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)

Funding Opportunity Title

Translational Programs in Lung Diseases (P01)

Activity Code

P01 Research Program Projects

Announcement Type

Reissue of PAR-09-185

Related Notices
  • June 6, 2014 - This Notice provides details for applicants regarding additional information on eligibility and on review criteria for PAR-14-245. See Notice NOT-HL-14-226.
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-245

Companion Funding Opportunity

None

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

93.838, 93.233

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites submission of Program Project (P01) applications from institutions/organizations that will perform collaborative, translational research with the goal of using mechanistic research as the basis for the rational design of clinical applications to improve prevention, diagnosis and/or treatment of lung diseases and sleep disorders. 

Key Dates
Posted Date

June 3, 2014

Open Date (Earliest Submission Date)

August 22, 2014

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 22, 2014; May 19, 2015; September 22, 2015; May 19, 2016; September 22, 2016; May 19, 2017, 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

February 2015, October 2015, February 2016, October 2016, February 2017, October 2017

Advisory Council Review

May 2015, January 2016, May 2016, January 2017, May 2017, January 2018

Earliest Start Date

July 2015

Expiration Date

May 20, 2017

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

Basic biomedical research has advanced rapidly with the advent of new technologies that have made it possible to examine biology and pathobiology at the molecular, cellular, and system levels in an unprecedented manner.  Researchers have successfully "translated" some of these research findings into the development of new therapeutics and treatments strategies that reduce morbidity, and, in some cases, significantly prolong survival.  However, for the most part, this wealth of new found knowledge has not been used to its full potential to improve prevention, diagnosis, and treatment of pulmonary diseases. Translational research, defined as applying new knowledge and techniques, generated by advances in basic research to application in the clinic to improve health, is not a straightforward process, and there are barriers to fulfilling the promise of translational research.  Multidisciplinary approaches are needed that bring together basic and clinical researchers in an interactive effort to enable the transfer of new found insight from basic to clinical application.

Research Objectives

The purpose of this translational program project grant (tPPG) program is to encourage interdisciplinary approaches to lung translational research, allowing for potentially high-impact research, which will translate basic observations to novel clinical application(s).  A P01 application in response to this FOA requires a minimum of three interrelated research projects that focus on the development of specific, novel clinical application(s) that will significantly improve the diagnosis and/or management of lung and/or sleep diseases.  The program is not discovery based and does not encourage mechanistic research into lung biology and/or pathobiology without an emphasis on development of a specific clinical application.  Applicants will be required to propose research that will become progressively more clinical and translational during the life of the tPPG, and they are expected to assemble interactive, multidisciplinary teams that have the combined expertise to formulate a plan for development of the proposed clinical application(s).  Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, practical approach that will result in the effective progression of mechanistic/basic concepts toward application in the clinic. 

This program allows for a maximum of two 5-year awards (a new application and a renewal for existing tPPGs).  The first 5-year grant cycle (Cycle I) will require a clinical/translational research component (at least 25% of the total research proposed) as defined by the PHS 398 for human subjects (http://grants1.nih.gov/grants/funding/phs398/phs398.pdf) that will test the potential of basic research observations for evolution into clinical application for the prevention, diagnosis or treatment of lung and/or sleep diseases.  In the second grant cycle (Cycle II), applicants seeking a renewal of an existing tPPG, or those applying directly for Cycle II, will further develop their project into a program with a significant clinical/translational research component (at least 50% of the total research proposed).  Applications that extend to the conduct of Phase I and Phase II clinical trials are encouraged.

Applications that address basic mechanistic questions of disease pathology without identification of a specific clinical application for development or without a translation plan that includes milestone(s) are not appropriate and will not fulfill the goals of this FOA.

Examples of research objectives that are encouraged through this program include, but are not limited to, the following:

  • Development of therapeutics for lung diseases that derive from studies of regenerative medicine which examine basic mechanisms of derivation and directed differentiation.
  • Identification and development of biomarkers of lung disease susceptibility or progression and/or targets for potential therapeutics from mechanistic studies of the pulmonary and/or immune systems.
  • Genomic, proteomic, metabolomic or imaging approaches for phenotyping lung diseases that lead to more accurate prognostic methodologies or guide targeted interventional procedures.
  • Characterization of epigenetic phenomena that influence disease susceptibility and progression of lung diseases with potential approaches to their clinical manipulation, leading to new diagnostic and/or treatment options.
  • Natural history studies of disease onset and/or progression which include mechanistic questions pertaining to susceptibility and/or pathophysiology that lead to new or improved modalities for diagnosis and/or treatment response.
  • Studies of lung and sleep diseases which lead to the development of relevant surrogate biomarkers that can predict safety and efficacy of therapeutic candidates.
Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal: One competing renewal is allowed for Cycle I programs. There is no competitive renewal for Cycle II programs.  Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but it is recommended that applicants not request a budget of more than $1.75 million per year direct costs (exclusive of F&A costs associated with consortia) for a maximum of $8.75 million directs costs over a five-year project period.

Award Project Period

The project period is 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

  • 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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.  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.

Eligible Individuals (Program Director/Principal Investigator)

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.

The PD/PI must be a research scientist of recognized stature in his/her scientific discipline with the demonstrated ability to ensure quality control, administrative oversight, and integration of all components of a Program.  The PD/PI, Project Leaders, and Core Leaders must be fully established at their institution at the time of submission of the application. 

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 a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept 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.

New applications applying for the first cycle:  At least 25% of the proposed program project must be clinical research.

Renewals or new applications applying directly for the second cycle:  At least 50% of the program project must be clinical research unless requesting a specific exception for preclinical development activities.  Cycle II applicants, see Section I for requesting an exception.

Applicants that have a mature translational program may apply directly for Cycle II and should clearly state that the application is for a Cycle II program.   Cycle II applications are eligible for only one cycle of this program.    

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

12

Core (use for Scientific Cores)

6

Project

12

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall Program:  required
  • Administrative Core:  required
  • Scientific Cores:  optional
  • Projects:  minimum of 3 required
Overall Program

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall Program)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall Program)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall Program)

Follow standard instructions.

Project/Performance Site Location(s) (Overall Program)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall Program)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.  The contact PD/PI will be expected to devote 3.0 calendar months (25% effort) in total to the overall Program. 

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall Program)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall Program.

Specific Aims: Describe the specific aims for the Overall Program as a whole. List the goals of the research and summarize expected outcomes.   

Research Strategy: The program overview section describes the significance, innovation and approach of the overall Program Project Grant (PPG) application and should highlight the program's conceptual unity by describing the scientific problems to be addressed and laying out a broad research strategy to address them.  A PPG should be viewed as a group of interrelated research projects, each of which is not only individually meritorious scientifically but also complementary to and interrelated with the other projects in the research program that contribute to the integrating theme. The theme of a proposed PPG should be established in the first few sentences of the general introduction. It should include a description of the major research objectives and strategic plan. Explain how the proposed projects and shared resource cores (if proposed) will be coordinated and work together to address the overall goals and aims of the program more effectively than if the projects were conducted independently.

The Overall Program overview is the appropriate place to indicate any prior collaborative arrangements between investigators in the group, to explain the genesis of the current application, to predict the anticipated unique advantages that would be gained by the research within the proposed PPG, to describe how the projects are interrelated, and to explain how the proposed PPG would enable the stated objectives of the proposed research to be addressed more efficiently and effectively than a group of individual research project grants.

It is not expected that all basic concepts will translate into direct clinical application within the two 5-year cycles.  However, promising initial findings, the intent to translate, the type of application envisioned, and a stepwise plan for progression that demonstrates feasibility and readiness must be described.  If appropriate, a discussion of anticipated interactions with federal regulatory agencies or other partners should be included as well as intellectual property issues.  Applicants are encouraged to leverage other programs such as NHLBI SMARTT https://www.nhlbismartt.org/), NIH Centers for Accelerated Innovations (NCAI), and the National Center for Advancing Translational Sciences (NCATS) as well as other federal and non-federal programs.  Cycle II applications should include plans for development beyond the end of the project period (i.e., engagement of development partners, clinical trial planning/execution).

Translation Plan: All applications must include a translation plan, as a section in the Program Introduction, that discusses how expected results will specifically inform the development of new diagnostic, prognostic or therapeutic strategies for lung and/or sleep diseases.  The applicant must discuss the ultimate goal of the particular research program:  the development and application of a specific product or output (e.g., small molecules, biologics, methodologies to be used in the prevention, diagnosis or treatment of lung and/or sleep diseases) and outline a progression for achieving this goal.  Project milestones, which will be used to monitor progress, must be included. 

Direct to Cycle II Applications: Applications that have a mature translational program may be submitted directly for the second cycle (Cycle II) and should clearly state that the application is for a Cycle II program. Cycle II applications that are in the preclinical development phase are expected to progress to filing of an Investigational New Drug (IND) by the end of the project period.  Cycle II applicants may request an exception to the 50% clinical research requirement only if they are planning that >50% of the projects will be devoted to preclinical development activities (e.g. non-GLP or GLP pharmacology/toxicology studies and/or non-GMP/GMP synthesis/production).  However, Cycle II applications proposing these activities will still be required to conduct at least 25% clinical research as described above for Cycle I.  Concomitant activities such as (but not limited to) the development of diagnostics to monitor safety and responsiveness, and definition of patient populations should still be addressed.  The exception must be requested, with a detailed rationale that includes evidence of gap analyses and regulatory planning and engagement of appropriate resources to conduct the proposed activities. Depending on the structure of the proposed program, it may be appropriate and is acceptable to have preclinical activities conducted in the proposed cores.  In this structure, it is expected that the projects will adhere to the 50% clinical research requirement.   Cycle II applications proposing preclinical activities should demonstrate appropriate resources and expertise to conduct the proposed activities with appropriate regulatory oversight and input. Cycle II applications should also include activities that are expected to extend beyond the end of the grant project (e.g. commercial partnering, clinical  trial planning and conduct) that will continue to facilitate development.

Summary Report of Progress: For renewal applications only, include a progress report that summarizes the aims and accomplishments of the Program during the prior funding period. See the SF424 instructions for details about what to include in the progress report. If a project from the prior funding period is being discontinued, explain in the overall progress report. A progress report is required for each research project and core unit in other sections of the application. The composite summary/progress report must include: a brief summary of major accomplishments that can be attributed to the PPG and a brief explanation of how they relate to the stated objectives of the Program; a list of changes, if any, in the professional staffing since the last competitive review; a list of research projects and core units, in tabular form, that have been discontinued, modified, or completed since the last competitive review, identified by number and title, with a brief explanation of the actions taken; and a list of research projects and core units in the current PPG, with the amount of current funding for each and the requested funding for the first budget period of each project and core unit that would be continued in the PPG. Identify each as a "new" or "continuing" component.

Progress Report Publication List: Include a list of publications that arose from this Program during the prior funding period.

Letters of Support: Attach letters of support relevant to the Program as a whole (e.g., letters of institutional support).  Letters of support relevant to specific projects or cores should be attached in the relevant Project or Core research plans.

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.

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.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components..

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the Administrative Core.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Leadand provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • For this FOA, only one Core Lead may be designated on the application for the Administrative Core.  Multiple Core Leads are not permitted  

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.  The Core Leader should dedicate appropriate time and effort commensurate with the complexity of the Core's function

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Administrative Core.

Specific Aims: Describe the specific aims for the Administrative Core.   

Research Strategy: The institution and the PD/PI are responsible for the application and collaborative research activities.  Explain the plans for organizational and administrative management of the entire Program, and for coordination and communication within the Program.  Explain the methods that will be used for monitoring progress in the projects and effective use of the shared resource cores.

Chain of Responsibility: Describe in detail, and by diagram, if appropriate, the chain of responsibility for decision making and administration, beginning with the PD/PI and including the leaders of the research projects and core units. Indicate where, in the chain of responsibility, advisory groups (internal and external consultants) would be used, and describe their function in ensuring quality control in the research efforts.

External and Internal Advisory Boards: Every Program Project Grant should have plans for both an External Advisory Board and an Internal Advisory Board. For an External Advisory Board, describe the expertise and responsibilities of your potential Board members. If submitting a new application, do not contact, recruit, or name potential members of the External Advisory Board.  New PPG applications should not constitute an External Advisory Board prior to or during the review of their application because individuals identified in an application cannot participate in its peer review. Renewal applications should provide the names of current and former members. The External Advisory Board should consist of two or three named advisers committed to the evaluation of the program by written documentation. Two or three additional advisers may be added once the progress of the program and its needs are clearer. The Internal Advisory Board should consist of three to five members outside of the Program but within the applicant institution who are able to assist in frequent, ongoing oversight.

Specific Managerial Responsibilities: Indicate who would be responsible for assisting the PD/PI with day-to-day administrative details, program coordination, and planning and evaluation of the program.

Relation of the Program Project Grant to the Administration of the Applicant Institution: Describe the relation between the proposed Program Project Grant and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.

Relation of Core Units to Research Projects: In tabular form, provide information as to which research projects each core unit would serve and the proportion of the cost of the core unit associated with each research project.

Designation of Replacement for PD/PI: Describe the procedure for selecting a proposed replacement for the PD/PI, should the need arise. The NHLBI must approve any request to replace thePD/PI.

Administrative Core Progress: (For renewal applications only.)  A progress report must be provided for the Administrative Core in renewal applications. Provide the beginning and ending dates of the most recent award period. Summarize the specific aims of the core during this period and the importance of the accomplished activities. Provide justifications for major changes in the core

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.

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.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Scientific Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Scientific Core)

Complete only the following fields:

  • Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Briefly describe how the core helps the program meet the public health goals of NHLBI.

Project /Performance Site Location(s) (Scientific Core)

List all performance sites that apply to each Scientific Core.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scientific Core)
  • For this FOA, only one Lead may be designated on the application for a Scientific Core.  Multiple Core Leads are not permitted. 
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific Core)

Budget forms appropriate for the specific component will be included in the application package.  While there is no minimum effort required, the Core Leader should dedicate appropriate time and effort commensurate with the complexity of the Core's Function.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Scientific Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each Scientific Core.

Specific Aims: Describe the specific aims for the Scientific Core.

Research Strategy: A Scientific Core must be utilized by a minimum of two research projects. The application should list the projects it will serve and services it will provide. A Scientific Core must accelerate the pace of discovery via essential support for the aims of proposed research projects. Hypothesis-driven aims are not required for a Scientific Core.

Describe the function of the Scientific Core as a resource to the PPG. Describe the facilities, techniques, and skills the core will provide and the role of the Core Leader and each key participant. State the percentage of total dollars required to support each project that will use each Scientific Core. Explain why the inclusion of this Scientific Core is essential to two or more of the individual research projects and to the entire Program.

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.

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.

Planned Enrollment Report  (Scientific Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Scientific Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Project)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Briefly describe how the project meets the public health goals of the NHLBI.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to each Project.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

  • For this FOA, only one Lead may be designated on the application for a Project.  Multiple Project Leads are not permitted. 
  • The PD/PI must also be the Project Leader of one of the Projects.
  • In the Project Director/Principal Investigator section, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.   The Project Lead will be expected to devote 2.40 calendar months (20% effort) to the Project.   

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each Project.

Specific Aims: Describe the specific aims for each Project.

Research Strategy: In addition to the standard scientific description, the interactions among Projects and Core(s) should be described within each Project.

Significance: Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventive interventions that drive the field will be changed if the proposed aims are achieved.

Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).

Approach: Describe the overall strategy, methodology, and analysis to be used to accomplish the specific aims of the project. Unless addressed separately in another section, include how the data will be collected, analyzed, and interpreted. In so far as possible, describe the experiments in the sequence in which they would be conducted. (It is important to convey to the reader that the proposed effort would require the time requested for the project period.) Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. 

If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.

Preliminary Studies for New Projects: For new projects, include information on Preliminary Studies as part of the Approach section.  Discuss the preliminary studies, data, and/or experience pertinent to this project.  Preliminary data can be an essential part of a project application and help to establish the likelihood of success of the proposed project.

Progress Report: For renewal applications only. Include a Progress Report that discusses the progress in this Project during the prior funding period, and the rationale for significant changes that may have occurred during the prior funding period.

Progress Report Publication List:  Include a list of publications that arose from this Project, during the prior funding period.

Letters of Support:  Attach letters of support relevant to the Project.

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.

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.

Planned Enrollment Report (Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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) using ASSIST or other electronic submission systems. 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.

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.

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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, NIH. Applications that are incomplete will not be reviewed.

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

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

1.  Contact the NHLBI Scientific/Research staff at least 3-4 months before submitting the application, i.e., as plans are being developed for the study; plan to discuss the proposed research project with NHLBI program via an in person meeting or a conference call; NHLBI staff must discuss plans with the applicant prior to granting permission to submit.

2.  Obtain agreement from the NHLBI that the Institute will accept the application for consideration for award.

3.  Include a cover letter with the application that identifies the NHLBI and the staff member who agreed to accept assignment of the application.

The instructions in this section apply to all new and renewal applications.

Please note that application budgets are not limited, but it is recommended that applicants not request a budget more than $1.75 million direct costs per year for both Cycle I and II applications.  As with new awards, no annual increases in noncompeting years may be requested.

Standard PPG

Translational Programs in  Lung Diseases (P01)

NHLBI approval           

required for submission over $500,000/year

Required

Required

Multi-disciplinary team

Not required

Expected

Prior collaboration among team members

Expected

Not required

Clinical research

Not required

Expected

Translation Plan

Not required

Required

Structure

Projects & Core(s)

Projects & Core(s)

Budget

$1.515 million direct costs per year, suggested maximum

Cycle I and II:  $1.75 million direct costs per year, suggested maximum

Duration

Not limited

2 grant cycles (10 years max.)

Review Criteria

Standard

Standard plus translation plan and, if applicable, justification for <50% clinical research in Cycle II applications due to preclinical development activities in projects.


Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

All Translational Program Project Grant applications are reviewed by a Tailored Review Committee.

The Tailored Review Committee is composed of scientific peers convened to review a group of Program Project Grant applications with similar content.

Overall Impact - Overall Program

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program proposed).

Scored Review Criteria - Overall Program

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 program that by its nature is not innovative may be essential to advance a field.

Significance

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program 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 program? 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 program?  

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 program? 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 program 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?     

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?   

Additional Review Criteria - Overall Program

As applicable for the program 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.

Does the application adequately describe the scientific merit of each research project and core and the Program as a whole? Are the Overall Program goals and scientific questions appropriate to a Program Project Grant? Are the scientific gains and potential improvements to the field achieved by combining the component projects into a multi-project program beyond the gains achievable if each project were pursued independently? Is the Program cohesive with the research projects and cores fitting into a common theme?  Does the PD/PI have sufficient time, effort, leadership ability, and scientific talent to develop a Program of integrated research projects with a well-defined central research focus?  For renewal applications, have the Program's accomplishments had  major  influence on the field or successfully achieved their original goals?   Are the administrative and organizational structures sound?

Translation Plan:  Will the results promote or enable the clinical application of basic scientific research? Is a specific clinical application for development described?  Is there a plan that effectively describes the expected evolution of the proposed research to application in the clinical or public health arena?  Are appropriate milestones for monitoring progress described? Is the expected translation of research results feasible?  Are anticipated interactions with regulatory agencies and/or other partners discussed, if appropriate?  Are appropriate project milestones proposed?  Do Cycle II applications include a discussion of development after the end of the TPPG?  What is the potential to improve disease burden in terms of public health?

If GLP and/or GMP activities are planned, have gap analyses been performed and has the FDA been consulted in the development of the preclinical activities?  Has the appropriate expertise been included to perform proposed activities?

Review Criteria for Individual Research Projects
Scored Review Criteria- Project

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/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?

Innovation

Does the Project 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?  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?

Review Criteria for Core Units Within the Program

Each Core will be evaluated as "Recommended" or "Not Recommended" based on whether it is essential for the proposed research and has the capability to fulfill the proposed function. Reviewers will evaluate the number of projects serviced by the core unit (the core unit must service two or more projects); strengths and weaknesses of the proposed approaches, resources, and interactions; whether the investigators are qualified for their role(s) in the core unit and have dedicated appropriate time and effort commensurate with the complexity of its functions; and whether the proposed budget for the core unit is appropriate.  While the core units will not receive numerical criterion scores, they will be considered in determining the overall impact score for the entire application.

Administrative Core

Does the application clearly describe and justify the proposed Administrative Core operational plan and organizational structure? Is the proposed Administrative Core adequate to accomplish the objectives of the Overall Program? How well does it fit into the central focus of the Overall Program? Do the Administrative Core Leader’s administrative, management, and leadership capabilities adequately provide for: internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements, fair, effective communication and cooperation among Program leaders and/or Program investigators, resolution of disputes, development of scientific meetings and allocation of funds?

Scientific Core(s)

Is the Scientific Core sufficiently justified? Does it support at least two research projects? Is the core adequately connected to the central focus of the overall program? Are the facilities or services provided by the core (including procedures, techniques, and quality control) high quality? Will the services be used effectively? Are the Scientific Core leader and key personnel well qualified and is there an adequate commitment of time?

Additional Review Criteria - Overall Program, Administrative Core, Scientific Core(s), and Projects

As applicable for the Overall Program, Project, or Core 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed program 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.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

For renewal applications, the progress should be evaluated for accomplishment of objectives for each of the prior projects, cores, and the Overall Program. Have investigators clearly and concisely described, for each project, core, and Overall Program the specific aims, whether they were achieved, and what peer-reviewed articles were published that present the data related to those specific aims? Were the data published in high-impact journals? Were the quality and quantity of publications resulting from the prior center grant appropriate for the research that was proposed?

Revisions

Not Applicable

Additional Review Considerations Overall Program

As applicable for the program 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.

2. Review and Selection Process

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.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this 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:

  • 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.
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’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.

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

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Patricia Noel, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: noelp@nih.gov

Peer Review Contact(s)

Chief, Review Branch
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:  301-435-0270
Email:  nhlbichiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Beckie Chamberlin
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0183
Email: chamberr@nhlbi.nih.gov

Section VIII. Other Information

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

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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.