Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)

Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional) is sponsored by NIH Office of Research on Women's Health (ORWH). This funding opportunity supports innovative research to advance the science on the health of women, children, pregnant and lactating individuals, and persons with disabilities.

PAR-25-311: Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) 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.

Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional) UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 . May 20, 2025 - Notice Announcing Webinar and Frequently Asked Questions (FAQs) for PAR-25-311 Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities. See Notice NOT-HD-25-002 .

March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research network infrastructure relevant to infants, children, women, including those who are pregnant and lactating, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies.

This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical study implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases.

A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community.

Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD. Funding Opportunity Goal(s) To conduct and support laboratory research, clinical trials, and studies with people that explore health processes.

NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury.

To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health.

NICHD’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. 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. 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 Purpose / Research Objectives The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research network infrastructure relevant to infants, children, women, including those who are pregnant and lactating, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies.

This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase of up to two years (UG3) and a full enrollment and clinical study implementation phase (UH3) up to a total of seven years. Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases.

A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community.

Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC). To operationalize those four guiding principles and avail this multisite clinical research infrastructure to a wider range of investigators, NICHD published PAR-23-037 in November 2022.

The cooperative (U01) mechanism provided an opportunity for non-Network investigators to work collaboratively with Network investigators to propose research projects to be conducted by and within participating NICHD-supported Clinical Research Networks.

All applications submitted in response to PAR-23-037 first underwent a rigorous pre-application process to assess the scientific scope and overall feasibility of proposed projects incorporating the collective and collaborative input from the respective and applicable NICHD Network component(s) as well as from the NICHD during its pre-application review.

Concept proposals approved via this pre-application process were developed by investigators into U01 applications and submitted via PAR-23-037 as investigator-initiated, multi-PD/PI grant applications with the respective DCC designated as the Contact PD/PI. Applications submitted in response to the funding announcement were reviewed by a NICHD-convened scientific peer review panel.

This NOFO replaces that initial funding announcement ( PAR-23-037 ) and incorporates feedback received during the first two years of operationalizing the four guiding principles described in NOT-HD-19-034.

Specific Areas of Research Interest This NOFO utilizes a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase of up to two years (UG3) and a full enrollment and clinical study implementation phase (UH3) of up to a total of seven years for both phases. The implementation of a phased grant mechanism approach to funding is a key component of this new funding opportunity.

A phased mechanism facilitates greater stewardship of clinical trials and observational studies and this NOFO aims to further the modernization of clinical research by supporting innovative projects that are flexible, cost-effective, incorporated into clinical care and of higher impact.

Applications submitted to this NOFO should hold the potential to advance patient care, inform treatment guidelines, and/or provide new US Food and Drug Administration (FDA) indications and labeling for biomedical interventions by leveraging NICHD Clinical Research Network infrastructure relevant to infants, children, women, including those who are pregnant and lactating, and persons with disabilities.

Applications submitted in response to this NOFO must address topics that align with one or more of the participating Networks and their corresponding scientific areas of interest.

Strong preference will be given to studies that: Optimize participant enrollment representative of the condition being studied Utilize innovative study designs to facilitate timely and informed study completion, including but not limited to, complex adaptive designs, embedded pragmatic trials, Bayesian statistical analyses, enriched enrollment, machine learning approaches, real-world data use and/or innovative follow-up methodologies Align with clinical practice and can be integrated into real-world clinical care in a timely manner Leverage electronic health records and other digital data for data collection Encourage and facilitate participation of junior investigators (e.g., Fellows, Assistant Professors, and NIH-defined early-stage investigators).

Applications submitted in response to this NOFO should address topics that align with one or more of the following Networks and their corresponding science: Collaborative Pediatric Critical Care Research Network (CPCCRN) The purpose of the CPCCRN is to investigate the efficacy of treatment and management strategies to care for critically ill and injured children, as well as to better understand the pathophysiological basis of critical illness and injury in childhood.

Given the relatively small and widely heterogeneous pediatric critically ill and injured patient population, the vigorous use of appropriate scientific methodologies deployed across a network of sites will achieve the numbers of patients required to provide robust clinical answers more rapidly than any individual clinical site acting alone.

The CPCCRN, consisting of 12 Clinical Sites and 12 ancillary sites with over 61,000 annual Pediatric Intensive Care Unit (PICU) admissions, maintains the infrastructure needed to conduct definitive, rigorous, and reproducible multisite research to enhance the understanding of critical illness in children, to advance the care of critically ill and injured children, and to improve outcomes for this most vulnerable population.

NICHD expects the CPCCRN to be its primary and first-line infrastructure involved in implementing multisite pediatric critical care clinical research and trials. The Request For Applications (RFA) for the current cycle of the CPPCRN was RFA-HD-21-016 .

Global Network for Women's and Children's Health Research (GN) The purpose of the Global Network for Women’s and Children’s Health Research is to improve health outcomes for women and children in low- and lower middle-income countries by researching sustainable, cost-effective health interventions, and strengthening research infrastructure and public health intervention capabilities in developing countries.

The objective is to improve maternal and child survival, focusing on high-need areas, such as preventing life-threatening obstetric complications, improving infant birth weight and nutrition, and reducing prematurity and complications from preterm delivery in rural and peri-urban communities.

The Network will increase opportunities for scientific linkages, interaction, knowledge development and transfer, and collaborative partnerships among US and foreign investigators and institutions. The current GN includes seven international sites in Bangladesh, the Democratic Republic of Congo, Guatemala, India, Pakistan, and Zambia, with partner institutions in the United States.

Scientists in these countries work with their peer and partner institutions in the United States to conduct clinical trials in these low-resource areas. The RFAs for the current GN cycle were RFA-HD-23-008 and RFA-HD-23-009 .

Maternal-Fetal Medicine Units (MFMU) Network The purpose of the Maternal-Fetal Medicine Units (MFMU) Network is to improve obstetric care and outcomes for pregnant and lactating women and their babies by reducing maternal, fetal, and infant morbidity and maternal complications.

This includes finding ways to reduce maternal mortality, complications, and morbidities related to pregnancy, such as preterm labor and pregnancy induced hypertension, labor, and postpartum recovery; reduce prematurity, low-birth weight, infant mortality, and morbidities; and expand the evidence base regarding the safety and efficacy of therapeutic products used during pregnancy and lactation.

The MFMU Network serves as NICHD's primary and first-line infrastructure involved in implementing multisite obstetric clinical trials. The MFMU focuses on clinical questions in maternal-fetal medicine and obstetrics, particularly with respect to the continuing problem of preterm birth. The Network provides an infrastructure to conduct multiple large studies simultaneously, in both a cost-effective and timely manner.

The participating clinical centers cover over 170,000 deliveries a year and are racially, ethnically, and geographically varied, allowing study results to be generalizable to the US population.

Results from MFMU Network studies have impacted clinical practice, both by finding treatments that prevent poor pregnancy outcomes and by stopping ineffective, costly, and potentially harmful therapies by providing the rationale for evidence-based, cost-effective obstetric practice.

The 14 MFMU clinical centers with the DCC work collaboratively to implement common protocols to enroll and follow-up enough participants to achieve statistical power to answer protocol hypotheses more rapidly and definitively than individual clinical centers acting alone. Applications for the current MFMU funding cycle were submitted in response to RFA-HD-23-016 and RFA-HD-23-017 .

Neonatal Research Network (NRN) The purpose of the NRN is to improve healthcare and outcomes for newborns. This includes finding ways to improve the chances for survival without neurodevelopmental impairment for infants born premature, low-birth weight, or babies of all gestational ages with serious conditions. The NRN currently consists of a DCC and 15 Clinical Centers encompassing 38 hospitals with more than 137,000 births per year.

NRN Centers have more than 34,000 neonatal intensive care unit admissions per year; 2,300 of these babies are born at less than 29 weeks gestational age. Applications for the current NRN funding cycle were submitted in response to RFA-HD-23-001 and RFA-HD-23-002 .

Pelvic Floor Disorders Network (PFDN) The purpose of the PFDN is to study clinical and health aspects of pelvic floor disorders in women including pelvic organ prolapse, urinary urgency/frequency, urinary incontinence, and fecal incontinence.

More specifically, relevant areas of study include understanding the etiology and pathophysiology of these conditions such that better preventative strategies as well as safe and efficacious treatments may be developed.

Other relevant research areas include the development of novel and nonsurgical treatments to treat pelvic organ prolapse and urinary incontinence including regenerative medical techniques, projects that optimize the effectiveness of existing treatments and minimize harmful adverse events and studies focused on understanding the psychosocial consequences and alleviating the burden of living with pelvic organ prolapse, urinary incontinence, and fecal incontinence.

The Network, currently consisting of seven Clinical Centers and a DCC, provides the infrastructure, the recruitment capabilities and the research expertise needed to perform definitive, rigorous, and reproducible multisite studies under common protocols that will provide efficient, high quality, evidence-based data to guide both the surgical and non-surgical care for these large and ever-growing clinical problems.

Applications for the current PFDN funding cycle were submitted in response to RFA-HD-22-021 and RFA-HD-22-022 . In addition to the Networks listed here, applications proposing to assess maternal and pediatric pharmacology interventions will be advised to utilize resources available via NICHD’s Maternal and Pediatric pRecisioN in Therapeutics (MPRINT) Hub and the Pediatric Trials Network (PTN).

MPRINT resources include, but are not limited to curated summaries of published literature around specific drugs, innovative approaches to maternal and pediatric real-world evidence extraction, clinical pharmacology and pharmacometrics, and model informed clinical trial design.

The Pediatric Trials Network (PTN) provides an environment and the appropriate infrastructure for conducting regulatory rigorous pediatric and lactation clinical trials that lead to updates in drug labels as directed by the Best Pharmaceuticals for Children Act ( BPCA ).

The Network is designed to address the longstanding concern of a paucity of FDA labels for off-patent therapeutics commonly used “off-label” in children or during lactation. Data collected from PTN trials help regulators revise drug labels for safer and more effective use in neonates, children, adolescents, as well as lactating women and their infants.

In addition, and in accordance with the BPCA legislation, the BPCA Priority List of Needs in Pediatrics outlines key needs in pediatric therapeutics.

Investigators who are interested in collaborating with the PTN on areas such as regulatory requirements for Investigational New Drug (IND) studies, methods developments or pharmacokinetic analyses of drugs, and/or are interested in proposing projects that align with the BPCA Priority List are encouraged to propose projects assessing medications and conditions that are a part of the BPCA mandate to improve knowledge in pediatric therapeutics.

Further, NICHD anticipates adding more Networks to this initiative in the future. If an investigator is considering a project that aligns with another NICHD Network (including the PTN and MPRINT HUB) or another area of science not directly aligned with the Networks listed in this NOFO, please contact this NOFO Scientific/Research Contact.

Prior to application submission, all proposals must first undergo a rigorous pre-application process , during which the scientific scope and feasibility of potential projects will be assessed by the NICHD. Potential applicants are encouraged to start this process early to allow ample time to prepare and submit a competitive application in response to this NOFO. Longer timelines are likely for non-Network investigators.

Timelines and instructions for the pre-application process can be found on the NICHD Pre-Application Process for NICHD Network Multisite Clinical Research website . APPLICATION PROCESS: UG3/UH3 PHASED MECHANISM This NOFO utilizes a different grant mechanism than PAR-23-037.

Applications under this NOFO will operate under a two-phase, milestone-driven grant mechanism (UG3/UH3) consisting of a start-up phase of up to two years (UG3) and a full implementation, enrollment and follow-up phase of up to five years (UH3) for a maximum of seven combined years.

Applications are expected to provide clear descriptions of overall project deliverables, timelines, and milestones and how they align with the goals of the study and the Network(s). The NICHD may negotiate changes to the study deliverables, timelines, and milestones as well as the process for their re-prioritization prior to award.

Continued funding of the project will be dependent upon meeting milestones throughout the project including during both the UG3 and UH3 Phases, and it is expected that the study will be completed within the project period.

The investigative team may be asked to re-prioritize and adjust activities, timelines, and milestones on a periodic basis based on feedback from the Network Steering Committee(s), External Scientific Matter Expert Committee, Community Engagement Board, Data and Safety Monitoring Board (DSMB), and/or NICHD staff. Transition to the UH3 phase requires NICHD approval.

Any study that fails to meet their UG3 milestones will NOT be approved to transition to the UH3 phase. In addition, it is not guaranteed that all projects that attain their UG3 milestones will be approved to advance to the UH3 Phase . That decision will be made by NICHD and only after review of the UG3 Phase results.

Applications to this NOFO that do not propose to utilize a NICHD Network or that did not receive NICHD approval of the Concept Proposal will be considered non-responsive. Additionally, applications proposing single center, animal studies, basic science or basic experimental studies involving humans are beyond the scope of this NOFO.

Projects that are seeking infrastructure support for another Network are also beyond the scope of this NOFO. Applications that are deemed non-responsive will not be reviewed for this NOFO.

The NIH Policy for Data Management and Sharing (Policy) expects that researchers maximize the sharing of scientific data and data be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (DMS Plan).

The DMS Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan ( NOT-OD-21-014) . The DMS Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved DMS Plan and any approved updates.

For human clinical trial data, NICHD expects the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Information about DASH may be obtained at https://dash. nichd.

nih. gov/ . For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the NIH Genomic Data Sharing Policy .

If use of DASH is not feasible for a given data type (e.g. non-clinical data), NICHD expects awardees to share data through other equivalent broad-sharing data repositories. For applications that aim to analyze existing data, DMS Plans should describe where and how other researchers can access that data to enable reproducibility and reuse.

Additional information on the Data Management and Sharing Policy is available on the NICHD Office of Data Science and Sharing website . 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 Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed Renewals will be considered on a case-by-case basis and will require NICHD approval prior to submission. Renewals will primarily be accepted for extended follow up of study participants. 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. Application budgets are limited to direct costs of $6,250,000 for the entire project period (both phases), but need to reflect the actual needs of the proposed project. Direct costs should include capitation dollars to conduct the research.

Projects requiring direct costs exceeding $6,250,000 may be proposed, but will require additional NICHD approval as part of the pre-application process. The maximum project period for the UG3/UH3 award is 7 years. The UG3 phase may not exceed 2 years.

The UH3 phase may not exceed 5 years. The scope of the proposed project should determine the project period and may be up to seven years. The extended seven-year project period is intended primarily to facilitate follow up of study populations as relevant outcomes may require longer term follow up, and should not be used to extend the enrollment phase.

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 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 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 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.

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.

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

The following additional instructions apply: The budget will be developed as part of the pre-application process and must include all study-related costs not covered by Network infrastructure awards. The application must provide detailed annual budgets that will enable the project to meet study milestones. Separate itemized budgets must be prepared for each subcontract.

The services provided by the Network DCC and/or other Network