Part 1. Overview Information

Key Dates

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

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

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

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

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This is a non-competitive funding opportunity intended to fund a single award. The NHLBI is announcing its intent to issue a single source cooperative agreement award to Cincinnati Children's Hospital Medical Center for the Data Coordinating Center (DCC) of the Molecular Atlas of Lung Development Program (LungMAP) Phase 3. The overall goal of LungMAP is to build a comprehensive molecular and cellular atlas of the human lung to serve as a reference platform to better understand both normal biology and disease pathobiology, and to identify critical cellular components, molecular pathways, and novel therapeutic targets in lung disease. The DCC is expected to perform data collection, harmonization, integration, and analysis; develop and maintain the LungMAP databases, data portals, and website; coordinate research activities of the LungMAP teams; and promote dissemination of LungMAP resources to the community.

Background and Objectives

Lung diseases are among the leading causes of morbidity and mortality worldwide, many of which have no cure. For instance, WHO reported recently that chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide, causing 3.23 million deaths in 2019, and lower respiratory tract infections are the fourth leading cause of death, claiming another 2.6 million lives in the same year. Other less common lung diseases such as acute respiratory distress syndrome (ARDS), pulmonary hypertension (PH), and pulmonary fibrosis (PF) are heterogeneous, progressive, and often fatal, collectively adding to the respiratory disease death toll. Part of the challenge in finding cures for these myriad diseases is that the lung is a complex organ, with a sophisticated 3D structure and high cellular heterogeneity, which lends itself to many possible pathways of pathogenesis when normal biology goes awry. The seemingly endless possibilities of pathogenic mechanisms can leave researchers searching for cures in a figurative molecular and cellular haystack. This was especially true in past decades, when identifying lung cell types was largely based on anatomy, morphology and a limited number of molecular markers, which significantly limited our understanding of the molecular nature of both normal development and disease pathogenesis. Moreover, while it has been well known for some time that lung cell identity and function show strong regional specificity, precise mapping of cell types within the context of the 3D lung structure remained beyond our grasp.

To address this scientific and technological gap, the LungMAP consortium was established in 2014 to define lung cells with molecular profiles and link that with knowledge of morphology, spatial information, and function during normal development. The long term objective of the LungMAP program is to build a comprehensive molecular and cellular atlas of the human lung to serve as a reference platform to better understand both normal biology and disease pathobiology, and to identify critical cellular components, molecular pathways, and novel therapeutic targets in lung disease. LungMAP is an open access resource integrating high-resolution, multiscale information to define lung cells with gene expression, physiological states, 3-dimensional locations, as well as developmental and pathological trajectories.

LungMAP Phase 1 completed a mouse lung atlas, developed reagents and implemented novel technology platforms for human study, and started to build the human lung development atlas. In Phase 2, LungMAP has surveyed normal human lungs from late gestational age to early adulthood as well as a small set of pediatric diseases such as bronchopulmonary dysplasia (BPD). As a result of these efforts, LungMAP has established an effective organization and process for human tissue collection, processing, and distribution. This marks the first biorepository comprised of normal human developing lung tissue that has been established and made accessible to the research community. In addition, multiscale, high-quality molecular and imaging data from normal human and BPD lungs has been generated, analyzed, and disseminated through the LungMAP website. Data produced to date includes high-resolution computed tomography (CT) images, 3D renderings of alveolar structure, single-cell transcriptomes of developing lungs, genome-wide chromatin accessibility information at single-cell resolution, protein markers for all major human lung cell types, bulk and single-cell proteomics, nanospray desorption electrospray ionization (nano-DESI)-derived spatial omics, and multi-omics analyses of specific cell types of the lung. To efficiently store and disseminate this data, the existing Data Coordinating Center (DCC) has designed and maintained a LungMAP database for data management, sharing, and analysis accessible via a user-friendly website. The LungMAP teams have also developed a variety of tools for data annotation, integrated data analysis, and enhanced sharing with the broader research community.

In Phase 3, LungMAP will extend its focus from normal lung development to the study of lung diseases. Leveraging its existing infrastructure and technology platforms, strong multi-omic expertise, and data integration capability, LungMAP Phase 3 will aim to utilize the power of single-cell omics and other innovative technologies to identify the pathogenic mechanisms of lung disease at cellular resolution, including cell types and states critical to disease initiation and progression, aberrant molecular pathways operational in abnormal and diseased cell states, and thus potential targets for novel lung disease therapies.

Data Coordinating Center Objectives and Scope

The LungMAP DCC is expected to perform data collection, harmonization, integration, and analysis; develop and maintain the LungMAP databases, data portals, and website; coordinate research activities of the LungMAP teams; and promote dissemination of LungMAP resources to the community. Specifically, this NOFO seeks an application, from the current LungMAP DCC, that proposes activities to meet the following broad goals:

• Facilitate and coordinate data collection, submission, annotation, and integration, and develop methods to enable automated data entry and ingestion
• Harmonize, integrate, and analyze multimodal datasets
• Develop tools to facilitate and improve data management, analysis, and visualization
• Develop novel data science approaches to facilitate data-mining to better understand disease mechanisms
• Create the molecular atlas of the lung
• Coordinate and manage the overall LungMAP consortium administrative activities, including pilot projects and skills development activities
• Enable open accessibility of all LungMAP resources to the broader research community

Organization and Governance

The Molecular Atlas of Lung Development Program (LungMAP) Phase 3 will be supported and governed by single source Cooperative Agreements awarded to a Human Tissue Core (HTC), a Data Coordinating Center (DCC), and Cooperative Agreements for Research Centers (RCs), funded collectively through NOFOs RFA-HL-24-012, RFA-HL-24-007, and RFA-HL-24-006, respectively. Separate applications to the HTC, RCs, and/or DCC NOFOs may be submitted from the same institution/organization provided they have different PD(s)/PI(s). Applicants are strongly encouraged to read the three NOFOs for LungMAP Phase 3 to better understand the overall structure and function of the entire program.

LungMAP 3 will serve as an open-access resource to the research community; therefore, all the consortium activities will be integrated and coordinated, which is key to enabling the consortium to achieve high-throughput, high-resolution, genome-wide coverage in producing molecular profiles of the human lung in diseased states. It is expected that awardees will collaborate and interact with the other consortium members, and that these activities will in part be facilitated through a website, teleconferences, working groups, and biannual meetings of the investigators organized by the DCC. NHLBI expects that samples, reagents, protocols, tools, and materials developed through the LungMAP 3 program will be publicly available and that LungMAP 3 data will be deposited and available for public access in a timely manner.

Human Tissue Core (HTC; RFA-HL-24-012): The main goal of the HTC in Phase 3 is to catalog, store, and distribute human lung samples from the current LungMAP repository and from the LungMAP RCs. The HTC will facilitate tissue processing in accordance with protocols co-developed with the RC investigators, maintain the BRINDL database and repository, and distribute the samples to the community upon request. The HTC will aim to increase specimen collection while enhancing diversity in ethnicity and ancestral coverage.

Research Centers (RCs; RFA-HL-24-006): The RCs will identify and manage tissue source sites and/or collaborate with organ donor programs to collect human lung samples from selected lung diseases. Using innovative approaches, the RCs will generate high-content, high-resolution, molecular anatomy data, create tools, perform data analysis, and conduct hypothesis-testing studies to understand disease mechanisms.

Data and Coordinating Center (DCC; this NOFO): The DCC will be guided by the FAIR (findability, accessibility, interoperability, and reusability) principles, to 1) maintain and expand the LungMAP database that stores and integrates data from a variety of sources (both existing and newly-generated by other Atlas programs), 2) develop tools for data analysis and integration, and 3) improve search functions to facilitate easy and immediate data access by the general research community. The DCC will work with the NHLBI Biodata Catalyst (BDC) team to establish infrastructure and processes to link LungMAP and BDC portals to facilitate data ingestion from both LungMAP research teams and the community to BDC. In addition, the DCC will serve as an administrative coordinating center to facilitate and coordinate consortium research activities, including soliciting and managing collaborative and pilot studies as well as skills development activities. The collaborative and pilot studies will support collaborations among LungMAP members and with the community researchers to generate hypotheses and preliminary data for mechanistic studies, pilot new technology, and develop and validate novel tools. Skills development activities may include supporting trainees of the program to attend consortium meetings and other relevant research conferences and developing short courses and webinars to disseminate new technologies across the program.

Steering Committee (SC): The SC will be composed of the lead Program Director/Principal Investigator (PD/PI) from each RC, HTC, and DCC award, and the NHLBI project scientist, and will be chaired by an independent investigator selected by the NHLBI. The NHLBI and the SC will be responsible for overall scientific direction, integration and coordination of the program. SC governance responsibilities will include the oversight of protocol development, sample distribution and coordination, assay standardization, data quality control, data submission, data integration, and data publishing.

External Advisory Committee (EAC): An EAC will advise NHLBI on the oversight of the program. The Committee will consist of non-LungMAP-affiliated scientists and other experts appointed by the NHLBI. The EAC will meet annually with the Steering Committee to review milestones and program progress, and to advise NHLBI program staff of scientific developments and opportunities related to the program goal.

The awardees are expected to collaborate extensively and share information fully. The awardees are also expected to abide by the priorities and policies agreed upon by the Steering Committee and NHLBI. The success of the overall program will be evaluated by EAC and NHLBI based on mutually agreed-upon metrics including quantity and quality of new data generated, number of new reagents and tools, and usage of the data by the research community including publications, grant applications, and other research productivity outcomes.

Notice of NIH's Interest in Diversity

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences. See NOT-OD-20-031 and NOT-OD-22-019 for details.

For More Details: To ensure uninterrupted continuity in support of the LungMAP Program goals, and to extend study into Phase 3, NHLBI intends to issue a single source cooperative agreement award to Cincinnati Children’s Hospital Medical Center for the data Coordinating Center. This single source cooperative agreement will enable the current awardee to continue to use and enhance existing infrastructure to build on the expanded goals of the LungMap Program, supporting the performance of data collection, harmonization, integration, and analysis; development and maintenance of the LungMAP databases, data portals, and website; coordination of research activities of the LungMAP teams; and to promote dissemination of LungMAP resources to the community.

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

Only the following applicant may apply for this single source funding: the Cincinnati Children’s Hospital Medical Center. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Only the following applicant may apply for this single source funding: the Cincinnati Children’s Hospital Medical Center. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Additional Information on Eligibility

Only a single award will be issued to Cincinnati Children's Hospital Medical Center under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Only the PI(s)/PD(s) associated with the award issued under RFA-HL-19-022 to the Cincinnati Children’s Hospital Medical Center is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI) Telephone: 301-435-0270
Email:NHLBIChiefReviewBranch@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The PD(s)/PI(s) must be experienced in conducting complex, multi-component, and collaborative research programs, and have required expertise and experience to facilitate and coordinate data collection and integration, and to develop methods for automated data entry and submission into the LungMAP database.

R&R Budget

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

Application budgets should plan for the following:

• Costs to support travel for the PD/PI and key collaborators to attend an initial one day in-person LungMAP kickoff SC meeting in Bethesda, MD during Q1 of budget period 1, as well as travel to biannual two-day LungMAP Investigators Meetings, one to be held in Bethesda, MD and another at one of the recipient's institutions, each year thereafter.
• $60,000 in direct costs for skills development activities each year. $400,000 in direct costs (plus associated institutional F&A) to execute awards for collaborative and pilot studies each year.
• Funds to support in person grantee meetings: an initial one day LungMAP kickoff SC meeting in Bethesda, MD during Q1 of budget period 1, and biannual two-day LungMAP Investigators Meetings, one to be held in Bethesda, MD and another at one of the recipient's institutions, each year thereafter. Recipients for HTC and RCs will budget for their travel to the meetings.
• Travel and related costs for three External Advisory Committee (EAC) members for meetings. Do NOT contact, recruit, or name potential EAC members in the application.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

The research strategy must describe the planned approach to achieve the following:

LungMAP Data Management

• Facilitate and coordinate data collection, submission, and integration, and develop methods to enable automated data entry and ingestion.
• Expand the LungMAP database to accommodate and integrate existing data with newly-generated data of varying formats.
• Curate and prepare datasets for distribution to investigators and provide linkage to other public databases in raw and analyzed formats.
• Coordinate with RCs and the HTC for the electronic transfer and curation of metadata.
• Ensure data security, to include a strategy for data backup.
• Establish infrastructure and processes to link LungMAP and NHLBI BDC portals to facilitate data ingestion from both LungMAP research teams and the community to BDC.
• Submit all data to public databases (GEO and/or dbGaP) on a regular basis in compliance with NIH Data Management and Sharing Policy.
• Ensure that the LungMAP dataset and documentation are in a "standard format" that is mutually agreed upon by the SC for maximum use (open access) prior to the close out of the project.
• Develop strategies to include relevant data generated by external investigators into the LungMAP database.
• Develop a cloud-based LungMAP data ecosystem.
• Develop novel tools to improve the community’s access, query, and mining of LungMAP data.

LungMAP Data Analysis

• Provide high-quality annotation of spatio-temporal data.
• Develop and/or adapt data analysis tools for data integration and cross-validation.
• Use quantitative, systems biology and computational approaches to build models for biological and pathological processes, such as morphogenesis, development of microstructures, and communication between and among lung cells and the microenvironment.
• Develop novel data science approaches to facilitate data-mining to better understand disease mechanisms.
• Develop and share tools for cloud-based data and image analysis.
• Develop and promote the use of ontologies with controlled vocabularies for both normal and diseased human lungs.
• Build analytic tools and models for multidimensional data.
• Develop data visualization tools to facilitate data access, browsing, navigation, analysis, and download by the public.
• Develop and maintain lung CellCards, an interactive tool for cell type/state annotation.
• Collaborate closely with the RC investigators to incorporate multi-modal datasets to generate molecular atlases of lung diseases.

LungMAP Website

• Develop or design, maintain, and enhance an open-access, public LungMAP website.
• Develop user-friendly interfaces to enable data access by the research community.
• Optimize a search function for all datasets, images, and other resources.
• Promote the access and utility of the LungMAP website to the research community.

Program Coordination

• Collaborate with the RCs and the HTC to design biostatistical and clinical studies that will facilitate power and sample size calculations.
• Work closely with each RC and the HTC to assist in the resolution of operational challenges related to data collection, ingestion, curation, and reporting.
• Coordinate the development and updating of data collection forms, informed consent documents, protocols and procedures for use by the LungMAP.
• Provide guidance on ethical issues related to establishing and maintaining public use databases containing clinical and genetic information.
• Plan, arrange and support teleconferences, meetings, and site visits of the Consortium; prepare and distribute meeting minutes.
• Support and organize working groups and subcommittees on specific topics and tasks.
• Direct and coordinate skills development core activities.
• Develop solicitations for collaborative and pilot studies, organize review of the proposals and manage the research funds for these studies.
• Prepare study progress and program reports for the LungMAP.
• Develop methods to distribute LungMAP data, tools and reagents to the research community.
• Communicate with the HTC and the RCs to provide specified resources (reagents, samples and tools) and datasets to the research community and promote community engagement.

Timeline and Milestones: Provide a timeline as well as PD/PI-determined milestones for each proposed year of funding. The milestones should be feasible and provide quantitative project-specific criteria, including specific outcomes to be achieved and the metrics by which the accomplishment of the milestones will be assessed. Milestones may be revised at the time of the award and yearly as described in the Cooperative Agreement Terms and Conditions of Award below.

Collaboration and Interaction: Provide a plan for effective interaction and coordination among LungMAP members and the NHLBI to promote productivity. State willingness to collaborate extensively and share information fully. State willingness to abide by the priorities and policies agreed upon 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 SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

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

2. Review and Selection Process

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

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

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National 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.
• Potential synergies will be considered for the selection of the complement of projects.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 45 CFR Part 75 and 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:

• All aspects of the scientific activities, including defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
• Collaborating with other investigators in the program for protocol development, sample, reagents and data sharing, data quality control, and data organization.
• Serving as a voting member of the LungMAP Steering Committee and attending the Planning Meeting and one Steering Committee meeting in the first year, two Steering Committee meetings a year in subsequent years and monthly teleconference calls.
• Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee, and being responsible for close coordination and cooperation with the components of the consortium and with NHLBI staff.
• Establishing written milestones for the project annually, in collaboration with NHLBI Project Staff.
• Releasing all study design materials and procedure manuals into the public domain and/or making them available to other investigators, according to the LungMAP SC approved plan for making data and materials available to the scientific community and the NHLBI, for the conduct of research at no charge other than the costs associated with reproduction and distribution.

NHLBI staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NHLBI Project Officer and other NHLBI scientists as needed will have substantial involvement in the study beyond the normal stewardship of an NIH NHLBI Program Official.

• The NHLBI Project Officer will serve on the Steering Committee as a nonvoting member; they or another NHLBI scientist may serve on other study committees when appropriate.
• The NHLBI Project Officer (and the other cited NHLBI scientists) may work with recipients on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

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. 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 Project Scientist will participate in activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication, etc., 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 Officer.

Areas of Joint Responsibility include:

Steering Committee (SC) - The NHLBI Project Scientist, PIs from the project funded through this and the companion NOFOs (RFA-HL-24-006, RFA-HL-24-012) will be responsible for forming a Steering Committee as described below. The SC will be the main governing board of the LungMAP. It will develop collaborative protocols, identify technological impediments to success and strategies to overcome them, and identify opportunities for sharing techniques and tools that might be developed in future LungMAP atlas projects.

• The SC will be composed of the PDs/PIs from the LungMAP Phase 3 awards and the NHLBI Project Scientist. Each award site will have one vote. NHLBI Project Scientist will have one vote. The SC chairperson will be appointed by the SC.
• The SC may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the scientific expertise of the Steering Committee when necessary.
• There will be two Steering Committee meetings annually, one in the Bethesda, MD area, the other in the institution of one of the recipients. In addition, a Planning Meeting will be held at the beginning of the first year.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Qing "Sara" Lin, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: sara.lin@nih.gov

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

Taylor Svilar
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-8545
Email: taylor.svilar@mail.nih.gov

Section VIII. Other Information

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

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