Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Human Genome Research Institute (NHGRI) National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Institute on Minority Health and Health Disparities (NIMHD) National Library of Medicine (NLM) National Center for Complementary and Integrative Health (NCCIH formerly NCCAM) Office of Behavioral and Social Sciences Research (OBSSR) Office of Strategic Coordination (Common Fund)
Funding Opportunity Title	Mentored Career Development Award in Biomedical Big Data Science for Clinicians and Doctorally Prepared Scientists (K01)
Activity Code	K01 Research Scientist Development Award -
Announcement Type	New
Related Notices	May 4, 2016 - This RFA has been reissued as RFA-ES-16-002. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. January 23, 2014 - See Notice NOT-HG-14-021. Notice of Clarification of Salary Support. January 17, 2014 - See Notice NOT-EB-14-002. Notice of NIBIB Participation.
Funding Opportunity Announcement (FOA) Number	RFA-HG-14-007
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.286; 93.989; 93.350; 93.213; 93.213; 93.394; 93.395; 93.396; 93.397; 93.398; 93.399; 93.867; 93.172; 93.233; 93.837; 93.838; 93.839; 93.866; 93.273; 93.855; 93.856; 93.846; 93.865; 93.279; 93.173; 93.121; 93.847; 93.113; 93.859; 93.242; 93.307; 93.853; 93.361; 93.879; 93.351; 93.313; 93.310
Funding Opportunity Purpose	In response to the spectacular opportunities and immense challenges presented by the dawning era of Big Data in biomedical research, the NIH has developed the Big Data to Knowledge (BD2K) initiative. The mission of BD2K is to enable the biomedical research community to use the various types of Big Data for research. To address the growing need for skilled researchers to fully utilize biomedical Big Data, a series of BD2K FOAs have been designed 1) to develop a sufficient cadre of researchers skilled in the science of Big Data and 2) to elevate general competencies in data usage and analysis across the biomedical research workforce. This BD2K FOA solicits applications for a mentored career development award in the area of Big Data Science. The aim of the initiative is to support additional mentored training of scientists who will gain the knowledge and skills necessary to be independent researchers as well as to work in a team environment to develop new Big Data technologies, methods, and tools applicable to basic and clinical research.

Posted Date	January 15, 2014
Open Date (Earliest Submission Date)	March 1, 2014
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	April 1, 2014; April 1, 2015, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July 2014; July 2015
Advisory Council Review	October 2014; October 2015
Earliest Start Date	December 2014; December 2015
Expiration Date	April 2, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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 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. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of this NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive research career development under the guidance of an experienced mentor, or sponsor, in biomedical Big Data Science. Because of the uniqueness of this research experience, multiple mentors are encouraged to encompass the areas of (1) computer science or informatics, (2) statistics and mathematics, and (3) biomedical sciences. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding in the area of Big Data Science.

In response to the spectacular opportunities and immense challenges presented by the dawning era of Big Data in biomedical research, the NIH has developed the Big Data to Knowledge (BD2K) initiative. The mission of BD2K is to enable the biomedical research community to use the various types of Big Data for research. Biomedical research is rapidly becoming data-intensive as investigators are generating and using increasingly large, complex, multidimensional, and diverse datasets. However, the ability to release data, to locate, integrate, and analyze data generated by others, and to utilize the software associated with the data is often limited by the lack of tools, accessibility, and training.

The long-term goal of the BD2K initiative is to support the advances in data science, other quantitative sciences, policy, and training that are needed for the effective use of Big Data in biomedical research. (In this document, the term 'biomedical' will be used in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease.) While the biomedical research enterprise is producing increasingly large amounts of digital data, it has not yet fully capitalized on the transformative opportunities that these data provide. As stated by the Data and Informatics Working Group (DIWG) of the Advisory Committee to the NIH Director, "Colossal changes in biomedical research technologies and methods have shifted the bottleneck in scientific productivity from data production to data management, communication, and interpretation" (Report).

In this context, the term 'Big Data' is meant to capture the opportunities and address the challenges facing all biomedical researchers in releasing, accessing, managing, analyzing, and integrating datasets of diverse data types. Such data types may include imaging, phenotypic, molecular (including omics), clinical, behavioral, environmental, and many other types of biological and biomedical data. They may also include data generated for other purposes. The datasets are increasingly larger and more complex, and they increasingly exceed the abilities of currently used approaches to manage and analyze them. Biomedical Big Data primarily emanate from three sources: 1) a few groups that produce very large amounts of data, usually as part of projects specifically funded to produce important resources for the research community; 2) individual investigators who produce large datasets for their own projects, which might be broadly useful to the research community; and 3) an even greater number of investigators who each produce small datasets whose value can be amplified by aggregating or integrating them with other data.

The major challenges to using biomedical Big Data include the following:

Locating data and software tools: Investigators need straightforward means of knowing what datasets and software tools are available and where to obtain them, along with descriptions of each dataset or tool. Ideally, investigators should be able to easily locate all published and resource datasets and software tools, both basic and clinical, and, to the extent possible, unpublished or proprietary data and software.

Gaining access to data and software tools: Investigators need straightforward means of 1) releasing datasets and metadata in standard formats; 2) obtaining access to specific datasets or portions of datasets; 3) studying datasets with the appropriate software tools in suitable environments; and 4) obtaining analyzed datasets.

Standardizing data and metadata: Investigators need data to be in standard formats to facilitate interoperability, data sharing, and the use of tools to manage and analyze the data. The datasets need to be described by standard metadata to allow novel uses as well as reuse and integration.

Sharing data and software: While significant progress has been made in broad and rapid sharing of data and software, it is not yet the norm in all areas of biomedical research. More effective data- and software-sharing would be facilitated by changes in the research culture, recognition of the contributions made by data and software generators, and technical innovations. Validation of software to ensure quality, reproducibility, provenance, and interoperability is a notable goal.

Organizing, managing, and processing biomedical Big Data: Investigators need biomedical data to be organized and managed in a robust way that allows them to be fully used; currently, most data are not sufficiently well organized. Barriers exist to releasing, transferring, storing, and retrieving large amounts of data. Research is needed to design innovative approaches and effective software tools for organizing biomedical Big Data for data integration and sharing while protecting human subject privacy.

Developing new methods for analyzing biomedical Big Data: The size, complexity, and multidimensional nature of many datasets make data analysis extremely challenging. Substantial research is needed to develop new methods and software tools for analyzing such large, complex, and multidimensional datasets. User-friendly data workflow platforms and visualization tools are also needed to facilitate the analysis of Big Data.

Training researchers for analyzing biomedical Big Data: Advances in biomedical sciences using Big Data will require more scientists with the appropriate data science expertise and skills to develop methods and design tools, including those in many quantitative science areas such as computational biology, biomedical informatics, biostatistics, and related areas. In addition, users of Big Data software tools and resources must be trained to utilize them well.

To address the growing need and opportunities for skilled researchers to fully utilize the vast amount of heterogeneous biomedical Big Data, a series of BD2K FOAs have been designed to 1) develop a sufficient cadre of researchers skilled in the science of Big Data and 2) elevate general competencies in data usage and analysis across the biomedical research workforce. The portfolio of BD2K training activities will include opportunities for the full spectrum of scientists, from students to senior faculty, from developers of methods and tools to investigators who need to use Big Data tools.

The NIH issued a Request for Information (NOT-HG-13-003; Report) to solicit input from the extramural community on what types of knowledge and skills are needed by individuals to effectively manage and utilize Big Data. In addition, the NIH organized a workshop (Report) that addressed what knowledge, skills, and resources are needed to organize, process, manage, analyze, and visualize large, complex data sets.

Due to the multifaceted challenges faced in meeting the opportunities provided by Big Data, the following principles were taken into account in designing the set of BD2K training FOAs:

• A combination of skills is needed to utilize Big Data, both technical and soft skills.
• Technical skills are needed in (1) computer science or informatics, (2) statistics and mathematics, and (3) biomedical science.
• Communication skills are critical to foster collaborations.
• The principles of study design and reproducible research (related to the practices that ensure the reproducibility of analyses of data) should be stressed.
• Big Data scientists must be prepared to be independent researchers, but at the same time, an interdisciplinary, team-science approach is frequently the optimal way to solve Big Data challenges or to use Big Data effectively.
• Individuals and scientists may need additional skills and knowledge to work effectively in interdisciplinary teams.
• Training in the quantitative sciences and experimental design will be increasingly important to researchers and clinicians.
• BD2K training programs should be designed to develop the ability of scientists to work at the intersection of multiple disciplines necessary to utilize Big Data.
• Team mentoring is encouraged.
• Innovative approaches to training are encouraged, in order to take best advantage of the particular talents and expertise available at the institution(s).
• The training environment is critical and should include access to large data sets and ongoing research projects of multiple types.
• Career paths for data scientists that recognize and reward contributions in methodology, computation, or development of tools are important.
• Training individuals to participate across the full spectrum of scientific roles is encouraged, even though the jobs necessary to Big Data science may not correspond to traditional scientific, particularly academic, jobs or fit neatly into existing departments.
• Recruitment of talent from diverse scientific backgrounds, such as computer science, engineering, informatics, mathematics, physics, and statistics, to biomedical Big Data Science is important.

In order to promote a diverse workforce and successfully reach scientists at all career levels, it is essential that training resources are widely disseminated, discoverable, and reusable. The active exchange of information is also essential and will be facilitated by an annual BD2K consortium meeting in Bethesda, MD for PDs/PIs and trainees.

Applicants are encouraged to utilize all appropriate expertise for the purpose of training Big Data scientists, whether that expertise lies within one or more institutions or within the industrial or public sectors. Applicants are also encouraged to consider whether other BD2K training FOAs are a good fit to the proposed project. A complete list of BD2K FOAs can be found at bd2k.nih.gov.

The BD2K initiative includes a multi-faceted approach to training, consisting of long- and short-term training and the development of open educational resources. This FOA focuses on career development of interdisciplinary researchers who will develop technology, methods, and tools to capitalize on the Big Data already being generated by biomedical researchers. Big Data Science is interdisciplinary and involves three major scientific areas: (1) computer science or informatics, (2) statistics and mathematics, and (3) biomedical science. It is anticipated that, by the end of the award period, the awardee will have acquired breadth across all of these areas as well as depth in areas of specialty.

Candidates may enter the program from various backgrounds: (1) biologists or clinicians who want to be cross-trained in the quantitative sciences (which includes computer science, statistics, mathematics, informatics, etc.), (2) quantitative scientists who want to be cross-trained in clinical/biological areas or other quantitative areas, and (3) biomedical data scientists who already have some background in areas relevant to Big Data Science but who want to gain further expertise.

Solving the challenges brought about by Big Data will likely involve a team science approach to problem solving. Candidates are expected to acquire knowledge and skills to become independent investigators, but they are also encouraged to work effectively as a member of a team to solve the challenges. In addition, candidates are encouraged to seek multiple mentors from disciplines necessary for capitalizing on Big Data.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIH intends to commit $1.5 million in FY2015 to fund 6-7 awards. Future year amounts will depend on annual appropriations.
Award Budget	Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period	The total project period should be three to five years.

Salary	NIH will contribute up to per year toward the salary of the career award recipient. Mentored career awards require the candidate to devote a minimum of 9 person-months to conducting health-related research. The remaining effort may be devoted to other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.
Other Program-Related Expenses	NIH will contribute $40,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. These costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) statistical services including personnel and computer time; and (d) travel costs for (1) awardees to attend the annual BD2K consortium meeting in Bethesda, MD and one professional meeting per year, and (2) one trip per year for one mentor to attend the annual BD2K consortium meeting.. Each trip should not exceed $1500. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grant 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)

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentors and 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. Multiple PDs/PIs are not allowed.

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

While former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other career development awards (K awards), or the equivalent NIH or non-NIH grants are eligible to apply, they must demonstrate their commitment to a future career as a full-time biomedical Big Data scientist and a significant shift in research focus to Big Data Science.

Candidates for this award must have a research or health-professional doctoral degree or equivalent. Such degrees include, but are not limited to, the PhD,MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing. This funding opportunity may support individuals who propose to train in a new field or individuals who have had a hiatus in their research career because of illness or pressing family circumstances.

The award is intended for research-oriented investigators at any level of experience, from the postdoctoral to faculty level, who have shown clear evidence of productivity and research excellence in the field of their training and who would like to expand their research capability, with the goal of making significant contributions to research areas in Big Data Science that are relevant to the NIH mission.

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 scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the specific aims of the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. The level of effort should be a minimum of 9 person months or 75% of full-time professional effort. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Before submitting the application, the candidate must identify two or more mentors who will supervise the proposed career development and research experience. The mentors or mentoring team will provide expert advice in all aspects of the Big Data Science research career development program.

The mentors should be active investigators in at least one of the areas involved in Big Data Science (computer science or informatics, statistics and mathematics, and biomedical sciences) and their experiences must complement each other. The mentors must be committed both to the career development of the candidate and to the direct supervision of the candidate s research. The mentors must document the availability of sufficient research support and facilities for high-quality research and access to large and complex datasets. The mentors or members of the mentoring team should have successful track records of mentoring. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate s research. The candidate must work with the mentor(s) in preparing the application.

The principal mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy) and the role of the other mentors in guiding the career of the awardee. The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists who are working on Big Data Science projects, both in the basic and clinical areas. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged, when appropriate. The primary mentor and co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

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.

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.

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 by e-mail to:

Michelle Dunn, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6881
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate s Background

• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent investigator who could make a contribution to Big Data Science. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• If the candidate is a faculty member, evidence must be provided that this is a significant career change

Career Goals and Objectives

• Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that would enhance the ability of the candidate to be a leader in Big Data Science research; (2) justifies the need for further career development to become an independent investigator; (3) utilizes the relevant research, especially in Big Data Science, and educational resources of the institution; and (4) encourages the awardee to apply for independent research support during the later phase of the career development award

Candidates Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline should be included in the application. The application should describe the roles of the mentoring team. The plan should include relevant coursework to provide knowledge and skills in the three areas relevant to Big Data Science (computer science or informatics, statistics and mathematics, and biomedical science) as well as rotations among research projects that provide the candidate with a variety of opportunities to understand the complexity and varieties of large and complex data (such as -omics, imaging, phenotypic, exposure, etc.) both in the areas of basic and clinical sciences. The plan should also show how the candidate will be encouraged to become an independent investigator, such as by submitting a grant application for outside peer review and funding in one of the scientific areas relevant to Big Data Science research.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent research career.
• Less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely didactic in nature and is followed by a period of intense, supervised Big Data research.
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a Big Data researcher.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities, if any, will help ensure career progression to achieve independence as an investigator.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).
• The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
• Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name a principal mentor (sponsor) and appropriate co-mentors, who, together with the candidate, are responsible for the planning, direction, and execution of the program. The mentors should include at least two researchers from at least two of the following areas: computer science or informatics, statistics and mathematics, and biomedical sciences.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The mentor(s) should have sufficient independent research support in at least one of the areas relevant to Big Data Science to cover the costs of the proposed research project in excess of the allowable research costs provided by this award.
• The primary mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
• The primary mentor should provide a statement about how the mentoring team will interact with the awardee
• The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators, contributers, and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program in one or more areas relevant to Big Data Science that is related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. It would also be important to demonstrate that these investigators have worked together productively as a team.
• Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate. It would be important to demonstrate that the institution is intensively involved in Big Data Science and that there are opportunities for the candidate to be exposed to complex and varied data sets in both basic and clinical sciences.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Research Strategy

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• The application must also describe the relationship between the mentors' research and the candidate’s proposed research plan.
• The application must include details of how the research project of the candidate will be separated from the research of the mentors.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 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.

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 by the Center for Scientific Review and for responsiveness by the NIH BD2K training subcommittee. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

Does the candidate have the potential to develop as an independent and productive researcher with a focus on Big Data Science? Is the candidate’s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in Big Data Science research? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence in the area of Big Data Science? Are the candidate's prior training and research experience appropriate for this award? Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence in Big Data Science? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Research Plan

Are the proposed research question, design, and methodology appropriate for Big Data Science research? Is the proposed research of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan? If applicable, are there adequate plans for data and safety monitoring of clinical trials?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentors research qualifications in the area of Big Data Science appropriate? Do the mentors adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentors' proposed role in providing guidance and advice to the candidate? Is the primary mentor s description of the elements of the research career development activities, including formal course work in the three critical areas of Big Data Science (computer science or informatics, statistics and mathematics, and biomedical sciences) adequate? Is there evidence of the mentor's, consultant s, and collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support in the area of Big Data Science? Is active/pending support for the proposed research project appropriate and adequate? Are there adequate plans for monitoring and evaluating the career development awardee s progress toward independence?

Environment & Institutional Commitment to the Candidate

Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities in Big Data, including faculty capable of productive collaboration with the candidate, adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality?

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

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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.

Training in the Responsible Conduct of Research

Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once 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. See also: NOT-OD-10-019.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Reviewin 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 for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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.
• Geographic considerations.

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Michelle Dunn, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6881
Email: [email protected]

Carol Shreffler, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: [email protected]

Raymond Jacobson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-996-7702
Email: [email protected]

Barbara Gittleman
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
Email: [email protected]

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