Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) Program Project Grant (P01) supports research related to fundamental processes and diseases of the heart, blood and lymphatic vessels, lungs, and blood, including transfusion medicine, blood resources, and sleep disorders and other programs including implementation science, health disparities, and translation research that address the mission of the Institute. This NOFO requires a minimum of three interrelated research projects that investigate a complex biomedical theme or research question. The projects may be supported by scientific cores, if justified, to facilitate economy of effort, space, and equipment. The NHLBI provides support for Program Project Grants (PPGs) in the belief that collaborative research efforts can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects that have no interaction or thematic integration.

NHLBI is particularly interested in encouraging new scientific directions in PPGs. Use of the P01 mechanism is viewed as an opportunity to attract and include scientists who traditionally have not been supported by the NHLBI. Further, the PPG environment presents an opportunity for emerging scientific leaders to gain insight into how to lead a successful scientific program, and applicants will have the opportunity to include a project led by an Early Stage Investigator (ESI). All projects in the Program must be interrelated and have objectives that address a central theme within the scientific mandate of the NHLBI.

Research Objectives

This Notice of Funding Opportunity (NOFO), issued by the NHLBI, invites PPG applications that address the mission of NHLBI as outlined in the Purpose section. Investigators are encouraged to visit the NHLBI website for additional information about the research mission and high-priority research areas of the NHLBI.

The purpose of the Program Project approach is to support integrated, collaborative research programs that have a well-defined, central research focus or objective. Applications must include a minimum of three individual research projects that contribute to the Program objective. Since the NHLBI is interested in supporting new, innovative research through the Program Project, no more than half of the Projects included in a funded Program Project Grant application may include Projects that significantly overlap in time and objectives with currently funded individual research project grants, i.e., individual research project grants that would have to be relinquished if the Program Project application is funded. Each individual research Project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator, the Project Leader. In addition, the individual Projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the Program as a whole will offer a distinct advantage over pursuing the individual projects separately. As part of this integration, the PD/PI (or each of the Multiple PD(s)/PI(s)) must also serve as the Project Leader of one of the Projects and each awarded Program Project must have a minimum of three distinct/individual Project Leaders.

In addition to individual research Projects, applicants may propose an Administrative Core and one or more shared Scientific Core(s) as necessary to facilitate the proposed research Projects. It is expected that each Scientific Core will be utilized by two or more Projects within the Program. Any proposed Scientific Core, if justified, is expected to be considered essential to conduct the Program and should not duplicate existing institutional resources. Responses to Frequently Asked Questions (FAQs) are available at: https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/program-project-grants.

Applications Not Responsive to this NOFO

Phase III and Phase IV Clinical Trials are considered non-responsive for this NOFO and will be withdrawn. Applications not responsive to this NOFO will not be reviewed.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

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

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

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

The PD(s)/PI(s) are expected to be a research scientist(s) 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(s)/PI(s), Project Leaders, and Core Leaders are expected to be fully established at their institution at the time of submission of the application. Additionally, Project Leaders are expected to have demonstrated the ability to lead an R01, or R01-equivalent, grant. The expectation of demonstrated ability to lead an R01, or R01 equivalent, grant does not apply to ESI Project Leaders or Core Leaders.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity 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.

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:

Program Project Review Office
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply- 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 How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: optional; maximum of 1
• Cores: optional
• Projects: minimum of 3
• ESI-Led Project: optional; maximum of 1

Overall Component

When preparing the application, 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)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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)

Follow standard instructions.

Project/Performance Site Locations (Overall)

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 and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

All PD(s)/PI(s) must be the Project Leader of one of the component Projects.

Note that multi-PD(s)/PI(s) are allowed for the Overall Program, however applicants must provide strong justification for the use of a multi-leadership model for the Overall Program. Multi-PDs/PIs for component Projects or Cores are not permitted in response to this NOFO.

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)

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)

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

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

Research Strategy: Describe the significance, innovation, and approach of the overall application and highlight the Program's conceptual unity by describing the scientific problems to be addressed and laying out a broad research strategy to address them. The Program Project 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 Program Project should be established in the first few sentences of this section. It should include a description of the major research objectives and strategic plan. Explain how the proposed Projects and shared Scientific Cores (if proposed and justified) 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.

Describe 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 Program Project, to describe how the Projects are interrelated, and to explain how the proposed Program Project would enable the stated objectives of the proposed research to be addressed more efficiently and effectively than a group of individual research project grants.

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(s) in the respective components of the application. The composite summary/progress report must include: a brief summary of major accomplishments that can be attributed to the Program Project 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(s), 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 Cores in the current Program Project. Identify each as a "new" or "continuing" component.

In addition, if an Administrative Core is not proposed, applicants must provide the information outlined in the Administrative Core Research Strategy section.

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 Plan forms.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

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

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type Admin Core.

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

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

SF424 (R&R) Cover (Administrative Core)

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 (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 specific component.

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 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.
• For this NOFO, only one Core Lead may be designated for the Administrative Core. Multiple Core Leads are not permitted. Applications that propose multiple Core Leads for the Administrative Core will be considered non-compliant and will not be peer reviewed.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package. Include budget information for Data Management and Sharing Costs, if applicable to the Administrative Core.

While there is no minimum effort required, the Core Lead 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 component.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core. In addition, state the Core’s relationship to the proposed Program’s goals and how it is related to the component Research Projects and Core(s) in the application.

Research Strategy: If an Administrative Core is not proposed, the following must be addressed in the Research Strategy of the Overall Program section. 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 Scientific Cores. Explain the plans for internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements (if applicable), and a plan for resolution of disputes. Describe how the Core Lead’s administrative, management, and leadership capabilities adequately provide for: internal quality control of on-going research, management of day-to-day program activities, and management of contractual agreements. Describe communication and cooperation among program leaders and/or program investigators, plans for resolution of disputes, development of scientific meetings and allocation of funds as applicable.

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 Cores. 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 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 Program Project Grant 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. 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, planning, and evaluation of the Program.

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

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 the PD/PI.

Administrative Core Progress: 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.

Letters of Support: Attach letters of support relevant to the Administrative Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. :

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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.

If including an ESI-led Project, please follow the instructions in the ESI-Led Project Section for that project.

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: 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) (Project)

List all performance sites that apply to the specific component.

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)

• In the Project Director/Principal Investigator section of the form, 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.
• For this NOFO, only one Project Lead may be designated on the application for an ESI-Led Project. Multiple Project Leads are not permitted. Applications that propose multiple Project Leads for any Project will be considered non-compliant and will not be peer reviewed.
• In general, each individual Project in a Program Project should have a different Project Leader. Although individual investigators are not precluded from leading more than one Project in a Program Project, strong justification must be provided for all such instances. In no case may one individual serve as Project Lead on more than two Projects. Each awarded Program Project must have a minimum of three distinct/individual Project Leads.
• All PD(s)/PI(s) must be the Project Leader of one of the component Projects.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package. Include budget information for Data Management and Sharing Costs, if applicable to the Project.

The Project Lead must devote a minimum of 2.40 person months (20% effort over 12 months) to the Project. If the Project Lead is also a PD/PI for the Overall Program, they must devote a minimum of 5% effort to one other component (e.g., another Project or a Core) for a total minimum of 3.0 person months (25% effort over 12 months). Applications that do not meet these minimum effort requirements for any Project will be considered non-compliant and will not be peer reviewed.

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 the Project component.

Specific Aims: List the broad long-range objectives and goals of the proposed research Project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual project's relationship to the Program’s goals and how it is synergistic to other projects and relevant cores.

Research Strategy: Use this section to describe the proposed research and how it will contribute to meeting the Program’s goals and objectives, and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application. In addition to the standard scientific description, the interactions among Projects and Core(s) must be described within each Project. Describe how inclusion of this Project within the Overall Program offers distinct advantage or scientific gain over pursuing the Project independently.

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 as provided in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information (Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

ESI-Led Project

An ESI-Led Project is optional and not required for submission of an application to this NOFO.

When preparing your application in ASSIST, use Component Type ESI-Led Project.

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

SF424 (R&R) Cover (ESI-Led 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 (ESI-Led Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (ESI-Led 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: 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) (ESI-Led Project)

List all performance sites that apply to the specific component.

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 (ESI-Led Project)

• In the Project Director/Principal Investigator section of the form, 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.
• For this NOFO, only one Project Lead may be designated on the application for an ESI-Led Project. Multiple Project Leads are not permitted. Applications that propose multiple Project Leads for the ESI-Led Project will be considered non-compliant and will not be peer reviewed.
• In general, each individual Project in a Program Project should have a different Project Leader. Although individual investigators are not precluded from leading more than one Project in a Program Project, strong justification must be provided for all such instances. In no case may one individual serve as Project Lead on more than two Projects. Each awarded Program Project must have a minimum of three distinct/individual Project Leads.
• All PD(s)/PI(s) must be the Project Leader of one of the component Projects.
• An ESI-Led Project is allowed only if a minimum of 4 total Projects comprise the Program and the Program must include at least 3 other Project Leaders who have demonstrated the ability to lead an R01 or R01-equivalent grant. Applications that include an ESI-Led Project with less than 4 total Projects comprising the Program will be considered non-compliant and will not be peer reviewed.
• The ESI Project Leader must have demonstrated independence. Evidence for independence may include:
  • The candidate has a full-time faculty position.
  • The candidate received a start-up package for support of his/her independent research.
  • The candidate has research space dedicated to his/her own research.
  • The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
  • The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.

Budget (ESI-Led Project)

Budget forms appropriate for the specific component will be included in the application package. Include budget information for Data Management and Sharing Plan, if applicable to the ESI-Led Project component.

The Project Lead must devote a minimum of 2.40 person months (20% effort over 12 months) to the Project. If the ESI Project Lead is also a PD/PI for the Overall Program, they must devote a minimum of 5% effort to one other component (e.g., another Project or a Core) for a total minimum of 3.0 person months (25% effort over 12 months). Applications that do not meet these minimum effort requirements for an ESI-Led Project will be considered non-compliant and will not be peer reviewed.

It is important to note that inclusion of an ESI as PD/PI for the Overall Program will result in the loss of the investigator's ESI status. Inclusion of an ESI as Project Lead but not PD/PI for the Overall Program will not result in a loss of ESI status. The budget allocations to an ESI Project must be at least $250,000 in direct costs.

Note: The R&R Budget form included in many of the component types allow 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 (ESI-Led Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the ESI-Led Project component.

Specific Aims: List the broad long-range objectives and goals of the proposed research project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual project's relationship to the Program’s goals and how it is synergistic to other Projects and relevant Core(s).

Research Strategy: Use this section to describe the proposed research and how it will contribute to meeting the Program’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the Project's relevance to the primary theme of the application. In addition to the standard scientific description, the interactions among projects and core facilities should be described within each Project. Describe how inclusion of this Project within the Overall Program offers distinct advantage or scientific gain over pursuing the Project independently.

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

Failure to include any of the following required letters will result in withdrawal of the application:

1. The ESI-Led Project must include a statement from the Overall PD(s)/PI(s) describing how the participation in the Program provides a good leadership skills development environment and how the ESI Project Leader's scientific and professional career development will be enhanced through participation in the Program.

2. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, outstanding investigator, provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s planned career development and research programs, and include a statement that the candidate is eligible to apply as the PD/PI for an independent research grant.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information (ESI-Led Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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 (Core)

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 (Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (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) (Core)

List all performance sites that apply to the specific component.

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 (Core)

• 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.
• For this NOFO, only one Core Lead may be designated on the application for a Scientific Core. Multiple Core Leads are not permitted. Applications that propose multiple Core Leads for any Scientific Core will be considered non-compliant and will not be peer reviewed.

Budget (Core)

Budget forms appropriate for the specific component will be included in the application package. Include Data Management and Sharing Plan costs, if applicable to the Scientific Core.

While there is no minimum effort required, the Core Lead should dedicate appropriate time and effort commensurate with the complexity of the Scientific 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 (Core)

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

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Scientific Core. In addition, state the Scientific Core’s relationship to the proposed Program’s goals and how it is related to the individual Research Projects and Cores in the application.

Research Strategy: The application should list the Projects the Scientific Core will serve and services it will provide. Scientific Cores must accelerate the pace of discovery via essential support for the aims of proposed research Projects. Hypothesis-driven aims are not required for Scientific Cores. Research activities should only be conducted in the research projects.

Describe the function of the Scientific Core as a resource to the Program Project. Describe the facilities, techniques, and skills the Scientific 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. Provide justification for the essential nature of this Scientific Core for the Program. Scientific Core activities should not duplicate existing institutional resources.

Letters of Support: Attach letters of support relevant to the Scientific Core. Each proposed Scientific Core must include an institutional letter from the Department Chair/Division Head/Dean documenting the need for the Scientific Core and must include information regarding other related Core facilities that are currently provided at the Institution. Each proposed Scientific Core should include a separate letter. Failure to include the required letter(s) will result in withdrawal of the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information (Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply- Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How To Apply- Application Guide.

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

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

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

Applicants to this NOFO should be prepared to:

1. Discuss the proposed Program Project Grant application with NHLBI program, review, and grants management staff via an in-person meeting or a conference call (i.e., staff consultation). Potential applicants are strongly encouraged to begin informal discussions with NHLBI scientific staff as early as possible in the process of planning their proposed research application, but no less than 10 weeks prior to the submission deadline. The formal staff consultation: (1) ensures that the NHLBI receives applications that are scientifically aligned with the Institute’s mission and strategic vision and (2) enables the Institute to consider the budgetary impact of supporting such a Program. NHLBI staff will not evaluate the technical and scientific merit of the proposed application/Program; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO.

2. Submit a letter of request to the NHLBI. After the formal staff consultation, the intended applicant(s) submit a letter of request (as a PDF attached to an email) to the Director of the NHLBI extramural Program Division whose research mission is most relevant to the proposed topic (Scientific/ Research Contact). This letter serves as the formal request seeking permission to submit an application with direct costs of $500,000 or more in any one year.

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

4. Applicants must include a cover letter with the application that identifies the NHLBI Program staff member(s) with whom they have been in contact regarding the application along with a copy of the written agreement letter from NHLBI. If the Subtotal Direct Cost on the cover page of the application exceeds the amount the NHLBI agreed to accept, the application may be withdrawn or not awarded.

Instructions for Resubmission (Amended) Applications

The NHLBI’s decision to accept a $500K application for peer review for a specific receipt date automatically allows for the submission a single amended application (i.e., an A1 application), provided that

1. the submission of the A1 application occurs within 37 months of the original receipt date for the initial new (A0) application, in accordance with NOT-OD-10-140,
2. the originally proposed research plan remains unchanged, and
3. the total direct costs per year do not exceed the amount the NHLBI originally agreed to accept (excluding increases in PI salaries due to changes to the NIH salary cap, if the new budget does not exceed the program project grant (PPG) cap of $1.515 million in direct costs in any one year). PPG applications including an Early Stage Investigator (ESI) as a Project Leader may have budget cap of up to $1.765 million per year if at least four projects are included in the application.

Contingent on meeting the three requirements above, an applicant intending to submit an amended (A1) application does not need to participate in another staff consultation or submit another letter of request. However, the NHLBI requests that every applicant intending to submit an A1 application first submit a letter of intent to the NHLBI so the Institute can plan for the receipt, referral, and review of the A1 application.

The applicant must initiate a new round of discussions with Institute staff (i.e., a staff consultation) and submit a new letter of request if:

• A resubmission (A1) application does not meet all three conditions above, OR
• The resubmission (A1) application proposes to add an ESI-led subproject when the initial new (A0) application did not, and the budget increases
• If a resubmission (A1) application does not meet all three conditions above, the applicant must initiate a new round of discussions with Institute staff (i.e., a staff consultation) and submit a new letter of request.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

All NHLBI Program Project Grant applications are reviewed through a two-step process by a Tailored Review Committee and by the Heart, Lung, and Blood Program Project Review Committee (HLBP) prior to review by the NHLBI Advisory Council.

The Tailored Review Committee is composed of scientific peers convened to review a Program Project application in their area(s) of expertise. The Tailored Review Committee will:

• Provide an overall assessment of each Project based on its intrinsic and scientific merit within the field and provide a percentile descriptor ranking score of that Project broken down into seven categories (i.e., top 1% of projects within the field, 1%-10% of projects within the field, 10-20% of projects within the field, 20-30% of projects within the field, 30-40% of projects within the field, 40-50% of projects within the field, and 50%+ of projects within the field).
• Assign numerical scores to each scored criterion and provide written critiques of the strengths and weaknesses of the scored review criteria.
• Rate each Core as "Recommended" or "Not Recommended" based on whether it is essential and justified for the proposed research and has the capability to fulfill the proposed function (reviewers will evaluate the number of Projects serviced by the Core; the Core must service two or more Projects).
• Assess whether the proposed budget is appropriate.

The HLBP considers the review reports from the Tailored Review Committee, makes recommendations, and assigns an overall impact score to each application. It may not change an individual Project assessment assigned by the Tailored Review Committee, but it is asked to provide written comments to be included in the summary statement if HLBP's impression of project merit significantly differs from the Tailored Review Committee.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

The Heart, Lung, and Blood Program Project Review Committee (HLBP) will consider each of the specific considerations below and the evaluation of the Tailored Review Committee in the determination of scientific and technical merit, and in providing an overall impact score. 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.

Is the Program as a whole scientifically compelling? Are there coordination and synergy of the individual research Projects and Cores towards the achievement of the central objectives of the Program? Will the integration of the individual Projects into a single Program be more beneficial than pursuing each Project independently? Do(es) the Program Director(s)/Principal Investigator(s) have the leadership and scientific ability to develop an integrated and focused research Program? Will the PD(s)/PI(s) devote adequate time and effort to the Program? Is there adequate evidence of sufficient institutional support for the PD(s)/PI(s)? For applications designating multiple PD(s)/PI(s), are there adequate and appropriate coordination and communication among the PD(s)/PI(s)? For renewal applications, have the Program's accomplishments made a major impact on the field or successfully achieved their original goals? Are the administrative and organizational structures sound?

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Review Criteria for Individual Research Projects Within the Program

The Tailored Review Committee will consider each of the six review criteria below in the determination of scientific and technical merit of each proposed research project, and give a separate numerical (1 to 9) score for each criterion. A project 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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications proposing an ESI-Led Project

Based on the investigator's prior research and training experience, track record, supporting letters, and the quality and originality of prior research and the current application, what is the investigator's potential to become a highly successful investigator who will contribute significantly to his/her research field? Will inclusion of the investigator in this Program enhance his/her career development scientifically and professionally? How capable does the applicant appear to be with respect to conducting independent research?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications proposing an ESI-Led Project

Do the Program and institution provide a high-quality environment appropriate for the investigator's scientific and professional development? Is there adequate evidence that the Program and institution are strongly committed to fostering the investigator's development scientifically and professionally?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Integration

How well-integrated is the Project within the Program? Does inclusion of this Project within a Program offer distinct advantage or scientific gain over pursuing the Project independently? Is the Project interrelated and synergistic within the overall Program? How well does the Project fit into the overall theme of the Program?

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 (the Core 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 and have dedicated appropriate time and effort commensurate with the complexity of its functions; and whether the proposed budget for the Core is appropriate.

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? Does the required institutional letter sufficiently justify the necessity of the Scientific Core for this Program or can the Core services be accomplished through other means?

Additional Review Criteria - Overall, Administrative Core, Scientific Core(s), Projects, and ESI-Led Project

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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, reviewers 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, reviewers will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall, Administrative Core, Scientific Core(s), Projects, and ESI-Led Project

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 NHLBI, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with resource sharing policies.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

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

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

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

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

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

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

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

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Division of Cardiovascular Sciences

Michelle Olive, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-443-7933
Email: [email protected]

Division of Lung Diseases
James Kiley, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0233
Email: [email protected]

Division of Blood Diseases and Resources
Julie A. Panepinto, MD, MSPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 202-450-9015
Email: [email protected]

Center for Translational Research and Implementation Science

George Mensah, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-1051
Email: [email protected]

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

Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8014
Email: [email protected]

Section VIII. Other Information

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

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