Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title

Lung Repair and Regeneration Consortium  Administrative Coordinating Center (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type


Related Notices
  • January 20, 2011 - See Notice NOT-HL-11-116 Corrections to Section II Award Information.
  • December 7, 2010 - FAQs have been developed for RFA-HL-12-006 and RFA-HL-12-010. See NOT-HL-11-135.
Funding Opportunity Announcement (FOA) Number


Companion FOA


Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)

 93.838, 93.286   

FOA Purpose

The National Heart, Lung, and Blood Institute (NHLBI) invites applications to participate as the Administrative Coordinating Center (ACC) for the Lung Repair and Regeneration Consortium (LRRC) (  The goal of the Consortium is to foster research by highly integrated multidisciplinary scientific teams to address an important knowledge gap in fundamental mechanisms underlying lung repair and regeneration and to translate this knowledge to new regenerative medicine strategies for reversing debilitating and life-limiting pulmonary disorders. The program is expected to support development of novel tools (e.g., reagents, models, imaging, and/or data analysis tools) which will accelerate research progress in lung repair/regeneration. The Consortium will assemble multiple independent research projects, each with a multi-disciplinary team of Principal Investigators, to develop new reagents, models and/or tools to advance research focused on lung repair and regeneration, and will develop a skills development Core for trainees.   

Key Dates
Posted Date
Open Date (Earliest Submission Date)

Not Applicable

Letter of Intent Due Date

January 10, 2011

Application Due Date(s)

February 10, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2011

Advisory Council Review

October 2011

 Earliest Start Date(s)

December 1, 2011

Expiration Date

February 11, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The National Heart, Lung, and Blood Institute (NHLBI) invites Administrative Coordinating Center (ACC) applicants to participate in, the Lung Repair and Regeneration Consortium (LRRC) which is a consortium of investigators and institutions.  Research Center applicants to the LRRC will utilize the FOA of identical scientific scope, RFA HL-12-006 " Consortium of Lung Repair and Regeneration: Building the Foundation (U01)", and be comprised of multidisciplinary teams that will work collaboratively with other Research Centers in the LRRC to accelerate science in lung repair and regeneration.  This FOA solicits Research Project Cooperative Agreement (U01) applications from institutions/organizations that will support the administrative and collaborative activities of research centers participating in the LRRC.  In addition to testing innovative hypotheses of mechanisms that control lung repair/regeneration, Research Centers will also propose at least two novel tools and/or reagents to facilitate research in lung repair/regeneration.  With the LRRC ACC coordination, the LRRC will also develop new collaborative research activities and a skills development component. The LRRC will be responsible for collaboratively generating, validating, and sharing necessary reagents, models, antibodies, assays, protocols, and technologies that are beyond the scope of any single research effort with the goal of accelerating lung repair/regeneration research specifically, but also the potential to advance basic research in general.  These tools and reagents will be rapidly shared with members of the Consortium, and eventually advertised and made available on a public website. These activities will be coordinated by the LRRC ACC.


The lung is exposed to many potentially injurious insults with resultant responses that can either restore/maintain lung function or lead to irreversible remodeling and dysfunction. Mechanisms of lung repair/regeneration are being explored in a variety of models, but the cellular and molecular events underlying effective vs. dysfunctional repair are poorly understood. Exploration of regenerative strategies is well underway for other organ system disorders such as neurodegenerative disease, trauma to skin and bones, and blood and heart diseases, which could be leveraged in understanding the unique aspects of regeneration of the lung.  Previous studies have revealed that stem/progenitor cells differ by lung compartment, that key stem cell signaling molecules such as Wnt can affect multiple cellular processes that may be antagonistic during tissue repair (progenitor expansion vs. fibrosis), and that lung regeneration and repair responses are maturation-dependent. This new program seeks to leverage innovative technologies such as tissue and bio- engineering, biomaterials and scaffolds, iPS technology, cell directed therapy, and humanized animal models that are not used widely in lung regeneration research, but are being applied to investigate regeneration and repair in organ systems outside of the lung, and incorporate these novel methods to further knowledge of lung repair and regeneration. The program also seeks to build on knowledge gained from research in molecular embryology and developmental biology of the lung, acute and chronic lung injury, pathobiology of pulmonary fibrosis, COPD, cystic fibrosis lung disease, and programs in lung progenitor cell biology. The goal is to bring together the investigators, ideas, and tools from each of these research domains as well as regenerative science experts of other organs, and new disciplines such as bioengineering, to create partnerships that will be needed to forge new research directions and identify strategies to induce functional lung tissue regeneration of lung cell compartments. 

The lung is normally not a highly proliferative tissue, but proliferation does occur following injury. Recent evidence suggests that there may not be true lung stem cells, but rather multipotent or lineage-committed cell populations (either progenitor or fully differentiated) that respond after significant injury in order to repopulate the epithelium with a myriad of cell types needed for functional recovery. Controversy exists however as to the differentiative repertoire (pluripotent, multipotent, or unipotent) of progenitor cells within the lung and whether these properties are possessed by a privileged few stem/progenitors cells or by a broad variety of many lung cells. Moreover, the reparative/regenerative mechanisms controlling the cell fate decisions, self-renewal decisions, or capacity for transdifferentiation (cell plasticity) of the cells in question remains unknown, in part because tools and models needed to explore the biology of lung repair/regeneration in specific cell subsets are lacking or insufficient. 

Research proposed for the companion FOA RFA HL-12-006 may utilize any compartment(s) of the respiratory system including epithelium, mesenchyme, and/or endothelium from the upper airway to alveolus and must have a clear translational target. The goal is to address an important gap in knowledge in the lung field that would lead to development of new regenerative medicine strategies for reversing debilitating and life limiting disorders such as acute lung and/or tracheal injury, bronchopulmonary dysplasia, cystic fibrosis, pulmonary fibrosis, and COPD.  Collaborations and rapid sharing of models/reagents developed in the Consortium will be expected. 

Known lung cell markers are insufficient for lung progenitor cell identification, isolation, and lineage tracing of >40 cell types in the lung. In addition, efforts to translate findings in preclinical models to human have highlighted the need for better models to reflect human disease. The RFA HL-12-006  FOA will require each Research Center to propose the development of at least two novel tools/reagents that would accelerate reaching the goal of improved understanding of human lung repair/regeneration.  These may include tools/reagents that would facilitate lung stem/progenitor cell identification, isolation, and lineage tracing; new technology that can support regeneration of lung tissue (such as gradients of growth/paracrine factors that can differentiate/ dedifferentiate lung cells); and new in vivo and in vitro injury models that replicate better than naphthalene or bleomycin human acute and chronic lung diseases.  Collaboration among research centers in both hypothesis-driven research and rapid sharing of models/reagents developed in the Consortium will be expected. 

Program Structure

The Consortium will consist of an Administrative Coordinating Center, multiple research projects, and collaborative research and tool development projects, and a skills development Core.

The goal of this FOA is to develop a highly interactive and synergistic Consortium of investigators who will share ideas, data, and resources to move the field of lung repair/regeneration forward. The Consortium will consist of up to six Research Center projects funded through the companion FOA RFA HL-12-006, and an Administrative Coordinating Center (ACC) supporting the Consortium funded through this FOA. The ACC will also administer funds to support collaborative research studies and tool validation studies between participating sites in the Consortium and the Skills Development Core in tissue regeneration. Collaboration and interaction among LRRC investigators will be a requirement of the program and will be facilitated with a website, teleconferences, and biannual meetings of the investigators organized by an Administrative Coordinating Core (ACC).

Administrative Coordinating Center (ACC): The ACC will serve a range of functions such as organizing meetings; arranging quarterly teleconference calls and two in person meetings/year of the Steering Committee, External Advisory Committee, and Consortium annual meetings; and designing and maintaining written materials and websites to support the Consortium. The ACC will be responsible for solicitation of applications for collaborative research studies and studies to validate new models/reagents/tools that are developed in the LRCC. The ACC will oversee the review and award of collaborative study funds for the Consortium, award subcontracts for these funds, assist in the Skills Development Core, and coordinate the submission of progress reports by the awardees for review by the External Advisory Committee and NHLBI staff.

Collaborative Research Studies: A major goal of the Lung Repair and Regeneration Consortium is to foster highly innovative, high-risk approaches that are not easily funded by traditional mechanisms and that have the potential for unusually high impact that could significantly advance the field. Solicitations for collaborative studies across two or more Consortium Research Centers will be initiated beginning in Year 1 by the ACC with project support for 1-3 years for approximately $100,000 direct costs per year starting in year 2. The studies are also expected to be helpful in developing young investigators and may bring in outside experts. The External Advisory Committee will be responsible for peer review of these new collaborative studies. Progress on these studies will be monitored by NHLBI program staff.

Collaborative Resource Validation Studies:  As new reagents, models, tools are developed by individual Research Centers, confirmation of the application of these will be fostered through  solicitations for tool validation by other Research Centers in the Consortium.  Beginning in Year 2, solicitations for tool validation studies will be issued by the ACC at direct costs of approximately $50,000-150,000 for one year. The External Advisory Committee will be responsible for peer review of these new validation studies. Progress on these studies will be monitored by NHLBI program staff.

Steering Committee: The LRRC will have a Steering Committee that will be responsible for overall scientific direction, coordination and oversight. The Steering Committee will be composed of the Lead PIs for each Research Center, the ACC PI, and the NHLBI Project Scientist. The Steering Committee will be chaired by an investigator selected by the NHLBI. The Steering Committee will meet in person for an implementation meeting at the start of the project period, by conference call at least quarterly, and in person at least twice a year throughout the project period. Participation in Steering Committee activities is a requirement of at least one PI from each Research Center. Funds should be requested to attend Steering Committee meetings as well as other collaborative meetings of the LRRC and funds should be available from the ACC for travel expenses of an SC chair, if chosen by the NHLBI from outside the Consortium.

Skills Development Core: A Skills Development Committee, composed of an investigator from each Research Center and from the ACC, will develop and coordinate activities between the Research Centers to enhance skills development for graduate students, postdoctoral fellows, and young faculty. The ACC will be responsible for coordination and implementation of a plan with the Research Center Skills Development Core Leaders.

External Advisory Committee: An External Advisory Committee (EAC) will oversee the Consortium. The Committee will consist of non-Consortium affiliated scientists and other experts appointed by the NHLBI to provide annual reviews of progress, and serve as the peer review panel for pilot studies.  The ACC should budget for travel expenses and honoraria for five EAC members.

Annual Grantee Meeting: The ACC will arrange annual meetings to encourage the exchange of information among the investigators who participate in this program. In the preparation of the budget for the grant application, applicants should include travel funds to organize and operate one meeting each year to be held in or near Bethesda, MD, for the Principal Investigators, key collaborators, and trainees. A major goal of these meetings is to facilitate progress by providing a forum that will lead to sharing skills, ideas, technology, data, and biological reagents.  At the meetings, participants will discuss quality assurance, bioinformatics, coordination, sharing, and a means of informing the community about progress made by the Consortium.

During the course of the funding period, technologies will improve and the rate of progress and scope of the research may change.  It is expected that the Principal Investigators, in consultation with NHLBI program staff, will make necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects funded under this FOA.

Data and Reagent Sharing: All applications submitted through this announcement and the companion FOA ( RFA-HL-12-006) must include technology transfer and sharing plans for both data and unique research resources that are generated by the projects in concordance with the LRRC policies, which the ACC will develop in consultation with the SC. It is expected that the ACC will develop a website for the LRRC for communications of LRRC research and tools in development, with the goal of coordinating collaborative activities within the LRRC, with the broader scientific community, and to communicate progress to the public. 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed


The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

 NHLBI/DLD intends to commit $6.3 million for 1 award in FY 2012.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

 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.

Section III. Eligibility Information

1. Eligible Applicants
Eligible Organizations

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



Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7214
Telephone: 301-435-0270
Fax: 301-480-0730

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730

Page Limitations
Research Plan

All instructions in the PHS398 Application Guide must be followed.

Resource Sharing Plans

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) Sharing Plan) as provided in the PHS 398 Application Guide.


Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact - Overall

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria - Overall

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.


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?   


Are the PD/PIs, 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?  Do the investigators have documented experience with coordinating basic and translational research, particularly in the areas related to organ repair/regeneration?  Do(es) the PI(s) have prior experience with collaborative research?  Are new multidisciplinary teams organized to address novel questions relevant to lung repair/regeneration?


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? 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? 

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?    


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?  Does the applicant demonstrate significant experience coordinating complex research efforts, including logistical support for meetings and calls, data management systems, and the development and archiving of reports and other documents?  Does the applicant demonstrate significant experience in development of web sites for research programs, in communication of research results to other scientists, and in communicating scientific principles to the lay public?  

Additional Review Criteria - Overall

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/priority 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.


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 Allowed



 Not Allowed

Additional Review Considerations - Overall

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications will:

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. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awarde0es 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.      

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, 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.

PD/PI Responsibility:

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

NIH Staff Responsibility:

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

Areas of Joint Responsibility include:

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.

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939

Scientific/Research Contact(s)

Carol J. Blaisdell, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10042
Bethesda, MD 20892-7952
Bethesda, MD 20817 (express/courier zip service)
Telephone: 301-435-0222

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethsda, MD 20817 (express/courier service)
Telephone:  301-435-0270
Fax:  301-480-0730

Financial/Grants Management Contact(s)

David Duane
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7134
Bethesda, MD 20892-7926
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0166
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Section VIII. Other Information

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

Authority and Regulations

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.

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NIH Funding Opportunities and Notices

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