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

Short-Term Institutional Training Grant for Clinician Scientists in Pediatric Respiratory, Sleep and Hematology/Transfusion Medicine (T35)

Activity Code

T35 National Research Service Award (NRSA) Short -Term Research Training

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-017

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.838, 93.839

FOA Purpose

The objective of this proposed Short-Term Institutional Training Grant (T35) in Pediatric Respiratory, Sleep, Hematology and Transfusion Medicine is to develop and enhance research training opportunities in basic or clinical research in these disciplines for medical and health professional students.

Key Dates
Posted Date

April 5, 2011

Open Date (Earliest Submission Date)

May 14, 2011

Letter of Intent Due Date

May 16, 2011

Application Due Date(s)

June 14, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August/September 2011 

Advisory Council Review

January 2012

Earliest Start Date(s)

April 2012

Expiration Date

June 15, 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 Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.  More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Research Training Objectives

The goal of this initiative is to address the shortage of physician scientists interested in pursuing research careers in pediatric respiratory, hematology and transfusion medicine disorders, by encouraging medical and health professional students to pursue research in these areas and expose them to mentors who can encourage their future career choices.

The objective of this proposed Short-Term Kirschstein-NRSA Institutional Training Grant (T35) in Pediatric Respiratory, Sleep, Hematology, and Transfusion Medicine is to develop and enhance research training opportunities for medical or other health professional students in basic or clinical research in these areas.

Pertinent Background Information

A renewed interest in primary prevention and early diagnosis of disease is moving the focus of clinical research to younger and younger populations of clinical subjects, and with the recognition that many chronic diseases begin in childhood and even in utero, and that early exposures during development  may influence disease outcomes, the NHLBI has identified a need for well-trained biomedical scientists to conduct translational research in the early detection and primary prevention of acute and chronic lung, blood diseases and sleep disorders.

The T35 mechanism provides the opportunity to attract medical and health professional students to clinical research by exposing them to the scientific investigative skills of NHLBI funded pediatric clinician scientists, who can serve as role models for students and influence their career choices. NHLBI Pulmonary Research Training Workshop participants in March 2009 provided an analysis of the status of pediatric pulmonary workforce. This analysis highlighted not only a shortage of well-trained physician scientists prepared to conduct translational research in pediatric respiratory disorders, but also of pediatric pulmonary programs with experience in training  translational research scientists.

Objectives of this Training Program

Pediatric Department Chairmen report that academic jobs available for well-trained pediatric pulmonologists often go unfilled for lack of qualified candidates. This shortage of well-trained research-oriented pediatric pulmonologists who are adequately prepared to seek peer reviewed funding, potentially threatens the viability of the field and our ability to develop new approaches to prevent, diagnose, and treat childhood respiratory diseases. For example, the recent discovery of new genetic markers for bronchopulmonary dysplasia, pulmonary hypertension, and other pediatric respiratory diseases, is awaiting a critical mass of investigators able to translate these discoveries into new diagnostics and therapies. The limited pool of well-established investigators is further threatened by the decreasing numbers of young physician scientists who choose to specialize in pulmonary medicine.

Sleep disorders are pervasive and under diagnosed in children. Many drugs used “off-label” as sedative-hypnotics to resolve prominent pediatric symptoms diminish sleep quality and may cause harm when used chronically. Pediatric research specialists are needed to assess the developmental and pathophysiological implications of pediatric sleep problems and develop improved treatment approaches. Pediatrics is the slowest growing domain of sleep research NIH-wide over the period 1995 to 2004.

The field of transfusion medicine, especially pediatric transfusion medicine, is currently experiencing a shortage of interested young investigators. Pediatric transfusion medicine is a small, specialized area within the transfusion medicine field that currently has no formal training programs, which are needed to attract interested students to the field in order to replenish the knowledge base as senior investigators are lost by attrition. While there are a few senior investigators who have been pioneers in the field, there is no established pathway to recruit physicians to this small, yet important field. In 2006, NHLBI established a program titled“Pediatric Transfusion Medicine Academic Awards,”which yielded four K07 grants to junior and senior investigators in the field of pediatric transfusion medicine. While this program serves to establish curricula and stimulate research in pediatric transfusion medicine, it is targeted to physicians who have already decided to become pediatric hematologists or transfusion medicine specialists, rather than recruiting new physician scientists to the field. NHLBI working groups in pediatric transfusion medicine held in 2005, 2008, and 2009 noted less than 10 of the approximately 60 children's hospitals in the US have a pediatric transfusion medicine specialist on staff.

In the case of pediatric hematology, the subspecialty training is linked with pediatric oncology so while there seem to be many pediatric hematologists, there are few research investigators who concentrate solely on non-cancer related pediatric hematology NHLBI supports a K12 program in hematology, but as in pediatric transfusion medicine, this program recruits trainees who have already selected hematology as a career, with the majority focusing on adult hematology. Short-term programs focused on attracting medical students to participate in research for pediatric hematology/transfusion medicine would be an ideal supplement to the K12/K07 pipeline that has already been established.

The 2009 NHLBI State of the Science in Transfusion Medicine and Hemostasis and Thrombosis Symposium (http://www.nhlbi.nih.gov/meetings/SOC-reportintro.htm) identified future areas that need to be studied and eventually to be developed for clinical trials in pediatric hematology and transfusion medicine; indicating that there are ample research opportunities for future investigators.

Programmatic Structure

The program will provide stipends for 2 to 3 months to 5 to 7 trainees per program to cover living expenses during the research training experience. Housing expenses, travel and training related expenses will also be part of this award. For the duration of the training, the students will be required to devote at least 40 hours per week to the program.  Interested students will be encouraged to continue their training in the following years to further their research experience. The applicant institution must have a high quality research program in pediatric respiratory, sleep or blood disorders and must have the staff and facilities to conduct the proposed research training.

The Training Program Director/Principal Investigator (Training PD/PI) should be a peer review funded research pediatrician, with a successful past training record, and the skills, knowledge, and resources to conduct the proposed training program.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIH intends to commit $300,000 in FY 2012 and $360,000/year for the subsequent 3 years to fund approximately six awards.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Award Project Period

The project period is 4 years.

Other Award Budget Information
Stipends, Tuition, and Fees

Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences. This award will provide also $400/month for housing.

The most recent stipend, tuition, and fee levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Trainee Travel

Trainee travel to the site of short term training that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense. 

Training Related Expenses

NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. The most recent levels of training related expenses are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site.  Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

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 not 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.

All registrations must be completed by the application due date.

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.

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 (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Training Program Director/Principal Investigator (Training 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 Training 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 Training PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

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 programmatically 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.

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.  

Trainees

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Trainees are required to pursue research training for 2-3 months on a full-time basis devoting at least 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program. Within the full time training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical and other duties to those that are an integral part of the research training experience. Successful trainees may be appointed for additional periods of short-term training, or when appropriate, they may be encouraged to enter an extended period of full-time training supported by an NRSA training grant or fellowship or an NIH career development award. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

NRSA institutional short-term training grants are intended to introduce predoctorates and postdoctorates to research that would not otherwise be available through their regular course of graduate study. Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program or any undergraduate training. Positions on NRSA short-term institutional training grants may not be used for courses and study leading to an M.D., D.D.S. D.O., D.V.M., or other clinical, health professional degree, nor do they support residency training. Research elective credit may be granted for students who complete a short-term research training experience supported by the T35.  The decision to award elective credit will be at the discretion of the sponsoring institution and must be consistent with the policies of the institution.  Any additional costs associated with the decision to allow research elective credit may not be charged to the T35.

Training Program

Trainees appointed to the short-term research training program must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career.  Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with NRSA guidelines. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. 

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
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (express/courier zip: 20817)
Telephone: 301-435-0270
Fax:  301-480-0730
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

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) 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 research training plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of trainees, including their levels (i.e., predoctoral, postdoctoral).

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.

Training 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:

Particular attention must be given to the required Training Data Tables.

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the Training 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.

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 trainees, 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 Training 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.

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 and metrics for assessing scholars’ career development and progression including degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. 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 Trainees. Describe the criteria to be used for candidate evaluation in the selection of Trainees. 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 trainees from both outside and inside the sponsoring institution. The appointment of Trainees 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.

Recruitment and Retention Plan to Enhance Diversity

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds.  These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs.  The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans:  Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.  Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those trainees who were enrolled in the training program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity (see SF424, Section 8.7. Research Training Program Plan Components, Item 4, Recruitment and Retention to Enhance Diversity).  Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

Applications without a diversity recruitment and retention plan will be considered incomplete and will not be reviewed.

Training in the Responsible Conduct of Research

Every trainee supported by this training grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction as detailed in NOT-OD-10-019.  Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.  All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.  Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.  The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.  See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.

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. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants since these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component.  

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 the NHLBI (see Section VII, Agency Contacts). 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.

Training Program and Environment

 For applications that request short-term research training positions: Is this aspect of the program well designed and, where appropriate, integrated with other aspects of the training program? Are the numbers of short-term positions appropriate? Does the program include features to encourage short-term trainees to consider careers in health-related research?

Are the objectives, design, direction, and quality of the proposed short-term research training program appropriate?   Does the proposed program provide suitable training for the levels of trainees being proposed and the area of science to be supported by the program?   Is the quality of proposed course contents and training experience appropriate for all levels of trainees to be included in the program?   Does the program have access to candidates for short-term research training and the ability to recruit high quality, short-term trainees from the applicant institution or some other health-professional school?   Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical scientists?   Do the objectives, design and direction of the proposed research program ensure effective training?   Is the proposed program of training likely to ensure that trainees will be prepared for successful and productive scientific careers?   Do the courses, where relevant, and research training experiences address state- of-the-art science relevant to the aims of the program?   Does the program provide training in inter- or multi-disciplinary research and/or provide training in state of the art or novel methodologies and techniques?   Is a significant level of institutional commitment to the program evident?

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

Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research training program? Does the Training PD/PI plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program?

For applications designating multiple Training PD/PIs: Is a strong justification provided that the multiple Training PD/PI leadership approach will benefit the training program and the trainees? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the Training PD/PIs?

Preceptors/Mentors

Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application? Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? Do the preceptors/mentors have strong records of training pre- and/or postdoctorates?

Trainees

Does the program have the ability to recruit high quality, short-term trainees?  Are the quality of the applicant pool and plans for the selection of individuals appointed to the short-term training program appropriate?  Are the size and quality of the applicant pool adequate to support the program?  Are the recruiting procedures, and trainee selection criteria, appropriate and well defined?  Are there advertising plans or other effective strategies to recruit high-quality trainees?

Training Record

How successful are the trainees (or for new applications, other past students/fellows in similar training) in completing the program? How productive are trainees (or for new applications other past students/fellows) in terms of research accomplishments and publications? How successful are trainees (or other past students/fellows) in obtaining further training appointments, fellowships, and career development awards? How successful are the trainees in achieving productive scientific careers, as evidenced by successful competition for research grants, receipt of honors or awards, high-impact publications, receipt of patents, promotion to scientific leadership positions, and/or other such measures of success? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees and monitoring trainees’ subsequent career development? Are plans presented to follow the careers of short-term trainees and to assess the effect of the training program on subsequent career choices?

For programs that provide research training to health-professional doctorates:

Are plans presented to follow the careers of short-term trainees and to assess the effect of the training program on subsequent career choices? What is the success in attracting students back for multiple appointments? What is the effect of the short-term component on the overall training program?

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

Not Applicable  

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.

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the training program, level of trainee experience, and the particular circumstances of the trainees, 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 of the review committee.

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 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:

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 Training 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.

 Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement at NIH Grants Policy Statement - Institutional Research Training Grants.

The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.

Leave Policies

Not Applicable

Inventions and Copyrights

Not Applicable

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, trainees 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 acceptedThe 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
Section VII. Agency Contacts

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

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

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)

Sandra Colombini Hatch, M.D.
Lung Biology and Disease Branch
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10162, MSC 7952
Bethesda, MD 20892-7952
Phone: 301-435-0222
Fax: 301-480-3557
Email: hatchs@nhlbi.nih.gov

Traci Heath Mondoro, Ph.D
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9142, MSC 7950
Bethesda, MD 20892-7950
Phone: 301-435-0065
Fax: 301-480-0868
Email: mondorot@nhlbi.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Beckie Chamberlin
National Heart, Lung, and Blood Institute
Office of Grants Management
Two Rockledge Center
6701 Rockledge Drive, MSC7926
Bethesda, MD  20892-7926
Telephone: 301-435-0183
Email:chamberr@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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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 63A 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.