NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00 Basic Experimental Studies Involving Humans Required)

NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00 Basic Experimental Studies Involving Humans Required) is sponsored by National Institute of Dental and Craniofacial Research (NIDCR). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-22-042: NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00 Clinical Trial Required) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Dental and Craniofacial Research ( NIDCR ) Funding Opportunity Title NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00 Clinical Trial Required) K99 / R00 Career Transition Award/Research Transition Award June 18, 2024 - Notice of Early Termination of NIDCR Dual Degree Dentist Scientist Pathway to Independence Award, PAR-22-042 (K99/R00 Clinical Trial Required) and PAR-22-043 (K99/R00 Basic Experimental Studies Involving Humans Required).

See Notice NOT-DE-25-031 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 NOT-DE-22-007 - Notice to Include Additional Application Due Dates for NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity K99 / R00 Career Transition Award/Research Transition Award K99 / R00 Career Transition Award/Research Transition Award See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The purpose of the NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) program is to develop and maintain a strong cohort of independently funded dentist scientists dedicated to improving dental, oral and craniofacial health.

This program is designed to facilitate a timely transition of outstanding dual degree dentist scientists from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions by providing support for two years of mentored training and three to five years of independent research.

An option for five years of independent (R00) support is available to accommodate clinical training in a dental specialty program at no more than 3 person-months effort (25% full-time professional effort) in any year of the R00 phase.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development.

Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA ( PAR-22-041 ). Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) 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 .

New Date June 18, 2024 (Original Date: January 08, 2025) per issuance of NOT-DE-25-031 Required Application Instructions It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.

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 Extramural Training Mechanisms website. The objective of the NIDCR Dentist Scientist Pathway to Independence Award (K99/R00) is to help outstanding postdoctoral researchers complete mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions.

A dual degree dentist scientist is defined as an individual with both a clinical DDS or DMD (or equivalent) degree and a PhD (or equivalent research doctoral) degree. Transition to research independence is particularly difficult for dual degree dentist scientists, whose time for scientific research experiences may be limited by their clinical responsibilities and further clinical specialty training.

Dual degree dentist scientists possess unique knowledge of dental, oral, and craniofacial health that is critical for accomplishing the NIDCR scientific mission. The K99/R00 award is intended to foster the development of creative and independent research investigators who can make long term contributions to dental, oral, and craniofacial research.

This program is also designed to meet the specific needs of the dentist scientist career path, including provisions for two years of protected time for mentored postdoctoral training and, under certain circumstances in the independent phase, part-time dental specialty training.

Applicants must have no more than 4 years of postdoctoral research experience since their most recent doctoral degree at the time of the initial or the subsequent resubmission application.

The strongest applicants will require, and will propose, a well-conceived plan for 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs.

An individual who cannot provide a compelling rationale for additional mentored research training at the time of award is not a strong candidate for this program. The K99/R00 award will provide up to 7 years of support in two phases. The initial (K99) phase will provide support for 2 years of mentored postdoctoral research training and career development.

Early R00 phase transitions require prior approval from NIDCR and are not encouraged for individuals with less than 2 years of postdoctoral research at the submission deadline. The second (R00) phase will provide either 3 or 5 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position.

Five years of R00 support will be permitted for an awardee who is offered an independent faculty position in a U.S. dental school in conjunction with the opportunity to matriculate into a clinical dental specialty program.

In such cases, the specialty program must be structured so that no more than the equivalent of 3 person-months (i.e. 25% full-time professional effort) in any year is devoted to clinical activities; at least the equivalent of 9 person-months (i.e. 75% full-time professional effort) each year must comprise protected research time.

NIDCR will not provide tuition for the dental specialty program; the dental school hiring the R00 awardee will be expected to support such training. Only dental specialties recognized by the National Commission on Recognition of Dental Specialties and Certifying Boards of the American Dental Association will be permitted during the R00 phase.

These specialties currently include: Dental Anesthesiology, Dental Public Health, Endodontics, Oral and Maxillofacial Pathology, Oral and Maxillofacial Radiology, Oral and Maxillofacial Surgery, Oral Medicine, Orofacial Pain, Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, Periodontics, and Prosthodontics.

In the initial K99/R00 application, applicants who propose clinical dental specialty training during the independent (R00) phase must identify which specialty he/she plans to pursue and how certification in that specialty relates to and will enhance the path towards an independent research career. Institutional commitment for dental clinical specialty training is not provided in the initial K99/R00 application.

Upon activation of the R00 phase, each awardee will be required to provide institutional assurance that the dental specialty program will be customized such that clinical activities will occupy no more than the equivalent of 3 person-months (i.e. 25% full-time professional effort) each year and will be supported in-kind by the sponsoring institution.

Dual degree dentist scientists who do not intend to pursue dental clinical specialty training during the independent R00 phase are also eligible and encouraged to apply for this award. In this case, a 3 year R00 project period should be requested.

Additionally, K99/R00 awardees who had proposed dental clinical specialty training in the peer reviewed application may elect not to engage in the proposed specialty training during the R00 phase. These individuals will receive a 3 year R00 award, if they meet all other requirements for R00 transition. The two award phases are intended to be continuous in time.

Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.

In addition to this initiative, NIDCR supports mentored career development programs designed to foster the transition of new investigators to research independence, which may be more suitable for some candidates. For information on other NIDCR-sponsored career development programs please refer to http://www. nidcr.

nih. gov/CareersAndTraining . Note: This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development.

Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA ( PAR-22-041 ). See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Required: Only accepting applications that propose an independent 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.

Award budgets are composed of salary and other program-related expenses, as described below. The total project period may not exceed 7 years. Mentored Phase (K99) : Support for 2 years mentored postdoctoral research training and career development.

Independent Phase (R00): Independent research support for either 3 or 5 years, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position.

R00 support beyond three years will be permitted for an awardee who is offered an independent faculty position in a U.S. dental school in conjunction with the opportunity to matriculate into a clinical dental specialty program Other Award Budget Information Intramural: Mentored candidates in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research.

Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory. Salary will be consistent with that offered scientists in similar, intramural NIH positions. Extramural: NIDCR will contribute up to $100,000 a year for salary support for mentored candidates at an extramural sponsoring institution/organization.

Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094 . The total NIH contribution to salary may not exceed the legislatively mandated salary cap.

See: http://grants. nih. gov/grants/policy/salcap_summary.

htm . The total cost for the independent phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research costs, and applicable indirect costs.

Indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation. Other Program-Related Expenses Intramural: Research-related expenses for the intramural phase are provided by the candidate's NIH intramural laboratory or branch.

Extramural: NIDCR will contribute $25,000 per year toward the research development costs of the award recipient, 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.

Research expenses during the K99 phase may include (a) tuition and fees related to career development activities; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

For the extramural K99 phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. For the R00 phase, indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

The applicant institution will be the mentored phase (K99) institution.

All institution/organization types listed above are eligible for both the mentored (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations.

The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 mentor and organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

Candidates must have both a clinical DDS or DMD (or equivalent) degree and a PhD (or equivalent research doctoral) degree and have no more than 4 years of postdoctoral research experience (i.e. employment in a research position since completing the requirements for the doctorate) at the time of application (resubmissions must also comply with this requirement).

It is not required that the degrees were earned together as part of dual degree (DSTP) training program. Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. Candidates in a clinical faculty position that denotes independence in clinical responsibilities, but not in research, may also be eligible for the K99/R00 award.

If an applicant achieves independence (i.e., has formally accepted an offer for any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI) , NIH will approve an extension of one year for childbirth within the 4 year K99 eligibility window.

Applicants who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the FOA at least 12 weeks before submitting an application. Potential candidates are encouraged to discuss their individual situation with the NIDCR Scientific Program Contact before applying.

In addition, parental, medical, military, or other well-justified leave for personal or family situations of generally less than 12 months duration is typically not included in the 4-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). Only time dedicated to research activities counts toward the 4-year limit.

Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Additional clarifications are provided under Frequently Asked Questions .

There is no citizenship requirement for K99 applicants. An applicant may be a citizen or a non-citizen national of the United States, 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), or be a non-U.S. citizen.

For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status during each phase of the K99/R00 award must allow the PD/PI to conduct the proposed research at the applicant institution.

For the K99 phase of the award, the applicant institution is responsible for determining and documenting, in the K99 application, that the candidate’s visa will allow him or her to remain in the U.S. long enough to complete the K99 phase of the award. For the R00 phase of the award, the U.

S institution at which the R00 phase of the award will be conducted is responsible for determining and documenting, in the R00 application, that the PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the R00 award.

Candidates in clinical faculty positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award and should contact the NIDCR Program Director for guidance.

Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk ) available for junior faculty development.

Candidates in positions other than postdoctoral fellow positions : It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the NIDCR before they begin to prepare their applications.

It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement.

If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, the request for an exception must be accompanied by an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.

Individuals are NOT eligible if they: Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or Have more than 4 years of related postdoctoral research training at the time of initial application or resubmission; or Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25) unless the previous career development award was used to earn a PhD or equivalent research doctoral degree, or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.

The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility. Evidence for non-independence may include: The candidate’s research is entirely funded by another investigator’s grants. The candidate’s research is conducted entirely in another investigator’s assigned space.

According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students. According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01). The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility, includes: The candidate has a full-time faculty position or has formally accepted a faculty position. The candidate received a start-up package for support of his/her independent research. The candidate has research space dedicated to his/her own research.

The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows. The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). At the time of award, the candidate must have a full-time appointment at the academic institution.

Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.

See NOT-OD-09-036 for more details. R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research.

The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research.

The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women should be involved as mentors to serve as role models.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research. 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 FOA. 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 SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications . All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. Include a description of your current research and the research you propose to continue in the independent phase.

SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. Itemized budget information is not required for the R00 phase; a total requested amount for each budget period is acceptable.

However, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period of the R00 phase: Select the appropriate Budget Type Provide the Budget Period Start Date and End Date In