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 population of people living with AD/ADRD continues to grow and is projected to reach 16 million Americans by the year 2050. Significant concerns exist over the cost of caring for people living with AD/ADRD. A moderate body of evidence has been compiled on AD/ADRD care costs, with the results suggesting an escalation of costs as people living with AD/ADRD progressively lose their ability to function independently and require assistance with activities of daily living.

The disease burden of AD/ADRD is marked by pronounced health inequities. Non-Hispanic Blacks/African-Americans and Hispanic/Latino Americans bear a disproportionate number of cases, are underrepresented in clinical trials, and experience higher rates of medication discontinuation compared to Non-Hispanic White Americans. Equally important, existing methodologies of evaluating new drug treatment costs may disadvantage racial and ethnic minorities in computing the costs and benefits of novel pharmacological treatments.

While racial and ethnic differences have been documented in the costs of AD/ADRD disease management and the impact of unpaid caregiving, less attention has been granted to the issue of quantifying the cost of treating AD/ADRD with new medications and the health equity implications of access to such therapeutics. There has been a lack of attention in estimating the cost of new AD/ADRD pharmacological treatments for members of the following populations: Black/African-American, Hispanic/Latino American, Asian-American, American Indian/ Alaska Native, Native Hawaiians/Other Pacific Islander, Veteran, rural American, and sexual and gender minority. The health equity implications of access to new pharmacological treatments is a vital consideration in plotting future projections of AD/ADRD treatment burden. Failure to address the costs and benefits of new pharmacological agents could lead to unnecessary delays in drug delivery, should an important therapeutic breakthrough occur. It is not clear how all Americans will gain access to new therapeutics that require significant out-of-pocket payments, given documented disparities in lifetime asset creation across different racial and ethnic minority groups. Therefore, creative research designs are needed to address scientific questions regarding the cost of new therapeutics for AD/ADRD. Specifically, stakeholder engagement with affected persons and their caregivers is needed to understand access to, and costs of, drugs for persons living with AD/ADRD from racial and ethnic minority populations. Stakeholder engagement efforts can ascertain whether people want new therapeutics; whether their health care providers discuss new therapeutics with them; their household's ability to pay out-of-pocket share of costs for novel treatments; and their preferred payment method for covering costs.

Purpose

This NOFO invites applications to address health equity, drug costs, and access to new therapeutics for people living with AD/ADRD. Applicants must identify preferences for pharmacological treatment among racial and ethnic minorities living with AD/ADRD, assess whether cost barriers to pharmacological care exist for these groups, and quantify expenditures and HRQoL among people interested in receiving novel drugs to treat AD/ADRD.

Research Objectives

The goals of this NOFO are to identify whether cost-associated barriers to receiving novel therapeutics exist for racial and ethnic minority people living with AD/ADRD, and to evaluate the cost- effectiveness and health equity implications of new therapeutics in these populations. Studies proposed under this NOFO must clearly identify sub-population(s) to be engaged and methods for recruitment. Additionally, studies must provide a scientific rationale for selecting specific sub-populations. Investigators must conduct research to understand how, why, and for whom novel drugs are recommended and prescribed; who receives novel drugs; how long drugs are taken; how much novel drugs cost patients and caregivers in out-of-pocket payments, and the real-world health-related quality of life and well-being impacts of receiving novel drugs. This NOFO will support new research projects that conduct rigorous stakeholder engagement efforts and develop model parameters using both stakeholder input and quantitative data.

NIH takes many steps to enhance diversity in its extramural programs. Applicants are encouraged to visit NIH's Leveraging Stakeholders to Promote Diversity web page to learn more. In support of NIH's effort, NIA expects applicants to support activities that will foster diversity in the scientific workforce. Therefore, in the Research Strategy, applications should articulate plans to reach and engage with scientific partners from various backgrounds.

R61/R33 Exploratory/Developmental Phased Award

This NOFO utilizes the R61/R33 Exploratory/Developmental Phased Award activity code. The R61 phase provides 1-2 years of support for planning activities. The R33 phase provides 3-4 years of support for implementation activities.

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

An R61/R33 award is not renewable.

R61 Phase (The Planning Phase)

During the R61 phase, researchers will conduct rigorous stakeholder engagement with individuals from racial and ethnic minority groups to identify, measure, and assess their demand for new drugs. Researchers must develop stakeholder engagement plans; recruit and engage the target sub-populations; establish access to data sources that will allow for quantitative parameters to be defined; and present a plan for modeling cost, access, patient preferences, and health outcomes. The following activities must be accomplished during the R61 phase:

• Establishing a theoretical framework for conducting the study
• Framing the study
• Designing the study
• Identifying and valuing outcomes and elucidating preferences through stakeholder engagement

The application must propose quarterly milestones for the R61 phase.

Specific details and application instructions for each activity are provided sequentially in Section IV.2 of this NOFO.

R33 Phase (The Implementation Phase)

During the R33 phase, researchers will operationalize their models, analyze model outputs, and disseminate their findings to the field. The following activities must be accomplished during the R33 phase:

• Data acquisition
• Estimating costs and benefits
• Analyzing parameter uncertainty
• Modeling parameter uncertainty
• Reporting results

Applications must propose annual milestones for the R33 phase.

Specific details and application instructions for each activity are provided sequentially in Section IV.2 of this NOFO.

The R61/R33 Transition Process

At the completion of the R61 phase, the applicant must submit a detailed request to transition to the R33 phase. Decisions on transitioning to the R33 phase will be based on the original R61/R33 peer review recommendations, successful completion of the originally described milestones, program priorities, and availability of funds. Prospective applicants should note that funding of a grant application for the R61 phase does not guarantee support of the R33 phase.

Non-Responsiveness Criteria (Applications Not Responsive to this NOFO)

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

• Applications that propose projects that are not relevant to AD/ADRD
• Applications that are not primarily focused on racial and ethnic minorities access to novel AD/ADRD drugs
• Applications that include non-human research studies
• Applications that only propose R61 or R33 activities

Frequently Asked Questions

Responses to frequently asked questions about this NOFO will be posted here.

Resources for Applicants

• NIA Guidance on Sharing Data and Other Resources
• Notice of NIH's Interest in Diversity

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

Priscilla Novak, Ph.D., MPH
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: Priscilla.Novak@nih.gov

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 Program Director(s) and Principal Investigator(s) (PD(s)/PI(s)) must have demonstrated appropriate experience with stakeholder engagement and in modeling costs of health and medical care.

R&R Budget

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

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: In the single Specific Aims attachment, the application must describe the specific aims of the R61 phase and the R33 phase. Distinct aims must be provided for each phase.

The application must include specific aims that will increase the understanding of whether there are racial and ethnic differences in access to new and repurposed pharmacological agents for AD/ADRD.

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 each phase. It is not necessary to repeat information or details in the R33 section that are described in the R61 section.

The application must include the following information in the Research Strategy:

• A description of proposed methods that align with standard approaches to modeling costs and HRQoL
• A description of specific innovative modeling approaches and code sharing approach
• A description of how the project will account for structural, institutional, and interpersonal racism
• A description of the sub-populations to be engaged and methods for recruitment
• A description of the dissemination approach?
• A description of the innovative approach to modeling that would make the model easily replicable/updatable as new data become available

The application must describe how the activities listed below will be accomplished:

R61 Activities (The Planning Phase)

• Establishing a theoretical framework for conducting the study. Researchers must assess the health equity (e.g., changes in health-related quality-of-life and well-being) ramifications of who does and does not receive new drugs in modeling costs and benefits. Researchers must address how, why, and for whom novel drugs are recommended and prescribed; who receives novel drugs; and how long drugs are taken
• Frame the study. Applications must clearly define the scope of research, including the sub-populations to be engaged and the scientific rationale for selecting those sub-populations. Applications should also describe how the findings from the R61 phase will inform development of the R33 phase
• Design the study. Applications may choose to employ techniques from qualitative, quantitative, and/or mixed methods research (e.g., literature reviews, focus groups, in-depth interviews, and surveys) for the R61 phase. Applications must clearly articulate rigorous plans for recruitment of stakeholders, data collection, and analysis. In the R61 phase, applications must also establish access to data sources that will allow for quantitative parameters to be defined and present a plan for modeling cost, access, patient preferences, and health outcomes
• Identify and value outcomes and elucidate health preferences through stakeholder engagement, including with people living with AD/ADRD, at risk for dementia, caregivers, and/or members of communities underrepresented in AD/ADRD research. Researchers must explore such questions as whether people want new therapeutics; whether their health care providers discuss new therapeutics with them; their household's ability to pay out-of-pocket share of costs for novel treatments; and their preferred payment method for covering cost. Stakeholder engagement activities should be cognizant of the fact that clinical efficacy of new therapeutics is often unknown for people living with AD/ADRD who are members of groups understudied in AD/ADRD research because clinical trials are not always representative

R33 Activities (The Implementation Phase)

• Data acquisition. The researchers should acquire the data needed for model input
• Estimate costs and benefits of treatments through simulation modeling. Acceptable techniques range from Monte Carlo simulation to discrete event modeling
• Analyze parameter uncertainty. Input-model parameters may be estimated from stakeholder information, expert opinion, or large datasets for the input processes driving the model. The estimation of unknown input-model parameters gives rise to output variability called "parameter uncertainty." Investigators should analyze the uncertainty
• Model parameter uncertainty. The investigators should examine how the model reacts when parameters are altered
• Report results. Applications must present a plan for disseminating the findings, including how the model reacts when parameters are altered. In the implementation phase the investigators shall make non-restricted data and code used to develop the models accessible to the scientific community through a public repository

Preliminary data are not required for this application. However, any preliminary data that will support or justify the proposed hypothesis, rationale, or development plan may be included.

The application should provide a description of how the study designs, methods, and assessments are complementary, such that outcomes from the planning phase will enhance the interpretation of outcomes at the implementation stage.

Milestones

The application must include a section labeled "Milestones." The section must include the following:

• A description of quarterly milestones to be achieved during the R61 phase
• A description of annual milestones to be achieved during the R33 phase

Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the specific aims for the R61 phase. Milestones must demonstrate the methods that will be used to carry out the activities required in both phases. The milestones must indicate products milestones that are quantifiable/measurable allowing for go/no-go decision-making.

The R61/R33 Transition Process

At the completion of the R61 phase, the applicant must submit a detailed request to transition to the R33 phase. Decisions on transitioning to the R33 phase will be based on the original R61/R33 peer review recommendations, successful completion of the originally described milestones, program priorities, and availability of funds. Prospective applicants should note that funding of a grant application for the R61 phase does not guarantee support of the R33 phase.

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.

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.

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 Ramesh.Vemuri@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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.

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 NIA, 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.

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

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

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

Priscilla Novak, Ph.D., MPH
National Institute on Aging (NIA)
Division of Behavioral and Social Research (DBSR)
Telephone: 301-401-3136
Email: Priscilla.Novak@nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Jeni Smit
National Institute on Aging (NIA)
E-mail: jeni.smits@nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.