PRDV009: Writing Grant Proposals

1. Requesting an Application Package

Applicants must obtain 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 the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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.

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

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form

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

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

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate's Background

• Describe the candidate's commitment to a career as an academic investigator. This should include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and their relationship to the proposed activities on the career award.
• Describe any prior training and how it relates to the immediate objectives and long-term career plans of the candidate.
• Describe the candidate's research efforts and training to this point in his/her research career, including any publications, prior research interests and experience; and how this effort relates to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's ability to interact and collaborate with other scientists.
• Provide evidence of the candidate's potential to develop into an academic investigator.
• Provide a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the program and related career development activities. The mentor or department chair must agree and provide a statement in the application documenting that this percent of your time will be protected.

Career Goals and Objectives

• Describe a systematic plan that: (1) shows a logical progression from the candidate's prior research and training experiences to the research and career development experiences that will occur during the Development Award period and then to independent investigator status; (2) justifies the need for further career development to become an independent academic investigator; (3) includes didactic and research components; and (4) utilizes the relevant research and educational resources of the institution.

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

• Provide details and the duration of planned structured activities, such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc. essential to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
• If there is a curriculum development component, describe how the results of the plan will contribute to an increase in the pool of individuals with academic or research expertise and/or enhance the educational or research capacity at the sponsoring institution.
• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline including a publication plan is strongly encouraged. Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidate's progress through the career development program.
• Describe the relationship of the research plan to the career development plan.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the Development Award. Explain how these responsibilities/activities will help ensure career progression to an independent research investigator.

Research Plan Section

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

Research Strategy

• A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate's research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
• The application must also describe the relationship between the mentor's research and the candidate's proposed research plan.
• If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
• Applications in basic cancer prevention sciences must include a plan to translate the results of the project into cancer prevention research using human subjects within the period of the K07 award.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

 

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

• The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the career development program and related career development activities.
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.

 

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• Advisory Committee members (if applicable): Signed statements must be provided by each member of the proposed Advisory Committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. These individuals generally do not need to provide their biographical sketches.

 

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to the Candidate's Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist.
• Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• Provide assurance that appropriate time and support will be available or any proposed mentor(s) and/or other staff consistent with the career development plan.
• Candidates who will be using the resources within a Clinical and Translational Science Award (CTSA) during the course of the award are requested to include a letter of agreement from the CTSA program director or the PD/PI as part of the application.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

 

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

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

 

4. Submission Dates and Times

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

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

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

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

 

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review. 

 

6. Funding Restrictions

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

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

 

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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

In order to expedite review, applicants are requested to notify the NCI Referral Office by email at ncirefof@dea.nci.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.