Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The purpose of this Funding Opportunity Announcement (FOA) is to develop of a cadre of talented scientists prepared and willing to take an active leadership role in transformative change that will lead to improved health care outcomes.

The numbers of physicians and other clinically trained individuals who are committing to, and sustaining independent research careers in the biomedical sciences remain inadequate to address the challenges confronting systems of care in the delivery of effective and improved treatments.

The Emerging Leadership Award supports clinically trained (primarily physician) faculty members who seek additional research, career and leadership skills essential for assuming a leadership role in a global biomedical workforce. NIH Emerging Leaders are early stage investigators conducting research who have shown early signs of leadership and who will use this award to further develop the tools, skills and resources to have a significant impact as leaders in their field of expertise. These skills will prepare them to assume academic leadership roles and independent careers in an emerging discipline within their professional specialty. Emerging leaders demonstrate a commitment to increase the visibility and overall research support and academic capacity within their educational, medical/health or research community. Their scientific expertise will be in demand as reviewers, educators and policy makers.

Within the field of aging research the small numbers of individuals skilled in geriatrics and the smaller numbers pursuing research on aging are inadequate to address the burgeoning needs of the rapidly growing older population. A key goal of this initiative therefore is to foster the careers of exceptionally talented clinical investigators who possess the skills and fortitude necessary for academic leadership in aging and geriatrics. Unlike other mentored K award programs, this initiative will recruit talented investigators who have had competitively awarded research support at the faculty level and who have shown early signs of leadership in their field of expertise. Although early stage investigators, through their efforts, these individuals are well poised to change theory, practice and health outcomes related to the health of older individuals. Emerging leaders will use this award to capitalize on current opportunities in clinical and translational research or groundbreaking basic research in aging and geriatrics to advance an emerging discipline or effect changes in practice within their professional specialty.

The program is named after Dr. Paul B. Beeson who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University and Professor and distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society. Dr. Beeson died in August 2006 at the age of 97.

The aims of the Paul B. Beeson Emerging Leaders Career Development Award in Aging (BEL-CDA) program are:

• To provide support for career development and advancing the leadership skills of medical and surgical specialties conducting clinically relevant basic, translational or clinical, and Patient-Oriented Research (POR) in disciplines relevant to aging and geriatrics.
• To deepen the commitment of research institutions to promote transformative academic research and leadership in aging and geriatric medicine by involving mentors with talented emerging leaders in aging research.

Clinically relevant research on aging, broadly defined, includes maintenance of health and independence in old age; diseases and disabilities of old age; issues in clinical management and systems of care for the elderly; and research where there is apparent clinical relevance e.g., the planned extension of animal models of disease to human study. Overall, the program will foster the independent research careers of exceptionally creative clinically trained investigators whose research will enhance overall health and quality of life of Americans, particularly older people.

Basic science research appropriate for this announcement includes work in animal models of aging or the use of secondary data analyses where there is apparent clinical relevance. Other examples include but are not limited to:

• The elucidation of basic biochemical, genetic, and physiological mechanisms underlying aging and age-related changes in humans and in appropriate animal models;
• Investigations focused on basic social and behavioral influences on the aging process, both at the individual and societal levels; models of transplantation in older patients; the utility and challenges of Medicare;
• Research on the neural and behavioral processes associated with the aging brain, including brain-behavior biomarkers and behavior in models of Alzheimer's disease.

Other research supported by this initiative includes but is not limited to:

• Transplantation in older patients;
• Outcomes of the older patients in hospital, acute and long term care settings;
• Multimorbidity in older patients: treatment and the disease burden;
• Studies of prevention approaches tailored to older adults;
• Studies of well-being in older adults in informal and formal care settings;
• Health disparities in aging populations.

Additional information on research programs supported by the NIA can be found at http://www.nia.nih.gov/research.

Program

The objective of the NIH Emerging Leaders Career Development Award is to provide salary and research support for a sustained period of protected time (3-5 years) for career development and advancing the leadership skills of scientists from medical and surgical specialties. These investigators conduct research in basic, translational or clinical, and Patient-Oriented Research (POR) in disciplines relevant to aging and geriatrics. The award will prepare them to assume academic leadership roles and independent careers in an emerging discipline within their professional specialty. Their scientific expertise will be in demand as reviewers, educators and policy makers.

The BEL-CDA is intended to provide guidance in academic research leadership as well as mentoring in the scientific research area of the candidate. The focus is on building a cadre of investigators and leaders to advance knowledge and skills (a new field, a new methodology, or a new approach) both through their own research and, through their leadership, in the broader community of their specialty.

As a career development award it will allow the candidate time to expand his/her research area of interest and pursue activities consistent with the expectation of future leadership in the candidate’s chosen field. Candidates must identify mentors who are senior researchers in aging and/or geriatrics and who agree to commit time to supervising and guiding the candidates during the period of the award. A part of that commitment is the intent to advance the candidate both as a researcher and as an emerging leader in the field.

The BEL-CDA is targeted primarily at individuals who have had prior training in research coursework, methods, and resources related to aging and who have received initial funding for research such as through Small Grant support from the NIH, through similar support from other federal agencies, or through foundation funding. The award(s) should have been competitively awarded to the candidate as the PD/PI at the faculty level. Individuals who have leveraged faculty-level research development support to advance and develop an independent line of research and who can provide evidence that they possess all the attributes of committed and skilled leaders in their respective fields are welcome to apply

Prior evidence of leadership can be in either clinical duties or in research activities that illustrate keen engagement and commitment to moving the respective field forward. Examples include: organizing seminar series, conferences or symposia at a national meeting, workshops or other activities where the candidate has played a leading role in enhancing her/his fields academic medical/health and research accomplishments and visibility.

The proposed career development and research should focus on aging or the aged. For this FOA, the candidate’s project may be in any of a broad range of basic, translational or patient-oriented research areas relevant to aging. The full range of research methods appropriate to completing the proposed investigation is encouraged provided that the application makes clear the clinical relevance of the proposed work. We expect that BEL-CDA scholars will contribute significantly to the research and scientific literature associated with the field of aging research.

Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. The BEL-CDA may provide from three to five years of support to attend an annual meeting where the candidate will gain additional, supplementary experience, knowledge and skills necessary to carry out high quality clinically relevant aging research and further advance the candidate as a leader in the chosen field.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

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

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

Applicant Organizations

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

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

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

All PD(s)/PI(s) must have an eRA Commons account. 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

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), are not eligible. Current and former PD/PIs of NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. Current (but not former) mentored K awardees are eligible to apply but may not hold two career development awards simultaneously.

Candidates for this award must have a health-professional doctoral degree. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, Pharm.D, ND (Doctor of Naturopathy), DVM as well as a doctoral degree in nursing research or practice. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Candidates with a PhD are eligible for this award if the degree is in a clinical field and they usually perform clinical duties.

Candidates must have completed clinical training including specialty and sub-specialty training, where appropriate, prior to receiving an award.

As a faculty member, candidates must have been awarded competitive federal or non-federal research funding as the PD/PI (e.g., R03, R21, institutional pilot funds, private foundation research support, or faculty-level research development support) within the last 3 years, prior to the submission of this application. Candidates are expected to have prior experience in leadership in clinical duties or research activities (e.g., organized seminar series, conferences or symposia at a national meeting; begun an interest group; held leadership position in student, clinical or professional groups).

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 for the K76 award must remain eligible for Early Stage Investigator status at the time of award of the BEL-CDA.

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.

At the time of award, the candidate must have a full-time appointment at the academic 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. 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 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 including leadership development. 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, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

Candidates for this award are expected to hold or have had prior competitively awarded research support as a PI/PD at the faculty level or have leveraged faculty-level research development support to advance and develop an independent line of research. Candidates must however retain their early investigator status at the time of award. Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the specific aims and other provisions (e.g., salary) 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.

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Chyren Hunter, Ph.D.
Telephone: 301-496-9322
FAX: 301-402-2945
Email: [email protected]

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

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

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

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

Biographical Sketch. Candidates should specify the competitive federal or non-federal research funding (e.g., R03, R21, institutional pilot funds, private foundation research support) they have received within the last 3 years.

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

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

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

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

Candidate s Background

• Describe the candidate's background as an emerging leader: describe how the candidate has (a) prior or current competitive external funding for research at the faculty level;(b) lead-author peer-reviewed publications, and (d) leadership either in clinical duties, or in research activities (e.g., organized seminar series, conferences or symposia at a national meeting; begun an interest group; held leadership position in student, clinical or professional groups).
• Demonstrate the applicant has an area of clinical specialty or similar focus where they intend to show leadership in promulgating research important to the growth of knowledge within the specialty.
• Demonstrate that the candidate has a commitment to increase the visibility and overall research support or academic capacity within their educational medical/health or research community.
• Describe how the candidate's background shows the potential for the candidate to become an outstanding investigator and a leader in a field of research on aging.
• Describe all of the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award.
• Present evidence of the candidate's ability to interact and collaborate with other senior scientists and more junior scientists and trainees.
• Describe the candidate's commitment to a health-related research career in aging. Explain how the award will contribute to the attainment of the objectives and long-term career plans of the candidate.
• Include a statement that the candidate will commit the minimum of 9 person-months (75% of full-time professional effort) to the career development program and related career development activities.

Career Goals and Objectives

• Describe a systematic plan: (1) that shows a logical progression from prior and current research, and leadership experiences to the research, career development and leadership activities that will occur during the career award period and post award; and (2) that justifies the need for further career development to become an independent investigator and emerging leader in her/his specific discipline; and (3) that utilizes the relevant research and educational resources of the institution
• Describe the immediate, near term and long range career development goals that include plans for leadership development as educators, investigators and policymakers with the skill and capability to implement change

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

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The mentor, in consultation with the applicant, may form a mentoring team (or an advisory committee) to assist with the development of the program of study or to monitor the candidate's progress through the career development program.
• 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 and leader. The plan must be tailored to the career goals of the candidate and the intent of this award to enhance independence as a researcher and leader within the fields of aging and geriatrics.
• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. The candidate must demonstrate prior training in fields of aging research or intend to participate in courses that provide exposure to this work. Formal course work is not required as part of the career development plan. Instead a plan should be tailored to the particular needs of the candidate seeking further development with the goal of becoming an independent investigator and leader in a field of aging research.
• Describe the professional responsibilities/activities including involvement in other research projects beyond the minimum required 9 person-months (75% effort full-time professional effort) commitment to the K76 award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator and leader within the fields of aging and geriatrics.
• Describe career development and training activities consistent with the expectation for future leadership in fields of aging and/or geriatrics. Examples may include training focused on leadership development and participation in activities which enhance the broader academic/medical/health research agendas within aging and geriatrics.

Training in the Responsible Conduct of Research

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

Statements and Letters of Support

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

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

• The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the proposed 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 advancing 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, individuals from underrepresented backgrounds, including individuals from underrepresented racial and ethnic groups, and individuals with disabilities and women should be recruited 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, mentioning any formal coursework and leadership guidance; 3) a plan for career and leadership progression for the candidate to move from the mentored stage of his/her career to independent research investigator/leadership status during the project period of the award including a statement identifying the aspects of the proposed research the candidate will be able to take when pursuing independent research; and 4) a plan for monitoring the candidate’s research, publications, and progression as an emerging leader in her/his field.
• Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the research program and related research career and leadership development activities.
• 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 agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
• Primary mentors should commit to attending one of the annual Beeson meetings with the awardee as a condition of accepting a BEL-CDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and 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.
• Advisory Committee members (if applicable): Signed statements must be provided by each member of the proposed Advisory Committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. These individuals generally do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program 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.
• Describe the resources and facilities that will be available to the candidate, including any resources that are within a Clinical and Translational Science Award (CTSA).

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to research and to related research career and leadership development activities. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent clinician-scientist, e.g. clinic responsibilities, teaching and administration, and/or additional research activities.
• 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.
• Candidates who will be using the resources within a Clinical and Translational Science Award (CTSA) during the course of the award are requested to include a letter of agreement from the CTSA program director or the PD/PI as part of the application.
• The institution must demonstrate a commitment to the candidate s development as a productive, independent investigator in aging-related research. Such commitment may be expressed in terms of the expected distribution of resources (for example, an independent laboratory) as the candidate progresses through the BEL-CDA.

Research Plan

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

Research Strategy

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research. It should be able to advance the chosen field of aging research and provide a basis for leadership in the area.
• For candidates proposing patient oriented research, complementary laboratory research directly related to patient-oriented research may be proposed in the application, thereby providing an opportunity for a career development experience in translational 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.

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

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

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the NOT-OD-11-079). 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 I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at [email protected]when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

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

• How well does the background of the candidate reveal potential to become an outstanding independent investigator and leader in research related to the mission of the NIA?
• How indicative are the candidate's interactions with senior and junior scientists and trainees of ability to lead?
• Is the candidate’s academic, clinical (if relevant), and research record of high quality?
• Is there likelihood that the award will contribute substantially to the academic and research career development of the candidate and the candidate's chosen field?
• Do the letters of reference on behalf of the candidate express her/his potential and commitment to the planned academic career program and the likelihood that the program will meet the candidate’s career goals for research and leadership?

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

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence in a field of aging research?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated objectives for achieving research independence and leadership in the field of aging and geriatrics?
• Are there adequate plans for monitoring and evaluating the candidate's research and career development progress?
• Is the proposed plan to enhance pedagogical and leadership skills of the candidate of high quality?
• Are the candidate's prior training and research experience appropriate for this award?

Research Plan

• Are the proposed research question, design, and methodology of significant scientific and technical merit to advance knowledge and skills (a new field, a new methodology, a new approach) in the chosen research field and, serve as a basis for leadership, in the broader community of their specialty?
• Is the research plan relevant to the candidate’s research career objectives?
• Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research and leadership skills described in the career development plan?
• 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 research and leadership objectives of the award?

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

• Are the mentor's research qualifications in the area of the proposed research appropriate?
• Do (es) the mentor(s) adequately address the candidate s potential and his/her strengths and areas needing improvement? Is there adequate description of the kind and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
• 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 and advancing leadership skills?
• Are the combined expertise, roles and responsibilities of any involved co-mentors, consultants, and/or collaborators likely to enhance the candidate’s career development
• Is the mentor’s description of the elements of the research career development activities, including any formal course work and leadership guidance adequate?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
• Is the institutional commitment to the career development of the candidate appropriately strong?
• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate, adequate and appropriate?
• Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
• 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, of high quality?

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

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 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.

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).

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute on Aging 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 National Advisory Council on Aging. 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Noah. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the 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. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Chyren Hunter, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9322
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]).

Lesa McQueen, M.Sc.
National Institutes on Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.