Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Heart, Lung, and Blood Institute (NHLBI)
July 14, 2023 - This RFA has been reissued as RFA-HL-24-012
RFA-HL-19-020, U01 Research Project - Cooperative Agreements
RFA-HL-19-022, U24 Resource-Related Research Projects - Cooperative AgreementsThe purpose of this FOA is to support LungMAP Phase 2 Human Tissue Core (HTC) to identify tissue sources and collect, process, preserve, and distribute human lung samples to the Research Centers (RCs), which will be funded through companion FOA (RFA-HL-19-020).
The overall objective of the LungMAP is to better understand human lung development by building an open-access reference resource of a comprehensive, dynamic, 3-D molecular atlas of the late-stage developing human lung with data and reagents available to the research community. Phase 1 of the LungMAP has generated foundational data from developing mouse and human lungs, created a web portal for public data sharing, and established a repository of human lung tissues. Phase 2 of the LungMAP will continue to generate and integrate high-resolution, multiscale molecular profiles associated with spatial information to provide molecular characterizations of functionally and anatomically defined cell types in the developing human lung. Phase 2 of LungMAP will focus on human lung only and will extend the scope to cover normal lung development into early adulthood (up to 25 years old), as well as abnormal lung development in selected neonatal and pediatric rare lung diseases.
Applicants are not required to have been funded in LungMAP Phase 1 (RFA-HL-14-007) in order to submit applications to this FOA.
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.
Conformance to all requirements (both in the Application Guide and the FOA) 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.
Purpose
The purpose of this FOA is to support LungMAP Phase 2 Human Tissue Core (HTC) to identify tissue sources and collect, process, preserve, and distribute human lung samples to the Research Centers (RCs).
The overall objective of the LungMAP is to better understand human lung development by building an open-access reference resource of a comprehensive, dynamic, 3-D molecular atlas of the late-stage developing human lung with data and reagents available to the research community. Phase 2 of the LungMAP will continue to generate and integrate high-resolution, multiscale molecular profiles associated with spatial information to provide molecular characterizations of functionally and anatomically defined cell types in the developing human lung. Phase 2 of LungMAP will focus on human lung only and will extend the scope to cover normal lung development into early adulthood (up to 25 years old), as well as abnormal lung development in selected neonatal and pediatric rare lung diseases.
Background
The lung is a complex organ with sophisticated 3D structure and high cellular heterogeneity. To date, identifying lung cell types using morphology and a limited set of molecular markers has significantly limited our understanding of the molecular nature of both normal development and disease pathogenesis. In addition, although regional specificity is a strong characteristic for lung cell identity and function, mapping specific cells accurately within the context of the 3-D lung structure remains elusive. Furthermore, although understanding normal biology is a necessary first step towards understanding diseases, our knowledge of normal lung development, especially human lung development, remains extremely limited. In particular, significant knowledge gaps still exist for lung development from late fetal to perinatal stages and through early adulthood, which is the critical stage for the formation of the gas-exchange units, or alveologenesis.
To begin to fulfil these knowledge gaps, the LungMAP consortium was established in 2014 with the overall goal of identifying the lung cells with molecular profiles associated with morphology and spatial information during development. The specific five-year goals of the program were to build: 1) A mouse lung atlas from embryonic day 16.5 to postnatal day 28 that integrates imaging, gene expression, and anatomical analysis; 2) A human lung atlas for normal development from 23-week gestation to postnatal year 10; and 3) An integrated, publicly accessible, and expandable database to accommodate the data.
In the past four years, the LungMAP team has collected and processed more than 200 human lungs ranging from 30-week gestation to 10 years old. Lung lobes, sorted cells, tissue blocks, and tissue sections along with detailed clinical and pathology review information have been provided to the LungMAP Research Centers and are now available to the broader research community. Multi-scale, high quality molecular and imaging data from both mouse and human lungs was generated, analyzed, and made available through the LungMAP website. Some of the highlights include high resolution 3D imaging of the alveolar structure, single cell transcriptome of the developing lung, identification of protein markers for all major lung cell types in human, cell type-specific omics, and trans-omics analysis of specific cell types of the lung. The Data Coordinating Center has developed and maintained the LungMAP website (https://www.lungmap.net/) and database for data management, sharing, and analysis. A variety of tools have been developed for data annotation, integrated data analysis, and enhanced sharing with the research community.
LungMAP Phase 2 Objective
This and the companion FOAs? (RFA-HL-19-021, RFA-HL-19-022) for LungMAP Phase 2 aim to expand the existing LungMAP by building a comprehensive molecular atlas of late stage lung development in humans that will serve as a critical reference platform for understanding both normal human lung biology and disease pathogenesis. The updated LungMAP database will be integrated, dynamic, and publicly accessible with both existing and newly-generated data.
The LungMAP Phase 2 will focus on human lung studies and expand the scope of the original program. Based on recent research results indicating postnatal alveologenesis of normal human lung development continues into early adulthood, LungMAP Phase 2 will extend coverage to early adulthood (25 years of age), the stage for rapid lung growth and peak lung function. It is expected that up to 25% of the LungMAP resources shall be delegated to selected rare lung diseases in children, such as Bronchopulmonary Dysplasia (BPD), congenital diaphragmatic hernia, surfactant protein deficiencies, childhood interstitial lung diseases, pediatric pulmonary hypertension, and cystic fibrosis. Final determination of which disease(s) to include will be made by the LungMAP Phase 2 steering committee after the program initiates.
LungMAP Phase 1 characterized the most abundant and major cell types of the lung, including epithelial cells, mesenchymal cells, endothelial cells, and mixed immune cells. Yet, subtypes and rarer cell types have not been sufficiently characterized. LungMAP Phase 2 will extend to more specific and rare cell types such as progenitor cells, neural cells, and cells of the innate immune system and the lymphatic system. It is expected that deeper coverage with single cell sequencing will lead to identification of new markers for sorting and enrichment of the rare cells. In addition to transcriptomic assays, LungMAP Phase 2 RCs may also expand the current epigenetic analysis of specific cell types. Significant technology developments have been achieved to use fewer cells for proteomic, lipidomic and metabolomic analysis. It is highly likely that multi-scale omics at the single cell level will be feasible in the next five years.
LungMAP Phase 2 will focus on developing and improving analytical methods and tools for integrating multi-scaled information such as imaging data and results from transcriptomic, proteomic, and epigenomic analyses of normal and diseased lungs. Such data integration will facilitate new insights into the mechanisms of lung disease pathogenesis. Emphasis will also be placed on developing better web-based tools for data analysis and visualization to facilitate public usage of the LungMAP resources.
Organization of the Molecular Atlas of the Lung Program
The Molecular Atlas of Lung Development Program (LungMAP) Phase 2 will be supported and governed by Cooperative Agreements of Human Tissue Core (HTC), Research Centers (RC), and Data Coordinating Center (DCC), funded through FOAs RFA-HL-19-020, RFA-HL-19-021, RFA-HL-19-022, respectively. Applications for the HTC, RC and DCC may be from the same Institution if they have different PD(s)/PI(s). Applicants are strongly encouraged to read the three FOAs for LungMAP Phase 2 to better understand the overall structure and function of the entire program.
LungMAP will serve as an open-access resource to the research community; therefore all of the consortium activities will be integrated and coordinated, which is key to allowing the consortium to achieve high-throughput, high resolution, genome-wide coverage in producing the molecular profile of the developing human lung. It is expected that awardees will collaborate and interact with consortium members. Collaboration and interaction activities will be facilitated through a website, teleconferences, and biannual meetings of the investigators organized by the DCC. NHLBI expects that samples, reagents, protocols, and materials developed through the LungMAP program will be publicly available and that LungMAP data will be deposited and available for public access in a timely manner.
Human Tissue Core (HTC; this FOA): The main goal of the HTC is to collect, process, catalog, store, and distribute human lung samples from the specified developmental window, from late canalicular stage in prenatal development to early adulthood, in humans. The HTC will identify and manage tissue source sites and/or collaborate with organ donor programs to collect human lung samples. The HTC will process and prepare the tissues in accordance with protocols co-developed with the RC investigators, and distribute the samples to the Research Centers.
Research Centers (RC; RFA-HL-19-020): The RCs will lead and perform molecular analyses, such as transcriptome, epigenome, protein expression and other molecular characterizations of the lung samples (provided by the HTC). Using innovative approaches, the RCs will generate high-content, high-resolution, molecular anatomy data, create tools, and develop reagents for the LungMAP.
Data and Coordinating Center (DCC; RFA-HL-19-022): The DCC will serve as the centralized data repository, public interface, and administrative coordinating center for LungMAP. The DCC will improve and maintain the curated, expandable central database of LungMAP that accommodates and integrates multiple types of data; develop annotations in collaboration with the HTC and RC teams; and develop web-based data analysis tools to facilitate public usage. The DCC will improve and maintain the LungMAP website for internal use as well as a publicly-available interface. In addition, the DCC will serve as an administrative coordinating center to facilitate and coordinate consortium research activities, including solicitating and managing collaborative and pilot studies as well as skills development activities.
Steering Committee (SC): The SC will be composed of the lead Program Directors/Principal Investigators (PD(s)/PI(s)) from each RC, HTC, DCC, and NHLBI project staff, and will be chaired by an investigator selected by the NHLBI. The NHLBI and the SC will be responsible for overall scientific direction, integration and coordination of the program. Governance will include the processes of protocol development, sample distribution coordination, assay standardization, data quality control, data submission, data integration, and data publishing.
External Advisory Committee (EAC): An External Advisory Committee (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 EAC will be responsible for review of the collaborative and pilot studies.
Extensive and effective coordination and integration are crucial to the success of LungMAP. 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 with 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 outcomes.
Human Tissue Core (HTC) Objective and Scope
The main goal of the HTC is to collect, catalog, process, and distribute human lung samples from the specified developmental window, from late canalicular to alveolar stage. LungMAP phase 2 will extend the coverage to early adulthood, i.e. 25 years old. Specific time points and criteria will be finalized by the Steering Committee after funding starts. In addition to lung samples representing normal development, LungMAP Phase 2 will study samples representing selected neonatal and pediatric rare lung diseases.
The HTC will identify, coordinate, and manage additional tissue source sites to acquire the human samples. NHLBI expects the HTC to have strong expertise in obstetrics, neonatology, lung histopathology, molecular and cell biology, and clinical management and have experience in conducting multi-center collaborative studies.
Working with the Research Centers in the consortium, the HTC will develop protocols with criteria for sample inclusion/exclusion, and for sample procurement, processing, transport, storage, and distribution. The HTC is expected to implement a variety of specific protocols to accommodate the specific requirements for particular types of molecular and imaging analyses. The HTC will be responsible for expedited autopsy, sample acquisition, preservation, as well as collecting and completion of proper documents, including consents and associated clinical data. The HTC will ensure that the human sample collection and handling procedures comply with current NIH policies.
After sample collection, the HTC will further process the samples, perform pathological review, and distribute the samples to the Research Centers. The HTC will catalog, annotate and store the human samples using methods that preserve bio-specimen integrity, and maintain an information system for sample management which should integrate well with the LungMAP central database managed by the DCC. The NHLBI expects that the HTC information system will be able to catalog and track the inventory of the biospecimens, facilitate sample distribution, and host metadata as well as SOPs and consent documents.?
Examples of neonatal and pediatric rare lung diseases of interest include, but are not limited to: bronchopulmonary dysplasia, congenital diaphragmatic hernia, surfactant protein deficiencies, childhood interstitial lung disease, pediatric pulmonary hypertension, and cystic fibrosis. Final determination of which disease(s) to include will be made by the LungMAP Phase 2 steering committee after the program initiates.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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NHLBI intends to commit total costs of up to $,1,600,000 per year in fiscal years 2019 through 2023 to fund 1 award.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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:
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:[email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Tissue Samples and Analyses: Describe proposed strategies that will be used to identify sources for tissue acquisition. Provide estimated sample number per year, a strategy to coordinate the tissue source sites for sample acquisition, and a plan to accommodate and implement different protocols for modern molecular biology analysis. Describe strategies to standardize protocol-driven procedure implementation to minimize process variables, and to ensure vigorous quality control along the work flow. Outline the proposed approach to distribute samples to the LungMAP Research Centers and the research community. Include a plan and specific criteria for sample inclusion/exclusion, and for sample procurement, processing, transport, storage, and distribution. Discuss how the HTC will develop and implement a protocols to accommodate the specific requirements for particular types of molecular and imaging analyses. The plan must also describe how the HTC will expedite post-mortem sample acquisition and preservation, as well as the proposed process for collecting and completing appropriate documentation, including consents and associated clinical data. Detail how the HTC will ensure that the human sample collection and handling procedures comply with current NIH policies.
Neonatal and Pediatric Rare Disease: Specify the neonatal and pediatric rare disease(s) of interest, including the scientific justification and inclusion criteria for the selection(s). Describe the feasibility of utilizing the proposed tissue collection. Examples of neonatal and pediatric rare lung diseases of interest include, but are not limited to: bronchopulmonary dysplasia, congenital diaphragmatic hernia, surfactant protein deficiencies, childhood interstitial lung disease, pediatric pulmonary hypertension, and cystic fibrosis
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 terms and conditions of a Cooperative Agreement 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.
Letters of Support:
Provide letters of support from the sites proposed to be sources of human tissue samples. Letters must demonstrate the capacity of the proposed sites to provide tissue samples as well as their commitment to provide such samples. Add FOA-specific instructions regarding any of the Research Plan sections here. Note that each section is uploaded as a separate attachment to the Research Plan form.
The following modifications also apply:
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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
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 Policy on Late Application Submission.
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.
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.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number 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.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
How likely is this project to advance the understanding of the normal lung development as well as neonatal and pediatric rare lung disease(s)?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Is there strong evidence that the proposed investigator team has the required experience in conducting complex, multi-component, and collaborative research programs? To what extent does the investigator team demonstrate their project management skills and robust productivity in data generation, integration, and analysis? Is the investigator team poised to adapt new technologies during this program?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
What are the strengths and weaknesses of the proposed strategy to coordinate the sites for tissue acquisition? Is the estimate for the expected number of tissue samples reasonable? How feasible is the plan to accommodate and implement various protocols for modern molecular biology analyses? Does the application adequately describe strategies that will be used to standardize and implement protocol-driven procedures to minimize process variables, and to ensure vigorous quality control along the work flow? How likely is the proposed approach for distributing samples to the LungMAP Research Centers and the research community to be effective and efficient? How sound is the plan for identifying tissue sources, processing tissues for collection, preservation, and distribution to the RCs and research community? How feasible and robust are the proposed plans for interaction, collaboration, and integration with other investigators in the Consortium? How feasible and reasonable are the milestones in the application? Do the letters of support demonstrate the HTC's ability to collaborate and coordinate with the tissue collection sites?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Relevance of the proposed project to program priorities.
In addition to scientific merit, potential synergies will be considered for the selection of the complement of projects.
Information regarding the disposition of applications is available 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 grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.
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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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 (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
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 as follows:
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 FOA and the companion FOAs (RFA-HL-19-020, RFA-HL-19-022) 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.
Dispute Resolution:
Any disagreement that may arise in scientific/programmatic matters (within the scope of the award) between award recipients and the NHLBI may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Executive Committee (with the NHLBI member absent from the discussion) or by the individual awardee in the event of an individual disagreement, a second member selected by NHLBI, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16, or the rights of NHLBI under applicable statutes, regulations and terms of the award.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. 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 Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions for Recipient Integrity and Performance Matters.
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