FORMS VERSION H SERIES

Released: October 25, 2022

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 11

G.130 - Program Overview 13

G.200 - SF 424 (R&R) Form 26

G.210 - PHS 398 Cover Page Supplement Form 47

G.220 - R&R Other Project Information Form 53

G.230 - Project/Performance Site Location(s) Form 70

G.240 - R&R Senior/Key Person Profile (Expanded) Form 76

G.300 - R&R Budget Form 90

G.310 - R&R Subaward Budget Attachment(s) Form 114

G.320 - PHS 398 Modular Budget Form 119

G.330 - PHS 398 Training Budget Form 125

G.340 - PHS 398 Training Subaward Budget Attachment(s) Form 131

G.350 - PHS Additional Indirect Costs Form 134

G.360 - SF 424C Budget Information – Construction Programs 137

G.400 - PHS 398 Research Plan Form 142

G.410 - PHS 398 Career Development Award Supplemental Form 163

G.420 - PHS 398 Research Training Program Plan Form 188

G.430 - PHS Fellowship Supplemental Form 206

G.440 - SBIR/STTR Information Form 231

G.500 - PHS Human Subjects and Clinical Trials Information 240

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 announcement.

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 announcement, 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 OER Glossary l Grants Policy Statement l 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.

Step 2. Use these instructions, together with the forms and information found in the funding opportunity announcement, to complete your application.

The funding opportunity announcement (FOA) will include specific instructions and the forms needed for your application submission.

Remember that the FOA 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 Selecting the Correct Application Instructions to determine which 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 FOA, 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.

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.

NIH GRANTS ONLY: Additional information on this topic can be found in this FAQ or by contacting your IC Privacy Coordinator.

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).

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 Project Director/Principal Investigator (PD/PI), to also include Project Leaders on sub-projects to multi-project projects l PD/PI title l PD/PI email address l Organizational name l Institutional 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. Additional elements may be made available after announcements through the NIH Guide for Grants and Contracts, a weekly electronic publication that is available on NIH’s Funding page, or additions to the NIH Grants Policy Statement, as needed.

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 funding opportunity announcement (FOA) for your research and learn about key information you will find in the FOA.

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.

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 FOA.

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.

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 FOA 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 grantee monitoring and reporting requirements.

Resources

News - Items of Interest

The NIH eSubmission Items of Interest page provides comprehensive information, in an informal format, on the changes impacting application development and submission.

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 grantees 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.

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 - October 25, 2022

How to Use the Application Instructions l Added reminder to not include personal identifiable information (PII) or protected health information (PHI) in the application.

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

R&R Budget and associated R&R Subaward Budget Attachment(s) Form l Added special instructions for applicants submitting a Data Management and Sharing (DMS) Plan within the following sections:

l Under “Who should use the R&R Budget Form?” “Additional instructions for Multi- Project” l B. Other Personnel. Other Direct Costs “8-17 Other” l L. Budget Justification

Forms-H Changes

FORMS-H application packages incorporate the latest versions of the PHS forms managed by

NIH (OMB Number: 0925-0001 and 0925-0770, Expiration Date: 09/30/2024). OMB approval for FORMS-H changes are underway and the updated expiration dates will be provided and incorporated once they are finalized.

PHS 398 Modular Budget Form l Added special instructions for applicants submitting Data Management and Sharing (DMS) Plans.

PHS 398 Research Plan Form l Added new item 11. Other Plan(s) and added instructions for applicants submitting Data Management and Sharing (DMS) Plans.

l Renumbered form fields.

l Updated instructions for section 10, Resource Sharing Plan(s) to remove instructions for the Data Sharing Plan and Genomic Data Sharing (GDS). The DMS Plan will now be attached in the new item 11, Other Plan(s).

l Clarified instructions for renewal or resubmission applications involving changes between single PD/PI to or from multiple PD/PIs.

PHS 398 Career Development Award Supplemental Form l Added new item 17. Other Plan(s) and added instructions for applicants submitting Data Management and Sharing (DMS) Plans.

l Renumbered form fields.

l Updated instructions for 16. Resource Sharing Plan(s) to remove instructions for the Data Sharing Plan and Genomic Data Sharing (GDS). The DMS Plan will now be attached in the new item 17. Other Plan(s).

PHS 398 Research Training Program Plan Form l Added new item 13. Other Plan(s) for potential future use with other plans.

l Renumbered form fields.

l Clarified instructions for renewal or resubmission applications involving changes between single PD/PI to or from multiple PD/PIs.

PHS Fellowship Supplemental Form l Added new item 17. Other Plan(s) for potential future use with other plans.

l Renumbered form fields.

l Updated instructions for 16. Resource Sharing Plan(s) to remove instructions for the Data Sharing Plan and Genomic Data Sharing (GDS).

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).

Institutional 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 Activity Codes Search Results website.

2. Refer to your specific FOA: Refer to your FOA 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.

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 NIH Academic Research Enhancement Award (AREA)

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 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 FOA: Refer to your FOA 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 FOAs and other guidelines are available on the NIH K Kiosk.

l Announcements for various career award opportunities are issued periodically in the NIH Guide for Grants and Contracts, a weekly electronic publication, that is available on NIH’s Funding page.

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 FOA 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 Award Yes Yes

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 Yes Yes

Program Description Mentor Reference Letter

Development Award

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 FOA.

Institutional 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 Funding

Opportunity Announcement (FOA) 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 Institutional Training Grants page.

2. Refer to your specific FOA: Refer to your FOA 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 FOAs and other guidelines are available on the NIH T Kiosk.

l Announcements 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 Institutional Training Programs

Activity Code Program Description NRSA?

D43 International Research Training Grants No

D71 International Research Training Planning Grant No

K12 Clinical Scientist Institutional Career Development Program Award No

T32 Institutional National Research Service Award (NRSA) Yes

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

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

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

Activity Code Program Description NRSA?

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: Fogarty International Center (FIC) and National Library of Medicine (NLM) 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 FOA.

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.

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 F Kiosk and the AHRQ-Sponsored Training Opportunities page.

2. Refer to your specific FOA: Refer to your specific FOA 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 FOAs and other guidelines are available on the NIH F Kiosk.

l Guidelines for the AHRQ fellowships may be found on AHRQ's 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 Training Advisory Committee Roster.

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 applicants are encouraged to review the 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

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 funding opportunity announcement (FOA). 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 FOA.

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

l The FOA 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.

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)

Form Overall

Admin Core, Core Project, Other named components

Indiv Career Dev

Career Dev

NRSA

Training

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 announcement (FOA) 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).

Targeted SBIR/STTR Funding Opportunity Announcements 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 Electronic Submission 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 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.

ApplicationType Definition Participating HHS Component

Commercialization Plan Requirement

Phase I

Focuses on the feasibility, technical merit, and com-mercial potential of the pro-ject.

NIH, CDC*, FDA* No

Fast-Track

Phase I and Phase II sub-mitted and reviewed in one application. The Fast-Track mechanism can minimize the funding gap between phases but requires a fully

NIH Yes

ApplicationType Definition Participating HHS Component

Commercialization Plan Requirement developed Phase II applic-ation/plan at the time of submission.

Direct Phase II (SBIR Only)

Small businesses that have already demonstrated sci-entific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project can apply for a Direct to Phase II. Small businesses can sub-mit a Direct to Phase II application regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. However, small businesses that are eli-gible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are required to submit the regular Phase II application.

NIH Yes

Phase II

Continues the research and development efforts ini-tiated in Phase I. A small business can apply for a Phase II award once the Phase I milestones have been reached, even if that occurs before the end of the Phase I award. Applications for a Phase II award may be submitted up to six receipt dates after the Phase I budget period expires. Only one Phase II award is allowed for each project supported by a Phase I award.

NIH, CDC*, FDA* Yes

Phase IIB

For projects that require extraordinary time and effort beyond the Phase II to achieve com-mercialization. . *Must have received a Phase II to apply*

NIH Yes

ApplicationType Definition Participating HHS Component

Commercialization Plan Requirement

Commercialization Read-iness (CRP) Pilot Program

Provides Phase II and Phase IIB awardees with technical assistance and/or funding for late stage development.

The CRP may fund com-mercialization activities that are not typically supported through SBIR/STTR Phase II or Phase IIB awards. *Must have Phase II or IIB to apply*

NIH, CDC Yes

* CDC and FDA participate in SBIR only.

The current budget guidelines for the SBIR and STTR programs can be found in the Omnibus SBIR/STTR solicitations. The budget guidelines are the same for both programs, but individual NIH Institutes and Centers can set their own budget limits and Targeted SBIR/STTR Funding Opportunity Announcements may have their own budgetary guidance. The NIH recognizes that some biomedical innovations require funding levels above the award guidelines to reach the marketplace. For those topics, the NIH has a waiver from the Small Business Administration (SBA) to allow larger awards. The list of approved topics can be found on the SBIR/STTR Funding page.

Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the total award amounts listed in the solicitation. Applicants are strongly encouraged to contact NIH Program Officers prior to submitting any application in excess of the guidelines and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. Not all Institutes or Centers offer Phase IIB or CRP awards and allowable budgets may vary. For a full listing of those Institutes or Centers that accept Phase IIBs or CPRs, see the Omnibus Solicitation program Descriptions and Research Topics document.

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

The SF 424 (R&R) Form is used in all grant applications.

This form collects information including type of submission, applicant information, type of applicant, and proposed project dates.

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Quick Links

1. Type of Submission

2. Date Submitted and Applicant Identifier

3. Date Received by State and State Application Identifier

4a. Federal Identifier

4b. Agency Routing Identifier

4c. Previous Grants.gov Tracking ID

5. Applicant Information

6. Employer Identification

7. Type of Applicant

8. Type of Application

9. Name of Federal Agency

10. Catalog of Federal Domestic Assistance Number and Title

11. Descriptive Title of Applicant's Project

12. Proposed Project

13. Congressional District of Applicant

14. Project Director/Principal Investigator Contact Information

15. Estimated Project Funding

16. Is Application Subject to Review by State Executive Order 12372 Process?

17. Certification

18. SFLLL (Disclosure of Lobbying Activities) or Other Explanatory Documentation

19. Authorized Representative

20. Pre-application

21. Cover Letter Attachment

Additional Instructions for Multi-project:

Overall Component: Fill in all the SF424 (R&R) Form fields, as they are all collected.

Other Components: You need to fill in only a subset of fields in the SF424 (R&R) Form. Skip the other fields, as any information provided in them will be discarded.

The fields you must fill in are:

5. Applicant Information

7. Type of Applicant (Optional)

11. Descriptive Title of Applicant's Project

12. Proposed Project

1. Type of Submission

This field is required. Check one of the "Type of Submission" boxes:

Pre-application:

The pre-application option is not used by NIH or other PHS agencies unless specifically noted in a funding opportunity announcement (FOA).

Application:

An "Application" is a request for financial support of a project or activity submitted on specified forms and in accordance with NIH instructions. (See NIH Types of Applications for an explanation of the types of applications).

Changed/Corrected Application:

Check this box if you are correcting either system validation errors or application assembly problems that occurred during the submission process. Changed/corrected applications must be submitted before the application due date.

When you submit a changed/corrected application, follow these guidelines:

l After submission of an application, there is a two-day application viewing window. Prior to the due date, you may submit a changed/corrected application. Submitting a changed/corrected application will replace the previous submission and remove the previous submission from consideration.

l If you check the “Changed/Corrected Application” box, then "Field 4.c Previous Grants.gov Tracking ID” is required.

l Do not use the “Changed/Corrected Application” box to denote a resubmission application.

Resubmission applications will be indicated in “Field 8. Type of Application.” See NIH Glossary for the definition of Resubmission.

Additional Instructions for SBIR/STTR:

SBIR/STTR Phase II, Phase IIB and CRP Applications: To maintain eligibility to seek Phase II, Phase IIB, or CRP support for a specific project, awardees should submit within the first six due dates following the expiration of their budget period.

2. Date Submitted and Applicant Identifier

The “Date Submitted” field will auto-populate upon application submission.

Fill in the “Applicant Identifier” field, if applicable. The Applicant Identifier is reserved for applicant use, not the federal agency to which the application is being submitted.

3. Date Received by State and State Application Identifier

Skip the “Date Received by State” and “State Application Identifier” fields.

4.a. Federal Identifier

New Applications without Pre-application: Leave this field blank.

New Applications following Pre-application: Enter the agency-assigned pre-application number.

Resubmission, Renewal, and Revision Applications: The Federal Identifier is required. Include only the IC and serial number of the previously assigned application / award number (e.g., use CA987654 from 1R01CA987654-01A1).

Additional Instructions for SBIR/STTR:

When submitting a Phase II application, enter the Phase I SBIR/STTR grant number in this field. When submitting a Phase IIB or CRP application, enter the Phase II SBIR/STTR grant number in this field.

NIH SBIR Contract recipients: When submitting a Phase II, Phase IIB, or CRP grant application connected to a Phase I or Phase II contract, the applicant should submit a New application (as opposed to a Renewal) with a predetermined ‘alternative’ Grant Number used for the Federal Identifier. The Federal Identifier will be the awarding IC code, followed by six 0s. For example, if the applicant would like for NHLBI to be the awarding institute, they’d enter HL000000. It is critically important for the applicant to inform the appropriate NIH SBIR/STTR Program Manager before they apply. The applicant should also include a cover letter indicating that the application is a Phase II or Phase IIB, and that the Phase I was from an NIH SBIR contract.

For more information on applying for SBIR/STTR Phase II, Phase IIB or CRP awards, see the following link, and the SBIR / STTR Frequently Asked Questions.

4.b. Agency Routing Identifier

Skip the “Agency Routing Identifier” field unless otherwise…