Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
NIA Academic Leadership Career Award (K07 Independent Clinical Trial Not Allowed)
Activity Code
K07 Academic/Teacher Award (ATA)
Announcement Type
Reissue of PAR-21-106
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
PAR-24-321
Companion Notice of Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to provide support for established investigators who have the expertise and leadership skills to enhance aging and/or Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) research capacity within their academic institution.

Through this award, investigators will endeavor to develop research and educational infrastructure, mentorship, and career development activities in support of new or emerging areas of aging and/or AD/ADRD research. These may include, but are not limited to, courses, curricula, research support, pilot funding, travel awards, visiting scholars, or networks.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFO (FON).

Funding Opportunity Announcement Goal(s)

To encourage biomedical, social, and behavioral research and research training directed toward greater understanding of the aging process and the diseases, special problems, and needs of people as they age. 

Key Dates

Posted Date
November 06, 2024
Open Date (Earliest Submission Date)
January 12, 2025
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
February 12, 2025 * March 12, 2025 * Not Applicable July 2025 October 2025 December 2025
June 12, 2025 * July 12, 2025 * Not Applicable November 2025 January 2026 April 2026
October 12, 2025 * November 12, 2025 * Not Applicable March 2026 May 2026 July 2026
February 12, 2026 * March 12, 2026 * Not Applicable July 2026 October 2026 December 2026
June 12, 2026 * July 12, 2026 * Not Applicable November 2026 January 2027 April 2027
October 12, 2026 * November 12, 2026 * Not Applicable March 2027 May 2027 July 2027
February 12, 2027 * March 12, 2027 * Not Applicable July 2027 October 2027 December 2027
June 12, 2027 * July 12, 2027 * Not Applicable November 2027 January 2028 April 2028
October 12, 2027 * November 12, 2027 * Not Applicable March 2028 May 2028 July 2028

All applications are due by 5:00 PM local time of applicant organization.

Applications are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
November 13, 2027
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall purpose 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. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development website.

The goal of the NIH Academic Leadership Career Award (K07) is to increase the pool of individuals with academic and research expertise in a specific area of biomedical, behavioral, or clinical research and to enhance the educational or research capacity at the grantee institution. 

Purpose

The NIA K07 Academic Leadership Award provides support for established investigators who are interested in improving the curricula and enhancing the aging and/or AD/ADRD research capacity within their academic institution. Candidates for the NIA K07 Academic Leadership Award must have (1) demonstrated scientific expertise and leadership skills and (2) sufficient research or clinical training or teaching experience in aging and/or AD/ADRD research to implement a program to advance the field of aging and/or AD/ADRD research within the sponsoring institution.

Scope

The immediate and long-term goals of the proposed program must meet the needs for expansion or enhancement of the aging and/or AD/ADRD academic or research capacity at the sponsoring institution. Proposed curricula and research development activities may be broad as related to aging, the aging process, and diseases and conditions associated with growing older, such as AD/ADRD, including frontotemporal, Lewy body, and vascular dementia. Applications are encouraged that reflect NIA’s programmatic interests in behavioral, biological, clinical, economic, epidemiological, genetic, neuroscience, and social research on aging, both basic and translational, as they relate to the health and well-being of older people. The NIA is committed to reducing health disparities among older adults through supporting projects that reflect the life-course perspective. Proposed curricula and research development activities that promote broad participation  are strongly encouraged, and may include but are not limited to, the importance of diversity and inclusion in the aging and AD/ADRD research workforce, strategies to recruit research participants representative of the population being studied, implications of demographic shifts in aging for healthcare and social services, factors contributing to health disparities (e.g., access to healthcare, socioeconomic status, discrimination), and strategies for addressing health inequities in aging and AD/ADRD research.

Activities of the Project

The Academic Leadership Career Award provides support for the development of research and educational infrastructure, mentorship, and career development activities in support of new or emerging areas of aging and/or AD/ADRD research. Research development activities may include, but are not limited to, the following:

  • Courses, seminars, workshops, or tutorials;
  • Curriculum development or research coordinator support;
  • Statistical services including personnel and computer time;
  • Pilot funds for research by early career investigators;
  • Travel funds for early career investigators;
  • A visiting scholar program;
  • A network of investigators or institutions;
  • Other formal or informal mentorship for early career investigators; and
  • Any other activities that directly advance the goals of the award.

Research development activities must be justified with evidence of their effectiveness and based on sound research concepts and educational principles that meet the scientific and educational requirements of the corresponding aging and/or AD/ADRD research field(s). The elements of the proposed program (e.g., courses, curricula, research support, pilot funding, travel awards, visiting scholars, networks) must be well-integrated to achieve a path of progression for early-career investigators to advance in the field. It is expected that support provided by this award will increase the academic capacity, rigor, and research support for aging-related research within the academic medical/health and research community. The proposed program may complement other ongoing research training and career development programs at the applicant institution, but the proposed experiences must be distinct from current programs currently receiving Federal support.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the How to Apply - Application Guide provides details on these application types.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

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.

Other Award Budget Information

Salary

NIH will contribute up to $75,000 per year toward the salary of the career award recipient. Total direct costs for the salary of the career award recipient and the curriculum development or research coordinator may not exceed $100,000, inclusive of fringe benefits (based on the sponsoring institution's rate) and the percent of effort contributed. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries provided by the institution from its own funds to other staff members of equivalent rank and responsibilities in the department concerned. If full-time, 12-month salaries are not 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.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

The total salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094.

Other Program-Related Expenses

In addition to salary support, NIH will contribute up to $50,000 per year toward research development costs, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

In addition to $50,000 for research development costs, up to $25,000 per year may be requested for the salary of a curriculum development or research coordinator.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

Local 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)

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
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. 
Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM)– 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

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 organization to develop an application for support. Individuals from all groups, including those from underrepresented populations in the U.S. biomedical, clinical, behavioral and social sciences research enterprise (see the Notice of NIH's Interest in Diversity, NOT-OD-20-031) are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

Applicants must be a named PD/PI on an active R01 or R01-equivalent NIA grant or on a sub-project of a multi-component NIA research project (e.g., P30, P01, U54, U19) at the time of the application submission. It is also expected that candidates have research support during the award period. Candidates losing this support during the award period must document efforts to replace this support and demonstrate that they continue to meet all other requirements of the career award in their annual Progress Reports.

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

Candidates for the K07 award must have a clinical, research, or health-professional doctoral degree. Such degrees include, but are not limited to, the PhD, MD, DO, DDS, DMD, OD, DC, DSW, DPH, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Candidates may work with their instiution to 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.

K07 Leadership: Candidates may not use the K07 Leadership Award to support the recipient’s clinical practice, professional consultation or other comparable activities, except when such activities are required by the objectives of this program.

 

Level of Effort

At the time of award, the candidate must have a “full-time” appointment at the academic institution. A minimum of 25% (3 person-months) but not more than 50% (6 person months) of full-time professional effort must be devoted to the program annually.

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.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Institutional Environment

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Project Summary/Abstract

Outline the intended program to be implemented that will initiate or expand a particular field of aging and/or AD/ADRD research at the applicant's institution.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

A salary for a curriculum development or research coordinator may be requested. Total direct costs for the career award recipient's salary ($75,000/year), research development support ($50,000/year), and the curriculum development or research coordinator salary support ($25,000/year) may not exceed $150,000/year inclusive of fringe benefits.

PHS 398 Career Development Award Supplemental Form

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

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

All instructions in the How to Apply - Application Guide must be followed.

Candidate Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

  • Provide evidence that the candidate has the capacity to provide leadership as a teacher or researcher.
  • Provide information describing the demonstrated 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 NIA.
  • Provide evidence that the candidate has the commitment to develop and implement effective 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. The program might include, but is not limited to, courses, curricula, pilot funds for research, a visiting scholar program, or travel funds for early career investigators.
  • Describe the planned collaboration(s) with other individuals to develop course(s) and curricula, as applicable. Describe the scope and nature of collaboration among participating schools and departments, as applicable.
  • Describe the candidate program director's ongoing independently-supported program of research and how it relates to the program being developed through the intended award. Describe all the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award.

Career Goals and Objectives​

  • 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 in the field of aging and/or AD/ADRD at the sponsoring institution.
  • Describe how the Leadership Award will increase the academic capacity, rigor, and research support in aging and/or AD/ADRD within the academic medical/health and research community.

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

  • Describe the curriculum 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 in the field of aging at the sponsoring institution.
  • Describe the proposed content and duration of the planned didactic and curriculum development components, as applicable.
  • 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 proposed program. Describe plans for enlisting the support of professional and other organizations as appropriate.
  • Show how the elements of the proposed program (e.g., courses, curricula, research support, pilot funding, travel awards, visiting scholars, networks) are well-integrated to achieve a path of progression for early career investigators to advance in the field, and to advance the field.
  • Describe the plans and procedures for evaluating the process, progress, and outcomes of the proposed program and the candidate. Describe the plans to share curricula and any education materials developed as a result of this award.

Research Plan Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

  • Describe the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • Describe the strategy to implement the program at the institution. The elements of the proposed program (e.g., courses, curricula, research support, pilot funding, travel awards, visiting scholars, networks) must be justified with evidence of their effectiveness and based on sound research concepts and educational principles that meet the scientific and educational requirements of the corresponding aging and/or AD/ADRD research field(s).
  • Describe the available pool of resources to aid in establishing the program. As applicable, describe how the proposed program complements, but is sufficiently distinct from, other ongoing research training and career development programs at the applicant institution.
  • As K07 awards are not renewable, describe plans and milestones for how the program is planned to continue at the institution after the award ends.
  • If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

Other Candidate Information Section

Candidate's Plan to Provide Mentoring

  • Describe the availability of appropriate pool of early career investigators (e.g. graduate students, residents, post-doctoral fellows) for mentoring and advancement; their previous training and specialization; plans for recruitment, selection and supervision; how planned educational and research experiences will be tailored to their background and experience; and the capacity in which the candidate program director for the career award will serve as a mentor.
  • If there is an existing (clinical) research curriculum (e.g., CTSA), describe how the mentoring plan will be integrated with the curriculum. Candidates must also describe a plan for supporting the research of their mentees during the period of the career award.
  • Describe the candidate’s record of mentoring. Describe the plan to enhance pedagogical and leadership skills of the candidate.

Training in the Responsible Conduct of Research

  • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See How to Apply - Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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

  • Upload a document that indicates that this information is not required for this NOFO.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants 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. 
  • Advisory committee members (if applicable): The research expertise to be sought in the Advisory Committee should be described, but the members should not be named in the application. The names should be submitted as part of the just in time information. Advisory Committee members may be established faculty at either the candidate’s institution or at another institution. Members should be chosen for their expertise in the research project proposed by the candidate.

Environmental and Institutional Commitment to the Candidate

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Description of Institutional Environment

  • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key 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

  • 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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

The following modifications apply:

Do not use the Appendix to circumvent page limits.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

  • For NOFOs that do not allow independent clinical trials, do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

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

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 NOFO number and title, PD/PI name, and title of the application.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: Reviewers should evaluate the candidate’s demonstrated capacity to carry out independent research and continue to make significant contributions to the field of aging, and advance the curricula and capacity for aging and/or AD/ADRD research at their institution.

Overall Impact

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.

Scored Review Criteria

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.

 
  • Does the candidate show potential to become a productive 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?
  • 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?
 
  • 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 deemed 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?
  • If proposed, will the clinical trial experience contribute to the applicant’s research career development?

Specific to this NOFO:

  • How likely is the developed curriculum to contribute to an increase in the pool of individuals with academic and research expertise and/or enhances the educational or research capacity in the field of aging and/or AD/ADRD at the sponsoring institution?
  • How adequate is the pool of early career investigators (e.g. graduate students, residents, post-doctoral fellows) available for mentoring and advancement? How well-described are the plans to tailor the planned educational and research experiences to their background and experience?
 
  • Is the prior research that serves as the key support for the proposed project rigorous?
  • Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Is the research plan appropriate for the candidate’s past experience and current academic/research 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?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Is the 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?
  • If proposed, will the clinical trial experience contribute to the research project?

Specific to this NOFO:

  • How strong is the scientific premise for the project? To what extent are the elements of the proposed program (e.g., courses, curricula, research support, pilot funding, travel awards, visiting scholars, networks) justified with evidence of their effectiveness and based on sound research concepts and educational principles?
 
  • Are the combined expertise, roles and responsibilities of any involved consultants, and/or collaborators likely to enhance the candidate’s career development?
     
 
  • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
  • 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 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?
Additional Review Criteria

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 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 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 or gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

 

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.

 

Not Applicable

 

Not Applicable

Additional Review Considerations

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 NOFO 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 candidate, including any prior instruction or participation in RCR as appropriate for the candidate’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 and NOT-OD-22-055.

 

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, 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:

  • 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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
  2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

5. Evaluation

In carrying out its stewardship of human resource-related programs, 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.

Section VII. Agency Contacts

.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Scientific/Research Contact(s)

Maria Carranza, Ph.D.
National Institute on Aging (NIA)
Email: [email protected]

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

Financial/Grants Management Contact(s)

Traci Lafferty
National Institute on Aging (NIA)
Telephone: 301-496-8987
Email: [email protected]

Section VIII. Other Information

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.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Authority and Regulations
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.
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