PKG00291111.pdf

FORMS VERSION I SERIES

Released: March, 2025

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 I Series

TABLE OF CONTENTS

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 9

M.130 - Program Overview 12

M.200 - SF 424 (R&R) Form 17

M.210 - PHS 398 Cover Page Supplement Form 32

M.220 - R&R Other Project Information Form 37

M.230 - Project/Performance Site Location(s) Form 48

M.240 - R&R Senior/Key Person Profile (Expanded) Form 52

M.300 - R&R Budget Form 62

M.310 - R&R Subaward Budget Attachment(s) Form 78

M.330 - PHS 398 Training Budget Form 81

M.340 - PHS 398 Training Subaward Budget Attachment(s) Form 87

M.350 - PHS Additional Indirect Costs Form 90

M.400 - PHS 398 Research Plan Form 93

M.410 - PHS 398 Career Development Award Supplemental Form 110

M.420 - PHS 398 Research Training Program Plan Form 135

M.500 - PHS Human Subjects and Clinical Trials Information 153

M.600 - PHS Assignment Request Form 189

Form Screenshots i

M - 2

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.

View the How to Apply Video Tutorials.

Quick Links Step 1. Become familiar with the application process

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

Step 3. Choose an application instruction format

Step 4. Complete the appropriate forms

Step 5. Stay informed of policy changes and updates

Step 6. Understand what data NIH makes public

Helpful Links

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

Step 1. Become familiar with the application process.

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

Use the 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.

M - 3 https://grants.nih.gov/grants/how-to-apply-application-guide/video/index.htm http://grants.nih.gov/grants/glossary.htm http://grants.nih.gov/policy/nihgps/index.htm https://grants.nih.gov/funding/searchguide/index.html#/ https://grants.nih.gov/faqs

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

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

Remember that the NOFO instructions always supersede these application instructions.

Step 3. Choose an application instruction format.

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

Comprehensive Instructions Program-Specific Instructions

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

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

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

Step 4. Complete the appropriate forms.

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

Program-specific instructions are presented in gray call-out boxes that are color coded throughout the application instructions. Consult the 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.

M - 4 http://grants.nih.gov/grants/how-to-apply-application-guide/selecting-application-instructions.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/general/g.100-how-to-use-the-application-instructions.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/general-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/career-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/training-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/fellowship-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/multi-project-forms-i.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/sbir-sttr-forms-i.pdf

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). There are also specific application attachment exceptions. The 21. Cover Letter Attachment on the SF 424 R&R Form is only seen by staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR). The Other Plan(s) attachment containing the Data Management and Sharing (DMS) Plan is only seen by NIH staff and will not be used by reviewers to evaluate the scientific merit of the application unless data sharing is integral to the project design and specified in the NOFO.

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

l Name of Program Director/Principal Investigator (PD/PI), to also include Project Leaders on sub-projects to multi-project projects l PD/PI title l PD/PI email address l Organizational name l Organizational address l Project summary/abstract l Public health relevance statement

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

M - 5 https://grants.nih.gov/policy-and-compliance/notice-of-policy-changes https://projectreporter.nih.gov/reporter.cfm https://report.nih.gov/exporter-data-dictionary https://grants.nih.gov/funding/searchguide/index.html https://grants.nih.gov/policy/nihgps/index.htm

M.110 - Application Process

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.

Register

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

Understand Funding Opportunities

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

Types of Applications

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

Submission Options

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

M - 6 http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/systems-and-roles.htm http://www.grants.gov/ https://www.era.nih.gov/ https://public.era.nih.gov/assist/public/login.era?TYPE=33554433&REALMOID=06-58b5535a-f2c3-40ec-b9ff-a06a3ed4ee18&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-HTTPS%3a%2f%2fpublic%2eera%2enih%2egov%2fassist%2f http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/registration.htm http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/registration.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/understand-funding-opportunities.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/type-of-applications.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/submission-options.htm

Obtain Software

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

Write Application

Write Your Application

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

Develop Your Budget

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

Format Attachments

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

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

Rules for Text Fields

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

Page Limits

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

Data Tables

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

Reference Letters

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

Biosketches

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

Submit

Submit, Track and View

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

M - 7 http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/obtain-software.htm http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-your-application.htm http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget.htm http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/rules-for-text-fields.htm https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm http://grants.nih.gov/grants/forms/datatables.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm http://grants.nih.gov/grants/forms/biosketch.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/submit-track-view.htm

How We Check for Completeness

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

Changed/Corrected Applications

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

Related Resources

Due Dates and Policies

Due Dates

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

Submission Policies

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

Dealing with System Issues

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

After Submission

Receipt and Referral

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

Peer Review

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

Pre-award Process

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

Post award Monitoring and Reporting

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

M - 8 http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/check-your-application.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/changed-corrected-application.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/submission-policies.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm https://grants.nih.gov/grants-process/review/receipt-referral https://grants.nih.gov/grants/peer-review.htm http://grants.nih.gov/grants/pre-award-process.htm http://grants.nih.gov/grants/post-award-monitoring-and-reporting.htm

M.120 - Significant Changes

Resources

Annotated Form Sets

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

Contacting NIH Staff

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

Contacting Staff at Other PHS Agencies

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

Systems

ASSIST

eRA Commons

Grants.gov

Information Collection

Authorization

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

Paperwork Burden

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

Collection of Personal Demographic Data

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

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.

M - 9 https://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm https://grants.nih.gov/help/ic-staff-roles https://grants.nih.gov/grants/how-to-apply-application-guide/resources/contacting-staff-at-other-public-health-service-agencies.htm https://public.era.nih.gov/assist/public/login.era?TYPE=33554433&REALMOID=06-58b5535a-f2c3-40ec-b9ff-a06a3ed4ee18&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-HTTPS%3a%2f%2fpublic%2eera%2enih%2egov%2fassist%2f https://www.era.nih.gov/ http://www.grants.gov/ http://grants.nih.gov/grants/authorization.htm http://grants.nih.gov/grants/paperwork-burden.htm http://grants.nih.gov/grants/collection-of-personal-demographic-data.htm

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

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

Release Notes - March, 2025 l FORMS-I application packages incorporate the latest active versions of the PHS forms managed by NIH (OMB Number: 0925-0001 and 0925-0770, Expiration Date: 01/31/2027).

l Updated instructions for the PHS 398 Research Training Program Plan Form to remove attachment no longer required.

l Updated instructions for the PHS 398 Career Development Supplemental Form and the PHS Fellowship Supplemental Form to indicate the Description of Candidate’s Contribution to Program Goals attachment is no longer required for NIH applications.

l General text and instruction updates throughout.

Release Notes - November, 2024

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

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

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

Forms-I Changes

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

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

M - 10

PHS 398 Research Training Plan Form l Updated instructions for the “Program Overview” section of the 7. Progress Report (for Renewal Applications) and added instructions for Renewal Applications to the 5. Plan for Instruction in Methods for Enhancing Reproducibility.

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

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

Relabeled items within section and updated instructions as follows:

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

Relabeled items within section and updated instructions as follows:

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

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

l Renumbered form fields

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

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

Form Screenshots l Updated form screenshots.

M - 11

M.130 - Program Overview

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 Notice of Funding Opportunity (NOFO). Components typically include general information (component organization, project period, project title, etc.), information about performance sites, information about proposed work to be accomplished, and a budget.

Additional Instructions for Multi-project:

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

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

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

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

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

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

M - 12

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

Before Applying:

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

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

l The NOFO will specify the types of Other Components that should be used when preparing the application, whether each component is optional or required, and any restrictions on the number of times each component can be included in an application.

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

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

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

A. Collaborating Organization as the Lead of a Component:

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

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

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

B. Collaborating Organization as a Consortium in a Component:

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

M - 13 http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf https://grants.nih.gov/grants/funding/ac_search_results.htm

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

M - 14 http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf

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 - 15 https://grants.nih.gov/grants/forms/required-disclosures-foreign-affiliations-or-relationships-foreign-countries https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm https://www.sbir.gov/foreign_disclosures https://www.sbir.gov/foreign_disclosures

• 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.

M - 16

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

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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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 Notice of Funding Opportunity (NOFO).

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.

M - 18 http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/type-of-application-submission.htm https://grants.nih.gov/grants/glossary.htm#ResubmissionApplication

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 NOFO 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 Organizational 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 for descriptions 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 NOFOs.

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 NOFO.

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

M - 23 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-088.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-088.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-088.html http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/type-of-application-submission.htm http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/type-of-application-submission.htm https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3.7_policies_affecting_applications.htm#Submissi https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3.7_policies_affecting_applications.htm#Submissi http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/application-submission-policies.htm http://grants.nih.gov/grants/competing-revisions.htm http://grants.nih.gov/grants/competing-revisions.htm http://grants.nih.gov/grants/administrative-supplements.htm http://grants.nih.gov/grants/administrative-supplements.htm 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.

Note: CFDA is equivalent to the Assistance Listing Number (ALN). The application forms and instructions will be updated in the future to align with this updated terminology.

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.

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Start Date:

This field is required. Enter the proposed start date of the project. The start date is an estimate, and is typically at least nine months after application submission. The project period should not exceed what is allowed in the NOFO.

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…