Multi-Project Instructions for NIH and Other PHS Agencies



FORMS VERSION H SERIES

Released: August 5

, 2023



MULTI - PROJECT 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)

Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

TABLE OF CONTENTS

TABLE OF CONTENTS 2

M.100 - How to Use the Application Instructions 3

M.110 - Application Process 6

M.120 - Significant Changes 10

M.130 - Program Overview 13

M.200 - SF 424 (R&R) Form 18

M.210 - PHS 398 Cover Page Supplement Form 33

M.220 - R&R Other Project Information Form 38

M.230 - Project/Performance Site Location(s) Form 49

M.240 - R&RSenior/Key Person Profile (Expanded) Form 53

M.300 - R&R Budget Form 64

M.310 - R&R Subaward Budget Attachment(s) Form 81

M.330 - PHS 398 Training Budget Form 84

M.340 - PHS 398 Training Subaward Budget Attachment(s) Form 90

M.350 - PHS Additional Indirect Costs Form 93

M.400 - PHS 398 Research Plan Form 96

M.410 - PHS 398 Career Development Award Supplemental Form 113

M.420 - PHS 398 Research Training Program Plan Form 138

M.500 - PHS Human Subjects and Clinical Trials Information 156

M.600 - PHS Assignment Request Form 192

Form Screenshots i

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.100 - How to Use the Application Instructions

M.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

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NIH Grants & Funding Glossary

l

Grants Policy Statement

l

NIH Guide to Grants and Contracts

l

Frequently Asked Questions

Step 1. Become familiar with the application process.

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

Use the M.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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.100 - How to Use the Application Instructions

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:

l

Research (R)

l

Career Development (K)

l

Training (T)

l

Fellowship (F)

l

Multi-project (M)

l

SBIR/STTR (B)

Step 4. Complete the appropriate forms.

Unless otherwise specified in the FOA, follow the standard instruction, as well as any additional

program-specific instructions for each form in your application.

Program-specific instructions are presented in gray call-out boxes that are color coded throughout

the application instructions. Consult the M.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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.100 - How to Use the Application Instructions

NIH GRANTS ONLY: Additional information on this topic can be found in this FAQ or by

contacting your IC Privacy Coordinator.

Step 5. Stay informed of policy changes and updates.

l

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

application instructions.

l

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

Step 6. Understand what data NIH makes public.

Information submitted as part of the application will be used by reviewers to evaluate the scientific

merit of the application and by NIH staff to make the grant award and monitor the grant after

award. The exception to this is the M.600 - PHS Assignment Request Form, which is only seen by

staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR).

If the application is funded, the following fields will be made available to the public through the

NIH Research Portfolio Online Reporting Tool (RePORTER) and will become public information:

l

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

projects to multi-project projects

l

PD/PI title

l

PD/PI email address

l

Organizational name

l

Institutional address

l

Project summary/abstract

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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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.110 - Application Process

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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.110 - Application Process

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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.110 - Application Process

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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.120 - Significant Changes

Release Notes - October 25, 2022

How to Use the Application Instructions

l

Added reminder to not include personal identifiable information (PII) or protected health

information (PHI) in the application.

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

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

l

Added special instructions for applicants submitting a Data Management and Sharing

(DMS)Plan within the following sections:

l

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

Project”

l

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

l

L. Budget Justification

Forms-H Changes

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

NIH (OMB Number: 0925-0001 and 0925-0770, Expiration Date: 01/31/2026).

PHS 398 Modular Budget Form

l

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

Plans.

PHS 398 Research Plan Form

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

Management and Sharing (DMS) Plans.

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Renumbered form fields.

l

Updated instructions for section 10, Resource Sharing Plan(s) to remove instructions for the

Data Sharing Plan and Genomic Data Sharing (GDS). The DMS Plan will now be attached in the

new item 11, Other Plan(s).

l

Clarified instructions for renewal or resubmission applications involving changes between

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

PHS 398 Career Development Award Supplemental Form

l

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

Management and Sharing (DMS) Plans.

l

Renumbered form fields.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.120 - Significant Changes

l

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

Sharing Plan and Genomic Data Sharing (GDS). The DMS Plan will now be attached in the new

item 17. Other Plan(s).

PHS 398 Research Training Program Plan Form

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

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Renumbered form fields.

l

Clarified instructions for renewal or resubmission applications involving changes between

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

PHS Fellowship Supplemental Form

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

l

Renumbered form fields.

l

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

Sharing Plan and Genomic Data Sharing (GDS).

Form Screenshots

l

Updated form screenshots.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.130 - Program Overview

Quick Links

Multi-project Applications ("M" Series).

Multi-project Applications ("M"Series)

A multi-project application is a single submission with multiple, interrelated components that

share a common focus or objective.

A component is a distinct, reviewable part of a multi-project application for which there is a

business need to gather detailed information as defined in a particular funding opportunity

announcement (FOA). Components typically include general information (component

organization, project period, project title, etc.), information about performance sites, information

about proposed work to be accomplished, and a budget.

Additional Instructions for Multi-project:

Additional multi-project instructions will be denoted by a gray call-out box with red

color coding and with the heading “Additional Instructions for Multi-project”

throughout these application instructions.

Although multi-project applications use the same forms used for single-project applications, there

are some differences in the way multi-project applications are structured. Every multi-project

application includes:

l

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

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

l

One or more Other Component Types: Other Component types (e.g., Admin Core, Project

Core) will vary by opportunity and will be specified in the FOA.

l

Summaries: Information is automatically compiled from the data provided by the applicant in

the individual components and included as part of the Overall Component in the agency-

assembled application to help reviewers and staff work with the application. The following

summaries are generated:

l

Component

l

Performance Sites

l

Human Subjects - Clinical Trials – Vertebrate Animals- hESC

l

Human Embryonic Stem Cell Lines

l

Budget

l

Program Income

l

Senior/Key Personnel

l

Biosketches

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.130 - Program Overview

For information on how your application will be automatically assembled for review and funding

consideration after submission, see the How eRA Assembles Multi-project Applications file.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the

activity code(s) for which support is being requested. A comprehensive list of all activity

codes, with their descriptions, is available on the Activity Codes Search Results website.

2. Refer to your specific FOA: Refer to your specific FOA for specific information

associated with the award mechanism, including special application instructions.

l

The FOA will specify the types of Other Components that should be used when

preparing the application, whether each component is optional or required, and

any restrictions on the number of times each component can be included in an

application.

3. Contact Awarding Component: Applicants are encouraged to consult with the NIH

Scientific/Research contact of the appropriate awarding component prior to submitting

an application, as eligibility criteria, support levels, and availability of awards may vary

among NIH Institutes or Centers and other PHS agencies.

Collaborating with Other Organizations

Multi-project applications often include a number of collaborating organizations in addition to the

applicant organization. The applicant organization always has primary responsibility for and leads

the Overall Component. A collaborating organization may be responsible for a small part of a

component or have lead responsibility for an entire Other Component within the application.

Depending on the role of the collaborating organization(s) in the project, there are two

approaches to structuring a component:

A. Collaborating Organization as the Lead of a Component:

When the bulk of the leadership and work on a component (other than the Overall

Component) is performed by a collaborating organization, then that organization can be set

up as the lead organization for that component. All the component forms (including the SF

424 R&R Form and the R&R Budget Form) are completed using the collaborating

organization’s information. On the R&R Budget Form, use the Budget Type “Project” to

identify it as the primary budget for the component and provide the collaborating

organization’s Unique Entity Identifier (UEI) number and name. Any other organizations

involved in the component (including the applicant organization) are included in

subaward/consortium budget forms.

From an administrative perspective, the entire component (minus any work done by the

applicant organization) is treated as a subaward/consortium to the applicant organization.

The structure of the application reflects where the proposed work is being done, not the flow

of funds. eRA systems use the Unique Entity Identifier (UEI) numbers included on budget

forms to determine the flow of funds.

B. Collaborating Organization as a Consortium in a Component:

When a collaborating organization does not have a leadership role for a component, then the

applicant organization is the component lead, and any collaborating organizations are

included using the subaward/consortium budget form.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.130 - Program Overview

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)

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

   

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.130 - Program Overview

Form Overall

Admin Core,

Core Project,

Other named

components

Indiv

Career

Dev

Career

Dev

NRSA

Training

PHS 398 Research

Training Program Plan

  

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:

l

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

program;

l

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

or another foreign country of concern; or

l

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

M - 16

Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.130 - Program Overview

• 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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

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

Other Components: You need to fill in only a subset of fields in the SF424 (R&R)

Form. Skip the other fields, as any information provided in them will be discarded.

The fields you must fill in are:

 5. Applicant Information

 7. Type of Applicant (Optional)

 11. Descriptive Title of Applicant's Project

 12. Proposed Project

1. Type of Submission

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

Pre-application:

The pre-application option is not used by NIH or other PHS agencies unless specifically noted in a

funding opportunity announcement (FOA).

Application:

An "Application" is a request for financial support of a project or activity submitted on specified

forms and in accordance with NIH instructions. (See NIH Types of Applications for an explanation

of the types of applications).

Changed/Corrected Application:

Check this box if you are correcting either system validation errors or application assembly

problems that occurred during the submission process. Changed/corrected applications must be

submitted before the application due date.

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

l

After submission of an application, there is a two-day application viewing window. Prior to the

due date, you may submit a changed/corrected application. Submitting a changed/corrected

application will replace the previous submission and remove the previous submission from

consideration.

l

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

Tracking ID” is required.

l

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

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

for the definition of Resubmission.

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.

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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).

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.

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.

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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.

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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.

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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.

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 Multi-project:

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

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.

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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.

l

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.

l

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.

l

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.

l

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

l

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.

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

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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.

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

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what is allowed in the FOA.

Ending Date:

This field is required. Enter the proposed ending date of the 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 M.240 - R&RSenior/Key Person Profile (Expanded) Form.

See M.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.

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.

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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.

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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.

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.

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.

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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.

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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.

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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 M.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)).

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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.

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M.210 - PHS 398 Cover Page Supplement Form

M.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 M.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.

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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 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.

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

rest of the “Human Embryonic Stem Cells” section.

l

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 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 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 M.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.

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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:

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.”

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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.

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.

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.

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M.220 - R&R Other Project Information Form

M.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

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).

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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 M.500 – PHS Human Subjects and Clinical Trials

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

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

complete the relevant questions in that form.

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 M.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 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 M.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.

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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 M.200 -

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

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

collaborating institution.

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 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.

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.

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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:

l

an animal care and use program;

l

facilities to house animals and conduct research on site; and

l

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.

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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.

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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 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.

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

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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 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

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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 Multi-project:

Overall and Other Components: The “Bibliography & References Cited”

attachment should include any references cited in M.400 - PHS 398 Research Plan

Form and in the M.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 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.

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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:

l

resources for classes, travel, or training;

l

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;

l

logistical support, such as administrative management and oversight and best practices

training;

l

financial support, such as protected time for research with salary support.

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.

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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.220 - R&R Other Project Information Form

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).

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

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

M.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 M.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:

l

an animal care and use program;

l

facilities to house animals and conduct research on site; and

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

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

l

an IACUC;

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

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 M.400

– PHS 398 Research Plan Form.

“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.

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

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.

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

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.

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

M.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 M.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.

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

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 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.

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.

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

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

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.

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

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.

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

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:

l

the name and location of the institution

l

the degree received (if applicable)

l

the month and year of end date (or expected end date). For fellowship applicants only,

also include the month and year of start date.

l

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

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

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:

l

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.

l

Indicate whether you have published or created research products under another name.

l

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.

l

Figures, tables, or graphics are not allowed.

Note the following instructions for specific subsets of applicants/candidates:

l

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.

l

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.

l

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:

l

Students, postdoctorates, and junior faculty should include scholarships, traineeships,

fellowships, and development awards, as applicable.

l

Clinicians should include information on any clinical licensures and specialty board

certifications that they have achieved.

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

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:

l

the historical background that frames the scientific problem;

l

the central finding(s);

l

the influence of the finding(s) on the progress of science or the application of those

finding(s) to health or technology; and

l

your specific role in the described work.

l

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)

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

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.

Prefix:

Enter or select the prefix, if applicable, for the name of the senior/key person.

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

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.

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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.

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.

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.

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.

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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.

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M.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

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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 M.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 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.

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Overall Component: Most budget data is collected within the Other Components.

Complete only the M.200 - SF 424 (R&R) Form, Estimated Project Funding section

and the M.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:

l

appear in the Overall section of the assembled application image in eRA

Commons;

l

will be compiled from R&R budget data collected in the Other Components;

and

l

will be generated upon submission.

Special Instructions for Applications Proposing the Use of Human Fetal Tissue:

l

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.

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

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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:

l

Project: The budget being requested is for the primary applicant organization.

l

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

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

End Date:

This field is required. Enter the requested/proposed end date of the budget period.

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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.

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).

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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 M.240 - R&R Senior/Key Person Profile (Expanded) Form. Note that

there must be at least one PD/PI per budget period.

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.

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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

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.

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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.

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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).

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.

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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

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

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"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.



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:

l

each consultant, the services he/she will perform, total number of days, travel costs, and

the total estimated costs;

l

the names and organizational affiliations of all consultants, other than those involved in

consortium/contractual arrangements;

l

consulting physicians in connection with patient care; and

l

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

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M.300 - R&R Budget Form

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.

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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 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.

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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.

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.

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

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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.

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.”

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.”

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).

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.

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”).

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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 M.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.

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.

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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).

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

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

M.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

M.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 M.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:

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 (M.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.

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

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 M.300 - R&R Budget Form and in the M.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 M.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 M.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 M.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

M.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:

l

period 1 - Jan 1, 2017 – Dec 31, 2017

l

period 2 - Jan 1, 2018 – Dec 31, 2018

l

period 3 - Jan 1, 2019 – Dec 31, 2019

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

l

period 4 - Jan 1, 2020 – Dec 31, 2020

l

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:

l

Unique Entity Identifier

l

Budget Type = Subaward/Consortium

l

Budget Period Start/End Dates (align with budget periods and dates of the prime budget)

l

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

l

Explanation of the inactive budget periods in the Budget Justification of the

subaward/consortium's R&R Subaward Budget Form

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.330 - PHS 398 Training Budget Form

The PHS 398 Training Budget Form is used only for

Training applications (e.g., T15, T32, T34, T35, T36, T90)

and Multi-project applications with a training

component.

The PHS 398 Training Budget Form is not applicable for

the K12, T37, D43, D71, or U2R activity codes. Applicants

to these activity codes should follow the instructions for

the R&R Budget Form and the instructions in the FOA (if

applicable).

For current stipend levels and allowable costs, refer to

the relevant FOA, NIH’s Research Training &Career

Development website, or consult the PHS awarding

component.

View larger image

Quick Links

Introductory Fields

A. Stipends, Tuition/Fees

B. Other Direct Costs

C. Total Direct Costs Requested (A+B)

D. Indirect (F&A) Costs

E. Total Direct and Indirect (F&A) Costs Requested (C+D)

F. Budget Justification

PHS 398 Training Budget, Cumulative Budget

Who should use the PHS 398 Training Budget Form?

Use this form if you will be submitting certain types of Training Applications (e.g., T15, T32, T34, T35,

T36, or T90), regardless of the amount of the requested budget.

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.

Certain types of Training Applications, such as K12, T37, D43, D71, and U2R, do not use the PHS 398

Training Budget Form. These applications use the R&R Budget Form.

Note on Subawards/Consortiums: If you have a subaward/consortium, you must use the PHS 398

Training Subaward Budget Attachment(s) Form in conjunction with the PHS 398 Training Budget Form.

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M.330 - PHS 398 Training Budget Form

The prime must extract the PHS 398 Training Subaward Budgets from the PHS 398 Training Subaward

Budget Attachment(s) Form and send the extracted file to the subaward/consortium. The consortium

should complete the PHS 398 Training Subaward Budget, following the instructions here and in M.340 –

PHS 398 Training Subaward Budget Attachment(s) Form.

Using the PHS 398 Training Budget Form:

You must complete a separate training 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,

leave the field blank.

You must round to the nearest whole dollar amount in all dollar fields.

Introductory Fields

Unique Entity Identifier (UEI):

This field is required. This field may be pre-populated from the SF 424 (R&R) Form and should

reflect the UEI of the applicant 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 the subaward/consortium

organization(s). Note: Separate budgets are required only for subaward/consortium organizations

that perform a substantive portion of the project.

If you are preparing an application that includes a subaward/consortium, in addition to

completing this form, also see M.340 – PHS 398 Training Subaward Budget Attachment(s) Form.

Organization Name:

This field may be pre-populated from the M.200 - SF 424 (R&R) Form.

Start Date:

This field is required and may be pre-populated from the M.200 - 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 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.

A. Stipends, Tuition/Fees

Number of Trainees

Enter the number of trainees for each category (undergraduate, predoctoral, postdoctoral, and

other), distinguishing between full-time training positions (i.e., a full year of training) and short

term trainees.

Note that some programs do not allow all categories of trainees (e.g., undergraduates are not

eligible for T32 applications). Refer to your FOA regarding the eligible types of trainees for your

specific application.

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M.330 - PHS 398 Training Budget Form

l

For undergraduate trainees: list separately the number that will be at the First-Year/Sophomore

stipend level and the number that will be at the Junior/Senior stipend level in the boxes

provided.

l

For predoctoral trainees: list separately the number that will be pursuing single degrees and

the number that will be pursuing dual degrees in the boxes provided. The "Total Predoctoral"

fields will be automatically calculated.

l

For postdoctoral trainees: list separately the number that are non-degree seeking and the

number that are degree seeking in the boxes provided. If a category (non-degree seeking or

degree seeking) contains various stipend levels (e.g., for varying levels of postdoctoral

experience or for varying appointment periods), itemize the number of postdoctoral trainees

by stipend level in the boxes provided. The "Total Postdoctoral" fields will be automatically

calculated.

Stipends Requested ($)

Enter the total stipend amount requested for each trainee type.

For current stipend levels and allowable costs, refer to the FOA or consult the PHS awarding

component. For more information, see the NIH’s Research Training and Career Development

website.

The “Total Stipends Requested” field will be automatically calculated.

Tuition/Fees Requested ($)

Enter the total tuition/fees requested for each trainee type.

See the NIH Grants Policy Statement, Section 11.3.8: Allowable and Unallowable Costs for NIH

policy regarding payment of tuition and fees.

Tuition at the postdoctoral level is limited to that required for specified courses that are to be

described in Section F. Budget Justification and may depend on whether the program supports

postdoctoral individuals in formal degree-granting training.

The “Total Tuition/Fees Requested” field will be automatically calculated.

You should request full needs for tuition and fees. The awarding component will determine the

amount of tuition and fees to be provided according to the policies current at the time of award.

The formula currently in effect will be applied by the NIH awarding component at the time an

award is calculated. Do not include health insurance in the tuition/fees fields.

Total Stipends + Tuition/Fees Requested

This total will be automatically calculated.

B. Other Direct Costs

Enter the total funds requested for Trainee Travel and Training Related Expenses (TRE). If

applicable, enter the Total Direct Costs from the R&R Budget Form and Consortium Training Costs.

Trainee Travel

Enter the total funds requested for trainee travel in the "Trainee Travel" field.

Some NIH awarding components provide a pre-determined amount for travel for each full time

trainee. Refer to the FOA and/or contact the awarding component to determine the amount

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.330 - PHS 398 Training Budget Form

provided for travel and enter it here. If the awarding component does not provide a pre-

determined amount, enter the requested amount here and provide an explanation in Section F.

Budget Justification, stating the purpose of any travel, giving the number of trips involved, the

destinations, and the number of trainees for whom funds are requested. PHS policy requires coach

class air travel be used. Justify any foreign travel in detail, describing its importance to the training

experience.

Training Related Expenses

Enter the total funds requested for TRE. You must base your requested amount on the number of

trainees at the predetermined rate.

Funds to defray other costs of training, such as health insurance, staff salaries, consultant costs,

equipment, research supplies, staff travel, etc., are requested as a lump sum based on the amounts

specified in the FOA and in the NIH Grants Policy Statement, Section 11.3.8.4: Training-Related

Expenses for each predoctoral and postdoctoral trainee.

Health insurance may be covered by TRE only to the extent that the same health insurance fees are

charged to non-federally-supported students and postdoctoral fellows.

TRE will be awarded as a lump sum. No further itemization or explanation is required in Section F.

Budget Justification.

The awarding component will apply the TRE level established for institutional programs for the

relevant fiscal year at the time of award.

Total Direct Costs from R&R Budget Form (if applicable)

Certain FOAs allow funds to cover direct costs for items other than those specified above. Use the

R&R Budget Form to submit those costs. The Total Direct Costs from the R&R Budget Form (M.300

- R&RBudget Form, Section G. Direct Costs) should be inserted here. This line should not include

any indirect costs.

Additional Instructions for Multi-project:

Skip the “Total Direct Costs from R&R Budget Form” field, as Kirschstein-NRSA

Training components do not include the R&R Budget Form.

Consortium Training Costs (if applicable)

If training occurs at more than one institution and there is a transfer of funds between

organizations, you must complete the M.340 - PHS 398 Training Subaward Budget Attachment(s)

Form. Total the direct costs from the Training Subaward Budget Attachment Forms and insert the

total here. The applicant institution is responsible and accountable for any arrangements,

expenditures, and submission of all required application forms when more than one institution is

involved in the research training program.

Total Other Direct Costs Requested

This total will be automatically calculated based on the sum of the funds requested in "B. Other

Direct Costs."

C. Total Direct Costs Requested (A+B)

This total will be automatically calculated based on the sum of the funds requested in both "A.

Stipends, Tuition/Fees" and "B. Other Direct Costs."

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D. 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.

Equipment and consortium costs are also excluded from the F&A costs on those training grants

where TRE are not calculated and awarded on a lump-sum basis, such as the Maximizing Access to

Research Careers Program (MARC).

State and local government agencies will receive the full F&A cost rate.

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 Cost.

Indirect (F&A) Type:

Enter “F&A.”

Indirect (F&A) Rate (%):

Enter “8.”

Facilities and Administrative (F&A) costs under Institutional Kirschstein-NRSA awards, other than

those issued to U.S., state, or local government agencies, will be awarded at 8%.

State and local government agencies should enter their full F&A cost rate.

Indirect (F&A) Base ($):

Enter the sum of the stipends and the Total Other Direct Costs requested, regardless of whether

those direct costs were listed on the PHS 398 Training Budget Form or on the R&R Budget Form.

Indirect costs are not paid on Tuition/Fees, equipment, or sub-grants and contracts in excess of

$25,000.

Funds Requested ($):

Enter the product of Indirect (F&A) Rate and the Indirect (F&A) Base. Refer to the NIH Grants Policy

Statement, Section 7.4: Reimbursement of Facilities and Administrative Costs for more

information.

E. Total Direct and Indirect (F&A) Costs Requested (C+D)

This total will be automatically calculated based on the sum of the "C. Total Direct Costs

Requested" and "D. Total Indirect (F&A) Costs Requested" fields.

F. Budget Justification

A Budget Justification attachment is required.

Attach one file for the entire project period. Hyperlinks and URLs are not allowed unless specified

in the funding opportunity announcement.

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M.330 - PHS 398 Training Budget Form

Explain in detail the composition of any of the above costs, as necessary, according to the

guidelines listed here:

l

Itemize tuition and individual fees. If tuition varies, (e.g., in-state, out-of-state, student status)

list these separately. Do not include health insurance in the tuition and fees category.

l

If tuition is requested for postdoctoral trainees, the specific courses or formal degree-granting

program must be described.

l

If the awarding component does not provide a pre-determined amount for travel for each full

time trainee, explain the requested amount and describe the purpose of any travel, indicating

the expected number of trips involved, the likely destinations, and the number of trainees for

whom funds are requested, bearing in mind that PHS policy requires coach class air travel be

used.

l

Any foreign travel must be justified in detail. Describe its importance to the training experience

and how those opportunities differ from and complement those offered by the grantee

institution. Also describe the relationship of the proposed off-site training experience to the

career stage of the grantee.

l

Justify the number of training slots (e.g., predoctoral and/or postdoctoral) requested. For

postdoctoral training slots, justify the stipend levels requested.

Note for Applicants Using both the PHS 398 Training Budget Form and the R&R Budget

Form: Generally, the Budget Justification included in the PHS 398 Training Budget Form should

reflect only funds requested on the PHS 398 Training Budget Form. When the R&R Budget Form is

also used, two separate Budget Justifications are required, each covering the costs requested in

the respective Budget Form.

PHS 398 Training 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 for each of the individual budget periods.

Therefore, no data entry is allowed or required to complete the “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).

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

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

M.340 - PHS 398 Training Subaward

Budget Attachment(s) Form

The PHS 398 Training 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 a PHS 398 Training Budget Form and has

subaward/consortium budgets.

Applicants using the R&R Budget Form should see M.300

- R&R Budget Form.

View larger image



Who should use the PHS 398 Training Subaward Budget

Attachment(s) Form?

The PHS 398 Training Subaward Budget Attachment(s) Form is required if you have a

subaward/consortium and are using the PHS 398 Training Budget Form.

Do not use this form if you do not have a subaward/consortium.

Each subaward/consortium that performs a substantive portion of the project must complete a Training

Subaward Budget, including the Budget Justification section. For most programs, this is not common

but is usually encountered when a portion of the training program takes place at a site other than the

applicant organization via a collaborative or consortium arrangement. In such situations, the applicant

organization is responsible and accountable for acceptable training arrangements, expenditure of

funds, and submission of all required forms.

Consortium/Contractual F&A Costs:

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

consortium/subawards in the Subawards/Consortium Costs field. If a subaward/consortium is not

performing a substantive portion of the project, they do not need to complete a Training Subaward

Budget; however, their costs must be included in the prime grantee’s Training Budget Form. All F&A

costs count toward the direct cost limit.

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.

Applicants should document how their budget falls below the direct cost limit in the Budget

Justification of the Training Subaward Budget.

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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 PHS398 Training Budget Form and in the M.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 PHS 398 Training Subaward Budget Attachment(s) Form:

The location of the PHS 398 Training 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 Training

Subaward Budget Form from the Training Subaward Budget Attachment(s) Form and send the

extracted file to the consortium for completion. After the consortium completes the Training Subaward

Budget Form, following the instructions here and in M.330 – PHS 398 Training Budget Form, the prime

grantee must then upload all the Training Subaward Budget Forms to the Training Subaward Budget

Attachment(s) Form.

For all submission methods, the Training Subaward 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 Training 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 the "Section F.

Budget Justification" of the project budget.

Regardless of how many subaward/consortium budgets you include, the sum of ALL

subaward/consortium budgets (those attached within the PHS 398 Training Subaward Budget

Attachment(s) Form and those provided as part of the parent budget’s Budget Justification), must be

included in the M.330 - PHS 398 Training Budget, Part B. Consortium Training Costs.

Format:

All attachments, including all Training Subaward Budget Forms and all Budget Justifications, must be

PDF files. The Training Budget Forms are already PDFs when extracted. Do not alter the format.

Hyperlinks and URLs are not allowed unless specified in the funding opportunity announcement.

Content:

On this PHS 398 Training Subaward Budget Attachment(s) Form, you will attach the Training Subaward

Budget files for your application. Each subaward/consortium will complete the Subaward Budget in

accordance with the M.330 - PHS 398 Training Budget Form instructions.

Submitting Subaward Budgets that are not Active for all Periods of the Prime Grant:

The Training Budget Forms do not allow for “empty” budget periods.

Subaward/consortium organizations should complete all budget periods in the Training 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 a PHS 398 Training Budget Form with the following periods:

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

l

period 1 - Jan 1, 2017 – Dec 31, 2017

l

period 2 - Jan 1, 2018 – Dec 31, 2018

l

period 3 - Jan 1, 2019 – Dec 31, 2019

l

period 4 - Jan 1, 2020 – Dec 31, 2020

l

period 5 - Jan 1, 2021 – Dec 31, 2021

The budget period numbers and dates should be the same in all Training Subaward Budgets included in

the PHS 398 Training Subaward Budget Attachment(s) Form.

The PHS 398 Training 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:

l

Unique Entity Identifier (UEI)

l

Budget Type = Subaward/Consortium

l

Budget Period Start/End Dates (align with budget periods and dates of the prime budget)

l

Explanation of the inactive budget periods in the Budget Justification (of the

subaward/consortium's Training Subaward Budget)

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.350 - PHS Additional Indirect Costs Form

M.350 - PHS Additional Indirect Costs

Form

The PHS Additional Indirect Costs Form is used only for

multi-project applications. The applicant organization

responsible for the Overall Component should use this

form to detail its first $25,000 F&A costs on each

subaward organization that leads a component.

View larger image

Quick Links

Introductory Fields

Indirect Costs

Budget Justification

PHS Additional Indirect Cost - Cumulative Budget

Who should use the PHSAdditional Indirect Costs Form:

The PHS Additional Indirect Costs Form is used only for multi-project applications.

The applicant organization responsible for the Overall Component should use this form to detail its first

$25,000 indirect (Facilities and Administrative [F&A]) costs on each subaward organization that leads a

component.

Introductory Fields

Unique Entity Identifier (UEI):

This field is required. Enter the UEI of the applicant organization.

Enter name of Organization:

This field may be pre-populated from the SF 424 (R&R) Form. Enter the name of the organization.

Budget Type:

This field is required. "Project" should be selected.

Budget Period:

This field is required.

Identify the specific budget period (for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10).

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.

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End Date:

This field is required. Enter the requested/proposed end date of the budget period.

Indirect Costs

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

the Budget Justification in this form if additional space is needed.

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.”

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.

See the NIH Grants Policy Statement, Section 7.4: Reimbursement of Facilities and Administrative

Costs for more information.

Total Indirect Costs:

This total will be automatically calculated from the “Funds Requested” column.

Budget Justification

The “Budget Justification” attachment is required.

Attach only one file. Attach this information as a PDF. Hyperlinks and URLs are not allowed unless

specified in the funding opportunity announcement.

Use the Budget Justification to provide the additional information requested in each budget

category identified above and any other information that supports the budget request. The

following budget categories must be justified, where applicable: equipment, travel,

participant/trainee support, and other direct cost categories.

PHS Additional Indirect Cost – Cumulative Budget

Indirect Costs Totals ($):

All values on this form are automatically calculated and the fields pre-populated. They present the

summations of the amounts you entered in the “Indirect Costs” section above, for each of the

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.350 - PHS Additional Indirect Costs Form

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).

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Multi-Project Instructions for NIHand Other PHSAgencies - Forms Version H Series

M.400 - PHS 398 Research Plan Form

The PHS 398 Research Plan form is used only for

research, multi-project, and SBIR/STTR applications.

This form includes fields to upload several attachments,

including the Specific Aims and Research Strategy.

The Research Plan, together with the rest of your

application, should include sufficient information needed

for evaluation of the project, independent of any other

documents (e.g., previous application). Be specific and

informative, and avoid redundancies.

View larger image

Quick Links

Introduction



1. Introduction to Application (for Resubmission and

Revision applications)

Research Plan Section



2. Specific Aims



3. Research Strategy



4. Progress Report Publication List

Other Research Plan Section



5. Vertebrate Animals



6. Select Agent Research



7. Multiple PD/PI Leadership Plan



8. Consortium/Contractual Arrangements



9. Letters of Support



10. Resource Sharing Plan(s)



11. Other Plan(s)



12. Authentication of Key Biological and/or Chemical Resources

Appendix



13. Appendix

Your application should represent a sound approach to the investigation of an important biomedical

research, behavioral research, technological, engineering, or scientific question, and be worthy of

support under the stated criteria of the FOA. It should be self-contained and written with the care and

thoroughness accorded to papers for publication.

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M.400 - PHS 398 Research Plan Form

Review the application carefully to ensure you have included information essential for evaluation. The

scientific and technical merit of the proposed research is the primary concern for all research supported

by the National Institutes of Health (NIH) and other PHS agencies.

Read all the instructions in the FOA before completing this form to ensure that your application meets

all IC-specific criteria.

Who should use the PHS398 Research Plan Form:

Use the PHS 398 Research Plan Form only if you are submitting a research, multi-project, or SBIR/STTR

application.

Applicants must follow all policies and requirements related to formatting, page limits, and

proprietary information. See the following pages for more information:

l

Format Attachments

l

Page Limits

l

NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information

l

NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act

Introduction

1. Introduction to Application (for Resubmission and Revision applications)

Who must complete the “Introduction to Application” attachment:

An "Introduction to Application" attachment is required only if the type of application is

resubmission or revision or if the FOA specifies that one is needed. An introduction is not allowed

for new or renewal applications.

Descriptions of different types of applications are listed here: NIH Types of Applications.

Format:

Follow the page limits for the introduction in the NIH Table of Page Limits unless otherwise

specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page. Hyperlinks and URLs

may not be used in this section unless specified as allowed in the funding opportunity

announcement.

Content:

Resubmission applications: See specific instructions on the content of the introduction on the

NIH's Resubmission Applications page.

Note: For resubmission applications changing from a single PD/PI to multiple PD/PIs,

changing the number or makeup of the multiple PD/PIs, the applicant must provide a

rationale for the change in the introduction and include the required Multiple PD/PI

Leadership Plan. A rationale for a change from a multiple PD/PI to a single PD/PI application

must also be provided in the introduction.

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M.400 - PHS 398 Research Plan Form

Competing Revisions: See specific instructions on the content of the introduction on the NIH's

Competing Revisions page.

Additional Instructions for Multi-project:

Overall Component: The “Introduction” attachment is required for all resubmission

and revision applications.

Other Components: The "Introduction” attachment is optional for resubmissions

and revisions applications. Although the “Introduction” attachment is optional, you

may get a system warning if there is no attachment.

Research Plan Section

2. Specific Aims

Who must complete the "Specific Aims" attachment:

The “Specific Aims” attachment is required unless otherwise specified in the FOA.

Format:

Follow the page limits for the Specific Aims in the NIH Table of Page Limits unless otherwise

specified in the FOA. A “Specific Aims” attachment that exceeds the page limit will be flagged as an

error by the Agency upon submission.

Attach this information as a PDF file. See NIH's Format Attachments page. Hyperlinks and URLs

may not be used in this section unless specified as allowed in the funding opportunity

announcement.

Content:

State concisely the goals of the proposed research and summarize the expected outcome(s),

including the impact that the results of the proposed research will have on the research field(s)

involved.

List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis,

create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice,

address a critical barrier to progress in the field, or develop new technology).

Additional Instructions for Multi-project:

Overall Component: The "Specific Aims" attachment is required.

Other Components: The "Specific Aims" attachment is required.

3. Research Strategy

Who must complete the "Research Strategy" attachment:

The “Research Strategy” attachment is required.

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M.400 - PHS 398 Research Plan Form

Format:

Follow the page limits for the Research Strategy in the NIH Table of Page Limits, unless otherwise

specified in the FOA. Although multiple sections of information are required in the Research

Strategy as detailed below, the page limit applies to the entirety of the single "Research Strategy"

attachment.

Attach this information as a PDF file. See NIH's Format Attachments page. Hyperlinks and URLs

may not be used in this section unless specified as allowed in the funding opportunity

announcement.

Content:

Organize the Research Strategy in the specified order and use the instructions provided below

unless otherwise specified in the FOA. Start each section with the appropriate heading –

Significance, Innovation, Approach.

Cite published experimental details in the Research Strategy attachment and provide the full

reference in M.220 - R&R Other Project Information Form, Bibliography and Reference Cited.

Note 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 include specific information in the Approach

section of the Research Strategy attachment. See specific instructions below in Section 3.

Approach. This information must be provided regardless of whether Human Subjects research is

proposed or not.

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.

Note for Applications Proposing the Involvement of Human Subjects and/or Clinical Trials:

l

Do not duplicate information in the Research Strategy and the PHS Human Subjects and

Clinical Trials Information form. Use the Research Strategy attachment to discuss the overall

strategy, methodology, and analyses of your proposed research. Use the PHS Human Subjects

and Clinical Trials Information form to provide detailed information for human subjects studies

and clinical trials.

l

The PHS Human Subjects and Clinical Trials Information form will capture detailed study

information, including eligibility criteria; inclusion of women, minorities, and individuals across

the lifespan; protection and monitoring plans; and statistical design and power.

l

You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials

Information form as appropriate in your discussion of the Research Strategy (e.g., see Question

2.4 Inclusion of Women and Minorities).

Note for Applicants with Multiple Specific Aims: You may address the Significance, Innovation,

and Approach either for each Specific Aim individually or for all of the Specific Aims collectively.

1. Significance

l

Explain the importance of the problem or critical barrier to progress that the proposed

project addresses.

l

Describe the strengths and weaknesses in the rigor of the prior research (both published

and unpublished) that serves as the key support for the proposed project.

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l

Explain how the proposed project will improve scientific knowledge, technical capability,

and/or clinical practice in one or more broad fields.

Additional Instructions for Multi-project:

Overall and Other Components: Describe how the concepts, methods,

technologies, treatments, services, or preventative interventions that drive this field

will be changed if the proposed aims are achieved.

2. Innovation

l

Explain how the application challenges and seeks to shift current research or clinical

practice paradigms.

l

Describe any novel theoretical concepts, approaches or methodologies, instrumentation

or interventions to be developed or used, and any advantage over existing

methodologies, instrumentation, or interventions.

l

Explain any refinements, improvements, or new applications of theoretical concepts,

approaches or methodologies, instrumentation, or interventions.

3. Approach

l

Describe the overall strategy, methodology, and analyses to be used to accomplish the

specific aims of the project. Describe plans to address weaknesses in the rigor of the prior

research that serves as the key support for the proposed project. Describe the

experimental design and methods proposed and how they will achieve robust and

unbiased results. Include how the data will be collected, analyzed, and interpreted, and

reference any Resource Sharing Plans and the Data Management and Sharing (DMS) Plan,

as appropriate. Resources and tools for rigorous experimental design can be found at the

Enhancing Reproducibility through Rigor and Transparency website.

l

For trials that randomize groups or deliver interventions to groups, describe how your

methods for analysis and sample size are appropriate for your plans for participant

assignment and intervention delivery. These methods can include a group- or cluster-

randomized trial or an individually randomized group-treatment trial. Additional

information is available at the Research Methods Resources webpage.

l

Discuss potential problems, alternative strategies, and benchmarks for success anticipated

to achieve the aims.

l

If the project is in the early stages of development, describe any strategy to establish

feasibility, and address the management of any high risk aspects of the proposed work.

l

Explain how relevant biological variables, such as sex, are factored into research designs

and analyses for studies in vertebrate animals and humans. For example, strong

justification from the scientific literature, preliminary data, or other relevant

considerations, must be provided for applications proposing to study only one sex. Refer

to the NIH Guide Notice on Sex as a Biological Variable in NIH-funded Research for

additional information.

l

Point out any procedures, situations, or materials that may be hazardous to personnel and

the precautions to be exercised. A full discussion on the use of select agents should

appear in the Select Agent Research attachment below.

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M.400 - PHS 398 Research Plan Form

l

If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line

from the NIH hESC Registry cannot be chosen, provide a strong justification for why an

appropriate cell line cannot be chosen from the registry at this time.

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

l

Use the specific heading: “Human Fetal Tissue Research Approach”.

l

Describe the proposed characteristics, procurement, and procedures for the research use of

HFT. The description should be sufficiently detailed to permit meaningful evaluation by NIH.

l

Justify the use of HFT in the proposed research by indicating the following:

l

Why the research goals cannot be accomplished by using an alternative to HFT.

l

What methods were used (e.g. literature review, preliminary data) to determine that

alternatives could not be used.

l

Results from a literature review used to provide justifications.

l

Plans for the treatment of HFT and the disposal of HFT when research is complete.

l

Description of planned written, voluntary, informed consent process for cell/tissue

donation, or description and documentation of process if cells/tissue were already

obtained.

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.

As applicable, also include the following information as part of the Research Strategy,

keeping within the three sections (Significance, Innovation, and Approach) listed above.

Preliminary Studies for New Applications:

For new applications, include information on preliminary studies. Discuss the PD/PI’s preliminary

studies, data, and or experience pertinent to this application. Except for

Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic

Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a

research grant application and can help to establish the likelihood of success of the proposed

project. Early stage investigators should include preliminary data.

Progress Report for Renewal and Revision Applications:

Note that the Progress Report falls within the Research Strategy and is therefore included in the

page limits for the Research Strategy.

For renewal/revision applications, provide a Progress Report. Provide the beginning and ending

dates for the period covered since the last competitive review. In the Progress Report, you should:

l

Summarize the specific aims of the previous project period and the importance of the

findings, and emphasize the progress made toward their achievement.

l

Explain any significant changes to the specific aims and any new directions, including

changes resulting from significant budget reductions.

l

Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women,

minorities, children, etc.) for any studies meeting the NIH definition for clinical research.

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Use the Progress Report section to discuss, but not duplicate information collected

elsewhere in the application.

Do not include a list of publications, patents, or other printed materials in the Progress Report.

That information will be included in the "Progress Report Publication List" attachment.

Renewal Applications: For renewal applications changing from a single PD/PI to multiple

PD/PIs, changing the number or makeup of the multiple PD/PIs, the applicant must provide a

rationale for the change and include the required Multiple PD/PI Leadership Plan. A rationale for a

change from a multiple PD/PI to a single PD/PI application must also be provided.

4. Progress Report Publication List

Who must complete the “Progress Report Publication List” attachment:

A “Progress Report Publication List” attachment is required only if the type of application is

renewal.

Descriptions of different types of applications are listed here: NIH's Types of Applications.

Format:

Attach this information as a PDF file. See NIH’s Format Attachments page. Use of hyperlinks and

URLs in this section is not allowed unless specified in these instructions or in the funding

opportunity announcement.

Content:

List the titles and complete references to all appropriate publications, manuscripts accepted for

publication, patents, and other printed materials that have resulted from the project since it was

last reviewed competitively.

You are allowed to cite interim research products. Note: interim research products have specific

citation requirements. See related Frequently Asked Questions on citing interim research products

and claiming them as products of your NIH award.

Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed

Central (PMC) reference number (e.g., PMCID234567) for each of the following:

l

Articles that fall under the Public Access Policy,

l

Articles that were authored or co-authored by the applicant and arose from NIH support,

l

Articles that were authored or co-authored by the applicant and arose from AHRQ

funding provided after February 19, 2016 (see the Guide Notice on Policy for Public

Access to AHRQ-Funded Scientific Publications).

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 are not allowed.

Additional Instructions for Multi-project:

Overall and Other Components: If you include a "Progress Report Publication List"

attachment, you can include it in either the Overall Component or within each Other

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Component, but do not attach the same information in multiple locations.

Other Research Plan Section

5. Vertebrate Animals

Who must complete the “Vertebrate Animals” attachment:

Include a “Vertebrate Animals” attachment if you answered “Yes” to the question “Are Vertebrate

Animals Used?” on the M.220 - R&R Other Project Information Form.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Do not use this attachment to circumvent the page limits of the Research Strategy.

Content:

If live vertebrate animals are involved in the project, address each of the following criteria:

1. Description of Procedures: Provide a concise description of the proposed procedures to

be used that involve live vertebrate animals in the work outlined in the “Research

Strategy” attachment. The description must include sufficient detail to allow evaluation of

the procedures. Identify the species, strains, ages, sex, and total numbers of animals by

species, to be used in the proposed work. If dogs or cats are proposed, provide the source

of the animals.

2. Justifications: Provide justification that the species are appropriate for the proposed

research. Explain why the research goals cannot be accomplished using an alternative

model (e.g. computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress: Describe the interventions including analgesia,

anesthesia, sedation, palliative care and humane endpoints that will be used to minimize

discomfort, distress, pain, and injury.

Each of the criteria must be addressed. Failure to adequately address the criteria may negatively

affect the application’s impact score. In addition to the 3 criteria above, you should also:

l

Identify all project performance (or collaborating) sites and describe the proposed

research activities with vertebrate animals that will be conducted at those sites.

l

Explain when and how animals are expected to be used if plans for the use of animals

have not been finalized.

See the following pages for more information:

l

NIH’s Office of Laboratory Animal Welfare website

l

NIH's Vertebrate Animals Section Worksheet

l

See the NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements (an

applicable Animal Welfare Assurance will be required if the grantee institution does not have

one)

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Additional Instructions for Multi-project:

Overall Component: The “Vertebrate Animals” attachment is optional unless

specifically requested in the FOA.

Other Components: Complete the “Vertebrate Animals” section if you answered

“Yes” to the question “Are Vertebrate Animals Used?” on the M.220 - R&R Other

Project Information Form.

6. Select Agent Research

Who must complete the “Select Agent Research” attachment:

Include a “Select Agent Research” attachment if your proposed activities involve the use of select

agents at any time during the proposed project period, either at the applicant organization or at

any performance site.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

For more information:

Select agents are hazardous biological agents and toxins that have been identified by HHS or

theU.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public

health and safety, to animal and plant health, or to animal and plant products. The Centers for

Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS)

Select Agent Programs jointly maintain a list of these agents. See the Federal Select Agent

Program website.

See also the NIH Grants Policy Statement, Section 4.1.24.1.1: Select Agents.

Content:

Excluded select agents: If the activities proposed in the application involve only the use of a

strain(s) of select agents which has been excluded from the list of select agents and toxins as per

42 CFR 73.3, the select agent requirements do not apply. Use this “Select Agent Research”

attachment to identify the strain(s) of the select agent that will be used and note that it has been

excluded from this list. The CDC maintains a list of exclusions, which is available on the Select

Agents and Toxins Exclusions website.

Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list

of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from

the list, use this section to indicate the status of your request or your intent to apply for an

exclusion and provide a brief justification for the exclusion.

All applicants proposing to use select agents: Address the following three points for each site

at which select agent research will take place. Although no specific page limitation applies to this

section, be succinct.

1. Identify the select agent(s) to be used in the proposed research.

2. Provide the registration status of all entities* where select agent(s) will be used.

l

If the performance site(s) is a foreign institution, provide the name(s) of the country

or countries where select agent research will be performed.

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l

*An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or

local), academic institution, corporation, company, partnership, society, association,

firm, sole proprietorship, or other legal entity.”

3. Provide a description of all facilities where the select agent(s) will be used.

l

Describe the procedures that will be used to monitor possession, use, and transfer of

select agent(s).

l

Describe plans for appropriate biosafety, biocontainment, and security of the select

agent(s).

l

Describe the biocontainment resources available at all performance sites.

7. Multiple PD/PI Leadership Plan

Who must complete the “Multiple PD/PI Leadership Plan” attachment:

Any applicant who designates multiple PD/PIs (on the M.240 - R&R Senior/Key Person Profile

(Expanded) Form) must include a Multiple PD/PI Leadership Plan. For applications designating

multiple PD/PIs, all such individuals must be assigned the PD/PI role on the M.240 - R&R

Senior/Key Profile (Expanded) Form, even those at organizations other than the applicant

organization.

Do not submit a Multiple PD/PI Leadership Plan if you are not submitting a multiple PD/PI

application.

Additional Instructions for Multi-project:

Overall Component: The “Multiple PD/PI Leadership Plan” attachment is required if

more than one PD/PI is specified on the Overall Component's M.240 - R&R

Senior/Key Profile (Expanded) Form.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

A rationale for choosing a multiple PD/PI approach should be described. The governance and

organizational structure of the leadership team and the research project should be described,

including communication plans, processes for making decisions on scientific direction, and

procedures for resolving conflicts. The roles and administrative, technical, and scientific

responsibilities for the project or program should be delineated for the PD/PIs and other

collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project

or the individual PD/PIs should be delineated in the Multiple PD/PI Leadership Plan. In the event of

an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award.

Resubmission Applications: For resubmission applications changing from a single PD/PI to

multiple PD/PIs, changing the number or makeup of the multiple PD/PIs, the applicant must

provide a rationale for the change in the introduction and include the required Multiple PD/PI

Leadership Plan.

Renewal Applications: For renewal applications changing from a single PD/PI to multiple

PD/PIs, changing the number or makeup of the multiple PD/PIs, the applicant must provide a

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rationale for the change in the progress report within the research strategy and include the

required Multiple PD/PI Leadership Plan.

For more information:

For background information on the multiple PD/PI initiative, see NIH's Multiple Principal

Investigators page.

8. Consortium/Contractual Arrangements

Who must complete the “Consortium/Contractual Arrangements” attachment:

Include a “Consortium/Contractual Arrangements” attachment if you have consortiums/contracts

in your budget.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Explain the programmatic, fiscal, and administrative arrangements to be made between the

applicant organization and the consortium organization(s). If consortium/contractual activities

represent a significant portion of the overall project, explain why the applicant organization, rather

than the ultimate performer of the activities, should be the grantee.

Note: The signature of the authorized organization representative in M.200 - SF 424 (R&R),

Authorized Representative signifies that the applicant and all proposed consortium participants

understand and agree to the following statement:

The appropriate programmatic and administrative personnel of each organization involved in

this grant application are aware of the agency’s consortium agreement policy and are prepared

to establish the necessary inter-organizational agreement(s) consistent with that policy.

For more information:

Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more

information.

Additional Instructions for Multi-project:

Overall and Other Components: Unless otherwise specified in the FOA, you have

the option to:

l

include a single consolidated “Consortium/Contractual Arrangements”

attachment in the Overall Component, or

l

include component-specific “Consortium/Contractual Arrangements” attachment

(s) within the components that include subawards, or

l

include a “Consortium/Contractual Arrangements” attachment in the Overall

Component and include component-specific attachments within the components

that include subawards. Each filename must be unique.

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9. Letters of Support

Format:

Combine all letters of support into a single PDF file and attach this information here. Do not place

these letters in the Appendix.

Follow the attachment guidelines on NIH's Format Attachments page. Use of hyperlinks and URLs

in Letters of Support is not allowed unless specified in the funding opportunity announcement.

Content:

Attach a file with all letters of support, including any letters necessary to demonstrate the support

of consortium participants and collaborators such as Senior/Key Personnel and Other Significant

Contributors included in the grant application.

Letters should stipulate expectations for co-authorship, and whether cell lines, samples, or other

resources promised in the letter are freely available to other investigators in the scientific

community or will be provided to the particular investigators only.

For consultants, letters should include rate/charge for consulting services and level of effort /

number of hours per budget period anticipated. In addition, letters ensuring access to core

facilities and resources should stipulate whether access will be provided as a fee-for-service.

Material Transfer Agreements may be included in this section.

Letters must focus on the topics listed above and not contain data / figures / tables / graphs,

preliminary data, methods, background and significance details that are expected to be found in

Research Strategy section of the application. Letters of Support serve to describe terms of a

collaboration or consultation and also are not de facto letters of reference from persons not

actively participating in the project. Applications with letters containing such excess information

may be withdrawn from the review process.

Letters are not required for personnel (such as research assistants) not contributing in a

substantive, measurable way to the scientific development or execution of the project.

Do not include consultant biographical sketches in the “Letters of Support” attachment, as

consultant biosketches should be in the “Biographical Sketch” section.

Additional Instructions for Multi-project:

Overall and Other Components: Unless specific instructions are provided in the

FOA, applicants have the option of including the “Letters of Support” attachment in

the Overall Component, Other Components, or both. To avoid duplication, each

letter should appear only once in the application. Letters that apply to the entire

application (or to multiple components) should be presented in the Overall

Component as a single PDF, while letters that apply only to a particular individual

component should be presented in that component as a single PDF.

10. Resource Sharing Plan(s)

Note: Effective for due dates on or after January 25, 2023, Data Management and

Sharing (DMS) Plans are now included in Section 11. Other Plan(s). Plans for Genomic Data

Sharing should be provided as part of the Data Management and Sharing Plan.

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Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Sharing Model Organisms: Regardless of the amount requested, all applications where the

development of model organisms is anticipated are expected to include a description of a specific

plan for sharing and distributing unique model organisms or state why such sharing is restricted or

not possible. For more information, see the NIH Grants Policy Statement, Section 8.2.3.2: Sharing

Model Organisms.

Research Tools:

NIH considers the sharing of unique research resources developed through NIH-sponsored

research an important means to enhance the value and further the advancement of the research.

When resources have been developed with NIH funds, and the associated research findings

published or provided to NIH, it is important that they be made readily available for research

purposes to qualified individuals within the scientific community. For more information, see the

Research Tools Policy on the NIH Scientific Data Sharing Website and the NIH Grants Policy

Statement, Section 8.2.3: Sharing Research Resources.

11. Other Plan(s)

Who Must Complete This Section: Refer to the list of NIH activity codes subject to the DMS

Policy and your Funding Opportunity Announcement to determine if your application is required

to provide an attachment and address a Data Management and Sharing (DMS) Plan. Applicants

proposing to conduct research that will generate scientific data are subject to the NIH Data

Management and Sharing Policy and must attach a Data Management and Sharing (DMS) Plan.

Scientific data is defined as the recorded factual material commonly accepted in the scientific

community as of sufficient quality to validate and replicate research findings, regardless of

whether the data are used to support scholarly publications. Scientific data includes any data

needed to validate and replicate research findings. Scientific data does not include laboratory

notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for

future research, peer reviews, communications with colleagues, or physical objects such as

laboratory specimens.

The NIH Genomic Data Sharing Policy expects applicants seeking funding for research that

generates large-scale human or non-human genomic data to provide a plan for sharing of these

data as part of their DMS Plan.

Applicants subject to both the NIH Data Management and Sharing Policy and the NIH Genomic

Data Sharing Policy must attach a single Plan including elements for both policies. For more on

applicability of each policy, see research subject to the NIH Data Management and Sharing Policy

and the research subject to the NIH Genomic Data Sharing Policy.

Format: Attach this information as a PDF file. See NIH's Format Attachments page.

A sample format is provided on the Data Management and Sharing Plan Format Page to assist

applicants with preparation of this attachment. Do not include hyperlinks in this attachment.

Recommended not to exceed two pages.

Content: Follow the expectations of the NIH Policy for Data Management and Sharing and

address the Elements of an NIH Data Management and Sharing Plan described below.

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Additional expectations: A Data Management and Sharing Plan should reflect the proposed

approach at the time the application is prepared. For some programs and data types, NIH and/or

NIH Institutes, Centers, Offices, or programs have developed additional data sharing requirements

(e.g., specifying which scientific data to share, relevant standards, repository selection, timelines)

that apply and should be reflected in a Plan. These additional requirements may be listed on NIH

Institute and Center Data Sharing Policies or in specific funding opportunity announcements. Note

that some NIH Institutes, Centers, Officers, or programs have developed additional expectations

for sharing genomic data that may be listed on NIH Institute and Center Genomic Data Sharing

Expectations or in specific funding opportunity announcements.

Elements of a Data Management and Sharing Plan:

Data Type: Briefly describe the scientific data to be managed, preserved, and shared,

including a general summary of the types and estimated amount of scientific data to be

generated and a description of which scientific data from the project will be preserved and

shared as well as the rationale for doing so. Briefly list the metadata, other relevant data, and

any associated documentation (e.g., study protocols and data collection instruments) that will

be made accessible to facilitate interpretation of the scientific data.

Related Tools, Software and/or Code: State whether specialized tools are needed to access or

manipulate shared scientific data to support replication or reuse, and name(s) of the needed

tool(s) and software. If specialized tools or software are needed, provide the name(s) of the

needed tool(s) and software and specify how they can be accessed.

Standards: State what common data standards will be applied to the scientific data and

associated metadata to enable interoperability of datasets and resources (e.g., data formats,

data dictionaries, data identifiers, definitions, unique identifiers, and other data

documentation), and provide the name(s) of the data standards that will be applied and

describe how these data standards will be applied to the scientific data generated by the

research proposed in this project. If applicable, indicate that no consensus standards exist.

Data Preservation, Access, and Associated Timelines: Provide plans and timelines for data

preservation and access, including the name of the repository(ies) where scientific data and

metadata arising from the project will be archived (do not include hyperlinks); how the

scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other

standard indexing tools; and when (i.e., no later than time of an associated publication or end

of the performance period, whichever comes first) the scientific data will be made available to

other users (e.g., the larger research community, institutions, and/or the broader public) and

for how long. See Selecting a Data Repository on the NIH Scientific Data Sharing website.

Access, Distribution, or Reuse Considerations: NIH expects that in drafting Plans, researchers

maximize the appropriate sharing of scientific data generated from NIH-funded or conducted

research, consistent with privacy, security, informed consent, and proprietary issues. Describe

and justify any applicable factors affecting subsequent access, distribution, or reuse of

scientific data related to informed consent, privacy and confidentiality protections, any

restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or

anticipated agreements, or any other considerations that may limit the extent of data sharing.

See Frequently Asked Questions for examples of justifiable reasons for limiting sharing of

data. State whether access to the scientific data will be controlled (i.e., made available by a

data repository only after approval).

Genomic Data Sharing Policy: For proposed research subject to the GDS Policy, state

whether data, including genomic summary results, will be made available through controlled

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or unrestricted access; see instructions for describing Genomic Summary Results in Data

Management and Sharing Plans.

If generating scientific data derived from humans, describe how the privacy, rights, and

confidentiality of human research participants will be protected (e.g., through de-

identification, Certificates of Confidentiality, and other protective measures). See NIH’s

Scientific Data Sharing page for additional information on protecting human research

participant privacy when sharing data.

Genomic Data Sharing Policy: For proposed research generating human genomic data

within the scope of the GDS Policy, applicants should complete the Data Management and

Sharing Plan anticipating sharing according to the assurances of the Institutional

Certification.

If there is any element of the Institutional Certification that the institution (in consultation

with the IRB) has determined cannot be met, please state which element and provide a

detailed explanation for why the element cannot be met. In such cases, the data management

and sharing plan should describe how genomic data will be shared to the maximal extent

possible (for example, sharing data in a summary format).

Oversight of Data Management and Sharing: Describe how compliance with the Plan will be

monitored and managed, frequency of oversight, and by whom at the applicant institution

(e.g., titles, roles).

For more information on developing a Data Management and Sharing Plan, see Writing a

Data Management and Sharing Plan on the NIH Scientific Data Sharing website.

For more information on the DMS Policy, including expectations for data management and

sharing, protecting research participant privacy, and identifying data repositories, see the NIH Data

Management and Sharing Policy on the NIH Scientific Data Sharing website and the NIH Grants

Policy Statement, Section 8.2.3.1: Data Sharing Policy. See also Frequently Asked Questions for

additional information on the DMS Policy on these and other topics.

For more information on the GDS Policy see the NIH Genomic Data Sharing Policy on the NIH

Scientific Data Sharing website and the NIH Grants Policy Statement, Section 8.2.3.3: Genomic

Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS).

Additional Instructions for Multi-project:

Overall Component Include a single consolidated “Data Management and

Sharing Plan” in the Overall Component.

Other Components: Do not include a “Data Management and Sharing Plan”

within other components. Any component-specific information should be described

within the overall “Data Management and Sharing Plan” attachment in the Overall

Component.

12. Authentication of Key Biological and/or Chemical Resources

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

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Content:

If applicable to the proposed science, briefly describe methods to ensure the identity and validity

of key biological and/or chemical resources used in the proposed studies. A maximum of one page

is suggested.

For more Information:

Key biological and/or chemical resources are characterized as follows.

l

Key biological and/or chemical resources may or may not have been generated with NIH

funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities

and/or qualifications that could influence the research data; and 3) are integral to the

proposed research. These include, but are not limited to, cell lines, specialty chemicals,

antibodies, and other biologics.

l

Standard laboratory reagents that are not expected to vary do not need to be included in

the plan. Examples are buffers and other common biologicals or chemicals.

l

See NIH's page on Rigor and Reproducibility for more information.

Appendix

13. Appendix

Refer to the FOA to determine whether there are any special appendix instructions for your

application. See the updated NIH Guide Notice on the Appendix Policy.

Additional Instructions for Multi-project:

Overall and Other Components: The "Appendix” attachment is optional.

Format:

A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 allowable appendix

attachments are needed, combine the remaining information into attachment #10.

Use filenames for attachments that are descriptive of the content.

A summary sheet listing all of the items included in the Appendix is encouraged but not required.

When including a summary sheet, it should be included in the first appendix attachment.

Content:

The only allowable appendix materials are:

l

Blank data collection forms, blank survey forms, and blank questionnaire forms - or

screenshots thereof

l

Simple lists of interview questions

Note: In your blank forms and lists, do not include items such as: data, data

compilations, lists of variables or acronyms, data analyses, publications, manuals,

instructions, descriptions or drawings/figures/diagrams of data collection methods or

machines/devices.

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l

Blank informed consent/assent forms

l

Other items only if they are specified in the FOA as allowable appendix materials

No other items are allowed in the Appendix. Simply relocating disallowed materials to other parts

of the application will result in a noncompliant application.

Some FOAs may have different instructions for the Appendix. Always follow the instructions in

your FOA if they conflict with these instructions.

Note: Applications will be withdrawn and not reviewed if they do not follow the appendix

requirements in these instructions or in your FOA.

Information that expands upon or complements information provided in any section of the

application – even if it is not required for the review – is not allowed in the Appendix unless it is

listed in the allowed appendix materials above or in your FOA. For example, do not include

material transfer agreements (MTA) in the appendix unless otherwise specified in the FOA.

For more information:

l

The NIH Guide Notice on Reminder: NIH Applications Must Be Complete and Compliant

With NIH Policy and Application Instructions At Time of Submission.

l

Failure of reviewers to address non-required appendix materials in their reviews is not an

acceptable basis for an appeal of initial peer review. For more information, see the NIH

Grants Policy Statement, Section 2.4.2: Appeals of Initial Scientific Review.

l

Appendix Policy Frequently Asked Questions

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M.410 - PHS 398 Career Development Award Supplemental Form

M.410 - PHS 398 Career Development

Award Supplemental Form

The PHS 398 Career Development Award Supplemental

Form is used only for career development applications

and multi-project applications with an "Indiv. Career

Dev" Component.

This form includes fields to upload several attachments

including the Specific Aims, Research Strategy, and

Candidate Background and Goals.

See NIH's Reference Letters page for information

including instructions for referees and how to submit

letters.

The attachments in this form, together with the rest of

your application, should include sufficient information

needed for evaluation of the project and the candidate,

independent of any other documents (e.g., previous

application). Be specific and informative, and avoid

redundancies.

View larger image

Quick Links

Introduction



1. Introduction to Application (for Resubmission and Revision applications)

Candidate Section



2. Candidate Information and Goals for Career Development

Research Plan Section



3. Specific Aims



4. Research Strategy



5. Progress Report Publication List (for Renewal applications)



6. Training in the Responsible Conduct of Research

Other Candidate Information Section



7. Candidate's Plan to Provide Mentoring

Mentor, Co-Mentor, Consultant, Collaborators Section



8. Plans and Statements of Mentor and Co-Mentor(s)



9. Letters of Support from Collaborators, Contributors, and Consultants

Environment and Institutional Commitment to Candidate Section

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

10. Description of Institutional Environment



11. Institutional Commitment to Candidate's Research Career Development



12. Description of Candidate’s Contribution to Program Goals

Other Research Plan Sections



13. Vertebrate Animals



14. Select Agent Research



15. Consortium/Contractual Arrangements



16. Resource Sharing



17. Other Plan(s)



18. Authentication of Key Biological and/or Chemical Resources

Appendix



19. Appendix

Citizenship



20. U.S. Citizen or Non-Citizen National?

Who should use the PHS 398 Career Development Award Supplemental Form:

Use the PHS 398 Career Development Award Supplemental Form only if you are submitting a career

development application or a multi-project application that has an "Indiv. Career Dev" Component.

Some sections of the PHS 398 Career Development Award Supplemental Form are required for all

career development award applications, while others are to be used only when required by the FOA.

Read all the instructions in the FOA before completing this section to ensure your application meets all

IC-specific criteria.

Applicants must follow all policies and requirements related to formatting, page limits, and

proprietary information. See the following pages for more information:

l

Format Attachments

l

Page Limits

l

NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information

l

NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act

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Introduction

1. Introduction to Application (for Resubmission and Revision applications)

Who must complete the “Introduction to Application” attachment:

An "Introduction to Application" attachment is required only if the type of application is

resubmission or revision. An introduction is not allowed for new or renewal applications.

Descriptions of different types of applications are listed here: NIH Types of Applications.

Format:

Follow the page limits for the Introduction in the NIH Table of Page Limits unless otherwise

specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Resubmission applications: See specific instructions on the content of the Introduction on the

NIH's Resubmission Applicationspage.

Competing Revisions: See specific instructions on the content of the Introduction on the NIH's

Competing Revisionspage.

Additional Instructions for Multi-project:

Other Components: The "Introduction” attachment is optional for resubmissions

and revisions applications. Although the “Introduction” attachment is optional, you

may get a system warning if there is no attachment.

Candidate Section

2. Candidate Information and Goals for Career Development

Who must complete the "Candidate Information and Goals for Career Development"

attachment:

The “Candidate Information and Goals for Career Development” attachment is required.

Format:

Follow the page limits for Candidate Information and Goals for Career Development in the

NIHTable of Page Limits, unless otherwise specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Organize your attachment into three sections, following the headings and specified order below,

and discuss each of the points listed below. Start each section with the appropriate section

heading – Candidate’s Background, Career Goals and Objectives, and Candidate’s Plan for Career

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Development/Training Activities During Award Period. Also include any additional information

requested in the FOA.

Candidate’s Background:

l

Describe your past scientific history, indicating how the award fits into past and future

research career development.

l

If there are consistent themes or issues that have guided previous work, these should be

made clear. Alternatively, if your work has changed direction, indicate the reasons for the

change.

Career Goals and Objectives:

l

Describe your short-term and long-term career development goals.

l

Justify the need for the award by describing how the career development award will

enable you to develop and/or expand your research career.

l

If applicable (e.g., K24), describe how this award will help you to serve as a mentor to early

career investigators.

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

l

Describe the new or enhanced research skills and knowledge you will acquire as a result of

the proposed award, including, as applicable, expertise in rigorous research design,

experimental methods, quantitative approaches and data analysis and interpretation.

l

For non-mentored career development awards, describe any planned release from

teaching, administrative, and/or clinical duties that will help you focus on your research

activities, and if applicable, your mentoring activities.

l

For mentored career development awards, describe any structured activities that are part

of the developmental plan, such as coursework or workshops that will help you learn new

techniques or develop needed professional skills.

l

Briefly discuss each of the activities, other than research, in which you expect to

participate.

l

For each activity, other than research, explain how it relates to the proposed research and

to the career development plan. Indicate the percentage of time to be dedicated to each

activity by year, expressed in person months. For more information about calculating

person months, see NIH's Frequently Asked Questions on Person Months.

l

You are encouraged to include a timeline, including plans to apply for subsequent grant

support.

Research Plan Section

A Research Plan is required for all types of individual career development awards.

The information in these introductory paragraphs to the Research Plan Section applies to all four

Research Plan attachments: Specific Aims, Research Strategy, Progress Report Publication List, and

Training in the Responsible Conduct of Research.

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The Research Plan is a major part of the overall career development goal. It is important to relate

the proposed research to the candidate's scientific career goals. Describe how the research,

coupled with other developmental activities, will provide the experience, knowledge, and skills

necessary to achieve the objectives of the career development plan. Also describe how the

research and other developmental activities will enable the candidate to launch and conduct an

independent research career or enhance an established research career.

For most types of research, the Research Plan Section should include:

l

a specific hypothesis,

l

a list of the specific aims and objectives that will be used to examine the hypothesis,

l

a description of the methods/approaches/techniques to be used in each aim,

l

a discussion of possible problems and how they will be managed, and

l

alternative approaches that might be tried if the initial approaches do not work.

A Career Development Award (CDA) Research Plan is expected to be tailored to the experience

level of the candidate and to allow him/her to develop the necessary skills needed for further

career advancement. Reviewers will evaluate the plan accordingly. The plan should be achievable

within the requested time period. Pilot or preliminary studies and routine data gathering are

generally not appropriate as the sole part(s) of a CDA Research Plan.

Although candidates for mentored career development awards are expected to write the Research

Plan, the mentor should review a draft of the plan and discuss it in detail with the candidate.

Review by other knowledgeable colleagues is also helpful. Although it is understood that CDA

applications do not require the extensive detail usually incorporated into regular research grant

applications, a fundamentally sound Research Plan that includes a reasonably detailed Research

Strategy section should be provided.

3. Specific Aims

Who must complete the “Specific Aims” attachment:

The "Specific Aims" attachment is required unless otherwise specified in the FOA.

Format:

Follow the page limits for the Specific Aims in the NIHTable of Page Limits, unless otherwise

specified in the FOA. A “Specific Aims” attachment that exceeds the page limit will be flagged as an

error by the Agency upon submission.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

State concisely the goals of the proposed research and summarize the expected outcome(s),

including the impact that the results of the proposed research will have on the research field(s)

involved.

List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis,

create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice,

address a critical barrier to progress in the field, or develop new technology).

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4. Research Strategy

Who must complete the "Research Strategy" attachment:

The “Research Strategy” attachment is required.

Format:

Follow the page limits for the Research Strategy in the NIHTable of Page Limits, unless otherwise

specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Organize the Research Strategy in the specified order and use the instructions provided below.

Start each section with the appropriate heading – Significance, Innovation, Approach.

Cite published experimental details in the Research Strategy section and provide the full reference

in M.220 - R&R Other Project Information Form, Bibliography and References Cited.

In general, less detail will be expected in descriptions of research planned for the future years of

the proposed CDA compared to the initial years’ descriptions. However, sufficient detail should be

provided to enable peer reviewers to determine that the plans for those years, including the

approach to be used, are worthwhile and are likely to enable the candidate to achieve the

objectives of the Research Plan.

Note for mentored CDA applications: Explain the relationship between the candidate’s research

on the CDA and the mentor’s ongoing research program.

Note for non-mentored CDA applications: In general, non-mentored CDA applicants are

expected to have independent, peer-reviewed research support. Applications should include a

brief description of currently funded research, along with a more extensive description of any new

research to be supported by the CDA.

Note 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 include specific

information in the Approach section of the Research Strategy attachment. See specific instructions

below in Section 3. Approach. This information must be provided regardless of whether Human

Subjects research is proposed or not. These specific instructions do not apply to institutional

career development applications (e.g. K12, KL2).

Note for Applications Proposing the Involvement of Human Subjects and/or Clinical Trials:

l

Use the Research Strategy section to discuss the overall strategy, methodology, and analyses of

your proposed research, but do not duplicate information collected in the PHS Human Subjects

and Clinical Trials Information form.

l

The PHS Human Subjects and Clinical Trials Information form will capture detailed study

information, including eligibility criteria; inclusion of women, minorities, and individuals across

the lifespan; protection and monitoring plans; and statistical design and power.

l

You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials

Information form as appropriate in your discussion of the Research Strategy (e.g., see Question

2.4 Inclusion of Women and Minorities).

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Note for Applicants with Multiple Specific Aims: You may address the Significance, Innovation,

and Approach either for each Specific Aim individually or for all of the Specific Aims collectively.

1. Significance

l

Explain the importance of the problem or critical barrier to progress that the proposed

project addresses.

l

Describe the strengths and weaknesses in the rigor of the prior research (both published

and unpublished) that serves as the key support for the proposed project.

l

Explain how the proposed project will improve scientific knowledge, technical capability,

and/or clinical practice in one or more broad fields.

l

Describe how the concepts, methods, technologies, treatments, services, or preventative

interventions that drive this field will be changed if the proposed aims are achieved.

2. Innovation

l

Explain how the application challenges current research or clinical practice paradigms.

l

Describe any novel theoretical concepts, approaches or methodologies, instrumentation

or interventions to be developed or used, and any advantage over existing

methodologies, instrumentation, or interventions.

3. Approach

l

Describe the overall strategy, methodology, and analyses to be used to accomplish the

specific aims of the project. Describe plans to address weaknesses in the rigor of the prior

research that serves as the key support for the proposed project. Describe the

experimental design and methods proposed and how they will achieve robust and

unbiased results. Unless addressed separately in the Resource Sharing Plan section,

include how the data will be collected, analyzed, and interpreted, as well as any resource

sharing plans and the Data Management and Sharing (DMS)Plan as appropriate.

Resources and tools for rigorous experimental design can be found at the Enhancing

Reproducibility through Rigor and Transparency website.

l

For trials that randomize groups or deliver interventions to groups, describe how your

methods for analysis and sample size are appropriate for your plans for participant

assignment and intervention delivery. These methods can include a group- or cluster-

randomized trial or an individually randomized group-treatment trial. Additional

information is available at the Research Methods Resources webpage.

l

Discuss potential problems, alternative strategies, and benchmarks for success anticipated

to achieve the aims.

l

If the project is in the early stages of development, describe any strategy to establish

feasibility, and address the management of any high risk aspects of the proposed work.

l

Explain how relevant biological variables, such as sex, are factored into research designs

and analyses for studies in vertebrate animals and humans. For example, strong

justification from the scientific literature, preliminary data, or other relevant

considerations, must be provided for applications proposing to study only one sex. Refer

to NIH Guide Notice on Sex as a Biological Variable in NIH-funded Research for additional

information.

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l

Point out any procedures, situations, or materials that may be hazardous to personnel and

precautions to be exercised. A full discussion on the use of select agents should appear in

the Select Agent Research section below.

l

If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line

from the NIH hESC Registry cannot be chosen, provide a strong justification for why an

appropriate cell line cannot be chosen from the registry at this time.

l

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:

l

Use the specific heading: “Human Fetal Tissue Research Approach”.

l

Describe the proposed characteristics, procurement, and procedures for the

research use of HFT. The description should be sufficiently detailed to permit

meaningful evaluation by NIH.

l

Justify the use of HFT in the proposed research by indicating the following:

l

Why the research goals cannot be accomplished by using an alternative

to HFT.

l

What methods were used (e.g. literature review, preliminary data) to

determine that alternatives could not be used.

l

Results from a literature review used to provide justifications.

l

Plans for the treatment of HFT and the disposal of HFT when research is

complete.

l

Description of planned written, voluntary, informed consent process for

cell/tissue donation, or description and documentation of process if

cells/tissue were already obtained.

l

Note: These specific instructions do not apply to institutional career

development applications (e.g. K12).

l

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.

l

If you are proposing to gain clinical trial research experience (i.e., you will not be leading

an independent clinical trial), briefly describe your role on the clinical trial.

As applicable, also include the following information as part of the Research Strategy,

keeping within the three sections (Significance, Innovation, and Approach) listed above.

Preliminary Studies (for New Applications):

For new applications, include information on preliminary studies. Discuss the PD/PI’s

preliminary studies, data, and or experience pertinent to this application.

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Progress Report (for Renewal and Revision Applications):

Most career development applicants will not complete this attachment. However, if you are

required to do so, note that the Progress Report falls within the Research Strategy and is

therefore included in the page limits for the Research Strategy.

For renewal/revision applications, provide a Progress Report. Provide the beginning and

ending dates for the period covered since the last competitive review. In the Progress Report,

you should:

l

Summarize the specific aims of the previous project period and the importance of the

findings, and emphasize the progress made toward their achievement.

l

Explain any significant changes to the specific aims and any new directions, including

changes resulting from significant budget reductions.

l

Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women,

minorities, children, etc.) for any studies meeting the NIH definition for clinical research.

Use the Progress Report section to discuss, but not duplicate information collected

elsewhere in the application.

Do not include a list of publications, patents, or other printed materials in the Progress

Report. That information should be included in the "Progress Report Publication List"

attachment.

5. Progress Report Publication List (for Renewal applications)

Who must complete the “Progress Report Publication List” attachment:

A “Progress Report Publication List” attachment is required only if the type of application is

renewal. Most career development applicants will not complete this attachment.

Descriptions of different types of applications are listed here: NIH's Types of Applications.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

List the titles and complete references to all appropriate publications, manuscripts accepted for

publication, patents, and other printed materials that have resulted from the project since it was

last reviewed competitively.

You are allowed to cite interim research products. Note: interim research products have specific

citation requirements. See related Frequently Asked Questions on citing interim research products

and claiming them as products of your NIH award.

Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed

Central (PMC) reference number (e.g., PMCID234567) for the following:

l

Articles that fall under the Public Access Policy,

l

Articles that were authored or co-authored by the applicant and arose from NIH support,

l

Articles that were authored or co-authored by the applicant and arose from AHRQ

funding provided after February 19, 2016 (see the Guide Notice on Policy for Public

Access to AHRQ-Funded Scientific Publications).

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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.

Additional Instructions for Multi-project:

Overall and Other Components: If you include a “Progress Report Publication List”

attachment, you can include it in either the Overall Component or within each Other

Component, but do not attach the same information in multiple locations.

6. Training in the Responsible Conduct of Research

Who must complete the "Training in the Responsible Conduct of Research" attachment:

The “Training in the Responsible Conduct of Research” attachment is required.

Format:

Follow the page limits for the Training in the Responsible Conduct of Research in the NIHTable of

Page Limits unless otherwise specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Mentored CDA applications should describe a plan to acquire instruction in the responsible

conduct of research (RCR).

Non-mentored (independent) CDAapplications should describe a plan to obtain or provide

instruction in RCR, depending on your level of experience with RCR.

Attach a description of plans for obtaining or providing instruction in RCR. This section should

document prior instruction or participation in RCR training during the applicant’s current career

stage (including the date instruction was last completed). This section should also propose plans

to either receive instruction or provide instruction (e.g., to participate as a course lecturer) to meet

the frequency requirement of RCR training (see the “For more information section” below).

The plan must address the five required instructional components outlined in the NIH Policy on

Instruction in the Responsible Conduct of Research (RCR), as more fully described in the NIH

Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of Research.

1. Format: Describe the required format of instruction, i.e., face-to-face lectures,

coursework, and/or real-time discussion groups (a plan with only on-line instruction is not

acceptable).

2. Subject Matter: Describe the breadth of subject matter (e.g., conflict of interest,

authorship, data management, human subjects and animal use, laboratory safety,

research misconduct, research ethics).

3. Faculty Participation: Describe the role of the mentor(s) and other faculty involvement in

the instruction.

4. Duration of Instruction: Describe the number of contact hours of instruction, taking into

consideration the duration of the program.

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5. Frequency of Instruction: Instruction must occur during each career stage and at least

once every four years. Document any prior instruction during the applicant’s current

career stage, including the inclusive dates instruction was last completed.

The plan may include career stage-appropriate individualized instruction or independent scholarly

activities. Instruction and activities should enhance the applicant’s understanding of ethical issues

related to their specific research activities and the societal impact of that research. The role of the

mentor in RCR instruction must be described.

Renewal Applications: Describe the RCR instruction activities undertaken during the previous

project period as well as future plans for RCR instruction.

For more information:

See the NIH Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of

Research.

Other Candidate Information Section

7. Candidate’s Plan to Provide Mentoring

Who must complete the “Candidate’s Plan to Provide Mentoring” attachment:

Include the “Candidate’s Plan to Provide Mentoring” attachment only when required by the FOA,

(e.g., K05 and K24).

Format:

Follow the page limits for the Candidate’s Plan to Provide Mentoring in the NIH Table of Page

Limits unless otherwise specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

The plan should provide information about both the candidate’s commitment to serve as a mentor

to other investigators and the candidate’s previous mentoring activities. State the candidate’s

proposed percent effort commitment to the mentoring plan, expressed in person months. For

more information about calculating person months, see NIH's Frequently Asked Questions on

Person Months.

Describe proposed mentoring activities: Describe the setting for mentoring and provide

information about the available pool of mentees with appropriate backgrounds and similar

interests in science as the candidate. Include information sufficient for reviewers to evaluate the

quality of the proposed mentoring experience, including the professional levels of mentees and

the frequency and kinds of mentoring interactions between the candidate and mentees. Describe

the productivity of the mentoring relationship for the scientific development of the new scientists

as judged by their publications and current research activities.

Describe past mentoring activities: Include sufficient information on the candidate’s past

mentees so that reviewers can evaluate the quality of prior mentoring experiences. Include

information such as the professional levels of mentees, and the frequency and kinds of mentoring

interactions between the candidate and mentees.

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Senior level (K05) candidates: Describe any financial and material support from your own

funded research and research resources that will be available to your mentees.

Mentor, Co-Mentor, Consultant, Collaborators Section

8. Plans and Statements of Mentor and Co-Mentor(s)

Who must complete the “Plans and Statements of Mentor and Co-Mentor(s)” attachment:

Any candidate applying for a mentored CDA (see Summary of Career Development Award

Mechanisms table) must include a "Plans and Statement of Mentor and Co-Mentor(s)" attachment.

All mentored career development applications should identify any and all co-mentors involved

with the proposed research and career development program. The mentor and each co-mentor

must provide a statement as described below.

Format:

Follow the page limits for the Plans and Statements of Mentor and Co-mentor(s) in the NIHTable

of Page Limits unless otherwise specified in the FOA.

The plans and statements must be appended together and uploaded as a single PDF file. See NIH's

Format Attachments page.

Content:

The mentor and co-mentor(s) (if applicable) must each document their role and willingness to

participate in the project, and explain how they will contribute to the development of the

candidate's research career. Each statement should include all of the following:

1. The plan for the candidate's training and research career development. Include

information not only about research, but also about other developmental activities, such

as seminars, scientific meetings, training in RCR, and presentations. Discuss expectations

for publications over the entire period of the proposed project. Define what aspects of the

proposed research project the candidate will be allowed to continue to pursue as part of

his/her independent research program.

2. The source of anticipated support for the candidate’s research project for each year of the

award period.

3. The nature and extent of supervision and mentoring of the candidate, and commitment to

the candidate's development that will occur during the award period.

4. The candidate's anticipated teaching load for the award period (number and types of

courses or seminars), clinical responsibilities, committee and administrative assignments,

and the portion of time available for research.

5. A plan for transitioning the candidate from the mentored stage of his/her career to the

independent investigator stage by the end of the project period of the award. Describe

the mentor's (or co-mentor’s) previous experience as a mentor, including type of

mentoring (e.g., graduate students, career development awardees, postdoctoral fellows),

number of persons mentored, and career outcomes.

Note for co-mentor statements: Co-mentors must also address the nature of their role in the

career development plan and how the responsibility for the candidate’s development is shared

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with the mentor. Describe respective areas of expertise and how they will be combined to enhance

the candidate’s development. Also describe the nature of any resources that will be committed to

this CDA.

Note: If the applicant is proposing to gain experience in a clinical trial as part of his or her

research career development, then the mentor or a member of the mentoring team should

include information in the statement to document leadership of the clinical trial (in addition to the

information above). Include the following:

l

Source of funding;

l

ClinicalTrials.gov Identifier (e.g., NCT87654321), if applicable;

l

A description of how your expertise is appropriate to guide the applicant in any proposed

clinical trials research experience; and

l

A statement/attestation that the mentor will be responsible for the clinical trial.

l

The mentor must have primary responsibility for leading and overseeing the trial and

must describe how she/he will provide this oversight (be careful not to overstate the

candidate’s responsibilities).

l

Include details on the specific roles/responsibilities of the applicant and mentor, keeping

in mind that the terms of a CDA award do not always permit the candidate to lead a

clinical trial.

Do not place these statements from the mentor(s) and co-mentor(s) in the Appendix.

9. Letters of Support from Collaborators, Contributors, and Consultants

Note that letters of support are not the same as letters of reference (also known as reference

letters), which are required for some K applications. For more information about letters of

reference, see the NIH's Reference Letters page.

From whom are letters of support required? From whom are letters not required?

Letters of support from collaborators, contributors, and consultants will be required for any such

person who will contribute to the scientific development or execution of CDA application’s

proposed project. Follow the requirements for letters of support as listed in the FOA.

Letters are not required for personnel (such as research assistants) not contributing in a

substantive, measurable way to the scientific development or execution of the project.

Format:

Follow the page limits for the Letters of Support from Collaborators, Contributors, and Consultants

in the NIH Table of Page Limits unless otherwise specified in the FOA.

Attach all appropriate letters of support. The letters must be appended together and uploaded as

a single PDF file. See NIH's Format Attachments page. Use of hyperlinks and URLs in this section is

not allowed unless specified in the funding opportunity announcement.

Content:

Letters from consultants should include rates/charges for consulting services.

Mentored CDA applications should identify collaborators, contributors, and consultants involved

with the proposed research and career development program, and not already included in the

“Plans and Statements of Mentor(s) and Co-Mentor(s)” section. Letters should briefly describe their

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anticipated contributions and document their role and willingness to participate in the project. The

letters should also briefly describe research materials, data, guidance, or advice each person will

provide.

Non-mentored CDA applications should include letters from collaborators, consultants, and

contributors. Letters should list proposed roles and document their willingness to participate in

the project. The letters should also briefly describe research materials, data, guidance, or advice

each person will provide.

Environment and Institutional Commitment to Candidate Section

10. Description of Institutional Environment

Who must complete the "Description of Institutional Environment" attachment:

The “Description of Institutional Environment” attachment is required.

Format:

Follow the page limits for the Description of Institutional Environment in the NIH Table of Page

Limits unless otherwise specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Mentored CDA applicants: Describe the institution’s research and career development

opportunities related to your area(s) of interest, including the names of key faculty members and

other investigators relevant to your proposed developmental plan and capable of productive

collaboration with the candidate. Indicate how the necessary facilities and other resources will be

made available for both career enhancement and the research proposed in this application – refer

to the resources description in M.220 - R&R Other Project Information Form, Facilities and Other

Resources in your “Description of Institutional Environment” attachment. Describe opportunities

for intellectual interactions with other investigators, including courses offered, journal clubs,

seminars, and presentations.

Non-mentored CDA applicants: Describe the institution’s research and career development

opportunities related to your area(s) of interest, including the names of other faculty members

who are willing to collaborate with you. Indicate how the necessary facilities and other resources

will be made available for both career enhancement and the research proposed in this application

– refer to the resources description in M.220 - R&R Other Project Information Form, Facilities and

Other Resources in your “Description of Institutional Environment” attachment. Describe

opportunities for intellectual interactions with other investigators, including journal clubs,

seminars, and presentations.

11. Institutional Commitment to Candidate’s Research Career Development

Who must complete the "Institutional Commitment to Candidate's Research Career

Development" attachment:

The “Institutional Commitment to Candidate’s Research Career Development” attachment is

required.

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Format:

Follow the page limits for the Institutional Commitment to Candidate’s Research Career

Development in the NIH Table of Page Limits unless otherwise specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

The sponsoring institution must provide a document on institutional letterhead that describes its

commitment to the candidate and the candidate’s career development, independent of the receipt

of the CDA. It is also essential to document the institution's commitment to the retention,

development, and advancement of the candidate during the period of the award.

The “Institutional Commitment to Candidate’s Research Career Development” attachment should

generally document the institution’s agreement to provide adequate time, support, equipment,

facilities, and resources to the candidate for research and career development activities. See the

list below for specific items to include in the document.

In the document describing its institutional commitment, the applicant organization must:

1. Agree to release the candidate from other duties and activities so that the candidate can

devote the required percentage of time for development of a research career, as specified

by the FOA. For most K awards, commitment of at least 75 percent or nine person months

of time is required.

a. 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.

2. Describe actions that will be taken to ensure that the candidate can devote the required

time to research career development (e.g., reduction of the candidate's teaching load,

committee and administrative assignments, and clinical or other professional activities for

the current academic year). If the candidate’s clinical or teaching responsibilities will be

reduced, describe how this will be accommodated (e.g., hiring additional staff, reassigning

staff, etc.).

3. Describe the candidate's academic appointment, bearing in mind that the appointment

must be full-time, and that the appointment (including all rights and privileges pertaining

to full faculty status if in an academic setting) and the continuation of salary should not be

contingent upon the receipt of this award.

4. Describe the proportion of time currently available for the candidate's research and what

the candidate's institutional responsibilities will be if an award is made.

5. Describe how the institution will provide the candidate with appropriate office and

laboratory space, equipment, and other resources (including access to clinical and/or

other research populations) to carry out the proposed Research Plan.

6. Describe how the institution will be supportive of any proposed mentor(s), other staff,

and/or collaborations with other faculty consistent with the career development plan.

Signatures:

The institutional commitment must be dated and signed by the person who is authorized to

commit the institution to the agreements and assurances listed above. In most cases, this will

be the dean or the chairman of the department. The signature must appear over the signer's

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name and title at the end of the statement. If the candidate will be working outside of the

applicant institution (i.e., sponsoring institution), signatures from both the

applicant/sponsoring institution and host institutions are required.

The sponsoring institution, through the submission of the application and in the institutional

commitment section, certifies that all items outlined above will be provided and that the

institution will abide by the applicable assurances and PHS policies.

Note: For applicable assurances, see the NIH Grants Policy Statement, Section 4: Public Policy

Requirements, Objectives and Other Appropriation Mandates.

12. Description of Candidate’s Contribution to Program Goals

Who must complete the "Description of Candidate’s Contribution to Program Goals" attach-

ment:

Applicants to diversity-related FOAs (e.g., diversity-related K01 and diversity-related K22s):

The “Description of Candidate’s Contribution to Program Goals” attachment is required.

All other Career Development applicants: Skip the “Description of Candidate’s Contribution to

Program Goals” attachment, as it is not required.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

The sponsoring institution must provide a document on institutional letterhead that explains how

the candidate’s participation will further the goals of the career development program to promote

diversity in health-related research. The letter should avoid revealing sensitive personally

identifiable information, such as the candidate’s specific racial/ethnic background or type of

disability.

For NIH’s Interest in Diversity, see the Notice of NIH's Interest in Diversity (NOT-OD-20-031).

Signatures:

The “Description of Candidate’s Contribution to Program Goals” attachment must be dated

and signed by an institutional official. In most cases, this will be the dean or the chairman of

the department. The signature must appear over the signer's name and title at the end of the

statement.

Other Research Plan Sections

13. Vertebrate Animals

Who must complete the “Vertebrate Animals” attachment:

Include the “Vertebrate Animals” attachment if you answered “Yes” to the question “Are

Vertebrate Animals Used?” on the M.220 - R&R Other Project Information Form.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

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Do not use the Vertebrate Animals attachment to circumvent the page limits of the Research

Strategy.

Content:

If live vertebrate animals are involved in the project, address each of the following criteria:

1. Description of Procedures: Provide a concise description of the proposed procedures to

be used that involve live vertebrate animals in the work outlined in the “Research

Strategy” attachment. The description must include sufficient detail to allow evaluation of

the procedures. Identify the species, strains, ages, sex, and total numbers of animals by

species, to be used in the proposed work. If dogs or cats are proposed, provide the source

of the animals.

2. Justifications: Provide justification that the species are appropriate for the proposed

research. Explain why the research goals cannot be accomplished using an alternative

model (e.g. computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress: Describe the interventions including analgesia,

anesthesia, sedation, palliative care, and humane endpoints that will be used to minimize

discomfort, distress, pain, and injury.

Each of the criteria must be addressed. Failure to adequately address the criteria may negatively

affect the application’s impact score. In addition to the 3 criteria above, you should also:

l

Identify all project performance (or collaborating) sites and describe the proposed

research activities with vertebrate animals that will be conducted at those sites.

l

Explain when and how animals are expected to be used if plans for the use of animals

have not been finalized.

See the following pages for more information:

l

NIH’s Office of Laboratory Animal Welfare website

l

NIH's Vertebrate Animals Section Worksheet

l

NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements (an applicable

Animal Welfare Assurance will be required if the grantee institution does not have one)

14. Select Agent Research

Who must complete the “Select Agent Research” attachment:

Include the “Select Agent Research” attachment if your proposed activities involve the use of select

agents at any time during the proposed project period, either at the applicant organization or at

any performance site.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

For more information:

Select agents are hazardous biological agents and toxins that have been identified by HHS or the

U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public

health and safety, to animal and plant health, or to animal and plant products. The Centers for

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Disease Control and Prevention (CDC) and the Animal APHIS Select Agent Programs jointly

maintain a list of these agents. See the Federal Select Agent Program website.

See also the NIH Grants Policy Statement, Section 4.1.24.1: Public Health Security and Bioterrorism

Preparedness and Response Act (Select Agents).

Content:

Excluded select agents: If the activities proposed in your application involve only the use of a

strain(s) of select agents which has been excluded from the list of select agents and toxins as per

42 CFR 73.3, the select agent requirements do not apply. Use this “Select Agent Research” section

to identify the strain(s) of the select agent that will be used and note that it has been excluded

from this list. The CDC maintains a list of exclusions which is available on the Select Agents and

Toxins Exclusions website.

Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list

of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from

the list, use this section to indicate the status of your request or your intent to apply for an

exclusion and provide a brief justification for the exclusion.

All applicants proposing to use select agents: Address the following three points for each site

at which select agent research will take place. Although no specific page limitation applies to this

section, be succinct.

1. Identify the select agent(s) to be used in the proposed research.

2. Provide the registration status of all entities* where select agent(s) will be used.

l

If the performance site(s) is a foreign institution, provide the name(s) of the country

or countries where select agent research will be performed.

l

*An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or

local), academic institution, corporation, company, partnership, society, association,

firm, sole proprietorship, or other legal entity.”

3. Provide a description of all facilities where the select agent(s) will be used.

l

Describe the procedures that will be used to monitor possession, use and transfer of

select agent(s).

l

Describe plans for appropriate biosafety, biocontainment, and security of the select

agent(s).

l

Describe the biocontainment resources available at all performance sites.

15. Consortium/Contractual Arrangements

Who must complete the “Consortium/Contractual Arrangements” attachment:

Include the “Consortium/Contractual Arrangements” attachment if you have consortium/contracts

in your budget.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Explain the programmatic, fiscal, and administrative arrangements to be made between the

applicant organization and the consortium organization(s). If consortium/contractual activities

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represent a significant portion of the overall project, explain why the applicant organization, rather

than the ultimate performer of the activities, should be the grantee.

Note: The signature of the authorized organization representative in M.200 – SF 424 (R&R),

Authorized Representative signifies that the applicant and all proposed consortium participants

understand and agree to the following statement:

The appropriate programmatic and administrative personnel of each organization involved

in this grant application are aware of the agency’s consortium agreement policy and are

prepared to establish the necessary inter-organizational agreement(s) consistent with that

policy.

For more information:

Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more

information.

Additional Instructions for Multi-project:

Overall and Other Components: Unless otherwise specified in the FOA, you have

the option to:

l

include a single consolidated “Consortium/Contractual Arrangements”

attachment in the Overall Component, or

l

include component-specific “Consortium/Contractual Arrangements” attachment

(s) within the components that include subawards, or

l

include a “Consortium/Contractual Arrangements” attachment in the Overall

Component and include component-specific attachments within the components

that include subawards. Each filename must be unique.

16. Resource Sharing

Note: Effective for due dates on or after January 25, 2023, Data Management and

Sharing (DMS) Plans are now included in Section 11. Other Plan(s). Plans for Genomic Data

Sharing should be provided as part of the Data Management and Sharing Plan.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Sharing Model Organisms: Regardless of the amount requested, all applications where the

development of model organisms is anticipated are expected to include a description of a specific

plan for sharing and distributing unique model organisms or state why such sharing is restricted or

not possible. For more information, see the NIH Grants Policy Statement, Section 8.2.3.2: Sharing

Model Organisms.

Research Tools: NIH considers the sharing of unique research resources developed through NIH-

sponsored research an important means to enhance the value and further the advancement of the

research. When resources have been developed with NIH funds, and the associated research

findings published or provided to NIH, it is important that they be made readily available for

research purposes to qualified individuals within the scientific community. For more information,

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see the Research Tools Policy on the NIH Scientific Data Sharing Website and the NIH Grants

Policy Statement, Section 8.2.3: Sharing Research Resources.

For more information:

NIH considers the sharing of unique research resources developed through NIH-sponsored

research an important means to enhance the value and further the advancement of the research.

When resources have been developed with NIH funds, and the associated research findings

published or provided to NIH, it is important that they be made readily available for research

purposes to qualified individuals within the scientific community. See the NIH Grants Policy