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.

Applicant Organizations for Phase 1:

For Phase 1 of the Career Transition (K22) Program, only NIH intramural laboratories are eligible to apply.

Eligible Applicant Organizations for Phase 2:

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)

The transition to (Phase 2) of the award will be submitted by the domestic non-profit, academic institution/organization (e.g. university, college, hospital, and laboratory) at which the Candidate has been recruited, offered and has accepted an independent research faculty position. Only successful Phase 1 Candidates may proceed to Phase 2.

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

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 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 mentor 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

Candidates for this award must have a clinical, research, or health-professional doctoral degree. Such degrees include, but are not limited to, the PhD, MD, DO, DDS, DMD, OD, DC, DSW, DPH, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice.

Individuals must be affiliated with an NIH Intramural Laboratory. Applicants may have a research appointment at any level in the NIH Intramural Research Program: Postdoctoral Fellows, Clinical Fellows, Staff Scientists, Tenure track and Tenured Intramural Investigators.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with 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.

Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00).

To obtain support for the extramural phase, at the time of the award the candidate must have a full time formal tenure track or equivalent appointment at the academic institution that is the applicant institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research training during the mentored phase. Practicing physicians with surgical specialties may devote 50% of full time effort (6 person months) to research in their faculty appointment, but will need strong support for the advancement of the research career by the Phase 2 institution. Consultation with program staff prior to the submission of the Phase 2 application is strongly encouraged. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

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 during Phase 1 of the program. The mentors or mentoring team will provide expert advice in all aspects of the Big Data Science research career development program.

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 encompass two of these areas and 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.

Institutional Environment

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 obtain 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, 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.

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 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 must be followed.

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

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

Project Summary/Abstract

Include a description of your current research and the research you propose to continue in the independent phase.

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

All instructions in the SF424 (R&R) Application Guidemust be followed

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

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

• Candidate
• Research Plan
• Other Candidate Information
• Mentor, Co-Mentor, Consultant, Collaborators
• Environment & Institutional Commitment to the Candidate
• Human Subjects Sections
• Other Research Plan Sections
• Appendix

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

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

Candidate Information and Goals for Career Development

Candidate s Background

• Describe the candidate’s commitment to a career in Biomedical Big Data Science research
• For individuals in postdoctoral and similar positions (i.e. still in training), describe current training and research efforts of the candidate in Big Data Science.
• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate in Big Data Science research.
• Provide evidence of the candidate's potential to develop into a successful independent investigator specifically in the field of Big Data Science Research. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• Present evidence of the candidate's ability to interact and collaborate with other scientists

Career Goals and Objectives

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status which will enhance the candidate to be a leader in Big Data Research; (2) that justifies the need for further career development to become an independent investigator in Big Data Science; (3) utilizes the relevant research, especially in Big Data Science and educational resources of institution; and (4) encourages the awardee to apply for independent research support during Phase 2 of the award.
• Describe how the candidate plans to separate scientifically from his/her mentor and advance to research independence.

Candidate s Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The sponsor/mentor may form a mentoring team (or an advisory committee) to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
• The didactic and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in the three areas relevant to Big Data Science (computer science or informatics, statistics and mathematics, and biomedical science) as well as participation 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, exposures, etc.) both in the areas of basic and clinical sciences.
• For individuals proposing to engage in patient oriented research, the candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects
• Candidates must justify the need for both the intramural and the extramural phases of the award, and provide a convincing case that the period of support (1 year of mentored intramureal support and three years of extramural support as an independent scientist) will substantially enhance his/her career and allow the pursuit of a productive research career in Big Data Science.
• The candidate and phase 1 mentor (see below) must describe a specific plan for the transition to the independent phase 2.

Research Plan Section

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

Research Strategy

• A sound research project that focuses on the development of tools, methods, and technology needed for fully utilizing Big Data generated by Biomedical Scientists 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 research.
• The research strategy must span both phases of the award. The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
• The application must include a description of how the mentored phase research will lead to the independent phase research.

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). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

The candidate must name a primary mentor (sponsor) in an NIH Division of Intramural Research, who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate should also identify a co-mentor in at least one of the other areas of career development: computer science or informatics, mathematics and biostatistics, 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 principal mentor should be an NIH Intramural Investigator. Co-mentors can be from the DIR or from academia or industry. 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, when appropriate. The mentor(s) should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.

The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research supervisor; (2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the candidate’s scientific and professional independence will be promoted; (3) a description of the elements of the planned research career development, including any formal course work; and (4) a plan for transitioning the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award.

Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor 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 face-to-face meetings.

The mentor must inidcate agreement to provide a final evaluation of the candidate’s progress as required in the phase 2 application.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators 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 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 related to the candidate's area of interest, including a high-quality research environment with key staff and other investigators capable of productive collaboration with the candidate.
• Describe the DIR scientific environment including the resources and facilities that will be available to the candidate.

Institutional Commitment to the Candidate’s Research Career Development

• The Scientific Director of the sponsoring IC must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award.
• Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• Provide assurance that appropriate time and support will be available or any proposed mentor(s) and/or other staff consistent with the career development plan.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. 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.

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) 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. 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 the BD2K Training Program Management Group. 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 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 in Big Data Science?
• Will the research experiences in the mentored phase prepare the candidate to implement successfully the independent phase research project
• Are the candidate's prior training and research experience appropriate for this award?
• 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 research in Big Data Science?
• Do the letters of reference address the five points listed directly above , and do they provide evidence that the candidate has a high potential for becoming an independent investigator?

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

• To what extent are the plans for evaluating the awardee s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award?
• Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the independent phase of the award?
• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
• Are the candidate's prior training and research experience appropriate for this award in Big Data Science?

Research Plan

• Is there a strong scientific premise for the project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Is the proposed research project appropriate for the candidate s stage of research development and as a vehicle for development of the research skills in Big Data Science described in the career development plan?
• Is the proposed research relevant to the stated career objectives in biomedical big data science?
• Is the proposed K22 phase 2 research significant, scientifically sound, and a logical extension of the phase 1 research? Is there evidence of long-term viability of the proposed phase 2 research plan?
• Does the project develop novel concepts, approaches, methodologies, tools, or technologies?
• To what extent is the proposed K22 phase 2 research likely to foster the career of the candidate as a successful, independent investigator in Big Data Science research?

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

• Are the qualifications of the mentor(s) in Big Data Science appropriate?
• Does the mentor(s) 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 mentor’s proposed role in providing guidance and advice to the candidate?
• Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
• Is there evidence of the mentor s, consultant s, and/or collaborator’s previous experience in fostering the development of independent investigators?
• Is there evidence of the mentor's current research productivity and peer-reviewed support?
• 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

• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is there clear commitment of the sponsoring institution to ensure that the required effort of the candidate will be devoted directly to the research training, career development, and research activities described in the proposed career development and research plans?
• Is there strong institutional commitment to fostering the career development of the candidate?
• Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Is the environment of high quality and relevance for scientific and professional development of the candidate?

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.

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.

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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

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.

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). 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.

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).

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) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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), 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 for initial peer review will not be accepted for applications submitted in 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 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.

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.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.

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.

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.

Transition from the mentored phase to the independent phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program as determined by annual scientific reviews and by the evaluation of a research and career development plan to be carried out at the institution. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time, space and resources needed to conduct the proposed research project and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. NIH will conduct a formal scientific progress review no later than two months before the end of the mentored phase.

Candidates must provide a progress report using form PHS 2590, which should detail progress achieved on the specific aims of the Research Plan and on the pursuit of identified career and career development goals. Future goals for the research project and for further career development should also be indicated. The mentor must provide a separate narrative of the research and career development of the candidate.

Form PHS 2590 must include the following:

• A description of the proposed research.
• A description of the institutional environment, including: research facilities and the availability of appropriate educational opportunities, including collaborating faculty, when necessary; quality and relevance of the environment for scientific and professional development of the candidate.
• Information about the sponsoring institution’s commitment to the candidate and to the candidate’s scientific independence, including: commitment to ensuring that the candidate’s effort required by the K22 program will be devoted directly to the research and career development activities described in the proposed career development and research plans; institutional commitment to fostering the career development of the candidate.
• Position Description: the institution should provide a detailed description of the candidate’s position, responsibilities, and duties. The institution’s tenure-track policy should be defined or a description should be provided of the equivalent arrangements for institutions without a formal tenure-track.
• Budget in detail, including justification for all requested funds:
• List the name, role on project and percent effort for all project personnel (salaried and unsalaried) and provide a narrative justification for each person;
• Identify all consultants by name and organization affiliation and describe the services to be performed;
• Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project;
• Describe specific resources committed by the sponsoring institution to support the Candidate’s research.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed.

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 Service Desk (Questions regarding ASSIST, 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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Carol Shreffler, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: BD2K_training@mail.nih.gov

Mark Caprara, PhD
Center for Scientific Review (CSR)
Telephone: 301-613-5228
Email: capraramg@mail.nih.gov