Department of Health and Human Services

Part 1. Overview Information

Key Dates

Required Application Instructions

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

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

Program Overview

This Funding Opportunity Announcement (FOA) invites applications to participate as the Administrative Coordinating Center (ACC) for the NHLBI Cardiovascular Development Consortium (CvDC) (RFA-HL-15-013 ) and the NHLBI Pediatric Cardiac Genomics Consortium (PCGC) (RFA-HL-15-012 ). These consortia compose a NHLBI translational program in pediatric cardiovascular disease called the Bench to Bassinet Program (B2B). The B2B was launched by the NHLBI in 2009 as a novel approach to break through the major barriers of translational research, identify the causes of human congenital heart disease, and ultimately improve outcomes for individuals with congenital heart disease. The B2B strategy is to accelerate the translation of scientific discovery into clinical practice through collaborations of basic, translational, and clinical researchers. The consortia interact with each other, and with the NHLBI Pediatric Heart Network (PHN) to encourage translation of results from basic science to clinical research, and to provide clinical input on pressing needs for basic and translational research.

The goal of the CvDC (RFA-HL-15-013 ) is to generate and disseminate comprehensive data about the molecular networks that regulate cardiovascular development. The CvDC will build on the current robust body of knowledge about the underlying mechanisms controlling cardiovascular development by facilitating the collaborative use of powerful new technologies and the adoption of common methods of data collection, integration, and analysis. The CvDC will comprise of up to four Research Centers (RCs). Scientific activities will include single-center projects and coordinated development and implementation of multi-center collaborative projects.

The PCGC (RFA-HL-15-012 ) aims to harness new genetic technologies and resources to move toward a comprehensive understanding of the genetics and genomics of congenital heart disease in humans. Another important goal of the PCGC is to understand how genetic variants affect clinical and neurodevelopmental outcomes. The PCGC will perform coordinated patient recruitment and phenotyping at up to five RCs utilizing common protocols. Scientific activities will include coordinated development and implementation of multi-center collaborative projects. At least one project will focus on the neurodevelopmental aspects of congenital heart disease.

Specific areas of research interest

This FOA supports the coordination and facilitation of the activities of the B2B program. The ACC awardee will work collaboratively with the PCGC and CvDC investigators to conduct a comprehensive program of basic research, genomic discovery, and genotype-phenotype clinical studies. The ACC supports the PCGC’s clinical protocols and performs administrative tasks for both PCGC and CvDC. The ACC also organizes meetings, coordinates activities of the OSMB and EAC, and issues subawards to core facilities that support the scientific work of the consortium.

Functions, which may be supported through subawards or provided in-house, include but are not limited to:

1. Operations:

• Provide logistical and administrative assistance in arranging meetings of the Steering Committees (SC) of the PCGC and the CvDC and various subcommittees (e.g., scheduling meetings, as well as preparing, distributing and maintaining minutes of meetings). Each SC is expected to meet by teleconference at least monthly and in-person at least twice a year. Subcommittees will meet as necessary and are expected to average about 10 teleconferences per month.
• Provide logistical and administrative assistance in arranging a B2B Program-wide annual meeting, in addition to the SC in-person meetings described above.
• Provide logistical and administrative assistance in arranging semiannual meetings of an External Advisory Committee (EAC) and an Observational Study Monitoring Board (OSMB). One meeting will be by teleconference, and the other will be an in-person meeting in conjunction with the annual B2B Program meeting.
• Produce, maintain, and disseminate all documents, including a Manual of Operations and procedures manuals.
• Develop and maintain an interactive web site to publicize the B2B, to announce the availability of B2B-supported resources, and to receive input from outside investigators.
• Develop and maintain infrastructure for internal communications to include a web portal for document sharing, scheduling, announcements, and other activities as needed.
• Work with the NHLBI Project Scientists on the review of applications/proposals submitted to the SCs.
• Provide a mechanism for rapid and routine exchange of materials (e.g., manuscripts, reports, etc.) among the B2B investigators, the NHLBI Project Scientists, and other NHLBI staff.

2. Protocol Development:

• Support the development, coordination, implementation, and conduct of B2B collaborative research protocols.
• Provide limited statistical analysis of B2B collaborative studies, including descriptive and inferential statistics of the clinical data. Statistical analysis of genetic data will be performed by RCs.
• Utilize electronic information management systems for collection of data and specimen tracking in individual and multi-center B2B studies, and perform data quality checks for all data generated in the PCGC data repository.
• Monitor PCGC protocol adherence, monitor data collection and submission, and report violations to the NHLBI, the PCGC SC and the OSMB.
• Develop uniform investigative protocols for data and specimen collection.
• Develop and maintain a computerized data system for data management and statistical analysis.
• Provide support services for the production of data forms and reports, graphics, and other materials.
• Provide advice and consultation to B2B investigators in study design and protocol development of B2B collaborative studies approved by the SC(s).

3. Core Facilities and Data Management:

• Support a biorepository of DNA and tissue specimens and cell lines. PCGC RCs will collect biospecimens from study participants for DNA preparation, storage, and distribution to Core Facilities as directed by the PCGC SC.
• Support a data repository or repositories with role-based permission levels (e.g., to all B2B investigators, subsets of investigators, or approved external investigators).
• Work with data repositories to make data publically available in real time, as determined by NHLBI and B2B data sharing policies.
• Manage the distribution of funds to Core Facilities by issuing subcontracts for sequencing, genotyping, development of analytical tools and other scientific tasks, taking into account the recommendations made by the SC(s) and reviews by the NIH in conjunction with outside expertise.
• Monitor Core activities, deliverables, and use of funds.
• Report at least quarterly to the Project Scientists the amount of Core funds spent, pending, and remaining for the budget year.
• Support development and implementation of standard procedures and instruction manuals for data collection at RCs.
• Interact with participating institutions to resolve data errors.

Program Structure

Research Centers are responsible for proposing, developing, and conducting studies, recruiting study subjects, entering data into a web-based B2B data repository, training junior investigators, and disseminating research findings. All RCs are expected to participate in a cooperative and interactive manner with one another, the sister consortium's Research Centers, and the ACC.

The Steering Committees (SCs) are the main governing bodies of the PCGC and CvDC. A Steering Committee is composed of the PDs/PIs of each Research Center and the ACC, and NHLBI and NICHD Program Scientists. The SC has primary responsibility for the general organization of the respective consortia, conduct and monitoring of studies, allocation of core resources, and expeditious reporting of study results. The PCGC SC is also responsible for approval of clinical protocols and genetic/genomic studies. All major scientific and administrative decisions are determined by majority vote of the SC, which meets at least monthly by teleconference.

Subcommittees are established as necessary, and membership includes appropriate representation from the Research Centers, the ACC, and the NIH. An important aspect of the B2B program is the interaction of scientists along the translational spectrum. Therefore, B2B investigators will meet regularly through teleconferences and in-person meetings to share data and discuss and implement collaborative projects. Investigators will also interact with investigators from the PHN to advise the PHN on genomics aims of PHN clinical studies and trials and to implement collaborative projects.

Cores are necessary to support the science and to provide resources and services to multiple Research Centers. A centralized biorepository stores all PCGC blood and DNA samples, and a centralized PCGC data hub manages all clinical and genomic data. Other core facilities are used in an ad hoc fashion, as driven by the science, to perform sequencing, genotyping, and other scientific tasks. During the initial funding cycle of the CvDC, cores included a centralized data hub to provide a platform to share model organism data within the B2B Program and with outside investigators; a Bioinformatics Core to standardize data format and analyses across the CvDC and to develop tools as needed; sequencing; functional testing of candidate disease genes, and other scientific tasks. Once the SCs are convened, requirements for Cores across the B2B will be evaluated. The NHLBI will determine the Core configuration with input from the SC and the EAC (see below). Cores can be located at Research Centers, the ACC, or at institutions or service providers outside of the B2B, depending upon expertise, performance, and cost. The ACC and NHLBI will oversee the process of Core selection, and the ACC will administer the budget for the Cores. Cores may be phased in and out based on scientific need during the course of the funding cycle.

The NHLBI and NICHD are responsible for organizing and providing overall support for the PCGC and CvDC. The NHLBI Program Office and Office of Grants Management are responsible for the overall management of the B2B. In addition to regular grant stewardship, NHLBI and NICHD Project Scientists will be involved substantially with the awardees as a scientific partner, consistent with the Cooperative Agreement mechanism.

An independent External Advisory Committee (EAC), appointed by the NIH and funded through the ACC, reviews the progress of the program every 6 months and provides advice to the B2B grantees about scientific direction. Members of the EAC and ad hoc external experts review all applications for potential cores and provide advice to the ACC about core selection.

An Observational Safety and Monitoring Board (OSMB), also appointed by the NIH and funded through the ACC, monitors patient safety and data integrity and reviews the performance of each study involving human subjects. The OSMB also reviews proposed PCGC ancillary studies for issues of patient burden. As a part of its monitoring responsibility, the OSMB submits recommendations to the NIH regarding the conduct and continuation of each protocol.

Data Sharing

A critical mission of the B2B program is to expand resources to the broader scientific community to advance research. The B2B strives to meet or exceed expectations of NIH data sharing policies. A goal of the CvDC will be to achieve real-time data sharing with the broader scientific community through a CvDC data repository and the B2B program's public website. Data generated by the PCGC are expected to be made available to the broader research community through open, shared databases such as dbGaP and ClinVar. A goal of the PCGC will be to achieve real-time data sharing with the broader scientific community through the ancillary study process or other bioinformatics solutions. Appropriate controls will be implemented to ensure patient privacy and regulatory compliance.

Frequently Asked Questions (FAQ)

Frequently Asked Questions related to this FOA and companion FOAs are posted at http://www.nhlbi.nih.gov/research/funding/opportunities/faq-bench-to-bassinet.htm .

Section II. Award Information

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

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 not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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.
• 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

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
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: [email protected]

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.

Facilities and Other Resources: Applicants are encouraged to describe special or unique strengths that may be relevant to B2B infrastructure and research. An example could include the availability of state-of-the art biomedical or research informatics systems (e.g., innovative tools, methods and algorithms), which may be shared or may be available to develop and expand scientific productivity of the B2B.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. Investigators are encouraged to describe special or unique strengths that may be relevant to B2B infrastructure and research. Examples could include significant previous experience coordinating genomics research programs or prior participation in research funded by NIH cooperative agreements, Investigators should describe previous experience in organizing, supporting, and conducting annual in-person, monthly teleconference, and videoconference meetings, and preparation of minutes and other related reports. Investigators should also demonstrate experience in providing logistical services for multi-center translational or clinical research, such as overseeing selection of technical laboratories Describe experience with similar financial arrangements and detail how the funds will be managed for the two Consortia.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. In addition, the budget should:

• Direct Costs for the Administrative Coordinating Center Operations are limited to $500,000 per year.
• Direct Costs for core and protocol development are limited to $5,730,000 per year.
• Designate a minimum of 2.4 calendar months effort for the PD/PI, or a minimum of 2.4 calendar months combined effort for all PDs/PIs if the application includes multiple PDs/PIs.
• Include travel costs for 2-3 members of the ACC to attend the two-day B2B Program annual meeting and 2 Steering Committee meetings per year in Bethesda, MD. Also include travel costs to the annual meeting for the 5-6 members of the EAC and the 5-6 members of the OSMB. Do not include travel costs for Research Center investigators. Travel for the Research Center PDs/PIs and other staff is supported through the Research Center grants.
• Include consultant costs for the 5-6 members of the EAC and the 5-6 members of the OSMB for meetings and calls. In Section F. Other Direct Costs, add a line item identified as "Core and Protocol Costs". For this added line item, enter the amount of funds reserved for subawards to Core facilities and protocol costs as Funds Requested ($). The number of subawards will be determined by the Steering Committees following award, but for application purposes, assume one subaward of $5,720 and apply the first $25,000 to the indirect cost base.

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: The main focus of the application should be to propose a plan to meet the research coordinaing activities to support the B2B Program; including operations, protocol development, and Core facilities and data management. The Research Strategy must consist of the following subsections:

A. Management Strategy

Provide a description of the leadership approach, governance, and organizational structure including an organized, feasible strategy for the coordination of the multiple overlapping activities of the two Consortia. The proposed strategy should include detailed timelines for the initiation and completion of key activities (operations, protocol development, and Core facilities and data management).

The application should include a statement indicating willingness to engage in collaborative activities across the B2B, in partnership with NHLBI and NICHD staff to support the goals of the B2B program and to accelerate translation of study findings to the scientific community and clinical practice.

B. Operations

Expertise and Experience in Logistical and other Support Services: The ACC provides arrangements for logistical support associated with meetings and conference calls for both PCGC and CvDC SCs, various subcommittees, the EAC, the OSMB, and other meetings as required by the Consortia. The application should describe plans for organizing, supporting, and conducting annual in-person, monthly teleconference, and videoconference meetings, and preparation of minutes and other related reports. The application should describe plans for providing logistical services for multi-center translational or clinical research, such as overseeing selection of technical laboratories.

Describe a plan to review applications submitted to the SCs, including protocols, Core services requests and ancillary studies.

Electronic Information and Data Systems: Describe plans to produce, maintain, and disseminate all doucments including a Manual of Operations and procedures manuals. Dissemination is expected to include:

an interactive web site to publicize the B2B, to announce the availability of B2B-supported resources, and to receive input from outside investigators; Provide a mechanism for rapid and routine exchange of materials (e.g., manuscripts, reports, etc.) among the B2B investigators, the NHLBI Project Scientists, and other NHLBI staff.

infrastructure for internal communications to include a web portal for document sharing, scheduling, announcements, and other activities as needed

The application should detail prior experience with these activities, including innovative systems for management and archiving of email traffic and electronic reports, development of standard operating procedures, and ensuring data safety and confidentiality. The application should demonstrate successful experience with web site development for similar programs.

C. Protocol Development

Describe a plan to support the development, coordination, implementation, and conduct of B2B collaborative research protocols to include but not limited to:

• limited statistical analysis of B2B collaborative studies, including descriptive and inferential statistics of the clinical data.
• monitoring PCGC protocol adherence and data collection and submission; and reporting violations to the NHLBI, the PCGC SC and the OSMB
• established uniform investigative protocols for data and specimen collection and tracking
• development and maintenece of a computerized data system for data management and statistical analysis
• providing support services for the production of data forms and reports, graphics, and other materials.
• providing advice and consultation to B2B investigators in study design and protocol development of B2B collaborative studies approved by the SC(s).

Describe a plan to review applications submitted to the SCs, including protocols, Core services requests and ancillary studies.

D. Core Facilities and Data Management

Applicants must describe plans for:

• support of a biorepository of DNA and tissue specimens and cell lines
• support of a data repository or repositories with role-based permission levels (e.g., to all B2B investigators, subsets of investigators, or approved external investigators)
• coordination with the data repositories to make data publically available in real time, as determined by NHLBI and B2B data sharing policies
• issuing subawards for sequencing, genotyping, development of analytical tools and other scientific tasks, taking into account the recommendations made by the SC(s) and reviews by the NIH in conjunction with outside expertise
• monitoring of Core activities, deliverables, and use of funds
• reporting at least quarterly to the Project Scientists the amount of Core funds spent, pending, and remaining for the budget year
• assuring data quality
• management and disbursement of funds for consortia Cores and protocols
• the scope of in-house Core services to be provided, if applicable

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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

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

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

The ACC awardee will work collaboratively with the PCGC and CvDC investigators to conduct a comprehensive program of basic research, genomic discovery, and genotype-phenotype clinical studies.

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? 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? How strong is the evidence that the investigators have a track record of success in carrying out human genomic research programs? Does the application demonstrate significant experience with the logistical challenges required, including support for multiple meetings and calls, data management systems, and the development and archiving of reports and documents? Does the applicant have experience overseeing selection of and management of subawards to technical laboratories?

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? Does the applicant propose innovative strategies for enhancing communication and/or managing data?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? Are the leadership approach, governance, and organizational structure appropriate for the program? Does the application provide a clear plan for the complex work-flow that will be required, including realistic timelines?

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? Are resources available within the scientific environment to support electronic information handling, data systems, web site development, and data security?

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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) Genome Wide Association Studies (GWAS).

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.

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 NHLBI 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.

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 the primary responsibility for:

• The ACC PD(s)/PI(s) will have the primary responsibility for the overall function of the ACC. This includes the (1) coordination of the activities of the of the Steering Committees and other committees, External Advisory Panel, and Observational Study Monitoring Board; (2) allocation of funds to the Cores and monitoring of Core deliverables and use of funds; (3) planning and organization of an annual investigators meeting; (4) designing and maintaining an internal website for document sharing; (5) designing and maintaining a public website to publicize the B2B Program and facilitate data sharing; (6) writing and maintaining governance documents such as a Manual of Operations; and (7) coordination of all aspects of the CHD GENES study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.
• The awardee agrees to the governance of the study through a PCGC Steering Committee and a CvDC Steering Committee. The awardee agrees to accept and implement policies approved by the Steering Committees. The Steering Committee voting member for the Awardee will be the PD/PI. If the ACC has multiple PDs/PIs, the ACC contact PD/PI will serve as the voting member.
• Awardee agrees to provide quarterly financial reports to the Project Scientists of Core funds paid out, pending invoices, and funds remaining for the budget year.
• The awardee will assure that all members of the ACC team are aware of B2B policies and procedures and kept informed of B2B activities, meetings, and results.
• The awardee agrees to publicly release data and other products of the study in a timely manner and publish results in peer-reviewed journals, in accordance with B2B policies and governance. Genomic data will be shared through dbGaP consistent with the NIH data sharing policies and PCGC policy as described in the PCGC Manual of Operations. The goal for the Program will be to share data in real time as promptly after quality assessment as feasible.
• The PD/PI will serve as a member of a joint leadership committee with the PCGC and CvDC PDs/PIs, and joint committees with the PHN members, as necessary.
• Awardees agree to follow best practice in clinical research and to follow procedures to protect and ensure the privacy of medical and genetic data and records of individuals.
• 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 DHHS, PHS, and NIH policies.

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

• The NHLBI is responsible for organizing and providing overall support for the B2B. The NHLBI Program Office and Office of Grants Management are responsible for the overall management.
• The NHLBI and NICHD Project Scientists will serve on the Steering Committees; he/she or other NIH scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and other NIH scientists) may work with the awardee on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.
• The NHLBI and NICHD Project Scientists, on behalf of the NIH, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.
• The NHLBI reserves the right to withhold funding or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of the protocol, substantive changes in the agreed-upon protocol, or B2B policies with which NHLBI cannot concur; or (d) human subject ethical issues that may dictate a premature end of the award.
• The NHLBI will appoint members of the External Advisory Committee (EAC).
• Support or other involvement of industry or any other third party in the study - e.g., participation by the third party; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources - may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIH.
• 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.

Areas of Joint Responsibility include:

• The Steering Committees have primary responsibility for the general organization of the respective consortia, approval of clinical protocols and genetic/genomic studies, conduct and monitoring of studies, allocation of core resources, and expeditious reporting of study results. All major scientific and administrative decisions are determined by majority vote of the Steering Committee(s).
• The Steering Committee voting membership shall consist of the Research Center principal investigators (i.e. PD/PI), the NHLBI Project Scientist, and the ACC PD/PI. Meetings of the Steering Committee will ordinarily be held by telephone conference call or in person. The Steering Committee Chair will be appointed by NHLBI from the Steering Committee membership or other experts and will be funded through the ACC. Additional members may be added by majority vote of the Steering Committee.
• An independent OSMB will be appointed by the Director, NHLBI, to provide overall monitoring of study data and safety issues. An NHLBI scientist, other than the NHLBI Program Scientist, will serve as Executive Secretary to the OSMB.

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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

The 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.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support(Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Scientific/Research Contact(s)

Charlene Schramm, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0510
Email: [email protected]

Melissa Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: [email protected]

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

John Diggs
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-4267
Email: [email protected]

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Section VIII. Other Information

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

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 Parts 74 and 92.