Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional)

Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). Supports research on interventions to prevent and address housing instability to advance health equity.

Expired RFA-NR-25-001: Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Nursing Research ( NINR ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) National Institute on Aging ( NIA ) November 1, 2024 - Participation added ( NOT-AG-24-069 ) Funding Opportunity Title Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional) R01 Research Project Grant November 1, 2024 - Notice of Participation of the National Institute on Aging in RFA-NR-25-001, "Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional)".

See Notice NOT-AG-24-069 . October 1, 2024 - Pre-Application Webinar for RFA-NR-25-001: Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional). See Notice NOT-NR-25-001 .

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this funding opportunity is to support research that advances health equity through development, testing, and evaluation of interventions that prevent and address housing instability. Applications responding to this Notice of Funding Opportunity should develop, test, and/or evaluate the impact of a housing intervention on both health and housing outcome(s).

NINR is interested in applications that focus on social determinants of health (SDOH) interventions that modify housing opportunities and/or interventions that address housing instability as a social risk by addressing individual and/or interpersonal-level housing needs. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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). Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

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

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Key Definitions for the NOFO: Housing instability encompasses homelessness and other forms of housing insecurity such as trouble paying rent, overcrowding, moving frequently, or spending the bulk of household income on housing ( Healthy People 2030 ). Health equity refers to a state in which every person attains their full health potential.

Achieving health equity requires addressing not only the prevalent unjust, unfair, and preventable health disparities but also the structural factors that shape and perpetuate them. See https://www. ninr.

nih. gov/aboutninr/ninr-mission-and-strategic-plan/research-framework for additional details regarding NINR’s perspective on health equity. Social determinants of health (SDOH) are the conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life.

These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www. ninr.

nih. gov/researchandfunding/nih-sdohrcc for additional detail on the NIH SDOH conceptualization. Populations that experience health disparities include racial and ethnic minority groups defined by OMB Directive 15; people with lower socioeconomic status (SES); underserved rural communities; sexual and gender minority (SGM) groups and people with disabilities.

See https://www. nimhd. nih.

gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters. html for additional detail. Housing instability encompasses homelessness and other forms of housing insecurity such as trouble paying rent, overcrowding, moving frequently, or spending the bulk of household income on housing ( Healthy People 2030 ).

Housing instability is currently on the rise in the U.S.—for example, the number of people experiencing homelessness rose 12% between 2022 and 2023 and the number of households with worst case housing needs reached a record high of 8. 53 million in 2021 ( HUD Worst Case Housing Needs: 2023 Report to Congress ). While housing instability affects people of all sociodemographic groups, its impact on some groups is disproportionate.

For example, compared with their proportion of the general US population, many populations that experience health disparities (see definition above) are overrepresented among those experiencing housing instability. Structural and environmental factors, such as historical and current housing policies and resettlement due to climate change, contribute to the increased likelihood of some groups experiencing housing instability.

The increase in the number of people experiencing housing instability in the U.S. is especially alarming because the health impacts of and health disparities associated with housing instability are wide-ranging.

For example, through a variety of pathways and mechanisms, housing instability may lead to increased risk of infectious diseases (e.g., tuberculosis, HIV, COVID-19), chronic diseases (e.g., diabetes, asthma exacerbation, hypertension), mental disorders (e.g., depression), and violence victimization.

Housing instability has also been shown to be associated with high-risk behaviors (e.g., tobacco use, alcohol use, substance use, inadequate physical activity). While housing instability has health impacts across the lifespan, certain age groups may experience unique and particularly deleterious health impacts. For example, housing instability may negatively impact developmental outcomes (e.g., cognitive development) among children.

While there have been many studies that examined associations between housing instability and health, fewer studies have examined the impact of interventions to prevent and address housing instability and resulting health outcomes.

Research examining the health impact of interventions to address housing instability is growing, however more support for this type of research is needed to reduce and eliminate the health disparities associated with housing instability.

For example, a recent analysis of the NIH, CDC, and HUD health and housing portfolios examined support for studies under each of four pathways by which housing influences health (housing stability [which encompasses housing instability as defined above], affordability, neighborhood/built environment, and housing safety/quality) and found that housing stability was the least-supported pathway across all three agencies and that intervention research comprised only 27% of studies within these agencies’ health and housing portfolios.

Additionally, many prior studies of interventions aiming to mitigate the health impacts of housing instability used approaches that focused on providing healthcare to improve health outcomes among people experiencing housing instability, without addressing housing directly.

More research is needed to understand the health impacts of interventions that address housing as a SDOH, such as those that modify housing policies and/or community-level housing opportunities, and interventions that address housing instability as a social risk, including those that address individual-, family- and/or interpersonal-level housing needs.

More research is also needed to examine the impact of interventions that address housing and other SDOH and/or social risks.

This funding opportunity will support research to develop, test, and evaluate the impact of housing interventions that address housing instability (i.e., homelessness and other forms of housing insecurity such as trouble paying rent, overcrowding, moving frequently, or spending the bulk of household income on housing) on health and health disparities.

Interventions must address housing instability—interventions focused on providing healthcare or other types of services to people experiencing housing instability that do not address housing itself will not be considered responsive to this funding opportunity. Researchers should partner with organizations that provide housing, if needed, to develop, test, and/or evaluate housing interventions.

Population-, system-, community-, and multi-level housing interventions that address housing as a SDOH could be responsive to this NOFO. Individual- and/or interpersonal-level interventions that address housing needs to mitigate social risks could also be responsive to this NOFO. Interventions may address other SDOH and/or social risks alongside housing.

In addition to measuring the impact of intervention(s) on housing outcome(s), studies must include one or more health outcome(s) as the primary outcome(s). Research studies should be guided by a conceptual framework that identifies, for example, how, for whom, under what conditions, and when the intervention affects the health outcome(s).

Investigators collecting primary data are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on housing and other SDOH and social risks across studies. In particular, studies with human participants should incorporate measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit ( www.

phenxtoolkit. org ). This NOFO could support efficacy or effectiveness trials, implementation studies, and studies where an exposure or change is not directly manipulated by the researcher, and where comparable control data are available and confounding variables can be limited through study design, sample selection, and statistical analysis.

Investigators are encouraged to leverage community strengths in intervention design. Community-based participatory research (CBPR) or other community-engaged approaches may be useful for understanding community priorities, needs, and preferences, as well as for leveraging strengths of and knowledge embedded in communities of interest.

Applications must examine the health and housing impacts of interventions to address housing instability.

Examples of these types of applications include, but are not limited to: Studies that examine community- or population-level programs or policies to prevent and address housing instability and its impact on health outcomes and health disparities, including studies that examine any unintended consequences of housing policies and programs on health Studies that examine housing instability interventions, such as interventions that directly address housing needs of individuals and families Additional topics of interest include, but are not limited to: Nurse-led interventions that integrate housing and healthcare Studies of interventions to address the unique housing needs of subpopulations experiencing housing instability, such as: Studies that examine housing instability interventions designed or adapted to meet the unique needs of health disparity populations, criminal legal system-involved populations, children, youth, and/or older adults Studies that examine housing instability interventions designed or adapted to meet the unique needs of migrant/resettled populations displaced by climate change/natural disasters Studies of interventions to address housing instability and one or more other pathways by which housing status (e.g., affordability, neighborhood, safety and quality) influences health and health disparities Studies of interventions to address housing instability and other related SDOH and/or social risks (e.g., interventions that address housing and food security, interventions that address housing and social connectedness, etc.) Non-Responsiveness Criteria Applications that are deemed non-responsive will be withdrawn and will not be reviewed.

This includes: Applications that do not include a Plan for Enhancing Diverse Perspectives Applications proposing interventions that do not address housing instability Applications that do not include health outcome(s) as primary outcome(s) Applications that do not include housing outcome(s) Construction and major renovations costs are unallowable through this RFA.

Applications that propose to use grant funds to support construction or major alteration and renovation projects will be considered non-responsive. See Section VIII. Other Information for award authorities and regulations.

Plan for Enhancing Diverse Perspectives (PEDP) The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams.

There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project.

Consistent with federal law, the race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status) of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

National Institute on Aging (NIA) NIA is interested in midlife exposures with an effect on later-life health (including but not limited to Alzheimer s Disease and Related Dementias (AD/ADRD) and aging. Housing is a critical macrosocial factor that affects health throughout the life course.

While considerable research on housing and health has taken place, relatively little has focused on adults over 65 or how housing affordability and stability closely tied to housing insecurity health.

The NIA is particularly interested in applications that can address these two gaps in what is known There are several emerging issues that highlight the importance of housing insecurity for health across the particularly older adults: the increasing mean age of unhoused individuals across the U.S.; individuals over 50 homeless for the first time; and the unique challenges of aging in place, particularly for adults with Helpful resources for applicants include the many data resources offered by NIA, such as those highlighted in the Gateway to Global Aging , as well as others accessible from the Data Resources for Behavioral and Social Research on Aging .

The NIA Health Disparities Research Framework may help frame examining important subgroup differences.

Other research foci of interest include, but are not limited to: The unique challenges of aging in place, particularly for adults with disabilities, cognitive challenges, or Research projects that focus on rural areas; Projects with a focus on older adults with a history of criminal penal system involvement & the resulting, challenges to housing stability; Research examining the potential psychobiological mechanisms linking housing insecurity with health; and Community-based participatory research on housing insecurity with populations of interest listed above.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The National Institute of Nursing Research (NINR) intends to commit $3,000,000 in FY 2025 to fund 4-6 awards. Application budgets are limited to no more than $500,000 direct costs in any year and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov 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. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 , and Notice of NIH's Interest in Diversity, NOT-OD-20-031 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

3. Additional Information on Eligibility 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 How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: 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: National Institute of Nursing Research (NINR) All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. Plan for Enhancing Diverse Perspectives (PEDP) In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.

Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.

The PEDP may be no more than 2 pages in length and should include: Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project; Description of how the PEDP will advance the scientific and technical merit of the proposed project; Anticipated timeline of proposed PEDP activities; Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to: Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).

Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process. Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds. Description of planned partnerships that may enhance geographic and regional diversity.

Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.

Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers. Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to: Selection or hiring of personnel for a research team based on their race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status). A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status).

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants. nih. gov/grants/policy/nihgps/html5/section_7/7.

1_general. htm. All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

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

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

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

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

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

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons ,