Part 1. Overview Information

Key Dates

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Program Overview

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to continue support of administrative coordination of the NHLBI Bench to Bassinet Program (B2B), the NHLBI translational program in pediatric cardiovascular disease. The Administrative Coordinating Center (ACC) will coordinate activities of the NHLBI Cardiovascular Developmental Biology Data Resource Center (CDDRC; RFA-HL-20-017) and the NHLBI Pediatric Cardiac Genomics Consortium (PCGC; RFA-HL-20-015).

The B2B was launched by 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 translation of scientific discovery into clinical practice through collaborations among basic, translational, and clinical researchers. The CDDRC and PCGC 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 CDDRC is to accelerate discovery of the genetic etiology and biologic pathways associated with cardiovascular development and congenital heart disease by facilitating access to and querying of annotated data from cardiovascular development studies. The CDDRC will facilitate analysis of candidate genes and variants associated with CHD by assembling the data output from previous funding cycles of the Cardiovascular Development Consortium (CvDC), plus external datasets, into a queryable data repository complete with computational tools. The product of the CDDRC would, by the end of the project period, be a coordinated and interoperable suite of harmonized datasets, computational tools, and links to model organism databases that could be inserted as a functional module into the NHLBI DataSTAGE platform.

The PCGC’s goal is to improve the outcomes of patients with CHD by translating discoveries of the genetic architecture of CHD into optimized diagnosis, management, and therapeutic strategies. To date, this goal has been pursued by identifying genetic and epigenetic causes of human CHD. In the renewal of the PCGC, the focus will shift to exploring how these genetic discoveries may be relevant to clinical applications. Another important goal of the PCGC renewal is to increase the human capital and resources to sustain multidisciplinary, integrated research in CHD pathogenesis. Equipping junior scientists with the skills and experience of conducting genomic research in CHD is central to accomplishing this mission. Increasing resources for the broader CHD research community to advance research through robust data sharing is also a critical goal and involves timely public release of datasets (e.g., submission to dbGaP) and access to PCGC data and specimens.

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 CDDRC investigators to conduct a comprehensive program of genomic discovery, genotype-phenotype clinical studies and build a queryable data repository complete with computational tools. The ACC supports the PCGC’s clinical protocols and performs administrative tasks for both PCGC and CDDRC. 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 PCGC Steering Committee (SC), joint meetings of the PCGC SC and the CDDRC, and various subcommittees (e.g., scheduling meetings, as well as preparing, distributing and maintaining minutes of meetings). The 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 of each of these groups 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 SC for ancillary studies, etc..
• 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.
• Provide logistical and administrative assistance in arranging an R25-like program (research education) in which trainees from outside of the PCGC centers and the CDDRC can come to a PCGC center or the CDDRC for a summer to learn about CHD genomic analysis. This program should be targeted to enhance diversity within the CHD research community.

2. Protocol Development and Implementation:

• 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 Research Centers (RCs).
• Use 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 rapidly publicly available, 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 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.
• Solicit applications from qualified groups for Core Facilities as needed.
• Support open research by releasing funding opportunities for analysis of PCGC data by Challenge Prizes. Challenge Prizes offer cash awards to any outside individual or group that provides a creative solution to a specifically defined problem. Such challenges might include (1) use of machine learning approaches on whole genome sequence datasets linked to clinical outcomes to identify novel genetic risk predictors for important CHD outcomes, or (2) integration of datasets from PCGC and the CDDRC (and other sources) to identify novel pathways involved in the pathogenesis of CHD. These Prizes may also be used to stimulate computation within the NHLBI Data STAGE.
• Collaborate with the CDDRC to stimulate use of the data through Challenge prizes.

Program Structure

PCGC Research Centers are responsible for proposing and developing human genomics studies, recruiting study subjects, entering data into the web-based data collection system, performing other aspects related to conducting the research, training junior investigators, and disseminating research findings. All individual Research Centers are expected to participate in a cooperative and interactive manner with one another and with the ACC and NHLBI.

The CDDRC will be responsible for assembling data relevant to cardiovascular developmental biology into a queryable data repository complete with computational tools. The CDDRC will collaborate with the ACC to establish an educational program and stimulate use of the data through Challenge prizes. The CDDRC will collaborate with the PCGC Steering Committee to use the CDDRC data resource to relate genes and variants identified by the PCGC to cardiovascular developmental biology and gene regulatory networks. The CDDRC will collaborate with the PCGC Data Hub to assure interoperability between the CDDRC data resource and human genomics data collected by the PCGC.

The Steering Committee (SC) is the main governing body of the PCGC. 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 data generation and other scientific tasks. During the previous funding cycles of the B2B, cores included genomic and transcriptomic sequencing services, model organism and stem cell cores, and support of clinical coordinators to enroll subjects into PCGC protocols.. Once the PCGC SC is 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 is responsible for organizing and providing overall support for the PCGC and CDDRC. 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 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 annually and as needed to provide advice to the NHLBI 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 CDDRC will be to achieve real-time data sharing with the broader scientific community through a CDDRC data repository and the B2B program's public website. Data generated by the CDDRC and PCGC are expected to be made available to the broader research community through open, shared databases such as GEO, dbGaP, DataSTAGE and ClinVar. A goal of the PCGC is to stimulate 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.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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

• 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

Applicant organizations

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

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

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

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

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  

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)

Special Requirements

The eligibility is restricted to the grantee originally funded under RFA-HL-16-004. Applications that do not adhere to the eligibility criteria will not be reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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
Email: [email protected]

Facilities and Other Resources: Describe special or unique strengths that are 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.

Without duplicating information from the individual biosketches, 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. Describe previous experience in organizing, supporting, and conducting annual in-person, monthly teleconference, and video conference meetings, and preparation of minutes and other related reports. 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.

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

In addition, the budget should designate a minimum of 2.4 person months effort for the PD/PI, or a minimum of 2.4 person months combined effort for all PDs/PIs if the application includes multiple PDs/PIs.  

Research Strategy: The main focus of the application should be to propose a plan to meet the research coordination 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. Include detailed timelines for the initiation and completion of key activities (operations, protocol development, and Core facilities and data management).

Include a statement indicating willingness to engage in collaborative activities across the B2B, in partnership with NHLBI 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 the PCGC SC and joint PCGC and CDDRC meetings, various subcommittees, the EAC, the OSMB, and other meetings as required by the Consortia. Describe plans for organizing, supporting, and conducting annual in-person, monthly teleconference, and videoconference meetings, and preparation of minutes and other related reports. 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 SC, including protocols, Core services requests and ancillary studies.

Electronic Information and Data Systems: Describe plans to produce, maintain, and disseminate all documents 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; and 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. Internal communications infrastructure is to include a web portal for document sharing, scheduling, announcements, and other activities as needed.

Provide details of prior experience with electronic information and data systems 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.

Describe plans for development and implementation of a program to enable trainees from outside of the PCGC centers and CDDRC to come to a PCGC center or the CDDRC for a summer to learn about CHD genomic analysis.

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
• uniform investigative protocols for data and specimen collection and tracking
• development and maintenance 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, challenge prize and ancillary studies.

D. Core Facilities and Data Management

Applicants must describe plans for:

• support of a biorepository of DNA and tissue specimens
• 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 publicly 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
• issuing Challenge Prizes to any outside individual or group that provides a creative solution to a specifically defined problem
• 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

The following modifications also apply:

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

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.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Significance  

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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:

Does the investigator team have sufficient bioinformatics expertise to carry out the functions of the ACC?

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?

Approach  

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

How well thought-out and reasonable is the plan to implement a summer research program? Is the plan to implement a summer research program targeted to enhance diversity? Is the plan to implement and judge Challenge prizes well thought out and reasonable?

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

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?

Protections for Human Subjects  

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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

Vertebrate Animals  

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

Biohazards  

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

Resubmissions  

Not Applicable

Renewals  

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

Revisions  

Not Applicable

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.

• 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.

• 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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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 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 Committee 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. The awardee agrees to accept and implement policies approved by the Steering Committee. 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 CDDRC 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 Project Scientists will serve on the Steering Committee; 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 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 Committee has primary responsibility for the general organization of the PCGC, 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.
• 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

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

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

Lynn Rundhaugen
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-4546

Section VIII. Other Information