PKG00290368.pdf

FORMS VERSION I SERIES

Released: November, 2024

GENERAL INSTRUCTIONS FOR NIH AND

OTHER PHS AGENCIES

SF424 (R&R) Application Packages

Guidance developed and maintained by NIH for preparing and submitting applications via Grants.gov to NIH and other PHS agencies using the SF424 (R&R)

TABLE OF CONTENTS

TABLE OF CONTENTS 2

G.100 - How to Use the Application Instructions 3

G.110 - Application Process 7

G.120 - Significant Changes 10

G.130 - Program Overview 13

G.200 - SF 424 (R&R) Form 27

G.210 - PHS 398 Cover Page Supplement Form 48

G.220 - R&R Other Project Information Form 54

G.230 - Project/Performance Site Location(s) Form 71

G.240 - R&R Senior/Key Person Profile (Expanded) Form 77

G.300 - R&R Budget Form 91

G.310 - R&R Subaward Budget Attachment(s) Form 115

G.320 - PHS 398 Modular Budget Form 120

G.330 - PHS 398 Training Budget Form 126

G.340 - PHS 398 Training Subaward Budget Attachment(s) Form 132

G.350 - PHS Additional Indirect Costs Form 135

G.360 - SF 424C Budget Information – Construction Programs 138

G.400 - PHS 398 Research Plan Form 143

G.410 - PHS 398 Career Development Award Supplemental Form 164

G.420 - PHS 398 Research Training Program Plan Form 189

G.430 - PHS Fellowship Supplemental Form 208

G.440 - SBIR/STTR Information Form 232

G.500 - PHS Human Subjects and Clinical Trials Information 241

G.600 - PHS Assignment Request Form 283

Form Screenshots i

G.100 - How to Use the Application Instructions

Use these application instructions to fill out the forms that are posted in your funding opportunity.

View the How to Apply Video Tutorials.

Quick Links Step 1. Become familiar with the application process

Step 2. Use these instructions, together with the forms and information in the funding oppor-tunity, to complete your application

Step 3. Choose an application instruction format

Step 4. Complete the appropriate forms

Step 5. Stay informed of policy changes and updates

Step 6. Understand what data NIH makes public

Helpful Links

The information on the following pages may be useful in the application process l NIH Grants & Funding Glossary l Grants Policy Statement l NIH Guide to Grants and Contracts l Frequently Asked Questions

Step 1. Become familiar with the application process.

Understanding the application process is critical to successfully submitting your application.

Use the G.110 - Application Process section of these instructions to learn the importance of completing required registrations before submission, how to submit and track your application, where to find page limits and formatting requirements, and more information about the application process.

https://grants.nih.gov/grants/how-to-apply-application-guide/video/index.htm http://grants.nih.gov/grants/glossary.htm http://grants.nih.gov/policy/nihgps/index.htm https://grants.nih.gov/funding/searchguide/index.html#/ https://grants.nih.gov/faqs

Step 2. Use these instructions, together with the forms and information found in the Notice of Funding Opportunity, to complete your application.

The Notice of Funding Opportunity (NOFO) will include specific instructions and the forms needed for your application submission.

Remember that the NOFO instructions always supersede these application instructions.

Step 3. Choose an application instruction format.

Do you know your activity code, but don’t know which application instructions to use? Refer to NIH’s table on Determine the Correct Application Instructions for Your Activity Code to identify the set of application instructions applies to your grant program.

Comprehensive Instructions Program-Specific Instructions

Use the General (G) instructions, available in both HTML and PDF format, to complete the application forms for any type of grant program.

Take advantage of the filtered PDFs to view specific application instructions for:

l Research (R) l Career Development (K) l Training (T) l Fellowship (F) l Multi-project (M) l SBIR/STTR (B)

Step 4. Complete the appropriate forms.

Unless otherwise specified in the NOFO, follow the standard instruction, as well as any additional program-specific instructions for each form in your application.

Program-specific instructions are presented in gray call-out boxes that are color coded throughout the application instructions. Consult the G.130 - Program Overview section for context for program specific instructions.

http://grants.nih.gov/grants/how-to-apply-application-guide/selecting-application-instructions.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/general/g.100-how-to-use-the-application-instructions.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/general-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/career-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/training-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/fellowship-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/multi-project-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/sbir-sttr-forms-i.pdf

IMPORTANT: Do Not Include Personal Identifiable Information (PII) Or Protected

Health Information (PHI) In the Application Sensitive PII (e.g., Social Security Number, personal financial information, Alien Registration Number) and PHI (e.g., personal medical conditions) require strict handling due to the increased risk to an individual if the data is compromised. Documents containing sensitive PII or PHI must not be included in the application.

Step 5. Stay informed of policy changes and updates.

l Refer to the G.120 - Significant Changes section for the most recent changes to these application instructions.

l Review Notices of NIH Policy Changes since the posting of the Application Guide.

Step 6. Understand what data NIH makes public.

Information submitted as part of the application will be used by reviewers to evaluate the scientific merit of the application and by NIH staff to make the grant award and monitor the grant after award. The exception to this is the G.600 - PHS Assignment Request Form, which is only seen by staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR). There are also specific application attachment exceptions. The 21. Cover Letter Attachment on the SF 424 R&R Form is only seen by staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR). The Other Plan(s) attachment containing the Data Management and Sharing (DMS) Plan is only seen by NIH staff and will not be used by reviewers to evaluate the scientific merit of the application unless data sharing is integral to the project design and specified in the NOFO.

If the application is funded, the following fields will be made available to the public through the NIH Research Portfolio Online Reporting Tool (RePORTER) and will become public information:

l Name of Program Director/Principal Investigator (PD/PI), to also include Project Leaders on sub-projects to multi-project projects l PD/PI title https://grants.nih.gov/policy-and-compliance/notice-of-policy-changes https://projectreporter.nih.gov/reporter.cfm l PD/PI email address l Organizational name l Organizational address l Project summary/abstract l Public health relevance statement

In addition, key elements related to ongoing funded projects will be made available to the public, including those listed in the data dictionary at ExPORTER. Changes to the elements made publicly available are announced through notices in the NIH Guide for Grants and Contracts and/or updates to the NIH Grants Policy Statement.

https://report.nih.gov/exporter-data-dictionary https://grants.nih.gov/funding/searchguide/index.html https://grants.nih.gov/policy/nihgps/index.htm

G.110 - Application Process

Understanding the application process is critical to successfully submitting your application.

Use this section of this guide to learn the importance of completing required registrations before submission; how to submit and track your application; where to find information about page limits, formatting requirements, due dates, and submission policies; and more information about the application process. This application process information is also available on our How to Apply – Application Guide page.

Quick Links Prepare to Apply and Register

Write Application

Submit

Related Resources

Prepare to Apply and Register

Systems and Roles

Learn about the main systems involved in application submission and the role you and your colleagues play in the submission process. The main systems are Grants.gov, eRA Commons, and

ASSIST.

Register

Determine your registration status. Organizations, organizational representatives, investigators, and others need to register in multiple federal systems in order to for you to submit a grant application. Registration can take six weeks or more to complete. Start today! See NIH’s Registration website.

Understand Funding Opportunities

Identify the right Notice of Funding Opportunity (NOFO) for your research and learn about key information you will find in the NOFO.

Types of Applications

Are you submitting a new, renewal, revision, or resubmission application? Learn about the different types of applications and special submission requirements.

Submission Options

Determine which system is most convenient for your application submission: NIH’s ASSIST web-based application submission system, Grants.gov Workspace, or, if applicable, your organization’s own submission system.

http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/systems-and-roles.htm http://www.grants.gov/ https://www.era.nih.gov/ https://public.era.nih.gov/assist/public/login.era?TYPE=33554433&REALMOID=06-58b5535a-f2c3-40ec-b9ff-a06a3ed4ee18&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-HTTPS%3a%2f%2fpublic%2eera%2enih%2egov%2fassist%2f http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/registration.htm http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/registration.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/understand-funding-opportunities.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/type-of-applications.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/submission-options.htm

Obtain Software

Applicants must have the free Adobe Reader software, a PDF generator, and a web browser to submit an application. Learn which versions are compatible with our systems.

Write Application

Write Your Application

Read tips for developing a strong application that helps reviewers evaluate its science and merit.

Develop Your Budget

Learn about the kinds of costs you may include in your budget submission, the difference between modular and detailed budgets, and more about how to develop your budget.

Format Attachments

Follow these requirements for preparing the documents you attach to your application.

Requirements include criteria for the PDF files, fonts, margins, headers and footers, paper size, citations, formatting pages, use of hyperlinks and URLs, etc.

Rules for Text Fields

Learn the rules for form text fields – allowable characters, cutting and pasting, character limits, and formatting.

Page Limits

Follow the page limits specified in this table for your specific grant program, unless otherwise specified in the NOFO.

Data Tables

Find instructions, blank data tables, and samples to use with institutional research training applications.

Reference Letters

Some types of programs, such as fellowships and some career development awards, require the submission of reference letters by the referee. Learn about selecting a referee and find instructions for submission.

Biosketches

Biosketches are required in both competing applications and progress reports. Find instructions, blank format pages, limitation on use of hyperlinks and URLs, and sample biosketches.

Submit

Submit, Track and View

Learn how to submit your application, and about your responsibility for tracking your application and viewing the application image in the eRA Commons before the application deadline. If you can’t view your application in eRA Commons, we can’t review it.

http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/obtain-software.htm http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-your-application.htm http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget.htm http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/rules-for-text-fields.htm https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm http://grants.nih.gov/grants/forms/datatables.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm http://grants.nih.gov/grants/forms/biosketch.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/submit-track-view.htm

How We Check for Completeness

Your application will be checked at Grants.gov, by eRA systems, and by federal staff before it is referred for review.

Changed/Corrected Applications

You will need to submit a changed/corrected application to correct issues that either you or our systems find with your application. Learn how and when you may submit a changed/corrected application.

Related Resources

Due Dates and Policies

Due Dates

View standard due dates for competing applications. The NOFO will identify whether to follow standard due dates or whether to follow an alternative due date.

Submission Policies

Learn the nuances of application submission policies, including when late applications might be allowed, what to do if due dates fall on a weekend or holiday, whether we allow post-submission materials, how to document system issues, the rules around resubmission applications, etc.

Dealing with System Issues

Are you experiencing system issues with ASSIST, Grants.gov, System for Award Management (SAM), or the eRA Commons that you believe threaten your ability to submit on time? NIH will not penalize applicants who experience confirmed issues with federal systems that are beyond their control. You must report the problem before the submission deadline.

After Submission

Receipt and Referral

Understand how and when applications are given an application identification number and assigned to a review group and an NIH Institute or Center (IC) for possible funding.

Peer Review

Learn about our two phase peer review process, including initial peer review, Council review, review criteria, scoring, and summary statements.

Pre-award Process

Learn what happens between peer review and award for applications that have been deemed highly meritorious in the scientific peer review process. Be ready: if you received a great score in peer review, you’ll have to submit Just-in-Time information.

Post award Monitoring and Reporting

If you receive a grant from the NIH, you will need a lot of information to be a successful steward of federal funds. This page provides a brief overview of recipient monitoring and reporting requirements.

http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/check-your-application.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/changed-corrected-application.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/submission-policies.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm https://grants.nih.gov/grants-process/review/receipt-referral https://grants.nih.gov/grants/peer-review.htm http://grants.nih.gov/grants/pre-award-process.htm http://grants.nih.gov/grants/post-award-monitoring-and-reporting.htm

Resources

Annotated Form Sets

These handy documents are a great visual resource for understanding many of the validation checks we will run against your submitted application.

Contacting NIH Staff

NIH staff is here to help. We strongly encourage NIH applicants and recipients to communicate with us throughout the grant life cycle. Understanding the roles of NIH staff can help you contact the right person at each phase of the application and award process.

Contacting Staff at Other PHS Agencies

Applicants are strongly encouraged to communicate with agency staff throughout the entire application review and awards process.

Systems

ASSIST

eRA Commons

Grants.gov

Information Collection

Authorization

The PHS Act establishes the authority with which NIH and other PHS agencies award grants and collect information related to grant awards.

Paperwork Burden

The paperwork burden provides the estimated time for completing a grant application.

Collection of Personal Demographic Data

NIH collects personal data through the eRA Commons Personal Profile. The data is confidential and is maintained under the Privacy Act record system.

G.120 - Significant Changes

The Application Instructions are updated and released 2-3 times per year as needed.

Additionally, minor revisions may be made outside of these releases.

This section details all significant changes and revisions made to the instructions since the last major release.

Within the instructions, new instructions will be marked with this symbol.

https://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm https://grants.nih.gov/help/ic-staff-roles https://grants.nih.gov/grants/how-to-apply-application-guide/resources/contacting-staff-at-other-public-health-service-agencies.htm https://public.era.nih.gov/assist/public/login.era?TYPE=33554433&REALMOID=06-58b5535a-f2c3-40ec-b9ff-a06a3ed4ee18&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-HTTPS%3a%2f%2fpublic%2eera%2enih%2egov%2fassist%2f https://www.era.nih.gov/ http://www.grants.gov/ http://grants.nih.gov/grants/authorization.htm http://grants.nih.gov/grants/paperwork-burden.htm http://grants.nih.gov/grants/collection-of-personal-demographic-data.htm

In the web version, use your mouse to hover over the icon to read an explanation of the change.

In a PDF version, this symbol will be visible but will not display hover text. For more information, see the explanation in the Significant Changes section below.

Release Notes - November, 2024

How to Use the Application Instructions l Minor text updates throughout to align with terminology in 2 CFR 200.

SF-424 Research and Related (R&R) Form Changes

Senior Key Person Profile (Expanded) Form l Removed instructions for D. Scholastic Performance in the “Instructions for a Biographical Sketch.”

Forms-I Changes

FORMS-I application packages incorporate the latest versions of the PHS forms managed by NIH (OMB Number: 0925-0001 and 0925-0770, Expiration Date: 01/31/2026). OMB approval for FORMS-I changes are underway and the updated expiration dates will be provided and incorporated once they are finalized.

PHS 398 Cover Page Supplement Form l Updated “Change of Investigator/Change of Organization” Section label.

PHS 398 Research Training Plan Form l Added new item 3. Recruitment Plan to Enhance Diversity in the “Training Program Plan” Section. Moved instructions for the Recruitment Plan to Enhance Diversity from the 2.

Program Plan to the new item 3. Updated instructions for the 2. Program Plan throughout.

l Updated instructions for the “Program Overview” section of the 7. Progress Report (for Renewal Applications) and added instructions for Renewal Applications to the 5. Plan for Instruction in Methods for Enhancing Reproducibility.

l Renumbered form fields.

PHS Fellowship Supplemental Form l Renamed “Candidate Section” (formerly “Fellowship Applicant Section”) and item 2. Goals, Preparedness, and Potential (formerly 2. Applicant’s Background and Goals for Fellowship Training). Updated instructions. Renamed “Candidate Section” (formerly “Fellowship

Applicant Section”) and item 2. Goals, Preparedness, and Potential (formerly 2. Applicant’s Background and Goals for Fellowship Training). Updated instructions.

l Streamlined and Consolidated items in the “Research Training Plan” Section and removed the former 5. Respective Contributions and 6. Selection of Sponsor and Organization.

Relabeled items within section and updated instructions as follows:

l Training Activities and Timeline l Research Training Project Specific Aims l Research Training Project Strategy l Streamlined and Consolidated items in the former “Sponsor(s), Collaborator(s), and Consultant(s) Section” and “Organizational Environment and Commitment to Training Section” and combined under the “Commitment to Candidate, Mentoring, and Training Environment” Section and removed the former 9. Sponsor and Co-Sponsor Statements and 11. Description of Organizational Environment and Commitment to Training.

Relabeled items within section and updated instructions as follows:

l Sponsor(s) Commitment l Letters of Support from Collaborators, Contributors and Consultants l Description of Candidate's Contribution to Program Goals.

l Updated 26, Childcare Costs to reflect changes in amount of childcare cost support available and new eligibility for F99 awards.

l Renumbered form fields

PHS Assignment Request Form l Reduced data entry redundancy on the form by removing the “Funding Opportunity Number” and “Funding Opportunity Title” fields.

l Reordered “List individuals who should not review your application and why” and “Identify scientific areas of expertise needed to review your application” fields.

Form Screenshots l Updated form screenshots.

G.130 - Program Overview

Quick Links Research and Other ("R" Series).

Individual Research Career Development Award (CDA) Application ("K" Series).

Organizational Research Training and Career Development Program Applications ("T" Series).

Individual Fellowship Applications ("F" Series).

Multi-project Applications ("M" Series).

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR).

Research and Other ("R" Series)

The purpose of research and other awards is to provide support for health-related research and development based on the mission of the NIH. Some examples of support include pilot studies;

conferences and scientific meetings; small research projects; institutional training and director program projects; resource programs; and new, exploratory, and developmental research projects.

Awards may be in the form of grants or cooperative agreements.

Additional Instructions for Research:

Additional research instructions will be denoted by a gray call-out box with yellow color coding and with the heading “Additional Instructions for Research” throughout these application instructions.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code for which support is being requested. These include many “R” activity codes, as well as some “DP,” “G," “S,” and “U” activity codes. A comprehensive list of all activity codes, with their descriptions, is available on NIH’s Research Career Development (K) Awards Kiosk page.

2. Refer to your specific NOFO: Refer to your NOFO for specific information associated with the award mechanism, including the eligibility requirements, review criteria, award provisions, any special application instructions, and names of individuals who may be contacted for additional or clarifying information prior to application submission.

l NOFOs and other guidelines are available on the NIH research training career development web page.

l Opportunities for various career award opportunities are issued periodically in the NIH Guide for Grants and Contracts.

l Some individual K-series programs supported by the NIH include a delayed-award activation and/or two award phases (e.g., K22, K99/R00). NIH https://researchtraining.nih.gov/programs/career-development https://researchtraining.nih.gov/programs/career-development https://researchtraining.nih.gov/programs/career-development https://researchtraining.nih.gov/programs/career-development intramural researchers may be eligible to apply for these awards. The NOFO will include any additional and/or specific instructions that must be followed when applying for such support.

3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

The following chart provides a summary of the existing research programs; however, the chart is not a comprehensive list of activity codes. Since this information is subject to change, prospective applicants are encouraged to review NIH’s Types of Grant Programs for the most current program information.

Summary of Research Award Programs*

Activity Code Program Description

R01 Research Project

R03 NIH Small Grant Program

R13 Conference

R15 Research Enhancement Awards

R21 NIH Exploratory / Developmental Research Grant Award

R25 Education Projects

R41 Small Business Technology Transfer (STTR) Grants - Phase I

R42 Small Business Technology Transfer (STTR) Grants - Phase II

R43 Small Business Innovation Research (SBIR) Grants - Phase I

R44 Small Business Innovation Research (SBIR) Grants - Phase II

U01 Research Project – Cooperative Agreements

U13 Conference - Cooperative Agreements

G07 Resources Improvement Grant

S10 Biomedical Research Support Shared Instrumentation Grants

DP1 NIH Director's Pioneer Award (NDPA)

*This is not a comprehensive list of activity codes.

Individual Research Career Development Award (CDA) Application ("K" Series)

The purpose of the career development award (CDA) program is to provide candidates at the postdoctoral, early career, and mid-career stages with opportunities to build on their initial https://grants.nih.gov/grants/funding/funding_program.htm research training and to further develop their research careers through individual or institutional awards.

This section provides instructions for candidates applying for individual career development awards. Applicants for institutional career development programs, such as the K12 award, should follow the guidance provided in the "Additional Instructions for Training" sections.

Reference Letters: Instructions for submitting the required reference letters for applicable programs are not contained in these application instructions. Instead, follow the instructions on NIH’s Reference Letters page. Referees must submit reference letters through the eRA Commons by the application due date.

Additional Instructions for Career Development:

Additional career development instructions will be denoted by a gray call-out box with green color coding and with the heading “Additional Instructions for Career Development” throughout these application instructions.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the K activity code for which support is being requested. A listing of “K” series activity codes, with their descriptions, is available on the Research Career Development Awards page.

2. Refer to your specific NOFO: Refer to your NOFO for specific information associated with the award mechanism, including the eligibility requirements, requirements for a mentor or mentors, review criteria, award provisions, any special application instructions, and names of individuals who may be contacted for additional or clarifying information prior to application submission.

l NOFOs and other guidelines are available on the NIH K Kiosk.

l Opportunities for various career award opportunities are issued periodically in the NIH Guide for Grants and Contracts.

l Some individual K-series programs supported by the NIH include a delayed-award activation and/or two award phases (e.g., K22, K99/R00). NIH intramural researchers may be eligible to apply for these awards. The NOFO will include any additional and/or specific instructions that must be followed when applying for such support.

3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

The following chart provides a summary of the existing individual career development programs.

Since this information is subject to change, prospective applicants are encouraged to review the K Kiosk for the most current program information.

Summary of Research Career Development Award Programs

Program Description Mentor Reference Letter

K01 Mentored Research Scientist Career Development Yes Yes http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm https://researchtraining.nih.gov/programs/career-development http://grants.nih.gov/training/careerdevelopmentawards.htm https://grants.nih.gov/funding/searchguide/index.html

Program Description Mentor Reference Letter

Award

K02 Independent Research Scientist Development Award No No

K05 Senior Research Scientist Award No No

K07 Academic Career Development Award * *

K08 Mentored Clinical Scientist Research Career Development Award Yes Yes

K18 Research Career Enhancement Award for Established Investigators Yes Yes

K22 Career Transition Award * Yes

K23 Mentored Patient-Oriented Research Career Development Award Yes Yes

K24 Mid-Career Investigator Award in Patient-Oriented Research No No

K25 Mentored Quantitative Research Career Development Award Yes Yes

K26 Mid-Career Investigator Award in Biomedical and Behavioral Research No No

K43 Emerging Global Leader Award Yes Yes

K76 Emerging Leaders Career Development Award Yes Yes

K99/R00 Pathways to Independence Award Yes Yes

*Varies with career status and source of award. Check the NOFO.

Organizational Research Training and Career Development Program Applications ("T" Series)

The purpose of research training awards is to provide support for institutional research training programs and opportunities for trainees at the undergraduate, graduate, and postdoctoral levels.

Training-specific instructions apply both to NIH-supported Ruth L. Kirschstein National Research Service Award (NRSA) institutional research training programs (e.g., T32, T34, T35, T36, T90) and to non-NRSA training and career development programs (e.g. T15, T37, D43, D71, K12, U2R).

Additional Instructions for Training:

Additional training instructions will be denoted by a gray call-out box with blue color coding and with the heading “Additional Instructions for Training” throughout these application instructions.

NRSA Programs: These programs help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to carry out the nation’s biomedical and behavioral research agenda. Certain specialized training grants, such as undergraduate training grants (T34), are provided under this authority.

Non-NRSA Programs: Non-NRSA training and career development programs operate under different regulatory authorities than NRSA programs. While much of the information may be the same, individuals interested in those programs should carefully read the applicable Notice of Funding Opportunity (NOFO) for specific program information and special application instructions. Non-NRSA training programs may have eligibility requirements, due dates, award provisions, and review criteria that differ from those of NRSA programs.

Payback Service Requirement: For NRSA programs that include postdoctoral trainees, the program director must explain the terms of the payback service requirement to all prospective postdoctoral training candidates. A complete description of the service payback obligation is available in the NIH Grants Policy Statement, Section 11.4.3: Payback.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code and the purpose of the specific program for which support is being requested. A listing of “T” series activity codes, with their descriptions, is available on the Organizational Training Grants page.

2. Refer to your specific NOFO: Refer to your NOFO for specific information associated with the award mechanism and the names of individuals who may be contacted for additional or clarifying information prior to application submission.

l NOFOs and other guidelines are available on the NIH T Kiosk.

l Opportunities for various training programs are issued periodically in the NIH Guide for Grants and Contracts, a weekly electronic publication, that is available on NIH’s Funding page.

3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

The following chart provides a summary of the existing training programs. Since this information is subject to change, prospective applicants are encouraged to review the T Kiosk for the most current program information.

Summary of Organizational Training Programs

Activity Code Program Description NRSA?

D43 International Research Training Grants No https://grants.nih.gov/grants/policy/nihgps/HTML5/section_11/11.4.3_payback.htm https://researchtraining.nih.gov/programs/training-grants https://researchtraining.nih.gov/programs/training-grants https://researchtraining.nih.gov/programs/training-grants

Activity Code Program Description NRSA?

D71 International Research Training Planning Grant No

K12 Clinical Scientist Organizational Career Development Program Award No

T32 Organizational National Research Service Award (NRSA) Yes

T34 Undergraduate National Research Service Award (NRSA) Organizational Research Training Grant Yes

T35 National Research Service Award (NRSA) Short-Term Organizational Research Training Grant Yes

T36 National Research Service Award (NRSA) Short-Term Organizational Research Training Grant Yes

T90 Interdisciplinary Research Training Award Yes

U2R International Research Training Cooperative Agreement No

Individual Fellowship Applications (“F” Series)

The purpose of individual fellowship awards is to provide individual research training opportunities to fellows at the graduate and postdoctoral levels. This section contains information for preparing Kirschstein-NRSA (NRSA) fellowship and non-NRSA fellowship applications.

Additional Instructions for Fellowship:

Additional fellowship instructions will be denoted by a gray call-out box with orange color coding and with the heading “Additional Instructions for Fellowship” throughout these application instructions.

NRSA Programs: The NRSA program helps ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to carry out the nation’s biomedical and behavioral research agenda. NRSA fellowships are awarded as a result of national competition for research training in specified health-related areas. Certain specialized individual fellowships, such as the predoctoral fellowships (F31 and F30), postdoctoral fellowships (F32), senior fellowships (F33), and other institute-specific fellowship programs, are provided under this authority.

Non-NRSA Programs: NIH Institutes and Centers also have unique funding authorities for fellowships that are not under the NRSA authority. Note that non-NRSA programs may have eligibility requirements, due dates, award provisions, and review criteria that differ from those of NRSA programs. Applicants should refer to their NOFO.

Reference Letters: Instructions for submitting the required reference letters for applicable programs are not contained in these application instructions. Instead, follow the instructions on NIH’s Reference Letters page. Referees must submit reference letters through the eRA Commons by the application due date. eRA Commons credentials are not required to submit reference letters.

http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm

Payback Service Requirement: For NRSA programs that include postdoctoral fellows, the program director must explain the terms of the payback service requirement to all prospective postdoctoral fellowship candidates. A complete description of the service payback obligation is available in the NIH Grants Policy Statement, Section 11.4.2: Implementation.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the “F” activity code for which support is being requested. A listing of “F” series activity codes, with their descriptions, is available on the NIH Individual Fellowships (F) Kiosk and the AHRQ Research Training and Education page.

2. Refer to your specific NOFO: Refer to your specific NOFO for specific information associated with the award mechanism, including the eligibility requirements, requirements for a mentor, review criteria, award provisions, any special application instructions, and names of individuals who may be contacted for additional or clarifying information prior to application submission.

l NOFOs and other guidelines are available on the NIH Individual Fellowships (F) Kiosk.

l Guidelines for the AHRQ fellowships may be found on AHRQ's AHRQ Research Training and Education website.

3. Contact Awarding Component: Applicants are encouraged to consult with the appropriate NIH IC or AHRQ staff prior to submitting an application, as not all predoctoral, postdoctoral, and senior fellowships are supported by each IC or AHRQ.

l A list of contacts specifically for extramural training at the NIH ICs can be found on the NIH Extramural Research Training Representatives page.

l For contacts at AHRQ, see AHRQ’s Research Training Staff Contacts website.

The following chart provides a list of fellowship activity codes. Since this information is subject to change, prospective candidates are encouraged to review the Individual Fellowships (F) Kiosk for the most current program information.

Summary of Individual Fellowship Award Programs

Activity Code Program Description NRSA?

F05 International Research Fellowships No

F30 Individual Predoctoral National Research Service Award (NRSA) for M.D./Ph.D. and Other Dual Degree Fellowships Yes

F31 Predoctoral Individual National Research Service Award Yes

F32 Postdoctoral Individual National Research Service Award Yes

F33 National Research Service Awards for Senior Fellows Yes

F37 Medical Informatics Fellowships No

F38 Applied Medical Informatics Fellowships No

F99/K00 Individual Predoctoral to Postdoctoral Fellow Transition Award No https://grants.nih.gov/grants/policy/nihgps/HTML5/section_11/11.4.2_implementation.htm https://researchtraining.nih.gov/programs/fellowships http://www.ahrq.gov/funding/training-grants/index.html https://researchtraining.nih.gov/programs/fellowships https://researchtraining.nih.gov/programs/fellowships http://www.ahrq.gov/funding/training-grants/index.html http://www.ahrq.gov/funding/training-grants/index.html https://researchtraining.nih.gov/ic-training-representatives http://www.ahrq.gov/funding/training-grants/contacts.html https://researchtraining.nih.gov/programs/fellowships

Multi-project Applications ("M" Series)

A multi-project application is a single submission with multiple, interrelated components that share a common focus or objective.

A component is a distinct, reviewable part of a multi-project application for which there is a business need to gather detailed information as defined in a particular Notice of Funding Opportunity (NOFO). Components typically include general information (component organization, project period, project title, etc.), information about performance sites, information about proposed work to be accomplished, and a budget.

Additional Instructions for Multi-project:

Additional multi-project instructions will be denoted by a gray call-out box with red color coding and with the heading “Additional Instructions for Multi-project” throughout these application instructions.

Although multi-project applications use the same forms used for single-project applications, there are some differences in the way multi-project applications are structured. Every multi-project application includes:

l A Single Overall Component: The Overall Component describes the entire application and provides an overview of how each of the other components fit together.

l One or more Other Component Types: Other Component types (e.g., Admin Core, Project Core) will vary by opportunity and will be specified in the NOFO.

l Summaries: Information is automatically compiled from the data provided by the applicant in the individual components and included as part of the Overall Component in the agency-assembled application to help reviewers and staff work with the application. The following summaries are generated:

l Component l Performance Sites l Human Subjects - Clinical Trials – Vertebrate Animals- hESC l Human Embryonic Stem Cell Lines l Budget l Program Income l Senior/Key Personnel l Biosketches

For information on how your application will be automatically assembled for review and funding consideration after submission, see the How eRA Assembles Multi-project Applications file.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code(s) for which support is being requested. A comprehensive list of all activity codes, with their descriptions, is available on the Activity Codes Search Results website.

2. Refer to your specific NOFO: Refer to your specific NOFO for specific information associated with the award mechanism, including special application instructions.

http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf https://grants.nih.gov/grants/funding/ac_search_results.htm l The NOFO will specify the types of Other Components that should be used when preparing the application, whether each component is optional or required, and any restrictions on the number of times each component can be included in an application.

3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

Collaborating with Other Organizations Multi-project applications often include a number of collaborating organizations in addition to the applicant organization. The applicant organization always has primary responsibility for and leads the Overall Component. A collaborating organization may be responsible for a small part of a component or have lead responsibility for an entire Other Component within the application.

Depending on the role of the collaborating organization(s) in the project, there are two approaches to structuring a component:

A. Collaborating Organization as the Lead of a Component:

When the bulk of the leadership and work on a component (other than the Overall Component) is performed by a collaborating organization, then that organization can be set up as the lead organization for that component. All the component forms (including the SF 424 R&R Form and the R&R Budget Form) are completed using the collaborating organization’s information. On the R&R Budget Form, use the Budget Type “Project” to identify it as the primary budget for the component and provide the collaborating organization’s Unique Entity Identifier (UEI) number and name. Any other organizations involved in the component (including the applicant organization) are included in subaward/consortium budget forms.

From an administrative perspective, the entire component (minus any work done by the applicant organization) is treated as a subaward/consortium to the applicant organization.

The structure of the application reflects where the proposed work is being done, not the flow of funds. eRA systems use the Unique Entity Identifier (UEI) numbers included on budget forms to determine the flow of funds.

B. Collaborating Organization as a Consortium in a Component:

When a collaborating organization does not have a leadership role for a component, then the applicant organization is the component lead, and any collaborating organizations are included using the subaward/consortium budget form.

Multi-project Application Component Forms You must complete a set of forms for each component.

The assembled application image created for a multi-project application has a predefined order.

For information on multi-project application assembly, see the How eRA Assembles Multi-project Applications file.

The chart below summarizes which forms must be completed for each component.

http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf

Component Data Forms

Form Overall

Admin Core, Core Project, Other named components

Indiv Career Dev

Career Dev

NRSA

Training

SF424 R&R cover

PHS 398 Cover Page Supplement

R&R Other Project Information

Project/Performance Sites

R&R Sr/Key Person Profile (Expanded)

PHS Human Subjects and Clinical Trials Information

PHS Assignment Request Form Optional

R&R Budget

R&R Subaward Budget Attachment Optional Optional Optional

PHS 398 Training Budget

Training Subaward Budget Attachment Form Optional

PHS Additional Indirect Costs Optional

PHS 398 Research Plan

PHS 398 Career Development Award Supplemental Form

PHS 398 Research Training Program Plan

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)

The Small Business Programs, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR), are known as America’s Seed Fund because they provide U. S. small businesses with over $1 billion each year in non-dilutive funding for early-stage healthcare product development. These programs support U.S.-owned and operated small businesses to engage in research and development activities to develop innovative technologies that have a strong potential for commercialization and patient impact. HHS focuses on a wide variety of high-impact technologies including drugs, biologics, medical devices, diagnostics, digital health products, and research tools.

Additional Instructions for SBIR/STTR:

Additional SBIR/STTR instructions will be denoted by a gray call-out box with purple color coding and with the heading “Additional Instructions for SBIR/STTR” throughout these application instructions.

New to SBIR/STTR?

View our SBIR/STTR How to Apply Instructions page.

View the Understanding SBIR / STTR description page.

Confirm Small Business Eligibility Criteria.

Develop an Innovative Research and Development Proposal with Commercial Potential

Determine which SBIR/STTR funding opportunity is most appropriate for your idea. The general Omnibus SBIR/STTR solicitations allow researchers to submit their own ideas to NIH, Center for Disease Control (CDC), and the Food and Drug Administration (FDA).Specific SBIR/STTR Funding Opportunities solicit proposal that address targeted research areas of special interest. Before starting the application process, you should speak with an HHS SBIR/STTR representative, usually referred to as Program Officials, to get feedback on the programmatic fit of your project. If you are unsure of who to contact, you can email SEED (Small business Education and Entrepreneurial Development) at SEEDinfo@nih.gov.

Required Registrations

The registration process may take 6 – 8 weeks, so it is important to start early. Learn about the registration process, including the SBA Company Registration, which is unique to SBIR/STTR applicants. Small businesses are encouraged to submit via ASSIST.

Phased Program:

Both the SBIR and STTR programs are organized in two phases of government funding:

l Phase I: Supporting Feasibility and Proof of Concept; and l Phase II: Supporting Research and Development.

An expectation of the SBIR and STTR programs is that award recipients will use internal resources, or additional follow-on funding from the private sector, to move the product or service developed through their Phase II award into the marketplace. While not a Phase I or II, The Commercialization Readiness Pilot (CRP) program uses SBIR funding to provide additional support to advance https://seed.nih.gov/small-business-funding/how-to-apply https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr https://seed.nih.gov/small-business-funding/small-business-program-basics/eligibility-criteria https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities#nonparenttable https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities#nonparenttable mailto:SEEDinfo@nih.gov https://seed.nih.gov/small-business-funding/how-to-apply/before-you-apply#register-company-card https://app.www.sbir.gov/company-registration/overview https://public.era.nih.gov/assist products toward commercialization. CRP applicants must comply with SBIR eligibility requirements and follow all SBIR Phase II application instructions.

The table below summarizes the types of SBIR/STTR applications.

Application Type Definition Participating HHS…