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

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

The overall goal of the NIH Research Career Development programs 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 Career programs may be found at the NIH Extramural Training Mechanisms website.

This funding opportunity announcement (FOA) encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NHLBI.

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

This FOA invites applications to create innovative institutional research career development programs to foster excellence in development of the next generation of biomedical investigators in the glycosciences, a mission area of the National Heart, Lung, and Blood Institute (NHLBI).

Glycans, one of the four building blocks of life, play a crucial role in nearly all aspects of biology. In recent years, there has been increasing recognition of the diverse roles and uses of glycans in biology and medicine, and in physiology and disease processes affecting heart, lung, blood and sleep systems. Yet glycans remain understudied and are routinely excluded from analytical processes and scientific discussions of biological systems. Consequently, an entire generation of mainstream biologists and physician scientists are being trained with little knowledge of the structure and function of glycans, their clinical implications or even the terminology required for discussing them. This lack of knowledge may be attributed to a nationwide-paucity of appropriately trained biomedical investigators in glycosciences which resulted in lost opportunities that would greatly benefit therapeutic development and medical practice. While graduate students learn about nucleic acids, proteins, lipids, and metabolites, their competency in understanding the chemistry and biology of glycans is conspicuously deficient. This deficiency of knowledgeable investigators in biomedical institutions, has created a scientific vacuum, resulting in a generation of otherwise superbly trained physicians and biomedical scientists who are nonetheless unfamiliar with the basic knowledge in this key aspect of all biological systems. When such individuals enter the biomedical workforce, they may not grasp the implications of glycosciences for their own work or that of others. In general, biomedical scientists are not routinely educated in the language of glycan chemistry or structural glycobiology and thus may overlook its clinical value, relegating their analyses and scientific interpretations to super specialized laboratories. As a result, the potential of this discipline is not being fully realized.

Therefore, there is an acute need for in-depth research career development in glycosciences such that scholars can learn and harness sophisticated techniques that can be easily performed by biologists/physician scientists promoting translatation of glycoscience discovery to the clinics. This FOA will be the first, nationwide effort to develop the careers of the next generation of biomedical investigators in glycosciences. The Consortium will enable scholars to integrate the study of glycans in their research pursuit while exploring its scientific potential, thus bringing glycosciences into the mainstream biomedical research.

The NIH encourages all proposed programs to foster the participation of individuals from diverse backgrounds. Of particular interest is the recruitment of individuals from racial and ethnic groups underrepresented in health-related sciences on a national basis; individuals with disabilities; and Individuals from disadvantaged backgrounds (NOT-OD-15-053).

The objective of this K12 career development program is to foster a core of emerging biomedical scientists in basic and applied glycobiology, using a combination of didactic instructions and skills development in laboratory glycosciences within the context of a well-defined and timely translational glycoscience project in HLBS sciences. The goal of this program is to enable a nationwide effort towards translation of knowledge from basic structural glycobiology to applications in clinical medicine relevant to heart, lung, blood and sleep disorders by utilizing advances from structural glycan analysis to manipulation of these complex sugars for the evaluation of their roles as mediators in physiology, disease processes, diagnostics and therapeutics. To accomplish this goal, this FOA will support applications that propose an integrated multi-disciplinary K12 career development program in glycosciences that supports four K12 sites across the nation and that encompasses all facets of glycobiology.

Career development activities specific to this FOA will take place within the context of translational research projects in HLBS sciences. Potential timely and significant translational application of glycosciences includes but is not limited to the following:

• Areas of regenerative medicine such as creation of appropriate tissue microenvironments with hyaluronic acid and other glycosaminoglycans
• Enabling vascular delivery of stem cells to sites of tissue injury via glycosyltransferase-programmed stereo substitution or its utility to direct trafficking to immunoregulatory T cells
• The development of glycan-based therapeutics such as anti-E-selectin based anti-inflammatory drugs and glycomimetics
• Heparanoid anti-coagulants, anti-infectives for HIV and other viruses that have "glycan shields"
• Novel therapeutic agents like use of galectins as anti-microbial for viral coat-glycan perturbation
• The identification of drug targets for treatment of diabetes, such as O-GlcNAc that could be utilized to modulate cellular signaling or metabolism
• Glycans in inflammation and thrombosis (examples include: studies of glycan-based adhesion molecules and their receptors in blood cell/platelet function in inflammation and thrombosis; glycosylation and glycan and/or protein sulfation in signaling and receptor systems associated in inflammation and leukocyte trafficking during inflammation and thrombosis; understanding the roles of glycans and glycan-binding proteins in inflammatory events in the vascular wall)
• Glycans in coagulation and blood diseases (examples include: effects of glycosylation on coagulation factor, platelet half-life and clearance; role of P-selectin in mediating erythrocyte adhesion in vaso-occlusive crises)
• Glycan-based therapeutics and targeted drug delivery (examples include: chemoenzymatic synthesis of heparins, heparan sulfate, proteoglycan-related molecules of importance in blood and vascular systems, which also includes dermatan sulfate, chondroitin sulfate, keratan sulfate and hyaluronan; therapeutic value of non-anticoagulant glycosaminoglycans; PSGL-1 and other selectin ligands to improve graft recovery following transplantation; glycan-coated particles for gene therapy, drug delivery and imaging)
• Glycans and infections (examples include defining glycans and glycoprotein interactions in blood and lymphatic systems that are recognized by bacterial pathogens, viral infections leading to life-threatening toxic shock/sepsis)
• Glycans in atherosclerosis, cardiovascular and pulmonary diseases (examples include: roles of glycans in initiation and progression of atherosclerosis in coronary, cerebral and peripheral arterial vessels, and in pathogenesis of pulmonary arterial hypertension; glycans as potential biomarkers for diseases)
• Glycans in vasculogenesis, angiogenesis, and lymphangiogenesis and in vascular wall remodeling (examples include: studies of glycoproteins/glycosaminoglycans/proteoglycans in new vessel formation during development and wound repair, and extracellular matrix in vascular remodeling)
• Glycans in lung inflammation, tissue repair, and remodeling (examples include: the roles of glycans, glycan-binding proteins, mucins, and lung surfactant proteins as initiators and/or regulators of innate and adaptive immune responses; the role of glycosylation of short-fragments of hyaluronic acid and heparin in pathogenesis of pulmonary fibrosis, and the role of endogenous and exogenous polysaccharidic molecules as modulators of lung inflammation and remodeling in asthma and COPD)
• Glycans in tissue/organ engineering for heart, lung, and/or blood diseases (examples include use of glycan-based biodegradable scaffolds; roles of glycosaminoglycans/proteoglycans and other glycoconjugates in connective tissue and extracellular matrix biology)
• Glycans in biological timing that are significant to the pathophysiology of heart, lung, and blood diseases (examples include sleep-disordered breathing and sleep deprivation)

These examples are not all inclusive and other areas of glycan-focused topics can also be considered. Applicants are strongly encouraged to contact the Scientific/Research contact at NHLBI to discuss their plans ahead of preparation and submission of grant applications.

See Section VIII. Other Information for award authorities and regulations.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

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 a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees 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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program 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 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 career development program in glycosciences. Multi-PD/PI applications are encouraged.

The PD(s)/PI(s) will be responsible for the selection and appointment of scholars to the approved glycosciences career development program, and for the overall direction, management, administration, and evaluation of the program.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program.

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

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

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

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

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

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. Scholars will receive salary support of up to $100,000 each year, plus fringe benefits commensurate with the applicant's salary structure for persons of equivalent qualifications, experience and rank.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Scholars interested in participating in this program can be either M.D., M.D./Ph.D., or Ph.D. early stage scientists. Post-doctoral fellows or junior faculties with Ph.D., or M.D./Ph.D., or M.D. are eligible to become K12 scholars. Physicians who have completed residencies or fellowships in clinical specialties with interests in glycosciences are also eligible to become K12 scholars. Scholars will be selected by the K12 Institution Program Directors through a national search. Each scholar selected to the K12 program will be supported for a maximum of two to three years during which time they will be expected to become conversant with all facets of glycosciences as detailed above, and be able to integrate the information with basic, translational and/or clinical research in heart, lung, blood, and sleep diseases.

It is expected that each glycosciences career development site will serve up to 10 scholars (in two cohorts) in 5 years through this rigorous program. Each site will have five career development positions for scholars and each scholar may be supported for 2 to 3 years depending on the research project.

The program will be open to all applicants eligible for these career development opportunities. On completing the program, the scholars should be knowledgeable about the molecular aspects of glycoscience and will be able to integrate the information with translational or clinical research in HLBS diseases.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review

National Heart, Lung, and Blood Institute
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

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

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

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application.

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

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., , postdoctoral, junior faculty), and intended outcomes.

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

Follow all instructions provided in the SF424 (R&R) Application.

Follow all instructions provided in the SF424 (R&R) Application.

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

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

• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant/Trainee Support Costs.

Scholars will be expected to devote a minimum of 9-person months (75% of full-time professional effort) during the appointment on the K12 award. Scholars will receive salary support of up to $100,000 each year, plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank.

Application budgets should include the following travel costs:

• Travel for five Scholars to rotate through four different sites for 2 to 3 weeks per year for specialized training in glycosciences.
• Travel to Bethesda, MD (NIH) for the PD/PI and 1 Mentor and/or Scholar once a year to attend annual grantees meeting

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix

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

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Training Program

Program Plan

Include the following sections:

• Program Administration
• Administrative Coordination Unit (Optional)
• Program Faculty
• Proposed Career Development Program
• Program Evaluation
• Scholars
• Institutional Environment and Commitment to the Program.

Program Administration:

Administrative Coordination Unit (Optional):
There will be one Administrative Coordination Unit to serve all the four Career Development sites. Applicants should indicate whether they wish to be considered for the Administrative Coordination Unit and must submit a description of how they would carry out the functions. The Administrative Coordination Unit will be selected from the applicants who wish to be considered and will receive additional funds to support the activities. The Administrative Coordination Unit will perform a range of functions such as coordinating workflow between scholars and program sites, arranging for travel and housing for rotating scholars, arranging conference calls, organizing investigator meetings and maintaining a website for sharing all training-related activities, including but not limited to generation of new tools and methodologies, lecture notes and publications.

Program Faculty:
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.

Explain how Mentors will commit to continued involvement throughout the total period of the Scholar's career development under this award. Applicants must describe the roles and responsibilities of program mentors. Applicants must include plans for scholar mentoring and frequency of mentoring.

Multidisciplinary research mentoring teams are required to support the research and/or clinical focus of the Scholar's research and career development. Describe process by which each Scholar will be designated a primary research mentor, as well as other scientific mentors (mentoring team) who can contribute to the Scholar's research development.

Proposed Career Development Program:
Provide an overview of the proposed program - Describe the immediate and long-term objectives of the program, including strategies and 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 career development program and mentored research experiences and activities. Institutions with existing career development programs must explain what distinguishes this application 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. 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.

The description should include planned strategies to be used to ensure that the objectives are met. If applicable, PD(s)/PI(s) could 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 instructions and training in grant writing in order to apply successfully for future career development and independent research support.

Each program site must provide a clear plan for both didactic and hands-on laboratory skills development pertinent to the wide range of glycan analysis and synthesis techniques.

Applications must include a description of how scholars will have the opportunity to develop knowledge of:

• Chemical methods to modify and study glycans on glycoconjugates
• Regulation of other post-translational modifications by glycans, such as disulfide bond cleavage
• Roles of glycans in thrombosis and hemostasis
• Roles of glycans in inflammation and immunity
• Roles of glycans in cellular signaling and adhesion
• Chemistry and molecular dynamic approaches to study the diverse types of glycoconjugates regulating different aspects of normal cellular functions and disease processes

Proposed laboratory techniques for the Career Development Program may include:

• Analytical methods for determining glycan structure such as intracellular O-glycans or cell surface N- or O- glycans
• Analytical techniques for glycosaminoglycans and proteoglycans
• Isolation and structural characterization of glycans, chromatographic, enzymatic and mass spectrometric analyses of glycoproteins, and measurements of glycan-protein interactions
• Computer modelling of glycan-protein interactions
• Glycan histopathology
• Application of array technology to the study of glycoconjugates
• Glycoconjugate isolation and purification

Recognizing that glycobiology encompasses a vast array of glyco-analytical tools and diverse technologies requiring specialized infrastructure and expertise and that these resources may not be available at a single K12 Career Development Program site, applicants must describe plans for rotating scholars through the other K12 sites for 2-3 weeks each year to get site-specific and project-related specialized experience to ensure that each scholar acquires the entire gamut of high-quality skills enhancement in glycosciences necessary to perform cutting-edge research in biomedical sciences and in clinical applications within the context of their translational project.

Applicants are expected to describe areas of advanced skills development which could include; analysis of glycoconjugates, glycan synthesis, detection and analysis of glycan interactions as well as interpretations of data from complex analysis such as chromatography, mass spectrometry, and nuclear magnetic resonance, thereby enabling the application of glycan technology to translational research and clinical diagnosis.

To complement laboratory/technical skills development, each K12 program site must also include plans for providing formal didactic lectures in glycobiology, glycan chemistry, molecular aspects of glycosciences as well as clinical impacts from glycan degradation or disorders of glycosylation and the global relevance of glycans to human biology and disease processes.

Scholars:

The goal of this program is to build a strong workforce by training the next generation of biomedical investigators in glycosciences.

Describe in general terms the pool of potential candidates including information about the types of clinical/research training and career level required for the program. Do not name prospective Scholars. Provide brief summaries of career development 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 Scholar candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training.

Institutional Environment and Commitment to the Program:

The application must include a statement from the applicant institution describing the commitment to the planned program. The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PD(s)/PI(s) and other Program Faculty and mentors to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

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.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. 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(s)/PI(s), mentors and scholars will be devoted directly to the research training, career development, and related activities?
• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

Specific to this FOA:

• Does the career development plan seem appropriate to promote the professional development skills and career guidance of scholars?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Do the PD(s)/PI(s) 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?
• For applications designating multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
• 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 career development program and the complementary expertise of the PDs/PIs?

Mentors

• Do the mentors have appropriate 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?

Scholars

• Is a recruitment plan proposed with strategies likely to attract high quality scholars?
• Are there well-defined and well justified recruitment and selection strategies?
• Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
• Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholars?
• What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training Record

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

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

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

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

Administrative Coordination Unit:

The Administrative Coordination Unit, if present in the application, will receive consideration based on the review criteria below.

1. What are the expertise, training, and experience of the investigators and staff, including the administrative abilities of the PD/PI (and multiple PD/PI, when applicable)?
2. Is the time they plan to devote to the Administrative Coordination Unit sufficient to provide for coordination and collaboration?
3. Do the administrative, supervisory, and collaborative arrangements provide for achieving the goals of the program, including a willingness to cooperate with the participating centers?
4. What is the quality of the facilities, equipment, and organizational structure to coordinate the program activities?
5. Does the plan explain how the focus and progress of the overall program will be maintained?

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

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.

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

As part of the scientific peer review, all applications:

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

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

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

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

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

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

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Change of Institution: The institutional career development program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD(s)/PI(s). A change in any of these parameters requires prior approval by the responsible program officer in the NHLBI. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

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.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final Progress Report.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 from databases and from participants themselves. Participants 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.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Rita Sarkar, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8289
Email: sarkarr@nhlbi.nih.gov

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

Andre Walker
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8061
Email: WalkerA@nhlbi.nih.gov

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

Awards are made under the authorization of 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 Part 52 and 45 CFR Part 75.