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

Excellence in Hemoglobinopathies Research Award (EHRA) (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-13-005

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.839

FOA Purpose

This Funding Opportunity Announcement (FOA) solicits five-year Cooperative Agreement (U54) grant applications to the Excellence in Hemoglobinopathies Research Award (EHRA) program.  The primary objective of this new program is to support the development of studies that will accelerate high-impact multi-disciplinary basic and translational research in the hemoglobinopathies and facilitate maximal collaborations among basic and translational scientists and clinical hematologists located throughout the US or at international sites.   An application must propose a single project that approaches a common scientific theme through innovative collaborations among investigators in two or more relevant disciplines, providing opportunities for research which will translate basic observations to applied clinical research. An EHRA application will also include a Translational Research Skills Development Core (TRC) for new investigators, an optional Summer Research Program for highschool students, and an Administrative Coordinating Center (ACC).  One ACC will be selected from the awarded Centers to provide a range of administrative support to all the awardees.

Key Dates
Posted Date

January 18, 2012

Letter of Intent Due Date

April 8, 2012

Application Due Date(s)

May 8, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October - November, 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

April 1, 2013

Expiration Date

May 9, 2012

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 purpose of this U54 program issued by the National Heart, Lung, and Blood Institute (NHLBI) is to encourage interdisciplinary approaches to translational research in the hemoglobinopathies, providing opportunities for potentially high-impact research, which will translate basic observations to applied clinical research. Applicants will be required to propose research that will, by the end of the project period, develop candidate potentially therapeutic molecules, biomarkers, or imaging modalities. Applicants are expected to assemble interactive, multidisciplinary teams that have the combined expertise to formulate a plan for successful translation.  Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, practical approach that will result in the effective progression of mechanistic/basic concepts toward application in the clinic. 

The proposed project should focus on the development of a specific discovery or deliverable (e.g., small molecules, biologics, biomarkers, and other methodologies) to be used in the diagnosis or treatment of sickle cell disease or the thalassemias.

Background

The hemoglobinopathies, sickle cell disease and the thalassemias, are the most common clinically significant human monogenetic diseases globally. Although the causative mutations primarily affect the qualitative or quantitative production of hemoglobin, the resultant pathophysiologies result in dysregulation of inflammatory and thromboregulatory pathways leading to damage of numerous organ systems, a process beginning shortly after birth.

Research in the hemoglobinopathies has traditionally focused on the red cell and the hemoglobin molecule. During the past decade, investigators have contributed new insights through work in genomics and epigenetics, drug development, the neurobiology of pain, iron metabolism, vascular biology, patient-reported outcomes (PROs), and comparative effectiveness research (CER). However, there have been few opportunities for broad-based programs that would benefit from collaboration among hematologists and investigators in relevant areas. Attracting new investigators to the hemoglobinopathies field is increasingly important because the potential scientific opportunities are expanding while the number of individuals choosing to pursue careers in academic hematology is contracting.

In 2008, a Subcommittee of the National Heart, Lung, and Blood Advisory Council (NHLBAC) issued a Report recommending a reprioritization of the Institute’s research program in sickle cell disease (SCD) that would permit a broad spectrum of investigators in relevant biomedical disciplines to collaborate with hematologists in addressing high priority areas in basic, translational, and clinical research.

Prioritized areas for research as determined by the NHLBI Workshop on Sickle Cell Disease, (October 2008), and the NHLBAC Subcommittee Review of the NHLBI Sickle Cell Disease Program (February 2008) may be found at http://www.nhlbi.nih.gov/meetings/workshops/scd_workshop.htm; http://bloodjournal.hematologylibrary.org/cgi/content/full/111/10/4852; and http://www.nhlbi.nih.gov/resources/docs/scd_program.htm)  Prioritized areas for research in the thalassemias, as determined by the NHLBI Workshop on Clinical Priorities in Thalassemia may be found at http://www.nhlbi.nih.gov/meetings/workshops/thal_workshop.htm.

NHLBI has been engaged in an ongoing process to reinvigorate the programs in sickle cell disease and the thalassemias to respond to the recommendations from the Advisory Committee and workshops. The Excellence in Hemoglobinopathies Research Awards (EHRA) represents the next major phase in this process. The EHRA program will focus on basic research and early translational (T1) trials involving small numbers of subjects.  “Basic” may include the pre-clinical toxicological and pharmacological studies required prior to a Phase I trial. It differs from the Specialized Centers of Clinically Oriented Research (SCCOR) program in that there are no prescriptive requirements for clinical trials. A separate FOA that provided funding for planning grants for phase II and III clinical trials was issued in 2010 (HL-11-009: "Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies") and awards were made in 2011. It is anticipated that EHRA–funded projects will generate data that will serve as the basis to advance earlier development of diagnostic, prognostic, and therapeutic interventions.

Seven to ten research centers will be funded, in accordance with the Congressional mandate for sickle cell disease. The EHRA extends the definition of a traditional Center program by encouraging the formation of Centers composed of qualified basic and early translational components and investigators each of whom may be in different institutions. This allowance for multiple institution/multiple site centers will facilitate interdisciplinary collaboration, since the availability of scientific expertise will not be constrained by geographic boundaries.  Applicants are expected to assemble interactive, cooperative multidisciplinary teams that have the combined expertise to formulate a plan for successful translation.  Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, rational experimental approach that will result in the effective progression of mechanistic/basic concepts toward clinical applications.

Description of a Center
Research Scope

Projects responsive to this FOA:

Applications not responsive to this FOA:

Selected research examples include, but are not limited to:

Program Structure

All of the Centers will form a consortium, with an Administrative Coordinating Center (ACC) and a Steering Committee.

Multidisciplinary Research Project (Required)

An application must propose a single project that approaches a common scientific theme through innovative collaborations among investigators in two or more relevant disciplines, providing opportunities for high-impact research which will translate basic observations to applied clinical research in the hemoglobinopathies. Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, practical approach that will result in the effective progression of mechanistic/basic concepts toward application in the clinic. 

Translational Research Skills Development Core (TRC) (Required): Applications must include a description of plans to develop and direct a translational research skills development component for new investigators. The core should be directed by an investigator with translational  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.

Summer Student Program (Optional):  A program directed at high school students to support summer hemoglobinopathies-related research for up to three qualified and interested high school students per year. If this program is offered by the Center, funds for it should be included in the budget. The review of the Summer Student Program will be based on a recommendation to approve or disapprove and will not be considered in the overall score of each Center. 

Administrative Coordinating Center (ACC) Required:  There will be one ACC to serve all the Centers which will perform a range of administrative functions including organizing investigator and External Advisory Committee meetings, arranging conference calls, and designing and maintaining a website for the program. This website would be for use by the EHRA investigators to communicate and share data. The ACC director does not have to be a project scientist.  A proposal for the ACC, which will service all the Centers, must be included in each EHRA application.  The ACC budget will include travel costs for the External Advisory Committee and for the ACC director to attend Steering Committee meetings. The ACC budget is not to exceed $150,000 in direct costs. The ACC is to be reviewed and scored separately and will be awarded to one of the funded Centers.

Steering Committee:  The Consortium will have a Steering Committee responsible for overall scientific direction, coordination and oversight.  The Steering Committee will be composed of the Research Center PD(s)/PI(s), the Administrative Coordinating Center (ACC) director, and the NHLBI Project Scientist. The Steering Committee will be chaired by an investigator selected by the NHLBI. In the first year of funding, the Steering Committee will meet in person for an implementation meeting at the start of the project period and by conference call at least quarterly. In the second through fifth year of funding, the Steering Committee will meet at least twice a year throughout the project period. One meeting will be held in or near Bethesda, MD and one meeting will be held at an EHRA grantee site. Each EHRA program should include funds for Principal Investigators(s) travel to the Steering Committee meetings.

Investigators’ Meetings: Investigators from individual Centers will meet annually in or near Bethesda, MD, to present updates on progress, to exchange ideas, and to discuss problems encountered. In the second through fifth year, the Investigators' Meeting will be held in conjunction with a Steering Committee meeting. The agenda for the meetings will be determined by the Steering Committee composed of the Principal Investigators of the Centers and the NHLBI Program Scientist. Each Centers budget should include funds for investigators to attend the investigators’ meeting.

External Advisory Committee: An External Advisory Committee (EAC) made up of three members will oversee this basic and translational program.  This Committee will consist of non-Consortium affiliated scientists and other experts appointed by the NHLBI to provide annual reviews of progress.  The EAC will attend one meeting per year in or near Bethesda, MD. Applicants do not have to identify the EAC members. Travel funds  and honoraria for the EAC should be included in the ACC budget.

Collaborative Activities:   Collaborations, standardization and sharing of data, and sharing and banking of biospecimens following review by the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) (https://biolincc.nhlbi.nih.gov/home/) will be expected and enabled by the Administrative Coordinating Center, a sub-committee of the investigator membership of the Steering Committee, and NIH program staff.

Clinical and Translational Science Awards (CTSA):  Applicants must use resources available through their CTSA program or similar Institutional program to maximize intellectural and physical resources.

Section II. Award Information
Funding Instrument

Cooperative Agreement

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 NHLBI intends to fund approximately 7-10 awards and commit $72.85 million total costs to the Excellence in Hemglobinopathies Research Awards program over a period of five years.  A total cost of $14 million will be committed for FY 2013.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project. Each application must also include a proposal for an Administrative Coordinating Center (ACC). The ACC budget cannot exceed $150,000 direct costs and will be awarded to one of the funded Centers.

Award Project Period

Five 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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are  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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(S) 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:

The letter of intent should be sent to:

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

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

Summary Table of EHRA Page Limits:

Section                                                                                     Page Limit

See section 6E. below for other submission requirements and instructions.

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, with the following modification:

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 the NHLBI. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Characteristics of the EHRA Program and Order of Presentation (see E. below on application order):

A.  An EHRA application must involve an interdisciplinary approach to translate basic science observations to applied clinical research in the hemoglobinopathies.

B. The multidisciplinary nature of the single EHRA project will require either a multiple-principal investigator model or a Program Director(s)/Principal Investigator(s) with Co-Investigators.  In order to maximize the options for utilizing appropriate scientific expertise, principal investigators need not be located in the same geographic area. 

All applications utilizing the multiple PD(s)/PI(s)-model or a single PD/PI with Co-investigators must include a robust Multiple-PD(s)/PI(s)(or PI/Co-investigator) Leadership Plan, including the governance and organizational structure, of the leadership team, and the research project, communication plans, processes for decision making on scientific direction, and procedures for resolving conflicts.  The roles and administrative, technical, and scientific responsibilities for the project should be delineated for each of the PD(s)/PI(s) and other collaborators.

C.  Program Director(s)/Principal Investigator(s):  The Principal Investigator(s) should be research scientist(s) of recognized stature in his/her scientific discipline, who has demonstrated ability to ensure quality control and to administer and integrate all aspects of the program.

Co-investigators must be individuals whose scientific publications demonstrate their potential to contribute to the project.

Investigators with excellent research training, who have not yet achieved established investigator status may participate.

D.  Components:

E. Supplemental Instructions for the Preparation of an EHRA Application with Multi-Components

The following section supplements the instructions found in Form PHS 398.  Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multiple components.

The order of presentation should be as follows:

 a.) EHRA Overview

b.)  Multidisciplinary Research Project

c.  Translational Research Skills Development Core

d.  Summer Students Program (optional)

e.  Administrative Coordinating Center

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.

The Multidisciplinary Research Project and the Translational Research Skills Development Core will be reviewed together and receive a single impact/priority score.  The optional Summer Student Program will be reviewed separately and receive an "approve" or "disapprove" recommendation. The Administrative Coordinating Center will be reviewed independently from the rest of the EHRA application and receive a separate impact/priority score.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed EHRA 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 EHRA  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 project address an important problem that will result in the development or refinement of high impact translational findings with direct relevence to the hemoglobinopathies? Does the project employ an interdisciplinary collaboration that benefits from close collaboration among basic and translational investigators? Is there a clear developmental plan based on study results that specifically inform translational  pathways for new diagnostic, prognostic, or therpeutic strategies for sickle cell disease or the thalassemias?                                                                                        

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the PD(s)/PI(s) research scientists of recognized stature within their disciplines, who have demonstrated abilities to work collaboratively in complex research programs? Are the co-investigators individuals whose scientific publications demonstrate their potential to contribute to 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? Does the project address an innovative hypothesis or critical barrier to progress that requires contributions from differing disciplines?      

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?   

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.   

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.

Translational Research Skills Development Core (TRC) Review Criteria:

Are the objectives, design, and direction for the training appropriate to the Center?  Are the approaches and methods proposed adequate to develop training curriculum, courses, and collaboration that provide the trainees with opportunities to interface with different disciplines?  Does the TRC reflect the interdisciplinary nature of the Center?  Does the TRC leader demonstrate experience in the development of training programs?  Does the TRC leader appear to devote adequate time to the trainees?  Are plans for the recruitment and selection of trainess appropriate?  Is the institutional commitment adequate? Is there an ongoing process to evaluate the training status of each participant?

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.

Review of the Administrative Coordinating Center Core

Each Center must propose an Administrative Coordinating Center (ACC) which will be scored separately according to the following review criteria:

Does the ACC director have experience in research administration and coordination?  Is there evidence of an ability to provide administrative support to all the participating Centers in terms of organizing investigator, Steering Committee,  and External Advisory Committee meetings, and for arranging conference calls ?  Is there a logical plan for designing and maintaining a website for the EHRA program?

The optional Summer Student Program will be approved or disapproved on the basis of the following considerations:  Is there an appropriate plan to recruit highschool students?  Is there an adequate mentoring plan to expose the students to the research being conducted by the EHRA investigators? Is there an appropriate plan to expose the students to specific hemoglobinopathy-related topics?  Is there a plan to evaluate the student's experience?  

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to 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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for: all aspects of the study, including study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

An NIH Project Scientist (or “Project Coordinator,” or “Project Collaborator,” or “Intramural Scientist”) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NHLBI Project Scientist will serve on the Steering Committee; NHLBI scientist(s) may serve on other study committees, when appropriate.  The NHLBI Project Scientist (and other cited NHLBI scientists) may work with awardees on issues before the Steering Committee, and as appropriate, other committees, for example: development and implementation of data and sample sharing plans, informed consent issues, sample collection, protocol development, quality control, data analysis and publication, and preparation and development of solutions to major problems such as efficiency and yield of iPS differentiation protocols.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Awardee agrees to governance, through voting and decision making, of the program through a Steering Committee.  Steering Committee voting membership shall consist of the principal investigator, site principal investigators, and the NHLBI Project Scientist.  Monthly meetings of the Steering Committee will ordinarily be held by telephone conference call.  In person meetings should be held twice yearly, once in Bethesda and once at a national conference.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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 regulations 42 CFR Part 50, Subpart D and HHS regulations 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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)

Harvey Luksenburg, MD
Blood Diseases Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9164
Bethesda, MD  20892-7950
Phone:  301-435-0050
Fax:  301-480-0867
Email:  luksenburgh@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Ronald E. Caulder
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health
6701 Rockledge Drive, Room 7150
Bethesda, MD 20892-7926
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0166
caulderr@nhlbi.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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.