Single Source: Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center (U01 Clinical Trial Required) is sponsored by National Heart, Lung, and Blood Institute (NHLBI). This opportunity seeks a single institution to serve as the Data Coordinating Center for the Cardiothoracic Surgical Trials Network (CTSN), responsible for data management, statistical analysis, and operational support for multi-center clinical trials.

Expired RFA-HL-19-010: Limited Competition: Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center (U01 Clinical Trial Required) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title Limited Competition: Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center (U01 Clinical Trial Required) U01 Research Project Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-HL-19-009 , UM1 Research Project with Complex Structure Cooperative Agreement Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This limited competition Funding Opportunity Announcement (FOA) is intended to support a Data Coordinating Center (DCC) to conduct the activities of the Cardiothoracic Surgical Trials Network (CTSN). The DCC will consist of two collaborating components including a Data Management and Analytics Center (DMAC) and a Clinical Coordination Center (CCC).

NHLBI strongly encourages multi-PD/PI applications with two PDs/PIs; one PD/PI for the DMAC and one PD/PI for the CCC. The primary responsibility of the DCC is to oversee the conduct of multiple randomized clinical trials in the CTSN. The DCC will support regulatory and administrative activities, data collection and management, and statistical analysis and reporting of trial results in a timely manner.

The DCC will promote collaboration and communication among CTSN investigators and the broader research community and will coordinate outreach activities including engaging foundations, research entities, and industry in trials of mutual interest and public health importance.

The DCC is responsible for integrating the efforts of individual CTSN Linked Clinical Research Centers, Consortium Center sites, core laboratories, and other collaborators, and conducting long-term follow-up centrally via telephone follow-up at the DCC.

The NHLBI anticipates that the DCC will collaborate strategically with the Clinical and Implementation Research Skills Program component of the LCRCs to enhance the development of junior investigators by facilitating their involvement in protocol development (including clinical trial design and statistical approaches), publication committees, and by providing datasets This FOA runs in parallel with a separate FOA that invites applications for the CTSN Linked Clinical Research Centers (LCRCs), described in detail in RFA-HL-19-009 .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) August 2, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) It is critical that applicants follow the Research (R) Instructions (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.

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

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission 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 The Cardiothoracic Surgical Trials Network (CTSN) has been a successful and impactful clinical research enterprise since 2007, building a cadre of cardiac surgical trial investigators and a platform for broad collaboration among allied specialties, foundations, professional societies and industry. The CTSN includes cardiac surgical academic centers across the U.S., Canada, and Germany.

The CTSN has become a critical resource to the cardiac surgery, cardiology, and neurology communities. Moreover, the CTSN is moving into the new area of implementation research, to go beyond adding to scientific knowledge to translate and sustain benefits to populations.

The inclusion of implementation research is needed to determine optimal strategies for delivery of randomized controlled trial-proven effective therapies and cardiac surgical approaches to populations in order to improve cardiovascular outcomes in communities.

During this funding cycle, the CTSN will transition from a traditional research network model to a flexible clinical trials platform accessible to the research community, industry, foundations, professional societies, and international research entities.

In this transition, funding of the enterprise will be shared by government and other sources wanting to leverage the infrastructure and collaborate on important scientific research Previous Network studies have fallen into three domains: (1) randomized clinical trials in the comparative effectiveness arena; (2) exploratory and proof of concept trials; and (3) observational studies directed at quality improvement.

Three trials are currently ongoing as are several ancillary studies. There is ongoing consideration of new trial concepts from both inside and outside the CTSN as well as efforts to develop new protocols of clinically meaningful questions that address important public health issues. Additional CTSN trial information can be found at ctsurgerynet.

org . This limited competition Funding Opportunity Announcement (FOA) is intended to support a Data Coordinating Center (DCC) to conduct the activities of the Cardiothoracic Surgical Trials Network (CTSN). The DCC will consist of two collaborating components including a Data Management and Analytics Center (DMAC) and a Clinical Coordination Center (CCC).

NHLBI strongly encourages multi-PD/PI applications with two PDs/PIs; one PD/PI for the DMAC and one PD/PI for the CCC. The primary responsibility of the DCC is to oversee the conduct of multiple randomized clinical trials in the CTSN. The DCC will support regulatory and administrative activities, data collection and management, and statistical analysis and reporting of trial results in a timely manner.

The DCC will promote collaboration and communication among CTSN investigators and the broader research community and coordinate outreach activities including engaging foundations, research entities, and industry in trials of mutual interest and public health importance.

The DCC is responsible for integrating the efforts of individual CTSN Linked Clinical Research Centers, Consortium Center sites, core laboratories, and other collaborators, and conducting long-term follow-up centrally via telephone follow-up at the DCC.

The NHLBI anticipates that the DCC will collaborate strategically with the Clinical and Implementation Research Skills Program component of the LCRCs to enhance the development of junior investigators by facilitating their involvement in protocol development (including clinical trial design and statistical approaches), publication committees, and by providing datasets for secondary This FOA runs in parallel with a separate FOA that solicits applications for the CTSN Linked Clinical Research Centers (LCRCs), described in detail in RFA-HL-19-009 .

Organization and Governance In this funding cycle, the CTSN will be a cooperative Network of up to five academic LCRCs, a DCC, a rotating Network Chair (cardiothoracic surgeon) and rotating Co-Chair (cardiologist), a Vice Chair for Strategic Development, a Vice Chair for International Collaboration, and NHLBI.

Clinical Research Centers (LCRCs), described in more detail in RFA-HL-19-009 , are responsible for proposing and developing protocols, recruiting participants, entering data into the web-based data entry system, assuring good clinical practice, mentoring junior investigators in both clinical research and implementation science, and disseminating research findings.

All LCRCs are required to participate in a cooperative and interactive manner with one another and with the Data Coordinating Center. Coordinating Center coordinates, administers, and supports all Network clinical research, operational, and administrative and statistical activities.

Briefly, these activities include but are not limited to supporting protocol development; developing manuals of procedures and electronic case report forms; providing sample size calculations, statistical advice, common questionnaires, and data analysis; supporting manuscript preparation; and providing overall study coordination and quality assurance, including support for the Data and Safety Monitoring Board (DSMB), the Protocol Review Committee (PRC), the Steering Committee, and other standing committees meetings/conference calls.

Funds to support execution of the protocols at the clinical centers are part of the DCC cooperative agreement (hereafter referred to as award ) and are distributed to the clinical centers (both LCRCs and Consortium Centers) by the DCC on a per-patient basis and according to the approved protocol budgets.

For some protocols the DCC conducts long-term Center (CC) sites are subcontracted through the DCC to enhance trial enrollment, protocol development, manuscript preparation, and other key Network activities. These sites are reimbursed on a per-capita basis and do not receive infrastructure funding. It is anticipated that up to 40 CCs in the US, Canada, and Europe will participate.

Steering Committee (SC) is the main governing body of the CTSN. The SC comprises the Principal Investigators (PIs) from the LCRCs and the DCC, the Network Chair, co-Chair, Vice Chairs, and NHLBI staff. Voting members of the SC include the Chair (a cardiothoracic surgeon) and Co-Chair (a cardiologist), the Vice Chairs and the remaining PIs of the LCRCs and DCC, and the NHLBI Program Official.

The Chair and Co-Chair positions may be rotated among the LCRC Investigators and others as appropriate. The SC has primary responsibility for the general organization of the CTSN, the approval of clinical protocols and protocol changes, the conduct and monitoring of studies, and the expeditious reporting of study results.

All major scientific and administrative decisions are determined by majority vote of the SC, which meets in-person an average of twice a year and by teleconference on a monthly basis. This Committee ensures that all decisions are reported to the Investigators Committee.

and Subcommittees of the SC, such as the Operations Committee and subcommittees for Protocol Development, Protocol Operations, Publications and Biorepository have been established and may be continued or added to at the Investigators Committee (IC) consists of all CTSN investigators and study coordinators from the LCRCs and Consortium Centers, staff members from the DCC and NIH, and the CTSN Chair, co-Chair and Vice Chairs.

The Network Chair, Co-Chair and Vice-Chairs are named by NHLBI to oversee and guide SC and IC activities. The IC meets in-person an average of twice a year and by teleconference on a monthly basis. Subcommittees are established as necessary and membership includes physician and nurse investigators from the LCRCs and CCs, representatives from the DCC, and members from NIH.

The NHLBI is responsible for organizing and providing overall support for the CTSN. The NHLBI Program Office and Office of Grants Management are responsible for the federal stewardship of the award (management, financial and administrative oversight). In addition to regular award oversight, the NHLBI Project Scientists will be involved substantially with the awardees as a partner, consistent with the Cooperative Agreement mechanism.

The NHLBI will appoint the Protocol Review Committee, the Data Safety and Monitoring Board, and the Network Chair, Co-Chair, and Vice Chairs. The Study Chairs are independent of the DCC and are responsible for ensuring that there are well-documented policies and procedures in place to guide all aspects of Network activities and operation.

In collaboration with NHLBI staff, the Chairs facilitate Network activities, oversee its functions, and conduct SC and IC meetings. Review Committee (PRC) is appointed by and advisory to the NHLBI.

It consists of a chairperson and clinicians and scientists with expertise in basic and clinical cardiothoracic surgery research, clinical trial design, biostatistics, enabling technologies, outcome measures, and other areas of expertise as needed.

The PRC will evaluate protocols approved by the SC based on the following criteria: importance of the question to be addressed, the scientific merit of the experimental design and approach, feasibility, appropriateness for the Network, and consistency with NHLBI mission and policies.

All new study protocols performed by the CTSN that have not previously been peer reviewed must be approved by the PRC before referral to the Data and Safety Monitoring Board. and Safety Monitoring Board (DSMB) is appointed by and advisory to the NHLBI, in accordance with established policies to ensure data quality and participant safety.

All CTSN protocols must be approved and monitored by the DSMB, generally after their approval by the PRC, or peer review. The DSMB will be responsible for providing independent advice to the NHLBI regarding the progress of each trial and the appropriateness of continuing each study.

The DSMB will meet approximately every six months, with interim meetings as An independent External Review Committee with expertise in areas such as cardiothoracic surgery, cardiology, cellular therapy, as well as clinical trial management and regulatory oversight will review the CTSN during the fourth or fifth year of the Network and advise the NHLBI (and Steering Committee) on opportunities to improve operations and future scientific directions.

for the CTSN Data Coordinating Center The DCC will coordinate all trials to be run in the Network facilitating use of the collaborative infrastructure. DCC planning should consider protocols to be completed in a two-to five-year time frame (awardees shall not assume that follow-up will occur outside of the lifetime of the award with Federal support).

The DCC will facilitate protocols and new concepts being reviewed and prioritized through the CTSN SC process after LCRC cooperative agreement awards are made. Protocols that are voted by the SC to be developed will be supported by protocol development committees coordinated by the DCC and comprised of membership from LCRCs, CCs, the DCC, and NIH.

The DCC will coordinate all CTSN conducted peer review of protocols through the PRC in collaboration with the The DCC will consist of two collaborating components including : a Data Management and Analytics Center (DMAC) a Clinical Coordination Center (CCC).

Management and Analytics Center (DMAC) NHLBI expects that the DMAC component will work in close collaboration with the CCC and that the DMAC will have primary responsibility management and coordination of the Network Management of overall funding of the DCC grant award, Network project timelines, and the CTSN website to ensure that it is updated at regular intervals; Overall coordination of Network activities across all components (i.e., the CCC, LCRCs, CCs, core laboratories, Network leadership, industry collaborators, and NIH); and provide coordination and leadership in the early identification and resolution of issues arising within the Network.

Administrative support to the Network Chairs, scientific leadership, and other stakeholders as needed, including but not limited to drafting Network meeting/teleconference agendas and minutes, manuscripts, and presentations, as well as publicizing ongoing clinical trials via appropriate advertising venues; Coordination and facilitation of meetings, teleconferences, and training among study personnel, committees, subcommittees, oversight bodies such as the DSMB, industry and other collaborators.

Additional responsibilities of the DMAC include developing, negotiating, and executing agreements and subcontracts such as investigator agreements, subcontracts with LCRCs, CCs and core laboratories identified by the CCC, materials transfer agreements, agreements with industry and other collaborators.

Design and Protocol Development Trial/study design, statistical and biomedical/scientific writing expertise to Protocol Development Committees (PDCs), including defining sample size requirements and randomization schemes, assisting in the determination of trial endpoints and analytical approaches, as well as developing trial stopping rules, as appropriate, for NHLBI review and DSMB approval.

It is also expected, the DMAC will facilitate PDC meetings/teleconferences, to ensure that protocols are developed within Network timelines and coordinate protocol review by the NHLBI-appointed PRC and DSMB in collaboration with the Executive Secretaries of each. The DMAC will also oversee data management-related document development and finalization for each trial/study in collaboration with the CCC.

Development, maintenance, and/or refinement of data dictionaries and a 21CRF Part 11-compliant electronic data capture system (EDC) for clinical research trials and studies conducted by the Network, assuring high data quality through edit/validation checks; Serving as a central repository for trial/study data and acquired large data sets (e.g., CMS and other relevant data sets) pertinent to Network trials and studies.

Additional DMAC responsibilities are expected to include overseeing secure data collection, storage, and, when appropriate, transfer of LCRC-, core laboratory-, and ancillary study-generated data; preparing confidential data analyses and reports as requested by the NHLBI, Network leadership, SC, the DSMB, and regulatory agencies in collaboration with the CCC; and coordinating data analysis, reporting, and publishing of Network research, the latter in high quality peer-reviewed journals.

Coordination Center (CCC) NHLBI expects that the CCC , working in close collaboration with the DMAC, will have responsibility for: Identification of CCs and administration of their corresponding subcontracts/investigator agreements; Administration of LCRC investigator agreements and site subcontracts and agreements including providing reimbursement for patient care costs as a fee for service arrangement after a protocol has been approved and the NHLBI has approved the funds for distribution; Integration of activities of all awarded LCRCs and subcontracted CCs to minimize duplication of effort and to maximize resources by utilizing existing resources whenever possible; Establishment and tracking of site enrollment targets, encourage recruitment, and development of strategies to encourage referrals from other specialty areas.

Additionally, the NHLBI anticipates the CCC will prepare, distribute for review, finalize, and then distribute protocols, protocol amendments, manuals of procedures (MOPs), and other materials necessary for study implementation. In collaboration with the DMAC, the CCC will provide protocol training as an integral part of site initiation activities and as needed throughout the trial.

Core and Collaborating Laboratories Identification and administration of subcontracts with biorepositories and core laboratories and investigators as needed; Administration of subcontract and agreement including providing reimbursement to these facilities as applicable and/or ensuring transfer of biospecimens to collaborating laboratories in a timely manner, training of clinical center personnel, as well as distribution of materials and supplies furnished by core laboratories.

Within the scope of these the CCC will also coordinate with biorepositories to ensure accurate inventories of fluid and tissue specimens for laboratory studies and their transfer to collaborating laboratories. The CCC is expected to assist biorepositories and core laboratories as needed with the preparation of procedures manuals and their distribution to clinical centers.

Administration of agreements with manufacturers and arrangement and tracking of the supply of study products, including drugs, biologics, devices and/or combination products, to clinical centers, and coordinate study product training of clinical center personnel, as Long-term follow-up of trial participants through centralized telephone visits at key time points.

Activities may include obtaining vital status, the occurrence of protocol-specified adverse events (e.g., major adverse cardiovascular and cerebrovascular events, other cardiovascular and neurological events), hospitalizations, and quality of life; Entering data obtained into the electronic data capture system and maintain GCP-compliant records of all telephone visits; Collection of source documentation pertaining to serious adverse events as defined by the protocol and upload the documents into the EDC for review by the Events Adjudication Committee.

Participation in Network activities to provide clinical trial operational guidance including SC, IC, and coordinator meetings and teleconferences, trial-specific operations teleconferences, and trial-specific training workshops Overseeing Human Subjects Protection within the Network by preparation of informed consent templates and patient-centered materials (e.g., brochures and letters) for review by the trial/study sponsor(s); Ensuring that all DCC, LCRC, CC, and core laboratory personnel are properly trained on protocol-specific procedures (including the informed consent process), CTSN policies, applicable regulations, and Good Clinical Practice (GCP), in collaboration with the DMAC.

Additional CCC responsibilities include evaluating screening logs and patient eligibility, as well as triaging unexpected adverse events regardless of the clinical center investigator’s determination for further assessment by independent Medical Monitors.

Facilitation of interactions with regulatory authorities such as the Food and Drug Administration (FDA), Health Canada, CMS, and other agencies; Appointment of a qualified staff member to serve as the ClinicalTrials.

Gov Responsible Party and Sponsor of Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDEs); Reporting and tracking of unexpected adverse events and unanticipated problems to NHLBI, other study sponsors, oversight bodies, and regulatory agencies.

Moreover, after triage, CCC staff will coordinate adverse event review by Network Medical Monitors, the Events Adjudication Committee, and IND/IDE safety monitors (the latter for IND/IDE trials).

Additional CCC responsibilities are expected to include preparing and submitting all regulatory documents (e.g., briefing packages, initial regulatory applications, amendments to regulatory applications, responses to regulatory authority inquiries, etc.) to regulatory agencies, as well as CMS applications for coverage of IND/IDE trials to CMS.

Assuring compliance with the Health Insurance Portability and Accountability Act (HIPAA) within the CTSN in accordance with 45 CFR Parts 160, 162, and 164 or corresponding regulations for Canadian and other international clinical centers; Implementation and supervision of the revised Common Rule (45 Part 46) within the CTSN, including the use of a single-IRB review for federally-funded, multi-institutional studies conducted in the United States.

In addition, the CCC will be expected to register and report results of clinical studies and trials in ClinicalTrial. Gov as required by 42 CFR Part 11. In collaboration with the DMAC, the CCC will be expected to establish and maintain written procedures for all internal processes within the DCC.

To supplement the monitoring program discussed below, the CCC will have independent auditing to assure regulatory compliance within the Network, as needed. Developing, organizing and conducting a monitoring program for all enrolling clinical centers, core laboratories, biorepositories, and other collaborators participating in CTSN research to ensure high quality clinical research.

The monitoring program will include preparing and providing trial-specific monitoring plans to the trial sponsor(s) and monitoring study execution at clinical centers, core laboratories, and biorepositories to assure compliance with the protocol, MOP, CTSN policies, applicable regulations and guidelines throughout the duration of the trial.

Additionally, the CCC will be responsible for conducting site initiation, interim and close-out visits (central/remote or on-site) in accordance with the monitoring plan; preparing monitoring reports for the trial sponsor (e.g., the NHLBI) and monitoring letters for enrolling clinical centers, core laboratories, and biorepositories after completion of monitoring visits and in accordance with required timelines; and providing monthly monitoring schedule updates/trackers to the trial sponsor (e.g., the NHLBI).

The CCC will be expected to identify underperforming centers and laboratories as early as possible, develop corrective and preventative action plans in consultation with the NHLBI, and oversee the implementation of the corrective and preventative action plan.

DCC key personnel will be expected to participate in site evaluation visits conducted with the NHLBI, and Network Chairs for each LCRC at least once during the 7-year funding period. The entire CTSN program will be reviewed by an External Review Committee during Year 4 or 5, and the DCC will be responsible for developing and providing relevant materials to the External Review Committee for this review.

Applications submitted in response to this FOA must propose one or more delayed onset clincial trial studies.

The delayed onset clinical trial studies represent future proof-of-concept/early feasibility/early translation area, RCTs in the comparative effectiveness realm, and innovative trials leveraging registry data and electronic medical records, among others approaches to be conducted by the CTSN and should not provide specific details about the proposed clinical studies. VIII. Other Information for award authorities and regulations.

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

2 for additional information about the substantial involvement for this FOA. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application Required: Only accepting applications that propose clinical help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NHLBI intends to commit $7,438,000 in total costs for FY Total application budgets must not exceed $5,700,500 direct costs in Fiscal Year 2019, $5,701,500 direct costs in Fiscal Year 2020, $5,701,500 direct costs in Fiscal Year 2021, $4,900,000 direct costs in Fiscal Year 2022, $4,699,500 direct costs in Fiscal Year 2023, $4,699,500 direct costs in Fiscal Year 2024, and $2,300,000 in Fiscal Year 2025.

For all non-protocol costs: Applicants may request no more than $2,500,000 direct costs in Fiscal Years 2019 through 2021, $2,400,000 direct costs in Fiscal Year 2022, and $2,300,000 direct costs in Fiscal Years 2023 through 2025. The scope of the proposed project should determine the project period. The maximum project period is up to 7 years.

Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

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 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 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. 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.

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 must have an active DUNS number and SAM registration in order to complete the 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 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 NHLBI strongly encourages multi-PD/PI applications with at least two PDs/PIs; one PD/PI for the DMAC and one PD/PI for the CCC. Only past awardees from RFA-HL-13-022 are eligible for this FOA.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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 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: Division of Extramural Research Activities National Heart, Lung, and Blood Institute