Required Application Instructions

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

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

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

The National Heart, Lung, and Blood Institute (NHLBI) invites applications for an Administrative Coordinating Center (ACC) to provide administrative infrastructure for the NHLBI Progenitor Cell Translational Consortium (PCTC). The PCTC will consist of multiple research hubs performing multidisciplinary research using progenitor cells in translational research to address heart, lung, and blood diseases. In order to maximize scientific exchange and accelerate research in that field, it is expected that all information, data, biomaterials, models, protocols, reagents, resources and methods developed by PCTC investigators will be shared in a timely way with other investigators in the PCTC and with the research community at-large.

The PCTC-ACC will provide the administrative infrastructure needed to organize interactions and facilitate collaborations between PCTC investigators, oversee programs using set-aside funds to stimulate collaborative research and skills development, and enable the timely sharing of PCTC-generated data and reagents among PCTC investigators and with the research community. The PCTC-ACC will also facilitate access to expertise for preparation of FDA IND and IDE applications.

The Consortium will consist of multiple Research Hubs funded through a separate FOA (RFA-HL-16-021),and an Administrative Coordinating Center (ACC) supporting the Consortium funded through this FOA. The ACC will also administer funds to support cores and pilot studies.

• Administrative Coordinating Center (ACC): The ACC will serve a range of functions such as organizing meetings and arranging telephone conference calls for the Steering Committee, Skills Development Committee, External Advisory Committee, and the Consortium’s joint annual meeting; as well as designing and maintaining written materials and websites to support the Consortium; and awarding subcontracts for Cores. The ACC will be responsible for solicitation of applications for cores, pilot studies, and collaborative and ancillary studies through websites and list-serves. The ACC will oversee the review and award of pilot study funds for the Consortium, and coordinate the submission of progress awards by the Awardees for review by program staff. The ACC will also coordinate skills development activities.
• Cores: Cores, such as a bioinformatics core, will provide resources and services to multiple Research Hubs. Requirements for Cores in the Consortium will be evaluated once the Consortium has been established. The NHLBI, with input from the External Advisory Committee, will determine the Core configuration, and the ACC will allocate funds accordingly.
• Pilot Studies: A major goal of the NHLBI Progenitor Cell Translational Consortium is to foster highly innovative, high-risk approaches that are not easily funded by traditional mechanisms and that have the potential for unusually high impact to significantly advance the field. Pilot studies are also expected to be helpful in developing the careers of young investigators. New pilot projects may be proposed to replace those that terminate. The External Advisory Committee will be responsible for peer review of these new pilot studies. Progress on these studies will be monitored by the PCTC-ACC and NHLBI staff.
• Ancillary and collaborative studies: As the resources and programs develop, it is anticipated that new opportunities will arise that will need additional expertise from outside the Consortium or require new collaborations with other members of the Consortium. To meet this need, funds will be made available through the ACC to fund ancillary and collaborative studies awards. These awards will be funded for a maximum of two years. Expedited peer review by the External Advisory Committee will be used to facilitate flexibility and rapid funding of these studies. Progress will be monitored by the PCTC-ACC and NHLBI staff.
• Steering Committee: The Consortium will have a Steering Committee that will be responsible for overall scientific direction, coordination and oversight. The Steering Committee will be composed of the lead PDs/PIs for each Research Hub, the ACC PD/PI, and the NHLBI Project Scientist. The Steering Committee will be chaired by an investigator selected by the NHLBI. Each member will have one vote; additional NIH staff attending will be non-voting ex-officio members. The Steering Committee will meet in person for an implementation meeting at the start of the project period, by conference call at least quarterly, and in person at least twice a year in the first year and once per year throughout the remaining project period.
• Skills Development Committee: A Skills Development Committee, composed of an identified investigator from each Research Hub and from the ACC, will develop and coordinate activities between the Research Hubs to enhance skills development for graduate students, postdoctoral fellows, and junior faculty. Skills development activities will be developed and agreed upon across the Consortium after funding, and do not need to be specified in the application.

External Advisory Committee: An External Advisory Committee (EAC) will oversee the Consortium and provide advice to Awardees and the ACC on scientific direction. The Committee will consist of non-Consortium affiliated scientists and other experts appointed by the NHLBI to provide annual reviews of progress, and provide advice on scientific direction to the Awardees. They will also provide feedback to the ACC on the quality of proposed pilot studies, ancillary and collaborative studies, and cores.

PCTC Coordinating Center (PCTC-ACC): Objectives and Scope

The PCTC-ACC will be responsible for facilitating interaction and collaboration across the PCTC, and for coordinating dissemination of data, resources and reagents within and outside the PCTC. Activities within the scope of the PCTC-ACC include:

• Organize scientific meetings, including an initial "kick-off" meeting of PCTC investigators within 60 days after the awards are made, and an annual 2-3 day scientific retreat of the Consortium thereafter; meetings will rotate among the research sites and ACC, or be held in or near Bethesda, MD.
• Develop and maintain a means for ongoing, rapid exchange of information and discussions between all members of PCTC within and across individual Consortia;
• Coordinate PCTC activities and consortia meetings, including conference calls of the individual consortium Steering Committees, Subcommittees, Working Groups, and PCTC External Advisory Committee;
• Generate minutes from meetings of the PCTC Steering Committee and its subcommittees as approved by the Chairs and membership of those committees;
• Manage the distribution of the set-aside funds by issuing subcontracts for pilot studies, ancillary and collaborative projects, cores, and skills development activities;
• Organize the web-based dissemination of PCTC-related information and develop a means to access validated data and resources generated by the PCTC research projects, including experimental models, protocols, biomaterials, resources, reagents and omics- and image-based data collections. Note: Individual research projects are responsible for sharing models, protocols, biomaterials, resources and reagents with other investigators as appropriate, once they are validated under policies implemented by the PCTC Steering Committees. Sharing of resources and reagents can be done through the individual laboratories or by depositing the materials in an appropriate resource facility.
• Facilitate, as needed, interactions with other NIH-supported research efforts or non-NIH partners. The focus should be on developing interactions that can benefit both PCTC investigators and PCTC partners through the sharing of information, expertise, and reagents, or through leveraging the coordination of research and technology development in areas of common interest.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicant Organizations

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

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

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

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

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

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

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

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

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
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants are encouraged to describe special or unique strengths that may be relevant to Consortium infrastructure. For example, 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 PCTC.

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

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

Applicants are encouraged to describe investigators' special or unique strengths that may be relevant to the Consortium research. Examples could include significant previous experience coordinating research related to progenitor cell biology, prior participation in research funded by an NIH cooperative agreement, or prior development of award-winning media programs to disseminate information about research to the public; significant prior experience in coordinating collaborative scientific research and ability to work as part of a multi-disciplinary team; experience coordinating complex research efforts, including logistical support for meetings and calls, data management systems, and development and archiving of reports and other documents; experience in development of web sites for research programs, in communication of research results to other scientists, and in communicating scientific principles to the lay public.

An investigator should be identified as skills development coordinator, and their experience in skills development documented in the biosketch.

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

The budget for the first year should include a minimum of 2.4 calendar months for the PD/PI, and sufficient additional staff support to accomplish the tasks required. There will be one Steering Committee meetings in Bethesda, MD, during the first year; therefore, the budget should include funds for travel for a one-day trip to Bethesda for the ACC PD/PI and at least one other staff member, as well as the costs associated with the meetings. Travel for the Research Hub PDs/PIs and other staff should not be included as it is included in the Research Hub grants. The budget should also provide for quarterly Steering Committee conference calls in the first year, as well as 6-8 additional subcommittee conference calls as needs arise. It is expected that most materials for meetings and calls will be in electronic form. The first year budget should reflect that needed for ACC operations including establishing all communication and related processes, and begining development of the internal and public web sites.

Applications should plan for $500,000 in direct costs (plus associated institutional F&A) to execute awards for pilot studies, ancillary studies, cores, and skills development activities in Fiscal Years 2018 through 2022The budgets for Years 2-7 should provide for continuing logistical support of the PCTC, quarterly calls for the Steering Committees, and the distribution process for ancillary and collaborative study and pilot study funds to investigators within or outside the Consortium in Years 3-7.

Annual Grantee Meeting: The budget for the ACC should include funds for this meeting. Hub Awardees will budget for their travel to the meeting.

External Advisory Committee: The ACC budget should include travel funds for EAC members, an honorarium of $200 per day for meetings and calls, and funds for the preparation of meeting and call materials. Do NOT contact, recruit, or name potential EAC members in the application.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The following items should be addressed satisfactorily by the applicant in the Research Strategy:.

Expertise and Experience in Logistical and Other Support Services: The ACC provides arrangements for logistical support associated with meetings and conference calls for the Consortium Steering Committee, the External Advisory Committee, the Skills Development Committee, and other meetings as required by the Consortium. The application should demonstrate substantial experience with organizing, supporting, and conducting in-person and teleconference meetings, and with the preparation of minutes and other related reports. The application should demonstrate successful experience arranging logistical services for multi-center translational or clinical research, such as overseeing selection of technical laboratories.

Capacity and Ability to Manage and Distribute Consortium Funds: The ACC will receive and disburse funds for Consortium Cores, ancillary and collaborative studies, and pilot studies for the Progenitor Cell Biology Consortium. The application should demonstrate experience with similar financial arrangements, and detail how the funds will be managed. The P/PI of ACC, upon advice of the Consortium Steering Committee, will be responsible for funding awards from set-aside funds provided to the ACC. To address this requirement, the application should

• Describe plans for establishment of subawards with applicant institutions

Electronic Information and Data Systems: The ACC will be required to oversee and coordinate communications in the PCTC, and will also be expected to take a leadership role in communicating with individuals and groups beyond the PCTC. Accordingly, the application should detail prior experience with these activities, including systems for management and archiving of email traffic and electronic reports, development of standard operating procedures, development of databases, and ensuring data safety and confidentiality. The ACC will be expected to develop a secure website for sharing of data, protocols and other research materials among PCTC members. In addition, the ACC will be expected to develop a public web site for the PCTC, with input from investigators and NHLBI staff. The application should demonstrate successful experience with web site development for similar programs.

Willingness to Collaborate: The application should include a statement indicating willingness to engage in collaborative activities across the Consortium, in partnership with NHLBI staff, to support the goals of the NHLBI progenitor cell biology Consortium, and to accelerate translation of study findings to the scientific community and clinical practice.

Cores, Pilot Studies and Collaborative and Ancillary Studies: The ACC will be responsible for solicitation of applications for cores, pilot studies, and collaborative and ancillary studies. Requests for Proposals will be developed by the PCTC Steering Committee. To address this requirement, the application must:

• Describe plans for notification of PCTC investigators of Requests for Proposals soliciting applications; where appropriate these internal notifications will be coordinated with notifications to the external community published in the NIH Guide by the NHLBI Project Officer
• Describe how they will establish secure procedures for submission of proposals and distribution to reviewers.
• Describe plans for coordination of reviews.

Skills Development Activities: Describe plans for how the ACC will also coordinate skills development activities; the specific skills development activities will be determined by a sub-committee of the PCTC Steering Committee.

Annual Grantee Meeting: Describe plans for arranging, on behalf of the NHLBI, annual meetings to encourage the exchange of information among the investigators who participate in this program. The annual meeting will be held in Bethesda, MD, or at one of the participating PCTC sites.

The External Advisory Committee (EAC) will be selected by NHLBI, but support for their activities will be provided by the ACC. The EAC is expected to include seven members, will meet in person in conjunction with the annual investigator meetings once a year, beginning in Year 1, and may have one or more additional conference calls each year. Do NOT contact, recruit, or name potential EAC members in the application.

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

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

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

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

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.

As noted in the Terms and Conditions:

• Grants funded under this FOA will not be awarded with the Streamlined Noncompeting Award Process (SNAP) authorities (NIH Grants Policy Statement 8.4.1.2 Streamlined Non-Competing Award Process).
• Grantees will not be able to submit a modified progress report.
• Grantees will not be provided the authority outlined in the NIH Standard Terms of Award to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Award. All extensions, including the first extension, will require NIH prior approval.
• Grantees will not have authority to automatically carryover funds. All carryover actions require NIH prior approval.
• Grantees must submit annual Federal Financial Reports (FFRs).
• This award is subject to the audit requirements as described in the NIH Grants Policy Statement.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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.

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

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Potential for Collaboration: Does the applicant demonstrate the ability to work as part of a multi-disciplinary team through significant prior experience in coordinating collaborative scientific research?

Coordination: Does the applicant demonstrate significant experience coordinating complex research efforts, including logistical support for meetings and calls, data management systems, and the development and archiving of reports and other documents?

Communication: Does the applicant demonstrate significant experience in development of web sites for research programs, in communication of research results to other scientists, and in communicating scientific principles to the lay public?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Specific to this FOA:

To what extent are the plans for handling logistics, managing and distributing funds, and managing electronic information systems appropriate?

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

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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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

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

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

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

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.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Heart, Lung, and Blood Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75 and other HHS PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U24, 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 Awardees' activities by involvement in and otherwise working jointly with the Awardees 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 Awardee will be primarily responsible for the planning and conduct of the operations defined by the terms and conditions of the cooperative agreement award.
• The Principal Investigator/Program Director will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research and administrative functions supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
• The Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government policies regarding rights of access consistent with current HHS, PHS, and NIH policies.
• All staff of the Awardee will maintain the confidentiality of the information developed by the investigations, including, without limitation, informatics tools, protocols, data analysis, conclusions, etc. per policies approved by the consortium as well as any confidential information received by third party collaborators.
• The Awardee must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
• All staff of the Awardee will be required to participate in a cooperative and interactive manner with NIH staff, PCTC investigators and one another.
• The Awardee is expected to share data, materials, informatics tools, methods, information and unique resources that are generated by the project in accordance with PCTC policies in order to facilitate progress and consistent with achieving the goals of ths program.
• The Awardee will submit a list of milestones and project aims to the PCTC-ACC Program Officer and the PCTC-ACC Program Officer prior to the initial PCTC meeting, and will update this list annually prior to the PCTC Investigators Meeting.
• The PCTC-ACC Awardee agrees to work with the PCTC Steering Committee to establish agreements that address the following issues: (1) procedures for data sharing among consortium members and data sharing with industry partners as appropriate; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing biospecimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner consistent with achieving the goals of the program; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
• The PCTC-ACC Awardee agrees that industry collaborations should be governed by a research collaboration agreement (e.g. CTA, RCA, etc) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies and procedures including the NHLBI Third Party Agreement Policy http://www.nhlbi.nih.gov/research/funding/human-subjects/third-party-clinical-trials and any policies and procedures developed by the PCTC.
• The PCTC-ACC Awardee must operate in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
• Upon completion or termination of the PCTC-ACC project, the Awardee is responsible for making all study materials, tools, databases and procedures developed by the PCTC-ACC broadly available (e.g., putting into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a plan to accomplish this within 90 days of the end of the study.

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

• The NHLBI will designate program staff, including a Program Officer to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer will be named in the Notice of Award (NoA).
• The NIH will invite experts with relevant scientific expertise to provide feedback to the NIH on PCTC-ACC activities. The External Advisory Committee (EAC) will meet to review the progress of the PCTC-ACC project and to advise NIH staff of opportunities that may enhance the operation and achievements of the PCTC-ACC.

An NHLBI Project Scientist will be substantially involved in this project and named in the NoA as follows:

• The NIH Project Scientist will coordinate and facilitate the activities of the PCTC-ACC, attend and participate in all meetings of the PCTC-ACC, and act as a liaison between the Awardee and the EAC.
• The NHLBI Project Scientist and Program Officer will review the scientific progress and administrative accomplishments of the PCTC-ACC, and review the project for compliance with operating policies developed by the PCTC Steering Committee. Based on this review, the Project Scientist and Program Officer may recommend to the NIH to continue funding, or to withhold or restrict support for lack of progress or failure to adhere to PCTC or NIH policies. Review of progress may include regular communications between the Principal Investigator and NIH staff, periodic site visits for discussions with Awardee research teams, fiscal review, and other relevant matters. The NIH retains the option of organizing periodic external review of progress.
• The NHLBI reserves the right to curtail or phase out the PCTC-ACC award in the event of (1) A substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application, (2) A failure to meet PCTC policies and procedures, (3) Substantive changes in the management of PCTC that are not in keeping with the objectives of the FOA.
• The NIH will enlist additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist in carrying out the goals and aims of the approved studies. The NIH will have one vote for any key committees, including the EAC, regardless of the number of NIH consultants involved in the project.
• The NHLBI Project Scientist will have substantial programmatic involvement in the coordination of the administrative management of PCTC and in monitoring performance of the PCTC-ACC. The dominant role and primary responsibility for the PCTC-ACC organization and activities resides with the Awardee, however, specific tasks and activities in carrying out the PCTC-ACC functions will be shared among the Awardee and the NIH Project Scientist.
• The NHLBI Project Scientist serves as a resource with respect to other ongoing NIH activities that may be relevant to PCTC-ACC operations to facilitate compatibility and avoid unnecessary duplication of effort.
• The NHLBI Project Scientist may review procedures for assessing and monitor the performance of the PCTC-ACC.
• The NHLBI Project Scientist may be a co-author on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

Areas of Joint Responsibility include:

Through the Awardee and NIH staff, PCTC-ACC will determine criteria and processes for quality control of information and data to be posted for the research community, consistent with NIH policies and achieving the goals of the program as described in the Funding Opportunity Announcement. The PCTC-ACC PD/PI and NHLBI Program Staff will meet by teleconference on a biweekly basis.

Steering Committee: By applying to this FOA, the PCTC-ACC Awardee agrees to the governance of the PCTC-ACC through a Steering Committee that is responsible for joint governance of the PCTC.

• A Chairperson for the PCTC Steering Committee will be chosen by the NIH. The Chairperson is responsible for coordinating the Steering Committee activities, for preparing meeting agendas and for chairing meetings.
• The PCTC Steering Committee will include the PCTC Project Scientist, the PCTC-ACC PD/PI, and the PDs/PIs of PCTC Research Projects. The PCTC Steering Committee will meet at least quarterly.
• All major scientific and policy decisions will be determined by voting policies as established by the PCTC Steering Committee at the initial meeting. This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project.
• NHLBI staff, in concert with the PCTC Steering Committee, will have the option to redirect activities or operations being pursued within the PCTC-ACC U24 grant if it is considered beneficial to the overall program.
• The Awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the PCTC Steering Committee. The PCTC Steering Committee will report progress with regard to PCTC-ACC activities at the Annual Investigator’s Retreat.

External Advisory Committee: An External Advisory Committee (EAC) composed of five to seven members will provide feedback to Awardees and the ACC on Consortium activities. This Committee will consist of non-Consortium affiliated scientists and other experts appointed by the NHLBI,to provide feedback to Awardees on progress and scientific direction, and to to give feedback to the ACC on the quality of applications for pilot studies, ancillary and collaborative studies, and cores, as needed.

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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Denis Buxton, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Division of Cardiovascular Sciences
Telephone: 301-435-0515
Email: buxtond@nhlbi.nih.gov

John Thomas, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Division of Blood Diseases
Telephone: 301-435-0065
Email: thomasj@nhlbi.nih.gov

Sara Lin, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Division of Lung Diseases
Telephone: 301-443-8797\
Email: sara.lin@nih.gov

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

Beckie Chamberlin
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0183
Email: chamberr@nhlbi.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.