Part 1. Overview Information

Key Dates

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

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

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Background

Bronchiolitis, a condition unique to the young lung, is the leading cause of hospitalization for viral lower respiratory tract infections (LRTI) in 0–2-year-old children, including those born preterm. There are critical knowledge gaps in defining the condition, predicting its severity, and understanding the reasons for hospitalization, including the immature host respiratory immune response to viral infection, heterogeneity in response to different viruses, current interventions, practice variation in diagnosis and management, and subsequent long-term impact on lung health. To address these needs and begin to move toward precision-based therapies, the Viral Infections in the Young Lung (VINYL) Consortium will conduct a deep phenotyping study of 1500 0-2 year old participants hospitalized in the United States with viral LRTI – bronchiolitis, pneumonia and/or Pediatric Acute Respiratory Distress Syndrome (PARDS), collect data and biospecimens to build a multidimensional database of this cohort that will be followed longitudinally until the age of 4–5 years, and thus elucidate the pathobiology and impact of early hospitalization for viral LRTI on lung and airways health at pre-school age. This will create the largest multidimensional and publicly accessible database to characterize this unique population and elucidate mechanisms and heterogeneity of host responses to Viral Infections in the Young Lung.

Purpose and Objectives

The purpose of the VINYL initiative is to establish a cooperative consortium funded for up to seven years under the UG3/UH3 phased award for a Clinical Coordinating Center (CCC) and a companion U24 award for a Data and Analytics Coordinating Center (DACC, RFA-HL-26-008). This NOFO seeks applications to support the VINYL Consortium CCC as a single award comprised of one clinical center (CC) within it, four additional CCs, and one Biorepository (located at the same or an allied site). Each CC should consist of one main site and 1-3 optional sub-sites, and plan on enrolling participants in a Consortium-wide longitudinal cohort study with deep phenotyping and characterization at enrollment during hospitalization. The application should include proposals for 2-4 single or multi-site scientific projects that are mechanistic and meet the criteria for Basic Experimental Studies in Humans (BESH). These may utilize the data, imaging, and/or biospecimens collected Consortium-wide in the proposal, with the goal of elucidating pathobiology but with no impact on clinical outcome, within this primarily pragmatic, observational study. The CCC Principal Investigator (PI) will lead one of the CC sites. The Biorepository may be led by a co-investigator. A Multiple PI (MPI)-led application may be proposed, with a clearly described leadership plan.  

It is anticipated that each CC will enroll 300 participants between 0–2 years of age for detailed phenotyping during hospitalization, to meet the total enrollment goal of 1500 participants over 3 years. The cohort will be maintained until the participants are 4–5 years of age. Each CC (together with sub-sites, if any) needs to provide evidence of ability to enroll 100 subjects per center per year, with emphasis on geographic variation and unique participant pools. 

The award will be a UG3/UH3 phased transitional award. The 1-year UG3 phase will support development of the common protocol and procedures, site activation, and meeting regulatory requirements ideally completed within the first 9 months, with a goal for enrollment of the first subject by the end of Year 1. 

The UH3 phase should consist of longitudinal studies, envisioned as visits at 6 months post-discharge from hospital for assessments, and subsequent maintenance of a ‘hybrid’ cohort. Cohort maintenance should employ in-person visits, telehealth, mobile technology, tracking devices and electronic health records, or a combination, depending on the research questions, capabilities and resources. A final visit should occur at 4–5 years of age for a comprehensive examination for pulmonary health, addressing the specific research question(s) posed of the cohort in the common protocol and BESH studies proposed. The CCC and the Biorepository will oversee data (including imaging data), biospecimen-related document development, and finalization of data shells with the DACC.

The Consortium-wide common protocol for deep phenotyping of these infants during their hospital admission would typically include, but is not limited to, clinical data, imaging (including novel techniques), and biosample collection to answer specific research questions relevant to pathobiology, clinical care decisions, clinical course in hospital, interventions, and immediate outcomes. Babies and infants admitted to the hospital, whether the pediatric floor or the intensive care unit, including those born preterm, should be included if they meet the inclusion criteria specific to the research questions posed. The longitudinal cohort study protocol, with harmonization between CCs and their sub-sites (if any), will collect data and samples based upon feasibility and ability to answer the research question(s). But, it is strongly encouraged that as many subjects as possible (and not less than 1200 subjects) from the initial cohort are studied up to age 4–5 years. Additionally, the CCC application will be required to propose 2-4 scientific projects that address hypothesis-driven scientific questions that involve basic experimental studies in humans (BESH). These scientific questions may be focused on the hospital course and/or post-hospital period, on pathobiology (such as central airway collapse versus peripheral airways obstruction in the pathobiology of wheeze, role of diaphragmatic fatigue in the pathophysiology of exhaustion and respiratory distress leading to hospitalization, biomarkers of disease severity, impact of the immunophenotype on clinical course and mechanistic bases of interventions and/or outcomes of severe LRTI in 0-2 year old children), and their relationship to pulmonary status at pre-school age.

This Consortium will generate key information about the heterogeneity (including clinical, physiological, and biological heterogeneity) and underlying mechanisms of viral LRTI, particularly as they relate to impact on ontogeny of the developing respiratory immunophenotype, that is both virus agnostic and virus specific, and may include the impact of the microbiome (including the virome and/or the fungome) and super-infection. The consortium will allow examination of cellular mechanisms and/or pathways using current and novel molecular methods such as single cell technology and RNA sequencing. A pragmatic observational study of these young children, when hospitalized will help to understand and clarify the different presentations, therapies, and clinical outcomes. The longitudinal follow-up will assess trajectory of respiratory health and lung development with detailed pulmonary phenotyping at pre-school age. Neurocognitive and sleep health evaluation at that time is strongly encouraged.

Throughout the program’s funding period, data (including imaging data) and biospecimens collected will be made available as a resource to the broader research community. Data collection will employ forward-looking data sharing policies compatible with broad consent to enable future research studies by others, both within and outside the Consortium. The process for sharing data and biospecimens throughout the program’s funding period with the broader research community will be developed in the first 6 months, consistent with NHLBI policies for deposition into NHLBI BioData Catalyst and BioLINCC. Data and biospecimens are expected to be shared as rapidly as possible, with processes that are simple and achievable. Wherever possible, the consortium will not hold data or biospecimens for its exclusive use or for the exclusive use of one of its components, and will endeavor to make samples (including information about how the samples were obtained and processed) and data available to the broader research community. In accordance with data and biospecimen policies set up within the first 6 months of the program, data will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst) and made available for use by the research community annually and at the end of the program.. Biospecimens will be deposited into NHLBI's repository (anticipated to be BioLINCC) and made available for continued use by the research community at the end of the program. Submission of biospecimens for genetic testing and multiomics analysis to TOPMed when appropriate and acceptable, is strongly encouraged.

Scientific questions that the VINYL consortium could help address, by providing a publicly accessible database of these participants include, but are not limited to:

1. Why do young children have such severe disease? Why are babies born preterm at higher risk?
2. What are the immune underpinnings of severe LRTI in this age group?
3. What are the prognostic indicators of clinical outcome-phenotypes and endotypes?
4. What clinical interventions are effective and in which subgroups?
5. How can those that are at risk for long term lung disease be identified?
   
   Some Examples of Research Interest

• Identification of underlying endotypes and sub-phenotypes in Viral LRTI in 0-2 year old children who are admitted to the hospital.
• Use of Artificial Intelligence (AI) algorithms in metrics and measures of severity and clinical decision-making.
• Novel approaches to analyze data from the inpatient setting - cutting-edge analytical workflows (e.g., machine learning and AI approaches) to elucidate and unpack human factors that influence treatment choices while in hospital. 
• Impact of immunization against RSV (vaccine or antibodies) on the immunophenotype and on susceptibility to other respiratory viruses.
• Specific characteristics and the underlying pathobiology of premature babies who develop severe Viral LRTI.
• Pathophysiology of the different clinical presentations- diaphragmatic function and fatigue, central airway collapse, contributions of pulmonary hypertension, intracardiac shunts and parenchymal disease as examples.
• Relevant clinical, radiological, immunological and genetic, molecular and immunologic ‘omics’ signatures that aid diagnosis, choice of and response to specific therapies, prediction of outcome, prognosis including long-term pulmonary morbidity, susceptibility to subsequent infection severity or asthma.
• Trajectories of recovery after viral LRTI in young children and factors influencing them.
• Pulmonary and airways health outcomes viral LRTI.
• Impact of the microbiome, virome, or fungome and other microbial infection/colonization on presentation, outcomes and pulmonary and immune outcomes.

Program Structure

It is anticipated that the VINYL Consortium will be funded as a single award to the CCC, which will make sub-awards to the CCs and the Biorepository. The successful single application will thus be enabled to pose common research questions, harmonize protocols and coordinate data and sample collection. These components will work together in a cooperative and interactive manner to develop, and implement a Consortium-wide longitudinal cohort study with deep phenotyping and characterization at enrollment during hospitalization. Plans to share data (including imaging data) with researchers both within and outside the VINYL Consortium are required in the application. The Investigator leading the Biorepository will create and maintain a database and repository of biospecimens, appropriately processed for the different novel investigative platforms being employed to answer the research questions, assist the CCs in biospecimen collection as needed and be responsible for distribution of samples within and outside the consortium as needed. The Biorepository will provide to the DACC an inventory of biospecimens that are, or will be made available as the study progresses, along with clinical and other phenotyping information to investigators available on the VINYL database. In addition, the CCC and the CCs may propose a minimum of two and a maximum of 4 mechanistic sub-studies that may utilize one or more CCs in the application. 

The final Consortium-wide common longitudinal cohort protocols with rationale, methods, and procedures for biospecimen collection will be developed or adapted for approval by the Steering Committee during the first six months of the program using the protocols and methods for biospecimens collection proposed by the successful CCC application. The application must demonstrate the feasibility of the CCs, and any sub-sites, of enrolling at least 100 participants per CC per year throughout the ideal enrollment period of three years, bringing the total number of participants to 1500 to meet the goals of the program. The CCC and the 5 CCs will be responsible for collecting and transferring clinical and imaging data for the Consortium-wide common protocol to the Data and Analytics Coordinating Center (DACC) for management, collation and establishment of the live publicly accessible platform.  

An independent Chair of the Steering Committee will be appointed by the NHLBI without any other roles or responsibilities within the study. Investigators must agree to use common guidelines and a manual of procedures developed by the Steering Committee that will also include NIH Program Staff as voting members and other Institute representatives at the NIH as needed as non-voting members, who will serve in an advisory capacity to the NHLBI Program Scientist.
 

Clinical Coordinating Center (CCC), Biorepository and Clinical Centers (CCs):

The responsibilities of the CCC include overseeing the preparation of informed consent templates, recruitment brochures, and other Consortium-wide study-related participant materials; ensuring that all CCC and CC personnel are trained on necessary human subject procedures including the informed consent process, VINYL Consortium policies, applicable regulations, and Good Clinical Practice (GCP); routine tracking and reporting of adverse events and unanticipated problems to NHLBI, the DSMB, and other regulatory agencies as appropriate; and monitoring study execution at CCs to assure compliance with the common protocol, manual of procedures, VINYL Consortium policies, applicable regulations, and guidelines throughout the duration of the program. The CCC will be expected to identify any study-related issues at the CCs as early as possible, develop corrective and preventative action plans in consultation with the NHLBI, and oversee the implementation of the corrective and preventative action plans.

Estimated protocol cost funds for the Consortium-wide protocol will be part of the CCC award and will be distributed by the CCC to the five CCs as sub-awards in accordance with the budget approved by the Steering Committee and NHLBI. As such, the CCC application will be expected to request a line item for protocol costs which will be restricted for this use only. Only research-related costs above those incurred as part of usual clinical care are eligible to be covered by reimbursement via protocol costs from the Coordinating Center. Costs for reimbursement will be in the form of capitated payments to the sites on a per participant basis.

Biorepository Establishment and Management

The Biorepository must demonstrate expertise in specimen collection, handling, shipping, processing and storage, and cataloging of the source and ontogeny of the samples. The centralized Biorepository will have the necessary personnel, equipment, and protocols and procedures for transfer of biospecimens from the enrolling sites to the centralized Biorepository, to core facilities/laboratories as needed for analysis in a timely manner, to investigators approved to obtain biospecimens during the project period, and to the NHLBI repository at the end of the project period. The CCC and Biorepository will also develop standardized protocols for the collection, preparation, processing, storage, and shipment of biospecimens (e.g., blood, urine, lung specimens) into and out of the Biorepository, provide training of CC personnel on the proper collection, preparation, processing, and storage of biospecimens as needed, and will maintain accurate inventories of what is available in the Biorepository. The Biorepository may exist either within the CCC institution or as a subaward.

Expenses associated with the day-to-day operations of a centralized Biorepository include those associated with collection containers, procurement, storage, and shipping of biospecimens collected as part of the Consortium-wide protocol from the CC sites to the CCC; training site coordinators and other study personnel to obtain the data and biospecimens for the protocols in a uniform manner; and instituting quality control measures. It is anticipated that the biospecimens collected may include, but are not limited to, blood, urine, and lung specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage fluid). The Biorepository budget is expected to include sufficient resources to establish procedures that meet quality standards of the NHLBI Biorepository (BioLINCC). Expenses are expected to include plans for facilitating data and biospecimen analyses on Consortium-wide protocol biospecimens, shipping containers and shipping costs for the CCs, costs for storage at the CCCC Biorepository during the project period, costs to facilitate sharing of biospecimens with approved investigators within and outside the Consortium during the project period, and costs for final shipping to the NHLBI Biorepository upon study completion. It is anticipated that CCs will ship biospecimens collected as part of the Consortium-wide protocol to the CCC Biorepository at regular intervals throughout the project period to facilitate sharing of samples both within and outside the Consortium. NHLBI expects the costs for routine biospecimen quality assurance to be included and described. The biospecimen collection plan will be finalized by the Steering Committee, but the CCC is expected to present a vision and budget for the biospecimen collection. A subcontract may be proposed for the bio repository.

Clinical Centers 

The Clinical Centers (CCs) will enroll participants hospitalized in the U.S. in the Consortium-wide longitudinal cohort study, and may participate either individually or together with other CCs in the mechanistic studies proposed in the application that do not impact clinical outcome (BESH). Between 2- 4 such studies that are feasible and within budget will be submitted together in the single application. Each CC will be expected to enroll 300 subjects over years 1, 2 and 3 of the awards, for a total of 1500 participants to be followed-up at 6 months post discharge and retained until 4-5 years of age. Investigators must agree to use common guidelines and a manual of procedures developed by the Steering Committee for all VINYL Consortium studies. Funding for the CC-specific scientific project(s), including personnel, related infrastructure costs, analysis of data, imaging, and/or biospecimen costs must be budgeted for in the CCC application. The CCs will be responsible for distributing the funds to any sub-sites.

CCs, in coordination with the CCC and DACC, are expected to (1) ensure that all participating sites are trained on VINYL Consortium policies, applicable regulations, and GCP; (2) be responsible for ensuring that study execution at the CC and sub-sites (when applicable) is compliant with the VINYL Consortium protocols, manual of procedures, and applicable regulations and guidelines throughout the duration of the program; and (3) routinely track and report adverse events and unanticipated problems, monitor enrollment and data quality, and identify and address any study-related issues through development of corrective and preventative action plans in consultation with the CCC and NHLBI.

CCC and CCs must agree to use of the single Institutional Review Board (sIRB) selected by the CCC for all VINYL Consortium studies, consistent with NIH policies regarding multi-site studies involving human subjects. The local IRBs at the CC sites (including the CC within the CCC) are expected to establish processes for working with the sIRB so that Consortium operations are streamlined as much as possible. 

NIH

NHLBI will be responsible for overall support, direction and oversight of the VINYL Consortium. The NHLBI Program Office and Office of Grants Management will oversee the overall direction and progress of the VINYL Consortium. In addition to regular grant stewardship, the NHLBI Program Officer and Project Scientist (envisioned to be the same individual) will be involved substantially with the awardees as one voting member of the Steering Committee, consistent with the Cooperative Agreement mechanism. The NHLBI will appoint an independent DSMB, Steering Committee chair and an independent Advisory Board to the Institute and the VINYL investigators. Representatives from other ICs may participate as needed as non-voting members of the Steering Committee and will provide input to the NHLBI representative, when indicated, on items presented to the Steering Committee for a vote.

Steering Committee

A Steering Committee composed of the principal investigators of the CCC and co-investigator of the Biorepository (if applicable), the DACC, CC investigators, a Steering Committee chair appointed by NHLBI, and NHLBI and other IC representatives will form the core governing body of the VINYL Consortium. All major scientific decisions will be determined by majority vote of the Steering Committee. The CCC, Biorepository co-investigator, each CC (independent of multiple PIs), the DACC, and the NHLBI will have one vote each; the Steering Committee chair will have a vote in case of a tie vote among the other Steering Committee members. It is anticipated that the Steering Committee will meet once a month by conference call and by in-person meeting once a year (with virtual meetings as an option/alternative if necessary). The Steering Committee has primary responsibility for the general organization of the VINYL Consortium, approval of the Consortium-wide longitudinal cohort study protocol and budget, including protocol revisions, before review by the DSMB, the conduct and monitoring of VINYL Consortium studies, the expeditious reporting of study results, and the rapid sharing agreements for VINYL consortium data and biospecimens. Subcommittees of the Steering Committee will be established to oversee specific functions such as protocol development and oversight, ancillary studies, publications, biorepository, and data and biospecimen sharing. The Steering Committee will monitor disclosures of financial interests and potential conflicts of interest among investigators, but such monitoring will not preclude investigators’ responsibility to report their financial disclosures to their respective recipient institutions. Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

During the first 6-9 months of the U24 award to the DACC, which matches the UG3 award year (Year 1 of the companion award to the CCC), the Steering Committee (in conjunction with the CCC and with assistance from the DACC) will be responsible for developing the consortium-wide longitudinal cohort protocol that outlines standardized procedures for enrolling participants and procedures and methods for the collection of data, images, and biospecimens across all participating sites within the VINYL Consortium. It is expected that the Consortium-wide protocol may be refined iteratively over the course of the project period as new data become available. The protocol, and any subsequent changes to that protocol, in the observational component, the peer-reviewed mechanistic studies (BESH) and the longitudinal and follow-up evaluation will be voted on and must be approved by majority vote of the Steering Committee to be implemented. In addition, NHLBI will appoint an independent expert advisory board to the VINYL consortium, the VINYL Advisory Board (VAB) that may be consulted for opinions and advice. The Advisory Board will comprise a chairperson, clinicians, and scientists with expertise in infectious diseases, viral immunology, airways disease, pediatric hospital and critical medicine and pulmonology, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. The Advisory Board will evaluate scientific merit, experimental design and approach, feasibility, appropriateness in the context of the VINYL Consortium program goals, and consistency with NHLBI’s mission and policies.

VINYL Advisory Board (VAB)

An independent VINYL Advisory Board (VAB) will be appointed by and be advisory to the NHLBI. It will consist of a chairperson, clinicians, and scientists who are recognized as experts in viral infections in the young lung, immunology, infectious diseases, cell biology, molecular biology, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. This Board may be consulted for independent advice on any aspect of the underlying science, the relevance and significance of research questions, clinical monitoring, human subject protection, policies and procedures, analysis of outcomes, and data analytics while building the VINYL consortium.

Observational Study and Data and Safety Monitoring Board

An independent Observational Study and Data and Safety Monitoring Board (DSMB) will be appointed by and advisory to the NHLBI. The DSMB will be responsible for providing independent advice to the NHLBI regarding study safety and related ethical considerations, the progress of the study, and the appropriateness of continuing the studies performed by the VINYL Consortium. The DSMB will oversee the observational studies in hospitalized participants, the BESH and the longitudinal cohort studies and concur with the implementation of the Consortium-wide protocol and associated studies. The DSMB will meet approximately every six months, with interim meetings being held as necessary.

Responsiveness to this NOFO
 

NHLBI will accept applications that include Basic Experimental Studies in Humans (BESH) - mechanistic human studies, with prospective interventions to elucidate pathobiology. In accordance with NOT-HL-19-690, for applications that propose Clinical Trials, NHLBI will accept applications that propose the following:

• Mechanistic studies that meet NIH’s definition of a clinical trial and that have the primary goal of understanding how an intervention works. Mechanistic studies are designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (the goal must not be to evaluate safety, pharmacokinetics or pharmacodynamics, efficacy, or clinical trial feasibility).
• Fundamental or basic experimental studies involving humans (BESH) that do not have specific processes or products in mind.
• Hybrid applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic or BESH clinical trial(s)
• Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect (these must not be efficacy studies, see next section) of the proposed mechanistic and fundamental or basic experimental study 

The following types of applications will be considered non-responsive to this NOFO and will be returned without review:

• Applications that propose to enroll participants hospitalized outside the United States
• Applications that propose to conduct preclinical studies involving vertebrate animals

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

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - 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

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

Local Governments

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

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Foreign Organizations/ International Collaborations

NIH will no longer issue awards (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. This new requirement was effective, May 1, 2025.

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.

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

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.

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.

Multi PD/PI applications are encouraged that include senior investigators with extensive clinical research experience and expertise in the areas of pediatric observational, longitudinal and mechanistic human studies. Familiarity with and support for data and biospecimen collection for sharing purposes is desirable.

2. Cost Sharing

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

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• 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).

CCC and DACC applications will be submitted as companion applications with the same submission and review dates.

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.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

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.

SF424(R&R) Cover

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.

Facilities and Other Resources: Describe the facilities and resources available for the coordination of a clinical consortium, including an organizational plan and proposed project management tools and strategies. Describe how the infrastructure of the Consortium and performance sites will facilitate the efficient and seamless collaboration between the CC sites, CCC and Biorepository in the operation of the proposed project. If applicable, discuss any community participatory agreements and/or stakeholder agreements to support the protocol.

Other Attachments: The attachments listed below that are marked as "Required" must be provided, or the application will not be peer-reviewed.

A. Clinical Center Research Capability (Required): Provide a detailed table documenting participation in, and /or leadership of clinical studies in Respiratory Diseases in Pediatrics, highlighting any studies in hospitalized children performed on the Pediatric floor or Pediatric Intensive Care Unit from the last 5 years by the PD(s)/PI(s). The table may not exceed 2 pages, must be titled Clinical Center Research Capability.pdf, and must include:

• Clinical study title 
• Applicant's role in the study 
• Dates of the study
• A brief description of the study design 
• Description of the study population, including the number, age range, race/ethnicity and disease condition of subjects enrolled 
• The Number of patients enrolled 

For studies with post-hospital follow-up, include details about the type of follow-up (e.g., telephone, virtual, in-person) and follow-up rates. A brief narrative of the capabilities of the Clinical Centers and sub-sites, if any, may also be provided in this attachment.

B. Consenting Procedures (Required): Provide a document entitled “Consenting Procedures.pdf” describing details of consenting procedures. Include specific processes to be used with families of severely ill children. The attachment may not exceed 1 page. 

C. Cohort Retention Plan (Required): Provide a document of not more than one page describing the strategy to retain the study cohort, which will ideally consist of at least 1200 subjects, and up to 1500 subjects through 4–5 years of age. The document must be titled Cohort Retention Plan.pdf. 

D. Organizational Plan (Required): A Leadership Plan must be provided. Describe how the proposed study will be managed, as well as the strategy that will be used throughout the project to ensure that management activities of the clinical sites will be performed, including supporting the needs of scientific study leadership to identify barriers, make timely responses, and optimize the allocation of limited resources to meet study objectives. Include a description of the organizational structure, the relationship between Data and Analytic Coordination Center (under the U24 application) and the CCC. The attachment must be named Organizational Plan.pdf and may not exceed one page. The organizational management plan should provide sufficient detail to demonstrate the ability to achieve the goals of the study on-budget and on-time and to successfully manage and mitigate risks.

E. Mechanistic Studies (Required): Provide details of the background, rationale and research methodology related to the Basic Experimental Studies in Humans proposed. The attachment must be titled “Mechanistic Studies.pdf”, and may not exceed one page per planned study, for a maximum of 4 pages.

F. Summary Budget Table (Required): Include a summary budget table for the proposed Consortium-wide cohort study. The table must be provided as an attachment named Consortium-Wide Protocol Budget.pdf and may not exceed 2 pages. This simple budget table will not replace the required PHS 398 budget page forms. The simple Consortium-Wide Protocol Budget.pdf should indicate the total direct costs of conducting the proposed Consortium-wide longitudinal protocol (e.g., including data, imaging, and biospecimen collection for 1500 participants during hospitalization) across all Clinical Centers (assuming five Clinical Centers, one of which is in the CCC and 1–3 subsites per Clinical Center, if applicable). The budget should include all per-patient costs associated with the conduct of the proposed protocol (e.g., recruitment, investigative procedures for enrollment and follow-up visits, participant reimbursements, study personnel, equipment, and supplies). These per-patient costs should include any protocol related study personnel costs over and above the proposed staff in the CCC and Clinical Center budget. For biospecimens, delineate the cost of obtaining the samples (including collection containers), sample preparation and processing (if necessary), and shipping them to the central laboratory in the per-patient budget, as well as the estimated cost of analyzing any specimens in the central laboratory. For budget preparation, it can be assumed that the equipment necessary to perform standard procedures and tests (e.g., bronchoscopy, pulmonary function testing, 6-minute walk testing, chest x-ray, chest CT) already is available. However, any equipment that may be unique and/or novel and relevant to the proposed study should be included in the budget. Consortium-wide cohort protocol funds will be distributed, as needed to the Clinical Centers and Biorepository by the Coordinating Center.
 

SF424(R&R) Senior/Key Person Profile

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

Multiple PD/PIs are encouraged to lead the CCC with proven and complementary skills. The PD(s)/PI(s) of the clinical consortium must be experienced in the conduct of multi-center human subject research projects, including success in meeting milestones and timelines, have demonstrated superior organizational skills, and have expertise in viral respiratory infections that lead to hospitalization of young children. The PI/PD must have expertise and experience in longitudinal cohort retention and pulmonary evaluation at preschool age. The experience of each PD/PI and all Key Personnel must be carefully documented, and roles and responsibilities must be well-defined. In addition, the responsibilities and authority of each PD/PI must be specified with a clear leadership plan. The application must ensure that a multidisciplinary team of appropriate personnel (clinician(s), Project Manager, study coordinator(s) etc.) is assembled. Relevant clinical and scientific expertise in pediatric pulmonology, pediatric hospital medicine, pediatric intensive care, immunology, infectious disease etc. must be proposed at the contributing institutions, depending upon the research question (s) posed, to facilitate the implementation of all aspects of the study, including recruitment of subjects, design/implementation of the study protocol, and coordination of roles/responsibilities of the Clinical Coordinating Center (CCC) leadership, Clinical Center (CC) leadership and Biorepository leadership. This would include knowledge of biospecimen and data sharing practices as they apply to the oversight of and collaboration with the Biorepository Co-investigator. Applications must include personnel and corresponding biographical sketches for the CCs. All Key Personnel who are major scientific contributors to the study must provide an NIH Biosketch whether they are budgeted or not. The PD/PI (or Multi-PDs/PIs) for the CC cannot be Key Personnel on the DACC application (RFA-HL-26-008). 

R&R Budget

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

This application must include only its own budget, including any subcontract budgets associated with it. Provide detailed annual budgets that will enable the CCC to meet its milestones. In the budget justification, provide the detailed budget needs (per year for each site and total) and an implementation and cost management plan (e.g., capitation). Include patient care costs for the Consortium-wide longitudinal cohort study. Patient care costs for the Consortium-wide longitudinal cohort study will be distributed by the CCC to the CCs in accordance with the Steering Committee and NHLBI approved budget. Only research-related costs above those incurred as part of usual clinical care are eligible to be covered by reimbursement via protocol costs from the Clinical Coordinating Center. Costs for reimbursement will be in the form of capitated payments to the sites on a per patient basis.

The budget should indicate the total direct costs of conducting the proposed Consortium-wide longitudinal protocol (e.g., including data, imaging, and biospecimen collection for 1500 participants during hospitalization) across all CCs (assuming five Clinical Centers, one of which is in the CCC, and 1–3 subsites per CC, if applicable). Include all per-patient costs associated with the conduct of the proposed protocol (e.g., recruitment, investigative procedures for enrollment and follow-up visits, participant reimbursements, study personnel, equipment, and supplies). These per-patient costs should include any protocol-related study personnel costs over and above the proposed staff in the CCC and Clinical Center budget. For biospecimens, the application should delineate the cost of obtaining the samples (including collection containers), sample preparation and processing (if necessary), and shipping them to the central laboratory in the per-patient budget, as well as the estimated cost of analyzing any specimens in the central laboratory. For budget preparation, it can be assumed that the equipment necessary to perform standard procedures and tests (e.g., bronchoscopy, pulmonary function testing, 6- minute walk testing, chest x-ray, chest CT) already is available. However, any equipment that may be unique and/or novel and relevant to the proposed study should be included in the budget. Applicants should note that only research-related costs above those incurred as part of usual clinical care are eligible to be covered by grant funds. Include equipment necessary (e.g., freezers) to store samples collected as part of the Consortium-wide protocol prior to transfer to the designated Biorepository.

Include a budget for at least 2 person-months for the contact PD/PI. For other Investigators/Staff, the person-months should be commensurate with the effort required for the proposed personnel activities. This should include support for clinical research support staff, e.g., clinical coordinators, at the participating sites with demonstrated clinical research experience to facilitate the day-to-day clinical study operations of the Clinical Center including managing collaborations with other clinical research coordinators; obtaining informed consent; processing, storage, and shipping of human biospecimens; management of data and imaging; a comprehensive knowledge of GCP study conduct; development and monitoring of study enrollment accrual benchmarks; completion of case report forms; administration of agreements with subaward sites, the Coordinating Center, and other research collaborators.

Include budget support for the Steering Committee Chair at 1.2 person-months. Include budget support for personnel to travel to one in-person Steering Committee meeting in year 1 and one meeting of the Steering Committee per year in years 2-7 to be held in the Washington, D.C. metro area. Include travel expenses for the PI of the Clinical Coordinating Center, the PI of the Biorepository and one representative from each of the Clinical Centers to attend one meeting of the Steering Committee in year 1 to be held in the Washington, D.C. metro area.

A budget for the Consortium-wide longitudinal cohort study must be provided in the SF 424 (R&R) Other Project Information form as the Summary Budget Table attachment, rather than the SF 424 budget page forms.

Do not include budget support for the Data Safety Monitoring Board (DSMB). Budget support for the DSMB should be included in the collaborative DACC application budget only.

Third party support of the proposed research activity (if approved) will be incorporated as a specific term and condition in the Notice of Award. If the Third Party support ceases and the study is no longer tenable without the Third Party support, a close-out plan may be requested. Applicants are reminded that although Cost Share is not required, if these types of costs are included in the research application and peer reviewed, it is expected that these costs will not be covered by NHLBI.

Include budget support for publication, dissemination of results, and data sharing.

Budgets should request only the costs that will be required for the activities to be performed in a given year. Generally, the NHLBI expects the requested costs in year 1 (UG3) to be lower than in the following years (UH3), depending on recruitment targets. It is also expected that the CCC budget will be lower in the final year.

R&R Subaward Budget

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

Any cores (e.g., imaging) must be a subcontract to either the CCC or DACC. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating center or core. If parts of the costs of the trial are to be provided by sources other than NHLBI, these contributions must be presented in detail in the budget justification.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

The following criteria must be addressed:

1. Overarching research Goals
2. Structure and Components with justification
3. Research Strategy
4. Analysis, analytics and database development
5. Significance of the research proposed to the
   1. Population
   2. Research Community
   3. Ongoing contributions beyond the life of the award

Research Strategy: The Research Strategy must present an overview of the state of the science, current status and relevance of the study, a detailed discussion of the specific protocol, and the approach to data collection. The Research Strategy must contain the three sections (A-C) described below:

A. Consortium-wide cross-sectional and longitudinal cohort study (suggested 4-5 pages)

• Describe the research questions and strategy for a Consortium-wide cross-sectional and longitudinal cohort study to be conducted across all participating VINYL Consortium sites. Applicants should anticipate that the Steering Committee will adapt or combine their proposed Consortium-wide longitudinal cohort study strategy with current state-of-the-art science to create a current plan that includes the hospitalized children and their follow-up. 
  • Include a plan for the common data, imaging, and biospecimen collection on all VINYL Consortium participants during hospitalization, after discharge from the hospital, at 6 months post-hospitalization, and at 4-5 years of age.
  • The data, imaging, and biospecimens proposed in the Consortium-wide longitudinal cohort study must include the data, imaging, and/or biospecimens necessary for the proposed Clinical Center-specific scientific project.
  • The proposed Consortium-wide longitudinal cohort study strategy should include plans for total enrollment of 1500 participants from 0–2 years of age hospitalized in the U.S. with viral lower respiratory tract infections (Bronchiolitis, Pneumonia and/or ARDS) across all Clinical Centers, with a plan to follow all subjects until the age of 4–5 years. A minimum of 1200 subjects must be followed up. 
  • Applications should plan for enrollment beginning at the end of Year 1 through end of Year 4.
• Provide information on why it is reasonable to expect that the data, imaging, and biospecimen collection proposed for the Consortium-wide longitudinal cohort study will be feasible at all VINYL Consortium sites.
• Include the questions to be addressed; background, rationale, and significance of the anticipated results; preliminary data; and methods and analytic plan.
   

B. Clinical Center-specific scientific project (suggested 4–5 pages)

• Describe the research questions and strategy for a Clinical Center-specific scientific project with hypothesis-driven research questions that utilize data, imaging, and/or biospecimens collected Consortium-wide. These questions may be focused on the hospital and/or post-hospital period, and they must address important scientific questions in viral bronchiolitis, pneumonia or ARDS or the combination thereof with severity ranging from admission to the Pediatric floor to severe ARDS and even mortality in the Pediatric Intensive Care Unit.
  •  Include the hypotheses or questions to be addressed; background, rationale, and significance of the anticipated results; preliminary data; and methods and analytic plan, including power and number of patients per group
  • Provide information on the expertise of the Clinical Center(s) for the Clinical Center(s)-specific scientific project.
  • Describe what data, imaging, and/or biospecimens from the Consortium-wide study will be needed for the Clinical Center-specific project. If special processing of biospecimens is required, please describe.
• The research strategy for the Consortium-wide longitudinal cohort protocol and Clinical Center-specific project must be clearly distinguishable. Clinical Center-specific scientific projects proposed will be included in the CCC application.

C. Clinical Center Organization and Recruitment Plan (suggested 2–4 pages)

Provide an overview of the overall organization of personnel in the research team of each Clinical Center (including the main site in CCC and 1–3 sub-sites) including previous collaborations or interactions and describe the ability and commitment of the investigators to function in a coordinated fashion, to work efficiently and expeditiously with, and to enhance the research goals of the VINYL Consortium.

• Provide an overview of the Clinical Center PI in the finalizing of protocols and conduct of the individual mechanistic studies.
• Demonstrate that the Clinical Center (including the main site and 1–3 sub-sites) has the ability to (1) enroll 100 children aged 0–2 years hospitalized in the U.S. with respiratory manifestations of viral LRTI per year, (2) successfully complete hybrid (a combination of in-person and remote) follow-up of the subjects at 6 months post-discharge and between 4–5 years of age per the attachment described above - see SF 424 (R&R) Other Project Information section).
   

Letters of Support

Letters of support are required from all participating Clinical Center sites indicating institutional willingness to participate in all aspects of the VINYL Consortium studies and related activities, including willingness to (1) use the single IRB (sIRB) (2) participate in Steering Committee meetings which may include conference calls two times a month and an in-person meeting once a year (3) participate in a collaborative and interactive manner with other Clinical Centers, the Clinical Coordinating Center, Data and Analytic Coordinating Center (DACC) in the companion U24 application and NIH in all aspects of the VINYL Consortium, including sharing of biospecimens and data; (4) use common guidelines and manual of procedures developed by the Steering Committee for all VINYL Consortium studies; and (5) accept fee for service reimbursement from the Clinical Coordinating Center (CCC) and via the Clinical Center for subsites) to execute the Consortium-wide longitudinal protocol according to the budget approved by the Steering Committee and NHLBI.
 

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.

Other Plan(s): 

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.
• Data will be deposited into NHLBI’s repositories (anticipated to be Biodata Catalyst and BioLINCC) and made available for use by the research community as soon as possible, minimally annually, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first.

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.

Delayed Onset Study

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

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

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 about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NHLBI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The VINYL Consortium will be funded as a single award to the Clinical Coordinating Center (CCC), which will make sub-awards to the Clinical Centers (CCs) and the Biorepository. The recipient of the CCC will have primary responsibility for developing the research design and study protocol, including definition of objectives and approaches, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
• The investigator leading the Biorepository will create and maintain a database and repository of biospecimens, appropriately processed for the different novel investigative platforms being employed to answer the research questions, assist the CCs in biospecimen collection as needed and be responsible for distribution of samples within and outside the consortium as needed. The Biorepository will provide to the Data Analytics and Coordinating Center (DACC) an inventory of biospecimens that are, or will be made available as the study progresses, along with clinical and other phenotyping information to investigators available on the VINYL database.
• The CCC Principal Investigator (PI) will lead one of the CC sites. The Biorepository will be led by a co-investigator. A Multiple PI (MPI)-led application may be proposed, with a clearly described leadership plan.     
• The CCC and the 5 CCs will be responsible for collecting and transferring clinical and imaging data for the Consortium-wide common protocol to the Data and Analytics Coordinating Center (DACC) for management, collation and establishment of the live public access platform. 
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NHLBI will be responsible for overall support, direction and oversight of the VINYL Consortium. The NHLBI Program Office and Office of Grants Management will oversee the overall direction and progress of the VINYL Consortium. 

The NHLBI Project Scientist will serve on the Steering Committee and other study committees, when appropriate, as the voting member representing NIH. All NIH staff members share one vote in support of the project. The NHLBI Project Scientist may work with recipients on issues coming before the Steering Committee such as recruitment, protocol development, follow-up, quality control, adherence to protocol, possible changes to the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and of solutions to major problems, such as insufficient participant enrollment. An independent Chair of the Steering Committee will be appointed by the NHLBI without any other roles or responsibilities within the study. 
 
The NHLBI Project Scientist will serve a dual role as the NHLBI Program Official, will be responsible for the normal program stewardship of the cooperative agreement, and will be named in the Notice of Award. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist/Program Official. The responsibility for final decision-making may reside with Senior Institute management, separate organizational components and/or oversight committees. Because it is anticipated that the Program Official will participate in activities that rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award. The NHLBI policy on authorship and manuscript review of NHLBI sponsored extramural research protects against conflicts of interest with the Program Official.

An independent Data and Safety Monitoring Board (DSMB) will be established to oversee participant safety in the clinical trial and provide overall monitoring of interim data and safety issues. As part of the collaborative activities under this cooperative agreement, the NHLBI will collaborate with the recipients to appoint and/or agree upon a single DSMB for monitoring the clinical trial. The DSMB may be appointed by the NHLBI, or with the approval of NHLBI, the DSMB could be an institutional DSMB. At the first meeting in the UG3 phase, the DSMB will review the recipient’s protocol and potentially recommend modifications. Subsequently, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and overall recipient performance. The DSMB has the responsibility to review interim data and final data, and recommend whether the protocol should be modified, and, at each meeting, whether the study should be continued or should be terminated early. An NHLBI scientist other than the NHLBI Project Scientist/Program Official will serve as Executive Secretary to the Board. Because the DSMB serves as an independent group advisory to the NHLBI, study investigators shall not communicate with DSMB members regarding study issues, except as authorized by the Board’s Executive Secretary.

NHLBI will also appoint an Advisory Board comprised of independent experts in the field to advise the VINYL Advisory Board for scientific direction and advice. It will consist of a chairperson, clinicians, and scientists who are recognized as experts in viral infections in the young lung, immunology, infectious diseases, cell biology, molecular biology, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. This Board may be consulted for independent advice on any aspect of the underlying science, the relevance and significance of research questions, clinical monitoring, human subject protection, policies and procedures, analysis of outcomes, and data analytics while building the VINYL consortium.

The NHLBI reserves the right to phase-out or curtail the study (or an individual award) in the event of: (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment milestones, core milestones mutually agreed upon by the recipient organization and PD/PI and the NHLBI, consortium participation and collaboration with other recipients, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or results that substantially diminish the scientific value of study continuation.

Areas of Joint Responsibility include:

• A Steering Committee composed of the principal investigators of the CCC and co-investigator of the Biorepository (if applicable), the DACC, CC investigators, a Steering Committee chair appointed by NHLBI, and NHLBI and other IC representatives will form the core governing body of the VINYL Consortium. All major scientific decisions will be determined by majority vote of the Steering Committee. The CCC, Biorepository co-investigator, each CC (independent of multiple PIs), the DACC, and the NHLBI will have one vote each; the Steering Committee chair will have a vote in case of a tie vote among the other Steering Committee members. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Marrah Lachowicz-Scroggins, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8229
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected]
Subject: RFA-HL-26-006

Section VIII. Other Information

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

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