Patient-Oriented Research Mid-Career Investigator Award (K24)

Patient-Oriented Research Mid-Career Investigator Award (K24) is sponsored by National Institute of Nursing Research (NINR) - NIH. Supports mid-career health-professional scientists for protected time to devote to patient-oriented research (POR) and to act as research mentors for junior clinical investigators pursuing POR.

Expired PA-14-047: Midcareer Investigator Award in Patient-Oriented Research (Parent K24) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Cancer Institute ( NCI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Aging ( NIA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and Stroke ( NINDS ) National Institute of Nursing Research ( NINR ) National Center for Complementary and Integrative Health ( NCCIH ) Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Dietary Supplements ( ODS ) Note : Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts , to make sure that their application is responsive to the requirements of one of the participating NIH ICs.

Funding Opportunity Title Midcareer Investigator Award in Patient-Oriented Research (Parent K24) K24 Midcareer Investigator Award in Patient-Oriented Research September 02, 2016 - Notice of Clarification to NHLBI's Policy Regarding Total Years of Support for K24 Funding. See Notice NOT-HL-16-442 . April 27, 2016 - Notice of Changes in Expiration Date of Midcareer Investigator Award in Patient-Oriented Research (Parent K24).

See Notice NOT-OD-16-085 . April 19, 2016 - This PA has been reissued as PA-16-206. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals August 6, 2015 - Notice to Update NIDCD's Guidance in Mentored-Research Career Development (Parent K) Programs.

See Notice NOT-DC-15-003 . June 1, 2015 - Notice of Revised NHLBI Submission Policies for PA-14-047. See Notice NOT-HL-15-261 .

supersedes instructions in Section III. 3 regarding applications that are essentially the same. May 2, 2014 - See Notice NOT-OD-14-088.

Notice of Clarification of Career (K) Award Eligibility. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.

847; 93. 242; 93. 856; 93.

855; 93. 846; 93. 213; 93.

113; 93. 398; 93. 839; 93.

838; 93. 837; 93. 233; 93.

279; 93. 361; 93. 865; 93.

273; 93. 866; 93. 173; 93.

865; 93. 853 Funding Opportunity Purpose The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates or equivalent who are typically at the Associate Professor level or the equivalent (see Section III.

Eligible Individuals) for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Prospective candidates are encouraged to contact the relevant NIH staff for IC-specific programmatic and budgetary information: Table of IC-Specific Information, Requirements and Staff Contacts .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply, with the first due date on February 12, 2014 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.

AIDS Application Due Date(s) dates apply, with the first AIDS due date on May 7, 2014 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 May 10, 2016 per issuance of PA-16-206 .

(Original Expiration Date: January 8, 2017 ) Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series) where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

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

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

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

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

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

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

In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators.

Information about all NIH Career Development programs may be found at the NIH Extramural Training Mechanisms website. The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) award is designed to enable mid-career clinician scientists to: Devote more time to augment their capabilities in Patient-Oriented Research (POR); and Provide mentoring to new clinical investigators in the conduct of POR (see below for definition).

The K24 award is intended to provide protected time to mid-career clinical investigators who are typically at the Associate Professor level or the equivalent (see Section III, Eligible Individuals) and who have their own independent peer-reviewed research support to provide mentoring to junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators so that they could continue to conduct POR and be available as mentors in POR.

A K24 award recipient who continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to new investigators can continue to contribute to the overall goals of the program after being promoted to Full Professor. This award has formed an important part of the NIH initiative to attract and retain talented individuals to the challenges of patient-oriented research.

The overall goal is to increase the pool of clinical researchers who can conduct patient-oriented research, who will be able to successfully compete for peer-reviewed grants, and who will mentor the next generation of clinical investigators. It is expected that K24 recipients will obtain new or additional independent peer-reviewed funding for POR as PD/PI and establish and assume leadership roles in collaborative POR programs.

In addition, it is expected that there will be an increased effort and commitment to act as a mentor to beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future.

For the purposes of this award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials; and (4) the development of new technologies.

Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects research are not included in this definition.

See also the NIH Directors Panel on Clinical Research Report Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program.

Therefore, a prospective applicant is urged to of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs. 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 Glossary and the SF424 (R&R) Application Guide provide details on 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 5 years.

The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) will provide salary for levels of effort between 3-6 person-months (or 25 and 50% full-time professional effort).

The actual salary provided by the award is based on a full-time, 12-month staff appointment at the sponsoring institution, the PD/PIs institutional salary, and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award (see: http://grants. nih. gov/grants/policy/salcap_summary.

htm ). The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award.

Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K24 award.

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100%.

Other Program-Related Expenses The NIH will provide up to $50,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the PD/PI and the mentees; (b) travel to research meetings or training; (c) statistical services including personnel and Salary for secretarial and administrative assistance, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions 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 Nonprofits without 501(c)(3) IRS Status (Other than Institutions 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 U.S. Territory or Possession Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations 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 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 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. Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

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 must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account.

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 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Multiple PDs/PIs are not allowed. By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.

Candidates for this award must have a health-professional doctoral degree or its equivalent. Such degrees include but are not limited to the M. D.

, D. O. , D.

D. S. , D.

M. D. , O.

D. , D. C.

, Pharm. D. , N.

D. (Doctor of Naturopathy), as well as a doctoral degree in nursing. Candidates with Ph.

D. degrees are eligible for this award if the degree is in a clinical field or they perform patient-oriented research (POR). This may include clinical psychologists, clinical geneticists, speech and language pathologists.

Candidates should typically be in the midcareer stage at the Associate Professor level or functioning at that rank in an academic setting or equivalent non-academic setting and must have an established record of independent, peer-reviewed patient-oriented research grant funding including at the time of application and record of publications.

This award is intended for individuals who have a record of supervising and mentoring patient-oriented researchers. A K24 award recipient who is promoted to Full Professor, but continues to have an independent peer-reviewed patient-oriented research program and provides mentoring to new investigators, may continue to be supported through the K24 program.

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Candidates must be able to demonstrate the need for protected time, 3-6 person months (25-50% of full-time professional effort) for a period of intensive research focus as a means of augmenting their capabilities in POR and act as a mentor to new clinical investigators in the conduct of POR during this period. Candidates for the K24 award may not have pending peer review or concurrently apply for any other PHS career award.

Depending on the policies of the awarding IC, K24 awardees may apply for a one-time renewal for an additional three to five years of support if the K24 recipient continues to have independent peer-reviewed research support at the time of submission of the renewal application.

Candidates should clearly demonstrate their continuing need for protected time to expand their research programs and to serve as mentors to more junior POR Depending on the policies of the sponsoring IC, candidates are expected to continue to hold independent peer-reviewed research support for the period of this award.

Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of and Submission Information Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.

gov . 2. Content and Form of Application Submission It is critical that applicants follow the instructions in (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Required and Optional Components The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be Other Project Information All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be PHS 398 Career Development Award Supplemental Form All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions: All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional Provide details of the candidate’s immediate and long-term career objectives in POR and in mentoring new clinician investigators.

Include a summary of the research career of the candidate, documenting the ability of the candidate to conduct high quality POR and commitment to a career in POR. Document the ability of the K24 candidate to provide mentoring to new clinician investigators.

Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, the specialties of the individual mentees and the stages in their professional career.

In addition, describe the types of research that were conducted by the individuals mentored, and the proportion of mentored individuals currently in academic medicine and/or directly Provide an explanation as to how relief from patient care or administrative responsibilities through the protected time provided by this award will contribute to the development or expansion of the candidate’s POR program and increased level of commitment to mentoring beginning clinician investigators.

It is important to convey to the reviewers the reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will permit the candidate to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution.

Describe the candidate’s career goals and objectives under this award, including prior experience, and current research support. Candidates are encouraged to provide a timeline for accomplishing these goals. Plan for Career Development/Training Activities During Award Period Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award.

Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator. The candidate should describe any new or enhanced research skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research programs as independent scientists.

in the Responsible Conduct of Research All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).

The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research Participation - may fulfill the requirement for instruction in RCR by participating as lecturers and discussion leaders; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years.

See also NOT-OD-10-019 . Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Plan to Provide Mentoring This required component should include a description of the availability of appropriate junior investigators for mentoring; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate 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. This plan should include active support for POR at the time of application for the career award, and may include research development support.

Candidates must indicate the proposed person months committed to All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional of Support from Collaborators and Consultants Signed statements must be provided by each collaborator and/or consultant confirming their participation in the project and describing their specific roles.

Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.

Institutional Commitment to the Candidate All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions: of Institutional Environment The sponsoring institution must define and document a well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate.

Include a description of the facilities and other resources that will be provided to the candidate. Descriptions of the institution should be sufficiently detailed so that reviewers can determine if the environment is conducive to performing high quality POR. This information will be evaluated very carefully by the peer reviewers and carry substantial weight in the evaluation of an application.

Commitment to the Candidate’s Research Career Development The sponsoring institution must provide a letter of commitment to the candidate's career goals as a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K24 award.

The letter of commitment from the institution should provide statements concerning the amount of protected time the candidate will receive (3-6 person-months or 25 to 50% full-time professional effort required); 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); and the institutional commitment to enhancing the candidate's ability to be a productive, independent investigator.

Provide assurance that the candidate is an integral part of the institution’s research and academic program.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided.

The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research. Currently supported research: There is no need to provide extensive detail with regard to ongoing, funded research.

Enough information should, however, be provided in the areas of Hypotheses and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the extent, special features and general quality of the candidate's research activities and opportunities for mentoring.

New research to be specifically supported by this award: Describe how this award will be used to help augment the candidate’s research skills and/or develop new directions in POR. This description should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims; Significance and Rationale; and Research Design and Methods.

Although it is not expected that this description would be as detailed as an application for an investigator-initiated research grant (e.g., R01), it is expected that sufficient detail be provided to permit an evaluation of the scientific merit of the research, and to clearly show research opportunities for mentoring.

Documentation must be provided that appropriate and adequate resources, both in terms of support and facilities, are available to the candidate to conduct the research program(s). This is an important part of the application because it will provide the main rationale and justification needing protected time for research.

The candidate must ensure that the inclusion of women, members of minority groups and their subpopulations, and children, has been addressed in the development of the design for all proposed patient-oriented research. The candidate must provide for each new research project proposed the information described in the PHS 398 Career Development Award Supplemental form Part 1, Section 7 of the R&R 424 instructions.

Candidates must provide plans for ensuring continuing support of their POR programs preferably with them as the Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Planned Enrollment Report When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) PHS 398 Cumulative Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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