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

New Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders (U01 - Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-18-577

Companion Funding Opportunity

None

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

93.837, 93.838, 93.839, 93.840, 93.233

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support new and innovative epidemiology research in heart, lung, blood, and/or sleep diseases, disorders, and/or phenotypes. Through this FOA, the National Heart, Lung, and Blood Institute (NHLBI) aims to establish a new epidemiology cohort of at least 2000 participants to stimulate research on a wide range of heart, lung, blood, and/or sleep research hypotheses.

Key Dates

 

Posted Date

January 12, 2018

Open Date (Earliest Submission Date)

May 5, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

June 5, 2018, June 5, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2018, October 2020

Advisory Council Review

January 2019, January 2021

Earliest Start Date

April 2019, April 2021

Expiration Date

June 6, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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


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

    The purpose of this Funding Opportunity Announcement (FOA) is to support new and innovative epidemiology research in heart, lung, blood, and/or sleep (HLBS) diseases, disorders, and phenotypes.  Through this FOA, the National Heart, Lung, and Blood Institute (NHLBI) aims to establish a new epidemiology cohort of least 2000 participants to stimulate research on a wide range of heart, lung, blood, and/or sleep research hypotheses that cannot currently be addressed in the large epidemiology cohort studies currently funded by the NHLBI.

    Background

    The NHLBI has significantly invested in observational population studies, in which people with a set of characteristics or exposures are followed over time. These studies have helped advance fundamental insights into key lifestyle, environmental, molecular, and genomic determinants of heart, lung, blood, and sleep related health outcomes. Observational cohorts are valuable resources that benefit the entire biomedical research community, and findings from cohort studies have helped inform prevention strategies, risk prediction models, and clinical trials. Cohort studies typically involve substantial infrastructure investment for the collection and management of data and biological samples, routine participant follow-up, and identification/adjudication of clinical events. The scientific hypotheses built upon this infrastructure encompass a multitude of ideas; as such, deeply phenotyped cohort studies equate in value to multiple research projects within a single overarching study design. 

    This FOA is being issued in response to recommendations made by a 2013 working group comprised of members from the NHLBI's Advisory Council and Board of External Experts (Roger VL et al., Am J Epidemiol 181(6):363-68) to implement a competitive peer review-based model for the NHLBI's portfolio of large epidemiologic and population studies. 

    Scope of the FOA

    The purpose of this FOA is to support new and innovative epidemiology research in heart, lung, blood, and/or sleep diseases, disorders, and/or phenotypes. To facilitate novel epidemiology research, the NHLBI aims to support a new cohort of at least 2000 participants to address a range of research questions that cannot be studied in the large epidemiology cohort studies currently funded by the NHLBI. Cohort studies that align with the Institute's Strategic Vision are of great programmatic interest, as are cohort studies that address research gaps in heart, lung, blood, and/or sleep disorders.

    Cohort eligibility

    Awards made under this FOA are intended to support hypothesis-driven cohort research that:

    • Enrolls at least 2000 participants by the end of the project period
    • Predominantly focuses on U.S. populations
    • Addresses research gaps in heart, lung, blood, and/or sleep diseases, disorders, or phenotypes
    • Is innovative (e.g., creative study designs, novel populations or scientific hypotheses, use of new or emerging technologies)
    • Investigates a broad array of putative exposures and risk factors, such as the confluence of diet, exercise, therapies, environmental, behavioral, and biological or other molecular factors
    • Supports the study of research questions across a range of heart, lung, blood, and/or sleep phenotypes

    Selected Research Examples

    Research supported by this FOA must fall within the NHLBI's mission of heart, lung, blood, and/or sleep related phenotypes. Potential research questions of interest may include the examples below; this list is not meant to be exhaustive or prescriptive, it is merely illustrative of potential topics.

    • Which exposures influence the early development of heart, lung, blood, and/or sleep preclinical signs, symptoms, and risk factors in children?
    • How is disease risk impacted by behaviors, cultural factors, and genomic variants in populations not included in NHLBI's portfolio of large cohort studies, such as racial/ethnic groups not currently well represented (e.g., ancestries from East Asia, the Middle East, or Hawaii or Pacific Island nations) or other populations that face significant health disparities (e.g., sexual and gender minorities, immigrants, rural communities)?
    • Which risk factors or molecular changes influence health outcomes in patients with a particular heart, lung, blood, and/or sleep disorder or condition (e.g., hemoglobin disorders, congenital heart disease)?

    Activities Supported Under this FOA

    Through this FOA, the NHLBI intends to fund both scientific and infrastructural components of new epidemiology cohort studies. Supported activities include, but are not limited to, the following:

    • Identification and recruitment of cohort participants (population or clinic-/disease-based)
    • Protocol development and approval
    • Detailed baseline assessment of cohort participants
    • Collection, analysis, storage, and maintenance of biological samples
    • Data cleaning and quality control
    • Data management, and administrative and communication tasks
    • Follow-up of participants (e.g., medical record review, vital records searches, participant re-contact)
    • Initial cross-sectional cohort data analyses
    • Manuscript preparation

    Interventions done to phenotype participants (e.g., induced phenotypes such as glucose or methacholine challenges) can be supported under this FOA; however, clinical trials are not allowed.  NHLBI staff can help determine whether a proposed intervention would be considered a clinical trial and thus not appropriate for this FOA.

    Estimated Study Timeline

    Awards made under this FOA have the opportunity for extended project periods (up to six years) to accommodate the many activities required to establish a new cohort study. An estimated study timeline is provided below for planning purposes.

    Pre-data Collection Activities: Years 1-2

    • Establishment of study infrastructure (e.g., field centers, sample biorepositories, steering committee)
    • Development and approval of standardized study protocols (potentially across multiple study/field sites)
    • Preparation of required consents and clinic forms (including translations as needed)

    Recruitment and Data Collection Activities: Years 2-4

    • Identification and recruitment of cohort participants
    • Conducting a detailed baseline assessment on all participants (e.g., clinical exam)
    • Repeated participant sampling if warranted by study hypotheses (e.g., microbiome variation, circadian rhythm fluctuations)

    Post-exam Activities: Years 4-6

    • Participant surveillance
    • Data cleaning and quality control
    • Data harmonization
    • Data submission to appropriate NIH-designated repositories, such as dbGaP or BioLINCC
    • Analysis of cohort baseline data

    Data Harmonization

    Applications that propose to preemptively address the challenges of analyzing data across multiple cohorts, such as by proposing to adopt or use data standards, common data elements, and/or standard ontologies that would facilitate harmonization and sharing/analysis of data across studies, are of high programmatic interest. For more information on common data elements, please refer to Section IV.7, Other Submission Requirements and Information, and the NIH's Common Data Element Resource Portal.

    IMPORTANT NOTE:  Applicants are strongly encouraged to pay close attention to the NHLBI's pre-submission processes communicated in Section IV.7 (Other Submission Requirements and Information) that are specific to this FOA.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

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

    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

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

    As a guidance, NHLBI has allocated $3 million in FY19, $6 million in FY20, $9 million in FY21, $12 million in FY22-FY24, $6 million in FY25, and $6 million in FY26.

    This FOA will fund one award in FY19 and one award in FY21.

    Award Budget

    As a guidance, application budgets should not exceed $1.948 million in direct costs in the first year of the project period, and should not exceed $3.896 million in direct costs in any subsequent year of the project period.

    Application budgets should reflect the actual needs of the proposed project.

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 6 years.

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

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

    Required Registrations

    Applicant Organizations

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

    Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    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

    Buttons to access the online ASSIST system or to download application forms 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 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.

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute
    Telephone: 301-435-0270
    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.

    Cover Letter Attachment:

    All applications requesting $500,000 or more in direct costs in any one year must include a copy of the NHLBI approval letter.

    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.

    Facilities and Other Resources:

    As appropriate, describe available resources such as clinical and laboratory facilities, geographic distribution of space and personnel, and resources relevant to the effective implementation of a detailed baseline assessment of cohort participants and, if applicable, the efficient operation of a multi-site study. Applicants must provide strong evidence of the availability of appropriate institutional resources and access to suitable participant populations. For multi-site applications, information must be provided for each participating site.

    Other Attachments:

    The attachments listed below must be completed and attached or the application will not be peer reviewed, with the exception of the "Biospecimen Plan" which must only be provided if applicable.

    1. Baseline assessment (3 pages)

    A brief description of the data that will be collected during the participant baseline assessment must be provided as an attachment using the filename "Baseline assessment.pdf" and may not exceed 3 pages.  Examples of data that may be collected on participants may include, but are not limited to, the following:

    • Demographics (e.g., education, residential and occupational history)
    • Clinical characteristics and basic diagnostic information (e.g., anthropometry, functional status, medication history, laboratory measurements)
    • Co-morbidities and risk factors (e.g., diabetes, environmental exposures, adverse childhood experiences or perinatal events, family history)
    • Lifestyle factors (e.g., diet, physical activity, smoking history, sleep habits)
    • Clinical endpoints (e.g., treatment response and/or side effects, progression/recurrence, overall and cause-specific survival, quality of life)
    • Participant- or patient-reported outcomes (e.g., social functioning, pediatric anxiety, pain impact)
    • Repeated or longitudinal measurements to support scientific hypotheses, if applicable (e.g., circadian fluctuations)

    2. Cohort management (5 pages)

    A description of how the proposed cohort will be managed must be provided as an attachment using the filename "Cohort management.pdf" and may not exceed 5 pages. Provide details for each bullet below:

    • Training/monitoring: Describe how training and monitoring of study sites and staff will be managed.
    • Data management: Describe how study data will be managed, including data cleaning, quality control, and database management approaches. Describe how clinical events will be adjudicated.
    • Data harmonization: Describe plans for data harmonization, metadata generation, and adoption/use of data standards or common data elements. If these activities are not possible or feasible for the proposed study, applicants must explain why.   
    • Innovative approaches: If applicable, describe the planned use of innovative approaches to data management/standards, data collection, and/or participant follow-up/surveillance.
    • Surveillance: Describe plans for active and/or passive participant follow-up or surveillance.

    3. Biospecimen Plan (must be provided if applicable to the study proposed, 5 pages)

    If applicable, a Biospecimen Plan should be provided as an attachment using the filename "Biospecimen Plan.pdf" and may not exceed 5 pages.  Provide details for each bullet below:

    • Brief description of which biospecimens will be collected (e.g., blood, urine, disease-impacted tissue) and, if applicable, plans for repeated or longitudinal biospecimen collection to support scientific hypotheses (e.g., microbiome sampling)
    • How study biospecimens will be collected, processed, analyzed, managed and tracked, and stored
    • Plans for adherence to Good Laboratory Practices (GLP) and use of current best practices for biospecimen management and quality control (e.g., the National Cancer Institute's Best Practices for Biospecimen Resources)
    SF424(R&R) Senior/Key Person Profile

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

    Biographical Sketch:

    PD(s)/PI(s) must describe their experience with epidemiology cohort studies, specifically documenting their abilities to organize and manage a cohort study and its related activities.  If a PD/PI has no prior experience with epidemiology cohort studies, then he/she must describe experience with large research consortia or multi-site studies. If applicable, note whether the study team has ever worked together.

    R&R Budget

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

    Specific to this FOA: Include budget support for travel to a yearly in-person Steering Committee/Observational Safety Monitoring Board meeting, as well as an initial kick-off meeting of investigators and NHLBI program staff; these meetings will be held in the Washington, D.C. area. Lead PD(s)/PI(s) are required to declare a minimum effort of 2.4 person months per year (equivalent to 20% effort); if the study is led by multiple PDs/PIs, then a minimum combined PD/PI effort of 2.4 person months per year is required.

    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: 

    Specific Aims:

    Provide Specific Aims for the establishment of a novel epidemiology cohort study and baseline assessment of all cohort participants.

    Research Strategy:

    Applicants proposing the involvement of Human Subjects should use the Research Strategy section to discuss the overall strategy, methodology, and analyses of the proposed research. Do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information Form.

    In the Research Strategy attachment, applicants must specifically address the following:

    • How the establishment of the proposed cohort study will permit research that will address multiple scientific hypotheses
    • How the proposed cohort study will fill or address a gap in heart, lung, blood, and/or sleep disease, disorder, and/or phenotype research
    • How the proposed research will align with the NHLBI's Strategic Vision
    • The short-, medium-, and long-term vision for the cohort
    • How the participant baseline assessment will support:
    • The study's multiple research hypotheses
    • Investigation of endpoints of clinical significance and other health outcomes of interest
    • Surveillance or follow-up of participants over time

    Letters of Support:

    A statement of commitment from each participating institution or organization must be provided. If parts of the study are to be provided by sources other than the NHLBI, provide Letter(s) of Support signed by an authorized representative.

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

    All applications, regardless of the amount of direct costs requested for any one year, are expected to include a Data Sharing Plan. Consistent with achieving the goals of the program, applications are expected to describe planned internal and external data and biospecimen sharing policies. Applicants may contact NHLBI staff to discuss any concerns about sharing study data from their proposed cohort.

    NHLBI expectations for data sharing:

    Data collected under this FOA are expected to be widely shared through the NHLBI BioLINCC repository (https://biolincc.nhlbi.nih.gov/home/) and/or other NIH-designated repositories. Metadata, protocols, manuals of procedures, algorithms for calculated data elements, and other documentation necessary to describe the study and resultant data to investigators not affiliated with the study are also expected to be widely available.  

    Genomic data sharing:

    If proposing to generate large-scale human genomic data, applications are expected to also describe a genomic data sharing plan per the NIH Genomic Data Sharing (GDS) Policy (https://osp.od.nih.gov/wp-content/uploads/NIH_GDS_Policy.pdf). Even if applications do not propose to conduct genomic or other -omic analyses, these types of analyses may occur during future data collection cycles; as such, applicants may wish to anticipate the potential for these types of studies by incorporating relevant language regarding genomic data collection, analysis, and sharing into their informed consent process. 

    The NIH has developed several guidance documents to assist applicants with the NIH GDS Policy.  Applicants are encouraged to review the following resources and to contact NHLBI staff to discuss any concerns about genomic data sharing:

    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 NIH-defined human subjects research, clinical research, and/or 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 with the following additional instructions:

    Section 2 - Study Population Characteristics:

    Section 2.4 (Inclusion of Women, Minorities, and Children) has the following additional instruction:

    • Justify the anticipated or projected sample size for the overall cohort and for any relevant subgroups (i.e., is the sample size sufficiently powered to address the study's aims?) 

    2.5 (Recruitment and Retention Plan) has the following additional instructions:

    • Demonstrate that each recruitment site has access to sufficient numbers of potential participants to attain its target enrollment
    • Provide estimates or other data (e.g., pilot data) to demonstrate the feasibility of meeting proposed recruitment goals, broken down by enrollment site if applicable
    • Describe contingency plans to manage potential delays or barriers with participant recruitment in the overall cohort as well as in key subgroups

    2.7 (Study Timeline) has the following additional instruction:

    Include the following milestones in the study timeline, as applicable:

    • IRB approval
    • Establishment of study infrastructure, such as committees, biospecimen storage, and study sites
    • Finalized standard operating procedures (SOPs), data collection protocols, and informed consent/assent document(s)
    • Anticipated start and end dates for participant recruitment and data collection(s)
    • Data cleaning and quality control

    Section 3 - Protection and Monitoring Plans:

    3.1 (Protection of Human Subjects) has the following additional instruction:

    When discussing potential benefits and risks to participants, include a description of whether any research data or findings might be returned to participants, and if so which type(s) of results would be returned (e.g., medically actionable genomic variation, clinically significant or incidental exam findings).

    3.5 (Overall Structure of Study Team) is required for this FOA, and has the following additional instructions:

    The Overall Structure of the Study Team attachment is required.  In addition to describing the various study sites (e.g., administrative sites, data coordinating sites, enrollment/participating sites, laboratory or testing centers), applicants must also describe any committees, sub-committees, and/or working groups that will be used to coordinate and oversee study activities (e.g., steering committee, publications, community engagement).

    Delayed Onset Study

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

    Important reminders:

    All PD(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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/Research Contact at least 14 weeks before the Application Due Date to schedule a staff consultation before submitting the application; applicants must follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

    FOA-Specific Instructions for Applications Requesting Direct Costs of $500,000 or More:

    The NHLBI anticipates that all applications submitted in response to this FOA will be subject to the NIH policy that requires investigator-initiated applications requesting $500,000 or more in direct costs in any one year to obtain documented approval from the NHLBI stating that the Institute will accept the application for initial peer review.  Applicants are strongly encouraged to review NHLBI's policy regarding applications with direct costs of $500,000 or more in any one year (https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/applications-with-direct-costs-of-500000-or-more-in-any-one-year) to learn more about the pre-submission review process, including content to include in the required Letter of Request.

    In addition, the NHLBI anticipates that most applications submitted in response to this FOA may request direct costs that exceed $1.515 million in any year. The NHLBI typically only considers requests to submit these larger applications twice per year. However, for this FOA only, the NHLBI will conduct a single ad hoc consideration of applications exceeding $1.515 million a year for each Application Due Date. To accommodate this ad hoc consideration, applicants MUST abide by the following deadlines for applications exceeding the PPG cap; these dates supersede the deadlines listed online in the NHLBI's policy. 

    For the June 5, 2018 application due date:

    • NHLBI staff consultation must be completed by March 1, 2018
    • Letter of Request must be received by March 6, 2018
    • The NHLBI will notify applicants in writing about its decision whether to accept an application for peer review by April 17, 2018; if the application will be accepted, it must be submitted by June 5, 2018

    For the June 5, 2020 application due date:

    • NHLBI staff consultation must be completed by February 28, 2020
    • Letter of Request must be received by March 8, 2020
    • The NHLBI will notify applicants in writing about its decision whether to accept an application for peer review by April 17, 2020; if the application will be accepted, it must be submitted by June 5, 2020

    After the NHLBI makes its decision regarding whether to accept a proposed application exceeding the PPG cap for peer review, applicants will have approximately 8 weeks to prepare their full application for submission by the June 5, 2018 or June 5, 2020 Application Due Dates. 

    Please note: Granting permission to submit the application for review does NOT guarantee that the NHLBI will fund the application or that it will fund the application at the requested levels, regardless of the outcome of peer review.

    Use of Common Data Elements in NIH-funded Research

    Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a "Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.  

    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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    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.

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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:

    How well will the establishment of the cohort and the proposed cohort study be able to address multiple scientific hypotheses? How feasible are the short-, medium-, and long-term visions for the cohort?

    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?

    Specific to this FOA:
    How well does the experience of the PD(s)/PI(s) qualify him/her to lead a large epidemiology cohort study and its related activities (e.g., recruiting participants, establishing study infrastructure, data cleaning and quality control, overseeing multiple study sites (if proposed))?

    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?

    Specific to this FOA:

    How well does the proposed cohort study address a research gap in heart, lung, blood, and/or sleep diseases, disorders, and/or phenotypes? What are the strengths and weaknesses of the innovative approaches to the facilitation of data collection or data management of the cohort, if applicable to the proposed study? 

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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? 

    Specific to this FOA:

    How feasible are the recruitment goals?  How realistically will the contingency plans manage potential delays or barriers with participant recruitment in the overall cohort as well as in key subgroups?  How achievable are the study's timeline and milestones? How well will the participant baseline assessment support: (a) the study's multiple research hypotheses?, (b) the investigation of endpoints of clinical significance and other health outcomes of interest?, and (c) surveillance or follow-up of participants over time?  If applicable, what are the strengths and weaknesses of the applicant's plan for collecting, processing, analyzing, managing and tracking, and storing study biospecimens?  How rigorous are the applicant's plans for managing study data? How feasible are the plans for active and/or passive participant follow-up or surveillance?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

    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? 

    Specific to this FOA:
    How will the facilities and other resources available to the applicant(s) enable the effective implementation of a detailed baseline assessment of cohort participants and, if applicable, the efficient operation of a multi-site study?  What are the strengths and weaknesses of the study team's overall structure?  How effectively will the proposed study sites, committees, sub-committees, and/or working groups be able to coordinate and oversee study activities?

    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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

    Inclusion of Women, Minorities, and Children 

    When the proposed 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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    Not Applicable

    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

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    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.

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

    As part of the scientific peer review, all applications:

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

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . 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.

    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.

    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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://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 http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at 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.

    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.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

    The PD(s)/PI(s) will have primary responsibility for:

    The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NHLBI for the performance and proper conduct of the research supported by the U01 award in accordance with these terms and conditions of the award. As such, the awardee PD(s)/PI(s) will be responsible for all aspects of the study and cohort, as well as any modification(s), unless otherwise provided for in these terms or by action of the cohort Steering Committee.

    Specific responsibilities include:

    • Defining objectives and approaches of the research
    • Defining the research plan and goals
    • Project design and protocol development
    • Obtaining all requisite study and protocol approvals
    • Participant recruitment and follow-up
    • Data collection and quality control
    • Safety and data monitoring
    • Oversight of study activities, such as data analysis and interpretation, manuscript preparation, and dissemination of study results
    • Overseeing/performing other scientific activities of the research plan
    • Monitoring the completion of the supported activities and taking corrective actions if needed
    • Participating in the activities of the cohort Steering Committee
    • Accepting and implementing the decisions approved by the cohort Steering Committee to the extent consistent with applicable grant regulations
    • Cooperating with NHLBI programmatic, technical, and administrative staff
    • Administratively managing the U01 award
    • Developing collaborations with and making data accessible to external investigators
    • Ensuring submission of reports to the OSMB, if applicable

    The awardee will be required to provide updated descriptive and meta-data to the NHLBI upon request, including cohort characteristics, study protocols, basic counts of study participants, enrollment progress, biospecimen availability, and study variable definitions.  Awardees must also provide analytical data files (illustrative examples include: derived/calculated data variables; finalized questionnaire data; data from procedures, such as spirometry, echocardiography, ECG, exercise testing, polysomnography, etc.; participant follow-up data; clinical event outcomes data) to the NHLBI periodically based upon a mutually agreed schedule and format and at the end of the period of this award, along with documentation necessary for their use.

    Awardees will be expected to evaluate and document compliance with NCI's Best Practices for Biospecimen Resources for collection, processing, and storage of future previously collected biospecimens (http://biospecimens.cancer.gov/bestpractices). Awardees will be required to explore, with NHLBI staff, the feasibility of data harmonization and pooling with other cohorts and studies. Awardees are encouraged to register the cohort through ClinicalTrials.gov (http://clinicaltrials.gov).  Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

    Awardees agree to the governance of the study through a Steering Committee and to accept and implement decisions approved by the Steering Committee (see "Joint Responsibilities" section below).

    Awardees are expected to make their data widely available to other investigators per NIH and NHLBI data sharing policies (https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_policies.html, https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies).  If awardees propose to generate large-scale genomic data, they are expected to comply with the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/). Study investigators are strongly encouraged to publish and disseminate results, tools, resources, and other products of the study, in accordance with the study protocols and governance.  It is expected that all methods, analyses, software, and algorithms will be made available in a timely manner to the scientific community.

    Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party; involvement of study resources; citing the name of the study or NHLBI support; or special access to study results, data, findings, or resources requires notification of and concurrence by NHLBI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to and concurrence by NHLBI.

    The PD(s)/PI(s) are required to commit to a minimum effort of 2.4 calendar months per year, equivalent to 20% effort.

    NHLBI staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    A designated NHLBI Project Scientist(s) will have the following responsibilities:

    • Participating in the activities of the cohort's Steering Committee, as well as any subcommittees as appropriate, and helping to address issues that come before these committees
    • Facilitating collaborations between the awardees and other NHLBI-sponsored programs, investigators, or organizations that may contribute to the study's goals
    • Assisting in the interaction between the awardees and investigators at other institutions, as appropriate for the cohort
    • Promoting collaborative research efforts that involve interactions with other NIH-supported projects, programs, and centers and helping with the coordination of such efforts
    • Facilitating harmonization of data and biospecimen resource optimization
    • Participating in study meetings
    • Providing technical assistance and advice to the awardees as appropriate
    • Organizing and conducting regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the study investigators and centers
    • Assisting with the development of research protocols
    • Monitoring participant recruitment and study progress
    • Ensuring disclosure of conflicts of interest and adherence to NHLBI policies

    At the discretion of the NHLBI, an independent Observational Study Monitoring Board (OSMB) may be appointed by the Director, NHLBI, to provide overall monitoring of data and safety issues in accordance with NHLBI DSMB/OSMB policy (https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-data-and-safety-monitoring-extramural-clinical-studies). Meetings of the OSMB will ordinarily be held in Bethesda, MD or via teleconference/videoconference. An NHLBI scientist other than the NHLBI Program Official or Project Scientist will serve as Executive Secretary to the Board. Because the OSMB serves as an independent group advisory to the NHLBI, study investigators shall not communicate with OSMB members regarding study issues, except as authorized by the Board's Executive Secretary.

    In addition to the Project Scientist, a separate NHLBI Program Official will be responsible for the normal program stewardship of the cooperative agreement, and will be in the Notice of Award.  However, the NHLBI may elect to have a dual-role approach where a single individual may act as both the NHLBI Project Scientist and Program Official.  Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist.  The responsibility for final decision making may reside with Senior Institute management, separate organizational components, and/or oversight committees.  Because it is anticipated that the Program Official will participate in activities that rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest (e.g., co-publication), other staff members such as direct line supervisor and/or other Senior NHLBI Program management staff may serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award.  Additional NHLBI staff members may be designated to have substantial involvement in the study.

    The NHLBI policy on authorship and manuscript review of NHLBI-sponsored extramural research protects against conflicts of interest with the Program Officer.

    The NHLBI reserves the right to withhold funding or curtail the study in the event that any of the following occur:

    • Substantial shortfall in participant recruitment, follow-up, data reporting, or quality control
    • Major breach of the protocol or substantive changes in the agreed-upon protocol, methodologies, and/or tools with which the NHLBI cannot concur
    • Failure to develop or implement a mutually agreeable protocol
    • Human participant ethical issues that may dictate a premature end of the award
    • Results that substantially diminish the scientific value of study continuation

    Areas of Joint Responsibility:

    Each cohort established under this FOA shall have a Steering Committee (SC) that serves as its main governing board.  The SC voting membership shall be determined jointly by the PDs/PIs and the NHLBI, but shall minimally consist of the study center(s) PI(s), the NHLBI Project Scientist(s), the Data Coordinating Center PI(s) (if applicable), and the biorepository PI(s) (if applicable).  Additional members may be added by majority vote of the SC.  Meetings of the SC will ordinarily be held by teleconference, videoconference, or in-person.

    The appointed voting Steering Committee members will be required to attend all Steering Committee meetings and tele/videoconferences, or to appoint a substitute that will be fully briefed on the issues at hand.  Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members.  The Steering Committee may also form an Executive Committee (EC) and/or subcommittees as needed.  The NHLBI Project Scientist(s) may serve on the EC and on subcommittees as deemed appropriate.  The Chair of the Steering Committee will be selected from the SC voting members.

    The Steering Committee will have primary responsibility for:

    • Overseeing the overall organization of the study's core functions
    • Providing guidance on scientific and infrastructural issues pertinent to the funded cohort study
    • Providing guidance, oversight, and coordination of the activities of the cohort investigators towards cross-cohort data harmonization, if requested by the NHLBI
    • Contributing to the development of policies and processes pertinent to the cohort infrastructure

    All investigators/staff within the study will be required to accept and implement the policies approved by the Steering Committee to the extent consistent with applicable grant regulations.

    Where applicable, the awardee will work with the NHLBI on efforts to harmonize data across NHLBI cohorts and studies, and explore the feasibility of using common data standards and elements.

    NHLBI will partner with the PD(s)/PI(s) to ensure dataset and documentation preparation is congruent for submission to the Biological Specimen and Data Repository Information Coordinating Center (BioLINCC) as described in the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies, and the Guidelines for Preparing Clinical Study NHLBI Data Sets for Submission to the NHLBI Data Repository.  Large-scale genomic data generated by the awardee are to be deposited along with associated phenotype data into the database of Genomic and Phenotype Data (dbGaP, accessed at http://www.ncbi.nlm.nih.gov/gap) in accordance with the NIH Genomic Data Sharing Policy available at https://osp.od.nih.gov/wp-content/uploads/NIH_GDS_Policy.pdf.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Division of Cardiovascular Sciences (DCVS)
    Mollie Minear, Ph.D.
    National Heart, Lung, and Blood Institute (NHLBI)
    Division of Cardiovascular Sciences (DCVS)
    Email: NewEpiCohorts@nhlbi.nih.gov

    Division of Cardiovascular Sciences (DCVS)

    Sean Coady, M.A.
    National Heart, Lung, and Blood Institute (NHLBI)
    Email: NewEpiCohorts@nhlbi.nih.gov

    Division of Lung Diseases (DLD)

    Lisa Postow, Ph.D.
    National Heart, Lung, and Blood Institute (NHLBI)
    Email: NewEpiCohorts@nhlbi.nih.gov

    Division of Blood Diseases and Resources (DBDR)

    Ellen M. Werner, Ph.D., M.A.
    National Heart, Lung, and Blood Institute (NHLBI)
    Email: NewEpiCohorts@nhlbi.nih.gov

    Center for Translation Research and Implementation Science (CTRIS)

    Emmanuel Peprah, Ph.D.
    National Heart, Lung, and Blood Institute (NHLBI)
    Email: NewEpiCohorts@nhlbi.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)

Benjamin Sakovich
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8049
Email: sakovichbj@mail.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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