Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Heart, Lung, and Blood Institute (NHLBI)
Funding Opportunity Title	Molecular Atlas of Lung Development - Human Tissue Core (HTC)(U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. March 20, 2013 - See Notice NOT-HL-13-173. Notice of Correction to Number of Applications.
Funding Opportunity Announcement (FOA) Number	RFA-HL-14-007
Companion Funding Opportunity	RFA-HL-14-008, U01 Research Project Cooperative Agreements RFA-HL-14-009, U01 Research Project Cooperative Agreements
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.838
Funding Opportunity Purpose	The National Heart, Lung, and Blood Institute invites cooperative agreement (U01) applications to serve as the Human Tissue Core (HTC) for the Molecular Atlas of Lung Development Program (LungMAP). The overall goal of this program is to build an open-access reference resource by creating a comprehensive molecular atlas of the late-stage developing lung (human and mouse) with data and reagents available to the research community. The atlas will integrate gene and protein expression profiles, transcriptome, epigenome, and other molecular characterizations with high-resolution anatomical information to provide molecular profiles of functionally or anatomically defined cell types in the developing lung. The HTC will identify and manage tissue source sites to collect, process, deposit, and distribute human lung samples to the Research Centers (RCs). Two separate solicitations seek applications for four RCs (RFA-HL-14-008) and one Data Coordinating Center (RFA-HL-14-009).

Posted Date	March 12, 2013
Open Date (Earliest Submission Date)	May 19, 2013
Letter of Intent Due Date(s)	May 19, 2013
Application Due Date(s)	June 19, 2013, 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.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2013
Advisory Council Review	January 2014
Earliest Start Date	April 2, 2014
Expiration Date	June 20, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Background

The lung is a complex structured organ with high cellular heterogeneity. Development and maintenance of respiratory function require interactive gene networks and dynamic crosstalk among multiple cell types to control and coordinate lineage specification, cell proliferation, differentiation, migration, morphogenesis and injury repair. Based on previous basic research efforts on lung developmental biology, many key signaling molecules, genes, and pathways have been discovered. Yet, significant knowledge gaps still exist in understanding lung development from late fetal to perinatal stages, and through early childhood. Little is known of human lung development at this critical period, when the diverse lung cells go through terminal differentiation and maturation, and when the gas exchange units, alveoli, form. Understanding alveologenesis has significant clinical relevance. Many prematurely born infants are as young as 24 weeks in gestation and have incomplete lung formation and developmental arrest prior to the alveolar stage. How to promote alveologenesis and maturation of the overly simplified lung in these babies remains an unsolved clinical challenge. Successful development of novel approaches to facilitate lung injury repair and regeneration depends on knowledge about the molecular definitions of the lung cells, genes that regulate their functions and behavior, and the crosstalk among the cells and the microenvironment during normal development. Molecular profiles of the diverse cell types in the lung, including epithelial, mesenchymal, neuronal, vascular, and other non-endoderm-derived lineages, knowledge of the dynamics of 3-D cellular structure of the airways and alveoli, and an integrative open-access database to assimilate complex multi-dimensional data are all necessary for a complete understanding of lung development.

Research Objectives

The overall objective of the Molecular Atlas of Lung Development Program (LungMAP) is to develop a molecular atlas of the developing lung from human and mouse to serve as a unique reference resource for the research community. The LungMAP will include comprehensive molecular characterizations of the diverse cell types by combining gene expression, imaging, lineage tracing, and anatomical analysis, to represent normal lung development between late canalicular to alveolar stage (22-24 weeks gestational age to early childhood, in human). The LungMAP will build an integrated, dynamic, and publically accessible database with existing and newly generated data. In addition, the LungMAP is intended to develop new tools, reagents, and technology that will facilitate the molecular profiling of the lung.

Organization of the Molecular Atlas of the Lung Program

The Molecular Atlas of Lung Development Program (LungMAP) will be supported and governed by Cooperative Agreements of one Human Tissue Core (HTC), up to 4 Research Centers (RC), and one Data Coordinating Center (DCC), funded through FOA RFA-HL-14-007, RFA-HL-14-008, RFA-HL-14-009, respectively. Applications for the HTC, RC and DCC may be from the same Institution if they have different PD/PI(s). Applicants are strongly encouraged to read the three FOAs for the LungMAP to better understand the overall structure and function of the entire program.

The LungMAP will serve as a resource to the research community; therefore all of the consortium activities must be integrated and coordinated, which is key to allowing the consortium to achieve high-throughput, genome-wide coverage in producing the molecular profile of the developing lung. Applicants must agree to 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. Samples, reagents, protocols, and materials must be publically available. Data must be deposited and available for public access in a timely manner.

HTC: The main goal of the HTC is to collect, catalog, and distribute human lung samples from the specified developmental window, from late canalicular to alveolar stage (22-24 weeks in gestational age to early childhood, in human). The HTC will identify and manage additional tissue source sites through fee for service agreements to collect normal human lung samples. The HTC will process and prepare the tissues in accordance with protocols co-developed with the RC investigators, and distribute them to the research centers.

RC: The RCs will lead and perform molecular analyses, such as spatio-temporal gene expression profiles, transcriptome, epigenome, protein expression and other molecular characterizations of the lung cells from mouse and human samples. The RCs will generate the molecular anatomy data, create tools, and develop reagents for the LungMAP.

DCC: The DCC will serve as the centralized data repository, public interface, and administrative coordinating center for the consortium. The DCC will develop/design and maintain a curated, expandable central database that accommodates and integrates multiple types of data, both existing and newly generated, develop annotations in collaboration with the RC teams, and develop online data analysis tools to facilitate public usage from the general research community. The DCC will develop and maintain the open-access, public LungMAP website. In addition, the DCC will serve as an administrative coordinating center to facilitate and coordinate research activities through the consortium.

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. The DCC should include the Steering Committee chair costs (for service and travel) in the consultant line of the budget.

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 DCC should include the EAC costs (for service and travel) in the consultant line of the budget.

Extensive and effective coordination and integration are crucial to the success of LungMAP. The applicants must state their willingness to collaborate extensively and share information fully. The applicants must state their willingness to abide by the priorities and policies agreed upon by the Steering Committee and NHLBI. In addition to scientific merit, potential synergies will be considered for the selection of the complement of projects.

Each HTC/RC/DCC application must include a timeline with milestones. The success of the overall program will be evaluated 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.

Specific Content for Human Tissue Core (HTC) Applications

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 (22-24 weeks in gestational age to early childhood, in human). These lung samples shall represent normal development. Specific time points and criteria will be finalized by the Steering Committee after funding starts. The HTC will identify, coordinate, and manage additional tissue source sites through subcontracts to acquire the human samples. The HTC should select the tissue source sites based on research capacity and experience, patient population size, neonatology/pathology expertise and commitment. The HTC needs to have strong expertise in obstetrics, neonatology, pulmonary histopathology, molecular and cell biology, and clinical management, and have experience in conducting multi-institution 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 cellular analyses. The HTC and the tissue source sites 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.

The tissue source sites will transmit the lung tissue samples to the HTC, which will further process the samples, perform quality control, and distribute the samples to the research centers. The HTC will perform histopathological analyses of the lung tissue specimens to ensure the lung specimens represent normal state, and transmit results to the DCC.

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.

An HTC application is required to propose 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. HTC applications shall propose strategies to standardize protocol-driven procedure implementation to minimize process variables, and to ensure vigorous quality control along the work flow. HTC applications will be required to identify the tissue source sites in the applications and provide supporting letters from these sites to demonstrate capacity and commitment.

Additional sample collections at time points outside of the target window may be included, but are not required.

Funding Instrument	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.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The award is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. One (1) HTC will be funded by this award. It is estimated that approximately $6,800,000 (Total Costs) will be awarded to the HTC over a five year period. Future year award amounts may vary depending on annual appropriations.
Award Budget	Application budgets are limited to a maximum of $250,000 direct cost for the first year and a maximum of $1,000,000 direct cost for each of the subsequent years. Budgets need to reflect actual needs of the proposed project.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

An individual may be PD/PI on only one LungMAP application submitted to this FOA, RFA-HL-14-008 or RFA-HL-14-009.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Applications for the HTC, RC and DCC may be from the same Institution only if they have different PD(s)/PI(s).

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

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:

• 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
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

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

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

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

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

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

Research Strategy: All applications should address the following in the Research Strategy section:

• An HTC application is required to propose 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. HTC applications should propose strategies to standardize protocol-driven procedure implementation to minimize process variables, and to ensure vigorous quality control along the work flow. HTC applications must identify the tissue source sites in the applications.
• Timeline and Milestones: Each application must include 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. Categories of milestones must include time needed for protocol development and number of samples to be collected.
• 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: Include letters of support from participating clinical sites.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

This initiative is not subject to intergovernmental review.

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

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

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.

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.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

In addition to standard review criteria, all applications will be judged on the documented ability of the investigators to meet the research objectives of the FOA.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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 evidence of experience with neonatal clinical research? Is there evidence of strong expertise in molecular and cell biology? Is there a track record for multi-institutional collaborative studies?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 applicants provided adequate evidence for their ability to recruit high-quality tissue source sites with sufficient capacity to collect adequate human lung samples? Are the milestones and timeline quantitative, feasible and appropriate?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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?

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.

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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:

• 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.
• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NHLBI Advisory Council or Board. 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.
• Willingness to participate collaboratively in all aspects of the LungMAP program.
• Agreement to accept the Cooperative Agreement Terms and Conditions of Award delineated in this FOA.
• Programmatic balance and potential synergies among complementary projects.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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:

• 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 Steering Committee and attending the Planning Meeting and two Steering Committee meetings 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.
• Adhering to PHS policy for the distribution of unique research resources produced with PHS funding as described under Special Requirements.
• Establishing written milestones for the project, in collaboration with NHLBI Project Staff prior to funding.
• Releasing all study design materials and procedure manuals into the public domain and/or making them available to other investigators, according to the 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 of reproduction and distribution.

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

• An NHLBI Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. However, the dominant role and prime responsibility for the project as a whole resides with the awardees.
• The NHLBI Project Scientist will attend and participate as a voting member in all meetings of the Steering Committee.
• The NHLBI Project Scientist will serve as a liaison, helping to coordinate activities among and for the awardees, including acting as a liaison to the NIH, and as an information resource for the awardees about lung development research activities.
• Prior to funding, NHLBI staff will negotiate milestones with the applicant, incorporating recommendations from the review panel, with the final mutually agreed upon milestones becoming a condition of the award.
• The NHLBI Project Scientist will review the scientific progress of the LungMAP consortium, access for compliance with operating policies developed by the Steering Committee, and may recommend to the NHLBI to withhold support, suspend, or phase out an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.

Areas of Joint Responsibility include:

• Steering Committee (SC) - The NHLBI Project Scientist, PIs from the project funded through this and the companying FOAs (RFA- HL-14-008, RFA- HL-14-009) will be responsible for forming a Steering Committee as defined below. An arbitration system, as detailed below, will be available to resolve disagreements among members of the Steering Committee. The SC will be the main governing board of the consortium. 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 PIs from the project funded through these FOAs, and the NHLBI Project Scientist. Each award site will have one vote. The SC chairperson will be appointed by the NHLBI.
• 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, both in the Bethesda, MD area. 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 award 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 awardee. This special dispute resolution procedure does not alter the awardee'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.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Qing "Sara" Lin, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: [email protected]

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]

John Diggs
Office of Grants Management
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-4267
Email: [email protected]

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 Parts 74 and 92.