Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of the NHLBI Outstanding Investigator Award (OIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors (PDs)/Principal Investigators (PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrate their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The NHLBI OIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards.

The NHLBI OIA will support the research program of NHLBI-funded investigators for up to seven years. The NHLBI OIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the NHLBI OIA should be within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission), sleep disorders closely-coupled to HLB outcomes, or basic sleep and circadian regulation.

The NHLBI is issuing a companion R35 FOA (RFA-HL-16-025) for investigators with two NHLBI R01 awards, of which one is an NHLBI-funded NIH Early Stage Investigator R01 award.

This FOA is intended for established investigators who have the potential to conduct outstanding, innovative research. For this reason, eligibility is limited. Please refer to Section III. Eligibility Information for specific details.

It is anticipated that the NHLBI OIA will:

• Provide a stable funding environment, thereby improving productivity and facilitating ambitious, creative research;
• Increase scientific innovation by enabling flexibility in pursuing new research directions as they arise, since PDs/PIs will not be bound to specific aims proposed in advance of the studies;
• Reduce the time researchers spend writing grant applications and managing multiple grant awards, thereby allowing more time to be devoted to conducting research;
• Facilitate PDs/PIs commitment to research through increased stability of funding; and
• Enable PDs/PIs to devote more time and energy to mentoring junior scientists and providing scientific service.

An NHLBI OIA is intended to be the primary, and in most cases, sole support for all of the NHLBI-related research conducted by an investigator. Research supported through the NHLBI OIA should be related to HLB research as described within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission), sleep disorders closely-coupled to HLB outcomes, or basic sleep and circadian regulation. Within these bounds, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research. Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component requires prior approval of NHLBI staff according to existing policies and procedures.

It is expected that the OIA will replace current NHLBI funding on other NHLBI individual research grants, with a limited number of exceptions as described below. NHLBI investigators with additional NIH support from other ICs are welcome to apply, however funds cannot be requested through the NHLBI OIA for activities supported by another NIH Institute or Center, federal or state agency, or private foundation. PDs/PIs will be expected to renegotiate their time and effort on other (non-NHLBI) NIH grants in order to accommodate the required NHLBI OIA level of effort.

The amount of a NHLBI OIA will be determined by NHLBI, based on the recommendations of the study section, the National Heart, Lung, and Blood Advisory Council (NHLBAC), and evaluation of the needs, expected productivity, and impact of the proposed research program. NHLBI will continue to implement the NIH $1,000,000 total direct cost Special Council Review policy in considering all sources of investigator support (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html).

The OIA is designed to be budget-neutral for the NHLBI. Thus, it is anticipated that the amount of an NHLBI OIA may be slightly less than the sum of all recent NHLBI support in order to accommodate budget neutrality. For some applications, exceptions may be considered and, in well-justified cases, NHLBI OIA support may somewhat exceed the level provided by the current awards. However, it is important to note that the level of support provided by the OIA will remain stable over the project period, unlike the often fluctuating level of support provided by a collection of individual grants.

Investigators should balance potential slight reductions in funding against the benefits of the award when deciding to apply. Benefits include:

• NHLBI OIAs will be for seven years instead of the current NHLBI average of four years;
• Support for other currently-funded NHLBI research grants of the individual PD/PI will be folded into the OIA and will thereby be renewed;
• Increased flexibility to pursue new ideas and opportunities as they arise during the course of research, since the OIA is not tied to specific aims or predicated on completing specific, pre-defined projects;
• A reduction in administrative burden associated with writing multiple grant applications and managing multiple grant awards.

It is anticipated that the NHLBI OIA will be highly competitive. To prevent a lapse in funding, a PD/PI can submit an R01 application and an NHLBI OIA application in parallel. Should both applications be selected for funding, the PD/PI will be permitted to accept only one of the awards. The NHLBI will not consider funding future individual PD/PI research grants from an NHLBI OIA awardee during the NHLBI OIA project period, except for applications included under the list of exempted awards below. To clarify which awards are exempted from this policy, applicants are strongly encouraged to contact NHLBI staff.

Since an NHLBI OIA is intended to provide the primary, and most likely sole, source of NHLBI funding on individual grant awards, most existing NHLBI grants (e.g., R01s, R03s, etc.) will be incorporated into the OIA award. However, the OIA does not eliminate the eligibility of the PD/PI for the following separate sources of NHLBI funding:

• Grants supporting research resources (e.g., P30, R24, or U24 awards);
• Contracts;
• Selected cooperative agreements;
• Grants supporting training, workforce development or diversity building (Note: individual career development grant mechanisms are not permitted except for the NHLBI K24 award [http://www.nhlbi.nih.gov/research/training/programs/established/mid-career-k24]);
• Clinical trials;
• SBIR/STTR grants;
• Conference grants;
• Multiple-PD/PI grants;
• NHLBI program project or center grants;
• Administrative Supplements;
• Applications submitted in response to selected targeted research programs (eligible FOAs to be determined by the NHLBI in consultation with the NHLBAC).

Research Not Supported by the NHLBI OIA

The following types of projects are not responsive to this FOA and will not proceed to review:

• Research outside the scope of the NHLBI mission; and
• Research that meets the NIH clinical trial definition (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).
• Please see https://wcms.nhlbi.nih.gov/research/funding/opportunities for a list of all available FOAs in which NHLBI participates, including those that support clinical trials.

Renewals: This NHLBI OIA (R35) program is considered a pilot; renewal applications will likely be permitted should the NHLBI continue this program beyond the pilot.

Supplements: NHLBI OIAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, and other types of administrative supplements, including equipment supplements that may be offered by the NHLBI through FOAs in the NIH Guide. Awardees are expected to reallocate existing resources to accommodate new research directions. Revisions to support increases in scope beyond reprioritization of existing resources are not permitted.

Evaluation: The NHLBI OIA is being developed and implemented as a pilot program and is being introduced on a limited scale. The overall success of the program will depend on the participation of well-funded investigators. The NHLBI intends to evaluate the OIA as it is implemented and periodically thereafter. Both the process and the outcomes of the awards will be monitored relative to the intent of the NHLBI OIA and the NHLBI mission.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Director/Principal Investigator (PD/PI)

All PD/PI must have an eRA Commons account. PD/PI 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 with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

Applications that do not meet eligibility requirements will not be reviewed.

Additional Individual Eligibility Requirements

Eligibility to apply to this FOA is limited to PDs/PIs who meet all of the following criteria.

• Are currently PD/PI or Multiple PD/PI on at least two NHLBI R01-equivalent (defined here as R01, R37, DP1, or DP2) awards;
• Have received continuous R01-equivalent support from the NHLBI for at least the past four years as a PD/PI; and
• Can commit a minimum of 50% research effort (i.e., minimum of six calendar months) throughout the duration of the NHLBI OIA.

PDs/PIs with effort on other NIH grants will be expected to provide, as part of the Just-in-Time information, a detailed explanation describing how effort on other NIH grants will be adjusted, if necessary, to permit 50% effort (i.e., a minimum of six calendar months) on the NHLBI OIA.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

Biographical Sketch: The NHLBI OIA is intended for investigators with track records of creativity, consistent productivity, and significant scientific impact. The PD/PI should, in the Biographical Sketch, address these considerations and demonstrate a history of conducting rigorous and reproducible research and reporting it in a transparent fashion. In addition, the PD/PI should demonstrate their suitability for funding through the NHLBI OIA, including flexibility and adaptability to new research opportunities. Explicitly address intellectual and technical contributions to any publications with former mentors and highlight contributions since becoming an independent investigator. Include experience as a mentor of undergraduate and graduate students, postdoctoral or clinical fellows, medical students, or junior faculty.

Current & Pending Support: Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form. List NHLBI grants first, followed by other NIH grants, followed by other sources of support.

Provide a list of all current and pending support for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications, regardless of source of support (e.g., Federal, private, non-profit). Show the total award amount for the entire award period (including indirect costs) as well as the number of calendar months per year to be devoted to the project by the senior/key person. Provide current and pending research support information at time of application using the format typically used for Just-in-Time information. Be sure to distinguish the direct costs per year that support research in the investigator's laboratory from support that goes to other investigators. Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice its review.

All instructions in the SF424 (R&R) Application Guide must be followed. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 7 years of support.

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

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

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

Specific Aims: Do not use. Specific Aims are not required and should not be submitted.

Research Strategy: The Research Strategy should include the following information:

1. Background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed relevant to HLBS research. Describe the potential for the identified area(s) of research to be groundbreaking or paradigm-shifting. Describe future impact on HLBS research.

2. Describe the overall vision, conceptual framework, and general strategies for furthering and sustaining the proposed research program, including plans for building on prior accomplishments to formulate a highly innovative program for advancing and transforming the research field.

3. Discuss the importance of the research question and how the research could impact the current understanding of the problem being addressed and/or advance the field of study. Describe how the research program could evolve as the work is being performed and how the risks and challenges will be addressed. Explain how the proposed research program is in an area that will continue to be important and generate significant new discoveries within the mission of the NHLBI (e.g., describe how the research program will result in new opportunities, explore new areas of scientific inquiry, and develop new systems and strategies, if applicable).

The proposed research can be either a continuation of the PD's/PI's previous or current work, or involve a new line of investigation. If the planned research diverges significantly from past/current work, explain the rationale for the changes and describe the PD's/PI's ability to undertake this new direction. A detailed experimental plan is not expected. Preliminary data are not required, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published. Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, the PD/PI will have the flexibility to change course and pursue them. Explain how the proposed research program will benefit from the flexibility, level of effort, and the longer-term funding offered by the NHLBI OIA.

Letters of Support: The application must include a Letter of Support from the institution’s Authorized Organizational Official (AOR). Applications that are missing a Letter of Support will not be reviewed.

In two pages or less, the Letter of Support should include:

• A statement that, if chosen to receive the NHLBI OIA, the PD/PI will commit a minimum of 50% research effort (i.e., a minimum of six calendar months) throughout the duration of the NHLBI OIA. Effort expended toward teaching, administrative, and/or clinical duties should not be included in the research effort calculation; however, a statement describing the PD's/PI's overall level of professional effort devoted to research duties versus teaching, administrative, and/or clinical duties is requested;
• A statement identifying the two current NHLBI R01-equivalent (defined here as R01, R37, DP1, or DP2) awards that render the PD/PI eligible for the OIA;
• Evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support, access to resources, protected time, space, etc.) for the duration of the award; and
• Awareness of and acceptance by the AOR that most NHLBI research awards must be relinquished as a condition of receiving an NHLBI OIA, as described in this FOA.

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, with the following modification:

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

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

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.

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

It is anticipated that the terms of award will include, but not be limited to, the following:

1. Carryover of an unobligated balance from one budget period to another budget period will require NHLBI Grants Management Officer prior approval.

2. Awards funded under this FOA are not subject to Streamlined Non-Competing Award Process (SNAP) authorities; annual financial reporting is required.

3. All funds must be expended within the approved project period.

4. Awards funded under this FOA will not be provided the authority to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Grant Award, as outlined in the NIH Standard Award Terms and Conditions. All extensions, including the first extension, will require NIH prior approval.

5. Change of PD/PI will not be allowed under the NHLBI OIA.

6. Change of grantee institution will be allowable if the original grantee institution agrees to relinquish the OIA and the receiving institution agrees to all of the required NHLBI OIA terms.

7. It is expected that the NHLBI OIA will replace all funded NHLBI single project/single PD/PI grants (see exceptions in Part 2, Section I of this FOA). NHLBI-funded multiple PD/PI and multiple project grants as well as other NIH funding will be excluded; however, effort on those grants will need to be accommodated outside the 50% research effort (i.e., a minimum of six calendar months) is required on the NHLBI OIA.

8. It is expected that the PD/PI will renegotiate effort on other NIH grants, if necessary, to permit the required effort on the NHLBI OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment must reduce those other commitments to accommodate the NHLBI OIA time and effort.

9. There must be continued evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support, access to resources, protected time, space, etc.) for the duration of the award.

10. The NHLBI will not consider funding future individual PD/PI research grants from an NHLBI OIA awardee during the NHLBI OIA project period, except for applications included under the list of exempted awards in Part 2, Section I of this FOA.

11. Transfer of an NHLBI OIA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval; however, NHLBI OIA grant funds may not be used to support this component.

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD/PI must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In an NHLBI OIA application, applicants should not propose research that is currently funded by, and that fits appropriately within the mission of, other NIH Institutes and Centers (ICs). PDs/PIs are encouraged to contact NHLBI Scientific/Research staff prior to submission of an NHLBI OIA application to discuss whether their application is relevant to the NHLBI mission and whether it overlaps with awards from other NIH ICs or independent funding entities.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The NHLBI OIA is meant to support an individual PD's/PI's research program focused on HLB research within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission), sleep disorders closely-coupled to HLB outcomes, or basic sleep and circadian regulation.

The NHLBI OIA is intended to promote scientific productivity and innovation by providing stable and flexible funding. Applicants are expected to provide an overview of the research program, the scientific questions they currently plan to address, and a general description of possible strategies. Experimental details and preliminary data are not expected, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published.

Accordingly, in addition to the criteria below, reviewers will emphasize the following:

1. Evidence of important previous contributions made by the PD/PI to their field (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; professional service; etc.);

2. PD's/PI's demonstrated outstanding HLBS research productivity of the highest quality for at least the past five years;

3. Potential that the PD/PI will continue to impact and influence HLBS research at the same high caliber level in the future.

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

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

Does the research program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the overall goals of the research program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will obtaining answers to the scientific questions posed change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: What is the heart, lung, blood or sleep (HLBS) scientific challenge to be addressed and why is this important? Is the proposed research program adequately broad and ambitious? How likely is the research program to be groundbreaking and provide future direction for HLBS research? Is the proposed research program substantive in scope?

Is the PD/PI well suited to the research program? Has the PD/PI demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Specific to this FOA: How has the PD/PI demonstrated outstanding research productivity of the highest quality for at least the past five years? What is the potential for the PD/PI’s research productivity and influence to continue at the same high caliber level? Does the PD/PI show promise as a mentor of undergraduate and graduate students, postdoctoral or clinical fellows, medical students, or junior faculty? Does the PD/PI demonstrate the potential to establish a record of professional service? Does the PD/PI have a record of conducting rigorous research and reporting it transparently?

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?

Specific to this FOA: Has the PD/PI provided evidence of the program’s novelty in HLBS research? How has the PD/PI's past research contributed to HLBS research? How likely is it that the proposed program will result in new opportunities, explore new areas of scientific inquiry, and/or develop new systems and strategies?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the overall goals of the research program? If the research program is in the early stages of development, will the strategy be feasible? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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 children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Does the application indicate appropriate commitment of time and effort for the proposed work? Does the PD/PI provide strong evidence that the research program will evolve appropriately as the work is performed? How likely is the proposed research to be performed rigorously and the results carefully interpreted?

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 research program proposed? Will the research program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed research involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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

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

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council. The following will be considered in making funding decisions:

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to 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.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The instructions are hereby amended as follows:

a) Under Section 6.2 B.1 What are the major goals of the project? Note that the goals of the program of research supported by the NHLBI OIA are broader than the specific aims of a single project and should be appropriately described. If the goals of the NHLBI OIA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and further contributions to the field, and an explanation of how the research continues to fit within NHLBI mission interests.

b) Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.

c) Under section D.2.c. additional information, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the NHLBI OIA.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Narasimhan Danthi, Ph.D.
Division of Cardiovascular Sciences
Telephone: 301-451-5170
Email: [email protected]

Lisa Postow, Ph.D.
Division of Lung Diseases
Telephone: 301-827-7843
Email: [email protected]

Andrei Kindzelski, Ph.D.
Division of Blood Diseases and Resources
Telephone: 301-827-8275
Email: [email protected]

Emmanuel Peprah, Ph.D.
Center for Translation Research and Implementation Science
Telephone: 301-496-3620
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: 301-435-0186
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.