Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations


National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Translational Research Centers in Thrombotic and Hemostatic Disorders (TRC-THD) (U54)

Activity Code


U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-008

Companion FOA
  
Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.839   

FOA Purpose

The National Heart, Lung, and Blood Institute (NHLBI) solicits grant applications to participate in the Translational Research Centers in Thrombotic and Hemostatic Disorders (TRC-THD).  The primary objective of this new Centers program is to enhance the translation of basic research discoveries that could lead to improved prevention, diagnosis, and treatment for thrombotic and hemostatic disorders.  The TRC-THD will advance early stage translation research, integrating applied and basic science to move research discoveries toward clinical application. The individual multiple project Centers will address important clinical questions and must have at least one assay, method, procedure, or agent in early phase translation.   Each Center will have a translational research skills development component and include collaborations with their Clinical and Translational Science Awards (CTSA) programs or institutional programs with similar capabilities to leverage existing resources to accelerate the translational research process.

Additional Information Available at http://www.nhlbi.nih.gov/funding/inits/faq-hl-11-008.htm

Key Dates
Posted Date
Open Date (Earliest Submission Date)

Not Applicable

Letter of Intent Due Date

March 1, 2011

Application Due Date(s)

April 1, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 1, 2012

Expiration Date

April 2, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The primary objective of the Translational Research Centers in Thrombotic and Hemostatic Disorders (TRC-THD) is to enhance the translation of basic research discoveries that would lead to improved prevention, diagnosis, and treatment.  The TRC-THD program will bring together clinical, translational, and basic investigators for a highly interactive, multi-disciplinary environment to address important clinical questions.  The research focus will be on early translation of basic research discoveries, testing their applicability, feasibility, and possible clinical benefit.  A translational research skills development component will provide a mentored research experience to young investigators to acquire the competencies needed for translational and clinical studies.  To enhance the potential success of this new program, the Centers will be required to leverage existing infrastructure and resources at their institutions through collaborations with their CTSA or comparable institutional programs to enable timely and cost-effective completion of proposed translational and clinical research.  Expected outcomes from this program are the identification of predictive markers of risk, the development of improved diagnostic tools, and the discovery of new therapeutic agents.

Background

NHLBI supports a strong program of mechanistic studies on the coagulation and fibrinolytic systems, platelet biology, and cell signaling.  Transgenic mouse models have been developed that identified new proteins, pathways, and cellular interactions for potential therapeutic targets. The challenge is translating the information gained from in vitro and animal studies to human conditions and diseases.  Conversely, a better understanding of the clinical challenges is needed to develop more predictive animal models and improved diagnostic tools.

Thrombotic disease or treatment to prevent thrombosis will affect most people in the United States at some point in their life.  Thrombosis is the critical event in myocardial infarction and stroke, and antithrombotic agents are widely used for preventive therapy in high-risk populations.  There is significant risk of venous thrombosis and pulmonary embolism associated with many orthopedic procedures, and it is a serious complication of diabetes, metabolic syndrome, sickle cell disease, hereditary diseases of the clotting system, pulmonary arterial hypertension, bone marrow disorders, and certain cancers or cancer therapies. Increasing age is independently associated with a dramatic increase in venous thrombosis. The aging US population, especially with multiple co-morbidities, escalates this serious health concern.

Maintaining hemostatic control and treatment of bleeding events is a challenge for hereditary and nonhereditary bleeding disorders such as hemophilia and platelet disorders. Acquired bleeding states represent a major complication of trauma, gastrointestinal ulcers, and adverse drug effects.  In addition, patient genetic variation can contribute to unpredictable therapeutic dosing resulting in acquired bleeding diathesis.  Hemorrhagic stroke can be the fatal result of high blood pressure, aneurysms, arteriovenous malformations, or medications.  A better understanding of the mechanisms of thrombosis and hemorrhage, and the regulatory systems that normally maintain the balance between the two, is needed to develop safer hemostatic and anti-thrombotic agents.

Currently available knowledge and tools to assess individual risk in a particular situation or response to hemostatic or antithrombotic therapy can lead to over-treatment of some and under-treatment of others.  There is a clear need to identify and validate biomarkers to diagnose and predict disease risk and to monitor therapy.  Individualized proteomic and genetic characterization will enable personalized clinical management.  Multi-disciplinary scientific teams with balanced basic and clinical expertise are needed to determine the impact of hemostatic and thrombotic mechanisms in the pathology of diverse disease entities and clinical conditions, develop efficient, cost effective diagnostic tools, and determine individual risks for bleeding, thrombosis or both.

General Program Design

The TRC-THD program will consist of up to five Centers addressing different clinical questions, exploring multiple approaches to improve prevention, diagnosis and treatment for thrombotic and hemostatic disorders.  The interaction between the Centers will be enhanced through meetings and conference calls to exchange information, encourage collaborations, and maximize resources.   Each Center will: (1) have at least one assay, method, procedure or agent in early phase translation;

(2) collaborate with their CTSA or similar Institutional program to maximize intellectual and physical resources; and (3) have a translational research skills development component to prepare young investigators for translational research.

The individual Centers, which may be multi-institutional, must have a minimum of three thematically unified interactive research projects and two mandatory cores.  Collectively the research projects must have basic, translational, and clinical research components addressing important clinical questions.  The required clinical research component may include observational studies, proof of concept studies, small or early Phase clinical trials.  The two mandatory cores in the applications are an Administrative Core and a Translational Research Skills Development Core.   The Administrative Core will serve the administrative needs for the Center and coordinate its activities with NHLBI, the Administrative Coordinating Center (ACC) and other TRC-THDs. A Translational Research Skills Development Core should provide the necessary competencies to two or more young investigator(s) interested in translational and clinical hemostasis/thrombosis research.  Additional Center specific cores that provide service to at least two research projects may be included.  Each Center must collaborate with their CTSA or similar Institutional program.  The Centers should define the resources and capabilities to be provided, which match the needs of the proposed translational and clinical research projects.  These could include: clinical resources, clinical study/trial design, clinical laboratory analysis, biostatical support, biomedical informatics, regulatory guidance, specific technical cores, and skills development of clinical research investigators.

Translational Research Skills Development Core:

A skills development core for new investigators interested in translational hemostasis/thrombosis research is mandatory.  The TRC-THD, which brings together basic, translational and clinical research scientists addressing important clinical questions, presents a rich environment for young investigators to be exposed to a broad range of research skills.  The individual Centers are expected to include among their research staff personnel who are newly trained and relatively inexperienced in research.  The skills development core should augment the developmental environment by supporting activities to assist two or more new investigators in progressing to more senior status by enhancing their research skills.  Innovative strategies should be proposed for cross-disciplinary career development to achieve the goal of exposing new investigators to additional research techniques and opportunities.  In addition to developing the research skills, the Core must ensure that the participating new investigators receive the mentoring they need to foster their research careers.  The Core is intended for staff investigators with limited translational research experience, including fellows and junior faculty members.  The Core should also address other skills necessary for a successful research career, such as grant writing, ethical conduct of research, and clinical trial design.  Participation or interaction with existing institutional programs is encouraged.  The Translational Research Skills Development Core must be directed by an investigator with strong educational and mentoring credentials who will devote a minimum of 5 percent effort as its Leader. To facilitate mentoring and multidisciplinary developmental activities, active involvement by the principal investigator and other senior investigators within the TRC-THD is strongly encouraged.

Administrative Coordinating Center (ACC):

There will be one ACC to serve all the TRC-THDs which will perform a range of administrative functions including organizing investigator and External Panel meetings, arranging conference calls, and designing and maintaining a website for the program.  A proposal for the ACC, which will service all the TRC-THDs, must be included in each TRC-THD application.

Specific Programmatic Requirements:

Translational Research Scientific Team: Each TRC-THD should focus on bringing together a multidisciplinary team with expertise in basic, translational and clinical research interested in applying this integrated knowledge to address important clinical questions in thrombotic and hemostatic disorders. Scientific partnerships between investigators who have not collaborated in the past are encouraged so that new interdisciplinary research teams can be formed that will have the required capacity to address common research goals. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included in the Research Strategy component of the Program Overview and Statement of Objectives section.

Basic, Translational and Clinical Research Components: Collectively the research projects must have basic, translational, and clinical research components addressing important clinical questions.  The required clinical research component may include observational studies, proof of concept studies, small or early Phase clinical trials. The TRC-THD must have at least one assay, method, procedure, or agent in early phase translation.

Collaboration with CTSA or other Institutional Programs:  Each TRC-THD must demonstrate collaboration with their CTSA or other Institutional programs that will maximize intellectual and physical resources. The TRC-THD should define the resources and capabilities to be provided and how they contribute to the proposed research goals.

Translational Research Skills Development Core: Applications must include a description of plans to develop and direct a translational research skills development component. The core should be directed by an investigator with research and mentoring credentials.  To facilitate multidisciplinary developmental activities, active involvement by other senior investigators in the TRC is encouraged.  Each TRC must budget for providing skills development for two or more new investigators.

Administrative Core: Each TRC-THD should have an administrative core to coordinate activities within the program, the Administrative Coordinating Center and the NHLBI Program Director.

Administrative Coordinating Center (ACC): All applicants must include a proposal for an ACC with a description of how they would carry out its functions and a separate budget for those functions. The ACC will serve all the TRC-THD centers and will perform a range of functions including organizing investigator meetings and External Review Panel meetings, arranging conference calls, and designing and maintaining a website to support the TRC-THDs. One AAC site will be selected from the TRC-THDs and will receive additional funds to support these activities.  

Internal Advisory Committee: Each TRC-THD will establish its own Internal Advisory Committee to evaluate progress and the effectiveness of interaction among participants.

Steering Committee: The Steering Committee composed of the TRC-THD Principal Investigators or their representative and the NHLBI Program Director will meet quarterly by conference call. The Steering Committee will plan the annual investigators’ meeting, and identify areas of shared interest and potential for collaboration in order to further the goals of the program.

Investigators’ Meetings: Investigators from individual TRC-THDs will meet annually in Bethesda, MD, to present updates on progress, to exchange ideas, and to discuss problems encountered. The agenda for the meetings will be determined by the Steering Committee composed of the Principal Investigators of the TRC-THDs and the NHLBI Program Director. The TRC-THD budget should include provisions for investigators to attend the investigators’ meeting.

External Review Panel: In order to maintain close scientific oversight of the TRC-THDs, an External Review Panel (ERP) consisting of eminent scientists in appropriate fields will be established by NHLBI. The ERP will meet periodically to review the progress of each TRC-THD and to assess the overall programmatic goals of the initiative. The ERP will make recommendations on structural and functional changes that should be made to enhance the TRC-THD program

Selected Research Examples

The following are examples of possible topics for the TRC-THD, but there are many other important challenges that would be responsive:

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards


The following NIH component intends to commit the following amounts in FY 2012:
NHLBI, $14,000,000, up to 5 awards

Award Budget

Application budgets are limited to $1.8 million direct costs per year for each Center.  An additional $150,000 in direct costs per year will be available for one Center selected to serve as the Administrative Coordinating Center (ACC).

Award Project Period

 5 Years

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National, Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email:chiefreviewbranch@nhlbi.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

 CHARACTERISTICS OF TRC-THD PROGRAM

A.    A Center must have a clearly defined, unifying, central theme to which each component project relates and to which each research investigator contributes.

B.    Component research projects that are interrelated and contribute scientifically to the central theme of the program.

C.    A principal investigator (PI) who is a research scientist of recognized stature in his/her scientific discipline and has the demonstrated ability to ensure quality control and to administer and integrate all components of the translational research program.

D.    Project leaders who provide expertise from several disciplines.

E.    Core leaders who have appropriate expertise.

F.    A plan to ensure extensive interaction among all participants and the communication of ideas and results.

G.    A section titled "Synergy and Interactions Among Projects and Project Leaders." The section must address:

The exceptions and additions noted below are the only changes from the general requirements provided in the instructions for PHS Form 398 that apply to each project and core unit of a TRC-THD application.

Specific Instructions

Face page

There is one face page for entire application.  Applications must not repeat face page for components.

Table of Contents

Detailed Budget for Initial Budget Period

Budget for Entire Proposed Period of Support.

Research Plan

Additional Format Instruction - The following sections must precede the portion of the application that contains the details of the individual projects.

Program Overview and Statement of Objectives (Limit of 12 pages)

Individual Projects

1.         Title and number each research project so that it can be readily distinguished from any other project in the program. An individual description should be prepared for each project. Provide the name and academic title of the project leader and each participating investigator.

2.         Present the budget for each research project according to the instructions for PHS Form 398. A detailed categorical budget is required for the first and all subsequent years. Include budget requests and explicit detailed budget justifications for all years.

3.         Describe in detail the facilities to be used by each project. This is to be accomplished by completing the "Resource and Environment" page included in the PHS Form 398 grant application packet.

4.         Specific Aims: List the specific aims of the research project for the total period of requested support. Indicate the general priority of each aim in the overall research plan.  (Limited to 1 page.)

5.         Research Strategy: State the overall objective for each proposed research project and explain how it relates to the central theme of the program and how it interrelates with and complements and/or supplements, the other research projects and core units. Organize the Research Strategy in the specified order using the instructions for PHS Form 398.  In addition, describe the overall expected biomedical significance of the proposed research.  (Limited to 12 pages.)

6.         The Human Subjects and Vertebrate Animals sections should be included for each individual project (see PHS Form 398 Instructions).  The usual NIH policies concerning research on human subjects and/or Vertebrate Animals apply.

Individual Core Units

In addition to the two mandatory cores, a core unit is defined as a resource for the program that provides centralized services to more than one of the research projects. 

1.         Title and assign a LETTER designation to each core unit so that it can be readily distinguished from any other core unit.

2.         Provide the name and academic title of the core unit leader and each participating investigator.

3.         Describe the function of the core unit as a resource to the program. This section must present clearly the facilities, techniques, and professional skills that the core unit would provide to the program and explain why its inclusion is essential to two or more of the individual research projects and to the overall research program. (Limited to 6 pages.)

4.         Describe in detail the facilities to be used by EACH core unit. This is to be accomplished by completing the "Resource and Environment" page included in the PHS Form 398 grant application packet.

5.         Present the budget for each core unit in the format and according to the instructions for Form 398. A budget for the entire proposed project period is required for all subsequent years of support (direct costs only). Include explicit and detailed categorical budget  justifications for all years and fully describe how the costs interrelate with those of the projects serviced by the core unit.

6.         Relation of the Core Units to the Research Projects: Provide in tabular form information concerning the research projects that each core unit would serve and the proportion of the cost of the core unit associated with each research project involved. (Limited to 6 pages.)

Administrative Coordinating Center (ACC):

A proposal for the ACC, which will service all the TRC-THDs, must be included in each TRC-THD application.  The ACC will perform a range of functions including organizing investigator meetings, External Review Panel meetings, arranging conference calls, and designing and maintaining a website to support the TRC-THDs. A description should be provided of how the ACC would carry out its functions and a separate budget for those functions. The ACC director should have qualifications necessary to manage the facility and devote at least 5 % effort.  In addition to costs associated with arranging annual meetings, four to six conference calls per year and design and maintenance of a TRC-THD website, travel costs for three External Review Panel members and two to three guest speakers to an annual meeting should be included within the $150,000 direct costs per year limit. The AAC proposal will be reviewed and scored independently from the rest of the TRC-THD.  One AAC site will be selected from the TRC-THDs and will receive additional funds to support the ACC activities. (Limited to 6 pages.)

Summary Table of TRC-THD page limits

Section                                                                                    Page Limit

ProgramOverview and Statement of Objectives           12

Individual Research Projects (each)                             12 + 1 Specific Aims Page

Cores (each)                                                                6

TRC-THD Administrative Coordinating Center               6

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

Each application will be reviewed in its entirety and receive a single impact/priority score.  The individual research projects will not receive separate scores.  The ACC component will be scored independently from the rest of the TRC-THD.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the application address an important clinical question(s) to improve prevention, diagnosis or treatment for hemostatic or thrombotic disorders?  Would successful completion of the proposed projects advance a basic research discovery toward clinical application?   

Investigator(s)

Are the PD/PIs, 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?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  What is the quality of the strategy to evaluate the feasibility, applicability or possible clinical benefit of the translational component?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Will the program's collaboration with their CTSA or other institutional program(s) assist in achieving the objectives of the proposed research?   

Additional Review Criteria - Overall

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/priority score, but will not give separate scores for these items.

 In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

 Review Criteria for Translational Research Skills Development Core:

The Core will be evaluated in terms of its potential effectiveness in developing the skills and research capabilities of new investigators as reflected in the following required elements of the application: 

Review Criteria for Administrative Coordinating Center:

The ACC will receive a separate impact/priority score based on the review criteria below, but that score will not be factored into the overall impact/priority score for the TRC-THD.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

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

The NHLBI Project Scientist will:

Areas of Joint Responsibility include:

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Rebecca P. Link, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9268, MSC 7950
Bethesda, MD 20892-7950 (Courier service zip: 20817)
Telephone: 301-435-0071
Email: linkr@nhlbi.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Patricia Reyes
Office of Grants Management
Division of Extramural Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7140, MSC 7926
Bethesda, MD 20892-7926
Telephone: 301-435-0166
Fax: 301-451-5462
Email:reyesp@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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