Implementation Science to Advance HIV Prevention, Treatment, and Care (R61/R33 Clinical Trial Optional)

Implementation Science to Advance HIV Prevention, Treatment, and Care (R61/R33 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH) — National Institute of Allergy and Infectious Diseases (NIAID). Supports implementation science studies that test the uptake, scale-up, and integration of proven HIV/AIDS interventions, evidence-based prevention, and clinical treatments into routine public health and healthcare delivery settings.

RFA-AI-27-018: Implementation Science to Advance HIV Prevention, Treatment, and Care (R61/R33 Clinical Trial Optional) 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 Allergy and Infectious Diseases ( NIAID ) Office of AIDS Research ( OAR ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Library of Medicine ( NLM ) National Cancer Institute ( NCI ) 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 ) Funding Opportunity Title Implementation Science to Advance HIV Prevention, Treatment, and Care (R61/R33 Clinical Trial Optional) R61 / R33 Exploratory/Developmental Phased Award Check for any recent Notices of NIH Policy Changes that may impact application requirements.

October 6, 2026 - Notice of Informational Webinar for RFA-AI-27-018, Implementation Science to Advance HIV Prevention, Treatment, and Care (R61/R33 Clinical Trial Optional). See Notice NOT-AI-26-004 Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 855, 93.

233, 93. 838, 93. 837, 93.

839, 93. 840, 93. 310, 93.

313, 93. 273, 93. 393, 93.

394, 93. 399, 93. 866, 93.

846, 93. 865, 93. 279, 93.

121, 93. 847, 93. 307, 93.

361, 93. 879, 93. 242 Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to support implementation research on strategies to improve the uptake, implementation, sustainment, scale and/or spread of evidence-based prevention, treatment, and care interventions in communities in the U.S. significantly impacted by HIV.

Projects should be large in scale with high potential for research and public health impact. Specifically, large single site studies, multi-site studies, and comparative studies are encouraged as scientifically appropriate.

Funding Opportunity Goal(s) NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Open Date (Earliest Submission Date) 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.

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 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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

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 Highly-effective evidence-based interventions (EBIs) are available for HIV prevention, treatment, and care, including new long-acting formulations that could crucially impact the HIV epidemic. Innovative and impactful approaches are needed to optimize the implementation of EBIs in real-world settings, and to expand their use across large healthcare delivery networks.

Implementation science is a rigorous approach for developing strategies that facilitate EBIs' regular use in clinical and community settings, and for evaluating the impact of these strategies on service delivery. These strategies include methods or actions taken to enhance an EBIs' adoption, reach, integration, and sustainment.

This type of research includes the assessment of implementation outcomes as well as dual assessments of effectiveness and implementation outcomes ( i.e. , hybrid designs). This differs from efficacy or effectiveness research which solely focuses on whether EBIs are effective at improving health outcomes. Conducting research across many locations and different settings informs what works in a variety of real-world situations.

This makes it easier to apply those lessons more broadly and support nationwide improvements. Better methods for scaling up and sustaining programs help ensure that evidence-based interventions (EBIs) are adapted to fit local needs, built into everyday practice, and continue to work well over time.

This notice of funding opportunity (NOFO) utilizes a phased award (R61/R33) consisting of a study start-up and planning (R61) phase with possible transition to an implementation (R33) phase.

The NOFO solicits applications that focus on U.S. populations facing significantly higher HIV burden, and that propose innovative, large-scale approaches with high potential for research and public health impact, for example: Evaluating a selected implementation strategy/strategies across multiple locations, healthcare delivery settings, or other contexts to develop generalizable knowledge about factors contributing to differences in health and implementation outcomes.

Comparing two or more implementation strategies - to assess how different approaches to implementing EBIs impact outcomes, and to gain insight into which strategies are most effective and cost-effective for different contexts. Developing and testing novel strategies at a single site with a broad, 'whole community' approach that engages a breadth of stakeholders.

Assessing strategies to support scale up and sustainment to advance EBI implementation across large-scale delivery systems Hybrid Type II or III implementation-effectiveness research designs or full implementation trials accelerate our understanding of how to implement EBIs in real-world settings.

Other research approaches, including pragmatic designs and research to advance novel implementation science methodologies may also support the NOFO goals of advancing significant public health and research outcomes.

Multidisciplinary Team Approach-- Partnerships between academic institutions and implementing organizations in the conceptualization, design, and execution of the research will be critical for success, with early integration of implementing partners in the study's leadership team likely to have the highest impact on local public health needs.

Developing a community of practice– Resources and support will be available for funded researchers to form a community of practice for reciprocal learning.

Available resources may include (1) an NIH-funded data coordination center (DCC) to assist in harmonizing data collection plans, assessing project characteristics and outcomes, and developing and disseminating shared findings (2) consultation resources for training and technical assistance in implementation science.

Research areas of interest Examples of specific research areas of interest include (but are not limited to): Strategies to support the introduction and expansion of novel HIV prevention, treatment, and care tools : Advancing innovations such as next-generation antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) formulations, self-testing technologies, or novel data science approaches for public health surveillance and response Technology-enabled solutions for healthcare providers such as nurses, pharmacists, dentists, registered dieticians, clinical case workers, and peer navigators Expanding access to novel EBIs beyond traditional healthcare settings Strategies to promote integrated prevention, treatment, and care across the lifespan: Advancing tailored care for infants, children, adolescents, young adults, women of reproductive age, and middle-aged and older adults Developing care coordination or integrated service delivery models to address HIV alongside a broad range of co-morbidities and co-infections, with the goal of enhancing whole-person health.

Relevant co-occurring conditions include but are not limited to: cardiovascular disease, anemia, pulmonary disease, sleep disorders, cancer, metabolic diseases, liver and kidney diseases, HIV-associated neurocognitive disorders, musculoskeletal disorders, oral diseases, skin conditions, hepatitis, and sexually-transmitted infections Strategies to address data-defined factors impacting HIV prevention and treatment outcomes: Addressing behavioral factors such as mental health conditions, tobacco, drug and alcohol use disorders, or intimate partner violence (among others) that impact people with or affected by HIV Advancing multi-level approaches to address defined and measurable contextual factors that impact HIV prevention, treatment and care outcomes that can be influenced by the healthcare system Applications proposing the following research will be considered non-responsive and will not be reviewed: Research that is not focused on U.S. populations.

Studies that are not grounded in implementation science and do not specify implementation science theories, models, or frameworks and how they guide the proposed work. Applications that do not include preliminary data from formative work or pilot studies that inform the strategies to be tested. Small-scale, pilot, or developmental studies, and applications focused only on understanding barriers and facilitators to implementation.

Research that does not specify how people or communities affected by HIV will be meaningfully engaged. Projects to develop de novo health interventions with a primary aim of testing efficacy. Research focused on identifying and characterizing drivers of health outcomes without implementing interventions.

Research focused only on surveillance to identify people with HIV who are sub-optimally engaged in existing HIV treatment programs. Drug or device safety trials with registrational requirements to the Food and Drug Administration (FDA). Research that has a primary audience of policymakers at the Federal, state, or local levels, as their actions do not directly advance biomedical science.

Research that is not actionable by researchers, clinicians, and patients to improve health. Research that is not derived via methods appropriate to the research question. Investigators are encouraged to consult with NIH staff (Scientific/Research Contact(s) in Section VII.)

before submitting their application. NIH intends to lead a web-based pre-application webinar for applicants. Information on how to attend the optional webinar will be published through a Notice.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information 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 following NIH components intend to commit the following amounts in FY 2027: NIAID, $20,000,000, 16-18 awards OAR, $1,000,000, 1-3 awards NCI, $750,000, 1-2 awards NHLBI, $3,465,000, 3-4 awards NIA, $1,000,000, 1-2 awards NIAAA, $2,000,000, 1-2 awards NIAMS, $1,000,000, 2-4 awards NICHD, $3,000,000, 3-4 awards NIDCR, $1,500,000, 1-2 awards NIDDK, $2,000,000, 1-2 awards NIDA, $2,000,000, 1-2 awards NIMH, $7,000,000, 5-7 awards NINR, $2,000,000, 1-2 awards NIMHD, $2,500,000 2-3 awards NLM, $750,000, 1-2 awards Application budgets for the R61 phase are limited to $750,000 direct costs per year, and must reflect the actual needs of the proposed activities.

Application budgets for the R33 phase are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. Applicants may request up to two years for the R61 phase and up to four years for the R33 phase.

The maximum project period for an application submitted in response to this NOFO cannot exceed five years total. 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 - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 Foreign Organizations/International Collaborations 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information. System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (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. Obtaining an eRA Commons account can take up to 2 weeks. All PD(s)/PI(s) must be registered with ORCID .

The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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.

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 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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. 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.

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. Include budget funds for travel to one two-day meeting of recipients per year, which will take place in the continental United States.

PDs/PIs are expected to attend the meeting and may also budget for other key personnel to attend. Include funds for participation of study team members in community of practice activities with other funded recipients (e.g. virtual meetings with other funded investigators; work on joint collaborative projects). 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: Introduction to Application: For Resubmission applications, an Introduction to Application is required. Specific Aims: Provide the overall goals for the entire project.

Specific Aims need not be separated by the R61 and R33 phases. Given the integration of the R61 and R33 phases, only one research strategy section is needed. The R61 phase will support preparatory activities that would inform the full-scale development and testing of the implementation strategies through the R33 phase.

Applicants must clearly delineate what will be accomplished in the R61 phase and R33 phase.

As applicable, activities in the R61 phase could include solidifying collaboration with implementing partners; finalizing study site participation; refining strategies through additional pilot data and/or implementing partner input; obtaining and integrating existing data sets; conducting health needs assessment; and preparing materials required for conducting a clinical study and obtaining required approvals by relevant governing bodies.

Note that the R61 phase should not be used for substantial formative work given the relatively brief nature. The R33 phase will support the proposed hybrid or implementation study. The Research Strategy for the R33 phase is expected to build upon the planning activities during the R61 phase, along with prior formative or pilot work.

The implementation research study planned for the R33 phase of the application should be well-developed and described in enough detail for reviewers to evaluate the merit of this section of the application, based on anticipated results.

The research strategy should include a description of the approach needed to accomplish the objectives for both the R61 and R33 phases, including the following: Describe how the proposed research builds on formative or pilot work to significantly advance the full-scale implementation or sustainment of EBIs with potential for large public health impact.

Describe any implementation science theories, models, frameworks, and approaches that guide the proposed research, and include strong scientific justification for study design. Describe the implementation strategies to be tested in a large-scale hybrid or implementation study. Provide preliminary quantitative and/or qualitative data on the effectiveness and scalability of the proposed strategies.

If applicable, describe how strategies will be further refined during the R61 phase prior to full-scale testing during the R33 phase. Describe composition of the research team highlighting relevant expertise including collaborators from both academic and implementing partner organizations. Include a well-developed, scientifically well-justified proposal for the hybrid or implementation study.

Identify, describe, and explain the selection and use of validated measures. As applicable, justify the selection of the control or comparison condition. Describe all planned sites.

Note that for a single-site study, the chosen study site must have agreed to participate in the research study, as documented in a letter of support. For multi-site research proposals, some sites may be finalized during the R61 phase, but desired characteristics of possible sites should be described.

Describe how cost analysis (e.g. resources expended, implementation costing, cost-benefit, cost-effectiveness, return-on-investment, budget impact, or other economic outcomes related to dissemination and/or implementation) will be included in the study design.

Describe plans for collaboration with implementing/community partners (e.g. public health departments, community-based organizations, health care organizations, social service agencies, etc.) during the project period, including plans for dissemination of research findings (e.g. via a playbook or toolkit). Describe plans to assess and promote sustainability of the interventions and strategies beyond the project period.

Describe plans for engaging with an NIH-funded data coordination center on data harmonization and project coordination. Discuss how the project team could engage in a community of practice, identifying potential areas of shared learning or collaboration with other funded investigators. The R61 to R33 transition is driven by the successful completion of milestones.

Milestones are defined as a scheduled event in the project timeline that signifies completion of a major project stage/activity. Applicants must propose timelines with well-defined benchmarks for the entire project, i.e. both the R61 and R33 phases, within the research strategy.

In addition, the application must include a section of proposed milestones for the R61 phase that are clearly specified, well-defined, scientifically justified, and include objective measurable criteria to allow for assessment of progress and success. The justification for the milestones and study targets should include the specific ways that reaching these targets will indicate readiness for the R33 implementation phase.

The milestone plan should address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies to address potential delays. Milestones may be refined and finalized in consultation with NIH Program Staff prior to award, if granted.

Examples of milestones to transition to the R33 phase may include, but are not limited to: Fully finalized agreements from study sites including, as relevant, Memoranda of Understandings, letters of support, and data sharing agreements.

Established commitments from all necessary implementing partners to participate in the research activities, and a plan agreed upon by all parties for how stakeholder/community input will be meaningfully incorporated throughout the research project. Finalized intervention and research protocols necessary to launch the R33 phase across all participating sites, including necessary regulatory approvals.

Plans for recruitment of the proposed study population with clear demonstration that the necessary study population is available for appropriate testing of the implementation research strategy.

Finalization of study-related documents, including consent/assent documents, Manual of Procedures, study procedure documents for practitioners, and study-specific data management plan, and approval by relevant governance bodies to safeguard data and protect participants. Applications that do not include transition milestones will be deemed incomplete and will not be reviewed.

At least one collaborating implementing/community organization must provide letters of support for the proposed research program. For multi-site studies, investigators are encouraged to have some indication of support from all possible participating sites, which can be finalized during the R61 phase.

Letters of support should articulate logistic and organizational responsibilities, as well as any commitments, including in-kind, signed by a business official on organizational letterhead. 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: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format.

Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 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 , NIH's electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide . 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9.

1 Selected Items of Cost. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply – Application Guide .

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III.

Eligibility Information contains information