertise in elder mistreatment, child abuse and neglect, and/or intimate partner violence. Expertise in bioethics is strongly encouraged.
• This NOFO encourages interdisciplinary collaborations among researchers and health care practitioners from both large and small health-delivery networks.
• NIA is particularly interested in supporting research from investigative teams that foster a culture of diversity, equity, inclusion, and accessibility, and that address NIH's Interest in Diversity.

Experimental Design and the NIH Stage Model

In the interest of developing potent and easily implementable screening tools and behavioral interventions in primary care settings, this NOFO will only support appropriately powered, rigorously designed Stage I and Stage III research studies that follow an iterative process, and take into account eventual dissemination and implementation, as conceptualized by the NIH Stage Model framework. It is expected that the majority of studies supported under this NOFO will be Stage I studies that culminate in a Stage III clinical trial. Applications proposing to develop a behavioral intervention are required to provide and test hypotheses for the potential mechanism(s) through which the intervention achieves the proposed effects. Applications can also explore the contexts in which an intervention is most effective (e.g., when and for whom) and how components in complex interventions interact to influence key outcomes. Applications that propose Stage II (i.e., Pure “Efficacy”), Stage IV (i.e., “Effectiveness”, Pragmatic trials), or Stage V (i.e., Implementation and Dissemination) research will be considered  non-responsive to this NOFO and will be withdrawn prior to review.

Stage I studies will encompass the creation/adaptation and feasibility testing of a screening tool and/or behavioral intervention. NIA strongly encourages, but does not require, applicants to consider the use of the experimental medicine approach to behavior change (see the information regarding NIH's Science of Behavior Change (SOBC) program).

Stage III studies will focus on real-world efficacy testing in primary care settings with diverse patient populations and primary care clinicians, while maintaining a high level of control necessary to establish internal validity (see Terms and Definitions below).

To increase the internal and external validity of research supported under this NOFO, all applications are required to develop and/or include a fidelity monitoring plan within all stages. This plan should include the essential elements of the tool or intervention that must be achieved to ensure that screening tools and/or interventions will be delivered as intended.

Additionally, applications are required to include meaningful outcome measures that will be used to assess the impact of screening tools and behavioral interventions on AN and their potential to improve health outcomes. Studies are expected to have sufficient power to allow for subgroup analysis (e.g., patient age, severity of illness, race/ethnicity, sexual orientation, gender identity, etc.) in order to determine consistency in screening and/or behavioral intervention effects. Furthermore, applications must propose an analytic plan for assessing the impact of patient-provider social concordance (e.g., race, ethnicity, sexual orientation, gender identity, etc.) on clinical decisions to screen and/or treat or patient decisions to consent to screening or treatment. 

Applications must also include demographic characteristics and selected patient characteristics of the study participants, and in aggregate form for the primary care setting (see Table 3B: Demographic Characteristics and Table 4: Selected Patient Characteristics in the 2022 Uniform Data System Manual). Applications also must propose a plan for equitably achieving a sample that is representative of the target patient population which includes strategies for the recruitment and retention of participants from underrepresented populations.

NIA strongly encourages applicants to propose research that aligns with guidance from the Agency for Healthcare Research and Quality's Evidence-based Practice Centers Program (e.g., Methods Guide for Comparative Effectiveness Reviews: Assessing the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions) and research that applies the lessons learned from recent evidence-based reviews (see  “Care Interventions for People Living with Dementia and Their Caregivers”).

Required Components of the R61/R33 Application

Applications must propose Stage I or Stage III research for screening tool and/or behavioral intervention development and pilot-testing in the R61 planning and pilot phase, and a Stage III research study to assess preliminary real-world efficacy in the R33 implementation phase. Applications are also required to propose specific aims for both phases as well as a set of milestones that will be achieved by the end of each phase. For the purpose of this NOFO, milestones are defined as scheduled, performance-based events that signify the successful completion of a significant stage in the project. Specific requirements, and examples of activities and milestones for each phase, are described below.

Applicants are required to specify the Population, Intervention, Comparators, Outcomes, Timing, and Setting (in other words, apply a PICOTS framework), and to incorporate PICOTS elements in study design.

The R61 Planning Phase

Research appropriate to the R61 phase will seek to develop a screening tool and/or behavioral intervention while simultaneously testing the proposed mechanisms of action. This NOFO supports projects that modify, adapt, and conduct preliminary efficacy testing of screening tools and/or brief behavioral interventions, and evaluate the hypothesized mechanisms of action. This may include adapting an intervention originally designed to screen for another condition, for use in a non-adult or different vulnerable population, or for delivery in non-primary settings, to be used for AN screening in primary care settings. Specific activities and milestones appropriate for the R61 phase will depend on the screening tool and/or behavioral intervention proposed and its/their stage of development. Examples of appropriate studies include, but are not limited to, the following:

1. Stage I mechanism-focused, adequately powered studies that leverage and incorporate Stage 0 (i.e., basic science) findings to create and conduct a preliminary test of a new AN behavioral intervention for efficacy and for its mechanisms of action.
2. Stage I mechanism-focused, adequately powered studies that modify/adapt an intervention, in accordance with its principles.  
   • Adaptation of an evidence-based, non-AN, non-older, non-AD/ADRD, or vulnerable adult; or non-primary care intervention.
   • Adaptation of an evidence-based AN screening tool or behavioral intervention for validation and use in diverse populations, including groups that are underrepresented in MCI and AD/ADRD intervention research.
   • Modification of an existing AN behavioral intervention into a more scalable, streamlined, and easily implementable form for primary care settings.
   • Modification of an existing AN behavioral intervention's form to improve potency.
3. Stage III studies testing efficacy using an adequately-powered and appropriate experimental design (e.g., experimental medicine or SOBC approach; factorial or partial factorial design; sequential, multiple assignment, randomized trial (SMART) approach) to determine/confirm efficacy and mechanisms of behavior change.

Research appropriate to the R61 phase will also seek to develop, test, and validate training materials to ensure fidelity in the delivery of the screening tool and/or behavioral intervention, or to test the principles/mechanisms of action. An efficacious screening tool or intervention is considered complete only when it can be delivered in real-world settings with fidelity. Therefore, all R61 projects must produce operationalized and validated training materials that result in fidelity. Training procedures to ensure optimal fidelity may be developed and preliminarily tested within Stage I studies, and further tested within primary care-based Stage III trials. Examples include, but are not limited to, the following:

1. Modules that train primary care providers to deliver specific elements of a screening tool or behavioral intervention with fidelity in primary care settings to patients and medical-visit companions.
2. Methods or procedures that increase retention of essential components (i.e., mechanisms of action) of the screening tool and/or intervention and its delivery, thus increasing fidelity.
3. Training materials for the delivery of screening tools and/or interventions with fidelity in diverse primary care settings.

Milestones and R61/R33 Transition

Each milestone must include the following three elements: 1) an action or event marking a significant change or stage in the project; 2) an estimate timeline for the completion; and 3) evidence of achievement. It is expected that Milestones will be specific, quantifiable, and scientifically justified, and will have well-defined criteria for success or go/no-go decisions within the R61 phase and for transitioning from the R61 to the R33 phase of the award. Investigators and NIA will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the R61 grant award, if issued.

Funding of the R61 planning phase grant does not guarantee support of the R33 implementation phase grant. Two months prior to the end of the R61 phase, recipients will submit a package that requests transition to the R33 phase. This package will include a Non-Competing Continuation Progress Report (PHS 2590) that describes accomplishments toward each of the R61 milestones as proposed in the application and plans for studies during the R33 phase. Materials will be reviewed by NIA grants management and program staff and, if approved, the grant will be transitioned to an R33 award without the need to submit a new grant application. The transition from the R61 to the R33 phase will be contingent upon: (1) assessment of the R61 phase progress report and determination that core milestones were successfully achieved and that there is evidence to support the potential success of the implementation phase of the project; (2) NIA program priorities; and (3) availability of funds. Investigators and NIA program staff will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the R33 grant, if awarded. If R61 recipients are not ready to submit an R33 transition package prior to the end of the R61 award, a no-cost extension may be requested for up to one year, during which time recipients 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.

Examples of R61 milestones include, but are not limited to, the following:

• For behavioral interventions, test the hypothesized mechanisms of the screening tool and/or intervention effects.
• Establish the acceptability of the tool and/or intervention in primary care settings.
• Develop, test, and validate scalable training materials and protocols for delivery of the screening tool or intervention with fidelity in primary care settings.
• Pilot test intervention(s) and produce preliminary data showing feasibility of R33 implementation research.
• For Stage I trials, refine and standardize an intervention, and further test feasibility, safety, and acceptability, with preliminary testing of the association between interventions and clinical outcomes.
• Validate objective, clinically-relevant outcome measures for assessments of benefits and harms. Note that no project involving complex intervention development will be allowed to move to the translation/implementation phase without validation data from instrument testing during the R61 phase.

The R33 Implementation Phase: Stage III Efficacy Trials

During the R33 phase, the PD(s)/PI(s) will test the efficacy of the screening tool and/or intervention in a primary care setting. Examples of general activities for this phase include, but are not limited to, the following:

• Minor screening tool and/or intervention refinement, based on insights from the R61 phase; standardization of outcome measures; and confirmatory testing of feasibility, safety, and acceptability.
• Refinement of estimates of sample size, numbers of sites, site-to-site heterogeneity, and the implementation timetable based on data derived from healthcare delivery partners.
• Studies supported by the R33 phase should be adequately powered. Applications are required to provide power calculations for the R33 phase within the R61/R33 transition package.

Additional Considerations

• To support the potential feasibility of the proposed study, applications should include institutional Letters of Support from clinical settings where research will be conducted.
• The proposed budget should include travel costs to attend and participate in one annual RFA recipient network meeting for each project year.
• NIA utilizes 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 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 and as described in this notice. 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 recipients must ensure:
  1. The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 46.116, all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.” If using the NIA informed consent template please see Section 6: Statement of Confidentiality.
  2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.

Non-Responsive Applications

Applications must include all of the following attributes, or they will be considered non-responsive to this NOFO and will be withdrawn prior to review:

• Research conducted in primary care settings (see Terms and Definitions below).
• Specific aims and well-defined milestones for both the planning (R61) and implementation (R33) phases, and milestones to transition from the R61 phase to the R33 phase.
• Well-described specific aims that address priority research needs and gaps highlighted in the U.S. Preventive Services Task Force’s 2018 final recommendation statement on Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening, related to 1) screening tests and/or interventions in primary care settings for the abuse of older or vulnerable adults, especially when there are no recognized signs or symptoms of abuse, and 2) the assessment of the balance of benefits and harms of screening and/or intervention in primary care settings to prevent such abuse.
• Research that focuses on the development of screening or treatment interventions that meet the definition of primary prevention (i.e., avoid the development of disease, or in this case, any or all subtypes of AN) or secondary prevention (i.e., identify and treat one or more subtypes of AN before it results in significant symptoms), that are designed for delivery in primary care settings or judged to be feasible for delivery in, or referable from, primary care. Refer to “Terms and Definitions” for additional information.
• Specific Aims that specify the Stage of research, as defined by the NIH Stage Model for the clinical trials proposed.
• Applications that propose Stage I (tool and/or intervention development) studies and/or Stage III (preliminary efficacy assessments in the "real-world") clinical trials. Applications that propose Stage II (Pure “Efficacy”), Stage IV (“Effectiveness”, Pragmatic trials), or Stage V (Implementation and Dissemination) research will be considered not responsive to this NOFO and will be withdrawn prior to review.

Terms and Definitions

For the purposes of this NOFO, unless otherwise specified, definitions for the following terms were adopted from the USPSTF’s Final Research Plan: Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening.

• Elder abuse: Relevant types of abuse include physical abuse, sexual abuse, emotional or psychological abuse, neglect, abandonment, and financial or material exploitation.
• Vulnerable adult: A person who is, or may be, mistreated and who, because of age, disability, or both, is unable to protect themself.
• Screening: A preventive service focused on detection of an undiagnosed disease in asymptomatic populations.
• Primary care: The provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community (as defined by the Institute of Medicine Committee on the Future of Primary Care) .
• Primary care setting: USPSTF recommendations address services offered, or judged to be feasible, in primary care settings as well as services referred by primary care professionals. Their  Procedure Manual (2015) states, “to be feasible in primary care, the intervention could target patients seeking care in primary care settings, and the skills to deliver the intervention are or could be present in clinicians and/or related staff in the primary care setting, or the intervention could generally be ordered/initiated by a primary care clinician.” Primary care settings include primary care clinics, emergency rooms, or other settings where primary care services are offered. This includes community-dwelling, assisted living settings where primary care services are delivered, and where patients/residents are able to live independently and receive care similar to a traditional primary care setting; and in nursing homes.
• Primary care providers: A Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Clinical Nurse Specialist (CNS), Nurse Practitioner (NP), or Physician Assistant (PA) who is certified in one of the following specialties: internal medicine, general medicine, geriatric medicine, family medicine, and/or hospice and palliative medicine.
• NIH Stage Model framework: Please see the NIH Stage Model framework webpage for more information. Please see the SOBC webpage for more information regarding the experimental medicine approach.

Applicants are strongly encouraged to consult with NIA staff while developing an application (see Section VII: Agency Contacts). This early contact will provide NIA staff an opportunity to clarify NIA policies and guidelines to applicants and identify whether the proposed project is consistent with NIA program priorities.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The investigative team must include key personnel with research and clinical expertise in the care of adults with cognitive impairment and/or AD/ADRD in primary care settings and research expertise in elder mistreatment, child abuse and neglect, and/or intimate partner violence. Expertise in bioethics is strongly encouraged. This NOFO also encourages interdisciplinary collaborations among researchers and health care practitioners from both large and small health-delivery networks. Applications are also strongly encouraged to foster a culture of diversity, equity, inclusion, and accessibility and to address NIH's Interest in Diversity. BioSketches of key personnel should provide evidence of relevant research and clinical expertise and experience in these required areas.

R&R Budget

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

Applicants should budget for travel costs to attend and participate in one annual RFA recipient network meeting for each project year.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Describe the specific aims for each of the two phases (R61 and R33) on the single Specific Aims attachment. Include headers indicating the R61 specific aims and the R33 specific aims.

Research Strategy: The Research Strategy must contain separate sections that describe the R61 and R33 phases, as well as a sub-section that is devoted to describing milestones to be achieved during the R61 phase, to qualify for the transition to the R33 phase, and for the R33 phase.

• The application must apply a PICOTS framework by specifying the Population, Intervention, Comparators, Outcomes, Timing, and Setting and by applying the elements in the proposed study design.
• Applicants must describe the criteria and quantitative measures for assessing the balance of benefits and harms of the proposed intervention(s) to patients, and to any or all medical-visit companions.
• Applicants must describe and provide rationale for the proposed Stage of Intervention Research (e.g., Stage 0 and Stage I or III of the NIH Stage Model). The justification should include evidence from previous basic behavioral research or from previous relevant clinical trials that the proposed Stage is appropriate.
• Applicants must provide a rationale for the intervention study design (e.g., single case study, multiple baseline design; adaptive/SMART design; factorial; partial factorial; etc.).
• Applicants must describe the intervention targets and provide an explanation of the hypothesized relevance of process variables (i.e., hypothesized causal targets, characteristics of the screening tool and/or behavioral intervention) and outcome variables (i.e., ultimate behavior to be modified) to the clinical and statistical hypotheses being tested (i.e., the hypothesized role that each variable plays in the causal chain; specification of variables as hypothesized moderators, mediators, or outcomes).
• Applicants must describe a plan for addressing the fidelity of the screening tool and/or intervention delivery.
• Applicants must describe outcome measures that will be used to assess the impact of screening tools and behavioral interventions on AN and their potential to improve health outcomes.
• Applicants must describe the analytic plan for assessing the impact of patient-provider concordance on clinical decisions to screen and/or treat or patient decisions to consent to screening or treatment. Provide justification for the social characteristics (e.g., race, ethnicity, sexual orientation, gender identity, etc.) assessed.
• Applicants must provide demographic characteristics and selected patient characteristics of the study participants, and in aggregate form for the primary care setting (see Table 3B: Demographic Characteristics and Table 4: Selected Patient Characteristics in the 2022 Uniform Data System Manual).
• Applicants must describe a plan for equitably achieving a sample that is representative of the target patient population and the proposed strategies for the recruitment and retention of participants from underrepresented populations.
• Applicants must propose a strategy for the recruitment and retention of participants from underrepresented populations.

Milestones: It is expected that R61 milestones will be well-specified and developed, feasible, and quantifiable, with regard to the specific aims of each phase, and with defined success or go/no-go criteria with respect to outcomes, and for advancing from the R61 to the R33 phase, which together, will demonstrate initial proof of concept and/or provide preliminary evidence that the new or refined screening tool and/or behavioral intervention can be implemented in primary care settings.

Letters of Support: Applications should include institutional Letters of Support from clinical settings where research will be conducted. Letters of Support should be attached to the PHS 398 Research Plan Form in the Other Research Plan Section, attachment #13.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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

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

The NIH announced a policy on allowable appendix materials (NOT-OD-17-098); however, this NOFO allows specific materials to be included as appendices that are otherwise disallowed by the general policy. Applications may include as appendices the following materials: focus group guides, structured interview schedules, blank questionnaires or surveys with instructions, observational coding systems, fidelity monitoring checklists and rating tools, and draft or sample intervention manuals.

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 3 - Protection and Monitoring Plans

3.1 Protections for Human Subjects

In addition to addressing the five required components, the Protections for Human Subjects section must 1) describe a plan for ensuring adherence to the basic ethical principles of nonmaleficence, autonomy, beneficence, and justice, in the context of the study proposed, for both patients and medical-visit companions; 2) include an explicit protocol for reporting suspected and confirmed abuse according to laws, local regulations, and statutory mandates, both federal and state; and 3) specify procedures for determining decisional capacity and competency in the context of informed consent, and for determining MCI or AD/ADRD in the context of the proposed research study..

3.2 Data and Safety Monitoring Plan

The Data and Safety Monitoring Plan (DSMP) should include a description of data monitoring activities, consistent with the NIA Guidance on Clinical Trials. This DSMP should include the following:

• Plans to ensure that validated systems and controls are in place to assure the integrity of the clinical trial data being collected.
• Proposed methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification and data validation. Describe the data query process and frequencies and any planned mitigation strategies in the event of noncompliance.
• The process for locking the final trial datasets for analysis.

Do not name members of any oversight board in the application. The NIA will appoint members of any oversight committees after consultation with the clinical trial investigator team.

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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.

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.

The R61/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 phases.

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.

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.

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.

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

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

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access 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

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Melissa S. Gerald, 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]

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 45 CFR Part 75 and 2 CFR Part 200.