My Document

FORMS VERSION H SERIES

Released:August 5

, 2023

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 14

G.200 - SF 424 (R&R) Form 28

G.210 - PHS 398 Cover Page Supplement Form 49

G.220 - R&R Other Project Information Form 55

G.230 - Project/Performance Site Location(s) Form 72

G.240 - R&RSenior/Key Person Profile (Expanded) Form 78

G.300 - R&R Budget Form 92

G.310 - R&R Subaward Budget Attachment(s) Form 116

G.320 - PHS 398 Modular Budget Form 121

G.330 - PHS 398 Training Budget Form 127

G.340 - PHS 398 Training Subaward Budget Attachment(s) Form 133

G.350 - PHS Additional Indirect Costs Form 136

G.360 - SF 424C Budget Information – Construction Programs 139

G.400 - PHS 398 Research Plan Form 144

G.410 - PHS 398 Career Development Award Supplemental Form 165

G.420 - PHS 398 Research Training Program Plan Form 190

G.430 - PHS Fellowship Supplemental Form 208

G.440 - SBIR/STTR Information Form 233

G.500 - PHS Human Subjects and Clinical Trials Information 242

G.600 - PHS Assignment Request Form 285

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

NIH Grants & Funding Glossary

Grants Policy Statement

NIH Guide to Grants and Contracts

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 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:

Research (R)

Career Development (K)

Training (T)

Fellowship (F)

Multi-project (M)

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.

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

application instructions.

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:

Name of Project Director/Principal Investigator (PD/PI), to also include Project Leaders on sub-

projects to multi-project projects

PD/PI title

PD/PI email address

Organizational name

Institutional address

Project summary/abstract

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.

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

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 - August 5, 2023

Program Overview - Small Business Innovation Research (SBIR) and Small Business Technology

Transfer (STTR)

Added new “Disclosure Requirements Regarding Ties to Foreign Countries” and “Denial of

Awards” subsections outlining requirements related to the implementation of NIH SBIR and STTR

Foreign Disclosure Pre-award Requirements and the HHS Due Diligence Program, applicable for

competing applications submitted for due dates on or after September 5, 2023.

R&R Other Project Information Form

Updated Additional Instructions for SBIR/STTR for the content of 10. Facilities & Other Resources

for applications submitted for due dates on or after September 5, 2023.

R&R Budget and associated R&R Subaward Budget Attachment(s) Form

Updated special instructions for applicants submitting a Data Management and Sharing (DMS)

Plan within the following sections for applications submitted for due dates on or after October 5,

2023:

Under “Who should use the R&R Budget Form?” “Additional instructions for Multi-Project”

B. Other Personnel. Other Direct Costs “8-17 Other”

L. Budget Justification

PHS 398 Modular Budget Form

Updated instructions for the “Additional Narrative Justification” Budget Justification attachment

content and special instructions for applicants submitting Data Management and Sharing (DMS)

Plans.

Release Notes - October 25, 2022

How to Use the Application Instructions

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

Added special instructions for applicants submitting a Data Management and Sharing

(DMS)Plan within the following sections:

Under “Who should use the R&R Budget Form?” “Additional instructions for Multi-

Project”

B. Other Personnel. Other Direct Costs “8-17 Other”

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: 01/31/2026).

PHS 398 Modular Budget Form

Added special instructions for applicants submitting Data Management and Sharing (DMS)

Plans.

PHS 398 Research Plan Form

Added new item 11. Other Plan(s) and added instructions for applicants submitting Data

Management and Sharing (DMS) Plans.

Renumbered form fields.

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).

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

Added new item 17. Other Plan(s) and added instructions for applicants submitting Data

Management and Sharing (DMS) Plans.

Renumbered form fields.

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

Added new item 13. Other Plan(s) for potential future use with other plans.

Renumbered form fields.

Clarified instructions for renewal or resubmission applications involving changes between

single PD/PI to or from multiple PD/PIs.

PHS Fellowship Supplemental Form

Added new item 17. Other Plan(s) for potential future use with other plans.

Renumbered form fields.

Updated instructions for 16. Resource Sharing Plan(s) to remove instructions for the Data

Sharing Plan and Genomic Data Sharing (GDS).

Form Screenshots

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 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

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.

FOAs and other guidelines are available on the NIH K Kiosk.

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.

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.

FOAs and other guidelines are available on the NIH T Kiosk.

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.

FOAs and other guidelines are available on the NIH F Kiosk.

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.

A list of contacts specifically for extramural training at the NIH ICs can be found

on the NIH Training Advisory Committee Roster.

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:

A Single Overall Component: The Overall Component describes the entire application and

provides an overview of how each of the other components fit together.

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.

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:

Component

Performance Sites

Human Subjects - Clinical Trials – Vertebrate Animals- hESC

Human Embryonic Stem Cell Lines

Budget

Program Income

Senior/Key Personnel

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.

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).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 [email protected].

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:

Phase I: Supporting Feasibility and Proof of Concept; and

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 Specific SBIR/STTR Funding

Opportunities 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 and STTR Funding Opportunities 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 CRPs, see the Omnibus Solicitation program

Descriptions and Research Topics document.

Disclosure Requirements Regarding Ties to Foreign Countries

Effective for competing applications submitted on or after September 5, 2023, applicants will be

required to disclose all funded and unfunded relationships with foreign countries, using the

Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form, (referred to

hereafter as the SBIR STTR Foreign Disclosure Form) for all owners and covered individuals.

Upon request, applicants will submit the completed SBIR STTR Foreign Disclosure Form via the

Just-In-Time (JIT) process described in the NIH GPS section 2.5.1 Just-in-Time Procedures. The

SBIR STTR Foreign Disclosure Form and any additional agency-specific information must be

submitted electronically using the Just-in-Time feature in the eRA Commons. Applicants must

continue to comply with NIH Other Support disclosure requirements as provided in Section 2.5.1.

SBC applicants applying to CDC and FDA will follow each agency’s policies for submitting

additional documents during the pre-award process. Applicants may be required to provide

similar information on the SBIR STTR Foreign Disclosure Form that is also submitted as a part of

the other support reporting for senior/key personnel identified in the application. Applicants that

do not submit the completed SBIR STTR Foreign Disclosure Form during the JIT process will not be

considered for funding.

Denial of Awards

Applicants are encouraged to consider whether their entity’s relationships with foreign countries

of concern will pose a security risk. Prior to issuing an award, NIH, CDC, and FDA will determine

whether the SBC submitting the application:

has an owner or covered individual that is party to a malign foreign talent recruitment

program;

has a business entity, parent company, or subsidiary located in the People’s Republic of China

or another foreign country of concern; or

has an owner or covered individual that has a foreign affiliation with a research institution

located in the People’s Republic of China or another foreign country of concern.

A finding of foreign involvement with countries of concern will not necessarily disqualify an

applicant. NIH, CDC, and FDA will provide SBC applicants the opportunity to address any identified

security risks prior to award. Final award determinations will be based on whether the applicant’s

involvement falls within any of the following risk criteria, per the Act:

• interfere with the capacity for activities supported by NIH, CDC, or FDA to be carried out;

• create duplication with activities supported by NIH, CDC, or FDA;

• present concerns about conflicts of interest;

• were not appropriately disclosed to NIH, CDC, or FDA;

• violate Federal law or terms and conditions of NIH, CDC, or FDA; or

• pose a risk to national security.

NIH, CDC, and FDA will not issue an award under the SBIR/STTR program if the covered

relationship with a foreign country of concern identified in this guidance is determined to fall

under any of the criteria provided above, and the risk cannot be resolved.

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.

View larger image

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:

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.

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

Tracking ID” is required.

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 specified in the FOA or notice in the

NIH Guide for Grants & Contracts.

Applications in response to a NIH Notice of Special Interest require the notice number (e.g., NOT-

IC-FY-XXX) to be entered into this field in order to assign and track applications and awards for the

described initiative.

4.c. Previous Grants.gov Tracking ID

The “Previous Grants.gov Tracking ID” field is required if you checked the “Changed/Corrected

Application” box in “Field 1. Type of Submission.” A Tracking ID number is of the form, for

example, GRANT12345678.

5. Applicant Information

The "Applicant Information" fields reflect information for the applicant organization, not a specific

individual.

Additional Instructions for Multi-project:

Other Components: The “Applicant Information” section is required and applies to

the lead organization of the component.

Additional Instructions for SBIR/STTR:

The small business is always the applicant organization for an SBIR or STTR award

(e.g., ABC Incorporated).

The small business must be located in the United States.

Unique Entity Identifier (UEI):

This field is required.

Enter the UEI of the applicant organization.

This UEI must match the number entered in the eRA Commons Institutional Profile (IPF) for the

applicant organization. The applicant’s Authorized Organization Representative (AOR) is

encouraged to confirm that a UEI has been entered into the eRA Commons IPF prior to application

submission. The same UEI should be used in the eRA Commons IPF, Grants.gov, System for Award

Management (SAM) registration, and in the UEI field in the application.

If your organization does not already have a UEI, you will need to go to the System for Award

Management (SAM.gov) to register and obtain a UEI.

Additional Instructions for Multi-project:

Other Components: If a component is led by an organization other than the

applicant organization, then you must provide the lead organization’s4UEI. If the

organization does not already have a UEI, you will need to go to the System for

Award Management (SAM.gov) to obtain a UEI. However, the lead organization does

not need to be registered in SAM or in eRA Commons at the time of application.

SAM registration is encouraged since it helps staff process your application if you

are selected for funding.

Legal Name:

Enter the legal name of the organization.

Department:

Enter the name of the primary organizational department, service, laboratory, or equivalent level

within the organization.

Division:

Enter the name of the primary organizational division, office, major subdivision, or equivalent level

within the organization.

Street1:

This field is required. Enter the first line of the street address for the applicant organization.

Street2:

Enter the second line of the street address for the applicant organization.

City:

This field is required. Enter the city for the address of the applicant organization.

County/Parish:

Enter the county/parish for the address of the applicant organization.

State:

This field is required if the applicant organization is located in the United States or its territories.

Enter the state or territory where the applicant organization is located.

Province:

If “Country” is Canada, enter the province of the applicant organization; otherwise, skip the

“Province” field.

Country:

This field is required. Select the country for the address of the applicant organization.

ZIP/Postal Code:

The ZIP+4 is required if the applicant organization is located in the United States. Otherwise, the

postal code is optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the applicant

organization.

Person to be contacted on matters involving this application

This information is for the administrative contact (e.g., AOR or business official), not the PD/PI. This

person is the individual to be notified if additional information is needed and/or if an award is

made.

Prefix:

Enter or select the prefix, if applicable, for the name of the person to contact on matters related to

this application.

First Name:

This field is required. Enter the first (given) name of the person to contact on matters related to this

application.

Middle Name:

Enter the middle name of the person to contact on matters related to this application.

Last Name:

This field is required. Enter the last (family) name of the person to contact on matters related to

this application.

Suffix:

Enter or select the suffix, if applicable, for the name of the person to contact on matters related to

this application.

Position/Title:

Enter the position/title for the person to contact on matters related to this application.

Street1:

This field is required. Enter the first line of the street address for the person to contact on matters

related to this application.

Street2:

Enter the second line of the street address for the person to contact on matters related to this

application.

City:

This field is required. Enter the city for the address of the person to contact on matters related to

this application.

County/Parish:

Enter the county/parish for the address of the person to contact on matters related to this

application.

State:

This field is required if the person to contact on matters related to this application is located in the

United States or its Territories. Enter the state or territory where the person to contact on matters

related to this application is located.

Province:

If “Country” is Canada, enter the province for the person to contact on matters related to this

application; otherwise, skip the “Province” field.

Country:

Select the country for the address of the person to contact on matters related to this application.

ZIP/Postal Code:

The ZIP+4 is required if the person to contact on matters related to this application is in the United

States. Otherwise, the postal code is optional. Enter the ZIP+4 (nine-digit postal code) or postal

code of the person to contact on matters related to this application.

Phone Number:

This field is required. Enter the daytime phone number for the person to contact on matters

related to this application.

Fax Number:

Enter the fax number for the person to contact on matters related to this application.

E-mail:

Enter the e-mail address for the person to contact on matters related to this application. Only one

e-mail address is allowed, but it may be a distribution list.

6. Employer Identification

This field is required.

Enter either the organization’s Taxpayer Identification Number (TIN) or Employer Identification

Number (EIN) as assigned by the Internal Revenue Service. If your organization is not in the United

States, enter 44-4444444. Your EIN may be 12 digits (e.g., Payment Management System (PMS)

Entity Identification Number), and if this is the case, enter all 12 digits.

Additional Instructions for SBIR/STTR:

The small business must be located in the United States or a U.S. territory.

7. Type of Applicant

This field is required.

In the first field under “7. Type of Applicant,” enter the appropriate applicant type. If your applicant

type is not specified (e.g., for eligible Agencies of the Federal Government), select “X: Other

(specify),” and indicate the name (e.g., the appropriate federal agency) in the space below.

Additional Instructions for Fellowship:

The information in “7. Type of Applicant” is for the applicant organization, not a

specific individual authorized organization representative (AOR) or fellowship PD/PI.

Additional Instructions for Multi-project:

Other Components: You may fill out “7. Type of Applicant,” but it is optional.

Additional Instructions for SBIR/STTR:

Select “R. Small Business.”

The applicant organization must certify (through Just-in-Time pre-award

procedures) that it will qualify as a small business at the time of award.

Other (Specify):

Complete only if “X. Other (specify)” is selected as the "Type of Applicant."

Women Owned:

Do not use the "Women Owned" checkbox.

Socially and Economically Disadvantaged:

Do not use the "Socially and Economically Disadvantaged" checkbox.

Note: NIH, CDC, and FDA use the Business Type information provided in the System for Award

Management entity record for the applicant organization, rather than the “Woman Owned” and

“Socially and Economically Disadvantaged” checkboxes, to determine the small business

organization type. For more information, see the NIH Guide Notice on Small Business Organization

Type Information Pulled from System for Award Management Record Rather than Grant

Application Form.

8. Type of Application

This field is required.

Select the type of application. Check only one application type. Use the following list of existing

definitions to determine what application type you have. For more information, see NIH Types of

Applications.

New. Check this option when submitting an application for the first time or in accordance

with other submission policies. See the NIH Grants Policy Statement, Section 2.3.7.4:

Submission of Resubmission Application.

Resubmission. Check this option when submitting a revised (altered or corrected) or

amended application. See also the NIH Application Submission Policies. If your

application is both a “New/Revision/Renewal” and a “Resubmission,” check only the

“Resubmission” box.

Renewal. Check this option if you are requesting additional funding for a period

subsequent to that provided by a current award. A renewal application competes with all

other applications and must be developed as fully as if the applicant were applying for the

first time.

Continuation. The box for “Continuation” is used only for specific FOAs.

Revision. Check this option for competing revisions and non-competing administrative

supplements. For more information on competing revisions, see NIH Competing

Revisions. For more information on administrative supplements, see NIH Administrative

Supplements.

Additional Instructions for Career Development:

The applicant should generally check “New” or “Resubmission.” Unless otherwise

specified in the FOA, individual career development awards usually cannot be

renewed, supplemented, or revised. Contact the awarding component staff or refer

to the FOA if clarification is needed.

Additional Instructions for Fellowship:

The applicant should generally check “New” or “Resubmission.” Unless otherwise

specified in the FOA, individual fellowship awards usually cannot be renewed,

supplemented, or revised. Contact the awarding institute or center staff or refer to

the FOA if clarification is needed.

Additional Instructions for SBIR/STTR:

Small Business Program Phases and Their Associated Application Types

Phase I: New/Resubmission

Phase II: Renewal/Resubmission. Phase II applications should not be listed as “New”

unless they are Direct to Phase II applications. Only one Phase II application may be

awarded for a specific project supported by a Phase I award

Fast-Track: New/Resubmission

Direct to Phase II (SBIR Only): New/Resubmission. Direct to Phase II awards should be

submitted as “New” applications and not continuations of Phase I SBIR or STTR

projects. Small businesses that are eligible to submit Phase II applications for projects

that were supported with a Phase I SBIR or STTR award are expected to submit the

regular Phase II application as a "Renewal" application based on the awarded Phase I

SBIR or STTR project.

Phase IIB: Renewal/Resubmission

Commercialization Readiness Pilot (CRP) Program: New/Renewal/Resubmission. The

"New" application designation utilized by the CRP PAR program announcements

allows active Phase II grants or contracts to receive a CRP concurrently with their

active award. This does not allow for a "New" CRP application after an unsuccessful

resubmission of a CRP application.

For more information about SBIR/STTR application types, see the SBIR/STTR

Frequently Asked Questions.

If Revision, mark appropriate box(es).

You may select more than one.

A. Increase Award

B. Decrease Award

C. Increase Duration

D. Decrease Duration

E. Other (specify)

If “E. Other (specify)” is selected, specify in the space provided.

The boxes for options B, C, D, and E will generally not be used and should not be selected unless

specifically addressed in a particular FOA.

Is this application being submitted to other agencies? What Other Agencies?

In the field “Is this application being submitted to other agencies?” check “Yes” if one or more of

the specific aims submitted in your application is also contained in a similar, identical, or essentially

identical application submitted to another federal agency.

Otherwise, check "No."

If you checked "Yes," indicate the agency or agencies to which the application has been submitted.

9. Name of Federal Agency

The “Name of Federal Agency” field is pre-populated from the opportunity package and reflects

the agency from which assistance is being requested with this application.

10. Catalog of Federal Domestic Assistance Number and Title

This field is pre-populated from the opportunity package and reflects the Catalog of Federal

Domestic Assistance (CFDA) number of the program under which assistance is requested.

This field may be blank if you are applying to an opportunity that references multiple CFDA

numbers. When this field is blank, leave it blank. The appropriate CFDA number will be

automatically assigned by the agency once the application is assigned to the appropriate

awarding component.

11. Descriptive Title of Applicant’s Project

This field is required.

Additional Instructions for Multi-project:

Other Components: The “Descriptive Title of Applicant’s Project” section is

required.

Enter a brief descriptive title of the project.

The descriptive title is limited to 200 characters, including spaces and punctuation.

New Applications: You must have a title different than any other NIH or other PHS Agency

project submitted for the same application due date with the same Project Director/Principal

Investigator (PD/PI).

Resubmission or Renewal Applications: You should normally have the same title as the previous

grant or application; however, if the specific aims of the project have significantly changed, choose

a new title.

Revision Applications: You must have the same title as the currently funded grant.

Additional Instructions for SBIR/STTR:

An SBIR/STTR Phase II application should have the same title as the previously

awarded Phase I grant.

12. Proposed Project

Additional Instructions for Multi-project:

Other Components: The “Proposed Project” section is required.

Start Date:

This field is required. Enter the proposed start date of the project. The start date is an estimate, and

is typically at least nine months after application submission. The project period should not exceed

what is allowed in the FOA.

Additional Instructions for Training:

The usual start date for an institutional training grant is July 1, but there are other

possible start dates. Refer to the Table of IC-Specific Information, Requirements and

Staff Contacts in your FOA or contact the awarding component staff for further

information.

Ending Date:

This field is required. Enter the proposed ending date of the project.

Additional Instructions for SBIR/STTR:

Phase I: SBIR and STTR Phase I awards typically last for 6-12 months and generally

do not exceed two years.

Phase II and Commercialization Readiness Pilot (CRP): Both SBIR and STTR

Phase II awards typically last for two years and generally do not exceed three years.

Applicants are encouraged to propose a project duration that is reasonable and

appropriate for completion of the research project.

13. Congressional District of Applicant

Enter the Congressional District as follows: a 2-character state abbreviation, a hyphen, and a 3-

character district number. Examples: CA-005 for California’s 5th district, VA-008 for Virginia’s 8th

district.

If outside the United States, enter 00-000.

For States and U.S. Territories with only a single congressional district, enter “001” for the district

number.

For jurisdictions with no representative, enter “099.”

For jurisdictions with a nonvoting delegate, enter “098” for the district number. Example: DC-098

or PR-098.

If you do not know your Congressional District: Go to The United States House of

Representatives website and search for your Congressional District by entering your ZIP+4. If you

do not know your ZIP+4, look it up on the USPS Look Up Zip Code website.

14. Project Director/Principal Investigator Contact Information

This information is for the PD/PI. The PD/PI is the individual responsible for the overall scientific

and technical direction of the project.

In the eRA Commons profile, the person listed here in “14. Project Director/Principal Investigator

Contact Information” must be affiliated with the applicant organization entered in “5. Applicant

Information.” If you are proposing research at an institute other than the one you are currently at,

do not create a separate Commons account with the proposed applicant organization. For

additional information on creating affiliations for users in the eRA Commons, see eRA Account

Management System's Online Help.

If submitting an application reflecting multiple PD/PIs, the individual listed here as the Contact

PD/PI in “14. Project Director/Principal Investigator Contact Information” will be the first PD/PI

listed in G.240 - R&RSenior/Key Person Profile (Expanded) Form.

See G.240 - R&R Senior/Key Person Profile (Expanded) Form for additional instructions for multiple

PD/PIs. To avoid potential errors and delays in processing, ensure that the information provided in

this section is identical to the PD/PI profile information contained in the eRA Commons.

Additional Instructions for Career Development:

Provide the name of the individual candidate (considered the PD/PI for career

development award programs). If the PD/PI is not located at the applicant

organization at the time the application is submitted, the information should reflect

where the candidate can be reached prior to the requested award start date. If the

PD/PI is not located at the applicant organization at the time of submission, the

Commons account for the PD/PI must be affiliated with the applicant organization.

If your proposed career award is at a different site than your current institution, the

proposed sponsoring institution will be the applicant organization. You must affiliate

your Commons account with the institution so that you have access to records

submitted on your behalf. Do not create a separate Commons account with the

proposed sponsoring institution.

Note: For some career transition award programs (e.g., K22) the applicant may apply

without an institutional affiliation. These individuals should refer to the specific FOA

for application instructions.

Multiple PD/PIs cannot apply for individual career development awards.

Additional Instructions for Fellowship:

Provide the name of the individual fellowship applicant (considered the PD/PI for

fellowship award programs). If the PD/PI is not located at the applicant organization

at the time the application is submitted, the information should reflect where the

fellowship applicant can be reached prior to the requested award start date.

If your proposed fellowship is at a different site than your current institution, the

proposed sponsoring institution will be the applicant organization. You must affiliate

your Commons account with the institution so that you have access to records

submitted on your behalf. Do not create a separate Commons account with the

proposed sponsoring institution.

Multiple PD/PIs cannot apply to fellowship applications.

Additional Instructions for SBIR/STTR:

For Single PD / PI Applications: Name the one person responsible to the applicant

small business for the scientific and technical direction of the project in the “14.

PD/PI Contact Information” section.

For Multiple PD / PI Applications: Name the contact PD/PI here in “14. PD/PI

Contact Information.” The Contact PD/PI (as designated here in “14. PD/PI Contact

Information”) must be listed first in the G.240 - R&R Senior/Key Person Profile

(Expanded) Form and must be affiliated with the applicant organization in the

PD/PI’s eRA Commons profile.

NIH and PHS staff conduct official business only with the named PD/PIs and

organizational / institutional officials listed on the application.

A revision / supplemental application must have the same contact PD/PI as the

currently funded grant.

SBIR

Phase I, Phase II, and CRP: The primary employment of the PD/PI must be with the

small business at the time of award and during the conduct of the proposed project.

Primary employment means that more than one half (greater than 50%) of the

PD/PI’s time is spent in the employ of the small business. Primary employment with

a small business precludes full-time employment at another organization.

Phase I, Phase II, and CRP Multiple PD / PI applications: The PD/PI listed here in

“14. PD/PI Contact Information" must be affiliated with the applicant small business

organization submitting the application and will serve as the contact PD/PI. The

primary employment of the “Contact PD/PI” must be with the small business at the

time of award and during the conduct of the proposed project.

PD / PI Definition: As defined in 42 CFR 52, the PD/PI(s) is or are the “…individual(s)

judged by the applicant organization to have the appropriate level of authority and

responsibility to direct the project or program supported by the grant and who is or

are responsible for the scientific and technical direction of the project.” When the

proposed PD/PI clearly does not have sufficient qualifications to assume this role,

the application is not likely to receive a favorable evaluation.

Verification of PD / PI Eligibility: The awarding component will require

documentation to verify the eligibility of the PD/PI, if at the time of submission of

the application, the PD/PI meets any of the following criteria:

is a less-than-full-time employee of the small business;

is concurrently employed by another organization;

gives the appearance of being concurrently employed by another

organization, whether for a paid or unpaid position.

If the PD/PI is employed or appears to be employed by an organization other than

the applicant organization in any capacity (such as Research Fellow, Consultant,

Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate), a

letter must be provided by each employing organization confirming that, if an SBIR

grant is awarded to the applicant small business, the PD/PI is or will become a less-

than-half-time employee of such organization and will remain so for the duration of

the SBIR project. If the PD/PI is employed by a university, such a letter must be

provided by the Dean's office or equivalent; for other organizations, the letter must

be signed by a corporate official.

This requirement applies also to those individuals engaged currently as the PD/PI on

an active SBIR project. All current employment and all other appointments of the

PD/PI must be identified in his or her “Biographical Sketch” required as part of the

application. Be certain that correct beginning and ending dates are indicated for

each employment record listed.

STTR

Phase I and Phase II: The primary employment of the principal investigator must

be with the small business or the research institution at the time of award and

during the conduct of the proposed project. Primary employment means that more

than one half (greater than 50%) of the PD/PI's time is spent in the employ of the

small business or the research institution. Primary employment with a small business

or research institution precludes full-time employment at another organization. A

small business may replace the principal investigator on an STTR Phase I or Phase II

award, subject to approval in writing by the Funding Agreement Officer. For

purposes of the STTR Program, personnel obtained through a Professional Employer

Organization or other similar personnel leasing company may be considered

employees of the awardee. This is consistent with the Small Business Administration

(SBA) size regulations, 13 CFR 121.106—Small Business Size Regulations.

For Multiple PD / PI Applications: The PD/PI listed here in “14. PD/PI Contact

Information” must be affiliated with the applicant small business submitting the

application and will serve as the Contact PD/PI. The Contact PD/PI may be from

either the small business or the single partnering research institution.

Note: The Contact PD/PI must have a formal appointment with or commitment to

the small business, which must be in the form of an official relationship between the

parties, but need not include a salary or other form of remuneration.

PD / PI Eligibility: The PD/PI must commit a minimum of 10% (1.2 calendar

months) effort to the project and must have a formal appointment with or

commitment to the applicant small business, which is characterized by an official

relationship between the small business and that individual. Such a relationship does

not necessarily involve a salary or other form of remuneration. In all cases, however,

the PD/PI’s official relationship with the grantee must entail sufficient opportunity

for the PD/PI to carry out his or her responsibilities for the overall scientific and

technical direction of the project. Although documentation (e.g., consortium and

contractual arrangements) describing the official relationship of the PD/PI with the

applicant small business should NOT be submitted with the grant application, a copy

must be furnished upon the request of the NIH awarding component.

Following is guidance for such documentation (describing the official relationship of

the PD/PI with the applicant small business), which is required prior to award. The

letter should be prepared on the letterhead of the independent PD/PI and

addressed to the small business. One page is recommended. At a minimum, the

letter should (1) verify the PD/PI’s commitment to the project; (2) refer to the specific

project by name; and (3) specify what assets or services the PI will contribute (e.g.

expertise, number of hours/percent effort) as well as the PD/PI’s remuneration. The

letter should also indicate that the PD/PI and the small business have reached an

agreement on proprietary interests (e.g., intellectual property).

Signatures of the authorized organization representative (AOR or signing official) for

the applicant organization on the Authorized Representative section and the

signature of the duly authorized representative of the research institution certifies,

among other things, that the PD/PI has a formal relationship with / commitment to

the small business when the PD/PI is an employee of the Research Institute.

The following are examples of situations describing the official relationship of the

PD/PI with the applicant small business organization:

PD/PI with a full-time, university appointment may also have appointments

with other organizations (with or without salary) and still appropriately

consider his or her commitment to the university to be “full-time,” consistent

with the personnel policies and procedures of the university applied on a

routine basis. The PD/PI’s commitment to the university and other

organizations (including the applicant small business) cannot exceed 100%

of his or her total professional effort.

PD/PI with a full-time, 12-month appointment with an small business would

be considered to have a commitment to the applicant organization of 100%

of his or her total professional effort.

PD/PI who has a part-time appointment with an small business and has

concurrent commitments or appointments with organizations in addition to

the small business concern would deem each commitment as a portion of

100% of his or her total professional effort.

As responsible stewards of funds, the NIH is concerned that the PD/PI has the time

available to carry out the proposed STTR research activities. Therefore, it should be

clear in the application that the time proposed for the PD/PI on a particular project is

reasonable and it should be clear that the PD/PI has sufficient time (minimum 10%

effort, which is 1.2 calendar months) from among his or her total professional

commitments to devote to this project.

Prefix:

Enter or select the prefix, if applicable, for the name of the PD/PI.

First Name:

This field is required. Enter the first (given) name of the PD/PI.

Middle Name:

Enter the middle name of the PD/PI.

Last Name:

This field is required. Enter the last (family) name of the PD/PI.

Suffix:

Enter or select the suffix, if applicable, for the PD/PI. Do not use this field to record degrees (e.g.,

Ph.D. or M.D.). Degrees for the PD/PI are requested separately in the R&R Senior/Key Person

Profile (Expanded) Form.

Position/Title:

Enter the position/title of the PD/PI.

Organization Name:

This field is required. This field may be pre-populated from the applicant information section in

this form.

Department:

Enter the name of primary organizational department, service, laboratory, or equivalent level

within the organization of the PD/PI.

Division:

Enter the name of primary organizational division, office, major subdivision, or equivalent level

within the organization of the PD/PI.

Street1:

This field is required. Enter first line of the street address for the PD/PI.

Street2:

Enter the second line of the street address for the PD/PI.

City:

This field is required. Enter the city for the address of the PD/PI.

County/Parish:

Enter the county/parish for the address of the PD/PI.

State:

This field is required if the PD/PI is located in the United States or its Territories. Enter the state or

territory where the PD/PI is located.

Province:

If “Country” is Canada, enter the province for the PD/PI; otherwise, skip the “Province” field.

Country:

Select the country for the PD/PI.

ZIP/Postal Code:

The ZIP+4 is required if the PD/PI address is in the United States. Otherwise, the postal code is

optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the PD/PI.

Phone Number:

This field is required. Enter the daytime phone number for the PD/PI.

Fax Number:

Enter the fax number for the PD/PI.

E-mail:

This field is required. Enter the e-mail address for the PD/PI.

15. Estimated Project Funding

All four fields in “15. Estimated Project Funding” are required.

a. Total Federal Funds Requested

Enter the total federal funds, including Direct Costs and F&A Costs (Indirect Costs), requested for

the entire project period.

Additional Instructions for Fellowship:

Applicants should refer to the NIH Research Training and Career Development

website for current stipend and other budgetary levels. Enter the total amount

requested for the entire period of support. This amount should include the

applicable stipend amount, the actual tuition and fees, and the standard institutional

allowance.

If new stipend or other payment levels for Kirschstein-NRSA fellowships are

announced after the time of application, these amounts will be automatically

adjusted at the time of award.

Extraordinary Costs: Additional funds may be requested by the institution when

the training of a fellow involves extraordinary costs for travel to field sites remote

from the sponsoring institution or accommodations for fellows who are disabled, as

defined by the Americans with Disabilities Act. The funds requested for extraordinary

costs must be reasonable in relationship to the total dollars awarded under a

fellowship and must be directly related to the approved research training project.

Such additional funds shall be provided only in exceptional circumstances that are

fully justified and explained by the institution in the application.

Additional Instructions for SBIR/STTR:

Enter total federal funds, including Direct Costs, F&A (Indirect) Costs, and Fee,

requested for the entire project period.

The current budget guidelines for the 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 Specific SBIR

/ STTR Funding Opportunities may have their own budgetary guidance. The NIH

recognizes that some biomedical innovations require funding levels above the

budget 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 Opportunities 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.

b. Total Non-Federal Funds

For applications to NIH and other PHS agencies, enter “0” in this field unless cost sharing is a

requirement for the specific FOA.

c. Total Federal & Non-Federal Funds

Enter the total federal and non-federal Funds requested. The amount in this field will be the same

as the amount in the “Total Federal Funds Requested” field unless the specific FOA indicates that

cost sharing is a requirement.

d. Estimated Program Income

Indicate any program income estimated for this project, if applicable.

Additional Instructions for Training:

Enter "0," as the "Estimated Program Income" does not apply to training

applications.

Additional Instructions for Fellowship:

Enter “0," as the “Estimated Program Income” does not apply to fellowship

applications.

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

Applicants should check “No, Program is not covered by E.O. 12372.”

17. Certification

This field is required.

The list of NIH and other PHS agencies Certifications, Assurances, and other Policies is found in the

NIH Grants Policy Statement, Section 4: Public Policy Requirements and Objectives.

The applicant organization is responsible for verifying its eligibility and the accuracy, validity, and

conformity with the most current institutional guidelines of all the administrative, fiscal, and

scientific information in the application, including the Facilities and Administrative rate. Deliberate

withholding, falsification, or misrepresentation of information could result in administrative

actions, such as withdrawal of an application, suspension and/or termination of an award,

debarment of individuals, as well as possible criminal and/or civil penalties. The signer further

certifies that the applicant organization will be accountable both for the appropriate use of any

funds awarded and for the performance of the grant-supported project or activities resulting from

this application. The grantee institution may be liable for the reimbursement of funds associated

with any inappropriate or fraudulent conduct of the project activity.

Check “I agree” to provide the required certifications and assurances.

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

Documentation

If applicable, attach the SFLLL or other explanatory document as per FOA instructions.

If unable to certify compliance with the Certification in the “17. Certification” section above, attach

an explanation. Additionally, as applicable, attach the SFLLL (Standard Form LLL, Disclosure of

Lobbying Activities) or other documents in this item.

For more information:

See the NIH Grants Policy Statement, Section 4.1.17: Lobbying Prohibition, and the NIH Lobbying

Guidance for Grantee Activities page.

19. Authorized Representative

The authorized representative is equivalent to the individual with the organizational authority to

sign for an application. This individual is otherwise known as the authorized organization

representative (AOR) in Grants.gov or the signing official (SO) in eRA Commons.

Prefix:

Enter or select the prefix, if applicable, for the name of the AOR/SO.

First Name:

This field is required. Enter the first (given) name of the AOR/SO

Middle Name:

Enter the middle name of the AOR/SO.

Last Name:

This field is required. Enter the last (family) name of the AOR/SO.

Suffix:

Enter or select the suffix, if applicable, for the AOR/SO.

Position/Title:

This field is required. Enter the position/title of the name of the AOR/SO.

Organization Name:

This field is required. Enter the name of the organization for the AOR/SO.

Department:

Enter the name of the primary organizational department, service, laboratory, or equivalent level

within the organization for the AOR/SO.

Division:

Enter the name of the primary organizational division, office, major subdivision, or equivalent level

within the organization for the AOR/SO.

Street1:

This field is required. Enter the first line of the street address for the AOR/SO.

Street2:

Enter the second line of the street address for the AOR/SO.

City:

This field is required. Enter the city for the address of the AOR/SO.

County/Parish:

Enter the county/parish for the address of the AOR/SO.

State:

This field is required if the AOR/SO is located in the United States or its Territories. Enter the state

or territory where the AOR/SO is located.

Province:

If “Country” is Canada, enter the province for the AOR/SO; otherwise, skip the “Province” field.

Country:

Select the country for the address of the AOR/SO.

ZIP/Postal Code:

The ZIP+4 is required if the AOR/SO is in the United States. Otherwise, the postal code is optional

Enter the ZIP+4 (nine-digit postal code) or postal code of the AOR/SO.

Phone Number:

This field is required. Enter the daytime phone number for the AOR/SO.

Fax Number:

Enter the fax number for the AOR/SO.

Email:

This field is required. Enter the e-mail address for the AOR/SO.

Signature of Authorized Representative:

Grants.gov will record the electronic signature for the AOR/SO who submits the application.

It is the organization’s responsibility to assure that only properly authorized individuals sign in this

capacity and/or submit the application to Grants.gov.

Date Signed:

Grants.gov will generate this date upon application submission.

20. Pre-application

Unless specifically noted in a FOA, NIH and other PHS agencies do not use pre-applications. The

"Pre-application" attachment field should not be used for any other purpose.

If permitted by your FOA, attach this information as a PDF.

21. Cover Letter Attachment

The cover letter is for internal use only and will not be shared with peer reviewers.

Who must complete the “Cover Letter Attachment”:

Refer to the “content” list below for items that are permitted, as well as for specific situations in

which a cover letter must be included.

A cover letter must not be included with post-award submissions, such as administrative

supplements, change of grantee institution, or successor-in-interest.

Format:

Attach the cover letter, addressed to the Division of Receipt and Referral, in accordance with the

FOA and/or these instructions.

Attach the cover letter in the correct location, specifically verifying that the cover letter has not

been uploaded to the “20. Pre-application” field which is directly above the “21. Cover

Letter Attachment” field. This will ensure the cover letter attachment is kept separate from the

assembled application in the eRA Commons and made available only to appropriate staff.

Content:

Do not use the cover letter to communicate application assignment preferences. The Assignment

Request Form is provided for that purpose.

The letter should contain any of the following information, as applicable:

1. Application title.

2. Title of FOA (PA or RFA).

3. For late applications (see Late Application policy on NIH's Application Submission

Policies) include specific information about the timing and nature of the delay.

4. For changed/corrected applications submitted after the due date, a cover letter is

required, and it must explain the reason for late submission of the changed/corrected

applications. If you already submitted a cover letter with a previous submission and are

now submitting a late change/corrected application, you must include all previous cover

letter text in the revised cover letter attachment. The system does not retain any

previously submitted cover letters; therefore, you must repeat all information previously

submitted in the cover letter as well as any additional information.

5. Explanation of any subaward budget components that are not active for all budget

periods of the proposed grant (see G.310 – R&R Subaward Budget Attachment(s) Form).

6. Statement that you have attached any required agency approval documentation for the

type of application submitted. This may include approval for applications that request

$500,000 or more, approval for Conference Grant or Cooperative Agreement (R13 or U13),

etc. It is recommended that you include the official communication from an NIH official as

part of your cover letter attachment.

7. When intending to submit a video as part of the application, the cover letter must include

information about the intent to submit it; if this is not done, the video will not be

accepted. See NIH Grants Policy Statement, Section 2.3.7.7: Post Submission Grant

Application Materials for additional information.

8. Include a statement in the cover letter if the proposed studies will generate large-scale

human or non-human genomic data as detailed in the NIH Genomic Data Sharing Policy

(see the NIH Grants Policy Statement, Section 2.3.7.10: NIH Genomic Data Sharing and

Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/Policy for Genome-Wide Association

Studies (GWAS)).

9. Include a statement in the cover letter if the proposed studies involve human fetal tissue

obtained from elective abortions (HFT), regardless of whether or not Human Subjects are

involved and/or there are costs associated with the HFT. For further information on

HFTpolicy refer to the NIHGrants Policy Statement, Section 2.3.7.11 Human Fetal Tissue

from Elective Abortions, Section 4.1.14 Human Fetal Tissue Research and Section 4.1.14.2

Human Fetal Tissue from Elective Abortions.

Additional Instructions for Career Development:

Mentored Career Development Award (CDA) applicants must include a cover

letter that contains a list of referees (including name, departmental affiliation, and

institution).

Non-mentored CDA applicants are encouraged, but not required, to include a

cover letter. The cover letter should include a list of referees (including name,

departmental affiliation, and institution).

Additional Instructions for Fellowship:

Individual fellowship applicants must include a cover letter that contains a list of

referees (including name, departmental affiliation, and institution).

Additional Instructions for SBIR/STTR:

If Phase I or Phase II was a contract or awarded from another federal agency, include

the contract or award number.

G.210 - PHS 398 Cover Page Supplement

Form

The PHS 398 Cover Page Supplement Form is used for all

grant applications except fellowships. This form collects

information on human subjects, vertebrate animals,

program income, human embryonic stem cells, inventions

and patents, and changes of investigator/change of

institution.

View larger image

Quick Links

1. Vertebrate Animals Section

2. Program Income Section

3. Human Embryonic Stem Cell Section

4. Human Fetal Tissue Section.

5. Inventions and Patents Section (for Renewal applications)

6. Change of Investigator/Change of Institution Section

1. Vertebrate Animals Section

Are vertebrate animals euthanized?

You must answer this question if you answered “Yes” to the question “Are Vertebrate Animals

Used?” on the G.220 – R&R Other Project Information Form.

Check "Yes" or "No" to indicate whether vertebrate animals in the project are euthanized.

Additional Instructions for Multi-project:

Overall Component: If vertebrate animals will be euthanized in any Component,

then you must answer “Yes” to the “Are vertebrate animals euthanized?” question.

If “Yes” to euthanasia: Is method consistent with American Veterinary Medical Association

(AVMA) guidelines?

You must answer this question if you answered “Yes” to the “Are vertebrate animals euthanized?”

question above. Check “Yes” or “No” to indicate whether the method of euthanasia is consistent

with the AVMA Guidelines for the Euthanasia of Animals.

For more information: See AVMA Guidelines for the Euthanasia of Animals.

If “No” to AVMA guidelines, describe method and provide scientific justification:

If you answered “No” to the “Is method consistent with AVMA guidelines?” question, you must

describe (in 1000 characters or fewer) the method of euthanasia and provide a scientific

justification for its use. This justification will be reviewed by Office of Laboratory Animal Welfare

(OLAW).

If you answered “Yes” to the “Is method consistent with AVMA guidelines” question, skip this

question.

2. Program Income Section

Is program income anticipated during the periods for which the grant support is requested?

This field is required.

If program income is anticipated during the periods for which grant support is requested, check

“Yes,” and complete the rest of the “Program Income” section.

If no program income is anticipated, check “No” and skip the rest of the “Program Income” section.

Additional Instructions for Training:

Check “No” for the “Is program income anticipated during the periods for which the

grant support is requested?” question.

Additional Instructions for Multi-project:

Overall Component: If you anticipate program income on any component, then

answer "Yes." Skip the other fields, as any information provided in them will be

discarded. Instead of program income information being provided in the Overall

Component, a system-generated summary of all program income information that

you provide in Other Components will be included in the summaries section of the

assembled application image.

Other Component: If you anticipate program income on any component, then

answer "Yes." Provide the budget period, anticipated amount, and source

information.

Budget Period:

Enter the budget periods for which program income is anticipated. If the application is funded, the

Notice of Grant Award will provide specific instructions regarding the use of such income.

Anticipated Amount ($):

Enter the amount of anticipated program income for each budget period listed.

Source(s):

Enter the source of anticipated program income for each budget period listed.

3. Human Embryonic Stem Cells Section

Use the following instructions to complete the fields in this section.

For additional guidance, see the NIH Grants Policy Statement, Section 4.1.13: Human Stem Cell

Research.

Does the proposed project involve human embryonic stem cells?

This field is required.

If the proposed project involves human embryonic stem cells (hESC), check “Yes” and complete the

rest of the “Human Embryonic Stem Cells” section.

Use of the cell lines must be in accordance with the NIH Guidelines for Human Stem Cell

Research.

If the proposed project does not involve hESC, check “No” and skip the rest of the “Human

Embryonic Stem Cells” section.

Additional Instructions for Training:

Check “Yes” if training plans include or potentially will include involvement of

trainees in projects that include hESC. Note that trainees may only conduct research

with hESC lines that are approved for use in NIH-funded research; these cell lines are

listed on the NIH hESC Registry. Use of the cell lines must be in accordance with the

NIH Guidelines for Human Stem Cell Research.

Additional Instructions for Multi-project:

Overall Component: If human embryonic stem cells are used in any Component,

then you must answer “Yes.”

Specific stem cell line cannot be referenced at this time. One from the registry will be used.

If you will use hESC but a specific line from the NIH hESC Registry cannot be chosen at the time of

application submission, check this box.

If you cannot specify which cell lines will be used at the time of application submission, specific cell

line information will be required as Just-in-Time information prior to award.

Additional Instructions for Research:

If you cannot choose an appropriate cell line from the registry at this time, provide a

justification in the G.400 - PHS 398 Research Plan Form, Research Strategy

attachment.

Additional Instructions for Career Development:

If you cannot choose an appropriate cell line from the registry at this time, provide a

justification in the G.410 - PHS 398 Career Development Award Supplemental Form,

Research Strategy attachment.

Additional Instructions for Training:

When individual project hESC line information is requested as Just-in-time (JIT), the

NIH will require information regarding project title, mentor, and specific cell line(s)

from the registry (NIH hESC Registry) for each trainee utilizing human embryonic

stem cells. Trainees may not participate in hESC related research until this

information has been provided.

Additional Instructions for Multi-project:

Overall and Other Components: If you cannot choose an appropriate cell line from

the registry at this time, provide a justification in the G.400 - PHS 398 Research Plan

Form, Research Strategy attachment.

Additional Instructions for SBIR/STTR:

If you cannot choose an appropriate cell line from the registry at this time, provide a

justification in the G.400 - PHS 398 Research Plan Form, Research Strategy

attachment.

Cell Line(s):

List the 4-digit registration number of the specific cell line(s) from the NIH hESC Registry (e.g.

0123). Up to 200 lines can be added.

Additional Instructions for Multi-project:

Overall Component: Skip the "Cell Line(s)" field, as any information provided here

will be discarded. Instead of cell line information being provided in the Overall

Component, a system-generated summary of all cell line information that you

provide in Other Components will be included in the summaries section of the

assembled application image.

Other Component: Provide any cell line information relevant to the work being

done in that component.

For more information:

See NIH’s Stem Cell Information page for additional information on stem cells, Federal policy

statements, and guidelines on federally funded stem cell research.

4. Human Fetal Tissue Section

Does the proposed project involve human fetal tissue from elective abortions?

This field is required.

If the proposed project involves the use of human fetal tissue obtained from elective abortions

(HFT), check “Yes” and complete the rest of the “Human Fetal Tissue” section.

If the proposed project does not involve the use of human fetal tissue obtained from elective

abortions (HFT), check “No” and skip the rest of the “Human Fetal Tissue” section.

Additional Instructions for Multi-project:

Overall Component: If the use of human fetal tissue obtained from elective

abortions (HFT) are proposed in any Component, then you must answer "Yes."

If the answer is "yes" then provide the HFT Compliance Assurance:

If the proposed project involves the use of human fetal tissue obtained from elective abortions

(HFT), the applicant must provide a letter, signed by the PD/PI, assuring the HFT donating

organization or clinic adheres to the requirements of the informed consent process and

documenting that HFT was not obtained or acquired for valuable consideration. The PDF-

formatted letter must be named ‘HFTComplianceAssurance.pdf’.

If the answer is “yes” then provide the HFT Sample IRB Consent Form

If the proposed project involves the use of human fetal tissue obtained from elective abortions

(HFT), provide a blank sample of the IRB-approved consent form. The PDF-formatted form must be

a blank sample and named ‘HFTSampleIRBConsentForm.pdf’.

o The informed consent for use of HFT from elective abortions requires language that

acknowledges informed consent for donation of HFT was obtained by someone other than the

person who obtained the informed consent for abortion, that informed consent for donation of

HFT occurred after the informed consent for abortion was obtained will not affect the method of

abortion, and that no enticements, benefits, or financial incentives were used at any level of the

process to incentivize abortion or the donation of HFT. The form must be signed by both the

woman and the person who obtains the informed consent.

For further information on HFTpolicy refer to the NIHGrants Policy Statement, Section 2.3.7.11

Human Fetal Tissue from Elective Abortions, Section 4.1.14 Human Fetal Tissue Research and

Section 4.1.14.2 Human Fetal Tissue from Elective Abortions.

5. Inventions and Patents Section (for Renewal applications)

Who must complete the “Invention and Patents” section:

Complete the "Inventions and Patents" section only if you are submitting a renewal application or a

resubmission of a renewal application.

Inventions and Patents:

If no inventions were conceived or reduced to practice during the course of work under this

project, check “No” and skip the remainder of the “Inventions and Patents” section.

If any inventions were conceived or first actually reduced to practice during the previous period of

support, check “Yes.”

NIH recipient organizations must promptly report inventions to the Division of Extramural

Inventions and Technology Resources (DEITR) Branch of the Office of Policy for Extramural

Research Administration (OPERA), OER, NIH, 6705 Rockledge Drive, Bethesda, MD 20892-2750,

(301) 435-1986. You must report inventions in compliance with regulations at 37 CFR 401.14,

which are described at Interagency Edison (iEdison). The grantee is required to submit reports

electronically using iEdison. See the NIH Grants Policy Statement, Section 8.4.1.6: Invention

Reporting.

Additional Instructions for Career Development:

Skip the “Inventions and Patents” section, as it is not applicable.

Additional Instructions for Training:

Skip the “Inventions and Patents” section, as it is not applicable.

Previously Reported:

If you answered “Yes” to the “Inventions and Patents” question, indicate whether this information

has been reported previously to the NIH or PHS agency or to the applicant organization official

responsible for patent matters.

6. Change of Investigator/Change of Institution Section

Change of Project Director/Principal Investigator:

Check this box if your application reflects a change in project director/principal investigator

(PD/PI) from that indicated on your previous application or award. Note that this box not

applicable to a new application, nor is a change in PD/PI permitted for revision applications.

For a multiple PD/PI application, check this box if this application represents a change in the

contact PI.

If you check the box, fill in the rest of the “Change of PD/PI” section with the information for the

former PD/PI according to the instructions below.

Additional Instructions for Career Development:

Skip the “Change of Project Director/Principal Investigator” section, as changes in

PD/PI are not allowed for career development awards.

Additional Instructions for Fellowship:

Skip the “Change of Project Director/Principal Investigator” section, as changes in

PD/PI are not allowed for fellowship awards.

Prefix:

Enter or select the prefix, if applicable, for the former PD/PI.

First Name:

Enter the first (given) name of the former PD/PI.

Middle Name:

Enter the middle name of the former PD/PI.

Last Name:

Enter the last (family) name of the former PD/PI.

Suffix:

Enter or select the suffix, if applicable, for the former PD/PI.

Change of Grantee Institution:

Check this box if your application reflects a change in grantee institution from that indicated

on your previous application or award. This question is not applicable to new applications.

Name of Former Institution:

Enter the name of the former institution if this application reflects a change in grantee

institution.

G.220 - R&R Other Project Information

Form

The R&R Other Project Information Form is used for all

grant applications. This form includes questions on the

use of human subjects, vertebrate animals, and

environmental impact. This form also has fields to upload

an abstract, project narrative, references, information on

facilities, and equipment lists.

View larger image

Quick Links

1. Are Human Subjects Involved?

1a. If YES to Human Subjects

2. Are Vertebrate Animals Used?

2a. If YES to Vertebrate Animals

3. Is proprietary/privileged information included in the application?

4. Environmental Questions

5. Is the research performance site designated, or eligible to be designated, as a historic place?

6. Does this project involve activities outside of the United States or partnerships with inter-

national collaborators?

7. Project Summary/Abstract

8. Project Narrative

9. Bibliography & References Cited

10. Facilities & Other Resources

11. Equipment

12. Other Attachments

Additional Instructions for Fellowship:

This R&R Other Project Information Form should be completed in consultation with

the sponsor and administrative officials at the sponsoring institution.

1. Are Human Subjects Involved?

This field is required.

If activities involving human subjects are planned at any time during the proposed project at any

performance site, check “Yes.” Check “Yes” even if the proposed project is exempt from regulations

for the Protection of Human Subjects, or if activities involving human subjects are anticipated

within the period of award but plans are indefinite, or if the proposed activities include public

health surveillance activities described in 45 CFR 46.102(l)(2).

If activities involving human subjects are not planned at any time during the proposed project at

any performance site, select “No” and skip the rest of the "Are Human Subjects Involved" section.

Whether you answer “Yes” or “No” to the “Are Human Subjects Involved?” question here, your

answer will populate the relevant field in the G.500 – PHS Human Subjects and Clinical Trials

Information form (see exception for Training Applications in the Training-specific instructions).

Follow the G.500 – PHS Human Subjects and Clinical Trials Information form instructions to

complete the relevant questions in that form.

Additional Instructions for Training:

K12 and D43 applicants: The general instructions above apply to you (i.e., your

answer to “Are Human Subjects Involved?” will populate the relevant field in the PHS

Human Subjects and Clinical Trials Information form).

All other Training applicants: The PHS Human Subjects and Clinical Trials

Information form is not applicable and will not be available to you.

Need help determining whether your application includes human subjects? Check out the

NIH Research Involving Human Subjects website for information, including an Infopath

Questionnaire designed to walk applicants through the decision process.

Note on the use of human specimens or data: Applications involving the use of human

specimens or data may or may not be considered to be research involving human subjects,

depending on the details of the materials to be used. If you check “No” to “Are Human Subjects

Involved?” but your application proposes using human specimens or data, you will be required to

provide a clear justification about why this use does not constitute human subjects research.

Follow the G.500 – PHS Human Subjects and Clinical Trials Information form instructions.

For more information on human biospecimens or data: Refer to the NIH page on Frequently

Asked Questions on Human Specimens, Cell Lines, or Data and the Research Involving Private

Information or Biological Specimens flowchart.

Additional Instructions for Training:

Check “Yes” if training plans include or potentially will include involvement of

trainees in projects that include human subjects as defined by 45 CFR 46.

Most Training grant application packages do not include the G.500 - PHS Human

Subjects and Clinical Trials Information form. Although it is not required, applicants

can provide additional information regarding potential or current involvement of

appointed trainees in human subjects research in the "Proposed Training" section of

the Program Plan attachment on the G.420 - PHS Research Training Program Plan

Form.

In many instances, trainees supported by institutional training grants will participate

in research that is supported by separate research project grants for which

Institutional Review Board (IRB) approval or a determination of exemption exists.

Existing IRB approval may be sufficient for trainees, provided that the IRB

determines the research would not be substantially modified by the participation of

a trainee.

Trainees may participate only in non-exempt human subjects research that is being

conducted by an institution that has an approved Federalwide Assurance (FWA) on

file with the Office for Human Research Protections (OHRP) and that has IRB

approval. The awardee institution is responsible for maintaining documentation of

FWA and IRB approvals for all trainee research projects and for providing this

information to NIH if requested.

Trainees may not design or conduct independent human subjects research as part of

the training award unless the institution where the research will be conducted has an

approved FWA on file with OHRP and IRB approval. The institution must also submit

certification of the date of IRB approval and must comply with NIH requirements for

human subjects protections (see the NIH Grants Policy Statement, Section 4.1.15:

Human Subjects Protections).

Trainees who will be involved in the design or conduct of research involving human

subjects must receive training in human subjects protections. It is the institution’s

responsibility to ensure that trainees are properly supervised when working with

human subjects.

These policies apply to all Performance Sites.

K12 and D43 applicants applying to FOAs that accept clinical trials (e.g.,

'clinical trial optional'): Follow the instructions in your FOA to determine whether

you must provide information in the G.500 - PHS Human Subjects and Clinical Trials

Information form.

Additional Instructions for Fellowship:

In many instances, the fellow will be participating in research supported by a

research project grant for which the IRB review of human subjects is already

complete or an exemption has been designated. This review or exemption

designation is sufficient, provided that the IRB determines that participation of the

Fellow does not substantially modify the research.

Additional Instructions for Multi-project:

Overall Component: If activities involving human subjects are planned at any time

during the proposed project at any performance site and/or on any Other

Component, check “Yes” to the “Are Human Subjects Involved?” question and

complete the remaining questions as instructed.

Other Components: Answer only the “Are Human Subjects Involved?” and “Is the

Project Exempt from Federal regulations?” questions.

1.a. If YES to Human Subjects

Your answers here in question “1.a. If YES to Human Subjects” will populate the corresponding

fields in the G.500 – PHS Human Subjects and Clinical Trials Information form.

Is the Project Exempt from Federal regulations? Yes/No

If the project is exempt from federal regulations, check “Yes” and check the appropriate exemption

number.

Human subjects research should only be designated as exempt if all of the proposed research

projects in an application meet the criteria for exemption.

If the project is not exempt from federal regulations, check “No.”

For more information, see the NIH’s Exempt Human Subjects Research infographic.

If yes, check appropriate exemption number 1, 2, 3, 4, 5, 6, 7, 8:

If you selected “Yes” to “Is the Project Exempt from Federal Regulations,” select the appropriate

exemption number.

The categories of research that qualify for exemption are defined in the Common Rule for the

Protection of Human Subjects. These regulations can be found at 45 CFR 46.

Need help determining the appropriate exemption number? Refer to NIH's Research

Involving Human Subjects Frequently Asked Questions.

The Office for Human Research Protections (OHRP) guidance states that appropriate use of

exemptions described in 45 CFR 46 should be determined by an authority independent from the

investigators (for more information, see OHRP's Frequently Asked Questions). Institutions often

designate their Institutional Review Board (IRB) to make this determination. Because NIH does not

require IRB approval at the time of application, the exemptions designated often represent the

opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is evaluated

during peer review. See NIH Grants Policy Statement Section 4.1.15 for more information.

4. Human Fetal Tissue Section

Notes on public health surveillance activities: Projects involving public health surveillance

activities described in 45 CFR 46.102(l)(2) must answer questions in Section 1.a. as if the exclusion

does not apply. In rare circumstances, applicants may request NIH approval for use of the

exclusion in accordance with Just-in-Time procedures.

Additional Instructions for Multi-project:

Overall Component: Check all the exemptions identified in all the Other

Components.

Other Components: If the Overall Component exemption is only E4 (box 4 is

checked) then no other exemption number can be set for any Other Component.

If no, is the IRB review Pending? Yes/No

If IRB review is pending, check “Yes.”

Applicants should check “Yes” to the question “Is the IRB review Pending?” even if the IRB

review/approval process has not started by the time of submission.

If IRB review is not pending (e.g., if the review is complete), check “No.”

Additional Instructions for Multi-project:

Other Components: Skip the "If no, is the IRBreview Pending?" question.

IRB Approval Date:

Enter the latest IRB approval date (if available). Leave blank if IRBapproval is pending.

An IRB approval date is not required at the time of submission when IRB review is pending. This

may be requested later in the pre-award cycle as a Just-In-Time requirement. See the NIH Grants

Policy Statement, Section 2.5.1: Just-in-Time Procedures for more information.

Additional Instructions for Multi-project:

Other Components: Skip the “IRB Approval Date” question.

Human Subject Assurance Number:

Enter the approved Federalwide Assurance (FWA) number that the applicant has on file with

OHRP. Enter the 8-digit number. Do not enter “FWA” before the number.

Enter “None” if the applicant organization does not have an approved FWA on file with OHRP. In

this case, the applicant organization, by the signature in the Certification section on the G.200 -

SF424 (R&R) Form, is declaring that it will comply with 45 CFR 46 and proceed to obtain a FWA

(see Office for Human Research Protections website). Do not enter the FWA number of any

collaborating institution.

Additional Instructions for Fellowship:

If research proposed in the fellowship application has been previously reviewed and

approved by an IRB and is covered by an approved FWA, provide the FWA number

and the latest IRB approval date for the proposed activities. The latest IRB approval

date must be within one year of the application due date.

Additional Instructions for Multi-project:

Other Components: Skip the “Human Subject Assurance Number” field.

2. Are Vertebrate Animals Used?

This field is required.

If activities involving vertebrate animals are planned at any time during the proposed project at

any performance site, check “Yes.” Otherwise, check “No” and skip the rest of the “2. Are

Vertebrate Animals Used?” section.

Note that the generation of custom antibodies constitutes an activity involving vertebrate animals.

If animal involvement is anticipated within the period of award but plans are indefinite, check

"Yes."

Additional Instructions for Research:

If you have answered “Yes” to the “Are Vertebrate Animals Used?” question, you

must also provide an explanation and anticipated timing of animal use in G.400 -

PHS 398 Research Plan Form, Vertebrate Animals. This attachment must be

submitted and reviewed prior to the involvement of animals in any research studies.

Additional Instructions for Career Development:

If you have answered “Yes” to the “Are Vertebrate Animals Used?” question, you

must also provide an explanation and anticipated timing of animal use in G.410 -

PHS 398 Career Development Award Supplemental Form, Vertebrate Animals. This

attachment must be submitted and reviewed prior to the involvement of animals in

any research studies.

Additional Instructions for Training:

In many instances, trainees supported by institutional training grants will participate

in research that is supported by a separate research project grant for which the

IACUC review and approval exist. This existing IACUC approval is sufficient for

trainees provided that the research would not be substantially modified by the

participation of a trainee.

Note that trainees may only participate in vertebrate animal research that is being

conducted at an institution that has an approved Animal Welfare Assurance on file

with the Office of Laboratory Animal Welfare (OLAW) and that has IACUC approval.

The awardee institution is responsible for maintaining documentation of the Animal

Welfare Assurance and IACUC approvals for all trainee research projects and

providing this information to NIH if requested.

Trainees may not design or conduct independent vertebrate animal research as part

of the training award unless the institution has an approved Animal Welfare

Assurance on file with OLAW and IACUC approval has been obtained. Verification of

IACUC approval (within 3 years) must be submitted to NIH, and NIH requirements

for research involving vertebrate animals must be addressed.

Prior to conducting any animal activities, the grantee must submit the detailed

information about the use of animals as required in the instructions in G.420 - PHS

398 Research Training Program Plan, Vertebrate Animals. This detailed information

must be submitted to the NIH awarding IC for prior approval.

The institution must ensure that trainees are enrolled in the institution's animal

welfare training and occupational health and safety programs for personnel who

have contact with animals. It is the institution's responsibility to ensure that trainees

are properly supervised when working with live vertebrate animals.

These policies apply to all Performance Sites.

Additional Instructions for Fellowship:

In many instances, the fellow will be participating in research supported by a

research project grant for which the IACUC review has been completed and approval

obtained. This review is sufficient, provided that participation of the fellow does not

substantially modify the research. The appropriate grant(s) must be identified along

with the IACUC approval date(s).

The sponsoring institution must ensure that the fellow is enrolled in the institution’s

animal welfare training and safety programs for personnel who have contact with

animals, as appropriate. It is also the sponsoring institution’s responsibility to ensure

that the fellow is properly supervised when working with live vertebrate animals.

If you have answered “Yes” to the “Are Vertebrate Animals Used?” question, you

must also provide an explanation and anticipated timing of animal use in G.430 -

PHS Fellowship Supplemental Form, Vertebrate Animals. This attachment must be

submitted and reviewed prior to the involvement of animals in any research studies.

Additional Instructions for Multi-project:

Overall Component: If activities involving vertebrate animals are planned at any

time during the proposed project at any performance site and/or on any Other

Component, check “Yes” and complete the remaining questions as instructed.

Other Components: Answer only the “Are Vertebrate Animals Used?” question. Skip

the questions in 2.a.

Additional Instructions for SBIR/STTR:

The small business applicant needs to answer “Yes” even if vertebrate animal work

will not be performed at the small business. If you have answered “Yes” to the “Are

Vertebrate Animals Used?” question, you must also provide an explanation and

anticipated timing of animal use in G.400 - PHS 398 Research Plan Form, Vertebrate

Animals. This attachment must be submitted and reviewed prior to the involvement

of animals in any research studies.

2.a. If YES to Vertebrate Animals

Is the IACUC review Pending?

If an Institutional Animal Care and Use Committee (IACUC) review is pending, check "Yes."

Applicants should check “Yes” to the "Is the IACUC review Pending?" question even if the IACUC

review/approval process has not started by the time of submission.

If IACUC review is not pending (e.g. if the review is complete), check “No."

Additional Instructions for Multi-project:

Overall Component: Complete the “Is the IACUC review Pending?” question when

the answer is “Yes” to “Are Vertebrate Animals Used?”

Other Components: Skip the “Is the IACUC review Pending?” question.

IACUC Approval Date:

Enter the latest IACUC approval date (if available). Leave blank if IACUC approval is pending.

IACUC approval must have been granted within three years of the application submission date to

be valid.

An IACUC approval date is not required at the time of submission. NIH does not require

verification of review and approval of the proposed research by the IACUC before peer review of

the application. However, this information is required under the NIH Grants Policy Statement

Section 2.5.1: Just-in-Time Procedures.

Additional Instructions for Multi-project:

Other Components: Skip the “IACUC Approval Date” question.

Animal Welfare Assurance Number

Enter the federally approved assurance number, if available.

Enter “None” if the applicant organization does not have an Office of Laboratory Animal Welfare

(OLAW)-approved Animal Welfare Assurance.

To determine whether the applicant organization holds an Animal Welfare Assurance with an

associated number, see the lists of Domestic and Foreign Assured institutions. Do not enter the

Animal Welfare Assurance number for a Project/Performance Site of a collaborating

institution.

When an applicant organization does not have an Animal Welfare Assurance number, the

authorized organization representative’s signature on the application constitutes declaration that

the applicant organization will submit an Animal Welfare Assurance when requested by OLAW.

If the animal work will be conducted at an institution with an Animal Welfare Assurance and the

applicant organization does not have the following:

an animal care and use program;

facilities to house animals and conduct research on site; and

IACUC;

then, the applicant must obtain an Inter-institutional Assurance from OLAW prior to an award.

Additional Instructions for Multi-project:

Other Components: Skip the “Animal Welfare Assurance Number” question.

3. Is proprietary/privileged information included in the application?

This field is required.

Patentable ideas; trade secrets; or privileged, confidential commercial, or financial information

should be included in applications only when such information is necessary to convey an

understanding of the proposed project.

If the application includes such information, check “Yes” and clearly mark each line or paragraph

on the pages containing the proprietary/privileged information with a statement similar to: “The

following contains proprietary/privileged information that (name of applicant) requests not be

released to persons outside the government, except for purposes of review and evaluation.” This

statement can be included at the top of each page as applicable.

If a grant is awarded as a result of or in connection with the submission of this application, the

government shall have the right to use or disclose the information to the extent authorized by law.

Although the grantee institution and the PD/PI will be consulted about any such disclosure, the

NIH and other PHS agencies will make the final determination. Any indication by the applicant that

the application contains proprietary or privileged information does not automatically shield the

information from release in response to a Freedom of Information Act (FOIA) request should the

application result in an award (see 45 CFR 5). Additionally, if an applicant fails to identify

proprietary information at the time of submission as instructed here, a significant substantive

justification will be required to withhold the information if requested under FOIA.

4. Environmental Questions

Question 4 pertains to the environmental impact of the proposed research.

4.a. Does this Project Have an Actual or Potential Impact - positive or negative - on the envir-

onment?

This field is required.

Indicate whether or not this project has an actual or potential impact on the environment.

Most NIH research grants are not expected to individually or cumulatively have a significant effect

on the environment, and NIH has established several categorical exclusions allowing most

applicants to answer “No” unless a specific FOA indicates that the National Environmental Policy

Act (NEPA) applies. However, if an applicant expects that the proposed project will have an actual

or potential impact on the environment, or if any part of the proposed research and/or project

includes one or more of the following scenarios, check “Yes.”

1. The potential environmental impacts of the proposed research may be of greater scope or

size than other actions included within a category.

2. The proposed research threatens to violate a federal, state, or local law established for the

protection of the environment or for public health and safety.

3. Potential effects of the proposed research are unique or highly uncertain.

4. Use of especially hazardous substances or processes is proposed for which adequate and

accepted controls and safeguards are unknown or not available.

5. The proposed research may overload existing waste treatment plants due to new loads

(volume, chemicals, toxicity, additional hazardous wasted, etc.).

6. The proposed research may have a possible impact on endangered or threatened species.

7. The proposed research may introduce new sources of hazardous/toxic wastes or require

storage of wastes pending new technology for safe disposal.

8. The proposed research may introduce new sources of radiation or radioactive materials.

9. Substantial and reasonable controversy exists about the environmental effects of the

proposed research.

4.b. If yes, please explain:

If you answered “Yes” to Question 4.a., you must provide an explanation here as to the actual or

potential impact of the proposed research on the environment. Your entry is limited to 55

characters.

4.c. If this project has an actual or potential impact on the environment, has an exemption been

authorized or an environmental assessment (EA) or environmental impact statement (EIS) been

performed? Yes/No.

This field is required if you answered “Yes” to Question 4.a. Check “Yes” or “No.”

4.d. If yes, please explain:

Enter additional details about the EA or EIS here. Your entry is limited to 55 characters.

5. Is the research performance site designated, or eligible to be designated, as a

historic place?

This field is required.

If any research performance site is designated, or eligible to be designated, as a historic place,

check the “Yes” box. Otherwise, check “No.”

5.a. If yes, please explain:

If you checked “Yes” to indicate that any performance site is designated, or eligible to be

designated, as a historic place, provide the explanation here. Your entry is limited to 55 characters.

6. Does this project involve activities outside of the United States or partnerships

with international collaborators?

This field is required.

Indicate whether this project involves activities outside of the United States or partnerships with

international collaborators. Check “Yes” or “No.”

Applicants to NIH and other PHS agencies must check “Yes” if the applicant organization is a

foreign institution or if the project includes a foreign component. See NIH Glossary for a definition

of a foreign component.

If you have checked “Yes” to Question 6, you must include a “Foreign Justification” attachment in

Field 12, Other Attachments. Describe special resources or characteristics of the research project

(e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the

facilities or other aspects of the proposed project are more appropriate than a domestic setting. In

the body of the text, begin the section with a heading indicating “Foreign Justification” and name

the file “Foreign Justification.”

Additional Instructions for Fellowship:

If you have checked “Yes” to Question 6, your justification must include a description

of how the foreign training is more appropriate than in a domestic setting. Include

reasons why the facilities, the sponsor, and/or other aspects of the proposed

experience are more appropriate in a foreign setting. The justification is evaluated in

terms of the scientific advantages of the foreign training as compared to the training

available domestically. Foreign training will be considered for funding only when the

scientific advantages are clear. The foreign justification should be provided as a

separate attachment in the "12. Other Attachments" section in G.220 - R&R Other

Project Information Form.

Additional Instructions for Multi-project:

Overall Component: If the answer to Question 6 is “Yes” for any Other Component,

then you must answer “Yes” for the Overall Component.

Additional Instructions for SBIR/STTR:

In rare and unique circumstances, for example, if a supply or material or the study

design (e.g., patient population) is not available in the United States, NIH may allow a

small portion of the work to be performed by a foreign organization. Foreign

involvement will be considered on a case-by-case basis and must be thoroughly

justified in the application. Applicants should discuss their unique situations with their

NIH program official prior to submission of the application. Whenever possible, non-

SBIR/STTR funds should be used for other work outside of the United States that is

necessary to the overall completion of the project.

6.a. If yes, identify countries:

This field is required if you answered “Yes” to Question 6. Enter the countries with which

international cooperative activities are planned.

You may use abbreviations. Your entry is limited to 55 characters.

6.b. Optional Explanation:

This field is optional. Enter an explanation for involvement with outside entities. Your entry is

limited to 55 characters.

7. Project Summary/Abstract

The "Project Summary/Abstract" attachment is required.

The project summary is a succinct and accurate description of the proposed work and should be

able to stand on its own (separate from the application). This section should be informative to

other persons working in the same or related fields and understandable to a scientifically literate

reader. Avoid both descriptions of past accomplishments and the use of the first person. Please be

concise.

Format:

This section is limited to 30 lines of text, and must follow the required font and margin

specifications. A summary that exceeds the 30-line limit will be flagged as an error by the Agency

upon submission. Use of hyperlinks and URLs in this section is not allowed unless specified in the

funding opportunity announcement.

Attach this information as a PDF file. See the Format Attachments page.

Content:

State the application's broad, long-term objectives and specific aims, making reference to the

health relatedness of the project (i.e., relevance to the mission of the agency). Describe the

research design and methods for achieving the stated goals. Be sure that the project summary

reflects the key focus of the proposed project so that the application can be appropriately

categorized.

Do not include proprietary, confidential information or trade secrets in the project summary. If the

application is funded, the project summary will be entered into an NIH database and made

available on the NIH Research Portfolio Online Reporting Tool (RePORT) and will become public

information.

Note that the "Project Summary/Abstract" attachment is not same as the "Research Strategy"

attachment.

Additional Instructions for Career Development:

In addition to summarizing the research project to be conducted under the career

development award, describe the candidate’s career development plan, the

candidate’s career goals, and the environment in which the career development will

take place. The entire “Project Summary/Abstract” attachment is limited to 30 lines

of text.

Additional Instructions for Training:

In addition to the content described above, also summarize the objectives, rationale

and design of the research training program. Provide information regarding the

research areas and scientific disciplines encompassed by the program. Include a

brief description of the level(s) (i.e., undergraduate, predoctoral, postdoctoral,

faculty) and duration of the proposed training, and the projected number of

participating trainees. The entire “Project Summary/Abstract” attachment is limited

to 30 lines of text.

Additional Instructions for Fellowship:

In addition to summarizing the research project to be conducted under the

fellowship award, describe the fellowship training plan and the environment in

which the research training will take place. The entire “Project Summary/Abstract”

attachment is limited to 30 lines of text.

Additional Instructions for Multi-project:

Overall and Other Components: A project summary is required for both the

Overall Component and all Other Components. Each project summary attachment is

limited to 30 lines of text.

8. Project Narrative

The "Project Narrative" attachment is required.

Content:

Describe the relevance of this research to public health in, at most, three sentences. For example,

NIH applicants can describe how, in the short or long term, the research would contribute to

fundamental knowledge about the nature and behavior of living systems and / or the application

of that knowledge to enhance health, lengthen life, and reduce illness and disability. Use of

hyperlinks and URLs in this section is not allowed unless specified in the funding opportunity

announcement. If the application is funded, this public health relevance statement will be

combined with the project summary (above) and will become public information.

Additional Instructions for Multi-project:

Overall Component: The "Project Narrative" attachment is required.

Other Components: Refer to the specific FOA to determine whether the "Project

Narrative" attachment is required for any Other Components. Note: The form may

show ‘*’ indicating it is a required field, but it is only required for the Overall

Component and the ‘*’ can be ignored for Other Components.

9. Bibliography & References Cited

Who must complete the “Bibliography & References Cited” attachment:

The “Bibliography & References Cited” attachment is required unless otherwise noted in the FOA.

Format:

Attach this information as a PDF file. See the Format Attachments page. Use of hyperlinks and

URLs in this section is not allowed unless specified in the funding opportunity announcement.

Content:

See the following instructions for which references to include in the “Bibliography and References

Cited” attachment.

Additional Instructions for Research:

The “Bibliography & References Cited” attachment should include any references

cited in G.400 - PHS 398 Research Plan Form and in the G.500 - PHS Human Subjects

and Clinical Trials Information form.

Additional Instructions for Career Development:

The “Bibliography & References Cited” attachment should include any references

cited in G.410 - PHS 398 Career Development Award Supplemental Form and in the

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

Additional Instructions for Training:

The “Bibliography & References Cited” Attachment should include any references

cited in G.420 - PHS 398 Research Training Program Plan Form and in the G.500 -

PHS Human Subjects and Clinical Trials Information form.

Additional Instructions for Fellowship:

The “Bibliography & References Cited” attachment should include any references

cited in G.430 - PHS Fellowship Supplemental Form and in the G.500 - PHS Human

Subjects and Clinical Trials Information form.

Additional Instructions for Multi-project:

Overall and Other Components: The “Bibliography & References Cited”

attachment should include any references cited in G.400 - PHS 398 Research Plan

Form and in the G.500 - PHS Human Subjects and Clinical Trials Information form.

Additional Instructions for SBIR/STTR:

The “Bibliography & References Cited” attachment should include any references

cited in G.400 - PHS 398 Research Plan Form and in the G.500 - PHS Human Subjects

and Clinical Trials Information form.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the

applicant, and arose from NIH support, provide the NIH Manuscript Submission reference number

(e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each

article. If the PMCID is not yet available because the Journal submits articles directly to PMC on

behalf of their authors, indicate “PMC Journal – In Process.” NIHmaintains a list of such journals.

Citations that are not covered by the Public Access Policy, but are publicly available in a free,

online format may include URLs or PubMed ID (PMID) numbers along with the full reference.

Active hyperlinks in this section are not allowed. The references should be limited to relevant and

current literature. While there is not a page limitation, it is important to be concise and to select

only those literature references pertinent to the proposed research.

You are allowed to cite interim research products. Note: interim research products have specific

citation requirements. See related Frequently Asked Questions for more information.

Additional Instructions for Training:

The "Bibliography & References Cited" attachment should be used only to cite

references supporting the need, rationale, and approach for the training program

described in the G.420 - PHS 398 Research Training Program Plan. Do not include

lists of publications of project directors, mentors or trainees in this section, as this

information will be included in the Biosketches and Data Tables.

Additional Instructions for Multi-project:

Overall and Other Components:Unless specific instructions are provided in the

FOA, applicants have the option of including the "Bibliography & References Cited"

attachment in the Overall Component, Other Components, or both. User-defined

bookmarks provided in the Bibliography & References Cited attachment will be

included with the bookmarks of the assembled application image in eRA Commons.

If you include the “Bibliography & References Cited” attachment only in the Overall

Component, you may want to use bookmarks to organize references by component.

10. Facilities & Other Resources

Format:

The “Facilities & Other Resources” attachment is required unless otherwise specified in the FOA.

Use of URLs and hyperlinks in this section is not allowed unless specified in the funding

opportunity announcement.

Content:

Describe how the scientific environment in which the research will be done contributes to the

probability of success (e.g., institutional support, physical resources, and intellectual rapport). In

describing the scientific environment in which the work will be done, discuss ways in which the

proposed studies will benefit from unique features of the scientific environment or from unique

subject populations or how studies will employ useful collaborative arrangements.

If there are multiple performance sites, describe the resources available at each site.

Describe any special facilities used for working with biohazards and any other potentially

dangerous substances. Note: Information about select agents must be described in the

Research Plan, Select Agent Research.

For early stage investigators (ESIs), describe institutional investment in the success of the

investigator. See NIH's Early Stage Investigator (ESI) Policies. Your description may include the

following elements:

resources for classes, travel, or training;

collegial support, such as career enrichment programs, assistance and guidance in the

supervision of trainees involved with the ESI’s project, and availability of organized peer

groups;

logistical support, such as administrative management and oversight and best practices

training;

financial support, such as protected time for research with salary support.

Additional Instructions for Career Development:

Include a detailed description of the institutional facilities and resources available to

the candidate. The information provided is of major importance in establishing the

feasibility of the goals of the career development plan.

Additional Instructions for Training:

Describe the facilities and resources that will be used in the proposed training

program, including any foreign performance sites. Indicate how the applicant

organization will support the program, financial or otherwise. This could include, for

example, supplementation of stipends, shared space and/or laboratory facilities and

equipment, funds for curriculum development, support for student activities, release

time for the PD/PI and participating faculty (e.g., protected time for mentoring),

support for additional trainees in the program, or any other creative ways to

improve the environment for the establishment and growth of the research training

program.

Additional Instructions for Fellowship:

Include a detailed description of the institutional facilities and resources available to

the fellowship applicant. The information provided is of major importance in

establishing the feasibility of the goals of the fellowship training plan.

Additional Instructions for Multi-project:

Unless specific instructions are provided in the FOA, applicants have the option of

including the "Facilities & Other Resources" attachment in the Overall Component,

Other Components, or both.

Additional Instructions for SBIR/STTR:

The research to be performed by the applicant small business and its collaborators

must be in United States facilities that are available to and under the control of each

party for the conduct of each party’s portion of the proposed project. Foreign sites

must be approved by the awarding agency. In rare and unique circumstances, for

example, if a supply or material or the study design (e.g., patient population) is not

available in the United States, NIH may allow a small portion of the research or R&D

work to be performed by a foreign organization. Foreign involvement will be

considered on a case-by-case basis and must be thoroughly justified in the

application. Applicants should discuss their unique situations with NIH program staff

prior to submission of the application. Whenever possible, non-SBIR/STTR funds

should be used for other work outside of the United States that is necessary to the

overall completion of the project. Be sure to discuss any plans for inclusion of foreign

institutions or sites with a Program Official.

Effective for applications submitted for due dates on or after September 5,

2023, in addition to describing the scientific environment and the company support,

the applicant must describe the business environment and resources, or how the

company will obtain access to the appropriate business resources, for completing and

commercializing the proposed product or service. This includes any relevant

intellectual property associated with the project necessary to facilitate

commercialization.

11. Equipment

The “Equipment” attachment is required.

Format:

Attach this information as a PDF file. Use of URLs and hyperlinks in this section is not allowed

unless specified by the funding opportunity announcement.

Content:

List major items of equipment already available for this project and, if appropriate, identify the

equipment's location and pertinent capabilities.

Additional Instructions for Multi-project:

Unless specific instructions are provided in the FOA, applicants have the option of

including the "Equipment" attachment in the Overall Component, Other

Components, or both (whichever is most appropriate for your application). User-

defined bookmarks provided in the Equipment attachment will be included with the

bookmarks of the assembled application image in eRA Commons. If you include the

“Equipment” attachment only in the Overall Component, you may want to use

bookmarks to organize equipment by component.

12. Other Attachments

Attach a file to provide additional information only in accordance with the FOA and/or agency-

specific instructions.

If applicable, attach a “Foreign Justification” here. (See Question 6 above).

Additional Instructions for SBIR/STTR:

NIH, CDC, SBIR, and CRP Applicants Only:

SBIR Application Certification for small business concerns that are majority-

owned by multiple venture capital operating companies, hedge funds, or

private equity firms (e.g. majority VCOC-owned): You are required to submit a

VCOC Certification with your application per the SBIR Policy Directive.

Certain small business applicants do not have to fill out the VCOC Certification.

Applicant small businesses that are more than 50% directly owned and controlled by

one or more individuals (who are citizens or permanent resident aliens of the United

States), other business concerns (each of which is more than 50% directly owned

and controlled by individuals who are citizens or permanent resident aliens of the

United States), or any combination of these (i.e. NOT majority VCOC-owned) should

NOT fill out this certification and should NOT attach it to their application package.

Download the “SBIR Application VCOC Certification” at the NIH Forms

&Applications page.

Answer the 3 questions and check the certification boxes.

The authorized business official must sign the certification.

Save the certification using the original filename (“SBIR Application VCOC

Certification”). DO NOT CHANGE OR ALTER THE FILENAME OR TYPE. Changing

the filename may cause delays in the processing of your application.

Attach this VCOC Certification PDF with the file name "SBIR Application VCOC

Certification.pdf" in 12, Other Attachments.

G.230 - Project/Performance Site

Location(s) Form

The Project/Performance Site Location(s) Form is used

for all grant applications. It is used to report the primary

location and any other locations at which the project will

be performed.

View larger image

Quick Links

Project/Performance Site Primary Location

Project/Performance Site Location 1

Additional Location(s)

Using the Project/Performance Site Location(s) Form:

This form allows for the collection of multiple performance sites. If you need to add more

project/performance site locations than the form allows, enter the information in a separate file and add

it to the “Additional Locations” section.

Project/Performance Site Primary Location

Generally, the primary location should be that of the applicant organization or identified as off-site

in accordance with the conditions of the applicant organization’s negotiated Facilities and

Administrative (F&A) agreement. This information must agree with the F&A information on the

budget form of the application.

Provide an explanation of resources available from each project/performance site on the "Facilities

and Resources" attachment of the G.220 - R&R Other Project Information Form.

If the proposed project involves human subjects or live vertebrate animals, it is up to the applicant

organization to ensure that all sites meet certain criteria:

Human Subjects: If a project/performance site is engaged in research involving human subjects,

the applicant organization is responsible for ensuring that the project/performance site operates

under an appropriate Federal Wide Assurance for the protection of human subjects and complies

with 45 CFR 46 and other NIH human subject related policies described in the NIH Grants Policy

Statement, Section 4.1.15: Human Subjects Protections.

Vertebrate Animals: For research involving live vertebrate animals, the applicant organization

must ensure that all project/performance sites hold an Office of Laboratory Animal Welfare

(OLAW)-approved Animal Welfare Assurance. If the animal work will be conducted at an institution

with an Animal Welfare Assurance and the applicant organization does not have the following:

an animal care and use program;

facilities to house animals and conduct research on site; and

an IACUC;

then applicant must obtain an Inter-institutional Assurance from OLAW prior to an award.

Additional Instructions for Research:

Describe any consortium/contractual arrangements in the "Consortium/Contractual

Arrangements" attachment in G.400 – PHS 398 Research Plan Form.

Additional Instructions for Career Development:

Indicate where the work described in the Research and Career Development Plans

will be conducted. Include any foreign sites (if applicable). If there is more than one

site, including any Department of Veterans Affairs (VA) facilities or foreign sites, list

them all in the fields provided for Location 1, and additional locations, as necessary.

Describe any consortium/contractual arrangements in the "Consortium/Contractual

Arrangements" attachment in G.410 – PHS 398 Career Development Award

Supplemental Form.

Additional Instructions for Training:

List all of the locations where training, program management, and the research

training experiences described in the Research Training Program Plan will be

performed, including any foreign sites (when applicable).

Describe any consortium/contractual arrangements in the "Consortium/Contractual

Arrangements" attachment in G.420 – PHS 398 Research Training Program Plan

Form.

Human Subjects: If investigators and trainees at a project/performance site will be

engaged in research involving human subjects, the applicant organization is

responsible for ensuring that all investigators and trainees at the

project/performance sites comply with the human subject protection regulations in

45 CFR 46 and with other NIH policies for the protection of human subjects.

Vertebrate Animals: For research involving live vertebrate animals, the applicant

organization must supply information for all training sites where animals will be

used by trainees. The applicant organization is responsible for assuring that all

project/performance sites have a current Animal Welfare Assurance and comply with

the PHS Policy on Humane Care and Use of Laboratory Animals.

Additional Instructions for Fellowship:

One of the sites indicated must be the sponsoring organization, and generally, the

sponsoring organization is the primary location. Indicate where the training

described in the Research Training Plan will be conducted. If there is more than one

training site, including any Department of Veterans Affairs (VA) facilities or foreign

sites, list them all in the fields provided for Location 1, and additional locations, as

necessary.

If there are unusual circumstances involved in the research training proposed, such

as fieldwork or a degree sought from an institution other than the one in which the

research training will take place, describe these circumstances in G.220 - R&R Other

Project Information Form, Facilities and Resources.

Additional Instructions for Multi-project:

Overall Component: Include only the primary site for the entire application, which

is typically the applicant organization.

Other Components: List the primary site for the component, which is typically the

lead organization of the component. Describe any consortium/contractual

arrangements in the "Consortium/Contractual Arrangements" attachment in G.400 –

PHS 398 Research Plan Form.

Additional Instructions for SBIR/STTR:

Describe any consortium/contractual arrangements in the "Consortium/Contractual

Arrangements" attachment in G.400 – PHS 398 Research Plan Form.

One of the performance sites indicated must be that of the applicant small business.

Phase I, Phase II, and CRP Applications: The research to be performed by the

applicant small business and its collaborators must be in United States facilities that

are available to and under the control of each party for the conduct of each party’s

portion of the proposed project. Foreign sites must be approved by the program

officer. In rare and unique circumstances, for example, if a supply or material or the

study design (e.g., patient population) is not available in the United States, NIH may

allow a small portion of the research or R&D work to be performed by a foreign

organization. Foreign involvement will be considered on a case-by-case basis and

must be thoroughly justified in the application. Applicants should discuss their

unique situations with NIH program staff prior to submission of the application.

Whenever possible, non-SBIR/STTR funds should be used for other work outside of

the United States that is necessary to the overall completion of the project. Be sure

to discuss any plans for inclusion of foreign institutions or sites with a Program

Official.

The research and analytical work performed by the small business (grantee

organization) is to be conducted in research space occupied by, available to, and

under the control of the SBIR/STTR grantee for the conduct of its portion of the

proposed project. However, when required by the project activity, access to special

facilities or equipment in another organization is permitted, as in cases where the

SBIR/STTR awardee has entered into a subcontractual agreement with another

institution for a specific, limited portion of the research project.

Whenever a proposed SBIR/STTR project is to be conducted in facilities other than

those of the applicant organization, the awarding component (Institute or Center)

will request that the small business provide a letter from the organization stating

that leasing/rental arrangements have been negotiated for appropriate research

space. This letter must be signed by an authorized official of the organization whose

facilities are to be used for the SBIR/STTR project and must certify that the small

business (grantee organization) will have access to and control over the research

space. In addition, the letter must include a description of the facilities and, if

appropriate, equipment that will be leased / rented to the small business (grantee

organization). If the letter is included with the application, it is excluded from the

page limitations. Attach this letter to the G.400 - PHS 398 Research Plan Form,

Consortium/Contractual Arrangements.

“I am submitting an application as an individual, and not on behalf of a company, state, local or

tribal government, academia, or other type of organization”:

Do not check the box for “I am submitting an application as an individual, and not on behalf of a

company, state, local or tribal government, academia, or other type of organization” unless

otherwise specified by the FOA.

Organization Name:

This field is required. Enter the organization name of the primary site where the work will be

performed.

Unique Entity Identifier (UEI):

This field is required for the primary performance site.

Enter the UEI associated with the organization where the project will be performed.

Street1:

This field is required. Enter the first line of the street address of the primary performance site

location.

Street2:

Enter the second line of the street address of the primary performance site location.

City:

This field is required. Enter the city for the address of the primary performance site location.

County:

Enter the county of the primary performance site location.

State:

This field is required if the site is located in the United States or its Territories. Enter the state or

territory where the primary performance site is located.

Province:

If “Country" is Canada, enter the province for the primary performance site; otherwise, skip the

“Province” field.

Country:

This field is required. Select the country of the address for the primary performance site location.

ZIP/Postal Code:

The ZIP+4 is required if the primary performance site location is in the United States. Otherwise,

the postal code is optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the primary

performance site.

Project/Performance Site Congressional District:

Enter the Congressional District as follows: a 2-character state abbreviation, a hyphen, and a 3-

character district number. Examples: CA-005 for California’s 5th district, VA-008 for Virginia’s 8th

district.

It is likely this field will be identical to the “Congressional District of Applicant” field provided

elsewhere in the application.

If the program/project is outside the United States, enter 00-000.

For States and U.S. territories with only a single congressional district, enter “001” for the district

number.

For jurisdictions with no representative, enter “099.”

For jurisdictions with a nonvoting delegate, enter “098” for the district number. Example: DC-098

or PR-098.

If all districts in a state are affected, enter “all” for the district number. Example: "MD-all" for all

congressional districts in Maryland.

If nationwide (all districts in all states), enter "US-all."

If you do not know the Congressional District: Go to the United States House of

Representatives website and search for the Congressional District by entering the ZIP+4. If you do

not know the ZIP+4, look it up on the USPS Look Up Zip Code website.

Project/Performance Site Location 1

Use this “Project/Performance Site Location 1” block to provide information on performance sites

in addition to the Primary Performance Site listed above, if applicable. Include any VA facilities and

foreign sites.

Additional Instructions for Multi-project:

Other Components: List all performance sites that apply to the specific component.

Organization Name:

Enter the organization name of the performance site location.

Unique Entity Identifier (UEI):

Enter the UEI associated with the performance site.

Street1:

This field is required. Enter first line of the street address of the performance site location.

Street2:

Enter the second line of the street address of the performance site location.

City:

This field is required. Enter the city for the address of the performance site location.

County:

Enter the county of the performance site location.

State:

This field is required if the project performance site is located in the United States or its Territories.

Enter the state or territory where the performance site is located.

Province:

If “Country” is Canada, enter the province for the performance site; otherwise, skip the “Province”

field.

Country:

This field is required. Select the country of the performance site location.

ZIP/Postal Code:

The ZIP+4 is required if the performance site location is in the United States. Otherwise, the postal

code is optional. Enter the ZIP+4 (nine-digit postal code) of the performance site location.

Project/Performance Site Congressional District:

Enter the Congressional District as follows: a 2-character state abbreviation, a hyphen, and a 3-

character district number. Examples: CA-005 for California’s 5th district, VA-008 for Virginia’s 8th

district.

If the program/project is outside the United States, enter 00-000.

For States and U.S. territories with only a single congressional district enter “001” for the district

number.

For jurisdictions with no representative, enter “099.”

For jurisdictions with a nonvoting delegate, enter “098” for the district number. Example: DC-098

or PR-098.

If all districts in a state are affected, enter “all” for the district number. Example: "MD-all" (for all

congressional districts in Maryland).

If nationwide (all districts in all states), enter "US-all."

If you do not know the Congressional District: Go to the United States House of

Representatives website and search for your Congressional District by entering your ZIP+4. If you

do not know the ZIP+4 look it up on the USPS Look Up Zip Code website.

Additional Location(s)

If you need to add more project/performance site locations than the form allows, enter the

information in a separate file and add it to the “Additional Locations” section.

A format page for Additional Performance Sites can be found on NIH's Additional Performance

Site Format Page.

G.240 - R&RSenior/Key Person Profile

(Expanded) Form

The R&R Senior/Key Person Profile (Expanded) Form is

used for all grant applications, and allows the collection of

data for all senior/key persons associated with the project.

Some information for the PD/PI may be pre-populated

from the SF424 (R&R) form. See instructions in G.200 - SF

424 (R&R) Form if these fields are empty.

View larger image

Quick Links

Profile - Project Director/Principal Investigator

Instructions for a Biographical Sketch

Profile - Senior/Key Person

Additional Senior/Key Person Profile(s)

Using the R&R Senior/Key Person Profile (Expanded) Form

This form allows for the data collection for a PD/PI and up to 99 other senior/key individuals (including

any multi-PD/PIs). After the first 100 individuals have been entered, use the “Additional Senior/Key

Person Profiles Format Page” to attach any remaining data.

To ensure proper performance of this form, save your work frequently.

Who qualifies as a Senior/Key Person?

Unless otherwise specified in a FOA, senior/key personnel are defined as all individuals who contribute

in a substantive, meaningful way to the scientific development or execution of the project, whether or

not salaries are requested. Consultants should be included in this “Senior/Key Person Profile

(Expanded)” Form if they meet this definition.

List individuals that meet the definition of senior/key regardless of what organization they work for.

Profile - Project Director/Principal Investigator

Enter data in this “Profile – Project Director/Principal Investigator” section for the Project

Director/Principal Investigator (PD/PI).

The PD/PI must have an eRA Commons account with the PI role, and the account must be affiliated

with the applicant organization. If you are proposing research at an institute other than the one

you are currently at, do not create a separate Commons account with the proposed applicant

organization. For information on eRA Commons account administration, see the eRA Account

Management System’s Online Help.

Special Instructions for Multiple PD/PIs: When submitting an application involving multiple

PD/PIs, list the “Contact” PD/PI in this field. List all additional PD/PIs in the Senior/Key Person

section(s) below.

Additional Instructions for Career Development:

For all career development award applications, the candidate is considered the

PD/PI. Therefore, the candidate must have an eRA Commons account with the PI

role and the account must be affiliated with the applicant organization. For

additional information on eRA Commons account administration, see the eRA

Account Management System’s Online Help.

If your proposed career development award will be at a different site than your

current institution, the proposed sponsoring institution will be the applicant

organization. You must affiliate your Commons account with that institution so that

you have access to records submitted on your behalf. Do not create a separate

Commons account with the proposed sponsoring institution.

Note that “multiple PD/PIs” are not applicable to career development award

applications, so do not use the PD/PI role for any other senior/key personnel.

Additional Instructions for Training:

If multiple PD/PIs are proposed, explain the rationale for how this will facilitate

program administration in the Program Plan attachment (in G.420 - PHS 398

Research Training Program Plan Form, Program Plan). Additionally, the application

must include a Multi-PD/PI Leadership Plan (in G.420 - PHS 398 Research Training

Program Plan Form, Multiple PD/PI Leadership Plan) describing how multi-PD/PIs

will benefit the program and the trainees.

Additional Instructions for Fellowship:

For all fellowship applications, the applicant is considered the PD/PI. Therefore, the

applicant must have an eRA Commons account with the PI role, and the account

must be affiliated with the applicant organization. For additional information on eRA

Commons account administration, see the eRA Account Management System’s

Online Help.

If your proposed fellowship is at a different site than your current institution, the

proposed sponsoring institution will be the applicant organization. You must affiliate

your Commons account with the institution so that you have access to records

submitted on your behalf. Do not create a separate Commons account with the

proposed sponsoring institution.

Note that “multiple PD/PIs” are not applicable to fellowship applications, so do not

use the PD/PI role for any other senior/key personnel.

Additional Instructions for Multi-project:

Overall Component: List the PD/PI (or Contact PD/PI if submitting a multi-PD/PI

application) for the entire application.

Other Components: List the component lead.

Additional Instructions for SBIR/STTR:

STTR Applications:

The STTR applicant organization must officially affiliate the PD / PI with the small

business in the eRA Commons if the PD/PI is not an employee of the small business.

For additional information on creating user affiliations in the eRA Commons, see the

eRA Account Management System's Online Help.

Prefix:

This field may be pre-populated from the SF 424 (R&R) and reflects the prefix, if applicable, for the

name of the PD/PI.

First Name:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the first

(given) name of the PD/PI.

Middle Name:

This field may be pre-populated from the SF 424 (R&R) and reflects the middle name of the PD/PI.

Last Name:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the last

(family) name of the PD/PI.

Suffix:

This field may be pre-populated from the SF 424 (R&R) and reflects the suffix for the name of the

PD/PI.

Position/Title:

This field may be pre-populated from the SF 424 (R&R) and reflects the position/title of the PD/PI.

Department:

This field may be pre-populated from the SF 424 (R&R) and reflects the name of the primary

organizational department, service, laboratory, or equivalent level within the organization of the

PD/PI.

Organization Name:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the name

of the organization of the PD/PI.

Division:

This field may be pre-populated from the SF 424 (R&R) and reflects the name of the primary

organizational division, office, major subdivision, or equivalent level within the organization of the

PD/PI.

Street1:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the first

line of the street address for the PD/PI.

Street2:

This field may be pre-populated from the SF 424 (R&R) and reflects the second line of the street

address for the PD/PI.

City:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the city

for the address of the PD/PI.

County/Parish:

This field may be pre-populated from the SF 424 (R&R) and reflects the county/parish for the

address of the PD/PI.

State:

This field is required if the PD/PI is located in the United States or its Territories. This field may be

pre-populated from the SF 424 (R&R) and reflects the state or territory in which the PD/PI is

located.

Province:

If “Country” is Canada, enter the province for the PD/PI; otherwise, skip the “Province” field. This

field may be pre-populated from the SF 424 (R&R) and reflects the province in which the PD/PI is

located.

Country:

This field may be pre-populated from the SF 424 (R&R) and reflects the country for the address of

the PD/PI.

ZIP/Postal Code:

The ZIP+4 is required if the PD/PI address is in the United States. Otherwise, the postal code is

optional. This field may be pre-populated from the SF 424 (R&R) and reflects the postal code of

the address of the PD/PI.

Phone Number:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the

daytime phone number for the PD/PI.

Fax Number:

This field may be pre-populated from the SF 424 (R&R) and reflects the fax number for the PD/PI.

E-mail:

This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the e-

mail address for the PD/PI.

Credential, e.g., agency login:

This field is required. Enter the assigned eRA Commons username for the project’s PD/PI. The eRA

Commons username must hold the PI role and be affiliated with the applicant organization.

Applications will not pass agency validation requirements without a valid eRA Commons

username.

Special Instructions for Multiple PD/PI: The Commons username must be provided for

all individuals assigned the Project Role of PD/PI on the application.

Additional Instructions for Career Development:

Enter the eRA Commons username for the PD/PI (Career Development candidate).

The eRA Commons Personal Profile associated with the username entered in the

Credential field must include an ORCID ID. For more information on linking an

ORCID ID to an eRA Commons Personal Profile, see the ORCID ID topic in the eRA

Commons online help.

Additional Instructions for Fellowship:

Enter the eRA Commons username for the PD/PI (Fellowship candidate). The eRA

Commons Personal Profile associated with the username entered in the Credential

field must include an ORCID ID. For more information on linking an ORCID ID to an

eRA Commons Personal Profile, see the ORCID ID topic in the eRA Commons online

help.

Project Role:

Enter "PD/PI" for the Project Role for the PD/PI.

Additional Instructions for Multi-project:

Other Components: For the “Profile – Project Director/Principal Investigator”

section, enter “Other (Specify)” and enter “Project Lead” for the “Other Project Role

Category” field, unless otherwise specified in the FOA. The PD/PI role is used only in

the Overall Component.

Other Project Role Category:

Skip the “Other Project Role Category” field, as no other role can be added to the PD/PI role.

Degree Type:

Enter the highest academic or professional degree or other credentials (e.g., R.N.).

Degree Year:

Enter the year the highest degree or other credential was obtained.

Attach Biographical Sketch

Provide a biographical sketch for each PD/PI. See instructions below on how to complete a

biographical sketch.

Attach Current & Pending Support:

Do not use this attachment upload for NIH and other PHS agency submissions unless otherwise

specified in the FOA.

While this information is not required at the time of application submission, it may be requested

later in the pre-award cycle. If and when this occurs, refer to the NIH Grants Policy Statement,

Section 2.5.1: Just-in-Time Procedures.

Instructions for a Biographical Sketch

These instructions apply to Research (R), Career Development (K), Training (T), Fellowship (F),

Multi-project (M), and SBIR/STTR (B). Hyperlinks and URLs are only allowed when specifically noted

in funding opportunity announcement (FOA) and form field instructions.

Who must complete the “Biographical Sketch” section:

All senior/key personnel and other significant contributors (OSCs) must include biographical

sketches (biosketches).

Format:

Use the sample format on the Biographical Sketch Format Page to prepare this section for all grant

applications.

Figures, tables (other than those included in the provided format pages), or graphics are not

allowed in the biosketch. Do not embed or attach files (e.g. video, graphics, sound, data).

The biosketch may not exceed five pages per person. This five-page limit includes the table at the

top of the first page.

Attach this information as a PDFfile. See the Format Attachments page.

Content:

Note that the instructions here follow the format of Biographical Sketch Format Page.

Name:

Fill in the name of the senior/key person or other significant contributor in the “Name” field of the

Biosketch Format Page.

eRA Commons User Name:

If the individual is registered in the eRA Commons, fill in the eRA Commons User Name in the “eRA

Commons User Name” field of the Biosketch Format Page.

The “eRA Commons User Name” field is required for the PD/PI (including career development and

fellowship applicants), primary sponsors of fellowship applicants, all mentors of candidates for

mentored career development awards, and candidates for diversity and reentry research

supplements.

The “eRA Commons User Name” field is optional for other project personnel.

The eRA Commons User Name should match the information provided in the Credential

field of the R&R Senior/Key Person Profile (Expanded) Form in your grant application.

Position Title:

Fill in the position title of the senior/key person or other significant contributor in the “Position

Title” field of the Biosketch Format Page.

Education/Training

Complete the education block. Begin with the baccalaureate or other initial professional

education, such as nursing. Include postdoctoral, residency, and clinical fellowship training, as

applicable, listing each separately.

For each entry provide:

the name and location of the institution

the degree received (if applicable)

the month and year of end date (or expected end date). For fellowship applicants only,

also include the month and year of start date.

the field of study (for residency entries, the field of study should reflect the area of

residency training)

Following the education block, complete Sections A-D of the biographical sketch.

A. Personal Statement

Briefly describe why you are well-suited for your role(s) in this project. Relevant factors may

include: aspects of your training; your previous experimental work on this specific topic or related

topics; your technical expertise; your collaborators or scientific environment; and/or your past

performance in this or related fields, including ongoing and completed research projects from the

past three years that you want to draw attention to (previously captured under Section D. Research

Support).

You may cite up to four publications or research products that highlight your experience and

qualifications for this project. Research products can include, but are not limited to, audio or video

products; conference proceedings such as meeting abstracts, posters, or other presentations;

patents; data and research materials; databases; educational aids or curricula; instruments or

equipment; models; protocols; and software or netware. Use of hyperlinks and URLs to cite these

items is not allowed.

You are allowed to cite interim research products. Note: interim research products have specific

citation requirements. See related Frequently Asked Questions for more information.

Note the following additional instructions for ALL applicants/candidates:

If you wish to explain factors that affected your past productivity, such as family care

responsibilities, illness, disability, or military service, you may address them in this “A.

Personal Statement” section.

Indicate whether you have published or created research products under another name.

You may mention specific contributions to science that are not included in Section C. Do

not present or expand on materials that should be described in other sections of this

Biosketch or application.

Figures, tables, or graphics are not allowed.

Note the following instructions for specific subsets of applicants/candidates:

For institutional research training, institutional career development, or research education

grant applications, faculty who are not senior/key persons are encouraged, but not

required, to complete the "A. Personal Statement" section.

Applicants for dissertation research awards (e.g., R36) should, in addition to addressing

the points noted above, also include a description of their career goals, their intended

career trajectory, and their interest in the specific areas of research designated in the FOA.

Candidates for research supplements to promote diversity in health-related research

should, in addition to addressing the points noted above, also include a description of

their general scientific achievements and/or interests, specific research objectives, and

career goals. Indicate any current source(s) of educational funding.

B. Positions, Scientific Appointments and Honors

List in reverse chronological order all current positions and scientific appointments both domestic

and foreign, including affiliations with foreign entities or governments. This includes titled

academic, professional, or institutional appointments whether or not remuneration is received,

and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary). High

school students and undergraduates may include any previous positions. For individuals who are

not currently located at the applicant organization, include the expected position at the applicant

organization and the expected start date.

List any relevant academic and professional achievements and honors. In particular:

Students, postdoctorates, and junior faculty should include scholarships, traineeships,

fellowships, and development awards, as applicable.

Clinicians should include information on any clinical licensures and specialty board

certifications that they have achieved.

C. Contributions to Science

Who should complete the “Contributions to Science” section:

All senior/key persons should complete the “Contributions to Science” section except candidates

for research supplements to promote diversity in health-related research who are high school

students, undergraduates, and post-baccalaureates.

Format:

Briefly describe up to five of your most significant contributions to science. The description of each

contribution should be no longer than one half page, including citations.

While all applicants may describe up to five contributions, graduate students and postdoctorates

may wish to consider highlighting two or three they consider most significant.

Content:

For each contribution, indicate the following:

the historical background that frames the scientific problem;

the central finding(s);

the influence of the finding(s) on the progress of science or the application of those

finding(s) to health or technology; and

your specific role in the described work.

Figures, tables, or graphics are not allowed.

For each contribution, you may cite up to four publications or research products that are relevant

to the contribution. If you are not the author of the product, indicate what your role or

contribution was. Note that while you may mention manuscripts that have not yet been accepted

for publication as part of your contribution, you may cite only published papers to support each

contribution. Research products can include audio or video products (see the NIH Grants Policy

Statement, Section 2.3.7.7: Post-Submission Grant Application Materials); conference proceedings

such as meeting abstracts, posters, or other presentations; patents; data and research materials;

databases; educational aids or curricula; instruments or equipment; models; protocols; and

software or netware. Use of hyperlinks and URLs to cite these items is not allowed.

You are allowed to cite interim research products. Note: interim research products have specific

citation requirements. See related Frequently Asked Questions for more information.

You may provide a hyperlinked URL to a full list of your published work. This hyperlinked URL must

be to a Federal Government website (a .gov suffix). NIH recommends using My Bibliography.

Providing a URL to a list of published work is not required.

Descriptions of contributions may include a mention of research products under development,

such as manuscripts that have not yet been accepted for publication. These contributions do not

have to be related to the project proposed in this application.

D. Scholastic Performance

* Note that only the following types of applicants must complete this section:

applicants for predoctoral and postdoctoral fellowships

applicants to dissertation research grants (e.g., R36)

candidates for research supplements to promote diversity in health-related research

from the undergraduate through postdoctoral levels

Scholastic Performance

Predoctoral applicants/candidates (including undergraduates and post-baccalaureates): List

by institution and year all undergraduate and graduate courses, with grades. In addition, explain

any grading system used if it differs from a 1-100 scale; an A, B, C, D, F system; or a 0-4.0 scale.

Also indicate the levels required for a passing grade.

Postdoctoral applicants: List by institution and year all graduate scientific and/or professional

courses with grades. In addition, explain any grading system used if it differs from a 1-100 scale; an

A, B, C, D, F system; or a 0-4.0 scale. Also indicate the levels required for a passing grade.

Additional Instructions for Multi-project:

Each Senior/Key Person, including the PD/PI, is allowed one biosketch for the entire

application. If an individual will participate on multiple components, attach the

biosketch to any single component.

Profile – Senior/Key Person 1

Enter data in this “Profile – Senior/Key Person 1” section to provide information on a senior/key

person (other than the PD/PI listed above), if applicable.

Format:

List all senior/key person profiles, followed by other significant contributors (OSC) profiles.

Content – Who to include in the “Profile – Senior/Key Person” section:

Senior/Key Persons: Fill in a separate “Profile – Senior/Key Person” block for each senior/key

personnel. Those with a postdoctoral role should be included if they meet the NIH Glossary

definition of senior/key personnel. A biosketch is required for all senior/key persons.

Other Significant Contributors: Also use the “Profile – Senior/Key Person” section to list any

other significant contributors (OSCs). Consultants should be included if they meet the NIH

Glossary definition of OSC. OSCs should be listed after all other senior/key persons.

A biosketch is required for all OSCs. The biosketch should highlight the OSC’s accomplishments as

a scientist. Reviewers assess these pages during peer review. For more information on review

criteria, see the Review Criteria at a Glance document. Although Other Support information is

required as a just-in-time submission, Other Support information will NOT be required or accepted

for OSCs since considerations of overlap do not apply to these individuals.

Should the level of involvement increase for an individual listed as an OSC, thus requiring

measurable effort on the award, the individual must be redesignated as “senior/key personnel.”

This change must be made before any compensation is charged to the project.

For more information:

For more information, refer to these NIHSenior/Key Personnel Frequently Asked Questions.

Additional Instructions for Career Development:

Who to include in the “Profile – Senior/Key Person” information section:

Mentored career development awards require a primary mentor, and there may also

be co-mentor(s). Mentors and co-mentors, should be identified as senior/key

personnel, even if they are not committing any specified measurable effort to the

proposed project, and they must provide an eRA Commons username.

In addition to involving mentor(s), applications may also involve collaborators,

consultants, and advisory committee members. These individuals are usually not

considered senior/key personnel unless they contribute in a substantive, meaningful

way to the career development of the candidate or the career development project.

In determining which individuals to identify as “Senior/Key,” mentored career

development award applicants may wish to keep in mind that those listed as

senior/key personnel on the application should not be asked to provide reference

letters, as such letters are expected to be from individuals not directly involved in the

application. For more information, see NIH's Reference Letters page.

Additional Instructions for Training:

Who to include in the “Profile – Senior/Key Person” information section:

The Program Director(s) (in case of multiple PD/PIs), and any other individuals

whose contributions are critical to the development, management, and execution of

the Research Training Program Plan in a substantive, measurable way (whether or

not salaries are reimbursed) should be included as senior/key persons. Include

program staff as applicable. Since the efforts of the senior/key persons are not

project related research endeavors, they should not be identified in the "Other

Support" information (which is required as a Just-in-Time submission).

Who not to include in the “Profile – Senior/Key Person” information section:

Do not include proposed mentors and training faculty members (except in the rare

cases where they are also senior/key persons). Biographical sketches for mentors

and other participating faculty will be included in the “Participating Faculty

Biosketches” attachment of the G.420 - PHS 398 Research Training Program Plan

Form.

Additional Instructions for Fellowship:

Who to include in the “Profile – Senior/Key Person” information section:

Fellowship awards require a primary sponsor, and there may also be co-sponsor(s).

Sponsors and co-sponsors should be identified as senior/key personnel, even if they

are not committing any specified measurable effort to the proposed project, and

they must provide an eRA Commons username.

In addition to involving sponsors and co-sponsors, fellowship applications may also

involve collaborators, consultants, advisory committee members, and contributors.

These individuals are usually not considered senior/key personnel unless they

contribute in a substantive, meaningful way to the project. In determining which

individuals to identify as “Senior/Key,” applicants may wish to keep in mind that

those listed as senior/key personnel on the application should not be asked to

provide reference letters, as such letters are expected to be from individuals not

directly involved in the application. For more information, see NIH's Reference

Letters page.

Prefix:

Enter or select the prefix, if applicable, for the name of the senior/key person.

First Name:

This field is required. Enter the first (given) name of the senior/key person.

Middle Name:

Enter the middle name of the senior/key person.

Last Name:

This field is required. Enter the last (family) name of the senior/key person.

Suffix:

Enter or select the suffix, if applicable, for the senior/key person.

Position/Title:

Enter the position/title of the senior/key person.

Department:

Enter the name of the primary organizational department, service, laboratory, or equivalent level

within the organization of the senior/key person.

Organization Name:

This field is required. Enter the name of the organization of the senior/key person.

Division:

Enter the name of the primary organizational division, office, major subdivision, or equivalent level

within the organization of the senior/key person.

Street1:

This field is required. Enter the first line of the street address for the senior/key person.

Street2:

Enter the second line of the street address for the senior/key person.

City:

This field is required. Enter the city for the address of the senior/key person.

County/Parish:

Enter the county/parish for the address of the senior/key person.

State:

This field is required if the Senior/Key person is located in the United States or its Territories. Enter

the state or territory where the senior/key person is located.

Province:

If “Country” is Canada, enter the province for the senior/key person; otherwise, skip the “Province”

field.

Country:

This field is required. Select the country for the address of the senior/key Person.

ZIP/Postal Code:

The ZIP+4 is required if the Senior/Key Person is in the United States. Otherwise, the postal code is

optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the senior/key person.

Phone Number:

This field is required. Enter the daytime phone number for the senior/key person.

Fax Number:

Enter the fax number for the senior/key person.

E-mail:

This field is required. Enter the e-mail address for the senior/key person.

Credential, e.g., agency login:

This field is required. Applies to Senior/Key Personnel as defined in the NIH Grants Policy

Statement (NIH GPS 1.2) as well as Other Significant Contributors (OSCs). Enter the assigned eRA

Commons username for the senior / key Person.

Additional Instructions for Research:

For Multiple PD/PI Applications: The eRA Commons username must be entered in

this field for any senior/key person with the PD/PI Project Role.

Candidates for diversity and reentry research supplement support must provide an

eRA Commons Username.

Additional Instructions for Career Development:

For senior/key person who are the primary mentor, an eRA Commons username

must be provided in the “Credential” field. For more information, see the NIH Guide

Notice on eRA Commons Username Requirements for Primary Mentors.

Additional Instructions for Fellowship:

For senior/key person who are the primary sponsor, an eRA Commons username

must be provided in the “Credential” field. For more information, see the NIH Guide

Notice on eRA Commons Username Requirements for Sponsors of Fellowship

Applications.

Project Role:

Select a project role. Use "Other (Specify)" if the desired category is not available.

Special Instructions for Multiple PD/PIs:All PD/PIs must be assigned the “PD/PI” role,

even those at organizations other than the applicant organization. The role of “Co-PD/PI”

is not currently used by NIH or other PHS agencies to designate a multiple PD/PI

application. In order to avoid confusion, do not use the role of “Co-PD/PI.”

Note on OSCs: For OSCs, enter “Other (Specify)” for the “Project Role” field, and enter “Other

Significant Contributor” in the “Other Project Role Category” field.

Additional Instructions for Career Development:

For mentors and co-mentors, enter “Other Professional” for the “Project Role” field,

and enter “Mentor” or “Co-mentor” as applicable in the “Other Project Role

Category” field.

“Multiple PD/PIs” are not applicable to career development applications. The PD/PI

role must be used only for the candidate and not for any other senior/key personnel.

Additional Instructions for Fellowship:

For sponsors and co-sponsors, enter “Other (Specify)” for the “Project Role” field,

and enter the appropriate role (e.g., Sponsor) in the “Other Project Role Category”

field.

“Multiple PD/PIs” are not applicable to fellowship applications. The PD/PI role must

be used only for the applicant and not for any other senior/key personnel.

Other Project Role Category:

Complete this field (e.g., Engineer, Chemist, Sponsor, Mentor) if you selected “Other Professional”

or “Other (Specify)” in the “Project Role” field.

Degree Type:

Enter the highest academic or professional degree or other credentials (e.g., R.N.).

Degree Year:

Enter the year the highest degree or other credential was obtained.

Attach Biographical Sketch:

Provide a biographical sketch for each senior/key person and each OSC. See instructions above on

how to complete a biographical sketch.

Attach Current & Pending Support:

Note: The terms “current and pending support,” “other support,” and “active and pending

support” are used interchangeably.

Do not use the "Current &Pending Support" attachment upload for NIH or other PHS agency

submissions unless otherwise specified in the FOA (see exception for career development

applications in the Career Development-specific instructions below).

While this information is not required at the time of application submission, it may be requested

later in the pre-award cycle. If and when this occurs, refer to the NIH Grants Policy Statement,

Section 2.5.1: Just-in-Time Procedures for instructions and use the Current and Pending Support

Format Page.

Additional Instructions for Career Development:

Who must complete the “Current & Pending Support” field:

For mentored career development award applications, you must include "Current

and Pending Support" pages for each of the mentor and co-mentor(s). You do not

need to include "Current and Pending Support" pages for the candidate.

Format:

Attach this information as a PDF. See the Format Attachments page. Use of

hyperlinks and URLs in this section is not allowed unless specified in the funding

opportunity announcement.

See also the Current and Pending Support Format Page.

Content:

Provide information on the following items for each of the mentor’s and co-

mentor’s current and pending research support relevant to the candidate’s research

plan. Each mentor/co-mentor(s)’s “Current & Pending Support” attachment is

limited to 3 pages.

Project Number: Provide the project number. If applicable, include a code or

identifier for the project.

Source: Identify the agency, institute, foundation, or other organization that is

providing the support. Include domestic, foreign, institutional, federal, public,

and private sources of support.

Major Goals: Provide a brief statement of the overall objectives of the project,

subproject, or consortium/contractual arrangement or a description of the

activity.

Project / Proposal State and End Dates: Indicate the inclusive dates of the

project/activity as approved/proposed. For example, in the case of NIH support,

provide the dates of the approved/proposed competitive segment. For in-kind

contributions, provide project dates when applicable.

Total Award Amount: For active projects, provide the total award costs for the

period of performance, including indirect costs. For example, in the case of NIH

support, provide the total award costs for the competitive segment. For a

pending project, provide the proposed total costs for the period of performance.

Do not include information on “percent effort/person months” or on “overlap.”

For more Information:

For more information on “Other Support Information,” see the NIH Grants Policy

Statement, Section 2.5.1: Just-in-Time Procedures.

Additional Senior / Key Person Profile(s)

If you need to add more Senior/Key Person Profiles than the form allows, enter the information in

a separate file and attach it as a PDF.

A format page for Additional Senior/Key Person Profiles can be found at NIH's Additional

Senior/Key Person Form page.

G.300 - R&R Budget Form

The R&R Budget Form is used in the majority of

applications; however, it is important to refer to your

specific FOA for guidance on which budget form(s) are

allowed for your application.

Some application forms packages include two optional

budget forms — (1) the R&R Budget Form and, (2) PHS

398 Modular Budget Form. Include only one of these

forms, but not both, in your application.

View larger image

Quick Links

Introductory Fields

A. Senior/Key Person

B. Other Personnel

C. Equipment Description

D. Travel

E. Participant/Trainee Support Costs

F. Other Direct Costs

G. Direct Costs

H. Indirect Costs

I. Total Direct and Indirect Costs

J. Fee

K. Total Costs and Fee

L. Budget Justification

Research & Related Budget - Cumulative Budget

Who should use the R&R Budget Form?

There are two primary types of Budget Forms: detailed R&R and PHS 398 modular. Generally, you must

use the R&R Budget Form if you are applying for more than $250,000 per budget period in direct costs,

and you must use the Modular Budget Form if you are applying for less than $250,000. However, some

grant mechanisms or programs (e.g., training grants) may require other budget forms to be used. Refer

to your FOA and to the following instructions for guidance on which Budget Form to use.

Note: The terms “detailed budget” and “R&R Budget” are used interchangeably.

If you are requesting a budget with $500,000 or more in direct costs for any budget period, contact the

awarding component to determine whether you must obtain prior approval before submitting the

application. For more information on applications that request $500,000 or more in direct costs, see the

NIH Grants Policy Statement, Section 2.3.7.2: Acceptance for Review of Unsolicited Applications

Requesting $500,000 or More in Direct Costs.

Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): All

competing (new, renewal, resubmission, and revision) grant applications from foreign (non-U.S.)

institutions must use the R&R Budget Form. Do not use the PHS 398 Modular Budget Form. For

additional information, see NIH Guide Notice on the Requirement for Detailed Budget Submissions

from Foreign Institutions and the NIH Grants Policy Statement, Section 13.3.1: Budget. Applications

from foreign organizations must request budgets in U.S. dollars.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use of

human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy

Statement) is included in the proposed application, you must use the R&R Budget Form and cannot

use the PHS Modular Budget Form, regardless of the activity code. Whether or not you incur costs to

obtain HFT, you will need to include a “Human Fetal Tissues Costs” line item (F.8-17) and a Budget

Justification attachment (L).

Note on Subawards/Consortiums: If you have a subaward/consortium, you must use the R&R

Subaward Budget Attachment(s) Form in conjunction with the R&R Budget Form. The prime must

extract the R&R Subaward Budget Attachment(s) from the R&R Subaward Budget Attachment(s) Form

and send the extracted file to the subaward/consortium. The consortium should complete the R&R

Subaward Budget Attachment, following the instructions here and in G.310 – R&R Subaward Budget

Attachment(s) Form.

For more information:

For more information on how to prepare your budget, see NIH's Develop Your Budget page.

Additional Instructions for Career Development:

Who should use the R&R Budget Form?

All career development applications must use the R&R Budget Form. The PHS 398

Modular Budget Form is not permissible.

Refer to your FOA for information regarding allowable costs for the candidate and

any allowable research development or other costs. Contact the targeted awarding

component if you are uncertain about allowable amounts for the applicable career

development award mechanism. Keep in mind that amounts vary with awarding

components.

Transitional Career Award applications: NIH intramural candidates applying for

transitional career award support (e.g., K22, K99/R00) should follow instructions in

the applicable FOA. For the mentored phase of these awards, budgets are

negotiated with the sponsoring intramural laboratory. For awardees who receive

approval to transition to the extramural phase, a budget will be required as part of

the extramural sponsored application.

Additional Instructions for Training:

Who should use the R&R Budget Form?

T90/R90 applications: Use the R&R Budget Form in conjunction with the PHS 398

Training Budget Form for the R90 portion of the application.

K12, D43, D71, T37, and U2R applications: Use only the R&R Budget Form.

All other Training applications: Most training applications should use the PHS 398

Training Budget Form. Use the R&R Budget Form only when allowed or required in

an FOA. See also instructions in G.420 - PHS 398 Research Training Program Plan

Form.

Additional Instructions for Multi-project:

Developing a Multi-project Budget: The structure of a Multi-project application

reflects where the work will be done and not necessarily the flow of funds. If most of

the work for a particular component is done by a collaborating organization, then

that organization can be set up as the lead organization for that component.

The main budget form for the component must reflect the Unique Entity Identifier

(UEI) for the lead organization and Project for the Budget Type. If the applicant

organization is responsible for a portion of the work for that component, then their

costs would be reflected on a Subaward Budget Form with the applicant

organization UEI and Subaward / Consortium for the Budget Type. Subaward Budget

Forms simply record budget data. They do not indicate that funds must flow

through the lead organization for the component.

The UEI on each budget form is used to identify the budget data associated with

each organization. When the UEI on the budget form is the same as the UEI on the

Overall Component’s SF424 R&R form, the budget data is associated with the

applicant organization. When the UEI is different, it is seen as belonging to a

subaward.

For more information, refer to NIH's Frequently Asked Questions on Applying

Electronically.

Overall Component: Most budget data is collected within the Other Components.

Complete only the G.200 - SF 424 (R&R) Form, Estimated Project Funding section

and the G.350 - PHS Additional Indirect Costs Form (if applicable). The PHS

Additional Indirect Costs Form is used to gather any additional information

allowable under the grantee's negotiated F&A rate agreement needed to calculate

the F&A rate for the Overall Component's first $25,000 on each subaward that leads

an entire component. The PHS Additional Indirect Costs Form should not be used

when all components are led by the applicant organization.

System-generated budget summaries (including a Composite Application Budget

Summary) based on budget data collected within the Other Components are

included in the summaries section of the assembled application image.

Budget summaries will:

appear in the Overall section of the assembled application image in eRA

Commons;

will be compiled from R&R budget data collected in the Other Components;

and

will be generated upon submission.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue:

If the use of human fetal tissue obtained from elective abortions (HFT) (as defined

in the NIH Grants Policy Statement) is included in the proposed application, you

must provide HFT budget information in the component(s) where the research

involving HFT is conducted.

Special Instructions for Applications Submitted with a Data Management

and Sharing Plan:

Overall Component: The "Data Management and Sharing Plan" attachment must be

provided within the PHS 398 Research Plan Form in the Overall Component. Do not

include budget information for Data Management and Sharing Costs in the Overall

Component.

Other Components: Include budget information for Data Management and Sharing

Costs within the applicable component(s). Do not include a “Data Management and

Sharing Plan” attachment within the components. Any component-specific

information should be described within the overall “Data Management and Sharing

Plan” attachment provided within the PHS 398 Research Plan Form in the Overall

Component.

Additional Instructions for SBIR/STTR:

Fast-Track SBIR/STTR Applications: You will need to create three separate budget

periods to cover your Phase I and Phase II overall budget period: typically one

budget period (6-12 months) for Phase I and two budget periods (one year each) for

Phase II. If the Phase I and Phase II last longer than the typical project length, then

you need one budget period for each year of the project. Complete a separate G.300

R&R Budget Form for each of the separate budget periods.

Using the R&R Budget Form:

The location of the R&R Budget Form may vary with the type of submission (e.g., under an “Optional

Forms” tab).

You must complete a separate detailed budget for each budget period requested. The form will

generate a cumulative budget for the total project period. If no funds are requested for a required field,

enter “0.”

You must round to the nearest whole dollar amount in all dollar fields.

Competing Revision Applications: For a supplemental/revision application, complete fields for which

additional funds are requested in addition to all required fields. If the initial budget period of the

supplemental/revision application is less than 12 months, prorate the personnel costs and other

appropriate items of the detailed budget.

Introductory Fields

Unique Entity Identifier (UEI):

This field is required. This field may be pre-populated and should reflect the UEI of the applicant

organization (or of the lead organization for the component of a multi-project application).

Enter name of Organization:

This field may be pre-populated. Enter the name of the organization.

Budget Type:

This field is required. Check the appropriate box for your budget type, following these guidelines:

Project: The budget being requested is for the primary applicant organization.

Subaward/Consortium: The budget being requested is for subaward/consortium

organization(s). Note, separate budgets are required only for subaward/consortium

organizations that perform a substantive portion of the project. For

subawards/consortiums that do not perform a substantive portion of the project, then

you must include their costs in Field F5. Subawards/Consortium/Contractual Costs and in

the prime’s Section L. Budget Justification.

If you are preparing an application that includes a subaward/consortium that performs a

substantive portion of the project, in addition to completing this form, see also the instructions for

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

Additional Instructions for Multi-project:

Project: The budget being requested is for the organization leading the component.

Subaward/Consortium: The budget being requested is for other organizations

performing work for the component. When the applicant organization is

participating on a component, but not leading that component, their costs should

be reflected on a Subaward/Consortium budget. This is true even if the money will

not flow through the lead organization. The budget justification can be used to

clarify the flow of funds.

Budget Period:

This field is required.

Identify the specific budget period (for example, 1, 2, 3, 4, 5).

Start Date:

This field is required and may be pre-populated from the SF 424 R&R Form. Enter the

requested/proposed start date of the budget period. For period 1, the start date is typically the

same date as the Proposed Project Start Date on the G.200 - SF 424 (R&R) Form.

End Date:

This field is required. Enter the requested/proposed end date of the budget period.

A. Senior/Key Person

Who to include in A. Senior/Key Person:

Include the names of senior/key persons at the applicant organization, (or organization leading

the component of a multi-project application), who are involved on the project in a particular

budget period. Include all collaborating investigators and other individuals who meet the

senior/key person definition if they are from the applicant organization.

Consultants designated as senior/key persons in the Senior/Key Person Profile Form can be

included in the "A. Senior/Key Person" section only if they are also employees of the applicant

organization. Otherwise, consultant costs should be included in Consultant Services in Question F

of this form.

Who not to include in A. Senior/Key Person:

Do not list details of collaborators at other institutions here, as they will be provided in the

Subaward Budget for each subaward/consortium organization.

Personnel listed as other significant contributors who are not committing any specific measurable

effort to the project should not be included in the Personnel section (sections "A. Senior/Key

Person" and "B. Other Personnel") since no associated salary and/or fringe benefits can be

requested for their contribution.

Additional Instructions for Career Development:

Include information only for the candidate in the “A. Senior/Key Person" section. Do

not include the mentor(s) or any other senior/key persons. For the candidate,

provide the base salary, person months, and requested salary and fringe benefits.

career development programs include a minimum effort requirement, usually 75%

or nine person months.

Salary description: For the salary column, most NIH ICs limit the amount of salary

contribution provided for career development programs. However, applicants

should include information on actual institutional base salary and fringe benefits,

and the actual amount of salary and fringe being requested. ICs may request

updated salary information prior to award. Any adjustments based on policy

limitations will be made at the time of the award.

The total salary requested must be based on a full-time staff appointment. The

salary must be consistent both with the established salary structure at the institution

and with salaries actually provided by the institution from its own funds to other

staff of equivalent qualifications, rank, and responsibilities in the department

concerned. If full-time, 12-month salaries are not currently paid to comparable staff

members, the salary proposed must be appropriately related to the existing salary

structure. The total salary contribution provided by the NIH may not exceed the

legislatively mandated salary cap. See NIH's Salary Cap Summary.

Salary supplements: The sponsoring institution may supplement the NIH salary

contribution up to a level that is consistent with the institution's salary scale.

However, supplementation may not be from federal funds unless specifically

authorized by the federal program from which such funds are derived. In no case

may PHS funds be used for salary supplementation. Institutional supplementation of

salary must not require extra duties or responsibilities that would interfere with the

purpose of the career award.

Prefix:

Enter the prefix (e.g., Mr., Mrs., Rev.), if applicable, for the name of the senior/key person.

First Name:

This field is required. Enter the first (given) name of the senior/key person.

Middle Name:

Enter the middle name of the senior/key person.

Last Name:

This field is required. Enter the last (family) name of the senior/key person.

Suffix:

Enter the suffix (e.g., Jr., Sr., PhD), if applicable, of the senior/key person.

Base Salary ($):

Enter the annual compensation paid by the employer for the senior/key person. This includes all

activities such as research, teaching, patient care, and other. An applicant organization may choose

to leave this blank; however, NIH or other PHS Agency staff will request this information prior to

award.

Months (Cal./Acad./Sum.):

NIH and other PHS agencies use the concept of “person months” as a metric for determining

percent of effort. For more information about calculating person months, see NIH's information at

Frequently Asked Questions on Person Months.

Identify the number of months the senior/key person will devote to the project in the applicable

box (i.e., calendar, academic, summer).

Use either calendar months OR a combination of academic and summer months. Measurable

effort is required for every senior/key person entry.

For an explanation of "measurable effort," see the Frequently Asked Questions on Senior/Key

Personnel.

If effort does not change throughout the year, it is OK to use only the calendar months column.

However, you may use both the academic and summer months columns if your institutional

business process requires noting each separately even if effort remains constant. If effort varies

between academic and summer months, leave the calendar months column blank and use only

the academic and summer months columns.

If your institution does not use a 9-month academic year or a 3-month summer period, indicate

your institution’s definition of these in Section L. Budget Justification.

Requested Salary ($):

This field is required. Regardless of the number of months being devoted to the project, indicate

the salary being requested for this budget period for the senior/key person.

Salary limitations. Some PHS grant programs are currently subject to a legislatively imposed

salary limitation. Any adjustment for salary limits will be made at the time of award; therefore,

requested salary should be based on institutional base salary at the time the application is

submitted and not adjusted for any limitation. For guidance on current salary limitations, see the

NIH's Salary Cap Summary or contact your office of sponsored programs.

Graduate student compensation: NIH grants also limit compensation for graduate students.

Compensation includes salary or wages, fringe benefits, and tuition remission. While actual

institutional-based compensation should be requested and justified, this may be adjusted at the

time of the award. For more guidance on this policy, see the NIH Grants Policy Statement, Section

2.3.7.9: Graduate Student Compensation.

Fringe Benefits ($):

Enter the amount of requested fringe benefits, if applicable, for the senior/key person.

Funds Requested ($):

This field is automatically calculated and will reflect the total requested salary and fringe benefits

for the senior/key person.

Project Role:

This field is required. Identify the project role of each senior/key person. Roles should correspond

to the roles included on the G.240 - R&R Senior/Key Person Profile (Expanded) Form. Note that

there must be at least one PD/PI per budget period.

Additional Instructions for SBIR/STTR:

STTR: If the budget type is “project,” you do not have to list a PD/PI if the PD/PI is

primarily employed by the partnering research institution. In this case, list the PD/PI

in the Subaward / Consortium budget.

Additional Senior/Key Persons:

If you are requesting funds for more senior/key persons than the form allows, you must include an

attachment listing the additional senior/key person(s) in this “Additional Senior/Key Persons” field.

Use the same format as the budget form and include all the information identified in this section.

Total Funds requested for all persons in the attached file:

If you have attached a file with additional senior/key persons, enter the total funds requested for

everyone listed in the attachment in the “Total Funds requested for all Senior/Key Persons in the

attached file” field.

Total Senior/Key Persons:

This total will be automatically calculated based on the sum of the “Funds Requested” column and

the “Total Funds requested for all Senior/Key Persons in the attached file” field.

Special Instructions for Joint University and Department of Veterans Affairs (V.A.)

Appointments: Individuals with joint university and V.A. appointments may request the university’s

share of their salary in proportion to the effort devoted to the research project. The individual’s salary

with the university determines the base for computing that request. The signature by the institutional

official on the application certifies that: (1) the individual is applying as part of a joint appointment

specified by a formal Memorandum of Understanding between the university and the V.A.; and (2)

there is no possibility of dual compensation for the same work, or of an actual or apparent conflict of

interest regarding such work. Additional information may be requested by the awarding

components.

B. Other Personnel

Additional Instructions for Career Development:

Skip the "B. Other Personnel" section.

Number of Personnel:

For each project role category, identify the number of personnel proposed.

Administrative, Secretarial, and Clerical Support Salaries: In most circumstances, the salaries

of administrative, secretarial, or clerical staff at educational institutions and nonprofit

organizations are included as part of indirect costs (Section H. Indirect Costs). However, examples

of situations where direct charging of administrative or clerical staff salaries may be appropriate

may be found at: 45 CFR 75.403.

Inclusion of such costs may be appropriate only if all of the following conditions are met:

1. Administrative or clerical services are integral to a project or activity;

2. Individuals involved can be specifically identified with the project or activity;

3. Such costs are explicitly included in the budget or have prior written approval of the

federal awarding agency; and

4. The costs are not also recovered as indirect costs.

Requests for direct charging for secretarial/clerical personnel (i.e., administrative and clerical staff)

must be appropriately justified in Section L. Budget Justification. For all individuals classified as

administrative/secretarial/clerical, provide a justification (in the Budget Justification) documenting

how they meet all four conditions. NIH ICs may request additional information for these positions

in order to assess allowability.

Postdoctoral and Graduate Students: For all postdoctoral associates and graduate students not

already named in "Section A. Senior/Key Person," individually list names, roles (e.g., postdoctoral

associates or graduate student), associated months, and requested salary and fringe benefits in

Section L. Budget Justification.

Project Role:

List any additional project role(s) (e.g., engineer, IT professionals, etc.) in the blank(s) provided.

Identify the number of each personnel proposed.

You may have up to six named roles. If you have more than six, you must combine project roles

here and add an explanation about the named roles in Section L. Budget Justification.

Do not include consultants in this section. Consultants are included below in Section F. Other

Direct Costs.

Months (Cal./Acad./Sum.):

NIH and other PHS agencies use the concept of “person months” as a metric for determining

percent of effort. For more information about calculating person months, see: NIH's Frequently

Asked Questions on Person Months.

Identify the number of months devoted to the project in the applicable box (i.e., calendar,

academic, summer) for each project role category.

Use either calendar months OR a combination of academic and summer months.

If effort does not change throughout the year, it is OK to use only the calendar months column.

However, you may use both academic and summer months columns if your institutional business

process requires noting each separately, even if effort remains constant. If effort varies between

academic and summer months, leave the calendar months column blank and use only the

academic and summer months columns.

If your institution does not use a 9-month academic year or a 3-month summer period, indicate

your institution’s definition of these in Section L. Budget Justification.

Requested Salary ($):

Regardless of the number of months being devoted to the project, indicate only the amount of

salary/wages being requested for this budget period for each project role. The amount entered

should reflect the total amount of funds requested for all personnel within a project role.

Salary limitations: Some PHS grant programs are currently subject to a legislatively imposed

salary limitation. Any adjustment for salary limits will be made at the time of award; therefore,

requested salary should be based on institutional base salary at the time the application is

submitted and not adjusted for any limitation. For guidance on current salary limitations, see the

NIH's Salary Cap Summary or contact your office of sponsored programs.

Graduate student compensation: NIH grants also limit the compensation for graduate students.

Compensation includes salary or wages, fringe benefits, and tuition remission. While actual

institutional-based compensation should be requested and justified, this may be adjusted at the

time of the award. For more guidance on this policy, see the NIH Grants Policy Statement, Section

2.3.7.9: Graduate Student Compensation.

Fringe Benefits ($):

Enter the amount of requested fringe benefits, if applicable, for this project role category. The

amount entered should reflect the total amount of fringe benefits requested for all personnel

within a project role.

Funds Requested ($):

This field will be automatically calculated and will reflect the total requested salary and fringe

benefits for each project role category.

Total Number of Other Personnel:

This total will be automatically calculated based on the Number of Personnel for each project role

category.

Total Other Personnel:

This total will be automatically calculated based on the sum of the Funds Requested for all Other

Personnel.

Total Salary, Wages and Fringe Benefits (A+B):

This total will be automatically calculated and represents the total Funds Requested for all

Senior/Key persons and all Other Personnel

Special Instructions for Applications Submitted with a Data Management and Sharing Plan:

For applications submitted for due dates on or before October 4, 2023, if a Data

Management and Sharing Plan is required in the proposed application, personnel costs specific to

Data Management and Sharing activities must not be included here but listed as a specific line

item under Section F.8.-17 Other.

For applications submitted for due dates on or after October 5, 2023, DMS costs must be

requested in the appropriate costs category.

C. Equipment Description

The “C. Equipment Description” section is for you to list items and dollar amount for each item

exceeding $5,000 (unless the organization has established lower levels).

Additional Instructions for Career Development:

Skip the “C. Equipment Description” section.

Equipment Item:

Equipment is defined as an item of property that has an acquisition cost of $5,000 or more (unless

the organization has established lower levels) and an expected service life of more than one year.

List each item of equipment separately and justify each in Section L. Budget Justification. Allowable

items ordinarily will be limited to research equipment not already available for the conduct of the

work.

Additional Instructions for Multi-project:

Other Components: You are allowed to add up to 100 equipment items in this list.

For additional equipment items, you must list them in the “Additional Equipment”

attachment.

Funds Requested:

This information is required. List the estimated cost of each item, including shipping and any

maintenance costs and agreements.

Additional Equipment:

If you're requesting funds for more equipment than the form allows, you must include an

attachment listing the additional equipment items in this “Additional Equipment” field. Enter the

information in a separate file and attach it as a PDF. List each additional item and the funds

requested for each individual item. The dollar amount for each item should exceed $5,000 (unless

the organization has established lower levels).

Total funds requested for all equipment listed in the attached file:

If you have attached a file with additional equipment, enter the total funds requested for all the

equipment listed in the attachment.

Total Equipment:

This total will be automatically calculated based on the sum of the “Funds Requested” column and

the “Total funds requested for all equipment listed in the attached file” field.

D. Travel

Additional Instructions for Career Development:

Skip the "D. Travel" section.

1. Domestic Travel Costs (Incl. Canada, Mexico, and U.S. Possessions):

Enter the total funds requested for domestic travel. Domestic travel includes destinations in the

U.S., Canada, Mexico, and U.S. possessions. In Section L. Budget Justification, include the purpose,

destination, dates of travel (if known), and the number of individuals for each trip. If the dates of

travel are not known, specify the estimated length of trip (e.g., 3 days).

2. Foreign Travel Costs:

Identify the total funds requested for foreign travel. Foreign travel includes any destination outside

of the U.S., Canada, Mexico, or U.S. possessions. In Section L. Budget Justification, include the

purpose, destination, dates of travel (if known), and the number of individuals for each trip. If the

dates of travel are not known, specify the estimated length of trip (e.g., 3 days).

Total Travel Cost:

This total will be automatically calculated based on the sum of the Domestic and Foreign Funds

Requested fields.

E. Participant/Trainee Support Costs

Unless specifically stated otherwise in a FOA, NIH and other PHS agencies applicants should skip

Section E. Participant/Trainee Support Costs. Note: Tuition remission for graduate students should

be included in Section F. Other Direct Costs when applicable.

1. Tuition/Fees/Health Insurance:

List the total funds requested for Participant/Trainee Tuition/Fees/Health Insurance.

2. Stipends:

List the total funds requested for Participant/Trainee stipends.

3. Travel:

List the total funds requested for Participant/Trainee travel.

4. Subsistence:

List the total funds requested for Participant/Trainee subsistence.

5. Other:

Describe any other Participant/Trainee support costs and list the total funds requested for all other

Participant/Trainee costs described.

Number of Participants/Trainees:

List the total number of proposed Participants/Trainees. Value cannot be greater than 999.

Total Participant/Trainee Support Costs:

This field is required if any data has been entered in “Section E. Participant/Trainee Support Costs.”

This total will be automatically calculated based on the sum of the Funds Requested column in

"Section E. Participant/Trainee Support Costs."

F. Other Direct Costs

1. Materials and Supplies:

List the total funds requested for materials and supplies. In Section L. Budget Justification, indicate

general categories such as glassware, chemicals, animal costs, etc., including an amount for each

category. Categories with amounts less than $1,000 are not required to be itemized.

Additional Instructions for Career Development:

In the "Material and Supplies" field, enter the total research development support

being requested for the initial budget period of the career development award.

Usually, a specific total amount is allowed for research development and other costs

(tuition, fees, research supplies, equipment, computer time, travel, etc.) that do not

require individual cost category identification. Unless instructed differently in the

applicable FOA, applicants should enter only the total requested research

development support (RDS) amount in this box. All remaining budget fields in this

section should be left blank.

Please note that while this method of entering only the total requested research

development support costs in "Section F. Other Direct Cost" will be simplest for

most applicants, some applicants, including some system-to-system applicants, may

instead choose to enter those costs in the applicable detailed budget categories.

When choosing this option, it is still the applicant’s responsibility to make certain the

total research development support costs do not exceed the allowable total.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If costs for

human fetal tissue obtained from elective abortions (HFT) as defined in the NIHGrants Policy

Statement are included in the proposed budget, they must not be included here but listed as a

specific line item under Section F.8-17 Other.

2. Publication Costs:

List the total funds requested for publication costs. The proposal budget may request funds for the

costs of documenting, preparing, publishing, or otherwise making available to others, the findings

and products of the work conducted under the award. Include supporting information in Section L.

Budget Justification.

3. Consultant Services:

List the total funds requested for all consultant services. Identify the following items in Section L.

Budget Justification, as applicable:

each consultant, the services he/she will perform, total number of days, travel costs, and

the total estimated costs;

the names and organizational affiliations of all consultants, other than those involved in

consortium/contractual arrangements;

consulting physicians in connection with patient care; and

persons who are confirmed to serve on external monitoring boards or advisory

committees to the project. Describe the services to be performed.

4. Automatic Data Processing (ADP)/Computer Services:

List the total funds requested for ADP/computer services. The cost of computer services, including

computer-based retrieval of scientific, technical, and education information may be requested. In

Section L. Budget Justification, include the established computer service rates at the proposing

organization, if applicable.

5. Subawards/Consortium/Contractual Costs:

List the total funds requested for:

1. all subaward/consortium organization(s) proposed for the project and

2. any other contractual costs proposed for the project.

This line item should include both direct and indirect costs for all subaward/consortium

organizations.

Contractual costs for support services, such as laboratory testing of biological materials, clinical

services, or data processing, are occasionally sufficiently high to warrant a categorical breakdown

of costs. When this is the case, provide detailed information as part of Section L. Budget

Justification.

NIH policy provides for exclusion of consortium/contractual F&A costs when determining if an

applicant is in compliance with a direct cost limitation. However, you must include the full cost of

consortium/subawards in this field. See the NIH Grants Policy Statement, Section 2.3.7.1:

Applications that Include Consortium/Contractual F&A Costs for policy related to the exclusion of

consortium/subaward amounts in determining whether an applicant is in compliance with a direct

cost limitation.

6. Equipment or Facility Rental/User Fees:

List the total funds requested for equipment or facility rental/user fees. In Section L. Budget

Justification, identify and justify each rental user fee.

7. Alterations and Renovations:

List the total funds requested for alterations and renovations (A&R). In Section L. Budget

Justification, itemize by category and justify the costs of alterations and renovations, including

repairs, painting, and removal or installation of partitions, shielding, or air conditioning. Where

applicable, provide the square footage and costs.

Under certain circumstances the public policy requirements that apply to construction activities

may also apply to A&R activities. Refer to the NIH Grants Policy Statement, Section 10.10:

Construction Grants – Public Policy Requirements and Objectives for more information.

Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): Minor

A&R costs (≤$500,000) are allowable on applications from foreign organizations and domestic

institutions with foreign components. When requesting minor A&R costs under this policy,

please provide detailed information on the planned A&R in the budget justification.

8-17 Other:

Add descriptions for any “other” direct costs not requested above. Use Section L. Budget

Justification to further itemize and justify.

List funds requested for each of the items in lines "8-17 Other.” Use lines 8-17 for costs such as

patient care costs, tuition remission and SBIR/STTR "Technical Assistance"(TABA) costs. If

requesting patient care costs, request inpatient and outpatient costs separately.

Lines "8-17 Other" may also be used to request direct costs related to the use of single

Institutional Review Board (sIRB)for multi-site human subjects research.

For more information on charging direct and indirect costs for single IRBactivities, see the

Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRBReview under the

NIHPolicy on the Use of a Single IRBfor Multi-Site Research.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use of

human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy

Statement) is included in the proposed application, regardless of whether costs will be incurred, it

must be noted as a single line item here. The line item must be titled “Human Fetal Tissue Costs”

(without quotation marks, but following exact phrase and spacing). The line item must only be

used for HFT costs and cannot include or be combined with any “Other” costs. If no cost will be

incurred (e.g. if HFT will be donated), enter “0” in the “Funds Requested” column. Details regarding

HFT must be specified in the Budget Justification attachment (L), pursuant to the instructions.

Applications proposing HFT that do not address these requirements will be administratively

withdrawn. For further information on HFTpolicy refer to the NIHGrants Policy Statement, Section

2.3.7.11 Human Fetal Tissue from Elective Abortions, Section 4.1.14 Human Fetal Tissue Research

and Section 4.1.14.2 Human Fetal Tissue from Elective Abortions.

Special Instructions for Applications Submitted with a Data Management and Sharing

(DMS) Plan:

For applications submitted on or before October 4, 2023, NIH recognizes that making data

accessible and reusable for other researchers may incur costs. If a Data Management and Sharing

Plan is required in the proposed application (see instructions for the “Other Plan(s)” attachment on

the PHS 398 Research Plan Form and the PHS 398 Career Development Award Supplemental Form,

as applicable), costs to support these activities, including personnel costs (e.g., personnel who will

be curating data for the project) must be noted as a single line item. The line item must be titled

"Data Management and Sharing Costs" (without quotation marks, but following exact phrase and

spacing). The line item must only be used for Data Management and Sharing costs and cannot

include or be combined with any "Other" costs. If no cost will be incurred, enter "0" in the "Funds

Requested" column. Details regarding Data Management and Sharing costs must be specified in

the Budget Justification attachment (L), pursuant to the instructions.

For applications submitted for due dates on or after October 5, 2023, NIH recognizes that

making data accessible and reusable for other researchers may incur costs. If a Data Management

and Sharing Plan is required in the proposed application (see instructions for the “Other Plan(s)”

attachment on the PHS 398 Research Plan Form and the PHS 398 Career Development Award

Supplemental Form, as applicable), costs to support these activities, may be requested in the

appropriate cost category. Details regarding Data Management and Sharing costs must be

specified in the Budget Justification attachment (L), pursuant to the instructions.

Allowable and Unallowable Costs: Allowable costs submitted in budget requests must be

incurred during the performance period, even for scientific data and metadata preserved and

shared beyond the award period. Budget requests must NOT include: Infrastructure costs that are

included in institutional overhead (for instance, NIH Grants Policy Statement Section 7.3 Facilities

and Administrative costs); costs associated with the routine conduct of research, including costs

associated with collecting or gaining access to research data; or costs that are double charged or

inconsistently charged as both direct and indirect costs. For more information, see Budgeting for

Data Management & Sharing on the NIH Scientific Data Sharing website and additional details to

help Develop Your Budget.

Additional Instructions for Research:

Special Instructions for Patient Care Costs: If inpatient and/or outpatient costs

are requested, provide the names of any hospitals and/or clinics and the amounts

requested for each in the Budget Justification.

State whether each hospital or clinic has a currently effective HHS-negotiated

research patient care rate agreement and, if not, what basis is used for calculating

costs. If an applicant does not have a HHS-negotiated rate, the PHS awarding

component can approve a provisional rate. Indicate, in detail, the basis for

estimating costs in this category, including the number of patient days, estimated

cost per day, and cost per test or treatment. If multiple sites are to be used, provide

detailed information by site.

Include information regarding projected patient accrual for the project/budget

periods and relate this information to the budget request for patient care costs. If

patient accrual is anticipated to be lower at the start or during the course of the

project, plan budget(s) accordingly.

Provide specific information regarding anticipated sources of Other Support for

patient care costs, e.g., third party recovery or pharmaceutical companies. Include

any potential or expected utilization of the Clinical and Translational Science Awards

(CTSA) program.

Additional Instructions for Multi-project:

Other Components, Special Instructions for Patient Care Costs: If inpatient

and/or outpatient costs are requested, provide the names of any hospitals and/or

clinics and the amounts requested for each in the Budget Justification.

State whether each hospital or clinic has a currently effective HHS-negotiated

research patient care rate agreement and, if not, what basis is used for calculating

costs. If an applicant does not have a HHS-negotiated rate, the PHS awarding

component can approve a provisional rate. Indicate, in detail, the basis for

estimating costs in this category, including the number of patient days, estimated

cost per day, and cost per test or treatment. If multiple sites are to be used, provide

detailed information by site.

Include information regarding projected patient accrual for the project/budget

periods and relate this information to the budget request for patient care costs. If

patient accrual is anticipated to be lower at the start or during the course of the

project, plan budget(s) accordingly.

Provide specific information regarding anticipated sources of Other Support for

patient care costs, e.g., third party recovery or pharmaceutical companies. Include

any potential or expected utilization of the Clinical and Translational Science Awards

(CTSA) program.

Special Instructions for Applications Submitted with a Data Management

and Sharing (DMS) Plan

Other Components: Include budget information for Data Management and Sharing

Costs within the applicable component(s). Do not include a “Data Management and

Sharing Plan” attachment within the components. Any component-specific

information should be described within the overall “Data Management and Sharing

Plan” attachment provided within the PHS 398 Research Plan Form in the Overall

Component.

Additional Instructions for SBIR/STTR:

Special Instructions for Technical and Business Assistance (TABA) Costs: The

Technical and Business Assistance (TABA) programs help small businesses identify

and address their most pressing product development needs. TABA programs, as

outlined in 15 U.S.C. § 638(q), assist small businesses in:

making better technical decisions concerning such projects;

solving technical problems which arise during the conduct of such projects;

minimizing technical risks associated with such projects; and

developing and commercializing new commercial products and processes

resulting from such projects, including intellectual property protections.

NIH provides SBIR/STTR recipients access to centralized TABA programs. Small

businesses do not request access to centralized TABA programs in their application

but request participation after award.

TABA Funding: If you wish to utilize your own technical and business assistance

provider/vendor, you are required to include them in your budget and to provide a

detailed budget justification. You may request up to $6,500 per year for a Phase I and

up to $50,000 per Phase II project (across all years) for assistance. You may request up

to these amounts for each Phase in a Fast-Track application. Technical and business

assistance funds cannot be requested for the Commercialization Readiness Pilot

(CRP) program. Reimbursement is limited to technical and business assistance

services received that comply with the goals stated above. Examples of technical and

business services that can be supported by TABA Funding include, but are not limited

to:

Assistance with product sales

Intellectual property protections

Market research and/or validation

Development of regulatory plans

Development of manufacturing plans

Access to technical and business literature available through on-line databases

TABAFunding cannot support:

Activities that the recipient can provide internally

General maintenance of or investment in an applicant/division within the small

business, an affiliate/investor of the small business, or a subcontractor/consultant

required as part of the awarded Phase I or Phase II

Contributions to the SBIR/STTR fee

Audit services

Bookkeeping services, including payroll management or general accounting

services

Patent costs above and beyond those outlined for the NIH funded program

Contingency costs or costs associated with the research and development

activities of the award

Awardees who request and receive TABA Funding through the grant award, either as

part of the application or through an administrative supplement, cannot utilize

centralized NIH TABA services for the phase of the SBIR/STTR that received TABA

Funding. For Fast-Track applications, centralized NIH TABA services may be used for

any phase of the project that did not request TABA Funding. However, any SBIR/STTR

awardee can utilize non-TABA SEED innovator support, including I-Corps, Concept to

Clinic: Commercializing Innovation (C3i), regulatory assistance, or pitch coaching from

Entrepreneurs in Residence (EIRs).

To request technical assistance from your own provider:

Label the requested cost “Technical Assistance” on one of the other direct cost

lines (8-17).

Include a detailed description of the technical or business assistance that your

vendor will provide, including the name of the vendor and the expected benefits

and results of the technical or business assistance provided in the Budget

Justification.

See NIH Technical and Business Assistance Programs.

Total Other Direct Costs:

This total will be automatically calculated based on the sum of the Funds Requested column in

"Section F. Other Direct Cost."

G. Direct Costs

This total will be automatically calculated based on the sum of the Total funds requested for all

direct costs (sections A-F).

H. Indirect Costs

Indirect costs (Facilities & Administrative [F&A] costs) are defined as costs that are incurred by a

grantee for common or joint objectives and that, therefore, cannot be identified specifically with a

particular project or program. See the NIH Glossary's definition of Indirect Costs.

For more information:

You are encouraged to visit the following Division of Financial Advisory Services (DFAS) Websites

or call DFAS staff at 301-496-2444 for guidance: Main DFAS website, DFAS Frequently Asked

Questions. The following website has a listing of unallowable and unallocable costs and the related

Federal Acquisition Regulation (FAR) citation for each: NIH Office of Management's

Unallowable/Unallocable Costs.

Refer to the NIH Grants Policy Statement, Section 7.4: Reimbursement of Facilities and

Administrative Costs for more information.

Additional Instructions for SBIR/STTR:

In accordance with the Small Business Innovation Development Act of 1982 and the

Small Business Technology Transfer Act of 1992, irrespective of the time period in

which the costs are incurred, no SBIR/STTR funds can be used to “support” any

commercialization activities except for the Technical and Business Assistance (TABA)

funds or with the Commercialization Readiness Pilot (CRP) funding opportunity.

“Support” in this case includes both direct and indirect costs.

SBIR agencies must establish an SBIR Program by reserving, in each fiscal year, not

less than 3.2 percent (FY 2018) of its extramural budget for awards to small

businesses for R / R&D. The Small BusinessAdministration's SBIR and STTR Program

Policy define “R&D activities” as any activities directed toward reducing the technical

risk of the technology.

Commercialization is defined as the process of developing marketable products or

services and producing and delivering products or services for sale (whether by

the originating party or by others) to government or commercial markets.

Based on this position, when NIH is negotiating indirect costs with SBIR/STTR

grantees/contractors, we are disallowing all indirect costs applicable to

commercialization activities related to SBIR/STTR awards.

Commercialization cost categories: Below is a list of cost categories NIH considers

to be commercialization.

marketing and sales;

market research;

business development/product development/market plans;

legal fees;

travel and other costs relating to license agreements and partnerships; and

labor costs for the Marketing Director and Director of Business Development, as

well as sales and marketing staff who are grantee/contractor employees or

contractors hired for those purposes.

Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): Foreign

institutions and international organizations may request funds for limited F&A costs (8% of modified

total direct costs less equipment) to support the costs of compliance with HHS and NIH requirements

including, but not limited to, those related to the protection of human subjects, animal welfare,

invention reporting, financial conflict of interest, and research misconduct. Foreign organizations

may not include any charge-back of customs and import fees, such as consular fees, customs surtax,

value-added taxes (VAT), and other related charges.

Indirect Cost Type:

Enter the type of indirect cost (e.g., Salary & Wages, Modified Total Direct Costs, etc.) and whether

the cost is off-site. If more than one rate or base is involved for a given type of indirect cost, then

list them as separate entries. If you do not have a current indirect (F&A) rate(s) approved by a

federal agency, indicate “None--will negotiate” and include information for a proposed rate. Use

Section L. Budget Justification if additional space is needed.

Additional Instructions for Career Development:

Indicate the Indirect Cost type as Modified Total Direct Costs.

Indirect Cost Rate (%):

Enter the most recent indirect cost rate(s) established with the cognizant federal office, or in the

case of for-profit organizations, the rate(s) established with the appropriate agency. If you have a

cognizant/oversight agency and are selected for an award, you must submit your indirect rate

proposal to the NIH awarding IC or to the PHS awarding office for approval. If you do not have a

cognizant/oversight agency, contact the awarding agency. This field should be entered using a

rate such as “55.5.”

Additional Instructions for Career Development:

Enter the indirect cost rate as 8%. For all career development award applications,

indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition

and fees and expenditures for equipment) rather than on the basis of a negotiated

rate agreement.

Additional Instructions for SBIR/STTR:

If you have an indirect cost rate: If the applicant small business concern has a

currently effective negotiated indirect cost rate with a federal agency, that rate

should be used when calculating proposed indirect costs. However, these rates must

be adjusted for independent [self-sponsored] research and development expenses,

which are not allowable by HHS.

If applicable, indicate your organization’s most recent indirect cost rate established

with NIH’s Division of Financial Advisory Services (DFAS) or with another federal

agency. If your applicant organization is in the process of negotiating or

renegotiating a rate, use that rate in the application.

If you don’t have an indirect cost rate: If the applicant organization does not

have a current negotiated rate, it should develop a provisional rate for application

purposes. Follow the guidelines below.

SBIR and STTR Phase I Applicants: If your organization does not have a currently

effective negotiated indirect cost rate with a federal agency, then propose estimated

F&A costs at a rate not to exceed 40% of the total direct costs. If awarded at a rate of

40% or less of total direct costs, the rate used to charge actual F&A costs to projects

cannot exceed the awarded rate. NIH will not negotiate F&A rates for Phase I

awards.

SBIR and STTR Phase II and CRP Applicants: SBIR and STTR applicants who

propose in the application an F&A rate of 40 percent of total direct costs or less will

not be required to provide further justification at the time of award, and F&A costs

will be awarded at the requested rate. However, DFAS will retain the authority to

require well-documented proposals for F&A rates on an ad hoc basis. If the

applicant small business has a currently effective negotiated indirect cost rate(s) with

a federal agency, such rate(s) should be used when calculating proposed F&A costs

for an NIH application. (However, the rates(s) must be adjusted for IR&D expenses,

which are not allowable under HHS awards.) Small businesses are reminded that

only actual F&A costs may be charged to projects. If awarded at a rate of 40 percent

or less of total direct costs, the rate used to charge actual F&A costs to projects

cannot exceed the awarded rate unless the small business negotiates an indirect

cost rate(s) with DFAS. DFAS will negotiate F&A/IDC rates for small businesses

receiving Phase II awards if the requested rate is greater than 40 percent of total

direct costs. For more detailed information, see NIH GuideNotice on the

Negotiation of F&A/Indirect Costs for Phase II SBIR/STTR Grants.

Indirect Cost Base ($):

Enter the amount of the base for each indirect cost type.

Funds Requested ($):

Enter the funds requested for each indirect cost type.

Total Indirect Costs:

This total will be automatically calculated from the “Funds Requested” column in "Section H.

Indirect Cost."

Cognizant Federal Agency:

Enter the name of the cognizant Federal Agency and the name and phone number of the

individual responsible for negotiating your rate (your point of contact). If no cognizant agency is

known, enter “None.”

Additional Instructions for Career Development:

You may either follow the general instructions above to complete the "Cognizant

Federal Agency" field or you may enter “Not Applicable.” Either response is

acceptable since indirect costs will be reimbursed as 8% of modified total direct

costs rather than on the basis of a negotiated rate agreement.

I. Total Direct and Indirect Costs

This total will be automatically populated from the sum of Total Direct Costs (from Section G.

Direct Cost) and the Total Indirect Costs (from Section H. Indirect Costs).

Additional Instructions for SBIR/STTR:

Award Limits: 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 Specific SBIR/STTR Funding Opportunities 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

Opportunities 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.

J. Fee

Do not include a fee in your budget, unless the FOA specifically allows inclusion of a “fee.” If a fee

is allowable, enter the requested fee.

Additional Instructions for SBIR/STTR:

A reasonable fee, not to exceed 7% of total costs (direct and indirect) for each Phase

(I and II) of the project, is allowed to be included in SBIR / STTR awards. The fee is

intended to be a reasonable profit factor available to for-profit organizations,

consistent with normal profit margins provided to profit-making firms for research

and development work.

Example:

$70,000 direct costs (includes all third party costs) + $28,000 F&Acosts (40% *

70,000) = $98,000.

Maximum allowable fee = 7% * $98,000 = $6,860 fee.

Total Award = $104,860.

Applicants must explain the basis and the amount requested for the fee in Section L.

Budget Justification.

The amount requested for the fee should be based on the following guidelines:

it must be consistent with that paid under contracts by the PHS for similar

research conducted under similar conditions of risk;

it must take into account the complexity and innovativeness of the research to be

conducted under the SBIR/STTR project; and

it must recognize the extent of the expenditures for the grant project for

equipment and for performance by other than the grantee organization through

consultant and subaward agreements.

The fee is not a direct or indirect "cost" item and may be used by the small business

concern for any purpose, including additional effort under the SBIR/STTR award. The

fee applies solely to the small business concern receiving the award and not to any

other participant in the project. However, the grantee may pay a profit/fee to a

contractor providing routine goods or services in accordance with normal

commercial practice.

Note: The electronic system automatically rounds up. If you get an error “The fee

must be less than 7%,” try using 6.99% as the rate.

K. Total Costs and Fee

This total will be automatically calculated from the sum of Total Direct Costs and Fee (from

sections “I. Total Direct and Indirect Costs” and “J. Fee”).

L. Budget Justification

The “Budget Justification” attachment is required. Attach only one file.

Use the Budget Justification to provide the additional information requested in each budget

category identified above and any other information the applicant wishes to submit to support the

budget request. If you have a quote(s), you may include it here (information in the quote may be

not used to supplement information provided in page-limited sections of the application, such as

the Research Strategy). The following budget categories must be justified, where applicable:

equipment, travel, participant/trainee support, and other direct cost categories.

In addition to the justifications described in the above sections, also include a justification for any

significant increases or decreases from the initial budget period. Justify budgets with more than a

standard escalation from the initial to the future year(s) of support.

Also use the Budget Justification to explain any exclusions applied to the F&A base calculation.

If your application includes a subaward/consortium budget, a separate Budget Justification must

be submitted. See G.310 - R&R Subaward Budget Attachment(s) Form.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use of

human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy

Statement) is included in the proposed application include a detailed justification including the

quantity, type(s), and source(s) of the HFT, including the stage of fetal development. This

information must be included if costs for the HFT are assigned to the grant or if the HFT is

acquired under the grant at no costs. The HFT justification must be clearly labeled in the budget

justification attachment.

Special Instructions for Applications Submitted with a Data Management and Sharing

(DMS) Plan:

If a Data Management and Sharing Plan is required in the proposed application (see instructions

for the “Other Plan(s)” attachment on the PHS 398 Research Plan Form and the PHS 398 Career

Development Award Supplemental Form, as applicable), include a brief justification of the

proposed activities that will incur costs. The Data Management and Sharing justification must be

clearly labeled as “Data Management and Sharing Justification” within the budget justification

attachment followed by the estimated dollar amount (total direct costs). Provide a brief summary

of type and amount of scientific data to be preserved and shared and the name of the established

repository(ies) where they will be preserved and shared. Indicate general cost categories such as

curating data and developing supporting documentation, local data management activities,

preserving and sharing data through established repositories, etc., including an amount for each

category and a brief explanation. Specify in the justification if no costs will be incurred for Data

Management and Sharing, if applicable. The recommended length of the justification should be no

more than half a page. For more information, see Budgeting for Data Management & Sharing on

the NIH Scientific Data Sharing website and additional details to help Develop Your Budget.

Additional Instructions for Career Development:

Use the Budget Justification to provide a detailed description and justification for

specific items within the Research Development Support costs (e.g., all equipment,

supplies, and other personnel that will be used to help achieve the career

development and research objectives of this award).

Research & Related Budget - Cumulative Budget

All values on this form are automatically calculated, and the fields are pre-populated. They present

the summations of the amounts you entered previously, under Sections A through K, for each of

the individual budget periods. Therefore, no data entry is allowed or required to complete this

“Cumulative Budget” section.

If any of the amounts displayed on this form appear to be incorrect, you may correct it by

adjusting one or more of the values that contribute to that total. To make any such corrections,

you will need to revisit the appropriate budget period form(s).

G.310 - R&R Subaward Budget

Attachment(s) Form

The R&R Subaward Budget Attachment(s) Form is used

for applications with a subaward or consortium.

This form is required only when the prime grantee is

submitting an R&R Budget Form and has

subaward/consortium budgets.

Applicants using the Modular Budget Form should see

G.320 - Modular Budget Form for instructions

concerning information on consortium budgets.

View larger image

Who should use the R&R Subaward Budget Attachment(s) Form?

The R&R Subaward Budget Attachment(s) Form is required if you have a subaward/consortium and are

using the G.300 - R&R Budget Form.

Do not use this form if you are using the PHS Modular Budget Form or if you do not have a

subaward/consortium.

Each consortium grantee organization that performs a substantive portion of the project must complete

an R&R Subaward Budget Attachment, including the Budget Justification section.

Consortium/Contractual F&A Costs:

Additional Instructions for SBIR/STTR:

These instructions on Consortium/Contractual F&A Costs do not apply.

NIH policy provides for the exclusion of consortium/contractual F&A costs when determining if an

applicant is in compliance with a direct cost limitation. However, you must include the full cost of

subaward/consortium in the Subawards/Consortium Costs field (G.300 - R&R Budget Form, Section F.

Other Direct Costs, Question 5). If a subaward/consortium is not performing a substantive portion of

the project, they do not need to complete an R&R Subaward Budget Form; however, their costs must be

included in the prime grantee’s R&R Budget Form. All F&A costs count toward the direct cost limit.

Refer to the NIH Grants Policy Statement, Section 2.3.7.1: Applications That Include

Consortium/Contractual F&A Costs for policy related to the exclusion of consortium/subaward amounts

in determining whether an applicant is in compliance with a direct cost limitation.

Applicants should document how their budget falls below the direct cost limit in their Budget

Justification on the R&R Subaward Budget Form.

Note on Project Roles for Consortium Lead Investigators:

It is appropriate and expected that someone may serve as the consortium lead investigator responsible

for ensuring proper conduct of the project or program at each subaward or consortium site.

Unless you are submitting your application under the multiple PD/PI policy, consortium lead

investigators are NOT considered PD/PIs for the “Project Role” field. This individual should be assigned

some other project role on the G.300 - R&R Budget Form and in the G.240 – R&R Senior/Key Person

Profile (Expanded) Form. However, the project role of “PD/PI” should be used for a consortium lead

investigator if they also serve as PD/PI for the entire application under the multiple PD/PI policy.

Using the R&R Subaward Budget Attachment(s) Form:

The location of the R&R Subaward Budget Attachment(s) Form may vary with the type of submission

(e.g., under an “Optional Forms” tab).

The steps needed to include a subaward budget in your application vary by submission method. If

submitting using the Grants.gov Workspace, the prime applicant can extract a copy of the R&R Budget

Form from the R&R Subaward Budget Attachment(s) Form and send the extracted file to the

consortium for completion. After the consortium completes the R&R Budget Form, following the

instructions here and in G.300 – R&R Budget Form, the prime grantee must then upload the R&R

Budget Form to the R&R Subaward Budget Attachment(s) Form.

For all submission methods, the R&R Budget Form with a "Budget Type" of Subaward/Consortium is

used to collect subaward budget data. However, ASSIST and other system-to-system solutions may

present a different interface than the R&R Subaward Budget Attachment Form shown here.

This form accommodates a set number of separate subaward budgets. If you need to add more

subaward budgets than the form allows, include the remaining budgets as part of Budget Justification

in G.300 – R&R Budget Form.

Regardless of how many subaward budgets you include, the sum of all subaward budgets (those

attached within the R&R Subaward Budget Attachment(s) Form and those provided as part of the

project budget’s Budget Justification), must be included in G.300 - R&R Budget Form, Section F. Other

Direct Costs, Question 5. Subawards/Consortium/Contractual Costs of the project budget.

Format:

All attachments, including all Subaward Budget Forms and Budget Justifications, must be PDF files. The

R&R Budget Forms are already PDFs when extracted. Do not alter the format. Use of hyperlinks and

URLs in this section is not allowed unless specified in the funding opportunity announcement.

Content:

On this R&R Subaward Budget Attachment(s) Form, you will attach the R&R Subaward Budget files for

your application. Each consortium should complete the Subaward Budget(s) in accordance with the

G.300 - R&R Budget Form instructions.

Submitting Subaward Budgets that are not Active for all Periods of the Prime Grant:

The R&R Budget Forms do not allow for “empty” budget periods.

Subaward/consortiums organizations should complete all budget periods in the R&R Subaward Budget

Form for their subaward budgets, aligning the budget period numbers, start dates, and end dates with

the budget periods of the prime grant.

Example: The prime fills out an R&R Budget Form with the following periods:

period 1 - Jan 1, 2017 – Dec 31, 2017

period 2 - Jan 1, 2018 – Dec 31, 2018

period 3 - Jan 1, 2019 – Dec 31, 2019

period 4 - Jan 1, 2020 – Dec 31, 2020

period 5 - Jan 1, 2021 – Dec 31, 2021

The budget period numbers and dates should be the same in all the R&R Subaward Budget Forms

included in the R&R Subaward Budget Attachment(s) Form.

The R&R Subaward Budget Forms include several required fields which must be completed (even for

inactive periods) in order to successfully submit the application. Provide the following information for

inactive budget periods in subaward/consortium budgets:

Unique Entity Identifier

Budget Type = Subaward/Consortium

Budget Period Start/End Dates (align with budget periods and dates of the prime budget)

In Question "A: Senior/Key Person," provide a single entry including the following:

PD/PI or subaward lead First and Last names

Project Role (may default to PD/PI; can be adjusted as needed)

Calendar Months = .01 (smallest amount effort allowed in the field)

Requested Salary = $0

Fringe Benefits = $0

Explanation of the inactive budget periods in the Budget Justification of the

subaward/consortium's R&R Subaward Budget Form

Additional Instructions for SBIR/STTR:

SBIR WorkRequirements

Phase I and Phase II: The basis for determining the percentage of work to be

performed by each of the cooperative parties will be the total of the requested costs

(direct and F&A/indirect, and fee) attributable to each party, unless otherwise

described and justified in G.400 - PHS 398 Research Plan Form,

Consortium/Contractual Arrangements. Deviations from these requirements may be

considered on a case by case basis. Please contact a program officer for additional

information. Deviations must be approved in writing by the Grants Management

Officer (GMO) after consultation with the agency SBIR Program

Manager/Coordinator.

Phase I: Normally, a minimum of two-thirds or 67% of the research or analytical

effort must be carried out by the small business. The total amount of all consultant

and contractual arrangements to third parties for portions of the scientific and

technical effort generally may not exceed 33% of the total amount requested (direct,

F&A/indirect, and fee).

Phase II and Phase IIB: Normally, a minimum of one-half or 50% of the research or

analytical effort must be carried out by the small business. The total amount of all

consultant and contractual arrangements to third parties for portions of the

scientific and technical effort generally may not exceed 50% of the total Phase II

amount requested (direct and F&A/indirect, and fee).

Commercialization Readiness Pilot (CRP): A small business may subcontract a

substantial portion of its CRP award to third parties through consultant and

contractual arrangements. The small business must perform a substantive role in the

conduct of the planned research and not merely serve as a conduit of funds to

another party or parties. This includes being able to provide appropriate oversight of

all scientific, programmatic, financial, and administrative matters related to the

grant.

STTR Work Requirements

Phase I and Phase II: At least 40% of the work must be performed by the small

business and at least 30% of the work must be performed by the single partnering

research institution. The basis for determining the percentage of work to be

performed by each of the cooperative parties will be the total of the requested costs

(direct and F&A/indirect, and fee) attributable to each party, unless otherwise

described and justified in G.400 - PHS 398 Research Plan Form,

Consortium/Contractual Arrangements.

The single “partnering” research institution must provide a letter to the applicant

small business certifying that at least 30% of the work of the STTR project will be

performed by the research institution. The small business will include this letter as an

attachment upload in G.400 - PHS 398 Research Plan Form, Consortium/Contractual

Arrangements.

In addition, an SBC must negotiate a written agreement between the small business

and the research institution allocating intellectual property rights to carry out

follow-on research, development, or commercialization. See the STTR Model

Agreement for the Allocation of Rights. This agreement is required to receive

support under the STTR program but is NOT submitted with the application. A copy

of the Agreement must be furnished upon request of the NIH awarding component.

SBIR / STTR

Contract Research Organizations (CRO) or Fee for Service providers: CROs or

Fee for Service providers not operating in the capacity as a subaward or subrecipient

may not be calculated in the total amount of all consultant and contractual

arrangements to third parties for portions of the scientific and technical effort.

A subaward is an award provided by the small business to a subrecipient for that

subrecipient to carry out part of the SBIR or STTR received by the small business. The

subrecipient:

Has responsibility for programmatic decision making;

Contributes to the scholarly/scientific conduct of the project as described in the

statement of work for the prime award;

Uses the funding to carry out a program for a public purpose specified in the

authorizing statute, as compared to providing goods or services for the benefit of

the pass-through entity;

Requires considerable discretionary judgment and the unique expertise of the

subrecipient in the performance of the work;

Investigator would be considered as a co-author of publications resulting from

the work performed under the prime award;

Performs work that involves human subjects or animal studies;

A consultant may provide advisory services related to an award.

A CRO or Fee for Service provider provides goods or services within normal

business operations and operates in a competitive environment providing similar

goods and services to a variety of customers. The contractor organization:

Provides a routine service (e.g., equipment fabrication or repair, data processing,

performing routine analytical testing services, etc.);

Provides the goods or services as part of its normal business operations;

Operates in a competitive environment (i.e., competes with others who can

provide a similar service);

Provides similar goods or services to many different purchasers;

Federal Laboratories: A small business may subcontract a portion of its SBIR or STTR

award to a federal laboratory within the limits above. A federal laboratory, as defined

in 15 U.S.C. § 3703, means any laboratory, any federally funded research and

development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is

owned, leased, or otherwise used by a federal agency and funded by the Federal

Government, whether operated by the Government or by a contractor. A small

business may subcontract a portion of its STTR award to a Federally Funded Research

and Development Center (FFRDC), either in its capacity as the Research Institution or

as a participant in the STTR project in another capacity. However, STTR funds may

not be used to pay for laboratory resources of non-FFRDCs, and no STTR funds

may be used to pay for subcontracting any portion of the STTR award back to

the issuing agency or to any other federal government unit unless a waiver is

granted by the Small Business Administration.

A fee cannot be entered for a subaward/consortium budget. A fee is allowable only

for the SBC budget page.

STTR only: If more than one subaward is included in the STTR application, identify

the single, partnering research institution (RI) on the RI Subaward Budget

Justification page.

G.320 - PHS 398 Modular Budget Form

Some application forms packages include two budget

forms — (1) the R&R Budget Form and (2) the PHS 398

Modular Budget Form. Include only one of these forms,

but not both, in your application.

Generally, the PHS 398 Modular Budget Form is

applicable only to research applications from domestic

organizations that are requesting $250,000 or less per

budget period in direct costs, but there are exceptions.

Refer to your specific FOA and these instructions for

guidance on which budget form(s) to use.

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Quick Links

Budget Period 1

A. Direct Costs

B. Indirect (F&A) Costs

C. Total Direct and Indirect (F&A) Costs (A+B)

Cumulative Budget Information

1. Total Costs, Entire Project Period

2. Budget Justifications

Who should use the PHS 398 Modular Budget Form?

There are two primary types of Budget Forms: the detailed R&R and PHS 398 modular. Generally, you

must use the PHS Modular Budget Form if you are submitting a research grant application from a

domestic organization and you are applying for $250,000 or less per budget period in direct costs. You

must use the R&R Budget Form if you are applying for more than $250,000 per budget period in direct

costs. However, there are exceptions and other distinctions. Refer to your FOA and to the following

instructions for guidance on which Budget Form to use.

Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): Foreign

organizations must use the R&R Budget Form in G.300 - R&R Budget Form.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use of

human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy

Statement) isincluded in the proposed application, regardless of whether you will incur a cost for

HFT, you cannot use the PHS Modular Budget Form regardless of the activity code and must use the

R&R Budget Form in G.300 - R&R Budget Form.

Note: The terms “detailed budget” and “R&R Budget” are used interchangeably.

For more information:

For more information on how to prepare your budget, see NIH's Develop Your Budget page.

Also see NIH's Modular Research Grant Applications page.

Modular Budget Guidelines:

Modular budgets are simplified; therefore, detailed categorical information is not to be submitted with

the application.

For all modular budgets, request total direct costs (in modules of $25,000), reflecting appropriate

support for the project. There will be no future year escalations. A typical modular grant application will

request the same number of modules in each budget period. Provide an additional narrative budget

justification (in the Additional Narrative Justification section) for any variation in the number of modules

requested.

Prior to award, NIH may request additional budget justification in exceptional circumstances.

Using the Modular Budget Form:

The Modular Budget Form provides budget fields for up to 5 periods of support (e.g., Budget Periods 1

- 5). A budget period is typically 1 year of support. If requesting fewer than 5 periods/years of support,

complete only the applicable budget periods and leave the others blank. The fields are the same for all

budget periods.

The form will generate information for the Cumulative Budget Information section, which reflects

information for the total project period.

The following instructions (under “Budget Period 1”) can be used for each Budget Period (1-5).

Budget Period 1

Start Date:

This field is required. Enter the requested/proposed start date of the budget period. Use the

following format: MM/DD/YYYY. For period 1, the start date is typically the same date as the

Proposed Project Start Date on the SF 424 (R&R) Form.

End Date:

This field is required. Enter the requested/proposed end date of the budget period. Use the

following format: MM/DD/YYYY.

A. Direct Costs

Direct Cost less Consortium Indirect (F&A):

This field is required.

Enter the amount of direct costs, but do not include actual consortium indirect (F&A) costs. This

figure must be in $25,000 increments, and it may not exceed $250,000 in a budget period. See the

NIH Glossary’s definitions of Direct Cost and Indirect Cost.

Consortium Indirect (F&A):

If this project involves a subaward/consortium, enter the actual consortium indirect (F&A) costs for

the budget period. If this project does not involve a subaward/consortium, leave the field blank.

Total Direct Costs:

This field will be automatically calculated based on the sum of the “Direct Cost less Consortium

Indirect (F&A)” and “Consortium Indirect (F&A)” fields.

B. Indirect (F&A) Costs

Indirect costs (Facilities & Administrative [F&A] costs) are defined as costs that are incurred by a

grantee for common or joint objectives and that, therefore, cannot be identified specifically with a

particular project or program. See the NIH Glossary's definition of Indirect Costs.

For more information:

You are encouraged to visit the following Division of Financial Advisory Services (DFAS) Websites

or call DFAS staff at 301-496-2444 for guidance: Main DFAS website, DFAS Frequently Asked

Questions. The following website has a listing of unallowable and unallocable costs and the related

Federal Acquisition Regulation (FAR) citation for each: NIH Office of Management's Unallowable /

Unallocated costs.

Refer to the NIH Grants Policy Statement, Section 7.4: Reimbursement of Facilities and

Administrative Costs for more information.

Indirect (F&A) Type:

Enter the type/base of indirect cost (e.g., Salary & Wages, Modified Total Direct Costs, etc.) and

whether the cost is off-site. If more than one rate or base is involved for a given type of indirect

cost, then list them as separate entries. If you do not have a current indirect (F&A) rate(s) approved

by a federal agency, indicate “None—will negotiate” and include information for a proposed rate.

Use the Budget Justification if additional space is needed.

Indirect (F&A) Rate (%):

Indicate the most recent Indirect (F&A) cost rate(s) established with the cognizant federal office, or

in the case of for-profit organizations, the rate(s) established with the appropriate agency. If you

have a cognizant/oversight agency and are selected for an award, you must submit your indirect

rate proposal to the NIH awarding IC or to the PHS awarding office for approval. If you do not

have a cognizant/oversight agency, contact the awarding agency. This field should be entered

using a rate such as “55.5.”

Indirect (F&A) Base ($):

Enter the amount of the base for each indirect cost type.

Funds Requested ($):

Enter the funds requested for each indirect cost type.

Cognizant Agency (Agency Name, POC Name and Phone Number):

Enter the name of the cognizant Federal Agency and the name and phone number of the

individual responsible for negotiating your rate (your point of contact). If no cognizant agency is

known, enter “None.”

Indirect (F&A) Rate Agreement Date:

If you have a negotiated rate agreement, enter the agreement date.

Total Indirect (F&A) Costs:

This field will be automatically calculated based on the sum of the "Funds Requested" fields from

all of the Indirect (F&A) Costs.

C. Total Direct and Indirect (F&A) Costs (A+B)

Funds Requested ($):

This field will be automatically calculated based on the sum of the “Total Direct Costs” and “Total

Indirect (F&A) Costs” fields.

Cumulative Budget Information

1. Total Costs,Entire Project Period

All values for the “Total Costs, Entire Project Period” section are automatically calculated and the

fields are pre-populated. They present the summations of the amounts you entered for each of the

individual budget periods. Therefore, no data entry is allowed or required in the “Total Costs,

Entire Project Period” section.

If any of the amounts displayed in this “Total Costs, Entire Project Period” section appear to be

incorrect, you may correct it by adjusting one or more of the values that contribute to that total. To

make any such corrections, you will need to revisit the appropriate budget period form(s).

2. Budget Justifications

Personnel Justification:

Format:

Attach this information as a PDF file. See NIH’s Format Attachments page. Hyperlinks and URLs are

not allowed in this section unless specified in the funding opportunity announcement.

Content:

List all personnel, including names, percent effort (use the Person Months metric), and roles on the

project.

Do not provide individual salary information. You must use the current legislatively imposed salary

limitation when estimating the number of modules. For guidance on current salary limitations,

contact your office of sponsored programs.

Administrative, Secretarial, and Clerical Support Salaries: In most circumstances, the salaries

of administrative, secretarial, or clerical staff at educational institutions and nonprofit

organizations are included as part of indirect costs. However, examples of situations where direct

charging of these salaries may be appropriate may be found at 45 CFR 75.403.

Inclusion of such costs may be appropriate only if all of the following conditions are met:

1. Administrative or clerical services are integral to a project or activity;

2. Individuals involved can be specifically identified with the project or activity;

3. Such costs are explicitly included in the budget or have prior written approval of the

federal awarding agency; and

4. The costs are not also recovered as indirect costs.

Requests for direct charging for administrative, secretarial, or clerical personnel must be

appropriately justified here in the “Personnel Justification.” For each individual classified as

administrative/secretarial/clerical, provide the name; percent effort; role; and a justification

documenting how they meet all four conditions. NIH ICs may request additional information for

these positions in order to assess allowability.

Graduate student compensation: NIH grants also limit compensation for graduate students.

Compensation includes salary or wages, fringe benefits, and tuition remission. While actual

institutional-based compensation should be requested and justified, this may be adjusted at the

time of award. This limit should also be used when estimating the number of modules. For more

guidance on this policy, see the NIH Grants Policy Statement, Section 2.3.7.9: Graduate Student

Compensation.

Consortium Justification:

Format:

Attach this information as a PDF file. See the NIH's Format Attachment page.

Content:

Provide an estimate of total consortium/subaward costs (direct costs plus indirect [F&A] costs) for

each budget period, rounded to the nearest $1,000.

List the individuals/organizations with whom consortium or contractual arrangements have been

made and indicate whether the collaborating institution is foreign or domestic.

List all personnel, including names, percent effort (use the Person Months metric), and roles on the

project.

Do not provide individual salary information.

Additional Narrative Justification:

Note: Additional explanation within the Additional Narrative Justification is not needed in

applications to FOAs with direct cost limits that do not spread evenly across budget periods (e.g.,

R21 NOFOs that allow $275,000 in direct costs over two years).

Special Instructions for Applications Submitted with a Data Management and Sharing

(DMS) Plan: If a Data Management and Sharing (DMS) Plan is required in the proposed

application, (see instructions for the “Other Plan(s)” attachment on the PHS 398 Research Plan

Form and the PHS 398 Career Development Award Supplemental Form, as applicable), the

Additional Narrative Justification is required.

Format:

Attach this information as a PDF file. See the NIH's Format Attachment page. Hyperlinks and URLs

are not allowed in this section unless specified in the funding opportunity announcement.

Content:

If the requested budget requires any additional justification (e.g., variations in the number of

modules requested, applications submitting a DMSplan), include that information in the

Additional Narrative Justification attachment. If you have a quote(s), you may include it here

(information in the quote may be not used to supplement information provided in page-limited

sections of the application, such as the Research Strategy).

Additional justification should include explanations for any variations in the number of modules

requested annually. Also, this section should describe any direct costs that were excluded from the

total direct costs (such as equipment, tuition remission) and any work being conducted off-site,

especially if it involves a foreign study site or an off-site F&A rate.

Note: Additional explanation for variations in the number of modules requested annually is not

needed in applications to NOFOs with direct cost limits that do not spread evenly across budget

periods (e.g., R21 NOFOs that allow $275,000 in direct costs over two years).

Special Instructions for Applications Submitted with a Data Management and Sharing

(DMS) Plan:

NIH recognizes that making data accessible and reusable for other researchers may incur costs. If a

Data Management and Sharing Plan is required in the proposed application (see instructions for

the “Other Plan(s)” attachment on the PHS 398 Research Plan Form and the PHS 398 Career

Development Award Supplemental Form, as applicable), the Data Management and Sharing

justification must be clearly labeled as “Data Management and Sharing Justification” followed by

the estimated dollar amount (total direct costs). If no cost will be incurred, enter "0" for the

estimated dollar amount. Also include a brief justification of the proposed activities that will incur

costs. Provide a brief summary of type and amount of scientific data to be preserved and shared

and the name of the established repository(ies) where they will be preserved and shared. Indicate

general cost categories such as curating data and developing supporting documentation, local

data management considerations, preserving and sharing data through established repositories,

etc., including an amount for each category and a brief explanation. The recommended length of

the justification should be no more than half a page.