PKG00258997-instructions.pdf

FORMS VERSION E SERIES

Released: September 25, 2017 Revised: December 7, 2018

GENERAL INSTRUCTIONS FOR NIH AND

OTHER PHS AGENCIES

SF424 (R&R) Application Packages

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

General Instructions for NIH and Other PHS Agencies - Forms Version E Series

TABLE OF CONTENTS

TABLE OF CONTENTS

TABLE OF CONTENTS 2

G.100 - How to Use the Application Instructions 3

G.110 - Application Process 6

G.120 - Significant Changes 10

G.130 - Program Overview 17

G.200 - SF 424 (R&R) Form 29

G.210 - PHS 398 Cover Page Supplement Form 50

G.220 - R&R Other Project Information Form 56

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

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

G.300 - R&R Budget Form 93

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

G.320 - PHS 398 Modular Budget Form 118

G.330 - PHS 398 Training Budget Form 123

G.340 - PHS 398 Training Subaward Budget Attachment(s) Form 129

G.350 - PHS Additional Indirect Costs Form 132

G.360 - SF 424C Budget Information – Construction Programs 135

G.400 - PHS 398 Research Plan Form 140

G.410 - PHS 398 Career Development Award Supplemental Form 161

G.420 - PHS 398 Research Training Program Plan Form 185

G.430 - PHS Fellowship Supplemental Form 202

G.440 - SBIR/STTR Information Form 225

G.500 - PHS Human Subjects and Clinical Trials Information 233

G.600 - PHS Assignment Request Form 277

Form Screenshots i

G.- 2

G.100 - How to Use the Application Instructions

G.100 - How to Use the Application Instructions

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

View the How to Apply Video Tutorials.

Quick Links Step 1. Become familiar with the application process

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

Step 3. Choose an application instruction format

Step 4. Complete the appropriate forms

Step 5. Stay informed of policy changes and updates

Step 6. Understand what data NIH makes public

Helpful Links

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

Step 1. Become familiar with the application process.

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

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

G.- 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/nih-guide-to-grants-and-contracts.cfm?Activity_Code=&Expdate_On_After=&OrderOn=RelDate&OrderDirection=DESC&OpeningDate_On_After=&maxreldate=&Parent_FOA=All&NoticesToo=0&PrimaryICActive=Any&RelDate_On_After=&Status=1&SearchTerms=&PAsToo=1&RFAsToo=1&TitleText=&AppPackage=Any&Activity_Code_Groups=&Include_Sponsoring=1&SearchTermOperator=Logical_OR http://grants.nih.gov/grants/frequent_questions.htm

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

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

Remember that the FOA instructions always supersede these application instructions.

Step 3. Choose an application instruction format.

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

Comprehensive Instructions Program-Specific Instructions

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

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

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

Step 4. Complete the appropriate forms.

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

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

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

Step 5. Stay informed of policy changes and updates.

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

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

Step 6. Understand what data NIH makes public.

Information submitted as part of the application will be used by reviewers to evaluate the scientific merit of the application and by NIH staff to make the grant award and monitor the grant after award. The exception to this is the G.600 - PHS Assignment Request Form, which is only seen by staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR).

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

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

In addition, key elements related to ongoing funded projects will be made available to the public, including those listed in the data dictionary at ExPORTER. Additional elements may be made available after announcements through the NIH Guide for Grants and Contracts, a weekly electronic publication that is available on NIH’s Funding page, or additions to the NIH Grants Policy Statement, as needed.

G.- 5 http://grants.nih.gov/grants/policy/notices.htm https://projectreporter.nih.gov/reporter.cfm https://exporter.nih.gov/about.aspx https://grants.nih.gov/funding/index.htm https://grants.nih.gov/policy/nihgps/index.htm

G.110 - Application Process

G.110 - Application Process

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

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

Quick Links Prepare to Apply and Register

Write Application

Submit

Related Resources

Prepare to Apply and Register

Systems and Roles

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

ASSIST.

Register

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

Understand Funding Opportunities

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

Types of Applications

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

Submission Options

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

G.- 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://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons 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 http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/find-and-understand-foas.htm 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/choose-a-submission-option.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, 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, 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.

G.- 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 http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/table-of-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 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.

G.- 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 http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/standard-due-dates.htm http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/application-submission-policies.htm http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/guidelines-for-applicants-experiencing-system-issues.htm http://grants.nih.gov/grants/receipt_referral.htm http://grants.nih.gov/grants/peer_review_process.htm http://grants.nih.gov/grants/pre-award-process.htm http://grants.nih.gov/grants/post-award-monitoring-and-reporting.htm

Resources

News - Items of Interest

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

Annotated Form Sets

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

Contacting NIH Staff

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

Contacting Staff at Other PHS Agencies

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

Systems

ASSIST

eRA Commons

Grants.gov

Information Collection

Authorization

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

Paperwork Burden

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

Collection of Personal Demographic Data

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

G.- 9 https://grants.nih.gov/grants/how-to-apply-application-guide/resources/news-items-of-interest.htm https://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm http://grants.nih.gov/grants/how-to-apply-application-guide/resources/contacting-nih-staff.htm 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://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons 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

G.120 - Significant Changes

G.120 - Significant Changes

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

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

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

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

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

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

Revision Notes - December 7, 2018

PHS Human Subjects and Clinical Trials Information l Clarified instructions on who must complete certain attachments in Section 2 - Study Population Characteristics. The affected fields are 2.5 Recruitment and Retention Plan, 2.6 Recruitment Status,

2.7 Study Timeline, and 2.8 Enrollment of First Subject.

Revision Notes - November 26, 2018

How to Use the Application Instructions l Added “Step 6. Understand what data NIH makes public.”

R&R Other Project Information Form l Proof of registration with the SBA Company Registry is no longer required for SBIR/STTR applicants.

l Instructions for submitting an institutional letter (formerly known as a certification letter) for predoctoral fellowships (F31) to promote diversity have been moved to the funding opportunity announcement.

l Modified text regarding exemption numbers 7 and 8 in question “1.a. If YES to Human Subjects.”

SF 424C Budget Information – Construction Programs form l The G.360 SF 424C Budget Information – Construction Programs form instructions have been added to the General Instructions for NIH and Other PHS Agencies.

G.- 10

PHS 398 Research Plan Form l Added instructions under the “Research Strategy” section for applications due on or after January 25, 2019:

o Under “Significance,” the term “rigor of the prior research” has replaced the term “scientific premise.”

o Under “Approach,” instructions to describe plans to address weaknesses in the rigor of the prior research have been added.

o See the NIH Guide Notice on NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications for more information.

PHS 398 Career Development Award Supplemental Form l Added instructions under the “Research Strategy” section for applications due on or after January 25, 2019:

o Under “Significance,” the term “rigor of the prior research” has replaced the term “scientific premise.”

o Under “Approach,” instructions to describe plans to address weaknesses in the rigor of the prior research have been added.

o See the NIH Guide Notice on NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Career Development Award Applications for more information.

l For applicants proposing to gain clinical trial research experience, instructions for the “Plans and Statements of Mentor and Co-Mentor(s)” section have been updated to include guidance on how the mentor should document leadership of the clinical trial and describe the respective roles and responsibilities of the mentor and the applicant.

PHS 398 Research Training Program Plan Form l Added language in the “Proposed Training” section of the “Program Plan” to provide guidance to applicants who choose to provide a description of opportunities for trainees to be involved in human subjects research.

l Added instructions under the ”Letters of Support” section for applications due on or after January 25, 2019 about including a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.

o See the NIH Guide Notice on Harassment and Discrimination Protections in NIH Training Applications.

PHS Fellowship Supplemental Form l Updated and clarified instructions under the “Applicant’s Background and Goals for Fellowship Training” section to provide a timeline of the proposed research training, professional development, and other activities planned during the fellowship.

G.- 11 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-228.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-228.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-229.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-229.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-029.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-029.html l For applicants proposing to gain clinical trial research experience, instructions for the “Sponsor and Co-Sponsor Statements” section have been updated to include guidance on how the sponsor should document leadership of the clinical trial and describe the respective roles and responsibilities of the sponsor and the applicant.

PHS Human Subjects and Clinical Trials Information l Clarified and updated instructions throughout these instructions. Significant changes include:

o Clarified instructions for K12 and D43 applicants.

o Added instructions for R25 applicants proposing to provide clinical trial research experience and R36 applicants proposing to gain clinical trial research experience.

o Clarified instructions for Career Development Award and Fellowship applicants who are proposing to gain clinical trial research experience.

o Added instructions about grouping Study Records.

o Clarified instructions for delayed onset studies.

o Removed language that indicated exemption numbers 7 and 8 should not be selected and are not being used.

o Clarified or changed character limits for certain fields.

o Includes the updated inclusion policy that goes into effect for applications due on or after

January 25, 2019. See the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects for more information.

Revision Notes - December 29, 2017 l Clarifications made to instructions in G.600 PHS Assignment Request Form.

Release Notes - September 25, 2017

How to Apply - Application Guide and Format Page Changes l Created a new Rules for Text Fields page that is accessible through the Write Application box.

l Minor clarifications to the instructions for the institutional training grant data tables, including:

o Table 8 – removed language to exclude officially approved leaves of absence from the average time to degree in Part IV. Program Statistics.

G.- 12 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-116.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-116.html 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/write-application.htm

SF424 Research and Related (R&R) Form Changes

FORMS-E application packages incorporate the latest versions of the federal-wide forms managed by Grants.gov (OMB Number: 4040-0001, Expiration Date: 10/31/2019).

R&R Budget and associated R&R Subaward Budget Attachment(s) Form l Added new “Total Costs and Fee” calculation to budget periods and cumulative budget l Added instructions under the “Other Direct Costs” section about requesting direct costs related to the use of single Institutional Review Board (sIRB) for multi-site human subjects research in item “8-10 Other.”

R&R Other Project Information Form l Added exemption numbers 7 and 8 to question 1.a; however, these exemptions will not be used at this time.

SBIR/STTR Information Form l Added "Agency to which you are applying" question with options for DOE, HHS, USDA and Other l Added "SBC Control ID" field for the 9-digit code obtained from the Small Business Administration l Added "Direct Phase II," "Phase IIA," "Phase IIB," and "Commercialization Readiness Program" as

Application Type Options l Added "Phase I Letter of Intent Number" field l Added "Agency Topic/Subtopic" field l Added two additional questions regarding eligibility:

o "1c. Is your small business majority owned by venture capital operating companies, hedge funds, or private equity firms?"

o "1d. Is your small business a Faculty or Student-Owned entity?"

l Added "DUNS Number of non-profit research partner for STTR" field l Minor text changes

Forms-E Changes

R&R Senior/Key Person Profile (Expanded) Form l Updated biosketch instructions so that scholastic performance requires only scientific/professional graduate courses to be listed

PHS 398 Career Development Award Supplemental Form l Updated OMB Expiration Date to 03/31/2020 l Removed Human Subjects Section, including the following attachments:

G.- 13 o Protection of Human Subjects o Data Safety Monitoring Plan o Inclusion of Women and Minorities o Inclusion of Children l Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form l Included instruction to describe research methods for trials that randomize groups or deliver interventions to groups l Renumbered form fields l Made minor text edits l Includes the updated appendix policy that goes into effect for applications due on or after January

25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS 398 Cover Page Supplement Form l Updated OMB Expiration Date to 03/31/2020 l Removed Human Subjects Section, including:

o "Clinical Trial" question o "Agency Defined Phase III Clinical Trial" question l Renumbered form fields l Made minor text edits

PHS 398 Modular Budget Form l Updated OMB Expiration Date to 03/31/2020

PHS 398 Research Plan Form l Updated OMB Expiration Date to 03/31/2020 l Removed Human Subjects Section, including the following attachments:

o Protection of Human Subjects o Data Safety Monitoring Plan o Inclusion of Women and Minorities o Inclusion of Children l Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form l Included instruction to describe research methods for trials that randomize groups or deliver interventions to groups l Renumbered form fields

G.- 14 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html l Made minor text edits l Includes the updated appendix policy that goes into effect for applications due on or after January

25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS 398 Research Training Program Plan Form l Updated OMB Expiration Date to 03/31/2020 l Removed the following attachments from the Other Training Program Section:

o Human Subjects o Data Safety Monitoring Plan l Renumbered form fields l Made minor text edits l Includes the updated appendix policy that goes into effect for applications due on or after January

25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS 398 Training Budget Form l Updated OMB Expiration Date to 03/31/2020

PHS 398 Training Subaward Budget Attachment(s) Form l Updated OMB Expiration Date to 03/31/2020

PHS Assignment Request Form l Updated OMB Expiration Date to 03/31/2020 l Clarifications made to instructions

PHS Fellowship Supplemental Form l Updated OMB Expiration Date to 03/31/2020 l Removed Human Subjects sub-section from Other Research Training Plan Section, including:

o "Human Subjects Involvement Indefinite" question o "Clinical Trial" question o "Agency Defined Phase III Clinical Trial" question o Protection of Human Subjects attachment o Data Safety Monitoring Plan attachment o Inclusion of Women and Minorities attachment o Inclusion of Children attachment l Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form

G.- 15 l Included instruction to describe research methods for trials that randomize groups or deliver interventions to groups l Removed "Vertebrate Animals Use Indefinite" question from the Vertebrate Animals sub-section of the Other Research Training Plan Section l Renumbered form fields l Made minor text edits l Includes the updated appendix policy that goes into effect for applications due on or after January

25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS Human Subjects and Clinical Trials Information l Introduced new form for consolidated human subjects, inclusion enrollment report, and clinical trial information l Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See the NIH Guide Notice on Notice of Extension of Effective Date for more information.

l Added exemption numbers 7 and 8 to question 1.3; however, these exemptions will not be used at this time

PHS Inclusion Enrollment Report l Discontinued use (data collection moved to new PHS Human Subjects and Clinical Trials Information form)

Supplemental Instructions l Discontinued use of Supplemental Instructions for all competing applications and progress reports l All information has been folded into the Application Form Instructions and/or is contained in the appropriate policy website (e.g., NIH Grants Policy Statement)

G.- 16 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html

G.130 - Program Overview

G.130 - Program Overview

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

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

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

Individual Fellowship Applications ("F" Series).

Multi-project Applications ("M" Series).

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

Research and Other ("R" Series)

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

conferences and scientific meetings; small research projects; institutional training and director program projects; resource programs; and new, exploratory, and developmental research projects. Awards may be in the form of grants or cooperative agreements.

Additional Instructions for Research:

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

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code for which support is being requested. These include many “R” activity codes, as well as some “DP,” “G," “S,” and “U” activity codes. A comprehensive list of all activity codes, with their descriptions, is available on NIH’s Activity Codes Search Results website.

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

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

The following chart provides a summary of the existing research programs; however, the chart is not a comprehensive list of activity codes. Since this information is subject to change, prospective

G.- 17 https://grants.nih.gov/grants/funding/ac_search_results.htm applicants are encouraged to review NIH’s Types of Grant Programs for the most current program information.

Summary of Research Award Programs*

Activity Code Program Description

R01 Research Project

R03 NIH Small Grant Program

R13 Conference

R15 NIH Academic Research Enhancement Award (AREA)

R21 NIH Exploratory/Developmental Research Grant Award

R25 Education Projects

U01 Research Project – Cooperative Agreements

U13 Conference - Cooperative Agreements

G07 Resources Improvement Grant

S10 Biomedical Research Support Shared Instrumentation Grants

DP1 NIH Director's Pioneer Award (NDPA)

*This is not a comprehensive list of activity codes.

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

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

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

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

Additional Instructions for Career Development:

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

G.- 18 https://grants.nih.gov/grants/funding/funding_program.htm http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm

Before Applying:

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

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

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

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

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

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

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

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

Summary of Research Career Development Award Programs

Program Description Mentor Reference Letter

K01 Mentored Research Scientist Career Development Award Yes Yes

K02 Independent Research Scientist Development Award No No

K05 Senior Research Scientist Award No No

K07 Academic Career Development Award * *

K08 Mentored Clinical Scientist Research Career Development Award Yes Yes

K18 Research Career Enhancement Award for Established Investigators Yes Yes

K22 Career Transition Award * Yes

G.- 19 https://researchtraining.nih.gov/programs/career-development http://grants.nih.gov/training/careerdevelopmentawards.htm http://grants.nih.gov/grants/guide/index.html http://grants.nih.gov/training/careerdevelopmentawards.htm

Program Description Mentor Reference Letter

K23 Mentored Patient-Oriented Research Career Development Award Yes Yes

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

K25 Mentored Quantitative Research Career Development Award Yes Yes

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

K43 Emerging Global Leader Award Yes Yes

K76 Emerging Leaders Career Development Award Yes Yes

K99/R00 Pathways to Independence Award Yes Yes

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

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

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

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

Additional Instructions for Training:

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

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

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

Payback Service Requirement: For NRSA programs that include postdoctoral trainees, the program director must explain the terms of the payback service requirement to all prospective

G.- 20 postdoctoral training candidates. A complete description of the service payback obligation is available in the NIH Grants Policy Statement, Section 11.4.3: Payback.

Before Applying:

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

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

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

l Announcements for various training programs are issued periodically in the NIH

Guide for Grants and Contracts, a weekly electronic publication, that is available on NIH’s Funding page.

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

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

Summary of Institutional Training Programs

Activity Code Program Description NRSA?

D43 International Research Training Grants No

D71 International Research Training Planning Grant No

K12 Clinical Scientist Institutional Career Development Program Award No

T32 Institutional National Research Service Award (NRSA) Yes

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

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

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

T90 Interdisciplinary Research Training Award Yes

U2R International Research Training Cooperative Agreement No

G.- 21 https://grants.nih.gov/grants/policy/nihgps/HTML5/section_11/11.4.3_payback.htm https://researchtraining.nih.gov/programs/training-grants https://researchtraining.nih.gov/programs/training-grants http://grants.nih.gov/grants/guide/index.html http://grants.nih.gov/training/T_Table.htm

Individual Fellowship Applications (“F” Series)

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

Additional Instructions for Fellowship:

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

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

Non-NRSA Programs: Fogarty International Center (FIC) and National Library of Medicine (NLM) also have unique funding authorities for fellowships that are not under the NRSA authority. Note that non-NRSA programs may have eligibility requirements, due dates, award provisions, and review criteria that differ from those of NRSA programs. Applicants should refer to their FOA.

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

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

Before Applying:

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

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

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

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

G.- 22 http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm https://grants.nih.gov/grants/policy/nihgps/HTML5/section_11/11.4.2_implementation.htm https://researchtraining.nih.gov/programs/fellowships http://www.ahrq.gov/funding/training-grants/index.html http://www.ahrq.gov/funding/training-grants/index.html https://researchtraining.nih.gov/programs/fellowships http://www.ahrq.gov/funding/training-grants/index.html http://www.ahrq.gov/funding/training-grants/index.html

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

l A list of contacts specifically for extramural training at the NIH ICs can be found on the NIH Training Advisory Committee Roster.

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

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

Summary of Individual Fellowship Award Programs

Activity Code Program Description NRSA?

F05 International Research Fellowships No

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

F31 Predoctoral Individual National Research Service Award Yes

F32 Postdoctoral Individual National Research Service Award Yes

F33 National Research Service Awards for Senior Fellows Yes

F37 Medical Informatics Fellowships No

F38 Applied Medical Informatics Fellowships No

F99/K00 Individual Predoctoral to Postdoctoral Fellow Transition Award No

Multi-project Applications ("M" Series)

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

A component is a distinct, reviewable part of a multi-project application for which there is a business need to gather detailed information as defined in a particular funding opportunity announcement (FOA).