National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
R33 Exploratory/Developmental Grants Phase II.
- November 22, 2024 - This RFA has been reissued as RFA-HL-26-016.
- NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
- NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
- March 24, 2022 - Notice of Application Submission and Due Date Changes for RFA-HL-23-010. See Notice NOT-HL-22-015.
See Notices of Special Interest associated with this funding opportunity
RFA-HL-23-012 , R33 Exploratory/Developmental Grants Phase II
RFA-HL-23-013 , R61/ R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II
RFA-HL-23-014 , R33 Exploratory/Developmental Grants Phase II
This Funding Opportunity Announcement (FOA) solicits grant applications to further develop enabling technologies and transformative platforms to catalyze next-generation predictive, diagnostic and therapeutic products to address heart, lung, blood, and sleep (HLBS)-related disorders and diseases. This FOA solicits R33 applications where major feasibility gaps for the enabling technology or transformative platform have already been overcome, as demonstrated with supportive preliminary data, but still requires further development and rigorous validation to encourage downstream demonstration, utilization and adoption. Well-suited applications must offer the potential to accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention or epidemiology, while addressing issues associated with HLBS-related diseases and disorders. Projects proposing application of existing technologies where the novelty resides in the biological or clinical target/question being pursued are not appropriate for this solicitation. Applications considered nonresponsive to the FOA will not be reviewed.
This FOA is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Product Definition or Preclinical FOAs.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| March 21, 2022 | March 21, 2022 | April 18, 2022 | July 1, 2022 | October 1, 2022 | December 1, 2022 |
| July 21, 2022 | July 21, 2022 | August 18, 2022 | November 1, 2022 | January 1, 2023 | April 1, 2023 |
| November 21, 2022 | November 21, 2022 | December 21, 2022 | March 1, 2023 | May 1, 2023 | July 1, 2023 |
| February 21, 2023 | February 21, 2023 | April 18, 2023 | July 1, 2023 | October 1, 2023 | December 1, 2023 |
| July 21, 2023 | July 21, 2023 | August 18, 2023 | November 1, 2023 | January 1, 2024 | April 1, 2024 |
| November 21, 2023 | November 21, 2023 | December 21, 2023 | March 1, 2024 | May 1, 2024 | July 1, 2024 |
| February 21, 2024 | February 21, 2024 | April 18, 2024 | July 1, 2024 | October 1, 2024 | December 1, 2024 |
| July 22, 2024 | July 22, 2024 | August 19, 2024 | November 1, 2024 | January 1, 2025 | April 1, 2025 |
| November 21, 2024 | November 21, 2024 | December 20, 2024 | March 1, 2025 | May 1, 2025 | July 1, 2025 |
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.
New Date November 22, 2024 per RFA-HL-26-016 (Original Expiration Date: December 21, 2024 ).
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
The NHLBI Catalyze innovation program is designed to provide a suite of comprehensive support and services to facilitate the transition of basic science discoveries into new treatments for diseases and disorders that fall under the NHLBI mission. The Catalyze Program initiatives support product development (supporting product definition studies and pre-clinical research and development) and enabling technologies and transformative platforms. Catalyze is coordinated by the Catalyze Coordinating Center, which provides program administration and evaluation, milestone-driven project management, communications and outreach, as well as development guidance for projects in the Catalyze portfolio. The Catalyze program aims to create cultural and systemic changes to more rapidly move breakthrough innovations to products that will have health, economic, and societal impact. Information on the Catalyze programs can be found on the Catalyze website
This specific Catalyze Funding Opportunity Announcement (FOA) solicits grant applications to rigorously validate transformative, multi-use platforms or technologies that can enable the next generation of predictive, diagnostic and therapeutic products or model systems relevant to heart, lung, blood and/or sleep (HLBS)-related diseases or disorders. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.
FOA Emphasis.The FOA is suitable for projects in which major feasibility gaps for the technology or platform have already been overcome, as demonstrated with supportive preliminary data, but still requires further development and rigorous validation to establish repeatable, reliable performance in an HLBS-relevant context. Successful awardees projects should be between a mid- stage TRL 3 and TRL4, for more information about technical readiness please refer to the Technology Readiness Guidelines. Projects where the novelty resides in the application of the technology to a single biological issue or clinical need, or involves an efficacy demonstration for a specific disease or condition, are not appropriate for this FOA. Applications considered nonresponsive to this FOA will not be reviewed. However, such applications may be appropriate for other Catalyze FOAs.
Specific Research Objectives and Scope of this FOA
The proposed projects must be focused on development and validation of an enabling or platform technology in a representative biologically or clinically relevant system. In addition, all projects proposed in response to this FOA must involve the following general attributes:
- Offers novel capabilities that may be judged by appropriate experts as potentially transformative in laboratory and/or clinical settings, and beyond providing incremental improvements to existing capabilities.
- Rigorous study design with a verifiable approach, based on well-defined, performance measures (see below for description of performance measures). An application lacking performance measures will not be reviewed. For details on addressing these requirements, see Section IV. Application and Submission Information.
Responsive Technologies and Scientific Scope
Responsive technologies include relevant novel or hybrid materials, chemical reagents, instrumentation, devices, and associated methods and models.These technologies may be intended for molecular, cellular and/or organ-level analyses in-vitro, in-situ, and/or in-vivo (with some exceptions listed below), and may target basic, diagnostic, translational, epidemiological, and/or clinical gaps. It must be clear that proposed projects are focused on the development of platforms and technologies to enable development in certain areas (e.g.,clinical detection, drug development, biomarker discovery and validation, or epidemiology), and NOT on pursuing specific discoveries (e.g., discovery of a novel biomarker or demonstrating efficacy for a novel therapeutic agent) or specific applications (e.g. detection of a known biomarker) in those areas.
Technology development projects that are HLBS-relevant are encouraged provided that the technology proposed meets the requirements stated above, including transformative potential. Technologies may target atomic, molecular, sub-cellular, cellular and/or organ-level features. At the core of any project must be a novel analysis or targeting capability (encompassing novel devices, materials, or chemical/biochemical approaches) with an accompanying validation plan. General areas of interest include, but are not limited to, the following:
- Drug discovery platforms for identification of molecules that stimulate endogenous repair mechanisms
- In vitro and in vivo models that enable clinically-relevant safety and efficacy testing of therapeutics
- Gene delivery and gene therapy technologies that minimize cost-of-goods and maximize safety (including reduced risk of insertional mutagenesis and ability to control expression levels and/or killing of cells with inappropriate expression)
- Technologies, including materials and devices, to deliver pharmaceutical or cell-based therapeutics
- Technologies for non-invasive, clinically relevant diagnosis and monitoring
- Cell expansion technologies that maintain adult stem cell self-renewal without concomitant increases in risk of transformation
- Tools to discover clinically-relevant biomarkers
- Novel tools or approaches for producing and improving animal models
- Technologies that can facilitate and/or enhance molecular analyses in HLBS disease epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of data)
- Point-of-care technologies (POCTs) to facilitate the collection of relevant biological data for examining the factors contributing to health disparities (e.g., for HLBS disease sub-types and differences across individuals with diverse racial/ethnic backgrounds)
- New approaches for stem cell authentication and standards
- Strategies for tracking and monitoring of stem cell therapies in vivo
IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the Scientific/Research Contact(s) listed below.
Non-Responsive Projects
Applications considered non-responsive to the FOA will not be reviewed. Focus on the following will be considered non-responsive:
- Biomarker discovery or biomarker validation. Pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question (i.e., traditional biological hypothesis-driven research) and NOT in the novel technical capability being developed;
- Development of specific contrast agents (though generalizable contrast agents are allowed);
- Development of drugs or therapies only intended to treat a specific disease or condition
- Development of devices only intended to treat a specific disease or condition
- Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods.
Projects which are earlier in development, without first-generation prototypes and/or where major feasibility gaps for the enabling technology or transformative platform have not already been overcome are not responsive to this announcement, but should consider applying for support under NOT-HL-21-024 "Notice of Special Interest (NOSI): Bold New Bioengineering Research for Heart, Lung, Blood and Sleep Disorders and Diseases (Reissue)."
Projects which are later in development, that have already developed a prototype of an enabling technology or transformative platform of proven feasibility, that has also satisfied rigorous performance measures, should consider applying for support from the Catalyze Product Definition FOAs listed on the NHLBI Catalyze website
Special Requirements for this FOA
Project Management
Each project is expected to use project management processes that guide the studies to successful completion of the established milestones. While it may not be possible to have a full-time project manager, each project is expected to identify a team member who will hold this responsibility as a part of their project management plan. The Catalyze Coordinating Center may support the local project management through resources, educational materials, and regular communications. The project manager will support the development of milestones, timelines, and identification of risks and mitigation strategies and will work closely with the Program Officer and with the support of the Catalyze Coordinating Center to update and refine these upon notice of award and as needed through the project.
Milestones
Applicants are expected to propose activities and milestones, with an associated timeline, to be completed during the proposed duration of award.
Successful awardees will develop specific, measurable, achievable, relevant, and time-bound Specific Aims for their project. Each Specific Aim should have at least one milestone associated with it. Milestones are an event or moment in time in a project that indicate progress toward a Specic Aim or a Specific Aim has been met. The project Specific Aims and milestones should be laid out as a timeline or GANNT chart as a part of the application.
Milestones will be peer reviewed as well as programmatically reviewed and if needed will be negotiated with the awardee before they are included in the terms of the award. NHLBI staff will monitor program progress against proposed milestones through quarterly meetings and make non-competing award decisions annually based on achieving milestones. NHLBI emphasizes the importance of the robustness and reproducibility of experimental results in evaluating progress.
Additional Considerations
Applicants are strongly encouraged to contact Scientific/Research Staff listed in Section VII to discuss potential research projects prior to submitting an application.
Prior to funding an application, NHLBI Program staff may contact the applicant to discuss the proposed performance measures, milestones, and any changes suggested by the NHLBI review panel or Program staff. A final set of approved performance measures and milestones will be specified in the Notice of Award.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NHLBI intends to commit total costs of up to $1,860,000 in FY 2023, $1,860,000 in FY 2024, and $1,1860,000 in FY 2025.NHLBI expects to fund up to 4 new awards in FY 2023, 4 new awards in FY 2024, and 4 new awards in FY 2025, for a total of up to 12 new awards.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets must not exceed $300,000 direct costs per year.
The total budget must reflect the actual needs of the proposed project and annual project budgets must reflect the actual costs anticipated in each year.
The maximum project period is two years. The scope of the project should determine the project period.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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 Government
- 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 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.
- 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
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, per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
Other Attachments
Statement of Potential Impact (Required)
The filename "Statement of Potential Impact.pdf" should be used. The attachment may not exceed one page. Provide a description of the expected potential of the proposed technology to transform HLBS-research and clinical practice. Address the following questions:
- How is the new capability provided by the proposed technology potentially transformative and why may it be expected to produce an unusually high impact on biomedical research and medicine (i.e., describe the potentially transformative outcomes that might be realized should this technology be successfully developed)?
- If applicable, how will the proposed technology overcome limitations for currently available technologies or alternative approaches (i.e., provide evidence to substantiate the claim of innovativeness beyond currently available technologies)?
- What are the next steps for the transformative capabilities to be transferred and/or demonstrated in a prototype product? Is there a track-record of such development, or are partnerships and collaborations in place?
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should include budget support for the PD/PI to participate in an NIH-held 1.5 day innovation meeting or workshop once each budget year in the Washington, DC/Metropolitan area.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Applicants must address all of the following required aspects:
- Advanced Development and Validation of HLBS-relevant Technology. Applications must focus on further development of a novel technology beyond the early-stage proof of concept demonstration and engage a rigorous validation of the novel capability in an HLBS-relevant biological context of use that targets the needs of basic, preventative, diagnostic, translational, epidemiological, and/or clinical research. Applications must provide appropriate background/preliminary data to justify that the proposed technology has passed the pilot developmental stage and shows promise. Describe the strategy and specific research steps to evaluate and rigorously validate the proposed technology within the context of its intended use (see performance measures, below).
- Substantial Improvement and/or New Capabilities.All proposed technologies must offer the potential for substantial improvements over conventional approaches and/or add qualitatively new research capabilities not provided by existing technologies and approaches.
- Transformative Potential.Define clearly the unmet technical need from the community being targeted by the technology and describe its anticipated use in laboratory research and/or clinical settings. Claimed potential impact is expected to be substantiated by specific performance measures (next bullet).
- Performance measures.Propose explicit performance measures that are objectively assessable measures for determining targeted performance capabilities. They should be carefully justified and selected, and precisely defined, and should clearly detail the expected advantages of the proposed technology relative to existing technologies/approaches. Appropriately targeted performance measures require that the underlying experimental results have been subjected to appropriate statistical analysis, yielding a reasonable level of certainty that the targeted level of performance has been achieved.
Additional Information on Performance Measures
Within Research Strategy there must be a dedicated subsection labeled "Performance Measures". Performance measures should be well-described, quantifiable, and scientifically justified. Critical components for proposed measures include the numerically described target of performance as well as the means by which it will be assessed. Proposed performance measures will be a means of supporting success for the validation of the technology. Performance measures should include the relevant statistical context for the targeted parameter. Whenever appropriate, present the proposed measures in the context of current technologies to substantiate the anticipated transformative potential. All performance measures should be described within the context in which they would be assessed, statistical strength of the resulting measures, and the approach by which they will be determined.
Specific aims may not be regarded as performance measures. The specific aims describe the goals and intended path of the research. Performance measures provide the means for objectively assessing progress against those aims and substantiate the potential impact the technology might have on HLBS research or clinical use. The project will be evaluated for success based on the completion of the performance measure(s) proposed. For some specific aims, it may be sufficient to define a single performance measure. For others, multiple performance measures may be more appropriate.
An example of a properly described performance measure could be achieving a detection limit of 1 femtogram of a targeted analyte per microliter of sample or less with a p value < 0.05 under conditions a, b and c, and with 95% confidence limits +/- 0.2 fg for a 2 fg reading over a concentration range of g to h. Other types of performance measures might include:
- Detection of a single mutated cell out of 109 differentiated therapeutic cells, with false positive detection rate <2%;
- Demonstration that the measured analyte is highly correlated (Pearson correlation coefficient r >0.95) for a given human serum sample when analyzed on different days. This should include mean, standard deviation, and relative standard deviation for repeatability targets superior to next best approach (if applicable);
- Reduction of sequence read errors to one in 5,000,000 base pairs; and/or
- Demonstration that the technology can be n-fold faster, or n-fold more sensitive, or n-fold more specific,etc,than the current "gold standard" technology.
Please note these additional performance measure examples should still be properly described in an experimental context as demonstrated in the example above.
Milestones, timeline and project managment plan (required)
The filename "Milestones, timeline and Project managment plan.pdf" should be used. The attachment may not exceed three pages.
Milestones: Define milestones that are specific, measurable, achievable, relevant, and time-bound. The milestones should allow program staff to assess progress during the period of the award. Specific aims or a list of activities are not considered milestones. Describe the milestones that need to be reached in the R33 phase to address the specific aims and ensure the successful completion of the entire project.
Timeline: Provide a detailed timeline with specific milestones for the work proposed in each year of the award. The timeline, specific goals and feasibility milestones should be clear and complete. Indicate when it is anticipated that essential components of the project will be completed. The proposed timeline with specific milestones should be clearly delineated and should be referenced in the Research Strategy Section.
Project Management
Describe specific plans for utilizing project management processes to enable continuous assessment of the progress of the project relative to the established milestones and how the progress assessments will be used to make strategic decisions regarding the proposed project. While it may not be possible to have a full-time project manager, each project is expected to identify a team member who will hold this responsibility as a part of their project management plan. The Catalyze Coordinating Center may support the local project management through resources, educational materials, and regular communications.
Rigor and Reproducibility
High-quality and reproducible product definition studies are an essential cornerstone of the translational research enterprise. Attention to principles of study design and transparency is essential to enable stakeholders to assess the quality of the experimental design and scientific findings. In support of this important goal, investigators must follow instructions to address Rigor and Reproducibility (https://grants.nih.gov/policy/reproducibility/index.htm).
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.
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.
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
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.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit 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) must include their eRA Commons ID in the Credential fieldof 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. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided 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 NHLBI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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).
Scored Review Criteria
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?
Specific to this FOA:
What is the potential of the proposed technology to transform HLBS research or clinical practice if the project is successfully completed? To what extent does the preliminary data establish that major feasibility gaps for the technology or platform have already been overcome? How realistic are the expectations in that area and how well do they align with the planned developmental efforts? How well do the proposed performance measures assess the transformative capacity for HLBS-relevant field of research or clinical care? How likely is it that the proposed technology will be widely adopted by the relevant research and development community? How does the proposed technology offer clear and significant improvement over currently available methods and platforms? How well does the statement of potential impact describe the potentially transformative outcomes that might be realized should this technology be successfully developed?
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?
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?
Sspecific to this FOA:
How will the proposed technology offer new and innovative possibilities for HLBS research or clinical practice relative to the current methods?
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?
Specific to this FOA:
Project Management
To what extent is the described project management structure likely to be efficient and effective in keeping the proposed activities on schedule according to the proposed timeline?
Milestones and Timelines
Are the listed milestones for each phase appropriate for achieving the goals of the project? To what extent are the milestones specific, measurable, achievable, relevant, and time-bound? How well-suited are the specified milestones for promoting the investigator to be successful in completing the proposed award activities? To what extent are the proposed timelines for achieving the milestones realistic, achievable and non-duplicative?
Performance Measures
To what extent are the performance measures well-described, quantifiable, and scientifically justified? How well do the proposed performance measures provide a means of supporting the success for the validation of the technology?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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 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.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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 the National Heart, Lung and Blood Institute 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 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 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.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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.
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.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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- 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.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
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.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In 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 45 CFR Part 75.205 and 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
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the 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.
3. Reporting
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.
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 FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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: http://grants.nih.gov/support/ (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]
General Questions
Mike Pieck, Ph.D.
Telephone: 301-827-7986
Email: [email protected]
Division of Blood Diseases and Research
Allison Gillaspy, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-7884
Email: [email protected]
Division of Cardiovascular Sciences
Albert Lee, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0567
Email: [email protected]
National Center on Sleep Disorders Research
Marishka Brown, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-7822
Email: [email protected]
Division of Lung Diseases
Sara Lin, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: [email protected]
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]
Ron Caulder
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8020
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.
and Human Services (HHS)
