Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title
Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)
Activity Code
R33 Exploratory/Developmental Grants Phase II.
Announcement Type

New

Related Notices

September 9, 2019 - Notice of Pre-Application Webinar for FOAs related to the NHLBI CATALYZE Program: RFA-HL-20-022, RFA-HL-20-023, RFA-HL-20-024, RFA-HL-20-027 and RFA-HL-20-028. See Notice NOT-HL-19-709.

NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Funding Opportunity Announcement (FOA) Number
RFA-HL-20-022
Companion Funding Opportunity

RFA-HL-20-023 R61/R33 Exploratory/Developmental Phased Award

RFA-HL-20-024 R61/R33 Exploratory/Developmental Phased Award

RFA-HL-20-027 R33 Exploratory/Developmental Grants Phase II

RFA-HL-20-028 R33 Exploratory/Developmental Grants Phase II

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

93.837, 93.838, 93.839, 93.840, 93.233

Funding Opportunity Purpose

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.

Key Dates

Posted Date

September 9, 2019

Open Date (Earliest Submission Date)
October 08, 2019
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 8, 2019, March 9, 2020, July 9, 2020, March 9, 2021, July 9, 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

December 9, 2019, May 11, 2020, August 11, 2020, May 11, 2021, August 11, 2021 by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

March 2020, July 2020, November 2020, July 2021, November 2021

Advisory Council Review

May 2020, October 2020, January 2021, October 2021, January 2022

Earliest Start Date

July 2020, December 2020, April 2021, December 2021, April 2022

Expiration Date
August 12, 2021
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
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.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 (https://www.nhlbi.nih.gov/node/87164).

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. 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 unresponsive 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-19-678.

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 (https://www.nhlbi.nih.gov/node/87164).

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 and any changes suggested by the NHLBI review panel or Program staff. A final set of approved performance measures will be specified in the Notice of Award.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Resubmission
Revision

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.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NHLBI intends to commit total costs of up to $1,424,000 in FY 2020, $1,424,000 in FY 2021, and $1,848,000 in FY 2022.

NHLBI expects to fund up to 3 new awards in FY 2020, 3 new awards in FY 2021, and 4 new awards in FY 2022, for a total of up to 10 new awards.

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

Award Budget

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.

Award Project Period

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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)

Section IV. Application and Submission Information

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: nhlbichiefreviewbranch@nhlbi.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
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?
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
 

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.

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Applicants must address 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.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
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.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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 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 NHLBI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials
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.

Section V. Application Review Information

1. Criteria

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.

Overall Impact
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.

 

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?

 

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?

 

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?  

 

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?

Specificto this FOA

How well do? the proposed performance measures assess the technology ? How realistic are the performance measures? How useful are the proposed performance measures for intended product developers?

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?

 

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.

 

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.

 

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.

 

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.

 

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.

 

Not Applicable

 

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations
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.

 

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.

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:
  • 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 Institute 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.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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.

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 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. 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

3. Reporting

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 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.

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.

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA 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: GrantsInfo@nih.gov#160;(preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Division of Blood Diseases and Research
Margaret Ochocinska, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-8285
Email: ochocinm@mail.nih.gov

Division of Cardiovascular Sciences
Albert Lee, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0567
Email: alee@mail.nih.gov

National Center on Sleep Disorders Research
Marishka Brown, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-7822
Email: brownmk@mail.nih.gov

Division of Lung Diseases
Sara Lin, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: sara.lin@nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

John Diggs
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8028
Email: diggsjw@nhlbi.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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