Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional)

Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional) is sponsored by National Center for Advancing Translational Sciences (NCATS). Offers career development awards to mentored researchers in clinical and translational science.

PAR-25-196: Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional) K12 Clinical Scientist Institutional Career Development Program Award Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 .

Funding Opportunity Number (FON) Companion Funding Opportunity Research Project with Complex Structure Cooperative Agreement Only one K12 application per UM1 applicant institution is allowed, as defined in Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This is a limited competition. The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA).

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding broadly-experienced pool of promising later stage postdoctoral fellows and junior faculty scholars who have made a commitment to independent clinical and translational science research careers (i.e., tenure-track or equivalent faculty positions) to facilitate their timely career advancement and continued engagement in research (i.e., sectors including academia, industry, nonprofit and government).

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion Institutional Career Development Award (K12). The remaining NOFOs in the suite are optional and include the Ruth L.

Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral), the Research Education Grant (R25), and the Specialized Innovation Program (RC2). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the optional NOFOs cannot be awarded until an award has been issued for the UM1.

(See Section III. Eligibility Information of this NOFO and the respective NOFOs for more information).

This Notice of Funding Opportunity (NOFO) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the Training (T) 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 the How 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Other Award Budget 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 Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Purpose and Background Information This is a limited competition.

The overall goal of the NIH Research Career Development programs is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This NOFO encourages applications from organizations that propose well-designed, rigorous institutional research career development programs in the mission area(s) of the NIH. The applicant organization must have the requisite faculty, staff, potential scholars and facilities on site to conduct the proposed institutional program.

In many cases, it is anticipated that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

The National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public.

Sustaining a vibrant clinical and translational research enterprise requires a 21st century workforce that can advance clinical and translational science that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.

The purpose of this NOFO is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare a pool of promising later stage postdoctoral fellows and junior faculty scholars who have made a commitment to independent clinical and translational science research careers, facilitating their timely transition (i.e., sectors including academia, industry, nonprofit and government), and continued engagement in research.

This program provides support and protected time to scholars for an intensive, research career development experience under the guidance of an experienced mentorship team with expertise in clinical and translational science.

The institutional research career development (K12) programs prepare scholars to transition into research independence in clinical and translational science and to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

Institutional research career development (K12) programs are expected to be designed with a sustained period of protected time to enhance the scholar’s research-focused career development experiences as clinical and translational science researchers, both in their chosen areas and in research areas that includes: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and/or 4) public health.

By understanding the scientific and operational principles underlying each step of the translational process, upon the completion of the institutional research career development program, the scholars will be prepared to launch into research independence.

The scholars should be able to turn observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public while simultaneously poised to take on leadership roles in clinical and translational science. The NCATS at the NIH is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster.

NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics, and medical devices to patients. Translation, translational research, and translational science are related but different.

Translation turns observations in the laboratory, clinic, and community into diagnostics, therapeutics, medical procedures, and behavioral changes that improve people’s health. Translational research moves a project to the next step in the translational process. Translational science enables these projects to reach their goals faster and more efficiently.

At NCATS, we define translational science as the field that generates scientific and operational innovations that overcome the long-standing barriers along the translational research pipeline. With its focus on improving the process, translational science ultimately leads to more treatments for all people more quickly. The NCATS Translational Science Principles characterize effective approaches for advancing translational progress.

These principles are described on the NCATS website (https://ncats. nih. gov/about/about-translational-science/principles).

These principles are intentionally broad and apply to research anywhere along the translational continuum. While they exemplify translational science approaches, they are not intended to be comprehensive.

The objective of the institutional research career development (K12) programs component of the Clinical and Translational Science Awards (CTSA) Program is to prepare and provide protected time to scholars for an intensive mentored research career development experience that leads to full research independence and leadership positions in clinical and translational science.

At the end of the research career development experience, the scholars should be well positioned with the knowledge, skills, and ability to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

Proposed institutional research career development (K12) programs are expected to nurture the scholars’ development of the following characteristics irrespective of their particular area(s) of expertise (Reference: Gilliland CT, et al. The Fundamental Characteristics of a Translational Scientist. ACS Pharmacol Transl Sci.

2019;2(3):213-216. doi:10. 1021/acsptsci.

9b00022): Domain Expert: Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between. Boundary Crosser: Breaks down disciplinary silos and collaborates with others across research areas and professions to collectively advance the development of a medical intervention.

Team Player: Practices a team science approach by leveraging the strengths and expertise and valuing the contributions of all players on the translational science team. Process Innovator: Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process.

Skilled Communicator: Communicates clearly with all stakeholders in the translational process across social, economic, and scientific backgrounds, including patients and community members.

Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.

Rigorous Researcher: Conducts research at the highest levels of rigor and transparency within their field of expertise, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility. Clinical and translational scientists exhibit both deep scientific domain expertise and systems understanding.

Their research is designed to produce discoveries that are simultaneously important for their discipline(s) and complementary disciplines, thus advancing the translational process as a whole. These characteristics are required in order for scholars to successfully transition into research independence, and to effectively traverse and contribute to the advancement of the translational science spectrum.

Applicants are expected to identify research career development needs and objectives (i.e., specific and measurable outcomes the program intends to achieve).

Funded programs are expected to implement the following: Core Knowledge Expectations in Clinical and Translational Science Research: The institutional research career development (K12) program should be designed to ensure that by the end of the research career development training period, scholars are able to launch into independent research careers in clinical and translational science research areas, which include 1) pre-clinical research, 2) clinical research, 3) implementation science, and/or 4) population science/public health research.

Scholars are expected to apply their cumulative experiential research training and knowledge in broad areas of research including, but not limited to: clinical and clinical trial research, regulatory science, biostatistics, epidemiology, health disparities, telehealth and telemedicine, dissemination and implementation science research, bioinformatics, community engagement and translational team science, entrepreneurship, scientific communication, project management, patents, Investigational New Drug (IND) filling process, FDA regulatory process, teaching pedagogy, leadership, and responsible conduct of research and rigorous research design.

The award may be used to support scholars with different levels of prior research training and at different stages in their mentored career development. For example, a scholar with limited experience in clinical and translational science may receive support in the career development experience that includes a designated period of didactic training followed by a period of closely mentored research experience.

A scholar with previous research experience and training may not require extensive additional didactic preparation and may receive support in the form of career development experience that focuses on an intensive, mentored research experience in clinical and translational science.

Clinical and Translational Science Research is a Cross-Disciplinary Team-Based Endeavor: The institutional research career development (K12) programs are encouraged to be personalized so that scholars can further refine their domain-specific knowledge, skills and abilities (KSAs) and effectively transition to full research independence in clinical and translational science.

Scholars are expected to carry out independent research in their disciplinary mastered competencies, while also gaining complementary knowledge of other disciplines and operational principles underlying at least two sectors of the translational science ecosystem to improve their capacity to effectively lead, communicate, collaborate, and break down barriers across multidisciplinary teams and the translational process.

Clinical and translational science research is a team-based endeavor that requires input from many different disciplines, sectors, and points of view to be successful.

Programs should support partnerships that give scholars scientific practice outside of their area(s) of expertise, both within the research academic domain and with stakeholders and with sectors outside it, such as patients, non-profit organizations, regulatory agencies, and industry.

Building on Institutional Strengths in Clinical and Translational Science Research: Each institutional research career development (K12) program is to be innovative in its research career development program efforts. The goal is for the scholars to improve their core competencies so that they can conduct high quality independent clinical and translational science research.

To achieve this, research-focused career development programs are encouraged to build on the local strengths and demonstrated translational innovations of their companion CTSA Program hub (e.g., health disparities, telehealth and telemedicine, community engagement, bioinformatics, dissemination and implementation, entrepreneurship, etc.) to effectively curate and foster research independence of clinical and translational science scholars.

In this spirit, programs should identify research-focused career development strengths, needs and objectives (e.g., specific and measurable outcomes the program intends to achieve) that will lead the scholar’s transition to fully independent research careers while creating a community of clinical and translational science research scholars that extends beyond the career development program.

Building on institutional strengths can include approaches on how to expose scholars to a larger cadre of mentors with a broad range of clinical expertise, experiences, resources, and backgrounds relevant to clinical and translational science and who can help the scholars launch into independent clinical and translational science research careers.

Optimizing Mentor Training: Effective mentoring is expected to increase self-efficacy, educational and career satisfaction, career advancement, and research productivity for individuals pursuing clinical and translational science research-focused careers.

Institutional research career development (K12) programs are to describe how the participating faculty and preceptors are trained to use evidence-informed mentoring practices that launch scholars into independent research-focused careers.

The evidence-informed mentor training assessments are expected to move beyond the faculty’s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness.

The application is to include a plan to assess and monitor how well the faculty mentor/preceptor promotes a safe and supportive research training environment and to make adjustments if needed. Scholars are to corroborate the self-report of changes in mentoring behaviors of each mentor in the mentoring team.

Institutions are encouraged to develop strategies to recognize and reward outstanding mentors, including mentor awards, and to create opportunities where effective mentoring practices pervade the education and clinical and translational science research landscape of the institution.

Leadership and Management : In addition to the above referenced Fundamental Characteristics of a Translational Scientist, leadership is another essential characteristic of clinical and translational science scientists.

Leadership and management training should be infused into the research-focused career development program activities of the institutional research career development (K12) program in Clinical and Translational Science Awards (CTSA) Program so that scholars can develop professional and leadership skills (e.g., emotional intelligence, conflict resolution, job offers negotiation, laboratory management, balancing competing priorities) to be effective leaders in clinical and translational science.

Career Visibility and Enhancement: The career outcomes of scholars supported by the institutional research career development (K12) program in Clinical and Translational Science Awards (CTSA) Program include, but are not limited to, independent research-intensive careers in academia and industry.

Research-focused career development programs must make available structured, career development advising and coaching which may include academic job search strategies, Individual Development Plans, workshops addressing grant-writing, and publishing aimed at increasing the competitiveness of the scholars to successfully transition, in a timely manner, to the next stage of their independent research career and become fully independent researchers.

The career development activities should enhance the scholars’ scientific and professional network beyond the local institution. NCATS seeks the submission of one set of companion applications. With this NOFO for the K12 application, a separate, companion NOFO seeks applications for a required UM1 ( PAR-24-272: Clinical and Translational Science Award ).

While the institutional research career development K12 required companion application must be submitted concurrently with the initial UM1 application or resubmitted at any time the submitted UM1 new or resubmission application or award remains active, the K12 required companion application will only be awarded if the UM1 is awarded. (See Section III. Eligibility Information).

Note : This NOFO allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Applications Not Responsive to this NOFO: The following types of applications will be deemed nonresponsive and will not be reviewed: Applications that are not submitted concurrently with the required UM1 (PAR-24-272: Clinical and Translational Science Award) application, or while the required UM1 application is either in review, under consideration for funding, or has been awarded.

Applications that do not meet the criteria noted under the eligibility criteria (see Section III). Applications that do not submit all of the required attachments. Application information, including Frequently Asked Questions and Technical Assistance Webinars, are found on https://ncats.

nih. gov/research/research-activities/ctsa/applicant-information Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Note : This Notice of Funding Opportunity (NOFO) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information 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 Resubmission - Resubmission Applications to PAR-21-336 and this NOFO The OER Glossary and the How to Apply - Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

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. Application budgets are to reflect no more than $700,000 Direct Costs for Hub Tier G; $900,000 Direct Costs for Hub Tier T; $1,000,000 Direct Costs for Hub Tier C; and $1,500,000 Direct Costs for Hub Tier A per budget period.

Hub tiers must be ascertained in order to determine the maximum budget that can be requested for the UM1 companion application. Please see PAR-24-272: Clinical and Translational Science Award. Budget tier requests (A, C, G, or T) of a companion K12 application submitted in response to the reissued NOFOs must be the same budget tier of the respective UM1.

Funds may be used only for those expenses that are directly related to and necessary for the career development of K12 Scholars and must be expended in conformance with OMB Cost Principles and the NIH Grants Policy Statement. The applicant must ensure the peer reviewed sections (budget section) of the application focus on the scholars to be supported by direct NIH funding via this funding opportunity.

Descriptions of other institutional career development and training programs should be included in the Facilities & Other Resources attachment and/or the Institutional Environment and Commitment to Training section of the application. The award budget includes salary support for the PD(s)/PI(s) and Scholars, research and development support, and administrative support costs. The project period duration is up to 5 years.

Other Award Budget Information Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Salary support for individuals involved in program administration and management must be substantially justified.

Salary support for ancillary personnel (e.g. administrative assistance or secretarial support) on CDAs is not allowable. Up to 3. 6 person months total effort per annum may be allocated for all PDs/PIs of the K12 program to partially offset their salaries and associated fringe benefit costs, depending on commitment of effort (https://grants.

nih. gov/grants/guide/notice-files/NOT-OD-16-045. html).

These salary and fringe benefit expenses must be included in Section A of the R&R Budget. Up to 6. 0 person months total effort per annum may be allocated for all other program leadership, administrative, and management personnel (e.g., co-investigators, program administrator/program coordinator and/or program assistant) to partially offset their salaries and associated fringe benefit costs.

These salary and fringe benefit expenses must be substantially justified and included in Section A of the R&R Budget. Salary requests for the Program Faculty or mentors are not allowed. Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program.

Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget. NCATS will contribute up to $120,000 per year toward the salary of each K12 scholar.

Note that the salary allowance will be commensurate with the actual number of person months committed applicable to their current salary and program-related activities. The $120,000 amount is exclusive of fringe benefits.

In general, 9 person-months (75 percent of the K12 full-time effort) must be devoted to the K12 program, except for those in surgical specialties, which can have less than 9 person-months (75 percent), but no less than 6 person-months (50 percent), protected time for this program, if sufficiently justified and programmatically approved. Additional support may be requested for research-related activities detailed below.

The total amount budgeted per scholar must not exceed $180,000 in direct costs per year. Scholar Research and Development Support: The K budget must include funds to support K scholar research projects and career development activities.

No less than $10,000 and up to $30,000 per individual Scholar must be provided for the following types of research-related expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to scientific meetings or training that the institution determines to be necessary for the individual’s career development experience; and (d) statistical services including personnel and computer time.

No more than $5,000 of the scholar research and development support funds per scholar may be pooled for program-wide activities only if such activities support the career development of all scholars. It is expected that the K12 Scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to the scholar.

These expenses must be itemized in Section F of the R&R Budget. The application must clearly indicate the number of scholar appointments proposed for each year. Candidates must have a full-time appointment at the applicant institution or a partnering institution.

Scholar support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of 12-month appointments, provided their progress towards an independent clinical and translational science research career is on track and satisfactory. Applications must be able to show their ability to recruit scholars who can complete the entire two to five-year proposed program.

Programs may not split funds for an awarded slot across two or more individuals. Other Program Related Expenses Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses (including expenses for mentor training activities) may be included in the proposed budget.

These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. K12 funds cannot be used to recruit scholars (e.g., travel for interviews, recruitment events, recruitment brochures, advertisement costs, etc.). All costs associated with recruitment will be deemed unallowable.

Cost sharing is not permitted for scholar salaries and fringe benefits and minimum research and development support NOFO requirements. Institutional funds may be used to support additional scholars allowing them to receive parallel training and research experiences based on the NCATS funded CTSA Program infrastructure for K12 scholars.

In general, applicants may provide institutional support (i.e.,voluntary uncommitted cost share) to enhance the resources and environment available to scholars. Any applicant identifying voluntary committed cost share in the budget sections of the application will be bound to the cost share commitment for the entire approved project period.

Personnel effort requested without salary support will be considered voluntary committed cost share, and the applicant institution will be bound to the relevant salary, fringe and associated Facilities & Administrative (F&A) costs for the entire approved project period.

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement. 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 All applicant organizations and/or active award recipients for PAR-24-272 or PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional) are eligible to apply under this NOFO. Only the primary UM1 CTSA hub organization is eligible to apply. Partner/Partnering and/or Collaborator/Collaborating institutions are not eligible.

The institutional research career development K12 required UM1 companion application must be submitted in accordance with the UM1 and K12 NOFOs application submission dates under the following scenario: Initial concurrent submission of both a UM1 application and a K12 application.

The K12 required companion application may be resubmitted in accordance with the applicable NOFO application submission dates under the following scenarios: concurrently with the resubmitted UM1 while the UM1 application is under review consideration after the UM1 application is funded while the UM1 is under consideration for funding While the K12 required companion application must be submitted concurrently with the initial UM1 application or resubmitted at any time the submitted UM1 new or resubmission application or award remains active, the K12 required companion application will only be awarded if the UM1 is awarded.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. 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 allowed. 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. The 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 Section 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