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

Clinical Hematology and Transfusion Medicine Research Career Development Program (K12)

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of RFA-HL-06-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-005

Companion FOA

None

Number of Applications

Only one application per institution is allowed, as defined in Section III.3. Additional Information on Eligibility Section III. 3. Additional Information on Eligibility.

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

93.839   

FOA Purpose

The purpose of this Program is to develop and evaluate multidisciplinary career development programs in non-malignant hematology and transfusion medicine that will equip new investigators with the knowledge and skills to address complex problems in blood diseases and transfusion medicine. Through this Program, the NHLBI will support the early career development of clinical researchers who are expected to become independent investigators and assume academic leadership roles in non-malignant clinical hematology and transfusion medicine. To accomplish this, NHLBI invites institutions with established clinical research infrastructures and expertise in non-malignant clinical hematology and transfusion medicine to submit applications to establish Clinical Hematology and Transfusion Medicine Research Career Development Programs. Programs supported under this FOA should provide comprehensive, multidisciplinary training in research designs and methodologies, standard and potentially future or innovative approaches to the clinical management of patients with non-malignant hematologic diseases as well as transfusion practices for multiple patient populations, and research opportunities in these clinical settings. Programs should include a core curriculum, didactics, and a short-term research project for each Scholar.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

May 20, 2011

Letter of Intent Due Date

May 20, 2011

Application Due Date(s)

June 20, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

September/October

Advisory Council Review

January 2012

Earliest Start Date(s)

April  2012

Expiration Date

June 21, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide especially the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development programs is to help ensure that a broad pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission areas of the NHLBI.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

Background

Advances in basic science in hematology and transfusion medicine await translation into clinical research. The newly emerging areas of stem cell biology, cell based therapies, gene therapy, systems biology, cord blood transplantation, cellular immunology, recombinant cytokines, and pathogen inactivation of blood components have potential for the improvement of transfusion practices and the management of hematologic diseases.  Examination of the NHLBI transfusion medicine and hematology portfolio shows that there are few clinical researchers to continue the work required to move basic and translational findings into therapeutic applications. 

The number of physicians entering the fields of pediatric and adult clinical hematology and transfusion medicine is decreasing. Over the last 5 years, programs in non-malignant hematology are training fewer physicians, and many of these physicians are spending less than half of their time on research. Consequently, a small percentage of these physicians remain in clinical hematology in an academic environment.  While the number of physicians entering transfusion medicine has remained relatively stable, fewer physicians are spending any of their time on research.  The existing program was put into place to create a pipeline of investigators for clinical hematology research.  This renewal will expand the programmatic scope to include patient-oriented research in transfusion medicine and cellular therapies.  Expansion of the program will allow eligible institutions to establish partnerships with specialized institutions, such as blood centers and children’s hospitals, which would not otherwise be sufficiently comprehensive to support their own K12 program. Scholars will be able to spend protected time at another institution learning a specialized technique or gaining experience with a patient population not represented at their home institution.

Research Career Development and Training Objectives

The primary goal of this FOA is to promote comprehensive research career development and training, thereby enhancing the early career development of fellows, and junior faculty health professionals who want to specialize in transfusion medicine and non-malignant clinical hematology. Through this initiative, the National Heart, Lung, and Blood Institute (NHLBI) will support multidisciplinary career development programs to prepare clinicians for academic research careers in transfusion medicine and non-malignant hematology.

The focus of this FOA is two-pronged.  One focus is on rare, non-malignant blood diseases for which there is a shortage of new research investigators. For the purposes of this initiative, non-malignant clinical hematology is defined as a discipline devoted to the clinical evaluation and management of individuals with: aplastic and hemolytic anemias, hemoglobinopathies, disorders of hemostasis and thrombophilia, hemorrhagic disorders, myeloproliferative disorders (MPD), and myelodysplastic syndromes (MDS).  Although myeloproliferative disorders (MPD) and myelodysplastic syndromes (MDS) are pre-malignant, and could be considered “malignant,” they are disorders for which a hematologist would be consulted. Leukemias are excluded from this program.

The other focus of this FOA is research in adult and pediatric transfusion medicine.  This is a field that is currently experiencing a critical shortage of new research investigators. A major clinical research need in this field is the optimization of transfusion strategies for blood product recipients, especially in vulnerable populations such as neonates, pediatric and adult critical care patients, and geriatric patients.

Clinical research is broadly defined to include epidemiologic and natural history studies, translational research, patient-oriented research, clinical trials, and health services and outcomes research. Patient-oriented research includes (1) mechanisms of human disease, (2) therapeutic interventions, (3) clinical trials, and (4) the development of new technologies.

The research career development objectives of this initiative are to:

These objectives stem from the fact that, despite scientific progress in basic research, there is a shortage of trained hematologists, especially in adult medicine, who are available to appropriately manage patients with non-malignant blood diseases. Conversely, there is a shortage of trained transfusion medicine specialists in pediatric medicine to collaborate with pediatric intensivists, pediatric cardiologists, neonatologists, and other physicians who order the transfusion of many blood products to severely ill children.

It is important to note that the proposed programs are distinct from traditional clinical fellowships or career development programs.  This initiative requires a one year or more of mentored research to foster careers in non-malignant hematology and transfusion medicine research.

Through the Clinical Hematology and Transfusion Medicine Career Development Programs, NHLBI will provide awards to academic research institutions to develop a core curriculum and a didactic component, and provide new clinical researchers with an opportunity to conduct a mentored research project. With this award, Scholars should develop the skills, knowledge, and experience to pursue additional grants (e.g., K23, R01), and eventually become independent investigators, and leaders in academic research programs in transfusion medicine and non-malignant hematology.

Programs should address the multidisciplinary nature of non-malignant hematology and transfusion medicine as well as the accompanying medical management and research.  Innovative teaching tools may be proposed as part of the core curriculum and didactics. Applications that propose innovative models of patient care, using primary care physicians, are allowed, as long as all other criteria are fulfilled.

The Program Director (PD) should draw on the strengths of his/her institution, its faculty and resources, to develop a specialized clinical core curriculum in non-malignant clinical hematology and transfusion medicine. The Program Director, as the scientific and administrative leader of the Program, should obtain guidance from a multi-disciplinary Advisory Committee responsible for program oversight and evaluation.

Faculty with expertise in multiple specialties should serve as Mentors.  They should be responsible for:

Developing, updating, enhancing, evaluating, and revising curricula and innovative research training methods and tools.

Special research topics such as obstetrics/gynecology, neonatology, pediatric, or gerontology should be available should a Scholar require more intensive training for their chosen research topic

Didactics in clinical research methods should expose Scholars to:

Scholars will enter the Program at various levels of research training and experience. Some individuals may not need to participate in the entire core curriculum, or didactics. These Scholars may elect additional research career development and training in areas of interest, such as bioinformatics, pharmacogenomics, epidemiologic methods, laboratory-based methods such as assay development, advanced biostatistics, survey research, or nutrition. Applicants are encouraged to submit plans to accommodate these potential Scholars, and to individualize their research career development and training experiences.

Late in year 1 and early in year 2, Scholars, with guidance and input from their research mentor, should desgn a short-term research project that can be implemented and the data analyzed in the remaining period of support.  The last several months of mentored research training, should allow the Scholar to prepare presentations, at least one publication, and a K23 or similar grant application.  

Scholars’ research projects may be experimental or observational, if the latter will generate hypotheses and preliminary data for future research.  

Examples of research topics that Scholars might pursue in their research project include, but are not limited to, the following:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHLBI intends to commit an estimated total of $13.5 million over a five-year period.

Award Budget

Application budgets are limited to $370,000 in direct costs per year.

Award Project Period

The maximum project period is 5 years.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. These expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Scholars are those  individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.

Other Program Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

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.

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.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
The applicant institution must have strong and high quality research programs in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program.  In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

The applicant institution and affiliated organizations should:

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) 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 SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

Eligible Principal Investigators should have a strong and active track record in transfusion medicine and/or non-malignant hematology clinical research and research training.  

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

 Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. 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.

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award. Mentors should have a strong and productive background in transfusion medicine or non-malignant hematology research.  Depending upon the scope of available research projects, supplementary mentors should have expertise in clinical trials, epidemiology, laboratory-based medicine, or any other subspecialties.

Participants

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

At the time of appointment, each scholar must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Scholars should be clinical or research fellows, clinical or research instructors, or recently-appointed assistant professors. 

Eligible Physician Scholars (i.e., with an M.D. or D.O. degree) should come from hematology, hematology/oncology, internal medicine, family practice, hematopathology, pediatrics, or transfusion medicine. Physician Scholars should have completed residency training.. 

In addition, doctorally-prepared health professionals may be selected as Scholars if they have documented clinical or research experience (e.g., a paper or dissertation) in one or more non-malignant or malignant blood disease. Doctorally-prepared health professionals may come from clinical fields such as epidemiology, health services and outcomes research, social work, nursing, nutrition, health education, pharmacology, neuropsychology, or psychology.  Each program may propose to provide career development and research training to one doctorally-prepared health professional at any time in the 5 years of funding, but no more than 2 during the 5 years. For example, if a psychologist is a Scholar in years 1 through 3, then the program may train another doctorally-prepared individual, e.g., a nurse, in years 4 and 5.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

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
Bethesda, MD 20892-7924 (Express mail zip code: 20817)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) Application Guide to determine which components are required.

Page Limitations

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

SF424 (R&R) Other Project Information Component

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

Project Summary/Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of Scholars, including their levels (i.e., postdoctoral, faculty).

Advisory Committee (Uploaded via the Other Attachments section)

A plan must be provided for the appointment of an Advisory Committee to monitor progress. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of participants should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

R&R Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:
Substitute all references to “trainees” in the SF 424 (R&R) Application Guide with “scholars” and all references to “training” in the SF 424 (R&R) Application Guide with “career development”.

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include active research and the planned strategy to be used to oversee and monitor the program. For applications with multiple PDs/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty (Component of Program Plan)

Describe the complementary expertise and experiences of the proposed mentors for the scholars. Include active research and other scholarly activities in which the mentors are engaged, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including training or career development activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this proposal from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential Scholars, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former scholars in establishing independent productive scientific careers. Programs should provide all Scholars with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. All postdoctoral Scholars should also be provided with instruction in laboratory and project management. 

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing scholars’ career development and progression including degree completion (if applicable), publications, and subsequent positions. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation in the selection of Scholars. Describe plans to recruit candidates, including those from economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. Provide brief summaries of training plans that the program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training. PDs/PIs should submit a plan for recruiting Scholars from both outside and inside the sponsoring institution. The appointment of Scholars should be documented by a Statement of Appointment Form (Form 2271) and submitted to the funding IC.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PDs/PIs, other faculty and mentors , and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program.

Personnel Costs for Program Director, and Program Faculty: Up to 25% of the Program Director's salary and fringes may be requested for the, and up to 15% per year thereafter. Program Director’s responsibilities throughout the award include program coordination, leadership, outreach and recruitment of Scholars, curriculum evaluation and revisions, and dissemination of curricula, innovative methods and tools.

Up to 15% of Program Faculty members’ salary and fringes may be requested for the first four-month start-up phase, and up to 5% per year thereafter. Program Faculty’s responsibilities include developing, updating, enhancing, evaluating, and revising curricula and innovative teaching methods and tools. Programs may include development of curricula, and innovative methods and tools for primary care physician Scholars who will become clinical researchers.

Ancillary Personnel Support: Up to 6 person-months effort may be budgeted for an administrative assistant in the first four-month start-up planning phase and 3 person-months effort thereafter. Expenses for this administrative effort must be for actions and responsibilities directly related to this K12 Program.  

Travel for the Program Director, active Mentors, and active Scholars to the annual grantees' meeting in Bethesda, MD, should be included in the budget.

The Advisory Committee chair and members may be paid a maximum of $2,000 per year to defray costs for their participation in this program.

Scholars will receive salary support of up to $75,000 each year, plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The K12 award will provide for two to three years of funding for each Scholar.  The institution may supplement the NHLBI contribution; however, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary requested must be based on a full-time, 12-month staff appointment.

Research and Development Support: This Program will provide $30,000 per Scholar  per year for the following types of expenses: (1) research expenses, such as supplies, equipment and technical personnel; (2) tuition and fees related to career development; (3) travel to research meetings, training, and NHLBI-sponsored annual grantees' meetings; and (4) statistical services including personnel and computer time. These costs must be specifically documented for each individual Scholar and must be specifically and directly related to the Scholar’s research activities. These costs may not be used for Program advertising or recruiting.

The institution must have a well-funded clinical research base, the infrastructure to support clinical research (for example, a CTSA, clinical coordinator(s), biostatistics expertise, etc.), and the facilities (e.g., inpatient and outpatient facilities, affiliate hospitals, etc.) and access to patient resources to expose Scholars to pediatric, adolescent, and adult patients with non-malignant blood diseases. For transfusion medicine, the Institution must demonstrate that a substantial number of transfusions are performed to a variety of patient populations and a well-established relationship with the blood provider.  If other institutions are involved, each must provide written commitments of resources that they will provide to the Program.

Institutional Environment: Applicant institutions should demonstrate their commitment to the Program's goals. Applications should include letters from appropriate institute officials addressing the following issues:

Appendix

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

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 submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program 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

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.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities? When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

How well does the program focus the Scholars’ research on benign hematology? 

Program Director(s)/Principal Investigator(s) (PDs/PIs)

Do the PD/PI and Research Administrator (if applicable), have the experience to develop, direct and administer the proposed program?  Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?   

Mentors

Do the mentors have expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?   

Candidates/Scholars

What is the quality of plans to identify, recruit, and select candidates, with a commitment to research relevant to the mission of the FOA, and the potential to develop as independent researchers? Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? How useful is the research plan as a vehicle for ensuring research training for all scholars as described in the career development plan? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the program include a plan to recruit, identify, and select scholars with a commitment to research relevant to the objectives of the FOA? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training Record

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

Additional Review Criteria

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. 

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. 

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. 

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. 

Resubmissions

Not applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.  Does the application describe the program’s accomplishments over the past funding period(s)?  Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Is there a report describing past instruction in the five components of the Training in the Responsible Conduct of Research?

Revisions

Not Applicable

Additional Review Considerations

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.   

Training in the Responsible Conduct of Research

 Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?  Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus rating of the review committee. Applications rated unacceptable will not be funded until the applicant provides an acceptable, revised plan.

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).

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 Review Branch (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:

Applications will be assigned to the National Heart, Lung, and Blood Institute. 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 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.

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, scholars  are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements (Financial Status Report) as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. The Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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. 

Other Reporting Requirements

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.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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)

Ellen M. Werner, Ph.D.
Blood Diseases Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10156
Bethesda, MD 20892-7950 (Express mail zip code 20817)
Telephone: 301-435-0050
FAX: 301-480-0868
Email: wernere@nhlbi.nih.gov

Traci Heath Mondoro, Ph.D.
Deputy Branch Chief
Transfusion Medicine and Cellular Therapeutics Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Room 9140, MSC 7950
6701 Rockledge Drive
Bethesda, MD 20892 
Telephone:  301-435-0052
FAX:  301-480-0867
Email:  mondorot@nhlbi.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Patricia Reyes
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7140
Bethesda, MD 20892-7926 (Express mail zip code 20817)
Telephone: 301-435-0166
Fax: 301-451-5462
Email: reyesp@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.


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