Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Center for Complementary and Integrative Health (NCCIH formerly NCCAM) Office of Dietary Supplements (ODS) Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.
Funding Opportunity Title	Academic Career Award (Parent K07)
Activity Code	K07 Academic/Teacher Award (ATA)
Announcement Type	Reissue of PA-10-058
Related Notices	June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. April 8, 2011 Per NOT-OD-11-063, AIDS and AIDS-related applications intended for the May 7, 2011 due date should continue to use the previously issued Parent announcements. Applications intended for June 12, 2011 and subsequent due dates must use the re-issued Parent announcements. See the Parent Announcements page for appropriate links. January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date.
Funding Opportunity Announcement (FOA) Number	PA-11-192
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.866, 93.272, 93.213
FOA Purpose	The purpose of the NIH Academic Career Award (K07) is to provide support to increase the pool of individuals with academic and research expertise to become academic researchers and to enhance the educational or research capacity at the grantee sponsoring grantee institution. The Academic Career Award supports K07 Development awards for more junior level candidates and K07 Leadership awards for more senior individuals with acknowledged scientific expertise and leadership skills. Prospective candidates are encouraged to contact the relevant NIH staff for IC-specific programmatic and budgetary information: Table of IC-Specific Information, Requirements and Staff Contacts.

Posted Date	April 8, 2011
Open Date (Earliest Submission Date)	May 12, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply , by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	September 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially 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 be 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 are available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objectives of the NIH Academic Career Award (K07) are to increase the pool of individuals with academic and research expertise in a specific area of biomedical research and to enhance the educational or research capacity at the grantee institution. This funding opportunity announcement (FOA) provides support for either of two types of activities:

• K07 Development award: This award provides up to 5 years (a minimum of 3 years is required) of salary and research support for more junior investigators who are interested in developing academic and research expertise in a particular health-related field, as a way to increase the overall pool of individuals capable of research or teaching in the identified area. During the period of the award, the candidate will become a successful academic researcher in the chosen area. Research, teaching, and leadership skills are to be learned during the tenure of the award. Curriculum building skills are encouraged. A mentor is required. A minimum of 9 person months (75%) of full-time professional effort is required annually; the remainder may be devoted to other research related and/or teaching pursuits consonant with the objectives of the award.
• K07 Leadership award: This award provides support for up to 5 years (a minimum of 2 years is required) for more senior investigators who are interested in improving the curricula and enhancing the health-related research capacity within an academic institution. The Leadership candidate must have acknowledged scientific expertise and leadership skills and sufficient clinical training, research, or teaching experience in the academic area of interest to an NIH awarding component to implement a program of curriculum development within the sponsoring institution. It is expected that support under this award will increase the visibility and the overall research support or academic capacity for the given field of research within the academic medical/health and research community. At least 3 person months (25%) but not more than 6 person months (50%) of full-time professional effort must be devoted to the program annually.

Development and Leadership awards are not renewable nor are they transferable from one PD/PI to another. Because the objectives of the K07 award are to increase the pool of individuals in academia and/or to implement or enhance curriculum development within the sponsoring institution, awards are not transferable to another institution. Only in exceptional circumstances would consideration be given for the transfer of a Development award.

Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.

Funding Instrument	Grant
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications..
Award Budget	Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period	The total project period may not exceed 5 years.

Salary	The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). The total salary requested must be based on a full-time 12 months 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. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution s rate and the percent of effort, are provided in addition to the salary. 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. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award. The total salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
Other Program-Related Expenses	The participating NIH Institutes and Centers will provide research development support for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). 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) travel to research meetings or training; and (d) statistical services including personnel and computer time. Salary for mentors, secretarial and administrative assistance, 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 grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

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

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

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

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)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

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

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

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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/hermentor (relevant to the Development award) 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 Principal Investigators 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). Individuals on temporary or student visas are not eligible.

Candidates for this award must have a clinical, research, or health-professional doctoral degree. Such degrees include but are not limited to the Ph.D., M.D., D.O., D.D.S., D.M.D., O.D., D.C., D.S.W., D.P.H., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice.

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. An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions 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.

K07 Development:

• Former PD/PIs of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible for a Development award.
• Individuals are not eligible for a Development Award if: (1) they have been a PD/PI or have an application pending for any other PHS career award (e.g., K01, K08, K22, K23, K25, K99/R00); or (2) if they are a current or former PD/PIs on NIH research project grants (e.g. R01), project leaders on sub-projects of program project (P01) or center (P50) grants; or (3) if they are PD/PI on an equivalent non-PHS peer-reviewed research grants that are over $100,000 direct costs per year. Candidates are encouraged to contact the awarding IC staff for further guidance.
• Candidates must identify a mentor(s) with extensive and appropriate research experience for the proposed research development plan.
• The sponsoring institution must provide a statement of commitment to the proposed level of effort required by this award.

K07 Leadership:

• Candidates may identify appropriate collaborator(s) from the relevant disciplines who will agree to collaborate on the development of the course(s) and curricula.
• Candidates may not use the Leadership Award to support the awardee’s clinical practice, professional consultation or other comparable activities, except when such activities are required by the objectives of this program.
• The sponsoring institution must provide a statement of commitment to the proposed level of effort required by this award; and describe a plan for relieving the candidate from administrative/clinical responsibilities to achieve the required effort commitment
• The sponsoring institution must provide a statement (plan) demonstrating a commitment to the further development and implementation of courses or curriculum resulting from the Leadership award.

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. 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 IC 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.

Candidates for a Development award must be able to commit a minimum of 9 person months (75%) of full-time professional effort to conducting research career development and research activities associated with this award. The remaining 3 person months (25%) effort can be divided among other research, clinical and teaching activities only if these activities are in a fashion consistent with the goals of the K07 award, i.e., the candidate's development into an independent investigator.

Candidates for a Leadership award must be able to devote from 3-6 person-months (25-50% full-time professional effort) to the program, a portion of which may include research.

Before submitting the application, the candidate for a Development award must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. The mentor, or a member of the mentoring team, should have a successful track record 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 mentor(s) should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The mentor and any 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 description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.

The applicant institution must have a strong, well-established record of career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research. The institution must demonstrate a commitment to the development of the candidate as a productive investigator and be willing to allow the protected time needed by the candidate. The candidate, mentor(s), and institution must describe a career development program that will maximize the use of this environment, including available facilities and resources.

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 be accepted for review.

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

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

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

K07 Development

Candidate’s Background (Component of Candidate Information)

• Describe the candidate's commitment to a career as an academic investigator. This should include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and their relationship to the proposed activities on the career award.
• Describe any prior training and how it relates to the immediate objectives and long-term career plans of the candidate.
• Describe the candidate's research efforts and training to this point in his/her research career, including any publications, prior research interests and experience; and how this effort relates to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's ability to interact and collaborate with other scientists.
• Provide evidence of the candidate's potential to develop into an academic investigator.
• Provide a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the program and related career development activities. The mentor or department chair must agree and provide a statement in the application documenting that this percent of your time will be protected.

Career Goals and Objectives (Component of Candidate Information)

• A systematic plan that: (1) shows a logical progression from the candidate’s prior research and training experiences to the research and career development experiences that will occur during the Development Award period and then to independent investigator status; (2) justifies the need for further career development to become an independent academic investigator; (3) includes didactic and research components; and (4) utilizes the relevant research and educational resources of the institution.

Career Development/Training Activities During Award Period (Component of Candidate Information)

• Provide details and the duration of planned structured activities, such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc. essential to develop the necessary knowledge and research skills in scientific areas relevant to the candidate’s career goals.
• If there is a curriculum development component, describe how the results of the plan will contribute to an increase in the pool of individuals with academic or research expertise and/or enhance the educational or research capacity at the sponsoring institution.
• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline including a publication plan is strongly encouraged. Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidate’s progress through the career development program.
• Describe the relationship of the research plan to the career development plan.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the Development Award. Explain how these responsibilities/activities will help ensure career progression to an independent research investigator.

Training in the Responsible Conduct of Research

• Applications must include a plan to obtain instruction in the responsible conduct of research.
• This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research.
• Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019.
• The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
• The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or may not be reviewed .
• The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

• The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• 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; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate s research, publications, and progression towards independence.
• 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 of the co-mentors are 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.
• SPECIAL NOTE: Only very limited use should be made of offsite co-mentors; and the primary mentor should be onsite. The mentor or department chair must agree and provide a statement in the application documenting that the candidate will be provided at least 9 person months (75%) of the full-time professional effort to devote to research and related activities in order to achieve the research objectives of the award.
• The mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
• Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator 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.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• 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 faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

• 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 the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
• 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 appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

Research Strategy (Component of Research Plan)

• 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 research.
• 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.

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.

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 required reference letters will not be reviewed (see: NOT-OD-11-036). Please note that the specified format must be used. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Referee Information link and not through Grants.gov.

K07 Leadership

Candidate’s Background (Component of Candidate Information)

• Provide evidence that the candidate has the capacity to provide leadership as a teacher or researcher.
• Provide Information describing the acknowledged scientific expertise and leadership skills of the candidate.
• Provide Evidence of the candidate’s commitment to an academic research career in a field of interest to the NIH and the supporting NIH institute.
• Provide Evidence that the candidate has the commitment to develop and implement course(s) or curricula that are based on sound research concepts and educational principles and that meet the scientific and educational requirements of the corresponding scientific field(s) and the institution.
• Describe the planned collaboration(s) with other individuals to develop course(s) and curricula.

Career Goals and Objectives (Component of Candidate Information)

• Describe past scientific history, indicating how the award fits into past and future research career development.
• Describe the immediate and long-term objectives of the Leadership Award and how those objectives will meet the needs for expansion or enhancement of the academic or research capacity of the institution.
• Describe how the Leadership Award will increase the visibility and overall research support or academic capacity within the academic medical/health and research community.

Career Development/Training Activities During Award Period (Component of Candidate Information)

• Describe the career development plan incorporating consideration of the candidate’s goals and prior experience. Include details of the plans to obtain the necessary research and pedagogical experience to facilitate further development as an academician. The plan must be tailored to the career goals of the candidate and the intent of this award.
• Describe how the results of the plan will contribute to an increase in the pool of individuals with academic or research expertise and/or enhance the educational or research capacity at the sponsoring institution.
• Describe the proposed content and duration of the planned didactic and curriculum development components.
• Describe the relationship of the research plan to the career development plan.
• Provide details of planned structured activities, such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc. essential to meet the goals of the candidate.

Curriculum Development Plan (Combined with the Career Development Plan Component of Candidate Information)

• Describe the Curriculum Development Plan and how it fits into the institutional plans and goals.
• An explanation as to how this curriculum is different from other curricula within the existing educational infrastructure and framework of the candidate/participating institution(s).
• Provide an explanation as to how the proposed educational experiences are distinct from those training programs currently receiving NIH support or other federally funded support.
• Provide plans for enlisting the support of professional and other organizations involved in medical education, as determined essential, in these efforts.
• Provide plans and milestones for institutionalizing the curriculum changes.
• Provide plans and procedures to evaluate the process, progress, and outcomes of this curriculum development initiative.
• Provide plans to share curricula and any education materials developed as a result of this award.

Training in the Responsible Conduct of Research

• Applications must include a description of a plan to provide instruction in responsible conduct of research. This section should document the nature of the applicant’s prior participation in responsible conduct of research instruction (lecturer, discussion leader, etc.), including the date of last occurrence) and propose plans to participate in instruction in responsible conduct of research instruction.
• Such plans must address four instructional components, format, subject matter, duration of participation, and frequency of participation, as outlined and explained in NOT-OD-10-019.
• The plan may include career stage-appropriate, independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
• Applications lacking a plan for participation in responsible conduct of research will be considered incomplete and may be delayed in the review process.
• The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• 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 faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

• Provide a statement of commitment from the sponsoring institution that the course(s) or curricula will become an integral part of the academic offerings of the institution.
• Provide a statement of institutional commitment to provide protected time to the candidate to meet the required effort commitment for the Leadership Award. This statement should include a description of the duties from which he/she will be relieved (if clinical duties the institution should describe specific steps that will be taken to cover these duties, such as hiring clinical staff). These descriptions should be sufficiently detailed so that reviewers can determine if the environment is conducive to the achievement of the objectives of the K07 Leadership Award.

Research Strategy (Component of Research Plan)

• 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 research.

Appendix

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

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

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

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

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

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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority 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.

K07 Development

Candidate

• Does the candidate show potential to become an outstanding investigator, teacher, resource person, and leader in research, educational and (where appropriate) clinical programs related to the mission of the NIH awarding component?
• Is there likelihood that the award will contribute substantially to the academic and research career development of the candidate?
• Do the letters of reference on behalf of the candidate express the potential and commitment to the planned academic career program and the likelihood that the program will meet the candidate’s career goals?

Career/Curriculum Development Plan

• Is the candidate’s career development plan, including plans for after termination of the award, of high quality and sufficient feasibility?
• Are the content and duration of the proposed didactic and curriculum development components appropriate and reasonable?
• Do the structured activities such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc., meet the career goals of the candidate?
• Are there appropriate timelines planned for the candidate s progress?
• Is there a satisfactory and appropriate relationship of the research plan to the career development goals and the candidate’s previous experience?

Research Plan

• Is the research plan appropriate for the candidate’s past experience and current academic/research goals?
• Is the scientific and technical merit of the research plan appropriate and adequate for developing new or enhancing existing skills needed to meet the candidate’s career goals?
• Is the plan for coupling the research with other planned activities, appropriate and adequate for providing the experience, knowledge, and skills necessary to achieve the objectives of the award?

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

• Are the qualifications of the mentor(s) including current and pending research support, prior research experience, and mentoring track record appropriate and adequate for guiding the candidate in meeting the goals of the Development Award?
• Do the mentor(s) adequately address the above review criteria including the candidate’s potential and his/her strengths and areas needing improvement?
• Does the mentor’s statement demonstrate a strong commitment to the candidate’s progression to independent academic investigator?
• Are the combined expertise, roles and responsibilities of any involved co-mentors, consultants, and/or collaborators likely to enhance the candidate’s career development?

Environment & Institutional Commitment to the Candidate

• Is there merit to the institution’s plan and commitment to strengthening research and education activities beyond the current status of activities and capacities?
• Is there a strong statement of commitment by the institution to the levels of effort required for this career award?
• Are the scope and nature of collaboration among participating schools and departments appropriate and adequate?
• Are there adequate research facilities and training opportunities for the award?
• Are the quality of the scientific environment and relevance to the candidate’s professional academic and scientific development, including any unique features of the scientific environment beneficial to the candidate, adequate and appropriate?

K07 Leadership

Candidate

• Does the candidate show potential to continue as an outstanding investigator, teacher, resource person, and leader in research, educational and (where appropriate) clinical programs related to the mission of the NIH awarding component?
• Is there likelihood that the award will contribute substantially to the academic and research career of the candidate?
• Is there adequate past experience in teaching, curriculum development and leadership?
• Does the candidate have the ability and commitment to work cooperatively with other scientists to develop innovative curricula, educational materials, and programs?

Career/Curriculum Development Plan

• Are the proposed curriculum and educational experiences therein distinct from other curricula and federally funded educational experiences within the existing educational infrastructure and framework of the candidate/participating institution(s)?
• Is it likely that the developed curriculum contributes to an increase in the pool of individuals with academic and research expertise and/or enhances the educational or research capacity at the sponsoring institution?
• Is the proposed plan to enhance pedagogical and leadership skills of the candidate of high quality?
• Are the plans for enlisting the support of professional and other organizations involved in medical education, as determined essential, in these efforts appropriate?
• Are the plans and milestones for institutionalizing the curriculum changes feasible and appropriate?
• Are the plans and procedures for evaluating the process, progress, and outcomes of this curriculum development initiative feasible and appropriate?
• Are the plans to share curricula and any education materials developed as a result of this award appropriate and adequate?
• Are the plans for collaboration(s) with other individuals to develop course(s) and curricula adequate and appropriate?

Research Plan

• Is the research plan appropriate for the candidate’s past experience and current academic/research goals?
• Is the scientific and technical merit of the research plan appropriate and adequate for developing new or enhancing existing skills needed to meet the candidate’s career goals?
• Is the plan for coupling the research with other planned activities, appropriate and adequate for providing the experience, knowledge, and skills necessary to achieve the objectives of the award?

Consultant(s), Collaborator(s)

• Are the combined expertise, roles and responsibilities of any involved consultants, and/or collaborators likely to enhance the candidate s career development?

Environment & Institutional Commitment to the Candidate

• Is there merit to the institution’s plan and commitment to strengthening research and education activities beyond the current status of activities and capacities?
• Is there a strong statement of commitment by the institution to the levels of effort required for this career award?
• Are the scope and nature of collaboration among participating schools and departments appropriate and adequate?
• Are there adequate research facilities and training opportunities for the award?
• Are the quality of the scientific environment and relevance to the candidate’s professional academic and scientific development, including any unique features of the scientific environment beneficial to the candidate, adequate and appropriate?

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

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Training in the Responsible Conduct of Research

Development award: Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions: Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Leadership award: Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, the reviewers will address the following questions: Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups that the candidate will participate in? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the candidate’s role in the participation in instruction in RCR? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

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), in accordance with NIH peer review policy and procedures, using the stated review criteria. . Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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/priority score.
• Will receive a written critique.

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. 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.

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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 specifically for K awards, see Section 12, Research Career Development ( K ) Awardees: http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch12.htm#_Toc271265177. More information is provided at Award Conditions and Information for NIH Grants.

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

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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 (relevant to K07 Development.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

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

Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Table of IC-Specific Information, Requirements and Staff Contacts

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Table of IC-Specific Information, Requirements and Staff Contacts

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.